Telix Pharmaceuticals Ltd (TLX) 2024 Q2 法說會逐字稿

Thank you. And thank you, everybody, for joining us today. We can just skip through our disclaimer slide there for (inaudible).

謝謝。感謝大家今天加入我們。我們可以跳過我們的免責聲明幻燈片（聽不清楚）。

If we go to slide 3, I just want to briefly introduce the agenda and the people on the call today. So we'll be taking you through the introduction and the results summary, our achievements for H1 2024, detailed financial commentary and outlook. So on the call, I'm joined by Dr. Chris Behrenbruch, our Managing Director and Group Chief Executive Officer; Darren Smith, our Group Chief Financial Officer; and David Cade, our Group Chief Medical Officer.

如果我們轉到投影片 3，我只想簡要介紹一下今天電話會議的議程和人員。因此，我們將向您介紹介紹和結果摘要、我們 2024 年上半年的成就、詳細的財務評論和展望。我們的董事總經理兼集團執行長 Chris Behrenbruch 博士也加入了我的電話會議。達倫‧史密斯 (Darren Smith)，我們的集團財務長；以及我們集團首席醫療官 David Cade。

We can turn to slide 4. Obviously, the purpose of today's briefing is to take you through our half year financial results and the detailed commentary, but also the operational achievements for the period. Once again, it's been a period of really high activity and progress across our commercial, clinical research, and manufacturing programs. And I think whenever I speak to investors, I always get the comment they say so much going on. And indeed, there has. But it's also been a period of really significant value creation. And I think we can really sum this up across three key areas of progress.

我們可以轉到投影片 4。顯然，今天簡報的目的是向您介紹我們半年的財務表現和詳細評論，以及該期間的營運成就。這又是我們的商業、臨床研究和製造專案非常活躍和進展的時期。我認為每當我與投資者交談時，我總是得到他們的評論，他們說發生了很多事情。確實有。但這也是一個真正創造重大價值的時期。我認為我們可以透過三個關鍵領域的進展來總結這一點。

Firstly being, momentum in our prostate cancer therapy program. We've released positive data and are ramping up the Phase III ProstACT GLOBAL study. We've got multiple opportunities across our precision medicine or diagnostics portfolio. We continue to deliver very strongly in terms of sales of Illuccix. We are now moving ahead with global expansion plans for that product and planned launches for three new imaging agents in the US. There's also been positive news of the proposed reimbursement reform in the US. So this all provides the platform for continued revenue growth.

首先是我們前列腺癌治療計劃的動力。我們已經發布了積極的數據，並正在加快 III 期 ProstACT GLOBAL 研究。我們的精準醫療或診斷產品組合擁有多種機會。我們持續在 Illuccix 的銷售方面表現強勁。我們現在正在推動該產品的全球擴張計劃，並計劃在美國推出三種新型顯影劑。美國擬議的報銷改革也有正面消息。因此，這一切都為持續的收入成長提供了平台。

And finally, completion of two important strategic acquisitions, which further enhance our manufacturing capabilities in line with our ongoing focus of vertical integration. So this is an investment which really is creating intrinsic value for us in the radiopharma business.

最後，完成兩項重要的策略性收購，這進一步增強了我們的製造能力，符合我們持續關注的垂直整合。因此，這是一項真正為我們放射性製藥業務創造內在價值的投資。

So we have multiple products. We have large market opportunities; we are in a growth phase. Subsequent to the half year, we did -- we completed the financing raising $650 million, which is significantly strengthened our balance sheet and provides the capacity to pursue these strategic opportunities.

所以我們有多種產品。我們有巨大的市場機會；我們正處於成長階段。半年後，我們完成了 6.5 億美元的融資，這顯著增強了我們的資產負債表，並提供了抓住這些戰略機會的能力。

So if we move to slide 5, I just want to recap here, our growth strategy, which encapsulates four pillars to continue to innovate and drive towards commercialization across our late-stage and early-stage theranostic pipeline and continue to build that step in manufacturing and supply chain. The achievements of our first half to align to this growth strategy and the strengthened balance sheet provides the capacity to really move ahead with the future plans. And Chris will talk about those in more detail later in the presentation.

因此，如果我們轉到幻燈片5，我只想在這裡回顧我們的成長策略，其中包括四個支柱，即繼續創新並推動我們的後期和早期治療診斷管道實現商業化，並繼續在製造方面踏出這一步和供應鏈。我們上半年所取得的與這項成長策略一致的成就和強化的資產負債表提供了真正推進未來計畫的能力。克里斯將在稍後的演示中更詳細地討論這些內容。

If you just move to slide 6, This shows a summary of the financial highlights that we have reported today, Darren will take you through these in detail, so I'm not going to talk through each number. But the key metrics, I think, really show -- sum up the financial story of Telix, which we are delivering a commercial profitable business while investing for future growth and continuing to create that value. I think it's been driven by strong sales ongoing focus on cost control but making really sensible and strategic investments to maximize the commercial opportunity and advance our pipeline.

如果您只是轉到投影片 6，這顯示了我們今天報告的財務要點的摘要，達倫將帶您詳細了解這些內容，因此我不會逐一討論每個數字。但我認為，關鍵指標確實表明了——總結 Telix 的財務故事，我們正在提供商業盈利業務，同時投資未來成長並繼續創造價值。我認為這是由強勁的銷售推動的，持續專注於成本控制，但做出真正明智的策略投資，以最大化商業機會並推進我們的管道。

So with that, I'd like to hand over to David to kick off the review of our operational achievements for H1.

因此，我想請 David 開始回顧我們上半年的營運成果。

Thanks very much, Ky. Glad to be with you this morning. So slide 8, moving on to our late-stage therapeutic programs, which are a critically important part of our pipeline. In summary, I think the first half of 2024 has been really characterized by the key data generated from our prostate therapy programs as well as by the progress made in the kidney and brain cancer therapy programs. And these will see further key data from these studies in the second half of this year.

非常感謝，基。很高興今天早上和你在一起。所以投影片 8，繼續我們的後期治療計劃，這是我們管道中至關重要的一部分。總之，我認為 2024 年上半年的真正特點是我們的前列腺治療計劃產生的關鍵數據以及腎癌和腦癌治療計劃的進展。這些將在今年下半年看到這些研究的進一步關鍵數據。

I think particularly pleasing was the ProstACT SELECT study, which reported an important efficacy signal in a population of patients with advanced prostate cancer. And this result was truly competitive with other radioligand therapies when they were at a similar stage of their development, particularly Pluvicto. This is a highly differentiated asset. So that's an important facet of the development of this asset. Our 591 asset was also granted an investigational new drug approval by the FDA, and that enables us to expand our ProstACT GLOBAL Phase III trial into key sites in the United States, and there's a very significant interest and desire to participate in this trial from key US investigators.

我認為特別令人高興的是 ProstACT SELECT 研究，該研究報告了晚期前列腺癌患者群體中的重要療效訊號。當其他放射性配體療法處於相似的開發階段時，這一結果確實具有競爭力，尤其是 Pluvicto。這是一種高度差異化的資產。所以這是該資產開發的一個重要面向。我們的 591 資產也獲得了 FDA 的研究性新藥批准，這使我們能夠將 ProstACT GLOBAL III 期試驗擴展到美國的關鍵地點，並且人們對參與這項試驗有非常濃厚的興趣和願望美國調查人員。

We also successfully completed the CUPID proof-of-concept study with our asset TLX592, which is our lead alpha asset. So that planning for the actinium alpha version of this asset will proceed into a first-in-human study starting later in 2024. Moving across to our kidney program. This consists of several Phase II trials with TLX250 in combination both with immunotherapies as well as with DNA damage repair inhibition and these continue to enroll and achieve important clinical milestones so that we anticipate interim clinical data becoming available later in 2024.

我們也利用我們的資產 TLX592（我們的主要 alpha 資產）成功完成了 CUPID 概念驗證研究。因此，該資產的錒 alpha 版本的規劃將在 2024 年稍後開始進行首次人體研究。轉到我們的腎臟計劃。這包括 TLX250 與免疫療法以及 DNA 損傷修復抑制相結合的多項 II 期試驗，這些試驗將繼續入組並實現重要的臨床里程碑，因此我們預計將在 2024 年晚些時候提供中期臨床數據。

And then over to the right, moving finally to our glioblastoma program, our brain cancer program, following on from the earlier IPAX-1 study of TLX101 in recurrent glioblastoma. This was recently published in Neuro-Oncology Advances. And that study demonstrated some very important disease control and survival outcomes. So our follow-on IPAX-2 trial in newly diagnosed patients is approximately 50% enrolled, and the IPAX-Linz Phase II trial in recurrent glioblastoma is now about 80% enrolled. So very well on track to complete this year. So there's going to be further data on the brain cancer front as well.

然後向右，最後進入我們的膠質母細胞瘤項目，我們的腦癌項目，這是繼早期 TLX101 在復發性膠質母細胞瘤中的 IPAX-1 研究之後進行的。這項研究最近發表在《神經腫瘤學進展》雜誌。該研究證明了一些非常重要的疾病控制和存活結果。因此，我們針對新診斷患者的後續 IPAX-2 試驗的入組率約為 50%，而針對複發性膠質母細胞瘤的 IPAX-Linz II 期試驗目前的入組率約為 80%。今年的工作進展順利。因此，還將有關於腦癌方面的更多數據。

So that's a snapshot of what we've achieved in the first half. I think it's very, very pleasing to see what we've done but further important clinical data between now and the end of the year. Over to you, Chris.

這是我們上半年所取得的成就的快照。我認為看到我們所做的事情非常非常令人高興，而且從現在到今年年底還會有更多重要的臨床數據。交給你了，克里斯。

Yeah. Thanks, David. So on the next slide, as we move on to the diagnostic imaging products, it's been a very active six months for the diagnostics business or what we increasingly refer to as our precision medicine business. We were successful with our preparation and submission for the Illuccix life cycle management product, TLX007, which we believe will bring meaningful additional clinical benefit to patients, and we look forward to talking more about that product's utility profile in the coming months, especially as it's inherently powered by the acquisition of ARTMS.

