Good day, and welcome to the Trinity Biotech Q4 and Fiscal Year 2020 Financial Results Conference Call. All participants will be in a 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. Ronan O’Caoimh. Please go ahead. Ronan O’Caoimh: Thank you very much. Good afternoon here and good morning to everybody in the United States. I’m joined by John Gillard, our Chief Financial Officer, and who is firstly going to bring you through the results for the quarter. Then, I’m going to give you an outline of progress in sales and marketing and give you revenue review. And then, we’ll open the call to question-answer-session. So, if I could ask, John, go ahead, please.

Thanks, Ronan. Good morning, everyone, or afternoon depending on where you are. And thank you for participating in our earnings conference call. Before we begin, I must inform you that the statements made in this earnings call may be deemed forward-looking statements within the meaning of the federal securities laws. These statements are subject to known and unknown risks and uncertainties that may cause actual results to differ from those expressed or implied in such statements. The risks include but are not limited to those set forth in the Risk Factors section of our annual report on Form 20-F filed with the SEC. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrences of unanticipated events. Now, I will take you through results for Q4 2020, and then the results for the full year 2020. You will notice from our press release that a non-cash impairment charge has been recognized this quarter, as has been the case in recent years. And this is of course at the end of the income statement commentary in the press release. I will give further details on this later in the call. In addition, earlier in 2020, the Company recognized one-off costs relating to the closure of our Carlsbad, California facility. The income statement metrics I will quote exclude the impact of these two charges. I will begin by outlining the results for Q4 2020, and then I will move on to discuss the results for the whole year, as I mentioned. Starting with revenues, total revenues for the quarter were $32.8 million compared to $21.3 million in Q4 2019. As is our typical approach, Ronan will disclose revenues in further detail later on the call. As such, I will move on…

[Operator Instructions] Our first question from Jim Sidoti with Sidoti & Company. Please go ahead.

Good afternoon, Ronan and John. Sorry, I had to join the call a little late. So, I’m sorry if you went over this already or not. But, last quarter, I think you indicated that the revenue from the COVID-related products was around $13 million. Did you break that out for this quarter? Ronan O’Caoimh: No, we haven’t actually said -- we haven’t separated it?

Was it similar to last quarter? Can you give us anything on that? Ronan O’Caoimh: It’s about exactly the same, Jim.

Okay. Right. And you indicated that you’re getting closer with the TrinScreen WHO approval. Should we assume that you’ll be generating revenue from TrinScreen in 2022? Ronan O’Caoimh: Yes, absolutely in 2022. So, the position we have at the moment is, despite all the COVID headwinds and trials were delayed in the various countries -- in two to three countries, we have now completed the trial. And we expect -- we actually expect to -- we had already submitted to the FDA [Technical Difficulty] World Health Organization various modules. And the final module -- which they’ve reviewed, the final module was the actual trials themselves. So, we expect to submit that actually literally in the next three or four days. So, everything’s been assembled and ready to take it. And so, now, really -- and by the way, the results were like extraordinarily good. They were absolutely really more or less beyond what we could expect. [Indiscernible]. So, it was a super, super product. And the WHO -- so now we just wait for them to reveal it. And how quickly they do it in the COVID environment is unclear. We’ve actually been speaking with them over the last number of days. And, of course, they’re giving precedence to sort of, for example, antigen test. But we’re hoping that they’ll get to it reasonably quickly. And while we don’t have any certainty, we’ll certainly be hoping to get an approval in quarter three. But it’s outside of our control. We don’t think we’ll get it in quarter two. And at that moment, we’re free to sell. So, yes, I think, we will undoubtedly have revenues in 2022. It’s possible that we get some minor revenues in 2021. It’s possible frankly hoping to do so. But, then, it’s a matter of winning algorithms and whatever as they come up for review. But in overall terms, as I said, in revenue -- potential revenue terms, this is in terms of market size, it’s bigger by a factor of 12, pricing is lower than confirmatory. But it’s a huge market that we stayed away from in the past and we’re now entering into it. It’s a market dominated by Alere, by Abbott’s Alere product range. And we think that we can take a significant market share over time.

And just in terms of timing, do you have to wait for tenders to start… Ronan O’Caoimh: If you consider -- if you look across sort of 30 to 40 countries, algorithms tend to be -- algorithms look for review, basically supplier review. So basically, the screening supplier will be -- reviewed are changed every -- typically two years, sometimes every year, but normally two years. So, there’s a constant stream of renewals happening at any one time. We’ve been going through them all, literally every one.

