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Trinity Biotech plc (NASDAQ:TRIB)

Q4 2013 Earnings Conference Call

March 04, 2014 11:00 AM ET

Executives

Joe Diaz – Managing Partner-Lytham Partners LLC

Kevin Tansley – Chief Financial Officer, Secretary & Head-Investor Relations

James Walsh – Executive Director and Chief Scientific Officer

Ronan O'Caoimh – Chairman and Chief Executive Officer

Analysts

Chris W. Lewis – ROTH Capital Partners LLC

Larry S. Solow – CJS Securities, Inc

Bill B. Bonello – Craig-Hallum Capital Group LLC

James Sidoti – Sidoti & Company

Ross Taylor – Somerset Capital Advisers LLC

Bill J. Nasgovitz – Heartland Funds

Operator

Good day and welcome to the Trinity Biotech Fourth Quarter and Fiscal Year 2013 Financial Results Conference Call. All participants will be in listen-only mode. (Operator Instructions) Please note this event is being recorded.

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

Joe Diaz

Thank you, Denise, and thank all of you for joining us today to review the financial results of Trinity Biotech for the fourth quarter and the full year 2013, which ended December 31, 2013.

With us on the call representing the company today are Mr. Ronan O’Caoimh, Chief Executive Officer; Mr. Rory Nealon, Chief Operating Officer; Mr. Kevin Tansley, Chief Financial Officer; and Dr. Jim Walsh, Chief Scientific Director, 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 today’s prepared remark, we submit for the record the following statement. Statements made by the management team of Trinity Biotech during the course of this conference call that are not historical facts are considered to be forward-looking statements subject to risks and uncertainties. The Private Securities Litigation Reform Act of 1995 provides a Safe Harbor for such forward-looking statements. The words believe, expect, anticipate, estimate, will, and other similar statements of expectation identify forward-looking statements.

Investors are cautioned that such forward-looking statements involve risks and uncertainties, including but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development, commercialization and technological difficulties and other risks detailed in the company’s periodic reports filed with the Securities and Exchange Commission.

Forward-looking statements, reflect management’s analysis only as of today. The company undertakes no obligation to publicly release the results of any revision to these forward-looking statements.

With that said, let me turn the call over to Kevin Tansley, Chief Financial Officer for a review of the results. At the conclusion of Kevin’s remarks, we will hear from Dr. Jim Walsh followed up by Ronan O’Caoimh on an overall overview for the year.

Kevin?

Kevin Tansley

Thanks Joe. Today I will take you through the results for quarter four and for the full year of 2013. Beginning with our revenues; total revenues for the quarter were $25.5 million, this compares to $20.8 million in quarter four 2012, and thus represents an increase of 22.2%. Later on the call, Ronan will provide you with more details as to the makeup of this growth.

Moving on to gross margin, as you would see from our press release this quarter’s gross margin was 50.4% which is a little over than the 50.6% we reported in quarter four of last year, but we will say that this is very much within the normal fluctuation level for gross margin from quarter-to-quarter.

Moving on to indirect costs, our R&D expenses increased from $765,000 in quarter four 2012 to $1.035 million for quarter four of 2013. Meanwhile, our SG&A expenses have increased from the same period from $5.2 million to $6.5 million. Both these increases were mainly due to the impact of the Immco acquisition. Just to remind you that this acquisition was made in the middle of 2013, so there is no comparative cost for last year.

We also have seen some of the impact of cardiac related sales and marketing costs we incurred in advance of the product launches which we will have in 2014.

Operating profit for the quarter was $5 million, up almost $700,000 compared to the same quarter last year representing an increase of 15%. Operating margin this quarter was 19.8% which is very closed to our target operating margin of 20%.

In terms of financial income this quarter we earned a $132,000 which is a decrease of nearly $400,000 in the equivalent period last year. This reflects the fall in interest rates which are now available in the market as well as a decrease in the level of funds on deposits.

I would also like to point out that this reduction in interest income represents approximately $0.02 in earnings for the quarter, and this is relevant when considering the profits for the quarter. Meanwhile our tax charge for the quarter was $328,000, this represents an effective rate of 6.4% which is slightly lower than the same period last year.

The net results of all that I’ve spoken of so far is that profits for the period increased from $4.5 million to $4.48 million for the medical device taxes. Our EPS for the quarter was $0.217 which represents an increase of over the $0.208 achieved in quarter four 2012.

However, as I mentioned earlier, this increase in earnings was achieved notwithstanding a decline in interest income equivalent to $0.02 or in a like-for-like basis, earnings have increased by over $0.02 this quarter by 13%. Meanwhile earnings before interest, tax, depreciation, amortization and share option expense for the quarter amounted to $6.7 million.

Before I move on to the balance sheet I’ll make some comments on the full year results. Annual revenues increased from $82.5 million to $91.2 million, which is an increase of 10.6%, again Ronan will address this growth later on.

Gross margin reduced from 51.2% in 2012 to 50.3% in 2013. This reflects the higher level of instrument shipped during the year and the impact of lower Lyme sales, which have higher margins on average than other products.

Operating profits increased by over 700,000 to $17.9 million, an increase of over 4% for the year. Gross profit before MDET or the Medical Device Excise Tax increased by 3%, from $17.3 million to $17.8 million.

Over the period EBITDA increased from $21.7 million to $23.5 million, which is an increase of over 8%. These profit growth rates are lower than we’ve achieved in the past number of years, there are specific reasons to why this is the case.

Firstly, we are now seeing the impact of cardiac prelaunch costs. Now that you’ve given the products, will not start to be launched into 2014 there were no revenues against to offset such cost in 2013. That can be we are now operating two additional facilities in the U.K. which are associated with blood bank screening acquisition. These facilities are scheduled to close in mid 2014, after which this business line will become significantly more profitable as the manufacturing will be transferred to two of the group’s facilities at minimal incremental cost.

With regards to the Immco acquisition, the initial integration cost as offset much of the profitability in the first few months of our ownership. In the months ahead these cost will disappear and the profits of Immco increase would increase as the business gross.

Finally, we also have the impact of transaction cost for both of these acquisitions which we mentioned. And these are about the order of $400,000 in the year, which itself is an impact of approximately $0.02 on EPS. Before moving away from the P&L, I would like to comment on the effective tax rate for the year, 6.8% this compares favorably to the 10.4% reported in 2012.

