Good day, and welcome to the Trinity Biotech Strategic Investment and Partnership Review and Financial Results of Q4 Full Year 2021. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Mr. Joe Diaz of Lytham Partners. Please go ahead.

Thank you, operator, and thanks to all of you for joining us today. The management team of Trinity Biotech will review the strategic investment and partnership with MiCo Limited that was announced earlier today, and they will also review the financial results of Q4 and full year 2021. Joining us on today's call is Ronan O'Caoimh, Chairman and Chief Executive Officer; and John Gillard, Chief Financial Officer. At the conclusion of today's prepared remarks, we will open the call for a question-and-answer session. Before we begin, I must inform you that statements made in this conference call may be deemed forward-looking statements within the meaning of 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. These risks include, but are not limited to, those set forth in the Risk Factors section of the company's annual report on Form 20-F filed with the Securities and Exchange Commission. Trinity Biotech undertakes no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrences of unanticipated events. With that said, I will now turn the call over to Ronan O'Caoimh to discuss today's partnership announcement. He will be followed up by John Gillard, who will also provide further details on the investment and partnership and will provide a review of the results of Q4 and full year -- full fiscal year, excuse me, 2021. With that, let me turn the call over to Ronan O'Caoimh, Chairman and CEO of Trinity Biotech. Ronan, please proceed. Ronan O?Caoimh: Thank you. Thanks for joining us today. As you would have seen in today's press release, we have entered into a strategic partnership with MiCo Limited, which is a…

Thank you, Ronan. Good morning, everyone, and thank you for joining. I will take a few moments to further elaborate on the exciting strategic investment and partnership with MiCo Group. As Ronan mentioned, the investment is approximately $45.2 million and consists of 2 parts. The first part is a subscription for 11.2 million newly issued ADSs at a price of $2.25 per ADS. This will result in Trinity having a total number of issued ADSs net of treasury shares of approximately 38 million. This will give MiCo a 29.9% shareholding in the company. The second part of the investment is a $20 million long-term low-interest rate convertible bond with a 1.5% annual interest rate and a 7-year term. The bond has a conversion price of $3.24 per ADS and is mandatorily convertible in certain circumstances. If converted, this should translate into approximately 6.2 million of additional ADSs. As Ronan mentioned, the company expects to use the majority of the $45 million investment to repay a portion of the $81.25 million term loan that we drew down in January 2020. Some of you may remember that a key feature of that term debt was the ability to repay it early in part or in full, albeit subject to a premium on repayment. This flexibility allows the company to repay a significant portion of the term debt, which currently has an interest rate of 12.25% and quickly reduce the company's expected annual interest cost by approximately $4 million or 40%. In addition, and critically important is the fact that this should allow us to reduce our leverage and interest costs and therefore, allow the company the opportunity to refinance the balance of the company's debt at a substantially lower interest expense. And as Ronan mentioned, we have already started the process of…

[Operator Instructions]

Can you hear me?

Yes, we can hear you.

Can you -- first, when looking at the current business, can you break out what the VTM revenue for the year was in 2021? Ronan O?Caoimh: [indiscernible] in our line.

Can you break out what your VTM revenue, your COVID-related revenue was for 2021?

About $21 million.

Okay. And obviously, as the pandemic starts to subside, that should come down. But do you think that as we look into 2022 that the ramp-up of sales with TrinScreen and some of the sales with the new partnership, will that be enough to offset that ramp in 2022 -- I'm sorry, offset the decline in 2022?

Yes. So I think we -- so we do expect some level of VTM revenue to continue. There is some level of ongoing demand as well as [ it's a good ] product. And as Ronan mentioned earlier, look, we've all seen with the variant situation, it can pop up quite quickly. So what we've done is, we've organized ourselves operationally in terms of raw materials that we're ready to flex that manufacturing capability as needed because that's when the best pricing is available in the market. And I suppose that's really the way we've decided to address that market. In terms of the other products, yes, certainly, we think in the medium term, TrinScreen would have the ability to substitute for that income, and that's not going to happen this year in terms of being able to reach those levels. It's really about us getting into a number of algorithms as they come off, proving out the success of the product from a regulatory and performance perspective and building from there. I think the area that there is the possibility for very, very significant growth is around the COVID antigen test. And that's just such a large market. And Jim, if we're successful at taking even a relatively smaller percentage of that market, then we'd expect that, yes, it would, I suppose, compensate for a declining VTM market.

And how about the products that you'll start selling for MiCo and the products that they'll be buying from you? Do you think that that is a relatively near-term thing? Or will that be more 2023?

