Good day and welcome to the Trinity Biotech Second Quarter Fiscal Year 2015 Financial Results Conference Call. All participants will be in a 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 with Lytham Partners. Please go ahead.

Thank you, Alison, and thank all of you for joining us to review the financial results of Trinity Biotech for the second quarter of fiscal year 2015, which ended June 30, 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 a question-and-answer session. 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 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, the Chief Financial Officer for a review of the results. After Kevin's remarks, we will hear from Dr. Jim Walsh on product development issues, and Ronan O'Caoimh will ramp up the prepared remarks which his perspectives on the quarter. Kevin?

Thanks so much, Joe. Today I will take you through the results for quarter two 2015. Beginning with our revenues, total revenues for the quarter were $24.3 million as compared to $26 million in quarter two of 2014. However, also is the case in quarter one this year, revenue this quarter particularly impacted by currency movements. This has to do with the strengthening of the dollar against a range of currencies which is the effect of reduce in the dollar equivalent of our Euro, Sterling and Brazilian Real revenues. We have restated the quarter two revenues on a constant currency basis which shows the revenues for the quarter would have been $25.4 million if the quarter two 2014 exchange rates were used. As well as reducing revenues, the same currency movements had a similar impact on foreign currency denominated expenses, in fact reduction. So FX will also be relevant we're considering both, gross profit and SG&A movement this quarter. In summary, whilst revenues are lower, so to our costs and these factors broadly offset and hence there is no impact on profitability which is what we mean when we say that the company is naturally hedged from a currency perspective. This brings us to this quarter's gross margin. As you can see from our press release, we are into gross margin of 47%, this represents reduction on the 48% that was reported in Q2 last year. Part of this reduction is attributable to the currency issues I've just mentioned. However, results are being impacted by lower sales of HIV and Lyme products, both of which are in higher than average margins for the company. Moving on to our indirect expenses our R&D expenses have increased slightly from $1.2 million to $1.3 million, meanwhile our SG&A expenses have increased from $6.4…

Thank you, Kevin. I'll take the opportunity to give you an update on progress on our cardiac market development programs. In particular, I will provide you with a detailed update on our Troponin clinical trials, which I'm delighted to say, is progressing very nicely with patient enrollment now complete. I will also update you on our Meritas BNP products, which as you know, obtained European CE market approval last year, on which we immediately plan to commence clinical trials to support an FDA application. So starting with Troponin, you will remember in February last, the company announced that it has shipped products to the US for clinical trials. Again, just to remind you, there are Tremaine [ph] sections to this trial and I filled each of the sections now individually. Firstly, and by far the most challenging is the ACS trial or the heart attack trial as we call it in the emergency room. Since February, the ACS trial has been running at 12 trial sites across the United States recruiting about 70 patients per week, also which holds almost 1,500 patients. Each of those patients with samples four times namely on arrival otherwise known as time zero, three hours, six hours, and 12 to 24 hours. At each time point, the Troponin level in the patient's whole blood in trials was mentioned. The end of this trial was to recruit efficient number of suspected MI patients to produce a cohort of at least 150 actual heart attacks. I'm happy to report that as of last week we have passed the 150 MI milestone and therefore, this section of the trial is now complete. This completed patient cohort that is for positive/negative MI patients is currently being adjudicated by a panel of three independent cardiologists. It is the role of…

Thanks, Jim. I'm going to review our revenues for the quarter before opening the call to a question-and-answer session. Our revenues for the quarter were $24.3 million, compared to $26 million in quarter two of 2014. However, when the impact of foreign currency exchange movements due to the strengthen of the U.S. Dollar, again the range of currency is removed, revenues would have been $25.4 million this quarter thus representing a decrease of 2%. Point of care revenues for the quarter were $3.4 million, which represents a decrease of $1.2 million on a constant currency basis which is a decrease of 25%. This decrease is entirely attributable to lower HIV sales during the quarter. This reflects the irregular ordering pattern which characterize this market rather than any underlying adverse change in the nature of the business. As you know, our HIV in Africa is funded almost entirely by NGOs, and some of these agencies tend to be haphazard and are unpredictable in the context of a 13-week reporting cycle. Our HIV Unigold product continues to be regarded as the gold standard and continues to be utilized as the confirmatory HIV test of choice across, virtually the entire continent as it has done for the past decade. In addition, funding continues to increase as more and more Africans are put on to anti-retroviral drugs with number now exceeding 20 million. So despite this very disappointing quarter, we are confident of our African HIV business continuing to grow. In the US, our HIV sales increased 5% over the prior quarter with hospital sales performing strongly aided by the fact that we are now selling HIV-1, HIV-2 combination products since we got the HIV-2 FDA approval last year. In December as you know, we were delighted to receive a CLIA waiver for our…

We will now begin the question-and-answer session. [Operator Instructions] And our first question comes from Drew Jones from Stevens [ph]. Please, go ahead.

