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Trinity Biotech plc (TRIB)

Q1 2016 Earnings Call· Tue, Apr 19, 2016

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Transcript

Operator

Operator

Good morning and welcome to the Trinity Biotech First Quarter Fiscal Year 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 Joe Diaz at Lytham Partners. Please go ahead.

Joe Diaz

Analyst

Thank you, Amy, and thank all of you for joining us to review the financial results of Trinity Biotech for the first quarter of calendar 2016, which ended on March 31, 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 forward-looking statements. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development, commercialization and technological difficulties and other risks detailed in the company’s periodic reports filed with the Securities and Exchange Commission Forward-looking statements reflect management’s analysis only as of today. The Company undertakes no obligation to publicly release the results of any revision to these forward-looking statements. With that said, let me turn the call over to Kevin Tansley, Chief Financial Officer, for a review of the results. After Kevin’s remarks, we will hear from Jim Walsh, on product development issues and Ronan O’Caoimh, will wrap up the prepared remarks with his perspectives on the quarter. Kevin?

Kevin Tansley

Analyst

Thank you Joe and I’ll today take you through the results for quarter one 2016. Total revenues this quarter were $23.5 million and this compares $25.2 million in quarter one of 2015. However revenues this quarter continue to be impacted by currency movement, strengthening of US dollar has served to reduce the dollar equivalent while Euros starting and Brazilian real revenues. As you all have seen from the press release we have restated the Q1 revenues on a constant currency basis, in order to put this into better context. Ronan will provide more details on the revenue for the quarter later in the call so I’ll move on now and discuss the other aspects of the income statements. As you will see from our press release, we’re now showing a gross margin of 43.1%. While this is a reduction on the 47.9% in quarter one last year, it is consistent with the margin reported in quarter four of 2015. Reduction in gross margin in comparison to the equivalent quarter last year is principally due to couple of factors. Firstly this quarter we had lower production levels due to lower revenues this quarter, even these lower production volumes this results in the level of under observes fixed cost namely production, labor and overheads. The result was that these unabsorbed costs then hit the income statement this quarter in effect increasing our cost of sales and thus reducing our gross margin. The second factor then was the lower level HIV sales and this is significant as on average these represent higher margin sales growth. Moving on to our indirect cost, our R&D expenses increased from 1 million to 1.1 million this quarter, meanwhile our SG&A expenses have increased in the quarter from 6.3 million in equivalent cost of our last year to…

Jim Walsh

Analyst

Thank you, Kevin. I’ll take the opportunity now to update you on our cardiac development programs. In particular today I’ll provide you with a detailed update on our Troponin FDA submission, given you an overview of our clinical trial data and also give you an update on recent communications with the FDA. I will also provide you with a brief update on Meritas BNP products, which as you know is currently undergoing clinical trials to support the 510(k) application. So starting with Troponin, firstly, let me give you a brief reminder of the excellent clinical performance we observed in our U.S. trials. It's only six short weeks ago since I provided you with a very detailed review of our clinical performance data. So today I’ll provide you with a very high level reminder. It's probably easiest to explain our clinical performance by comparing ourselves to two of the market leading products currently approved and widely used in United States today, mainly the Abbott i-STAT point-of-care Troponin products and the Abbott architect central lab Troponin products. According to the manufacturers package insert, the admission sensitivity of the current FDA approved Abbott Architect Central Lab System is 60% with a corresponding specificity of 95%. And in recent study carried out by Dr. Apple at Hennepin County, the Abbott i-STAT Troponin product was determined to have admission sensitivity of 32% with the specificity of 92%. In our recent U.S. clinical trials, the Meritas product demonstrates a whole blood sensitivity of 66% and a corresponding specificity of 94%; thus, beating the market leading i-STAT product by a 35 percentage points in sensitivity, while the Meritas also beats Abbott Architect Central Lab System by 6 percentage points in sensitivity. However, although these results look excellent for Meritas, you need to keep in mind that we’re…

Operator

Operator

Thank you [Operator instructions]. Ronan O’Caoimh: Hi Larry Solow is in queue to ask for question, Larry can you hear us?

Larry Solow

Analyst

Just a couple of quickies, just on the Meritas, it sounds like -- just to confirm the only the potential variability, and I realize the exact filing date really given the day is not the major concern, but the only potential variability would be timing of just accrual in getting these three trail sites non-key party site complete, is that fair to say? And rest of the other data is sort of in your controlling house and should be done fairly soon?

