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Trinity Biotech plc (TRIB)

Q4 2014 Earnings Call· Tue, Mar 3, 2015

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Transcript

Operator

Operator

Welcome to the Trinity Biotech Fourth Quarter and Fiscal Year 2014 Financial Results Events. 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 at Lytham Partners. Please go ahead.

Joe Diaz

Analyst

Thank you, Amy, and I thank all of you for joining us to review the financial results of Trinity Biotech for the fourth [sic] quarter of fiscal year 2014, which ended December 31, 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 a question-and-answer session. Before we begin with prepared remarks, we submit for the record the following statement. Statements made by the management team of Trinity Biotech during the course of this conference call that are not historical facts are considered to be forward-looking statements subject to risks and uncertainties. The Private Securities Litigation Reform Act of 1995 provides a Safe Harbor for such forward-looking statements. The words believe, expect, anticipate, estimate, will, and other similar statements of expectation identify forward-looking statements. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development, commercialization and technological difficulties and other risks detailed in the company's periodic reports filed with the Securities and Exchange Commission. Forward-looking statements reflect management's analysis only as of today. The Company undertakes no obligation to publicly release the results of any revision to these forward-looking statements. With that said, let me turn the call over to Kevin Tansley, Chief Financial Officer, for a review of the results. After Kevin’s remarks, we will hear from Jim Walsh, on product development issues and then a cardiac update, and Ronan, will wrap up the prepared remarks with his perspectives on the quarter. Kevin?

Kevin Tansley

Analyst

Thanks so much, Joe. Today I’ll take you through the results for quarter four and the full-year 2014. Beginning with our revenues, total revenues for the quarter were $26.7 million. This compares to $25.5 million in quarter four of 2013, and thus represents an overall increase of 5%. Ronan will provide more details as to the makeup of this growth later on in the call. Moving on to gross margins. I think you will see from our press release this quarter’s gross margin was 47.5%, and this compares to 49.6% from quarter four of last year. This is consistent with the trends in other quarters this year whereby gross margins have been lower than in the equivalent quarter of 2013. This is mainly attributable to sales mix due to lower line sales, which have higher gross margins, and higher instrument sales, which conversely have lower margins. And moving on to our indirect cost, our R&D expenses for the quarter decreased slightly compared to quarter four 2013 to just under $1 million. Meanwhile our SG&A expenses have increased in the quarter from $6.5 million to $7.2 million. This is mainly due to sales and marketing costs associated with our cardiac business, which is currently not generating matching revenues. Operating profit for the quarter was $4.3 million. This compares to the higher figure of $4.8 million in 2013, and here we are seeing the combined impact of the lower gross margins and higher SG&A costs. Operating margin this quarter was over 16%. Moving on to our net financial income next, this quarter we earned $14,000, which is a decrease from the $118,000 earned in equivalent period last year. Meanwhile our tax charge for the quarter was $187,000 and this represents an effective rate of 4.3% which is slightly lower than the same…

Jim Walsh

Analyst

Thank you, Kevin. I'll take the opportunity to update you on the progress on our cardiac marker development program. In particular, I will like to provide you with a detailed update on our Troponin clinical trials, which I'm delighted to say, has restarted and is once again recruiting patients. I'll also update you on our Meritas BNP product, which as you know, obtained CE market improvement in Europe late last year. Firstly, and probably foremost on your minds, let me address our Troponin product, and the recent recommencement of our U.S. clinical trials. As you know, in October last we announced the temporary suspension of enrollment into our Troponin clinical trial in the USA. The reason for this temporary suspension was the observation of higher than normal CV's in whole blood data. Essentially when testing very lower level whole blood samples for Troponin, we absorbed an increased spread in the data from what we would have expected to see. Following a root cause investigation, the problem was positively identified as a formal change to a chemical dye, which is purchased from a third-party supplier. All clinical trial size which had received batches of the product manufactured using offending chemical were instructed to discontinue patient testing immediately, and all clinical data generated using the effective batches was identified quarantined and excluded from the clinical trial data session. So since October last, multiple new batches of the chemical, in its original format, have been obtained from our supplier, and multiple new batches of Meritas Troponin product has been manufactured and extensively tested. The result of this work is that a product is again demonstrating the same excellent clinical performance as witnessed in our European CE trials, and indeed in the independent clinical evaluation carried out by Dr. Apple, at Hennepin County Medical…