是的。謝謝，大衛。因此，在下一張幻燈片中，當我們轉向診斷影像產品時，診斷業務或我們越來越多地稱之為精準醫療業務的六個月是非常活躍的。我們成功地準備並提交了Illuccix 生命週期管理產品TLX007，我們相信該產品將為患者帶來有意義的額外臨床益處，我們期待在未來幾個月內更多地討論該產品的實用概況，特別是因為它收購 ARTMS 為其提供了內在動力。

The international registration processes for Illuccix are progressing well all across the board. And this means that our currently essentially negligible rest of world revenue is expected to undergo a material change next year. This is something that we welcome from a revenue diversification perspective, alongside our efforts around commercial product portfolio diversification.

Illuccix 的國際註冊流程全面進展順利。這意味著我們目前在世界其他地區基本上可以忽略不計的收入預計明年將發生重大變化。從收入多元化的角度來看，這是我們歡迎的事情，同時也是我們圍繞商業產品組合多元化所做的努力。

And so speaking of which, we made major progress on both the renal and brain cancer imaging front so far this year, notwithstanding a fairly minor speed bump on the FDA submission for Zircaix. Commercial readiness is going very well, and we expect to submit the updated BLA with the manufacturing issue addressed in the next few weeks. They're obviously not waiting around for the FDA. And so with our current recent capital raise, we are driving ahead indication expansion studies in the metastatic setting for both Zircaix and Pixclara. And then these are indications that we believe will significantly further increase the size of the market potential for these products should our filings and label expansion activities be successful from a regulatory perspective.

說到這裡，今年到目前為止，我們在腎癌和腦癌影像方面都取得了重大進展，儘管 Zircaix 向 FDA 提交的進展相當小。商業準備工作進展順利，我們預計將在接下來的幾週內提交更新的 BLA，並解決製造問題。他們顯然不會等待 FDA 的批准。因此，透過我們最近的融資，我們正在推動 Zircaix 和 Pixclara 在轉移環境中的適應症擴展研究。這些跡象表明，我們相信，如果我們的備案和標籤擴展活動從監管角度取得成功，這些產品的市場潛力將進一步顯著增加。

Pixclara is going to file any day now following our successful final clinical package review with the FDA. We've been granted Fast Track designation for this asset. So we expect it to progress through review relatively quickly because it's north of drug indication, and our expanded access program, or EAP, as we like to call it, is now open, which is really great because it delivers on Telix's commitment to providing access to critical medicines for unmet medical need. I should note that the EAP is also open to pediatric patients, which was a really nice gift from the FDA. Frankly, kids with brain cancer need all the help they can get from a treatment planning complexity perspective.

在我們成功向 FDA 進行最終臨床包審查後，Pixclara 將隨時提交文件。我們已獲得該資產的快速通道稱號。因此，我們預計它會相對較快地通過審查，因為它超出了藥物適應症的範圍，而且我們的擴展准入計劃（我們喜歡稱之為EAP）現已開放，這真的很棒，因為它兌現了Telix 提供准入的承諾為未滿足的醫療需求提供關鍵藥物。我應該指出，EAP 也向兒科患者開放，這是 FDA 的非常好的禮物。坦白說，患有腦癌的孩子需要從治療計劃複雜性的角度獲得所有可以得到的幫助。

Can I have the next slide, please? So from a revenue vantage and Darren Smith will talk more about this in detail, Illuccix is a -- is a product that continues to perform very well. And Telix as a commercial execution team continues to take market share in the United States, our major market for this product had a highly successful period of sustained growth, really based on our clinical supply chain and service differentiation.

我可以看下一張投影片嗎？因此，從收入的角度來看，Darren Smith 將詳細討論這一點，Illuccix 是一款繼續表現出色的產品。Telix 作為商業執行團隊繼續在美國佔據市場份額，我們該產品的主要市場有一個非常成功的持續增長期，真正基於我們的臨床供應鏈和服務差異化。

We also have uniquely a multiproduct view of how the PSMA landscape will evolve from both a clinical and a reimbursement perspective. And as most of you know, the US reimbursement landscape is quite challenging. And so next year is going to be an even more exciting year for our prostate cancer imaging franchise. We expect to see sustained growth in market share capture and the addressable market just continues to expand for this product. We've also been successful in capturing our fair share of the GPO space, and so this will also continue to support revenue growth into 2025 and 2026.

我們也從臨床和報銷的角度對 PSMA 格局將如何演變擁有獨特的多產品視角。正如大多數人所知，美國的報銷情況相當具有挑戰性。因此，對於我們的前列腺癌影像系列來說，明年將是更加令人興奮的一年。我們預計該產品的市場份額將持續成長，並且潛在市場將繼續擴大。我們也成功地獲得了 GPO 空間的公平份額，因此這也將繼續支持 2025 年和 2026 年的收入成長。

If I can have the next slide, please? So as you know and Ky mentioned in her opening comments, Telix is a highly acquisitive company, and we've had a strategic focus for around the last 18 months on building out our clinical and commercial supply chain through some highly targeted acquisitions and partnerships. And I can't emphasize enough how important this is from a commercial delivery perspective. I've mentioned ARTMS in the context of Illuccix and TLX007, but it underpins much of our commercial product portfolio, including obviously, Zircaix for the zirconium-89 as well as delivering future actinium capability to our Seneffe or South Brussels site in Belgium, which is now preparing for GMP inspections next month and then cyclotron installations for future isotope production by year end.

可以給我下一張投影片嗎？如你所知，Ky 在她的開場白中提到，Telix 是一家收購性很強的公司，在過去18 個月裡，我們的策略重點是透過一些針對性很強的收購和合作夥伴關係來建立我們的臨床和商業供應鏈。從商業交付的角度來看，我無法充分強調這一點的重要性。我在 Illuccix 和 TLX007 的背景下提到了 ARTMS，但它支撐了我們的大部分商業產品組合，顯然包括用於鋯 89 的 Zircaix 以及為我們位於比利時的 Seneffe 或南布魯塞爾工廠提供未來的錒能力，這目前正在為下個月的GMP 檢查做準備，然後在年底前為未來的同位素生產安裝迴旋加速器。

So really a ton of activity on the manufacturing slide. The isotherapeutics site in Texas has also been a pleasure to integrate in most of our bioconjugation in key radiochemistry projects and are now operated out of our Texas site. This was an absolutely stellar acquisition for Telix, particularly from a people perspective and really nicely complements our activity in Optimal Tracers in Sacramento. So for example, we recently started shipping product for an international clinical trial for one of our early-stage alpha programs. It was conjugated at ITG in Texas, radio labeled at Optimal in California and shipped to our Melbourne radio chemistry team for clinical use all under one roof. So this is a real speed and execution advantage for these very fast-moving clinical programs, not to mention really controlling the cost of clinical translation.

製造幻燈片上確實有大量活動。德克薩斯州的等治療站點也很高興能夠整合到我們關鍵放射化學項目中的大部分生物共軛中，並且現在在我們的德克薩斯站點之外運作。對於 Telix 來說，這絕對是一次出色的收購，特別是從人員的角度來看，並且確實很好地補充了我們在薩克拉門託的 Optimal Tracers 活動。例如，我們最近開始為我們的一項早期 alpha 計畫的一項國際臨床試驗運送產品。它在德克薩斯州的 ITG 進行結合，在加利福尼亞州的 Optimal 進行放射標記，然後運送到我們的墨爾本放射化學團隊，在同一屋簷下進行臨床使用。因此，對於這些快速發展的臨床計畫來說，這是真正的速度和執行優勢，更不用說真正控制臨床翻譯的成本了。

I'd probably also be remiss in not mentioning our partnerships. Long term, we expect to continue to work with key strategic partners in different geographies, including the US. However, in future growth jurisdictions like Latin America and APAC, we're deepening out ties with key strategic partners, for example, the establishment of the manufacturing joint venture in Brazil with R2 Pharma to supply locally manufactured Illuccix and other products for regional markets. And that's really about factoring in the regulatory and the commercial nuances of those specific markets.

如果我不提及我們的合作關係，那也可能是我的失職。從長遠來看，我們期望繼續與包括美國在內的不同地區的主要戰略合作夥伴合作。然而，在拉丁美洲和亞太地區等未來成長的司法管轄區，我們正在深化與主要戰略合作夥伴的聯繫，例如，與R2 Pharma 在巴西建立製造合資企業，為區域市場供應本地製造的Illuccix 和其他產品。這實際上是要考慮這些特定市場的監管和商業細微差別。

The R2 Pharma JV is particularly promising as we do still expect Illuccix's approval in Brazil any day. And these are the regulators experiencing some workforce interruptions. But as soon as that resolves we expect to get the all clear. It's South America. So it's kind of always mañana.

R2 Pharma JV 特別有前途，因為我們仍然預計 Illuccix 隨時會在巴西獲得批准。這些監管機構正在經歷一些勞動力中斷。但一旦這個問題得到解決，我們希望一切都清楚。這是南美洲。所以這總是mañana。

On that note and in summary, Darren, I will send it over to you for the finance section.

就這一點而言，總而言之，達倫，我會將其發送給您的財務部分。

Okay. Thanks, Chris. Now turning to Telix's excellent half year financial results. My key takeaways are that: firstly, built on the back of Illuccix. Telix commercial business continues its strong growth trajectory, funding our extensive R&D programs. Secondly, we remain focused on creating value for our theranostic pipeline. And thirdly, we have strengthened our balance sheet to commit further investment into enhancing our production and supply chain capabilities and to accelerate advancing our pipeline.

好的。謝謝，克里斯。現在我們來看看 Telix 出色的半年財務業績。我的主要收穫是：首先，建造在 Illuccix 的背面。Telix 商業業務持續保持強勁的成長軌跡，為我們廣泛的研發項目提供資金。其次，我們仍然專注於為我們的治療診斷管道創造價值。第三，我們加強了資產負債表，以進一步投資增強我們的生產和供應鏈能力，並加速推進我們的產品線。

Now turning to slide 13. Telix's revenue performance improved 65% in the first half of 2024 over the prior corresponding year. Kudos goes to our US commercial team who are responsible for delivering a majority of the group's revenue through the sales of Illuccix. And they continue to capitalize on the demand in the US market.

現在轉到投影片 13。Telix 2024 年上半年的營收表現比去年同期成長了 65%。感謝我們的美國商業團隊，他們透過 Illuccix 的銷售為集團帶來了大部分收入。他們繼續利用美國市場的需求。

Over the last couple of years, we have seen clinical utilization of our product to spend, leading Telix to increasing its initial total addressable market estimates by 60% to $2.4 billion, and we expect further upside through guideline evolution. This is all positive news for this year's revenue expectations, noting we have increased revenue guidance in July by 10% to $745 million to $776 million. This is an increase of approximately 50% on last year's revenue. Illuccix is looking very strong. We, firstly -- a growing US Illuccix market, ongoing geographic expansion in Europe and Asia Pacific, and then also the expected US regulatory approvals of our kidney and brain cancer precision medicine products, FDA willing, of course.

