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Trinity Biotech Plc (NASDAQ:TRIB)

Q3 2012 Earnings Conference Call

October 18, 2012 11:00 a.m. ET

Executives

Joe Diaz – Lytham Partners

Ronan O’Caoimh – CEO

Kevin Tansley – CFO

Rory Nealon – COO

Analysts

Chris Lewis – ROTH Capital Partners

Laura McGuigan – B Riley

Ross Taylor – Somerset Capital

Dave Cohen – Midwood Capital

Walter Schenker – MAZ Partners

Jeffrey Warshauer – Sidoti

Paul Nouri – Noble Equity Funds

Operator

Hello, and welcome to the Trinity Biotech Third Quarter 2012 Financial Results Conference Call. (Operator Instructions)

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

Joe Diaz

Thank you, Amy, and good morning to all of you joining us to review the financial results of Trinity Biotech for the third quarter ended September 30, 2012.

As the operator indicated, my name is Joe Diaz. I’m with Lytham Partners. We’re the financial relations consulting firm for Trinity Biotech.

With us on the call representing the company today are Ronan O’Caoimh, Chief Executive Officer; Rory Nealon, Chief Operating Officer; Kevin Tansley, Chief Financial Officer; and Jim Walsh, Chief Scientific Officer and Business Development Director.

At the conclusion of today’s prepared remarks, we’ll open the call for a question-and-answer session. If anyone participating on today’s call does not have a full text copy of the press release, you can retrieve it off the company’s website at trinitybiotech.com or numerous financial sites on the Internet.

Before we begin with prepared remarks, we submit for the record the following statement. Statements made by the management team of Trinity Biotech during the course of this conference call that are not historical facts are considered to be forward-looking statements subject to risks and uncertainties.

The Private Securities Litigation Reform Act of 1995 provides a Safe Harbor for such forward-looking statements. The words believe, expect, anticipate, estimate, will, and other similar statements of expectation identify forward-looking statements. The forward-looking statements contained herein are subject to certain risks, uncertainties and important factors that could cause actual results to differ materially from those reflected in the forward-looking statements included herein.

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.

Participants on this call are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

With that, let me turn the call over to Kevin Tansley, Chief Financial Officer of Trinity Biotech. He will be followed by Rory Nealon with a review on the Premier project, and he will be followed then by Mr. Ronan O’Caoimh, the Chief Executive Officer with his review of the quarter. Kevin?

Kevin Tansley

Thanks, Joe. I am going to give you an update on the financial results for quarter three 2012, the details of which are contained in the press release as we issued earlier today.

Firstly, I’ll briefly discuss our revenue performance. As you’ll have seen from the press release, our total revenue this quarter were $20.9 million. This compares to $19.8 million in quarter three of last year, and represents growth of 5.2%. However, excluding the impact of foreign exchange movements – mainly the weaker euro – the overall increase would have been approximately 8%.

Point-of-care revenues increased by 20.6% from $3.9 million to $4.8 million. Meanwhile clinical laboratory revenues increased from $15.9 million to $16.1 million, an increase of 1.4%. However, excluding the impact of currency movements and Fitzgerald revenues, which were down slightly in the quarter, the increase in clinical lab revenues would have been 6%. Ronan will provide you with more details on revenue later in the call.

Now, moving on to gross margin. This quarter’s gross margin was 51%, which is slightly down on the 51.7% we reported in quarter three last year. Lower gross margins attributable to higher instrument placements – predominantly sales of our new Premier instrument, which increased to 54 units this quarter. I’ve mentioned before that we can expect gross margins to be a little lower than some quarters due to placements such as these, as instrument sales typically have lower margins.

Moving on to indirect expenses, our R&D expenses of $800,000 this quarter were at similar levels to those recorded in the equivalent quarter last year. Meanwhile, our SG&A expenses have decreased slightly to $5.1 million. This has been due to continuous cost management, but it’s also impacted by exchange rate movements.

As I’ve mentioned on previous calls, we effectively have a natural hedge from an FX perspective. In other words, our foreign-currency-denominated revenues and expenses are broadly equal. Whilst our revenues have been impacted by a weaker euro, so our SG&A expenses are down also for the same reason.

Operating profits for the quarter increased from $4.1 million to $4.35 million. And this brought the operating margin up to 20.9%. This is the highest operating margin that the company has ever achieved. As I mentioned in the press release, this is the key metric for us, as it indicates the extent to which future revenue growth will be converted into enhanced profits going forward. This is now the sixth quarter in a row with an operating margin in excess of 20%.

Moving on next to our net financial income, this quarter we earned $597,000, which is slightly up in the equivalent period last year, thus reflecting our strong cash balances. Meanwhile, our tax charge for the quarter was $460,000, which represents an effective tax rate of just under 9.3%, bringing the average for the year to 11%. This is obviously a lower rate than many companies similar to ours, and demonstrates the benefits we are deriving from lower corporation tax rates in Ireland.

From an overall profitability point of view, we’ve had a very good quarter. Profit after tax has now grown to close to $4.5 million, and this compares to $3.9 million last year, or an increase of 13%. It’s not that long ago since $4.5 million would have been close to the company’s profit for the year as a whole, rather than in one quarter. And this shows the rapid increase in profits that we have achieved in a few short years.

