Takeda Pharmaceutical Co Ltd (TAK) 2025 Q2 法說會逐字稿

(inaudible) (interpreted) To join the FY24 Q2 earnings -- by Takeda. I'm the master of ceremony, Head of IR. My name is O'Reilly. (Operator instructions)

（聽不清楚）（已解釋）加入 2024 財年第二季財報中－武田 (Takeda)。我是司儀，IR 主管。我叫奧萊利。 （操作員說明）

Let me start, I'd like to remind everyone discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in the most recent Form 20-F and our other SEC filings.

首先，我想提醒大家討論 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。可能導致我們的實際結果出現重大差異的因素在最新的 20-F 表格和我們的其他 SEC 文件中進行了討論。

I'd also refer to the important note on page of the presentation regarding forward-looking statements of our non-IFRS financial measures, which will also be discussed during this call. Definitions of non-IFRS measures and the reconciliations with comparable IFRS financial measures are included in the appendix to the presentation.

我還想提及簡報頁面上有關我們的非國際財務報告準則財務指標前瞻性陳述的重要註釋，該註釋也將在本次電話會議中進行討論。非國際財務報告準則措施的定義以及與可比較國際財務報告準則財務措施的調節表包含在簡報的附錄中。

Now we would like to start the presentation. Today, we have President and CEO, Christophe Weber; Chief Financial Officer, Milano Furuta; R&D President, Andy Plump, presenting to you. And the presentation will be followed by Q&A. Let's get started.

現在我們要開始示範。今天，我們的總裁兼執行長 Christophe Weber；米蘭古田財務長；研發總裁 Andy Plump 向您介紹。演講結束後將進行問答。讓我們開始吧。

Thank you, Chris, and thank you, everyone, for joining us today. Our fiscal year 2024 first half performance demonstrates the strong momentum of our Growth & Launch product portfolio, the potential of our pipeline and our commitment to driving efficiencies to improve our margins.

謝謝克里斯，也謝謝大家今天加入我們。我們 2024 財年上半年的業績展示了我們的成長和推出產品組合的強勁勢頭、我們的產品線的潛力以及我們對提高效率以提高利潤的承諾。

First half revenue grew 5% at constant exchange rate, driven by our Growth & Launch product, which grew 18.7% at constant exchange rate and now account for 47% of total revenue. Revenues declined 29% in the US and 18% globally, a slower-than-expected erosion in the US.

在我們的成長和推出產品的推動下，上半年收入按固定匯率計算增長了 5%，該產品按固定匯率計算增長了 18.7%，目前佔總收入的 47%。美國營收下降 29%，全球營收下降 18%，美國的下降速度低於預期。

We, however, I assume that VYVANSE generic erosion will potentially accelerate in the second half as generic supply normalized, impacting our revenue and profit growth in the second half of the year. I will discuss our Growth & Launch product performance in more detail on the following slide.

然而，我認為隨著仿製藥供應正常化，VYVANSE 仿製藥的侵蝕可能會在下半年加速，從而影響我們下半年的收入和利潤成長。我將在下面的幻燈片中更詳細地討論我們的成長和發布產品效能。

In the first half of the fiscal year, our core operating profit margin was 30.2%, benefiting from product mix, phasing of R&D investment as well as the early impact of our efficiency programs. Our progress in the multiyear efficiency program announced in May 2024 is on track. We have taken tough but necessary decision to drive efficiencies and deliver operating profit margin improvement while rigorously prioritizing our pipeline.

本財年上半年，我們的核心營業利潤率為 30.2%，受益於產品組合、分階段研發投資以及效率計畫的早期影響。我們在 2024 年 5 月宣布的多年效率計畫進展順利。我們採取了艱難但必要的決定，以提高效率並提高營業利潤率，同時嚴格優先考慮我們的管道。

However, we are waiting our R&D investment toward the second half of the fiscal year to support our late-stage pipeline, where we have multiple programs in Phase 3. This has been factored into our profit outlook for the full year. Our innovative late-stage pipeline is advancing, and we have multiple programs in Phase 3 development this year.

然而，我們正在等待本財年下半年的研發投資，以支持我們的後期管道，我們在第三階段有多個項目。我們的創新後期研發管線正在推進，今年我們有多個專案處於第三階段開發中。

In August, we initiated the Phase 3 clinical trial of TAK-861 for narcolepsy type one, a significant step towards reducing the overall burden and functional impact of this disease. Following this in October, we presented proof-of-concept data for the treatment of immunoglobulin and [arthropathy] with mezagitamab at the American Society of Nephrology, highlighting its potential in the treatment of this disease.

8月，我們啟動了TAK-861治療第1型發作性睡病的3期臨床試驗，這是減輕這種疾病的整體負擔和功能影響的重要一步。隨後十月份，我們在美國腎臟病學會上提交了美紮吉他單抗治療免疫球蛋白和[關節病]的概念驗證數據，強調了其治療這種疾病的潛力。

Turning again to our financials. We are raising our full year '24 management guidance and reported on core forecast, reflecting first half performance and updated foreign exchange assumption for the year. In his presentation, Milano will speak in more detail about our updated guidance as well as progress in implementing our efficiency program.

再次回到我們的財務狀況。我們正在提高 24 年全年管理指導並報告核心預測，反映上半年業績和今年更新的外匯假設。在演講中，米蘭將更詳細地介紹我們的最新指南以及實施效率計劃的進展。

Turning to slide 5. We achieved robust performance broadly across our Growth & Launch product portfolio. Together, this life-transforming treatment now accounts for 47% of total revenue and achieved significant growth, 18.7% at constant exchange rate in the first half. The performance of our Growth & Launch product is underscored by ENTYVIO return to double-digit growth, accelerated by the launch of the ENTYVIO Pen in the United States.

轉向幻燈片 5。目前，這種改變生活的治療方法合計佔總收入的 47%，並實現了顯著增長，以固定匯率計算，上半年增長了 18.7%。 ENTYVIO 恢復兩位數成長，突顯了我們的成長和發布產品的業績，而 ENTYVIO Pen 在美國的推出加速了這一增長。

Mainstay such as immunoglobulin and TAKHZYRO continued robust growth, a newly launched product, FRUZAQLA and ADZYNMA, have a strong early uptake exceeding revenue expectation. Approvals of ADZYNMA in the European Union and FRUZAQLA in Japan support the geographical expansion of these new treatments and underscore our future potential. I will discuss this in more detail on the next slide.

免疫球蛋白和 TAKHZYRO 等支柱產品持續強勁成長，新推出的產品 FRUZAQLA 和 ADZYNMA 早期吸收強勁，超越營收預期。 ADZYNMA 在歐盟的批准和 FRUZAQLA 在日本的批准支持了這些新療法的地理擴張，並強調了我們未來的潛力。我將在下一張幻燈片中更詳細地討論這一點。

As I just noted, FRUZAQLA launch has been flawless and has exceeded expectations since it launched in the United States in November '23, pointing an update to our forecast. We have seen a strong uptake in fourth line with new patient market share reaching 29% of our latest data in July.

正如我剛才指出的，自 23 年 11 月在美國推出以來，FRUZAQLA 的推出完美無缺，並且超出了預期，這表明我們的預測有所更新。我們看到第四線藥物的強勁成長，新患者市佔率達到我們 7 月最新數據的 29%。

We're also seeing continued momentum in the third-line setting, reflecting the positive earlier reception on demand for this therapy. Significant need for new treatment options in metastatic colorectal cancer and positive feedback from oncologists have been key drivers of its initial update.

我們也看到三線治療的持續勢頭，反映了對該療法需求的早期積極接受。轉移性大腸直腸癌對新治療方案的巨大需求以及腫瘤學家的積極回饋是其最初更新的關鍵驅動力。

FRUZAQLA's inclusion in both National Comprehensive Cancer Network and European Society for Medical Oncology guidelines, further validate its important in the treatment of metastatic colorectal cancer and underscore its position as a critical -- for oncologists and patients.

FRUZAQLA 被納入美國國家綜合癌症網絡和歐洲腫瘤內科學會指南，進一步驗證了其在治療轉移性結直腸癌中的重要性，並強調了其對於腫瘤學家和患者的關鍵地位。

With eight regulatory approval in less than a year since US approval, we are positioned to begin commercialization more broadly this year, further supporting global growth. This includes our recent approval in Japan, where we will build on our heritage in colorectal cancer. As we continue to expand into additional markets, we expect further regulatory decision on launch throughout fiscal year '24 and '25, which will provide more patients with access to FRUZAQLA.

自美國批准以來不到一年的時間裡，我們已獲得八項監管批准，我們準備在今年開始更廣泛的商業化，進一步支持全球成長。這包括我們最近在日本的批准，我們將在日本鞏固我們在大腸癌方面的傳統。隨著我們繼續擴展到其他市場，我們預計在整個財年 24 和 25 財年將做出進一步的監管決定，這將為更多患者提供 FRUZAQLA 的使用機會。

Turning to the right of the slide. Congenital thrombocytic -- or cTTP, is an ultrarare and potentially -- blood clotting disorder with limited treatment option. ADZYNMA launched in the United States in November '23 for the treatment of cTTP and has generated strong prescriber interest. Since then, ADZYNMA is also launched in Japan, Germany and Austria. Further launch are planned in the -- where ADZYNMA is the first and only enzyme replacement therapy specifically for the treatment of cTTP.

轉向幻燈片右側。先天性血小板增多症（cTTP）是一種極為罕見且潛在的凝血障礙，治療選擇有限。 ADZYNMA 於 23 年 11 月在美國上市，用於治療 cTTP，並引起了處方醫生的強烈興趣。此後，ADZYNMA 也在日本、德國和奧地利上市。計劃在該地區進一步推出——ADZYNMA 是第一個也是唯一一個專門用於治療 cTTP 的酶替代療法。

EOHILIA is currently the only oral therapy available for eosinophilic esophagitis, a chronic immune-mediated inflammatory disease. Since its launch in the United States in February '24, we have seen growing patient demand due to increasing awareness and progressive yet slightly slower-than-expected coverage. [Unaided] awareness among health care professional is approaching 80% and initial patient experience has been positive.

