Trinity Biotech plc (TRIB) Q3 2016 Earnings Report, Transcript and Summary

Good day and welcome to the Trinity Biotech Third Quarter 2016 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Mr. Joe Diaz of Lytham Partners. Please go ahead.

Thank you, Allison, and thank all of you for joining us today to review the financial results of Trinity Biotech for the third quarter of calendar year 2016, which ended September 30, 2016. With us on the call representing the company are Ronan O’Caoimh, Chief Executive Officer; Kevin Tansley, Chief Financial Officer; and Dr. Jim Walsh, Business Development Director. At the conclusion of today’s prepared remarks, we will open the call for question-and-answer session. But before we begin with those 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 those 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 identified 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 Ronan O’Caoimh with his perspectives on the quarter. Kevin?

Thanks very much, Joe. Today I will take you all through the results for quarter three 2016. Beginning with our revenues, total revenues for this quarter were $26.1 million and this compares to $25.8 million in quarter three of 2015. This represents an increase of 1.4%. The impact of foreign exchange and revenues was not significant this quarter while compared to the equivalent quarter last year hence we have not retranslated the revenues in constant currency in this quarter's earnings announcement and calculations. Foreign exchange rate impact was to reduce this quarter's revenue by less than 0.5% with sterling being the biggest single factor. However in this quarter, we did softer the impact of lower distributor pricing and this was due to the impact of the strong dollar on local pricing on a number markets such as Turkey and Columbia. It impacted revenues more this quarter than in quarter three last year. And as you will see, similarly have an impact on gross margins. Ron will provide more details on the revenues for the quarter later in the call, so I'll move on and discuss the other aspects of the income statement. Gross margin this quarter was 44.7% and this compared with 46.5% in quarter three 2015. This continues the trend of lower gross margins compared to 2015 caused by mainly currency factors and this instance the impact on distributor pricing that alluded to earlier on. However, I will point out that the 44.7% does represent an increase on the margins for the first half of the year, which average 44.1%. I will now move on to our indirect costs. Our R&D expenses for the quarter of $1.3 million was virtually identical to that of quarter three 2015. Similarly, our SG&A expenses are also consistently with quarter three 2015 at $7.5 million in both the periods. Operating profit for the quarter was $2.7 million, which is $300,000 lower than quarter three 2015. However, I will point out the improvement versus quarter one and quarter two of this year whereby operating profits has grown from $1.8 million in quarter one to $2.4 million in quarter two and now $2.7 million in quarter three. Principal reasons for this improvement are the increased revenues and improving gross margin on a sequential basis. Moving on to our financing costs which includes the impact of the company's exchangeable notes. Financial income for the quarter was $212,000 compared to $204,000 in 2015, which reflects improved deposit interest rates. Financial expenses for the quarter were $1.2 million and relate almost entirely to the cash interest element of the exchangeable note. Meanwhile the non-cash financial expense is $2.1 million of which $1.9 million relates to an increase in the fair value of the derivatives embedded in the exchangeable notes with the remainder being $180,000 of accretion interest also related to the exchangeable notes. Our tax charge for the quarter was $148,000 and this represents an effective rate of 18.5% and was lower than the 16.2% reported in the equivalent quarter last year. This rate is lower than experienced by a lot of NASDAQ companies and here you are primarily seeing the benefit of the very competitive Irish corporation tax rates as well as R&D tax credit arising in our Irish, U.S. and Canadian operation. The net result of all that I've spoken about so far is that the net result for the quarter is a loss of $517,000. This gives a basic loss for ADR of $0.023. However, when adjusted for non-cash exchangeable note expenses, the profits after-tax for the quarter was actually $1.6 million, which equates to a EPS of $0.07 per ADR and the fully diluted EPS for the quarter was $0.097, which is the same as last year. Earnings before interest, tax, depreciation, amortization and share option expense for the quarter was $4.6 million. Finally, before leaving the income statement I want to talk about one item that has not been recorded this quarter. This is the impact of our recent decisions to withdraw our Troponin submission from the FDA and close our Swedish facility. As pointed out in our communication on October 4 and reiterated in today’s release, these decisions will result in, one, likely recognizing an impairment on the Meritas assets currently on our balance sheet; and two, incurring a further charge in respect to the closure costs for Swede, both of which will be recognized in quarter four’s income statement given the decision to both withdraw and close occurred after the quarter end. We are currently in the process of calculating both amounts. The larger and easier of the two to calculate is the impairment of