Meanwhile, we have also grown EPS for the quarter to 20.7 cents per ADR or an increase of 12% and in diluted EPS terms, we’re seeing this grow from 17.7 cents to 19.8 cents per ADR over the same period, again an increase of 12%.

Finally, earnings before interest, tax, depreciation, amortization and share option expense for the quarter amounted to $5.6 million. I’d like to reiterate it’s been a very strong quarter from a profits perspective. I’ll now move on to talk about the significant balance sheet movements since the end of June 2012.

Property, plant and equipment have increased by $400,000. And this is made up of additions of $800,000 as offset by a depreciation charge of $400,000. During the same period, our intangible assets increased by $3.4 million, and this was due to additions and other movements of $3.8 million, which is higher than in previous quarters due to increased expenditure in developing our new cardiac test at our Fiomi subsidiary in Sweden. So the additions have been partly offset by an amortization charge of almost $400,000.

Moving on to inventory, you’ll see that this has increased by about $600,000 this quarter. It was well within the norm of fluctuations for inventory quarter-on-quarter, and the principal reason is the increase in Premier-related inventory, which as well as safety stock of finished instruments, also now include spare parts we are required too hold to support the increasing number of instruments in the field.

Meanwhile, trade and other receivables have increased by $600,000 to $15.6 million. Our overall AR book remains in very good shape at 54 days.

Finally, in relation to working capital, our trade and other payables have remained static at $11.8 million.

Before I hand it over to Rory I will discuss our cash flows for the quarter. Cash from operations increased during the period to $4.9 million reflective of the improved operating margins and profitability that I mentioned earlier. However, we are seeing a reduction in free cash flows as was the last quarter. This was due to the additional expenditure on the development of our new point-of-care cardiac product following the acquisition of Fiomi earlier this year.

Notwithstanding this, we still achieved free cash flow for the quarter of just under $2 million, which is very much in line with our revised expectation. I would like to point that, but notwithstanding the fact that we are undertaking a significant R&D program, we’re able to fund this cash from operations, while at the same time generating a surplus which can be used for share buyback or annual dividend.

Finally, we spent closed to $1.1 million purchasing additional 85,000 shares during the quarter. On an overall basis, we had a very good quarter with the key points being achievements of profits of $4.5 million for a single quarter; EPS growth of 12% and so far for the first nine months of this year we’ve achieved earnings of just over $0.60 per share. So I’m confident that we will exceed our target of $0.80 for the year as a whole.

I’ll now hand over to Rory, who’ll update you on the Premier project.

Rory Nealon

Thanks, Kevin. I’ll just give you a very brief update on the Premier project after which Ronan will give you an overview of the quarter. Some of you have heard me say on this call before that there are various phases to our Premier project.

Phase I look to develop the Boronate Affinity instrument, which as you know was FDA-approved in December 2011 and as noted in our press release we’re on target – well on target to sell 200 of these instruments in 2012.

Phase II of the project is to develop an ion exchange version of the same instrument. Now you’ve heard me tell you before the benefits of boronate affinity over ion exchange. So I don’t propose to go through them again. However, ion exchange does have one particular advantage in certain unique markets. Specifically, ion exchange will enable the physician to identify the presence of hemoglobin variance and normally when one is measuring A1c, it is not a requirement but in certain jurisdictions for Thalassemia is endemic.

It is accepted practice to look for such variance in particular A2 and F while measuring A1c. Southern Europe in particular the Mediterranean countries of Italy, Spain, Portugal and Greece is the main area where Thalassemia is present and as a result we are currently developing an ion exchange version of the Premier to enable Menarini target those particular countries.

As an Italian company you can appreciate there are significant proportion – just less than 50% of the Menarini business – is in these Mediterranean countries and consequently this will result in a major increase in monthly sales of instruments to Menarini once we launch this ion exchange instrument in these markets.

So we’ve been working on this ion exchange project for over a year now. And as of today we have firstly with the hardware in place which is essentially the same hardware as the boronate affinity instrument with some minor changes. We have the first version of software completed and working on the instruments. And we’re currently dialing in the gradient or fine-tuning the chemistry to complete the system. As a result we expect to go to clinical trials in the first half of next year and we expect to launch this new product in Europe with Menarini in quarter three 2013. So from 2013 onwards or Q3, 2013 onwards customers will obviously then be in a position to choose between either the boronate affinity version of the instrument or the ion-exchange version of the instrument.

Back to you, Ronan.

Ronan O’Caoimh

Thank you, Rory. Our sales in the quarter were $20.9 million, up from $19.8 million and it’s a quarter three of last year, which has increased to 5.2%. As Kevin has said when the impact of the weakening euro is taken into account, the underlying organic growth is 8%. HIV point-of-care revenues were at $4.8 million, up from $3.9 million, which is an increase of 20%. Within these numbers U.S. HIV revenues were actually down 8% compared with the same quarter last year and this reflects reduced spending by many individual states on their HIV programs. This reduction is being experienced also by our principal competitor in this market in the USA.

