Takeda Pharmaceutical Co Ltd (TAK) 2025 Q3 法說會逐字稿

(audio in progress) (interpreted) Head of IR. My name is O'Reilly. Thank you for this opportunity. I would like to explain about the language setting first. Please find the button for the language section at the bottom of the Zoom window.

（音訊正在進行中）（翻譯） IR 負責人。我的名字是奧萊利。謝謝你給我這個機會。首先我想解釋一下語言設定。請在 Zoom 視窗底部找到語言部分的按鈕。

If you wish to listen to Japanese, please select Japanese. If you wish to listen to English, please select English. Or if you want to listen to the original language, please keep it off. Please select English in the Zoom language select button.

如果您想聽日語，請選擇日語。如果您想聽英語，請選擇英語。或者如果您想聽原文，請關閉。請在 Zoom 語言選擇按鈕中選擇英語。

Let me start, I'd like to remind everyone that we will be 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.

首先，我想提醒大家，我們將討論 1995 年《私人證券訴訟改革法案》所定義的前瞻性陳述。實際結果可能與今天討論的結果有重大差異。

The factors that could cause actual results to differ materially are discussed in our most recent Form 20-F and other SEC filings. Please also refer to the important notice on page 2 of the presentation regarding forward-looking statements, and our non-IFRS financial measures, which we will also be discussing during this call.

我們在最近的 20-F 表和其他 SEC 文件中討論了可能導致實際結果大不相同的因素。另請參閱簡報第 2 頁有關前瞻性陳述和我們的非國際財務報告準則財務指標的重要通知，我們也將在本次電話會議中討論這些內容。

The definitions of our non-IFRS measures and the reconciliations with the comparable IFRS, the financial measures are included in the appendix of the presentation. Please refer to page 2 as well for important notices. We will begin the call.

我們的非國際財務報告準則指標的定義以及與可比較國際財務報告準則的調節、財務指標均包含在簡報的附錄中。請參閱第 2 頁的重要通知。我們將開始通話。

First of all, we would like to invite our CEO, Christophe Weber to comment.

首先，我們想邀請我們的執行長 Christophe Weber 來發表評論。

Thank you, Chris. Hello, everyone, and thank you for joining us. As you might have seen from our press release, today marks an important announcement regarding our Q3 results. Milano will speak to that, and my retirement from Takeda and succession.

謝謝你，克里斯。大家好，感謝大家的參與。正如您可能從我們的新聞稿中看到的那樣，今天是有關我們第三季業績的重要公告。米蘭諾將談論此事以及我從武田退休以及繼任事宜。

After 12 fulfilling years with Takeda, the Board and I have agreed on June 2026 as a date of my retirement from Takeda. I will no longer be on the Board of Takeda after June 2026. I'm very pleased to announce that the Board has selected Julie Kim, President of our US business unit as my successor.

在武田公司工作了12年之後，董事會和我同意2026年6月為我從武田公司退休的日期。2026 年 6 月之後，我將不再擔任武田董事會成員。我很高興地宣布，董事會已選定我們美國業務部門總裁朱莉金 (Julie Kim) 為我的繼任者。

Julie will be proposed as a new candidate for the Board at the Ordinary General Meeting of Shareholders in June '26, and will then be nominated as President and CEO. The unanimous decision to select Julie was made after a very robust multiyear process, assessing both internal and external candidates.

朱莉將在 26 年 6 月的股東常會上被提名為董事會新候選人，然後將被提名為總裁兼執行長。在經過多年非常嚴格的評估、對內部和外部候選人進行評估後，一致決定選擇朱莉。

To ensure a smooth transition, we are sharing this decision now, the timing aligned with our exciting growth outlook on potential drug launches which may start as early as the second half of 2026. It will allow us to select and nominate Julie's successor, obviously, a key role as the US represents 50% of our revenue.

為了確保順利過渡，我們現在分享這一決定，時間與我們對潛在藥物上市的令人興奮的增長前景相一致，該藥物可能最早在 2026 年下半年開始上市。這將使我們能夠選擇和提名朱莉的繼任者，顯然，這是一個關鍵角色，因為美國占我們收入的 50%。

This time frame also aligned with anticipated retirement of several external independent directors, allowing both Julie and me to be actively involved in the Board member selection process. Now I wanted to share some words about Julie.

這個時間框架也與幾位外部獨立董事預計退休的時間一致，這使得朱莉和我能夠積極參與董事會成員的選拔過程。現在我想分享一些關於朱莉的話。

Julie joined the Takeda executive team in 2019. She has been the President of the US Business Unit and US Country Head for the past three years. Prior to that, Julie led our plasma-derived therapy business unit. With over 30 years of healthcare experience, Julie is uniquely qualified for this role.

朱莉於 2019 年加入武田執行團隊。過去三年她一直擔任美國業務部總裁兼美國國家負責人。在此之前，朱莉領導我們的血漿衍生療法業務部門。朱莉擁有超過 30 年的醫療保健經驗，非常適合擔任此職位。

The Board and I have absolute confidence in the Julie capabilities and leadership qualities. She embodies our corporate values, ensuring decisions are patient first, inclusive and thoughtful. Importantly, our commitment to Takeda's purpose is unwavering.

董事會和我對朱莉的能力和領導絕對有信心。她體現了我們的企業價值觀，確保決策首先考慮耐心、包容且深思熟慮。重要的是，我們對武田宗旨的承諾堅定不移。

I have witnessed firsthand that she also has the right character and to lead a complex global company like Takeda. For now, nothing changed. We are focused on advancing our promising late-stage pipeline and preparing for future launches. I couldn't be more excited about what lies ahead for Takeda. Back to you, Chris.

我親眼目睹了她擁有正確的性格特徵，能夠領導像武田這樣複雜的全球性公司。目前，什麼都沒有改變。我們專注於推進我們有前景的後期產品線並為未來的發布做好準備。我對武田的前景感到無比興奮。回到你身邊，克里斯。

(interpreted) I would like to start the presentation from our CFO, Milano Furuta, and this will be followed by Q&A session. Milano-san, the floor is yours.

(翻譯) 我想從我們的財務長 Milano Furuta 開始演講，然後是問答環節。米蘭諾先生，現在請您發言。

Thank you, Chris. Hello, everyone. This is Milano Furuta speaking. It's my pleasure to give an update on Takeda's Q3 results for FY 2024. The positive momentum of our portfolio has continued into quarter three, with year-to-date revenue growth of 4.5% at constant exchange rate or CER, driven by our Growth & Launch products, which grew by 14.6% at CER.