As I pointed out before, which are seeing there is the benefit after having the company headquartered in Ireland with the corporate tax rates considerably lower than in the U.S.

I’ll then move on and talk about the significant balance sheet movements since the end of September.

Property, plants, and equipments increased by $0.9 million. This increase was made up of additions of $1.4 million in the quarter as offset by depreciation charge of approximately $0.5 million.

During the same period, our intangible assets increased by $2.2 million, additions were approximately $5.9 million as offset by amortization of $0.7 million and the remaining movement is related to the finalization of the acquisition accounting for the recent Immco and Blood Bank Screening.

Moving on to inventories, you would see that at $29.7 million, these have increased from $27.4 million from quarter three. This increase was mainly due to our new blood bank screening business where we have build up inventories from very low base since the acquisition days.

This is now stage 2 of back orders and to prepare for increased production levels in the months ahead. Trade and other receivables have increased by $1.1 million to $24.3 million. This reflects the increase in revenues from quarter three 2013. Trade receivables should start at 66 days at the end of quarter three are broadly in line with that now standing at 67 days at year end.

Meanwhile, our trade and other payables, which includes both current and non-current of decreased from $27.6 million to $24.7 million. The reduction this quarter was mainly due to scheduled license fees including the first launch of the HIV-2 license fee that we announced last quarter. Before leading to balance sheet I’ll focus on some of the maiden movements year-on-year. Firstly, intangible assets will increase from $73 million to $128.5 million. This again is due to the two acquisitions namely Immco Diagnostics, and the Blood Bank Screening Business which we purchased during the year.

Together these results have an increase of $38.4 million and the reminder of the increases is made up of normal additions incurred during the year of $19 million which was up by amortization of $1.9 million. Secondly, you will notice that trade and other receivables increasing $14.5 million to $24 million. This was due to the combination of the impact of acquisitions, higher revenues, and slightly slower collections.

Meanwhile inventories increased from $20.7 million to $29.7 million for the same period, in both cases the main driver again – the main driver has been the inventory acquired on acquisition will sort of reassert that the Blood Bank Screening inventories that we’ve build out during the last quarter is also a factor here.

Finally, I’ll discuss our cash flows of the quarter. Cash from operations for the quarter was $3 million, capital expenditure in the quarter increased to $5 million versus $4.2 million in quarter four of 2012. This was due to additional expenditure on the development of our new cardiac products, were expenditure is currently running at a significantly higher level on this project. Now that we are in the clinical trials phase and are making preparations for full scale production. The net result is that we have a cash outflow of $2.1 million in the quarter.

The other main outflows in the quarter were the payment of the license fees totaling $2.4 million. The net result is that at the end of the year, the company had cash balance of over $22 million. I’ll now hand over to James, who will take you through the latest development with regard to cardiac.

James Walsh

Thank you, Kevin. As lot of happened since we spoke in October last, I’d like now to take few more minutes to update you on the progress on our cardiac market development programs in Sweden. Just to remind you almost exactly two years ago Trinity acquired a Swedish company Fiomi Diagnostics, Fiomi had developed a high sensitivity precise, quantitative point of care immunoassay platform on which Trinity is now developing a range of high sensitivity cardiac products, namely high sensitivity Troponin for the detection of acute MI, BNP for the detection of heart failure and D-Dimer for the detection of pulmonary embolism and deep vein thrombosis otherwise known as PE and DVT.

Currently there are only three dominant players in the POC cardiac market, namely Alere, Roche and ours. Another most important production meets the new guidelines for MI which has now been adopted by the FDA. The general and the lighter report that progress on all fronts of our cardiac product development program are progressing well.

I’ll take time now to update you on our recently announced CE mark for the high sensitivity Troponin products, and I’ll follow-up with a fairly detailed description of our plans as it related to the U.S. FDA approval and the scope and timing of the clinical trials involved.

As you are probably aware on January 29, last we announced CE marking our guideline compliant point-of-care Troponin product. CE is regulatory standard necessary to market a product in Europe.

At this stage it is probably we’re taking a few moments to discuss with you what is meant by the term guideline compliant. As it is our achievement of guideline compliance for the Troponin products that fundamentally distinguishes Trinity’s product from all of your POC Troponin products and which now represents Trinity with enormous commercial opportunity.

In 2007 a top stores consisting of the European society of Cardiology, the American College of Cardiology foundation, the American Heart Association and the World Heart Foundation was compliant to the fine MI and to standardize its diagnosis. Based on the recommendation of this task force, Troponin was identified as the preferred biomarker to identify suspected heart attacks. Furthermore according to the task force, a heart attack is diagnosed only when Troponin levels in the blood exceeds the 99% upper reference limit of a normal healthy population when accompanies by one or a clinical symptom.

Moreover, in order to improve the quality of diagnosis the task force further stipulated that troponin products also demonstrates excellent precision at very low concentrations of troponin. Namely 10% or less variation, 99% of a normal population.

As we have already mentioned none of POC diagnostic products currently on the market come close to meeting this guideline. The Trinity Biotech high sensitivity troponin probably is now the only true point of care of product on the market meeting those recent guidelines.

In our CE trial which was carried out under the supervision of Professor Bertil Lindal as part of the Swedish test trial, our product which was very strong clinical performance data with a limit of the detection of 19 picograms troponin for blood and the variation of 10%, a 36 picograms which corresponds with the 99% of the referenced population. In terms of precision, tested on [indiscernible] over 20 days, the products exhibited CVs of 6.8% at 46 picograms and a CV of just 8.2% at 25 picograms, which is in fact less than the 99% of the normal population.

Moreover our product demonstrated a specificity of 98% at time zero, thus making it an exceptional good rule out test and showing that any patient coming up positive on this sooner on presentation can be rapidly moved to the current lab for the necessary treatment with an exception load likely ahead of our test which was a positive results.

The above results represent excellent performance and fall in all aspects of the guidelines thus making true this troponin product the only POC product on the market today meeting the guidelines.

As quoted by Dr. Frank Peacock, Professor of Emergency Medicine at Baylor on announcing the CE mark he said, the Meritas product outperforms most historical central lab systems. It’s on par with some of the highest sensitivity laboratory that is only available in Europe and all of the point of care in only 15 minutes. It’s a real results a long spending critical need and serves as an inflection point to improving patient care.

