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. .

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 Korean-based conglomerate traded on the KOSDAQ Stock Exchange in Seoul.

The conglomerate comprises principally a business that serves as the largest semiconductor companies in the world as well as a ceramics business, a renewable energies business and MiCo BioMed, which is a diagnostic company. .

MiCo will make an investment of $45.2 million as of 2 components. Firstly, MiCo will subscribe for 11.2 million shares at a price of $2.25 per share, totaling $25 million, which will give them 29.9% of the company.

In addition, they will invest $20 million in a 7-year convertible unsecured note with a fixed interest rate of 1.5% and a conversion price of $3.24 per share. The convertible will mandatorily convert into shares if the share price of the company stays at or above $3.24 per share for 5 days.

So in the event of conversion, a total of 17.3 million shares will be issued at an average price of $2.60 per share, which is a 265% premium to the closing share price of Trinity Biotech last Friday night. .

These funds will be almost entirely used to repay a portion of the company's $81 million term loan, and it is expected that the company's annual interest cost will be decreased by in excess of $4 million per year.

However, the company also expects that this investment will enable the elimination of the balance of the high-yielding debt with lower cost bank funding in the short term. The company is well advanced in this endeavor at this time. The investment is subject to customary Korean Central Bank approvals and is expected to close before the end of April. .

Trinity Biotech has a near 30-year history in the point-of-care diagnostics market and has a broad range also of clinical chemistry products across infectious disease, hemoglobin and autoimmunity and has a pan-global market presence providing a strong platform on which it can expand its product offering through organic and inorganic growth to serve the needs of the changing diagnostic market.

Meanwhile, MiCo BioMed is an in vitro diagnostics company focused -- biotechnology company with innovative technologies, including Lab-on-a-Chip and artificial intelligence-based rapid point-of-care testing applications that are supported by a competitive large-scale manufacturing base in Korea. .

In addition, it has a leading-edge desktop molecular PCR test platform that has achieved impressive growth in Africa, Asia and South America with approximately 800 placements over the past 2 years. This platform carries a COVID test and an ever-expanding range of infectious disease products.

I'm particularly excited that Trinity will have access to this high-quality molecular PCR platform, as it is an area that Trinity has been endeavoring to enter for a number of years.

Through distribution and joint development agreements, it is intended that Trinity will distribute MiCo BioMed's molecular PCR and next-generation ELISA diagnostic platforms in Trinity's core markets, including North America and Western Europe, thereby providing Trinity with significant expansion of its product portfolio. .

In addition, it is intended that MiCo BioMed will obtain commercial rights to sell certain of Trinity's products in numerous local markets, including countries within the Asia Pacific region.

The partnership is also focused on other key areas of collaboration, including research and development and pan-global regulatory certifications and manufacturing synergies. .

In summary, this strategic investment and partnership is intended to accelerate the growth of Trinity Biotech, both organically and inorganically, and to transform it into a diagnostic company of scale with a focus on innovative technology-driven point of care and at-home diagnostic products and services.

The company will continue to be led by a senior management team, including John Gillard as Chief Financial Officer and a Board member and myself as CEO. I am genuinely delighted and warmly welcome into the Chairmanship of the company, Mr. Sun-Q Jeon who is the Founder and Chairman of the MiCo Group of Companies and its principal shareholder. .

Despite his many other business interests, Sun-Q will be committing significant time to Trinity in his determination to make it global force in diagnostics. I particularly would like to thank Sun-Q for traveling to Ireland today to join John and I for the signing ceremony.

I would like to say that -- how delighted I am to be entering this partnership with his company. In addition, we are really pleased that Mr. Aris Kekedjian and Mr. Michael Sung Soo Kim have agreed to join the Trinity Biotech Board of Directors. .

Michael Sung Soo Kim has a wealth of financial experience, having spent the last 3 decades within international finance across areas such as Asset Management, Real Estate Investments, Robo-Advisory and Wealth Management and has held a number of senior executive positions, including CEO of Hyundai Securities, and we are very excited to have someone with Michael's skillset to join the Board.

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Aris is a globally experienced dealmaker, having spent 30 years with GE, General Electric, and a number of senior roles, including 5 years as GE's Chief Investment Officer until 2019. Most recently, Aris was CEO of Icahn Enterprises. We are somewhat flattered that an individual of Aris' caliber and experience has agreed to join the Board.

