Q4 2023 Trinity Biotech PLC Earnings Call

Operator: Transcribed by https://otter.ai ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? [inaudible] Greetings, welcome to Trinity Biotech's fourth quarter of a full year 2023 earnings conference call. At this time, all participants are in listen only mode.

Oh go ahead.

[music].

Eric Ribner: A question and answer session will follow the formal presentation. If anyone should require operator assistance during today's conference, please press star zero from your telephone keypad. Please note, this conference is being recorded. At this time, I'll now turn the conference over to Eric Ribner from Investor Relations. Eric, you may now begin. Good morning, everyone, and thank you for joining us on today's call.

Eric Ribner: Before we begin, please note that statements made during this presentation may be deemed forward-looking statements within the meaning of federal securities laws. Such statements are subject to known and unknown risks and uncertainties that may cause actual events to differ from those expressed or implied in such statements. These risks include, but are not limited to, those set forth in the Risk Factor Statement in the company's annual report on Form 20-S filed with the Securities and Exchange Commission. Trinity Biotech undertakes no obligation to publicly advise, update, or revise these forward-looking statements to reflect events or circumstances after today or the occurrence of unanticipated events. And with that, I'll turn the call over to John Gillard, CEO.

Greetings and welcome to Trinity Biotech fourth quarter and full year 2023 earnings conference call.

At this time, all participants are in listen only mode.

Question and answer session will follow the formal presentation.

None: If anyone should require operator assistance during todays conference. Please press star zero from your telephone keypad.

None: Please note this conference is being recorded.

None: At this time I'll now turn the conference over to Eric <unk> with Investor Relations, Eric You May now begin.

Eric: Good morning, everyone and thank you for joining us on today's call before we begin. Please note that statements made during this presentation may be deemed forward looking statements within the meaning of federal securities laws.

Eric: These statements are subject to known and unknown risks and uncertainties that may cause actual events to differ from those expressed or implied in such statements. These risks include but are not limited to those set forth in the risk factor statement in the company's annual report on form 20-F filed with the securities and <unk>.

John Gillard: Thank you, Eric. Good morning, everyone.

John Gillard: And thank you for joining today's call. We really do appreciate you taking the time. This morning, I will take you through some key business, including new financial guidance, our progress in our recently acquired biosensor business, and our comprehensive transformation plan that I set out to investors in early March at the Emerging Growth Conference. I will then hand you over to Des to bring you through the financial results for Q4 and fiscal year 2023. Right now, Trinity Biotech is an experienced diagnostician that, under new leadership and with fresh thinking, plans to transform its existing business into a high-performing, cash-generative enterprise. This morning, we are pleased to introduce financial guidance, which is predicated solely on growth from the existing businesses, including hemoglobin and HIV tests, and Planned Improvement to Operating Merger. This does not include any contribution from the newly acquired biosensor platform technology.

Eric: Change Commission.

Eric: The biotech undertakes no obligation to publicly advise update or revise these forward looking statements to reflect events or circumstances after today.

Or the occurrence of unanticipated events.

Speaker Change: And with that I'll turn the call over to John Good Lord C E O.

Speaker Change: Thank you Gary Good morning, everyone and thank you for joining today's call. We really do appreciate you taking the time.

John Gillard: This morning, I would take you through some key business updates, including new financial guidance.

Speaker Change: Our progress in our recently acquired Biosensor business.

Speaker Change: And our comprehensive transformation plan that I set out for investors in early March as the emerging growth conference.

John Gillard: We are targeting approximately $20 million of annualized run rate EBITDA, or earnings before interest, tax, depreciation, amortization, impairment, and share-based competition, by Q2 2025. This is based upon targeted annualized run rate revenues of approximately $75 million by Q2 2025.

Speaker Change: I will then hand, you over to Deb to bring you through the financial results for Q4 fiscal year 2023.

Deb: Right now Trinity biotech is an experienced diagnostics.

Deb: That under new leadership and with fresh thinking.

To transform its existing business into a high performing.

Deb: Cash generated of enterprise.

Deb: This morning, we are pleased to introduce financial guidance, which is predicated on.

John Gillard: We believe that this guidance is achievable, based on our comprehensive transformation plan for the business, which we will review in more detail today. Additionally, 2024 is already off to a strong start, which increases our conviction in our outlook, in addition to strengthening the base business. We aim to scale the company by building a global, and Weriba Biotech, initially, would have focused on Continuous Glucose Monitors or CGM. We believe that this product can be a real game changer for the company. This represents the key growth driver for Trinity Biotech into the medium. As many of you will know, just over two months ago, we announced the acquisition of the biosensor technology of waveform technology. Waveform had established and proven biosensor technology, with the European Regulatory Approved CGM product, in addition to acquiring this technology and ProductRite.

Deb: Growth from the existing businesses, including hemoglobin.

Deb: HIV testing.

Deb: Planned improvements to operating margin.

Deb: Yeah.

Deb: This does not include any contribution from the newly acquired bio sensor platform technology.

Deb: We are targeting approximately $20 million.

Deb: Annualized run rate EBITDA.

Deb: So earnings before interest tax depreciation.

Deb: Jason impairment and share based compensation costs by.

Deb: By Q2 2025.

Deb: This is based upon targeted annualized run rate revenues of approximately $75 million by Q2 2025.

Deb: We believe that this guidance is achievable.

Deb: Based on our comprehensive transformation plan for the business.

John Gillard: We have hired a number of key individuals who created this technology at Waves. Using this established technology, we intend to update Waveform's existing product and launch a more affordable version. High Quality CGM into a broad number of markets globally. Since the acquisition, we have been progressing this plan across a number of areas, including one, building out our biosensor team with a number of key appointments from Established Medical Device and Diabetes Technology Companies, such as Phil. Johnson & Johnson and LifeScare. Two. We have re-established CGM manufacturing capability with this great new system. Planning and Executing Sensor Design Improvements. This work is based on the existing CGM product and has been carried out with the assistance of world-class external technical and design consultants Three. The team is also initiating enhanced data analysis on Waveform's large existing data bank of clinical trial results, and we are very excited by the potential outcomes of that analysis. In addition to this technical work, we are progressing discussions and agreements with potential commercial partners, such as Bayer, for the launch of our CGM product. Finally,

Deb: Which we will review in more detail today.

Deb: Additionally, 'twenty 'twenty four is already off to a strong start.

Deb: Which increases our conviction in our outlook.

Deb: In addition to strengthening the base business we.

Deb: We aim to scale the company.

Deb: By building a global business.

Deb: In wearable biosensors.

Deb: Initially with a focus on continuous glucose monitors or C. J.

Deb: We believe that this product can be a real game changer for the company.

Deb: This represents the key growth driver for Trinity biotech into the medium term.

As many of you would know just over two months ago, we announced the acquisition of the biosensor technology of wave form tecogen.

Deb: Wave form had an established and proven bio sensor technology with a European regulatory approved CGM products.

Deb: In addition to acquiring this technology.

Deb: On product rights.

Deb: We have hired a number of key individuals who created this technology it wasteful.

Deb: Okay.

Deb: Using this established technology.

Deb: We intend to uptake waveforms existing problems.

John Gillard: We are establishing a scientific and user advisory group for CGM. This is to ensure that strong clinical outcomes and user needs remain at the forefront of our As you can see, there are a broad range of activities ongoing, and we will keep investors appraised of our progress on this business, as we advance our plan forward. Now, I would like to transition over.

Deb: And launch a more affordable.

Deb: High quality CGM into.

Deb: Into a broad number of markets globally.

Deb: Since the acquisition.

Deb: We have been progressing this plan.

Deb: Ross and known Brava areas.

Deb: Including <unk>.

Deb: <unk> spending.

Deb: Building out our biosensor team when a number of key appointments.

Mr Douglas medical device and diabetes technology company.

John Gillard: Discussing Trinity's Comprehensive Transformation Plan, which is a key pillar of our new management team's fresh vision and strategy for the company. As I have said previously, this is a vision and strategy that builds on the past, but also breaks from the past, toward a future of more ambitious goals. As part of our near-term transition plan in 2024 and 2025, we will drive a step change in our financial performance by building on our existing revenue and eliminating Unnecessary Overhead and Complexity. My immediate priority is to dramatically improve the financial performance of the company's existing business. As such, we are totally focused on Getting Us To A Position Where Trinity's Existing Business Is Delivering Substantial Free Cash Flow. I believe this is critically important for three key reasons.

Deb: Such as fixed.

Deb: Johnson, and Johnson and life Scott.

Deb: We have reestablished CGM manufacturing capability.

Deb: This greatly system.

Deb: Planning and executing sensor design improvements.

Deb: This work is based on the existing CGM product is that.

Deb: And it's being carried out with the assistance of a world class external technical.

Deb: And design consultants.

Three.

