Joe Diaz - Lytham Partners LLC Ronan O'Caoimh – Chief Executive Officer Kevin Tansley – Chief Financial Officer Jim Walsh - CSO & Business Development Director.

Bill Bonello – Craig-Hallum Jim Sidoti – Sidoti & Company Larry Solow – CJS Securities Ross Taylor – Somerset Capital Chris Lewis – ROTH Capital Partners Paul Nouri – Noble Equity Funds Randy Saluck – Mortar Rock Capital.

Good morning, and welcome to the Third Quarter 2014 Financial Results Conference Call. All participants will be in listen-only mode. (Operator Instructions) After today's presentation, there will be an opportunity to ask questions. (Operator Instructions) Please note this event is being recorded.

I would now like to turn the conference over to Joe Diaz with Lytham Partners. Please go ahead..

Thank you, Kate, and I thank all of you for joining us today to review the financial results of Trinity Biotech for the third quarter of fiscal year 2014, which ended September 30, 2014.

With us on the call representing the Company are Ronan O'Caoimh, Chief Executive 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 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 Ronan O'Caoimh, Chief Executive Officer of Trinity Biotech.

Ronan?.

Good afternoon everybody. The first thing we are going to do today is that Jim Walsh is going to talk to you about Troponin. Then Kevin will talk about the results for the quarter, I'll review with business developments and then we'll hand the call over to question-and-answer session. So if I could ask Jim to commence the call..

Thank you, Ronan. I take the opportunity to update you on the progress on our cardiac marker development programs. In particular, I will provide you with a detailed update on our Troponin clinical trials and our decision to suspend enrollment of patients in the short term.

I will also update you on our Meritas ENT products, which as you know recently obtained CE Marking approval. And finally I'll provide a very brief update on D-dimer. But firstly and most importantly let me address our Troponin product and our decision to temporarily suspend enrollments into the U.S. clinical trials.

Earlier today we announced that we are temporarily suspending enrollment into our Troponin clinical trials in the U.S.A. The reason for this suspension is that in the past number of days as part of internal product testing we became aware of higher than normal CV's in whole blood testing.

Essentially on testing very low whole blood samples for Troponin, we observed an increased spread in the data from that which we normally see. Immediately on noticing this data a root cause investigation was launched to determine the nature and source of the problem.

And very quickly, we positively identified the cause as formal change to a chemical dye, which we purchased from a third party supplier. The result of this change causes instability and increased variability in the products performance. The offending chemical was first introduced into manufacturing in the week of July 14, 2014.

All batches of product manufactured from that date are therefore suspect and have been quarantined.

All chemical trial sites which have received batches manufactured post July 14 have been instructed to discontinue their use, and all clinical data generated using the affected batches has been identified and to be excluded from the clinical trial data set. All instructions have gone out as of today to the trial sites.

The trial sites which did not receive the problem batches, however, and that will be five trial sites, continue to recruit patients although those sites will continue to – we will reach a stock out situation over the coming, short number of weeks.

The root cause of the problem lies with a filing change to a fluorescent dye material procured from a third party supplier. Previously the dye was supplied to the company as a powder measured out in 1 milligram quantities.

At our request the supplier was asked to supply the dye in 1 quarter milligram amounts, as our conjugation procedure requires only 1 quarter milligram amounts per batch of product.

In dispensing a quarter milligram quantities rather than 1 milligram quantities, the ratio of the dye to the dissolving solvent changed by a factor of four, this formulation change resulted in a change the chemical conformity of the dye material resulting in increased variation.

In layman terms, the mistake made was that the volume of solvent was kept constant even though the quantity of chemical dye was quartered, thus changing an important ratio providing a knock-on effect to the resulting product.

Having identified the offending chemical we have this week manufactured a pilot batch of Troponin product with another dye in its original 1 milligram format. We are happy that the resulting product has returned to its normal performance specifications.

We're confident therefore that our team has identified it positively identified the root cause of the current issue and the corrected actions identified have solved this problem. Moving forward then new batches of the chemical in its original format have been ordered from our supplier, new material will be available within four weeks.

On receipt of the dye, new batches of Meritas products will be manufactured immediately. Our production cycle however is an eight week process, to get [ph] our new product will be available ready to re-enter clinical trials in about mid-February, the trials will run through February to the end of May to reach completion.

Adjudication and statistical analysis and submission drafting will take place during the month of June and July, followed by FDA submission in August 2015. In relation to the clinical data generated today as of Friday 17th last, 624 cases have been enrolled in our ACS study; of those 50 have been tested on the effective batches.

Excluding these 50 subjects the total valid enrollment now stands at 574 patients. Finally, since we last spoke to number of sites enrolling has increased probably six to now 12, with the 12 – to 11 sorry, with the 12th site coming online which is Vanderbilt coming online at the end of this week.

In summary therefore, it is essentially to point out that we firmly believe that we have positively identified the problem but the fixing of implemented action to solve the problem under the promise manufacturers going forward will continue to exhibit the same excellent performance characteristics as the products which obtain CE marking earlier this year and which was independently tested and presented by Dr.Apple at the ACC meeting in Chicago only in July last.

I'll move on briefly then to talk about Meritas BNP. On September 25th last the company announced that we have received CE marking approval for the Meritas BNP heart failure test.

As we got to BNP levels in pulse rate increase as the severity of heart failure increases, thus BNP has emerged as a conditional biomarker indicating the diagnose and clinical severity of acute and chronic heart failure. Our CE approval, sorry for our CE approval the Meritas BNP product was tested on a predominantly U.S.

population of 1,424 normal healthy individuals and six of them 65 patients which have been diagnosed at heart failure managing cross all four major heart failure classifications as outlined in the New York Heart Failure Association.

The Meritas BNP product demonstrated exceptional sensitivity in procession which is at least comparable to much larger or far more expensive central laboratory systems, while delivering results in 10 minutes right at the point-of-care. To tell you more most of the CE mark that was generated in the U.S. on the U.S.

patient population this clinical data said we'll make up a sizeable portion of our FDA submission package. The current data needs to be augmented with respective study of about 300 heart rate of patients in two U.S. sites.