assets. This will effectively equate to the cost incurred on the project to-date to the extent to which those costs are recognized on our balance sheet. This will consist of three elements: the cost of acquiring Fiomi in 2012, all development costs which have been capitalized today's, and finally the cost of any tangible assets on hand such as plant and equipment and inventory. I also don't have an exact number to give you at this point, we have indicated it will be in excess of $50 million, more likely be of the order $55 million to $60 million. Second element, i.e., the Swedish closure costs are harder to estimate, but we're still going through the process of working with the employee representatives in Sweden in order to finalize the redundancy process and packages. In addition we will also have to withdraw from other non-labor commitments and are going to be looking to renegotiation – rather negotiate exit mechanisms with a number of third parties. The order of magnitude that we're talking about here is about $5 million, although it could vary up or down from this amount. We'll now move on and talk about the significant balance sheet movements since the end of June 2016. Property, plant and equipment has decreased by $300,000. This was due to depreciation of $800,000 and retranslation movement of $200,000 being offset by additions of $700,000. In the same period, our intangible assets increased by $4.2 million. This was made up of additions of $5.1 million offset by retranslation movements of $100,000 and amotization charges of $800,000. Moving on to inventories, you'll see these have increased from $39.3 million to $39.9 million, which is well within our normal quarterly fluctuations. This quarter trade and other receivables meanwhile have decreased significantly by $2 million to $25.8 million reflecting very strong cash collections during the period. Meanwhile, our trade and other payables including current and non-current, but excluding the exchangeable notes increase by approximately $600,000. Finally, I will discuss our cash flows for the quarter. Cash generated from operations for the quarter was $5.6 million, which is $1.9 million higher than in quarter three 2015. This was offset by capital expenditure in the quarter of $5.6 million and net interest and taxes paid of $200,000. Net results that we had a slight decrease in cash for the quarter of approximately $200,000 with quarter end balance being $84.8 million. This has been the best return from a cash point of view for a number of quarters, but it is somewhat artificial as we benefited from very strong cash collections as well as being on absence of any schedule of interest payments which occur every six months or HIV license payments which occur annually. When taking such factors into account, we will be in a higher underlying cash outflow position. However, this will obviously improve considerably once our Meritas costs diminish still putting us on a more cash neutral forcing. I’ll now hand over to Ronan who will take you through the revenues for the quarter and other aspects of the business. Ronan O’Caoimh: Thank you. I’m not going to review our revenues for the quarter before opening the call to your question-and-answer session. Our revenues for the quarter were $26.1 million compared to $25.8 million in quarter’s three of 2015, which is an increase of 1.4%. Point-of-care revenues for the quarter were $4.9 million compared with $5.4 million in the comparable quarter, which represent a decrease of 10%. This decrease is entirely attributable to lower HIV sales in Africa during the quarter. This reflects the irregular ordering pattern, which characterize this market rather than any underlying adverse change in the nature of the business. As you know, our HIV business in Africa is funded almost entirely by NGOs. Product orders from these agencies tend to be hazard and are unpredictable in the contest of a 13-week reporting cycle. However, our HIV product continues to be regarded as the goal standard and continue to utilized as the confirmatory HIV test of choice across virtually the entire continent as it has done for over a decade. If you eliminate quarter-on-quarter variations, the underlying line dynamic is that funding continues to increase as more and more Africans are put on to antiretroviral drugs with the number now exceeding 23 million people. Over the past 15 years, we have dominated the HIV confirmatory market in Africa. We have now decided to enter the screening market which in volume terms is 7x or 8x greater than confirmatory market albeit at a more modest selling price. Over the past two years, we have developed a new HIV screening test which is now undergoing independent trials as part of the approval process with the WHO. We will be entering the African screening market in late 2017 with this product. In the U.S. our HIV sales were flat when compared with the prior quarter with hospital sales performing strongly aided by the fact that we're now selling HIV 1, HIV 2 combination product. Moving onto chemical laboratory, our revenues for the quarter were $21.2 million, up from $20.3 in the corresponding quarter last year representing an increase of 4.3%. On a constant currency basis, the revenue increases 4.7%. Our diabetes and hemoglobin, variance businesses performed strongly with revenues increasing 8%. We had strong instrument placements in all of our principal markets with 78 instruments being placed during the year leaving us on target to exceed 350 placements for the year. The exception is Brazil where we made