EOHILIA 是目前唯一可用於治療嗜酸性粒細胞性食道炎（一種慢性免疫介導的發炎性疾病）的口服療法。自 2024 年 2 月在美國推出以來，由於意識的提高和覆蓋範圍的進展但略慢於預期，我們看到患者的需求不斷增長。醫療保健專業人員的[獨立]意識接近 80%，並且患者的初步體驗是積極的。

Turning to the next slide, I would like to provide more details about ENTYVIO performance. Since the launch of the ENTYVIO Pen in the US, ENTYVIO's growth rate in the US has accelerated back to double digit at plus 10% in the first semester and plus 13% in the second quarter at constant exchange rate compared to a 4.2% growth rate in fiscal year '23. This is a great performance, but slightly below our expectation. The issues have been a somewhat lower market growth than expected and slower-than-expected access pathway.

轉向下一張投影片，我想提供有關 ENTYVIO 性能的更多詳細資訊。自ENTYVIO Pen在美國推出以來，ENTYVIO在美國的成長率已加速回兩位數，以固定匯率計算，第一季成長10%，第二季成長13%，而成長率為4.2%在'23財政年度。這是一個很棒的表現，但略低於我們的預期。問題是市場成長略低於預期，且准入路徑慢於預期。

However, as of July this year, ENTYVIO Pen coverage extends to more than ttwo-third of the eligible patient population in the United States, and will continue to work on the pull-through supporting doctors and patients to get reimbursed while transferring from an IV under Part D plan to a subcu under a Part D plan. Based on very positive satisfaction feedback from patients and doctors, we are optimistic of demand for the subcu formulation and ENTYVIO overall will accelerate in the future.

然而，截至今年 7 月，ENTYVIO Pen 的覆蓋範圍已擴大到美國三分之二以上的符合條件的患者群體，並將繼續致力於支持醫生和患者在從靜脈注射轉移時獲得報銷根據D 部分計劃將其轉換為D 部分計劃下的subcu。基於患者和醫生非常積極的滿意度回饋，我們對 subcu 配方和 ENTYVIO 整體需求未來將加速成長持樂觀態度。

Nevertheless, at this stage, based on first half results, we have updated our global full year growth forecast for ENTYVIO to 11%, an acceleration from 6.6% in fiscal year 2023. Our updated forecast assume a potential growth slowdown in Europe and a demand acceleration in the US, although the expected revenue acceleration is probably insufficient to propel our overall growth into the high teens.

儘管如此，現階段，根據上半年業績，我們已將ENTYVIO 的全球全年成長預測更新至11%，較2023 財年的6.6% 有所加快。下降儘管預期的收入成長可能不足以推動我們的整體成長達到十幾歲，但美國的成長卻在加速。

ENTYVIO will continue to outperform the overall inflammatory Boral disease advanced therapy market. We continue to see long-term growth potential for ENTYVIO, powered by demand for the ENTYVIO Pen, and we are confident in our peak sales outlook of USD 7.5 billion to USD 9 billion, even when considering the potential impact of the Inflation Reduction Act in the United States.

ENTYVIO 將繼續跑贏整個發炎性博羅爾病先進治療市場。在對 ENTYVIO 筆的需求的推動下，我們繼續看到 ENTYVIO 的長期成長潛力，並且我們對 75 億美元至 90 億美元的峰值銷售前景充滿信心，即使考慮到通貨膨脹減少法案的潛在影響也是如此。美國。

The continued strong performance of ENTYVIO as well as our new Growth & Launch product, such as FRUZAQLA, ADZYNMA and EOHILIA demonstrate the value of this portfolio and its ability to address patient needs.

ENTYVIO 以及我們新的成長和推出產品（例如 FRUZAQLA、ADZYNMA 和 EOHILIA）的持續強勁表現證明了該產品組合的價值及其滿足患者需求的能力。

In closing, we are very pleased with what we have achieved in the first half of fiscal year '24. In a challenging environment, we continue to deliver on our financial commitment to progress our pipeline and to create long-term value for our stakeholders. We look forward to the opportunities at . Thank you for your continued support and confidence in Takeda.

最後，我們對 24 財年上半年的成就感到非常滿意。在充滿挑戰的環境中，我們繼續履行我們的財務承諾，以推進我們的產品線並為利害關係人創造長期價值。我們期待著機會。感謝您對武田的持續支持與信任。

I will now hand over to Milano to discuss our financial results and outlook.

我現在將請米蘭討論我們的財務表現和前景。

Thank you, Christophe, and hello, everyone. This is Milano Furuta speaking. slide 9 summarizes our financial results for the first half or H1 of fiscal 2024. We had a very strong six months driven by momentum, Growth & Launch products, and continued VYVANSE demand. We also had some benefits from the phasing of investments, particularly in R&D.

謝謝你，克里斯托夫，大家好。我是米蘭諾古田。投影片 9 總結了我們 2024 財年上半年或上半年的財務業績。我們也從分階段投資中獲得了一些好處，特別是在研發方面。

H1 revenue was almost JPY2.4 trillion, an increase of 13.4% versus prior year, or 5% growth at constant exchange rate or CR. Corporate profit, core OP was JPY719.9 billion, a year-on-year increase of 22.3% or 12.9% at CER. Reported operating profit was JPY350.6 billion, growing almost 200%.

上半年營收接近 2.4 兆日元，較上年成長 13.4%，以固定匯率或 CR 計算成長 5%。企業利潤、核心營業利潤為 7,199 億日元，較去年同期成長 22.3%，以固定匯率計算成長 12.9%。報告營業利潤為 3,506 億日元，成長近 200%。

We booked less impairments and other onetime costs comparing to the last fiscal year, which contributed to this reported operating profit increase on top of the strong core OP performance. Core EPS and reported EPS was JPY310 and JPY119, respectively. Operating cash flow was JPY451.3 billion, up 54.9% year-on-year, reflecting our strong profit growth as well as improvements in working capital. Adjusted free cash flow was JPY247.5 billion.

與上一財年相比，我們計入的減損和其他一次性成本減少了，這在強勁的核心營運業績的基礎上促成了報告的營業利潤成長。核心每股盈餘和報告每股盈餘分別為 310 日圓和 119 日圓。經營現金流為 4,513 億日元，年增 54.9%，反映出我們利潤的強勁成長以及營運資金的改善。調整後自由現金流為 2,475 億日圓。

Let's look into the details starting from revenue dynamics on slide 10. Our Growth & Launch products grew strongly, 18.7% at CER, more than offsetting the loss of exclusivity impact such as VYVANSE in the US and AZILVA in Japan. Additionally, net positive growth in other brands contributed to 5% revenue growth at CER. The depreciation of the yen versus major currencies was an additional tailwind of JPY176.5 billion, resulting in 13.4% growth on actual FX basis.

讓我們從幻燈片 10 上的收入動態開始詳細了解。此外，其他品牌的淨正成長推動 CER 營收成長 5%。日圓兌主要貨幣貶值帶來了 1,765 億日圓的額外推動力，導致實際匯率增加 13.4%。

Slide 11 shows the year-on-year bridge for core operating profit. In addition to the profit contribution from positive revenue dynamics, we benefited from phasing reinvestment, particularly in R&D. R&D investment in H1 decreased by 8.3% at CER. This is primarily due to the termination of [sale] programs during our pipeline privatization at the end of FY23. However, it is worthwhile to note that with multiple programs moving into Phase 3, we expect an increase in R&D spend for the full fiscal year.

幻燈片 11 顯示了核心營業利潤的同比橋樑。除了積極的收入動態帶來的利潤貢獻外，我們還受益於分階段的再投資，特別是在研發方面。上半年研發投資以固定匯率計算下降 8.3%。這主要是由於我們在 2023 財政年度結束時的管道私有化期間終止了[銷售]計劃。然而，值得注意的是，隨著多個專案進入第三階段，我們預計整個財年的研發支出將會增加。

We managed our OpEx lower than the last year with cost discipline. Core OP grew at 12.9% at CER and with a positive FX impact, we landed with absolute growth of 22.3% for the first half year.

我們透過成本控制將營運支出控制在低於去年的水平。核心OP以固定匯率計算成長了12.9%，在匯率的正面影響下，我們上半年的絕對成長達到了22.3%。

Next, reported operating profit. This H1, the impairment of intangible assets became much smaller comparing to the last year when we recognized the impairment of ALOFISEL and EXKIVITY. Although we have booked sizable restructuring expenses for the ongoing efficiency program this year, operating expenses benefited from lower legal provisions and the reversal of a prelaunch inventory. These factors, on top of our strong core OP growth, helped almost triple our H1 reported operating profit to JPY350.6 billion.

接下來，報告營業利益。今年上半年，無形資產減損比去年我們確認ALOFISEL和EXKIVITY減損時小很多。儘管我們今年為正在進行的效率計劃計入了大量重組費用，但營運費用受益於法律規定的減少和啟動前庫存的逆轉。這些因素，加上我們強勁的核心營業收入成長，幫助我們上半年報告的營業利潤幾乎增加了兩倍，達到 3,506 億日圓。

Next slide, 13. As announced in May, we have kicked off an enterprise-wide efficiency program. Our aim is to free up resources to invest for future growth while to improve core operating profit margin by 100 to 250 basis points each year from FY25 towards our low to mid-30s percentage target. Please note that baseline of this margin improvement is our original forecast of 23% margin this year.

下一張投影片，13。我們的目標是釋放資源，投資未來成長，同時從 2025 財年開始，每年將核心營業利潤率提高 100 至 250 個基點，實現 30 多歲至 30 多歲的百分比目標。請注意，這項利潤率改善的基準是我們今年最初預測的 23% 利潤率。

Slide 14, starting with organizational agility, we have made structural changes across several corporate and the regional functions. For example, in R&D, we implemented changes to reflect the pipeline prioritization decisions made last fiscal year. We also exited our research site in San Diego, meaning we will focus our research activities in two sites going forward, which is Cambridge in the US and [Shonin], Japan. In addition, we have a project that had been announced and become effective in the second half of the year, such as the future carrier program in Japan.

投影片 14，從組織敏捷性開始，我們對多個公司和區域職能部門進行了結構性變革。例如，在研發方面，我們實施了一些變革，以反映上一財年所做的管道優先決策。我們也退出了聖地牙哥的研究基地，這意味著我們未來的研究活動將集中在兩個地點，即美國的劍橋和日本的[Shonin]。另外，我們還有一個項目已經宣布並在下半年生效，例如日本的未來航母計畫。

In procurement, our team continues to have opportunities to unlock savings across various cost categories capturing JPY20 billion of savings to date. And as a company, we are focused on embedding data, digital and technologies to drive efficiency and enable savings. We are building capabilities in-house with our innovation capability centers now providing solutions to tasks where we previously relied upon external vendors. The impact of our [D&T] initiatives can be seen across the value chain from accelerating patient recruitment in clinical trials to reducing inspection times in our manufacturing network and to optimizing our plasma fluxion processes.