This city will be conducted over the remainder of this year and early next year for submissions with the FDA by the end of quarter one 2015. BNP approval is anticipated during on quarter three 2015. And finally development of the heart product in our cardiac market panel D-dimer is progressing well.

We are approaching design freeze and the short treatments testing clinical samples. In general this part of development program is progressing well. I can say it now that we're happy to take your questions and I'll hand over to Kevin..

Thanks very much, Jim. Today now I will take you through the financial results for our quarter three 2014. Starting with our revenue performance, total revenues for the quarter were $27.2 million this compares to $24.1 million in quarter three 2013, thus representing an increase of 12.6%. Ron will provide more details on revenues later on in the call.

This quarter's gross margin was 47.9% compared to the 49.7% we reported in quarter three last year that was similar to the level of opportunities [ph] in quarter two this year.

The reduction in gross margin from quarter three last year's level was partly the results of the impact of the higher level of placement of Premier instruments which have 120 significantly higher than the 81 placements achieved in quarter three last year.

We are also still seeing the impact of running two additional facilities in the UK associated with the blood banking whole blood screening acquisition that we made last year.

These plans were closed at the end of July this year and hence or like the previous two quarter this year, we are only seeing one amount of cost this quarter as oppose to a full quarter.

However, we did incur some additional costs associated with the closure itself, these included premises or institution costs, i.e., cost restoring leased premises to their original condition.

We also incurred significant disposal costs given the nature of some of the materials being used at these premises for regulatory reasons it was not possible to transport some raw materials and component inventories across border to our overseas facilities and hence they have to be disposed locally.

Due to environmental regulations in the UK which are very strict, the disposal of such materials is very costly. Finally we also encourage freight costs transporting firstly production equipment and secondly to a lesser extent inventories to our other facilities also.

The next impact is that these costs have eliminated the savings we yielded by having these factories closed for the last two months of the quarter.

Moving on to our indirect costs, our warranty expenses in the quarter increased from $0.9 million to $1.1 million this quarter, similarly our SG&A expenses increased from $5.9 million to close to $7 million in the same period.

Both of these increases were largely due to the impact of Immco which was acquired during quarter three 2013 and hence would not have been included for a full quarter in the comparative numbers.

An additional reason for the increase in SG&A cost is the prior to launch of our new cardiac product, Meritas, the company has started in place a sales and marketing function dedicated to the launch and support of this product.

And in this quarter we also incurred some additional cost in relation to our new test for Sjogren syndrome which was rolled out nationally in the U.S. at the end of June this year. This quarter’s operating profits was $4.6 million versus $4.8 million in the same quarter last year, and this equates to an operating margin of 17.1% in the quarter.

It has been impacted by the additional UK and sales and marketing costs previously mentioned, and excluding these costs operating profit would actually have increased to $5 million.

Moving on next to our net financial expense, this quarter our net interest income was more or less offset by interest expenses in the P&L compared to net financial income of $203,000 in the equivalent period last year.

This mainly reflects reduced level of firms following last year's acquisition and to a lesser extent a fall in deposit interest rates which are now available in the market.

Our tax charge in this quarter was $276,000 which has an effective rate of 6%, continues to be very attractive and led us a low corporate tax rate 12.5% and were also benefiting from R&D tax credits in both, Ireland and Canada.

The net results of all this is that profit for the periods decreased margin from $4.5 million to $4.4 million, meanwhile EPS was $0.19 for the quarter.

So again, I will point out perhaps the additional cost incurred this quarter being excluded would have resulted in an increase in profits to $4.8 million which equates to $0.21 versus $0.19 which we are reporting today.

Finally, earnings before interest, tax, depreciation, amortization and share option expense for the quarter amounted to $6.2 million. I will now move on to talk about significant balance sheet movements since the end of June 2014.

Property, plant and equipment’s increased by almost $1 million, and this was made up of addition of $1.5 million as offset by depreciation charge of approximately $500,000.

The additions are made of production equipment mainly in Sweden but also includes instrument placements, particularly premier instruments in Brazil which are placed on a reagent rental basis.

During the same period, our intangible assets increased by just under $4 million, this was mainly due to additions of $4.9 million which was partially offset by amortization charges of approximately $600,000 and FX movements of $300,000. Moving on to inventories you will see that this has increased by about $700,000 this quarter.

This is partly due to increased premier inventories but also includes the increased levels for Sjogren’s inventory, first nationwide launch calendar year this year.

Meanwhile trade and other receivables have decreased by $2 million to $25.2 million, of this decrease $1.4 million relates to trade receivables decreased due to improved cash collections and the remainder relates to reduction in prepayments, mainly due to the timing of stage payments associated with purchase of production equivalents.

Finally relating to working capital are trade and other payables have decreased this quarter by $900,000 to $15.2 million reversing the increase we saw in quarter two. Finally before handing back to Ronan I will discuss our cash flows for the quarter.

Operating cash flows before working capital movements increased by $300,000 from $5.8 million to $6.1 million. Movements in working capital improved when outflow of $2.3 million in quarter three 2013 to $500,000 to the current quarter.

Total net capital expenditure in the quarter increased to $6.4 million from $4.6 million in quarter three 2013, this was largely driven by the increased property plans and equipment’s expenditure I mentioned earlier.

After taking into account of tax and interest the free cash outflow this quarter was just under $1.2 million, it's considerably lower than on previous quarters as the company moves towards the position when it will be generating positive free cash flows.

Our dividend was paid at the beginning of quarter three resulting in an outflow of just over $5 million and the net result of all this is that the total cash outflows for the quarter were approximately $6.2 million resulting in the cash balance at the end of the quarter of almost $9 million. I'll now hand back to Ronan..