We believe that Aris and Michael will bring new and innovative skillset to the Board. .

And current directors, Kevin Tansley, Clint Severson and James Merselis, will retire from the Board upon completion of the transaction, and I wish to thank them for their many years of dedicated service to the company.

We are really very excited to enter into this partnership with MiCo and believe that this represents a new chapter in the history of Trinity Biotech. .

At this point, I'm going to hand over to John Gillard. .

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 engaging with banks on this matter.

The bond has a number of key features, including its comparatively low interest rate, relatively long term and the fact that it is unsecured, and we believe that these features will allow potential refinancing banks view the convertible as sitting significantly below them in the company's capital structure.

This is important as it should facilitate the company securing new bank debt on relatively competitive terms, thus allowing us to repay the balance of the term debt and further substantially reducing the company's annual interest expense. .

While we have started to engage with banks in this process, we do intend to be thoughtful in securing a new lending partner, and we will provide an update on this process if and then when completed. .

In addition to the financial investment from MiCo, I am also very excited about the strategic partnership between the 2 companies.

MiCo is a global group with the leading technology solutions across a number of sectors, and we believe that this partnership will allow both companies scale and develop in the diagnostics space much faster than on their own.

As I have spoken about before, we at Trinity Biotech believe that COVID-19 has been a catalyst for a dramatic change in how people view and engage with health and wellness diagnostics. .

Whereas in the past, individuals typically would seek diagnostic information only from their doctor or health care provider, since COVID-19, people have taken a much more hands-on role in their diagnostic journey.

Many people are now comfortable engaging directly with diagnostic providers and many of those are now very familiar with taking biological samples themselves, for example, for use in lateral flow test. .

In that context, it seems highly unlikely that individuals and families who have gotten used to the rapid information and assurance that can come from frequent point-of-care diagnostics will not seek and expect the same type of diagnostic journey for other conditions and wellness parameters.

Very early on in our conversations with the MiCo Team, it became apparent that they too recognize this fundamental shift in the diagnostic world, with the change in diagnostic practices away from centralized lab-based testing to disperse testing in at-home and at point-of-care setting. .

We agree that this change is leading to a need for a broader range of high-quality, technology-enabled point of care and at-home testing products and services to support the expected global adoption of distributed diagnostics.

We collectively believe that Trinity Biotech with its rich heritage in providing high-quality diagnostic products across a number of clinical areas and with a long experience of operating diagnostic laboratories through our Immco subsidiary is very well-positioned to meet the needs of this changing market. .

With the financial and technological collaboration with MiCo, Trinity's ability to rapidly execute against this opportunity would be vastly enhanced. Trinity has well-established global sales and regulatory functions, both of which are critical to the successful scaling of any new diagnostic technology.

As such, we believe that Trinity can prove to be a very effective platform in scaling the adoption of these new diagnostic technologies and services, whether that is through organic development of new technologies or services or inorganic opportunities to scale the business. .

As such, we are very excited to welcome Sun-Q, Aris and Michael to the Board and look forward to working with them and the broader MiCo Team in driving Trinity's success into the future. .

I will now take you through the results for Q4 2021 and then the results for the full year 2021. Turning first to Q1 2021. You will notice in the press release that a noncash impairment charge has been recognized this quarter, as has been the case in Q2 2021 and indeed in prior years.

And this is disclosed at the end of the income statement commentary in the press release.

In addition, in Q4 2021, the company recognized one-off costs relating to a voluntary redundancy process that ran at our manufacturing plant in Ireland and lower commitment in professional fees incurred relating to the $81.25 million term loan we entered into in December 2021. I will give further details on these charges later in the call. .

The income statement metrics I will initially quote exclude the impact of these 3 charges. Starting with revenues. Total revenues for the quarter were $20 million compared with $33 million in Q4 2020. As is typically the case, Ronan will discuss revenues in further detail later on the call.

As such, I will move on to disclose other aspects of the income statement. Gross margin for the quarter was 37.1% compared to 47.8% achieved in Q2 2020.

The reduction in gross margin is mainly due to the exceptionally strong sales and margins recorded in Q4 2020 within our COVID-19 related portfolio of products with the pricing for such products progressively falling over the course of 2021 as a result of lower demand as the pandemic somewhat subsided in North America and the availability of greater supply from other manufacturers.

As ever, our gross margin remains susceptible to product mix changes, geographic spread, currency fluctuations and product level variation. .