The situation in Africa is very different where our revenues have increased 29% compared with the same quarter last year. The exceptional quality of our product which is the only FDA approved HIV product available in Africa is leading to a situation where we are the confirmatory HIV test of choice for the NGOs and the countries in virtually all African countries. The outlook for our African business in coming quarters is very strong.

Clinical Laboratory revenues were $16.1 million, up from $15.9 million in the same quarter last year, which is an increase of 1.4%. However, again as Kevin has stated, if we exclude the impact of the weakening euro and our growth achieved was 5% and 6% if we also exclude the drop in Fitzgerald revenues. Although, again as Kevin has pointed out, although the weaker euro has the impact of reducing our revenues it also reduces our cost by an equal amount. And given that we have a virtual balance between euro revenues and costs those have bottom line and our earnings per share are not impacting us.

Our core infectious disease business performed well particularly in the United States and China. The launch of our new Vitamin D test is attracting a lot of interest and will drive instrument placements. We anticipate that the Vitamin D test will be a real catalyst for growth. We have received FDA approval for the product to be used on the DS2 instrument and have submitted to the FDA for use on the more popular DSX instrument.

When the product is approved on the DSX instrument which, we expect over the next six weeks, we expect then significant success with the Vitamin D product in the U.S. market. And we have developed – we’ve commenced a development of three new lines of tests for Chagas, West Nile Virus and Dengue, which will run on our DSX instrument. Development of these products will be completed in quarter two of next year and the product should be FDA approved within the year of today.

This project is part of our plan to make available esoteric tests for our customers that differentiate us from our competitors. The Chagas, West Nile Virus and Dengue tests are being developed for sale in the United States and in the case of Chagas in Brazil also and in the case of Dengue in Southeast Asia as well as the United States. We’re continuing to work for more products approvals in both China and Brazil, which are two key growth markets for the company.

Moving on to diabetes, the launch of our new Premier instrument continued successfully, and we are pleased to report that we placed 54 instruments this quarter up from 31 instruments in quarter one and 52 instruments in quarter two. A further 67 placements in quarter four would achieve our target of 200 placements for the year 2012, and we are confident of exceeding this number.

Shipments to Menarini in Europe in quarter three were marginally lower than quarter two, but this reflects the fact that Italy closes down completely more or less completely for the month of August and orders on hand for quarter four indicate a significant upturn. As we already have explained in some detail to you a moment ago, Menarini has very significant upside potential as soon as we complete the ion exchange version of the Premier instrument.

The level of placements with Menarini will virtually double in quarter three or quarter four of 2013 when we launch the ion exchange instrument, because again as Rory’s pointed out, at the moment our instrument – at the moment our instrument is unsuitable for Southern Italy, Southern Spain and all of Greece and Portugal, which are Menarini’s strongest markets.

Meanwhile in the United States placements are improving as opinion leaders are progressively supporting our instrument and as we achieve better engagement from Thermo Fisher. A key market for us will be China and we believe that we would get the instrument approved by the Chinese FDA during the month of January coming i.e., in three months time. We believe that this will immediately be a 100 instrument per year market for us. Remember, we already have 120 of our old instrument placed in China.

Brazil will also be a big market for us and we are getting ever closer to an approval. We now estimate approval in quarter two of 2013. We continue to launch around the world and as examples during the quarter we gained Taiwanese approval and placed five instruments in Taiwan, and also we launched in the South American Andean region and placed four instruments there.

In summary, we are confident of exceeding our goal of 200 instrument placements in 2012. We expect to exceed 300 placements in 2013 and 400 in 2014.

Moving on to our point-of-care development projects at our San Diego facility, we have submitted Giardia and Cryptosporidium to the FDA and expect approval for both in the coming weeks. Clostridium Difficile and Strep pneumonia are in clinical trials will be CE marked before Christmas with FDA approval anticipated four months later.

This means that Giardia, Cryptosporidium, Clostridium Difficile, Legionella Urinary Antigen and Strep pneumonia will all be on sale in Europe by the year end and all available in the U.S. by quarter two of next year.

Now if I may, I’d like to take this opportunity to provide you with a brief update on progress of our cardiac market development program in Uppsala, in Sweden. You’ll remember that seven months ago Trinity Biotech announced the acquisition of the Swedish company Fiomi Diagnostics for a consideration of $13 million. Fiomi has developed a high sensitivity, quantitative instrument-based point-of-care immunoassay platform on which we are developing a complete range of high sensitivity cardiac marker assays.

Just to remind you the point-of-care cardiac market is currently estimated to be worth $900 million and is growing at a rate of 14% annually. The main participants in this market are Alere with the Biosite Triage platform, Abbott with the i-STAT platform and Roche with the COBAS handheld platform.

The market is segmented as a 45% United States, 27% Europe, 13% Japan and the rest of the world as 15%. The entire $900 million market is almost completely addressed through two key products namely high sensitivity Troponin I, which is the indicator of acute cardiac issues, and BNP, which is the indicator of heart failure.

