Trinity Biotech PLC (TRIB) 2024 Q2 法說會逐字稿

Welcome to the Trinity Biotech second-quarter 2024 earnings conference call. (Operator Instructions) As a reminder, this conference is being recorded.

歡迎參加 Trinity Biotech 2024 年第二季財報電話會議。（操作員指示）謹此提醒，本次會議正在錄製中。

I will now turn the call over to Eric Ribner. Thank you. You may begin.

我現在將把電話轉給埃里克·里布納。謝謝。你可以開始了。

Thank you. And before we begin, please note that statements made during this presentation may be deemed forward-looking statements within the meaning of federal securities laws. These statements are subject to known and unknown risks and uncertainties and 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 statements in the company's annual report on Form 20-F filed with the SEC. Trinity Biotech undertakes no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrence of unanticipated events.

謝謝。在我們開始之前，請注意，本簡報中所做的陳述可能被視為聯邦證券法含義內的前瞻性陳述。這些陳述受到已知和未知的風險和不確定性的影響，並可能導致實際事件與此類陳述中明示或暗示的情況有所不同。這些風險包括但不限於公司向 SEC 提交的 20-F 表格年度報告中風險因素聲明中列出的風險。Trinity Biotech 沒有義務公開更新或修改這些前瞻性聲明以反映今天之後的事件或情況或意外事件的發生。

I will now hand the call over to John Gillard, President and CEO of Trinity Biotech, who will give an overview of Q2 performance and a business update. John will be followed by the company's Chief Accounting Officer, Simon Dunne, who will give further details on Q2's financials.

我現在將把電話轉交給 Trinity Biotech 總裁兼執行長約翰·吉拉德 (John Gillard)，他將概述第二季度的業績和業務更新。緊隨約翰之後的是公司首席會計官西蒙鄧恩 (Simon Dunne)，他將提供有關第二季度財務狀況的更多詳細資訊。

John, I'll turn it over to you.

約翰，我會把它交給你。

Shortly after I took over as company's (technical difficulty) I set out a plan (technical difficulty) revenues in the short-term due to training TrinScreen HIV production; two, deliver a sustainably profitable business by transforming operations to deal with the root causes of historical inefficiency; and three, build an exciting and truly scalable new business in wearable biosensors starting with a meaningfully different continuous glucose monitor. This is an ambitious plan. It is a plan with bold steps. We are now taking those bold steps at speed.

在我接任公司（技術難度）後不久，我制定了一項計劃（技術難度），透過培訓 TrinScreen HIV 生產來實現短期收入；第二，透過營運轉型以解決歷史低效率的根本原因，實現可持續獲利的業務；第三，從有意義的不同連續血糖監測儀開始，在穿戴式生物感測器領域建立令人興奮且真正可擴展的新業務。這是一個雄心勃勃的計劃。這是一個步驟大膽的計劃。我們現在正在快速採取這些大膽的步驟。

This quarter, we are pleased to report that, again, significant advances are being made across our entire business and the plan is working. We are growing our revenue base while at the same time, reducing costs. We have had over 50% quarter-on-quarter revenue growth in point-of-care revenue, driven by the continued successful scaling of rapid HIV test output. This was accompanied by a 45% improvement in operating profitability before impairment charges and restructuring costs quarter over quarter.

本季度，我們很高興地報告說，我們的整個業務再次取得了重大進展，並且該計劃正在發揮作用。我們正在擴大收入基礎，同時降低成本。在持續成功擴大愛滋病毒快速檢測產量的推動下，我們的即時照護收入較上季成長了 50% 以上。同時，不計減損費用和重組成本的營業利潤率較上季提高了 45%。

We are enthusiastic that the ambitious and aggressive comprehensive transformation plan we developed and set out earlier this year is working and delivering results. Given our team's success in executing against this plan, we are now even more confident that we are on the cusp of significant step changes in our financial performance and profitability.

我們對今年早些時候制定和製定的雄心勃勃、積極進取的全面轉型計劃正在發揮作用並取得成果感到興奮。鑑於我們的團隊成功執行了該計劃，我們現在更加有信心，我們正處於財務業績和盈利能力發生重大變化的風口浪尖。

We remain on track to achieve annualized run rate revenues of approximately $75 million by Q2 2025 with approximately $20 million in EBITDASO that is earnings before depreciation, amortization, tax and share-based compensation costs from our existing business.

我們仍有望在 2025 年第二季實現約 7,500 萬美元的年化運行收入，其中 EBITDASO​​ 約為 2,000 萬美元，即我們現有業務的折舊、攤提、稅收和股權激勵成本前的收益。

Now let me walk you through some of our key achievements and provide more detail across the three main priority areas for our new leadership team, which to remind you were: one, growing TrinScreen HIV revenue; two, aggressively executing on the key initiatives underpinning our comprehensive transformation plan; and three, progressing our main long-term growth strategy based on our newly acquired continuous glucose monitoring or CGM technology.

現在，讓我向您介紹我們的一些關鍵成就，並為我們的新領導團隊提供有關三個主要優先領域的更多詳細信息，以提醒您：一是增加 TrinScreen HIV 收入；二是積極落實全面轉型重大措施；第三，基於我們新收購的連續血糖監測或 CGM 技術，推動我們的主要長期成長策略。

Firstly, let's discuss growing TrinScreen HIV revenues. As I mentioned in our last two calls, we've been focused on successfully ramping up production of rapid HIV test, in particular, TrinScreen HIV, and this continued to scale from Q1 into Q2 2024.

首先，讓我們來討論一下不斷成長的 TrinScreen HIV 收入。正如我在過去兩次電話會議中提到的，我們一直專注於成功提高快速 HIV 檢測的產量，特別是 TrinScreen HIV，而這一規模從 2024 年第一季到第二季持續擴大。

As you can see in today's results, the financial impact of that increase with the quarter-over-quarter increase of over 50% in our point of care revenue which itself is an increase of almost 120% year-over-year and is a testament to our current team ability to execute.

正如您在今天的業績中看到的那樣，這一增長帶來的財務影響，我們的護理點收入環比增長了 50% 以上，這本身就同比增長了近 120%，這證明了以我們目前團隊的執行能力。

Our current focus is to continue to ramp production, whilst also significantly increasing the profitability and margin contribution from this new product. We successfully implemented further automation of our manufacturing processes as planned, which reduces the net cost of manufacturing.