在採購方面，我們的團隊繼續有機會在各種成本類別中實現節省，迄今為止已節省了 200 億日元。作為一家公司，我們專注於嵌入數據、數字和技術，以提高效率並實現節省。我們正在透過創新能力中心建立內部能力，現在為我們以前依賴外部供應商的任務提供解決方案。我們的 [D&T] 計劃的影響貫穿整個價值鏈，從加速臨床試驗中的患者招募到減少我們製造網絡的檢查時間以及優化我們的血漿流化流程。

With regards to implementation costs associated with this efficiency program, in H1, we booked JPY61.6 billion of expenses. This is in line with plan and are on track towards a full year forecast of JPY140 billion. As you can see from the breakdown, the majority of expenses have been related to severance, but there are also project cost and write-off expenses included in the total.

關於與該效率計畫相關的實施成本，上半年，我們登記了 616 億日圓的費用。這符合計劃，並有望實現全年 1,400 億日元的預測。從明細可以看出，大部分費用與遣散費有關，但總金額還包括專案成本和沖銷費用。

Next, let me give an update on our revised outlook for the full year. Starting with management guidance. We are upgrading each line item to reflect the strong H1 performance driven by overall positive revenue momentum. Revenue is now expected to be flat to slightly increasing. Core operating profit and mid-single-digit percentage decline, and core EPS approximately 10% decline on a CER basis. Our updated forecast is now JPY4.48 trillion of revenue, JPY1.05 trillion of core operating profit and JPY456 of core EPS.

接下來，讓我介紹一下我們修訂後的全年展望的最新情況。從管理指導開始。我們正在升級每個項目，以反映整體積極收入動能推動的上半年強勁業績。目前預計收入將持平或略有成長。核心營業利潤出現中個位數百分比下降，核心每股收益（以固定匯率計算）下降約 10%。我們更新後的預測目前為營收 4.48 兆日圓、核心營業利潤 1.05 兆日圓和核心每股收益 456 日圓。

In terms of currency assumptions, we have revised a euro from JPY160 to JPY165 while keeping US dollar unchanged. This update has a positive impact on revenue but negative impact on core operating profit due to our large manufacturing cost base in Europe. On a reported basis, we forecast operating profit to be JPY265 billion and reported EPS to be JPY43. We raised our free cash flow forecast range to reflect the uplift in core operating profit.

在貨幣假設方面，我們將歐元兌日圓從 160 日圓調整為 165 日圓，同時保持美元不變。此更新對收入有正面影響，但由於我們在歐洲龐大的製造成本基礎，對核心營業利潤產生負面影響。根據報告，我們預計營業利潤為 2,650 億日元，報告每股收益為 43 日元。我們提高了自由現金流預測範圍，以反映核心營業利潤的成長。

Slide 16 shows a moving part in our updated forecast. The biggest driver of incremental revenue is finance. While [NTD] growth is accelerating, we made an adjustment to the forecast. In the meantime, there is a stronger-than-expected -- of other products such as FRUZAQLA, ADCETRIS, QDENGA and TAKHZYRO. This results in an overall positive revision of revenue categorized as other products on this slide. FX is also positive to our revised revenue forecast.

投影片 16 顯示了我們更新的預測中的一個變化部分。增量收入的最大驅動力是金融。雖然[新台幣]成長正在加速，但我們對預測進行了調整。同時，FRUZAQLA、ADCETRIS、QDENGA 和 TAKHZYRO 等其他產品的表現也強於預期。這導致本投影片中歸類為其他產品的收入整體呈現正向修正。外匯對我們修訂後的收入預測也有正面影響。

For core operating profit, we expect the incremental profit contribution from VYVANSE to be partially offset by a number of items. First, there is a slightly unfavorable product mix impact due to the relatively high profitability of [NTDO]. Also within the other products [column], we anticipate incremental manufacturing expenses such as the preparation for future supply of QDENGA.

對於核心營業利潤，我們預期 VYVANSE 的增量利潤貢獻將被多項專案部分抵銷。首先，由於[NTDO]的獲利能力相對較高，因此對產品組合產生了輕微不利的影響。此外，在其他產品[列]中，我們預計會增加製造費用，例如為未來供應 QDENGA 做準備。

Slight increase in OpEx includes additional investment in launch products such as FRUZAQLA and higher personnel costs based on timing of exits during the efficiency programs. Finally, FX -- positive to revenue has a negative impact on core OP due to the depreciation of the yen versus.

營運支出的小幅成長包括對 FRUZAQLA 等推出產品的額外投資，以及基於效率計畫期間退出時間的更高的人員成本。最後，由於日圓貶值，外匯——對收入的正面影響對核心業務產生了負面影響。

Slide 17. Let me explain some of the variance between H1 core OP results and implied H2 core OP. First, we expect a reduction in gross profit from product revenue. Roughly 50% of this is our ADHD portfolio, mainly VYVANSE due to acceleration -- erosion. There are many different elements included in the other 50% such as phasing of shipments like vaccines, tender timing for certain rare disease products and a general competitive trend in some markets.

投影片 17。首先，我們預期產品收入毛利將減少。其中約 50% 是我們的 ADHD 投資組合，主要是由於加速侵蝕而導致的 VYVANSE。其他 50% 包含許多不同的要素，例如疫苗等分階段出貨、某些罕見疾病產品的招標時機以及某些市場的整體競爭趨勢。

The second biggest driver is R&D. Our forecast reflects plans to ramp up investment in latest programs such as TAK-861, TAK-279 and mezagitamab based on timing of Phase 3 trials.

第二大驅動力是研發。我們的預測反映了根據 3 期試驗的時間安排增加對 TAK-861、TAK-279 和 mezagitamab 等最新項目的投資的計劃。

For the cost and SG&A, our forecast reflects expectations for expenses to be more weighted towards the second half. Although we usually have seasonality that results in higher cost in H2, that trend is even more pronounced this year. In part, this is because of spending slowed during the early stages of the efficiency program as organizational changes were being made. Finally, there is -- our main headwinds from FX built into the plan.

對於成本和銷售管理費用（SG&A），我們的預測反映了下半年支出將更重要的預期。儘管季節性因素通常會導致下半年成本較高，但今年這種趨勢更加明顯。部分原因是在效率計畫的早期階段，隨著組織變革，支出放緩。最後，計劃中還存在來自外匯的主要阻力。

So this year, we are dealing with dynamic situations of the LOE of guidance, acceleration of the ENTYVIO growth with the Pen launch, the enterprise-wide efficiency program and the progression of the late-stage pipeline. While there may be some liabilities, we are very confident that we can deliver this updated management guidance.

因此，今年，我們正在處理指導 LOE 的動態情況、隨著 Pen 的推出而加速 ENTYVIO 的成長、企業範圍的效率計劃以及後期管道的進展。儘管可能存在一些責任，但我們非常有信心能夠提供最新的管理指南。

Thank you for your attention. And now, I will hand over to Andy.

感謝您的關注。現在，我將把工作交給安迪。

Thank you very much, Milano, and hello to everyone on today's call. We go to the next slide, please. This quarter, we have several significant updates to our late-stage pipeline. Last month, we presented important long-term extension data from the Phase IIb trial of our oral orexin agonist TAK-861 in narcolepsy type one or NT1 at Sleep Europe 2024, which is one of the most impactful sleep conferences of the year. The results demonstrate TAK-861 continues to be highly efficacious and well tolerated at six months and beyond. TAK-861 also shows improvement on cognitive domains like sustained attention -- an executive function after eight weeks on therapy, a first for the orexin class.

非常感謝米蘭，並向參加今天電話會議的所有人問好。請轉到下一張投影片。本季度，我們對後期管道進行了幾項重大更新。上個月，我們在2024 年歐洲睡眠會議上展示了口服食慾素激動劑TAK-861 治療發作性睡病1 型或NT1 的IIb 期試驗的重要長期擴展數據，這是今年最具影響力的睡眠會議之一。結果表明，TAK-861 在 6 個月及以後仍保持高效且耐受性良好。 TAK-861 也顯示出認知領域的改善，例如持續注意力——治療八週後的執行功能，這在食慾素類藥物中尚屬首次。

Following discussions with regulatory authorities, in August, we initiated the first LiGHT study, a global Phase 3 development program for TAK-861 NT1. Enthusiasm amongst investigators is high and enrollment is progressing well. I'm pleased to share that recruitment has been completed significantly ahead of time lines for two pivotal head-to-head Phase 3 trials of our TYK2 inhibitor, zasocitinib versus apremilast in psoriasis.

經過與監管機構的討論，我們在 8 月啟動了第一項 LiGHT 研究，這是 TAK-861 NT1 的全球 3 期開發計劃。研究人員的熱情很高，入組進展順利。我很高興與大家分享，我們的 TYK2 抑制劑扎索西替尼與阿普斯特治療銀屑病的兩項關鍵頭對頭 3 期試驗的招募工作已大大提前完成。

In addition, our partner protagonist who is developing resferatide, an injectable hepcidin mimetic, had -- Phase 3 enrollment for the treatment of polycytemiavera, or PV. As you may recall, Takeda and Protagonist entered a worldwide license and collaboration agreement for resertide earlier this year.

此外，我們正在開發瑞斯拉肽（一種可注射的鐵調素模擬物）的合作夥伴主角，已進入治療多細胞血症（PV）的第三階段。您可能還記得，今年早些時候，武田 (Takeda) 和 Protagonist 簽署了一項關於 resertide 的全球許可和合作協議。

Last week, Takeda presented positive interim results from a proof-of-concept trial evaluating mezagitamab in primary IgA nephropathy or IgAN, at the American Society of Nephrology's Kidney Week. Mezagitamab, a potential best-in-class anti-CD38 antibody, demonstrates rapid and sustained reductions from baseline in serum IDA up to 70% and galactose deficient IgA up to [62%] as an add-on to the standard of care.

上週，武田在美國腎臟病學會腎臟週上展示了評估美紮吉他單抗治療原發性 IgA 腎病或 IgAN 的概念驗證試驗的積極中期結果。 Mezagitamab 是一種潛在的同類最佳抗 CD38 抗體，作為標準治療的補充，其血清 IDA 較基線快速持續降低高達 70%，半乳糖缺乏型 IgA 降低高達 [62%]。

At week 36, participants also achieved a [35%] mean reduction from baseline in 24-hour proteinuria. And of course, with the caveats of small patient numbers, we see signs of clinical benefit with stable renal function up to 36 weeks. Mezagitamab demonstrated a favorable safety profile and was well tolerated with no discontinuation to drug-related adverse events. We plan to engage with regulatory authorities this year as we are already preparing for Phase 3 development.