謝謝你，克里斯。大家好。我是米蘭諾古田 (Milano Furuta)。我很高興向您介紹武田 2024 財年第三季的業績。我們產品組合的積極勢頭一直延續到第三季度，按固定匯率或 CER 計算，年初至今的收入增長了 4.5%，這得益於我們的增長和發布產品，按 CER 計算，增長了 14.6%。

In addition to top line growth, we also delivered margin improvements, with 28.5% core operating profit margin, an increase of 1.6 percentage points. This reflects the strength of our Growth & Launch products, slower-than-anticipated VYVANSE generic erosion, and OpEx savings from the efficiency program we initiated in May 2024.

除了營業收入成長之外，我們的利潤率也提高了提高，核心營業利潤率達到28.5%，增加了1.6個百分點。這反映了我們成長與上市產品的強勁表現、VYVANSE 仿製藥的衰退速度慢於預期，以及我們於 2024 年 5 月啟動的效率計劃帶來的營運支出節省。

We are also very excited about our late-stage pipeline. This month, we completed the licensing agreement for elritercept, a late-stage potential best-in-class oncology program. And as we introduced at our R&D Day in December 2025 will be an important tier for our pipeline with three Phase III data readouts expected this calendar year, with rusfertide in PossemiaVera, oveporexton in Narcolepsy Type 1 and zasocitinib in psoriasis.

我們對我們的後期研發管線也感到非常興奮。本月，我們完成了 elritercept 的許可協議，這是一個後期潛在最佳的腫瘤學課程。正如我們在 12 月的研發日上所介紹的那樣，2025 年將是我們產品線中的一個重要層級，預計今年將有三個 III 期數據讀數，分別是用於治療 PossemiaVera 的 rusfertide、用於治療 1 型發作性睡病的 oveporexton 和用於治療牛皮癬的 zasocitinib。

Based on our positive business momentum, we are raising our full management guidance again this quarter, and now expect revenue core operating profit and copy margin growth this year. And with the extra cash flow generated from this upside, we also plan to initiate a share buyback of up to JPY100 billion.

基於我們積極的業務發展勢頭，我們本季再次上調了全面管理指導，並預計今年收入核心營業利潤和利潤率將增長。利用這一成長帶來的額外現金流，我們還計劃啟動高達 1,000 億日圓的股票回購。

Slide 4 summarizes our financial results for the first nine months of FY24. Revenue was over JPY3.5 trillion, an increase of 9.8% versus prior year, or a 4.5% growth at CER. Core operating profit reached JPY1 trillion, year-on-year increase of 16.3% or 10.1% at CER. Reported operating profit was JPY417.5 billion, growing at 86%.

投影片 4 總結了我們 24 財年前九個月的財務表現。營收超過3.5兆日圓，較上年成長9.8%，以固定匯率計算成長4.5%。核心營業利潤達1兆日圓，年增16.3%，以固定匯率計算成長10.1%。報告營業利潤為4175億日元，成長86%。

Core EPS and reported EPS were JPY443 and JPY134, respectively. Operating cash flow was JPY835 billion, an increase of 90.8% year-on-year, reflecting profitable growth, lower cash taxes, and smaller increase of working capital. Adjusted free cash flow was JPY568.3 billion.

核心每股盈餘和報告每股盈餘分別為443日圓和134日圓。經營現金流為8,350億日元，較去年同期成長90.8%，反映獲利成長、現金稅項下降、營運資本增幅收窄。調整後自由現金流為5683億日圓。

Slide 5 shows a breakdown of our key business areas and the Growth & Launch products, which are driving our performance. These products represent 47% of total revenue and grew by 14.6% at CER year-to-date. Within GI, ENTYVIO growth was 6.6% at CER.

幻燈片 5 展示了推動我們業績成長和發布的關鍵業務領域和產品的細目。這些產品佔總收入的 47%，以 CER 計算，今年迄今成長了 14.6%。在 GI 內，ENTYVIO 成長率以 CER 計算為 6.6%。

Although underlying demand remains strong and in line with our plan, the growth rate was impacted by two specific factors. First, there was a higher baseline for Q3 growth due to shipment timing last year. On top of that, we booked a gross to net adjustment in Q3 this year of approximately USD50 million.

儘管基礎需求依然強勁且符合我們的計劃，但成長率受到兩個特定因素的影響。首先，由於去年的出貨時間，第三季的成長基準較高。除此之外，我們今年第三季的毛利與淨利調整額約為 5,000 萬美元。

This adjustment was a correction of our past statutory government price calculations that had accumulated over 10 quarters since mid-2022. If we exclude the impact of shipment timing and this gross to net adjustments, year-to-date ENTYVIO growth would have been 9.4% at CER.

此次調整是對我們自 2022 年中期以來 10 個季度累積的法定政府價格計算的修正。如果我們排除出貨時間和總淨額調整的影響，以固定匯率計算，年初至今 ENTYVIO 的成長率將達到 9.4%。

Next, rare disease, where TAKHZYRO continues to lead the HAE prophylaxis market, delivering 16.4% growth at CER. LIVTENCITY and ADZYNMA also continued their strong launch momentum.

接下來是罕見疾病領域，TAKHZYRO 持續引領 HAE 預防市場，以 CER 計算成長 16.4%。LIVTENCITY 和 ADZYNMA 也延續了強勁的發布勢頭。

Within plasma-derived therapies, immunoglobulin and albumin grew by 11.9% and 2.2% respectively. For albumin, on top of our plan and temporary shutdown of production lines, we also observed the cost of containment measures in China, which is influencing the growth rate.

在血漿衍生療法中，免疫球蛋白和白蛋白分別增加了 11.9% 和 2.2%。對於白蛋白，除了我們的計劃和生產線的暫時關閉之外，我們還觀察到中國遏制措施的成本正在影響成長率。

In oncology, FRUZAQLA is expanding very well. Most of the revenue is currently from the US, but we recently launched in Japan, and we are making progress with approvals and reimbursement in Europe.

在腫瘤學領域，FRUZAQLA 擴張得非常好。目前大部分收入來自美國，但我們最近在日本推出了該產品，並且在歐洲的審批和報銷方面也正在取得進展。

In vaccines, QDENGA is now available in 27 countries, and we see strong global demand in both endemic and non-endemic markets. We have sold over 10 million doses since launch in 2022, and we remain focused on further expanding access to this important vaccines.