在過去的幾年裡，我們看到了我們產品的臨床使用情況，導致 Telix 將其最初的總目標市場估計增加了 60%，達到 24 億美元，我們預計透過指南的發展將進一步提高。這對今年的收入預期來說都是正面的消息，並指出我們將 7 月的營收指引提高了 10%，達到 7.45 億美元至 7.76 億美元。這比去年的收入增長了約 50%。伊魯卡看起來非常強大。我們首先是不斷成長的美國 Illuccix 市場，在歐洲和亞太地區持續的地理擴張，然後是我們的腎癌和腦癌精準醫療產品預期美國監管機構的批准，當然 FDA 願意。

Now turning to slide 14. The group's profit and loss presents our focus on growing the top line and controlling expenditure as a percentage of sales. And then strategically allocating the funds generated to build the capabilities and capacity of the business and to develop our product pipeline, building value for our shareholders. With this aim, we have been very successful.

現在轉到投影片 14。該集團的損益表明我們專注於增加收入和控制支出佔銷售額的百分比。然後策略性地分配所產生的資金，以建立業務能力和能力，並開發我們的產品線，為我們的股東創造價值。帶著這個目標，我們取得了巨大的成功。

As spoken about, we have grown the top line, which has permit us to self-fund the rapidly growing business. We have controlled costs, as demonstrated by the gross margin improving by 3% of sales in the prior year thus, optimizing funds generated. Then the planned build-out of Seneffe and the strategic acquisition of ARTMS and ITG, we are enhancing our internal manufacturing and supply chain capabilities to support our growing commercial business and our increased investment in developing our pipeline.

如前所述，我們的收入有所成長，這使我們能夠為快速成長的業務提供自籌資金。我們控制了成本，毛利率提高了上一年銷售額的 3%，從而優化了資金產生。然後，計劃擴大 Seneffe 以及策略性收購 ARTMS 和 ITG，我們正在增強我們的內部製造和供應鏈能力，以支援我們不斷增長的商業業務以及我們在開發管道方面增加的投資。

Finally, to top it all off, over the last three halves, we have taken our 2023 first half loss before tax of $12 million to be a profit of $35 million this half. Now that's a great achievement for a company whose commercial business only started two years ago.

最後，最重要的是，在過去的三個半月裡，我們將 2023 年上半年的稅前虧損 1,200 萬美元改為今年上半年的利潤 3,500 萬美元。對於一家商業業務剛起步兩年的公司來說，這是一項偉大的成就。

Now turning to slide 15. Here, we highlight the unadulterated performance of the Telix's commercial business and how it is funding Telix's growth. The first thing you'll notice is that the product revenue makes up 99% of the group's total revenue stream. The next thing you'll note is that we are improving the efficiency of our commercial expenditure. That is, we are focused on reducing costs as a percentage of sales.

現在轉到投影片 15。在這裡，我們重點介紹 Telix 商業業務的純粹績效以及它如何為 Telix 的成長提供資金。您首先會注意到的是，產品收入佔集團總收入流的 99%。接下來您會注意到我們正在提高商業支出的效率。也就是說，我們致力於降低成本佔銷售額的百分比。

This permits us to continue to invest in growth, increasing dollars invested while improving the cents per dollar earned from sales we generate for Telix. As a result, the commercial business' operating profit improved 86% over the prior corresponding half to $175 million, representing $0.49 in the dollar of sales. Now that's leverage. And that's what funds the rest of the business.

這使我們能夠繼續投資於成長，增加投資金額，同時提高 Telix 銷售額的每美元收入。結果，商業業務的營業利潤比去年同期成長了 86%，達到 1.75 億美元，相當於銷售額 0.49 美元。現在這就是槓桿。這就是其餘業務的資金來源。

Now turning to slide 16 and Telix's cash flow for the half. While the company's cash position has remained relatively flat for the half, we did a lot with it. As per the previous slide, the commercial business generated $175 million. We then invested $136 million back into developing our pipeline and building the business' infrastructure to support future growth. This resulted in a respectable positive operating cash flow of approximately $39 million. These funds were then used to acquire strategic businesses and to enhance Telix's in-house production and supply chain capabilities and into further pipeline expansion.

現在轉向幻燈片 16 和 Telix 的一半現金流。儘管公司的現金狀況在上半年保持相對平穩，但我們還是做了很多事情。根據上一張投影片，商業業務創造了 1.75 億美元的收入。然後，我們投資 1.36 億美元用於開發產品線和建造業務基礎設施，以支持未來的成長。這帶來了約 3900 萬美元的可觀的正營運現金流。這些資金隨後用於收購策略業務​​、增強 Telix 的內部生產和供應鏈能力以及進一步的管道擴張。

Obviously, there is still significant investment opportunities until for Telix in this rapidly growing pharmaceutical market. So in July, we raised $650 million in convertible bonds. Obviously, this placement significantly strengthens Telix's balance sheet and permit us to pursue appropriate strategic opportunities as and when they arise.

顯然，在這個快速成長的醫藥市場中，Telix 仍然存在著重大的投資機會。因此，我們在 7 月籌集了 6.5 億美元的可轉換債券。顯然，這次配售極大地增強了 Telix 的資產負債表，並使我們能夠在適當的策略機會出現時尋求它們。

Now turning to slide 17 and an overview of Telix's pipeline investment. R&D is at the heart of Telix's future value creation. And as such, Telix places considerable focus and resources, 23% of revenue this half into this area of the business. During the half, we focused on the US regulatory submission with three new precision medicine assets in kidney, brain, and prostate cancer. We expect to have these products on market next year, availing us to an aggregated total addressable market of approximately $4.5 billion for Telix.

現在轉向幻燈片 17，概述 Telix 的管道投資。研發是 Telix 未來價值創造的核心。因此，Telix 投入了大量的精力和資源，今年一半的收入中有 23% 投入了這個業務領域。上半年，我們重點關注了腎癌、腦癌和前列腺癌三項新的精準醫療資產向美國監管機構提交的申請。我們預計這些產品將於明年上市，為 Telix 帶來總計約 45 億美元的潛在市場。

Telix has also made significant progress and investment with its ProstACT GLOBAL Phase III clinical trial and in a number of other therapeutic assets. Over the coming years, the therapeutic assets will become an increasing proportion of the company's R&D investment. For this year, we remain on plan and reaffirm our R&D investment guidance.

Telix 也透過其 ProstACT GLOBAL III 期臨床試驗和許多其他治療資產取得了重大進展和投資。未來幾年，治療資產在公司研發投入中所佔比例越來越大。今年，我們仍按計劃進行，並重申我們的研發投資指引。

Okay, Chris, back to you to take us through the outlook for the business.

好的，克里斯，現在請您帶我們展望一下業務前景。

Yeah. Thanks very much Darren. And I just note in passing, as additional comment on the finance side of things. That we post our results after market close just to enable both Australian and US shareholders to digest our financial results. So we think this is important given the significant US shareholding of the company and interest from US investors and strategic partners.

是的。非常感謝達倫。我只是順便指出，作為對財務方面的補充評論。我們在收盤後發布業績只是為了讓澳洲和美國股東能夠消化我們的財務表現。因此，考慮到該公司在美國擁有大量股權以及美國投資者和戰略合作夥伴的興趣，我們認為這一點很重要。

So moving to outlook and what's coming down the path on the next slide, please. So further elaborating Ky's earlier strategy slide, over the next six months, you're going to see a very significant transformation of Telix enabled by our recent highly successful financing, The really main -- there are really four main areas of focus, and we are currently reorganizing ourselves around these execution themes.

請前往 Outlook 以及下一張投影片中的內容。因此，進一步闡述Ky 早期的戰略幻燈片，在接下來的六個月中，您將看到Telix 通過我們最近非常成功的融資而實現的非常重大的轉變，真正的主要- 有四個主要關注領域，我們目前正在圍繞這些執行主題重組我們自己。

Firstly, our prostate glio and brain cancer therapy study for our beta-emitting therapeutic products, such as those based on the TSM177, made really a lot of progress this year, as David previously outlined, particularly our ProstACT GLOBAL study, which is now recruiting in the US and APAC and is expected to be extended into other commercially important jurisdictions this year and early next year.

首先，正如David 先前概述的那樣，我們針對β 發射治療產品（例如基於TSM177 的產品）的前列腺膠質細胞和腦癌治療研究今年取得了很大進展，特別是我們的ProstACT GLOBAL 研究，該研究目前正在招募在美國和亞太地區，預計將在今年和明年初擴展到其他具有重要商業意義的司法管轄區。

With our significantly enlarged balance sheet, we are focused on pushing brain and renal cancer, imaging products, therapeutic products started towards pivotal trials in the back half of this year. So again, just to reemphasize, that's about pushing the rest of our kind of mid-stage pipeline in renal and brain cancer towards pivotal trials in a very near-term viewpoint.

隨著我們的資產負債表顯著擴大，我們專注於推動腦癌和腎癌、影像產品、治療產品在今年下半年開始進行關鍵試驗。再次強調，從近期的角度來看，這就是將我們腎癌和腦癌的中期研發管線的其餘部分推向關鍵試驗。

On the early-stage development front, Telix now has multiple alpha-emitter candidates in the clinic, which is really super exciting. There's a growing body of evidence that biologics are an ideal delivery vector for alpha emitters due to their selectivity and lack of renal excretion and so 2025 is going to hopefully be data-rich in terms of progress and outcomes for those assets too, particularly our actinium prostate cancer product, which safely completed dose escalation in pharmacology studies in humans this year. That was the CUPID study.

在早期開發方面，Telix 現在在臨床上擁有多個 alpha 發射體候選藥物，這真的非常令人興奮。越來越多的證據表明，生物製劑因其選擇性和缺乏腎臟排泄而成為 α 發射體的理想輸送載體，因此 2025 年有望在這些資產的進展和結果方面擁有豐富的數據，特別是我們的錒前列腺癌產品，今年安全地完成了人體藥理學研究的劑量遞增。這就是丘比特研究中心（CUPID）。

I've already mentioned our initiatives around the precision medicine portfolio. And again, with our current war chest, we're not going to hold back on indication expansion for the two major follow-on products Pixclara and Zircaix, which can essentially double the market potential of those assets, subject to regulatory approvals. Obviously, international expansion remains a priority across the board, including for Illuccix, as I've already outlined earlier in the presentation.