Deb: The team is also initiating enhanced data analysis of waveforms.

Deb: Existing database of clinical trial results.

Deb: And we are very excited by the potential outcomes of that analysis.

Deb: In addition to this technical work.

Deb: We are progressing discussions and agreements with potential commercial partners such as Behr.

Deb: <unk> for the launch of our CGM products.

Deb: Finally.

Deb: We are establishing a scientific and user advisory group for CGM.

John Gillard: The obvious, cash-generated businesses are generally more valuable, which increases value for our shareholders; better performing businesses strengthen our balance sheet. I've heard that We believe that our new and future biosensor technology provides a tremendous opportunity for Significant Future, that is, strong value, will permit us to capitalise on this opportunity more rapidly, looking at our transformation plans for the existing business. It has several key components that we believe are rapidly achievable, in most cases by mid 2025. The three main components are 1.

Deb: This is to ensure that strong clinical outcomes.

And user needs remain at the forefront of our thinking.

Deb: As you can see.

There are a broad range of activities ongoing.

Deb: We will keep investors apprised of our progress all of this business.

Deb: As we advance our plan forward.

Deb: Now I would like to transition to discussing <unk> comprehensive transformation plan.

Deb: For our existing business.

Deb: This transformation plan is a key pillar of our new management teams fresh vision and strategy for the company.

John Gillard: Producing Complexity and Casting Through Consolidation, Reducing the cost of goods. Unknown Attendee, Joe Diaz, Aris Kekedjian, John Gillard, Kerstin Ahlfont, Des Fitzgerald, Trinity Biotech, and three further simplifying our internal operations. Consolidation in Lower Cost Locations. Let me expand on this.

Deb: As I have said previously.

Deb: This is a vision and strategy that builds on the past.

Deb: Also breaks from the past.

Deb: Toward a future of more ambitious school.

Deb: As part of our near term transition plan in 2024, and 2025, we would drive a step change in our financial performance.

John Gillard: In the first of these, we are considerably reducing complex manufacturing processes by consolidating our main manufacturing operations into a considerably smaller number of main sites and also moving to an outsourced model for a significant amount of our less complex manufacturing activities. As part of this initiative, we are today announcing that we will cease manufacturing at our Kansas site before the end of 2020. This site has traditionally supported our diabetes HbA1c testing and hemoglobin variants. We believe that we can create a multi-million dollar annualized operation by absorbing much of this activity into our other manufacturing footprint and outsourcing other aspects of operations. These additional, coupled with the 4 million annualised savings from other projects in our Diabetes HbA1c business, are a game changer in terms of this business's profitability and cash flow generation profile. This will create a recurring revenue business of significant value. This change is part of a broader strategic objective. We centralize our most complex... Unvaluable.

Deb: By building on our existing revenue base, and eliminating unnecessary overhead and <unk>.

Deb: Excellent.

Deb: My immediate priority is trigger medically improve the financial performance of the company existing business.

Deb: As such we are totally focused on getting us to a position where treasuries existing business is delivering substantial free cash flow.

Deb: I believe this is critically important.

Deb: For three key reasons.

Deb: Firstly the obvious point.

Deb: Cash generative businesses are Jeremy more valuable which increases value for our shareholders.

Deb: Secondly, better performing businesses strengthen our balance sheet.

Deb: And Turkey.

Deb: We believe that our new and future biosensor technology provide a tremendous opportunity for significant future growth.

Deb: And that is strong balance sheets with permit us to capitalize on this opportunity more rapidly.

John Gillard: Manufacturing, so as to maximize quality and intellectual property protection while outsourcing less complex manufacturing activities, so as to drive efficiency and reduce complexity. By using this strategy, we believe we can significantly reduce our costs, while maintaining the high quality of our products and protecting our intellectual property, in the second. We are also considerably reducing the cost of goods for many of our products by changing suppliers and negotiating new deals with existing suppliers. This is an area where we have already achieved millions of dollars in annual life savings, and I believe there is even more we can do here over the coming quarter. [inaudible] We are further simplifying our internal processes and centralizing business support functions at lower costs. As such, today we are announcing a project to move a significant portion of our business support focus to a lower cost and centralized location.

Deb: Looking at our transformation plan for the existing business.

Deb: It has several key components.

Deb: That we believe are rapidly achieve.

Deb: In most cases by mid 2025.

The three main components.

Deb: Right.

Deb: Reducing complexity and cost.

Deb: <unk>.

Deb: Two.

Deb: Reducing cost of goods through negotiation and supplier changes.

Deb: I have three.

Deb: Further simplify our internal operations through consolidation in lower cost locations.

None: Let me expand on these.

None: In the first of these we are considerably reducing complexity and cost.

By consolidating our main manufacturing operations.

None: A considerably smaller number of main sites.

None: And also moving to an outsourced model for a significant amount of our less complex manufacturing activities.

None: As part of this initiative.

John Gillard: This should drive a significant reduction in RSG and AX, and, importantly, provide us with a contribution and highly scalable platform that can efficiently support our expansion to the growth of our wearable biotech. We are currently well advanced in working with our partners and our staff on these changes, and we expect to have these changes complete by Q4 2025.

None: We are today announcing that we would have ceased manufacturing at our Kansas sites.

None: Before the end of 2024.

None: This site has traditionally supported our diabetes H B C testing and hemoglobin variant test.

None: We believe that we can create multi million dollar annualized operation efficiencies by.

None: By absorbing much of this activity into our other manufacturing footprint and outsourcing other aspects of operations.

John Gillard: Why many of these initiatives are focused on cost optimization. They are within my realm of... As a result, I have a high degree of confidence that these will deliver the financial benefits we have targeted in my prior role at CFO before I took over as CEO in late December last year. We began planning and executing on many of these initiatives, and as a result, we are already beginning to realize some of the financial benefits. As you can see from today's announcement, we have clear steps underway to deliver the remaining benefits to the base business between now and Q2 2025, when we are targeting approximately $20 million of annualized run rate EBITDA. This is on targeted annualized run-out revenues of approximately £75 million.

None: These additional efficiencies.

None: Those are the 4 million annualized savings from other projects in our diabetes H B C business are a game changer in terms of this business its profitability and cash flow generation profile.

This will create a recurring revenue business.

None: Significant value.

None: This change is part of a broader strategic objectives.

None: Yeah.

None: To centralize I'm always complex and valuable manufacturing activities, so as to maximize quality and intellectual property protection.

None: But outsourcing less complex manufacturing activities.

John Gillard: We plan to give further details on these initiatives and their progress during our future earnings announcements and presentations. As I have said before, we recognize that in this we are taking some big bets, but we believe these are necessary to deliver the fundamental change in financial performance that will emerge from a more streamlined and nimble organization. We have mitigated execution risk in the following ways.

None: So as to drive efficiencies and reduce complexity.

None: By using this strategy.

None: We believe we can significantly reduce our cost.

None: While maintaining the high quality of our products and protecting our intellectual property.

None: In the secondary markets.

We are also considerably reducing the cost of goods.

John Gillard: A, putting in place highly skilled and experienced people who have come from large and sophisticated organizations and have significant experience in driving and delivering these types of change projects; careful selection of our transformation partners. We have selected highly capable and reputable outsourcing and supply chain partners who have a strong track record in our industry; and C, developing a strong culture of change execution in the business. Our strong start in 2024 is a testament to the effectiveness of our efforts and the strong culture of execution we are building within Trinity. Let me share some examples.

None: Many of our products by changing suppliers and negotiating new deals with existing supplies.

None: This is an area, where we have already achieved millions of dollars of annualized savings.

None: And I believe there is even more we can do here over the coming quarters.

None: In the third at it.

None: We are further simplify our internal operations.

None: And centralizing business support functions in lower cost locations.

None: As such today, we are announcing a project to move a significant portion of our business support functions to lower cost and centralized location.

None: This should drive a significant reduction in our SG&A expenditure.

None: Sure.

John Gillard: I am delighted and very proud of our team's performance, successfully scaling our rapid HIV testing manufacturing capacity in Q1 2024 to meet the additional output requirements for Trinscreen HIV's screening algorithm win in Kenya. Our ability to scale manufacturing output four-fold required some major changes in the business and the way it operates. This was critical for us in demonstrating our capability and commitment to be a strong and reliable partner to our Trinscreen HIV testing partner, just as we have been for many years to our Unigloid HIV testing partner. We were also very pleased this week to receive a further purchase order for an additional 2 million transgreen HIV tests for the Kenyan market. We expect to supply this in Q2 2024. We received this order in spite of another legal challenge against the Kenyan government's HIV testing algorithm. This time from the manufacturer of a competitor product. We will be monitoring this case against the Kenyan government for any impact on orders for twin screen HIV testing in Kenya.

None: Very importantly.

None: Provide us with a cost efficient.