negligible placement this quarter despite strong demand for our product. This arises due to the weakness of the Brazilian real. However, we plan to reenter this market when we increase our level of manufacturing activity in Brazil thereby saving on import duties and on sales taxes and by creating a natural hedge. In addition, we are seeking price increases against the backdrop of a high inflationary environment. Another positive factor is that the Brazilian real have strengthened over the past number of months and has now recovered to a rate of 3.11 today. And at this level we are in a position to reenter the market on a selective pricing basis during the coming quarter. Moving onto infectious disease, this business was flat compared to the prior quarter. Our infectious disease in the U.S. performed well with strong Lyme sales on the back of a mild winter. China was flat when compared with the prior quarter but our revenues in Canada, Turkey, Russia, Colombia and the United Kingdom continue to suffer due to the weakness of these currencies against the U.S. dollar. Monoclonal antibody sales in our Fitzgerald subsidiary were down 2% when compared to the revenues from the corresponding quarter last year. Meanwhile sales of our autoimmune product in Immco performed strongly with revenues increasing 6% compared to the corresponding quarter last year with a reference laboratory having another strong quarter. Following the huge disappointment of our FDA Troponin submission, I’m going take a moment to review our core business which will generate approximately $102 million of revenues in the current year. Using broad rounding, our business has made up of the following: Fitzgerald monoclonal antibodies 10%; infectious disease 20%; diabetes and hemoglobin 30%; autoimmunity 20%; and HIV 20%. Our Fitzgerald monoclonal business has been flat over the past two years and although it is highly profitable it is unlikely to generate significant growth. Our infectious disease business which constitutes 20% of our overall business comprises principally a strong loan franchise in the U.S. which is growing marginally, a traditional ELISA business, which is declining approximately 2% annually, a Chinese ELISA business, which is growing 4% or 5% annually, and finally a rapid point-of-cash fitness test which is currently annualizing at about $1.3 million but which we believe has the potential to grow over the next three years to a level of approximately $5 million per annum. In summary, we believe that our infectious disease business overtime will be somewhere between flat and 2% to 3% of annual growth. Our next business segment is diabetes and hemoglobin which constitute 30% of our revenues. This business is our strongest growth engine driven primarily by premier placements which have averaged over 350 placements per year since 2012. We believe that we can continue with this placement rate in the coming years given our strong franchise in Europe with Menarini in China, in Brazil, and in the United States. During the year, we also launched our new premier resolution instrument which serves the hemoglobin variance market, for example, first sickle cell anemia thalassemia. This is a high value market with few competitors and we believe that with our best instruments we can take significant market share. Since the launch of the instrument in April this year, we have made 23 placements. We are confident of our diabetes and hemoglobin business giving double digit growth in the coming years. Our next business segment is autoimmunity which constitutes 20% of our revenues and which has grown strongly in the past. It is comprised of both the reference laboratory and also product sales. The reference laboratory has been the best performer with significant growth coming from our Sjogren product and also from the growth of our business with the two U.S. mega labs. However, the greatest potential in our autoimmunity business is in the product revenue part of the business where we continue to expand our instrument offering such as middle and low volume laboratories in both the United States and across the world. We believe that this expanded instrument offering in line with a never expanding immunofluorescence underlies the product range will result in strong double digit growth in the coming years. We’ve recently launched our new ANA screening product which is the best in class flagship product that can drive growth and instrument placements. Lastly, HIV constitutes 20% of our business. For more than 15 years, we have held more than 90% of the African confirmatory market and we believe that we will continue to do so given the status of our product as gold standard. However, as I said earlier, we have over the past two years developed a HIV screening product which is about to be launched on the African market. Given the quality of the product and given the price with which we can manufacture the product and given our long held reputation as manufacturer of the gold standard on the continent, we believe that we can take significant market share in this market segments. So in summary when all the components of our business are taking together, we believe that we can achieve high single digit organic growth in our business over the coming year and that this growth rate can accelerate quickly into double digit growth thereafter. So if I could now hand back please to question-and-answer session.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] And our first question will come from Bill Bonello of Craig-Hallum. Please go ahead.