I believe that Dr. Peacock also describes the benefits of our troponin product very well and gives us strong indication as the clinical benefit of product now being available in the ER for the first time.

Moving onto our plans for FDA approval of our troponin product, following a series of [indiscernible] IDE meetings with the FDA and obtaining the necessary headings committee approvals, U.S. trials are finally ready to kick off and we will start enrolling patients within the next two weeks.

Further more although we are not allowed to use the data, the clinical facilities which supported our CE approvals almost exactly mirrored the clinical studies and this is for FDA approval. And of course the results obtained provide us a great confidence of the successful outcome as we embark upon the more expensive FDA study program.

In general there were three aspects to the U.S. clinical trials, namely a normal population study to determine the upper reference level or 99% of our population, a chest pain study in the intended used population and an analytic performance study which in terms switch backs as a limit of detection precision, cross-reactivity interfering substances stability et cetera.

Currently there are five U.S. clinical trials which have agreed to participate in our FDA studies. These are Dr. Apple at the Hennepin County Medical Center in Minneapolis and Dr. Apple is also our overall trial coordinator. Dr. Wu at San Francisco General Hospital, Dr. Shapshak at Medical University Hospital South Carolina; Dr. Peacock at Baylor College of Medicine and Dr. Hollander, at University of Pennsylvania.

As previously mentioned, the U.S. trials are structured almost identically to the European trials albeit the newer sampling times and patient numbers are significantly increased. Therefore, starting with the easiest component of the U.S. trials and moving on from there, the first part of the trial consist of an analytical and procedural study. This study is very well defined and when started it can be completed within six weeks to eight weeks.

Secondly, there is a normal population trial which we carried out at three sites. For this we intend to recruit a minimum of 700 healthy donors aged between 27 years and 75 years. The group should be ethically diverse and gender matched. The Troponin levels of this group will be measured in both fresh whole blood and plasma. And the 99% trial those determined will be used as a cut off in our acute coronary syndrome trial. This second part of the study while logistically more difficult can be completed within a two month timeframe.

Finally, the chart and by far the most complex component of FDA study is the acute coronary syndrome trial. This study which will be run at five trial sites will be carried out of on a minimum of 50 notifications presenting in the ER, with symptoms suggested of ACS. Patients must be older than 21 years of age and will sign a consent form.

From these patients whole blood and plasma samples will be drawn at the time of presentation. Then a two to four hours followed by six to 9 hours and finally 12 to 24 hours. Furthermore these patients will be followed up at the 30 day, 90 and one year post admission in order to generate a prognostic claim.

It is difficult at this time to determine exactly how long it will take to collect all the ACS data. This heavily dependent on enrollment rates and also on prevalence, i.e., the proportion of people presenting with chest pain that will actually have a cardiac event. 13% seem to be the university accepted prevalence number. However we have seen significant variation in that number. To be statistically significant, we hope to recruit approximately 200 actual MI’s as part of the 1,500 patient cohorts. In consulting conservation with trial sites, we are currently projecting five months to collect this data.

As I mentioned before however for the data generated during the CE trial and from data more recently generated on the study on 293 suspected MI patients at Dr. Apple’s lab in Minneapolis. We are extremely confident that this product has the necessary clinical performance to gain FDA approval. As has demonstrated performance characteristic currently, needs and in fact exceed the FDA’s current performance guidelines.

Finally, as mentioned on the last call, product development that will be in pre-product is progressing well. We have reached design freeze and are currently transferring the product to manufacturing where batches of clinical trial will be manufactured. We expect to commence CE marking trials both in Europe and USA in mid-April with a view to having the product CE marked in the June timeframe.

A pre-IDE meeting has been set up with the FDA – will be set up with the FDA as soon as possible, to discuss the scope of the U.S. trials and assuming that they are no surprises coming out of that discussion, the U.S. trials will be get underway in June of this year with FDA submission expected in September.

Finally, we have recently commenced the development of the third product in our cardiac marker panel namely D-dimer. D-dimer is a marker for the diagnosis of DVT and PE [ph]. We are at a very early stages of development of this product and it’s difficult at this stage to get to make that timeline for market. However, I expect we’ll be in a position to provide a detailed D-dimer time on our next conference call.

So, in summary therefore, we are very pleased with the progress made today on the development of our high sensitivity Troponin and BNP products of sale. A significant milestone has been reached for the CE approval of our guideline compliance reporting product. And based on the clinical data obtained in both Europe and USA, we move forward into U.S. trials with a justified optimism of FDA approval in early 2015.

I conclude now, but we’re happy to answer questions later and I hand over to Ronan.

Ronan O'Caoimh

Thank you, Jim. And I’ll review revenues for the quarter and the year and discuss the business development before opening the call to question-and-answer session. Our revenues for the quarter were $22.5 million, up from $20.8 million. It is an increase of 22.2%, was when the impact of the Immco and the syphilis blood bank acquisition are eliminated the actual organic growth rate for the quarter was 6.2%.

Our HIV sales for the quarter were $5.1 million, compared with $4.9 million in the prior quarter, an increase of 4.4%. African sales increased 8% for the quarter, and with a very strong performance in Nigeria, we expect continuing strong performance, the strong revenue growth.

However, sales were down 4% in the U.S. compared with the prior quarter, and this reflect a reduced spend by individual states on public health programs due to budgetary constrains. However, during the quarter we began to benefit from our new HIV-2 Claim which was received during quarter four. As we won new business in hospital throughout the U.S. now that we have HIV-1/2 product, we’re confident of growing this business in double-digit terms year-on-year.

Our Clinical Laboratory business for the quarter increased from $15.95 million to $20.37 million, an increase of 27.3% over the prior quarter, before the impact of Immco and blood banking acquisitions are excluded. Our organic growth for the quarter was 7%, revenues on our life science business, such as Fitzgerald were down 4% over the prior quarter by the infectious disease revenues increased 4% over the prior quarter and the quarter excludes Immco and blood banking.

With U.S. performing satisfactorily and China continuing to perform very strongly. Three factors will transform our infectious disease and business. Firstly, the Immco autoimmune acquisition giving us obvious synergies with our infectious disease business. Secondly, our syphilis blood banking acquisitions, and thirdly the launch of our 10 new points-of-care products around the world.