Thanks, good morning guys.

Good morning. How are you?

Good. When exactly will you guys be unblinded from full ACS results or is that something that happens after the URL part of the trial is completed?

Essentially it will take probably another 30 days or maybe 40 days for that complete adjudication set, for adjudication to be complete. At that stage what will happen is, okay, at that stage we thought adjudicated results, there will be determined on the 150 MI patients. The full 1,500 patients will be adjudicated as either positive or negative for MI, so that will take about another 30 to 40 days I guess. What happens then is you take - so the adjudicators are blinded to the Meritas results and are blinded to the adjudicated results. What happens then is, you take - the result on the Meritas system which will again determine whether a patient is positive or negative based on the level of Troponin is persistent versus that 99 percentile number. We will judge which adult patients were either positive or negative, they will then be compared to the adjudicated results and you will look for equivalents if you like. In an ideal world, it would line up perfectly match, everything that the adjudicators has got will be positive on our test, everything the adjudicators got negative would be negative on our test but of course that won't happen. But that's the process as it goes, so it will be another 30 to 40 days before complete adjudication set of results so we can actually compare our data against the adjudicated data.

Okay. Moving on to Syphilis, and trying to understand that ramp a little bit better. Can you tell us how many customers ordered in 2Q and how many you expect to order in 3Q?

I don't have that information right on my fingertips, and what I could say is that I think we have - we expect - we basically have 400 customers in our system at this moment in time, whether they've actually all - I'm not clear. I don't have those numbers available at this moment.

Okay. And then last one from me, can you walk us through utilization trends for premier boxes?

Yes, the average consumables utilized on the premier instruments are $11,000 per year. That varies greatly from country to country, and it also would vary greatly depending because in some instances we're setting direct as in Brazil and in the United States, and in other countries we're not. So at this step we're taking 50% margin but all in all, our average revenues are $11,000 and our most productive instruments in terms of dollar terms will be in the United States, second most productive will be Brazil, and then I think a portion of the buyer really would be China in terms of usage. That's something I think that will change in time but as we set all along, the medical community in China are tuning into hemoglobin A1C, both the GPs and indeed the diabetics tuning into the usage of hemoglobin A1C and 4X a year testing, it's being reimbursed by the government but awareness is the only - it's a learning curve now. There is huge potential, but at the moment, modest silence.

Thanks guys.

Thank you.

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

Good morning, can you hear me?

Good afternoon, I guess in your case.

Good afternoon, Jim here, loud and clear.

Great. Can you break out what your Lyme disease tests were in the quarter and compared under a year ago?

You mean in terms of dollar numbers?

Yes, or percentage or just give us something.

I mean we're looking at something around basically $2.5 million and sort of $2.5 million last quarter, last year $2.1 million, this year at that kind of level.

Okay. So the big change from year-over-year with them was the HIV test, I guess to Africa?

Yes, I mean our African HIV test were down $1.5 million. As I kind of explained earlier, there is hazard purchasing and it's almost surprising to some extent that we've haven't had these kind of significant variability in the past, we seem to have avoided it but this quarter was particularly weak, it just happened that in the 13-week cycle we didn't receive as many orders as normal. And I don't think it was just a timing, it's just not as if like three orders that came in on the July 1st instead of June 30th, it was just basically haphazard weakness. I'm not sure we recovered over one quarter or over three or four but what I have said in prepared remarks is that, we're confident that our business is in bold and strong hands, and that there is ever increasing spending at dollars being spent fighting HIV in Africa that it's not a hopeless fight anymore because every time you identify HIV positive you can save their lives if you get them onto retroviral treatment at the right time. So it's a battle that can be won, and we're not arbitrages of doing anymore but rather of hope. So in that sense, as more dollars are being spent we absolutely own the confirming, there is nobody else confirms, only Trinity Biotech rights, you can't instance a contrary that we don't do the confirmations in. So this is just random.