And COVID’s been… Ronan O’Caoimh: I think in some instances -- Jim, in some instances in some of the bigger countries, take Nigeria, where there might be 60 million, 70 million tests -- 50 million tests in a year, and the screening can be split between two companies.

And then the last one from me, COVID’s definitely been a pass on certain products. But then, as you indicated, it’s definitely put some pressure on things like your diabetes sales and some of your other products. Are you seeing that pressure starting to subside in Q1 and do you expect the diabetes business comes back to at least 2019 levels in 2021? Ronan O’Caoimh: Yes. I mean, if you look at diabetes, for example. Our instrument placements collapsed in quarter, during the months of April and May, just completely collapsed to virtually nothing and began to recover somewhat in quarter three and more in quarter four. But like, we’re -- still during quarter four we were still at 50% of normalized placement levels. And for reagents, we’ve characterize it at about 90% of normal, which actually -- we think we’re surprised that how strong it is, given that people are trying to avoid going to hospitals or indeed doctors as well as hospitals. But, that’s what we’ve been achieving. We’re absolutely confident that the market will return -- recover completely in the post-pandemic environment, as soon as we kind of have a significant -- as soon as majority of people are vaccinated.

The next question comes from William Lapp, [ph] private investor. Please go ahead.

Good morning or good afternoon to you gentlemen. John, nice to have you on Board. I got a few questions. Number one, I presume you did not qualify for the second draw on the PPE loans. You didn’t meet the criteria? Have you applied for the second draw to PPE loan?

In some of our businesses, we did, in two, I think, we did qualify, but not for the others.

Okay. So, you’ve submitted. Have you got -- yes, you’ve got to meet to 20% test, but did you

Yes.

Okay. Have you got the loan yet, or you haven’t got it yet?

Yes, we have. We received two of them…

And how much was that?

$1.7 million.

$1.7 million, which you anticipate to be proved…

$1.7 million…

Yes. And don’t forget about the employee tax credit too, if you do that.

It’s difficult to predict at this stage where it’s going in terms of the forgiveness. The first step is, we receive the fund.

Okay. Well, that’s good. Ronan, could you kind of -- last quarter -- the third quarter, you had more of a profit than you did on the fourth quarter. Didn’t you -- weren’t you at $22 million on the third quarter versus the fourth quarter? What are the comparisons of the third quarter of 2020 versus the fourth quarter of 2020? Did you not -- you didn’t make as much money in the fourth quarter? Ronan O’Caoimh: No, we didn’t. Not after -- so I suppose, yes, the move impact would be an increase in SG&A cost in quarter four and I think a reduction in margin as well. So, those are main contributing factors to that.

Okay. So now... pardon? Did you say something, Ronan? Ronan O’Caoimh: Yes. No, go ahead.

Yes. Ronan O’Caoimh: I was just about to say, but…

Go ahead. You say first. Ronan O’Caoimh: I was going to say that there was strong profitability and strong cash generation, the cash from $19 million to $27 million.

Okay. Well, that’s good, because we have the big loan coming up. Then, could you explain a little bit more on the COVID where -- you said this quarter may not be as good as the fourth quarter. But, isn’t your -- is your COVID consist of sending out supplies that they use for the swabs, et cetera. But what about -- and that you’re doing pretty well, I think. And then, how is your testing, your one that’s running through the lab, have those produced much revenue that you developed for the laboratory rather than the rapid tests? Has that been successful or where are you at with that? Ronan O’Caoimh: Well, we’re starting with United States, and now -- we’re now in the -- the European Union has opened to us as well. We’re working right on that. I think in terms of significant potential, I think the bigger potential is in the rapid test, is in the point-of-care test rather than laboratory. And as you know where we are with the rapid antibody and of course we’re working on the antigen test as well. So, I think, the most significant revenue potential lies there in the point-of-care than in the other. I also will talk to you that we were doing very well in monoclonal antibodies and [Technical Difficulty]

Could you explain the difference between -- is there two rapid tests that one is an antibody? I was just kind of looking at -- the two rapid tests you’re -- the rapid tests you’re doing for the COVID, is there two of them? One is a blood test, right? Ronan O’Caoimh: Yes.

