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Transcript
OP
Operator
Operator
Good day and welcome to the Trinity Biotech Second Quarter 2013 Quarterly Conference Call. (Operator Instructions) After today's presentation, there will be an opportunity to ask questions. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Joe Diaz of Lytham Partners. Please go ahead, sir.
JD
Joe Diaz
Operator
Thank you Denise and thank all of you for joining us to review the financial results for Trinity Biotech for the second quarter of 2013 which ended June 30, 2013. As the operator indicated, my name is Joe Diaz, I’m with Lytham Partners. We are the financial relations consulting firm for Trinity Biotech. With us on the call representing the Company today are Mr. Ronan O’Caoimh, Chief Executive Officer; Mr. Kevin Tansley, Chief Financial Officer; and Jim Walsh, Chief Scientific Officer and Business Development Director. At the conclusion of today’s prepared remarks, we will open the call for a question-and-answer session. If anyone participating on today’s call does not have a full text copy of the release, you can retrieve it off the Company’s website at www.trinitybiotech.com or numerous other financial sites on the Internet. Before we begin with prepared remarks, we submit for the record the following statements. 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. 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 said, let me turn the call over to Kevin Tansley, Chief Financial Officer for review of the results. After that we will hear from Jim Walsh regarding developments of the cardiac business at Fiomi and finally, Ronan will provide his overview of the quarter as well as the acquisitions that were announced in today’s press release. With that said, Kevin, I will turn it over to you.
KT
Kevin Tansley
Analyst
Thank you very much Joe. Today I'll take you through our results for quarter two 2013. To begin with our revenues, total revenues for the quarter were just over $21.3 million, this compared to $20.8 million in quarter two of 2012 and thus represents a growth rate of 2.4%. Later in the call, Ronan will provide more details as to the makeup of this growth and in particular the impact Lyme sales have had this quarter. Before going through the rest of the income statement, I would like to mention quickly the Medical Device Excise Tax or MDET, as I pointed out last quarter this is a new in 2013 and thus for comparability purposes we’ve disclosed it separately. So, returning to the income statement, the next item is our gross margin as you can see from our press release, this quarter’s gross margin was 49.8%, while this represents a strong gross margin, it was lower than the 51.6% we reported in quarter two last year. This decrease is attributable to two main factors, firstly it reflects the higher instrument placements predominantly sales of our new Premier instruments which had 80 this quarter is the highest in any single quarter. And secondly, is the impact of the lower Lyme sales which historically these products have had higher gross margins. Moving onto our indirect costs, our R&D expenses are just over $900,000, which represents a slight increase in the $800,000 announced in quarter two of 2012. Meanwhile our SG&A expenses have increased in the quarter from $5.2 million to $5.5 million. This increase is entirely explained by the acquisition expenses related to Immco. Our operating profit was 3.8 million which is down approximately $500,000 compared to the same quarter last year and again the biggest factor here is the acquisition cost…
JW
Jim Walsh
Analyst
Thank you, Kevin. I will take a few moments to provide a brief update on our cardiac marker development program at Fiomi in Uppsala. Very briefly for the very few of you who by now may not know about Fiomi I will just take a few seconds to recap on the background here. About 16 months ago Trinity acquired a Swedish company, Fiomi Diagnostics for a consideration of $13.1 million. Fiomi had developed a high sensitivity precise quantitative immuno-assay platform on which Trinity is now developing a range of high sensitivity cardiac marker products, namely high sensitivity Troponin for the detection of acute myocardial infarction and BNP for the detection of heart failure. Again, by way of a reminder, the point-of-care cardiac marker market is large, is growing rapidly and is served only by three real players namely Alere, Roche and Abbott. It is also the case however that none of the point-of-care Troponin products offered by either Alere, Roche or Abbott meet the current FDA guidelines. There is therefore enormous opportunity, market opportunity for a guideline compliant Troponin product and that is what Trinity is developing at Fiomi in Uppsala. I mentioned on the conference call of April 25 last, that we had just reached design phase of our Troponin product at that stage in our hands this Troponin products fully met all aspects of the FDA guidelines. I also mentioned on the call that the product had just commenced clinical trials required to obtain CE marking and allow European sales commence. I am happy to report today that these trials are progressing well and that we remain on track to have Troponin product CE marked in late Q4 of this year and available for sale in or immediately thereafter. In general there are two aspects to the European…