So do you think you will see that business rebound at the back half of this year or do you think it could take to 2016?

Frankly, I don't know. It would probably rebound overall, I think if we stand back and look at 2014 sales in comparison to 2015 sales, I think you will see we're probably going to end up being at 5% or 6%, not sure of that but that will be my sense. But I think that - if your graph doesn't look at the trajectory over it and extended period of time, it's all trending in the right direction, this is just a haphazard quarter really, basically NGOs don't confirm within the 13-week cycle, the way we had wished them to.

Right. Or you do think you will see that business rebound at some point in the next three months?

Yes, absolutely. When I don't want to say I think that basically we're in one half down this quarter so we're one half up next quarter, I don't necessarily think that would be the case, maybe but I don't so much think so, but I think if you look at the year as a whole it will be - I think 2015 will have higher sales of HIV in Africa than 2014.

Okay, all right. And now switching to Troponin, it sounds like you're basically on the same schedule, you waited out three months ago, maybe couple of weeks or so but nothing dramatic?

No, we're pleased with - the recruitment went very well for us. I think when I spoke in - whenever in the March call, we had hoped we would recruit about - we hoped for 72 patients per week. We started off slower, we started off with momentum maybe 20 or 40 - in the end we were admitting 100 a week, it came in - I think the recruitment came in back on time or within a week or two. So we're quite pleased with it.

Okay, all right. So then can you just give us a sense of what do you think timing will be for the next 12 months? I know you said you will have the products submitted to the FDA, it sounds like early October. Do you think you can get a response back by March of 2016?

Well, we will definitely get a response back within 90 days, that's the rule. So what type of response it will be, it's a different question. We'll have a response within 90 days, that's just a rule for the FDA to have to respond within 90 days. And by the way, I just have to say, at this stage we have a very good relationship with the FDA. This work is being done in collaboration with the FDA, and we are bending over backwards to make sure that everything is done as exactly as this suggests before the go in. So I think underneath that's important to say that this is a collaboration and it has been quite helpful to us. So when it goes in, it will say October, we would expect a response within 90 days, that response could be, guys it's perfect and you're approved; that I think unlikely just difficult product. That will probably come back sometime during the 90 days with list of questions and those questions could be - tell me more information about patients, numbers 1-2-3-4-5, or it could be - show me that the monitoring of the sites was on property and show me the reports from the monitors. There could be some questions like that, that could even say collect more data on 75-year old patients or whatever. So there is probably going to be some questions, we have about a month to submit that data, then you would expect that if you answer those questions correctly, the next month read will result in an approval.

Okay. So assuming you got approval but say April of 2016, are you in a position where you could begin sales right away? Do you have manufacturing capacity to start production?

Absolutely, we're ready willingly to be able to go at that stage.

Okay. So you think it's reasonable to start recognizing revenue by the - let's say the third quarter of 2016 or by the year from now?

Again, as FDA depends what I think is reasonable, absolutely, it's just six months we should see this thing - we need to look through the FDA.

All right. And then, you know on the acquisition front, you've raised the money, are you actively searching for targets right now, what should we think for that?

Peter, we have been actively seeking to identify attractive acquisition targets and to assist us in the process we've attended services of a number of consultants, people whom we've used before and who knows well. So people who have a proven success record - record of success with us, today we've made initial valuations on numerous potential targets but none of them in regard are really suitable, alternatively regardless overpriced. While obviously we love to be in a position to tell you which stage of - a very advanced stage of making an acquisition, we actually can do that because we're not - like we're very mindful of not making an acquisition in haste. So at this moment in time, basically we have not identified anything that we've moved onto the second stage with - we have a number of people looking for helping us to seek out acquisitions. And in terms of what we're looking for, we're looking for a growing company in a growth sector, reasonably into product lifecycle, we're looking for something that's profitable, cash flow positive from day one; we're looking for something that has synergies with the rest of the Trinity's business. But the search goes on, we don't have anything to talk about unfortunately at this time.

Okay, all right. And then the last question, it's just a book keeping question, can you just repeat what you said the add back was to get to the diluted EPS number?