我已經提到了我們圍繞精準醫療產品組合的舉措。再說一遍，憑藉我們目前的資金，我們不會阻止兩個主要後續產品 Pixclara 和 Zircaix 的適應症擴張，這基本上可以使這些資產的市場潛力翻倍，但須經監管部門批准。顯然，國際擴張仍然是全面的優先事項，包括 Illuccix，正如我之前在演示中概述的那樣。

Finally, we've made significant inroads into our strategic vertical integration strategy. We're not quite done yet with this but -- so that's part of the premise for the capital raise, and we look forward to keeping you informed of our progress on this front over the coming months.

最後，我們在策略性垂直整合策略方面取得了重大進展。我們還沒有完全完成這件事，但是——所以這是籌集資金的前提的一部分，我們期待在未來幾個月內隨時向您通報我們在這方面的進展。

By the way, I'd probably be remiss as the CEO, not noting that we are hiring. So we're looking for talent across the board, commercial and scientifically and clinically. So if you're listening to this call and believe like we do that radiopharma is the hottest new area of oncology. Please do check out our career page on our website.

順便說一句，作為首席執行官，我可能會失職，沒有註意到我們正在招聘。因此，我們正在尋找全面的人才，包括商業、科學和臨床方面的人才。因此，如果您正在聽這個電話並且像我們一樣相信放射性製藥是腫瘤學最熱門的新領域。請查看我們網站上的職業頁面。

All right. Moving on to the next slide. This slide nicely illustrates straight to the growth and expansion of our pipeline, including the addition of several alpha programs, as I mentioned, which are now clinical stage as well as our newer musculoskeletal franchise around sarcoma and bone metastases, the results a mixture of both life cycle management and new disease areas with significant market opportunities attached to them. Over the next six months, we'll be talking a lot more about how Telix is focused on our therapeutic business again, enabled by our balance sheet, positions us as a leading player in this space with significant portfolio differentiation.

好的。轉到下一張投影片。這張投影片很好地直接說明了我們管道的增長和擴展，包括添加了幾個alpha 項目，正如我所提到的，這些項目現在處於臨床階段，以及我們圍繞肉瘤和骨轉移的新肌肉骨骼專營權，結果混合了兩者生命週期管理和具有重大市場機會的新疾病領域。在接下來的六個月中，我們將更多地討論Telix 如何在我們的資產負債表的支持下再次專注於我們的治療業務，使我們成為該領域的領先企業，並具有顯著的投資組合差異化。

I have the next slide, please. Again, however, despite the financial, clinical and execution focus around our therapeutic pipeline, we remain highly committed to our precision medicine business. We think it's a differentiator. We think it's important to the field of radiopharma, and this clearly illustrates how we believe we can get to a couple of billion dollars of revenue over the next few years just through what we've already developed. So what we've completed clinical development around -- let alone what is coming down the pathway from a therapeutic perspective.

我有下一張投影片。然而，儘管財務、臨床和執行重點圍繞著我們的治療管道，但我們仍然高度致力於我們的精準醫療業務。我們認為這是一個差異化因素。我們認為這對放射性製藥領域很重要，這清楚地說明了我們如何相信，透過我們已經開發的產品，我們可以在未來幾年內獲得數十億美元的收入。因此，我們已經完成了臨床開發，更不用說從治療角度來看即將發生的事情了。

I note in particular that the return on capital for the indication expansion activities, which is probably in the $25 million to $30 million range over the next couple of years is just a huge return and gives us further financial means and incentives to vertically integrate as well as double down on our investment in pipeline expansion, both in terms of diagnostics and therapeutics.

我特別注意到，適應症擴展活動的資本回報率在未來幾年內可能在 2500 萬至 3000 萬美元範圍內，這是一筆巨大的回報，並為我們提供了進一步的財務手段和垂直整合的動力我們在診斷和治療方面雙倍加大對管道擴張的投資。

And certainly, guideline-driven growth will continue to take place across the whole portfolio as the practice of medicine is currently undergoing a major transformation through the use of molecular imaging. We can see this happening in prostate cancer today, and it will invariably happen in other disease areas, too. And that growth doesn't even factor in the potential upside of things like bringing molecular imaging into the operating theater such as through our acquisition of Lightpoint Medical.

當然，隨著分子影像的使用，醫學實踐目前正在經歷重大轉變，整個產品組合將繼續出現指南驅動的成長。今天我們可以看到這種情況發生在前列腺癌中，它也將不可避免地發生在其他疾病領域。這種成長甚至沒有考慮到諸如透過收購 Lightpoint Medical 將分子影像帶入手術室等潛在的好處。

If I can have the next slide, please. So this slide summarizes in a nutshell what our organic and inorganic growth has delivered to patients, customers and shareholders. We are an utterly unique company that understands intuitively that integrated capabilities in precision medicine, medtech, and command over our supply chain and manufacturing capabilities deliver really outstanding outcomes for patients and shareholders.

請給我下一張投影片。因此，這張投影片簡要地總結了我們的有機和無機成長為患者、客戶和股東帶來的成果。我們是一家完全獨特的公司，直觀地理解精準醫療、醫療技術的綜合能力以及對我們供應鏈和製造能力的控制可以為患者和股東帶來真正出色的成果。

At the heart of Telix, as it's currently evolving, is our therapeutics business that is enabled by a patient-centric treatment approach, deep understanding of clinical workflows, and of course, digital health, and the last mile product delivery capabilities that we've established globally. No other company in our space has this mixture of capabilities like we do.

Telix 目前正在不斷發展，其核心是我們的治療業務，該業務透過以患者為中心的治療方法、對臨床工作流程的深入了解、當然還有數位健康以及我們擁有的最後一英里產品交付能力來實現。在我們這個領域，沒有其他公司像我們一樣擁有如此多的能力。

This slide, in some respects marks the milestone in Telix development in terms of how we are organized commercially and technologically. And we're looking forward over the coming months to reveal kind of new Telix strategy and, of course, the leadership structure to deliver that revolves around these areas of focus and cross-functional collaboration.

在某些方面，這張投影片標誌著 Telix 開發在商業和技術組織方式方面的里程碑。我們期待在未來幾個月內公佈新的 Telix 策略，當然還有圍繞這些重點領域和跨職能協作實現這一目標的領導結構。

Can I have the next slide? So tying the prior slide to our execution expectations for the year on a segmental basis, you can start to get a sense of how our strategy is playing out both in terms of what we have achieved so far, but also what is yet to happen in the coming months. There's still a very big list left in 2024. And although we've kicked off some key -- picked off some key items in the first half, the second half of this year has some very significant inflection points around revenue and geographic expansion as well as clinical outcomes. So there's still lots to look forward to.

我可以看下一張投影片嗎？因此，將先前的投影片與我們對今年的執行預期進行分段聯繫起來，您可以開始了解我們的策略是如何發揮作用的，既包括我們迄今為止所取得的成就，也包括我們尚未發生的事情。2024 年還有一個非常大的清單。儘管我們在上半年已經啟動了一些關鍵項目，但今年下半年在收入、地理擴張以及臨床結果方面出現了一些非常重要的轉折點。所以還有很多值得期待的地方。

Thanks again for your attention and the opportunity to give you this update on all of our progress activities and growth. I'll now open it up to questions.

再次感謝您的關注並有機會向您提供有關我們所有進展活動和成長的最新資訊。現在我將開放提問。

(Operator Instructions) Laura Sutcliffe, UBS.

（操作員說明）Laura Sutcliffe，UBS。

Hello. Thank you for taking the questions. Firstly, could you talk a little bit about whether the market penetration of Illuccix in the US as it stands is uniform or whether some groups are receiving essentially those scans, while some are getting several times more than average? Or maybe to put it another way, could we be mistaken what looks like quite a well-penetrated market with something that has a lot of potential left? I'm really asking about original Illuccix. So just to keep the question simple, I'm ignoring any TAM you could add with 007?

你好。感謝您提出問題。首先，您能否談談 Illuccix 在美國的市場滲透率是否均勻，或者是否有些群體基本上接受了這些掃描，而有些群體的掃描數量是平均水平的幾倍？或者換句話說，我們會誤以為這個市場看起來滲透率很高，但實際上還有很大的潛力？我真的想問關於原始 Illuccix 的事情。因此，為了簡單起見，我忽略了您可以在 007 中添加的任何 TAM？

Yeah, I think it's an interesting question. So I mean, as we've talked about in the past, the market dynamic, the commercial dynamic in the US is shifting away from winning individual account business to IDN and group purchasing organization. So that inherently means that the sort of landscape of customer acquisition goes from being fairly granular to being much larger scale. So it's possible to pick up and win much larger swaths of business or take it away from competition in that mature market model.

是的，我認為這是一個有趣的問題。所以我的意思是，正如我們過去談到的，美國的市場動態、商業動態正在從贏得個人帳戶業務轉向 IDN 和團購組織。因此，這本質上意味著客戶獲取的格局從相當細粒度轉變為規模更大。因此，有可能獲得並贏得更大範圍的業務，或在成熟的市場模式中將其從競爭中奪走。

So penetration and ability to acquire market share aren't necessarily correlated. I think specifically on the penetration issue, we still see a fairly large concentration of PSMA imaging in major metropolitan areas, major academic centers. There's still opportunities for penetration in the community setting. We think that's inherently one of our advantages. And in fact, if you look at our relative growth to our competition, I think we demonstrate that, that advantage is being realized.

因此，滲透率和獲得市場份額的能力並不一定相關。我認為特別是在滲透問題上，我們仍然看到 PSMA 成像相當多地集中在主要大都市地區、主要學術中心。社區環境仍有滲透的機會。我們認為這本質上是我們的優勢之一。事實上，如果你看看我們相對於競爭對手的成長，我認為我們證明了這一優勢正在實現。

Nobody wants to travel two, three hours to the big smoke to get a scan. And so as Kevin Richardson our venerable leader of the US business and a Texan. So I can't do this with text and draw, I won't even attempt, but the ability to deliver PSMA kind of locally farmed to scanner is a real advantage for patients. And so we're going to see more and more shift, I think, of PSMA imaging being utilized in the community setting.