在疫苗方面，QDENGA 目前已在 27 個國家上市，我們看到全球在地方病和非地方病市場都有強勁的需求。自 2022 年推出以來，我們已售出超過 1,000 萬劑，我們仍致力於進一步擴大獲得這種重要疫苗的機會。

From slide 6, I'll explain more about year-on-year growth dynamics. First, a revenue growth. Our Growth & Launch products more than offset loss of exclusivity impact mainly VYVANSE and ADDERALL XR in the US, and AZILVA in Japan.

從第 6 張投影片開始，我將進一步解釋年成長動態。第一，收入成長。我們的成長和上市產品遠遠抵消了獨佔權喪失的影響，主要是美國的 VYVANSE 和 ADDERALL XR 以及日本的 AZILVA。

In addition, net positive growth in other brands, such as GATTEX, TRINTELLIX, ADCETRIS and ICLUSIG contributed to a 4.5% revenue growth at CER. The depreciation of the yen versus major currencies contributed JPY171.9 billion, resulting in 9.8% growth on actual FX basis.

此外，GATTEX、TRINTELLIX、ADCETRIS 和 ICLUSIG 等其他品牌的淨正成長推動 CER 營收成長 4.5%。日圓對主要貨幣貶值貢獻1,719億日圓，以實際匯率計算成長9.8%。

Slide 7 shows a year-on-year bridge for core operating profit. There was a positive gross profit contribution from revenue dynamics, partially offset by a JPY29.9 billion adjustment due to implementation of the accounting process to recognize accumulated FX impact of inventories.

投影片 7 顯示了核心營業利潤的年比變化。收入動態產生了正的毛利貢獻，但由於實施會計流程以確認庫存累積的外匯影響而產生的299億日圓的調整部分抵消了這一貢獻。

Moving to OpEx, we had a year-on-year reduction in spend at CER with lower R&D expenses, primarily due to the termination of several programs during our pipeline prioritization at the end of FY23. We are also starting to see the benefits of our efficiency program on OpEx. Overall, core operating profit grew by 10.1% at CER or 16.3%, including the benefit from FX.

轉向營運支出，由於研發費用降低，我們的 CER 支出同比減少，這主要是由於在 23 財年末進行管道優先排序期間終止了幾個項目。我們也開始看到我們的效率計劃對營運支出 (OpEx) 帶來的好處。總體而言，包括外匯收益在內，核心營業利潤以固定匯率計算成長了 10.1%，即成長了 16.3%。

Next, reported operating profit. In addition to core growth, the main driver of the 86% increase was a lower impairment costs compared to the last year. Restructuring costs primarily related to the efficiency program or JPY107.4 billion on track with our plan.

接下來是報告的營業利益。除了核心成長外，86%成長的主要驅動力是與去年相比減損成本的降低。重組成本主要與效率計劃有關，或按我們的計劃進行，金額為 1074 億日元。

Next, our updated outlook for FY24. We are protruding management guidance. Revenue and core operating profit are both expected to increase at low single-digit percentage. This is a remarkable change from our initial outlook for revenue and the core OP decline this year. Core EPS guidance has also improved to flat to slightly declining at CER.

接下來，我們對 24 財年進行了更新。我們正在突出管理指導。預計營收和核心營業利潤均將以低個位數百分比成長。這與我們最初對今年的收入預期以及核心營業利潤的下滑相比發生了顯著變化。核心每股收益指引也已提升至以固定匯率持平或略有下降。

Updated forecast is now JPY4.59 trillion of revenue, JPY1.15 trillion of core operating profit, and JPY507 of core EPS. It means our core OP margin is now expected to be 25.1%, an increase over last year. This also reflects our updated currency assumptions for the year. Now with JPY153 to the US dollar, our assumption for the euro is unchanged.

更新後的預測為收入 4.59 兆日圓、核心營業利潤 1.15 兆日圓、核心每股收益 507 日圓。這意味著我們的核心營業利潤率預計達到25.1%，比去年增加。這也反映了我們今年更新的貨幣假設。目前日圓兌美元匯率為153，我們對歐元的假設維持不變。

On a reported basis, we forecast operating profit to be JPY344 billion and reported EPS to be JPY75. We're also raising our free cash flow forecast range to JPY550 billion to JPY650 billion. This is due to the uplift in core OP and expected proceeds as a part of the upcoming sale of Takeda Teva, our joint venture in Japan. With this performance and cash flow, we have decided to implement a share buyback of up to JPY100 billion.

根據報告，我們預測營業利潤為 3,440 億日元，報告每股收益為 75 日圓。我們也將自由現金流預測範圍上調至 5,500 億日圓至 6,500 億日圓。這是由於核心營業利潤的提升以及即將出售我們在日本的合資企業 Takeda Teva 的預期收益所致。憑藉這樣的業績和現金流，我們決定實施高達1,000億日圓的股票回購。

Slide 10 shows the moving parts in our upgrade forecast. We are upgrading revenue by JPY110 billion, mainly reflecting year-to-date performance versus the previous forecast. Based on year-to-date trends, we expect VYVANSE upside of around JPY40 billion versus our prior forecast.

投影片 10 展示了我們升級預測中的變動部分。我們將收入提高 1100 億日元，主要反映今年迄今的表現與先前的預測相比。根據今年迄今的趨勢，我們預計 VYVANSE 的銷售額將比我們先前的預測上漲約 400 億日圓。

We also expect a net positive impact from the rest of the portfolio. FX is also a benefit to our revised revenue forecast. For core OP, the majority of the JPY100 billion increase is driven by product performance and R&D savings, partially offset by the accounting change impact to cost of goods that was not included in our prior forecast.

我們也預期其餘投資組合將產生淨正面影響。外匯也有利於我們修改後的收入預測。對於核心營業利潤而言，1,000億日圓的成長大部分是由產品性能和研發節省推動的，部分被我們先前預測中未包括的會計變更對商品成本的影響所抵銷。

Of the reduction in R&D expense forecast, approximately half is due to post-trial access cost for TAK-611 and TAK-609 previously expected as R&D expense, but now in other operating expenses. The remaining benefit is due to VYVANSE savings. This brings our Q3 earnings presentation to an end, and we would like to welcome your questions. Thank you.