None: And highly scalable platform that can efficiently.

None: Rapidly.

Supports our expansion to the growth of our wearable biosensor business.

None: We are currently well advanced in working with our partners and our staff on these changes.

And we expect to have these changes completed by Q4 2024.

None: While many of these initiatives are focused on cost optimization.

None: With the AMA robust control.

None: As a result.

None: I have a high degree of confidence.

None: That these will deliver financial benefits we have target.

None: In my prior role as CFO.

None: Before I took over as CEO in late December last year.

None: We began planning and executing on many of these initiatives.

None: And as a result, we are already beginning to realize some of the financial benefits.

None: As you can see from today's announcements, we have clear steps underway to deliver the remaining benefits to the base business between now and Q2 2025.

John Gillard: But at this stage, our focus is on delivering the quality tests that have been ordered by our customers to support the critically important HIV screening program in Kenya. Outside of HIV, we have continued to execute on our key change initiatives in our existing diabetes HbA1c test. We have now completed the development and testing of our new diabetes HbA1c column on Tide, set out in today's press.

None: When we are targeting approximately $20 million annualized run rate EBITDA.

None: This is our targeted annualized revenues of approximately $75 million.

None: We plan to give further details on these initiatives and their progress.

None: During our future earnings announcements and presentations.

None: As I said before.

None: We recognize that in this we are taking some big bets.

John Gillard: The results of this development program have exceeded expectations, with our new column system now delivering up to four times the number of injections compared to the existing product. As planned, we are now executing on the commercial launch of these new products. This new column is more convenient for many of our users and reduces our cost of goods to service these customers. We expect to see the financial benefits from this rollout to accrue from Q2 this year. We have also now completely brought the manufacturing process of our key diabetes HbA1c component in-house and will cease to order any further product from our external providers. Again, this project has been delivered on time and as planned. Finally, we are now using lower cost components in our hemoglobin instrument bill. This is as a result of our supply chain optimization. These three initiatives are expected to deliver approximately $4 million of annual savings and significantly benefit the profitability and value of our haemoglobin business. So, to sum up from me,

None: But we believe these are necessary to deliver the fundamental change in financial performance.

None: That will emerge from a more streamlined and nimble organization.

None: We have mitigated execution risk in the following ways.

None: Hey.

Putting in place a highly skilled and experienced team who have come from large and sophisticated organizations.

None: I'd have exceed Michigan experience in driving and delivering these types of change projects.

None: B.

None: Careful selection of our transformation Packers.

None: We have selected highly capable.

None: Reputable outsourcing and supply chain partners, who have a strong track record in our industry.

None: And see developing a strong culture of change execution in the business.

None: Our strong start in 2024 is a testament to the effectiveness of our efforts and the strong culture of execution, we are building within Trinity.

Let me share some examples.

None: I am delighted and very proud of our team's performance in successfully scaling our rapid HIV testing manufacturing capacity in Q1 2024.

John Gillard: Our recent strategic acquisition gives us a foothold in a vast and rapidly expanding CGM market into which we plan to introduce a highly competitive product that we believe can successfully disrupt the market and capture significant value for our shareholders. We are pleased to be progressing on target with our initial plan for the business. Trinity Biotech. As I said, it's an experienced diagnostic company that, under new leadership and with fresh thinking, can transform its existing business into a high-performing cash-generative enterprise, and we are very focused on executing on this plan. With that, I will hand you over to Des Fitzgerald, our CFO, who will bring you the financial results for Q4 and fiscal year 2022. Thank you.

None: To meet the additional requirements for twin screen H Ivs screening algorithm when in Kenya.

None: Yeah.

None: Our ability to scan manufacturing output for fault required some major changes in the business.

None: The way it operates.

This was critical for us and demonstrating our capability and commitment.

None: To be a strong and reliable partner to our trend screen H I V testing partners.

None: Just as we have been for many years in our U. Two are you to go with HIV testing.

None: Yeah.

None: We were also very pleased this week to.

None: Received a further purchase order for an additional 2 million trend screen HIV tests for the Kenyan markets.

We expect to supply this in Q2 2024.

None: We received this order in spite of another legal challenge.

Des Fitzgerald: Thank you, John. I will now speak to our financial results for the fourth quarter of 2023, and following that, I will briefly discuss our full year 2023 financial results. Our revenues for the fourth quarter of 2023 were $13.4 million compared to $15.7 million for the same quarter in 2022, a decline of $2.3 million. This movement was driven primarily by declines in our hemoglobin business of $1 million quarter on quarter as we deferred year-end shipments of products at sub-optimal pricing as we renegotiated contract terms, terms that are now agreed as of Q1 2024. Secondly, a decline of $0.6 million quarter on quarter in our autoimmune business due to the already communicated cessation of our transplant testing activity in our Buffalo lab business, and thirdly, lower period-over-period revenue from our COVID-19 VTM products, leading to a decline of 0.2 million in that product.

None: Against the Kenyan government HIV testing.

None: This time from the manufacturer of a competitive product.

None: We will be monitoring this case against the Kenyan government for any impact on orders for twin screen HIV for Kenya.

None: But at this stage our focus is on delivering the quality test that had been ordered by our customers to support the critically important HIV screening program in Kenya.

None: Outside of HIV, we have continued to execute on our key change initiatives in our existing diabetes teach be able to see testing.

None: We have now completed the development and testing.

Of our new diabetes, H be able to see Colin system.

None: Ty.

None: As set out in todays press release the results of this development program has exceeded expectations with our new column system now delivering up to four times excuse me the number of injections compared to the existing products.

None: As planned we are now executing on the commercial launch of these new products.

None: This new column system is more convenient for many of our users.

Des Fitzgerald: Additionally, in our point of care business, we experienced a decline of 0.5 million driven by lower sales in our Univolt test due to irregular artery patterns in that business. That decline is partially offset by revenue from our TrinScreen test of 0.4 million. This quarter was the first quarter we recorded revenue from our sales of our TrinScreen product in Africa, and we expect this test to be a key growth driver for us going forward. Our gross profit for the quarter was $4.6 million, representing a gross margin percentage of 34%, which is broadly in line with Q4 2021. Order operating income decreased from $0.3 million in Q4 2022 to $0 in Q4 2023, and auto operating income in Q

None: And reduces our cost of goods to service these customers.

None: We expect to see the financial benefits from this rollout.

None: Crew from quarter two this year.

None: We have also now completely brought in house the matter of factoring process of our key diabetes HBA when see consumer.

None: And ceased ordering any further products from our it started provider.

Again. This project has been delivered on time and as planned.

None: Yeah.

None: Finally, we were now using lower cost components in our hemoglobin instrument business.

None: This is as a result of our supply chain optimization focus.

None: These three initiatives are expected to deliver approximately $4 million of annualized savings.

None: And significantly benefit the profitability and value of our hemoglobin business.

None: So.

Des Fitzgerald: in relation to R&D activities.

To sum up from me.

Des Fitzgerald: research and development expenses were $1.1 million for the quarter, in line with Q4. SG&A expenses were $6.9 million in the quarter, $2.8 million lower than the $9.7 million incurred in Q4 2022. Key drivers of this reduction were a lower share-based payment expense of $2.3 million when compared to the same period in Q4 2022, primarily due to the reversal of cumulative share-based payment expenses for unvested options related to our former CEO's resignation in this quarter. Additionally, included with our SG&A spend this quarter was $1.8 million for non-product development, legal, audit, and professional services. These fees were elevated in the quarter, with the main driver being due to our acquisition of the CGM assets of Waveform in January 2024.

None: Our recent strategic acquisition.

None: It gives us a foothold in a fast and rapidly expanding CGM markets.

None: Each of which we plan to introduce a highly competitive offering that.

That we believe can successfully disrupt Americas and cap sure significant value for our shareholders.

None: We are pleased to be progressing on target with our initial plan for the business.

None: Tracy biotech as I say is an experienced diagnostic company.

None: Under new leadership.

None: With fresh thinking can transform its existing business into a high performing cash generated of enterprise.

None: We are very focused on executing on this plan.

None: With that I will hand, you over to debts discharged our CFO, who will bring you through the financial results for Q4 and fiscal year 2023.

CFO: Thank you for your time.

CFO: Thank you John.

CFO: I'll now speak to our financial results for the fourth quarter of 2023, and following that I will briefly discuss our full year 2023 financial results.

Des Fitzgerald: Our expected level of non-product development, advisory, audits, and consulting fees going forward is expected to be broadly a quarter of the Q4 2023 level. We recognize an impairment charge of 0.3 million in Q4 2023, which compared to a charge of 3 million in the same quarter last year. In the quarter, we recognized 0.3 million impairments across our cash generating units, IMCO, and Trinity Biotech in Brazil, as their value and use were below their current values. We are seeking to implement profit initiatives in both.