I’m really happy to report at this time that for both of these assays the Fiomi platform is consistently displaying significant to superior sensitivity, but more importantly superior precision to the market leading platforms thus leading Trinity to believe that it can take a significant share out of this market when its panel of cardiac assays are released to the European market towards the end of 2013 and to the U.S. market following the U.S. – following U.S. FDA approval in mid to late 2014.

With regard to the planning for the U.S. regulatory process, two pre-IDE meetings have been held with the FDA to-date. We have reviewed very clearly – clearly with the FDA the new clinical guidelines, particularly as they relate to the approval of high sensitivity Troponin I assay.

At this time, the size and scope of the U.S. clinical trials has been determined; moreover, we have engaged with a number of key opinion leaders in both the U.S. and Europe to help identify the appropriate trial sites and to help guide us through the clinical trial process all going well data collection for CE marking of the Troponin assay will commence in April 2013 with U.S. data collection commencing in the July 2013 timeframe.

BNP will follow approximately three months after this. In summary, we are very pleased with the Fiomi team and with the technology and look forward to taking a significant share of the $1 billion point-of-care cardiac market in 2014 and onwards.

Now before I open up for question-and-answer session, I just mention that on the subject of buyback, during the quarter, the company bought back 85,000 shares at an average price of $12.53. On a related note, at the end of the quarter, we held an EGM, which approved the conversion of the company’s B shares into A shares or ADRs at a discount of 15%.

At the end of the quarter we entered in agreement to repurchase 100,000 of the newly created ADRs from the former B shareholders at a price of $12.47 or a total consideration of $1.25 million. However, this agreement is only processed in the early days of quarter four. Thus the effective purchases for the quarter were 185,000 shares at a total cost of $2.3 million.

So if I could hand back to the operator now for a question-and-answer session. Thank you.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from Matt Dolan at ROTH Capital Partners.

Chris Lewis – ROTH Capital Partners

Hey, guys. This is Chris Lewis on the line for Matt. Thanks for taking the questions.

Ronan O’Caoimh

Hi, Chris.

Chris Lewis – ROTH Capital Partners

First question is really on the guidance. Just for the remainder of the year, it looks like EPS is tracking above while the revenues are tracking a bit below. Just can you talk about how you hit that guidance given next quarter requires a step-up in revenues and how does that step-up in revenues during the next quarter flow down to the bottom line?

Kevin Tansley

Chris, just in terms of the overall profitability, you’re right, we are tracking ahead in relation to profit. As I said, we’re just over $0.60. We need therefore another $0.20 to make the guidance of $0.80, which is on basic EPS. So I feel comfortable that we’re going to do that and maybe probably be a little bit above the guidance of $0.80.

But what I’m looking at in terms of quarter four, you’re right we are a little bit behind in relation to the top line, but as Ronan as point out a lot of that’s to do with the exchange rate movements, which help themselves are neutral in terms of the P&L as a whole.

So we’ll be as we’ll be. On a nominal basis, we’re a bit behind on the revenue target, but clearly from the more important profitability side, we’d actually exceed. So I’m not particularly concerned about quarter four from that point of view.

Chris Lewis – ROTH Capital Partners

Okay. And then on Premier, it sounds like you remain confident in the company’s guidance this year for 200 instruments placed. Can you talk about the distribution mix for the Premier placements this quarter across Europe with Menarini and U.S. with Fisher indirect and how you expect that to track over the next 12 months?

Ronan O’Caoimh

Sure. As we indicated, I think, we would need to do 67 instruments in quarter four in order to achieve the 200 that we had anticipated. So we’re confident of exceeding that number, just to make that general point. I made – I mean we’re not free to actually indicate exact numbers for Menarini on a quarter basis, but I think they constitute in quarter two just over 50% of 52 instruments if you work that. Broadly speaking, they were a little bit behind that in quarter three because they had an effective closedown in Europe for full four weeks.

So in essence this was a nine-month – a nine-week quarter for us with Menarini, but the orders on hand for Menarini for quarter four would indicate a significant improvement there on that and so we’re happy that Menarini is firing on – I have to say on – I chose on two or four cylinders if I go back to the point that Rory was making about the potential for ion exchange. So I think, again, Menarini should be running at 120 instruments a year approximately, but as a potential to double at the point at which the ion exchange instrument comes on stream, which will be sometime in quarter three of next year.

With respect to the United States, we’re taking a two-fold approach. We’re selling ourselves, and we’re selling to Thermo Fisher. I think up to now we’ve been very successful ourselves and somewhat less so with Thermo Fisher, but in fairness we think that they’re basically beginning to work very effectively now.

And as an example, there’s a possibility that we’ll place a six instrument order in one hospital through them in the current quarter although it’s not up to certain. And beyond that then Turkey continues to be a very impressive market for us and for example we expect to place about 40 instruments there in 2013 having placed may be 30 in 2000 and 25 this year.

And the Andean region, I mentioned we’ve launched and that’s doing well. We expect to place maybe 10 instruments out next year. Southeast Asia is coming on stream with Taiwan approval having been approved.

China is very big for us and we think that we will do between 80 and 100 instruments in calendar 2013 and a lot depends on what months we get the FDA, Chinese FDA approval. We’re hoping to get in January before their New Year, but of course that’s not absolutely certain.