在預計的研發費用減少中，約有一半是由於 TAK-611 和 TAK-609 的試驗後使用成本，此前預計將作為研發費用，但現在已計入其他營運費用。剩餘的收益來自於 VYVANSE 的節省。我們的第三季財報到此結束，我們歡迎您的提問。謝謝。

(interpreted) Thank you. Now we would like to entertain questions from you. Christophe, Milano; and R&D President, Andy Plump will be joining in this session. (Event Instructions)

（翻譯）謝謝。現在我們想回答您的問題。克里斯托夫，米蘭；兼研發總裁 Andy Plump 將參加本次會議。(活動須知)

The first is from Jefferies, Mr. Barker.

第一個是來自 Jefferies 的巴克先生。

Yes, Steve Barker from Jefferies. Thanks very much. So my question is around some of the accounting issues. So you have a negative impact on your forecast because you -- I just want to understand that a little bit more. So you're devaluating the yen-denominated value of inventory. So that's going to boost your COGS.

是的，傑富瑞 (Jefferies) 的史蒂夫巴克 (Steve Barker)。非常感謝。我的問題是關於一些會計問題。因此，你的預測會受到負面影響，因為你——我只是想更多地了解這一點。因此，你正在貶低以日圓計價的庫存價值。這將會提高你的銷貨成本。

And then I also -- there was the R&D question. Is that going to be -- is that a one-off where you -- is it related to specific clinical trials, and we won't expect to see that increase in other expenses going forward? Yes, so two accounting questions, please. Thank you.

然後我還 — — 還有研發問題。這是一次性的嗎？是的，請問兩個會計問題。謝謝。

Okay, thank you, Steve. Milano, would you like to answer those questions?

好的，謝謝你，史蒂夫。米蘭諾，你願意回答這些問題嗎？

Yes. Hi Steve, and thank you for the questions. So the first one is COGS one. So it's a little bit technical, so bear with me. So as you know, there is in the intercompany transactions, we're going to have some internal markups. And then within -- in the consolidation accounting process, there is a process of eliminating the markups.

是的。你好，史蒂夫，謝謝你的提問。因此第一個是 COGS。這有點技術性，所以請耐心聽我說。如您所知，在公司間交易中，我們會有一些內部加價。然後在合併會計過程中，有一個消除加價的過程。

Sometimes due to the different functional currencies and high volume transactions, this kind of adjusting accounting like accounts will be used to appropriately reflect our inventories. And then these accounts have been accumulated with -- we believe this is largely due to the FX impact in the past movement.

有時由於功能貨幣不同且交易量大，將使用此類調整會計科目來適當反映我們的庫存。然後這些帳戶就累積起來了——我們相信這主要是由於過去走勢中的外匯影響。

And then this time, we decided to implement an accounting process to recognize this accumulated foreign currency impact of the inventories, and then as a kind of onetime recognition of about JPY26 billion for the past ones. And then for this fiscal quarter three, like about JPY39 -- or sorry, JPY3.9 billion of the recognition. That's a kind of combination of the recognition of the FX impact in the inventories.

然後這次，我們決定實施會計流程來確認庫存的累積外幣影響，然後作為過去約 260 億日圓的一次性確認。然後，對於本財政季度，大約有 390 億日元——或者抱歉，是 39 億日元的確認金額。這是對庫存中外匯影響的一種綜合識別。

Right, so really a one-off?

對，真的是一次性的嗎？

Yes. But we are now introducing this -- the process of recognizing this FX impact kind of automatically, like systematically through the COGS, like amortization. So it's going to be -- it will not be this big amount. Actually, we are recognizing like a two years equivalent amount. So this will be much smaller amount, will be recognized kind of regularly throughout the quarters.

是的。但是我們現在正在引入這種自動識別外匯影響的過程，例如透過 COGS 系統地識別，例如攤銷。所以，金額不會這麼大。實際上，我們確認的是相當於兩年的金額。因此，這個金額會小得多，並且會在各個季度內定期確認。

Right. It won't build up anymore?

正確的。不會再堆積起來了嗎？

No.

不。

Thank you.

謝謝。

And for 611 -- the 609, this is -- these programs were -- we had decided to contaminate or stop the developments, the programs based on the clinical trial results. But based on a patient's request, we decided to offer access to these molecules to the patients who wants to have kind of post-trial access.

對於 611 到 609 項目，我們決定根據臨床試驗結果來抑製或停止這些項目的開發。但根據患者的要求，我們決定向想要獲得試驗後使用權的患者提供這些分子的使用權。

So then we -- with these decisions, we made an accrual for this a post-trial access cost, which booked in Q3, which is almost like JPY16 billion, which we booked in other operating expense. So it's kind of one-off the one-time for this program.

因此，透過這些決定，我們對此進行了應計的試驗後接入成本，該成本已計入第三季度，約為 160 億日元，我們將其計入其他營運費用。所以對於這個程序來說，它是一次性的。

Understood. And a related question, could you help me understand the ENTYVIO issue, so gross to net true up adjustment? I don't understand what that is.

明白了。還有一個相關的問題，您能幫助我理解 ENTYVIO 問題，即從總額到淨額的真實調整嗎？我不明白那是什麼。

Yes. So there is a gross to net adjustment in the US market, right? And then that's going to be the referred to especially the government pricing. And there is some -- we identified some miscalculation in the past 10 quarters.

是的。那麼美國市場存在總調整到淨調整的情況，對嗎？這就是所指的政府定價。我們發現過去 10 個季度中存在一些錯誤計算。

And all these things it's not material. The accumulated number is about USD50 million over the more than the two years. But we identified this kind of miscalculation. So we are now addressing or crafting this kind of variances, and then we are booking as a kind of negative to the revenue.

所有這些都不是物質的。兩年多來累計約5000萬美元。但我們發現這種誤判。因此，我們現在正在解決或發展這種差異，然後將其視為收入的一種負面影響。

Understood. Thanks very much.

明白了。非常感謝。

Thank you, Steve.

謝謝你，史蒂夫。

(interpreted) Citi, Yamaguchi-san.

（譯）Citi，山口先生。

Can you hear me?

你聽得到我嗎？

Yes, we can hear you.

是的，我們能聽到你的聲音。

Thank you. So two questions from Yamaguchi from Citi. The first question is regarding the management change. And my sense was the -- for me, at least it sounds like you're trying to do the management up until the ENTYVIO, (inaudible) which is around 2030s.