Thanks, Kevin. Well, I am going to review revenues for the quarter and discuss business developments before opening the call to question-and-answer session. Our revenue for the quarter were $27.2 million, up from $24.1 million in the corresponding quarter, which is an increase of 12.6%.

Our HIV sales for the quarter were at $5.5 million, up from $5.3 million which is an increase of 3%. U.S. HIV sales were up 8%. Public health spend by individual states continues to be very depressed and we see this reflected in the result of our competitors.

However, our hospital HIV sales continue to improve due largely to the fact that we are now selling an HIV-1 HIV-2 product following FDA approval for our HIV-2 Claim at the end of last year, and also due to us taking HIV-2 license at that time.

Our African HIV revenues were at level with the prior quarter but the fundamentals of our business in Africa continue to strengthen. We are the confirmatory test of choice in virtually all African countries and continue to receive a premium price for our premium product right throughout the whole continent.

In addition, our Nigerian revenues continue to strengthen. Our chemical laboratory business increased from $18.8 million to $21.7 million in the quarter which is an increase of 12.6%.

However, when the impact of both the Immco and blood banking acquisitions are excluded, our underlying organic growth for this quarter compared with the corresponding quarter last year is 3%. Our diabetes business grew 11%. Our infectious disease business grew 1%, while Fitzgerald decreased by 6%.

The diabetes business performed strongly with 120 Premier instruments placed during the quarter, compared with 81 instruments during quarter three last year, giving us 327 placements in the first three quarters of the year. This means that we are in line to achieve our target of 460 placements for the year as a whole.

All markets performed strongly, U.S., Europe, and China, but Brazil merits special mention as 41 instruments were sold during the quarter by our direct sales force, following the sale of 21 instruments in quarter one, and 27 instruments in quarter two, therefore 89 instruments have been placed in Brazil since Brazilian approval was granted in January of this year.

Moving on to infectious disease which excludes Immco and the recent acquired blood banking business, the infectious disease business grew by 1% compared to the prior quarter.

The lyme component of the business was down in excess of $500,000 or 15% compared with the prior quarter, and this arises due to the particularly severe winter experience last year which killed most lyme ticks. However, our lyme business varies annually, it depends on winter weather conditions with our dominant market share remains unaltered.

The balance of our infectious disease business traded strongly during the quarter and was up 7% compared to the prior quarters. The U.S. performed strongly and is benefiting from the advantages having the Immco autoimmune product range added to its offering. China performed well, and in Brazil the approval process is continuing.

Moving on to Immco, which we acquired just over one year ago, we are very pleased with its performance and are confident of growing the business 20% this year. The performance of our newly launched Sjögren's test which is a dry eye disease test is worth noting.

We have decided not to make this test available to laboratories and hospitals around the country but instead we market the product directly to opthalmists, eye specialists, through our marketing partner Nicox, and then run the test in our own reference laboratory.

We launched the test nationally in June of this year and have revenues for this product in the quarter exceeded $250,000, and we believe we'll reach $500,000 in the current quarter. So that completes our review and I will now like to hand the call back to the operator for question-and-answer session..

Thank you. We will now begin the question-and-answer session. (Operator Instructions) Our first question comes from Bill Bonello from Craig-Hallum. Please go ahead..

Good morning guys, and thanks for all the colors. I'm going to try and understand some of the Troponin situation a little bit more, even beyond the detailed you gave, if you would bear with me, I wanted to make sure I understand this.

It sounds like from what you are saying that you learned about the variance in the growing CVs from your own product testing.

This wasn't feedback that you got from the trial sites?.

That's correct, we had no feedback from the U.S. trial sites. Quite frankly, they wouldn’t be able to notice that. There wouldn’t have been all of a sudden great change in the product performance, it is not like that the product sell off the cliff, the variation we saw is on a slightly more than what it should be.

So it probably would not affect clinical performance but we saw in our own testing and we felt we have to do something about it..

Okay, that makes sense.

And then did the manufacturer happen to notify you or have to notify you that they had changed the construction of the product when they made that change?.

No, what happened was we actually asked that the fluorescent dye be packaged in the smaller package, basically in quarter of mg quantities. And as Jim explained, basically they changed the fluorescent dye content but they didn't change the solvents.

So basically they kept mixing – they kept dissolving in 1 ml instead of a 0.25 ml, there error was made. And already when we basically looked at our retained – when we do ongoing review of our retained batches, and it came to light in that review.

We are just talking about a very marginal deterioration in the products, we're talking about a very, very marginal increase in the CV, bear in mind this is something that arguably we could have left continue. It was a very judgmental margin, a very marginal color to whether or not we would actually suspend the trials.

We could have gone on, the product would probably be an FDA approved and we're talking about a marginal change in the CV. But in the context of the fact that when we decided that we would actually suspend the trial given the impact that has on the timing we felt that we ought to basically announce it now.

Just to make another point, I think that the pure timing coincidence that this announcement coincides with our quarterly results, basically we only made the determination last night to actually suspend this trial..

Sure. And just so we get kind of how the trials are being run and all of that, I mean, I guess to an outsider who has never had to do this, you will look at it and you say, gosh, if there was a change in one of the inputs it seems like that would be something that would be tested when you are in the middle of a clinical trial.

So maybe you could help us to feel comfortable on sort of how that decision was made and implemented?.

Bill, that's a reasonable question. Firstly, we certainly we did ask for this change from the manufacturer and I'll just explain why. When we make the particular, what do we call a conjugate which is not just our batch size, we actually use one quarter of a milligram of this particular dye per batch of products.

It had previously been sending to us in one milligram batches and with the best intents possible our scientist felt that having to dip a spatula into a powder if you like four times perhaps introduce contamination or variation. So it seems like a prudent thing to get the supplier to pack it in and do the right unit sizes if you like.

So that's where the call came from just so it would match with our manufacturing batch size. The product would have passed all of our QC testing, so when manufacture products we've got particular dye, it did pass our QC testing, the same QC testing every other batch passes. Our LC [ph] have got into the market if you like.