Other operating income decreased from $1.8 million in Q4 2020 to $0.7 million in Q4 2021. This income relates to a Paycheck Protection Program loan received by the company in 2021, totaling $0.7 million, that was forgiven during Q4 2021 and has therefore been recognized as income this quarter.

The loan was treated as a short-term liability at September 30, 2021. .

Moving on to R&D expenditure. This decreased to $0.9 million compared to $1.3 million in Q4 2020. Meanwhile, SG&A costs have decreased from $6.9 million in Q4 2020 to $5.2 million in Q4 2021.

The company continues to focus on operating efficiency and cost control and has continued to reduce headcount as it pursues greater automation and simplification of processes.

These resulted in an operating profit for Q1 2021 (sic) [ Q4 2021 ] of $1.7 million compared to $9.1 million reported in Q4 2020, with the aforementioned reduction in revenue and margin contribution from our COVID-related portfolio of products being the main driver of that reduction in operating profit, with these being somewhat offset by lower R&D and SG&A expenses.

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Moving on to financial expenses. This includes the quarterly cash interest cost for the exchangeable notes of $1 million. The remaining $200,000 relates to notional finance charges associated with leased premises. These notional finance charges are required by the relevant accounting standard, IFRS 16.

You will note that there is also noncash financial net expense of $152,000, which is made up of a $10,000 fair value adjustment to the derivatives embedded in the exchangeable notes as required by the relevant accounting standard, less accretion interest of $162,000 in the accounting carrying value of the exchangeable notes.

As you may have seen from prior press releases, in December 2021, the company entered into exchange agreement with holders of over 99% of the convertible notes that provide for the early repurchase of the convertible notes, and these exchanges took place in January 2022. .

Profit after tax before impairments, one-off items and noncash financial expenses was $1.7 million in Q4 2021 compared to a profit of $8.6 million in Q4 2020. As in prior quarters, and as set out in the press release, we report earnings per ADS, effectively our equivalent of EPS.

Earnings per ADS have increased from a loss of $0.48 in Q4 2020 to a loss of $0.06 in Q4 2021. Our unconstrained diluted earnings per ADS have also increased, in this case from a loss of $0.308 in Q4 2020 to a loss of $0.004 in Q4 2021. .

As I mentioned previously, the company incurred impairment and one-off costs, and I want to provide you with more information on those now. In Q4, the company recognized a noncash impairment charge of $0.9 million.

The impairment charge arises from an accounting standard driven impairment review we are required to carry out under IFRS, as we have carried out in prior years. In 2021, we undertook this review in Q4 and Q2. In Q2, this process gave rise to an impairment charge of $6.1 million, which was reported as part of our Q2 results.

There are a number of factors taken into account in calculating the impairment, including the company's period-end share price, calculation of the company's cost of capital, net asset value and future projected cash flows for individual cash-generating units in the business.

In addition, the company examines individual project costs for indicators for impairment. .

Now moving on to the loan origination costs of $1.6 million. As previously announced, the company and subsidiaries entered into an $81.25 million senior secured term loan credit facility with Perceptive Advisors in December 2021. Q4 2021 loan origination costs of $1.6 million were incurred, comprising loan commitments and professional fees.

These costs have been expensed in the income statement in Q4 as the loan was subject to shareholder approval, and that approval was not received until post year-end.

Finally, the company incurred $300,000 of restructuring costs in Q4 2021 associated with a voluntary redundancy scheme undertaken at our Irish manufacturing facility, which reduced our manufacturing workforce headcount by 7%. This was part of a broader and continuing move towards automation and simplification of our operations. .

I will now move on to address some of the main balance sheet movements that we've seen since quarter 3 2021. Intangible assets increased by $1.7 million, which was made up of additions of $1.9 million, somewhat offset by amortization. .

Moving on to inventories. You will see that these have reduced by $3 million, which is largely as a result of us holding less inventories at year-end, which is partially due to an increase in demand for VTM deliveries in Q4, which allowed us to ship almost all inventory of these finished goods. .

Finally, I will discuss our cash flow for the quarter. Cash generated from operations during the quarter was $3.9 million. The company paid $2 million in interest on the exchangeable notes.

Other major cash flow for the quarter included capital expenditure of $2.4 million and payments of $0.8 million in relation to putting in place the new term loan with Perceptive Advisors. Overall, this resulted in a cash balance of $25.9 million at the end of 2021. .