And then, what’s the other one then. Ronan O’Caoimh: Yes. So, we’ve got two tests. We’ve got an antibody test, which is exactly like the HIV test. And so basically you take -- you use a spring loaded -- you get a drop of blood with finger prick, and you put that sample, then like 50 -- 30 micro liters. You basically -- put it basically onto the test, add 4 cups of wash solution and within 12 minutes you get the results. So, that’s an antibody test. That tells whether or not you’ve got basically -- and in fact it tells you whether you previously had COVID or not. The other tests we’re developing -- and that test is very close. So, as I said, we expect to get an EUA from the FDA basically during quarter two. So, basically, within the next three months, we expect to be in the market with our product. The other test we talked about is an antigen test. There’s a lot of publicity about antigen. And an antigen test basically detects whether you actually have at a particular moment in time got COVID.

Okay. So, it’s like the Alere test -- it’s like the Abbott tests that are out there, they Q and whatever that is, right, those other tests? Ronan O’Caoimh: It’s same way as Abbott’s test or Quidel’s test, antigen test. So, we’re working on that. We’re making very good progress, without giving timelines, we just don’t want to tie as timelines. And I would prefer to not to over promise. But, the confidence is that developing a high-quality tests which can be manufactured in high volume in our automated systems of manufacturing facility here in Ireland, we already can manufacture in high volume. And we’re confident basically of developing a good test, very, very good antigen test, quality tests for the long term.

Well, that sounds good. I mean, there’s quite a market for that. And I mean, that’s what people have to go, like to go to the airport, they have to go to another country, they have to have the test 72 hours, that test would be performed, an antigen test, right? Like if you’re going to go from the United States, maybe to Hawaii, you got to have a test before you get on the airplane 72 hours before. Would that test would be used to say you can go and you are safe, right, an antigen test? Ronan O’Caoimh: That’s actually -- that normally is a PCR test. The advantage of the antigen test is, for example, it can be done literally, at the point of embarkation. I mean, it only takes 12 minutes. So, it can be done on the spot. PCR test, before you travel, you have to get it done 24 to 36 hours earlier.

Okay. So, given your whole -- that’s very helpful for the distinction. So, given where you’re at in 2021, what do you look for? What do you see as the rainbow coming forward as to where Trinity’s really going to shine, without giving any guidance? Where do you look for the big upsurge? Ronan O’Caoimh: I think, the most exciting thing at the moment for us is our TrinScreen product. So basically, we have been a dominant force in Africa with HIV testing, screening. We have HIV confirmatory testing for 15 years now, and we’re now entering a market, which is multiple times bigger, which is a screening market, with an absolutely superb product. And we think we can take a big share there. There are 117 million of these testing run every year in Africa, and we intend taking -- are confident of taking a decent share of that business.

Okay. That’s pretty profitable -- and that’ll be pretty profitable. Ronan O’Caoimh: Absolutely, yes. And beyond that, we would be very excited about our COVID range of products, because we think, although as the entire population becomes vaccinated, it’s not going to be a huge problem, but with COVID is -- not going away. And so, we think we have a suite of products for the long term.

Okay. That’s good. And I presume that you’re thinking very heavily on our repayment of that. Is that $100 million due in April of 2022. Is that a target for the loan? Ronan O’Caoimh: Yes.

Well, thanks for taking my question. And I appreciate the progress you’re making. And keep up the good work.

Thank you so much. Okay. Operator, we’re just going to take a last question and then wrap up the call.

Okay. The last question comes [indiscernible] a private investor. Please go ahead.

Just quick question on that 4% senior note. I think, the prior caller asked the same question. But he didn’t really let you finish. So, my question is, what are the plans for senior notes? It seems like it’s common due in May of 2022?

Today that -- it obviously matters that we’ve given some considerable thought here both in management team and as a Board. We have a number of options available to us. That date is still some time away. And we’ll use that time to determine what the optimal approach would be. You can probably understand that I’m unlikely to on a conference call, an open conference call, to give you our most intimate source on it. That probably wouldn’t be a great idea. You will, however, note, for example, that our cash balance increased from $19 million to $27 million, which obviously is very positive development in the context of the pending maturity of that note. I don’t mean to be obscure in my response, but I think that’s about as far as I can reasonably go.

Okay. That’s fair enough. Thank you. Ronan O’Caoimh: So, we see no more questions. So, if I could just wrap up the call now and say, thank you very much for your support and your interest, and look forward to talking to you, actually, in not too many weeks away, because this is a small gap to our quarter one results. So, thank you, and good morning.

Thank you, everybody. Have a good day.

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