CFO: Our revenue for the fourth quarter of 2020 trillion worth $13 4 million compared to $15 $7 million for the same quarter in 2022 at the telling of $2 3 million.

CFO: This movement is driven by firstly as declines in our hemoglobin this business of $1 million quarter on quarter as we deferred year end shipments of product. That's so Bob stope optimal pricing if we renegotiated a contract terms terms that are now agreed as of Q1 2024.

CFO: Secondly, at the signing of the <unk> $6 million quarter on quarter in our autoimmune business due to the already communicated seasoning of our transport, that's an activity and our Buffalo lab business.

CFO: Target lower period over period revenue from our COVID-19, bcm product, leading towards Italian <unk> 2 million and that product line.

Des Fitzgerald: All of the above led to an operating loss of $3.8 million in the quarter, compared to $8.2 million in Q4 2022, with the key drivers for the lower loss being lower impairment charges and lower SG&A expenses offset by lower risk. Financial Income, representing movements in the derivative liability related to warrants granted to perceptive advisors or the main lender for the period, was $0.6 million compared to $0.3 million in Q4. Financial expenses in the fourth quarter of 2023 were $2.3 million compared to $2.4 million in Q4 2022, with a slight decrease due to a lower principal amount over the quarter offset by higher prevails. Loss before depreciation, amortization, impairment, tax, interest, and share option charges of $4 million for the quarter; a basic loss per ADS of 71.8 cents compared to 132.3 cents in Q4. Our cash balance decreased from $6.3 million in Q3 2023 to $3.7 million in Q4 2021. Cash generated by operations was a positive $0.3 million in the quarter, inclusive of net movement and net working capital of $0.4 million.

CFO: Additionally, in our point of care business, we experienced a decline of <unk> 5 million driven by lower sales and are you going to go test due to irregular ordering patterns in that business.

CFO: That decline was partially offset by revenue from our transferring tests of the airport for them.

CFO: This quarter was the first quarter, we recorded revenue from our sales of our trend screen product Africa, and we expect this test to be a key growth driver for us going forward.

CFO: Our gross profit for the quarter with $4 $6 million.

CFO: Representing a gross margin percentage of 34%, which was broadly in line with Q4 of 2022.

CFO: Other operating income decreased from zero point $3 million in Q4 of 2020 220 in Q4 2023.

CFO: Other operating income in Q4 of 2022 comprised government gratis in relation to R&D activities and there was no equivalent in fourth quarter of 2023.

CFO: Research and development expenses were $1.1 million for the quarter in line with Q4 2022.

CFO: SG&A expenses were $6 $9 million in the quarter $2 $8 million lower than the $9 $7 million incurred in Q4 of 2022.

CFO: Key drivers of this reduction were lower share based payments expense of $2 $3 million when compared to the same period in Q4 of 2022, primarily due to the reversal of cumulative share based payments expenses for unvested options related to our former Ceo's resignation in this quarter.

Des Fitzgerald: In January 2024, the company entered into an amended credit agreement with our existing main lender, Perceptive Advice. Under the amended term loan, an additional £22 million of funding was made available to us, with £12.5 million being used to acquire the waveform. The remaining nine and a half million is available for general corporate purposes, including for the further development of the CGM and Biosense.

CFO: Additionally included in our SG&A spend this quarter was $1 8 million of non product developments legal audit and professional advisory fees.

CFO: These fees were elevated in the quarter with the main driver being due to our acquisition of the CGM assets away for them in January 2024.

CFO: Our expected level of non product developments advisory audit and consulting fees going forward. It is expected to be broadly a quarter of the Q4 2023.

Des Fitzgerald: In addition, the loan provides for additional liquidity of up to 6.5 million that may be drawn down by us between April and December 2024, which can be used for general corporate purposes, again providing further liquidity to fund the development of the CDM and biosense. The term loan also, the amended term loan also immediately reduced the annual rate of interest on the loan by 2.5% to 8.75% plus the greater of the term secured overnight overnight financing rate or SOFR or 4% per annum and allows for a further 2.5% reduction in the base rate to 6.25% once the outstanding principal under the amended terminal falls below $35 million. Additionally, the term loan reduced the early repayment penalty from a range of 8% to 7%, down to 4% to 3.5% depending on the timing of early repayment, and also reduced the revenue power. The amended term loan matures in January.

CFO: We recognized an impairment charge was <unk> 3 million in Q4 of 2020 trait, which compared to a charge of $3 million in the same quarter last year.

CFO: In the quarter, we recognized <unk> 3 million impairments across our cash generating units in coal and Trinity biotech, but Brazil is there value in use with below their carrying values.

CFO: Looking to implement profit initiatives.

CFO: All of the above led to an operating loss of $3 $8 million in the quarter compared to $8 $2 million in Q4 of 2022 with the key drivers for the Lord Austin, lower impairment charges, and lower SG&A expenses offset by lower right.

Financial income representing movements in the derivative liability related to warrants gratitude protector advisors. Our main lender for the period was <unk> $6 million compared to zero point $3 million in Q4 2022.

CFO: Financial expenses in the fourth quarter of 2023 or $2 $3 million compared to $2 $4 million in Q4 of 2022 with a slight decrease due to a lower principal amount to over the quarter offset by higher prevailing interest rates.

CFO: Loss before depreciation amortization impairment.

CFO: <unk> interest and share option charges of $4 million for the quarter basic loss per ADR to 71, eight cents compared to $122.03 in Q4 2022.

Des Fitzgerald: Now I will move on to the full year 2023 results and give a brief overview of the financial performance. Revenue for the full year is 56.8 million, a decrease of approximately 9% on revenue. The key drivers of the decrease were, firstly, lower COVID revenues of $1.8 million year-on-year as COVID testing programs scaled down, and secondly, lower autoimmune lab services revenues of $1.8 million as we lost a key transplant testing service contract. And thirdly, declines in our haemoglobin business due to their predicted decline in sales related to our ULTRA2 instrument. And also, as discussed earlier, lower sales in the fourth quarter as we deferred shipments. Growth Margin for the year amounted to $19.5 million, representing a growth margin percentage of 34.2%. This is 6.6% higher than in 2022.

CFO: Our cash balance decreased from $6 $3 million in Q3, 2023 to $3 $7 million in Q4 of 2023.

CFO: Cash generated by operations was a positive <unk> 3 million in the quarter and cases above NAV movements.

CFO: Working capital of $4 4 million.

CFO: Okay.

CFO: In January 2024, the company entered into an amended credit agreements, but its success with our existing mainlander perceptive advisors.

CFO: Under the amended term loan and an additional $22 million of funding was made available to us with $12 5 million used to acquire the way for us.

The remaining $95 million is available for general corporate purposes, including for the further development of the CGM, our biosensor technology.

CFO: In addition, the loan provides for additional liquidity of up to $6 $5 million that may be drawn down by off between April and December 2024, which can be used for general corporate purposes again, providing further liquidity to fund the developments of the CGM, our biosensor technology.

CFO: The terminal and also the amended term loan also immediately reduce the annual rate of interest on the loan by two 5% to 875% plus degrees or all the term secured overnight overnight financing race our sulfur.

Des Fitzgerald: This increase was due to a significant inventory obsolescence charge of $4.7 million that we experienced in Q3, or SG&A selling general and administrative expenses in FY23 increased by $4.2 million to $31.2 million for a successful year, an increase of nearly 60%. Significant elements of this increase relate to an increase of 1.6 million in technical advisory, legal, and professional fees, primarily due to the acquisition of the biosensor assets of Waveform, which was complex in nature as we conducted a NASA deal, together with other corporate development and corporate finance activities as we continue to assess our strategic opportunities and balance sheet optimisation. We also experience higher operating losses, largely related to the re-evaluation of your denominated leases. We experienced impairment charges of £11.1 million in FY23, largely driven by an impairment in income due to the loss of revenue relating to the transplant testing activity, together with a write-down of our investment in iMore, which is operating last for the year with 27.

CFO: Our 4% per annum.

CFO: And allows for a further two and a 5% reduction in the base rate to $6 two 5% once the outstanding principal under the amended term loan loss charge of $5 million.

Additionally, the term loan reduced the early repayment penalty from a range of 8% to 7% down to 4% to train half, 2%, depending on the timing of variety of repayments and also reduce the revenue covenants.

CFO: The amended term loan matures in January 2026.

CFO: Now I will move on to the full year of 2023 results give a brief overview of the financial performance of the year.

CFO: Revenue for the full year at $66 8 million a decrease of approximately 9% on revenues in 2022.

The key drivers of the decrease for firstly, lower Covid revenues of $1 8 million year on year.

CFO: Covid testing program scandal, secondly, lower autoimmune last services revenues of $1 $8 million as we lost the key China Fantastic service contract entirely declines in their hemoglobin business to today's depict true to that predicted decline a third is related to our ultra two instruments.