我們目前的重點是繼續提高產量，同時顯著提高該新產品的獲利能力和利潤貢獻。我們按計劃成功實現了製造流程的進一步自動化，從而降低了製造的淨成本。

In addition to increasing efficiency through automation, we are running a twin-track approach of outsourcing the less complex aspect of our rapid HIV production to a lower-cost offshore location as part of our comprehensive transformation plan, and I will speak to that further a little later.

除了透過自動化提高效率之外，我們還採用雙軌方法，將愛滋病毒快速生產中不太複雜的部分外包到成本較低的離岸地點，作為我們全面轉型計劃的一部分，我將進一步討論這一點稍後。

Outside of scaling production to meet incoming orders and focusing on manufacturing efficiency. Our technical and sales teams continue to be very active in pursuing new commercial opportunities for TrinScreen HIV. They met with many key stakeholders at the recent International AIDS conference that took place in Germany.

除了擴大生產以滿足新訂單並專注於製造效率之外。我們的技術和銷售團隊繼續非常積極地為 TrinScreen HIV 尋找新的商業機會。他們最近在德國舉行的國際愛滋病會議上會見了許多主要利害關係人。

There is significant interest from many key stakeholders in sourcing a high-quality test such as TrinScreen HIV from an established and trusted partner such as Trinity Biotech. As I've mentioned before, TrinScreen HIV is in various stages of evaluation processes across several countries in Africa. We expect to further grow TrinScreen HIV revenues from new wins across many of these evaluation process.

許多主要利害關係人對從 Trinity Biotech 等成熟且值得信賴的合作夥伴那裡採購高品質的檢測試劑（例如 TrinScreen HIV）非常感興趣。正如我之前提到的，TrinScreen HIV 正在非洲多個國家的評估過程中處於不同階段。我們預計，透過在許多評估過程中取得的新勝利，TrinScreen HIV 收入將進一步增加。

Now moving on to our comprehensive transformation plan that I set out earlier this year. To recap, this plan is designed to deliver a much lower manufacturing and SG&A cost base, which will drive significant profitability from the growing revenues from our existing business, and importantly, provide an efficient, scalable platform to facilitate the next stage of the company's growth.

現在開始實施我今年早些時候制定的全面轉型計劃。總而言之，該計劃旨在大幅降低製造和銷售、一般行政費用(SG&A) 成本基礎，這將從我們現有業務不斷增長的收入中帶來可觀的盈利能力，更重要的是，提供一個高效、可擴展的平台，以促進公司下一階段的成長。

The new management team continues to be united in our vision that we can fundamentally improve upon the prior commercial and financial performance of our existing business through series of ambitious and aggressive incremental changes. With the significant progress in execution and successes we have already had, we are very excited about the opportunity and believe we are on the cusp of near-term significant step changes in our financial performance.

新的管理團隊繼續團結在我們的願景中，即我們可以透過一系列雄心勃勃、積極進取的漸進式變革，從根本上改善現有業務之前的商業和財務表現。隨著我們在執行方面取得的重大進展和已經取得的成功，我們對這個機會感到非常興奮，並相信我們正處於財務業績近期重大變化的風口浪尖。

To recap, the transformation plan has three main pillars to optimize the existing business and prepare the company for our next stage of growth. One, consolidate and offshore manufacturing; two, optimize supply chain; and three, centralize an offshore corporate services. We have again made significant advancements in our key objectives across each of these three pillars since I spoke with you last, with a key focus on executing against our plan.

總而言之，轉型計畫有三個主要支柱，旨在優化現有業務並為公司下一階段的成長做好準備。一、整合和離岸製造；二、優化供應鏈；三是集中離岸企業服務。自從我上次與您交談以來，我們在這三個支柱的關鍵目標上再次取得了重大進展，重點是執行我們的計劃。

As I did last quarter, let me take a few moments to give you some examples of the key objectives we achieved in this period. With respect to pillar number one, consolidate and offshore manufacturing, we continue to prioritize on our two largest businesses, being rapid HIV test and diabetes HbA1C testing.

正如我上個季度所做的那樣，讓我花一些時間向您提供一些我們在此期間實現的主要目標的範例。關於第一支柱，即整合和離岸製造，我們繼續優先發展我們最大的兩項業務，即快速 HIV 檢測和糖尿病 HbA1C 檢測。

In HIV testing, I am very excited to report that we have successfully completed the technical transfer of one of our rapid HIV product manufacturing processes to our offshore manufacturing partner. This was a very significant achievement by Board team. It is a complex process. We set out audacious time lines and we have been successful. I believe that this is a critical milestone in our comprehensive transformation plan and further increases our confidence in reaching our ambitious financial performance target.

在愛滋病毒檢測方面，我非常高興地報告，我們已成功完成將愛滋病毒快速產品製造流程之一技術轉移給我們的離岸製造合作夥伴。這是董事會團隊取得的一項非常重大的成就。這是一個複雜的過程。我們制定了大膽的時間表，並且取得了成功。我相信，這是我們全面轉型計畫的一個重要里程碑，進一步增強了我們實現雄心勃勃的財務績效目標的信心。

Our team is now preparing the data to support our upcoming submissions to the relevant regulator to permit commercial manufacturer with this outsourced partner, and we expect this to be received later this year. In diabetes HbA1C testing, as we previously announced, by the end of this year, we are ceasing main manufacturing activity at our Kansas City facility. Since our last earnings call, we have made further significant progress in executing on this closure.

我們的團隊現在正在準備數據，以支援我們即將向相關監管機構提交的文件，以允許商業製造商與該外包合作夥伴合作，我們預計將於今年稍後收到。在糖尿病 HbA1C 檢測方面，正如我們之前宣布的那樣，到今年年底，我們將停止堪薩斯城工廠的主要生產活動。自上次財報電話會議以來，我們在執行此次關閉方面取得了進一步的重大進展。

We are currently moving many parts of the manufacturer of these products to our Irish facility, which will utilize spare capacity created by the offshoring of HIV test assembly, I referred to earlier while allowing us to maintain the highest quality of product. As part of this move, we have had teams from our Irish facility in Kansas City being trained on these manufacturing process.

