Telix Pharmaceuticals Ltd (TLX) 2024 Q4 法說會逐字稿

Thank you, Ashley, and thank you everybody for joining us this morning, Australian time. We're pleased to share with you our full-year results for 2024, which we lodged with the ASX yesterday afternoon, Australian time aftermarket closed. Just flicking through our standard disclaimer.

謝謝你，阿什利，也謝謝大家今天早上（澳洲時間）加入我們。我們很高興與您分享我們 2024 年全年業績，我們於昨天下午（澳大利亞時間盤後）向澳大利亞證券交易所提交了該業績。只需瀏覽一下我們的標準免責聲明。

I am joined today by Dr. Chris Behrenbruch, our Managing Director and Group CEO; Darren Smith, our Group CFO; Kevin Richardson, our CEO of the Telix Precision Medicine business; and Richard Valeix, the CEO of Telix Therapeutics. Together we will be taking you through our performance, financial results, and focus for 2025.

今天與我一同出席的還有我們的董事總經理兼集團首席執行官 Chris Behrenbruch 博士、我們的集團首席財務官 Darren Smith、我們的 Telix Precision Medicine 業務首席執行官 Kevin Richardson 以及 Telix Therapeutics 首席執行官 Richard Valeix。我們將共同向您介紹我們的業績、財務結果和 2025 年的重點。

If we could move to slide 5, please. Just by way of some introductory remarks, 2024 is going to be once again been an extraordinary year for Telix. We are delivering against all aspects of our growth strategy, and some of these operational highlights include the continued strong commercial performance driven by sales of Illuccix and the creation of a platform for further growth as we prepare to launch three new products in the US next year and roll out Illuccix globally into Europe, UK, specifically.

請移至投影片 5。僅通過一些介紹性的話來說，2024 年對於 Telix 來說將再次成為不平凡的一年。我們正在實現成長策略的各個方面，其中一些營運亮點包括由 Illuccix 的銷售推動的持續強勁的商業表現，以及為進一步成長而創建的平台，我們準備好明年在美國推出三款新產品，並將 Illuccix 推廣到全球，特別是歐洲（特別是英國）。

We're making great progress across our therapeutic pipeline, notably in the late stage assets being brain, kidney, and of course our prostate cancer program, which is now in Phase 3.

我們的治療管道正在取得巨大進展，特別是在腦、腎臟以及前列腺癌計畫的後期階段，目前處於第三階段。

And we've had some really exciting developments across the next generation pipeline, including delivery of a clinical proof of concept for our prostate cancer alpha candidate.

我們在下一代藥物研發管線中取得了一些非常令人興奮的進展，包括為我們的前列腺癌 α 候選藥物提供臨床概念驗證。

It's been a year of many acquisitions, and these are supporting the strategic expansion of our pipeline and the buildout of our global product delivery or manufacturing infrastructure.

今年我們進行了多次收購，這些收購支持了我們產品線的策略擴張以及全球產品交付或製造基礎設施的建設。

So in short, the business looks very different to what it did a year ago, and at the end of 2025, it will look very different again as a result of this great progress.

簡而言之，我們的業務與一年前相比已經發生了很大變化，而到 2025 年底，由於這一巨大進步，我們的業務將再次發生很大變化。

If we could move to slide 6, please. This is also reflected in the financial performance which Darren will take you through today. Our commercial performances underpinned delivery of our second consecutive year of profit and growth in a year that saw us increase our investment in R&D and this which we expect will translate into near-term value creation for shareholders, and in strategic transactions that have assisted in the transformation of TLX and set us up for ongoing leadership in this rapidly growing market.

請移至投影片 6。這也體現在 Darren 今天將帶您了解的財務表現。我們的商業表現支撐了我們連續第二年實現盈利和成長，在這一年，我們增加了對研發的投資，我們預計這將轉化為股東的短期價值創造，以及有助於 TLX 轉型的戰略交易，並使我們在這個快速增長的市場中持續保持領先地位。

Today's outline presentation outlines these key developments and the step change in our operations as a result of the acquisitions we've made. With that, I'd like to hand over to Chris to talk further about the strategy and our performance over the past year.

今天的概要介紹概述了這些關鍵發展以及我們收購後營運的逐步變化。說完這些，我想把時間交給克里斯，讓他進一步談談我們的策略和過去一年的表現。

Thanks very much, Kyahn. And good morning, everybody. And we can move to slide 8, please. Although Kyahn has somewhat introduced the strategy outlined in a prior slide, this is a nutshell summary of how we see the Telix growth strategy over the next 3 to 5 years or so. It's focused on 4 priority areas of business activity.

非常感謝，Kyahn。大家早安。請移至投影片 8。儘管 Kyahn 在某種程度上介紹了上一張投影片中概述的策略，但這只是對 Telix 未來 3 到 5 年左右的成長策略的簡要總結。它主要關註四個優先的商業活動領域。

Firstly, our R&D investment, which will be well covered in this presentation both financially and operationally. It's really about delivering long term shareholder value and patient outcomes through our therapeutics pipeline. At the end of the day, that's what the core mission of Telix is, and as I'll show you in a minute, represents a step change for the company when we achieve it. Richard Valeix, who leads this business unit, will go through the details shortly.

首先，我們的研發投資將在財務和營運兩個方面充分介紹。這實際上是為了透過我們的治療管道實現長期股東價值和患者治療效果。歸根結底，這就是 Telix 的核心使命，正如我稍後將向你們展示的，當我們實現這一使命時，這代表著公司的重大變化。領導該業務部門的 Richard Valeix 將很快介紹詳細資訊。

Within this effort, we are building the strongest portfolio in the industry of next generation radiopharma products with a focus on novel targets and alpha emitting radionuclides. We've made several transactions and licensing deals that support this, and in some respects it represents a pivot towards a more internally sourced innovation model, and this is reflected in our R&D growth.

在此努力中，我們正在建立業內最強大的下一代放射性藥物產品組合，重點關注新目標和發射阿爾法放射性核素。我們已經達成多項支持此目標的交易和授權協議，從某種程度上來說，這代表著向更內部採購的創新模式的轉變，這反映在我們的研發成長中。

The engine room of the business today is our precision medicine business led by Kevin Richardson, which encompasses our diagnostic imaging products but also has the mandate to ensure that we have well thought out patient selection strategies for our therapeutics program and strategically designed clinical trials that have a high degree of certainty of success because we're utilizing the whole [pharanostic] power of radiopharma. That's why we call that business unit precision medicine and not diagnostic imaging.

當今業務的引擎室是我們的精準醫療業務，由凱文·理查森 (Kevin Richardson) 領導，該業務不僅涵蓋我們的診斷成像產品，還負責確保我們為治療計劃制定周密的患者選擇策略，並戰略性地設計臨床試驗，這些試驗具有高度的成功確定性，因為我們正在利用放射性藥物的全部[法醫學]力量。這就是為什麼我們將該業務部門稱為精準醫療而不是診斷影像。

And lastly, infrastructure. This has been a big focus for Telix over the last couple of years with some significant investments such as our state-of-the-art European manufacturing footprint in Belgium and the acquisition of Artemis and RLS, among others. We have also been steadily adding important R&D infrastructure that really enables the other pieces of the strategy puzzle.

最後是基礎設施。過去幾年來，這一直是 Telix 關注的重點，並進行了一些重大投資，例如我們在比利時建立的最先進的歐洲製造基地以及對 Artemis 和 RLS 的收購等。我們也一直在穩步增加重要的研發基礎設施，以真正實現戰略難題的其他部分。

To move to slide 9 please. M&A activity maps very well onto this strategy, and while I'm not going to go through this diagram deal by deal, you can read about that in our annual report. Our M&A supports our strategy to building the fundamental delivery vehicles of our business, new platform technologies, and the expansion of our product pipeline. This pipeline expansion consists of both new molecules, but also other relevant assets that enable us to obtain new indications or clinical use cases for our products, such as software, AI, and medical devices.

請移至投影片 9。併購活動與這項策略非常契合，雖然我不會逐一解釋這個圖表，但您可以在我們的年度報告中閱讀相關內容。我們的併購支持我們的策略，即建立我們業務的基本交付工具、新平台技術以及擴展我們的產品線。此管道擴展不僅包括新分子，還包括其他相關資產，使我們能夠獲得產品的新適應症或臨床用例，例如軟體、人工智慧和醫療設備。

Nuclear medicine is a bit unique like that. As you can see last year, we really enriched the scope of our business activities while remaining pretty disciplined around the disease focus areas that we think are going to be the most important for the future. We've been busy.

核子醫學在這方面有一點獨特。正如您所看到的，去年我們確實豐富了業務活動的範圍，同時在我們認為對未來最重要的疾病重點領域保持了相當的紀律性。我們一直很忙。

Slide 10 please. So clearly a strategy is not temporarily static and with specific reference to our 2024 financial results, I'd like to impress upon you that we are moving into the next epoch of the company's growth and development empowered by both our M&A activity and our product development success.

請看投影片 10。因此，很明顯，策略不是暫時靜止的，具體參考我們 2024 年的財務業績，我想讓大家明白，在併購活動和產品開發成功的推動下，我們正在進入公司成長和發展的下一個時代。

Since becoming a commercial stage by a pharma company in 2021, we've ramped up quickly to build all the key components of a commercialization company in key markets. The remarkable success of Illuccix particularly in the US, has really enabled this transformation from the typically hypothetical and aspirational baby biotech to a fully-fledged commercial organization.

自 2021 年由一家製藥公司進入商業階段以來，我們已迅速發展，在關鍵市場建立了商業化公司的所有關鍵組成部分。Illuccix 取得了顯著的成功，尤其是在美國，真正實現了從典型的假設和理想的嬰兒生物技術公司向成熟的商業組織的轉變。

As we roll into 2025, this is essentially a new phase in the company's journey. We transition from a single product, mostly a single market company, to a diversified product company. This year we will subject to regulatory approvals, launch three new and innovative products in the United States for a total of five approved products in the US and Europe.

隨著我們進入 2025 年，這實際上是公司發展歷程的新階段。我們從單一產品、主要為單一市場的公司轉型為多元化產品公司。今年我們將在獲得監管部門批准的情況下，在美國推出三款全新創新產品，這樣在美國和歐洲總共將有五款產品獲得批准。

We will add about 20 commercial territories to our international coverage. It's a big diversification of our revenues, and we expect to see commensurate growth in our top line. We've given guidance for financial year 2025 well north of $1 billion, but this figure excludes our new product launches and territories that have not yet received national approvals. So you have to put that forecast into perspective.

我們的國際覆蓋範圍將增加約 20 個商業區域。這是我們收入的重大多樣化，我們預計我們的營業收入將相應增長。我們已為 2025 財年給出了遠超過 10 億美元的指導，但這一數字不包括我們新產品的發布和尚未獲得國家批准的地區。所以你必須正確看待這個預測。

This exciting product revenue growth in turn enables us to largely self-finance the major R&D activity required to achieve that next inflection point, which is becoming a therapeutics company. This is not far away. Our pre-commercial launch year as a therapeutics company is 2027. That is now less than 2 years away. So between now and the end of 2027, our goal is to put as much firepower as possible into our R&D activity, and of course, the delivery capabilities in the key markets we serve. That's why we've been investing so heavily in infrastructure.

這一令人興奮的產品收入成長反過來使我們能夠在很大程度上自行籌資實現下一個轉折點所需的主要研發活動，即成為一家治療公司。這距離並不遠。作為一家治療公司，我們的商業化上市前年份是 2027 年。現在距離這項目標已不到兩年。因此，從現在到 2027 年底，我們的目標是將盡可能多的火力投入到我們的研發活動中，當然還有我們所服務的關鍵市場的交付能力。這就是我們在基礎設施方面投入如此多資金的原因。

But to be clear, our R&D spend will grow commensurately with our revenue in the next few years. All of our R&D spend is discretionary, and so we can essentially achieve whatever level of earnings we wish. But clearly the priority is to go hard and to unlock the value of the pipeline, and we're going to maximally invest to achieve this goal, while of course maintaining sensible cash reserves and financial optionality.