We have now received CE marking on Clostridium difficile, Giardia, Cryptosporidium, GDH, syphilis, herpes, Legionella Urinary Antigen, dengue, strep pneumonia and in January we received CE mark on our h-pylori antigen rapid test, there are many h-pylori anti body test available around the world, but this is only the second h-pylori antigen rapid test available in the market.

Moving on to Immco, which we acquired at the end of July of last year, the business is performing strongly, and we’re confident of delivering the 20% growth annually that we spoke about at the time of the acquisition. And the U.S. is a blank canvas with virtually no reagent sales, but with monstrous sales potential. Given that over the past three years, the management have reconfigured and standardized the entire product range and have gained FDA approvals on the full IFA autoimmune products and ELISA range of products over the past 18 months.

Now our sales force upgrading the product range onto our existing installed instrument base right across the U.S. with significant success. At the Immco reference laboratory, which is a simplex low, as we launched in new children’s test, that’s dry eye test and this is being marketed through Nicox, which is a specialty ophthalmic company and the initial sales are extremely promising.

I’ll now move on to the blood banking business, which you’ll recall we announced the acquisition of this business which is part of the Lab 21’s business, last quarter for $7.5 million. The acquired businesses generate annual revenues of approximately $4 million of which $3.5 million is generated from syphilis products and the remainder from malaria products. And we originally acquired this business there were virtually no inventory and there were significant back orders, since the acquisition we have rapidly we reestablish relationships with the suppliers from key raw materials and dramatically improved project production levels.

We have since reduced stock orders to negligible levels and have not lost any customers whatever. The differentiated process is moving production as set of these products to existing facilities in Jamestown, New York and Ireland. This integration side is very much in target by mid quarters three of this year, we will close the manufactures facilities in Newmarket and Cambridge in the UK; this was a result of significant operation of synergies and efficiencies, which would be fully reflected in our results from quarter four onwards.

I will remind you that the business products were acquired that’s when required have the market share of 75% in each of the key blood banking markets of the UK, France, Germany, Netherlands, Switzerland, Austria and Belgium.

Our patient trial on acquisition was to broaden the markets into these products sold and in particular to focus on the U.S. market. This project is progressing well and we believe we will meet our stated goal of growing the business by 20% annually.

Moving on to diabetes, our business grew 11% when compared with the prior year quarter and with shipments of 93 Premier instruments during the quarter, we met our target for the year with the total of 321 instruments. All of our major markets performed strongly USA, Menarini and Europe and China. Very importantly, we recently received Brazilian regulatory approval to sell the Premier instruments.

We’ve invested in the direct selling operation in Brazil including five sales reps on the ground and we confidentially expect this market to be a significant success with our first sales being achieved during the current quarter. In summary, we are confident of achieving Premier sales of 460 units during 2014.

At this point, I’ll hand back to the operator for a question-and-answer session.

Question-and-Answer Session

Operator

Thank you. Ladies and gentlemen, we will now begin the question-and-session. (Operator Instructions) Our first question will come from Chris Lewis of ROTH Capital Partners. Please go ahead.

Chris W. Lewis – ROTH Capital Partners LLC

Hi, guys thanks for taking the question.

Ronan O'Caoimh

Hi, Chris, how are you?

Chris W. Lewis – ROTH Capital Partners LLC

Good. First question, I guess just is on potential guidance for the year, I know last year you gave a rough outlook for 2013 you talked about in 10% growth rate on the top and bottom line. Obviously, this year there is some acquisition impact and than you are assuming, but there is something you can provide any color and perhaps setting quantitative guidance for revenues and EPS in 2014?

Kevin Tansley

Chris, Kevin here. Just to take as you know our policy is not to give guidance, we gave maybe very sensitive guidance in the past and already is going to quantify at this point in time, the impact of acquisitions, we’ve grown to given very good treatment there, sort of the any opportunities are that are there in terms of revenue growth, but we’ve got a very good year ahead of in terms of both revenue growth and translates in terms of probability also, but we’re going to stick to our policy have not giving formal guidance that’s all right.

Chris W. Lewis – ROTH Capital Partners LLC

Yes, understood.

Ronan O’Caoimh

I think Chris, you do research and sort of Craig-Hallum, CJS and Sidoti and then maybe I think people wanted to have a feel for where we are going at exactly very usefully look at those support?

Chris W. Lewis – ROTH Capital Partners LLC

Okay, understood. And then turn into Fiomi now to CE mark in place. Can you just talk about the types of adoption you expect to see in that market this year and perhaps go into more detail on the commercial strategy you’re planning to take in Europe?

Ronan O’Caoimh

Okay, we got to CE mark on the Troponin products on the 29 of January as Jim said. We are now to pre sell the products to Europe, we’re going to sell product through our direct sales in the United Kingdom and we have refused to sale through more than one of the competitor point of care to Troponin products, to sell the product directly in Sweden, Norway and Finland so basic in Scandinavia and quite as clearly a familiarity among the cardiologists there with our product and with our trails, many of them had been involved in those trials.

Throughout the rest of Europe, we have now completed the appointment of distributors. In most cases, these are not our existing distributors, but rather the companies with experience of cardiac products and we are now organizing, it’s very importantly in conjunction with our distributors. We are organizing valuations over our product to be conducted by key opinion leader cardiologists in each of the major European countries. Basically those evaluations by key opinion leaders are just commencing as we speak, in the primary countries of the UK, France, Germany, Italy and Spain.

You may ask quite us necessary, I think it’s necessary given that the adoption of point of care Troponin test again in Europe has been marginal with testing volume joining at about 10% to 15% of U.S. levels. There is a much bigger awareness in the U.S. these efficiencies of existing point of care Troponin test given FDA activity and the much greater usage levels of Troponin test.

In Europe, realistic again in Europe in addition to converting users from existing to point of care Troponin test, we need to convince the cardiologist to move their Troponin testing from the 1.5 hour laboratory environment to 15 minutes test. I mean clearly there are no circumstances in which anybody feels like waiting 1.5 hours for an answer to the Troponin test.