目前，我們正在將這些產品製造商的許多部件轉移到我們的愛爾蘭工廠，該工廠將利用我之前提到的愛滋病毒測試組裝離岸外包所產生的閒置產能，同時使我們能夠保持最高的產品質量。作為這項舉措的一部分，我們已經讓堪薩斯城愛爾蘭工廠的團隊接受了這些製造流程的培訓。

We are also moving less complex manufacturing process currently carried out in Kansas to lower-cost offshore locations. This is building on our previously announced manufacturing and supply chain optimization in our hemoglobin's business. And with further support us building a business of significant value in this area. In pillar 2, optimized supply chain.

我們也將目前在堪薩斯州進行的不太複雜的製造流程轉移到成本較低的離岸地點。這是我們先前宣布的血紅蛋白業務製造和供應鏈優化的基礎。在進一步的支持下，我們在這一領域建立了具有重要價值的業務。第二個支柱，優化供應鏈。

This past quarter, we successfully transitioned a significant proportion of our hemoglobin instrumentation supply chain to lower cost providers. As we set out in today's press release, we expect this shift to be gross margin accretive and provide meaningful working capital benefits. This is a project that has been ongoing for some time and I believe takes away a significant proportion of cost of our instrumentation and allows us much greater agility commercially as we move forward in that business.

上個季度，我們成功地將血紅蛋白儀器供應鏈的很大一部分轉移給了成本較低的供應商。正如我們在今天的新聞稿中所述，我們預計這一轉變將增加毛利率並帶來有意義的營運資金效益。這是一個已經持續了一段時間的項目，我相信可以節省我們儀器儀表的很大一部分成本，並讓我們在業務發展過程中獲得更大的商業靈活性。

In pillar 3, we have substantially progressed the setup of our centralized and offshore corporate services function. This is designed to provide us with an efficient and highly scalable corporate services platform to support growth while reducing our SG&A costs. We have identified the functions that will transfer to this new centralized location and these are currently being recruited for.

在第三支柱中，我們在集中式和離岸企業服務功能的設置方面取得了實質進展。這樣做的目的是為我們提供一個高效且高度可擴展的企業服務平台，以支援成長，同時降低我們的 SG&A 成本。我們已經確定了將轉移到這個新的集中地點的職能，目前正在招募這些職能。

Our current focus is ensuring a smooth transition of these functions to this new location and maximizing the operational benefits and ongoing efficiencies that can be delivered by this change. To conclude, we are excited by the very real progress we are making on all major fronts in delivering this step change in financial performance and that continues to give us the confidence to reiterate our previous guidance of approximately $20 million of annualized run rate EBITDASO and annualized run rate revenues of approximately $75 million by Q2 2025.

我們目前的重點是確保這些職能順利過渡到這個新地點，並最大限度地提高這項變更可以帶來的營運效益和持續效率。總而言之，我們對我們在實現財務業績這一階梯變化方面在所有主要領域取得的真正進展感到興奮，這繼續讓我們有信心重申我們之前的指導，即年化息稅折舊攤銷前利潤(EBITDASO ) 和年化息稅前利潤(EBITDASO​​) 約為2000 萬美元到 2025 年第二季度，運行收入約為 7500 萬美元。

Now moving to our long-term growth driver, continuous glucose monitoring or CGM. As I said before, in addition to strengthening our existing business, we aim to build a global business in wearable biosensors, initially, with the focus on CGM. Since we made the acquisitions, we've been, a, further developing our commercial strategy around CGM and biosensors. And b, advancing the design and development of the next-generation CGM device.

現在轉向我們的長期成長動力，連續血糖監測或 CGM。正如我之前所說，除了加強我們現有的業務外，我們的目標是建立可穿戴生物感測器的全球業務，首先以 CGM 為重點。自從我們進行收購以來，我們一直在進一步製定圍繞 CGM 和生物感測器的商業策略。b、推動下一代 CGM 設備的設計與開發。

Now let me take you through our main activities in these areas since we last spoke. With respect to commercial strategy, we attended the American Diabetes Association Conference in Florida, where we met with several key global industry participants. It is clear from these discussions that there is a real desire in the industry for our CGMs key differentiators of being a more affordable and sustainable CGM that delivers a great user experience and that the product development direction we are taking will realize that vision in an exciting and compelling way. That has further increased our confidence that our unique technology provides a great platform on which to develop a next-generation CGM that can truly disrupt the diabetes care market.

現在讓我向您介紹自上次演講以來我們在這些領域的主要活動。在商業策略方面，我們參加了在佛羅裡達州舉行的美國糖尿病協會會議，並會見了幾位全球主要行業參與者。從這些討論中可以清楚地看出，業界真正希望我們的CGM 成為一種更實惠、更永續的CGM，提供出色的用戶體驗，並且我們正在採取的產品開發方向將以令人興奮的方式實現這願景。這進一步增強了我們的信心，我們獨特的技術提供了一個很好的平台，可以在該平台上開發下一代 CGM，真正顛覆糖尿病護理市場。

For those of you who may not -- who may be new to this area or have not heard me speak on this before, our CGM technology is not some unproven noninvasive solution. Like the two main players, Abbott and Dexcom, it uses a minimally invasive sensor wire or filament. I think it is important that I take a moment to again explain the importance of some of the technical differences in the Trinity Technology and the valuable differentiated product features they facilitate.

對於那些可能不熟悉這個領域的人，或者之前沒有聽過我談論過這個問題的人，我們的 CGM 技術並不是某種未經證實的非侵入性解決方案。與雅培（Abbott）和德克斯康（Dexcom）這兩個主要參與者一樣，它使用微創感測器線或燈絲。我認為我需要花點時間再次解釋 Trinity 技術中一些技術差異的重要性以及它們所帶來的有價值的差異化產品功能，這一點很重要。

Like the other CGMs I mentioned, in the Trinity Solution, an ultra thin sensor wire or filaments is inserted a few millimeters into the skin and this transmits live data about the level of blood glucose in the body to smartphone. However, a critical distinction and benefit of our technology is that the sensor wire can be inserted into the body without the use of a needle. What this means is that our sensor is inserted using a reusable sensor applicator.