I will now address the full year results for 2021. Starting with revenues. Total revenues for the year were $93 million compared with $102 million for the prior year. As I already mentioned, Ronan will discuss revenues in further detail later in the call. As such, I would again move on to discuss other aspects of the income statement.

Gross margin for the year was 41% compared to 47.6% last year. As I referred to above regarding Q4, a reduction in the gross margin in 2021 compared to 2020 is mainly due to comparatively higher sales prices for VTM in 2020 caused by exceptionally high demand with prices and consequently gross margin reducing progressively during 2021. .

Lower margins were also reported in our Fitzgerald life sciences supply business in 2021 compared to 2020, as the company made a strategic decision to pursue larger volume orders that typically have lower pricing but are expected to add to overall profitability.

Additionally, the receipt of government payroll supports in 2020 related to COVID-19 helped the increase -- helped to increase the gross margin in 2020, and these supports are not being claimed in 2021. Other operating income increased from $1.9 million in 2020 to $4.7 million in 2021.

In both years, this income is almost entirely comprised of income received under the U.S. Government's Cares Act, principally its Paycheck Protection Program and its Provider Relief Fund. .

All Paycheck Protection Program loans received in 2020 and in 2021 have now been 100% forgiven by the U.S. Government. 4 PPP loans received in 2020, but not forgiven until 2021, totaling $2.9 million were treated as short-term liabilities at December 31, 2020. .

Moving on to R&D expenditure. This decreased from $5.1 million in 2020 to $4.5 million in -- sorry, yes, to $4.5 million in 2021. This reduction is mainly due to the closure of our Western Blot R&D facility in California in June 2020 and continued focus on cost control.

Selling, general and administrative expenses decreased from $24.2 million to $23.4 million, a decrease of approximately 3%. In 2020, SG&A expenses were unusually low due to certain nonrecurring savings, principally the furloughing of employees because of the pandemic and government payroll supports related to COVID-19.

Despite neither of these savings occurring in 2021, a reduction in SG&A costs was recorded due to a continuing focus on costs and efficiency, which saw SG&A head count reduced by approximately 7%. .

Our share operating costs increased from $800,000 to $1.1 million in 2021. This resulted in operating profit before the impact of one-off charges of $13.8 million compared to $20.3 million reported for the full year 2020.

The main drivers of the decrease in operating profit were reduced revenues and gross margin, somewhat offset by higher other operating income, lower R&D costs and lower SG&A costs. .

Moving on to finance costs. This includes the annual cash interest cost of our exchangeable notes that have now been largely exchanged of $4 million and $800,000 in relation to notional finance charges associated with lease premises, again as required by the relevant accounting standard, IFRS 16.

The company reported noncash financial income of $600,000 for 2021 as a whole, which is made up of noncash accretion interest charge of $600,000, offset by a $1.2 million gain in the noncash fair value adjustments to convertible aspects of the note and required by the relevant accounting standards.

Profit after tax before impairments, one-off items and noncash financial items for 2021 was $9.2 million compared to $15.7 million reported in 2020. .

The company recognized an income tax credit of just under $200,000 in 2021, which is broadly flat with 2020. As I already mentioned, the company incurred impairment and one-off charges of $2.8 million in Q4 and a previously recognized impairment charge of $6.1 million in Q2 2021.

This results in a total impairment and one-off charge cost of $8.9 million. As such, the company had a profit after tax of $875,000 in 2021 compared to a loss after tax of $6.4 million in 2020. Earnings per ADS for 2021 have increased from a loss of $0.306 in 2020 to a profit of $0.042.

Unconstrained diluted earnings per ADS have also increased from a loss of $0.02 to a profit of [ $0.161 ]..

I will now hand back to Ronan, who will bring you through the revenues. Thank you. .

Thanks, John. I'm going to review revenues for the year before opening the call to a question-and-answer session. Our revenues for 2021 were $93 million compared with $102 million in 2020, which is a decrease of 8.8%. Our point-of-care revenues increased from $9.2 million in 2020 to $10.3 million in 2021, which is an increase of 12%.

This was driven by higher HIV sales in Africa. Non-HIV point-of-care revenues, which mainly comprise syphilis, were broadly unchanged year-on-year. However, during the quarter, we received WHO approval for our TrinScreen HIV test.