In terms of dilutive, there is two things you need to do is, all that revolves around - the normal options that will be added in just in the denominator. But in terms of the convertible notes you just assume that it is converted in its entirety on the first day of the quarter, so on a realistic assumption, and what you do is, you take all the 5.2 million of shares and include that into the denominator, then obviously you can double count, so hence anything that was associated with the noted health is interest or those non-cash items I talked about would all be removed. So that table in the press release there which shows an impact of $156,000 is a net impact of those add back.

Okay. So that $156,000 gets added to the net income number?

Yes.

Super. All right, thank you.

Thanks, Jim.

The next question comes from Larry Solow from CJS Securities. Please go ahead.

Thanks, good afternoon. Just a few follow-ups on premier, Ronan, I know you don't like to give exact placements but just it looks like year-to-date you're about flat with last year, maybe slightly down this quarter at least. Is that - do you think you've sort of reached a plateau here around this number? Any thoughts on that would be great.

Sure. I think your comments are accurate, we did 460 last year, we did just over 100 last quarter, and quarter one we did just over 90, now we're just under 200, and just five or six short of 200 now. So I think we'll do 400 or something but it would probably be early 400s. And I don't consider that negative, I don't consider that negative, I think that we basically are seeing a situation where instruments are probably - the instruments are doing more consumed than we had expected they would do. In general terms around the world, particularly in Europe, this consolidation - I think everybody knows that this consolidation, so you've left labs doing more testing. And so within that environment I think we had hoped we might hit 500 and did we may have actually do so but it won't be this year. And we've come from nowhere and taken over 20% of the market share, as you can imagine, our competitors have hit back and are using product pricing and whatever as they are fighting back hard. I mean we've just walked into Brazil and taken such a monster share of the market, it must be golden. In Brazil, it continues to be very strong and I think with 200 or more instruments to share. All the markets are performing strongly, I think any of this is taking a bit longer than we'd hoped, it probably is - kind of Korean, and Malaysian, and the Philippine approval process that we had hoped to turn those countries a bit more quickly but it's just searching on bureaucracy in regulation that it just takes time. So some of those markets - but they are opening up more slowly than we had hoped. So I think we may get to 460, same as last year, but I don't think so, I think it will be kind of early 400, but we still have very, very strong growth trajectory.

And looking at it so just to be concerned, do you think you can always sort of - this 400 number is a sustainable number on placements from an annual basis?

Yes, I do because remember - I mean, firstly, remember that every single one of those 400 instruments or 420 or 430 which is new business for biotech, and in all, it's every case taken away from the competitor because not that many new hospitals being opened and every hospital really has one of these instruments right across the world. So the replacement cycle is lengthening, that's the other factor I should have mentioned, the replacement cycle is lengthening so instruments tend to stay, instruments are probably getting better, more durable, they - and hospitals are more cautious and everyone is financially cautious. So the replacement cycle is close to eight years that makes no difference now. So the positive side of that is, at Trinity Biotech without any installed they can - we will only start replacing our own instruments in six years' time, so after that it's all new business, after that it becomes replacement business. So as a consequence it continues to goes months for growth.

Right. And you mentioned the US has the highest utilization rates but I know that's also one of the areas where you have not had great success in placements, I know you had a market partner, they are still onboard - what do you think is giving you some resistance in the US?

I'm not supposed to democrat the partner but I mean, they really - I couldn't - they did not reason all [ph], they have no relevance to this conversation anymore, they've just - I think they've given up. I think the position we have really in the United States is that, the United States market is different than anywhere or everywhere else in the world with the exception of Germany, and that is that the big immunoassay systems actually are utilized for testing hemoglobin A1C. So that means that the Abbott machine, the Abbott Artek, the Roche instruments, Beckman Coulter instruments, the Johnson & Johnson instruments, those - the Big 5 basically do hemoglobin A1C, they are not utilized around the rest of the world but they are utilized in the United States and Germany. The reason they are not used largely because they give CVs which is like standard deviation errors, about 6% each side; standard deviation but 6% CV whereas ours is a CV of 1.1%. As in fairness to our competitors, it will use HPLC as in also Bio-Rad. So fundamentally, I would argue, we would argue that I think it's not so much a discussion point and absolute fact that chromatography/HPLC gives much greater accuracy than immunoassay systems. But anyway, the bottom line, for better for worse, the United States basically run poor quality immunoassay of hemoglobin A1C testing which doesn't happen around rest of the world. And as a consequence, we only do about 50 instruments a year, so in fact, we've actually been very successful in the much smaller markets in the United States.