沒有人願意花兩三個小時到大煙霧處進行掃描。凱文·理查森 (Kevin Richardson) 也是我們德高望重的美國商界領袖，他是德克薩斯人。所以我不能用文字和繪圖來做到這一點，我什至不會嘗試，但將本地種植的 PSMA 傳送到掃描儀的能力對患者來說是一個真正的優勢。因此，我認為，我們將看到 PSMA 成像在社區環境中的使用發生越來越多的轉變。

And that's where the nuclear pharmacy distribution model has a very big advantage. Does that answer your question satisfactorily?

而這正是核能藥房分銷模式具有非常大優勢的地方。這是否滿意地回答了您的問題？

Yeah, sure. And then I was also staying on the prostate cancer theme but moving to 591. Wondering whether the infrastructure and the relationships that you've built for Illuccix and the financial resources that you've now got give you a bit of optionality around whether to try and market 591 yourselves or seek a partner if assuming it comes to market?

是的，當然。然後我也停留在前列腺癌主題上，但轉向了 591。想知道您為 Illuccix 建立的基礎設施和關係以及您現在擁有的財務資源是否為您提供了一些選擇權，讓您可以自己嘗試行銷 591，還是在假設 591 上市時尋求合作夥伴？

We haven't really given guidance on that, but I mean you would have to appreciate, Laura, that we've built a very, very capable commercial team and we're delivering on a large-scale indication already, which is sort of rather atypical for a biopharma, a small biotech company. I think that as we add Zircaix and Pixclara to the mix, we get a lot of operating leverage. Darren's talked about that. And so we build a sales force that really has a ton of firepower. And the most important thing is that we are delivering.

我們還沒有真正就此提供指導，但我的意思是，勞拉，你必須感謝我們已經建立了一支非常非常有能力的商業團隊，並且我們已經提供了大規模的指示，這有點像對於一家小型生技公司來說，這是非常不典型的生物製藥公司。我認為，當我們將 Zircaix 和 Pixclara 添加到其中時，我們將獲得很大的營運槓桿。達倫談到這一點。因此，我們建立了一支真正擁有強大火力的銷售團隊。最重要的是我們正在交付。

Now there's a strong nexus between Illuccix and the currently approved PSMA therapy in the market. We deliver Illuccix to those customers every single day. So and the -- the majority of Pluvicto therapies that are done are selected with an Illuccix scan. And so we already have a nexus with that customer base. So I think we have -- I'm not going to commit one way or another because I don't think at this point it's commercially prudent to do that, but we are not lacking in capabilities to commercialize our products.

現在，Illuccix 與目前市場上批准的 PSMA 療法之間存在著緊密的聯繫。我們每天都向這些客戶提供 Illuccix。因此，大多數 Pluvicto 療法都是透過 Illuccix 掃描進行選擇的。因此，我們已經與該客戶群建立了聯繫。所以我認為我們——我不會做出這樣或那樣的承諾，因為我認為目前這樣做在商業上並不明智，但我們並不缺乏將我們的產品商業化的能力。

Okay. Thanks. And then maybe just one final one. Could you talk a little bit about the opportunity that you see in Brazil? If I remember correctly, it's a heavily tender-driven market for drugs, but I don't know how -- if that applies to these types of diagnostics? And is it a market you're interested in beyond the Illuccix once you've built some capability there?

好的。謝謝。然後也許只是最後一件事。您能談談您在巴西看到的機會嗎？如果我沒記錯的話，這是一個嚴重由招標驅動的藥品市場，但我不知道如何——這是否適用於這些類型的診斷？一旦您在 Illuccix 上建立了一些能力，您還會對這個市場感興趣嗎？

Look, our goal -- I mean, Brazil itself is -- it's really about a partnership around delivering access to our medicines sort of more broadly in Latin America. Brazil is a substantial market. As you know, there's a lot of prostate cancer in Brazil and Latin America generally. We obviously want to service patients globally. I think it's fair to say that outside of the United States, there's probably 20 jurisdictions that can be somewhere between $5 million and $20 million a year in revenue for us.

聽著，我們的目標——我的意思是巴西本身——實際上是圍繞著在拉丁美洲更廣泛地提供我們的藥品建立夥伴關係。巴西是一個巨大的市場。如您所知，巴西和拉丁美洲普遍存在大量前列腺癌。我們顯然希望為全球患者提供服務。我認為可以公平地說，在美國以外，可能有 20 個司法管轄區每年可為我們帶來 500 萬至 2,000 萬美元的收入。

We see a scenario where maybe three years from now that maybe we can achieve something like 30% to 40% rest of WORLDS relative to the US market. So whatever we're doing in the US, sort of about 30% to 40% of that can be in the Rest of World. And there are some key jurisdictions like Brazil, like Japan, like some of the larger European countries where the majority of that contribution will come from. And so that's why we continue to persist in developing those relationships.

我們看到這樣一種情況，也許三年後，我們可以實現世界其他地區相對於美國市場 30% 到 40% 的目標。因此，無論我們在美國做什麼，其中大約 30% 到 40% 可以在世界其他地區進行。還有一些關鍵司法管轄區，如巴西、日本和一些較大的歐洲國家，其中大部分捐款將來自這些國家。這就是我們繼續堅持發展這些關係的原因。

And the R2 Pharma relationship in Brazil is also a bit special because from a regulatory perspective, Brazil tends to be sort of a gateway country to other Latin American countries. So -- it's not just about what we do in Brazil potentially once we get an ANVISA approval. And we're confident we'll get an ANVISA approval. We're really in an administrative process right now. But once that approval comes through, it kind of opens up the whole continent and it's a nice incremental revenue to have.

R2 Pharma 在巴西的關係也有點特殊，因為從監管角度來看，巴西往往是通往其他拉丁美洲國家的門戶國家。因此，這不僅僅是我們獲得 ANVISA 批准後我們在巴西可能做什麼的問題。我們有信心獲得 ANVISA 批准。我們現在確實處於行政程序中。但一旦獲得批准，整個大陸就打開了大門，這是一筆不錯的增量收入。

Thanks very much.

非常感謝。

Shane Storey, Wilsons Advisory.

肖恩·斯托里，威爾遜諮詢公司。

Yeah. Good morning, everyone. I was hoping to start with the therapeutic programs as you can see in the investor deck, you've reiterated the intention to do an interim analysis on global first half of '25, I can see also the site activation sort of happening in the US, but I wondered if you could comment, please, on trial enrollment elsewhere and just how that interim cohort kind of comes into the 10 over the next measure six to nine months. Thanks.

是的。大家早安。我希望從治療計劃開始，正如您在投資者平台中看到的那樣，您重申了對 25 年全球上半年進行中期分析的意圖，我還可以看到美國正在發生的網站激活，但我想知道您是否可以評論一下其他地方的試驗註冊情況，以及在接下來的六到九個月內，臨時隊列如何進入10 名。謝謝。

Yeah, we don't really give kind of blow-by-blow progress on clinical trials. So yes, we still are expecting to put out some interim results next year, somewhere around the middle of the year. Site ramp up site activation is going well. Obviously, there's clinicaltrials.gov is not like a perfect in-sync summary of where we're going, but we certainly are adding sites constantly. So we have a good number of US and APAC sites that are ramping up, and we do expect -- we're still working from a regulatory perspective to be able to add European and other countries towards back half of this year and early next year.

是的，我們並沒有真正提供臨床試驗的詳細進展。所以，是的，我們仍然期望明年（年中左右）公佈一些中期業績。網站升級網站啟動進展順利。顯然，clinicaltrials.gov 並不像我們要去的地方的完美同步總結，但我們肯定會不斷添加網站。因此，我們有大量的美國和亞太地區站點正在增加，我們確實預計 - 我們仍在從監管角度進行工作，以便能夠在今年下半年和明年初添加歐洲和其他國家。

So there's plenty of -- I think qualitatively, there's plenty of demand for the trial. it's viewed as a really exciting study just because of the differentiation in the asset. And of course, now that the market is getting more informed about PSMA therapeutics and an understanding of some of the strengths and limitations of different approaches, we turn up with something that's really novel and clinically interesting. So I think it's fair to say that we've been delighted with the response on the study. I don't know, David, if you want to add anything to that from a clinical perspective.

因此，我認為從品質上來說，對試驗的需求很大。僅僅因為資產的差異性，它就被視為一項非常令人興奮的研究。當然，現在市場對 PSMA 療法有了更多的了解，並了解了不同方法的一些優點和局限性，我們發現了一些真正新穎且臨床上有趣的東西。因此，我認為可以公平地說，我們對這項研究的反應感到高興。我不知道，大衛，你是否想從臨床角度補充這一點。

Look, thanks, Chris and its David. Shane, thanks for the question. Yeah, all I would add is that -- I think the key global investigators in North America, Europe, and Australia are very familiar with what peptide-based radioligand therapies can achieve in prostate cancer. And so there's two sort of dynamics going on. Number one is that there aren't any significant competing Phase III trials competing for the same population of patients at the moment. So it's a very opportune time to enroll patients to a trial like ProstACT GLOBAL.

聽著，謝謝克里斯和大衛。謝恩，謝謝你的提問。是的，我要補充的是——我認為北美、歐洲和澳洲的主要全球研究人員非常熟悉基於勝肽的放射性配體療法在前列腺癌中的效果。因此，存在兩種動態。第一是目前沒有任何重要的 III 期試驗針對相同的患者群體進行競爭。因此，現在是招募患者參加 ProstACT GLOBAL 這樣的試驗的絕佳時機。

And then the second dynamic is that these are differentiated asset. So the key investigators that have reported in the literature over the last couple of years, VISION and the subsequent trials are very I think academically and scientifically interested to know whether a different delivery vector, an antibody approach will bring therapeutic benefit beyond what we've already seen. So there's a very high scientific interest in a differentiated asset approach and that extends to the patients that we've consulted for this trial.