Kevin Tansley

Analyst

That’s absolutely correct Larry. Virtually everything can be done in house except the part of the bit that I outlined on the precision study okay. Now, it’s limited to three trial sites, so it’s actually limited to 9 patients sample as well, so it’s not a mega study. It will take us a couple of weeks to get the IRBs. We’ve already submitted to the hospital for the IRBs. And because we are not making any diagnosis, this is truly for precision, the IRB is process is fairly short and pretty lean. So we’d hopefully have our IRBs approved in the first week, second week of May. We then conduct the work, it's actually three weeks of solid work to do that and then we have to write it up et cetera, et cetera. So I’m hopping quite frankly that the same end of July is giving us a little bit of wiggle room there, but it’s not an expensive trial for that.

Larry Solow

Analyst

I got it, I just wanted to make sure that you’re giving yourself a little bit of room there.

Kevin Tansley

Analyst

The problem I'll tell you is, the only problem I can foresee is, what they’ve asked us to do is, is to take real patients with either with high, medium and lower Troponins. And so somebody with 200 somebody and somebody with 100 and somebody with a 20, if you like. So it’s often hard just on the day your there to get the guy with a 50, he might be three 30s and there might be a bunch of 100s. So there is a little bit of selection work to be done, but it’s not a big deal. Ronan O’Caoimh: But Larry, just to remind you, as Kevin just said earlier, they we’re quietly pleased about this because it will enable us to showcase our improved CV performance.

Larry Solow

Analyst

Right, so at the end of the day hopefully this actually benefits you guys for the label and all, so it will hopefully be a high pass problem. And these three sites, were these -- are these former sites, where we did other study? Ronan O’Caoimh: We're using two former and one new one actually, because the IRB process it's open. We wanted to do it quickly, so -- but it is that they are all guys who know what they're doing Larry.

Larry Solow

Analyst

Good, that’s okay great, good to hear that. And just a couple of quickies on the operations, Ronan in terms of HIV, I know it’s inherently a lumpy business, yes, you had a little lump last year too and may be sales are flat or slight down year-over-year even though, you think they are still growing, is there any chance you make up some of these sales in the coming quarters? What gives you confident that may be there is a slowdown for several quarter in a row, maybe not as quite as this low, but do you have any color on that? Ronan O’Caoimh: I know that we had a miss last year in quarter two when HIV came in low in Africa as well, but despite that I just think we’ve been just dipped into a poor 13-week cycle there. If it had been a 14 week cycle, an extra week it would have been fine, that kind of thing you know. So I just think the reality is that HIV -- our HIV revenues don’t just do us a favor of coming in equal every 13 week period. Yes, I think probably it will come back, I think probably quarter two will be stronger, but nothing as lower from back then. But I think over the longer period it will all equalize and so it’s just one of those things and reality is what it is, the revenues just are haphazard.

Operator

Operator

The next question is from Nicholas Johnson at Raymond James.

Nicholas Johnson

Analyst

First, I want to talk a little bit about the balance sheet, obviously you’re guys raised capital about a year ago from the convert. We haven’t seen any M&A activity, certainly I would expect valuations to potentially adjust given the end markets and considering some of that’s going on in the capital markets. But just wanted to get your thoughts on M&A, where we stand, and is it likely that we see something this year from a deal perspective? Ronan O’Caoimh: Nick I think I am certainly hoping that you will see something this year, and we continue to seek out acquisition opportunities. Yes, I think that we’re going to see valuations become more civilized. But although having said that, we would have also been shown that recent Magellan acquisition that Meridian did and we would have taken a view that it was too pricy, it's over four times revenue itself. But as I told it’s a matter perspective, but certainly that was our perspective. But we continue to seek out more and more acquisitions and we will certainly be hopeful of finding something that may not be with the history over the years as being able to identify and close deals, and this is a new experience for us to have sourced an acquisition for such an extended period of time without success. So I think we will get there, but we’re just mindful of not overpaying.

Nicholas Johnson

Analyst

That’s helpful, and then my second question would just be on overall consolidated organic growth. Obviously, it's been a little bit lumpy over the last few quarters certainly HIV in Africa plays a role in there. But I am of the understanding that you finally cycled through some more easier comparisons beginning in the June quarter. So I just want to get a better sense of your thoughts on can you deliver consolidated organic revenue growth in the back half of this year irrespective of what goes on with that back from here? Thanks. Ronan O’Caoimh: Well, I think in my prepared remarks I made reference to that I think that yes that I think we can and I believe we will. And I think this particular quarter was just a particularly weak one. It's traditionally the weakest in any event. And then you had -- you just had a very poor week of HIV sales. So yes I think that the rest of the year will be much stronger, and I think we’ll benefit as I indicated from additional Sjogren and also immune business submitted, additionally Syphilis. And from the content and maybe just clocking away with the placement of the new premiers and I can think of back on then it was stronger as opposed to what we’ve had this year, it was very-very weak. Lyme seasons will be stronger this year undoubtedly. And in addition to that, we should get some price increases in Brazil and the currency has -- the Brazilian currency has come back from 4 to I think 3.55-3.60 [ph] over the last few days. So, yes absolutely we believe that our revenues will grow organically through the rest of the year.