Hi, can you guys talk a little bit about your latest thoughts on capital deployment and for a long time you had been talking about searching for an acquisition where you could get a good amount of synergies and higher marginal returns. Then on the prior conference call to this one I think you had talked about you’re stepping up the pace with share repurchase. Just curious where you stand right now in terms of prioritization for the use of cash that you have on the balance sheet? Ronan O’Caoimh: Bill, Ronan here. Based on today’s share price, we believe that buying back our own shares represents the best use of our cash. So if the price continues to be at anywhere around these levels, our intention will be to buyback and to buyback aggressively. So that’s our intention. I think that that doesn’t mean that we wouldn’t do an acquisition and we continue to seek an acquisition if we could find something that’s accretive, and those are types of synergies we would do so but our primary focus at this time will be on buyback.

Okay. And just when I think of the growth profile that you laid out in terms of where the business could be going, I think that probably gets us into the mid to moderately high single digits overall revenue growth at least in the clinical laboratory business and then HIV being a wildcard, what kind of leverage do you think you can get from an income statement standpoint on that? What type of top line growth do you need to see margin expansion and where could margins go overtime?

Bill, Kevin here, it’s a good question. As a lot of people on the call would have heard me saying in the past, our income statement is very much characterized by having a high level of fixed costs, our labor is essentially fixed, our overheads are essentially fixed and what you’re really talking about in terms of variable costs are essentially the materials in hands in our product. So to the extent to which we can add to our top line, it means that we can have an immediate favorable impact on our gross profit and also our operating profit. One effect we are doing there is spreading those fixed costs over a wider base and getting an immediate synergy. So for example if we were to grow our top line, we roughly are going to do by 102 million this year. If we were to grow by even $6 million to bring up to around $108 million you would expect hopefully around $4 million of that to drop to the operating profit line which would obviously mean an improvement in both the operating margin and gross profit, so growing somewhere from I’m probably going to do somewhere between $9 million and $10 million of operating profit this year, call of $10 million, that will mean growing our operating profit by $4 million or just 40% obviously not in the context of a top line growth of less than 6%. To the extent to which the leverage works and that leverage actually increases to further down the income statement to go profit after tax this year is likely to be somewhere between $5 million and $6 million, call it $5 million for argument sake. To use my example there with operating profit has gone up by about $4 million you’re likely to see the profit after tax by going up by about $3.5 million. That means you’re seeing a growth from $5 million to 8.5 million but the 70% growth on the bottom line. So you can see a 6% growth in the top line translates into a 40% on the operating line, translates into 70% on the bottom line and obviously 70% growth is reflected in EPS which is liked to be in mid 20% on the basic level, so that will push it well into the mid to high 30s as such, and so possibly quicker than as well pertaining on the extent of the buyback that Ronan just referred to. Does that answer your question Bill?

Yes, that’s very helpful. And I guess the last thing I would ask and I’ll hop back in the queue is just how you’re thinking about the various businesses from a strategic standpoint? In other words, is it critical that you have each of these offerings? Is there at the leverage that you just described? Does that diminish if you don’t have the base of revenue that you currently have? If you don’t have all of the businesses to one extent you should have leveraging same sales force and infrastructure. Or is there anything in the portfolio that it might make sense to try and monetize?

Yes, I think you’re right. I think in your supposition and reality is that our model is fairly straightforward. Every additional million dollars of revenue probably drops about 50% to the bottom line. So if you take a scalp and cut out a segment say $10 million, the impact will be dropped profit $5 million because largely our costs are fixed. You lose synergies or cost of sales or some manufacturing operations et cetera. So the model is fairly straightforward, maybe incremental million dollars of sales, you increase your profit by million dollars and vice versa. So to cut out peats would actually have a very negative dramatic impact.

Okay. Perfect. Thank you.

Our next question will come from Jim Sidoti from Sidoti and Company. Please go ahead.

Good afternoon. Can you hear me? Ronan O’Caoimh: Hi, Jim, how are you?

Good, good. Can you tell me how much is available for share repurchase? How much is the board authorized? Ronan O’Caoimh: At our last AGM, we were granted authorization to buyback up to 10% of our share capital. So taking into account the purchases will we’ve already made since that date, this means that as of today, we are entitled to buyback approximately 2.2 million shares. And I just make to counterpart, even if we look like exceeding this amount before our next AGM, we are in a position to call an extraordinary general meeting with the purpose of increasing our authorization level. And just to say that that’s a relatively simple process and it can be achieved in a four to four and a half week timeframe.

Great. And can you give us some kind of timeline as far as consolidating the facility into your Iris facility, the facility where you’re developing Troponin and into your Irish facility? Ronan O’Caoimh: Yes, work is underway already, Jim. We are working through the redundancy process at the moment with our Swedish employees and that’s coming to a close at the moment. We will retain a transition team who will then work on migrating the technology from the Swedish pounds down to Ireland. That takes a little bit of time. All the instrumentation has to be just recalibrated one last time before putting it carefully into boxes, packing it up and then transport is carefully down to Ireland where the process will be reviewed on tact and then recalibrated again, so it is quite intrigue equipment to lot of us, and will take some time. So we envisage to that will take us into quarter one next year before that’s completed.

All right. And have you had any other communication with the FDA since the – which were all of the component test?