在第 36 週，參與者的 24 小時蛋白尿較基線平均降低了 [35%]。當然，考慮到患者數量較少，我們看到了臨床效益的跡象，腎功能穩定長達 36 週。美札吉他單抗表現出良好的安全性，並且耐受性良好，沒有出現與藥物相關的不良事件。我們計劃今年與監管機構合作，因為我們已經在為第三階段的開發做準備。

Looking beyond our late-stage new molecular entities, as Christophe has already noted, we achieved regional expansions for our Growth & Launch brands, including ADZYNMA, FRUZAQLA and HYQVIA.

正如 Christophe 已經指出的那樣，除了我們的後期新分子實體之外，我們還實現了成長和推出品牌的區域擴張，包括 ADZYNMA、FRUZAQLA 和 HYQVIA。

Next slide, please. Very excited to extend an invitation for all of you to join our R&D Day on September 12, starting at 6:30 in the evening, Eastern Standard Time and 8:30 in the morning, December 13 in Japan. The main focus of this event will be a deep dive into our high-value, late-stage pipeline programs with a focus on zasocitinib, our orexin franchise, including TAK-861 and TAK-360, Risper tie, pasirsiram and mezagitamab. During the session, we will review the unmet medical need in multiple indications these programs are targeting as well as Phase 3 study designs, time lines, competitive positioning and commercial potential of each asset.

請下一張投影片。非常高興邀請大家參加 9 月 12 日的研發日活動，活動時間為東部標準時間晚上 6:30 和 12 月 13 日早上 8:30（日本）。本次活動的主要焦點將是深入探討我們的高價值後期管道項目，重點是我們的食慾素系列產品 zasocitinib，包括 TAK-861 和 TAK-360、Risper tie、pasirsiram 和 mezagitamab。在會議期間，我們將審查這些項目針對的多種適應症中未滿足的醫療需求，以及每項資產的第 3 階段研究設計、時間表、競爭定位和商業潛力。

We will also provide updates on our evolving R&D strategy in our four therapeutic areas of gastrointestinal inflammation, neuroscience and oncology including disease areas of focus and business development strategy. We have made substantial strategy enhancing our clinical development capabilities with an emphasis on data, digital and technology. Of note, we will review Takeda's future-looking development model and demonstrate how it has yielded positive results in accelerating these late-stage pipeline programs. The format will be a hybrid event featuring live presentations in Tokyo with a virtual option for any participant. Please save the date.

我們還將提供胃腸道發炎、神經科學和腫瘤學四個治療領域不斷發展的研發策略的最新信息，包括重點疾病領域和業務發展戰略。我們制定了重大策略，增強我們的臨床開發能力，重點是數據、數位和技術。值得注意的是，我們將回顧武田面向未來的開發模式，並展示它如何在加速這些後期管道項目方面取得積極成果。該活動將採取混合活動的形式，在東京進行現場演示，並為任何參與者提供虛擬選項。請保存日期。

Thank you very much. And at this point, I'll turn it back to Chris for the Q&A session.

非常感謝。此時，我會將其轉回給克里斯進行問答環節。

(interpreted) questions as respondents. In addition to Christophe and Andy, we have Ramona Sequeira, President of Global Portfolio division, President of US Business Unit platform, PDT business enterprise and President of Global Oncology unit if. (Operator Instructions)

（解釋）作為受訪者提出的問題。除了 Christophe 和 Andy 之外，我們還有全球產品組合部門總裁、美國平台、PDT 業務部門總裁以及全球腫瘤部門總裁 Ramona Sequeira。 （操作員說明）

Okay. I'd like to take the first question from Steve Barker at Jefferies.

好的。我想回答傑富瑞 (Jefferies) 史蒂夫巴克 (Steve Barker) 提出的第一個問題。

Steve Barker from Jefferies. My first one is about the -- your plasma business. So on a half year basis, the trend looks very healthy. However, looking at the quarter-to-quarter trend, it looks like sales did decline in the second quarter compared to the first quarter. If you could please comment on the underlying dynamics. And then if -- yes. So that's the first question.

來自傑富瑞集團的史蒂夫·巴克。我的第一個是關於你們的血漿業務。因此，從半年來看，趨勢看起來非常健康。然而，從季度趨勢來看，第二季的銷售額與第一季相比確實有所下降。如果可以的話請評論潛在的動態。然後如果——是的。這是第一個問題。

And second question, I'd like to ask Andy about mezagitamab, and congratulations on the good data, showing . But just looking at the time lines, it looks like mezagitamab will come to the market behind other disease-modifying products such as the -- inhibitors. And so I was just wondering how you see anti-CD38 like mezagitamab fitting into the treatment for ?

第二個問題，我想向 Andy 詢問有關 mezagitamab 的信息，並祝賀您獲得了良好的數據，顯示 。但僅從時間線來看，美札吉他單抗似乎將落後於其他疾病緩解產品（例如抑制劑）進入市場。所以我只是想知道您如何看待像 mezagitamab 這樣的抗 CD38 藥物適合治療？

Okay. Thank you, Steve. So for the first question on PDT, I'd like to ask Giles to comment on that. And then for the second question on mezagitamab, perhaps Andy can comment on the data. And then Ramona has any comments on the positioning at this point, then that would be great to have your comments as well.

好的。謝謝你，史蒂夫。對於關於 PDT 的第一個問題，我想請 Giles 對此發表評論。然後對於關於 mezagitamab 的第二個問題，也許 Andy 可以對數據發表評論。然後雷蒙娜對此時的定位有任何評論，那麼也很高興收到您的評論。

Thank you, Steve, for the question. This is Giles speaking. We did have strong first half growth for our PDT business with 14% year-over-year evolution. IG business continues to perform well with growth of 16% and with accretive growth from innovative subcu portfolio. And our albumin portfolio, particularly driven by strong demand in China, but also with some supply phasing delivered growth of 11%.

謝謝你，史蒂夫，提出這個問題。這是賈爾斯的演講。上半年，我們的 PDT 業務確實實現了強勁成長，年成長 14%。 IG 業務持續表現良好，成長了 16%，並且創新的 subcu 產品組合實現了增值成長。我們的白蛋白產品組合，尤其是在中國強勁需求的推動下，以及一些供應階段性的推動下，實現了 11% 的成長。

We maintain our full year guidance of high single-digit growth for the PDT business overall, 5% to 15% for our IG portfolio and single-digit growth for our albumin business. We have flagged that we will see slightly slower growth this year due to planned upgrades and associated shutdowns of our manufacturing facility for albumin.

我們維持 PDT 業務整體高個位數成長、IG 組合 5% 至 15% 以及白蛋白業務個位數成長的全年指引。我們已經指出，由於計劃升級和白蛋白生產設施的相關關閉，今年的成長將略有放緩。

I would just call out that we continue our trend of positive margin expansion as well, driven by reducing donor compensation levels, investments in data, digital and technology to drive donor experience, but also productivity of our collections network, improvements in yield in our fractionation process and also positive product mix, as I alluded to, with accretive growth from our innovative subcutaneous IG portfolio.

我只想指出，我們也繼續保持利潤率積極擴張的趨勢，這是由降低捐贈者報酬水平、對數據、數字和技術的投資來推動捐贈者體驗以及我們的收藏網絡的生產力、提高我們的分餾產量所推動的。

And Steve, it's Andy. Thank you for your question, and thank you very much for recognizing the strong data that we presented last week. And your question gives me the opportunity to again remind you and everyone that we will be having the R&D Day in December -- on December 12 and 13 in Japan and Eastern time and doing -- and our focus on that day will be addressing exactly questions that you're asking for mezagitamab for all of our late-stage programs, which is to help you better understand the programs, how we're designing the programs, the competitive positioning and what we see as the commercial opportunity.

史蒂夫，是安迪。感謝您提出問題，也非常感謝您認可我們上週提供的強有力的數據。你的問題讓我有機會再次提醒你和大家，我們將在 12 月舉辦研發日——12 月 12 日至 13 日（日本東部時間），我們在那一天的重點將是準確解決問題您要求為我們所有的後期專案提供mezagitamab，這是為了幫助您更好地了解這些專案、我們如何設計這些專案、競爭定位以及我們所看到的商業機會。

I'll say that the data that we presented and again, the numbers -- the patient numbers are relatively small, but the consistency of the observations that we're seeing, and the potency of the effect is quite remarkable and suggests the potential for a best-in-class across all of the potential disease-modifying agents.

我要說的是，我們提供的數據以及數字——患者數量相對較少，但我們所看到的觀察結果的一致性以及效果的效力是相當顯著的，這表明了潛在的​​在所有潛在的疾病緩解藥物中是同類最佳的。

So there are a few features that I'll just highlight around the mezagitamab activity and IgAN and remind you that we saw similar robust effects in ITP. The first is the rapidity of the effect. The onset of the effect seems to be faster than what we're seeing with other potentially disease-modifying agents.

因此，我將重點介紹 mezagitamab 活性和 IgAN 的一些特徵，並提醒您我們在 ITP 中看到了類似的強大效果。首先是效果的速度。效果的起效似乎比我們在其他潛在的疾病緩解藥物中看到的要快。

The second is when we look at the reductions in IgA and galactose-deficient IgA, which many believe is the pathogenic form of immunoglobulin in IgAN, we're seeing over 60% and close to 70% reduction, which is disproportionate to what we see for other immunoglobulins. And we don't know exactly why, but it's clearly something unique about this particular mechanism and maybe even our molecule.

第二個是當我們觀察IgA 和缺乏半乳糖的IgA（許多人認為這是IgAN 中免疫球蛋白的致病形式）的減少時，我們看到減少超過60% 甚至接近70%，這與我們所看到的不成比例對於其他免疫球蛋白。我們不知道確切的原因，但這顯然是這種特殊機制甚至我們的分子的獨特之處。

We've seen stabilized renal function, up to 36 weeks, of course, again, small patient numbers and a relatively short time frame. But when we add all of this up, incredibly encouraged by the potential of the molecule.