CFO: So as discussed earlier lower sales in the fourth quarter as we deferred shipments, while we renegotiated contract terms with key customers.

CFO: Gross margin for the year amounted to $19 $5 million, representing a gross margin percentage of 34, 2%. This was six 6% higher than 2022.

Des Fitzgerald: Our financial expenses for the year were $11.1 million compared to $24.7 million in FY20, with a decrease primarily driven by two material items. Firstly, we experienced a loss of £9.7 million in FY22 relating to the disposal of exchangeable notes. Secondly, we incurred a larger period-on-period early repayment penalty relating to a repayment of the perceptive term loan in FY22 of £3.5 million versus a similar penalty of £0.9 million in FY23 related to a smaller repayment during the year. Profit from discontinued operations totaled £12.9 million in FY23, largely attributable to the gain of £12.7 million arising from the divestiture of Fitzgerald in 2012, Cash used by operations was $11.9 million in the year, inclusive of a negative net movement in working capital of 2.7%.

CFO: This increase was due to a significant inventory obsolescence charge of $4 $7 million that we experienced in Q3 'twenty to 'twenty two.

CFO: Our SG&A selling general and administrative expenses in FY, 'twenty trade increased by $4 $2 million $31 $2 million.

CFO: Slide 22.

CFO: An increase of nearly 16%.

CFO: Significant elements of this increase related to an increase an.

CFO: An increase of $1 6 million in technical advisory legal and professional fees, primarily due to the acquisition and the bio sensor assets away way for which was complex in nature as we conducted enough deal to do.

CFO: Or what other corporate development corporate finance activities as we continue to assess our strategic opportunities and balance sheet optimization initiatives.

CFO: We also experienced higher FX losses, largely related to the revaluation of euro denominated leases.

CFO: We experienced impairment charges of $11 1 million in FY 'twenty trade largely driven by an impairment in ankle due to the loss of revenue related to the trust fund testing activity together with the write down of our investments in anymore.

Our operating loss for the year was $27 million.

CFO: Our financial expenses for the year were $11 1 million compared to $24 7 million in FY 'twenty two.

CFO: The decrease primarily driven by two material items.

CFO: We experienced a loss of $9 7 million in FY 'twenty two relating to the disposal of exchangeable notes secondly, we incurred a larger period on period early repayment penalty relating to a repayment of the perceptive turned on in FY 'twenty two of $3 5 million.

Des Fitzgerald: To finish, as CFO and as part of this new management team, I will reiterate that we are fully focused on the implementation and execution of the transformation plan that was laid out by John earlier in the call to transform Trinity into a high-performance cash-generative enterprise, and I'm excited to be part of this company as we plan to disrupt the rapidly expanding CGM market on the back of our recent strategic acquisition of West. Now, I'll hand you back to the operator for questions.

CFO: A similar penalty with the airplane and $9 million in FY 'twenty treat related to a smarter repayments joining this financial year.

CFO: Profit from discontinued operations totaled $12 9 million in FY 'twenty trade largely attributable to the gain of $12 7 million arising from the divestiture of Fitzgerald industries.

CFO: Loss from continuing operations before interest taxes, depreciation amortization share based payments on impairment charges of $12 $1 million.

CFO: Cash used by operations was $11 $9 million in the year and keep some of the negative net movements in working capital of $2.

Operator: Thank you. If you'd like to ask a question at this time, please press star one on your telephone keypad, and a confirmation tone will indicate your line in the question queue. You may press star two if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

CFO: To finish our CFO honest parts of this new management team I want to reiterate that we are fully focused on the implementation and execution of the transformation plan that was laid out by John earlier in the call to transform <unk> into a high performing cash generative enterprise and I'm excited to be part of this company.

CFO: As we've had to disrupt the rapidly expanding CGM market on the back of our recent strategic acquisition of way for now.

Operator: One moment, please, while we poll for questions, and that's star number 1. Thank you. Our first question is from the line of Jim Sidoti, Sidoti & Company. Please proceed with your question. Hi, good morning, and thanks for taking the questions. First one on the diabetes business. Are all the new products that you have, the new consumables, are those all approved and ready for market? Or are there approvals that you need to get before you can start to sell those devices?

None: Now I'll hand, you back to the operator for questions.

None: Thank you.

Be conducting a question and answer session.

None: I'd like to ask a question at this time, Please press star one from your telephone keypad.

None: Information don't indicate your line in the question queue.

None: You May press Star two if you like to throw your question from the queue.

None: Participants using speaker equipment may be necessary to pick up your handset before pressing the star keys, one moment. Please while we poll for questions Thats Star one thank you.

None: Thank you.

None: Our first question is from the line of Jim Sidoti Sidoti <unk> Company. Please proceed with your questions.

John Gillard: There may be local registrations required, but they are effectively a variant on the existing approved product, so we don't have to go for a new 510k or anything like that Jim. So, you know, they're available to roll out immediately in certain markets, and other markets, there's just registration requirements. We, you know, we've finished all the testing, all the trials, you know, there's no regulatory risk at this point around

James Philip Sidoti: Hi, good morning, and thanks for taking the questions first one on the diabetes business.

James Philip Sidoti: Or are all the new products that you have.

James Philip Sidoti: The new consumables are those all approved and ready for market or other approvals that you need to get before you can start to sell those devices.

James Philip Sidoti: There may be local registration is required but they are effectively a a variance on the existing approved products. So we don't want to have to go for a new five 10-K or anything like that you. So.

John Gillard: And so, that applies to the fact that you've changed manufacturing locations for the consumables and the instruments. Has that all been worked out with the FDA?

James Philip Sidoti: They are available to roll out immediately in certain markets and other markets Theres just registration requirement. We you know we finished all of the testing on the trial as you know.

John Gillard: Yeah, so they go through what's called a variation change process, and you need to show that you have basically comparable performance. And so without boring everyone on the call with some of the regulatory issues, but effectively, Jim, you know, you, there are requirements that the various facilities need to have, okay. And then they have to operate a specific type of quality system. And we need to carry out testing to show that, you know, the products that we manufactured in a particular place or in a particular way previously are comparable to the product that we manufacture now. And, and I suppose that's why it's very important for us to have an experienced and highly specialized team that can plan and execute on those types of initiatives.

James Philip Sidoti: There is no read regulatory risk at this point around that.

James Philip Sidoti: Okay.

James Philip Sidoti: So.

So that applies to the fact that you've you've changed manufacturing locations for the consumable when we used to but that's all been worked out with the F. D. A.

James Philip Sidoti: Yeah. So they go through the West coast.

James Philip Sidoti: Variation change process.

James Philip Sidoti: And you need to show them.

James Philip Sidoti: You need to show a basically comparable performance and so without boring everyone on the call [laughter] with Ted with with some of the regulatory issues, but effectively Jim you. There are requirements that the various facilities need to have okay. And then they have to operate a specific type of quality system.

James Philip Sidoti: And we need to carry out testing to show that.

James Philip Sidoti: The product that we manufactured in a particular place or in a particular way previous is comparable to the product that we manufacture now and I suppose that's why it's very important for us to have an experienced and highly specialized team that can plan and execute on those types of initiatives.

John Gillard: You know, as I said, there are very significant savings associated with this. And that's one of the reasons that, over the last two or three years, we have been making these senior hires to give the company the capability, number one, to identify these opportunities, and then, number two, to be able to execute on them efficiently and quickly. And I think that's something we have developed very significantly over the last two to three years, and we're now seeing the benefits of having those people in place. And I suppose having the management focus and discipline around executing those.

James Philip Sidoti: As I sat out there's very significant savings associated with this and that's one of the reasons that over the last two or three years, we have been making the senior hires to give the company the capability to number one identify these opportunities and then number two to be able to execute on them and execute on them.

James Philip Sidoti: Efficiently and quickly.

And I think that's something as a business we have developed very significantly over the last two to three years.

James Philip Sidoti: We're now seeing the benefits of having those people in place and I suppose having the management focus and discipline around executing Josh.

James Philip Sidoti: Okay.

John Gillard: And so it sounds like by this second, by this current quarter, you should be in the market with a product that has similar results but significantly lower manufacturing costs. So I would assume you'd be able to compete on price more effectively starting the second quarter of 2024. Is that correct?

Josh: And so it sounds like by the SEC, but this current quarter you should be in the market with our product.

Josh: Similar similar results, but significantly lower manufacturing costs, so I would assume you'd be able to.

None: Compete on price more effectively starting with second quarter of 2024 is that correct. Yeah, yeah exactly Jim right. So the reason that we pushed these changes are really twofold right.