Ronan O'Caoimh

Analyst

Thank you, Jim. Now, I got to review our revenue for both the quarter and the year and discuss the developments before opening the call to question-and-answer session. Our revenues for the quarter were $26.7 million, up from $25.5 million for the corresponding quarter, which is an increase of 5%. However, when the impact of the strengthening dollar is excluded, the real increase is in revenue for the quarter is 6.4%, which is all organic growth as the Immco of blood banking acquisitions were completed prior to quarter four of 2013. It should be noted that the significant weakening of both euro, and the weakening of the Brazilian Real, serve to reduce our dollar sales in quarter four. And that this weakening continued, actually intensified during the past few months. If rates stay as they are, our 2015 revenues will be 3% lower than they would otherwise be. But it should be noted very importantly that there would be a corresponding reduction in euro and Brazilian cost base, and the overall impact would be a wash as in no change to profits. In summary, if revenues, sorry, if the exchange rates stay where they are, our revenues would decrease by 3.5% and our cost would also decrease by 3.5%, therefore, basically be making no impact on EPS. Moving just back to looking on our revenues. Our HIV revenues for the quarter were $5.5 million, up from $5.1 million, which is increase of 7.1%. African sales performed strongly, showing growth of 9% with shipments to Nigeria, in particular continuing to increase. In the U.S., our HIV sales increased 3% over the prior quarter with hospital sales performing strongly aided by the fact that we are now selling an HIV-1 HIV-2 product since we got a HIV-2 FDA approval last year. Public…

Operator

Operator

[Operator Instructions]. Our first question comes from Bill Bonello at Craig-Hallum.

Bill Bonello

Analyst

I just wanted to follow up a little bit, Ronan, on the comments the seconds that you just went through on some of things that are driving growth. And I guess may be a twofold question. I guess I'm wondering, if in addition to line, if there are other legacy businesses that are either hardly growing or may be declining year-over-year, because with the positives that you've listed at the strong premier placements what seems like it should be good consumable pull through, the new HIV product, the traction you're getting on Sjogrens et cetera, it seems like we should be seeing may be better organic revenue growth than what you're putting up. And so I guess I'm just -- I'm trying to have a sense of what are the offsets to those things, may be what are you really seeing in terms of premier consumable revenue right now and then again, what the outlook may be for 2015 would be?

Ronan O'Caoimh

Analyst

All right. Just to tell you about that lyme is not a declining business. I mean lyme is basically we have 100% of lyme confirmative business in the United States and it’s not a declining business. In fact, I think we took a 10-year graph, there’s more people being bitten. But it took that basically a severe winter can have a big impact, so we've had two bad winters, well from our two bad -- from our perspective but clearly nothing in the public interest. But in any event so that’s not a declining business. But just to talk about so but just look at the components of our business like what's declining and what's not. Clearly artists show that our Monoclonal Antibody selling business is a flat business. We haven't given up in terms of growing it, but it is flat, although months just say profitable. And so that’s basically $10 million, $11 million component that just basically refuses to grow and drives our overall growth rate down. And I think the other piece of our business that we struggle to grow and I think people who know the business well will hardly be surprised by it is our infectious disease line of business the traditional measles, mumps, varicella, [indiscernible], all those business that business right is a difficult business to grow because of the fact that you said drive is only from two sides, one basically labs are closing or sending us up to Quest & LabCorp, and the bigger -- and then the bigger hospitals are using the big average instruments or whenever so we're kind of being squeezed in the middle, and that’s certainly is a challenge for us to grow that business. And that’s one of the logics behind getting involved in autoimmune where a customer really wants autoimmune there is a real, real demand but there is very few competitors and it runs on our existing installed instrument base. But there is no doubt that so what we struggle with really basically is, is obviously Fitzgerald and the infectious disease business albeit not the lyme component rather. But I think everything else we have basically promises really impressive growth in the future, hence its premier, high resolution, our HIV business now obviously greatly supported by its companion Syphilis product, and of course then I think monstrous potential of cardiac. I think that’s -- that’s basically -- that’s what's happening there and we believe it is that we can move from kind of fairly 5% to 6%, 4% 5% 6% organic growth into strong double-digit growth as basically, as the growth drivers basically contribute a bigger and bigger share of the business.

Bill Bonello

Analyst

Okay that’s helpful. And just a point of clarification just so I make sure I'm not confused here. I appreciate your sentiment on lyme not being a declining business sort of overall trend. But did I hear you right; I mean it was down year-over-year because of the weather et cetera this year?