我們已經看到腎功能穩定，長達 36 週，當然，患者數量較少且時間相對較短。但當我們把所有這些加起來時，我們對分子的潛力感到難以置信的鼓舞。

And then before I hand it over to Ramona, and Ramona can make some comments about competitive positioning, I'll say that we are meeting with the FDA in the coming weeks. And we have a very aggressive and proactive Phase 3 program. And our goal is to accelerate our study as much as possible. We have a number of different ways that we're going to be looking at doing that. Ramona, would you like to add?

然後，在我將其交給雷蒙娜之前，雷蒙娜可以對競爭定位發表一些評論，我會說我們將在未來幾週內與 FDA 會面。我們有一個非常積極主動的第三階段計劃。我們的目標是盡可能加速我們的研究。我們將考慮採用多種不同的方式來實現這一目標。雷蒙娜，你想補充嗎？

Yes. Thank you, Andy and Steve, I think Andy answered that so perfectly. I'll add just a couple of things. First of all, we know this is going to be a large and growing market in the coming years as you see more disease-modifying treatments available for patients, which is important.

是的。謝謝安迪和史蒂夫，我認為安迪的回答非常完美。我將添加幾件事。首先，我們知道未來幾年這將是一個龐大且不斷成長的市場，因為您會看到更多的疾病緩解治療可供患者使用，這一點很重要。

But based on what we know and what we're seeing, we're very excited about the positioning of 079, kind of where it hits the immune cascade, the efficacy, as Andy mentioned, very rapid, the dosing and safety profile, we feel it's going to be very unique for patients and have an edge for sure in first-line utilization for a disease-modifying agent.

但根據我們所知道的和我們所看到的，我們對 079 的定位感到非常興奮，它擊中免疫級聯的地方，功效，正如安迪提到的，非常迅速，劑量和安全性概況，我們認為這對患者來說將是非常獨特的，並且在疾病緩解藥物的第一線使用方面肯定具有優勢。

Mike Nedelcovych, TD Cowen.

麥克·內德爾科維奇，TD·考恩。

I have two, if that's okay. The first relates to ENTYVIO. We've gotten quite a bit of IBD data across mechanisms in the last few weeks. I know you have reiterated your long-term intent outlook, but have any of these updates caused you to change thinking about the market one way or the other? And a related question on that topic, does your peak sales outlook contemplate a successful ENTYVIO combination? And if not, could there be upside to your projection?

我有兩個，如果可以的話。第一個與 ENTYVIO 相關。在過去的幾周里，我們已經獲得了大量跨機制的 IBD 數據。我知道您重申了您的長期意圖展望，但是這些更新是否導致您以某種方式改變對市場的看法？關於該主題的一個相關問題是，您的最高銷售前景是否考慮了成功的 ENTYVIO 組合？如果沒有，您的預測還有什麼好處嗎？

And then my second question relates to QDENGA, which has been a bright spot. There may be competition on the horizon. However, as Merck pursues its own dengue vaccine, are you aware of any differentiation in the competitor's candidate?

我的第二個問題與 QDENGA 相關，它是一個亮點。可能即將出現競爭。然而，當默克公司開發自己的登革熱疫苗時，您是否意識到競爭對手的候選疫苗有任何差異？

Okay. Thank you, Mike. So I'd like to ask Ramona to take those.

好的。謝謝你，麥克。所以我想請雷蒙娜拿走這些。

Sorry, my apologies. I will take the ENTYVIO question before I move on to QDENGA. So first with your question on peak sales for ENTYVIO, the answer is no. So when we did the peak sales estimate, which we still believe is absolutely achievable, we did not contemplate combination therapy.

對不起，我很抱歉。在繼續 QDENGA 之前，我將回答 ENTYVIO 問題。首先，關於 ENTYVIO 的高峰銷售問題，答案是否定的。因此，當我們進行高峰銷售預測時（我們仍然相信這是絕對可以實現的），我們沒有考慮聯合治療。

And certainly, in this market now, we see more desire for physicians to use combination therapy in different types of patients, particularly in Crohn's and are doing some evidence generation ourselves to look at how ENTYVIO may be used in combination therapy. But certainly, that is an open question. And we think ENTYVIO is such a foundational therapy that, that combination is -- just makes sense clinically for physicians.

當然，現在在這個市場上，我們看到醫生更希望在不同類型的患者中使用聯合療法，特別是克羅恩病，並且我們自己正在做一些證據生成，以研究如何在聯合療法中使用 ENTYVIO。但當然，這是一個懸而未決的問題。我們認為 ENTYVIO 是一種基礎療法，這種組合對於醫生來說在臨床上是有意義的。

So we will -- that remains to be seen, but our peak sales did not anticipate that. And certainly, we did see the market continuing to evolve and change with new entrants coming in. I think the reality is ENTYVIO is the most frequently prescribed brand in the US The only gut-selective advanced treatment option.

所以我們會——這還有待觀察，但我們的銷售高峰並沒有預料到這一點。當然，我們確實看到市場隨著新進業者的加入而不斷發展和變化。

The only product have demonstrated head-to-head superiority against another advanced therapy in UC, and we're very confident in the efficacy and safety profile across all the patient populations where we're used. And so we certainly see that franchise continuing to grow for us and doing very well.

該產品是唯一一款在 UC 治療中與另一種先進療法相比表現出直接優勢的產品，我們對使用我們產品的所有患者群體的療效和安全性非常有信心。因此，我們當然看到該特許經營權繼續為我們成長並且做得非常好。

Then your question on QDENGA, could you just remind me again, maybe Mike or Chris, the question on QDENGA. It was Merck, I think, was it, the [Butantan]?

那你關於 QDENGA 的問題，可以再提醒我嗎，也許是 Mike 或 Chris，關於 QDENGA 的問題。我想是默克公司的，是嗎，[布坦坦]？

That's right. Yes, the competitive landscape.

這是正確的。是的，競爭格局。

Yes. So I think this is another one where truly Takeda has set the bar for what good looks like when looking at efficacy and safety in endemic disease such as dengue. I haven't seen anything from any competitor that can even come close. In fact, I think there's still a lot of opacity in the actual data for some of the competitors coming out.

是的。因此，我認為這是武田真正為登革熱等地方性疾病的功效和安全性設定了標準的另一個舉措。我還沒有看到任何競爭對手可以與之相提並論。事實上，我認為一些競爭對手的實際數據仍然存在著許多不透明之處。

The data that's been shared has been in very small data sets. And we haven't seen anything to indicate first, that the efficacy is going to be similar to QDENGA, but also the amount of time that we spent in these trials, doing the follow-up and showing the long-term durability of the asset, we think has set a new bar for other companies.

共享的資料都位於非常小的資料集中。我們還沒有看到任何跡象表明，其功效將與 QDENGA 類似，但我們在這些試驗中花費的時間、進行後續工作並顯示資產的長期耐久性，我們認為為其他公司樹立了新的標準。

And based on the safety needs in this population, we feel other companies are going to have to demonstrate that level of efficacy and safety as well. And certainly, I haven't seen that yet, and I believe that's going to take some time to do if they're even able to do it.

基於這一人群的安全需求，我們認為其他公司也必須證明這種有效性和安全性水準。當然，我還沒有看到這一點，而且我相信，如果他們能夠做到的話，那將需要一些時間。

Citi, Yamaguchi-san.

花旗銀行，山口先生。

So this is Yamaguchi, Citi. two questions, please. The first one is regarding same ENTYVIO, but I'm trying to ask about the company guidance change. I used to have 60% now -- 11% I think in the US And you're doing better, but there seems to be some marketing situations and patient situations, which is more the macro side. But can you give me what do you think about changing and what you did not think about changing and how the SG promotion has been going through? So that's the first ENTYVIO corporate guidance changing assumption question. That's the first one.

這是山口，花旗。請提出兩個問題。第一個是關於相同的 ENTYVIO，但我想詢問公司指導方針的變化。我以前有 60%，現在是 11%，我認為在美國，你們做得更好，但似乎存在一些行銷情況和耐心情況，這更多是宏觀方面。但你能告訴我你對改變有什麼看法，你沒有考慮改變什麼，以及SG促銷進度如何嗎？這是第一個 ENTYVIO 公司指導改變假設的問題。這是第一個。

The second one, the total company guidance change. I understand the VYVANSE erosion is going to happen in the second half. But given -- what has been exceeding your expectation in the first half, first half already, you are generating around JPY700 billion already. And JPY50 billion up revision sounds very conservative to me, even though ENTYVIO has been cut as well.

第二個，公司整體指引的改變。我知道 VYVANSE 的侵蝕將在下半年發生。但鑑於上半年的情況超出了您的預期，上半年已經產生了約 7,000 億日圓的收入。儘管ENTYVIO也被削減，但500億日圓的上調對我來說聽起來非常保守。

But can you remind me, it looks pretty conservative to me given you're doing the cost cutting as well. Is it the right way to observe or not really? You are really not that conservative as far the company guidance? That's a second question.

但你能提醒我嗎，考慮到你也在削減成本，我覺得這看起來相當保守。這是正確的觀察方式還是不正確的觀察方式？就公司指導而言，你真的不那麼保守嗎？這是第二個問題。

Thank you, Yamaguchi-san. So the first question on ENTYVIO, perhaps I'll ask Julie to add some comments on that. And then the second question on the total company forecast, I'd like to ask Milano to take that one.

謝謝你，山口先生。關於ENTYVIO 的第一個問題，也許我會請朱莉對此添加一些評論。然後是關於公司整體預測的第二個問題，我想請米蘭回答這個問題。

Thank you for the question, Yamaguchi-san. In regards to the growth of ENTYVIO, when you look at the US, yes, we are seeing accelerated growth for ENTYVIO versus last year. And we expect to continue to have accelerated growth through the rest of the year.

謝謝山口先生的提問。關於 ENTYVIO 的成長，當你看看美國時，是的，我們看到 ENTYVIO 與去年相比加速成長。我們預計今年剩餘時間將繼續加速成長。

In regards to the dynamics to why we lowered the overall guidance from 16% to 11% is because the acceleration is not as fast as we had anticipated at the beginning of the year. And so part of that, as you heard from Christophe, as he was going through the presentation is in regards to the -- to improve our access pull-through for the patients as we have both Part B and Part D on ENTYVIO IV and Pen.

就動態而言，我們將整體指引從 16% 下調至 11% 是因為加速速度沒有我們年初預期的那麼快。因此，正如您從 Christophe 那裡聽到的，當他進行演示時，其中一部分是關於改善我們對患者的訪問，因為我們有關於 ENTYVIO IV 和 Pen 的 B 部分和 D 部分。

So this is part of the reason why we lowered the overall expectation from 16% to 11%. And also in Europe, for the second half of the year, we expect a lower growth due to competitive dynamics and increased pressure on pricing. So that's why the change from 16% to 11%.

