使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Thank you for standing by. Welcome to the Telix half-[year] (corrected by the company after the call) 2025 results and investor webcast.
感謝您的耐心等待。歡迎參加 Telix 2025 年半年業績(電話會議後公司更正)及投資者網路直播。
(Operator Instructions)
(操作說明)
I would now like to hand the conference over to Ms. Kyahn Williamson. Please go ahead.
現在我將把會議交給凱恩威廉森女士。請繼續。
Kyahn Williamson - Senior Vice President - Corporate Communication, Investor Relations
Kyahn Williamson - Senior Vice President - Corporate Communication, Investor Relations
Thank you, everybody, for joining us this morning; and this evening, for those joining from overseas.
感謝各位今天早上的參與;也感謝今晚從海外收看節目的朋友們。
My name is Kyahn Williamson. I'm the SVP of Investor Relations and Corporate Communication at Telix. You can see there our disclaimer.
我的名字是凱恩‧威廉森。我是 Telix 的投資者關係和企業傳播資深副總裁。您可以在那裡看到我們的免責聲明。
Just moving forward to slide 4, I'd like to introduce today's speakers that are on the line with me. We have Chris Behrenbruch, our Group CEO and Managing Director; Darren Smith, our Group Chief Financial Officer; Kevin Richardson, CEO of the Telix Precision Medicine; and Richard Valeix, CEO of Telix Therapeutics.
接下來請看第 4 張投影片,我想介紹一下今天和我連線的演講嘉賓。我們有集團執行長兼董事總經理克里斯·貝倫布魯赫;集團首席財務官達倫·史密斯;Telix 精準醫療首席執行官凱文·理查森;以及 Telix Therapeutics 首席執行官理查德·瓦萊克斯。
Today, we'll be taking you through the H1 2025 financial results presentation, lodged earlier today on the ASX; and our operational achievements for the half.
今天,我們將帶您了解我們今天稍早在澳洲證券交易所提交的 2025 年上半年財務業績報告,以及我們上半年的營運成果。
This call is scheduled to run for one hour. Following the presentation, we'll take questions firstly from analysts on the phone and request that you ask one question at a time and hop back in the queue if you have further questions. If we do not get to your questions on the webcast, we will reply to you directly.
本次通話預計持續一小時。演示結束後,我們將首先接受分析師的電話提問,請您一次只提一個問題,如果您還有其他問題,請重新排隊。如果在網路直播中我們沒有回答您的問題,我們將直接回覆您。
Moving on to slide 5, please. In today's presentation, our business leaders will be talking to the investments we have made in the business to set it up for long-term value creation. This slide illustrates the scale of our business today, spanning development, commercialization, and global production and manufacturing.
請繼續看第5張投影片。在今天的演講中,我們的業務領導將談到我們為實現長期價值創造而對業務進行的投資。這張投影片展示了我們如今的業務規模,涵蓋研發、商業化以及全球生產製造。
It's been a rapid transformation. This time last year, we had one approved product, Illuccix, which was commercial in just a handful of companies. Today, we have multiple approved products. We're preparing to roll out Illuccix across Europe and are preparing for launch of Zircaix and Pixclara.
這是一個快速的變化。去年這個時候,我們只有一款核准產品 Illuccix,而且這款產品只在少數幾家公司進行商業銷售。目前,我們有多款產品獲得批准。我們正準備在歐洲推廣 Illuccix,並準備推出 Zircaix 和 Pixclara。
The acquisitions we have made have seen our manufacturing and distribution sites grow to 38. Our workforce has more than doubled, with now over 1,000 employees globally.
透過收購,我們的生產和分銷基地已增至 38 個。我們的員工人數已經增加了一倍多,目前在全球擁有超過 1000 名員工。
Next slide, please. We've previously presented our growth strategy that is in place to drive value creation for the long term. You can see the four pillars on the left-hand side of the slide and the achievements we have delivered against each one of this half.
請看下一張投影片。我們之前已經提出了旨在推動長期價值創造的成長策略。您可以在投影片的左側看到四個支柱,以及我們在本半年中針對每個支柱所取得的成就。
These pillars are to grow our Precision Medicine, our commercial stage imaging business. The achievements this half are focused on the goal to grow our share in the PSMA market and bring new products to patients. Kevin will discuss this further.
這些支柱旨在發展我們的精準醫療業務和商業化影像業務。本半年的成就主要集中在擴大我們在PSMA市場的份額,並為患者帶來新產品這一目標。凱文將進一步討論此事。
Delivering on our late-stage therapeutic pipeline and building our next-generation pipeline, including Alpha therapy candidates, this half, we have made solid progress across an array of programs, which Richard will take you through in more detail.
本半年,我們在推動後期治療產品線和建立下一代產品線(包括 Alpha 療法候選藥物)方面取得了穩步進展,理查德將為大家詳細介紹這些項目。
Finally, the expansion of our global delivery infrastructure, a key highlight this half has been the integration of the RLS business. Chris will take you through this and the key value drivers aligned to our strategy.
最後,我們全球交付基礎設施的擴展,本半年的一個亮點是 RLS 業務的整合。Chris 將帶你了解這一點以及與我們的策略一致的關鍵價值驅動因素。
Firstly, however, Darren will talk you through the financial results for H1 2025 in more detail. I'll hand over to you, Darren.
不過,首先,達倫將更詳細地向大家介紹 2025 年上半年的財務表現。達倫,我把麥克風交給你了。
Darren Smith - Group Chief Financial Officer
Darren Smith - Group Chief Financial Officer
Okay. Thanks, Ky. Welcome, everyone.
好的。謝謝你,Ky。歡迎各位。
From a financial perspective, the first half of 2025 was characterized by strong commercial growth in our Precision Medicine business and continued investment into building our business for the future.
從財務角度來看,2025 年上半年我們精準醫療業務實現了強勁的商業成長,並持續投資於業務的未來發展。
We delivered strong revenue growth in the first half of 2025, with group revenues improving 63% year on year, driven by growth in the Illuccix, and the addition of third-party revenue from RLS.
2025 年上半年,我們實現了強勁的營收成長,集團營收年增 63%,這主要得益於 Illuccix 的成長以及 RLS 帶來的第三方收入。
Our Precision Medicine revenues were up 30% year on year, with EBITDA improving 24%. Gross margins in our Precision Medicine business remains stable at 64%, reflecting efficient manufacturing of Illuccix.
我們的精準醫療收入年增 30%,EBITDA 成長 24%。我們的精準醫療業務毛利率保持穩定在 64%,這反映了 Illuccix 的高效生產。
The group's gross margin was 53%, reflecting the addition of RLS third-party product mix and the associated manufacturing and distribution costs.
該集團的毛利率為 53%,反映了 RLS 第三方產品組合的加入以及相關的製造和分銷成本。
In this half, we have made a significant investment into our global manufacturing infrastructure to ensure that we are well positioned for long-term growth. We continue to invest in our R&D pipeline, with investment up 47% year on year. Following these investments, we generated $18 million in operational cash flow and finished the half year with a healthy $207 million cash on hand.
上半年,我們對全球製造基礎設施進行了大量投資,以確保我們為長期成長做好充分準備。我們持續加大研發投入,年增 47%。經過這些投資,我們產生了 1,800 萬美元的營運現金流,並在上半年結束時擁有 2.07 億美元的健康現金儲備。
Now, moving to the next slide, our group revenues.
現在,我們來看下一張幻燈片,關於我們集團的收入。
Telix generated revenues of $390 million. This consisted of $79 million in revenues from RLS third-party sales and $311 million mainly from our Precision Medicine business. This represents an increase of 63% year on year and 41% compared to the second half of 2024.
Telix公司創造了3.9億美元的收入。這其中包括來自 RLS 第三方銷售的 7,900 萬美元收入,以及主要來自我們精準醫療業務的 3.11 億美元收入。這比去年同期成長了 63%,比 2024 年下半年成長了 41%。
Illuccix continues to deliver strong growth, especially as it relates to volume doses. Kevin will provide more detail later in the presentation.
Illuccix 繼續保持強勁成長勢頭,尤其是在大劑量方面。凱文將在稍後的演講中提供更多細節。
Now, moving on to the next slide, in the group P&L. As stated previously, the group P&L represents a period of solid growth and strategic investment into preparation for delivering future long-term growth. Group gross margin landed at 53%, following the addition of RLS third-party products and RLS-associated manufacturing and distribution expenditure.
現在,我們來看下一張投影片,即集團損益表。如前所述,集團損益表反映了一段穩健成長和策略投資時期,為實現未來的長期成長做好了準備。集團毛利率為 53%,主要得益於 RLS 第三方產品以及 RLS 相關製造和分銷支出的增加。
R&D increased 47% to $82 million. As planned, we increased our investment into our Therapeutics pipeline to be 54% of our overall investment in R&D from 43% last year. Richard will talk to our Therapeutics portfolio later in the presentation.
研發支出成長47%,達8,200萬美元。正如計劃的那樣,我們將對治療藥物研發管線的投資從去年的 43% 增加到研發總投資的 54%。理查德將在稍後的演講中談到我們的治療產品組合。
Selling and marketing expenses increased to 13% of revenue from 10% last year. As we prepare for the product and geographic expansion of our Precision Medicine business and the addition of $7 million in selling and marketing expenses from RLS, manufacturing and distribution expenditure, excluding RLS COGS, increased to 5% of revenue from 4% last year, driven by investment in our manufacturing and distribution infrastructure in ARTMS, IsoTherapeutics, and multiple TMS facilities.
銷售和行銷費用佔收入的比例從去年的 10% 增加到 13%。隨著我們為精準醫療業務的產品和地理擴張做準備,以及 RLS 帶來的 700 萬美元銷售和行銷費用的增加,製造和分銷支出(不包括 RLS 銷售成本)從去年的收入的 4% 增加到 5%,這主要得益於我們在 ARTMS、IsoTherapeutics 和多個 TMS 設施方面的製造和基礎設施方面的投資。
General and administration expenses decreased to 12% of revenue from 16% of revenues last year. As a result, adjusted EBITDA declined to $21 million, driven by our investment.
一般及行政費用佔收入的比例從去年的 16% 下降到 12%。因此,受我們投資的影響,調整後的 EBITDA 下降至 2,100 萬美元。
Now, moving on to the next slide. This slide represents the income statement of our Precision Medicine business. As you can see, gross margin is steady at 64%. This indicates that we have maintained our operational efficiency, enhancing our abilities to reinvest in growth.
現在,我們來看下一張投影片。此投影片展示了我們精準醫療業務的損益表。如您所見,毛利率穩定在 64%。這顯示我們保持了營運效率,增強了我們再投資於成長的能力。
As planned, we prepared for new product launches and geographic expansion, increasing selling and marketing expenses to 12% of revenue, facilitating the build-out of our commercial infrastructure ahead of the expected revenue growth. This increase was offset by reductions in the percentage of revenue spend on R&D and general and administration. As a result, the Precision Medicine EBITDA improved $20 million year on year, driven by 29% revenue growth,
我們按計劃為新產品發布和地理擴張做好了準備,將銷售和行銷費用提高到收入的 12%,以便在預期收入成長之前建立我們的商業基礎設施。這一增長被研發和一般及行政支出佔收入比例的下降所抵銷。因此,在29%的營收成長推動下,精準醫療業務的EBITDA年增了2,000萬美元。
Moving to the next slide, our TMS business. Moving on to the next slide. As we have made significant investments into TMS, I thought it was important to provide details. In particular, the contribution of RLS, which we are reporting for the first time.
接下來是下一張投影片,我們的TMS業務。接下來是下一張投影片。由於我們對TMS進行了大量投資,我認為提供詳細資訊非常重要。特別是 RLS 的貢獻,這是我們首次報導。
RLS is the largest component of the TMS business, employing over 500 people across more than 30 locations, integrating last-mile delivery capabilities for Telix. In the five months since that acquisition, RLS EBITDA was close to breakeven. The addition of further volumes of Telix products through RLS will improve the contribution.