但要先明確的是，未來幾年我們的研發支出將與我們的收入同步成長。我們所有的研發支出都是可自由支配的，因此我們基本上可以實現我們想要的任何收益水準。但顯然，當務之急是努力釋放管道的價值，我們將最大限度地投資以實現這一目標，同時當然保持合理的現金儲備和財務可選性。

But from the end of 2027, as this diagram shows, things change. That's when we'll expect to see a step change in our profitability and for cash generation to start to really exceed our immediate planned R&D needs. I'm sure Richard and Kevin, whom you'll hear from in a minute, will continue to find exciting things to invest in. Radiopharma is such a nascent opportunity and it's got a very bright future, but it is the transition point where things will start to accelerate financially.

但從 2027 年底開始，正如該圖所示，情況發生了變化。那時，我們期望看到獲利能力發生顯著變化，現金產生量將開始真正超過我們近期計劃的研發需求。我相信理查德和凱文（您稍後會聽到他們的消息）將繼續尋找令人興奮的投資項目。放射性藥物是一個新興的機遇，有著非常光明的未來，但它是一個財務上開始加速發展的轉捩點。

Anyone hanging out for a Telix dividend will need to wait until at least then. So frankly, the day that we start paying dividends will be the day that we signal to the market that we have run out of ideas to build shareholder value. There's just, there's so much opportunity to invest in this field and so many problems to solve in oncology. So I hope this perspective, it's a little bit of a different diagram. We haven't really talked about the company in this way before, but I hope this perspective is useful.

任何等待 Telix 股息的人都至少需要等到那時。因此坦白說，我們開始支付股息的那一天將是我們向市場發出信號的一天，表明我們已經沒有辦法創造股東價值了。這個領域有很多投資機會，腫瘤學領域也有很多問題需要解決。所以我希望從這個角度來看，這是一個有點不同的圖表。我們之前並沒有真正以這種方式談論過這家公司，但我希望這種觀點是有用的。

I'd like to now hand over to Darren Smith, our group CFO, to explain how as we launch into this next phase of the company's growth, how the numbers stack up. 2024 was a really great year and he has a lot to talk about. So Darren, over to you.

現在，我想把時間交給我們集團財務長達倫史密斯 (Darren Smith)，讓他來解釋一下，隨著我們進入公司發展的下一階段，各項數據如何累積。 2024 年確實是偉大的一年，他有很多話要說。那麼 Darren，就交給你了。

Thanks, Chris, hello everyone. Today it gives me great pleasure to talk to Telix's strong financial achievements and progress during 2024. So let's now turn to slide 12 and Telix's key financial metrics. It's been an excellent year for Telix with all six of these metrics improving dramatically compared to the prior year. Just listen to the headline numbers.

謝謝，克里斯，大家好。今天，我很高興談論 Telix 在 2024 年取得的強勁財務成就和進展。現在讓我們翻到第 12 張投影片，看看 Telix 的主要財務指標。對 Telix 來說，這是出色的一年，與前一年相比，這六項指標都有顯著提升。只要聽聽看標題數字即可。

Revenue improves 56% lead in guidance. Adjusted EBITDA improves 70% to $99 million. Operating cash inflow improved 80%. Profit after tax improved 860%. And the end of year cash position finished at a solid $710 million on the back of a convertible bond placement. I will now go into some detail on these metrics on the following slides.

收入比預期高出 56%。調整後的 EBITDA 成長 70%，達到 9,900 萬美元。經營現金流入提高了80%。稅後利潤提高了860%。在可轉換債券發行的推動下，年底現金狀況達到 7.1 億美元。我現在將在下面的幻燈片中詳細介紹這些指標。

But now let's turn to slide 13 and review the group's operating profit. As can be seen in the simplified P&L on the slide, operating profit and similar metrics all improve significantly year on year. The headline drivers of the results were, firstly, that we achieved excellent commercial growth by Illuccix in the US, accounting for 97% of our revenue. Kevin Richardson, the CEO of Precision Medicine, will talk later in the presentation on how this has been achieved.

但現在讓我們翻到第 13 張投影片並回顧一下該集團的營業利潤。從投影片上簡化的損益表中可以看出，營業利潤和類似指標均較去年同期大幅提高。業績的主要驅動因素首先是，Illuccix 在美國實現了出色的商業成長，占我們收入的 97%。Precision Medicine 執行長 Kevin Richardson 將在稍後的演講中談論如何實現這一目標。

Secondly, we improve gross margin for efficiencies and stable pricing across key market segments, and thirdly, we are effectively managing expenditure as a percentage of revenue.

其次，我們提高毛利率，以提高主要細分市場的效率和穩定價格；第三，我們有效管理支出佔收入的百分比。

Now turning to slide 14 and the groups adjusted EBITDA. As can be seen on the bubble on the right side of the slide, the adjusted EBITDA improves 70% on the prior year. And this is a testament to the strong underlying performance of the Telix business model.

現在翻到第 14 張投影片，查看各組調整後的 EBITDA。從幻燈片右側的氣泡可以看出，調整後的 EBITDA 比前一年提高了 70%。這證明了 Telix 商業模式的強勁潛在表現。

The graph on the slide shows the bridge from operating profit to the $99 million adjusted EBITDA, highlighting the impact of the main non-reoccurring corporate initiatives that are impacting the operated profit in 2024. This can be classified into two main categories.

投影片上的圖表顯示了從營業利潤到 9,900 萬美元調整後 EBITDA 的轉變，凸顯了影響 2024 年營業利潤的主要非經常性公司舉措的影響。這可以分為兩大類。

There's $9 million associated with the listing on the NASDAQ and $8 million associated with Telix's strategic M&A activities. Now let's turn to slide 15 and an overview of our research and development investment. In line with guidance, we invested $195 million into R&D.

其中 900 萬美元與納斯達克上市有關，800 萬美元與 Telix 的策略併購活動有關。現在讓我們翻到第 15 張投影片，概述一下我們的研發投資。根據指導方針，我們向研發投資了 1.95 億美元。

As it continues to be a key component of our growth strategy. It is growing our industry-leading precision medicine business with R&D focused on the regulatory filings for Pixclara, Zircaix, and Gozellix, and the scale up of inventory in preparation for the commercial launches.

因為它仍然是我們成長策略的關鍵組成部分。它正在擴大我們行業領先的精準醫療業務，研發重點是 Pixclara、Zircaix 和 Gozellix 的監管備案，以及為商業發布做準備的庫存擴大。

This accounted for approximately half of the investment in 2024, with these assets expected to generate revenue in 2025. It also is delivering our therapeutic pipeline. As we build momentum in our TX clinical activity, the R&D investment is increasing. And it is concentrated on progressing our late-stage assets for prostate, kidney, and brain cancer therapies.

這約佔2024年投資的一半，預計這些資產將在2025年產生收入。它還提供我們的治療管道。隨著我們在 TX 臨床活動中不斷累積動力，研發投資也不斷增加。公司致力於推動前列腺癌、腎癌和腦癌治療的後期資產。

Now let's turn to slide 16. Our precision medicine business is currently the commercial engine house of Telix, focused on growing our industry-leading precision medicine products. As noted already, it delivered revenue growth of 55% for sales of Illuccix. Gross margin improved 3% to 65%, reflecting the higher realized average price due to improved market mix and steady cost goods.

現在我們翻到第 16 張投影片。我們的精準醫療業務目前是 Telix 的商業引擎，專注於發展我們領先業界的精準醫療產品。如前所述，Illuccix 的銷售收入成長了 55%。毛利率提高 3% 至 65%，反映出由於市場結構改善和成本商品穩定而實現的平均價格較高。

And we also continue to invest in selling and marketing to drive further growth of the Illuccix in the US and launching Europe in 2025. We're also progressing the US market for the launch of 3 new imaging agents. As a result, the precision medicine business grew its adjusted EBITDA by 79%.

我們也將繼續投資銷售和行銷，以推動 Illuccix 在美國進一步成長並於 2025 年在歐洲推出。我們也正在推動美國市場推出 3 種新的成像劑。因此，精準醫療業務的調整後 EBITDA 成長了 79%。

This funded not only its own R&D but also the rest of the business. Now let's turn to slide 17 in our therapeutic business segment. This segment of Telix is focused on delivering a late-stage therapeutic pipeline and building the clinical products and services of the future, leveraging our research platform to develop the next generation of radio pharmaceuticals. During 2024, Telix increased its investment by 74% into the therapeutic pipeline to $82 million.

這不僅為其自身的研發提供了資金，也為其餘業務提供了資金。現在讓我們翻到治療業務部門的第 17 張投影片。Telix 的這一部門專注於提供後期治療管道和建立未來的臨床產品和服務，利用我們的研究平台開發下一代放射性藥物。2024 年，Telix 對治療領域的投資增加了 74%，達到 8,200 萬美元。

And over time this is becoming a larger proportion of our R&D investment. The majority of the investment in 2024 was focused on commencing the Phase 3 ProstACT Global clinical trial, including production of clinical doses to support the ramp up of recruitment. Richard Valeix, our CEO of Therapeutics, will shortly present the details regarding progress in our 2025 plans for our therapeutic pipeline.

隨著時間的推移，這將成為我們研發投資中越來越大的一部分。2024 年的大部分投資都集中在啟動第 3 階段 ProstACT Global 臨床試驗，包括生產臨床劑量以支持招募的增加。我們的治療學執行長 Richard Valeix 很快就會介紹我們 2025 年治療產品線計畫的進展細節。

Now let's turn to slide 18 and Telix's manufacturing solutions. Operations scaled up this year as a result of the acquisition of ARTMS and isotherapeutics Group, as well as the expansion of our facility in Brussels South. This site expansion included the installation of two new cyclotrons in the preparation of commencement of GMP production in 2025.

現在讓我們翻到第 18 張幻燈片和 Telix 的製造解決方案。由於收購了 ARTMS 和 isotherapeutics Group，以及擴建了位於布魯塞爾南部的工廠，今年的業務規模有所擴大。此次工廠擴建包括安裝兩台新的迴旋加速器，為 2025 年開始 GMP 生產做準備。

The expansion of operations has resulted in an incremental increase of $19 million in operating expenses for TMS. This will continue to involve as in January we completed the acquisition of RLS, which included the footprint of 31 pharmacies across the United States. Results of RLS, which is immediately accretive, will be included in the TMS results from 2025 onwards.

業務擴張導致TMS的營運費用增加了1900萬美元。這將繼續涉及，因為今年 1 月我們完成了對 RLS 的收購，其中包括遍布美國的 31 家藥局。RLS 的結果將立即累積，並從 2025 年起納入 TMS 結果中。

Now let's turn to my last slide 19, which highlights the cash position and performance. Telix finished the year with a very respectable $710 million on the balance sheet, mainly bolstered by the $650 million dollar convertible bond placement that we undertook in July 24.

現在讓我們翻到最後一張投影片 19，它重點介紹了現金狀況和表現。Telix 在本財年結束時的資產負債表上達到了相當可觀的 7.1 億美元，這主要得益於我們在 7 月 24 日進行的 6.5 億美元可轉換債券配售。

This enabled us to continue to pursue our strategic M&A opportunities such as the RLS acquisition, as well as providing the resources to provide Further acceleration to the investment in our late stage clinical programs.

這使我們能夠繼續尋求策略併購機會，例如 RLS 收購，並提供資源以進一步加速對我們後期臨床專案的投資。

Net cash used in investing activities in 2024 totaled $135 million. This included $31 million in expanding our global production infrastructure. $20 million to expand our portfolio of intangible assets. $14 million for risk mitigation by the strategic acquisition of crucial raw materials, and $50 million was placed in a security deposit.