No, I think it will be near term, Jim, absolutely. I think the -- that is merely one component of the partnership, right? I think it's very important to understand that from our conversations with MiCo, their investment and their partnership is focused on the long term. And this is really about building a platform business to serve the changes happening in the diagnostic market. So rather than thinking about this as just us taking their existing products and they taking ours, this is really around taking existing technologies that both groups have, leveraging them across new disease types, new diagnostic methods, and of course, geographically as well. I think one of the key strengths that MiCo identified with Trinity is we have a very, very broad regulatory level of experience in the U.S.A., Western Europe, really around the world and that they have saw the value in that, and we think that gives us a very good platform and advantage in building a platform to build out a much broader range of products. So to go back to original question, yes, we certainly would expect revenue accretion from being able to market MiCo's products and vice versa. But I think that is just one aspect of the partnership here. I think what we're all collectively envisaging and striving for is something more substantial and more transformation.

So if you look at the near term now and you factor in the inevitable decline of the VTM, as well as the ramp-up of sales from TrinScreen and MiCo, and then you factor in the expense cuts you've made, do you think that you'll be about breakeven in 2022?

Yes, I'd expect so, Jim.

And there's a follow-on to that, is if you are running at breakeven, you have a lower leverage rate, how quickly do you think you'll be able to refinance the remaining portion of that 12% debt?

Yes. We're moving to do it as quickly as we can. As I mentioned in my prepared remarks, we want to do that partially, right? So we're looking for a long-term partner, and we're looking for the best commercial deal we can get over the medium term. So -- but we've already progressed that. We've had a favorable response from the banking community, I think, particularly in terms of how the MiCo deal is structured with the low interest rate convert being particularly attractive to the banks in terms of their position in the capital structure. So we're hopeful of doing it quickly, Jim, but you'll forgive me if I don't set a time line because we all know from dealing with banks, it's not all within your own gift in terms of timing.

But with $26 million in cash on your balance sheet now, it doesn't appear that there's going to be any issue as far as cash flow management in the near term. You have plenty of cash to fund the operations over the next few quarters, it seems to me. Is that the way you feel?

Yes. Yes, absolutely. I think the MiCo investments, and we will choose how much of the Perceptive debt to repay. And as we said, we're planning on paying a very, very large chunk of that. And obviously, liquidity is critical in terms of us being able to finance further development work on products, but also gearing up for the larger volume sales of TrinScreen and the lateral flow test that will take some level of working capital investment from our behalf, but that's an investment worth making. Ronan O?Caoimh: I think, Jim, when you look at the convertible, I mean, in reality, it's quasi-equity, a 7-year term, 1.5% interest, and it's unsecured. And so in the circumstances, if you look at our EBITDA, it's not a big ask to imagine that some of the biggest banks in the world that we're already speaking to would be quite interested in basically putting us in a situation to eliminate the expense of debt that we have at the moment. So I think the MiCo investment today ought to enable that to happen in reasonably short order, although there's no certainty surrounding that.

So I know you're reluctant to give any specific guidance. And I know 2022, things will change quite a bit depending on how fast TrinScreen ramps and how fast the VTM business declines. But I mean as you get past that and you look out to 2023 and beyond, do you think that you can sustain a double-digit growth rate? Ronan O?Caoimh: I think we can. And I think it's important probably to look at VTM as kind of a one-off. I mean [ I don't mind to say ] it did $31 million in 2020 and $21 million in 2022, but I mean it's not core repeatable business. So I mean I think if you stand back and you look at -- if you look at our business, well, what are the principal dynamics at the moment, you've got a hemoglobin business, which is growing again and growing strongly. We've got a 16% growth this year. But I mean we're placing instruments again. Basically, people are doing A1C testing again. So I think we should be able to get back to a scenario where we're placing somewhere between 200 and 300 instruments a year. So that's clearly a big growth engine for us. Autoimmune business, we talked about lab testing in Sjogren's, et cetera, et cetera. And again, we're beginning to see -- we're seeing that business basically getting back to the kind of growth trajectory that it previously had. And it had a very strong previous growth trajectory. And then obviously, our clinical chemistry business is very solid. Our Fitzgerald business is a great cash cow. And now in the flow rapid business, so our HIV business is doing just fine. You see it was up 12% this year. But our HIV TrinScreen business, having just got the…

And then last one for me. Can you just remind me what the market is today for the HIV screening products in Africa? Ronan O?Caoimh: About 170 million tests a year at $0.85, $0.90 a test, although we will come -- we will be in around the $0.80 mark. That's where we're positioning ourselves, dominated by one company, yes.

[Operator Instructions] The next question comes from Paul Nouri with Noble Equity.

What were the COVID sales in the quarter.

About $2 million, Paul?