與我提到的其他 CGM 一樣，在 Trinity 解決方案中，超細感測器線或細絲插入皮膚幾毫米，將體內血糖水平的即時數據傳輸到智慧型手機。然而，我們技術的一個關鍵區別和優點是感測器線可以在不使用針的情況下插入體內。這意味著我們的感測器是使用可重複使用的感測器塗抹器插入的。

The others I refer to require a single-use applicator that punctures the skin with the retractable needle. This leads to the entire plastic and metal applicator becoming nonrecyclable biohazard waste. In contrast, our sensor applicator is reusable and lasts for years with all the sustainability and cost benefits that brings.

我提到的其他人需要一次性塗抹器，用可伸縮針刺穿皮膚。這導致整個塑膠和金屬施用器成為不可回收的生物危害廢物。相比之下，我們的感測器塗抹器可重複使用，可持續使用多年，並具有可持續性和成本效益。

While it may not sound like a big issue for every person using one of the leading products, over two years, they will generate about 11 pounds or 5 kilograms of nonrecycled plastic and metal across 72 applicators, which is not insignificant, especially when it is multiplied by the number of global users of these devices. This drives two big problems with the main CGM solutions on the market today. One is cost, which creates a barrier to broader adoption of this life-saving technology and the second problem is the massive amount of nonrecyclable waste they create. By contrast, over that two-year period, our solution would use just one applicator.

雖然對於每個使用其中一種領先產品的人來說，這聽起來可能不是一個大問題，但在兩年多的時間裡，他們將透過72 個塗抹器產生約11 磅或5 公斤的非回收塑膠和金屬，這並非微不足道，尤其是當乘以這些設備的全球用戶數量。這給當今市場上的主要 CGM 解決方案帶來了兩個大問題。一是成本，這為更廣泛地採用這種救生技術設置了障礙，第二個問題是它們產生了大量不可回收的廢物。相較之下，在這兩年的時間裡，我們的解決方案只使用一個塗抹器。

Our technology coupled with our design philosophy, greatly reduces the cost, environmentally harmful waste created by just this part of the solution, thereby solving two major problems with the current market-leading CGM devices. But we are not stopping there. As part of our modular solution, we are combining this reusable applicator with a reusable transmitter, encompassing a rechargeable power stores and electronics to further reduce the cost and harmful waste of our solution compared to the two main competitors on the market. This powerful combination of reusable applicators and transmitters dramatically reduces the cost of our solution.

我們的技術與我們的設計理念相結合，大大降低了這部分解決方案所產生的成本和對環境有害的廢物，從而解決了當前市場領先的 CGM 設備的兩個主要問題。但我們並沒有就此止步。作為我們模組化解決方案的一部分，我們將這種可重複使用的塗抹器與可重複使用的發射器相結合，包括可充電電源和電子設備，與市場上的兩個主要競爭對手相比，進一步降低了我們解決方案的成本和有害浪費。這種可重複使用的塗抹器和發射器的強大組合極大地降低了我們解決方案的成本。

And we believe we can provide a CGM solution at a daily cost that is at least 40% less expensive than the current main products on market. We believe this gives us a very significant competitive advantage and a great opportunity to disrupt the market, and this view was confirmed at our recent meetings with key opinion leaders within the industry.

我們相信我們可以提供 CGM 解決方案，其日常成本比目前市場上的主要產品便宜至少 40%。我們相信這給我們帶來了非常顯著的競爭優勢和擾亂市場的絕佳機會，這一觀點在我們最近與行業內關鍵意見領袖的會議上得到了證實。

We understand that this is a very large market opportunity for a company of Trinity's current size. And that is why since the acquisition, we have continued to be focused on creating a team of world-class designers and engineers to develop and design the next-generation CGM solution, focused on: A, usability; B, affordability; and C, sustainability.

我們知道，對於 Trinity 目前規模的公司來說，這是一個非常大的市場機會。這就是為什麼自收購以來，我們持續專注於打造一支由世界一流的設計師和工程師組成的團隊來開發和設計下一代CGM解決方案，重點關注：A、可用性； B、經濟承受能力； C、永續性。

We believe that by creating a next-generation product around these three teams, we can reach as many people as possible with this life-saving solution. This is similar to the way that the company has supported accessibility to HIV healthcare for over 25 years. We have substantially moved the project forward over the last quarter, and we are now entering a new and advanced stage.

我們相信，透過圍繞這三個團隊創造下一代產品，我們可以透過這種拯救生命的解決方案惠及盡可能多的人。這與該公司 25 年來支持愛滋病毒醫療保健的方式類似。我們在上個季度大幅推進了該項目，現在正進入一個新的高級階段。

We now have designed two prototypes that showcase the key advantages of our technology and design philosophy. We plan to road test these prototypes with representative user groups over the coming weeks and months. Given our strong focus on usability and accessibility, this engagement is important to us in guiding the finalization of these designs. We are also working with a hyperscale contract manufacturer to optimize these designs for high-quality and efficient automated manufacturer scale.

我們現在已經設計了兩個原型，展示了我們的技術和設計理念的主要優勢。我們計劃在未來幾週和幾個月內與代表性用戶群一起對這些原型進行路測。鑑於我們對可用性和可訪問性的強烈關注，這種參與對於我們指導這些設計的最終確定非常重要。我們還與一家超大規模合約製造商合作，優化這些設計，以實現高品質和高效的自動化製造規模。

We have designed prototypes of the next-generation key digital interfaces and we are working with digital health care company on the development of the overall digital technology stack that can support our vision of delivering key data-driven health care and wellness insights. Again, the digital prototype designs are focused on true differentiation and usability.

我們設計了下一代關鍵數位介面的原型，並正在與數位醫療保健公司合作開發整體數位技術堆疊，以支持我們提供關鍵數據驅動的醫療保健和健康見解的願景。同樣，數位原型設計注重真正的差異化和可用性。

Since acquisition, we have also made a number of enhancements to the sensor technology itself and we've begun a prepivotal clinical trial, which we expect to conclude in early September. We have also applied for approval to begin a second pre-pivot clinical trial in quarter four 2024 and we expect to receive Competent Authority approval to commence the trial in the coming weeks. These prepivotal clinical trials will give us insights into the sensor optimization pathways. On overall timing, we remain on track to enter pivotal clinical trials by summer 2025 with EU regulatory approval targeted by the end of 2025.