2024年投資活動所用淨現金總計1.35億美元。其中包括 3,100 萬美元用於擴大我們的全球生產基礎設施，2,000 萬美元用於擴大我們的無形資產組合，1,400 萬美元用於透過策略性收購關鍵原材料來降低風險，以及 5,000 萬美元作為保證金。

Turning to operating cash, as previously discussed, Telix invested $195 million of its operating cash into R&D through our therapeutics and precision medicine business, plus funded the $36 million contingent consideration payment to our former ANMI shareholders.

談到營運現金，如前所述，Telix 透過我們的治療和精準醫療業務將其營運現金中的 1.95 億美元投資於研發，另外還向我們的前 ANMI 股東支付了 3,600 萬美元的或有對價。

After netting off these payments, Telix still improved its net operating cash flow over the last year by 80% to $43 million. This clearly illustrates the sustainability of the Telli business. I'll now hand you over to Kevin Richardson, the CEO of Precision Medicine.

在扣除這些付款後，Telix 去年的淨營運現金流仍提高了 80%，達到 4,300 萬美元。這清楚地說明了 Telli 業務的可持續性。現在我將您交給精準醫療執行長凱文理查森。

Thank you, Darren. Slide 21, please. To help define the precision medicine business, please see the slide on our expanding commercial portfolio. We will go over in more detail our prostate imaging asset, as well as our kidney and brain over the next few slides, but I did want to make note of a recent announcement that we intend to bring into our precision medicine business unit and further develop Syntimun as a companion patient selection and safety assessment tool for TLX 66, its therapeutic bone marrow conditioning candidate. The plan is to increase sales for its current indication by improving product availability worldwide with commercial consistency.

謝謝你，達倫。請轉到第 21 張投影片。為了協助定義精準醫療業務，請參閱有關我們不斷擴大的商業組合的幻燈片。在接下來的幾張幻燈片中，我們將更詳細地介紹我們的前列腺成像資產以及我們的腎臟和大腦，但我確實想指出最近的一項公告，我們打算將其納入我們的精準醫療業務部門，並進一步開發 Syntimun 作為其治療性骨髓調理候選藥物 TLX 66 的伴隨患者選擇和安全評估工具。該計劃旨在透過提高全球範圍內的產品供應量和商業一致性來增加其當前適應症的銷售。

Slide 22. Telix continues to strengthen its position in the PSMA market with the Illuccix, our first commercial product, driving revenue growth for the 10th consecutive quarter since launching in April 2022. Q4 2024 saw a 55% increase over Q4 2023 while achieving over $500 million in US sales for full year 2024, reflecting our strong market momentum.

投影片 22。Telix 憑藉其首款商業產品 Illuccix 繼續鞏固其在 PSMA 市場的地位，自 2022 年 4 月推出以來連續第 10 個季度推動收入成長。2024 年第四季較 2023 年第四季成長 55%，同時 2024 年全年美國銷售額超過 5 億美元，反映了我們強勁的市場動能。

Our commitment to clinical accuracy, reliable delivery, and exceptional customer service attracts and retains our customers. What we mean by that is that our lucid product has the highest inter-reader agreement of the currently marketed PSMAs, delivering an accurate diagnosis, while our 245 points of distribution puts our PSMA within minutes of our customer at dispensing. We are your friendly neighborhood pharmacy. We like to say it's locally farmed a scanner, and our customers say that our multi-functional approach to the customer experience lets the customer hit the Telix easy button when they begin using our products. Our performance is driven by executing a commercial strategy with consistency, expanding our market reach and capturing more share.

我們致力於臨床準確性、可靠交付和卓越的客戶服務，以吸引和留住我們的客戶。我們的意思是，我們的 lucid 產品在目前市售的 PSMA 中具有最高的讀者間一致性，能夠提供準確的診斷，而我們的 245 個分銷點使我們的 PSMA 能夠在幾分鐘內送達客戶手中。我們是您友善的鄰裡藥局。我們喜歡說它是本地種植的掃描儀，我們的客戶說我們針對客戶體驗的多功能方法讓客戶在開始使用我們的產品時點擊 Telix 簡易按鈕。我們的業績源自於持續執行商業策略、擴大市場範圍和取得更多份額。

With CMS reform providing a tailwind, Illuccix retains pass through status through June 30, 2025. With CMS reform as a backdrop in the impending launch of Gozellix, we look ahead to our two-product strategy as Telix establishes itself as a leader in prostate cancer imaging, enabling continued innovation and reimbursement for new products in the years to come.

在 CMS 改革的推動下，Illuccix 保留了直通狀態直至 2025 年 6 月 30 日。在 CMS 改革即將推出 Gozellix 的背景下，我們展望我們的雙產品策略，因為 Telix 將確立其在前列腺癌成像領域的領先地位，從而在未來幾年繼續創新和報銷新產品。

Slide 23. Global expansion of Telix's industry-leading precision medicine portfolio is a key driver of our growth strategy. In the US, our commercial portfolio will continue to expand with the launches of our urology products Gozellix and Zircaix, followed by Pixclara for our neuro franchise. Gozellix is an innovative new TSMA candidate, that is designed to increase availability and efficiencies in large urban areas and extend our product reach to distant PET/CT scanners that are in areas where patients can't access PSMA because they are out of reach for current technologies.

幻燈片 23。Telix 產業領先的精準醫療產品組合的全球擴張是我們成長策略的關鍵驅動力。在美國，我們的商業組合將繼續擴大，首先推出泌尿科產品 Gozellix 和 Zircaix，然後推出神經科產品 Pixclara。Gozellix 是一種創新的新型 TSMA 候選藥物，旨在提高大城市地區的可用性和效率，並將我們的產品覆蓋範圍擴展到遠端 PET/CT 掃描儀，這些地區的患者由於現有技術無法接觸 PSMA。

Once approved, we expect to apply for transitional pass through payment with the Centers for Medicare and Medicaid Services. Once approved, Telix will be the only company with two PSMA agents in the market, allowing us to satisfy the needs of both hops accounts and non-hops accounts.

一旦獲得批准，我們希望向醫療保險和醫療補助服務中心申請過渡性轉付。一旦獲得批准，Telix 將成為市場上唯一一家擁有兩家 PSMA 代理商的公司，從而能夠同時滿足 hops 帳戶和非 hops 帳戶的需求。

Zircaix is our first in class renal imaging agent designed to diagnose patients with ccRCC with undiagnosed renal masses. This is a new diagnostic area for PET imaging, and Telix will leverage our success with the urologic physician and imaging centers who have a growing confidence in PSMA imaging.

Zircaix 是我們同類產品中首個腎臟造影劑，旨在診斷患有未確診腎臟腫塊的 ccRCC 患者。這是 PET 成像的一個新的診斷領域，Telix 將利用我們與對 PSMA 成像越來越有信心的泌尿科醫生和成像中心取得的成功。

Finally, our Pixclara agent will bring to neurology customers a technology that will quickly identify treatment-related inflammation from tumor progression or pseudo progression and determine the best treatment pathway for the patient.

最後，我們的 Pixclara 代理將為神經病學客戶帶來一項技術，該技術可以快速識別與腫瘤進展或假進展相關的治療相關炎症，並確定患者的最佳治療途徑。

Looking ahead, towards our precision medicine pipeline, we will drive sustained growth through active product life cycle management and introduce novel products that align with our therapeutic focus. We plan to expand patient reach through label expansion, advancing studies in prostate, kidney, and brain, with a particular focus on metastatic disease for our kidney and brain products.

展望未來，對於我們的精準醫療產品線，我們將透過積極的產品生命週期管理來推動持續成長，並推出符合我們治療重點的新產品。我們計劃透過標籤擴展來擴大患者覆蓋範圍，推進前列腺、腎臟和大腦的研究，特別關注腎臟和大腦產品的轉移性疾病。

Our global growth strategy includes expanding our footprint across Europe and the UK while simultaneously preparing for regulatory pathways into China and Japan in the Asia-Pacific region. These efforts will ensure broader access to our precision medicine solutions, reinforcing Telix's leadership and targeted medicines worldwide.

我們的全球成長策略包括擴大我們在歐洲和英國的業務，同時為進入亞太地區的中國和日本的監管途徑做好準備。這些努力將確保我們的精準醫療解決方案能夠得到更廣泛的應用，從而加強 Telix 在全球的領導地位和針對性藥物。

We plan to leverage our commercial success in the US across products, indications, and geographies, protecting and growing our share through strategic account management and a two-product PSMA strategy, strengthening our relationships with leading cancer institutions worldwide.

我們計劃利用我們在美國各個產品、適應症和地區的商業成功，透過策略客戶管理和雙產品 PSMA 策略保護和增加我們的份額，加強我們與全球領先癌症機構的關係。

You may note our recent announcement on our AI partnership that is designed to bring technology together with Illuccix or Gozellix to increase patient throughput in an imaging center, allowing them to treat more patients and reduce the wait time to get this life saving PSMA scan.

您可能注意到我們最近宣布的 AI 合作夥伴關係，旨在將技術與 Illuccix 或 Gozellix 結合起來，以提高影像中心的患者吞吐量，使他們能夠治療更多患者並減少等待這種挽救生命的 PSMA 掃描的時間。

Utilizing the success we've experienced in the US, we plan to take that commercial playbook and strengthen the global brand into new markets around the globe. Slide 24, please. Turning towards 2025, we've already talked about the potential to launch three new products this year which are subject to regulatory approval. Our launch planning is well underway. We built out the commercial infrastructure. We trained our customer facing teams, and we're currently delivering disease awareness education to the customer base through multiple channels. This investment is reflected in the financial results.

利用我們在美國的成功，我們計劃採用這種商業策略，並將全球品牌推向全球新市場。請翻看第 24 張投影片。展望 2025 年，我們已經討論過今年推出三款新產品的可能性，這些產品需獲得監管部門的批准。我們的發布計劃正在順利進行中。我們建設了商業基礎設施。我們培訓了面向客戶的團隊，目前正在透過多種管道向客戶群提供疾病意識教育。此項投資已反映在財務結果中。

Gozellix, our second PSMA agent, has a PDUFA goal date of March 24, 2025, and is a key for Telix and rounds out our two-product strategy in the US. The global expansion of Illuccix is a priority for Telix. Following the positive opinion from the German regulatory body, we are set to launch in 19 countries, including the UK. As approvals are finalized, we will begin implementing our country commercialization plans beginning in the first half of 2025. Additionally, we are nearing the completion of China Phase 3 bridging study as we progress our Asia Pacific rollout strategy.

Gozellix 是我們的第二款 PSMA 藥物，其 PDUFA 目標日期為 2025 年 3 月 24 日，對於 Telix 來說，Gozellix 至關重要，並完善了我們在美國雙產品策略。Illuccix 的全球擴張是 Telix 的首要任務。在獲得德國監管機構的積極意見後，我們將在包括英國在內的 19 個國家推出該產品。隨著批准的最終確定，我們將從 2025 年上半年開始實施我們的國家商業化計劃。此外，隨著我們亞太地區推廣策略的推進，中國第三階段橋接研究也即將完成。

In the US, Zircaix has filed a BLA in December of 2024, and we are expecting a PDUFA date after the US summer in 2025. With an expanded access program already in place across the US and globally, physicians are already using our innovative kidney agent around the world on their patients, and it is included in the EAU guidelines as an emerging technology.

在美國，Zircaix 已於 2024 年 12 月提交了 BLA，我們預計 PDUFA 日期將於 2025 年美國夏季之後。隨著擴大使用計劃在美國和全球範圍內實施，醫生已在世界各地的患者身上使用我們的創新腎臟藥物，並且它作為一項新興技術被納入 EAU 指南。

Moving to our neurology platform, Pixclara has an NDA with the PDUFA date of April 26, 2025. Also with an ongoing expanded access program in the US, our neurology franchise will target global regulatory filings based on market opportunities as we gain momentum around the globe.