所以這就是我們將整體預期從 16% 下調至 11% 的部分原因。同樣在歐洲，由於競爭動態和定價壓力加大，我們預計下半年成長將放緩。這就是從 16% 變成 11% 的原因。

And Milano, over to you for the question.

米蘭，請你回答這個問題。

Thank you for your question. So the -- there is a lot of moving parts, actually, if you compare the H1 results and the H2. So the -- maybe the first one is you were asked like a guidance. We expect -- we still believe a VYVANSE will -- the generic erosion will accelerate it in H2, that's the first one.

謝謝你的提問。所以，如果你比較 H1 結果和 H2，其實有很多變化的部分。所以——也許第一個是你被要求作為指導。我們預計——我們仍然相信 VYVANSE 會——通用侵蝕將在下半年加速，這是第一個。

And there is like a -- dynamics between H1 and H2, like in terms of timing shift, like shipment of the like vaccines or shipment -- or shift of the -- from H2 to H1, like tender or contract renewal and then sometimes those tony change. That's also the impact like H1, H2, the profitability.

H1 和 H2 之間存在動態變化，例如時間轉移，例如類似疫苗的運輸或運輸 - 或從 H2 到 H1 的轉移，例如招標或合約續簽，有時還有這些托尼改變。這也是上半年、下半年獲利能力的影響。

At the same time, there is general like a competitive trends in some hemophilia or multi-myeloma, those markets. So all in all, we expect some declining in terms of gross profit contribution when you compare H1 to H2.

同時，一些血友病或多發性骨髓瘤市場普遍存在競爭趨勢。總而言之，當您比較上半年和下半年時，我們預期毛利貢獻會有所下降。

At the same time, the second biggest driver is actually R&D. In H1, we had some less expense in R&D, partly or mainly because we terminated some programs in the last fiscal year. But instead, we are kind of accelerating our activities to ramp up the Phase 3 activities, right? That's going to weigh towards H2. That's why those dynamics and combined, this H1, H2 profile is a little bit the kind of -- we see the contracts in H1, H2. That's how I see it.

同時，第二大驅動力其實是研發。上半年，我們的研發費用減少，部分或主要是因為我們在上一財政年度終止了一些專案。但相反，我們正在加速我們的活動以加強第三階段的活動，對吧？這將對 H2 產生影響。這就是為什麼這些動態和組合，這個 H1、H2 概況有點像——我們看到 H1、H2 中的合約。我就是這麼看的。

Right. So can I make a quick follow-up on ENTYVIO, Chris?

正確的。克里斯，我可以對 ENTYVIO 進行快速跟進嗎？

Okay. Yes, please go ahead.

好的。是的，請繼續。

So you talk about access, is it getting better now? It might be the time issue. So now is it okay or not really? How about the access?

那麼你談到訪問，現在變得更好了嗎？可能是時間問題。那現在真的可以嗎？訪問怎麼樣？

Yes, Yamaguchi-san. So it is improving as time passes. We are working on a number of different tactics to improve the access. And so we are seeing the impact of that as we have the acceleration in our demand. So while it was not as fast as we had wanted initially, it is improving, and we are making progress.

是的，山口先生。所以隨著時間的推移它正在改善。我們正在研究多種不同的策略來改善訪問。因此，隨著需求的加速，我們正在看到其影響。因此，雖然它沒有我們最初想要的那麼快，但它正在改善，我們正在取得進展。

(interpreted) Let's move on to the next question. Next, please, Matsubara-san, Nomura Securities, please.

（已解釋）讓我們繼續下一個問題。接下來有請野村證券松原先生發言。

(interpreted) I have two questions. One is about ENTYVIO. I'd like to know more about the current market situation. Regarding Pen, access issues were answered. Now I understand. And concerning IV, why is not growing so much because , I think they have been progressing very well. And ENTYVIO IV and -- is it coming from the portioning differences of those products? .

（翻譯）我有兩個問題。其中之一是關於 ENTYVIO 的。我想更多地了解目前的市場情況。關於筆，訪問問題得到了解答。現在我明白了。至於IV，為什麼沒有成長那麼多，因為我認為他們進展得很好。 ENTYVIO IV 和－是否來自這些產品的分配差異？ 。

And another question is about TYK2 inhibitor. Phase 3 will be finishing earlier. And I think the first Phase 3 will be finishing within December. And the data read out, can we consider it's going to be at the beginning of the next year?

另一個問題是關於TYK2抑制劑。第三階段將提前完成。我認為第一個第三階段將在 12 月內完成。那麼讀出的數據，是不是可以認為是明年年初呢？

And thanks to the acceleration of this development. Do you think that the -- for approval, that's timing will be also accelerated or not?

感謝這種發展的加速。您認為批准的時間是否也會加快？

His question was on ENTYVIO again. So on the overall market dynamics, not around just the Pen access, but also on the IV in particular, positioning, vis -- vis, SKYRIZI and RINVOQ. And then so I'd like to ask Julie to take that question.

他的問題又問到了ENTYVIO。因此，就整體市場動態而言，不僅是圍繞Pen訪問，而且還圍繞著IV，特別是定位、vis-vis、SKYRIZI和RINVOQ。然後我想請朱莉回答這個問題。

And then the second question on the TYK2, TAK-279 Phase 3 timing, when we expect to get data and whether we can accelerate the filing time lines. I'd like to ask Andy to comment on that, please.

然後是關於 TYK2、TAK-279 第三階段時間的第二個問題，我們預計何時獲得數據以及我們是否可以加快歸檔時間。我想請安迪對此發表評論。

Thank you, Matsubara-san, for the question. In regards to the competitive dynamics for ENTYVIO IV in the US So ENTYVIO overall is still the market leader when it -- in regards to IBD and market leader in regards to bio-naive starts. So where we see SKYRIZI and other competitive entrants creating movement in the market is in second line and further lines of therapy.

謝謝松原先生的提問。就 ENTYVIO IV 在美國的競爭動態而言，ENTYVIO 總體上仍然是市場領導者，在 IBD 方面和生物初始啟動方面的市場領導者。因此，我們看到 SKYRIZI 和其他競爭性進入者在市場上創造活力的是二線和更遠的治療線。

So in first line, as I said, we're quite proud of ENTYVIO's performance. It's a product that's been on the market for over 10 years and still able to hold the first-line position due to its strong track record in terms of safety and efficacy. It's still the only gut-selective product that's available in IBD, and that's further reason why we believe ENTYVIO continues to perform really well in the first line.

因此，正如我所說，在第一線，我們對 ENTYVIO 的表現感到非常自豪。該產品已經上市10多年，由於其在安全性和有效性方面的良好記錄，仍能保持一線地位。它仍然是 IBD 中唯一可用的腸道選擇性產品，這也是我們相信 ENTYVIO 在一線繼續表現出色的進一步原因。

This is Andy. So thank you for your question on zasocitinib. So we're quite pleased with the execution of the Phase 3 psoriasis program. We're six to seven months ahead of our schedule, our benchmarks. And actually, our benchmarks are not based on our own estimates. They're based on -- they're based on benchmarking across the industry for psoriasis studies. So this is a great example of the new capabilities that we've built into development.

這是安迪。謝謝您關於扎索西替尼的問題。因此，我們對第三階段銀屑病計畫的執行感到非常滿意。我們比計劃和基準提前了六到七個月。事實上，我們的基準並不是基於我們自己的估計。它們基於——它們基於整個行業的銀屑病研究基準。這是我們在開發中內建的新功能的一個很好的例子。

To be fair, we haven't disclosed a specific filing date yet for the program. As you can look in the backup slides, we have FY26, '27, as our target filing date. So what we'll plan to do in December at the R&D Day is in a much more explicit way, go through the design of the program, what we're anticipating we would include in the filing and what that filing date will look like. I mean as you can imagine, given the acceleration, we're looking at the -- we're looking at the front end of that '26 to '27 time frame, but we'll get into that in more detail next month.

公平地說，我們尚未透露該計劃的具體申請日期。正如您可以在備份幻燈片中看到的那樣，我們將 27 財年和 2026 財年作為我們的目標提交日期。因此，我們計劃在 12 月的研發日以更明確的方式進行，包括計劃的設計、我們預計將在備案中包含的內容以及備案日期。我的意思是，正如你可以想像的那樣，考慮到加速，我們正在關注 26 至 27 年時間範圍的前端，但我們將在下個月更詳細地討論這一點。

Okay. So can I assume the first trial, the read out will be -- [after year]?

好的。那麼我可以假設第一次審判的讀數將是—[一年後]？

We haven't disclosed when we'd read out. Just so you understand, we have multiple ongoing studies. There are two primary comparison studies to [apremilast]. We've completed enrollment for each of those studies. We have a third Phase 3 study that's a safety study that's ongoing. There are some requirements for safety that we'll have to meet with the FDA in particular.

我們尚未透露何時宣讀。正如您所了解的，我們正在進行多項研究。 [apremilast] 有兩個主要比較研究。我們已經完成了每項研究的註冊。我們正在進行第三項三期研究，這是一項正在進行的安全研究。我們必須特別滿足 FDA 的一些安全要求。

And then we have a fourth study that will be important in terms of positioning, which will be a head-to-head study against zasocitinib. So how we then manage disclosure of data from all these, we still have to work through.

然後我們還有第四項研究，就定位而言很重要，這將是針對扎索西替尼的頭對頭研究。因此，我們如何管理所有這些數據的揭露，我們仍然需要解決。

Tony Ren, Macquarie.

托尼·任，麥格理。

Actually, just stay on TAK-279, zasocitinib. So this question is again for my first question is for Andy. So like you just alluded to, I noticed that the LATITUDE psoriasis three study is recruiting. And it's looking to recruit a very large number of 1,300 patients over four years of follow-up.

實際上，就繼續使用TAK-279，扎索西替尼吧。所以這個問題又是針對我的第一個問題是針對安迪的。正如您剛才提到的，我注意到 LATITUDE 乾癬三項研究正在招募患者。該公司計劃在四年的追蹤期間招募大量 1,300 名患者。

And Andy also just mentioned the FDA possibly requiring safety longer-term safety observations and the study description is going to check the side effects of the agent and how well it is tolerated. So I just want to get a sense, you have already completed enrollment of your LATITUDE one and two Phase 3, right? So why start such a trial right now? I mean, would this affect your regulatory time line? So that's my first question.