自收購以來，我們也對感測器技術本身進行了許多改進，並開始了關鍵前臨床試驗，預計將於 9 月初結束。我們還申請批准在 2024 年第四季開始第二次樞軸前臨床試驗，我們預計將在未來幾週內獲得主管機關的批准以開始試驗。這些關鍵前臨床試驗將使我們深入了解感測器優化途徑。就整體時間表而言，我們仍有望在 2025 年夏季之前進入關鍵臨床試驗，並計劃在 2025 年底之前獲得歐盟監管機構的批准。

We expect regulatory approval for further global markets will follow the initial approval in the EU. With all these developments, we are more excited than ever of the opportunity CGM represents for Trinity Biotech and we are rapidly building the team and technology to deliver on that opportunity.

我們預計，繼歐盟的初步批准之後，全球市場的監管部門也將批准該產品。有了所有這些發展，我們對 CGM 為 Trinity Biotech 帶來的機會比以往任何時候都更加興奮，我們正在迅速建立團隊和技術來實現這一機會。

To conclude, overall, I am very satisfied with the significant progress we've made over the past few months on our ambitious priorities and believe that the company is now at a very exciting point of transformation and opportunity with significant financial benefits set to be realized in the near-term. We have again had some key wins gaining our TrinScreen HIV, which provides us with growth and additional profitability. We have further executed on our comprehensive transformation plan, which will support us shortly delivering step changes in profitability.

總而言之，總的來說，我對過去幾個月我們在雄心勃勃的優先事項上取得的重大進展感到非常滿意，並相信公司現在正處於一個非常令人興奮的轉型和機遇點，即將實現顯著的財務收益在短期內。我們再次取得了一些關鍵勝利，獲得了 TrinScreen HIV，這為我們帶來了成長和額外的獲利能力。我們進一步執行了全面的轉型計劃，這將支持我們很快實現盈利能力的階躍變化。

Finally, we've made real progress on the realization of a highly impressive both differentiated CGM solution that can disrupt this massive market, help millions of people globally and deliver very significant growth to Trinity Biotech.

最後，我們在實現令人印象深刻的差異化CGM 解決方案方面取得了真正的進展，該解決方案可以顛覆這個巨大的市場，幫助全球數百萬人，並為Trinity Biotech 帶來非常顯著的成長。

As Eric said, today, I'm joined by Simon Dunne, our Chief Accounting Officer. We are excited that our new group CFO, Louise Tallon, joins within a few weeks. And I am thankful to Simon for supporting us on this call during this transition period.

正如艾瑞克所說，今天我們的首席會計官西蒙鄧恩 (Simon Dunne) 也加入了我的行列。我們很高興我們的新集團財務長 Louise Tallon 將在幾週內加入。我感謝西蒙在過渡時期對我們這次電話會議的支持。

I would like to thank you all for your attention, and I will now hand you over to Simon to bring you through the Q4 financial results in more detail.

我要感謝大家的關注，現在我將請西蒙為您更詳細地介紹第四季度的財務表現。

Thanks, John. Our revenues for quarter yeo 2024 were $15.8 million, which was 14% higher than in quarter two 2023. Our point-of-care revenues more than doubled with revenues increasing by $2.5 million to $4.6 million, equating to an increase of 119% compared to Q2 2023. This increase was driven by our HIV screening test, TrinScreen HIV, which had sales of approximately $3.1 million.

謝謝，約翰。我們 2024 年第二季的營收為 1,580 萬美元，比 2023 年第二季成長 14%。我們的床邊護理收入增加了一倍以上，收入增加了 250 萬美元，達到 460 萬美元，與 2023 年第二季度相比增長了 119%。這一增長是由我們的 HIV 篩檢測試 TrinScreen HIV 推動的，該測試的銷售額約為 310 萬美元。

Our clinical laboratory revenues were $11.3 million, which is a decrease of 4.6% compared to Q2 2023. There was a strong performance in the quarter from our clinical chemistry portfolio, which grew by over 20% year over year. This increase was offset by lower hemoglobins revenues, which were down 10.8% year over year primarily as a result of lower instrument sales in the period. We expect the decline in instrument sales to be a temporary one as we are in the process of repositioning our instrument offering in line with our new improved diabetes column system, which is currently being rolled out.

我們的臨床實驗室收入為 1,130 萬美元，與 2023 年第二季相比下降 4.6%。本季我們的臨床化學產品組合表現強勁，較去年同期成長超過 20%。這一增長被血紅蛋白收入下降所抵消，血紅素收入年減 10.8%，主要是由於該期間儀器銷量下降。我們預計儀器銷售的下降將是暫時的，因為我們正在根據目前正在推出的新改進的糖尿病柱系統重新定位我們的儀器產品。

Our gross profit for the quarter was $5.7 million, representing gross margin of 36.2%, which is consistent with the gross margin for the comparative quarter in 2023. There are two main trends in our gross margin, one favorable and one unfavorable, which are currently offsetting each other, resulting in the gross margin being flat year on year.

本季毛利為 570 萬美元，毛利率為 36.2%，與 2023 年同期毛利率一致。我們的毛利率主要有兩種趨勢，一種是有利的，一種是不利的，目前這兩種趨勢相互抵消，導致毛利率比去年同期持平。

Firstly, in our largest division, hemoglobins we are seeing improved gross margins. We succeeded in lowering our manufacturing costs through supply chain initiatives and from our revised in-house manufacturing process. Secondly, the TrinScreen HIV sales are currently diluting our overall margin percentage, but we are expecting this to improve incrementally over the next three quarters due to increased operational efficiency through automation and the expected transfer of assembly activities to a lower cost manufacturing location by the end of 2024.

首先，在我們最大的血紅蛋白部門，我們看到毛利率增加。我們透過供應鏈計劃和改進的內部製造流程成功地降低了製造成本。其次，TrinScreen HIV 的銷售目前正在稀釋我們的整體利潤率，但我們預計這一情況將在未來三個季度逐步改善，因為透過自動化提高了營運效率，並且預計到年底將組裝活動轉移到成本較低的製造地點2024 年。

Research and development expenses for Q2 2024 were $1 million, down $200,000 versus Q2 2023. Following on from our acquisition of the waveform assets in January of this year, we continue to progress the development of our CGM offering in line with our previously communicated plan. Our overall capital expenditure in the quarter relating to our CGM Biosensor division was $2.8 million for the quarter.