If one can satisfy the market as the product is good enough and largely the market will move to the rapid test. There is no merits in waiting 1.5 hours only to enter and that’s very much what we need to do in Europe is unlike what we need to do in the U.S. because we believe there is as soon as a guideline compliance point of care become sale the cardiologist will no longer which use a non-guidance compliance test for good medical reasons and clearly also for insurance reasons.

And so I think in summary, the European Troponin opportunity is enormous and there are about $400 million of Troponin testing performed in Europe on an annual basis. The point of care products have already said is of good enough quality than testing will move from the laboratory to emerge through them, but we need to temper short-term revenue expectations, and it will be excellent that they will take time.

Chris W. Lewis – ROTH Capital Partners LLC

Great, and thanks for that. Yes, that’s great. And then how much is the cardiac U.S. trial going to cost.

Kevin Tansley

Somewhere between $3 million and $3.5 million, I believe.

Chris W. Lewis – ROTH Capital Partners LLC

Okay, great. And then if I could sneak one more and on the premier side, can you just provide some more detail on kind of expectations from Brazil and then when does the iron exchange version began contributing to that new placement number you talked about? Thanks.

Kevin Tansley

Okay, with respect to Brazil, we think it’s going to be a significant contributor, but we are just a little bit coy about giving you any numbers on adjust. We took up the approval literally in the last few weeks and so we have by the way just to explain, what we were doing and how we got approval so quickly is, we are actually manufacturing or assembling the product down there, built a product down the instrument, we’ll enter all about [Indiscernible] jump into Brazil quickly and as I mentioned that we are doing that – the third party is doing that first. And in this task, we have a point to deliver, set up a direct selling operation.

We are very optimistic what it can do, but that's what you see what it does, I mean obviously keep your best with us. So you are going to see is, our first sales in a few weeks time and there will be sales there but anyway in an event, we think it’s going to be a very important contributor a bit color but giving you a number, so what number we can’t give you is, we can say that we did 320 well last year in 2013 and we believe we do 460 this year. I think we can say that was reasonable confidence.

The key contributors to those numbers will clearly be Menarini, the U.S. direct sales, Chinese as we did 100 units and Turkey at maybe 30 units and of course Brazil. Then just with respect to your question about Ion Exchange, the Ion Exchange instrument has and we’ve completed it. It has been undergoing one of evaluation after another, the key needed around Europe, I think they’ve gone very well, and the product is about to be put into the market.

And so therefore, I think soon would be filing [Indiscernible] with Menarini in the sense that we would both have the built in synergy on the Ion Exchange instrument available and available in our markets.

Chris W. Lewis – ROTH Capital Partners LLC

Okay, thanks for the time.

Kevin Tansley

Answered the question, Chris.

Operator

The next question will come from Larry Solow of CJS Securities. Please go ahead.

Larry S. Solow – CJS Securities, Inc

Hi good afternoon guys, just a few follow-ups on Fiomi first, Fiomi anything positive or negative that you learned from the European trial that you’ve sort of adapted in your U.S. trials.

Kevin Tansley

Larry, definitely there are a few things. The first thing is we have learned a lot about recruitment here okay, the speed at which this tried want to actually comes to continuation. It’s all about recruitment of ACS patients and the trial we did in Sweden was quite an academic trial. It was owned by a group of academies and that trial this is running by the way, and trial will continue on as an academic program until next June or July.

But they took a very academic approach to it and they didn’t proactively try and recruit MI patients into the group. And so the trial is for probably three months longer than we would have hoped they would have done okay. Whereas in the U.S., we have five very, very strong in cardiologists, who really see the need for such a product, okay.

And they will be aggressively we at sort of cardiology nurses recruiting patients and that’s really – the product is exactly the same product as in Europe that is Europe as in the USA, but essentially it’s all going to speed the recruitment of our patients to get this thing true. And that’s really demand thing moving our cost from European, we know how to do it now. There are just no surprises for us.

Larry S. Solow – CJS Securities, Inc

All right, the results are also very good, in terms of D-dimer, really the timeline still little bit uncertain but could you just maybe stick to what the market opportunity potentially could be?

Kevin Tansley

The first of all, the D-dimer is a complex product okay, so we actually be – believe in our three FDA applications will see in the D-dimer okay. The first thing will be again part of the detection of D-dimer itself okay, which is fine and that’s what the most products have okay. The second will be an FDA application for our PE preliminary embolism, which is a separate clinical trial. And the third one will be which is re-needed where we need to get to is a claim for an exclusion claim, IE to be able to exclude D-dimer from a diagnosis, that cannot be done as a perspective study and then monitoring a patient over a period of maybe about one year, post the initial diagnosis. But the market itself for point-of-care is about $100 million worldwide.

There are very, very few players out there with good point of care products. But it’s going to take a while because it’s complicated, I’ll say, complex clinical trials and it’s going to take some time, but optimistically we hope that the product available that these are the first claims in Europe very early next year. But we still haven’t had a meeting with the FDA to determine what the need of the U.S. trials so, I’ll be a bit previous to sort of give you a figure for where we – how long to take now.

Larry S. Solow – CJS Securities, Inc

It sounds like you’d have to run obviously in the U.S. to the D-dimer upon their employees and then the exclusionary claim successively before you got approval or could you potentially get approval?

Kevin Tansley

You can get approval sequentially. You can get approval for diagnosis of DDT first of all. And at the same time not too far away from that because you can actually couple of trials to get that. So you do your PE and DDT trials together, okay. And then what you would actually do is monitor the patients in your DDT trial for a period of up to 12 months post the original diagnosis, and then you start to see a prognostic products you have given patients and sufficiently specific enough to take used or exclude DDT when a person comes and they get the results from your test on day zero.

Larry S. Solow – CJS Securities, Inc

Got it. Okay, and then you always talked a little bit, in terms of other opportunities outside cardiac, I don’t know if you guys have begun to look at that, but just hypothetically or potential other areas?

Kevin Tansley

Absolutely the beautify of the Fiomi platform is we’ve actually started with the hardest assays okay, proponent by far is the hardest assay. And then of course we have supporting, we have the BNP, we have the D-dimer, okay. The next believe it or not, one of the bigger assays in the ERs, so it’s in the ER panel we would like to go together. One of the – what’s interesting but a very significant market, hence really brought for blood pregnancy testing, blood hCG, which is the pregnancy test marker. ER, whenever lady arrives in the ER whatever trauma has effected her. The first thing that you need to do is determine, before to do too much manipulation or certainly run x-rays stuff like that, is to determine in if that lady is pregnant.