RLS 是 TMS 業務中最大的組成部分,在 30 多個地點擁有 500 多名員工,為 Telix 整合了最後一公里配送能力。自收購以來的五個月裡,RLS 的 EBITDA 接近損益兩平。透過 RLS 增加 Telix 產品的供應量將提高貢獻率。
RLS currently processes one-third of Telix's group revenue, with total network revenues for the five months being $110 million. This includes $79 million of third-party products and [$30 million] (corrected by the company after the call) of inter-segment revenues related to (inaudible). Gross margins for RLS was 7%, which is typical for this type of business and includes manufacturing and distribution costs from the radiopharmacy. RLS operating expenditure, excluding COGS, for the five months since acquisition totaled $15 million. We expect these costs for the second half of 2025 to remain at a similar percentage of revenue.
RLS 目前處理 Telix 集團三分之一的收入,五個月的網路總收入為 1.1 億美元。這包括7,900萬美元的第三方產品收入和[3,000萬美元](公司在電話會議後更正)與以下方面相關的部門間收入:(聽不清楚)RLS 的毛利率為 7%,這對此類業務來說是典型的,其中包括放射性藥物的生產和分銷成本。自收購以來的五個月內,RLS 的營運支出(不包括銷售成本)總計為 1,500 萬美元。我們預計 2025 年下半年這些成本將維持在收入的類似比例。
Our TMS business also includes various subsidiaries such as IsoTherapeutics; ARTMS; and TMS Brussels, Melbourne, Yokohama, Sacramento, where we increased our investment to advance operational activity at each of these sites. Chris will expand on the TMS strategy later in the presentation.
我們的 TMS 業務還包括多家子公司,例如 IsoTherapeutics、ARTMS 和 TMS Brussels、Melbourne、Yokohama、Sacramento。我們增加了對這些子公司的投資,以推進其營運活動。Chris 將在演講的後半部詳細介紹 TMS 策略。
Now, moving on to the group's cash flow. In the first half of 2025, Telix has again achieved a positive operating cash flow totaling $18 million, demonstrating the ability of the commercial business to fund the development of our R&D pipeline in funding preparations for market and product expansion.
接下來,我們來看看集團的現金流。2025 年上半年,Telix 再次實現了 1,800 萬美元的正經營現金流,證明了商業業務有能力為我們的研發管線開發提供資金,為市場和產品擴張做好準備。
As previously mentioned, Telix utilized cash on hand to make a number of strategic acquisitions. The largest of these was RLS. Cash on hand at the end of June was a healthy $207 million.
如前所述,Telix 利用手頭現金進行了一系列策略性收購。其中規模最大的是 RLS。截至6月底,公司現金儲備充足,高達2.07億美元。
Now, moving on to the next slide. I'd like to take a moment to go over our capital allocation priorities.
現在,我們來看下一張投影片。我想花點時間回顧一下我們的資本配置優先事項。
Telix is focused on four areas. Firstly, R&D development. Secondly, optimizing our commercial performance. Third, strategic growth opportunities through M&A. And fourth, supply chain resilience and production capacity. We believe these four areas of focus will enable us to deliver long-term growth.
Telix專注於四個領域。首先是研發。其次,優化我們的商業表現。第三,透過併購獲得策略成長機會。第四,供應鏈韌性與生產能力。我們相信,這四個重點領域將使我們能夠實現長期成長。
Within R&D, we are advancing several late-stage clinical programs.
在研發方面,我們正在推動多個後期臨床項目。
We are optimizing our commercial infrastructure to advance our commercial assets and expand into new areas of focus in geography.
我們正在優化商業基礎設施,以提升商業資產,並拓展到新的地域重點領域。
In terms of M&A, we invested in three strategic assets in the first half of 2025. They were RLS radiopharmacies, ImaginAb, and a FAP candidate.
在併購方面,我們在 2025 年上半年投資了三項策略資產。它們分別是 RLS 放射性藥局、ImaginAb 和一名 FAP 候選者。
We continue to invest strategically into our manufacturing and supply chain infrastructure to preserve our competitive edge and to ensure we are in a position to scale efficiently as demand grows. We do all of this in a disciplined way by ensuring that we have a prudent cash buffer on our balance sheet.
我們將繼續對製造和供應鏈基礎設施進行策略性投資,以保持我們的競爭優勢,並確保我們能夠隨著需求的成長而有效率地擴大規模。我們以嚴謹的方式進行所有這些工作,確保資產負債表上保持充足的現金緩衝。
Now, moving to my final slide. As stated on this slide, we are reaffirming our full-year revenue and R&D guidance. We expect our revenue from the Illuccix and RLS to be in the range of $770 million to $800 million. Now, R&D investment, we expect to fall in the range of 20% to 25% increase on last year.
現在,進入最後一張投影片。如本投影片所示,我們重申全年營收和研發預期。我們預計 Illuccix 和 RLS 的營收將在 7.7 億至 8 億美元之間。至於研發投入,我們預計將比去年成長 20% 至 25%。
Finally, I'd like to take the opportunity to reiterate our investment strategy. For the next three years, we will grow revenues by advancing assets from clinical development to commercialization, expanding indications and geographic expansion. We will reinvest the earnings into our portfolio and ensure that we have the capabilities, infrastructure, and readiness to deliver on our Therapeutics programs.
最後,我想藉此機會重申我們的投資策略。未來三年,我們將透過推動資產從臨床開發到商業化、擴大適應症和地理擴張來增加收入。我們將把收益再投資到我們的投資組合中,並確保我們擁有實施治療計畫所需的能力、基礎設施和準備。
At this stage of our development, our priority is building long-term asset value, rather than optimizing near-term GPS growth. We believe that focus on earnings too early can be tracked from the strategic investments needed to unlock the full potential of our pipeline.
在我們發展的現階段,我們的首要任務是創造長期資產價值,而不是優化短期GPS成長。我們認為,過早關注獲利可能會影響到我們為充分發揮產品線潛力而進行的策略性投資。
I'll now hand you over to Chris Behrenbruch, Managing Director and Group CEO. Thank you.
現在我將把麥克風交給董事總經理兼集團執行長克里斯·貝倫布魯赫。謝謝。
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Thanks very much, Darren. Good day to everybody online.
非常感謝,達倫。各位網友大家好。
I'd like to start by taking a moment -- if you could advance on to the next slide, please -- to talk about why Telix is highly-differentiated and built for long-term success.
我想先花一點時間——如果您可以翻到下一張幻燈片的話——談談為什麼 Telix 具有高度差異化,並且是為長期成功而打造的。
Starting with our Therapeutics pipeline, our pipeline is built around areas of high unmet medical need with a diversified portfolio strategy that gives us multiple shots on goal, even, in some cases, concentrated in the same disease area.
從我們的治療產品線開始,我們的產品線圍繞著尚未滿足的重大醫療需求領域構建,採用多元化的產品組合策略,使我們能夠多次嘗試,甚至在某些情況下,集中於同一疾病領域。
Our R&D efforts remain sharply focused on advancing next-generation assets, whether that's in the alpha or beta therapies, novel isotopes, or innovative targeting agents. As a data-driven organization, our decisions are grounded in rigorous scientific and clinical evidence, ensuring that we prioritize our limited resources toward the most promising opportunities.
我們的研發工作仍高度集中在推動下一代資產的開發,無論是α療法或β療法、新型同位素,或是創新標靶藥物。作為一個數據驅動型組織,我們的決策以嚴謹的科學和臨床證據為基礎,確保我們將有限的資源優先投入最有前途的機會。
Turning to manufacturing and supply chain excellence, I want to emphasize that radiopharmaceutical manufacturing and distribution is an extremely complex business, from an operational quality and regulatory perspective. A robust, reliable supply chain is critical to long-term success, especially for a multi-product portfolio like ours that's also going to, one day, deliver Therapeutics outcomes.
談到製造和供應鏈卓越性,我想強調的是,從營運品質和監管角度來看,放射性藥物的製造和分銷是一項極其複雜的業務。強大、可靠的供應鏈對於長期成功至關重要,尤其是對於像我們這樣擁有多種產品組合,並且有朝一日還能帶來治療效果的公司而言。
This is why we've made strategic investments in selective aspects of vertical integration over the past couple of years, alongside deepening relationships with key strategic partners that we think are best aligned with our long-term commercial strategy.
這就是為什麼在過去幾年裡,我們對垂直整合的特定方面進行了策略性投資,同時加深了與關鍵策略合作夥伴的關係,我們認為這些合作夥伴最符合我們的長期商業策略。
Our investment in commercial infrastructure is starting to deliver real operational and financial returns, including with continued volume growth for Illuccix in a maturing market landscape. This performance reflects our proven track record in commercial execution. I think it positions us very well for future product launches.
我們對商業基礎設施的投資開始帶來真正的營運和財務回報,包括在日趨成熟的市場環境中,Illuccix 的銷售持續成長。這一業績反映了我們在商業執行上的卓著成就。我認為這讓我們為未來的產品發布做好了充分的準備。
This year also marks a major inflection point for Telix as we transition from effectively a single-product, single-market company to a multi-product, multi-region commercial organization. We've done it pretty cost effectively.
今年也是 Telix 的一個重要轉捩點,我們將從一家單一產品、單一市場的公司轉型為一家多產品、多區域的商業組織。我們以相當低的成本完成了這項工作。
With this global infrastructure in place, our Precision Medicine assets are laying the operational and financial foundation for the roll-out of our future Therapeutics pipeline, which, as a reminder, is really not that far away.
憑藉這項全球基礎設施,我們的精準醫療資產正在為我們未來的治療產品線的推出奠定營運和財務基礎,需要提醒的是,這一天其實並不遙遠。
Next slide, please. Within prostate cancer, our multi-product strategy, supported by next generation follow-on assets, is designed to drive sustained revenue growth. This approach strengthens our market position while expanding our commercial runway.
請看下一張投影片。在前列腺癌領域,我們以下一代後續資產為支撐的多產品策略旨在推動持續的收入成長。這種方法既能鞏固我們的市場地位,也能擴大我們的商業發展空間。
We may have been second to market with Illuccix but we are leading our new strategy through a life cycle management initiative that will enable us to continue to capture market share and to compete on the merits of our product portfolio to dramatically reduce the impact and viability of new entrants.
雖然我們憑藉 Illuccix 在市場上落後了,但我們正在透過生命週期管理計劃引領我們的新策略,這將使我們能夠繼續獲取市場份額,並憑藉我們產品組合的優勢參與競爭,從而大幅降低新進入者的影響和生存能力。
We'll continue to expand the market through new indications and indication expansion, notably our BiPASS study, our groundbreaking Phase 3 study that's aimed at expanding the label to Illuccix and Gozellix right to the front of the patient journey, with the potential to disrupt current diagnostic pathways and significantly expand the total addressable market. Kevin's going to talk more about this exciting near-term opportunity during his part of the presentation.
我們將繼續透過新的適應症和適應症擴展來擴大市場,特別是我們的 BiPASS 研究,這項突破性的 3 期研究旨在將 Illuccix 和 Gozellix 的適應症擴展到患者治療過程的前端,有可能顛覆當前的診斷路徑並顯著擴大潛在市場。凱文將在他的演講部分更詳細地談論這個令人興奮的近期機會。
Finally, we continue to focus on product innovation, leveraging the strength of our distribution model, customer service, and innovation focus to maximize product choice to the benefit of physicians and patients.
最後,我們將繼續專注於產品創新,利用我們的分銷模式、客戶服務和創新重點,最大限度地增加產品選擇,從而造福醫生和患者。
For example, we recently unveiled the AlFluor Chemistry [platform] (corrected by the company after the call). The first application is the development of a PSMA targeting agent that enables us to combine the imaging benefits of Fluorine-18 with the convenience of gallium kit-based workflows the market has already come to appreciate.
例如,我們最近發布了 AlFluor 化學技術。[平台](通話後由公司更正)。第一個應用是開發一種 PSMA 標靶劑,使我們能夠將氟-18 的成像優勢與市場已經認可的基於鎵試劑盒的工作流程的便利性結合起來。
We have an extensive clinical data package to support this, including a Phase 3 study in a significant number of patients. Following a helpful consultation with the FDA, we are now planning a registration-enabling study to take this forward to a New Drug Application.