2024 年第二季的研發費用為 100 萬美元，比 2023 年第二季減少 20 萬美元。繼今年 1 月收購波形資產後，我們繼續按照先前溝通的計畫推進 CGM 產品的開發。本季與 CGM 生物感測器部門相關的總資本支出為 280 萬美元。

SG&A expenses were $6.4 million in Q2 2024 compared to $7.9 million in Q2 2023, a decrease of $1.5 million. The majority of the reduction in SG&A expenses is due to lower employee remuneration costs, comprising salary costs and share-based payment charges. The cost saving here is due to the headcount optimization activities during 2023. These SG&A savings were partly offset by an unfavorable movement of $0.5 million in foreign currency retranslation charges.

2024 年第二季的銷售管理及行政費用為 640 萬美元，而 2023 年第二季為 790 萬美元，減少了 150 萬美元。SG&A 費用減少的主要原因是員工薪資成本降低，包括薪資成本和股份支付費用。這裡的成本節省是由於 2023 年期間的人員優化活動。這些 SG&A 節省部分被外幣換算費用 50 萬美元的不利變動所抵銷。

This quarter, you will see from our release that we've incurred restructuring costs totaling $1.9 million related to our comprehensive transformation plan, which John described earlier. These costs mainly comprise termination payments, factory closure costs, and costs associated with the transfer of activities to the offshore service provider. The majority of the cash outflow related to these restructuring costs will happen in the second half of 2024.

本季度，您將從我們的新聞稿中看到，我們已經產生了與約翰之前描述的全面轉型計劃相關的總計 190 萬美元的重組成本。這些成本主要包括終止付款、工廠關閉成本以及與將活動轉移到離岸服務提供者相關的成本。與這些重組成本相關的大部分現金流出將發生在 2024 年下半年。

We've recorded a noncash impairment charge of $0.4 million this quarter compared to an impairment charge of $10.8 million in quarter two 2023. The impairment test performed as of June 30, 2024, identified that the value and use of some of our cash-generating units was below the value of the carrying amount of their assets, other than inventories, accounts receivable, cash and cash equivalents and deferred tax assets. All of what I have described so far led to an operating loss of $4.1 million in the quarter compared to an operating loss of $14.9 million in quarter two 2023.

本季我們記錄的非現金減損費用為 40 萬美元，而 2023 年第二季的減損費​​用為 1,080 萬美元。截至 2024 年 6 月 30 日進行的減損測試發現，我們的部分現金產生單位的價值和用途低於其資產（存貨、應收帳款、現金及現金等價物及遞延資產除外）的帳面價值稅資產。到目前為止，我所描述的所有內容都導致本季營運虧損 410 萬美元，而 2023 年第二季營運虧損為 1,490 萬美元。

Net financial expense reduced by approximately $900,000 from $3.8 million in quarter two 2023 to $2.8 million in Q2 2024. In Q2 2023, we incurred a penalty of $905,000 for the early settlement of a portion of our senior secured term loan. And this charge did not repeat in Q2 2024, and this is the main reason for the decrease in net financial expense year on year.

淨財務費用減少約 90 萬美元，從 2023 年第二季的 380 萬美元減少到 2024 年第二季的 280 萬美元。2023 年第二季度，我們因提前償還部分優先擔保定期貸款而被處以 905,000 美元的罰款。而這項費用​​在2024年第二季沒有重複，這是淨財務費用較去年同期減少的主要原因。

You will see from the table in our earnings release that our term loan interest has increased to $3.1 million in Q2 2024, up from $2.5 million in the comparative period. And this increase is mainly due to the additional loan drawdowns related to the Waveform acquisition. Just over $800,000 of these incremental borrowing costs have been capitalized to the CGM intangible asset this quarter as required by IFRS accounting standards.

您將從我們的收益報告中的表格中看到，我們的定期貸款利息已從去年同期的 250 萬美元增加到 2024 年第二季的 310 萬美元。這一增長主要是由於與 Waveform 收購相關的額外貸款提取。根據 IFRS 會計標準的要求，本季這些增量借款成本中超過 80 萬美元已資本化為 CGM 無形資產。

Net loss from continuing operations was $6.8 million in the quarter compared to $18.3 million in the same quarter last year. The adjusted EBITDASO for the quarter, which is the loss before depreciation, amortization, impairment charges, restructuring costs, tax, interest, and share option charges, was $1.4 million compared to $2.6 million in the equivalent period last year. Basic loss per ADS was $0.71 compared to $0.78 in Q2 2023.

本季持續經營業務淨虧損為 680 萬美元，去年同期為 1,830 萬美元。本季調整後的 EBITDASO​​（扣除折舊、攤提、減損費用、重組成本、稅金、利息和股票選擇權費用前的虧損）為 140 萬美元，去年同期為 260 萬美元。每份 ADS 的基本虧損為 0.71 美元，而 2023 年第二季為 0.78 美元。

Finally, I'll talk about our cash flow statement for the quarter. The cash balance decreased from $5.8 million at March 31 to $5.3 million at the end of June. Cash used by operations was $1.1 million in the quarter, an improvement of $3.3 million compared to Q2 2023.

最後，我會談談我們本季的現金流量表。現金餘額從3月31日的580萬美元減少到6月底的530萬美元。本季營運使用的現金為 110 萬美元，比 2023 年第二季增加了 330 萬美元。

We had investing cash outflows of $3.2 million, which mainly related to our R&D capital expenditure for CGM and hemoglobin products. Cash inflow from financing activities was $3.9 million in the quarter primarily driven by the drawdown in April of $6.5 million from our lender perceptive, offset by our quarterly interest payments.

我們的投資現金流出為320萬美元，主要與CGM和血紅素產品的研發資本支出有關。本季融資活動產生的現金流入為 390 萬美元，主要是由於 4 月我們從貸方角度提取了 650 萬美元，但被我們的季度利息支付所抵銷。

Now, I'll hand you back to the operator for questions.

現在，我會將您轉交給接線員詢問問題。

(Operator Instructions) James Sidoti, Sidoti & Company.