Urine pregnancy test, won’t work in that situation. I mean, in fact I have sent it also, pregnancy is one of the next products on our list, okay. There is obviously in the ER again, there is a number of markets for things like kidney failure or kidney damage or liver failure or liver damage and of course the holy grail will be a test for success in general in hospitals, for also in ER. So yes we have a program, we know very well how we like to do next, but there is only so much bandwidth we have.

Larry S. Solow – CJS Securities, Inc

Got you. Then real quick, switching gears to just to premier. Obviously you have some pretty aggressive expectations for growth and placement in 2014, and it sounds like qualitatively you gain more and more approvals. Does this 460 number, do you see that continuing to grow out as you go to 2015 and beyond?

Ronan O’Caoimh

Larry, Ronan here and I suppose what we think is we think that we have potential to go to about 600 instruments a year, which we believe constitutes to over 30% of where that placement. I mean that’s I think where we could see ourselves going and for the questions when we would get there. I think the answer is probably 2015.

Larry S. Solow – CJS Securities, Inc

Got you. And thus in terms of the reagent or royalty utilization is that been running sort of near your expectation of $10,000 per year and how has the ramp that I know you had further ramp has been a little bit slower than originally expected. In terms of ramp of utilization once the machine is placed?

Kevin Tansley

Yeah, I think instrument license have been probably more quicker than we anticipated …

Larry S. Solow – CJS Securities, Inc

The placement itself, so how about one such place, I mean is there …

Kevin Tansley

I think there is, I think in particularly in the Chinese market I think because some distributors used. I think there is probably a six to seven months gap between time it leaves Kansas City and actually ends up, actually operating in a hospital. Right, that’s a little bit disappointing and that means that given that we only got Chinese registration approval last June, it actually means that we don’t have got many instruments actually working at this moment of time

Larry S. Solow – CJS Securities, Inc

Right.

Kevin Tansley

By in fact replacing 25 in the quarter, but I mean that’s a one off. And jus to go back to your question about individual usage, yeah, I think $10,000 or $11,000 is about where is that and we hope that as Chinese usage increases because remember reinvestment is being adapted progressively more so around China, we’re hoping that number will creep up.

Larry S. Solow – CJS Securities, Inc

Gotcha. Okay, great. Thanks very much.

Operator

Our next question will come from Bill Bonello of Craig-Hallum Capital Group. Please go ahead.

Bill B. Bonello – Craig-Hallum Capital Group LLC

Great, thanks for taking my questions. Jim just a question on the trial. You described three components, do those have to happen consecutively or did they all sort of start concurrent way?

James Walsh

No, they all have to end with the same time Bill, you have to think. Okay, but what we’ll actually do is we’re going to start the ACS trial immediately because that’s the longest one that’s what I said five months maybe six months to get all that data’s together. Okay and that’s what we are actually activating right now whether to say we will be recruiting patients with that trial within two weeks of now. Okay, as soon as we get up and running into the pretty quick.

For the normal it’s actually relatively easy to collect normals, okay. And we’re talking about maybe running healthcare drives and that sort of itself pretty close to the clinical trials. You’re looking at three sites, happy to collect 250 samples per site that can be done – the samples can be collected within. If we’re lucky within three or four days and certainly a week and then we run them, and they are actually run by ourselves actually okay, but to run by the trials like coordinators, but and then the banks plasma from those samples will be taken and stored instead facilities in Hennepin County.

And then the actual procedure studies are really again very defined. Okay, it’s a matter of running multiple samples a number of times at multiple sites. So that will go on that wouldn’t take place sometime during the middle of the trail. In order of the rollout, number one we start the ACS that’s the longest one okay.

Number two, then when set up and running we’re pretty happy that it’s going according to plan, after one month, after month or so. We will then roll out the normal studies and then probably about two months into the whole program we get our – we catch our breath from the Montreal within the physician study. But we all need to come together at the same time as the results of the ACS study.

Bill B. Bonello – Craig-Hallum Capital Group LLC

Okay. And then would it be like in Europe where you’re certainly either have been slide into what the 99% trial ended up being and whether you’re able to detect at 10% CV. In other words is that part not blinded and where we something about that, ahead of sort of getting the final results on sort of chest pain study?

James Walsh

Unfortunately it won’t okay. The main factor is we are running 99% study, our 99% out study and yes, I’m sure we will know what our 99% highly is, okay and that will be a number. Let just assume the same number as in Europe okay.

So we will have that number, but that number is actually meaningless because not in just the complete 1,500 samples have been collected across all three trials packs, will the same be adjudicated by the 2/3 cardiologist okay, and its only at that point we then actually if you like putting the 99% number into our sensitivity, calculator and determine that the actual overall sensitivity of this one. Unfortunately in this case we have a nice academic trial running in and Europe probably had they reported back to us every couple of months. In this instance we will be running blind until the very end.

Kevin Tansley

Because actually we won’t know the diagnosis, the actual true diagnosis from our test until the very end, because we can’t the samples are blind until the very end, until we trug in our 99% number in there.

Bill B. Bonello – Craig-Hallum Capital Group LLC

Okay, that make sense, and then just two questions for Kevin. How should we think about operating margin in 2014 with some of the duplicative expanses carrying through a bit of the year and continued investment in cardiac and then maybe sort of how we should think about it longer-term?

Kevin Tansley

Okay the probably the three answers for that question, so the movement are roughly in around the sort of the 20% which where been for quite a while. I see it sort of continuing around that area sort of for the first half of next year. We will get an initial boast then from the closure of our Blood Bank Screening facilities which will help profitability and operating margin consequently.

And so you can start seeing it raising then. Then in the long-term you should see further improvements will come ultimately add of the Fiomi the cardiac business. Now we’ll say that the cardiac business in the near-term as Ronan approved in the sort of European markets and whether revenue is going to be a fraction of what the U.S. once are, that will be little bit of a drag there in terms of the sort of the sales and marketing cost associated with that and the sort of the lower volumes of production ex cetera.

And it should be sort of in and around where we are at the movement, bit of an improvement towards the end of the year, but an underlying trend where by Fiomi will definitely result in an improvement albeit not in 2014 and may not even be in the initial part of 2015, it’s really when the U.S. kicks in as when that will happen.