This is Jim Walsh. Yes, in fact we had, okay. We got a formal notice from the FDA early last week which really – it wasn’t particularly long, it’s a little one page email which basically outlined the same concerns they had outlined to us verbally on our call with them in September 29. So what’s happening now is without information and quite frankly it wasn’t very deep, it was very, very high level stuff again. We are starting what we call is pre-submission process, okay, a presold process is a process whereby you essentially – is the formal process by which you communicate with the FDA in such circumstances, so we’re doing that. And the purpose of that presold will be essentially to using the information at the centers back to ask them the question us back as to how they drew the certain conclusion that they have drawn et cetera and then following up from that what the conclusion would be. But suppose, Jim, what we really is our understanding at the moment is that in order for any new point-of-care product obtain FDA clearance, the FDA will require to demonstrate performance equivalent to the most recently cleared laboratory based device. And as I said before, we believe that there is – performance can be achieved on the Meritas system. So even though we will actually run those the preso process and will work very diligently to get to the bottom line of this where we still really don’t believe that the Meritas product can actually match probably amended by the FDA in terms of performance relative to the current central lab systems.

Do you think are there other applications for the technology that might be easier to win approval for? Ronan O’Caoimh: Yes, absolutely Jim. The platform is an exceptional tough one. It is generally good, and we generally have a very, very good product on that platform. So there are marinate application. For example, our BMP product, just for example, which is quite a difficult product, we sat on that platform and worked on that platform without virtually a glitch, we are perfectly well, same for annular [indiscernible] liver markers, any market that would run in the critical care, will run on this platform. There is huge value with the platform and that’s the reason we’re moving it down to couple of year to actually take that time to analyze what the right profile, other product on the platform would be and assuming that is – we can copyright profile, we will engage and development again sometime in the future but the platform is excellent.

All right, thank you.

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

Good morning or good afternoon. Just a couple of follows-up. Ronnie, you have a nice overview of look for each of the products. Just on each of the in particular I realize its lumpy so this quarter has dropped, the points up lumpiness. How about – what’s your outlook annually just on the confirmatory side. Do you view this as historical flat market? I know you said funding continues to grow in Africa which is your bigger piece. So do you expect some growth on the confirmatory side and then obviously would screening, would I just cannibalize over that but it would be at a much higher volume. So if you just explain those two dynamics. Ronan O’Caoimh: Yes, I think if you look over the past four or five years, our HIV business has grown new 2% or 3% annually. I would expect that levels. I know it’s been ups and downs in the middle, it puts lumpy but broadly speaking that’s what it is done. And I expected to continue to do something like that, to be challenging growing. Just to make the other point that I believe that we can enter screening market without cannibalizing our Uni-Gold confirmatory product which mark the higher price because they are two entirely different products. But I do believe that arguably this is a big opportunity for us in this screening. We developed a product that can be manufactured at a cost that enables us to compete in a very real way. And I think if you add that with the reputation we have, wouldn’t underestimate the importance of our reputation, it’s truly excellent. I believe that we can make inroads, this is going to take time, difficult to the regulatory process of approvals with the WHO will take time. So I think we can enter the market late 2017. In terms of what kind of growth we can get in terms of percentages, it’s difficult to really to assess but just to make a general point that it’s upwards of $90 million to $100 million market, the screening market is. It’s dominated by Byler [ph] and I think it’s very realistic to take a good market share there. I think I’d say the combination of our reputation and the broad and our pricing capabilities should achieve that.

And is that $90 million to $100 million squatty market you’re referring to, that’s just in Africa alone or that a worldwide market? Ronan O’Caoimh: South Africa.

And could you have this to screening and the confirmatory test in particular country or is there checks and balances where you can provide can to both? Ronan O’Caoimh: Given that the recent posts because our products are entirely different, they use entirely different components. So just to reminder of sales dynamic, what happens is a 1,000 people would be tested for HIV and let’s say typical algorithm is and that’s stayed that 120 of them would turn positive. So maybe 120 people will be screened using [indiscernible] and then 1,000 people will be screened using [indiscernible], if 120 of them come up with positive, then there all of a sudden people will be tested with Uni-Gold product. So that’s the way it’s worked over the past over the past 15 years broadly speaking to meet some other players, but broadly that’s what has happened. So [indiscernible] volumes would be – some indeterminates and some mistakes made, so on average the volume is probably approximately 7 times ours.

Got you. Is there anything going on with – you have all these other iImmunoassay point of care tests approved quite a few years back. I know you had a little $0.5 million in Indonesia or in some other maybe Mediterranean countries, is there – have those basically – I don’t – given up on them, but is there any potential coming from those or is that basically around there? Ronan O’Caoimh: [indiscernible] we are building our sales, it’s primarily a European effort, but don’t know we are building our sales and that’s continuing, that’s part of our infectious diseases business. We don’t want to be isolated, but $700,000, $800,000 at this moment in time.