Where it became evident is about six or eight weeks after manufacturing you start to see a creep, I supposed some better word, in the product. It makes it somewhat – for some reason unstable and you only see it and it manifests or maybe in a modular fashion, six or eight weeks post manufacturing.

And of course at that stage it had shipped to trial sites, in fact only one lot had actually shipped to trial sites there was never two or three lots that had been manufactured in-house that have never shipped to trial sites. And I think I said in the summary there was only – so we – there is still five trials sites running.

And indeed there are only 50 patient samples run on the affected batches and those have been quarantined and kept out of the data test..

Okay, that's very helpful. So that kind of explains why it took some time.

So, you said in the recent past, I mean, like within the past week or something, that you guys discovered this change in CV?.

Yes, last week in internal test we discovered this and immediately alarm bells rang for us. And in credit to the guys in Sweden I think in the space of a week we have identified – we genuinely have positively identified the problem, it's very clear. You can see it before and after in our data, very clearly have identified the problem.

We have identified what the fix is which is really to go back to what we used to do and we have made a pilot batch, a small batch with a pilot batch nevertheless the product with the old process and it's exactly the same as what you would expect that came out exactly like old product.

And so basically we identified and we came up with the fix and we have the solution. So along in here again just to put in perspective so we have a CV of about 10% and it seems as if they say we were gradually now and could extend as time period goes on. But the worst that we got that was out towards 20% of the CV. Now given that the U.S.

trial is blind there is 50 samples out there and we don't know what they were tested on but it might be that we never missed any hard stock it might be that we did because they see that meant that there was product out there that sees the higher CV than we wanted but ironically still within the relaxed FDA guideline.

But we made a decision in an event to suspend the trial and to recall the batches and to basically look for – to make the only trial on our best quality products, and so that's it..

So just one more thing on that, I think Jim you touched on this.

But I think what I understand – because one of the questions I've gotten is, gosh, why did it take so long to see the impact? And if I hear you right, what you are saying is the impact sort of grows as the product sits on the shelf?.

Exactly, like there are any diagnostic manufacturers there is biological components in this case so the antibodies it's draws biological components that do degrade overtime, so that's why for instance our products have shelf life of 12 months at 4 degree centigrade, 2.28 is the actual number.

That means there is a gradual deterioration at all times in these biological systems. So however this change accelerated that change process.

I genuinely can't tell you why I don't know the mechanism as to why it should have done this but it just – overtime is not noticeable for a number of weeks until you start and again as Ronan said it's very marginal, it's was very hard to see these changes while they took six to eight weeks to figure..

And again another point to make is that it would not be normal for us to go back and test retain it overtime and that was luckily was something that we had put in place at this time because we were in the trial situation and but that would not be normal to be testing, remotely testing the change basically reallocate. .

Okay, that makes sense. And then, just – you mentioned that you exclude any results from the sort of problematic batch of test.

Is that something the FDA has agreed to or you have to get the FDA to agree to?.

At this stage Bill we don't have to tell the FDA anything. First of all, this is not unusual in clinical trials, this happens frequently, it just happens that probably Troponin was the most highest – visibly highest project in Trinity’s portfolio but this happens from time to time, it's not unusual.

So what we have to do essentially we don't have to tell the FDA at this time anything about this thing.

What we will have to do when we makers our submission is tell them it happened, show them that we identified what the problem was, show them forensically that none of the samples got through into the data sets or tested on these one lot of product that's poor.

And they will want to see a very thorough validation on the new batches of products to make sure that to prove categorically that it's same as the old batches of product.

So it is a paperwork exercise, I am not pretending you prefer not to have this in your clinical trial but it won’t be the first time and last time the FDA received in a data set, it's a procedure of process, our regulatory people know it very well and indeed it's just a double work that has to be done but there is no onus on the fatality at this stage..

I mean this identical scenario has happened in numerous occasion, there are quite a number of occasions over the past 20 years on FDA submission, it's just that none have been quite so high profile..

Sure.

And starting with the long questions, so if I can ask just two more if you bear with me, is there – what type of incremental cost do you think the delay might create for you?.

I think very marginal. For our clinical trial as we pay about sample not by the hour if you know the mean. So it's halted so there is no more samples being tested so the cost stops and we start again..

Okay. And then, just – right but then I assume there is some manufacturing startup and what not but I'll take you, admitted skills that sounds good.

And then just the last thing, if your commercial product out in the market from this new compensation that you are going to have to recall, etcetera?.

Nothing. There is opportunity absolutely nothing..

Okay, perfect. I will hop back into the queue cause I’ve hogged so much time. Thank you..

Thanks, Bill..

And the next question comes from Jim Sidoti from Sidoti & Company. Please go ahead..

Good morning.

Can you hear me?.

Hi Jim, absolutely..

Great. I just followed up on the lot of questioning from before.

If it takes a few weeks for the problem to manifest itself, how can you be confident that this greatest patch made won’t have there probably few weeks there?.

What we will have to do Jim is to credit normal accelerate this when the result is okay.

So let’s just say while the fact is our product is a four degree storage product okay, if you want to accelerate deterioration there is a sort of a process playing it would put that products into an incubator at 37 degrees and 45 degress, and maybe 52 degrees, and that's a known process in order to accelerate real life staging at that kept temperature.

So we will have to do that sort of testing at the end but we are doing that testing at a point that we made and we will have to do it on the new batches as we make them.

But if you think of the same thing we'll need a change, now we're going back to exactly what we did before, and exactly what we did before when through all of this had a protocol of stability testing, etcetera. So you can never be sure but experience would say that it was exactly the same as we did before, it should be the same as before.

But we will have to test in this accelerated environment..

I think we've earlier said that a good time and actually all that any context of recommending the clause in the mid February..

Okay.

So you're commencing that accelerated rise tested now, so you should do within a couple of weeks if that are probably emerges?.