But as soon as we get up and running and we should be running at about a rate of 100 a year given that we know that market reasonably well that and we already have a 120 of our very old instruments in there. So there’s a lot of pent-up demand for the new one. So we’re very confident there.

In terms of Brazil, again, it’s a very protracted and tiring and existing approval process that we believe that we’ll get there in mid year even earlier than that. That should open up in the order of 40 instruments a year probably for us.

So if you add it all up, we think that we’d be confident of doing 300 and more in 2013 and 400 and more in 2014. And four, five years of that kind of 400 a year gets us moving towards a 20% world market share, which is what we want to go to and beyond. So I hope that’s too lengthy of an answer.

Chris Lewis – ROTH Capital Partners

No, that was helpful. Thank you. And then just to follow-up on that now that the Premier installed base is growing, when can we expect some of those revenues to begin point through from the increase in placed systems and how does that contribute top line growth going forward?

Ronan O’Caoimh

Well, I think you see it immediately. I mean, clearly if we take 200 instruments this year, you’re going to get the impact of approximately somewhere to 90 and 100 due to the impact of year of 9,200 flow of reagent in a sense that you place instruments probably halfway through the year on average.

And as a typical rule, an instrument should be worth around $10,000 of reagents. So you can work it from there you know. So basically, 200 instruments for full year is $2 million worth of reagents on an ongoing basis on a very, very strong margin. Again, the profitability comes more from the reagent than from the instruments.

Chris Lewis – ROTH Capital Partners

Okay. Thanks. And then if I could just sneak one more in, it looks like you made some nice progress of Fiomi, thanks for the update there. Can you talk about the company’s commercialization strategy and initial marketing pitch during the product launch expected to be next year I think you said.

Ronan O’Caoimh

Are you talking about Fiomi? Yeah, right. Well, I think, quarter four of next year 2013. So exactly a year from today we expect to be CE marked for Troponin I in Europe. And we’re already working with identifying distributors in Europe to actually handle that. In some cases, our existing distributors would be the right choice and in other cases they wouldn’t be.

In the UK we’ll do it direct; in the rest of the Europe we will go through distributors. And so we’re working quite hard in terms of lining up distributors talking to them assessing their interest et cetera, et cetera at this time. So basically – so on overall terms, basically we will market the products directly in the United States through our sales force directly in the UK through our sales force and elsewhere through distributors. Sorry – with the exception of Sweden, where we will actually sell directly as well, given the fact that we have a plant in Stockholm.

Chris Lewis – ROTH Capital Partners

Okay. Thanks a lot.

Ronan O’Caoimh

Thank you.

Operator

The next question comes from Laura McGuigan at B Riley.

Laura McGuigan – B Riley

Good afternoon, guys. Thanks for taking my call – my question, excuse me.

Ronan O’Caoimh

Hi Laura.

Laura McGuigan – B Riley

Hi. So firstly I wanted to see if you could provide any more color on how we should be thinking about margin trends in the near term. Obviously, we expect some pressure from Premier placements, but perhaps you could comment on the extent of that pressure and when you might think we could see an inflection point where the reagent revenues in the point-of-care segment will offset that pressure?

Rory Nealon

Yeah, Laura, you are correct. You have a couple of things going on when you got placements like these. The more placements that go out, it tends to drive the margin down a little bit, and then the more reagents that are pulling through as you achieve critical mass in the markets, those higher margins drag it up a little bit. Well, I expect it to be sort of hovering around the sort of – the sort of the 51% could be up a little bit, might be down a little bit in the sort of the – in the forth coming quarters, which they will reach in the next few quarters, we will reach a point where we should be in the 51% once we get pass the points, where we’re placing more instruments that are really in the field already. We’ve got a very sort of speed for growth rate over the last four or five quarters, (inaudible) contributing to slight downward pressure this quarter.

Laura McGuigan – B Riley

Okay. And then perhaps I can ask, can you talk a little bit more about the Vitamin D test kind of the significance of that test being approved by the DSX system. What the opportunity is, the market dynamics and how it might differ from other existing test?

Ronan O’Caoimh

Yeah Laura, Ronan here. We are very confident about taking market share here. And remember that we operate in a particular segment, which is the open system, a license systems and there is only one competitor supplying a vitamin D test in there, there is a company called IDF, and we would be confident of taking significant share from them.

Given, remember that we have a very big installed base anyway. And so, I mean, clearly Abbott and Roche are beginning to put vitamin D on their big instruments as the architect, it’s COBAS, et cetera, and – but that’s a slightly different market that we don’t really participate in. So in our kind of middle-sized hospital segment where we have hundreds of instruments all around the United States, we only have one competitor and we have a product probably marginally stronger than theirs that we think we can do really, really well with and given that we have an existing instrument placement.

And again the important point to point out is also we have a big much broader menu than they have, so we have a full-range broad menu of 50 products, which they don’t have. So there is lot of attractions to running with us rather than having using up sort of limited lab space with a special instrument that runs just vitamin D, which happens in the case of their – their case of them as well we have – if the hospital takes on our instrument as well as running vitamin D they get to run 49 other tests as well and lab spaces.