我們擁有大量的臨床數據包來支持這一結論,其中包括一項針對大量患者的 3 期研究。在與美國食品藥物管理局 (FDA) 進行了有益的諮詢後,我們現在正計劃開展一項註冊研究,以便推進新藥申請。
Next slide, please. Let's take a moment to understand what transitioning from a single-product, single-market company to a multi-product, multi-region commercial organization actually means. It takes a highly-complex global manufacturing and distribution infrastructure to deliver our Precision Medicine assets and obviously, future Therapeutics that are coming down the pathway to patients.
請看下一張投影片。讓我們花點時間來了解一下,從單一產品、單一市場的公司轉型為多產品、多區域的商業組織究竟意味著什麼。要將我們的精準醫療資產以及即將上市的未來療法交付給患者,需要高度複雜的全球製造和分銷基礎設施。
Due to the relatively short half-lives of isotopes and the need for just-in-time manufacturing, highly-specialized facilities and logistics are required to avoid factors throughout the journey that can lead to disruptions and delays.
由於同位素的半衰期相對較短,且需要即時生產,因此需要高度專業化的設施和物流來避免運輸過程中可能導致中斷和延誤的因素。
We have continued investing in our manufacturing infrastructure globally to have greater control throughout the process and significantly reduce quality and delivery risk. We see this as a crucial point of competitive advantage because without reliability, there is no commercial traction in this industry.
我們持續投資於全球製造基礎設施,以更好地控制整個生產過程,並顯著降低品質和交付風險。我們認為這是競爭優勢的關鍵所在,因為如果沒有可靠性,在這個行業就沒有商業吸引力。
Our global footprint reflects our commitment to leadership in radiopharma. We believe a truly global presence is critical to becoming and maintaining market leadership in this space.
我們的全球佈局體現了我們致力於成為放射性藥物領域領導者的承諾。我們認為,真正的全球化佈局對於成為並維持該領域的市場領導至關重要。
Next slide, please. On the topic of RLS integration, the RLS acquisition was a highly-strategic investment enhancing our US presence, which is a critical market, with a production and distribution network that covers over 85% of the US; and provides last-mile delivery and a footprint to expand our manufacturing capability in the US.
請看下一張投影片。關於 RLS 整合,收購 RLS 是一項極具戰略意義的投資,增強了我們在美國的業務,美國是一個至關重要的市場,其生產和分銷網絡覆蓋了美國 85% 以上的地區;並提供了最後一公里配送服務,為我們在美國擴大製造能力奠定了基礎。
Darren has already talked to the financial contribution of RLS. I want to touch on the value drivers and integration progress, to date. In just five short months, the integration is going very well. I have been personally extensively involved in the process alongside Darren Patti, Telix's Group COO.
Darren 已經和 RLS 談過財務捐助事宜。我想談談迄今為止的價值驅動因素和整合進展。短短五個月內,整合工作進展非常順利。我自己與 Telix 集團首席營運長 Darren Patti 一起深入參與了這一過程。
RLS can deliver value in the following ways:
RLS 可以透過以下方式創造價值:
Firstly, we are already seeing the synergies of having two distinct commercial teams that complement each other in terms of the way that they view and engage with the market. Having a nuclear pharmacy network provides a new entry point and insights, bringing us closer to the customer and enabling us to identify significant new opportunities.
首先,我們已經看到了兩個截然不同的商業團隊之間的協同效應,這兩個團隊在看待市場和與市場互動的方式上相互補充。擁有核藥房網路為我們提供了新的切入點和見解,使我們更貼近客戶,並使我們能夠發現重要的新機會。
To be clear, our team manages everything from producing the end dose, quality controlling it, to walking it into the clinical site. This business is all about service to the end customer.
需要說明的是,我們的團隊負責從最終劑量生產、品質控製到將其運送到臨床試驗現場的所有環節。這家企業的核心在於為終端客戶提供服務。
Second is a pathway to margin improvement. The volume of Illuccix sales through the RLS network has increased by 50% on a dose-volume basis in the first six months since the acquisition. This is not at the expense of our key partners, rather, it demonstrates the synergies between the two commercial organizations and our ability to capture commercial white space and optimize our competitiveness.
其次是提高利潤率的途徑。自收購以來的前六個月,Illuccix 透過 RLS 網路的銷售量(按劑量計算)成長了 50%。這並非以犧牲我們主要合作夥伴的利益為代價,而是展現了兩個商業組織之間的協同效應,以及我們開拓商業空白市場和優化自身競爭力的能力。
PET agents like Illuccix and Gozellix reflect higher-margin, higher-value products for nuclear pharmacies to distribute. As we increase product distribution of our own products through RLS, we expect to see long-term improvement in gross margins and the ability to mitigate competitive and distributor risk.
像 Illuccix 和 Gozellix 這樣的 PET 顯影劑代表了核藥房分銷的高利潤、高價值產品。隨著我們透過 RLS 增加自有產品的分銷,我們預計毛利率將長期改善,並能夠降低競爭風險和分銷商風險。
Finally, our goal with RLS is to build a radiometal production network to meet future demand for imaging and therapeutic radiopharmaceuticals to grow the RLS business but also to reduce our own reliance on third parties for supply chain in the US. Again, with this investment, we will be focusing on high-margin products, not historical, commoditized products.
最後,我們與 RLS 合作的目標是建立一個放射性金屬生產網絡,以滿足未來對成像和治療放射性藥物的需求,從而發展 RLS 業務,同時減少我們自身對美國供應鏈第三方的依賴。同樣,透過這項投資,我們將專注於高利潤產品,而不是歷史悠久的、同質化的產品。
We are currently in facilities planning and development for six cyclotrons across the RLS network initially, with the facilities upgrade process to commence in the second half. We'll be complemented by in-house capabilities to produce select Therapeutics products alongside our pharmacy production function for dose-drawing and dispensing. This will support both commercial activity and clinical activity.
我們目前正在對 RLS 網路中的六台迴旋加速器進行設施規劃和開發,設施升級過程將於下半年開始。我們將利用內部生產能力,結合我們的藥房生產功能,生產精選的治療產品,用於劑量抽取和分發。這將有助於商業活動和臨床活動。
Next slide, please. The third part -- third pillar -- of value creation that I want to touch on is our Therapeutics pipeline and platform. We are deeply committed to bringing our Therapeutics to the market. This ambition remains the central focus of our investment strategy. As you heard from Darren, it's a growing proportion of our R&D expenditure.
請看下一張投影片。我想談談價值創造的第三部分——第三個支柱——那就是我們的治療產品線和平台。我們致力於將我們的治療藥物推向市場。這個目標仍然是我們投資策略的核心。正如達倫所說,這在我們研發支出中所佔的比例越來越高。
We are making meaningful progress across the entire pipeline. The momentum we're building reflects the strength of our execution. I'm going to let Richard speak more about our progress generally across the pipeline.
我們在整個生產流程中都取得了實質進展。我們所取得的成就反映了我們執行力的強大。我將讓理查德詳細介紹我們整個生產流程的整體進展。
With the acquisition of Los Angeles-based ImaginAb, we acquired a biologics and drug development platform that's really well optimized for targeted alpha therapies. This is an incredibly talented team of people with a huge amount of experience, backed by Key Opinion Leaders that have a great vision for what the future targeting platform will look like in radiopharma.
透過收購位於洛杉磯的 ImaginAb 公司,我們獲得了一個生物製劑和藥物開發平台,該平台針對標靶 α 療法進行了非常優化。這是一支才華洋溢、經驗豐富的團隊,背後有關鍵意見領袖的支持,他們對放射性藥物未來標靶平台的發展方向有著遠見卓識。
The acquired platform uses small engineered biologics or antibodies that enable highly-specific cancer targeting combined with fast tumor uptake and blood clearance. With our capabilities in antibody engineering, linker and chelator optimization, and isotope selection, we're really well positioned to develop highly-potent and targeted radiopharmaceuticals that range from small molecules all the way to advanced biotherapeutic products. We believe these specialist in-house R&D capabilities are fundamental for long-term success of the company.
收購的平台利用小型工程生物製劑或抗體,實現高度特異性的癌症靶向,並結合快速的腫瘤吸收和血液清除。憑藉我們在抗體工程、連接子和螯合劑優化以及同位素選擇方面的能力,我們完全有能力開發高效且具有靶向性的放射性藥物,其範圍從小分子到先進的生物治療產品。我們相信,這些專業的內部研發能力對於公司的長期成功至關重要。
The next slide, please. Just to wrap up in terms of expectations around top-line and bottom-line growth and reiterating some of the messages that Darren's giving you, I've been showing this chart in our investor presentations since the start of the year and there are some important signaling aspects to this graphic.
請看下一張投影片。最後總結一下關於營收和利潤成長的預期,並重申一下達倫向大家傳達的一些訊息,我從年初開始就在投資者演示中展示這張圖表,這張圖表有一些重要的信號方面。
We are now in the middle stage of our trajectory, where we're diversifying our revenue streams, expanding globally, and de-risking the business. If you recall, our midterm strategy has been to reinvest our revenues into the business to fuel long-term growth.
我們現在正處於發展軌跡的中期階段,在這個階段,我們將實現收入來源多元化,拓展全球業務,並降低業務風險。如果您還記得的話,我們的中期策略是將收入再投資於業務,以推動長期成長。
We're making very targeted investments today to position the company for long-term growth, both in top-line expansion and bottom-line performance. But right now, it's about putting every last dollar into that growth in infrastructure that when we hit our pre-commercial launch year for the Therapeutics business, we are really ready to go.
我們今天進行有針對性的投資,旨在使公司在營收成長和獲利能力方面實現長期成長。但現在,最重要的是把每一分錢都投入到基礎建設中,這樣當我們的治療業務進入商業化啟動前的第一年時,我們才能真正做好準備。
I want to give a little final comment before I hand over to Kevin and take a moment to address the information request from the SEC. I know many people have had questions about it. I'm personally disappointed to be in this situation, as I really don't believe it reflects the quality of our organization or our commitment to excellence.
在將發言權交給凱文之前,我想再補充一點,並花點時間回應美國證券交易委員會的資訊請求。我知道很多人對此都有疑問。我個人對此感到非常失望,因為我真的不認為這能反映出我們組織的品質或我們對卓越的承諾。
The subpoena was a request for documents primarily relating to our disclosure activity related to the development of our prostate cancer therapeutic candidates. We are in the process of responding to the SEC to resolve this as soon as possible. I want to make clear that there have been no allegations or charges leveled at the company or any individuals. We do not know what or who triggered this.
傳票要求提供的文件主要與我們前列腺癌治療候選藥物的研發相關的揭露活動有關。我們正在積極回應美國證券交易委員會的要求,以盡快解決此事。我想澄清的是,目前沒有任何針對公司或任何個人的指控或控告。我們不知道是什麼或誰引發了這件事。
Let me be clear: this has no impact on our commercial portfolio or the momentum of our pipeline development. In fact, we're operating with more urgency and focus than ever before to bring these breakthrough assets to patients. I believe you can see evidence of this progress in today's presentation.
我要明確指出:這不會對我們的商業產品組合或產品線開發勢頭產生任何影響。事實上,我們比以往任何時候都更加緊迫和專注地開展工作,力求將這些突破性成果帶給患者。我相信大家可以從今天的報告中看到這項進展的體現。
With that, I'd like to transition over to Kevin, our CEO of Precision Medicine, for a commercial update. Thanks, Kevin.
接下來,我想把麥克風交給精準醫療的執行長凱文,讓他為大家介紹公司的商業最新狀況。謝謝你,凱文。
Kevin Richardson - Chief Executive Officer - Telix Precision Medicine
Kevin Richardson - Chief Executive Officer - Telix Precision Medicine
Sure. Thank you, Chris.