Ronan O'Caoimh

Analyst

Yes, I mean yes and if I guess the second consecutive year it's been down. But we are -- recollect that the previous winter was a very, very long winter in the East Coast.

Bill Bonello

Analyst

Okay. And then just a second point of clarification, with premier, where do you think you are these days with consumable pull through, are you still holding to the 10,000 per instrument, how many instruments do you think there are actually generating that amount of revenue or if that’s hard to get a visibility on. Just trying to get some sense of where we're at with premier consumable revenue today and at which point that that really high margin growth starts to offset the impact of the lower margin equipments?

Ronan O'Caoimh

Analyst

Well just to say then, we paid 460 instruments this year; I think 320 the previous year, and the first year 200. So we have 1,000 instruments in the market now let's say probably 900 of them are probably up and running. There is always six or seven months particularly in China where it takes a bit longer to get into the market. In terms of how they're performing Menarini, is performing amazingly well in terms of the actual number of tests per instrument but it's probably selling less instruments than we had expected. But so guys we have originally I think talked about to 11,000 test per instrument in fact we’re running in 22,000 or 3,000. So with less instruments and that reflects kind of consolidation, in particular in their strongest markets which are Spain and Italy which is being through a recession. And USA performing reasonably strongly certainly very good volumes, but remember USA is primarily in immune assay market so the overall size -- the overall available market is great. China is probably the most disappointing lots and lots of instruments but not as much reagent as you'd like. But that’s what we kind of expected. Because basically the Chinese are in the top today one see, and the government is reimbursing and bought the actual individual doctor in the village hasn’t quite tuned into it yet and that’s kind of an evolving scenario. And then Brazil, and Brazil what can I say about Brazil, I mean just wonderful, I mean huge numbers of instruments and very big value money to each instrument so it's kind of a mix but overall Bill to answer your question it’s about probably marginally ahead in terms of volume per instrument than what our expectation was.

Bill Bonello

Analyst

Okay. And in terms of the gross margin, do you think 2015 could be a year where the consumable pull-through starts to offset the instrument dilution to gross margin or should that not, should we not be speculative?

Kevin Tansley

Analyst

No, I think this is really what you’re going to see it I mean, we now have a basically I mean I think in, during January we sent out a 1000 instruments -- and by the end of the year will be up to 1500, around 1500 instruments. So every instrument is an additional $1100 of ongoing revenue at a very, very high margin. So, you tip the balance at some point, clearly you’re improving all the time.

Operator

Operator

The next question comes from Larry Solow at CJS Securities.

Larry Solow

Analyst

Just one quick follow-up in terms of placements Brazil had a really good year for premier. Do you expect that to continue and what the -- if you had to put out a business at about 500 placements you’re targeting for '15 or bit of more than that?

Ronan O'Caoimh

Analyst

Larry, I’m, yes -- I think 500, we gave it 500 now take it, it’s a little bit there and we’re very close to 500 may not quite get to 500, but that's what we hope to do. And in terms of Brazil, yes I think Brazil will have another equally good year, might even surpass this year. Now I can't keep doing that because you end up in a situation where you’ve most instruments in the market. But I would say we could certainly have will have a great 2015 and a reasonably good 2016 and after than we’re going to have just good years, but there’s only so many instruments being replaced every year, you can't keep doing a 120 in Brazil.

Larry Solow

Analyst

Right. And just long-term as a acute number do you sort of typed all around the 5, 550 mark is that something that got to?

Ronan O'Caoimh

Analyst

It’s going to be -- I think it’s going to be I think we will mature at sort of in the 500 somewhere in the 500 I don’t think -- I do not convince we will get to 600 its more or less what I've been indicating all along somewhere between 5 and 600 will be maturity. Bear in your mind, I mean 600 will constitute 70% of all the instruments and tapes in the world.

Larry Solow

Analyst

Okay. Just turning to the Meritas just in terms of the modest delay in BNP might that not really matter because what in -- is it possible the FDA would considering the both of the filings were going to be relatively soon or relatively at the same time might they look at both together considering to new platform. And on the flip side, I think you probably wouldn’t, you might not launch until they’re both ready to go, anyhow, so is that a fair assessment?