Laura McGuigan – B Riley

Okay, so the competitors isn’t just runs vitamin D, therein lies the key advantage.

Ronan O’Caoimh

Yes, yes.

Laura McGuigan – B Riley

Okay.

Ronan O’Caoimh

Yes.

Laura McGuigan – B Riley

Okay. That’s helpful and then just one quick question with respect to the reagent revenue in the quarter, do you have a number for me on that?

Ronan O’Caoimh

Laura sorry you broke up there, do you have reagent number for...

Laura McGuigan – B Riley

Sorry, the reagent revenue number for the quarter.

Ronan O’Caoimh

I don’t – Kevin.

Kevin Tansley

The other than – so the main instrument’s revenue is in relation to Premier, so we put about – we thought 54 of those out there, so roughly just over $1 million there and the balance clinical laboratory really is reagent or reagent-related revenues albeit in some leases we do recover certain instrument portion, we don’t split it as a such, because a lot of our sales are bundled in terms of revenue from both reagents and the instruments and sales.

From terms of new sales of instruments, we’ve just worth of – sort of 1.1 million mark. But you are in the 90s Laura when you add everything up. The actual instrument placements will be less than 10%.

Laura McGuigan – B Riley

Okay got it. And I’ll leave it there. Thanks guys and congratulations on a very solid quarter.

Ronan O’Caoimh

Thanks Laura.

Operator

Our next question comes from Ross Taylor at Somerset Capital.

Ross Taylor – Somerset Capital

Yeah, great quarter gentlemen. A few questions. One have you seen interest in the Fiomi technology from any other organizations with regard to other types of tests or is this really something that’s going to be focused primarily on the one market?

Ronan O’Caoimh

Ross just to deal with that, I’ll let you in a moment. Now this is a platform technology, all right? And so this – then there is a quantitative technology it has an instrument, so it can give you reading, so this is applications way beyond just cardiac. But I think we’re finding our piece with good cardiac, ironically probably the most difficult area of all. But Ross it’s a platform technology, it can read many, many different parameters, I’ll let maybe Jim on that.

Kevin Tansley

Well, indeed – well, Ross it consists of an instrument about the size of a telephone I guess that you’re speaking to right now and a disposable. It’s a very sensitive, very specific and quantitative. It multiplex up to about six amyloids from one assay, so you could actually add one sampler and maybe get ending up to six individual answers from that sample. So we just happen to be working on cardiac right now, because it is such a nice market size and market reach for us and very suitable to the sort of the high sensitivity of the platform, but there are multiple areas where we can apply the Fiomi platform within our own current set of assays and indeed in sort of in new novel markers where you need these high sensitivity platforms.

So, yeah, it has huge broad application. We just – at the moment, focus is the name of the game, Ross. We just want to focus on getting the cardiac assays through.

Rory Nealon

To put it another way, Ross, if this can do what not just – I don’t know – something – lateral flow tests do. This can do it, except do it much more accurately and with greater precision.

And so all the kind of infectious disease the lateral flow test from pregnancy to HIV, this platform could do them and do them better in reality, all right? But just remember, they’re just yes/no typically. In addition to that then, it can do all of that and beyond because it can also run quantitative tests.

So I mean, I think there will be many applications that’ll become apparent in the years to come for us with this platform. This is an exceptional platform.

Ross Taylor – Somerset Capital

Yeah. And as far as what I’m going to say is basically what you have is, you have the chance to get a major share of a huge market that has exceptionally high operating margins, but that only really a tow in the water of what this system can do?

Rory Nealon

Correct, absolutely.

Ronan O’Caoimh

Yeah. Now remember – you remember that this technology is licensed from Johnson & Johnson and the royalty attaches. And we don’t have all human application. So there are restrictions. For example, they have – Johnson & Johnson have retained cancer, so we can’t do cancer. But we have a very broad range of opportunities here.

Rory Nealon

We have all infectious disease, all allergies, all veterinary applications. There are...

Ronan O’Caoimh

Coag...

Rory Nealon

Coagulation perhaps, there is lots and lots of applications that are outside that the cancer area, where the platform assist.

Ross Taylor – Somerset Capital

Since you’re talking about potentially billions of dollars of market that you can address as this machine develops?

Ronan O’Caoimh

Absolutely.

Ross Taylor – Somerset Capital

Okay. And you’re confident – you sound very confident that your tests or everything is going well and that you’re not going to face or you’re not seeing any technological hurdles at this point in time that should cause us to fall short on our initial efforts?

Ronan O’Caoimh

Okay. Jim and I have just got off a plane a few hours ago from Stockholm, and so I’m – we’re – no, we’re really happy with the way things are going there.

I’ll remind you we’ve tripled the amount of employment of that, with a lot of – we’ve gone from 7 up to 23 or 24 now.

They’re a very focused team of people that that they’ve – they – remember that’s how they sold their shares effectively to us and left a lot of that their equity on the table and sense that they would don’t need get – they would only get a return on their share, if they actually achieve the FDA approvals there. So they’re very focused very confident and very capable, and are really, really impressed with these guys.