John Gillard: Yeah, yeah, exactly, Jim, right? So, you know, the reason that we push these changes is really twofold, right? Number one, to reduce our cost of manufacture, and that should give us higher revenue and higher cash flows from that business. And then secondly, to allow us to compete in different parts of the market, especially in A1C testing, that traditionally hasn't been, you know, really that open to us, right? And I would categorize that in two ways. So by, you know, updating our column system and now allowing a higher number of injections. That opens us up to labs that run a higher number of tests. Unknown Attendee, Joe Diaz, Aris Kekedjian, John Gillard, Kerstin Ahlfont, Des Fitzgerald, And then secondly, by reducing our cost, it allows us to target maybe lower price markets, right, where we traditionally have either not sought to compete or have been able to affect, and very much what goes hand in hand with that is the work that we've done to reduce the cost of building the instrument

None: Number one to reduce down our cost of manufacturer and that should give us higher revenue and higher cash flows from that business and then secondly to allow us to compete in different parts of the market, especially in a one C testing that traditionally hasn't been.

Really that open to us right and I would categorize that in two ways. So by you know updating our updating our column system and now, allowing a higher number of injections that.

None: That opens us up to labs that ruin a higher number of tests and that wouldn't really being practically available to us and in many markets. Okay. So that kind of increases our tam across those across the number of labs that are potentially open to our type of solution.

None: And then secondly by reducing down our cost it allows us to target maybe lower priced markets right, where we traditionally have either not sought to compete or have you been able to effectively compete and very much what goes hand in hand with that is the work that we've done to reduce down the cost of building the instruments.

John Gillard: And now what we're doing around outsourcing more aspects of manufacturing. So by reducing the cost of the consumables and reducing the cost of the instrument, you reduce the total cost of ownership, either for the distributor or for the lab itself of our solution, and we think that would give us a more competitive offering in those other parts of the market that we haven't been able to aggressively attack in the past.

None: And now what we're doing around outsourcing more aspects of the manufacturing of that instrument, so by reducing down the cost of the consumables and reducing down the cost of the instruments you reduce down the total cost of ownership either to the distributor or the lab themselves of our solution and we think that would give us a.

None: More competitive offering in those other parts of the market that we haven't been able to we haven't been able to aggressively attack in the past.

John Gillard: All right, and then if we switch over to the trim screen, it sounds like you've made progress getting that manufacturing up and running. You've got sales already in Kenya. Are there other markets in Africa where you can sell the product?

None: Alright, and then if we switch over to trim screen it sounds like you've made progress.

None: Roberts getting back manufacturing up and running you got.

None: They already have and can you are there other markets in Africa, where you can sell the product.

John Gillard: Yeah, like we, because we have WHO PQ approval, there are many markets effectively open to us from a regulatory perspective. You know, as you know, Jim.

None: Yeah, like we because we have W. H O PQ approval there are many markets affect the open trucks from a regulatory perspective.

None: You know Jim.

John Gillard: The way that this testing happens in Africa is through national algorithms, that's effectively a list of approved products, or selected products, I should say, to be used in the national testing program. We typically have a screening test, which is what TrinScreen is for. You have a confirmatory test, which is Unigold, and you maybe have a second line confirmatory test, which again could be Unigold, right?

The way that this testing happens in Africa is through national algorithms, that's effectively a list of approved products aim our selective products I should say to be used in the national testing programs. You typically have the screening test, which we're transferring as far you have a confirmation test, which is unicorn and you maybe as a second line compromise.

None: <unk> tests, which again could be unicorn right. So we cover off the screening and the confirmation tests.

John Gillard: So we cover off the screening and the confirmatory test markets with both products. Those algorithms come up for change every so often, and that is both a positive and a negative. It is a negative when you're trying to get into new countries, but it's a positive when you get selected from that algorithm, because typically, it doesn't change that terribly often, provided you continue to provide the quality product, right? So it takes some time to build a business within that, but as we've seen with our Unigold business for the last 20, 25 years, that can provide a very stable, recurring business. So there are a number of countries that the team is working hard at getting the product into. It's a competitive market, right?

None: With both products so all of that.

None: I'd agree with them come up for change and every so often and that is both a positive and a negative it is a negative when you're trying to get into new countries, but it is a positive when you get selected from that algorithm because typically it doesn't change that terribly often provided you continued to provide the quality.

None: Right and so it takes some time to build the business within that but as we've seen what are you going to grow our business for the last 2025 years that can provide a very stable recurring recurring business. So there are a number of countries that the team is working hard at getting the product into and it's a competitive market.

None: Right and you know.

John Gillard: We will not release the names of those countries until we have to, for competitive reasons. But we have a senior team that is very experienced, both within Trinity and from other companies that are highly successful in this market, working for us on these initiatives. And we do expect to win further countries as we move through. And, as I said, it doesn't happen overnight, but the flip side of that is that it does give you some recurring revenue and some predictability. And it's both an asset and a liability once you win some of those countries.

None: We will not release the names of those and those countries until we have to and for competitive reasons, but we have a senior team that are very experienced both within Trinity and from other companies that are highly successful in this market is working for us on these on these initiatives and we do expect to to win.

None: And further countries as we move through and but as I said it doesn't happen overnight, but the flip side of that is is is that it does give you. Some some recurring revenue and some predictability and as people with an asset once you once you win some of those countries.

John Gillard: So it sounds like nothing, nothing, may happen in the near term, but by 2025, you do think that you'll be selling the product to other countries in Africa.

None: So it sounds like nothing nothing.

None: It may happen in the near term, but by 2025, you do think that you'll be selling the product to other countries in Africa.

Unknown Attendee: Unknown Attendee Exactly what I think

None: Is that I think that's exactly.

None: Yeah, I think that's a fair way to categorize it Jim that would agree with that.

John Gillard: Okay. All right. And then, I just want to be clear, the guidance you gave for revenue in EBITDA for 2025, that includes no revenue from CGM, is that correct?

None: Okay Alright.

None: Alright, and then.

None: I just wanted to be clear the guidance you gave for for revenue and EBITDA for 2025.

None: That includes no revenue from CGM is that correct.

John Gillard: Yeah, exactly. So that's really built upon the existing business, right? You know, we would expect continued growth from Trendscreen in Kenya and winning some of those in your countries, as we spoke about. And then also some growth within our hemoglobin business, from those changes that we already spoke about in terms of the lower cost and our ability to grow, like we typically see year-on-year growth in our hemoglobin business. But we do expect these changes to really position us for stronger growth in the second part of this year and onwards, and as we roll out the more efficient instrument from a cost perspective and our new column system. So I think, you know, we fairly expect additional growth there, and that's really where we expect to build over time to that 75 million run rate number that we talked about earlier.

None: Yeah exactly so that's that's really built upon the existing business right. Now we would expect continued growth from trend screen through Kenya, and winning some of those on new countries as we spoke about.

None: And then also some growth within our hemoglobin business.

None: From those changes that we already spoke about in terms of the lower cost and our ability to grow like we typically see year on year growth in our hemoglobin business, but we do expect these changes to really position us for stronger growth in the second part of this year and onwards, and as we rollout the.

None: It'll more efficient instrument from a cost perspective, and our our new column system. So I think you know.

None: We fairly expect additional growth there and that's really where we expect to build over time to that 75 million run rate number that we talked about earlier.

John Gillard: And when do you think it's reasonable to assume that you'll start generating revenue from CGM?

None: And when do you think it's reasonable to assume that you will start generating revenue from CPE that.

John Gillard: At this point, we're not seeing a huge amount of that, right? We are very much looking at the data from the Waveform's existing device. And, you know, the Waveform device has been through a number of clinical trials over the years, right? So there's a rich vein of data for us to work with there.

None: At this point, we're not seeing a huge amount on that horizon aim.

None: We are very much looking as the data.

None: From the wave forms existing device and you know the way from device has been through a number of clinical trials over the years right. So there's a rich vein of days for us to work with there. We're also speaking with commercial partners and that will inform what we will do in terms of commercial launch.

John Gillard: We're also speaking with commercial partners, and that will inform what we will do in terms of commercial law. What we've previously said is, with regard to the next generation device, we expect to be in clinical trials in the summer of 2025, and we'd expect to be in the market, you know, ideally within six months after that. Right. And, you know, depending on the outcome of the various data analyses that we're doing right now and conversations with commercial partners. We may change that. We may take a different approach, but I don't want to say too much about that now until we decide what we're going to do based upon further data analysis and further discussions and feedback from the market.

None: Well. We've previously said is with regards to the next generation device, we expect to be in clinical trials. Some of our 2025 and we'd expect to be in the market.

None: Ideally within six months after that right.

None: Yeah.

None: Depending on the outcome of the various data analysis that we're doing right now in conversations with commercial partners. We may change that we may take a different approach, but I don't want to say too much about that now.

None: <unk> until we decide what we're going to do based upon based upon further data analysis and further discussions and feedback from them.

From the Americas, but I will say is you know we have been.