當然。謝謝你,克里斯。
For my first slide. I would like to start with our Precision Medicine growth strategy. Our growth strategy is based on three pillars: expand product offerings; expand geographies; and then, expand indications on those products.
我的第一張投影片。我想先談談我們的精準醫療成長策略。我們的成長策略基於三大支柱:擴大產品供應;擴大地理範圍;然後,擴大這些產品的適應症。
In terms of our first pillar, expanding our product offerings, we have now launched Gozellix, further strengthening our position in the PSMA space. Looking ahead, we have two near-term regulatory milestones with Zircaix and Pixclara. These assets will build on our strong commercial foundation established by Illuccix.
就我們第一個支柱——擴大產品供應而言,我們現在已經推出了 Gozellix,進一步鞏固了我們在 PSMA 領域的地位。展望未來,我們近期將迎來 Zircaix 和 Pixclara 兩項監理里程碑。這些資產將鞏固 Illuccix 為我們建立的強大商業基礎。
Moving on to our second pillar, the global roll-out of Illuccix continues to progress well, with marketing authorizations now secured in over 23 countries.
接下來是我們的第二個支柱,Illuccix 的全球推廣工作繼續順利進行,目前已在超過 23 個國家/地區獲得市場准入許可。
Turning to our third strategic pillar, we are actively exploring new indications for our existing assets, particularly indications where we believe we can deliver meaningful impact for patients.
談到我們的第三個策略支柱,我們正在積極探索現有資產的新適應症,特別是我們認為可以為患者帶來有意義影響的適應症。
We remain laser-focused on the execution of these three strategic pillars, driving the expansion of our global Precision Medicine business and paving the road for our Therapeutics business.
我們將繼續全力以赴執行這三大策略支柱,推動全球精準醫療業務的擴張,並為我們的治療業務鋪平道路。
Next slide, please. Illuccix continues to deliver strong growth in the high single digits. In the second quarter, Illlucix's revenues were up 2% quarter over quarter or 25% year over year, with those volumes up 7%.
請看下一張投影片。Illuccix 繼續保持高個位數的強勁成長。第二季度,Illlucix 的營收季增 2%,年增 25%,銷量成長 7%。
Q2 represents the highest unit volume growth we've seen in the last five quarters. Despite competitive pricing pressures, we continue to manage the impact to our average selling price. To do so, we continue to drive shared growth and clinical accuracy and reliability of dose delivery.
第二季銷售增幅是近五季以來最高的。儘管面臨激烈的價格競爭壓力,我們仍能有效控制對平均售價的影響。為此,我們將繼續推動共同成長,提高劑量傳遞的臨床準確性和可靠性。
Our clinical message is Telix PSMA gallium agents have fewer indeterminate bone lesions and higher inter-reader agreement than F-18 assets. We couple the clinical message with a highly-specialized salesforce and customer-facing teams that differentiate Telix with our customers every day. We've developed a reputation in the marketplace as an innovator, paving the way for successful launch of our follow-on products.
我們的臨床資訊是,與 F-18 試劑相比,Telix PSMA 鎵試劑的骨病變不確定程度更低,且閱片者之間的一致性更高。我們將臨床資訊與高度專業化的銷售團隊和客戶服務團隊結合,使 Telix 每天都能為客戶帶來差異化優勢。我們在市場上建立了創新者的聲譽,為後續產品的成功上市鋪平了道路。
Next slide, please. Moving on to geographic expansion and the global roll-out of Illuccix, as you can see, we've established a strong commercial footprint across key markets, including the US, Canada, Australia, Brazil, the UK, and Europe, with marketing authorizations now secured in 23 countries.
請看下一張投影片。接下來是地理擴張和 Illuccix 的全球推廣,正如您所看到的,我們已經在包括美國、加拿大、澳洲、巴西、英國和歐洲在內的主要市場建立了強大的商業基礎,目前已在 23 個國家/地區獲得了市場准入許可。
In the second quarter, we successfully launched Illuccix in the UK and see encouraging uptake. In the next wave of launches, we are focused on key markets like France, Germany, Italy, and Spain. As you move further east, we're focused on China and Japan. In China, we have completed our registration study and are preparing an NDA for Illuccix; while in Japan, we are just initiating our Phase 3 study for Illuccix and we are happy with the progress, thus far.
第二季度,我們在英國成功推出了 Illuccix,並看到了令人鼓舞的市場反應。在下一波產品發布中,我們將重點放在法國、德國、義大利和西班牙等重點市場。再往東走,我們的重點就轉移到中國和日本了。在中國,我們已經完成了註冊研究,正在準備 Illuccix 的新藥申請;而在日本,我們剛剛啟動了 Illuccix 的 3 期研究,到目前為止,我們對進展感到滿意。
Now, on to Latin America, where we have the first approved product for PSMA PET and we have commenced commercial operations there with our partner on the ground.
現在,讓我們把目光轉向拉丁美洲,我們在那裡擁有首個獲批的PSMA PET產品,並且我們已經與當地的合作夥伴開始了商業運營。
Overall, we remain on track with the global rollout of Illuccix, supported by strong execution in the US.
總體而言,在美國的強勁執行支持下,Illuccix 的全球推廣工作仍在按計劃進行。
Next slide, please. We launched Gozellix earlier this year and successfully delivered our first commercial doses in June. The launch is progressing well through our comprehensive network of distribution partners, Cardinal Health, PharmaLogic, Jubilant, and RLS.
請看下一張投影片。今年早些時候我們推出了 Gozellix,並在 6 月成功交付了首批商業劑量。透過我們全面的經銷合作夥伴網絡,包括 Cardinal Health、PharmaLogic、Jubilant 和 RLS,此次產品上市進展順利。
Telix is the first company to bring two PSMA targeted agents to the market. A differentiated strategy that we believe is central to our competitive advantage. This dual product approach gives customers meaningful choice, whether in terms of economic value or scheduling flexibility. It reinforces our commitment to meeting diverse clinical and operational needs.
Telix 是第一家將兩款 PSMA 目標代理商推向市場的公司。我們認為,差異化策略是我們競爭優勢的核心所在。這種雙產品模式為客戶提供了有意義的選擇,無論是在經濟價值還是在時間安排靈活性方面。這進一步鞏固了我們滿足多樣化臨床和營運需求的承諾。
Now, from a reimbursement point of view, we are pleased with the recent HCPCS code we received from CMS, a major reimbursement milestone, and look forward to getting an update on the decision around transitional pass-through status in the near future. The HCPCS code will be effective October 1, 2025, streamlining the billing and reimbursement in the hospital outpatient setting for Medicare-eligible patients.
從報銷的角度來看,我們對最近從 CMS 收到的 HCPCS 代碼感到滿意,這是一個重要的報銷里程碑,並期待在不久的將來獲得有關過渡性轉付狀態的決定的最新消息。HCPCS 代碼將於 2025 年 10 月 1 日生效,簡化符合 Medicare 資格的患者的醫院門診計費和報銷流程。
Next slide, please. Moving on to our third pillar of growth strategy, label expansion. I wanted to talk about a study that we think has the potential to become the future of prostate cancer diagnosis, our BiPASS biopsy study or Biopsy of the Prostate Avoidance Stratification Study.
請看下一張投影片。接下來是我們的第三個成長策略支柱—品牌擴張。我想談談一項我們認為有可能成為前列腺癌診斷未來發展方向的研究,即我們的 BiPASS 活檢研究或前列腺活檢避免分層研究。
Biopsies are highly invasive and carry risk. There are more than 1 million patients getting a biopsy every year, with up to 75% of them being negative. When you think about it, what it takes to really be disruptive in this space and be innovative, we think it's minimizing patient trauma, reducing risk and recovery time, and lowering cost while improving patient outcomes.
活檢屬於侵入性操作,且有風險。每年有超過 100 萬名患者接受活檢,其中高達 75% 的患者結果為陰性。仔細想想,要想在這個領域真正具有顛覆性和創新性,我們認為需要最大限度地減少患者創傷,降低風險和恢復時間,降低成本,同時改善患者預後。
Next slide, please. BiPASS is the first registrational study combining MRI and PSMA PET in diagnosing prostate cancer. Patients are categorized into high-, medium-, and low-risk categories for prostate cancer. For high-risk category, an image-guided biopsy would be recommended. For the intermediate or indeterminate category, a precision biopsy would be recommended since PSMA is much more sensitive in the detection of prostate cancer and we can perform one and done. For the low-risk category, if there is no uptake of PSMA in the scan, we can conclude that no biopsy is needed, none and done.
請看下一張投影片。BiPASS 是首個將 MRI 和 PSMA PET 結合用於診斷前列腺癌的註冊研究。根據罹患攝護腺癌的風險,患者被分為高風險、中風險和低風險三類。對於高風險族群,建議進行影像引導活檢。對於中間或不確定類別,建議進行精準活檢,因為 PSMA 在檢測前列腺癌方面更加敏感,我們可以一次完成。對於低風險類別,如果在掃描中沒有 PSMA 攝取,我們可以得出結論,不需要活檢,就此結束。
So with this study, we aim to improve the predictive accuracy of prostate cancer while reducing the number of biopsies. This study has the potential to significantly broaden our market opportunity, potentially doubling it. We see significant value in moving earlier in the care pathway by positioning our scan at the front of the patient journey.
因此,透過這項研究,我們旨在提高前列腺癌的預測準確性,同時減少活檢次數。這項研究有可能大幅拓寬我們的市場機會,甚至可能使其翻倍。我們認為,將掃描環節放在病患就診流程的前端,能夠大幅提升診療流程的早期階段,進而帶來巨大的價值。
Next slide, please. Moving on to Pixclara, we've engaged with the FDA and agreed on a pathway forward and plan to resubmit the NDA. Recall that the FDA has granted Pixclara orphan drug and fast-track designation, an acknowledgement of the drug candidate's importance in addressing a significant unmet medical need.
請看下一張投影片。接下來是 Pixclara,我們已經與 FDA 進行了溝通,並就未來的發展方向達成了一致,計劃重新提交 NDA。請記住,FDA 已授予 Pixclara 孤兒藥和快速通道資格,這認可了該候選藥物在滿足重大未滿足醫療需求方面的重要性。
Turning to Zircaix, our PDUFA date is approaching next week. We view this as a transformative opportunity targeting an area with no approved therapies. If approved, Zircaix will be the first to market, positioning us to lead in a space with significant unmet need for patients and commercial potential.
再來看看 Zircaix,我們的 PDUFA 日期就在下週。我們認為這是一個具有變革意義的機遇,可以針對一個尚未獲得批准療法的領域。如果獲得批准,Zircaix 將成為首個上市產品,使我們在患者需求尚未充分滿足且具有巨大商業潛力的領域中佔據領先地位。
To summarize, we built a robust commercial infrastructure that continues to deliver, highlighted by high-single-digit growth for Illuccix in the US. We've secured marketing authorizations in 23 countries and successfully launched in the UK. Gozellix our next-generation PSMA agent, is now on the market with HCPCS reimbursement starting in October.
總而言之,我們建立了一個強大的商業基礎設施,並持續取得成效,其中 Illuccix 在美國實現了接近兩位數的成長。我們已在 23 個國家/地區獲得市場准入許可,並在英國成功上市。Gozellix 是我們的下一代 PSMA 代理,現已上市,並將於 10 月開始接受 HCPCS 報銷。
Looking ahead, we have several near-term regulatory milestones. And then, we believe our BiPASS study has the potential to redefine the diagnostic pathway in prostate cancer.
展望未來,我們有幾個近期監理里程碑需要達成。而且,我們相信我們的 BiPASS 研究有可能重新定義前列腺癌的診斷路徑。
With that, I'd like to introduce you to Richard who will provide you an overview of the Therapeutics assets.
接下來,我將向大家介紹理查德,他將為大家概述治療資產狀況。
Richard Valeix - Group Chief Commercial Officer
Richard Valeix - Group Chief Commercial Officer
Thank you, Kevin.
謝謝你,凱文。
Let me present to you today the update of our Therapeutics business units. You will see that during the first half of this year, 2025, we were moving the needle on all our Therapeutics areas.