Jim Walsh

Analyst

Sure. Larry first of all the FDA will handle them absolutely as two separate products, okay. They just don’t want -- it will be two separate applications and there will be two separate evaluations by FDA. So there is no bundling there to say like that. They will go in very roughly the same time okay to the FDA. My own gut feeling is that Troponin is a much more complex product. There is no doubt about that, much more complex product to evaluate. BNP is there are three or four already on the market so there is no and in fairness, they are decent products. They work reasonably well. So I think the review the process for Troponin will probably take a couple of months longer than it will for BNP and I would -- it was a bet on it, I would suggest BNP will come out first product by Troponin. But we are talking weeks -- couple of months tops difference in the two. And I think I doubt whether we would launch BNP first without coming with Troponin because Troponin is the real driver here and BNP is the add-on, if you know what I mean?

Larry Solow

Analyst

Absolutely, right. So at the end of the day, might I make a big difference for you guys Troponin you would be waiting for that anyway?

Ronan O'Caoimh

Analyst

Ronan here, I mean, you wouldn’t see Troponin, you wouldn’t sell BNP, you wouldn’t get an instrument place, BNP in its own so therefore you wouldn’t launch BNP without a defer. All you to do with BNP is make sure it gets approved at the same time as Troponin or there's earlier no advantage really.

Larry Solow

Analyst

Got you. Sjogren in the quarter, would give how much sales they’re actually doing what’s sort of your outlook for the next 2015?

Ronan O'Caoimh

Analyst

Well I said I did just over 550 in the quarter. But it’s very remarkable, I mean we’re only did a National launch in June. One thing I should just mention is I will mention is that we have a distributor who basically sells it basically into the atomics around the country and that distributor was Nicox. So probably something you never heard small French Public Company. But they sold their business to Baush & Lomb during the quarter. And Baush & Lomb had a very, very big sales, atomic sales, atomic sales force. And so basically we regard that as a very, very positive development. So Baush & Lomb went out and paid basically quite a lot of money for basically the business is our contract in essence and so I think that’s the positive development. In terms of its potential difficult enough to assess given that now we’re also dealing with a new owner but I --

Larry Solow

Analyst

You kind of long-term what kind of product could this take, assuming its middle of the road or whatever it’s see – is it the new owner or is not better or not worse and what Nicox was in terms of your expectations?

Ronan O'Caoimh

Analyst

Just to say the new owner would be a lot better because the new owner has actually targeted this as an acquisition basically and is based quite a significant I mean it's quite -- paying a quite significant fee for it. And the only thing that was in that business was our distributor agreement basically just recent agreement. In terms of what I can do, I’m just submitted a coy, by kind of saying a number, but clearly as more quickly and I can grow more. But I'm just not going to say a number if you don’t mind.

Larry Solow

Analyst

No, no, no, that’s fair number. Just lastly on syphilis, we anecdotally we as early in the game and firstly where we’re in the simplest market but it certainly sounds like at least anecdotally things are going well. Could you just remind us what your expectation I think you have some public expectations for 2015 correct on that for sales?

Ronan O'Caoimh

Analyst

Yes, well I think if you looked at the presentation that we make to investors and if you look at our website, you can see that well we talk about as we say, and I mean this is just this is kind of a guess. We take $2 million to $4 million in this current year of 2015 and then we say $4 million to $8 million in 2016 and then we say $10 million plus in 2017. So and then what I said today well as I said HIV is a $50 million market, will be 20% of it, which will be $10 million, will we be 40% which is $20 million. I said, I don’t know. I mean, I actually just don’t know. What I do know is that we’re out to door with enquires and we have been in contact with all the 50 individual state public health department and most of the city’s, most of the actual contacts have been initiated by them in most instances, they came [indiscernible] immediately. The CDC are supporting this whole thing very, very in a major way. I think people may have noticed that the FDA did a very unusual thing which I never did they actually put a press release out about that. They put a press release, it’s certainly outside my experience and so we’re very enthusiastic about it, but we’re just reluctant to say a number and build an expectation that wouldn’t materialize. I think what's really important to here is the run rate we achieved by December or indeed by whatever months you take and give an apple it’s still the run rate that matters. In terms of quarter one it's going to about 100k it might be 150, but its small enough because each of the individual, as I outlined in the prepared notes there, each of the individual states have to go through such a big long routine. I mean they can't just buy I mean that sets the whole procedures.

Larry Solow

Analyst

Right, right. Understood.

Ronan O'Caoimh

Analyst

But so the real thing is what's going to matter what the run rate is towards the end of the year. What I would say this just say to this and without quantifying it we are really very optimistic about its potential.