Yes. I mean what we really care about it, we are not going in the voyage of discovery, we have actually discovered what the problem is and we've resolved this as long as all that we should simply doing is going back to what we were doing all along.

I mean bear in mind the problem is the CV problem, CV equals variation and it means that every product have to identical to the ones before.

So it's a matter of having no variability between cats, it's simple as that, it's not like we are trying to rediscover how to manufacture the product, how to make it work, simply just a matter of repeatability and we're satisfied we've achieved that..

And it just sounds like such a miniscule change that when – the fact that it's having an impact on the results is surprising..

May be see what CV is [ph], I mean anything in a tight CV means that basically if I take a blood sample from somebody, again I break it up into and I use it, basically I just nine of my 20 times in the table and I test use that sample basically one, two, three, four, five, six right across the whole 20 samples, I've known them that I need to get an exact same result all 20 times.

I remember that's the game we're in, its high precession, high CV. So the tiniest, tiniest change can actually – they have good in those circumstances, particularly what I am trying to determine basically is picogram of Troponin basically drops into basically like an Olympic swimming pool kind of thing which is what we're looking at.

So the tiniest variation can have major impact and that's sort of written here..

Okay, alright.

Are you concerned that such a small change affects the results, and maybe there might other small changes that could throw it off as well?.

Well that's what the whole development process we have, it is all about – we have a design control process, this product is no different to any other diagnostic product, it is very sensible, all diagnostic products are prone to external effects, they don't like being put at high temperatures, they don't like being put at into high humidity’s, the area stinks.

But which build in Jim that sort of that durability I guess into the product and your test sort of from developing it. But they are sensible products, the diagnostic products are sensitive products. [Indiscernible]..

Does this change impact any of the other products that you have on the Meritas side?.

No, absolutely not. Believe it or not we had scheduled to change BNP to the same – to move over to the quarter make but you can imagine that schedule has dropped, so it doesn't affect any other product is the answer..

So the bottom line is you have maybe a six-month delay in getting the results to the FDA.

But you are still confident that the results would be as sensitive as they were in the initial pilot runs and that this will still be the only test on the market that will meet the FDA guidelines?.

I think the rumor is, I think the actual delay that has arrived as a constant to what happened is to two and a half to four months.

I think the fact that we are saying that we will go through August, and in reality what we are doing is we are allowing what we feel is plenty, plenty or adequate, or more than adequate time to actually – to pull all the 36 [ph] gathered at the end and you have the cardiologist in plus etcetera, etcetera.

I think so basically we're being cautious in our timing. So you could confirm that rather the delay has been four months or six months, but it's not that magnitude. Again, to go back to what Jim said, we have about 700 samples already obtaining to refund when we come after to pick up another 900..

Okay, that was my next question.

So you still have about 900 more to complete?.

Yes, and then we have the cardiologist review and basically pulling together the whole on December after submission and I think we are allowing two month so that I think we are allowing plenty of time and we are allowing public more time than we were in our previous calculation.

So when we talked about submitting these products at the end of January or start of February of 2015. So we've moved to that timeframe until August of 2015 but I think we've allowed more than adequate headroom in that timeframe..

Okay. And in regards to the quarter that just ended, it seemed like there was some additional operating expense related to the shutdown of the plants from the acquisitions last year.

Do you think in the fourth quarter you have passed all that? And where do you think margins will get to in the fourth quarter and in 2015, ballpark range?.

Jim, now I do, yes, you are right there were additional costs there in quarter three in relation to close down, I do think about other issues and then gone and pointed again that the plants to be closed at the end of July for the bitter distance between now and then, so that's obviously was fully cared up, so we will see an improvement.

It's difficult to be precise about what that level of improvement is because it's going to be depend very much on our mix going forward, we will have lower line sales eventually which will cause a little bit of a downward pressure, we will – the fact that we will possibly have more instrumentation as well which could have a downward impact, but we will have the benefit now of the efficiencies coming through from these plants which will push things up.

So we do have forces pushing in different ways and I do anticipate we will get some increase, hopefully in quarter four in relation to that.

And we've said that's the more instruments that glows, the greater pressure will be on margin, so a lower margin is a bunch that do not necessarily mean about being – you can be indicative of that very strong sales..

Right. If you have a lower margin because of high instrumentation sales, I think everybody could live with that..

Exactly, so I am saying exactly so no margin are not necessarily by new choice..

Okay. Alright, thank you very much..

Thank you..

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

Good afternoon. Just a couple of clarifying things, you guys actually have gone over this pretty well.

So you basically didn't have any idea there was – I mean, you knew you made the change but you didn't really realize that things were not changed to your liking or it wasn't quartered, the solvent wasn't quartered until you saw the variance which you took until last week to discover. Right? Basically….

Yes, correct..

And so the trials essentially were halted as of last night. Is that….

No, not as of today. Just to be clear, the trials as it turns out are still running. There was only one batch of product, so five of the trial sites are still running although they didn't run out pretty sharply but the sites got a formal notification only today..

So there was 11 sites, you heading a 12th, so essentially the other six sites had basically – one of them had started with the new batch, the other five have not actually started yet?.

Essentially yes, and what we said to those sites, we didn't say to the sites last week, we're shooting another trial, we said please do not use last number one, two, three, four, just they did the last number while the other and any other products you have..

Got you. So essentially you have a little bit of a tail in the trials to completely stop as you guys use up the last of the old batch, if you will.

And then you have to wait for the revised batch to be made for them to all start back up again?.

Exactly. I believe there is enough products out there, maybe to about another 60 or 70 patients..

That's what I was going to ask you.

So okay, so you will get back up to that, you will make up the difference that you lost, so you get back to the 6.25ish area?.

Give or take, that's exactly yes..

Got you.

And you've have confirmed but just – this is basically for that be assay used in the Troponin part of it, it's not the actual read, it's the drop that you drop into the liquid into the fluid chip?.

Exactly, it's the consumable not the reader..

Got you. And the entire capsule, the quarter milligram that you used that to make an entire batch of assays, not per assay.