OP
Operator
Operator
Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions) The first question will come from Chris Lewis of Roth Capital Partners, please go ahead. Chris Lewis – Roth Capital Partners: Hi guys, thanks for taking the questions. Ronan O’Caoimh: No problem, Chris. Chris Lewis – Roth Capital Partners: I just wanted to confirm with the Immco acquisition. Can you say that it closed on July 26? I just wanted to make sure. Ronan O’Caoimh: It closed after hours on – essentially closed after hours on Friday, last Friday. There were some minor filings that still had to be done yesterday and certain parts of the consideration were still moving. So, in essence, officially, sort of, ink was put on documents, albeit if not everything executed in time for close of business on Friday. So, it was still working through yesterday. Chris Lewis – Roth Capital Partners: Okay, and then maybe, I was hoping you could just provide some more color on the history on how the acquisition really came to be, is it something that you looked at for a while now or it's something that you recently taken a look at and then just in terms of timing, your Fiomi kind of ramping up and seems like some of your focus, a lot of your focus is around that. So, why do you think now is the right time for this acquisition? Ronan O’Caoimh: Well, I think that we had been aware of the company for a long time given that we have been a very big player in autoimmunity with $2 million worth of revenue and but basically for their own reasons, the venture capital were closing the fund and put it up for sale. So with that, it was put out to…
OP
Operator
Operator
The next question will come from Larry Solow of CJS Securities, please go ahead. Lawrence Solow – CJS Securities: Just a quick follow-up on the Immco. Is the expectations for accretion – I know you talked about a period of transition. Is that just sort of last quarter, obviously, you had some acquisition charges, but looking out over the next couple of quarters, do you expect that to be accretive pretty much immediately? Are there cost-cutting opportunities or is it more increased economies of scale and revenue synergies? Ronan O’Caoimh: I think the costs that would arise other than the acquisition costs are very modest. We’re talking about under a couple of hundred thousand dollars of integration costs. It would be immediately accretive, I think, very marginally so in quarter three, because we’ve only got two months of it, but certainly a quarter four it should be earning $500,000, $600,000, $700,000 for us. In terms of rationalization there would have been none really. I mean, there would be absolutely no rationalization within the actual manufacturing organization. As I mentioned, the fact that it’s a strong management team, [inaudible] full of confidence and I think – actually going back to the last question you referred that do with us. We don’t see this as being a huge drag on management time. We’re very much wanting to concentrate on the – on our primary focus is the strategy. It’s one of, obviously, [one of which is Troponin] [ph] at this time. So, we don’t think this will be a drag in that sense because of just how competent the management team is. I think where Trinity is really going to make a big difference will be not in the manufacturing side of things at all, there will be no changes, but rather…
OP
Operator
Operator
Our next question will come from Paul Nouri of Noble Equity Fund. Please go ahead.
Paul Nouri – Noble Equity Fund: Do you have a revenue number for the year?
KT
Kevin Tansley
Analyst
Just in that context, I’m going to just mention and approximately we should have mentioned it earlier on, anticipate that next quarter we’ll earn an additional $2 million of revenues from Immco because we only have about two months there and the equivalent then about three months of revenue to be $3 million in quarter more. So, we’ll have an additional $5 million of revenues coming in the next five months or so. Then, in terms of our underlying business, we would expect growth over what we’re seeing in this quarter. We have – Ronan has mentioned that the Lyme business has come back on stream. So, I’d be expecting – and its hard if it’s removed to be exactly sure, but we’re probably going to be talking somewhere in the sort of the 22s that sort of number for each of those two quarters. Again, given the variability and things like Lyme and HIV you never know, but it couldn’t be a bit higher than that, depending on those. So, the extent to which Lyme continues to show, its promise to showing at the moment, I think we’ll go north of 22 in each of those. So, 22 plus 2 plus a bit maybe for quarter three, 22 plus a bit again plus 3 in quarter four, so we may be up around sort of 25, 26 million for each of those quarters.