Operator

Operator

The next question is from Bill Bonello with Craig-Hallum.

Bill Bonello

Analyst

Ronan I am wondering if you can just comment a little bit on the broader environment, obviously with Abbott planning on acquiring Alere, there is the potential for disruption and in lot of the markets that you play in, there has been some switches in the HIV market in terms of some of the providers there and what distributors you’re working with. And just wondering, if you see sort of a unique opportunity right now in the marketplace to take share because of some of this disruption and any other journal commentary on the environment? Ronan O’Caoimh: With respect to HIV I mean clearly now with Alere being the goliath in African HIV, Abbott now becomes -- takes over that space. What’s happening up to now is that Alere dominates screening and we dominate -- we entirely dominate confirmatory. And I don’t really see much change happening there, I mean I don’t know exactly what Abbott’s plans are, I assume they won’t divest this and so I don’t see much change there. And of course when you refer to some distributor changes, we haven’t actually has any distributor changes. So I am not sure what you mean there. So in that sense I don’t see really much difference unless Abbott were to surprise us by divesting, bear in mind that we have developed a new product which we haven’t talked an awful lot about and which is a new recombinant based rapid HIV test that with enable us to enter the screening market and of course that remains our plan. To move on then to cardiac I mean clearly the two major incumbent space in world rapid Troponin testing are number one and Abbott’s with i-SAT, number two, Alere with their trial spot and of course now Abbott’s acquiring Alere.…

Bill Bonello

Analyst

Okay that makes sense and then just on the distributor side, I was been talking about you always talking about Chembio kicking back the sales of its own product and Alere. Ronan O’Caoimh: Yes well just to be able to -- again that hasn’t really made much of the difference that we can see. I mean that piece if December was only 6 million piece for us in any event and just we've said if possible, probably about 2 million is sold into public health, we are really not feeling much difference. I mean really from our point of view whether Abbott -- whether Alere is selling the product or whether Chembio themselves it, doesn’t make a huge amount of difference to us, you know.

Bill Bonello

Analyst

Just as a follow up and maybe also a little bit more color on what you see happening in the A1c market whether you are seeing the kind of because you talked about 8% growth whether you are seeing that kind of consumable pull through even what kind of uptick you are seeing in Europe just anything of note on Premier? Ronan O’Caoimh: Yes, I mean just I would take advantage of your question just to clarify something. When I say we've got 8% growth in our hemoglobin business of course, what actually we have is we have no growth in our traditional variant business and with 16% growth in our in hemoglobin A1c business. So the Premier is doing extremely well but bear in mind it is a legacy business which does okay. We’re now about to launch our new instrument and I think it will do quite well it can do very well and that will be close but just bear in mind that it was the legacy business which is fairly static and then you got the Premier business going very well. So the actual growth of Premier is more like 16% and given that the two components are more or less of equal ties at this moment in time. In terms of how it's doing, I mean it's sort of very well obviously it's stressful to be in a situation where there is huge amount of Brazil and we can't satisfy it because of the real has halved in value. But outside of that and our partnership with Manaswini [ph] is moving on very well and in due course we will enhance 40% of the European market and that is basically -- that is happening in the U.S.A. which is largely and I’ll say we’re doing…

Operator

Operator

The next question is from Walter Schenker at MAZ Partners.

Walter Schenker

Analyst

Just really two questions. First if we were to understand that the FDA to the best of your knowledge has reviewed the full component filing and therefore at this point this the list of questions you received were all they came up with -- after doing the due diligence a review of the whole file they didn’t stop halfway through and come up with a list of questions or something like that?

Kevin Tansley

Analyst

Hi. Walter you are absolutely correct. This is a further review of our full filing document and the list of the questions we have range across the full documents. So it is not a partially review and a stop. This is a full review and a full comprehensive list of questions on the full documentation.

Walter Schenker

Analyst

Okay. So that's the main reason you feel kind of seeing everything they’re sending backwards, so comfortable never knowing that the FDA of what they come up with to this point?