轉向我們的神經病學平台，Pixclara 擁有一份 NDA，其 PDUFA 日期為 2025 年 4 月 26 日。此外，隨著我們在美國持續開展擴大准入計劃，隨著我們在全球範圍內獲得發展勢頭，我們的神經病學特許經營將根據市場機會瞄準全球監管備案。

All the hard work our team's put in 2024 has set 2025 to be an exciting year as we transition to a multi-product, multinational commercial company, diversifying our revenue streams through multiple products across geographies.

我們團隊在 2024 年付出的所有努力，使得 2025 年成為令人興奮的一年，因為我們將轉型為一家多產品、跨國商業公司，透過跨地區的多種產品實現收入來源多元化。

Thank you. Onto Richard Valeix, CEO of Therapeutics.

謝謝。介紹 Therapeutics 執行長 Richard Valeix。

Thank you, Kevin. Hello. I'm pleased to be able to speak to you today about the strategy of Telix Therapeutic Business. Telix has built a pipeline of highly differentiated therapeutic candidates based on validated targets and clinical data.

謝謝你，凱文。你好。我很高興今天能夠和大家談論 Telix 治療業務的策略。Telix 根據經過驗證的目標和臨床數據建立了高度差異化的治療候選藥物管線。

Our focus is two-fold. First, in the short term, our priority is on the delivery of three main late stages assets for prostate, kidney, and brain cancer. Our lead asset, TLX591, is already in phase three, and our goal this year is to advance the kidney and brain cancer therapies to pivot to pivotal trials. And we'll talk more to that shortly.

我們的重點是雙重的。首先，短期內，我們的首要任務是提供前列腺癌、腎癌和腦癌的三種主要晚期資產。我們的主要資產 TLX591 已經進入第三階段，我們今年的目標是推進腎臟和腦癌治療，以轉向關鍵試驗。我們很快會就此進行更多討論。

The second part of our strategy is building our pipeline of next generation assets. Telix has one of the deepest alpha pipeline in the industry. Now, we are transitioning these programs which have been stage gated through our internal R&D and based on excellent preclinical data into clinic.

我們策略的第二部分是建構下一代資產管道。Telix 擁有業界最深的 alpha 管道之一。現在，我們正在將這些已通過內部研發階段性檢驗並基於優秀臨床前數據的項目轉入臨床。

The 592 and 102 compounds are the natural evolutions of our portfolio life cycle management with alpha radioisotopes in order to expand indication. While TLX90, the board seeking assets we acquired last year from QSM, is being developed initially for treatment of pain from bone metastasis. That gives us the potential to treat prostate cancer patients right across their disease journey. This is also on our strong urology footprint established with precision medicine.

592 和 102 化合物是我們利用 α 放射性同位素進行產品組合生命週期管理的自然演變，旨在擴大適應症。而我們去年從QSM收購的董事會尋求資產TLX90，最初是為治療骨轉移引起的疼痛而開發的。這使我們有可能在整個前列腺癌病程中對其進行治療。這也是我們透過精準醫療建立的強大的泌尿科足跡。

Finally, we have a unique opportunity to explore multi-indication or pan-cancer asset strategy. Let me explain. The CAIX and FAP are both validated as pan-tumor targets. Pursuing this strategy can add value to these assets, generating first in-human data in multiple indications in a limited time frame.

最後，我們有一個獨特的機會探索多適應症或泛癌資產策略。讓我解釋一下。CAIX 和 FAP 均被驗證為泛腫瘤標靶。實施此策略可以增加這些資產的價值，在有限的時間內產生多種適應症的首批人體數據。

Next slide please. In the next two slides you can see our pipeline. The first slide is presenting our late-stage assets with our pivotal trial ProstACT Global that supports TLX591 compound data generation. And our two additional late-stage compounds, TLX250 and TLX101, that will move in pivotal trials by the end of the year 2025.

請看下一張投影片。在接下來的兩張投影片中，您可以看到我們的管道。第一張投影片展示了我們的後期資產以及支持 TLX591 化合物數據產生的關鍵試驗 ProstACT Global。我們的另外兩種後期化合物 TLX250 和 TLX101 將於 2025 年底進入關鍵試驗階段。

Next slide, please. The second pipeline slide illustrates the early-stage compound that will enter in clinics, mainly first in humans, with several of these being alpha therapies.

請看下一張投影片。第二張流程幻燈片展示了即將進入臨床的早期化合物，主要首先用於人體，其中幾種是 α 療法。

Next slide please. Moving to 591, our lead therapeutic candidate. It is a highly differentiated asset. It's an antibody versus the classical peptide TSMA available. It's a big opportunity. Key to the differentiation is the strategy or side effect profile and the short dosing regimen.

請看下一張投影片。轉向 591，我們的主要治療候選藥物。它是一種高度差異化的資產。它是一種針對現有經典勝肽 TSMA 的抗體。這是一個很大的機會。區分的關鍵在於策略或副作用概況以及短期給藥方案。

Indeed, when you have the privilege to meet patients who have been treated with physical therapy, either on a clinical trial or via some compassionate access program, they will often mention that they have experienced very little in the way of side effects.

事實上，當您有幸見到接受過物理治療的患者時，無論是在臨床試驗中還是透過某些同情治療計劃，他們通常會提到他們幾乎沒有遇到任何副作用。

We can deliver the therapy as a short two-week course. This is appealing to patients and physicians and may enable TLX101 to be more easily added to existing standard of care hormone therapy regimens. During 2025 -- 2024, we released data from our study, Prostate Select, which reinforced the safety profile in earlier patient population.

我們可以將這種治療以兩週的短期課程形式進行。這對患者和醫生來說很有吸引力，並且可能使 TLX101 更容易添加到現有的標準護理荷爾蒙治療方案中。在 2025 年至 2024 年期間，我們發布了 Prostate Select 研究的數據，該研究強化了早期患者群體的安全性。

The hematology toxicity was reversible, less severe, and manageable. The patient case on the right part of the slide is from the select study and illustrates a stable disease with radiographic progression free survival for almost 9 months in line with the positive study results.

血液學毒性是可逆的、較不嚴重且可控制的。幻燈片右側的患者病例來自精選研究，顯示病情穩定，放射學無惡化存活期近 9 個月，與積極的研究結果一致。

As mentioned, this asset is now being studied in the ProstACT Global Phase 3 trial. ProstACT Global is the first trial to combine the synergistic effects of PSML radioactive antibody drug conjugate with androgen receptor pathway inhibition and the well-known docetaxel. It is generating a lot of KL interest.

如上所述，該資產目前正在 ProstACT Global 第 3 階段試驗中進行研究。ProstACT Global 是首次將 PSML 放射性抗體藥物偶聯物與雄激素受體通路抑制和眾所周知的多西他賽的協同作用相結合的試驗。它引起了吉隆坡的極大興趣。

This study is relating well, including ramping up in the US. We are on track to deliver interim rollout in H1.

這項研究的相關情況良好，包括在美國的推廣。我們預計在上半年實現中期推出。

As a reminder, the interim readout will be focusing on the part one of the study with the first 30 patients, which is looking at safety and dosimetry of one in combination with the standard of care administered in the study.

提醒一下，中期讀數將重點放在研究的第一部分，即前 30 名患者，該部分將結合研究中實施的護理標準來觀察患者的安全性和劑量。

Next slide, please.

請看下一張投影片。

TEX250 is our CAIX targeting asset being developed initially in renal cell in renal cancer. This target is well validated in clear cell renal cell carcinoma with our Zircaix study, the registrational trial for Zircaix. Phase 1 and 2 studies have demonstrated the safety profile and efficacy potential. The images on the right part of the slide represent a ccRCC patient case with PET scan before and after treatment. It clearly reinforces our confidence and interest in this compound.

TEX250 是我們最初針對腎臟癌腎細胞開發的 CAIX 標靶資產。我們的 Zircaix 研究（Zircaix 的註冊試驗）已在透明細胞腎細胞癌中充分驗證了這一目標。階段 1 和 2 的研究已經證明了其安全性和療效潛力。幻燈片右側的影像代表 ccRCC 患者治療前後的 PET 掃描情況。這顯然增強了我們對這種化合物的信心和興趣。

We have been running a number of studies concurrently on this asset, exploring it in combination with immunotherapies and DNA damage repair inhibitors in renal and other cancers. In 2025, we will advance the pivotal phase three trial as a monotherapy in late-stage metastatic setting, building on the early phase one and two data.

我們一直在對該資產同時進行多項研究，探索將其與免疫療法和 DNA 損傷修復抑制劑結合用於治療腎癌和其他癌症。2025 年，我們將在早期第一階段和第二階段數據的基礎上，推進作為晚期轉移性環境中單一療法的關鍵第三階段試驗。

We had a pre-IND meeting this month in February with the FDA to consult on the trial design. And based on the positive feedback, we are working towards the mission of an IND this year. We will continue with the combination studies. The STARLITE studies have been run as investigator-led studies giving us the flexibility to explore the optimum dose sequence. STARLITE 2 is a groundbreaking study, the first time the combination of lutetium girentuximab and nivolumab, has been investigated with positive preliminary safety data presented in the recent SAGU Conference.

我們於本月 2 月與 FDA 舉行了一次 IND 前會議，就試驗設計進行磋商。根據正面的回饋，我們正在努力完成今年的 IND 使命。我們將繼續進行組合研究。STARLITE 研究以研究者主導的方式進行，使我們能夠靈活地探索最佳劑量順序。STARLITE 2 是一項開創性的研究，首次對镥吉妥昔單抗和納武單抗的組合進行了研究，並在最近的 SAGU 會議上展示了積極的初步安全性數據。

Finally, the STARLITE study, which is ongoing, is the first work of the pine tumor approach. The study will authorize to deliver data for several indications expressing the CN9 target, and we generate data for the first time regarding a radioactive ADC compound and a DDRI association.

最後，正在進行的 STARLITE 研究是松樹腫瘤方法的首次研究。該研究將授權提供表達 CN9 目標的幾種適應症的數據，並且我們首次產生有關放射性 ADC 化合物和 DDRI 關聯的數據。

Next slide, please. The 101. TLX101 is our investigational therapy in brain cancer and has obtained orphan drug designation for glioblastoma. This is a severe disease with very poor survival outcomes. Published data from the IPAC one study in recurrent setting demonstrated promising efficacy signals with a median OS of 23 months from initial diagnosis.

請看下一張投影片。101。TLX101 是我們針對腦癌的試驗療法，並已獲得膠質母細胞瘤孤兒藥資格。這是一種嚴重的疾病，存活率很低。IPAC 發布的一項復發性研究數據顯示了有希望的療效訊號，從初次診斷開始的中位 OS 為 23 個月。

We have now completed the (inaudible) study, which is the combination of external beam radiation therapy and Phase 1, 101 at low dose. We expect data later this half. Late last year, we had another pre-IND meeting with the FDA on a pivotal trial design. We are preparing the IND submission for pivotal trial planned for the second half of this year.

我們現在已經完成了（聽不清楚）研究，這是體外放射治療和低劑量 1 期 101 治療相結合的研究。我們預計數據將於今年下半年公佈。去年年底，我們與 FDA 就一項關鍵試驗設計舉行了另一次 IND 前會議。我們正在準備今年下半年進行的關鍵試驗的 IND 提交。

We all feel very driven to move this program forward. The image on the right part of the slide illustrates why. You can see a patient case from a compassionate youth program in Europe presented at the ENM Congress in 2024.