John Gillard: What I will say is, you know, we have been very positively influenced and happy with the feedback from some commercial partners in terms of the desire to have a product on the market as quickly as possible, and people will recognize the unique benefits of the waveform device, particularly in terms of cost of care and reducing down that daily cost of this critical technology and solution for people who have diabetes. And so, you know, we're confident the demand is there, and we just need to decide which way we can best meet that demand in a way that allows us to build a very successful business and brand for the future.

None: Very positively and influenced and happy with the feedback from some commercial partners in terms of the desire to have a product on the Americas as quickly as possible and people recognize the unique benefits of the wave form device.

None: Typically in terms of cost of care and reducing down that daily cost of this critical technology and solution for people and who have diabetes and so you know we're confident the demand is there and we just need to decide which way, we or which way we can best meet that demand and in <unk>.

None: That allows us to build a very successful business and brand for the future going forward.

John Gillard: All right, and then some general modeling questions. You know, what should we use for an effective share count in 2024?

None: Alright, and then some general modeling questions.

None: Should we use for our effective share count for 2024.

John Gillard: I think we're at about 9 million ADSs now; that's after our reverse share split a number of weeks ago, so I think we're at about 9 million.

None: I think worried about 9 million a D. S is no aim that's after a reverse share split.

None: And a number of weeks ago. So I think we're at $9 million.

John Gillard: Okay, and that includes the shares that were used to complete the diversity chairs.

None: Okay.

None: That includes the shares that were used to complete the diversity of turbines.

John Gillard: Yeah, the waveform acquisition, do you remember that?

None: Yeah, I'd say the way farm acquisition, Jim is it.

John Gillard: Unknown Attendee, Joe Diaz, Aris Kekedjian, John Gillard, Kerstin Ahlfont, Des Fitzgerald, Do you think with the cash on hand and the six million pounds available, do you think you have enough cash to make the changes in 2024 that you want to make?

None: Oh I'm sorry.

None: The acquisition right right Yeah, yeah.

None:

Do you think with the cash on hand, and 6 million cash available do you think you have enough cash to to make the changes in 2024 that you want to make.

John Gillard: We're running fast to do that, and you know the benefit of improving. The cost basis of the business is twofold, Jim, right? The quicker we do it, the less cash we need to get there, and then each initiative that we successfully execute on provides further positive cash flow to fund the other initiatives. And that's because we're running very, very fast. We're, we're being aggressive here. We think it's necessary and it's a warranted aim. So I would be hopeful that that would be enough to get us to where we need to get to within the changes around the existing business. But look, we'll do it.

None: We're running fast to do that aim.

None: No.

None: The benefits of improving.

The cost basis of the business is to forward Jim right.

None: The quicker we do it the less cash we need to get there.

None: And then each initiative that we successfully execute on provides further positive cash flow right to fund the other initiatives.

None: We're running very very fast, where we're being aggressive here, we think it's necessary and we think it's worth just aim so I would be hopeful that that would be enough to get us to where we need to get to within the within the changes around the existing business and believe it will obviously keep that under review.

John Gillard: Okay. All right. And then you mentioned a couple of times that 2024 is off to a strong start. Can you give us any guidance on that first quarter, or would you rather wait a couple of weeks for that?

None: Like I said, we're working hard to make sure that's the case.

None: Okay, and then you mentioned a couple of times the 'twenty 'twenty four is off to a strong start okay can you give us any guidance on the first quarter or would you rather wait a couple weeks for that.

John Gillard: We're only four days post-quarter end, so what I will say is we do expect revenues to be stronger in Q1 2024 than they were in Q4 2023. So certainly some positive momentum there. And yeah, so for us, the focus is on executing on these initiatives to change our cash generation profile and our cost profile and then to build that revenue base. So I think, you know, we've had a strong start on both sides of the equation.

None: We're only four days post the first quarter and so what I will say is we do expect revenues to be stronger in Q1 2024 than they were in Q4 2023, So certainly some positive momentum there.

None: Yeah, so for us look at.

The focus is on executing on these initiatives.

None: To change our cash generation profile of their cost profile and then to build that revenue base. So I think you know where where we've we've had a strong start on both on both sides of the equation.

John Gillard: Alright, seems like there's quite a bit going on. I appreciate all the color. Thank you.

None: Alright, it seems like there is quite a bit going on I. Appreciate all the color. Thank you.

John Gillard: Thank you. Our next question is from the line of Paul Nury with Noble. Please answer your questions.

None: Thanks, Jim.

None: Thank you. Our next question is from the line of Paul Knight with Noble. Please proceed with your questions.

Paul Nouri: Hey, good morning. Thanks for taking the questions.

Paul Knight: Hey, good morning, Thanks for taking my questions.

Paul Nouri: [inaudible] Do you have a target gross margin for 2025 that you could share, or a range?

Paul Knight: Hi, Paul.

Paul Knight: So.

Paul Knight: Do you have a target gross margin for 2025 that you could share or a range.

John Gillard: Unknown Attendee, Joe Diaz, Aris Kekedjian, John Gillard, Kerstin Ahlfont, Des Fitzgerald, We haven't really planned on going that deep, Paul, right? I think we'd expect it to be, you know, 60% would be kind of where we would be hoping to get to and are targeting to get to, and that's really from the procurement efficiencies that we're talking about, the outsourcing of some of the less complex aspects of our manufacturing, and the consolidation of the manufacturing sites. I mean, they will have a, you know, significant impact on that gross margin. And then, I suppose, so that we turn that into a higher degree of cash generation. That's the reason we're focused on our SG&A.

Paul Knight: Okay.

Well, we haven't really Penn go and dive deep all right I think we'd expect it to be Gil.

Paul Knight: 60% would be kind of where we would be hoping to get to aim our targeting to get to.

Paul Knight: And that's really from.

Paul Knight: The procurement efficiencies that we're talking about the outsourcing of.

Paul Knight: Some of the less complex aspects of our manufacturing right and the consolidation of the manufacturing sites I mean, they would have a significant impact.

Paul Knight: On on that gross margin.

Paul Knight: And then I suppose so.

Paul Knight: So that we turn that into a higher degree of cash generation. That's the reason we're focused on our SG&A and very much focused on reducing down.

John Gillard: Unknown Attendee, Joe Diaz, Aris Kekedjian, John Gillard, Kerstin Ahlfont, Des Fitzgerald

Paul Knight: The cost of complexity that we have within the business.

John Gillard: and very much focused on reducing the cost of complexity that we have within the business. And, you know, I know from speaking to shareholders that people have, and I think rightly are, been concerned about the extent of SG&A. Some of the key drivers for that are we have a broad breadth of products, we operate in a highly regulated industry, and we also sell to a large number of countries globally.

Paul Knight: You know I know from speaking to shareholders.

Paul Knight: You know.

Paul Knight: Yeah.

Paul Knight: I have I think rightly be concerned about the the extent of SG&A, whereas some of the key drivers for that are we have a broad breadth of products we.

Paul Knight: We operate in a highly regulated industry.

And we also sell to a large number of countries globally right.

John Gillard: Right

John Gillard: and all of those drive complexity, and we have traditionally been managing that complexity across a number of different sites, usually co-located with our manufacturing facilities, and our manufacturing facilities are not in low-cost locations. Our manufacturing facilities in the whole world are in Ireland, and they're in the US. And that leads to a situation where you have a high degree of complexity, you need to resource that complexity, and doing it in a distributed way reduces efficiency, and doing it in higher-cost countries increases the cost and amplifies the cost of that inefficiency. And that's really why we're focused on centralizing a lot of those functions into a lower-cost country where we can get those efficiencies, and we can also reduce the cost of servicing that compliance burden.

Paul Knight: All of those drive complexity.

Paul Knight: We have traditionally be managing that complexity across a number of different sites.

Paul Knight: Usually typically co located with our manufacturing facilities.

Paul Knight: At our manufacturing facilities are not in low cost locations you know our manufacturing facility in the order in Ireland and they're in the U S and that leads.

Paul Knight: You know to a situation where you have a high degree.

Paul Knight: Of complexity, you need to resource that complexity.

Paul Knight: And do it in a distributed way reduces down the efficiency and do it at a higher cost countries or increases the cost and amplifies the constant that inefficiency and that's really why we're focused on centralizing.

Paul Knight: A lot of those functions into a lower cost country.

Paul Knight: Name, where we can get those efficiencies and we can also reduce down the cost of servicing that compliance burden.

John Gillard: Unknown Attendee, Joe Diaz, Aris Kekedjian, John Gillard, Kerstin Ahlfont, Des Fitzgerald

Paul Knight: So.

Paul Knight: No that's got a little bit longer to gross margin, but I think I just want to make it clear.

Paul Knight: We're targeting all areas of the P&L right to try and get back to that.