Paul Nouri – Noble Equity Fund: And what is the company you purchased, what does the operating margin look like for them?
KT
Kevin Tansley
Analyst
For Immco, there currently making about $3 million of EBITDA. So, and Op revenue is about $12.5 million, so it’s sort of about 23%, 24% of EBITDA and margin.
Paul Nouri – Noble Equity Fund: And does your tax rate change at all with the purchase?
KT
Kevin Tansley
Analyst
I don't think it will be influenced hugely. My calls is little bit, but in terms of how we are structuring it I think we will still be able sort of maintain a very favorable ratio and you can see that it’s between 6% to 7% this quarter and I don’t see a significant move of that.
Paul Nouri – Noble Equity Fund: Are you going to use the lab to develop any other, kind of lap develop test or are you going to leave it to the specialty that it has right now?
JW
Jim Walsh
Analyst
Jim here, absolutely. That's one of the key things about having the lab is, it is the source of a whole new panel of test. Like for instance, this year, Immco produced a proprietary patent protected outfit for disease called sorghum disease and they also produced a panel of tests for syndrome called chronic rhino sinusitis. Those came directly from research they took that in the lab and they have a program of eight or ten of those relatively esoteric diseases with very prevalent disease in the United States. So, I would expect we can see at least two or three of those at least two or three of those type projects could turn into actual testing service revenue every year for the next number of years. The pipeline is very strong.
Ronan O’Caoimh: So, one other thing that we haven't mentioned and that is that just under 40% of the revenue is the lab related actually to transplant the testing. So, there is a lot of transplant samples going in there. And clearly there are opportunities there also potentially, but not that we have extraordinary details at this time.
Paul Nouri – Noble Equity Fund: And does the lab have its own sales force or does it mostly go out to the quest and lab to the world and, kind of, have the markets, the test for them?
Ronan O’Caoimh: Well, the lab actually had recently just put in place for people in the United States and who are out marketing the products to the bigger labs. And we intend to be integrating that with our own existing sales force. So, they had recently commenced doing some of that. Our intention is to probably, is to integrate those because we have deep relationships with quest and lab corporate for example.
Paul Nouri – Noble Equity Fund: Yeah. And the life sciences business is shifting to that was that down year-over-year I assume?
KT
Kevin Tansley
Analyst
Sorry, could you repeat that question?
Paul Nouri – Noble Equity Fund: Your organic life sciences business.
KT
Kevin Tansley
Analyst
Sure it was flat. Absolutely flat inverted to the dollar.
Paul Nouri – Noble Equity Fund: And there were a couple of the new point-of-care tests approved in the second quarter. Is that correct?
Ronan O’Caoimh: Yeah. And I dealt with that. Yeah, we have had quite a number of approvals, but the approvals have been principally in Europe rather than the United States, but we now have an entire enteric range available in Europe. So, due to IHT essay and Biologic crypto and so basically, they’re all available in the United States, sorry, excuse me, in Europe and being sold as we speak through that whole – we have been working with that – with our distributor network there.
Paul Nouri – Noble Equity Fund: Okay. Thanks.
KT
Kevin Tansley
Analyst
Thank you.
Ronan O’Caoimh: Thank you.
OP
Operator
Operator
Our next question will come from Ross Taylor of Somerset Capital, please go ahead.
Ross Taylor – Somerset Capital: Thanks for the chance to ask some questions. On the Premier, currently you have what, just under 500 instruments in the field?
KT
Kevin Tansley
Analyst
202 – no, about 400 Ross, just under 400.
Ross Taylor – Somerset Capital: There are over 400 and you are getting what, on average, reagent sales and like about $20,000 per machine?
KT
Kevin Tansley
Analyst
No, about $10,000.
Ross Taylor – Somerset Capital: At the CJS Conference, I think, the number was given out was substantially higher than that of not what you’re projecting, but actually what you’re seeing.
KT
Kevin Tansley
Analyst
No, I don’t think so. I mean we’d be doing – no, I don’t think so, I know neither was there, but – no, about $10,000 on average per instrument.