Bill B. Bonello – Craig-Hallum Capital Group LLC

Okay, but we should start to see then it sounds like at least margin holdings steady, so operating income growth sort of more in line with where our revenue growth is?

Kevin Tansley

Yes, I would have thought I mean with – yes, it will happen. I mean we’re going to be in and around 20% going forward for the initial quarters ahead.

Bill B. Bonello – Craig-Hallum Capital Group LLC

Okay. And then just thoughts on the tax rate for 2014?

Kevin Tansley

You see, we had a very good tax rate recorded in 2013 and as a point of that in the remarks earlier that was to a large extend due to the fact that Irish tax rates here considerably lower than in the U.S., the 12.5% being the headline corporation tax rate. On top of that there is a benefit relation to R&D tax credits which we do benefit from. Both of those factors will continue in the year ahead and beyond, the Irish tax rate has been confirmed with Irish government that we will maintain 12.5% for the years ahead. So as a target rate, I would say low double-digits and it could be improving upon that, 10% slightly lower.

Bill B. Bonello – Craig-Hallum Capital Group LLC

Okay. Thank you very much.

Ronan O’Caoimh

Can I just go back and one comment on your original question on just the blinding up the U.S. trials. I mentioned during the prepared remarks, so just to say obviously to help because this trial is going to take six months minimum and I know it’s blinded till the very end. To help us all sleep at night we obviously need to know that the outcome is going to be positive. To that end to make sure that the results obtainable in the U.S. are going to be equivalent or perhaps even better than in Europe, we have had over the last couple of months.

We have had Dr. Apple in the clinical trial on 293 patients within his hospital, okay and this was not fully FDA. It was purely to give us a good feeling of U.S. clinical trials would want to go and out of that 293 patient clinical trial, which is still running by the way, we will run it little bit longer. We are getting slightly, well, certainly equivalent and perhaps even slightly better data than we're getting in Europe. So we actually are – we have the confidence that moving into this thing that we are going to authorized side of the FDA in the end.

Bill B. Bonello – Craig-Hallum Capital Group LLC

And two things on that; one, will you release that data when it’s completed?

Ronan O’Caoimh

It's going to be published. We’re writing – well, Dr. Apple is writing an abstract to have it published at AACC and I have to get you with data as to when that might be published, but within the next few months.

Bill B. Bonello – Craig-Hallum Capital Group LLC

Okay. And then the second piece is that just sort of defining a normal population or does that actually have the sort of chest pain component too?

Ronan O’Caoimh

These are 293 chest pains. There will be no trouble with the normal population. Blood is blood, there are 293 chest pains and the data is pretty decent.

Bill B. Bonello – Craig-Hallum Capital Group LLC

Okay. But you had there the cutoff level that you choose, right? To do that?

Ronan O’Caoimh

Yes, we use the European cutoff levels and they were fully reviewed by three cardiologists as just like the FDA file. So it's pretty decent data.

Bill B. Bonello – Craig-Hallum Capital Group LLC

That's excellent. Thank you.

Operator

(Operator Instructions) The next question will come from Jim Sidoti of Sidoti & Company. Please go ahead.

James Sidoti – Sidoti & Company

Good afternoon. Can you hear me?

Kevin Tansley

Yes, Jim. Go ahead.

James Sidoti – Sidoti & Company

Great, great. A couple of questions on the acquired revenue. It sounds like between Immco and Lab21, it was about a little lower $3 million revenue from those two acquisitions. Is that right?

Kevin Tansley

Yes, absolutely. As Ronan pointed out, 6.2% will be organic growth within quarter four. So if you back calculate that would be the figures mentioned there.

James Sidoti – Sidoti & Company

Okay. Now is that split more towards the Immco side? Can you give us a little color on that?

Kevin Tansley

Yes, very much towards the Immco side. Immco is obviously very much, first of all, a larger MC to begin with and very much of a nodding in terms of how it’s business has been progressing. The Blood Bank Screening business, we acquired in some particular circumstances that were back orders of the time we’re getting sort of up and running in terms of normal production levels on that and are beginning to sort of meet demand on that. So coming from a different place. So, yes, very much weighed towards the Immco side.

James Sidoti – Sidoti & Company

Now when do you expect the blood bank business to get back to normal?

Kevin Tansley

We would expect, throughout quarter one and be fully back to normal by quarter two.

James Sidoti – Sidoti & Company

Okay, all right. And then, just a final question on the share count, it seems to be picking up as the function of the price going up, any plans to do any buybacks going forward?

Ronan O’Caoimh

Jim, Ronan here. I don’t think so, I think not with the current bank balances I don’t think that would make sense, you know.

James Sidoti – Sidoti & Company

Okay, well, I would assume by 2015 as the cardiac business picks up and the trial cost go down, you are thinking of taking a look at that in?

Kevin Tansley

Yes. Absolutely, obviously we all be looking at it, but I don’t think it’s our current intention, I wouldn't want to mislead on you that. I think with $22 million in the bank at this moment of time, I think it’s probably it wouldn’t make sense.

James Sidoti – Sidoti & Company

Sure, right. Thank you.

Operator

The next question will come from Ross Taylor of Somerset Capital. Please go ahead.

Ross Taylor – Somerset Capital Advisers LLC

Thank you. Most of my questions have been answered, but quickly, can you gives us an update on the point-of-care of syphilis test, you were looking for a waiver on that one which basically would from what I understand would significantly increase the value of that test?

Ronan O’Caoimh

Hi Ross, Ronan here. Yes. We continue to answer the FDA queries, we continue to corporate with them, and I am hoping at this stage that, when I think about the extend of the question, the extend of the queries, the extend of the expense we’re incurring, not they aren’t, but they have a willingness in principle to grant us a key waiver, and I think the best way I could just, answer you question is to say, I simply don’t know, but on balance we think we have 61% chance of getting a clear waiver from them. If you ask me, how I work that one of those, I really couldn’t answer you, with any way to satisfy, but our balance that kind of what we think, what I can say is that we do guess the clear waiver that the product will be a significant success for us.