Operator

Operator

The next question comes from Jim Sidoti at Sidoti & Company.

Jim Sidoti

Analyst

Good afternoon, can you hear me?

Ronan O'Caoimh

Analyst

Good afternoon, Jim.

Jim Sidoti

Analyst

Great. Just following up on syphilis, so do you think you will ship any in the first quarter or do you think that will be more a second half of 2015 product?

Kevin Tansley

Analyst

No, Jim, we said we said we ship about 100 to 100 grand may be quarter one. So we got it won’t be any public health it’s got a community-based organization things like that are actually just buying. You won’t land any actual orders but what we’re doing is sending 5 and 10 tests for evaluation that kind of thing to the Public Health Departments. So I think what soon happen is I think virtual all, maybe even all high, difficult to know how much is high.

Jim Sidoti

Analyst

Okay. All right. And in terms of BMP, the change in regulatory approval strategy, does that have a significant impact on the cost?

Ronan O'Caoimh

Analyst

The answer is a little but not a lot, okay. There are two parts of the trial. Firstly, we have to run about 500 or 600 normal patients, okay. These are patients who don't have heart failure to get a baseline, if you like, okay. And we are piggy-backing that on the same set of [indiscernible] or recruiting for the Troponin trial. So it's an extra few blood to be taken, not more than that. So that's insignificant. Then we have to get about 650 heart failure patients. Now, we had already suggested to the FDA that we would recruit 300 heart failure patient, so we -- it's an extra 300 patients, it's the cost of this particular change and call dose for -- it could be 300 by $300 maybe, something like that, okay. That is the probation[ph]. That's the sort of -- then there will be a little bit of demand on that sort of stop, but it's not mega books.

Jim Sidoti

Analyst

Okay. All right. And then, in terms of the trial for Troponin, in the press release you said you have 12 sites, are they all running now and are they running at the level they were prior to the trial suspension?

Ronan O'Caoimh

Analyst

Like everybody else, it takes a while to get up to a speed but they all are running. And by the end of the month, I would have thought, by the end of March, it will albeit go through the floor collecting samples.

Jim Sidoti

Analyst

Okay. And then, finally, can you just review what your distribution strategy will be for Troponin? Ronan, you've indicated you have got some extra cost for sales and marketing people. So are those people in-house or are those on board already, those people? And how many folks you think you're going to need to sell the product?

Ronan O'Caoimh

Analyst

We're already having a good sales force in the USA. And some 30 people in USA, so they will take the products in States and they've been preparing for us. I think most of the support -- most of the spend -- actually, we have at the moment more marketing spend and a whole support mechanism on the ground for trials. Like as a matter of -- for example, I mean we have three teams of people traveling consistently, and these are sales and marketing personnel who travel consistently between the trial sites for example. And then, we would have two product managers in Europe handling the European evaluations. We have direct sales guy in Sweden who was basically setting his hands after this difficulty we had for few months and now is he would say he should be the happiest thing to have. So basically he hasn't been in the position to sell, he has no product to sell. But has again product to sell. So John, is that spend, which is $2.3 million this year. So basically, $2.3 million spend with revenue attaching. So I'll just make it the point that it hits our P&L, hits it hard.

Jim Sidoti

Analyst

Okay. All right. And I guess that's it for me. Thank you.

Ronan O'Caoimh

Analyst

Thank you.

Operator

Operator

The next question comes from Chris Lewis at ROTH Capital Partners.

Chris Lewis

Analyst

Hi, guys. Thanks for taking the questions. First for 2015, I understand you don't give a guidance, but can you at least provide a high level overview of how we should think about revenue growth in 2015?

Kevin Tansley

Analyst

Yes. Well, you're absolutely right. We actually don't give guidance. It actually makes that question somewhat difficult in some respect. But I think what Ronan has done very well in the call is outlined the number of opportunities that are out there in terms of growth. So obviously, the Premier business is going to continue growing. We're going to have our first Syphilis sales. Sjogren is looking very good. And I suppose the only lifeline ointment[ph] in terms of revenue growth per say is the currency, which could knock about 3% off with the key point there, that's not going to have any impact profitability-wise. So definite growth next year. We're not putting a number on it. We've said in the past we'd like to target double digit growth. So you can read within that what you will. And that would be taken into account the FX sort of about versus movement [indiscernible].