Right?.

No, we make that higher lot number of assays..

Right, exactly..

So that's why it's such a small, minute – it's already a minute number, it just gets, obviously minute..

And just last thing on this and then I'll move on.

The revised or the re-revised stuff – are they going to still quartile for you or you're going to go back to the 1 milligram and you're going to quartile it yourself?.

No, no. We're going back to exactly what we did before. The process is exact, we're going direct with the exact process like we did before..

But even though essentially you may be able to – I guess you just don't want to play with fire but you realize that they didn't – the reason why the difference because they didn't quartile the solvent but you are not going to go try and play with that; you're just going to go back and quartile it yourself during the process, essentially?.

Correct..

Moving on, the Sjögren's product, you said it's going to be a little of sales this quarter and it's ramping nicely next quarter to potentially $0.5 million.

What do you think that's like a $2 million run rate? What do you think the ultimate potential or target market is and other participants in the market and how do you view that for this product?.

This is like a confirmatory and it's actually confirmatory and dry eye testing and it costs over $300 per test. It's quite expensive.

And so maybe it will come after the screen typically and in terms of the potential, it's quite significant, I mean I hope that we would have a run rate of $2 million annually, basically by – but within another couple of months.

In terms this rather could become a blockbuster for us, I probably don't think so but I think it certainly has the scope to double in that size maybe 50 on that but I am just a bit reluctant to say because I don't know but certainly it has already met our expectations, I mean we thought we've got $2 million products and it ended being a $2 million in sort of 16 weeks.

So let’s just kind of keep our fingers crossed and see how they go, but very promising..

But it could be – not the way to put $5 million annual product in a couple years is not –doesn't sound like it's out of the realm of….

I mean I think that's probably where it will go, I think it could go beyond that..

And then just on the increased expenses, so the SG&A – I imagine some of it is sort of sustainable because it's for Meritas and for the Fiomi Meritas and then Sjögren's or is there some sort of initial bump up maybe on Sjögren's, at least, that will sort of subside?.

There is a certain amount there, I mean you're seeing three factors within the bump up there, between the factors you got a full quarter in relation to incur as a whole. The fact we're carrying about $0.5 million a quarter in relation to Meritas related costs.

And then Sjögren's itself, and as Sjögren's goes on, the more successful again Sjögren's become the more likely those costs are going to go up. There was some initial cost there but you can expect, I mean we have to – we partner with a partner and that we share some of that relation with that.

So again the more successful and the more heavily the test is across the country and obviously a big marketplace, there will be a cost going forward. So I would not overemphasize the start-up cost at this juncture but given the fast ramp we're seeing already..

Got it. Just switching gears real fast, point of care, HIV, I know initially you guys had thought it would be a double-digit grower in the U.S.

this year, it sounds like that the further declines in public funding and the slower testing, is public clinics is impacting you? But it is – I guess growing sort of in the mid-single digits in the U.S., is that a better assessment?.

Basically what's happening the hospitals are performing very strongly and public health is performing weakly but the combination is that we’re actually growth at single-digits but we're actually strong and we're growing confident strong double-digits..

And then Africa I know sometimes it's lumpy and timing related. But it's sort of flat this year. Has there been some impact from Ebola? I realize it's localized in a certain part of the continent.

But has that impacted you guys at all?.

I think for example in Nigeria, in particular we're hoping when we get in quarter four, in the current quarter, and that's just not materializing and I think that there are – the indications are that they are very classified with Ebola.

And so it is having an effect not in fact a big one but in that area and sort of it’s around certainly own matter of yesterday’s mess around the rest of Africa most of our HIV business is kind of sub-Saharan, so it's really not unaffected but it's having an impact in Nigeria but hopefully just a gradual timing difference..

Okay.

Then Premier continues to sort of meet expectations? I guess you launched the new product in this quarter too for the non-variant portion of it?.

Yes, I didn't talked about that in the update but that's performing very well it's very promising, I mean it puts us into – as I talked about last quarter it puts us into a whole new area we're in the areas but it puts us into the area in a competitive way now and we have a $7 million business, we can grow very significantly.

And there is areas of competition only, we're not the major competitor and I am sure know who it is and we’ve got the wherewithal now to really take them on.

So I think that we could do very well there and I mentioned that we had one contracted in the Sao Paolo and Rio de Janeiro for only newborns and so that promises those very well for us in the future.

Just going back to Premier and in the diabetes side of things, just to mention that on the [indiscernible] like just to mention that we paid 120 instruments in the quarter which is very gratifying, we will say this year 23% of all diabetes A1C instruments placed in the world so we’re pleased about that..

Right, and you are still targeting getting up to like a 30% run rate which would be – I guess over the mid – north of 550?.

Yes, that's our target and we want to get there next year we get close to it, we probably won’t quite get there but hopefully we'll get there in 2016..

And just lastly, on just the last negative or sort of the little bit of an eyesore that remains on Fitzgerald, I know that sort of been flat to down the last couple of year and it seems the last couple quarters it has declined a little bit more again.

Is that something that we should be aware of anything going on there?.

Just to say that it's not that we don't try very hard, we do and we're just finding it almost impossible to do own this business. We've worked very hard and we've made changes, we've done all sorts of things.

I would just say in its defense that it is an extremely profitable business, I mean this product, this business generates EBITDA of over $4 million, so it certainly contributes to the overall company very significantly and albeit we're not growing the revenues..

Right, so it's kind of like a good 40%, 50% EBITDA margin there, right? North of 40%, it sounds like?.

Well, it’s like $11 million – so four of our 11 whatever is like that’s pretty close….

Got it, okay. Great, thank you very much Ron..

Thanks, Larry..

And the next question comes from Ross Taylor from Somerset Capital. Please go ahead..

Ronan, I am trying to get to what the core business would be earning without that Troponin effort.

So can you break us down to either tell us how much you are spending, all in, on Troponin – not just on the testing but on building out the infrastructure and all that? Or could you give us an idea of what the rest of the Company would be doing?.