謝謝。花旗的山口提出了兩個問題。第一個問題是關於管理變革。我的感覺是 — — 對我來說，至少這聽起來像是你試圖進行管理直到 ENTYVIO（聽不清楚），大約在 2030 年代。

And -- but you decided to change the management next year. Is there any kind of trigger from the fundamentals of the company is concerned? So can you tell me why now? I mean, next year, but can you tell me the kind of the trigger point you think about this time? That's the first question.

而且——但你決定明年更換管理階層。從公司基本面來看，是否有某種觸發因素？那你現在能告訴我為什麼嗎？我的意思是明年，但你能告訴我這次你想到的觸發點是什麼樣的嗎？這是第一個問題。

And the second question is that this year's earnings is getting stronger and stronger because of the residual of the buybacks and also currency. But at the same time, it does mean that next fiscal year hurdle is getting a little bit higher.

第二個問題是，由於回購和貨幣的剩餘，今年的獲利會越來越強勁。但同時，這也意味著下一財年的門檻會更高一些。

Can you give me some -- I know you don't have any guidance at the moment, but can you give me what's the pros and cons for next fiscal year starting for next April? And is that OP wise, it is flattish or slight decline, or it depends on a lot of factors, but can you give me what do you see at the moment for the next fiscal year's trend as far as sales and operating profit is concerned. Thanks.

你能給我一些——我知道你現在沒有任何指導，但你能告訴我從明年四月開始的下一個財政年度的利弊嗎？從 OP 角度來看，是持平還是略有下降，或者取決於許多因素，但您能否告訴我，就銷售額和營業利潤而言，您目前對下一財年的趨勢有何看法？謝謝。

Thank you, Yamaguchi-san. The first question on the rationale behind the management change, and second on outlook for 2025. So Christophe, would you like to take those questions?

謝謝你，山口先生。第一個問題是關於管理變革背後的理由，第二個問題是關於 2025 年的展望。那麼克里斯托夫，你願意回答這些問題嗎？

Yes. Thank you very much, Yamaguchi-san. On the management change, we feel that this is a good timing. In 2026, I will have been 12 years, which is quite a long period. So 2032 will not have been impossible, but it would have been very, very long.

是的。非常感謝，山口先生。關於管理階層的變動，我們認為這是一個很好的時機。到2026年，我就12歲了，這是一個相當長的時期。因此，2032 年並非不可能，但將會非常非常漫長。

But it's also a good window now because we are at the end of the VYVANSE impact actually. I'll come back to that in your second question. And we are before the wave of new product launch. You don't want to make management change during a new product launch. You want to do that before.

但現在也是一個很好的機會，因為我們實際上正處於 VYVANSE 影響的末期。我將在你的第二個問題中再次討論這個問題。我們正處於新產品發布的浪潮之前。您不想在新產品發布期間進行管理變更。您想先做那件事。

And that's why we are also announcing now with this transition period, that will give us time to find and select the successor of Julie, who will be in place and with a more stable leadership before we launch this product in the US.

這就是為什麼我們現在宣布這一過渡期，這將使我們有時間尋找和選擇朱莉的繼任者，在我們在美國推出該產品之前，她將到位並擁有更穩定的領導地位。

It also coincides with some change that will happen at our Board. We do have 10 years tenure limit for our external directors. So there will be some rotation happening in 2026. And we feel it's good to have the future Board and the future CEO in a way of synchronized. So that's also another consideration that we discussed, and that's why we decided for June 2026.

這也與我們董事會即將發生的一些變化相吻合。我們的外部董事的任期確實有 10 年的限制。因此 2026 年將會發生一些輪調。我們認為讓未來的董事會和未來的執行長保持同步是件好事。這也是我們討論的另一個考慮因素，這就是我們決定在 2026 年 6 月進行的原因。

On the second question, Yamaguchi-san, of course, the upside, 40% of the upside is VYVANSE, but 60% is non-VYVANSE. So we shouldn't forget that we have a good dynamic with our Growth & Launch product. Obviously, VYVANSE is a big upside this year. The residual impact of VYVANSE in next year will be more limited. If you look at the generic penetration today, it's 65% of the molecule.

關於第二個問題，山口先生，當然，好處是，40％的好處是 VYVANSE，但 60％ 的好處是非 VYVANSE。因此，我們不應忘記，我們的成長與發布產品有著良好的動態。顯然，VYVANSE今年有很大的成長空間。VYVANSE 明年的殘留影響將更加有限。如果你看看今天的通用藥物滲透率，它已經佔了分子的 65%。

So even though we had some upside, the generic penetration has happened. And today, we are at 65%. So we have not reached the bottom, but we are getting close to it. So that's why we feel confident that next year will be a growth year in revenue and bottom line.

因此，儘管我們有一些優勢，但通用藥物的滲透已經發生。如今，這一比例已達 65%。因此，我們尚未觸底，但正在接近底線。因此，我們有信心明年將是營收和利潤成長的一年。

Why? Because once -- yet, we will see some VYVANSE impact, but it will be a residual impact, and we expect our Growth & Launch product to continue to grow in the future. Thank you.

為什麼？因為一旦——然而，我們會看到一些 VYVANSE 的影響，但這將是一種殘留影響，我們預計我們的成長和發布產品將在未來繼續成長。謝謝。

Thank you very much.

非常感謝。

TD Cowen, Mike Nedelcovych.

TD Cowen，麥克·內德爾科維奇。

Hi, everybody. Thank you for the question. I have two, both on the topic of zasocitinib's Phase III psoriasis program. So first, when we see the first readout, what would you define as success? Or put another way, what result would make you feel more confident in your head-to-head ducravasitinib trial?

大家好。感謝您的提問。我有兩篇關於扎索替尼 III 期牛皮癬計畫的文章。那麼首先，當我們看到第一個讀數時，您將什麼定義為成功？或者換句話說，什麼樣的結果會讓您對頭對頭的 ducrasitinib 試驗更有信心？

And what result might make you feel a little more concerned? Just as an example, should we focus on PASI 75, the primary endpoint? Or would you urge us to scrutinize PASI 100? That's my first question.

什麼樣的結果可能會讓您感到更擔憂呢？舉個例子，我們應該關注主要終點 PASI 75 嗎？或者您會敦促我們仔細審查 PASI 100？這是我的第一個問題。

And then my second question is on timing. One of zasocitinib's Phase III psoriasis trials latitude 3002 is actually a couple of months past its primary completion date on clinicaltrials.gov. Should we take this to mean that the 16 week primary endpoint has been recorded? And if so, do you have data in-house? Or do you remain blinded until the longer term endpoints readout? Thank you.