我們都非常有動力推動這個項目向前發展。幻燈片右側的圖像說明了原因。您可以看到 2024 年 ENM 大會上展示的歐洲富有同情心的青年計劃中的患者案例。

It presents two PET scans performed with our Pixclara product, which will be our companion diagnostic agent before and after treatment. And we can clearly see the changes in tumor activity presented by the color changes. This case represents a stable disease response, an amazing compound.

它展示了使用我們的 Pixclara 產品進行的兩次 PET 掃描，它將作為我們治療前後的伴隨診斷劑。而我們可以透過顏色的變化清晰的看到腫瘤活性的變化。這個案例代表了穩定的疾病反應，這是一種令人驚訝的化合物。

Next slide, please. These slide summarize our next generation pipeline strategy. As mentioned previously, we are aiming to move three of our alpha assets into first inhuman trial in 2025, commencing with the TLX592 for ProstACT cancer.

請看下一張投影片。這些投影片總結了我們的下一代管道策略。如前所述，我們計劃在 2025 年將我們的三項 alpha 資產投入首次非人體試驗，首先是用於治療 ProstACT 癌症的 TLX592。

I noted earlier that we are adding to our urology portfolio the two recent acquisitions TLX90 and TLX400. And finally, we are reinforcing our R&D capabilities with the recent ImaginAb platform acquisition in order to create a new portfolio of next generation diagnostic products optimized for radio pharmaceutical drug delivery.

我之前提到過，我們正在將最近收購的兩款產品 TLX90 和 TLX400 添加到我們的泌尿科產品組合中。最後，我們透過最近收購的 ImaginAb 平台加強了我們的研發能力，以便創建針對放射性藥物輸送而優化的新一代診斷產品組合。

All the deliverables in 2024 were paving the way for the disruptive year 2025 for the Telix therapeutic portfolio with three pivotal trials, multiple first inhuman alpha therapy, and innovative pan-tumor development approach with validated targets. Thank you.

2024 年的所有成果都為 Telix 治療組合的顛覆性一年 2025 年鋪平了道路，其中包括三項關鍵試驗、多種首次非人類 α 療法以及具有驗證目標的創新全腫瘤開發方法。謝謝。

Thanks very much, Richard. Great summary and just to reiterate, we'll have 33 programs in pivotal studies by the end of this year, which I think is a really good testament to Richard's team and the great effort, that's underpinned our R&D this year.

非常感謝，理查德。很好的總結，再次重申一下，到今年年底，我們將有 33 個關鍵研究項目，我認為這是對理查德團隊和他們今年研發工作巨大努力的一個很好的證明。

I'm going to talk now a little bit about our manufacturing solutions activity. Darren Patty, our Chief Operating Officer, is on the road at the moment, but I'm going to step in and give a little bit of an update here. If you can move to slide 34.

我現在要稍微談談我們的製造解決方案活動。我們的營運長達倫·帕蒂 (Darren Patty) 目前正在路上，但我將介入並在此提供一些最新情況。請移至第 34 張投影片。

So this is a summary slide of really why we think this is so important. Radiopharma is about whether it's a diagnostic or a therapeutic product is really about proximal manufacturing and just in time manufacturing, as Kevin noted for the Illuccix product, we're distributing that product now out of about 240 points of distribution in the United States. To deliver these products globally, you need to have infrastructure to really be able to go that last mile and make the product available with a high degree of confidence for patients.

這是一張總結投影片，說明了我們為什麼認為這麼重要。Radiopharma 關心的是診斷產品還是治療產品，實際上它涉及近端製造和即時製造，正如 Kevin 針對 Illuccix 產品所指出的那樣，我們現在正在美國約 240 個分銷點分銷該產品。為了在全球範圍內提供這些產品，您需要擁有基礎設施，以便真正能夠走完最後一英里，並讓患者高度放心地使用產品。

We've been focusing on building that infrastructure, scaling it to meet the demand both today and the expected demand for our products, and this is really a two-part model for success. We are heavily dependent on key partnerships.

我們一直專注於建立基礎設施，並對其進行擴展以滿足當前需求以及對我們產品的預期需求，這實際上是一個由兩部分組成的成功模式。我們嚴重依賴關鍵的合作關係。

Our goal is not to go at the task of manufacturing alone and in almost every market we operate in, we have key supply chain manufacturing, distribution, and even sales and marketing partnerships. But we also have a certain amount of facilitative infrastructure ourselves, and the wheel diagram on the right-hand side shows how the acquisitions that we've made over the last few years map onto that or the investments that we've made really map onto that activity. And this is of course a bit of a simplification of how we do radiopharmaceutical development, but you can see now, we've got a really complete capability from early clinical development and dose production.

我們的目標不是單獨完成製造任務，在我們營運的幾乎每個市場中，我們都有關鍵的供應鏈製造、分銷，甚至銷售和行銷合作夥伴關係。但我們自己也擁有一定數量的便利基礎設施，右側的輪形圖顯示了我們過去幾年進行的收購如何映射到這些基礎設施上，或者我們進行的投資如何真正映射到這些活動上。當然，這只是我們進行放射性藥物開發的簡化，但您現在可以看到，我們已經具備了從早期臨床開發到劑量生產的完整能力。

For example, we produce most of the doses for our clinical trials internally for Phase 1 and Phase 2 trials. We've got an amazing radio chemistry team and bioconjugation capabilities, including GMP conjugation. We are active in isotope production, not because we want to be in the isotope business, but because we want to have the ability to innovate and generate efficiencies in the way that isotopes are produced. And then of course with the acquisition of RLS in tandem with key commercial partners really focus on that last mile of patient delivery.

例如，我們內部生產用於第 1 階段和第 2 階段臨床試驗的大部分劑量。我們擁有一支出色的放射化學團隊和生物結合能力，包括 GMP 結合。我們積極參與同位素生產，並不是因為我們想從事同位素業務，而是因為我們希望有能力創新並提高同位素生產方式的效率。當然，透過與主要商業合作夥伴一起收購 RLS，我們真正關注的是患者交付的最後一英里。

Next slide 35, please. So for the US market, this is what it looks like in the left-hand map there you can see the outline of our very important and key partnerships in the United States. This is a multi-distributor model to really take advantage of all the nuances of local commercial markets in the United States. We have also built our own network of capabilities through both the acquisition of RLS and the combination of the ARTMS technology. What this means is that we can do very high production level isotope production for zirconium, gallium, and other potential key radionuclides in the future, and build a very efficient distribution capability out of a very small number of nuclear pharmacies.

請翻到下一張投影片第 35 張。對於美國市場來說，左側地圖是這樣的，您可以看到我們在美國非常重要且關鍵的合作關係的輪廓。這是一種多分銷商模式，可以真正利用美國當地商業市場的所有細微差別。我們也透過收購RLS和結合ARTMS技術建立了自己的能力網絡。這意味著我們將來可以對鋯、鎵和其他潛在的關鍵放射性核種進行非常高產量的同位素生產，並透過極少數核藥房建立非常高效的分銷能力。

This is not to supplant our US distribution model, but rather to augment it, to make sure that we've got backup for our key partners, to make sure that we are providing radio nuclide efficiencies, and in particular over the next 18 to 24 months we've got a big focus on how do we provide very cost effective large scale gallium and zirconium production to our pharmacy partners. That's going to -- it's going to have a pretty big impact on our production efficiency and eventually our cost of goods as well.

這不是要取代我們的美國分銷模式，而是為了增強它，以確保我們為主要合作夥伴提供支持，確保我們提供高效的放射性核素，特別是在未來的 18 到 24 個月內，我們將重點關注如何為我們的藥房合作夥伴提供極具成本效益的大規模鎵和鋯生產。這將對我們的生產效率以及最終的商品成本產生相當大的影響。

Next slide, please. Globally, the story repeats itself. We've got a significant investment in infrastructure in Europe, particularly with the Brussels South or the [Synes] facility. We are also building some distribution in hot lab capability in Australia to support regional clinical trials, but like the US, we are also very much partner driven with our, for example, collaboration with China Grand Pharma for the Greater China market. And also our manufacturing joint venture with R2 Pharma in Brazil.

請看下一張投影片。在全球範圍內，這個故事正在重演。我們在歐洲的基礎設施方面進行了大量投資，特別是布魯塞爾南部或[Synes]設施。我們也在澳洲建立了一些熱實驗室分銷能力，以支持區域臨床試驗，但與美國一樣，我們也非常注重合作夥伴，例如與中國遠大醫藥合作開發大中華區市場。以及我們與巴西 R2 Pharma 的製造合資企業。

And so what you can really see is that we're committed to that localized production in the major markets that we serve, and this is really about guaranteeing supply and patient access for our products. Of course, there's no doubt that by achieving some degree of verticality that we also have the opportunity for marginal improvement as these businesses scale.

因此，您真正看到的是，我們致力於在我們服務的主要市場進行在地化生產，這實際上是為了確保我們產品的供應和患者獲得產品的機會。當然，毫無疑問，透過實現一定程度的垂直化，隨著這些業務的擴大，我們也有機會實現邊際改善。

Slide 37 please. So just to wrap up our presentation and get ready to go into Q&A, we put out a summary of our guidance. Our top line number is about AUD1.2 billion or USD770 million to USD800 million. This is our 2025 revenue guidance.

請看第 37 張投影片。為了結束我們的演示並準備進入問答環節，我們給出了指導摘要。我們的最高數字約為 12 億澳元或 7.7 億至 8 億美元。這是我們 2025 年的收入指導。

This is revenue from the sales of Illuccix and only the jurisdictions that we have a marketing authorization at this point in time, and it also includes about 11 months of RLS revenue as well. What it does not include is Gozellix, Pixclara, and Zircaix. So those products have not yet achieved a marketing authorization. Once we achieve a marketing authorization, then we will update our guidance.

這是來自 Illuccix 銷售的收入，並且僅限於我們目前擁有行銷授權的司法管轄區，其中還包括約 11 個月的 RLS 收入。它不包括 Gozellix、Pixclara 和 Zircaix。因此這些產品尚未獲得上市許可。一旦我們獲得行銷授權，我們就會更新我們的指導。

Similarly, although we have received BPharm, which is the German regulator's positive opinion on European approval, we have not yet received national phase approvals yet for any other countries other than Denmark. They, of course, they're coming. That's an administrative process, but we have not included European countries that have not achieved national approval in our guidance, and we will update our guidance when we achieve those, particularly for the major European markets.

同樣，儘管我們已收到 BPharm，這是德國監管機構對歐洲批准的正面意見，但我們尚未獲得丹麥以外任何其他國家的國家階段批准。他們當然會來。這是一個行政程序，但我們沒有將尚未獲得國家批准的歐洲國家納入我們的指導範圍，當我們獲得這些批准時，我們將更新我們的指導範圍，特別是針對主要的歐洲市場。

On the R&D side of things, we expect our R&D to increase, 20% to 25% over, excuse me, over 2024 numbers.

在研發方面，我們預期我們的研發投入將比 2024 年增加 20% 至 25%。

Slide 39 please. So just to wrap up, 2025 will be an incredible year for the company and it really builds on the foundation that we've laid in 2024 from a delivery and commercial execution perspective. I'm particularly excited about our ex-US expansion this year, but clearly our US and Canadian colleagues are going to be super busy with product launches in North America. An indication expansions as well.

請看第 39 張投影片。總而言之，2025 年對公司來說將是不可思議的一年，從交付和商業執行的角度來看，它確實建立在我們 2024 年奠定的基礎之上。我對今年我們在美國以外的擴張感到特別興奮，但顯然我們的美國和加拿大同事將會非常忙於在北美推出產品。也顯示擴張。

The pipeline development, as Richard has outlined, is extremely expansive. We've got a lot of clinical data readouts this year, a lot of news flow to report on, so that's super exciting. And of course, the name of the game there is about demonstrating the patient benefit of our extremely deep therapeutics pipeline.