Ross Taylor – Somerset Capital

That sounds like it’s going exceptional well. Could you talk about the economic opportunity in the other point-of-care, the lateral flow test and like that you’re bringing in the market over the next six, nine months what kind of overall top-line impact should we be looking at from those?

Ronan O’Caoimh

There’s so many variables, we’re a bit reluctant to put too many hard numbers on the table.

And I think for the (inaudible) we’ve spoke about today, which were – some are C Diff, Crypto, Giardia and then Strep pneumonia and Legionella – I think there is significant opportunity in Europe and there’s significant opportunity in the United States. But I think you’re not looking at blockbuster numbers. You’re talking about a couple of million dollars maybe in year one – that kind of order of magnitude. And then you’re going to grow your market share in time.

I think where there’s possibly kind of blockbuster potential will be, for example, on the Syphilis test, which we have FDA approved, but where we await the CLIA Waiver. And that could be an exceptional winner for us, and we’re very close to CLIA Waiver, but you never know until you get it with the FDA. And CLIA Waivers are hard to come by these days.

That certainly would have very significant potential, if we could get it approved. It would be the only CLIA Waiver Syphilis Rapid Test available in the market, or indeed the only Rapid Syphilis in the market. Similarly for HSV.

So different variables – there’s different variables there. We can – it could be where we could get a very, very significant benefit if we were to get those two CLIA Waivers, and absent that, it’s more modest but still significant.

In terms of bottom line, 50% will fall to the bottom line of whatever we do.

Ross Taylor – Somerset Capital

Okay. Well, it sounds like everything continues to roll out very well at this point in time. Obviously cash keeps building. What are your thoughts on – beyond the buyback and the dividends, what are your thoughts on cash?

Ronan O’Caoimh

As you know, we continued to buyback. We bought as many of those B shares as we could over the last couple of weeks. And we’re continually in the market. I suppose we’ll be stronger in the market when the prices are weaker than otherwise.

And – but we are committed to continuing to do buyback. We’ve increased our dividend, as you know, and we’ll probably continue to do that, Ross.

Beyond that, I think we would like to maintain a reasonably strong balance sheet as we move forward. I think the company was crippled by debt in the past, and we don’t want to go back in to that space. And we’re not looking for acquisitions – solidly, we can say that we are not looking for acquisitions. But at the same time, I think a strong balance sheet will enable us to deliver on our mission. And at the same time, if an opportunity was to be compelling and to present itself, that we would be in position to take advantage of it.

But in the meantime, we continue with our buyback. And I think we feel that’s the right approach.

Ross Taylor – Somerset Capital

Okay. I think it’s clear. I’ll see you next week.

Ronan O’Caoimh

Yeah, yeah. Look forward to seeing you then, about next Wednesday.

Ross Taylor – Somerset Capital

Okay.

Ronan O’Caoimh

Thanks a lot.

Ross Taylor – Somerset Capital

Thank you.

Operator

Our next question comes from David Cohen at Midwood Capital.

Dave Cohen – Midwood Capital

Thanks. My questions have been answered.

Operator

Okay. Our next question comes from Walter Schenker at MAZ Partners.

Walter Schenker – MAZ Partners

Hi, guys. Two questions. One, given the potential for the Fiomi technology beyond what you are currently working on, is there a point where you look for partners to move ahead in some of these other different markets – again, allergies, coax, something like that – as opposed to gradually, given the size of your staff, moving this stuff forward one-by-one?

And the second question, which is unrelated, to what extent are the new Premier machines replacing your existing machines? And therefore, how incremental will the reagent sales be, once you get up to – pick a number – 1,000 machines in a couple of years, which otherwise would generate $10 million of revenues and big operating profit?

Rory Nealon

Hi, Walter. I’ll take the second question first.

In the United States, we have no instruments in the market. So it’s all new business, right? We’re not eating our young there at all. In Europe, we have virtually no presence. It’s Menarini so it’s all new. In Brazil, we have nothing and we’ll be all new.

So the only place where there will be an element of us replacing existing instruments will be in China, where we do have 120 instruments. And to be frank, the sooner we replace them, the better, because they’re old and quite tired.

So – but remember I mentioned to you that we hope to do upwards about 100 a year in China. And so you’d be getting net new placement very, very quickly.

So if I had to guess, I’d say that in our first year, probably 50% – 40% of our placements will be replacing old instruments. I’m not exactly sure on that because there’s different distributors within it. So the answer is very little. Very little.

Remember, our existing hemoglobin business is mostly a variant business. Like we said, we’re a significant supplier into Quest and LabCorp and the very big hospitals in the United States, and then the MegaLabs around Europe. So we’re not really significantly involved in main line A1C, other than, ironically, in China. So we are effectively a new participant in this main line Hemoglobin A1C market.

Walter Schenker – MAZ Partners

And the reagents machines, at this point, only use your reagents? Or other people can use other people’s reagents?

Ronan O’Caoimh

No, this is a bar-coded system. I mean the only thing that our products will run on – the only thing that you can run on our instruments is our reagents.

Walter Schenker – MAZ Partners

So this becomes a very big number given the margins on reagents by like 2015, when you’ve got 1,000 machines out there and growing rapidly?