我的第二個問題是關於時間。zasocitinib 的其中一項 III 期乾癬試驗（緯度 3002）實際上已超過 clinicaltrials.gov 上公佈的其主要完成日期幾個月。我們是否應該將此理解為已經記錄了 16 週的主要終點？如果是的話，您有內部數據嗎？或者您會一直蒙蔽雙眼，直到獲得長期終點讀數為止？謝謝。

Thank you, Mike. Andy, would you like to take those two questions, please?

謝謝你，麥克。安迪，您願意回答這兩個問題嗎？

Sure, Chris. Hi, Mike. And actually maybe Christophe can also provide some thoughts in terms of the overall profile of zasocitinib in what we would consider I've differentiated. So Mike, let me start with your second question first, which is timing.

當然，克里斯。你好，麥克。實際上，Christophe 也許還可以就紮索替尼的整體概況提供一些想法，我們認為我已經將其區分開來。那麼麥克，讓我先從你的第二個問題開始，那就是時間問題。

So as we've mentioned, as of November of last year, we've completed enrollment of the two primary Phase III studies. These are the pivotal and registration enabling studies, with (inaudible) as a comparator. As you mentioned, the primary endpoint is a 16-week endpoint. But the studies are completely blinded until week 52 for one of the studies, in week 60 for the second study.

正如我們所提到的，截至去年 11 月，我們已經完成了兩項主要 III 期研究的招募。這些是關鍵的、註冊支持性研究，以（聽不清楚）作為比較。正如您所提到的，主要終點是 16 週終點。但其中一項研究要到第 52 週才完全盲法，第二項研究則要到第 60 週才完全盲法。

And so that's ensured that we maintain the full integrity of these studies that we have a one year safety database. So the direct answer to your question is that we don't have data in-house, and we're not planning an interim analysis. And quite excited about the speed at which we've enrolled these studies, and we're looking forward to seeing data at the end of the year. .

這樣就確保了我們保持這些研究的完整性，我們擁有一年的安全資料庫。所以對你的問題的直接回答是我們沒有內部數據，而且我們也不打算進行中期分析。我們對於進行這些研究的速度感到非常興奮，我們期待在年底看到數據。。

Before I hand it over to Christophe, I'll mention that the primary endpoint for the study is PASI 75, and there are historical reasons why we've used PASI 75 as the primary endpoint. But the study is very well powered to see benefits on one of the key secondary endpoints.

在將其交給 Christophe 之前，我要說一下，這項研究的主要終點是 PASI 75，而我們使用 PASI 75 作為主要終點是有歷史原因的。但該研究非常有力地證明了其對一個關鍵次要終點事件的益處。

And the one that we're most enthusiastic about will be PASI 100. There's been a trend in psoriasis, particularly driven by some of the effications parenteral agents, subcu and IV agents, where patients are now really focused on clear skin, and that's where we really see our clear advantage.

其中，最讓我們熱衷的是 PASI 100。牛皮癬的治療出現了一種趨勢，特別是在一些療效顯著的腸外藥物、皮下和靜脈注射藥物的推動下，患者現在真正關注的是清潔皮膚，而這正是我們真正看到明顯優勢的地方。

Christophe, I'll hand it back to you if you have additional comments.

克里斯托夫，如果您還有其他意見，我會將其回饋給您。

Yeah, thank you Andy. Thank you, Mike. Our goal with zasocitinib is to redefine what an overall product can do, again, psoriasis in terms of efficacy and safety. So we will look at significant efficacy whether it is 100 or 75 compared to what overall have been able to deliver in the past, and being much closer to a biological efficacy.

是的，謝謝你安迪。謝謝你，麥克。我們對扎索替尼的目標是重新定義整個產品在療效和安全性方面對牛皮癬的作用。因此，我們將專注於顯著功效，無論與過去整體所能達到的功效相比，它是 100 還是 75，並且更接近生物學功效。

And that's what we believe will redefine the overall segment and the role of overall product in the treatment of psoriasis. So I think that's really our maintain, and that's what we are looking for when we look at the result of the study.

我們相信，這將重新定義整個領域和整個產品在牛皮癬治療中的作用。所以我認為這確實是我們所堅持的，這也是我們在研究結果中所尋找的。

Thank you, and congratulations on your upcoming retirement.

謝謝您，並祝賀您即將退休。

Thank you.

謝謝。

(interpreted) Nomura Securities, Matsubara-san.

（翻譯）野村證券，松原先生。

(interpreted) Yes, this is Matsubara, Nomura Securities. Can you hear me?

（翻譯）是的，我是野村證券的松原。你聽得到我嗎？

(interpreted) Yes, we can hear you.

（翻譯）是的，我們能聽到你的聲音。

(interpreted) Thank you. I have two questions. First question is about ENTYVIO. Compared to the previous quarter, growth of ENTYVIO is not very clear. I don't think it's growing. Is this because of the holidays pushing down the shipment? Or is it due to the competitive environment changing? That's my question.

（翻譯）謝謝。我有兩個問題。第一個問題是關於 ENTYVIO 的。與上一季相比，ENTYVIO 的成長並不十分明顯。我不認為它在增長。這是因為假期導致出貨量減少嗎？還是因為競爭環境改變了？這就是我的問題。

The second question, sorry, is about the CEO. I understand you have thought about the timing of switching to the new CEO. Now under the new CEO, what do you expect to happen? I understand that Julie has experience in business in the United States, and in the (inaudible) So those aspects of the company may grow. But what is the growth strategy under her? What do you expect her to do for Takeda?

抱歉，第二個問題是關於執行長的。我知道您已經考慮過更換新執行長的時機。如今在新任 CEO 的領導下，您期待發生什麼事？據我所知，朱莉在美國有商業經驗，並且在（聽不清楚）因此公司的這些方面可能會發展。但她實施的成長策略是什麼？您希望她為武田做些什麼？

Thank you Matsubara for the questions. So the first one was on ENTYVIO quarter-on-quarter growth. Is there anything of note here in terms of competitive dynamics changes? And then the second question on expectations for Julie as the incoming CEO. So I'd like to ask Christophe to answer those questions, please.