第二個動態是這些是差異化資產。因此，過去幾年在文獻、VISION 和隨後的試驗中報告的主要研究人員在學術和科學上都非常感興趣，他們想知道不同的遞送載體、抗體方法是否會帶來超出我們現有範圍的治療益處。因此，人們對差異化資產方法具有非常高的科學興趣，而這種興趣也延伸到了我們為本次試驗諮詢的患者。

Yeah. And just one other thing. There's a lot of data that's coming out now, Shane. So we've got the two-year follow-up on VISION trial from Pluvicto that showed 40% of patients have renal insufficiency. And that's something that I've been talking about for, as you well know, for years and years about how we have to think about clearance organ pharmacology when we do radioligand therapy. So again, we come to the table with a proposition around a more intensive treatment that we hope will give a better overall survival and a better dosing -- better clinical experience for patients but also something that we also hope will have better long-term outcomes for patients given that prostate cancer patients are living longer and longer, right?

是的。還有一件事。肖恩，現在有很多數據出來。我們對 Pluvicto 的 VISION 試驗進行了兩年的隨訪，結果顯示 40% 的患者患有腎功能不全。如您所知，這就是我多年來一直在談論的問題，即我們在進行放射性配體治療時必須如何考慮清除器官藥理學。因此，我們再次提出了圍繞更強化治療的建議，我們希望這種治療能帶來更好的整體存活率和更好的劑量——為患者帶來更好的臨床體驗，但我們也希望能獲得更好的長期結果鑑於前列腺癌患者的壽命越來越長，對吧？

My last one, maybe for Darren. I just noticed on -- in the investor debt to capital expenditure, they just noted at $22.6 million, which is obviously higher than just the TP&E number. in the cash flow. But -- So I was just hoping that Darren could maybe unpack that a little bit. And then maybe I'm also trying to consider talking about vertical integration and how to think about sort of infrastructure investments over the next two or three years? Thank you.

我的最後一篇，也許是給達倫的。我剛剛注意到，在投資者債務與資本支出之比中，他們剛剛指出為 2,260 萬美元，這顯然高於 TP&E 數字。在現金流中。但是——所以我只是希望達倫能夠稍微解開這個問題。然後也許我也在嘗試考慮談論垂直整合以及如何考慮未來兩三年的基礎設施投資？謝謝。

Yeah, sure, Shane. So obviously, capital expenditure, part of it is just the finalization of the build-out or the continued build-out of the Seneffe manufacturing site. So that's a part of it. The other component is actually acquisition of some sourced materials for isotopes, it's more of kind of an insurance policy to make sure that we have access to the appropriate materials we need to continue our progress and development. So they're kind of the key two items that make up that (inaudible) I miss your -- part of your question.

是的，當然，肖恩。顯然，資本支出的一部分只是用於完成擴建或繼續擴大 Seneffe 製造基地。這就是其中的一部分。另一個組成部分實際上是獲取一些同位素原材料，這更像是一種保險政策，以確保我們能夠獲得繼續進步和發展所需的適當材料。因此，它們是構成（聽不清楚）我想念您問題的一部分的關鍵兩項。

Maybe on the manufacturing -- I mean, Darren is being a bit coy, but we do buy a large amount of raw material. We buy we're a kilo quantity buyer of ytterbium for making lutetium. We have raw materials. We have -- we buy all of the ultra-pure metals to make large quantities of zirconium-89 gallium, copper-64, we're really focused on building that radio metal infrastructure. So that does require some inventory investment.

也許在製造方面——我的意思是，達倫有點害羞，但我們確實購買了大量原料。我們購買一公斤的鐿買家，用於製造镥。我們有原料。我們購買了所有超純金屬來製造大量的鋯 89 鎵、銅 64，我們真正專注於建造無線電金屬基礎設施。所以這確實需要一些庫存投資。

Just in terms of future vertical integration, I mean we haven't given much guidance on that. But clearly, there was a delta in capital raise sort of expectations between what we put out in the F1 versus where we landed with the convertible bond. So we do have some specific investments in mind, and we'll keep the market informed about that in the coming months.

就未來的垂直整合而言，我的意思是我們還沒有對此給予太多指導。但顯然，我們在 F1 中投入的資金與我們透過可轉換債券獲得的資金之間存在一定的資本籌集預期差異。因此，我們確實考慮了一些具體的投資，我們將在未來幾個月內向市場通報這種情況。

Thanks, Christian. That's all I had.

謝謝，克里斯蒂安。這就是我所擁有的一切。

Thanks, Shane.

謝謝，謝恩。

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特，TD·考恩。

Hi. This is Nick on for Tara. Thanks for taking our question. Congrats on the progress in the first half. My question is around Zircaix and Pixclara. And really, can you discuss your expectations for the launch of these two diagnostics given that these will be the first approved targeted PET diagnostics in their respective indications? Thanks.

你好。這是塔拉的尼克。感謝您提出我們的問題。恭喜上半年的進展。我的問題是關於 Zircaix 和 Pixclara 的。事實上，鑑於這兩種診斷方法將是各自適應症中第一個獲得批准的靶向 PET 診斷方法，您能否討論一下您對推出這兩種診斷方法的期望？謝謝。

Yeah. Look, we're very optimistic about these assets. The urologist has had a spectacular couple of years with PET and really in PSMA has just informed that referral physician segments so well about what the benefits are of molecular imaging and patient management. And if you look at the indications that we're working towards on Zircaix, which is really around in determining renal masses and detection and staging. These have a lot of similarities to the indications that we have in prostate cancer.

是的。看，我們對這些資產非常樂觀。這位泌尿科醫生在 PET 領域度過了輝煌的幾年，實際上在 PSMA 中，他剛剛告知轉診醫生部門，他們非常了解分子成像和患者管理的好處。如果你看看我們正在 Zircaix 上努力的跡象，你會發現它確實在確定腎臟品質、檢測和分期方面發揮著重要作用。這些與前列腺癌的適應症有許多相似之處。

And then you can well imagine, well, if you look at the market evolution in prostate cancer, right now, we're seeing -- we're seeing much more use of PSMA imaging around surveillance and therapy monitoring and therapy response assessment. So that's clearly the future of where the renal cancer space can go as well and that's a vast market opportunity that's not even reflected in the market opportunity, in the sort of the TAM analysis that we put out, which I think are very conservative and defensible, given the indications that we kind of have on foot at the moment.

然後你可以很好地想像，如果你看看前列腺癌的市場演變，我們現在看到——我們看到 PSMA 影像在監測、治療監測和治療反應評估方面有更多的使用。因此，這顯然也是腎癌領域的未來發展方向，這是一個巨大的市場機會，甚至沒有反映在市場機會中，在我們推出的 TAM 分析中，我認為這是非常保守和站得住腳的。 ，鑑於目前我們有點步行的跡象。

And the nice thing about -- I mean the reason why we built a sales force to go after prostate cancer, frankly, from the very beginning was because we have a product portfolio strategy that we will have next year, early next year, we'll have a renal cancer product in the market, which is the same referral physicians. So we're currently foot soldering the urology space very effectively. It's a natural touch point.

好的一點是——我的意思是，坦率地說，我們從一開始就建立一支銷售隊伍來應對前列腺癌，是因為我們有一個產品組合戰略，我們將在明年、明年初實施，我們”市面上有腎癌產品，這是相同的推薦醫生。因此，我們目前正在非常有效地焊接泌尿外科領域。這是一個自然的接觸點。

We do have an expanded access program right now running in the US at 25 sites. That's primarily an access to medicine strategy, obviously, but it does contribute to physician awareness as to where the product is going and what it can do. And so we expect a really rapid adoption of the kidney cancer product. And it's just very highly aligned with what we are experiencing and what we've accomplished with Illuccix.

我們目前確實有一個擴展訪問計劃在美國的 25 個站點運行。顯然，這主要是一種獲得藥物的策略，但它確實有助於提高醫生對產品的方向和作用的認識。因此，我們預計腎癌產品將得到真正快速的採用。它與我們正在經歷的事情以及我們透過 Illuccix 所取得的成就高度一致。

So if you look at the ramp-up of PSMA imaging generally, but our ramp-up of the Illuccix specifically, I think that we should expect to see really good growth on launch of Zircaix. And there's been no shortage of opportunities to take the podium. We've probably done 20 or 30 major medical conferences this year, educating about what role PET imaging can play in renal cancer. And as you note, we have a blue ocean in terms of competitive landscape there.

因此，如果你總體上觀察 PSMA 成像的增長，特別是 Illuccix 的增長，我認為我們應該期望在 Zircaix 推出時看到真正良好的增長。而且不乏登上頒獎台的機會。今年我們可能已經舉辦了 20 或 30 場大型醫學會議，宣傳 PET 影像在腎癌中的作用。正如您所指出的，就競爭格局而言，我們擁有一片藍海。

On the Pixclara side of things, that's a very compact market. You can sort of count on a few pairs of hands, the number of centers in the US that are really the centers of excellence from a tertiary referral neuro-oncology perspective, that means that you've got a high degree of concentration in specific customers.

在 Pixclara 方面，這是一個非常緊湊的市場。你可以依靠幾雙手，從三級轉診神經腫瘤學的角度來看，美國有多少中心是真正的卓越中心，這意味著你高度關注特定客戶。

Again, expanded access is available today. So we -- we're grateful for the support we've had from the FDA in terms of making product availability in advance of market launch. Obviously, that's not a revenue stream. That's a commitment to patient access. But there probably isn't a major site in the US today that doesn't have access to Pixclara if they want to use it.

今天再次強調，擴大了訪問範圍。因此，我們非常感謝 FDA 在產品上市前的支持。顯然，這不是收入來源。這是對病人訪問的承諾。但如今，如果美國的主要網站想要使用 Pixclara，可能沒有一個無法訪問它。

And so I think, again, the adoption will be swift when we get approvals, particularly because FET-PET or Pixclara is already included in -- it's been included in European practice guidelines for years. it's embedded into the RANO criteria. So it's just well understood by neuro-oncology that this is something that the rest of the world uses. It's got well-established clinical understanding and utility.

因此，我再次認為，當我們獲得批准時，採用將會很快，特別是因為 FET-PET 或 Pixclara 已經包含在歐洲實踐指南中多年。它已嵌入 RANO 標準中。因此，神經腫瘤學很好地理解，這是世界其他地方使用的東西。它具有完善的臨床理解和實用性。

And I think the product is really going to fly once it's available in the US. And then when you look at the indication expansion potential for CNS mets for non-CNS primaries, you go from a patient opportunity that's maybe 25,000, 30,000 scans a year at the face of it, ignoring the fact that we repeat scan GBM patients a lot. But then when you start to manage met from non-CNS primaries, then the size goes to 100,000-plus scans.