今天我向大家報告我們治療業務部門的最新情況。你會發現,在 2025 年上半年,我們在所有治療領域都取得了進展。
You can see, on this slides, our strategic focus is centered around three Therapeutics pillars. First, urologic oncology. Second, neurologic oncology. And third, the solid tumors and hematology.
從這些投影片中可以看出,我們的策略重點圍繞著三大治療支柱。首先是泌尿腫瘤科。其次,神經腫瘤學。第三,實體腫瘤和血液疾病。
Within urology, we have a pipeline assets for prostate cancer and more specifically, targeting the mCRPC, standing for metastatic castration Resistant Prostate Cancer. Also, kidney cancer, we're targeting the ccRCC indication for clear cell Renal Cell Carcinoma.
在泌尿外科領域,我們擁有針對前列腺癌的在研產品,更具體地說,是針對轉移性去勢抵抗性前列腺癌(mCRPC)的標靶產品。此外,對於腎癌,我們正在針對透明細胞腎細胞癌(ccRCC)此適應症進行研究。
But we have also a therapeutic agent such as the TLX090 for metastatic bone pain palliation, which is frequent in the prostate cancer, late-stage.
但我們也有像 TLX090 這樣的治療藥物,用於緩解轉移性骨痛,這種疼痛在晚期前列腺癌中很常見。
With neuro oncology, we have a pipeline assets for glioblastoma. I'm happy to share that we are also adding a new indication for leptomeningeal disease, with the alpha version of the TLX102 compound.
在神經腫瘤學領域,我們擁有針對膠質母細胞瘤的研究產品。我很高興地宣布,我們還新增了 TLX102 化合物的 alpha 版本,用於治療軟腦膜疾病。
Within our third pillar, regarding solid tumors and hematology, we have the TLX400, our FAP-targeting asset that we closed the acquisition during the Q1 2025. This asset has pan-cancer potential. We are exploring various indications. We also have molecules for soft tissue sarcoma and bone marrow conditioning agents for pediatric high-risk leukemia patients. I will come back on that in a minute.
在我們的第三大支柱領域,即實體瘤和血液疾病領域,我們有 TLX400,這是我們針對 FAP 的資產,我們在 2025 年第一季完成了收購。該資產具有治療多種癌症的潛力。我們正在研究各種指標。我們也擁有用於治療軟組織肉瘤的分子藥物和用於治療兒童高風險白血病患者的骨髓預處理藥物。我稍後會再談到這一點。
In summary, you can see that we have 10 early- and late-stage assets. Late-stage assets primarily focused on beta therapies, followed by earlier-stage assets exploring alpha therapies.
總而言之,我們目前擁有 10 個處於早期和後期階段的資產。後期資產主要集中於β療法,其次是探索α療法的早期資產。
In addition to these 10 assets, we also have pre-clinical compounds targeting for the most well-known DLL3 and alpha-v-beta-6, coming from the ImaginAb acquisition. We are exploring the best combination with isotopes for these targets.
除了這 10 項資產外,我們還有針對最著名的 DLL3 和 alpha-v-beta-6 的臨床前化合物,這些化合物來自對 ImaginAb 的收購。我們正在探索針對這些目標的最佳同位素組合。
Our theranostic strategy includes having a companion diagnostic for all our disease areas of focus. We are working in close collaboration with Kevin and the Precision Medicine colleagues.
我們的診療一體化策略包括針對我們所有重點關注的疾病領域配備相應的診斷試劑。我們正與凱文和精準醫療領域的同事們密切合作。
Next slide, please. Let's talk about ProstACT as the first pillar of our urology strategy. TLX591 is our phase 3 asset for mCRPC. Let me remind you that ProstACT Global is a combination trial with standard health care, namely, we are associating the product with abiraterone, and enzalutamide and docetaxel.
請看下一張投影片。讓我們來談談ProstACT,它是我們泌尿科策略的第一支柱。TLX591 是我們用於治療 mCRPC 的 3 期臨床試驗產品。讓我提醒您,ProstACT Global 是一項與標準醫療保健相結合的試驗,也就是說,我們將該產品與阿比特龍、恩扎盧胺和多西他賽聯合使用。
With 10 patients in each arm, this is a two-part study where the primary read-out from Part 1 will be safety and dosimetry. I'm pleased to disclose that we have reached target enrollment of 30 patients in Part 1. We'll provide an update once the data analysis is complete.
本研究分為兩部分,每組有 10 名患者,第一部分的主要讀數將是安全性和劑量測定。我很高興地宣布,第一部分我們已經達到了招募 30 名患者的目標人數。數據分析完成後,我們將提供最新進展。
Part 2 of the study is a randomized treatment expansion, including 490 patients. In order to accelerate ProstACT Global Part 2, firstly, we are currently in the process of getting the required regulatory approvals in various countries in order to expand the number of sites. Secondly, the protocol in Part 2 is more patient-friendly in that the patients will not need to come back to the hospital for multiple scans, which were required in Part 1 to complete the dosimetry data.
研究的第二部分是一項隨機治療擴展研究,包括 490 名患者。為了加快 ProstACT Global 第二部分的進程,首先,我們目前正在各個國家/地區獲得必要的監管批准,以便擴大試驗點的數量。其次,第二部分中的方案對患者更加友好,因為患者無需像第一部分那樣多次返回醫院進行掃描以完成劑量測定數據。
Let's move on to TLX592, which is our next-generation PSMA-targeting alpha therapy using actinium in development. Earlier this year, we presented data at ASCO-GU from our clinical study evaluating the biodistribution and the dose to the organs of the copper-64 labelled imaging version.
接下來我們來看看 TLX592,它是我們正在開發的下一代 PSMA 標靶 α 療法,使用錒系元素。今年早些時候,我們在 ASCO-GU 會議上展示了我們臨床研究的數據,該研究評估了銅-64標記成像版本的生物分佈和器官劑量。
This was essentially a proof of concept of this asset. We are really looking forward to moving into Phase 1. I'm pleased to say that we have now received the Human Research Ethics Committee approval in Australia for first-in-human studies with this TLX592 asset.
這本質上是對該資產的概念驗證。我們非常期待進入第一階段。我很高興地宣布,我們現在已經獲得了澳洲人類研究倫理委員會的批准,可以對 TLX592 進行首次人體試驗。
Let's move for the TLX90, our samarium agent. This is being developed to treat pain palliation in in patients that have osteoblastic metastatic disease. It fits nicely and perfectly with our urologic platform because frequently, the patients that have osteoblastic metastatic disease have prostate cancer.
讓我們轉向 TLX90,我們的釤代理人。該療法正在研發中,用於緩解患有成骨性轉移性疾病患者的疼痛。它與我們的泌尿科平台非常契合,因為患有成骨性轉移性疾病的患者通常也患有前列腺癌。
Currently, we are developing this as a single-dose agent for pain palliation but there is potential in the future for multiple dose regimen, as well. I'm pleased to announce that we just received FDA approval for a Phase 1 study and look forward to start. It is another great milestone for the first half of the year 2025. I'm sure you can agree with me.
目前,我們正在將其開發為一種用於緩解疼痛的單劑量藥物,但未來也有可能開發為多劑量給藥方案。我很高興地宣布,我們剛剛獲得了FDA對1期臨床試驗的批准,並期待著試驗的開始。這是2025年上半年的另一個重要里程碑。我相信你會同意我的看法。
Moving to the next slide. Our second pillar of the urology strategy is focused on kidney cancer. TLX250 is our CAIX- targeting agent. We know that CAIX is expressed in greater than 90% of clear cell Renal Cell Carcinomas. It's also being expressed in a number of solid tumors.
進入下一張投影片。我們泌尿外科策略的第二個支柱是腎臟癌。TLX250 是我們的 CAIX 標靶藥物。我們知道,CAIX 在超過 90% 的透明細胞腎細胞癌中表現。它也在一些實體瘤中表現。
We have a few ongoing studies exploring mono and combination therapy. We are focusing on monotherapy for advanced third- and fourth-line patients with ccRCC. I am pleased to announce again that we are moving forward a pivotal trial named LUTEON with the submissions completed to the Human Research Ethics Committee in Australia.
我們目前正在進行一些研究,探索單藥療法和聯合療法。我們專注於對晚期三線和四線 ccRCC 患者進行單藥治療。我很高興地再次宣布,我們正在推進一項名為 LUTEON 的關鍵性試驗,目前已向澳洲人類研究倫理委員會提交了申請。
On the right-hand side, you can see images. This is a patient with metastatic advanced Renal Cell Carcinoma. On the top, you can see the initial images that have been performed with zirconium-labelled girentuximab scan. You can see intense activity in the sacrum where there was a metastatic lesion. After three cycles of therapy with Lu-girentuximab, you can see on the bottom row that the amount of activity in the sacral lesion has significantly decreased; again, giving us confidence that the injected therapy has made its way to the bone lesion.
右側可以看到圖片。這是一位患有轉移性晚期腎細胞癌的患者。在頂部,您可以看到使用鋯標記的吉倫妥昔單抗掃描進行的初始影像。你可以看到骶骨處有劇烈的腫瘤活動,曾經發生過轉移性病變。經過三個療程的 Lu-girentuximab 治療後,您可以在底行看到骶骨病變的活性顯著降低;這再次讓我們相信注射的藥物已經到達了骨病變部位。
Now, if we consider the life cycle of girentuximab compound, let's have a look to the TLX252, our CAIX-targeting alpha therapy for pan-tumor approach, including ccRCC. When patients have high expression of CAIX, they often face resistance to chemotherapy; immunotherapy; and with time, also radiotherapy.
現在,如果我們考慮吉倫妥昔單抗化合物的生命週期,讓我們來看看 TLX252,這是我們針對 CAIX 的泛腫瘤療法,包括 ccRCC。當患者體內 CAIX 表現量較高時,他們往往會對化療、免疫療法以及隨著時間的推移對放射療法產生抗藥性。
We think this is a good target for targeted radionuclide therapy. Because with an alpha isotope, we can use the increased activity directly targeting the tumor cells. We have submitted to the Human Research Ethics Committee application in Australia in late Q2 and look forward to start our Phase 1 trial ,once we receive Ethics Approval.
我們認為這是一個很好的標靶放射性核素治療目標。因為使用α同位素,我們可以利用其增強的活性直接靶向腫瘤細胞。我們已於第二季末向澳洲人類研究倫理委員會提交了申請,並期待在獲得倫理批准後開始我們的第一階段試驗。
Let's move to the next slide. I'm moving to the neuro oncology portfolio. I will start with the good news of receiving full Ethics Approval in Australia to start the IPAX BrIGHT.
我們來看下一張投影片。我將轉移到神經腫瘤領域。首先,我要宣布一個好消息:我們在澳洲獲得了全面的倫理批准,可以啟動 IPAX BrIGHT 計畫了。
IPAX BrIGHT is a pivotal registration-enabling study in recurrent glioblastoma. Given the absence of effective options for glioblastoma, we are very pleased that this agent has been granted an orphan drug designation, both in the US and Europe, for treatment of gliomas.
IPAX BrIGHT 是一項針對復發性膠質母細胞瘤的關鍵註冊研究。鑑於目前尚無治療膠質母細胞瘤的有效方法,我們非常高興該藥物已在美國和歐洲獲得孤兒藥資格認定,用於治療神經膠質瘤。
Our initial focus with TLX101 is going to be in glioblastoma, the most common and aggressive form of primary brain cancer. There is no established second-line treatment, at this point. If we look at the NCCN guidelines in the US, it tells you that the clinical trial is a very common option for treating second-line patients with recurrent disease.
我們最初將 TLX101 的重點放在膠質母細胞瘤上,這是最常見、最具侵襲性的原發性腦癌。目前尚無已確立的二線治療方案。如果我們查看美國的 NCCN 指南,就會發現臨床試驗是治療復發性疾病二線患者的一種非常常見的選擇。
Also, I just wanted to summarize data that we disclosed previously this year. IPAX-1 and IPAX-Linz in the recurrent setting demonstrated an acceptable safety profile as well as encouraging overall survival duration, both from the time of recurrent diagnosis -- ranging from 12 to 13 months -- and time from initiation of treatment, from 23 to 32 months. It's a great achievement when we know the average life expectation, which is extremely reduced in this debilitating disease.