安迪也提到 FDA 可能需要安全性的長期安全觀察，研究描述將檢查該藥物的副作用及其耐受性。所以我只是想了解一下，您已經完成了 LATITUDE 第一和第二階段 3 的註冊，對吧？那為什麼現在就開始這樣的試驗呢？我的意思是，這會影響你們的監管時間表嗎？這是我的第一個問題。

The second question is on a TAKHZYRO. So in HAE, so in [Telia] announced its Phase II data of their in vivo CRISPR gene editing therapy. So the data looks very good. So I just want to get a sense from you, how do you think that might affect TAKHZYRO's future prospects? What would be the clinical differentiation of the 2? So these will be the two questions for me. Thank you.

第二個問題是關於 TAKHZYRO 的。 HAE、Telia 宣布了其體內 CRISPR 基因編輯療法的 II 期數據。所以數據看起來非常好。所以我只是想聽聽您的意見，您認為這可能會如何影響TAKHZYRO 的未來前景？兩者的臨床差異是什麼？所以這將是我的兩個問題。謝謝。

Andy, would you like to begin with the zasocitinib question?

安迪，您想從扎索西替尼的問題開始嗎？

Sure. Thank you, Tony. So again, I'll just emphasize that -- details and we'll go very deep into these details in -- on December 12 and 13 at the R&D Day. Dialing up for the psoriasis program, the 3 core elements to the package -- the regulatory package, and there's a fourth element around commercial competitiveness and positioning. The first are the first two studies, the penalized head-to-head studies. By far and away, the most important studies demonstrating the efficacy and safety profile.

當然。謝謝你，托尼。所以，我再次強調，細節，我們將在 12 月 12 日和 13 日的研發日深入探討這些細節。制定銀屑病計劃的三個核心要素是監管計劃，第四個要素是商業競爭力和定位。首先是前兩項研究，即懲罰性的頭對頭研究。到目前為止，最重要的研究證明了其功效和安全性。

The third, which is why we started the LATITUDE three study is to have an adequate patient safety database at one year. We don't expect that we'll need to wait for the completion of every patient in that study. That's to supplement the safety package from the first two studies.

第三，這就是我們開始 LATITUDE 三研究的原因，是為了在一年內擁有足夠的病患安全資料庫。我們預計不需要等待研究中每位患者的完成。這是對前兩項研究的安全方案的補充。

The third piece, of course, will be the CMC package. So those three elements, efficacy and safety from the two main -- studies head-to-head studies, extended safety from LATITUDE three to then our CMC package. Those will be the key elements of our regulatory package.

第三部分當然是 CMC 包。因此，這三個要素，即有效性和安全性，來自兩個主要研究——頭對頭研究，將安全性從 LATITUDE 3 擴展到我們的 CMC 套件。這些將是我們監管方案的關鍵要素。

And then the head-to-head study against ducravacitinib, that won't necessarily be part of the -- that won't slow down our registration package, but our hope is to have that study completed and ready for launch of zasocitinib.

然後是針對 ducravacitinib 的頭對頭研究，這不一定是 - 這不會減慢我們的註冊計劃的一部分，但我們希望完成該研究並為 zasocitinib 的推出做好準備。

So did the FDA come back to you and required and demanded the safety study after looking at the -- after the discussion with them? When do you decide...

那麼，在與他們討論之後，FDA 是否回去找你並要求進行安全性研究？你什麼時候決定...

No, no. I mean, to be clear, there are general guidelines for the number of patients that are required to have been dosed on active drug for a year. So -- I mean, of course, every program has a unique conversation with FDA, but there's nothing particular about our safety profile. Our safety profile and overall therapeutic index is quite strong. Predominantly, we're following guideline as is.

不，不。我的意思是，需要明確的是，對於一年內需要服用活性藥物的患者人數有一般準則。所以，我的意思是，當然，每個項目都與 FDA 進行了獨特的對話，但我們的安全概況沒有什麼特別之處。我們的安全性和整體治療指數非常強。我們主要遵循原樣的指導方針。

And I can jump in here and answer the question on TAKHZYRO. So let me first say that TAKHZYRO, after six years in the market, continues to be the number one prescribed advanced long-term prophy treatment. And we've got right now commercial presence for TAKHZYRO in 55 countries. So we see continued growth as you see in our results being fueled by growth of the prophylactic market as well as additional launches coming.

我可以跳到這裡回答 TAKHZYRO 上的問題。因此，我首先要說的是，TAKHZYRO 在上市六年後，仍然是排名第一的高級長期預防治療藥物。目前，TAKHZYRO 的商業業務已遍及 55 個國家。因此，我們看到了持續的成長，正如您在我們的業績中看到的那樣，這是由預防性市場的成長以及即將推出的更多產品所推動的。

So with respect to new therapies and certainly a gene therapy, there's questions that we would want to see answered that will come over time, such as the durability, the efficacy, the safety, the access to the number of patients worldwide that need it. But right now, we've got very, very strong open-label extension data, real-world evidence data, strong improved quality of life and over 2.5 years on therapy, showing very, very strong reduction in attacks and attack free for many patients.

因此，對於新療法，當然還有基因療法，我們希望看到一些隨著時間的推移而得到解答的問題，例如持久性、有效性、安全性以及全球需要它的患者數量。但現在，我們擁有非常非常強大的開放標籤擴展數據、真實世界的證據數據、生活品質的顯著改善以及超過 2.5 年的治療，顯示許多患者的發作非常非常強烈地減少並且無發作。

So confident in our positioning, confident in what the product has been able to do for patients truly transform their lives. And certainly, on behalf of patients, welcome new entrants in the future, but it's very early days.

對我們的定位充滿信心，對產品能為患者真正改變他們的生活充滿信心。當然，代表患者歡迎未來的新進入者，但現在仍處於早期階段。

Okay. I'd like to take the next question, please. So up next, UBS Securities, [Sakai-san] Or Haruta-san.

好的。我想回答下一個問題。接下來是瑞銀證券、[Sakai-san] 或 Haruta-san。

Haven't asked the question for some time. So this is my time. Just a couple of questions regarding the -- your domestic operations. One, PDT. Now the government is talking about the improving supply plasma in Japan. And I think Takeda name has been mentioned about the expanding the infrastructure and also the facility of the PDT here in Japan. Are you doing anything? Or are you going to proactively dealing with this issue in Japan? That's my first question.

有一段時間沒有問這個問題了。所以這是我的時間。只是幾個關於你們國內業務的問題。一、PDT。現在政府正在討論改善日本的血漿供應。我認為武田的名字在日本擴大基礎設施和 PDT 設施時被提及。你在做什麼嗎？或者您打算在日本積極處理這個問題嗎？這是我的第一個問題。

And second question, again, regarding Japan operation. Amazingly, your sales proportion in Japan is now risen 10% of your total revenues. The question is how you manage your Japanese business going forward? Now you are taking this new Korea development program, kind of [general] program, right? And you have done this in the US I think that a part of the margin improving exercise.

第二個問題又是關於日本的運作。令人驚訝的是，你們在日本的銷售額佔總收入的比例現在上升了 10%。問題是您如何管理您的日本業務？現在你正在採取這個新的韓國發展計劃，一種[一般]計劃，對吧？我認為你們在美國已經做到了這一點，這是提高利潤率的一部分。

But what are you going to end up in Japan, really? I mean it seems to be you don't require that many reps in Japan considering your product portfolio right now. So I'm just wondering what you're thinking about. So that these two questions, please.

但你最終會在日本得到什麼，真的嗎？我的意思是，考慮到您目前的產品組合，您在日本似乎不需要那麼多代表。所以我只是想知道你在想什麼。那麼這兩個問題，請教。

Thank you, Sakari-san. So I think the first question specific to PDT. I'd like to ask Giles to comment on that. And then the second question on our broader positioning in Japan. I'd like Christophe to comment on that one, please.

謝謝你，佐卡里桑。所以我認為第一個問題是針對 PDT 的。我想請賈爾斯對此發表評論。然後是關於我們在日本更廣泛的定位的第二個問題。我希望克里斯托夫對此發表評論。

Thank you, Sakari-san for the question. This is Giles speaking. We have announced in 2023, an investment in an -- to manufacturing facility for plasma therapies in Japan. We remain on track to bring that facility online by the end of this decade. And we are also working very hard to improve standard of care for patients who depend on plasma-derived therapies with primary immunodeficiencies, secondary immunodeficiencies and indications like CIDP and MMN.

謝謝佐卡里桑的提問。這是賈爾斯的演講。我們已宣佈於 2023 年在日本投資血漿療法製造工廠。我們仍有望在本十年末將該設施上線。我們也非常努力地提高那些依賴血漿衍生療法患有原發性免疫缺陷、繼發性免疫缺陷以及 CIDP 和 MMN 等適應症的患者的護理標準。

We have launched our first global subcutaneous IG product, CUVITRU, already for patients with PID and SID. And we have recently, in quarter two of fiscal '24, filed with the Japan authorities IQVIA for treatment of CIDP and MMN, and we expect to file for [globin] 10% by the end of this fiscal year as well.

我們推出了首款全球皮下 IG 產品 CUVITRU，已針對 PID 和 SID 患者。最近，我們在 24 財年的第二季度向日本當局 IQVIA 提交了 CIDP 和 MMN 的治療申請，我們預計在本財年末也將提交 10% 的 [globin] 申請。

So we are working closely with the authorities to support in addressing their concerns around sustainable supply and supply chain sovereignty around plasma therapies for the patients who need them in Japan. Thank you for the question.

因此，我們正在與當局密切合作，支持解決他們對日本需要血漿療法的可持續供應和供應鏈主權的擔憂。謝謝你的提問。

Yes. Just a follow-up. Is that going to be business opportunity? Or is that going to be risk of margin deterioration? I know you don't disclose the margin from PDT, but can you just -- well, qualitative comment. I would appreciate your qualitative comment, if you could make.

是的。只是後續行動。這會成為商機嗎？或者這會帶來利潤率惡化的風險嗎？我知道您沒有透露 PDT 的利潤，但您是否可以——好吧，定性評論。如果您能提出定性評論，我將不勝感激。

Well, there is a high unmet need for plasma-derived therapies in Japan. This is a market that today is relatively underdeveloped. And I would say, historically, perhaps not fully valued. That's why we're working with the authorities to invest in a manufacturing facility to meet the needs of patients in Japan.