Rory Nealon

Absolutely, yeah. Instruments keep generating the revenue. It’s a razor/razor-blade model.

Just to deal then with your second question about partners. And it’s an interesting point from a business development point of view, and it’s the kind of thing we’re thinking about. It’s a point well-made, Walter.

I’m not going to explore all the detail on the telephone, but it’s a very interesting point you make, and it’s one that had – we had thought about and we’re coming to terms with. The potential here is so broad that maybe it’s too much for us to deliver entirely on our own. It’s a point well-made, Walter.

Walter Schenker – MAZ Partners

Okay. Thank you.

Rory Nealon

All right, thank you very much.

Operator

Our next question comes from Jeffrey Warshauer at Sidoti.

Jeffrey Warshauer – Sidoti

Hi. Good afternoon. Thanks for taking my question. You mentioned weakness in U.S HIV market and in Life Science division, as well. Maybe you could give us a little more color on how we should think about those two going forward?

Ronan O’Caoimh

Yeah, just to deal with HIV for a moment. We’re selling the same amount, I think, of HIV into hospitals as we were. Where we’re experiencing weakness is basically on the kind of – the sexually transmitted disease programs run by individual states around the United States of America. And they are just spending less.

I think if you look, for example, at OraSure’s numbers, I know they haven’t reported yet this quarter, but if you look at last quarter, they were experiencing the same thing. And I suspect you may see that – I don’t know – in a few days, when they report again.

But we are finding it – we are just finding basically that they are just spending less dollars as part of the recession. How long that’s going to continue is difficult to say, but we are feeling it. We seem to be feeling a little bit less than they are. I think we were down 8% this quarter.

There is not much more I can say about them. I mean I can conjecture as to whether it’s going to change, but it’s idle speculation, really. I just don’t know.

But at the moment, it’s – for the year – for this quarter, rather, we are at about 8%. For the year, we are about 6%. So it’s very disappointing.

But I will make the general point that it’s not a very big portion of our entire business, but it’s – still we feel it.

And the second part of your question was...

Jeffrey Warshauer – Sidoti

Fitzgerald.

Ronan O’Caoimh

Fitzgerald. Yes, Fitzgerald – Fitzgerald maybe suffers from just one thing, which is that basically a significant portion of Fitzgerald’s revenue is derived from selling monoclonal antibodies to Japanese flu manufacturers, right? And they were buying a lot of our flu antibody. And over the last 2.5 years, they have bought virtually nothing.

And this relates back to the pandemic related to H1N1, we believe, which I think was 2009 – 2009 and sort of 2010 when I think basically a lot of manufacturers sold a lot of flu and bought lot of antibodies, and then basically H1N1 just did a disappearing act. And as a consequence, the pipeline of both raw material antibody and possibly also finished goods has been clogged up. And you would have expected that the revenues would have returned by now, but we’re still not seeing it.

So Fitzgerald basically had been a drag on the company for the last – I say that with respect – it’s a profitable entity within the company – but in terms of revenue performance there has been a drag on us for the last couple of years, and it hasn’t turned yet, despite the fact that we’ve launched a new website and are trying to concentrate lot of our efforts and turning into kind of an Internet size where institutions all over the world and researchers all over the world will buy our monoclonal from the Internet. That side of the business is growing well, but it’s not growing quickly enough to compensate for the loss of the flu monoclonals. That’s the situation there.

Jeffrey Warshauer – Sidoti

Okay. That’s helpful. Thanks.

Ronan O’Caoimh

Thank you.

Rory Nealon

Maybe we’d have the last question?

Operator

Yes. Our last question comes from Paul Nouri at Noble Equity Fund.

Paul Nouri – Noble Equity Funds

Turning back to the Vitamin D test, can you talk about your addressable markets for it, and how quickly you can get there?

Rory Nealon

You say the addressable market. Yeah, it’s – can somebody help me in terms of the size of the market? We’re talking -

Ronan O’Caoimh

IDS business in Vitamin D is $30-odd million from memory, and that’s specifically in the ELISA business, so that’s what we’re targeting.

Rory Nealon

Yeah. I mean what you had here was – what you had was – I think worldwide, about 120 million tests a year. So a very significant market, dominated initially by TSR and then IDS came in to the ELISA segment.

What’s happened over the last number of years is that Johnson & Johnson, Roche and Abbott and Siemens have all just about launched a product in the last year or are in the process of doing so. So in the large hospital, the business is migrating really away from TSR and towards – on to the bigger instruments.

But the segment that we operate in, which is the middle-sized hospital and open systems, our competitor really is IDS, who have had it to themselves. And as Rory was saying, about $30 million. So a lot to play for there. Some of that business maybe will have migrated towards the bigger instruments.

So the market is getting more competitive definitely, but within our segment, it’s really IDS and ourselves.

Paul Nouri – Noble Equity Funds

Okay. Thanks.

Rory Nealon

Thanks very much. So, I think at this stage, operator, will we close the call.

Operator

Yes, please. Would you like to make any closing remarks?

Ronan O’Caoimh

Just to say thank you to everybody. And thank you for your support and look forward to talking to you again in three months time or four months because it’s the last quarter one here. Thank you.

Operator

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

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