If you bear in mind that the public health, the HIV rapid market in the USA is $58 million to $60 million and that probably $45 million of that is public health and the rest is kind of needle stick injuries in hospitals. Then there is no reason logically why, a syphilis test wouldn’t replicate the size of the HIV test in the public health lab which would be about $45 million.

I think it had that kind of potential, bear in mind there is no other product at this time we are the only syphilis approved product. We have a 510(NYSE:K) approval related to the clear waiver, the problem is at hospital and when they run a syphilis test, I have no really reason to run a rapid one day there, quite [indiscernible] blood. And therefore and syphilis approval without a clear waiver is really of very little value, I mean I think our current syphilis sales are running may be a couple of $100,000 a year.

So in summary, it has lots of potential and there is nobody else around basically you submitted any thing on this. We have invested very heavily in this, and we just simply don’t know where the FDA going with this one. They seem to have and these will look and it’s actually grant clear waivers, they don’t really like allowing sort of non – so they don’t really in principle kind of like the concept of people testing for disease outside of the hospital and doctor’s office. And so they have that kind of [indiscernible] but at the same time our balance given every thing we’ve gone through over the past two years. We think we wouldn’t be still doing this, we didn’t think we had a real fighting chance. Positively not a good answer, but I have given you a very honest answer.

Ross Taylor – Somerset Capital Advisers LLC

No, I appreciate it. So basically it’s a coin flip on what could be $30 million to $45 million market with economics similar to that what you see on the HIV test.

Ronan O’Caoimh

Yes, I think it’s visible the market ought to be a similar size and the difference would be that in the HIV there are three participants and syphilis, there would only be one.

Ross Taylor – Somerset Capital Advisers LLC

Right. Okay.

Ronan O’Caoimh

And our sales reps would be endeavoring to sell the syphilis product into the very same customers that already have the HIV product, which is the public health lab. So we have – into those labs.

Ross Taylor – Somerset Capital Advisers LLC

So if we see this approval, we think basically looking at 12 months out of run rate of equivalent to what the overall market for HIV is, right?

Ronan O’Caoimh

So I think that will be – no, I wouldn’t mind. I’m not going to say that we’ll be doing $40 million, but I think certainly it could be a year, could be a $10 million, $15 million bounce very quickly. I don’t want to kind of give excess of expectation here, but certainly in the context of Trinity Biotech it can be a blockbuster. It certainly has $10 million, $15 million immediate potential.

Ross Taylor – Somerset Capital Advisers LLC

Okay. Second question, since you don’t seem want to buy stock and you and I had this debate for a long time. We won’t have it here. What do you want to do with the $22 million in cash, particularly given that as you look at the model for your business 2015, 2016 should be massive free cash flow generation years?

Kevin Tansley

I think, Ross, we look at that as we move forward, but certainly we have cash generation opportunities, but in light of this moment in time given the extent of our plans I think we’re best sitting on our cash.

Ross Taylor – Somerset Capital Advisers LLC

Okay. Lastly, how many times a month does Roche call you?

Ronan O’Caoimh

I couldn’t really answer that on this call, but again I wouldn’t want to give you expectation by suggesting that they call us an awful lot. If you don’t mind, I think that’s a tongue in cheek question, Ross. I hope it is…

Ross Taylor – Somerset Capital Advisers LLC

Only this far it looks to me classy. It looks to me like you guys have what appears to be the only product that possibly works. I just had a family member who literally spend three days in the hospital because they made a mistake of having what the doctor thought might have been a heart attack on a Friday night instead of being intelligent and having it on a day when the experts were actually in the hospital, because the test that was run was ineffective and could not give them a comfort to send this person home. Obviously in the U.S. there is a huge market. Roche is actually not selling a product in the U.S. point-of-care market right now, correct?

Ronan O’Caoimh

Correct. Yes.

Ross Taylor – Somerset Capital Advisers LLC

And so it seems to be at some point one of these three players, because it’s basically a global market – one of the three, it makes sense, would attempt to jump the line and capture this product. I know you’ve in the past talked about whether you would license this technology or this testing to someone, but it seem made more sense to see if someone actually was willing to take the whole thing. Why am I wrong in that logic?

Ronan O’Caoimh

I don’t know that you are. You may possibly be right. I simply don’t know. I think what we need to do is – I mean, to move forward bring the product to the market and it’s just a wonderful product and that will be rough. I don’t see what else we can really – I think that’s the right thing for us to do.

Ross Taylor – Somerset Capital Advisers LLC

I would agree with you. I just think that there’s a chance that somewhere between here and there that someone attempts to – given science to science if someone attempts to get on the front side of that line?

Ronan O’Caoimh

Yes.

Ross Taylor – Somerset Capital Advisers LLC

Okay. Thank you, Ronan.

Ronan O’Caoimh

Thanks a lot. Thanks. Nice talking to you. And we had a breakdown. So I don’t know if anybody else wants to ask a question. It is 12 minutes past 5. So if there is one more question because we take one more. We can’t see the list. Operator, is anybody else asking questions?

Operator

One moment please, we’ll pause for questions. Okay, we do have a question from Bill Nasgovitz of Heartland Funds. Please go ahead.

Bill J. Nasgovitz – Heartland Funds

Ronan, I am sorry. Hello to you, I’m sorry I missed most of the call here, because of a conflict. But I just wanted to congratulate you and your team. My gosh, what a wonderful picture you have painted for shareholders and what a joy to have you back at Trinity. My gosh, I am thinking back to the better days of single digits, when things looked pretty tough.

Ronan O’Caoimh

Bill, you’re making me blush. Anyway thank you very much indeed. Thank you very much, all of the establishment here, it’s a very big team effort here you know.

Bill J. Nasgovitz – Heartland Funds

Well congratulations.

Ronan O’Caoimh

Thanks for that. Thanks Bill. See you soon. Thank you.

Bill J. Nasgovitz – Heartland Funds

Yes, bye, bye.

Ronan O’Caoimh

Thank you. Operator maybe could you close the call. I think I’ll close the call at this stage because we started a little bit later, apologies for that. Thank you to everybody for your support and you interest and we’ve told you, actually it’s not so many, it’s not so long, I think about the middle of April. So, it’s only about five weeks away, we’ll be talking to you with our first quarter results, look forward to that. Bye and thank you.

Operator

Ladies and gentlemen, the conference has now concluded. We thank you for attending today’s presentation. You may now disconnect your lines.

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