日本對血漿衍生療法的需求尚未被滿足。這是一個當今相對不發達的市場。我想說，從歷史上看，也許沒有充分重視。這就是為什麼我們正在與當局合作投資一家製造工廠，以滿足日本患者的需求。

At the same time, ensuring that the authorities in Japan understand the value that these treatments bring to patients, to their families and to the health system at large so that this investment does provide both supply for patients but also sustainable business growth.

同時，確保日本當局了解這些治療方法為患者、其家人和整個衛生系統帶來的價值，以便這項投資既能為患者提供治療，又能提供可持續的業務成長。

And this is why we also announced that facility would not only be supplying patients in Japan, but would be hub, both for the Asia region and globally to support the needs of patients who depend on these therapies.

這就是為什麼我們也宣布該設施不僅將為日本的患者提供服務，而且將成為亞洲地區和全球的中心，以滿足依賴這些療法的患者的需求。

Understood.

明白了。

This is Christophe. A couple of points here. First, the Japanese business is our second biggest business in the world after the US Yes, Japanese revenue is less than 10% because the world is big and Takeda is a big global company. But this is our second biggest business in the world.

這是克里斯托夫。這裡有幾點。首先，日本業務是我們在全球僅次於美國的第二大業務是的，日本的收入不到10%，因為世界很大，而武田是一家全球性的大公司。但這是我們全球第二大業務。

What we need in Japan is to grow. And we will grow by launching more innovative new medicine and that what we have started to do for many years. So that this is our intent with Japan, is a very high priority. We have, obviously, a very strong presence in Japan, and we'll continue to have a very strong presence and very strong reputation, so we can really launch efficiently new products. So we are ambitious in Japan.

我們在日本需要的是成長。我們將透過推出更多創新的新藥以及我們多年來開始做的事情來成長。因此，這是我們與日本的意圖，也是一個非常重要的優先事項。顯然，我們在日本擁有非常強大的影響力，並且我們將繼續擁有非常強大的影響力和良好的聲譽，因此我們可以真正有效地推出新產品。所以我們在日本雄心勃勃。

We launched every single global product in Japan, is launched -- in the world is launched in Japan. Plus, we always find opportunities to launch specifically some new innovative medicines in Japan. We did that very well, for example, in our oncology business. Today, we are one of the leader in oncology in Japan because we launched our global product in Japan, but also we were able to in-license many products as well for the Japanese market. So we are ambitious in Japan.

我們在日本推出的每一款全球產品，都是在日本推出的。另外，我們總是尋找機會在日本專門推出一些新的創新藥物。例如，在我們的腫瘤學業務中，我們做得很好。今天，我們是日本腫瘤學領域的領導者之一，因為我們在日本推出了全球產品，而且我們也能夠為日本市場獲得許多產品的許可。所以我們在日本雄心勃勃。

The reorganization that we are doing now is really to align an organization to a portfolio of product, which has evolved, but we have more treating rare disease, specialty disease. We have -- we used to be more a general medicine type of portfolio, but we are now much more innovative, but also we have more targeted therapy. We want to provide the best possible service and provide the best information to doctors, and this is why we are reorganizing our operation today to be able to provide.

我們現在正在進行的重組實際上是使組織與產品組合保持一致，產品組合已經發展，但我們有更多的治療罕見疾病、特殊疾病的藥物。我們過去更多的是普通醫學類型的產品組合，但現在我們更具創新性，而且我們也有更有針對性的治療。我們希望為醫生提供盡可能最好的服務並提供最好的信息，這就是我們今天重組我們的業務以便能夠提供的原因。

Miki Sogi, Bernstein.

曾木美紀，伯恩斯坦。

So two questions, please. So first of all, ENTYVIO, I imagine that in ENTYVIO growth, and a 10% -- congratulations, it's a great, the recovery of growth. And it's coming from the price of Pen as well as patient expansion. Can you tell us what is the kind rough division of the -- at these two, the growth drivers?

那麼有兩個問題請教。首先，ENTYVIO，我想 ENTYVIO 會成長，並且成長 10%——恭喜，這是一個偉大的成長恢復。它來自筆的價格以及患者的擴張。您能否告訴我們這兩個成長動力的大致劃分是什麼？

And the second one is for TYK2. So it in the US continue to make kind of slow progress for its launch. And despite the fact that it has shown pretty clear, the efficacy superiority the -- vis -- vis, [Otezla]. And I'm wondering given that situation, you continue to believe that the head-to-head the -- your TYK2 inhibitor against TYK2 is important for your future positioning. Can you tell me the -- that you're thinking -- despite the situation of the TYK2? These are the two questions.

第二個是TYK2的。因此，它在美國的推出繼續取得緩慢的進展。儘管事實上它已經顯示得相當清楚，但與[Otezla]相比，其功效優越。我想知道，鑑於這種情況，您仍然相信，針對 TYK2 的 TYK2 抑制劑對您未來的定位非常重要。儘管 TYK2 的情況如此，您能告訴我您的想法嗎？這是兩個問題。

Thank you, Miki. So the first question was on the ENTYVIO sources of growth. And so I'd like to ask Julie to take that question. And perhaps Julie can also take the second question on our thoughts of the TYK2 positioning in the market, zasocitinib, vis -- vis, TYK2.

謝謝你，米基。所以第一個問題是關於 ENTYVIO 的成長來源。所以我想請朱莉回答這個問題。也許朱莉也可以回答第二個問題，關於我們對 TYK2 在市場中的定位的看法，zasocitinib，vis - vis，TYK2。

Yes. Thank you for the questions. And in regards to ENTYVIO, when you look at the US in particular, I'm assuming that's what your question is focused on. When you look at the US in particular, with the launch of the Pen, we've had access to new patient populations, new HCPs that we did not have access to before.

是的。謝謝你的提問。關於 ENTYVIO，當你特別關注美國時，我假設這就是你問題的重點。尤其是在美國，隨著 Pen 的推出，我們已經接觸到了新的患者群體、新的 HCP，這是我們以前無法接觸到的。

So that is part of the acceleration in our demand. But as we also shared previously to some of the other questions, ENTYVIO overall still performs very well. It continues to be the benchmark in IBD, and that's why we are able to hold on to our first-line position. In regards to the revenue, you were asking, I believe, the split between demand and revenue.

這是我們需求加速的一部分。但正如我們之前在其他一些問題中也分享過的那樣，ENTYVIO 整體表現仍然非常出色。它仍然是 IBD 的標桿，這就是我們能夠保持一線地位的原因。關於收入，我相信你問的是需求和收入之間的分配。

So some of the revenue growth is coming from the mix between Pen and IV. And as I mentioned in the earlier part for the second half of the year, while we do continue to expect demand acceleration, we do expect to see some of the channel dynamics and mix to have less acceleration on revenue than on demand overall, but still continuing to grow into the second half of the year. So hopefully, that addresses your question on ENTYVIO. For your second --

因此，部分收入成長來自 Pen 和 IV 的混合。正如我在今年下半年的早些時候提到的，雖然我們確實繼續預計需求加速，但我們確實預計一些通路動態和組合的收入加速將低於整體需求加速，但仍然下半年繼續保持成長勢頭。希望這能解決您關於 ENTYVIO 的問題。對於你的第二個——

Sorry, about ENTYVIO, is it also right to understand that the -- actually, the Pen price patient is higher, so that the just conversion from IV to Pen also contributes to the to your growth? Or as you were saying that really accessing a more broader patients and broader in the physicians at the base, that's the kind of more the driver?

抱歉，關於 ENTYVIO，實際上，患者的 Pen 價格更高，因此從 IV 到 Pen 的轉換也有助於您的增長，這也是正確的理解嗎？或者正如您所說，真正接觸到更廣泛的患者和更廣泛的醫生，這才是更多的驅動力？

It is both.

兩者都是。

And roughly, is it in the half and half? Or --

粗略地說，是一半一半嗎？或者 -

Half and half in regards to?

一半一半關於？

So the contribution coming from the price difference versus the actual expansion of patient base.

因此，貢獻來自於價格差異與患者基礎的實際擴張。

So in regards to the split, roughly 7% is from demand and the rest is from price. Does that answer your question? .

因此，就分割而言，約 7% 來自需求，其餘則來自價格。這能回答你的問題嗎？ 。

Yes.

是的。

Julie, Julie it's Christophe. It's 7% out of 10%, right?

朱莉，朱莉，這是克里斯托夫。是 10% 中的 7%，對嗎？

Correct.

正確的。

Yes. So 70% is demand, 30% is price. So it's 7% of 10%, just to be clear.

是的。所以70%是需求，30%是價格。需要明確的是，這是 10% 的 7%。

Yes. Thank you. No, that's clear.

是的。謝謝。不，這很清楚。

I'm sorry, did you have another --

抱歉，你還有嗎——

I just wanted to also follow up on the TYK2 question as well.

我也想跟進 TYK2 問題。

Yes. So TYK2 -- so our TYK2 versus TYK2. So first and foremost, we are waiting to see the data that comes out of our Phase 3, but we're very encouraged by the data that we have thus far. And if we are able to have that differentiated positioning and the stronger efficacy, vis -- vis, zasocitinib then that is going to help us with our positioning in the US So that is a key component.

是的。所以 TYK2——所以我們的 TYK2 與 TYK2。因此，首先也是最重要的，我們正在等待第三階段得出的數據，但我們對迄今為止所掌握的數據感到非常鼓舞。如果我們能夠擁有與扎索西替尼相比的差異化定位和更強的功效，那麼這將有助於我們在美國的定位，所以這是一個關鍵組成部分。

And then the second part of what we will have to do with 279 is in regards to how we address the access challenges. So here, we will learn from what our competitor has had to deal with, but also what we are learning as we continue to pull through access with ENTYVIO Pen.

然後，我們對 279 要做的第二部分是如何應對訪問挑戰。因此，在這裡，我們將學習我們的競爭對手必須處理的問題，以及我們在繼續使用 ENTYVIO Pen 進行訪問時所學到的東西。

So with this, I'd like to bring today's conference call to a close. Thank you all very much for your participation. Thank you.

我想結束今天的電話會議。非常感謝大家的參與。謝謝。

Portions of this transcript that are marked (interpreted) were spoken by an interpreter present on the live call. The interpreter was provided by the company sponsoring this event.

此文字記錄中標記（翻譯）的部分是由現場通話中的口譯員說出的。口譯員由贊助本次活動的公司提供。