Okay. Got it. And then just sticking with the infectious diseases side, Lyme disease this quarter was that up year-over-year in the U.S., I thought the last couple of years have been sort of pretty down significantly and you had a milder winter this year, was that – has that proven? Ronan O’Caoimh: For the year we are up, but this particular quarter we are just about level with last year.

Okay. And is that just some kind of – is that explainable or I mean I guess it’s – land us more numbers, I thought maybe you could get a pop out of that this year as there have been…? Ronan O’Caoimh: We’ve had a good Lyme season compared with last year and that’s the consequence of the very mild winter that we had last winter, just happens at this quarter. It’s just about level with last quarter and the corresponding one, but overall we are up.

And then the outlook on autoimmune side, I guess, that’s mostly Immco, it’s been sort of mid to high single-digit growth and you think it can get back to the double-digit. Is that – can you just sort of give us a little more color on that? Is that from the Sjögren's product, is there other approvals coming on board, what’s sort of the – you think will be the driver of that acceleration in growth? Ronan O’Caoimh: I mean Sjögren's has got huge potential as you know we moved from Nicox to Bausch and Lomb and it’s been betting in period of time, but I do believe it’s got – that got huge potential. We are still running around kind of $700,000 a quarter on Sjögren's, but it’s got huge potential beyond that. The other things that’s significant that’s happened to us in the reference laboratory side of things is that we’ve won a couple of contracts or a number of contracts with the two mega labs in the United states where they would choose to use us to do some of their testing rather than run it in-house. So those events have been fairly positive for the reference laboratory, which has performed really strongly. But I think as I said in the prepared comments, the real bigger growth potential, which hasn’t been realized yet, but which is out there is, in terms of our product revenue potential. And really even still our product revenues in the United States are very modest. They have huge potential. So we are competing with two competitors and we really, as part of our revenues, at this time, are modest, but I think as soon as we have fitted out all of our EIA allies’ approvals with the FDA and added then an instrumentation offering for the middle and smaller laboratories and we take into account the strength of our immunofluorescence parts offering and you also take into account the strength of our just launched ANA Screen product. I think that we’ve got monstrous potential across the world, but particularly in the United States where we're kind of starting from almost a zero base. So I think over the coming years, you're going to see the autoimmunity business be really, really strong growth engine for us and we will be solidly into the double digits, I believe, we are already close to that. So basically I’m not saying, if there is two engines for growth, there’s reference laboratory and there's the product revenues and only one engine is really running at this moment.

Okay. And then just lastly, on premier, I think still you highlight or in terms of growth, as you outline, this sort of double-digit expectation for growth, is that -- do you expect sort of level play at this 350, maybe a little higher as you get Brazil and then just rising reagent sales as utilization improves on these machines, what’s kind of drive the growth, is it more replacements and rising install base or rising utilization or both? Ronan O’Caoimh: Well, I think firstly you should bear in mind that we've gone this business from I think from the $14 million to $30 million over the past few years or in fact four, so it means growth has been strong, but bear in mind also that every premier that’s placed, it’s not replacing existing primaries, they are all new placements and so we're still under tentative, with the first one in terms of the cycle let’s say seven or eight year cycle, we are only four years into it. So every placement is new incremental business just to make that point. In terms of growing the business, I think that reopening Brazil is going to make a big difference, and Brazil is in effect closed at the moment. We're not – we are virtually making no placements there. And we suffered a situation where the real moved from 1.8 to 4 against the US dollar which was – it's catastrophic from our point of view. But now it's come back, it’s coming back gradually, 3.11 today, it's something we watch every day. And so we are getting to the stage where we can get back into that market. So I think that's going to drive the instrument placements way above 350. And the other factor that’s going to make a huge difference, to our premier – our diabetes business is basically an increased reagent usage in China. So we're continuing to place instruments at a very impressive rate in China. Broadly speaking, 25 a quarter, 100 a year. But the run rate on those instruments is modest, but it's increasing all of the time as more GPs in China plug in to reimbursement the fact it’s available and the fact that A1c testing is available basically and reimbursement is available on it. So that – I think – so the combination of kind of Brazil being clubbed back in and China building are going to make a big impact. And then I did mention also in the prepared remarks, the fact that we’ve just launched premier resolution, which basically is going to serve the variant market, significant market with very few competitors. And of course also I will add to that is the neonatal market and I think so – bear in mind, we have a strong franchise there, over $10 million business already, but it's been a business for the last five 5 years has been flat, but now with the advent of this new instrument I think we can grow that business significantly and I gave the example that having 23 have placed since April since we launched.

Got it. Okay, great, thank you.

Our next question will come from Nicholas Johnson of Raymond James. Please go ahead.