Since then, a number of country algorithms have come up for review in Africa, and we are deeply involved in endeavoring to be selected as the screening choice in those countries. We are very encouraged to be making such rapid progress so quickly after approval. .

Clinical laboratory revenues decreased from $92.8 million to $82.6 million in '21, which represents a decrease of 10.9%. This decrease is entirely due to lower sales of our PCR Viral Transport Media product.

In 2020, demand for VTM products was exceptional, but as the pandemic has persisted, manufacturing capacity has ramped up significantly throughout the world with a consequent negative impact on revenues.

While the situation in relation to COVID-19 products remains fluid with the evolving impact of the new variants, the company has seen increased customer demand for VTM products over the recent months. .

The company has retained the capacity to flex manufacturing volumes should market conditions warrant. Meanwhile, we expect to gain CE Mark certification for our COVID rapid antigen test during the month of May.

This product has exhibited excellent performance in its clinical trials, and we are confident of successfully marketing the product throughout Europe. Meanwhile, we will proceed with an EUA with the FDA, and additionally, MiCo BioMed will market the product in Southeast Asia, where its distribution channels are strong. .

Moving on to diabetes testing. In 2021, there was a partial return towards more normalized levels of hemoglobin testing. Our COVID-19 public health restrictions remained in place in 2021 in many markets.

These restrictions were not as severe as in 2020, and as a result, our diabetes-related testing revenues increased 16% in 2021, and we are continuing to see increasing demand for these instruments and consumables as diabetic testing programs continue to return to normal.

Meanwhile, Fitzgerald, which is our life sciences business, and our clinical laboratory chemistry product lines, both reported single-digit revenue growth during 2021. .

Moving on to our autoimmune products. Our revenues decreased by 1% compared to 2020, primarily due to lower revenues in our reference laboratory.

This relates to our New York reference laboratory, which offers laboratory testing services for autoimmune disorders such as Sjogren's syndrome, hearing loss, celiac disease, lupus, rheumatoid arthritis and systemic sclerosis.

While revenues for our proprietary Sjogren's syndrome test increased by 46% compared to 2020, these were offset by a reduction in testing for other disorders due to fewer patients visiting their physicians for pandemic reasons and also due to the ending of certain testing that was carried out for high-volume customer. .

We expect demand for Sjogren's testing to continue to grow, as there appears to be commonality between Sjogren's symptoms and long COVID. In addition, we continue to focus on expanding the range of tests available at the reference lab, including testing panels specifically aimed at autoimmune conditions associated with long COVID..

So thank you. And at this stage, I want to hand back to the operator for a question-and-answer session, please. .

[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?.

[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. .

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?.

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 TrinScreen approval, I mean, I think, has the potential for very significant growth and I may kind of reference to the fact that we have very positive signals coming out for, at the moment, one of the biggest HIV markets in Africa. .

I'm hoping to get on the algorithm as the screener of choice. And so we do believe, as we said all along, that we can basically take reasonable market share from the leading supplier to that market, which has always been our target. And I think we're very encouraged by the most recent developments we've had in the last 2 months since we got approval.

And then that brings me on to our COVID antigen test. So I know we've been very slow. It's embarrassingly slow. But the fact of the matter is we have now developed a wonderful -- seriously wonderfully performing COVID test and COVID hasn't gone away, and we believe that we'll do well with that. .

We are about 4 weeks away from a CE Mark, which will enable us to sell throughout Europe. MiCo are very interested and will take it in Southeast Asia. And we will go for EUA. And that part is unclear because the rules keep changing.

But we're reasonably confident of getting that product into the U.S.A., although there's no certainty of that, but we're quietly confident of doing so. And so if you look then at all the overall components of the business, I think they're looking very promising.

And we now have a very strong partner, well-financed, and very determined, very experienced and very successful conglomerate, who are full square behind us with their Chairman and Founding Director and principal shareholder in the building at the moment in the office next door listening to this call, our new Chairman. .

And so I think -- and basically, we have significantly restructured our balance sheet. We're confident of basically completing that restructuring by one of the -- structuring with one of the leading banks in the world come in and basically eliminate the rest of the high-yielding debt.

So we think we're in a really, really good position, Jim, and we're really excited and very, very pleased today. We think this is a really big day, new beginning for Trinity Biotech. .

And then last one for me.

Can you just remind me what the market is today for the HIV screening products in Africa?.

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?.

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?.

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?.

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. .

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?.

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..