正如理查德所概述的，管道開發極為廣泛。我們今年獲得了大量的臨床數據讀數，並且有很多新聞流需要報道，所以這非常令人興奮。當然，遊戲的名稱是為了展示我們極其深入的治療管道對患者的益處。

And then last of all, making sure that every day, when we get out of bed and aspire to deliver outcomes to patients that we do so with a high degree of confidence and capability and not just doing it in the US but really expanding that capability globally. And of course that's through partially internal investment and partially through continuing to double down and invest in our very valued commercial partnerships around the globe.

最後，確保每天當我們起床時，我們都會以高度的信心和能力為患者提供治療結果，並且不僅在美國這樣做，而且真正在全球範圍內擴展這種能力。當然，這部分是透過內部投資，部分是透過繼續加倍投資於我們在全球範圍內非常有價值的商業夥伴關係。

And now moving to the last slide, slide 40. I'm not going to go through the individual bubbles in here, and this is by no means exhaustive, but it does certainly highlight with a bit of a focus on the first half of this year, the just very large number of catalysts that we are expecting clinically, commercially, and in terms of the expansion of the business. So just a lot to look forward to this year and a lot of milestones to achieve for the company as we progress the business forward.

現在轉到最後一張投影片，第 40 張。我不會在這裡逐一討論各個泡沫，而且這也絕不是詳盡無遺的，但它確實突出了今年上半年的情況，我們預計在臨床、商業和業務擴展方面將出現大量的催化劑。因此，隨著我們業務的不斷推進，今年有很多值得期待的事情，公司也將實現許多里程碑。

With that, I will wrap up the presentation and hand it back to you, Kyahn.

就這樣，我將結束演講並將其交還給你，Kyahn。

Thank you. We will now move into question and answer. So Ashley, you take questions from the phone, please.

謝謝。我們現在進入問答階段。那麼，阿什利，請你透過電話回答問題。

Thank you. (Operator Instructions) David Stanton, Jefferies.

謝謝。（操作員指示）大衛·斯坦頓，傑富瑞。

Good morning team and thanks very much for taking my questions. If we could start with the revenue guidance, please. You've talked to, 11 months of RLS radiopharma. I note that in 2023, when you, bought it, you noted that, they did $158 million worth of revenue. What should we be, in broad brush, what should we be thinking about, revenue growth for 202,025 in that division and or a number for that division please? That's my first question.

大家早安，非常感謝你們回答我的問題。如果我們可以從收入指導開始，請。您已經談過，11 個月的 RLS 放射性藥物治療。我注意到，2023 年，當您購買它時，您注意到他們的收入為 1.58 億美元。概括地說，我們應該考慮什麼，該部門 202,025 的收入成長，或該部門的數字？這是我的第一個問題。

Yeah, that number we put out was an all-inclusive number. We obviously don't double count the Illuccix's revenue in that number going forward, and generally across the US business inclusive of Illuccix and RLS we'd be looking at high single-digit, low double-digit growth and our viewpoint and we've outlined it. If you have a look at my CEO letter in the annual report, we think that that this guidance is a reflection of a continuing growth in our business, continuing expansion of opportunity for PSMA, but it also considers some of the headwinds that we have this year in terms of uncertainties in the US health care system.

是的，我們公佈的數字是一個包羅萬象的數字。顯然，我們不會在未來的數字中重複計算 Illuccix 的收入，並且總體而言，包括 Illuccix 和 RLS 在內的整個美國業務都會看到高個位數、低兩位數的增長，我們的觀點已經概述過了。如果您看過年度報告中致執行長的信，我們認為該指引反映了我們業務的持續成長、PSMA 機會的持續擴大，但它也考慮到了我們今年在美國醫療保健系統不確定性方面面臨的一些阻力。

Obviously, we're facing a government environment perhaps with more challenging resourcing from an FDA and a CMS perspective.

顯然，從 FDA 和 CMS 的角度來看，我們面臨的政府環境可能具有更具挑戰性的資源配置。

And so we think that, that sort of guidance is a good balance of the risk and opportunities that we see in the market this year. Obviously, David, we haven't yet included substantive European revenues in that forecast, so you should think of that as a primarily a US-centric forecast. Is that useful?

因此我們認為，這種指導很好地平衡了我們今年在市場上看到的風險和機會。顯然，大衛，我們還沒有將實質的歐洲收入納入該預測中，因此您應該將其視為主要以美國為中心的預測。這有用嗎？

Understood. Very useful. So on that basis then, second question, just for the market in general, would you be able to sort of help us understand what you think market growth might be for US Illuccix sales in 2025?

明白了。非常有用。那麼在此基礎上，第二個問題，僅針對整個市場，您能否幫助我們了解您認為 2025 年美國 Illuccix 銷售的市場成長情況？

Will it slow from, frankly very good growth in 2024?

坦白說，到 2024 年，它的成長速度會放緩嗎？

I'll start and maybe I'll ask Kevin to chime in since he's a little more coal face on that, but I think, we continue to see the expansion of the PSMA opportunity. It's one of those things where new indications and new opportunities still have the potential to cause step change and growth in the market. We also think that as we start to roll out Gozellix, which you have to remember, it has a PDUFA goal date next month, but you know that means that the CMS reimbursement will be sort of more around mid-year. So the impact of Gozellix will start to really come in in the second half of the year.

首先，我先開始，也許我會請凱文加入，因為他在這方面更有經驗，但我認為，我們會繼續看到 PSMA 機會的擴大。這是新跡象和新機會仍有可能引起市場發生重大變化和成長的事物之一。我們還認為，當我們開始推出 Gozellix 時，您必須記住，它的 PDUFA 目標日期是下個月，但您知道這意味著 CMS 報銷將在年中左右進行。因此，Gozellix 的影響將在下半年開始真正顯現。

We see that as also expanding our reach and our percentage of the market in an accelerating fashion. So, the second half of the year can certainly see good acceleration. I think one of the things that we're dealing with right now, and maybe I'll get Kevin to expand on it, is just all the changes in the reimbursement landscape have made the kind of near-term customer interaction, it's pretty complicated. There's a lot for customers to digest.

我們認為這也將加速擴大我們的覆蓋範圍和市場份額。因此，下半年肯定會出現良好的加速。我認為我們現在正在處理的事情之一（也許我會讓凱文詳細說明）就是報銷領域的所有變化都使得短期客戶互動變得非常複雜。顧客需要消化的東西很多。

There's obviously, differing commercial behaviors in the marketplace. We have succeeded against that backdrop of very stable pricing. We've continued to take market share, so we feel that our commercial team is doing a good job. But I don't know, Kevin, if you want to add anything to that?

顯然，市場上存在著不同的商業行為。我們在價格非常穩定的背景下取得了成功。我們繼續佔領市場份額，因此我們認為我們的商業團隊做得很好。但是凱文，我不知道您是否想補充一些內容？

Yeah, I would just answer specifically on the market in general and all the changes and things that are happening right now that may affect, the customer that we sell to doesn't really affect the patients that we scan. So we still see good growth in the scanning side of that and the patients that are still coming in to get scanned, the growing confidence in PSMA scans by urology physicians and really beginning, continuing to utilize it at the same rate. So we don't see that trajectory changing.

是的，我只是想具體回答整個市場的情況，所有正在發生的變化和事情都可能影響到我們銷售產品的客戶，但實際上並不會影響到我們掃描的患者。因此，我們仍然看到掃描方面的良好增長，仍然有患者前來接受掃描，泌尿科醫生對 PSMA 掃描的信心不斷增強，並且真正開始繼續以相同的速度使用它。因此，我們認為該軌跡不會改變。

Yeah, that's right. Yeah.

是的，沒錯。是的。

And final one for me, thank you. That's very clear. Final one from me.

對我來說這是最後一個了，謝謝。這非常清楚。我的最後一個。

We have in terms of the PDUFA dates, we have noted that, some other pharma companies who had a PDUFA date in February have had theirs delayed. I note that you've got your PDUFA date, as you say, in, coming up reasonably soon for a number of different products, given the change in regulatory environment in the US, is there, what would you say is the risk around that those dates being delayed or postponed?

就 PDUFA 日期而言，我們注意到，一些其他製藥公司的 PDUFA 日期在 2 月已被推遲。我注意到，正如您所說，對於許多不同的產品來說，PDUFA 日期很快就會到來，考慮到美國監管環境的變化，您認為這些日期被推遲或延期的風險是什麼？

Thank you.

謝謝。

So we have contemplated that risk management in our guidance, and clearly that, we haven't got Illuccix, Gozellix, and Pixclara yet in our guidance for the year.

因此，我們在指導中考慮了風險管理，並且很明顯，我們今年的指導中還沒有包括 Illuccix、Gozellix 和 Pixclara。

So I suppose that somewhat disintermediates it. I would say, without sounding overconfident about something that I don't personally control, I think that Gozellix is in fine shape to meet its goal date. We have not had any guidance from the FDA on changing PDUFA date for Pixclara. And we've had clinical site inspections and stuff like that scheduled on time. So we're feeling very good about that. We've already got clinical site inspections happening for Zircaix as well. So the FDA appears to be highly engaged. I think not all divisions of the FDA are going to be impacted equally.

所以我認為這在某種程度上消除了中間環節。我想說的是，對於我個人無法控制的事情，我並不會表現得過於自信，但我認為 Gozellix 完全有能力實現其目標日期。我們尚未收到 FDA 關於更改 Pixclara 的 PDUFA 日期的任何指導。我們已經按時安排了臨床現場檢查等工作。所以我們對此感覺非常好。我們已經對 Zircaix 進行了臨床現場檢查。因此，FDA 似乎高度參與。我認為 FDA 的各部門不會受到同等影響。

But there's no doubt, I would say, not making a Telix specific concern, but as an industry-wide phenomenon, I think there's a lot of concern about the structure and nature of the US government going forward in the FDA and CMS, and the NIH. I think it's a Richter scale shift, and I think we're all dealing with, what the potential consequences of that will be.

但毫無疑問，我想說，這並不是針對 Telix 的一個擔憂，而是一個全行業現象，我認為人們對美國政府在 FDA、CMS 和 NIH 未來的結構和性質有很多擔憂。我認為這是一次里氏規模的轉變，而且我認為我們都在應對其可能造成的後果。

I would just add that we continue to have good communication as of today, and, as Chris mentioned, our visits are scheduled and we're moving forward in the process. So that that really hasn't changed.

我想補充一點，截至今天，我們仍然保持著良好的溝通，而且正如克里斯所提到的，我們的訪問已經安排好了，而且我們正在推進這一進程。所以那確實沒有改變。

Very clear.

非常清楚。

Thank you. I'll get back in the queue.

謝謝。我會回到隊列中。

Thank you.

謝謝。

Laura Sutcliffe, UBS.

勞拉·薩特克利夫，瑞銀。

Hello, thank you for taking my questions. Could we look at slide 10, which is like you said, a new slide, I think for us, this time around. It looks as though your first therapeutic product to market, will be hitting around 2028.

您好，感謝您回答我的問題。我們能看一下第 10 張投影片嗎？正如您所說，對我們來說，這是一張新幻燈片。看起來您推出的第一款治療產品將在 2028 年左右上市。

Which of your pipeline assets do you think will make it first?

您認為哪項管道資產會先取得成功？

Yeah, we haven't sort of given specific guidance on that. I mean actually what I said was that 2027 is our pre-commercial year. So what that means is that in 2027, we expect to have regulatory filings in place. I think that at the rate that we're going with ProstACT Global, I would expect in 2027 that we are having those filing discussions, of course, subject to the clinical data being what we hope, certainly, based on PSS data.