And didn't you have -- or is there a status update on the new hemoglobin instrument in the U.S? Ronan O?Caoimh: Yes. Premier Resolution, Paul, we are expecting to submit this July -- June, July, say, July at latest. You remember, we had the warning letter, and that's what held it up. That's all resolved now. Maybe I should have said that. So just to deal with that, the warning letter is all resolved, it's all -- and we're out of that. And that's why we can go ahead now and submit Premier Resolution. So next 3 months, it would be submitted, and I think it should go through reasonably quickly. And I think Premier Resolution will present a big opportunity for organic growth within the U.S.A. The product is already approved in Europe, as you know. And meanwhile, of course, we've been unable to launch this in China because of the fact we had to have origination country and approval. So as soon as we get the FDA approval, we can then move into this -- into China, where we have a very strong distribution base and a very big, as you know, premier [ placement ] base. And so I think a lot of possibility there as well. So basically, the Premier Resolution being submitted to the FDA opens up not just U.S.A., but also China.

Okay. And the workforce reduction that was mentioned in the press release, was that in the fourth quarter or prior to that?

That part was in the fourth quarter, Paul, but that was kind of the last step, I would say, in a broader rationalization of our manufacturing workforce here in Ireland. So we -- over the course of the year, we went from about 180 people down to about 110 in our workforce at our Irish manufacturing plant. And that's -- those efficiencies have been driven by an increased focus on automation and simplification of processes. So we can produce the same level of output, Paul, with a significantly reduced workforce. That workforce reduction was primarily achieved through natural attrition, which we managed. And then the last piece was a voluntary redundancy scheme to kind of get us to the numbers that we were focused on.

Okay. And for the screening test, you're going to be producing it mostly out of -- or maybe exclusively out of Ireland?

This is for TrinScreen, Paul?

Yes.

Yes. That's the intent, Paul, but I suppose back to the MiCo partnership, that they have the facility for very large volume, lateral flow manufacturing in Korea. So this partnership now opens up the possibility for us to manufacture that at very, very large volumes at potentially a lower price point. So we could well end up manufacturing at both locations, and it is approved for manufacture here in Ireland, and it certainly will stay here. But if the volumes get to the level that we expect and we hope, then having high-value, highly automated manufacturing capability in Korea, available to us on a contract basis, will be very helpful for us in terms of supporting our growth and ensuring that growth is profitable.

And in Europe, assuming you get the CE Mark for the antigen test, are you allowed to sell it over-the-counter directly to consumers? Or is that a secondary approval you need for that? Ronan O?Caoimh: Yes, Paul, so yes, the primary -- the CE Mark that we're going -- about to get is for professional use. The over-the-counter is an addendum basically, it's a further step which we're undertaking, but it will take a number of months longer.

Sure. And do you expect any TrinScreen sales in 2022? Ronan O?Caoimh: Yes. I'd be hopeful of them but -- I mean, the indications so far are really, really positive. But there's no certainty relating to that. But I'd be extremely disappointed if we didn't have some decent breakthrough in the short term. It would have virtually immediate impact. Like we're -- sorry, go ahead.

No, go ahead. Ronan O?Caoimh: So like we're preparing to produce and sell in 2020, it is our expectation -- '22, sorry.

And then could you broadly talk about the impetus for this deal considering that you had cleaned up the balance sheet. I know that the interest rate on the loan was high, but did financials lead the deal? Was it more strategic? Was this a discussion you had been having for the past couple of months and then it was just kind of the right timing to execute it? Ronan O?Caoimh: No. I mean the discussions have come basically really very, very recently. But I mean, we were delighted to do the Perceptive deal. I think we needed to do it, and clearly, but no disrespect to Perceptive, I mean, 12.5% is a very high interest rate for any company to bear. I mean, I think clearly, it was more of an interim measure. I think everybody would've realized that. So I think what we've done today constitutes a really, really good move for Trinity. I think that $45 million effectively is equity. I think it's all effectively equity. And I mean there's a mandatory conversion at $3.24. So to raise, I think, $45.2 million at an average price of $2.60 is, I think, by anybody's gauge, a good day's work. But when you add to that that you actually -- that you have gained a strategic partner with the advantage of being a molecular PCR platform to Trinity Biotech, something that we've been wishing for, for a decade, that gives us access to cheaper Southeast Asian manufacturing capabilities, a broader range of products, geographical spread for us, access into the South Asian -- into the Asian markets where we have typically not been so successful and then also to bring their products into U.S.A. and Europe and also to bring in the management team with great strength and a history of serious success within this conglomerate is for us almost an ideal scenario, and one that we're extremely pleased with. And the last piece of the puzzle is basically we think that the amount of equity that we've brought in, right, and the balance sheet restructuring that that constitutes is enough basically to get one of the leading banks of the world, whom we are speaking to already, over the line to basically eliminate all of the high-yielding debt in very, very short order. So it's a solution, basically a total solution. And we are really, really pleased with today's work. So -- and very much wholeheartedly welcome MiCo in here. And we believe that they've earmarked Trinity as a vehicle that they would like to use to build a world class diagnostic company with. Can I just suggest that we're virtually an hour on the phone, and I think maybe we have taken enough of your time. So I was going to ask the operator to just close off the call and say thank you, and good afternoon to everybody. Thank you.

All right. This conference has now concluded. Thank you for attending today's presentation. You may now disconnect.