另外,我還想總結一下我們今年稍早公佈的數據。IPAX-1 和 IPAX-Linz 在復發情況下表現出可接受的安全性,且總存活期令人鼓舞,無論是從復發診斷之時起算(12 至 13 個月),還是從開始治療之時起算(23 至 32 個月)。考慮到這種致殘性疾病患者的平均預期壽命極短,這的確是一項了不起的成就。
On the right part of the slide, you can see a patient case coming from a Compassionate Use Program in Europe. In these patients, the scans describe a stable disease for 18 months, very encouraging when you know the severity of the disease.
在幻燈片的右側,您可以看到一個來自歐洲同情用藥計劃的患者案例。在這些患者中,掃描結果顯示病情穩定了 18 個月,考慮到疾病的嚴重程度,這非常令人鼓舞。
Turning to our targeted alpha therapy approach in neuro oncology utilizing astatine isotope, we believe patients with smaller, more diffuse disease may be well suited with the mechanism of actions and the higher energy deposition of astatine-211.
轉向我們利用砹同位素在神經腫瘤學中採用的標靶α療法,我們認為,對於病情較小、較彌散的患者,砹-211 的作用機制和更高的能量沉積可能非常適用。
We are currently in the process of preparing regulatory filing for submissions for leptomeningeal disease and conducting a collaborative investigator-initiated trial in glioblastoma.
我們目前正在準備提交軟腦膜疾病的監管文件,並進行一項由研究者發起的膠質母細胞瘤合作試驗。
Let's move to the next slide please, focusing on the other solid tumors and hematology disease. Let's start with the TLX400, our FAPI, which stands for Fibroblast Activation Protein Inhibitor, an antigen expressed on the tumor microenvironment.
請進入下一張投影片,重點關注其他實體腫瘤和血液疾病。我們先從 TLX400 開始,它是我們的 FAPI,代表纖維母細胞活化蛋白抑制劑,一種在腫瘤微環境中表現的抗原。
The diagnostic piece has been confirmed in patients. We have several publications on the topic. We are looking forward to bringing this molecule to the clinic, the Phase 1 pan-cancer basket study which starts in 2026.
此診斷方法已在患者身上得到證實。我們有多篇關於這個主題的出版品。我們期待將這種分子帶入臨床,即 2026 年啟動的 1 期泛癌籃式研究。
The other two molecules we have are TLX300, in-licensed from Lilly, PDGFR alpha for advanced metastatic soft tissue sarcoma. We have initiated a Phase 1 Zolar imaging trial that is recruiting patients in New Zealand and Australia.
我們擁有的另外兩種分子是 TLX300(從禮來公司獲得許可)和 PDGFR α(用於治療晚期轉移性軟組織肉瘤)。我們已啟動一項 1 期 Zolar 影像試驗,目前正在紐西蘭和澳洲招募患者。
We also have the TLX66 for bone marrow conditioning for allogeneic stem cell transplantation, more specifically in myelodysplastic syndrome and acute myeloid leukemia.
我們還有 TLX66,用於異體造血幹細胞移植的骨髓預處理,更具體地說是用於骨髓增生異常症候群和急性骨髓性白血病。
Let's move to the next slide. In conclusion, it is an extremely busy first part of the year. Telix has one of the most complete therapeutic portfolios, with 10 pipeline assets; and even a few more, if I add from the research stage with ImaginAb's recent acquisition.
我們來看下一張投影片。總之,今年上半年非常忙碌。Telix 擁有最完整的治療產品組合之一,目前有 10 個在研產品;如果算上最近收購的 ImaginAb 的研究階段產品,數量還會更多。
Within urology and neuro oncology, we are progressing, initiating three pivotal trials. First, advancing the pivotal trial with ProstACT Global; second, preparing the pivotal trial LUTEON for the 250 compound; and starting the pivotal trial, IPAX BrIGHT.
在泌尿科和神經腫瘤學領域,我們正在取得進展,啟動了三項關鍵性試驗。首先,推進與 ProstACT Global 的關鍵性試驗;其次,準備針對 250 化合物的關鍵性試驗 LUTEON;並啟動關鍵性試驗 IPAX BrIGHT。
We are also starting the clinical trial with the TLX090, which is the perfect companion product for a prostate portfolio. And don't forget that we are entering first-in-human trials with two alpha emitters, TLX592 and TLX252.
我們也啟動了 TLX090 的臨床試驗,它是前列腺產品組合的完美配套產品。別忘了,我們正在對兩種α粒子發射體TLX592和TLX252進行首次人體試驗。
Thank you for your attention.
感謝您的關注。
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Thanks very much, Richard. A great rundown. It really conveys the depth of the pipeline and development activity and progress over the last six months.
非常感謝,理查德。一份很棒的概述。它真實地展現了過去六個月來專案研發活動的深度和進展。
As is typical, I get to end the presentation with a summary of our upcoming catalysts and key objectives. This is by no means an exhaustive list but captures some of the key value-creation events that are on the near-term horizon.
按照慣例,我會在演講的最後總結我們即將推出的催化劑和關鍵目標。這絕不是一份詳盡的清單,但涵蓋了近期即將發生的一些關鍵價值創造事件。
Many of these catalysts are new commercial opportunities that will add to our revenue and earnings growth and will support our expansion and transition into a fully-fledged theranostics company. Some of these catalysts relate to new clinical data points that I believe will reinforce our leadership position as an innovative player in the radiopharma space, with pipeline of either best-in-class or first-in-class assets.
這些催化劑中的許多都是新的商業機會,它們將增加我們的收入和利潤成長,並支持我們擴張和轉型成為一家成熟的診療一體化公司。其中一些催化劑與新的臨床數據點有關,我相信這些數據點將鞏固我們作為放射性藥物領域創新參與者的領導地位,我們擁有同類最佳或同類首創的資產儲備。
Expanding our capabilities is a key driver of near-term value creation as we work to deliver our products into major global markets. Our investments are focused on building the operational strength needed to unlock these markets and then, of course, to scale sustainably.
在我們努力將產品推向全球主要市場的過程中,拓展自身能力是近期創造價值的關鍵驅動力。我們的投資重點在於建立開拓這些市場所需的營運實力,然後當然,還要實現可持續的規模化發展。
In closing, Telix continues to demonstrate strong growth and operational improvement. We've never been more focused or committed to delivering value for our shareholders; our clinical partners; and most importantly, the patients we serve.
總之,Telix 繼續展現出強勁的成長動能和營運改善。我們從未像現在這樣專注於為我們的股東、我們的臨床合作夥伴以及最重要的,我們所服務的患者創造價值。
Thank you for your attention. I hope you found this presentation interesting and informative.
感謝您的關注。希望您覺得這次演講有趣且內容豐富。
I now open it up for questions.
現在開始接受提問。
Operator
Operator
Thank you.
謝謝。
(Operator Instructions)
(操作說明)
David Low, J.P. Morgan.
David Low,摩根大通。
David Low - Analyst
David Low - Analyst
Oh. Great. Thank you for taking my question.
哦,太好了。感謝您回答我的問題。
If we could start with just the outlook for gross margins, I think it was very useful to get all the update on RLS and understand exactly where the contribution is. But I heard the message that you think it can improve. And then, of course, we've seen some fairly significant changes in PSMA pricing in the last quarter to be the back end.
如果我們只從毛利率前景入手,我認為了解 RLS 的所有最新情況並準確了解其貢獻所在是非常有用的。但我聽出你的意思,你認為情況可以改善。當然,在過去一個季度裡,我們也看到了 PSMA 定價方面一些相當大的變化,這主要是後端方面的變化。
Just wondering how that's going to play out and, of course, trying to understand how Gozellix fits into that mix as well. So if I could have someone have a go at answering some of those facets, please.
我只是好奇事情會如何發展,當然,也想了解 Gozellix 在這其中扮演的角色。所以,如果可以的話,請問有人能嘗試回答其中的一些問題嗎?
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Well, Darren, why don't you -- it sounds like three questions, not one, but why don't you go ahead, Darren, and start off with the gross margin.
達倫,你為什麼不——聽起來像是三個問題,而不是一個,但達倫,你為什麼不先從毛利率開始呢?
Darren Smith - Group Chief Financial Officer
Darren Smith - Group Chief Financial Officer
Yeah. Sure. Thanks, David.
是的。當然。謝謝你,大衛。
Obviously, this past year has been quite a change for the organization where compared to the prior year, we're only selling Illuccix. I think the first key point is that the Illuccix gross margin -- and you can see this by looking at that Precision Medicine slide -- has remained fairly consistent.
顯然,過去一年對公司來說發生了很大的變化,與前一年相比,我們現在只銷售 Illuccix 產品。我認為第一個關鍵點是,Illuccix 的毛利率——你可以從精準醫療的幻燈片中看出這一點——一直保持相當穩定。
I think we reported 65%, last year. 64%, this year. Obviously, no real change in the gross margin perspective for Illuccix in the market, from the gross margin.
我認為我們去年報告的比例是 65%,今年是 64%。顯然,從毛利率來看,Illuccix 在市場上的毛利率前景並沒有真正的變化。
Then, when we look at RLS, we see that the addition of those third -party products and also, the internal contribution that it receives by selling our Illuccix product into the market, they're able to achieve a 7% gross margin once you've included the radio pharmacy cost into the overall cost of goods.
然後,當我們觀察 RLS 時,我們發現,加上這些第三方產品,以及向市場銷售我們的 Illuccix 產品而獲得的內部貢獻,一旦將無線電藥房成本計入總商品成本,他們就能實現 7% 的毛利率。
The interesting thing we have done a little bit of benchmarking. What we found is the industry -- that's similar. Some of our partners/competitors are doing a very similar growth margin in that low- to mid-range single-digit yield.
有趣的是,我們做了一些基準測試。我們發現,這個行業——是相似的。我們的一些合作夥伴/競爭對手也實現了非常相似的成長幅度,收益率在個位數的低到中等。
Gross margin is obviously a result of those two businesses brought together. So the 53% is the average, based on the load of business. I think the important thing to remember though is RLS -- is that as we start to push a product like a Illuccix and the higher contribution that it provides to the RLS business, that should help grow the dollar gross margin. That business is little, minimal cost impact on being able to deliver that to patients.
毛利率顯然是這兩家企業合併後的結果。所以 53% 是根據業務量計算出來的平均值。但我認為需要記住的重要一點是 RLS——當我們開始推廣像 Illuccix 這樣的產品,以及它對 RLS 業務的更高貢獻時,這應該有助於提高美元毛利率。這項業務規模很小,對患者提供醫療服務的成本影響微乎其微。
What we would potentially see is that we add more Illuccix and potentially, the future products that we're looking to bring to market in the U.S., Pixclara and Zircaix. That will continue to assist that business to make a better contribution to the organization.
我們可能會看到 Illuccix 的增加,以及我們未來計劃在美國推出的產品 Pixclara 和 Zircaix。這將繼續幫助該企業為組織做出更大的貢獻。
Hopefully, that answers the question, David.
希望這能解答你的疑問,大衛。
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Yeah. I think I don't have anything to add except for that, obviously, we didn't acquire RLS for its commodity radiopharmaceutical business. We acquired it to put a larger proportion of our own products through and to prepare for when we have to distribute Therapeutics unit doses, which you can't do that without a nuclear pharmacy dose-dispensing.
是的。我想我沒什麼要補充的了,顯然,我們收購 RLS 並不是為了它的商品放射性藥物業務。我們收購它是為了讓更多我們自己的產品通過這家工廠,並為將來分發治療藥物的單位劑量做好準備,如果沒有核藥房的劑量分發系統,這是不可能的任務。
If you want to deliver a pre-filled syringe to a customer, which is the name of the game, you've got to have a pharmacy network to do that. So this is not about, like, what's going to happen this quarter. it's what's going to happen in the next quarter and the quarter after that and three years from now.