Ross Taylor – Somerset Capital: Okay.
KT
Kevin Tansley
Analyst
And the sales price of the instrument is about $20,000. The $10,000 is the correct number per instrument. Ross Taylor – Somerset Capital: Okay. And so what we’re looking at having is by the end of 2014, we’ll chat about that at another point Ron. I can kind of, we can get on the same page because my notes on that are very different than what – the $10,000 number. Ronan O’Caoimh: Ross, to give you a flavor for that, what happens is in 12 with zero set in Premier in 13, 2013 we did $4 million, nearly to the dollar, and I think this year we’ll do $10 million. Ross Taylor – Somerset Capital: Okay. Ronan O’Caoimh: Now, obviously and initially that’s skewed mostly towards instruments and then over time, I would say, you have more reagents. The reagents were on at about 90% margin. The instruments were on there like 15% or in the case of China 0% margins. So, that’s the dynamic. The number of ACB is I think is – it was $4 million last year and $9.9 million, we’ll probably do $10 million this year, but I’m afraid the reagent principle is actually $10,000. Now, it’s about – it’s over $20,000 in the United States because or course we’re selling direct, but – and in – but anyways, it’s – so it’s $20,000 – it’s $10,000 anyway per instruments. Ross Taylor – Somerset Capital: Okay. And so we are looking at, therefore, having – by the end of 2014 you would expect something in the neighborhood of about 1,000 instruments in the field? Ronan O’Caoimh: Well, with the 202 in 2012, we’re going to do 320 in 2013, and I think 400 – yeah, so it would be very close to – yeah, just under…
KT
Kevin Tansley
Analyst
Yes, and I think that’s absolutely correct.
Ross Taylor – Somerset Capital: Okay.
Ronan O’Caoimh: Because I think that after four years – after five years of placing 600 instruments you have – you know you have 3000 instruments in the market, averaging $30 million at 90% margin is comfortably more than $1 a share.
Ross Taylor – Somerset Capital: Yes. Okay, and then so – and also, looking at this acquisition, you’re talking about seeing – you think you can go about 20%. You paid about 12 – 11 times EBITDA for it. Is – how right – is that – it seems to me that 20% might be a kind of a cautious estimate on your part?
KT
Kevin Tansley
Analyst
It is because – it was very unusual circumstance where the United States company is selling – purchasing nothing in the United States and it’s got leading-edge products and I think they’re going to do very, very well. So, the timing of the acquisition, the timing of the disposal of the company related just to, you know, the closing of a particular fund by venture capitalists. So, there was a lot of competition and the main players that we talked about, the leading players competed right till the end on this one. So, a very attractive opportunity we believe. I think, very importantly, you know, we have a big business in infectious disease in the United States and this deal that we’ve done, I mean to say this, it reinvigorates it is to understate the reality. It’s a big opportunity for us. It’s not just that our reps would go to the same laboratory, it’s that they can actually put all these products on the same instrument that we already have sitting in the lab. Furthermore, there’s an awful lot more unique about these autoimmune products. Then there about our existing infectious disease Lyme which actually isn’t that particularly unique. We have made it attractive by adding esoteric products sort of undersize, but inherently, it's not that exciting and ironically this autoimmune, it autoimmune acquisition, makes it exciting. Because I think a key thing to remember here, maybe something I should have said in the prepared notes is that autoimmunity is going nowhere in terms of – it's not going to Abbott, there is no way that Abbott are going to put it on their huge architect instrument because the volume aren't big enough. Autoimmunity is going to stay with ELISA and with IFA and ironically, IFA which is going…
KT
Kevin Tansley
Analyst
Yeah of that order, yeah. Ross Taylor – Somerset Capital: Okay. And other than that, you know that, now that you spend $30 million buying this, I know that Kevin talked to you the number you showed us today, I know that they will be that I don’t do my job if I didn't tell you can now spend $20 million buying stock? Ronan O’Caoimh: We will see about that. I mean we know we will review. I mean, Ross, we know that you are all kind of subject and I think that – I mean, we may do clearly the price of two week and we go to the market and right at this moment in time, I probably have no intention to go in, but clearly we will have the market suffice in two week. I mean, I think there is that kind of, there is the amount of cash that one would like to keep of the balance sheet, let's say we are quite there. We wouldn't be far away from it. Ross Taylor – Somerset Capital: I think that a lot of the fee, if you are successful in Premier, we just talk about the ability to generate a dollar share and earnings a couple of years out of that business. We are looking at, in previous calls, you talked about Fiomi and you would be disappointed if it only generated $50 million in the annual sales and by the math that I and others do that another dollar share, you are looking at a company that’s trading $19 a share here and quite honestly three years down the road, it's not hard to imagine that the price would be two or three times that. So, we would look at it saying that this would be…
OP
Operator
Operator
Our next question will come from Declan Morrissey of Davy. Please go ahead.