Chris Lewis

Analyst

So double-digit longer-term, but you'll actually measure it, 5% I think you've been growing kind of organically in that five to mid-single-digit range. So what gives you confidence to get back up to that double-digit outlook?

Kevin Tansley

Analyst

What we're seeing is a lot more things coming through. I mean I'd say Ronan will give a very good description there. There are sort of the number of things that are actually happening in the company. We have had a couple of bad years in-line. Back hand continue, retained all the business, but we have these sort of suffering from the bad years, little bit of headwind for us. We would hope that that would eliminate at the same time as Premier sort of continues to grow and get the pull-through in terms of the high level of installed base. We are going to have to say we have Syphilis, and our autoimmune business continues to growth. And particularly, there you're seeing Sjogren already over $2.2 million run rate as such.

Chris Lewis

Analyst

Okay. Great. And then, in terms of operating margins you laid out incremental investments with cardiac, clearly in 2014, expect those continue in 2015. How should we think about operating margins from the 2014 levels and kind of what are the key levers there?

Kevin Tansley

Analyst

Well, obviously again you're going to -- the business like ours where the cost base tends to be reasonably fixed in terms of how revenue would operate. So I'd say as the revenue comes through, we shouldn't see improved margins, should be contributed to fact hopefully restored, line sales, improved pull-through in Premier instruments. We get good margins on the Syphilis business as well we would expect. So we would expect vast improvement in gross margin combine the higher revenues would then provide leverage on the operating margins. The operating margin has been somewhat surprised by the factors we talked about earlier in the call. So we'd expect an improvement throughout the year.

Chris Lewis

Analyst

Great. And then on the Troponin side, once you submit that to the FDA, can you walk us through the regulatory review process the different steps involved there and then timing expectations for a potential approval decision?

Ronan O'Caoimh

Analyst

I'm assuming this is -- you're suggesting post having submitted the application to the FDA, yes?

Chris Lewis

Analyst

Yes.

Ronan O'Caoimh

Analyst

Yes. Well, the normal processes, okay, as far as I understand with the FDA is that that when you submit -- they have 90 days essentially to review the dossier that you put in, okay. And that dossier consists of all your clinical trial data, your all the sort of interfering substances data, et cetera, et cetera. It’s a pretty big pack of data, okay. So they have their 90 days to review that and invariably and I will say. So two things are going to happen. A) It can say everything is perfect and we approve you. So the shortest time could be 90 days, and they generally do not come back a couple of days before that 90th day in any case, okay. I would suggest that’s unlikely in this case that it's such a complex product and have changed sort of the like the rules around cardiac and expectations around Troponin have changed over the years, I would suggest that they'll come back with some questions, okay. What those questions I don’t know obviously because we've had three individual calls with the FDA to scope out the trials, to disclose all aspects of the trials and we are following that letter of the law as you can imagine to make sure that we're supplying everything that we believe they think they need, okay. But I would suggest they will come back with some questions. What they will be, maybe they'll ask for more data, maybe they'll ask for different statistics to be done on the data but you expect some questions. You will then have to run prepare an answer submit that in. We will try to do that within, depending on the question, we try to get those up just back in -- in a couple of weeks of getting the questions. But if data hasn’t generated maybe a month may be even six weeks then it goes back into another 90 day cycle, okay, there are 90 days to review that and approve. And you would expect at that stage if the answers to the first two round of questions are appropriate and correct that next time around you should be hearing the word approved. But there is no guarantee there either, they have the right to come back that they have to answer -- they're going to come back as often as they want to with questions but that’s the process but it goes in 90 day cycles.

Chris Lewis

Analyst

Perfect. And I think you may have mentioned it, I missed it, how many tests there need be performed to complete enrollment?

Ronan O'Caoimh

Analyst

We believe they need more than 1,000 patient samples, another 1,000 patient samples for the heart attack trial.

Chris Lewis

Analyst

Okay, that’s it. I appreciate it, guys, thanks.

Operator

Operator

The next question is from Ross Taylor, Somerset Capital.

Ross Taylor

Analyst

Yes, thank you, Ronan, for providing some of the cost related to Troponin and its impact on the EPS line. Could you also tell us what were the cost related to the blood banking facilities? You were running kind of dual facilities in moving over during the year. How much did that cost us?

Ronan O'Caoimh

Analyst

That’s not something about just what's that’s something not impacting in quarter four just to clarify, that something that was cleared up in quarter three.