我認為一旦該產品在美國上市，它真的會大受歡迎。然後，當您查看中樞神經系統代謝物對非中樞神經系統原發的適應症擴展潛力時，您會發現每年可能進行 25,000 至 30,000 次掃描的患者機會，而忽略了我們經常重複掃描 GBM 患者的事實。但是，當您開始管理非 CNS 初選的滿足時，掃描規模就會達到 100,000 多次。

And I think that, that's as I commented in the presentation, that's an amazing return on capital for us once Pixclara is established in the market. I hope that gives you a sense of what -- how we see it. Zircaix is potentially bigger for Telix than Illuccix is, although we do continue to perform really well on the prostate cancer side. And then when you throw in Pixclara and then indication expansions across the precision medicine portfolio, I think the revenue trajectory looks really bright for the company over the next few years.

我認為，正如我在演示中評論的那樣，一旦 Pixclara 進入市場，這對我們來說將是驚人的資本回報。我希望這能讓您了解我們如何看待它。對於 Telix 來說，Zircaix 的潛力可能比 Illuccix 更大，儘管我們在前列腺癌方面確實繼續表現出色。然後，當你考慮 Pixclara 以及整個精準醫療產品組合的擴張時，我認為該公司未來幾年的收入軌跡看起來非常光明。

That's super helpful. Thank you very much for all that. Just one more question on ProstACT GLOBAL. What are the expectations for that interim data for next year, given that it is just an interim, I believe that you previously mentioned that would be when about 30% of events have occurred. So should we expect early rPFS data to come. And if not, if it's too early, when would that data come? Thanks.

這非常有幫助。非常感謝您所做的一切。關於 ProstACT GLOBAL 還有一個問題。對明年中期數據的預期是多少，因為這只是一個中期，我相信你之前提到過，大約30%的事件發生時。因此，我們是否應該期待早期 rPFS 資料的到來。如果沒有，如果還為時過早，那麼這些數據什麼時候會出現？謝謝。

We haven't given guidance on that, but we will elucidate that over the next short while. And the reason for that is that -- as you may recall, we broke the study into two sections. So we have a run-in phase, which is really about CMC comparability. It's a biologic. So it's got some different bar there.

我們尚未就此提供指導，但我們將在接下來的一段時間內予以闡明。原因是—您可能還記得，我們​​將這項研究分成兩個部分。所以我們有一個磨合階段，這實際上是關於 CMC 的可比性。這是一種生物製劑。所以那裡有一些不同的酒吧。

we've got a CMC run-in study into the main randomization event, and we think it's prudent for us to hold off on giving guidance on that second part, the randomization phase until the run on it has been finalized and that we've presented those results to the FDA and that we have agreement on the second phase of the trial. Does that make sense?

我們已經對主要隨機化事件進行了 CMC 磨合研究，我們認為謹慎的做法是推遲對第二部分（即隨機化階段）提供指導，直到最終確定運行，並且我們已經向FDA 提交了這些結果，並且我們就第二階段試驗達成了一致。這樣有道理嗎？

Yes, definitely. Thanks very much for taking my questions.

是的，絕對是。非常感謝您回答我的問題。

Thank you very much for listening.

非常感謝您的聆聽。

(Operator Instructions) Andy Hsieh, William Blair.

（操作員說明）Andy Hsieh，William Blair。

Great. Thanks for taking our questions and congratulations on all the progress. I have one for TLX250, the STARLITE-2 study. I'm struggling to find kind of a bar for maybe just like nivolumab monotherapy in the post-IO setting. There's a lot of contemporary studies combining with TKI.

偉大的。感謝您提出我們的問題並祝賀所有的進展。我有一個用於 TLX250 的 STARLITE-2 研究。我正在努力尋找一種可能就像 IO 後環境中的納武單抗單一療法一樣的標準。當代有很多與TKI結合的研究。

The most recent one is probably the Contact 03 study, 40% response rate there. But mostly it's probably driven by cabo. So just curious about how you think about that. You kind of mentioned about -- speaking about having a pivotal study strategy. So maybe you can frame for us what the expectation on the efficacy side would be?

最近的一項可能是 Contact 03 研究，有 40% 的回覆率。但大多數情況下它可能是由 Cabo 驅動的。所以只是好奇你對此有何看法。你提到了一個關鍵的學習策略。那麼也許您可以為我們闡述對功效的期望是什麼？

And maybe also kind of a question on the targeted conditioning asset that you have, probably not talked about a lot, but there is a development from Actinium regarding their approach negative feedback from the FDA. I'm just curious about what lessons can be learned in terms of improving on the trial design, so you can better position from a regulatory perspective. Thank you.

也許還有一個關於您擁有的目標調理資產的問題，可能沒有談論太多，但 Actinium 就 FDA 的負面反饋方法取得了進展。我只是好奇在改進試驗設計方面可以吸取哪些經驗教訓，以便您可以從監管角度更好地定位。謝謝。

Well, those are good questions, Andy, as always. So I think -- well, the first one is pretty straightforward. So we have two STARLITE trials. We have one in the second-line setting, which, as you pointed out, is in nivo progressive patients. And then we also have a kind of a triple in the first-line study that's being run primarily out of MD Anderson, which is really a nivo TKI rate-targeted radiation combo.

嗯，這些都是好問題，安迪，一如既往。所以我認為——嗯，第一個非常簡單。所以我們有兩次 STARLITE 試驗。我們有一個二線治療方案，正如您所指出的，是在 nivo 進展患者中進行的。然後，我們在一線研究中還有一種三重療法，主要由 MD 安德森進行，這實際上是一種 nivo TKI 速率靶向放射組合。

And look, there's -- there's a couple of specific goals and objectives with these studies. But one of them is, I'll focus on STARLITE-2 since you did ask. The goal there really is to look at whether or not we can take patients that have -- that are nivo progressive that were prior responders. -- and really resensitize them back to nivolumab. So it's about understanding the clinical question of how do you layer targeted radiation with an immune checkpoint inhibitor -- and of course, we're interested -- I mean, we're interested in efficacy, but we're also interested in how do you cycle that?

看，這些研究有幾個具體的目的和目標。但其中之一是，既然你問了，我將專注於 STARLITE-2。我們的目標實際上是看看我們是否可以接受那些先前有反應的患者，這些患者是 Nivo 進展型患者。 ——真正讓他們重新對納武單抗敏感。因此，這是關於了解如何將靶向放射與免疫檢查點抑製劑分層的臨床問題 - 當然，我們感興趣 - 我的意思是，我們對功效感興趣，但我們也對如何你循環那個嗎？

And what's the safety profile look like? And what's the overlapping toxicities because anything that you add on to a checkpoint inhibitor in that kind of late-stage patient population, you have to think about really carefully from an overlapping toxicity perspective. We haven't put out data on it yet, but we've been really encouraged by experience of that study. And I imagine that, in fact, we've given indication to the market that sort of in the next three to four months that we'll put out an update on how those combo IO studies are going. And clearly, if you look at renal cancer overall, we'd be fairly remiss in not considering how targeted radiation in immuno-oncology kind of layer in with each other.

安全狀況如何？什麼是重疊毒性，因為在這種晚期患者群體中添加到檢查點抑制劑中的任何東西，您都必須從重疊毒性的角度仔細考慮。我們還沒有公佈相關數據，但這項研究的經驗讓我們深受鼓舞。我想，事實上，我們已經向市場表明，在接下來的三到四個月內，我們將發布有關這些組合 IO 研究進展的最新資訊。顯然，如果你從整體上看待腎癌，我們如果不考慮免疫腫瘤學中的標靶放射是如何相互結合的，那就是相當的疏忽了。

It's -- IO has had a profound impact on renal cancer care. In fact, that's one of the reasons why we have now this enormous prevalence pool of patients sitting in the back end of their patient -- of their disease journey. That is something we think about commercially, both from a therapy perspective, but also from a diagnostic imaging perspective because clearly, they're entwined with each other. The other development, I think, that's really happened in renal space, which we've watched closely over the last 12 months has been the approval of Belzutifan. I think that, that's taken us some time to digest in terms of what the impact is on trial design.

IO 對腎癌治療產生了深遠的影響。事實上，這就是為什麼我們現在有如此巨大的患病率的患者群體處於其疾病旅程的後端的原因之一。這是我們在商業上考慮的問題，無論是從治療的角度，還是從診斷成像的角度，因為顯然，它們是相互交織的。我認為，另一個真正發生在腎臟空間的進展是 Belzutifan 的批准，我們在過去 12 個月裡密切關注了這一進展。我認為，我們花了一些時間來消化這對試驗設計的影響。

And I think where we've landed is when we look at really the incremental efficacy there, there's clearly a need for a therapeutic option in really late-stage renal cancer. And so I think that we haven't sort of formalized exactly the game plan yet, but I think it's fairly likely that at least as a starting point, to really get into that care continuum for renal cancer therapeutically that will at least start with an end-stage monotherapy study, which will give us the opportunity to develop that monotherapeutic signal, show some competitive efficacy to Belzutifan and TKI use in that end-stage patient setting and then move up from there. And then having these combo trials running where we're getting really meaningful and interesting data, I think then will allow us to understand then how targeted radiation layers into some of the earlier line earlier line stages of care where things like IO are very prevalent. Does that make sense?

我認為，當我們看到真正的增量療效時，我們已經到達了終點，很明顯，晚期腎癌需要一種治療選擇。因此，我認為我們還沒有正式確定具體的遊戲計劃，但我認為至少作為一個起點，真正進入腎癌治療護理連續體很可能至少從終末期單一治療研究，這將使我們有機會開發單一治療信號，顯示出Belzutifan 和TKI 在該終末期患者環境中使用的一些競爭療效，然後從那裡繼續前進。然後進行這些組合試驗，我們獲得真正有意義和有趣的數據，我認為這將使我們能夠了解如何將目標輻射層納入一些較早的早期護理階段，其中 IO 之類的事情非常普遍。這樣有道理嗎？

Yeah, totally. Thanks for that very comprehensive answer. Appreciate it.

是的，完全可以。感謝您的非常全面的回答。欣賞它。

I probably gave you too much detail, but at least you can sort of get a sense of how we're thinking. You also asked about the bone marrow conditioning program. So yeah, we obviously watched with some dismay what happened with Actinium. It's a bit of a bummer, but it's really more of a regulator engagement issue than it is anything else. I mean, obviously, if the FDA tells you, you aren't going to get an approval based on a trial. That's something you probably need to tell the market about.