Paul Nouri: Okay, and in terms of the source of the growth, because it's pretty dramatic expected growth, do you see it evenly between point of care and the lab business, or should it be more weighted towards one or the other?

Paul Knight: Get back to that very positive EBITDA number. So it's a comprehensive you were trying to take.

Paul Knight: Okay and in terms of the.

Paul Knight: Source of the growth because its pretty.

Paul Knight: Dramatic expected growth.

Paul Knight: Do you see it evenly between.

Paul Knight: Point of care and the.

Paul Knight: The lab business or should it be more weighted towards one or the other.

John Gillard: It's probably a bit more on point of care, Paul, but, you know, not usually so. And as I said, we normally see year-on-year growth with our hemoglobin business anyway, right? So within that, as I said, because of the changes in the product, we do expect to have a more competitive product to go to the market. And we do expect to have a growing market share over time. And we also have the premier resolution within that, you know, as you know, that type of sales process and installation process is a slow burner, right? And it's not a high volume type of game, but it's very sticky when you get it in when you get into a lab, right?

None: It's probably a bit more on point of care, Paul, but but not you know not hugely so aim.

None: Said, we normally see year on year growth with our hemoglobin business anyway, right. So within that as I said because of the changes in the product. We do expect to have a more competitive product to go to the markets and we do expect to to have grown market share over time.

None: We also have the premier resolution within that.

None: As you know that type of sales process and installation process is a slow burner right aim it's not a high volume type of type of play, but it is very sticky when you get into when you get into a lot right. So I think both of them will drive some hemoglobin scope aim, but obviously the point of care, especially.

John Gillard: So I think both of them will drive some hemoglobin growth, but obviously, the point of care, especially with TRINSCREEN, because that is designed for the screening market, they are generally much, much higher volume than the HIV confirmatory testing market that we've been in previously. So the example I always give is, you know, if someone, if 10 people go for a screening test, you know, maybe only one person goes and gets a confirmatory test, right? Because you've got to go positive on the screening test.

None: With trane screen the cause that is designed for the screening market. They are generally much much higher value.

None: The HIV confirmation testing markets that we'd been in previously so the example, I always give is if if if if if someone if 10 people go for a screening test.

None: Maybe only one person goes and gets a confirmation test like because you've got a positive on the screening test you might even be less so in that example, the screening market from a volume perspective is 10 times the size of the confirmation test market. So that's why we and especially in a reasonable sized country right can have quite a bit.

John Gillard: It might even be less. So, in that example, the screening market, from a volume perspective, is 10 times the size of the confirmatory test. So that's why a win, especially in a reasonable-sized country, can have quite a big impact in terms of revenue for a company of our size. And I suppose that's why it's a little bit of a game changer for us to be into that space. So to take your point, there is growth within that, but I suppose, you know, we have built in wins in terms of Kenya and then just growth from our hemoglobins and, particularly, that new product rollout.

None: Impact in terms of revenue for a company of our size.

None: That's why it's a little bit of a game changer for us to be entered that space. So to take your point there is growth within that but I suppose we had been 10 wins in terms of Kenya, and then just growth from a hemoglobin, some particularly that new protocol.

Paul Nouri: And I know in hemoglobin, you have a presence in China, you have a presence in Brazil, but going forward in the next couple years, do you see more of your growth in the U.S. or in some of those international markets?

None: And I know in in hemoglobin.

None: You have a presence in China, you have a presence in Brazil, but.

None: Going forward. The next couple of years do you see more of your growth in the U S or in some of those international markets.

John Gillard: No, I think it's more in the international markets. Like, the reality is, you know, HbA1c testing in the US is typically now on the larger scale, where we, where we continue to have a strong presence is in, you know, your research areas, or, you know, some of the more high-quality, lower-volume-type labs, right, that are very focused on, very, very focused on the... Unknown Attendee, Joe Diaz, Aris Kekedjian, John Gillard, Trinity Biotech, John Gillard, Kestrin Ahlfont, Des Fitzgerald, Trinity Biotech, if you look where diabetes is growing, it is growing, you know, it's still growing in the US, but it's growing very much internationally, right. And, you know, a lot of the countries that have a high degree of So I expect, you know, a good chunk of our growth to come from those more, as you would call it, international markets, rather than the US and probably rather than Western Europe. They're just using a different type of technology.

None: No I think it's more in the international markets like the reality is you know HBA when C testing in the U S is typically now on the larger chemistry systems aim where are we where we continue to have a strong presence is in your research area.

None: He is.

None: Sure you know some of the more.

None: High quality lower volume type that strikes that are very focused on and.

Very very focused.

None: <unk>.

None: Quality of the test.

None: And very focus on accuracy right.

None: And we know our products really upset deliberate that very well, especially in populations, where there is a significant about the hemoglobin variance right. So you know we continue to hold a position there.

If you look our diabetes is growing it is growing.

Still growing in the U S, but it's growing very much internationally right.

None: And you know a lot of the countries that have a high degree of hemoglobin variant, where there's arguably a greater benefit from using our technology.

None: As you know in Asia, right easy in Africa and in.

None: Those types of countries. So I expect you know a good chunk of our growth to come from those more as you would call the international markets.

None: Him rather than the U S and probably rather than than western Europe, and Theyre just use a different type of technology.

Paul Nouri: And then just two more quick ones. Did the Sjogren's test continue to grow?

None: And then just two more quick ones.

None: The children's test continue to grow.

John Gillard: Yes, that continues to grow and grow in terms of terms. I think, you know, post COVID, we've all kind of forgotten about that, thankfully, but you know, we're still seeing autoimmune issues arise from that. And, you know, so it's an area we are focusing on. And, you know, we think that the autoimmune space, particularly around kind of esoteric tests, is screening that has prognostic value and can be very, very beneficial. So that continues to be a good performing part of our business in terms of the children's tests. And we think it may be a good model for growth going forward and without a huge amount of capital expenditure, which is helpful.

None: Yes that continues to grow and continued growth in terms of I think it'll post COVID-19 as you know, we've always kind of forgotten about that thankfully, but you know were still seeing an autoimmune issues arise from that.

None: So it's an area we are focusing on aim.

None: We think that the.

None: The autoimmune space, particularly around kind of east of Terry tests.

None: Our screening tests that have a prognostic value and can be very very beneficial. So you'll get that continues to be a good performing parts of our business in terms of the children's test and we think gives US you know maybe a good model for for growth going forward.

None: Oh without a huge amount of capital expenditure, which is helpful.

Paul Nouri: And then the last question,

None: And then last question the the EBITDA guidance that includes the spending youre doing in the CGM segment.

Paul Nouri: The IBIDASO guidance, which includes

Paul Nouri: The spending you're doing in the CGM segment.

John Gillard: No, so we capitalize that part under IFRS, right, and we capitalize that expenditure as we typically would have with product development spend. So look, what I would say about that is CGM spend is optional. Okay.

None: No. So we capitalize that Poland right for it, whereas we capitalize that expenditure as we typically would have with with product development spend aim.

None: But what I would say about that is the CGM spend is optional okay.

John Gillard: We will only continue to spend on developing that product if it is generating results for us, right? And we're confident with the technology direction and the market direction. I think we have no question over the market direction. We know that this market is exploding. And we know from speaking with market participants that there is a strong desire for a lower cost solution. The technology piece, I think we have substantially de-risked by acquiring technology that's already proven and has European regulatory approval. What we're really doing is looking to tweak that, change the form factor. Unknown Attendee, Joe Diaz, Aris Kekedjian, John Gillard, Kerstin Ahlfont, Des Fitzgerald, Transcribed by https://otter.ai

None: We will only continue to spend on developing that product. If it is developing results for us right and we're confident that the technology direction and the market direction. I think we have no question over the market direction. We know that this market is exploding and we know from speaking with America.

None: Participants that there is a strong desire for lower cost solution right.

None: And the technology piece I think we have substantially de risked by acquiring the technology, that's already proven and has the European regulatory approval.

None: Approval.

None: Well, we're really doing is looking to tweak that change the form factor.

None: You know improve the manufacturing process as an experienced high scale medical device manufacturer says we're confident we can do that.

None: So you know that's.

None: That's not a.

None: Built in ongoing drain on cash resources, we will only continue to invest in that business for why we why we are very confident that we will see returns and that's my own personal view would be we will see very very significant returns on any investment in that area.

Paul Nouri: Okay, thanks a lot.

Operator: Thank you. At this time, we've reached the end of our allotted time for the question and answer session today, and that will also conclude today's conference. Thank you for your participation and have a wonderful day. Thank you, everybody.

None: Okay. Thanks, a lot.

None: Thank you at this time, we've reached the end of or a lot of time for question and answer session thing and that will also conclude today's conference.

None: You for your participation and have a wonderful day.

None: Thank you everybody.

None: [noise].