Alright Ross, you always have the tricky questions. And in terms of why we spent on Troponin this whole project from the day we bought it and in terms of including the acquisition cost, I think just got in $30 million at this moment.

Kevin, I think that's – just on $30 million and would be really spent on this and in terms of – it's actually about the profitability of the business, the profitability excluding Troponin is slightly more the profit that we've announced today because of course and because we have marketing etcetera, etcetera, but remember we are capitalizing some of the R&D cost.

So I suppose and I will put it in another word, the EBITDA of this company is $27 million, absence Troponin it probably would be $31 million..

Okay..

Does that answer your question? I think that in terms of earnings per share, and I would say and you are putting me on the spot here and doing my math and arithmetic but I would have said and the $0.88 the net outcome.

Okay, does that answer your question?.

Yes. And it assumes that you also then have a little bit – we would have a run rate into the fourth quarter.

So if we are talking about basically $4 million difference in EBITDA, it probably would be $5 million, $5.5 million on an annual basis?.

Yes, $5.5 million on an annual base, right..

Yes. I'm just trying to figure out on what the annual effect is because this is – we are talking three quarters and obviously the year has four..

Yes but I was talking four, I was talking annualized..

Okay, fantastic. Now additionally, obviously, with the stock down here you stated that you are very confident that you get approval under like you have, what $9 million in cash sitting on the balance sheet.

You have talked about rolling this thing out, money we thought we might need to roll out the product as early as the second quarter of 2015 is now likely per year calendar which seems that you have kind of bought another three or four months of protection in your August….

I just have to jump in there Ross, probably bought another two months of protection not so much….

Okay, two months. Why don't you step into this market given all these things and given the endgame value of this product and aggressively buy stock? I mean, the stock is probably trading well under with the core business alone is worth, let alone what they call value of Troponin would be. It strikes me as if I am sitting on your board.

I am pounding on the table saying this is a strong free cash flow generating business that's what we are doing in some of these wrap-up efforts. .

It's a great time to buy stock if you can buy that $17, $18, $16 a share this was $27 a year ago. I do agree it's a great opportunity to buy back stock but the issue is would it be expedient to do so.

I mean we have $9 million in our balance sheet at the moment, I know we just paid a dividend and our possible [ph] strength as year goes out but at the same time we have limited headroom to do that.

And the other factor one has to get in mind this is that if our cash balances were to considerably weakened and that in itself can make investments in our as well, so things are bouncing back.

But I will tell you, starting we will look at it and we'll consider is clearly not my call, it's not the management call alone which have to be talked about before at an board level. But it’s an interesting point to make Ross, I accept that. But I would say I just caution that we have limited headroom. .

I think actually running from the past before you started this effort you were generating over $1 million a month in free cash flow about $1.1 million or so. I would assume giving the steps you had made and the increase in Premier and like that number should actually be substantially higher than it was prior to that.

So I am really struggling with the idea of saying that you are not capable or not comfortable stepping out when it seems that a lot of the issue here and even the cash flow issues are really tried into what are sometime a onetime events and it strikes me as if you have this confidence that even this business can just as good a free cash flow generator as it was two years ago you should be aggressively buying stock.

And anything other than that is kind of a more or little that kind of mentality..

Genuinely, we will take your comments on board and we'll consider it. .

Thank you. We can chat afterwards, I will talk to you a little bit more about it later. Thanks..

Thanks, Ross. .

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

Hey guys, can you hear me alright?.

Yes, no problem. .

Great, so I just wanted to circle back on Troponin, I think most of my questions have been answered there.

But in terms of the formal notification sent out to the centers today, have you had any communication with any of those enrolling centers at this point after they received the formal notification? If so, what’s been the feedback? And do you think there is a risk that some of those centers who have used the tests and have already been enrolling here for a couple of quarters.

Is there a risk that any of those centers drop out and you might need to get a couple of new centers once resume the trial?.

To answer your first question, no, there hasn’t been any formal feedback yet because we waited for the announcement to go out and have this call before we send out any letters about anything to anybody. So they are only really gone out if you like okay. And quite frankly, I absolutely don’t think there will be any fallout from supplier side.

This is the big deal for us, we are very disciplined to have the software trials today but it's a frequent enough event. In any of these trials sites we have right now there is probably around [ph] five to seven different clinical trials ongoing within those hospitals at only one time.

We have a good relationship with each of their PIs, and I don't believe there is going to be any fall out but we will have to work with them, they will be disciplined as we will have to work with them, have to convince him that the product is very, very good.

Don't forget they only have longer product to date, there is only 50 samples out of the 600 samples that have had a problem. And we reacted prudently and conservatively, so I think we may be seen as a sort of a conservative partner in this thing. And so we would have to work out of it but I don't believe there is any problems..

And so your mid-February timing expectation to resume enrollment, has that assumed any type of ramp up period to reengage into those centers to begin driving enrollment again?.

No, we have plenty of time to get the centers ready and they are already trained, they are already up and running. There should be a moderate upholding products into the labs and don't forget we are now up to 12 sites of the medical and products into the labs and getting going.

We will have train them and press them and get them ready and we train them all that good stuff but that we have plenty of time to do that in the month of January. .

Understand. .

We would only have to retrain and even to change the personnel. But as we prudent to one more [indiscernible] for a few months. .

Understood. And then in terms of the FDA, sounds like you don't have to disclose this change with them but are you trying to have any type of discussion with the FDA prior to reconnecting the trial just to be on the safe rather sorry side to make sure the delay and disruption wont ultimately put you at risk erased.

I am concerned when you submit that data to the FDA?.

I asked the very same question of our regulatory people.

As you could imagine a number of times last week and they [ph] told me was, no, there is actually no need as long as we make sure that we are almost clean in our paperwork, that we cover everything that we can prove to them that all products have been removed from market, that all data has been removed from the actual data banks, and that the corrective actions have been put in place and are working.