我可能給了你太多細節，但至少你可以了解我們的想法。您也詢問了骨髓調理計劃。是的，我們顯然對錒發生的事情感到有些沮喪。這有點令人失望，但這實際上更多的是監管者參與問題而不是其他問題。我的意思是，顯然，如果 FDA 告訴你，你將不會獲得基於試驗的批准。這可能是你需要告訴市場的事情。

We've -- we've never had any real belief in that asset. The target is an okay target, but it's not a great target from a kind of disease heterogeneity perspective. The main issue with that asset is its I-131 asset with a very, very high level of activity associated with it. And no nuclear medicine department ideally wants to handle a query of iodine-131, and you're clearly never going to put that anywhere near a pediatric patient either.

我們——我們從來沒有真正相信過這項資產。這個目標是一個不錯的目標，但從疾病異質性的角度來看，它不是一個很好的目標。該資產的主要問題是其 I-131 資產，其相關活動水準非常非常高。理想情況下，沒有一個核子醫學部門願意處理碘 131 的查詢，而且顯然也永遠不會將其放在兒科患者附近。

So I think we've focused on yttrium -- yttrium-90 with our program. We love yttrium-90 in this application because it's a beta -- fairly low energy beta with a large radiation distance, which is perfect for bone marrow conditioning, but the shielding and radiation handling requirements from a clinical perspective are very straightforward. You're talking about per spec shielding, right? And we know how to use yttrium, we use it for search, for microsphere therapy all the time. It's really easy to handle. And so we think that the clinical workflow considerations for the 66 program are much better competitively and that the efficacy will be better as well as a consequence.

所以我認為我們的計劃重點是釔——釔90。我們喜歡此應用中的釔 90，因為它是 β 型——能量相當低的 β 型，具有較大的輻射距離，非常適合骨髓調節，但從臨床角度來看，屏蔽和輻射處理要求非常簡單。你說的是照規格屏蔽，對嗎？我們知道如何使用釔，我們一直用它進行搜尋、微球治療。這真的很容易處理。因此，我們認為 66 項目的臨床工作流程考量更具競爭力，且功效和結果也會更好。

Awesome. Thanks for that. Maybe can I ask one more quick one, I promise. So for 592, the Actinium program, obviously, you mentioned about the Fc optimization to shorten the biological half-life, I'm curious about the other regions of the antibody. Is there a difference in finding the epitope or things like that we should be aware of?

驚人的。謝謝你。也許我可以再問一個，我保證。因此，對於 592，錒項目，顯然，您提到了 Fc 優化以縮短生物半衰期，我對抗體的其他區域感到好奇。尋找表位或我們應該注意的類似事情有什麼不同嗎？

No, the CDRs are the same. So the affinity and the on-off rates and the target interaction are the same as for 591. It's really about the PK engineering. We did modify the scaffold of the antibody so that it has better manufacturability. 591 is a fairly old humanization and sometimes cells squeeze it out happily and sometimes they don't. So we've modernized that as well. But yes, 591 is a -- from a targeting perspective is a very well-understood antibody. I hope that answers your question.

不，CDR 是相同的。因此親和力、開關速率以及目標交互作用與 591 相同。這實際上是關於 PK 工程的。我們確實修改了抗體的支架，使其具有更好的可製造性。 591 是一個相當古老的人源化，有時細胞會愉快地將其擠出，有時卻不會。所以我們也對其進行了現代化改造。但是，是的，從標靶角度來看，591 是一種非常容易理解的抗體。我希望這能回答你的問題。

Yes, very well. Thank you so much.

是的，很好。太感謝了。

I think we have time for probably one more question if there is one. Maybe, Ky, a question from -- from online?

我想我們還有時間再問一個問題（如果有的話）。凱，也許有一個來自網路上的問題？

Sure. So I've got a -- first question is with your -- can you explain with the EAP for the Zircaix in the US the patients pay out of pocket and what does it cost? And what are the plans on getting European rest of world approval for Zircaix?

當然。所以我有一個問題——第一個問題是關於你的——你能用 EAP 解釋一下美國 Zircaix 的患者自付費用嗎？Zircaix 獲得歐洲和世界其他地區批准的計劃是什麼？

Sure. So the EAP in the US is a company supported program. So it really is about making sure that the key renal cancer centers get access to drug to support patient care in advance of approval. And that's really about our commitment to access to medicine.

當然。所以美國的EAP是一個公司支持的專案。因此，這實際上是為了確保主要腎癌中心在獲得批准之前獲得藥物來支持患者護理。這確實是我們對獲得藥物的承諾。

EAP programs are not homogenous. So they vary from jurisdiction to jurisdiction in the US. We have a small amount of cost recovery. That's possible. But generally speaking, it's not a -- it's not a charged program.

EAP 專案並不同質。因此，美國不同司法管轄區的規定有所不同。我們有少量的成本回收。這是可能的。但一般來說，它不是一個收費程序。

In other parts of the world, certainly, we can make the drug available for a fee under special access or EAP programs, although generally, we are reluctant to do so. We don't take the view that selling unapproved products is a commercially or ethically viable thing to do. So we do it in a very controlled way where there's a formal program and a formal established patient benefit to be achieved. I hope that answers the question around the EAP.

當然，在世界其他地區，我們可以根據特殊准入或 EAP 計劃付費提供該藥物，儘管一般來說，我們不願意這樣做。我們不認為銷售未經批准的產品在商業或道德上是可行的。因此，我們以一種非常受控的方式來做這件事，有一個正式的計劃和正式確立的患者利益要實現。我希望這能回答有關 EAP 的問題。

Regarding expansion for Zircaix. We've actually had a European scientific consultation around Zircaix, which was very positive. We had that quite recently with the Paul-Ehrlich-Institut, which is kind of the brainiac Institute of the European Medicines Agency. It's run through the German competent authority. We have clear guidance on and feedback on the suitability of the zircon data for European submission, and it was very positive. So once we have the manufacturing and the BLA submission in for the FDA, the next step then is to submit in Europe, and we will be pursuing a centralized submission in Europe because we have a beautiful Phase III trial result.

關於 Zircaix 的擴張。事實上，我們已經圍繞著 Zircaix 進行了一次歐洲科學諮詢，這是非常積極的。我們最近與保羅-埃利希研究所進行了合作，該研究所有點像歐洲藥品管理局的大腦研究所。它由德國主管當局管理。我們對鋯石數據是否適合歐洲提交有明確的指導和回饋，這是非常積極的。因此，一旦我們向 FDA 提交了生產和 BLA 申請，下一步就是在歐洲提交，我們將在歐洲進行集中提交，因為我們有一個漂亮的 III 期試驗結果。

We have to package the results of the zircon trial slightly differently for European regulators, and we've been working on that. But it's a very near-term objective for the company to be able to submit in Europe. And yes, we actually believe we'll get a very good price point for Zircaix in Europe. So it's well worth our while to pursue. And in parallel to that, the Seneffe side is getting ready to be a producer of several of our products, including Zircaix. So our manufacturing and supply chain activities are aligned with our regulatory activities for Zircaix submission in Europe probably early next year.

我們必須為歐洲監管機構提供稍微不同的鋯石試驗結果，我們一直在努力解決這個問題。但能夠在歐洲提交申請是該公司的近期目標。是的，我們確實相信 Zircaix 在歐洲會得到一個非常好的價格點。所以這是非常值得我們花時間去追求的。同時，Seneffe 方面正準備成為我們多種產品的生產商，其中包括 Zircaix。因此，我們的製造和供應鏈活動與我們可能在明年初在歐洲提交 Zircaix 的監管活動保持一致。

Maybe one more, Ky, anything else?

也許還有一個，Ky，還有別的嗎？

Yes. We just have one final question that we have time for. And last, and it is do you have any views on the 64 -- 64 Cu SAR-bisPSMA product in development versus Illuccix?

是的。我們只有最後一個問題，我們有時間回答。最後，您對正在開發的 64 -- 64 Cu SAR-bisPSMA 產品與 Illuccix 有何看法？

Well, first of all, it's not a product because it's still in clinical development. And some years away from being available and in the market and approved and reimbursed. And there are significant supply chain issues around copper-64 that I think are underappreciated by the market. And very significant clinical deployment issues in using copper-64. So fundamentally, there's no real evidence of change in patient management for this product candidate.

嗯，首先，它不是一個產品，因為它仍處於臨床開發階段。距離上市、批准和報銷還需要幾年時間。我認為 64 銅周圍存在重大供應鏈問題，但市場並未充分認識到這些問題。使用 Copper-64 時有非常重要的臨床部署問題。因此從根本上來說，沒有真正的證據表明該候選產品的患者管理髮生了變化。

The late time point imaging, it's just a red herring. Prostate cancer imaging is a high throughput activity. Nobody wants to have a -- an imaging center full of people waiting around that are radioactive. The goal is to get a patient in and out as quickly as possible. That's why F-18 and gallium-68 have been so commercially successful.

後期時間點成像，這只是轉移注意力。前列腺癌成像是一項高通量活動。沒有人想要一個影像中心，裡面擠滿了放射性的人。目標是盡快讓病人進出。這就是 F-18 和鎵 68 在商業上如此成功的原因。

And -- and I just think that we understand the market very well. We understand the reimbursement landscape very well. And I think that in the fullness of time, there will be a small segment of the markets that we know will be always attractive from an innovation and novelty perspective. But for mainstream real-world use, it's not going to be a significant player in the market.

而且——我只是認為我們非常了解市場。我們非常了解報銷情況。我認為，隨著時間的推移，我們知道從創新和新穎的角度來看，一小部分市場將始終具有吸引力。但對於現實世界的主流使用來說，它不會成為市場上的重要參與者。

Thank you. That completes the time we have allocated. Any closing remarks, Chris?

謝謝。我們分配的時間就這樣完成了。克里斯，有什麼結束語嗎？

Yeah. Well, thanks very much, everyone, for attending. I hope that the information was useful, and we're delighted with our progress and look forward to continue to keep you informed and lots of opportunities and change over the next six months. So look forward to keeping you abreast of all of our progress. Thanks for your time today.

是的。嗯，非常感謝大家的出席。我希望這些資訊有用，我們對我們的進展感到高興，並期待在接下來的六個月內繼續向您通報情況以及大量機會和變化。因此，期待讓您隨時了解我們的所有進展。感謝您今天抽出時間。