DR
Declan Morrissey - Davy Research
Analyst
Hi, I think most of my questions have probably been answered, but just one question on Lyme, you alluded earlier just the pick of the Lyme sale in the beginning of Q3, and I am just wondering do you see the Lyme season being extended or because of the less summer I suppose or do you see spending up a normal stage and just having, I suppose you are taking a hit on Lyme for the year and consequently your gross margin is going to be down. Maybe you can give some color on that.
Ronan O’Caoimh: Well, Declan, I think, firstly, just before I came on the call I saw our sales, our line sales, our line confirmatory sales. So far in July with two days to go they were actually identical to last year’s sales. So, that I know there is more to go, but it got the reason and indicated that we’re back to our normal run rate, although not okay. But certainly competing, I don’t think so much, I think those sales are gone if you mean, basically just the ticks weren’t there and in terms of will it give rise to some of the extended season I don’t think so. I think, the only thing by the way that the line season actually turn into a virtually 12 months season, we just with much bigger highs in quarter two and three, but we do have kind of a residual level of line sales in quarter four and quarter one.
DR
Declan Morrissey - Davy Research
Analyst
Okay.
Ronan O’Caoimh: Just be caught by the time people get to in for testing and all accounting else. So, it’s not that just sales are completely eliminated, but I don’t know I think these sales are gone basically. You know they are not going to be recovered it’s not a season won’t extend.
DR
Declan Morrissey - Davy Research
Analyst
Played onto your gross margin kicker and edge two?
Ronan O’Caoimh: And realistically, no, I mean, put it simply $750,000 of sales, $750,000 down this quarter and that comes to $400,000 and profit comes to $0.02 it’s really as simple as that.
DR
Declan Morrissey - Davy Research
Analyst
Okay, thank you.
Ronan O’Caoimh: Thank you.
OP
Operator
Operator
The final question will be a follow up question from Paul Nouri of Noble Equity Funds, please go ahead.
Paul Nouri – Noble Equity Fund: You have managed not to pay a whole lot of tax for few quarters, what kind of tax should we look for a like 14.5%?
Ronan O’Caoimh: We have been successful in terms of our tax rate obviously we’re availing below tax rate here in our end, we also avail certain R&D benefits again here in our end another jurisdiction as well. I think that will continue for some time, we’re doing particularly well this year and I see that if we do increase and it will happen eventually it’ll be in the sort of the low double digit as such, as it’ll be a little wide before that comes here.
Paul Nouri – Noble Equity Fund: Okay. So, you are benefiting from some R&D incentives and we can expect that to continue for the foreseeable future?
Ronan O’Caoimh: Yeah, R&D and so well, I don’t have control over R&D in centers unfortunately, but to the extent which we know they are available scale yes and we’ll be able to see put a lot of work into it and how we structure our tax affairs, so we will continues to work hard in that regard as well.
Paul Nouri – Noble Equity Fund: All right, thanks.
OP
Operator
Operator
And ladies and gentlemen this will conclude our question-and-answer session. I would like to turn the conference back over to Ronan O’Caoimh for his closing remarks.
Ronan O’Caoimh: Well, I just like to say thank you to everybody for participating and for your support and interest and we look forward to talking to you next quarter, bye, bye.
OP
Operator
Operator
Ladies and gentlemen, the conference has now concluded. We thank you for attending today’s presentation; you may now disconnect your lines.