Ross Taylor

Analyst

Correct.

Ronan O'Caoimh

Analyst

Just in case there is any confusion there. The, we were rolling the two facilities for the first seven months of the year and -- we would have closed it in July and once we've moved then over to Ireland we would have staffed them with personnel from here and ditto to in relation to the U.S. The extra sort of cost tying the two businesses and sort of the incremental staff because we managed to do with lower staff here, as you can image, given we've got all the infrastructure in place, we estimate that the adverse impact of all that things would be about $0.07 in EPS terms.

Ross Taylor

Analyst

So basically, we've lost $0.10 a share during the year -- to not loss, but we had a negative impact of $0.10 a share to Troponin and another $0.07. So basically ex-that you would have, the company would have earned about $0.93 a share in the year ex those two issues?

Ronan O'Caoimh

Analyst

Right, yes.

Ross Taylor

Analyst

Okay, which is fairly significant considering there are people out there who basically are valuing your core business at $12 on the sell side including Syphilis, which seems to me to be a little bit on the low side to what would be realistic. Also, you had $24 million in CapEx during the year. Could you look at give us an idea what a normalized run rate going forward should be?

Kevin Tansley

Analyst

Yes, so what I will say there on the $24 million, but what's significant expenditure there in PPE there was some manufacturing equipment that we purchased. We have, we did purchased that will not be recurring at that sort of levels, so I can see that falling by somewhere between $1 million and $2 million. The remainder then is in relation to our project and such. And again, once we get to the trials out of the way etcetera you can sort of see a substantial pull there, based on the projects we're running at the moment. So the extent to which we enter into new projects obviously that is something different but I have to comment on that at this stage just to say you could see it tailing off there $2 million to $3 million as well.

Ross Taylor

Analyst

Okay, so the $24 million number should fall somewhere probably in the $19 million to $21 million exing new projects that you guys put on?

Kevin Tansley

Analyst

Yes, of that order.

Ross Taylor

Analyst

Okay, once again fairly significant. And then could you talk about the market potential for resolution in Brazil, and is that something that will also have opportunities outside of Brazil?

Ronan O'Caoimh

Analyst

Yes, and Ross they're on, yes -- I mean just to remind people our legacy business was resolution and we only kind of diverted into mainline diabetes testing. So the original business we have that core of $12 million, $14 million business was the resolution, but always kind of holding us back was that we had the old Ultra instrument that really needed replacement, and now we've done that. But what's in there is that we supply Quest & LabCorp if we do just about all of U.S. resolution testing so far -- testing most commonly known is sickle cell anemia and of course all the newborns progressively around the world have been tested as well for variance. So is a big market, it's dominated by Bayer AG. We now with the launch of the high res instrument have a really, really compelling offering we believe. And we're just beginning to get going in the United States. I think we have two of the states; they would have the rest. And then outside of that, we just basically one Rio and Sao Paulo and corresponding regions in Brazil which is a big breakthrough for us. But that is the success that we hope to replicate in -- with the European mega labs; it's mostly mega labs that run these variant testing, it's a very specialized area. So we have our [indiscernible] we want to do sort of get into the big Japanese labs and the big French [indiscernible] etcetera not beyond the [indiscernible]. And so that they're on that target; we think we have the wherewithal to do it. So I think the key point is -- it’s a high resolution which has been kind of stagnant business relatively over the past four or five years I think will no longer be that; I think it can become a growth engine for us as we move forward. That’s the point trying to get across today and I think the first big breakthrough for us has been the Rio and Sao Paulo neonatal market. And basically -- over 60% of all Brazilian newborn babies now are being tested as of a month ago with our high res instrument.

Ross Taylor

Analyst

Okay, and back on the cash flow side of things. As you move forward, it sounds to me this company a few years ago was generating $12 million, $13 million a year in free cash flow; it's you gone to where, the comment was made with basically you finally had a quarter, first quarter in sometime where you didn’t have a cash burn. One would expect that this company should that this company should move back to be in fairly aggressive cash flow generator as we move even through this year as you put some of these one-time expenses behind you and as we start to develop revenue streams for things like syphilis as well as eventually Troponin/BNP.