And you don't see this trend of this immunoassay back tracking, going internationally, right?

I think the movement is in the direction of going back towards HPLC, the momentum is marginally now moving basically in that direction, it's moving away from immunoassay but the momentum is very modest. So you're not far off in kind of equilibrium position, but you're certainly losing out to immunoassay but getting some gains.

Got it. And you mentioned that the utilization rate - it's still early stages but it's actually running a little bit ahead of the $10,000 - $10,000 was the number you had initially expected. Do you - overtime do you think this number could - which is now $11,000 can grow?

Absolutely it will grow because Meritas volumes are growing significantly. They are growing significantly but the number of instruments are less, I made that point because there has been a lot of consolidation, particularly there are stronger markets which are Spain and Italy. And indeed in France again, you've had a lot of the private labs, and people realize that lot of private hospitals are closing down. And then, of course China is the one that can bring that number way up when it starts gathering momentum. Brazil has performed very strongly, Brazil is way ahead of the curve in terms of - they are very busy instruments.

Okay. Just in terms of quick out there in - it sounds like Sjogrens test, it's slowed a little bit but that sounds like it's just growing pains or the switch into Bausch and Lomb which I think is inevitably will turn out to be a high-class problem. But do you still see this is growing 20% per year in the top line on a long run basis?

I talked well that 20% is a total order but I think we - I'm hoping that it will do, it may fall somewhat short but not significantly short to that. I think Sjogrens - just to deal with Sjogrens specifically, I mean Sjogrens was only launched last year and so it went from zero to 600 in seven months and I'm so far sort of to say at 600,000 quarter one at this year and 600,000 in quarter two. So it lost its momentum, but we seek time that is beginning to pick up again as the Bausch and Lomb sales reps are trained, a lot of them haven't been tuned into a test. So we'll begin to see signs that are improving, I think that was the decent growth driver and we're having good success with some of the mega labs in terms of them taking our products, basically sending it to our reference lab in Buffalo. We've had good success in Europe, and we're having good success basically putting the ELISA range of products - the ultra-immune ELISA products on to our existing installed base. So, I think we're getting very close to 20%, we may not beat it but we get close to it. And I think that's a growth rate we can maintain.

Okay. And I guess that the Lyme is sort of nothing you can really do about sort of a macro factor, but how about just in terms of Fitzgerald, sales of - I think it seems like it's taking another ligand, is there anything causing that or is that just sort of a business that's going to bouncing along in the bottom?

The thing to say about Fitzgerald is it turned over $11 million which gives us EBITDA of about $4 million. It's a very profitable business, it just doesn't give any growth and it contracts marginally, it seems like year-on-year. The difficulty we face really with Fitzgerald is, we're a middle man in Fitzgerald, we basically source monoclonal antibodies and we sell them onto into the trade. The difficulty we face is that we can work very, very hard but basically when a customer is using quite a lot of the products he has a big incentive to basically seek out and find the original supplier. And of course, such a scenario results inevitably in our demise, we just get zeroed out of the equation. And that's basically the weakness in the model really. So basically, you can work very hard to go two steps forward and doing that three months in a row and then suddenly going six steps backward.

Got you. Just a couple of quick questions on the cost side, gross margin is obviously continuing to trend down. I guess this quarter was clearly, probably regularly impacted by the drop in HIV, let's hope that this is the bottom but what's your sort of outlook and perhaps premier - I don't know if that get accretive on the gross margin side but any thoughts on that will be great.

Yes, obviously from our point of view I hope it has hit the bottom, I mean it is down a little bit this quarter and as we've highlighted there it is impacted by the fact that both Lyme and HIV which are very good margin products for us, and that's where our revenue line has suffered. So there is an impact there on the gross margin. The percentage is also a couple of hundred blips in relations to the FX effect as well which really isn't an impact on overall profitability but those manifests after a small extension relation to gross profit line. And premier, as each quarter goes by, deals improve in terms of its contribution, obviously when the instruments were being placed such high volumes would vary few actually, relatively speaking, and the field already - it was having more of a drag and just continue to go, haven't reached the crossover point, whereby it is higher than the groups average. So that will be coming in the forthcoming quarters. The key thing for margin in the future that will be what the revenues are going to be, just given our sort of fixed cost nature - the fixed nature of our cost base, and also the mix of such. Now I think we're going to let somebody else in.