是的，我們還沒有就此給出具體的指導。我實際上說的是 2027 年是我們的商業化前期。這意味著我們預計在 2027 年就會完成監理備案。我認為，按照我們與 ProstACT Global 合作的速度，我預計我們將在 2027 年進行這些備案討論，當然，這取決於我們所希望的臨床數據，當然，這基於 PSS 數據。

In 2027, we would also expect to be on the cusp of pivotal trial data readouts potentially for 101 and 250 because those two assets will go into pivotal trials this year and we think that based on the clinical trial strategy that we have, those can be fairly streamlined trials.

2027 年，我們也預計將處於 101 和 250 關鍵試驗數據讀數的邊緣，因為這兩項資產將在今年進入關鍵試驗階段，我們認為，基於我們現有的臨床試驗策略，這些試驗可以相當精簡。

So I think that there's a lot of momentum in the therapeutics program in the second half of 2027 as we get ready to launch those products in 2028.

因此，我認為，隨著我們準備在 2028 年推出這些產品，2027 年下半年的治療計畫將有很大的發展勢頭。

Okay, thank you. And could I ask about the 591 interim? Obviously, you've been pretty clear that the data will be from the safety run in phase from part one. Do you expect to be able to give any insights on efficacy or should we purely expect safety and symmetry data?

好的，謝謝。我可以問一下有關 591 臨時的情況嗎？顯然，您已經非常清楚，這些資料將來自第一部分的安全運行階段。您是否希望能夠提供任何有關功效的見解，或者我們是否應該純粹期待安全性和對稱性數據？

So as an immediate effect of completing the enrollment of Part 1, it will be safety and dose symmetry, although it will be very interesting because it will be comparative information across enzalutamide, abiraterone, and docetaxel combinations.

因此，完成第 1 部分招募的直接影響是安全性和劑量對稱性，儘管它將非常有趣，因為它將是恩雜魯胺、阿比特龍和多西他賽組合的比較資訊。

But the intention is still to provide interim PFS data. It will be event driven, obviously. So I can't give the exact guidance of when that's going to be. But there will certainly be ongoing reporting on that study as it progresses. I don't know, Richard, if you want to add anything to that?

但目的仍然是提供中期 PFS 數據。顯然，它將由事件驅動。所以我無法給出確切的時間指示。但隨著研究的進展，肯定會有持續的報導。我不知道，理查德，你是否想補充一些內容？

Yeah, as you say, so the primary focus will be the safety and dose symmetry, which are already very interesting data for the development of this compound in association with the classical treatments. So the ARPBS will come perhaps a little bit later, but we are monitoring that and we will be keen to disclose that without penalizing the clinical trial.

是的，正如您所說，主要關注點是安全性和劑量對稱性，這對於與傳統療法相結合開發這種化合物來說已經是非常有趣的數據。因此 ARPBS 可能會晚一點到來，但我們正在監測這一點，並且我們會在不懲罰臨床試驗的情況下披露這一點。

Yeah, thank you, Richard.

是的，謝謝你，理查。

What else have you got Laura?

蘿拉，你還有什麼？

I'll just go with one more. For your bone palliation agent, so 090, what is the pathway to approval for something like that look like? Do you need one or more full Phase 3s -- how big do they need to be and what does the FDA think is the right comparator in this situation?

我再說一個吧。對於您的骨質緩解劑 090，其核准途徑是怎樣的？您是否需要一個或多個完整的第 3 階段——它們需要多大，以及 FDA 認為在這種情況下正確的比較器是什麼？

Yeah, so we've actually had a pre-IND consultation with the FDA to talk about our current state of data. The predicate product for that is, there is in fact a predicate product for that that gives us quite a bit of guidance on how a product like that would be developed. We do have really nice data, including repeat dosing data that shows the clinical utility of the product. The study that we would expect to run is not a classical therapeutic treatment response study. Our first indication is focused on pain management, and that results in a very compact trial design. So historically, and we haven't put a trial protocol in front of the FDA.

是的，我們實際上已經與 FDA 進行了 IND 前磋商，討論我們目前的資料狀態。謂詞產品是，事實上有一個謂詞產品，它為我們如何開發這樣的產品提供了相當多的指導。我們確實有非常好的數據，包括顯示該產品臨床效用的重複給藥數據。我們期望進行的研究不是經典的治療反應研究。我們的第一個適應症集中在疼痛管理上，因此試驗設計非常緊湊。從歷史上看，我們還沒有向 FDA 提交試驗方案。

We've been invited to do so, but historically a trial like that has been in the vicinity of 150 to 200 patients with the primary endpoint being pain scoring for a period of time, typically 12 to 16 weeks of pain scoring. And that results in a very tractable trial design that can recruit and complete very quickly. So the attractiveness of that agent is really that, we are doing some bridging and comparative dose symmetry work right now to the predicate product. Once we have that data to present to the FDA, then we will go back with a trial design that is along the lines of what I've just outlined.

我們已被邀請這樣做，但從歷史上看，這樣的試驗通常涉及 150 至 200 名患者，主要終點是一段時間內的疼痛評分，通常為 12 至 16 週的疼痛評分。這使得試驗設計變得非常容易處理，可以非常快速地招募和完成。因此，該藥物的吸引力實際上在於，我們現在正在對謂詞產品進行一些橋接和比較劑量對稱工作。一旦我們獲得可以提交給 FDA 的數據，我們就會重新進行與我剛才概述的類似的試驗設計。

Super, thank you.

非常好，謝謝。

Andy Hsieh, William Blue.

安迪謝，威廉布魯。

Oh great, thanks for taking our questions. A couple from us if you don't mind. So one, I want to go back to the ProstACT Global study, especially with the symmetry, portion of the interim analysis. I'm curious if you'll be able to detect what, Doctor Louise Emmett had shown in ENZA-p study, where enzalutamide could up regulate PSMA expression just from that dose symmetry portion of your trial as a way to kind of amplify the response? So that's question number one. Question number two has to do with the CAIIX9 franchise.

哦，太好了，感謝您回答我們的問題。如果您不介意的話，我們可以給您一對。首先，我想回顧一下 ProstACT Global 的研究，特別是其中的對稱性、中期分析部分。我很好奇，您是否能夠檢測到 Louise Emmett 博士在 ENZA-p 研究中顯示的內容，即恩雜魯胺是否能夠僅從試驗的劑量對稱部分上調 PSMA 表達，從而在某種程度上放大反應？這是第一個問題。第二個問題與 CAIIX9 特許經營有關。

I'm curious if you could comment on the labeling efficiency of Zircaix, since you're doing, you're using a different chelator for this one. Obviously, has some gross margin implications here. And related to that also start like two really curious about what and when the results will come in. So I'm just curious if you can comment on kind of the timing, so what type of data in combination with all of that, we can expect?

我很好奇您是否可以評論一下 Zircaix 的標記效率，因為您正在這樣做，所以您對此使用了不同的螯合劑。顯然，這對毛利率有一定影響。與此相關，我們也開始真正好奇結果會是什麼以及何時會出現。所以我只是好奇您是否可以評論一下時間安排，那麼結合所有這些，我們可以期待什麼類型的數據？

Thank you so much.

太感謝了。

Okay, so I think it's kind of three questions there. The first one is very straightforward. I mean, we obviously wouldn't, we wouldn't estimate what we might see in clinical data that we haven't yet got in our hands, but you are right. Certainly the part of the basis for the trial design is that there's a synergistic effect for both the RPs and in fact the taxanes and up regulation of PSMA is one of them. Those patients are scanned serially in the study. The dose symmetry is a multi-time point do symmetry study.

好的，我認為這裡有三個問題。第一個非常簡單。我的意思是，我們顯然不會，我們不會估計我們可能在尚未獲得的臨床數據中看到什麼，但你是對的。當然，試驗設計的基礎部分是兩種 RP 具有協同作用，事實上紫杉烷和 PSMA 的上調就是其中之一。這些患者在研究中接受連續掃描。劑量對稱性是多時間點劑量對稱性研究。

So if there is an effect around PSMA expression levels, then we may well see it from the data. And that's exactly, Richard commented, and I won't ask him to repeat it, but that's why Richard commented having the comparative data between the three different standards of cares is going to be really interesting, and you know we'll certainly put that commentary out there when it's available.

因此，如果 PSMA 表達水平存在影響，那麼我們很可能會從數據中看到它。這正是理查德所評論的，我不會要求他重複這一點，但這就是為什麼理查德評論說，擁有三種不同護理標準之間的比較數據將會非常有趣，而且你知道，當該評論可用時，我們一定會將其發佈在那裡。

Regarding the second question, which was relabeling efficiency. So generally, I mean, as a general statement across the antibody drug conjugates, one of the one of the consequences of the type of chelators that we use and the radio chemistry that we use is very high radio labeling efficiency, typically because of the slightly higher cost of goods of a biologic compared to a small molecule. We don't have a tolerance for poor radio labeling efficiency. But typically, radio labeling efficiency we shoot for 85% to 90% radio labeling efficiency.

關於第二個問題，即重新標記效率。所以一般來說，我的意思是，作為抗體藥物偶聯物的一般性陳述，我們使用的螯合劑類型和我們使用的放射化學的一個結果是放射性標記效率非常高，通常是因為與小分子相比，生物製劑的商品成本略高。我們不能容忍較差的無線電標記效率。但通常情況下，我們追求的放射性標記效率是 85% 到 90%。

I am bound to tell you though, it does not have a profound consequence on the cost of goods. And the reason is that the production efficiency of zirconium and gallium with the ARTMS target system that we have is extremely high. We produce multi-curry quantities of radionuclides. So if the efficiency is plus or minus 5%, it's in the rounding noise of the economics for the product.

不過我必須告訴你，它對商品成本不會產生深遠的影響。原因是我們採用ARTMS靶材系統生產鋯和鎵的效率極高。我們生產數咖哩量的放射性核種。因此，如果效率為正負 5%，則屬於產品經濟性的捨入噪音。

And then the third question relates to STARLITE too. So on the back end of ASCO, where we obviously wanted to give our KOLs the chance to have some podium and poster time. We actually will be shortly running an update on the STARSTRUCK1, STARSTRUCK2 -- sorry, STARLITE1, STARLITE2 studies. So yeah, that will be the subject of some further data release quite shortly.

第三個問題也與 STARLITE 有關。因此，在 ASCO 的後期，我們顯然希望讓我們的 KOL 有機會獲得一些展示講台和海報的時間。實際上，我們很快就會對 STARSTRUCK1、STARSTRUCK2——抱歉，是 STARLITE1、STARLITE2 研究進行更新。是的，這很快就會成為進一步數據發布的主題。

That's super helpful.

這非常有幫助。

Thank you so much and congratulations on all the progress.

非常感謝您，並祝賀您取得的所有進展。

Thanks very much, Andy.

非常感謝，安迪。

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特（Tara Bancroft），TD Cowen。

Hi, good evening, or I guess good morning for you. But I'm hoping you could help us better understand what the implied impact in the second half for pass through expiry is for Illuccix in your 2025 revenue guidance? So I mean, I guess specifically upon that expiry, do you have an idea of what the average MUC-based pricing would be for a fee-for-service patients based on historicals? And also how many of treated patients would this impact, like how many now are CMS patients and specifically fee for service?

嗨，晚上好，或早上好。但我希望您能幫助我們更好地理解您在 2025 年收入預測中對 Illuccix 在下半年到期隱含的影響是什麼？所以我的意思是，我猜具體到那個到期日，您是否知道根據歷史記錄，按服務收費的患者的平均基於 MUC 的定價是多少？這又會對多少接受治療的患者產生影響，例如現在有多少人是 CMS 患者，具體有多少人需要支付服務費？

I'll start and then I'll hand over to Kevin. I mean we don't give guidance on what we think our MUC pricing will be since that's obviously a future event that will depend on a number of other pricing parameters at the time that that that comes into effect.