Hi, guys, a lots been covered. But just want to focus a little bit more on the Meritas kind of strategic alternatives decision. How do we think about the - what's going into that evaluation vis-à-vis, either building out that portfolio on your own, partnering outright sale, any sort of conversation or discussion on how we should be thinking about that being evaluated internally would be helpful. Ronan O’Caoimh: Right. I mean as Jim mentioned, it’s an excellent platform, I mean the BNP product that we went on to, it was perfect and we were confident that we could put many different parameters on to it. The problem for us was that you know our plan A was that that Troponin would lead out – we lead out with Troponin and we put various other parameters onto the menu, but the Troponin would lead it out. The issue now we need to basically consider very carefully and the constitute part of our review is basically in the absence of Troponin as the lead blockbuster product, how we can best use lies in this platform. And we are confident that the platform can carry very impressive menu, it’s a matter of identifying what that would be. Whether we would that, activate that alone, whether we would basically partner, or whether indeed we would actually dispose of the platform is basic constitute part of the review and we are really only starting it. So I'm afraid I can't really help you so much in that sense, at the moment, we're just looking at the whole thing with an open mind, but we do make this point that this not a valueless platform. There is value in this platform and we believe that we will realize that value as I say whether on our own – basically with our own menu, our own instrument, sold and marketed ourselves, whether in partnership or whether by – through a disclosure, we are not just sure at this time.

Okay. That’s helpful. And then the second question I had more so on just the cash on the balance sheet $8.5 million. I know there’s going to be some cash restructuring charges and some things in the very near term before you get to that near break-even level, but how much do we think we fall off of this $85 million level before we get to that kind of break-even forecast, we think about kind of the availability or flexibility with your balance sheet? Thanks.

Yeah, obviously, Nick, we are entering into a period now where we are going to try and unwind the Swedish facility and we anticipate that that’s going to come down by about $7.5 million annually, which is close to, but not quite $2 million a quarter. I wouldn't expect to see any reduction in quarter four. We will have the redundancies for the Swedish employees, which will be like in excess of the average wage bill as such. The facility will still be the open while we do the transition. So we will burn the cash in quarter four and I expect there will be an element of that in quarter one of next year as well. Quarter two next year will be the first year where we’re really going to be clear of everything. And so it's a question that ultimately how much that whole Swedish unwind is going to be. I’m going to be a bit vague to be honest because we have a lot of commitments that we need to just negotiate our way out of and that will cause a certain amount of variability upside or downside in the amount of that. So you are probably going to see couple of million for next quarter and then potentially the same again the following quarter, so there will be continued cash burn whether it ends up being low-10s or high-70s, mid-to-high 70s, that kind of number, it’s difficult to say.

Okay. That’s helpful. And just to confirm the over $50 million that you discussed regarding the Meritas that’s all non-cash for the fourth quarter?

Yes, exactly, all non-cash and anticipate that it will probably be in the region $55 million to $60 million and it’s all non-cash.

Okay, all right, guys. Thanks.

Thanks, Nick.

[Operator Instructions] Our next question will come from David Cohen of Midwood Capital. Please go ahead.

Hi. I just wanted to do dig in on the diabetes a little more. Did you actually – I couldn't – I may have missed it, but did you give placements in the quarter or year-to-date? Ronan O’Caoimh: Yeah, 78 placements in the quarter. And I'm not sure year-to-day…

That's roughly, would be sort of doing [indiscernible]… Ronan O’Caoimh: Yeah. It's just more of them, yeah, about – anyway 78 in the quarter, I think 83 last quarter and I don’t have quarter one in front of me here.

Okay.

85, 83. Ronan O’Caoimh: 85, 83, 78. So just on…

Yeah.

Got you. And can you quantify the premier reagent sales in the quarter or year-to-date, how big of a business is the consumable portion of the business today?

It’s above $3 million, a little over $3 million in the quarter and it does fluctuate a bit. Quarter three tends to be a little bit weaker because of sort of vacation period particular in the Europe and such.

And overall you characterized – Ronan characterized 30% of the business, so roughly $30 million business. Is any of that or how much of that if any is not premier related? Ronan O’Caoimh: There’s about $10 million of non-premier, which is the – it’s the legacy variant business, which is – when I talked about – we just launched a new premier resolution instrument, that’s going to replace an older instrument, which is a non-premier instrument, we call the ultra. And just for example, that would do all the sickle cell anemia testing and variant testing, well, virtually all of the variant testing for the two U.S. mega labs for example. All right?