感謝松原提出的問題。第一個問題是關於 ENTYVIO 季度環比增長的情況。就競爭動態變化而言，有什麼值得注意的嗎？第二個問題是關於對朱莉作為新任執行長的期望。因此我想請克里斯托夫來回答這些問題。

Thank you for the question. For ENTYVIO, I think you need to take out the one-off effect that Milano mentioned, phasing up shipment. So Q3 last year was very strong for phasing issue or phasing pattern. And then the one-off adjustment that we mentioned on the gross to net price ASP. If you take that out, our year-to-date growth is 9.2%, and our quarter growth is much higher, a bit lower than Q2.

感謝您的提問。對於 ENTYVIO，我認為你需要消除米蘭諾提到的一次性效應，逐步增加出貨。因此，去年第三季的分階段問題或分階段模式非常強勁。然後我們提到了毛價與淨價 ASP 的一次性調整。如果去掉這個數字，我們今年迄今的成長率為 9.2%，而且本季的成長率要高得多，略低於第二季。

And we do believe that indeed, that there has been some effect with year-end, which was especially long this year as a break between Christmas and New Year's Eve. But I think it's really important to look at the year-to-date.

我們確實相信，年末確實產生了一些影響，因為今年的年末特別長，介於聖誕節和新年前夕之間。但我認為回顧今年迄今為止的情況非常重要。

If you take out these two one-offs, we are at a bit more than 9%. So a bit short of our 11% new guidance and forecast, but we'll see how things are evolving. We are quite pleased with the response that we are seeing on the PENN launch.

如果去掉這兩項一次性支出，我們的利潤率會略高於 9%。因此，這比我們 11% 的新指導和預測略低，但我們將觀察事態如何發展。我們對 PENN 發表會所獲得的反應感到非常滿意。

Quarter-to-quarter, we have seen a 30% increase of prescribers, number of prescribers prescribing the drug, (inaudible) And also, our access has improved significantly, but it's not at the maximum yet. We have a bit more than 70% access at the moment, and we want to reach a 90% plus. So I think there's still some work to do there.

與上一季相比，我們看到開立處方的人員數量增加了 30%，（聽不清楚）而且，我們的藥品可及性也得到了顯著改善，但還沒有達到最大值。目前，我們的訪問率略高於 70%，我們希望達到 90% 以上。所以我認為還有一些工作要做。

So overall, the pattern has not changed. ENTYVIO is keeping its leading position, especially in the first-line biological treatment. We have lost some market share in second and third line, but we are growing faster than the market. So we are pleased with the performance. And obviously, as we discussed in the past, the launch of the panel is very much important in the life cycle of ENTYVIO.

所以整體來說，格局沒有改變。ENTYVIO繼續保持領先地位，特別是在一線生物治療領域。我們在二線和三線市場的份額有所下降，但是我們的成長速度快於市場。因此，我們對錶現感到滿意。顯然，正如我們過去討論的那樣，該小組的推出在 ENTYVIO 的生命週期中非常重要。

For your second question, I would just want to reemphasize that Julie will lead our US business until we have a successor joining us, a successor of Julie, that will take some time. We will look internally and externally. So no distraction, very much focused on that business. And then once we have a successor for Julie, she will be able to focus on the transition and progressively take the lead.

對於您的第二個問題，我只想再次強調，朱莉將領導我們的美國業務，直到我們有繼任者加入我們，朱莉的繼任者，這需要一些時間。我們將從內部和外部進行審視。因此，不要分心，全神貫注於業務。一旦我們找到了朱莉的繼任者，她將能夠專注於過渡並逐步發揮領導作用。

So I think she has been part of the TT since 2019. So she has been extremely involved in our overall strategy direction. She is leading our US business today, which is really -- which is 50% of our total revenue. So directionally, she has been very much in favor and supportive of our strategy.

所以我認為她自 2019 年以來一直是 TT 的一部分。所以她非常參與我們的整體策略方向。她現在領導我們的美國業務，這實際上占我們總收入的 50%。所以從方向上看，她非常贊同並支持我們的策略。

So don't expect major change of direction. But she will respond ourself to a question like that from 2026 onwards. I think that's the way to see the timing. Thank you.

因此不要期待發生重大的方向改變。但從 2026 年起，她將親自回答這樣的問題。我認為這就是判斷時機的方法。謝謝。

(interpreted) Thank you very much.

（翻譯）非常感謝。

Tony Ren, Macquarie.

麥格理的 Tony Ren 。

Great. Yeah. Thank you for the opportunity to post my questions. My first question is again on ENTYVIO. the gross to net true up adjustment. I think I heard Milano saying that it was due to selling ENTYVIO to the US government over the last 10 quarters.

偉大的。是的。感謝您給我機會提出我的問題。我的第一個問題再次是關於 ENTYVIO 的。總額至淨額的實際調整。我想我聽到米蘭諾說這是由於過去 10 個季度將 ENTYVIO 出售給美國政府。

I just want to confirm that I heard it correctly. With that, would you say that the 11% CER growth rate you initially guided would not be possible. So that is on ENTYVIO.

我只是想確認我聽得沒錯。那麼，您是否認為您最初預測的 11% CER 成長率是不可能實現的？這就是關於 ENTYVIO 的事情。

The other question is on the US IRA price negotiation. So Amgen's Otezla is now officially included in the 15 drugs for the 2025 pricing negotiation. So does -- how does that affect your clinical development or commercialization plans for zasocitinib? Thank you.

另一個問題是關於美國IRA價格談判。因此安進的 Otezla 現已正式被列入 2025 年定價談判的 15 種藥物之列。那麼—這對您對扎索替尼的臨床開發或商業化計劃有何影響？謝謝。

Thank you, Tony. So the first question on some more detail on the gross to net for ENTYVIO and any impact on the 11% full year that we previously disclosed for ENTYVIO. So Milano, if you'd like to follow up on that one. And then the second question on the IRA, any impact on zasocitinib because of Otezla's inclusion. I'd like to ask Christophe to comment on that one, please.

謝謝你，托尼。因此，第一個問題是關於 ENTYVIO 的毛利與淨利潤的更多細節，以及對我們先前揭露的 ENTYVIO 全年 11% 的影響。那麼米蘭諾，如果你想跟進這一點。然後是關於 IRA 的第二個問題，Otezla 的加入會對 zasocitinib 產生什麼影響。我想請克里斯托夫對此作出評論。

Hi, Tony, thank you. So this -- again, this adjustment is related to our like a gross to net calculation like (inaudible) government pricing calculations, and then we are sharing this information with (inaudible) in the US.

