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Trinity Biotech plc (TRIB)

Q3 2012 Earnings Call· Thu, Oct 18, 2012

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Transcript

Operator

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

Management

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

Management

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…

Rory Nealon

Management

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…

Operator

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

Management

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,…

Operator

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

Management

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…

Kevin Tansley

Management

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

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

Management

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

Management

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

Management

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

Management

We have all infectious disease, all allergies, all veterinary applications. There are... Ronan O’Caoimh: Coag...

Rory Nealon

Management

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…

Operator

Operator

Our next question comes from David Cohen at Midwood Capital. Dave Cohen – Midwood Capital: Thanks. My questions have been answered.

Operator

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

Management

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

Management

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

Management

All right, thank you very much.

Operator

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…

Rory Nealon

Management

Maybe we’d have the last question?

Operator

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

Management

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

Management

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

Management

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

Operator

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.