Sounds good, thank you.

Thanks, Larry.

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

Hey guys, thanks for taking the questions.

Hi, Chris.

I wanted to start on Troponin update, you talked about your encouragement with the data you've seen so far. I understand some of that is still blinded but I think you mentioned some hospital data, so perhaps you can elaborate on just what type of data you've seen at this point and what gives you that encouragement you talked about?

What actually happened is, on a daily basis when we're doing our clinical trial, the patient comes in, he comes into ER because he is feeling ill, he is either positive or negative but he will be treated in ER as he would normally be and if he looks like a cardiac patient, she will be more likely a Troponin sample will be taken, at least the central laboratory of the hospital or wherever to send the sample and they will test that sample for Troponin, either we get a result, and that the Troponin result couples with the other clinical symptoms like an EKG and etcetera, etcetera. Then make a determination whether that person is either having an heart attack or is not having an heart attack. So that data is known to us. Separately to that, our sample is taken from that same patient, it's on our device and we of course can see our results. So we can compare our results in general to the hospital outcome. So you can see - it's not adjudicated but you can see what the hospital got and there is no guarantee that this will work fine for very clear cut heart attacks and very clear non-heart attacks. It only becomes so you are going to be very much aligned, adjudication of the hospital is probably going to be very much in line on the very clear samples, it's only under very marginal samples that are very close to them etcetera where the adjudication may differ from the hospital result. So all we can say at the moment is we can track results against the hospital or either central lab system or whatever is running in the hospital. And that data - we track pretty well with that data. I'm really saying is that based on what - we have sight of how we compare with the million dollar machine that takes an hour and a half to run, but what we're saying is we're very closely aligned to their results.

Okay, good. And then what type of announcement or data will you release or what should we expect when that adjudication review is completed and then when you submit to the FDA?

It's a question that we still ponder here but our favorable mind is that we won't announce that result, we won't announce the results of our clinical trials, and the reason for that is, as I said earlier on, we have a very, very good relationship with the FDA right now, there is no rule to say that you can't announce the results, so that's the first thing. We could if we felt we have to, we would, but it may well be seen as this was forcing the FDAs hand that the Trinity Biotech announces excellent results or whatever now submitted to the FDA and it's - I believe it will be a negative against Trinity in terms of our relation with the FDA, if we were to go - as to put out a statement like that because it backs the FDA to a corner and quite frankly, I don't think any of us want to do that. So our good feel is that we should - we will obviously say when the clinical trials are complete, we will tell you whether we have submitted, what I think you can take for granted that we wouldn't submit if we didn't feel our data was good enough to be approved by the FDA. I think what we'll do, we'll do the same as Abbott and Roche etcetera do. We won't basically just put up and highlight basically on the billboard how wonderful our results were because we think that could be counter-productive.

Understood. And then FX impact, I understand it was a headwind on the topline, on the bottom line, was it…

It's pretty close to neutral actually Chris, so we pick up and turn to the cost of sales, and we pick up in terms of SG&A, and that offsets the negative impact on revenues, that's very broad, it's pretty much a natural hedge.

Okay, and just one more for me. Clinical lab, I understand Lyme was down a little bit this quarter but up 3% on a constant currency basis, going forward is that low single digit growth rate, say 3% to 4% on a constant currency basis for clinical lab a sustainable growth rate level to expect? Thanks.

I think more like 5% to 6% I think is probably more to sustainable level, I mean, I obviously don't have crystal ball but that's what I think excluding what's just after happening this quarter I think that's probably over that course, I think that's where it would be averaging.

All right, thank you.

Thanks, Chris.

[Operator Instructions]

Operator, I think we're running over 5' o clock, I think with just two more questions I think we'll leave it at that if you don't mind.

Our next question comes from Pearl [ph] from Craig-Hallum Capital. Please go ahead.