（操作員說明）James Sidoti，Sidoti & Company。

I start with TrinScreen, which was very strong in the quarter. I think you said it was $3.1 million that compares to $1.2 million in the first quarter. How does that compare to your internal expectations? And do you still think that TrinScreen will be about $8 million in revenue in 2024?

我從 TrinScreen 開始，它在本季度非常強勁。我想你說的是 310 萬美元，而第一季為 120 萬美元。與您的內在期望相比如何？您還認為 2024 年 TrinScreen 的收入約為 800 萬美元嗎？

Yes, look, it meets our expectations the two greatest uncertainties as we came into this year, Jim, was the ordering pattern for that, we've have received it before and how that would pan out in terms of quarter-over-quarter variability. And then the second, obviously, was around frankly, our ability to be able to scale up manufacturing to meet those types of volumes. And so it certainly has met our expectations.

是的，看，它符合我們的預期，吉姆，今年我們進入的兩個最大的不確定性是訂購模式，我們之前已經收到過它，以及季度環比變化的結果如何。坦白說，第二個顯然是我們擴大製造規模以滿足這些類型產量的能力。所以它確實滿足了我們的期望。

In terms of the full-year outlook, I think we are on track for that $8 million, and we are currently kind of looking at the landscape for the rest of the year and we are assessing whether there's potentially some upside around that number. And that's something we'd hopefully be able to bottom out on in the short-term.

就全年前景而言，我認為我們預計將實現 800 萬美元，目前我們正在關註今年剩餘時間的前景，並評估這個數字是否有潛在的上升空間。我們希望能夠在短期內觸底反彈。

All right. And then moving on to clinical chemistry that was up very nicely in the quarter. Can you give us some color on what drove that and if that is something that you think will be sustainable?

好的。然後轉向本季度增長非常好的臨床化學。您能為我們介紹一下是什麼推動了這個趨勢嗎？

Yes. I think the driver that was price increases we were able to put through and for one of our products, which the market was able to bear and that's likely to be sustainable, certainly in the short to medium term. And there also has been some challenges in the market more broadly in terms of availability of product and that has allowed some switching in which we'd be able to benefit from.

是的。我認為驅動因素是我們能夠實現的價格上漲，對於我們的一種產品，市場能夠承受，而且這可能是可持續的，當然在中短期內。在產品的可用性方面，更廣泛的市場也存在一些挑戰，這使得我們能夠從中受益。

Right. And then moving on to the Premier instruments. You indicated those were down in the quarter as the market waits for the new instruments come out? When do you expect those new instruments to be available?

正確的。然後轉向 Premier 樂器。您表示，隨著市場等待新工具的推出，這些價格在本季有所下降？您預計這些新儀器何時上市？

Yes. It's less around the new instruments. I suppose it's more about the new column, the new column system. So that is currently being rolled out, that's active at the moment. We have literally people in the field, putting through the changes required to the instrumentation to use that new column system. And the reason that we held off on instrument placements and sales during the quarter is that, as I said previously, a key driver for us around that new column system is that its higher level of test per column allow us to be more aggressive on pricing for growth and should allow us to attack parts of the market for A1C testing that we historically have not been able to get into and given pricing pressures.

是的。圍繞新樂器的內容較少。我想更多的是關於新專欄、新專欄系統。目前正在推出，目前處於活動狀態。我們確實有現場人員，對儀器進行所需的更改以使用新的色譜柱系統。我們在本季度推遲儀器放置和銷售的原因是，正如我之前所說，我們圍繞新色譜柱系統的一個關鍵驅動因素是，每色譜柱的測試水平更高，使我們能夠在定價上更加積極增長，並且應該允許我們攻擊A1C 測試的部分市場，這些市場是我們歷來無法進入並考慮到定價壓力的。

And obviously, you can imagine, we make most of our sales outside of the US and Brazil to distributors. And they look at the overall package in terms of cost of the instrument, cost of the consumables and then how much they can get paid from the health care system per test. And so it's an overall package. And I would also say in the past, there have been placements that we probably would have liked to optimize the level of consumable revenue from further, and that's where we make our money. Selling instruments is not our business. We sell instruments in order to facilitate our business, which is selling HbA1C test.

顯然，您可以想像，我們的大部分銷售都是在美國和巴西以外的地區向分銷商進行的。他們會根據儀器成本、消耗品成本以及每次測試可以從醫療保健系統獲得多少報酬來審視整體方案。所以這是一個整體包。我還想說，過去，我們可能希望在某些位置進一步優化消費品收入水平，而這就是我們賺錢的地方。賣樂器不是我們的事。我們銷售儀器是為了促進我們的業務，即銷售 HbA1C 測試。

So because of that combination, we are very much looking at the column and the instrumentation as an overall commercial package. And that's I suppose while that's being rolled out, and distributors, in particular, are coming up to speed with the features around the new column system and the revised economics that allows and we not push instrument sales as much as we have in the past.

因此，由於這種組合，我們非常將色譜柱和儀器視為整體商業包。我想，在推出該產品的同時，尤其是經銷商，正在加快新色譜柱系統的功能和修訂後的經濟性的步伐，這使得我們不會像過去那樣推動儀器銷售。

If we assume that the growth in the clinical chemistry business continues because of the price increases and that the Premier business improves as the new columns come out. Should we expect the overall clinical laboratory business? Do you expect those numbers to be positive in the -- by the fourth quarter of this year?

如果我們假設臨床化學業務由於價格上漲而持續成長，並且隨著新色譜柱的推出，Premier 業務有所改善。我們是否應該期待整個臨床實驗室業務？您預計到今年第四季這些數字會是正數嗎？

In terms of growth, Jim?

在成長方面，吉姆？

Yes.

是的。

Yes, yes, absolutely. No, I would expect so.

是的，是的，絕對是的。不，我希望如此。

Okay. All right. And then moving on to CGM. It sounds like you'll have the two pivotal trials completed. The two prepivotal trials completed in the next couple of quarters. When do you think you'll lock in the design and how does the final trial, how does that compare to some of the other trials you've done at Trinity?