如果你想向顧客交付預填充注射器(這才是關鍵所在),你必須擁有一個藥房網路才能做到這一點。所以,這並非關乎本季會發生什麼,而是關乎下個季度、再下個季度以及三年後會發生什麼。
Let's move on to the next question.
我們來看下一個問題。
Operator
Operator
Tara Bancroft, TD Cowen.
塔拉·班克羅夫特,TD Cowen。
Nicholas Lorusso - Analyst
Nicholas Lorusso - Analyst
Great. Thanks for taking our question. This is Nick, on for Tara.
偉大的。感謝您回答我們的問題。我是尼克,替塔拉發言。
One on the guidance and the continued growth of Illuccix, moving forward. To reach the 2025 guidance with assuming stable RLS revenue, obviously, it's a little bit difficult to say that right now but it appears like Illuccix sales growth may be slowing a little bit.
一是關於 Illuccix 的發展方向和持續成長。要實現 2025 年的業績指引,並假設 RLS 收入保持穩定,顯然現在很難說,但 Illuccix 的銷售成長似乎正在略微放緩。
Is this due to the loss of pass-through status and what impact could this have on a Illuccix net sales? Also, could gozellix return to growth once it does have pass through status? Thanks.
這是由於失去了轉嫁地位嗎?這會對 Illuccix 的淨銷售額產生什麼影響?另外,一旦gozellix獲得過境許可,它能否恢復成長?謝謝。
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Yeah. Obviously, we give guidance on an annualized basis, not on a quarter-by-quarter blow. You're absolutely correct. July 1, we came off pass-through.
是的。顯然,我們提供的業績指引是按年度計算的,而不是按季度計算的。你說得完全正確。7月1日,我們結束了過境行程。
We actually reported 7% growth quarter on quarter, which is, I think, exceptional -- 7% growth in volume quarter on quarter, which is really exceptional performance, particularly if you take some of our competitors' financial results into consideration.
我們實際上實現了季度環比增長 7%,我認為這非常出色——季度環比銷量增長 7%,這確實是一個非常出色的業績,特別是考慮到我們一些競爭對手的財務業績。
What we did is we made a decision that we were going to stabilize our customer book going into the third quarter. We have the situation where we have one product coming off pass-through and then, another product getting reimbursement effective October 1. We've got to bridge that gap and we chose to take certain commercial actions to do that.
我們決定在第三季穩定客戶群。我們現在面臨的情況是,一種產品即將停止報銷,而另一種產品將於 10 月 1 日起開始報銷。我們必須彌補這一差距,為此我們選擇採取某些商業行動。
We still had growth in revenue quarter on quarter, again, where, our competition didn't. And so I think we have a nice stabilization strategy for Q3; and then, Q4 continues with the advantage that we uniquely have of a second product introduction.
我們的營收依然實現了季度環比成長,而我們的競爭對手卻沒有。所以我認為我們為第三季制定了一個很好的穩定策略;然後,第四季我們將繼續保持我們獨有的優勢,即推出第二款產品。
I don't know, Kevin, if you want to add anything to that?
凱文,我不知道你是否還有什麼要補充的?
Kevin Richardson - Chief Executive Officer - Telix Precision Medicine
Kevin Richardson - Chief Executive Officer - Telix Precision Medicine
I would just add that we just continue to take the market pragmatically and continue to sell clinically on our accuracy, as we spoke of earlier in my presentation; and then, continue to drive that message with reliability.
我只想補充一點,我們將繼續務實地開拓市場,繼續以臨床精準度為賣點進行銷售,正如我在前面的演講中提到的那樣;然後,繼續以可靠性來傳遞這一信息。
Again, we have a strategic pillar in our customer-facing team that really represents well and is able to really manage that ASP and volume mix that we work on with that piece of the business and the strategic accounts.
再次強調,我們面向客戶的團隊擁有一個策略支柱,能夠很好地代表並真正管理我們與該業務部門和策略客戶合作時所採用的平均售價和銷售組合。
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Yeah. I think you'd be mistaken in thinking that this is just a pricing game. It's not. I think there's four pieces to commercial success in the market dynamic today, as Kevin said.
是的。如果你認為這只是一場價格戰,那就大錯特錯了。它不是。正如凱文所說,我認為當今市場動態中的商業成功包含四個要素。
Selling on clinical value proposition, which we have, demonstrably the strongest clinical value proposition. It's selling on service and service quality.
我們以臨床價值主張為賣點,而我們擁有無可爭議的最強臨床價值主張。它主打服務和優質服務。
Then, there is, of course, pricing and pricing structure, particularly for large volume customers. Unlike our competition, we throw it all at the same price to everybody. We give benefits to our customers that are more loyal than smaller customers.
當然,還有定價和定價結構,特別是對於大批量客戶而言。與競爭對手不同,我們對所有顧客都收取相同的價格。我們給予忠誠度較高的顧客比給予小客戶更多的優惠。
I think the last thing is clearly reimbursement status. Again, to reiterate, we go into Q4 with a very strong and differentiated commercial strategy with Gozellix. We're excited about that. We're looking forward to it.
我認為最後一點顯然是報銷狀態。再次重申,我們帶著非常強大且差異化的商業策略進入第四季度,Gozellix 就是最好的例證。我們對此感到興奮。我們很期待。
Sales teams' pumped.
銷售團隊士氣高昂。
Next question.
下一個問題。
Operator
Operator
(inaudible), UBS.
(聽不清楚),瑞銀集團。
Unidentified Participant
Unidentified Participant
Just curious about the Zircaix launch readiness. Maybe you can highlight some of the things they've been doing for Zircaix and how should we think about the launch in the first and the second quarter, after approval on August 27?
只是好奇 Zircaix 的發布準備。或許您可以重點介紹他們為 Zircaix 所做的一些工作,以及在 8 月 27 日獲得批准後,我們應該如何看待第一季和第二季的發布?
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
It's probably not too much to really openly discuss. The commercial team, it's not their first rodeo. We're selling into the same customer base, same referral position base as Illuccix so it's a very straightforward pathway to the customer.
這或許不至於太過分,不值得公開討論。商業團隊並非初次涉足此類領域。我們面對的是與 Illuccix 相同的客戶群和推薦客戶群,因此接觸客戶的途徑非常直接。
We're clearly focused on using our Illuccix customer base to see that product launch. I would say, commercial team is ready to rock-and-roll on Zircaix.
我們顯然專注於利用 Illuccix 的客戶群來實現產品上市。我認為,商業團隊已經準備好在 Zircaix 上大展拳腳了。
I don't know if you want to add anything to that, Kev?
凱文,我不知道你是否還有什麼要補充的?
Kevin Richardson - Chief Executive Officer - Telix Precision Medicine
Kevin Richardson - Chief Executive Officer - Telix Precision Medicine
I think the combination of a urological call point with a nuclear med physician base that's reading that is really the key to success there. We've had an expanded access program going for a while that's demonstrated exactly what we saw in the ZIRCON study. So we're excited about the launch and just haven't given guidance for 2026 yet.
我認為泌尿科醫師和核子醫學醫師群體結合,讓他們閱讀相關資料,才是成功的關鍵。我們已經開展了一段時間的擴大准入計劃,該計劃證實了我們在 ZIRCON 研究中看到的結果。所以我們對這次發布感到興奮,只是還沒有給出 2026 年的預期。
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Yeah. We've had a lot. The Expanded Access program, the EAP, has been a huge success. We've done a very, I think, well-orchestrated, unbranded, physician education campaign.
是的。我們已經有很多了。擴大准入計畫(EAP)取得了巨大的成功。我認為,我們開展了一項組織得非常周密、沒有品牌識別的醫生教育活動。
So as far as we're concerned, the market's ready for this product.
所以就我們而言,市場已經準備好接受這款產品了。
Operator
Operator
Andy Hsieh, William Blair.
謝家華,威廉布萊爾。
Andy Hsieh - Equity Analyst
Andy Hsieh - Equity Analyst
Thanks for taking our questions. Congratulations on the on the performance.
謝謝您回答我們的問題。恭喜你取得如此佳績。
For the BiPASS study, obviously, very provocative in terms of the disruptive potential. I'm curious, the trial is posted on clinicaltrials.gov.; you have some primary endpoints, just curious about some secondary endpoints that you're contemplating on and how you think about some of the longer-term outcomes for patients pertaining to survival or treatment steps that you can really convey the value of taking this agent upfront?
顯然,BiPASS 研究具有非常大的顛覆性潛力,因此極具爭議性。我很好奇,這項試驗已發佈在 clinicaltrials.gov 上;你們有一些主要終點,我只是好奇你們正在考慮的一些次要終點,以及你們如何看待患者的一些長期結果,例如生存期或治療步驟,以便真正傳達一線服用這種藥物的價值?
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Yeah. This study was really born out of and driven by KOL engagement around where is PSMA going to really go, as we move up the treatment cascade. To be quite honest with you, on the front line of patient management, not a lot has really changed in the last 15 years. It's pretty archaic.
是的。這項研究的真正起源和驅動力是 KOL 對 PSMA 未來發展方向的參與,隨著我們推動治療流程,PSMA 的發展方向究竟是什麼。坦白說,在病患管理的第一線,過去 15 年並沒有太大的改變。它相當古老。
Whilst MRI, of course, gets better and better, we're still doing well over a million biopsies a year. A good proportion of those biopsies aren't adding any value to the patient journey.
當然,儘管核磁共振成像技術越來越好,但我們每年仍要進行超過一百萬例活檢。相當一部分活檢對患者的治療過程沒有任何益處。
So just to be clear, our goal is not to eliminate biopsy. That's a nonsensical clinical objective. A biopsy is super important. What our goal is to make biopsy count and to use it where it's absolutely essential and to use the scope of biopsy where it absolutely makes sense to do that.
所以要先明確的是,我們的目標不是取消活體切片檢查。這是一個毫無意義的臨床目標。活檢非常重要。我們的目標是讓活檢發揮作用,在絕對必要的情況下使用它,並在絕對合理的情況下使用活檢的範圍。
In terms of the --we will, of course, be putting out the trial design on clinicaltrials.gov. It's only just that study is just launching so, clearly, we want everybody to understand the end points.
至於試驗方案——我們當然會在clinicaltrials.gov網站上公佈。這項研究剛剛啟動,所以很顯然,我們希望每個人都能了解研究的終點。
But to the implied part of your question, yes, there will be a monitoring period. It won't be a very long monitoring period but there's definitely a follow-up period that's part of the evaluation of the utility of prostate imaging in that patient segment.
但對於你問題中隱含的部分,是的,會有一個監測期。監測期不會很長,但肯定會有一個後續追蹤期,這是評估前列腺影像在該患者群體中實用性的一部分。
So stay tuned, Andy, we've got more updates on that trial design coming down the pathway.
安迪,請繼續關注,我們稍後會發布更多關於該試驗設計的最新消息。
Operator
Operator
David Nierengarten, Wedbush Securities.
大衛‧尼倫加滕 (David Nierengarten),韋德布希證券公司 (Wedbush Securities)。
David Nierengarten - Analyst
David Nierengarten - Analyst
Hi. Thanks for taking the question. I just had one on the ProstACT study. Just around the parameters you've recruited the patients. What are you looking for on the dosimetry and safety side? When you think about the movement into the Part 2 of the study, is it still the plan to carry forward all three combinations or could that change in the future when you talk about the results from these first 30 patients? Thanks.
你好。感謝您回答這個問題。我剛參加了ProstACT研究。就在你招募患者的這些參數範圍內。您在劑量學和安全性方面想了解什麼?當您考慮進入研究的第二部分時,您是否仍然計劃繼續進行所有三種組合,或者當您談到前 30 名患者的結果時,未來是否有可能改變這一計劃?謝謝。
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Well, things can always change based on data. But we -- at present, our plan remains as stated. The real purpose of the Part 1 study and, frankly, the reason why it took a while to accrue is because it's a multi-time point analysis -- a lot of patient visits typically requires specialist centers so it's really a subset of departments that are really suitable for running that study.