Thanks, good afternoon guys. I will try to be brief here. First question for you, probably for Jim here, on BNP, you talked about the 12 sites recruiting, are these the same 12 that you were utilizing for Troponin? And do you get any benefit because of the familiarity with the instrument or anything like that from using some more sites across the two separate trials?

The answer is adverse. There might be two exceptions but I think virtually the same set of sites. And their optional fees is advance to that because the research nurses are now trained, they understand the platform very well; we're not starting - it's not like the first time we're starting with Troponin where we're starting it from scratch and it just takes ages to get them up and running and you've got muse for the system. So there is directional advantage in that. The PIs know us well, the research nurses know us well. So I think 10 of those 12 sites are actually the same sites as before, and quite frankly, we might have started the BNP trial maybe a month ago but we didn't wanted to distract from the focus that the sites had on Troponin. So now that the ACS and URL trials are over, they are going to kick right straight into the BNP trial.

Perfect, that makes sense. And then just a follow-up I guess on Troponin, I think it's probably been asked a few different ways and so just I guess, maybe one little new ones on it. You obviously had some vagaries with the timing of recruitment for the ACS trial because you're kind of contingent on getting the right people in and getting them to buy into the trial but it sounds to me like the stuff that's left, the precision study is more or less with the 20 day timeline. So I guess as you look out at it, is there really anything that can take a left or right turn on you to impede that kind of late September, early October submission at this point?

The only kind I can think of right now is the adjudication. I would assess 90% of the samples are easy to adjudicate, so - but if you take we have 1,500 samples, a 150 MIs, so that means there is 1,350 negatives. Of those 1,350 negatives, probably one ER [ph] got negatives, you or I can't adjudicate it because it's actually negative. So they can be adjudicated in a matter of minutes I would have said certainly, less than an hour per patient. There can be a few samples where - that can be difficult to adjudicate and the adjudicators may want to ring up the hospital and ask for further data, etcetera, etcetera and/or extra copies of the ECGs or that sort of stuff. So it's the only thing to control, the rest we can do ourselves. The adjudicators are independent, yes we are paying them, but they are there to adjudicate properly. And so I can't see it slipping or I can't see them taking more in a couple of weeks more than I'm saying but that's the only thing that's out of our control, it would be to adjudicate us. And the other thing is, I can't dictate if one of them doesn't go and take two weeks holiday in Hawaii, that's the sort of thing that can - I can't think of anything, not major that's outside our control.

We have a final question from Walter [ph] from Ness Partners. Please go ahead.

I think I'm the only person who wasn't from sale side. And to kill it but to do it quickly on Troponin, you are well aware that [Technical Difficulty].

Walter, you're breaking up there. You've disappeared, Walter.

Okay. You are well aware of the standards the FDA is looking for, for a new point of test for Troponin?

Absolutely, Walter.

You have indicated that your test is - as best you could tell us so far coming in very close to central lab tests?

I think we have proven that Walter in the independent trial by Fred Apple. Our data would be equivalent, indeed better than some central labs if that was done.

And therefore the conclusion in question is, the central lab level that you are - have generally been comparable to on this trail would meet the criteria the FDA has indicated that you need for a new approval - I relish this very simple, for a new point of care Troponin test?

I think you're - that's the reason we are already out there. We are very, very clear, we are absolutely confident that we might meet the FDA guidelines, absolutely we're confident of that. And we feel that we meet it very comfortably, with plenty of - with plenty to spare.

And that would mean, just to again reiterate, it would be substantially more accurate than any of the current point of care test in the marketplace?

Walter, we again - we know that and it's not just independent proven again, if you look at some of the work Fred Apple did when he evaluated our product, it was the best product in the market right now undoubtedly in point of care, it's the Abbott ISO product, the others don't count as far as I'm concerned, the Abbott ISO product is the best product in the market. And in an independent trials done by Fred Apple about a year or 18 months ago, I noted two separate trials but the Trinity Biotech products, he got a sensitivity at time zero, 75% on the ISO products, in a similar trial 6 months prior to that, he got insensitivity of 32%. So that's just independent data, I have a 32% Trinity having 75%. So it's fair to say we're better than that result, and that's independent, not done by us.

Okay. Thank you very much.

Thank you, Walter.

Thank you. I know we ran out a bit longer, so sorry. Thank you to everybody, and we'll talk to you soon. Bye.