Kevin Tansley

Analyst

[Multiple Speakers] It is very encouraging for instance, I said in my statement that it was encouraging that the ACS trial it was undoubtedly the most complex trial ever undertaken by Trinity Biotech. We got one question on it and it was a clarification question, the 99 percentile trials for the normal, I don't believe -- I can't remember the bit between -- no question of [indiscernible]. And it’s in those areas where we see other companies have been thrown out to date. There a lot of companies having to have go through the reviewed and essentially they were told to rerun the trials. So that’s what gives us some comfort, there is a full review and the questions we got are the questions I guess, okay. What will happen next is when we put in our answers, I am assume it will lead to another round of questions, they will try and understand our answers to those questions, but theoretically with the fair wind that should be it, it will be down to ideally down to labeling issues and that type of discussion then. That's definitely an idea world, obviously can't guarantee that, but that’s what’s all that should happen.

Walter Schenker

Analyst

And just one sort of general question, when one looks at the 20-F, you forecast various developmental spending for 20 -- you showed ’15 and showed ’16, there is 10 different products or programs, I made up 10, where you're spending enough money to put it in the 20-F, are there any those that we should be specially cognizant of or specifically eye on which we haven’t discussed as to a whole bunch of new different types of tests?

Kevin Tansley

Analyst

Most of the -- Walter, Kevin here, I think most of those projects you’d be very familiar with and they are obviously concentrated on the Troponin area and there will be separate project there for cardiac, aerobics, Troponin, D-dimer and BMP. We don’t have the device itself, the projects there on that and similarly then in relation to the diabetes side we've been enhancing our instrument there and with the new version usually coming out there in the near future as well. So there are a range of projects in there, but there is a level of granularity you're seeing in the 20-F, is probably we tend to group through maybe more so when we're talking on the call, I don’t think you’ll be familiar with all of those virtually.

Operator

Operator

The next question is from Ross Taylor from Somerset Capital.

Ross Taylor

Analyst

Most of my questions have been asked, but could you go into little bit more depth and how you've seeing -- see yourselves adjusting your operations so that you can sell into Brazil, that you can potentially sell into Russia with currencies that might well stay weak for some time? Ronan O’Caoimh: Yes, Ross, frankly in terms of Russia, I mean I think there are political issues involved here also. I mean the extent to which our business has collapsed there isn’t just attainable to currency. I think it comes right from the top directive, which basically is discouraging importation. But today with Brazil and which is very significant for us and apart from riding candid and hoping that the real will actually strengthen, I guess that it has done, it has kind of come from 4 back to 3.50. I know it’s 3.60 now, but and I think that we are also having an inflationary background so as an example we have to give it -- and we have no choice so you have to give 12% salary increases to our people in Brazil recently and so again that to back 15% inflation background so that will enable us to get price increases. And beyond that what we're doing is at the movement we're using a contract manufacturer to do some of our manufacturing products but not extensive amounts of manufacturing and that enables us to basically save some and some transportation cost because there is an awful lot of reagents of water basically or heavy reagents used in the preliminary testing. So we save on transportation cost which are quite expensive in Brazil, but we also save on duties. And however if we were to move manufacturing ourselves which is what we’re endeavoring to do, there are certain…

Ross Taylor

Analyst

Okay also when you announced the buyback in place of the dividend, I think that it was viewed by many new investors as positive. That said, I got a number of comments this morning from people who felt the pace of the buyback was rather anemic, can you explain or talk or tell us how aggressive are going to become, I mean you're looking at a story, you guys seem very confident what’s going on, obviously you have a ton of cash on the balance sheet. A more aggressive buy back but probably built from goodwill with your investors who felt the little flustered with the convertible offering year ago. So I was looking at this where you put $1.5 million in where the year before you then went about $5.5 million on a dividend, just seems that somehow shareholders, we haven’t quite gotten what we’ve given up yet, so can you address that?

Kevin Tansley

Analyst

Just to say that, obviously we’re only in the position to buyback for a limited period of time because we only announced our results six week ago and then we went into a closed period of 31 March. So we were only actually able to be in the market for only two weeks, our last two weeks and two and a bit week, so we’ve bought back $1.5 million worth of stock, which I know wasn't significant. And the issues for us are that there are constraints on what we can buy, we can't be the first buyer and we can’t be the first place, we can’t be the last. And we can basically buy I think 25% in the moving average excluding what is outlined. So basically there is a limit to what we can buy. Now we can buy blocks and we will endeavor to buy block, so we didn't actually get any in the short period of time we were in the market. But just to be very clear Ross, we are committed to a buyback and we think that a buyback makes compelling sense at the prices that we find ourselves at this moment in time. So you'll see us buy aggressively and as soon as we can go in, I think we go back in tomorrow. It's a 36-hour -- maybe I can't remember, 48 hours we can go back and we will be straight back in. So you'll see us in the market and we would buy aggressively and more aggressively. So basically we only were in the market for very short period of time, we have to check the market again and tell you first. I know we could have put a plan in place but we chose not to at that stage. So we can put a plan in place. We could have been in the market for the past 3 weeks.