好的。好的。然後轉向 CGM。聽起來你將完成兩個關鍵試驗。兩項關鍵前試驗在接下來的幾季完成。您認為什麼時候會鎖定設計？

Yes. So I'll take -- I'll answer both questions separately. So in terms of locking in the design, look, it's obviously a measure of process. So we're very, very happy with the progress we have made to date. I'm very, very excited about the designs that we've developed. I think the additional utility that brings to users is very significant and the advantages we could have in terms of cost, et cetera, is very exciting, right, and sustainability.

是的。所以我將分別回答這兩個問題。因此，就設計中的鎖定而言，看，這顯然是一種流程衡量標準。因此，我們對迄今為止所取得的進展感到非常非常滿意。我對我們開發的設計感到非常非常興奮。我認為為使用者帶來的額外效用是非常重要的，我們在成本等方面可以擁有的優勢是非常令人興奮的、正確的和可持續性的。

And as we said, they are prototypes. We now need to get user feedback and that's both from people who wear the devices, clinicians, et cetera, and that would feed in further to design. And then our manufacturing advisory partners will also feed into. So these are evident, right, these are evident. And we will continue and continue to narrow the scope for change as we get towards the end of the year and early into next year. And then I'd expect us to be very much honing in the final products, probably by the end of Q1, early Q2 next year just before we go into trial.

正如我們所說，它們是原型。我們現在需要獲得用戶回饋，這些回饋來自佩戴裝置的人、臨床醫生等，這將有助於進一步設計。然後我們的製造諮詢合作夥伴也將參與其中。所以這些都是顯而易見的，對，這些都是顯而易見的。隨著年底和明年初的到來，我們將繼續縮小變革的範圍。然後我預計我們會在最終產品上進行大量磨練，可能是在明年第一季末、第二季初，就在我們進入試用之前。

And in terms of the trials, it's not too dissimilar from previous trials we would have run. And I suppose the differences in -- normally, in our case, the tests are outside the body. In this case, there's something going into someone's body and so there's different protocols around that and different safety requirements. But that's something that our team has experience in. And I would say the scale of the trial is the other unknown at this stage.

就試驗而言，它與我們之前進行的試驗並沒有太大不同。我想，通常情況下，在我們的例子中，測試是在體外進行的。在這種情況下，有東西進入某人的身體，因此有不同的協議和不同的安全要求。但這是我們團隊有經驗的事。我想說的是，試驗的規模是現階段的另一個未知數。

We have not decided whether we would do what's called a global trial that we would look to gather data from a large number of different sites around the world and use that to support regulatory submissions in a number of different countries and regions or whether we would do individual trials. And that's probably one of the main unknown at this point, Jim. And we will make an incision on that as we progress forward based upon what the regulatory environment at that time and the cost difference associated with those options.

我們還沒有決定是否會進行所謂的全球試驗，即我們希望從世界各地的大量不同地點收集數據，並利用這些數據來支持許多不同國家和地區的監管提交，或者我們是否會這樣做個人試驗。吉姆，這可能是目前主要的未知數之一。隨著我們的進展，我們將根據當時的監管環境以及與這些選項相關的成本差異來對此做出決定。

Okay. All right. And the last one for me. I'm not sure it was end of last week, earlier this week, you announced a new distribution partner for the clinical chemistry products. How do you expect that to impact your business?

好的。好的。最後一張對我來說。我不確定是在上週末，本週早些時候，你們宣布了一個新的臨床化學產品分銷合作夥伴。您預計這會對您的業務產生什麼影響？

Yes. Look, in short, we expect it to be positive. We've been impressed with our interactions and work with that partner to date. And they have got boots on the ground in the UK and they have a strong desire to grow that business. So that allows us in that more kind of simplified organization structure that we are striving for to deliver profitability to also have the opportunity to have more resource -- more trained resource and more focused on those sales. So we expect that to be margin -- gross profit and revenue accretive over the term.

是的。簡而言之，我們期望它是積極的。到目前為止，我們與該合作夥伴的互動和合作給我們留下了深刻的印象。他們已經在英國紮根，並且有強烈的願望來發展這項業務。因此，這使我們能夠在更簡化的組織結構中努力實現盈利，同時也有機會擁有更多的資源——訓練有素的資源，並且更加專注於這些銷售。因此，我們預計這將是利潤率——期內毛利和收入的成長。

So does that give you access to new geographies?

那麼這是否能讓您進入新的地理區域？

It's UK focused. So I won't say gives access to new geographies, it gives us access to new sales contacts, okay, where we wouldn't have had access before. And because they have a sales force on the ground in the U, and that gives us a greater opportunity to target new hospitals and clinics, et cetera.

它專注於英國。所以我不會說可以訪問新的地理位置，它可以讓我們訪問新的銷售聯絡人，好吧，我們以前無法訪問。因為他們在美國有一支銷售隊伍，這讓我們有更大的機會瞄準新的醫院和診所等。

Got it. All right. Thank you. Thank you. It seems like you're making a lot of progress.

知道了。好的。謝謝。謝謝。看來你已經取得了很大的進步。

Thanks, Jim. Appreciate it.

謝謝，吉姆。欣賞它。

Thank you. (Operator Instructions) Andrew Mei, Investor.

謝謝。（操作員說明）Andrew Mei，投資者。

Hey, John. Thanks for taking my questions. Very excited for the future. But as a long-term investor here, we just were curious if there's still a relationship with MiCo.

嘿，約翰。感謝您回答我的問題。對未來非常興奮。但作為這裡的長期投資者，我們只是好奇與 MiCo 是否仍有關係。

And so MiCo made a public filing that they had disposed of their investments, I think, late last year or earlier this year. So that's the status on that.

因此，MiCo 公開提交了一份文件，表示他們已在去年年底或今年稍早處置了投資。這就是目前的情況。

Thank you. Ladies and gentlemen, as there are no further questions, I would like to hand the conference over to John Gillard for closing remarks.

謝謝。女士們、先生們，由於沒有其他問題了，我想將會議交給約翰·吉拉德致閉幕詞。

Thanks, everybody, for your attention. We continue to be excited about the progress that we are making and we appreciate your support, and we look forward to updating you and around the time of Q3 results. Thanks very much. And again, thanks to Simon for your support today.

謝謝大家的關注。我們對所取得的進展繼續感到興奮，感謝您的支持，我們期待在第三季結果公佈時向您提供最新資訊。非常感謝。再次感謝西蒙今天的支持。

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。