Right. So I guess where I’m getting at is, is the degree to which with that variant instrument whether that’s a – going to be incremental revenue or going to kind of cannibalize our own revenue, which I understand if we are going to cannibalize our revenue, someone else might do at someday as well, so we might as well maintain that revenue stream, but – are we displacing our legacy revenue with that new variant instrument? Ronan O’Caoimh: Yeah, so just to go back, theirs is two elements for our diabetes [indiscernible] hemoglobin business right. There is a new diabetes premier business. That’s all new. We were never in that before.

Right. Ronan O’Caoimh: And then there is the legacy business, the original business which we already bought when we bought the business and really that was a variant -- hemoglobin variant business that was typically sold to big major labs running on an old instrument called the ultra. So, basically, when we launched new – when we just announced the launch of our new premier resolution instrument, that’s going to do two things, that’s going to open new markets for us as we are doing for example with Menarini, when I talked about – rather 23 instruments was gone there. But in addition to that, what it will do is it will secure that legacy business by providing a new instrument base for us.

Okay. Ronan O’Caoimh: So it will be a combination of new and replacement of existing.

Okay. And then shifting gears a bit, so you have reiterated the comments you made in the past about the go forward effects of reducing your expenditures related to the Meritas development, $9 million to $1.5 million. But if I’m not mistaken is that all cash flow or statement of cash flow related or in other words, if I look at your P&L and exclude the derivative accounting around the convert, what will change on your P&L from a cost standpoint, so your $1.3 million of R&D, your $7.5 million of SG&A, will those numbers start to come down. Ronan O’Caoimh: The answer really is, it’s a cash flow benefit because virtually all – virtually everything that went into the whole [indiscernible] project has been capitalized because, you know, U.S. and European rules are different there, so we were obliged to capitalize that. So the – so what’s after happening will have negligible P&L impact with very significant cash flow impact. So the cash flow impact will be $9 million minus $1.5 million, which is $7.5 million a year, but the P&L impact will be negligible.

So in the absence of growth, we are still looking at what sort of pro forma profitability, because I mean this is a company that in its past and it wasn’t that long ago did – was earning $0.20 a share of earnings and now we do $0.07 on an adjusted basis, so I’m just trying to understand what has to happen to get us – to get the company back to showing higher rates of bottom line profitability? Can it only come – I mean is that only going to come from growth? We aren’t going to cut costs or P&L expenses in any particular way?

I think you are right, Dave. The key driver – and this goes back to the answer I gave to Bill’s question earlier on was in relation to growth on the top line. Because so much of that additional growth even of the quite modest and I used the example and it was purely illustrative, the 6% growth in the top line kind of result in 40% of the operating can result in 70% on the bottom line. So that’s the best bang for the buck. Now we are not going to adapt to sort of a you need to mention strategy, we will also look at our costs, we will have some cost reduction coming from the cost that we are going through the statement in relation to Meritas, there will be small reduction in that, there might be a bit of leakage of costs that were going to the balance sheet back into the income statement because they are no longer capitalizable. But on top of that, we will look at our overall cost base and look at our trending cost somewhat. That’s something that we do on a periodic basis anyway. But the bigger will come from the revenue growth. The other kicker than obviously is in relation to the buyback. So if you are looking short of EPS, the revenue and profit measures will improve the profitability into profit after tax then into EPS, then can be further improved by reducing [indiscernible] by buying back shares.

Okay. And I guess, so you got – I mean, you broadly categorized as five components of the business, I don’t think we’ve heard about Fitzgerald growth for some time, I think we’ve heard about very modest if any growth in Lyme, which is different portion of infectious disease. HIV notwithstanding the entry into the screening market has been very up and down business and it seems to be very hard to predict quarter to quarter. Premier has been certainly been a winner. The investments in the point of care, testing menu doesn’t seem to have affected the P&L, so – and I got involved in this stock in 2011 when the growth plan was around premier as the first building block, then the point of care, then the point of care testing program as a second building block achieve this double-digit growth. Here we are and we are supposed that we are going to somehow have a new way of achieving that double-digit growth when some prior organic mechanisms or initiative just really haven’t panned out. So I encourage you to think very differently about how you are maximize value of this company and going alone – I said this on your last call, going alone to me isn’t the way to that, that’s obviously not a question, you guys can move onto the next caller. Ronan O’Caoimh: Thank you, Dave. I think at this stage we don’t appear to have any more questions. So maybe we could close up the call, operator, please.

Yes, ladies and gentlemen, that will conclude our question-and-answer session. Mr. O’Caoimh, would you like to do any closing any remarks or would you like to conclude at this time. Ronan O’Caoimh: Thank you to everybody for your attention and interest and we will talk to you again at the next conference call. Good afternoon and thank you.

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