The advice has been given from a number of regulatory people, there is no need to do it and there is nothing to be gained by doing that. We need to make sure that our house is in order when they come to us..

Okay. And circling back on the last question about cash and cash balance and uses of that cash, your balance has really come down pretty considerably here over the past year or two, $9 million – that's pretty low from where you have been.

Obviously, you had some costs with Fiomi and other initiatives here but how should we think about your cash position here? And how should we think about potential needs going forward over the next six to 12 months? And paying out a $5 million dividend in the quarter with only $9 million in cash, give me your thoughts on that and if you expect that to continue?.

Just bear in mind that we’ve done four things with our cash, we bought Immco, we bought Fiomi, we bought blood banking business in UK, and we bought back $11 million worth of stock, as well as paying the dividend I think so four years in a row.

So that's where the money went and the cash – the businesses remain cash flow positive and so the cash flows will strengthen as we move forward just to make that point..

Okay.

So you feel comfortable with your cash position?.

Absolutely, yes..

Okay.

And then as we look forward into 2015, I understand you don't give guidance but can you give us a sense of just – the organic growth has seen kind of net low single digit range, do you feel comfortable that you can sustain that through 2015?.

Well we'll be very disappointed if we only sustained as we want to improve and then we believe we were as premiere as a new point of care products that we've launched principally in Europe.

And we believe that that organic growth rate will improve and clearly to performing very strongly and then of course coming through and now beginning to look like realistically and number of months later and having a big impact when it arrives. We'll be very satisfied if we were just to maintain our current closed rate and we think we can grow it..

Okay, thanks for this angel..

Operator, can I suggest it's sort of five past five, and it's probably the longest call I can remember having. We're just going to take two last calls. I notice more than that many question out there but I don't need to exclude anybody but I suggest we better confine it to two last questions..

Okay. The next question we have comes from Paul Nouri from Noble Equity Fund. Please go ahead..

The $500,000 or so in Meritas sales and marketing costs – are those pre-ramp in America or is it more towards Europe, where it's already approved?.

It's pre-ramp worldwide and we probably an accent on Europe because that's where it's happening at the moment. So for example, it will include – but it will include two U.S. based, it will include an actual sales in the ground in Scandinavia and then it's the sales and marketing team based in Dublin as well but the action would be on Europe..

So even given that the approval is going to be pushed back a little bit, the resources that were in place this past quarter will probably stay there for the foreseeable future?.

I mean we did consider maybe pairing it but given the actual duration of the delay didn't really matter taking that kind of action. And I think it would be counterproductive and it's come to conclusion etcetera, and the experience have been built up but we did consider putting on – we're posting the hedge with the same team..

And what stage you are with with European sales for the point of care cardiac?.

The European situation is – we've got a CE Mark in January but it does sounds right the remark, so it's registry system.

So we then needed to get involved with opinion leaders and do evaluations in individual European countries and we're doing that at the moment in the five top European countries which is UK, Spain, Italy, France, and Germany, and also then in The Netherlands.

We are doing that and some of it we haven't actually talked about today that there has been a marginal impact on those valuations by subject of today's call clearly as you can imagine but it's not significant and we're dealing with that. But what's happened today will actually result in the element of delay on those valuations also.

So those valuations are containing and it's only really on a successful conclusion of those valuations that we can realistically sell in the European countries because the cardiologists need to be convinced about the quality of our products.

And unlike an FDA situation where an FDA approval carries a lot of kudos [ph] and CE Mark carries no such kudos because it's an entirely self-regulatory environment.

So for the timeline I see sales starting in Europe probably in quarter two of 2015 realistically because again our whole evaluations are suffering in Europe, are suffering delays as a consequence of what's happened. .

And last question is Menarini [ph] already selling your Immco products?.

Yes, Menarini and the situation is that Menarini basically have a very significant role to immunity business and they buy from a number suppliers and we would expect that they will be consolidating that supply and that's happening as there is no space etcetera required in all of that.

But that's exactly its intention and I hope I’m not saying anything sensitive in terms of commercially sensitive to say that on the phone, but that is the intention. So basically Menarini have a very significant very cross results immune business and I think we will share in that prospect with you as we move forward..

Okay. Thanks. .

Thanks, Paul..

And the final question comes from Randy Saluck from Mortar Rock Capital. Please go ahead.

Hello, Randy?.

Randy?.

Hi, sorry. Most of my questions have been answered but I wanted to ask one or two more things.

First of all, what is your anticipation of the timeframe with respect to your syphilis test and hearing back from the FDA?.

On the syphilis Randy, we basically have just about everything that one could imagine that the FDA could possibly require. We have, and we’ve answered endless questions and the thing has gone on for nearly three years. So we’re on the belief now that we will either succeed or fail in the short term.

And our assessment of our chances of that is concept basically 50-50 maybe it's marginal and advances on the positive side, so 51% chances of succeeding.

And in terms of it if we do get that approval, it will remain that we have the only clear way satisfies and we believe its potential in the market very significant I think that’s what’s happening it’s a concept Randy..

I see. And real fast, I didn’t quite understand why it takes until February for you to restart those sites. Is it because you are waiting for to get enough for the reagent product or is there something else? I just….

You think of it negative Randy, today is the 23rd so it's going to take mostly before we got, is only four weeks before we actually get the fluorescent dye in from supplier. So that gives me 23rd of November, right? Then it takes me eight weeks to go through [indiscernible] get me to 23rd of January, holiday whatever.

I’m saying it might the end of January but by the time we just actually have the product in those 11 house often running I’m saying 2015 to – it's broadly where we think it will happen..

Okay.

And your timing on BNP hasn’t changed in the U.S.?.

No. Timing is exactly the same, Randy..

Okay, thanks..

Thank you. Okay. Thank you very much. I'm sorry to those people who didn't get to ask question but I just have to kind of close it off at some point. So just to say see you and talk to you in few a months. And thank you very much and good afternoon..

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