Kevin Tansley

Analyst

Yes. I mean overall for 2015, you've got a number of factors which are going to help our cash flow going forward. Obviously, revenue growth is one, and expect to improve margins, as I mentioned earlier on, if we get our line sales back which tend to be higher margins we were moving from a phase whereby the instruments revenue isn’t dampening our Premier overall revenue so the pull-through is going to become a great proportion that will help us from a revenue point of view. We'll get operating leverage as per the questions that Chris would have asked. At the same time once we get through the first half of the year and the trials disappear we're going to guess a sort of a lift from that a cash point of view as well. So throughout 2015 things should improve from a cash perspective for the accumulation of those factors as such.

Ross Taylor

Analyst

Okay, so then I'll put off to the second quarter call the idea of pushing you on using some of these free cash flow you are going to be generating to buying in stock because it seems to me that right now the core value of our business, if you are actually owning about $0.93 in the core value, probably is worth roughly or perhaps even more than the stock is trading at if we look out 12 months given the ramp-up in Premier and the like. And as you move to where you are not spending capital on some of these are the one-time items that would strike me as a very positive use of capital, and I think speaking to a lot of your shareholders I think they would agree that the company get into the market again; you are in the market not all that long or a while back but not all that far price-wise but this company has developed pretty favorably in that timeframe although the earnings have been masked by al lot of these one-time charges.

Ronan O'Caoimh

Analyst

Okay. Thanks for that.

Operator

Operator

Our next question comes from Randy Saluck at Mortar Rock Capital.

Randy Saluck

Analyst

Hey, guys. Well I guess part of disadvantage of being last in the queue is that everybody asked the questions that you are going to ask. So I withdraw my questions. Next time move me up a little.

Ronan O'Caoimh

Analyst

You sure will have and then pick up something to ask us.

Randy Saluck

Analyst

Well if I have to think of one the only question that I would have is what do you have to do is a company is to get ready for selling Troponin? You mentioned that your sales force is 30 people. It seems like given the massive opportunity that Troponin represents you would want to add sales people. And that also leaves me the question who busy are they right now?

Kevin Tansley

Analyst

Well I mean probably will add, we will add people; there's going to be a lot of people but the model we use is a generalist model. So our sales reps basically sell everything that we have. I mean, they are very busy at the moment. I mean clearly, the syphilis opportunity is top of their agenda as we speak and the put a lot time with Premier and to the neonatal side of things, etc, etc. They are selling everything; they are busy, but just as of today we have been progressively training them in cardiac and they for example have been meticulously working from household to household as they visit them in the normal course of their duties and would be would know for each hospital what is SWOT, how to handle Troponin, what point of care product is being purchased, how many instruments there are, when they are due for renewal and what the usage rate and all of that. So basically you can imagine that we have a big body of information developed and they are ready to go. But we will add some people under you.

Ronan O'Caoimh

Analyst

And then, thanks very much, it's gone past 5 o'clock. I see Bill. I think Bill Bonello might be just asking. If Bill you are could we make up the last question please; I don’t see any of the questions on the list.

Operator

Operator

You'd like go have Mr. Bonello's question?

Ronan O'Caoimh

Analyst

Please, yes, I may make up the last one.

Bill Bonello

Analyst

I appreciate you are taking the follow-up. I appreciate the color you are giving on one time expenditures and I think it's important that we all understand sort of earnings power here. At the same time, I want to be sure we don’t get our ahead of you on the numbers, and so I just want to be sure that Troponin cost that you sort of called out you are expecting continued cost again this year, I mean, we shouldn’t be looking -- I guess again you don't give guidance but we shouldn’t be looking at growth beyond this sort of adjusted $0.90-some number whatever, I mean I guess I am imagining we are still talking at 2015 EPS number that going to be in the lower half of the 80s given the non-recurring cost. I mean is that how you guys are thinking about things?

Kevin Tansley

Analyst

Well obviously right as well. I now reaffirm we don’t get guidance but the number obviously was an adjusted number just to sort of take out items I thought I think you expect but those [indiscernible] costs will obviously be incurred again in 2015 and wouldn’t make so much sense to withdraw them at this particular sort of juncture as you can imagine. So that is sort of a one-time cost in terms of '14 only. That is going to continue. It's just the key point there is ordinary revenues matching that as present and that's what makes us that sort of an impact on '14 profits per se. We'll get that obviously out of the UK business and they will become part of the 2015 numbers and such.

Ronan O'Caoimh

Analyst

Right. So thanks just and close the conference call and thank everybody. Thank you so much and we speak to you in a couple of months at for the quarter one results. Thank you and good afternoon.

Operator

Operator

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