當然,情況會根據數據而改變。但是,目前我們的計劃仍然保持不變。第一部分研究的真正目的,坦白說,也是它耗時較長的原因,是因為它是一項多時間點分析——許多患者就診通常需要專科中心,因此只有一部分科室真正適合開展這項研究。
It is, as I said, a demanding study on patients. We know that when we move into the second part of the study, which in some countries is a seamless transition so that's already in play, it's a very straightforward transition and a much more straightforward study protocol from a patient perspective.
正如我所說,這是一項對患者要求很高的研究。我們知道,當我們進入研究的第二部分時,在一些國家,這是一個無縫過渡,所以這部分已經開始實施,這是一個非常直接的過渡,從患者的角度來看,研究方案也更加直接。
The three different arms were because we had the aspiration in this study to have flexibility on the choice of ARPI. We think that that's an important thing. And so, really, what we're looking to get out of Part 1 is confirmation of our understanding of the safety profile in combination with both ARPIs, different ARPIs, and docetaxel.
之所以設定三個不同的群組,是因為我們希望在 ARPI 的選擇上具有靈活性。我們認為這很重要。因此,我們真正希望從第一部分中得到的,是確認我們對兩種 ARPI、不同的 ARPI 和多西他賽聯合使用時的安全性概況的理解。
We fully expect that that's what's going to progress into the second part of the study. We think that there's a compelling clinical use case for all three of those combos. Our mission is to really demonstrate to the agency that that safety profile is consistent across really across different RPs.
我們完全預期這將進入研究的第二部分。我們認為這三種組合都有充分的臨床應用價值。我們的使命是向該機構證明,這種安全狀況在不同的RP中是一致的。
So I hope that answers your question. But we're really excited to have that first run-in part done. It's a pretty painful study protocol. The rest of the study now is going to pick up at a much greater pace.
希望這能解答你的疑問。但我們很高興完成了第一次試跑部分。這是一個相當痛苦的研究方案。接下來的研究工作將以更快的速度推進。
Operator
Operator
John Hester, Bell Potter.
約翰·赫斯特,貝爾·波特。
John Hester - Analyst
John Hester - Analyst
Yes. Good morning, Chris.
是的。早上好,克里斯。
I wanted to just come back to the situation with PSMA pricing. I'm sure everyone on the call heard the comments from Lantheus a few weeks ago regarding the competitive situation and also, Kevin referred to competitive pricing pressures in the market in his prepared comments.
我只想回到 PSMA 定價的問題上來。我相信參加電話會議的每個人都聽到了蘭瑟斯幾週前關於競爭情況的評論,而且,凱文在他的準備好的評論中也提到了市場上的競爭性定價壓力。
So the question is this, are you worried about that pricing pressure contagion spreading to your own market? Can you also update perhaps on what you've seen on those pricing pressures in this current quarter?
所以問題是,您是否擔心這種價格壓力會蔓延到自己的市場?您能否也更新一下本季觀察到的價格壓力狀況?
Thank you.
謝謝。
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Well, I think we've reported all the numbers so the numbers are the numbers. I think that pricing is a direct function of both competitive dynamics and clearly, reimbursement status. The market's complicated, as there are multiple customer segments in the market that have different competitive dynamics and different pricing dynamics.
嗯,我想我們已經公佈了所有數據,所以數據就是數據了。我認為定價直接取決於競爭動態,而且顯然也取決於報銷情況。市場很複雜,因為市場上有多個客戶群體,它們的競爭動態和定價動態各不相同。
What we do know is that customers prefer, understandably, to use a reimbursed product. Pylarify came off reimbursement. That certainly puts pressure on their business. We've now come off reimbursement, albeit for a very transient period of time, because we have been granted a HCPCS code for our life cycle management product, which, by the way, has innovative aspects in its own right. Like, it's not just a direct follow on, there's some genuine clinical and clinical workflow benefits that come from that product.
我們知道的是,客戶更傾向於使用可報銷的產品,這是可以理解的。Pylarify 已停止報銷。這無疑會給他們的業務帶來壓力。雖然只是暫時的,但我們現在已經停止了報銷,因為我們的生命週期管理產品獲得了 HCPCS 代碼,順便說一句,該產品本身也具有創新性。它不僅僅是直接的後續產品,該產品還帶來了真正的臨床和臨床工作流程的好處。
So the way that we manage pricing and pricing consistency is by ongoing innovation and capability delivery to our customers and differentiating ourselves in both the clinical use case for the product and the reimbursement profile of the product.
因此,我們管理定價和定價一致性的方式是透過不斷創新和為客戶提供能力,並在產品的臨床應用案例和報銷情況方面實現差異化。
And so -- I hope I don't sound facetious but no, pricing pressure is not what we worry about because we have a life cycle management strategy to address it.
所以——我希望我的話聽起來不像是在開玩笑,但是,價格壓力不是我們擔心的問題,因為我們有生命週期管理策略來解決這個問題。
Next question, please.
下一個問題。
Operator
Operator
Andya Hsieh, William Blair.
安迪婭·謝,威廉·布萊爾。
Andy Hsieh - Equity Analyst
Andy Hsieh - Equity Analyst
Oh. Thanks for squeezing me in for one more.
哦,謝謝你擠出時間再幫我一次。
Chris, I'm just curious if you can comment a little bit more about the aluminum fluorine technology that you mentioned that allows you to traverse between the gallium-68 and fluorine-18 isotopes. Can you speak to maybe the commercial implication? What is the next steps in terms of potential regulatory pathway and then, supply chain? How does that fit into your goal of being a vertically integrated company, leveraging the RLS and ARTMS platforms?
克里斯,我很好奇你是否可以再多談談你提到的鋁氟技術,這項技術可以讓你在鎵-68和氟-18同位素之間轉換。您能否談談這可能帶來的商業影響?下一步在潛在的監管路徑和供應鏈方面應該採取哪些措施?這如何契合您成為一家垂直整合型公司,並利用 RLS 和 ARTMS 平台的目標?
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Yeah. I'm the nerd so I'll start off with the science lesson and then, I'll hand it over to Kevin to talk about the commercial implications in the physician preference.
是的。我是個書呆子,所以我會先講科學知識,然後把麥克風交給凱文,讓他談談醫生偏好背後的商業影響。
But essentially, when you react to aluminum and fluorine together, it's a pretty violent coupling. What you end up with is a metallized version of F-18. It turns out that that metallized version of F-18 is a drop-in replacement for gallium. So what it means is that you can have the same targeting agent and you can interchangeably substitute either gallium or F-18.
但本質上,當鋁和氟一起發生反應時,這是一種非常劇烈的偶聯反應。最後得到的是金屬化的 F-18。事實證明,金屬化的 F-18 可以直接取代鎵。這意味著你可以使用相同的靶向劑,並且可以互換地用鎵或 F-18 代替。
The beautiful thing about aluminum fluoride is that you make it in extremely large quantities at a cyclotron facility. It's not a drug, per se. It's essentially an API, a hot API. You can drop that activity then into a nuclear pharmacy.
氟化鋁的優點在於,你可以在迴旋加速器設施中大量生產它。它本身並不是毒品。它本質上是一個 API,一個熱門 API。然後你可以把那項活動轉移到核藥局。
Using all of the benefits and the production workflow advantages that we have of the kit-based approach, we can essentially -- particularly in high density areas or where we want to service large academic customers that really are enamored by F-18; and I'll get Kevin to characterize the customer base a bit more -- but it enables us to seamlessly transition between gallium and F-18 and, of course, continue that life cycle management.
利用套件式方法的所有優勢和生產工作流程優勢,我們基本上可以——尤其是在高密度地區或我們想要服務真正迷戀 F-18 的大型學術客戶的地方;我會讓 Kevin 更詳細地描述一下客戶群——它使我們能夠在鎵和 F-18 之間無縫過渡,當然,還可以繼續進行生命週期管理。
PSMA-11 is really well demonstrated in terms of its sensitivity and specificity as a targeting agent. Now, we get to marry that superior pharmacology of PSMA-11 with the utility of F-18; and still, by the way, utilizing our, well-trodden and well-understood distribution model.
PSMA-11 作為標靶劑,其靈敏度和特異性已被充分證實。現在,我們可以將 PSMA-11 的優異藥理學特性與 F-18 的實用性結合;順便說一句,我們仍然採用我們久經考驗且廣為人知的分銷模型。
Maybe Kevin, you want to copy on comment on physician preference?
凱文,或許你想轉發一則關於醫生偏好的評論?
Kevin Richardson - Chief Executive Officer - Telix Precision Medicine
Kevin Richardson - Chief Executive Officer - Telix Precision Medicine
We launched Illuccix three years ago. We've successfully taken over a third of the market, pushing 40% of the market with gallium. We believe that gallium is a fantastic product and we're going to continue to execute on our Illuccix and our Gozellix plan through the marketplace.
我們三年前推出了Illuccix。我們已成功佔領三分之一的市場份額,其中鎵的市佔率達到了 40%。我們相信鎵是一種非常棒的產品,我們將繼續透過市場執行我們的 Illuccix 和 Gozellix 計劃。
But what we do see is some stalwarts that have used F-18 for many other products through the years and tend to favor that more. The reality is that we believe our reliability story, along with our commercial customer-facing team, can support that in the next couple of years as we move in our life cycle management from Gozellix and continue to maximize gallium sales and then find, if you will, the corners of the canvas, if you will, to paint with fluorine.
但我們確實看到一些忠實用戶多年來一直將 F-18 用於許多其他產品,並且往往更喜歡這種做法。事實上,我們相信,在接下來的幾年裡,隨著我們從 Gozellix 過渡到生命週期管理,並繼續最大限度地提高鎵的銷售額,我們的可靠性以及我們面向商業客戶的團隊能夠支持這一目標,然後,如果你願意的話,找到畫布的角落,如果你願意的話,用氟來作畫。
We believe that's a great party to do it through our distribution and commercial network.
我們相信,透過我們的分銷和商業網絡來舉辦這場盛會是一個絕佳的選擇。
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Christian Behrenbruch - Group Chief Executive Officer, Managing Director, Executive Director, PhD, MBA and JD
Yeah. Maybe just to wrap up because it's a super great question -- by the way, you're the first analyst that's ever asked a question about it so that's why I'm grateful to elaborate a bit more.
是的。最後我想補充一點,因為這是一個很好的問題——順便說一句,你是第一個提出這個問題的分析師,所以我很感激能再詳細解釋一下。
But going forward, I think what you're going to really see is we have a whole pile of imaging products coming down the pipe, including, for example, there's a gallium FAP agent there. As we develop that agent, we'll think about how this time do we avoid having to participate in a physician preference discussion, right?
但展望未來,我認為你們將會看到我們有許多影像產品即將問世,例如,其中就包括鎵 FAP 顯影劑。在開發該代理時,我們會思考這次如何避免參與醫生偏好討論,對吧?
Some folks like gallium, some folks like F-18. Some guys drive a Beemer [BMW] (added by the company after the call) , some guys drive a Mercedes. We're going to set up shops so we can make those available, depending on what the preference is.
有些人喜歡鎵,有些人喜歡F-18。有些人開寶馬(BMW)(通話後公司補充),有些人開賓士。我們將開設店鋪,以便根據顧客的喜好提供這些產品。
All right. Well, look, I think we're --
好的。嗯,你看,我認為我們--
Yeah. I think we're at the end of time, anyway. Well, thanks.
是的。我覺得我們反正已經到世界末日了。謝謝。
I just want to say thanks very much to everybody for your time today and appreciate the opportunity to give you an update. Thanks very much.
我只想對大家表達衷心的感謝,感謝大家今天抽出時間,也很感激有機會向大家報告最新情況。非常感謝。
Operator
Operator
That does conclude our conference for today. Thank you for participating. You may now disconnect your lines.
今天的會議就到此結束。感謝您的參與。現在您可以斷開線路了。