我先開始，然後交給凱文。我的意思是，我們不會就我們認為的 MUC 定價給出指導，因為這顯然是一個未來事件，並且將取決於生效時的許多其他定價參數。

And clearly, I think it's a general statement. The MUC, the hot impacted segment of the market is roughly half of the market. I think that's generally known, it's a similar phenomenon for [lanthius]. So that's the impacted patient population, although there are obviously subcategories of patients within that segment. So that's my initial sort of answer, high level answer your question. I know Kevin, if you want to chime in on adding anything?

顯然，我認為這只是一種普遍的說法。MUC，也就是受市場熱影響的部分，大約佔據了一半的市場份額。我認為這是眾所周知的，對於[lanthius]。這就是受影響的患者群體，儘管該群體中顯然還有患者子類別。這就是我最初的回答，高層次回答你的問題。我知道凱文，你想加入補充什麼嗎？

I think I would just add that, that's why we have a two-product strategy, the CMS pass through exploration is a known event, and, we plan for that known event with Gozellix launch and we're timing that up very nicely and then we'll manage smoothly through that transition. So I think, the larger answer to your question is based on our guidance, and you'll be able to look at that and see what we think and what we're going to be able to do in terms of product mix. Remember, we'll be the only company out there with a two-product strategy and PSMA to manage that situation.

我想我只想補充一點，這就是為什麼我們有雙產品策略，CMS 通過探索是一個已知事件，並且，我們計劃通過 Gozellix 推出該已知事件，並且我們的時間安排非常好，然後我們將順利完成這一過渡。所以我認為，對你的問題的更大答案是基於我們的指導，你將能夠看到這一點，了解我們的想法以及我們在產品組合方面能夠做什麼。請記住，我們是唯一一家採用雙產品策略和 PSMA 來應對這種情況的公司。

Yeah, and just to reiterate earlier that our guidance as it stands does not include the impact of Gozellix in the marketplace. So it's Illuccix only guidance.

是的，我之前只是重申一下，我們目前的指導並不包括 Gozellix 對市場的影響。所以這是 Illuccix 唯一的指導。

Okay, got it. And so just to be clear, so your commercial strategy for Gozellix is almost that it will cannibalize the Illuccix's revenue after the pass through expiry or will it also do you plan for it to take from competitors or do you plan for it to grow the market? Maybe just a little more detail on that.

好的，明白了。所以需要明確的是，您對 Gozellix 的商業策略幾乎是在通過期滿後蠶食 Illuccix 的收入，還是您也計劃讓它從競爭對手那裡奪走收入，或者您計劃讓它擴大市場？也許只是對此有更詳細的說明。

I don't think cannibalization is quite what we expect. We genuinely expect the two products to exist side by side. Commercial payers have a different dynamic than medicare and government payers, like FSS and 340B and stuff like that. So what we see is that there are some markets where there's an advantage to having a reimbursed product, and we would like to competitively service that advantage.

我認為蠶食並不像我們想像的那樣。我們真誠地希望這兩種產品能夠並存。商業付款人與醫療保險和政府付款人（如 FSS 和 340B 等）的動態不同。因此，我們看到，在某些市場上，報銷產品具有優勢，我們希望以有競爭力的方式提供這種優勢。

So that's really about taking market share and we are consistently taking market share even in this current backdrop. We accept, expect that market share acquisition to accelerate with Gozellix. Again, that's not in our guidance at the moment. So that's an update for later in the year, but it really is about a two-tier, as Kevin said in his presentation, it's really about having a two-tier strategy that can deal with different price sensitivity and different reimbursement dynamics, and we think that's very powerful.

所以這其實是為了佔領市場份額，即使在當前的背景下，我們也在不斷佔領市場份額。我們接受，並期望隨著 Gozellix 的出現，市場份額的收購將加速。再次強調，這目前不在我們的指導範圍內。這是今年稍後的更新，但它實際上是關於兩層的，正如凱文在他的演講中所說的那樣，它實際上是關於一個可以處理不同價格敏感度和不同報銷動態的兩層策略，我們認為這非常強大。

Okay, great, yeah, thank you for that. And so I guess, one last question. So I guess, at peak what do you expect the Gozellix and Illuccix franchise, what market share are you expecting to achieve?

好的，太好了，是的，謝謝你。所以我想，還有最後一個問題。所以我想，在巔峰時期，您對 Gozellix 和 Illuccix 特許經營權有何期望，您預計會達到多少市場份額？

All of it. No, I'm just joking. I don't think we really put out an aspirational number. I mean our goal, we chip away, we take, 2% to 3% market share every quarter, we continue to expect to do that.

全部。不，我只是在開玩笑。我認為我們並沒有真正給出一個理想的數字。我的意思是，我們的目標是，我們每季逐步佔據 2% 到 3% 的市場份額，我們將繼續期望做到這一點。

Obviously again because Gozellix isn't in our guidance, we haven't given an updated TAM with what we think Gozellix will do. I think currently our competition and ourselves have a very similar viewpoint around what the size of the market is, it's around maybe the 600,000 scan level. We do see some opportunities to increase that market size. You should remember that, probably 20% -- 15% to 20% of the US market is still not reached in terms of scanner footprint and patient footprint. We expect to change that with Gozellix.

顯然，由於 Gozellix 不在我們的指導範圍內，我們還沒有給出更新的 TAM 來表明我們認為 Gozellix 將會做什麼。我認為目前我們的競爭對手和我們自己對市場規模的看法非常相似，大概在 60 萬次掃描的水平左右。我們確實看到了一些擴大市場規模的機會。您應該記住，就掃描儀佔地面積和患者佔地面積而言，美國市場可能仍有 20%——15% 到 20% 尚未達到。我們希望透過 Gozellix 來改變這種狀況。

The key attribute of Gozellix being a six-hour shelf life instead of a two-hour shelf life, which really gives us enormous reach at a nuclear pharmacy. You have to remember that the advantage of the nuclear pharmacy model is Kevin said in his Texas twang, it's locally farmed to bedside or locally farmed to scanner. What that means is that when we compound that product or when we produce that product out of a nuclear pharmacy, there's nowhere where we can't go with Gozellix.

Gozellix 的主要特點是其保質期為六小時，而不是兩小時，這確實使我們在核藥房中獲得了巨大的影響力。你必須記住，核藥房模式的優勢是凱文用他的德克薩斯口音說的，它是在當地種植到床邊或當地種植到掃描儀。這意味著，當我們配製該產品或從核藥房生產該產品時，Gozellix 無處不在。

And so we really get to pick up that patient population and it's been well studied, it's been well reported in our field that we have significant patient deserts. Patients travel two, three hours to the big smoke to get a PSMA scan, and you know we can if we can bring that to the patient, that gives us an enormous competitive advantage.

因此，我們確實能夠找到這群患者，並且這已經得到充分研究，據我們領域充分報道，我們存在大量患者缺醫少藥的情況。患者需要花兩三個小時前往大城市進行 PSMA 掃描，如果我們能為患者提供這項服務，那麼我們將擁有巨大的競爭優勢。

Okay great. Yeah, thank you so much for all that detail.

好的，太好了。是的，非常感謝您提供如此詳細的資訊。

Steve Wheen, Jarden.

史蒂夫惠恩，賈登。

Yeah, thanks very much. I just wanted to go back to the guidance slide. I'm just wondering if you might be able to help us understand in the RLS revenue, what amount has been removed for double counting purposes, giving the starting point for RLS revenues about USD158 million?

是的，非常感謝。我只是想回到指導幻燈片。我只是想知道您是否可以幫助我們了解 RLS 收入中，為了避免重複計算而刪除了多少金額，使得 RLS 收入的起點約為 1.58 億美元？

We haven't. Non-material. The RLS Illuccix component is non-material at this stage. So there isn't much to account for.

我們沒有。非物質。RLS Illuccix 組件在此階段是非物質的。因此沒有什麼好解釋的。

Okay, great. And so then the balance of the RLS revenue, just trying to understand the cost structure of that business that you've acquired, how would we think about the cost and sort of the profitability of that revenue? Obviously, it would look quite different to sort of just straight out at least 6 profitability.

好的，太好了。那麼 RLS 收入的平衡，只是試圖了解您所收購的業務的成本結構，我們如何看待該收入的成本和獲利能力？顯然，這與直接實現至少 6 個盈利能力看起來完全不同。

Yeah, so we're going to start reporting RLS as you have to remember that our acquisition has just completed. So we're going to start reporting RLS as part of the breakdown for TLX manufacturing solutions. I think for simplicity, if you exclude the impact of our product, you can assume that the RLS cost base is neutral to Telix.

是的，所以我們將開始報告 RLS，因為您必須記住我們的收購剛剛完成。因此，我們將開始報告 RLS 作為 TLX 製造解決方案細分的一部分。我認為為了簡單起見，如果排除我們產品的影響，您可以假設 RLS 成本基礎對 Telix 來說是中性的。

Okay, got it. And then there's the final question I had just to help with some of the modeling. You've obviously been so busy with a lot of acquisitions. When we look at the cost structure, I'm just talking about G&A and sales and marketing lines. When we look at that for FY24, can we divide the second half of 24 up and say that's, a lot of those costs from those acquisitions are fully baked into those lines, or is there further annualization of those costs that we need to be accounting for in FY25?

好的，明白了。最後還有一個問題，我只是想幫忙進行一些建模。顯然，您一直忙於許多收購。當我們看成本結構時，我只是在談論一般行政費用以及銷售和行銷線。當我們查看 24 財年時，我們能否將 24 年的後半部分分開，並說這些收購產生的許多成本已完全計入這些項目，還是我們需要在 25 財年對這些成本進行進一步的年化？

No, those costs are baked in. I mean, there is some headcount growth in line with our general R&D and commercial plans. I think we've given guidance to the market previously on what we think that SG&A increase will look like. But again, I mean, I know Steve, I know you're so focused on earnings and bottom line and everything, but it's just not our focus. Our focus is to reinvest everything we can back into our R&D platform, barring some reasonable risk management and balance sheet, prudence, right? So, you should expect, and I think you know the numbers are there. Darren's gone through them. I think it's going to be a continued trajectory from where we were last year.

不，這些成本已經包含在內了。我的意思是，根據我們的整體研發和商業計劃，員工人數有所成長。我認為我們之前已經向市場提供了有關銷售、一般和行政費用增長的指導。但再說一次，我的意思是，我了解史蒂夫，我知道你非常專注於收益、底線和一切，但這不是我們的重點。我們的重點是將所有精力重新投入到我們的研發平台中，除非進行一些合理的風險管理和資產負債表，這是謹慎的做法，對嗎？所以，你應該預料到，而且我想你知道這些數字就在那裡。達倫已經看過它們了。我認為這將是我們去年所處的軌跡的延續。

Okay. I mean, I'm not that focused on it. I'm focused on the top line, but I just kind of -- we've got to produce a whole thing now. So that's just helpful on that basis. Thank you.

好的。我的意思是，我並沒有那麼專注於此。我專注於營收，但我只是有點——我們現在必須生產一個完整的產品。因此，從這個角度來看，這很有幫助。謝謝。

All right.

好的。

Thanks.

謝謝。

I think we're -- I think we're past the end of the hour. So I think, if there are some remaining questions or some online questions, we had sort of a bumper attendance in this call. So we'll do a follow up separately, but maybe Kyahn, if I could hand back to you?

我想我們已經——我想我們已經過了那個小時了。所以我認為，如果還有一些剩餘的問題或一些線上問題，那麼這次電話會議的出席人數將會非常多。因此我們將分別進行跟進，但是也許 Kyahn，我可以把話交給你嗎？

Yeah, absolutely. Look, thank you very much. We have run over time. I will respond to the webcast questions and Darren and I are available today. But thanks for your attention and for tuning in.

是的，絕對是如此。瞧，非常感謝。我們已經超時了。我將回答網路直播的問題，今天我和 Darren 都有空。但感謝您的關注和收看。