Operator

Operator

The next question is from Chris Lewis, Roth Capital Partners.

Chris Lewis

Analyst

Just a couple of follow ups on the simplest point of care product, can you just provide an update on where you are in terms of getting those public health departments on board. Ronan, you've talked about that being a $10 million dollar product within 2 to 3 years, so when you think you’ll start to see more of an inflexion point in that business? Ronan O’Caoimh: I think soon and although I mean soon is the answer, we're beginning to see bits and pieces coming through, but just the whole process from training to evaluation to funding, purchasing and it just seems to be such a slow process. And I know it’s frustrating, but we actually are going through that process at virtually all the state as we speak. And so we do believe we can get the kind of quantum that we said in the timeframe to set. But it’s got a slow -- it’s a bit of a slug frankly.

Chris Lewis

Analyst

Understand and premier, can you tell us how many placements do you have in the quarter and how many placements you’re expecting for premier for the year? Ronan O’Caoimh: With 85 this quarter and we’re hoping to do 350 plus for the year. To remind you, we did 460 last year and the difference really reflects the fact that we came out of the Brazilin market. So that’s 350 within, I think 350 may be hallow over that. It depends on when we get really me get really back into the Brazilin market property. If we do we'll exceed that number comfortably.

Chris Lewis

Analyst

Got in and then on then on the gross margin side of things, talked about the under observation of fixed every head and some unfavorable product mix it’s been around 42% the past two quarter, how should we think about gross margins going forward from here? Thanks.

Kevin Tansley

Analyst

The couple of things, the couple of those one off features in the last couple of quarters we said our 43% if you remember last quarter the margin was impacted by a requalification concentrated within quarter four itself, you were getting four times the impact in one quarter. So if it wasn’t for that the margin would have been in or around 44% and 45% that sort of number, but for the absorption issue this quarter, it would have been somewhere between 44% and 45% again, so that’s roughly where I would be thinking of us. Obviously the big driver margin however for margin from our point of view will be the extent to which the top line grows and that has a direct correlation between top line growth and margin improvements took in very heavy fixed cost nature of our cost base of such and you’re seeing it particularly this quarter and what is happening in relation to the HIV production per say. Okay. Could we just have the, I think the last question is Larry Solow. And I will update and then we’ll finish.

Operator

Operator

Okay. We have Larry Solow from CJS Securities.

Larry Solow

Analyst

Just two quick follow-ups. Just on the SG&A you mentioned there is some, it sounds like that those translation expenses those non-cash stuff is that basically balance sheet to stuff that move in the currency don’t know really what that is, on the SG&A?

Kevin Tansley

Analyst

Okay, Larry, Kevin here. Yes, that’s exactly yes that will certain part denominated, balances, recharges, recalculaters at the start and at the end of each quarter. And that’s what you’re seeing there. So hence it's a non-cash so it's a noncredit foreign [indiscernible].

Larry Solow

Analyst

$400,000 something like that?

Kevin Tansley

Analyst

Approximately that number, yes.

Larry Solow

Analyst

Okay, I didn’t get that clearly you sort of put in and below the line too, I know some companies put that up on the other line, but that’s okay. And then lastly just on Immco. I know when you guys acquired it you viewed it as a 20% annual grower. It's obviously been a little -- it has been a little shy of that, is that all mostly due to Sjogren's slowness in the ramp because of the transfer to Bausch & Lomb, or are there other issues there? Thanks. Ronan O’Caoimh: Larry, Ronan here. Well, it's not so much as other issues, I mean yes I think in the first year we did get 20% growth out of it and this year we may not I mean in this current quarter we’ve got 7%. But I think certainly if Sjogren were doing better we’d be getting closer to the 20%, but the 20% was aspiration and overall I mean it’s an aspiration that we continue to have. But in overall terms I think we have to characterize in close performing well and we do see it as a niche, but with that we can really grow into. And it is an ideal niche for us, and we think that also immunity is a good space to be in and we think this is going to be big for us in time and this going to be another Premier. So we’re very enthusiastic about this, but we’re just not quite getting 20% right this quarter this fast. But we’re very optimistic on it, we like the business a lot. Ronan O’Caoimh: Okay. And thank you very much and I think at this stage we will close the call and thank you for your support and look forward to talking to you next quarter. Bye-bye.

Operator

Operator

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