嗨，托尼，謝謝你。所以這個—再說一次，這個調整與我們的總額到淨額計算有關，例如（聽不清楚）政府定價計算，然後我們與美國（聽不清楚）分享這些資訊。

But this impact is, unfortunately, we didn't -- of course, we didn't have forecasted or like we didn't -- we had not anticipated when we developed this guidance of 11%. So the -- by this amount, maybe it might be a little bit challenging to reach 11%. But basically, if we take out this impact, overall, we are in line with our internal plan.

但不幸的是，我們在製定 11% 的指引時並沒有預料到這種影響。所以 — — 以這個金額，要達到 11% 可能有點困難。但基本上，如果我們消除這種影響，總體而言，我們是符合我們的內部計劃的。

And for the IRA, yes, Otezla is among the product selected in this second wave. It reinforced -- it doesn't change our clinical development plan. It just reinforced the fact that we believe that we will have a very different profile in terms of efficacy and therefore, we'll be able to really differentiate ourselves from previous oral product.

對 IRA 來說，Otezla 是第二波入選的產品之一。它強調——它不會改變我們的臨床開發計劃。這只是強化了這樣一個事實，我們相信我們在功效方面將擁有非常不同的形象，因此，我們將能夠真正地與以前的口服產品區分開來。

The fact that it is in the IRA, it doesn't change our strategy. It just reinforced the fact that we need to be differentiated, and we believe we will be in terms of efficacy and safety. Not only, by the way, against a product like Otezla, but also, as you mentioned earlier, against Ducra, because we are doing this head-to-head study against Ducra later on. Thank you.

事實上，它是在愛爾蘭共和軍中，但這並不會改變我們的戰略。這只是強化了我們需要差異化的事實，我們相信我們將在功效和安全性方面做到這一點。順便說一句，這不僅針對 Otezla 這樣的產品，而且正如您之前提到的，還針對 Ducra，因為我們稍後會對 Ducra 進行正面交鋒的研究。謝謝。

Thank you very much.

非常感謝。

(interpreted) Morgan Stanley, Muraoka-san.

（譯）摩根士丹利，村岡先生。

(interpreted) Good evening. This is Muraoka, Morgan Stanley. I hope you can hear me.

（翻譯）晚上好。我是摩根士丹利的村岡。我希望你能聽到我的聲音。

Yes, we can hear you.

是的，我們能聽到你的聲音。

Thank you. My first question is about next fiscal year, which is coming in three months. How do you see the next fiscal year, 100 to 250 basis point margin improvement that you have always talked about. Do you think you can sustain that for next fiscal year, can we expect that to happen?

謝謝。我的第一個問題是關於下一個財政年度的，三個月後就到來了。您如何看待下一財年？您認為您能在下一財政年度維持這種狀況嗎？

And another question is what about dividends? This year, you made upward revision twice, but the dividend was the same. It's still the same. But if the OP margin improves in the next fiscal year, based on our progressive policy, do you think the dividend could increase? Or can we be confident that the dividend will increase? That's my first question.

另外一個問題是股利怎麼樣？今年你兩次上調股息，但股息是一樣的。還是一樣。但是，如果根據我們的漸進式政策，下一財年的營業利潤率有所提高，您認為股利會增加嗎？或者我們能否確信股利會增加？這是我的第一個問題。

And the second question is about ENTYVIO biosimilar. Alvotech Teva started a Phase III program recently, and it is becoming more crowded, it seems. Timing-wise, while you always maintain that you'll be okay up until 2030, maybe that is still true.

第二個問題是關於ENTYVIO生物相似藥。Alvotech Teva 最近啟動了第三階段計劃，看起來，該計劃正變得越來越擁擠。從時間角度來看，雖然您總是堅持到 2030 年都會沒事，但也許這仍然是正確的。

But really focus on the timing, are you going to be okay up until 2030 or 2032 in terms of biosimilar entry timing. Can we please -- can you help me organize my thoughts on this?

但真正關注的是時間問題，就生物相似藥的進入時間而言，到 2030 年或 2032 年您是否還能安然無恙。我們可以嗎──你能幫我整理一下這方面的想法嗎？

Just a question on outlook for margin improvement in 2025. I'd like to -- and also thoughts around the dividend for next year. I'd like to ask Milano to comment on that. And then the second question on biosimilar assumptions for ENTYVIO, if there's any change around entrance timing. I'd like to ask Christophe to comment on that.

我只是想問一下 2025 年利潤率改善的前景。我想——也想談談關於明年股息的想法。我想請米蘭諾對此發表評論。然後第二個問題是關於 ENTYVIO 生物相似藥的假設，進入時間是否有任何變化。我想請克里斯托夫對此發表評論。

(interpreted) Good evening, Muraoka-san, and thank you for your question. First with regard to OP margin, 100 to 250 basis points improvement, and this is the basic thinking. And 23% is the base number that we were thinking about for this fiscal year.

(翻譯) 晚上好，村岡先生，感謝您的提問。首先關於營業利潤率，提高100到250個基點，這是基本想法。23% 是我們本財年考慮的基數。

However, based on the latest outlook 25.1% landing for OP margin is expected, which means that we are now putting together the budget for next fiscal year. So we will take a close look at that, and we would like to make an official announcement in May.

然而，根據最新展望，預計營業利潤率將下降 25.1%，這意味著我們現在正在製定下一財年的預算。因此我們將仔細研究這個問題，並計劃在五月正式宣布這項消息。

Core OP margin is something that we always want to improve. This is always the policy of the management. So we will be finalizing the numbers in order to help improve that. This is about dividend, (inaudible) payment is different from the share buyback that we have announced recently.

我們始終希望提高核心 OP 利潤率。這始終是管理層的政策。因此，我們將最終確定數字，以幫助改善這種狀況。這是關於股息的，（聽不清楚）支付與我們最近宣布的股票回購不同。

We want to do something that is stable for long term and also progressive sustaining the level or increasing, if possible. It's very difficult to comment at this point in time. But I don't think you have to worry about reducing of the dividend at the very least.

我們希望做一些長期穩定的事情，如果可能的話，逐步維持或提高水平。目前很難發表評論。但我認為你至少不必擔心減少股息。

Thank you. Could you please respond to the question about ENTYVIO.

謝謝。您能回答有關 ENTYVIO 的問題嗎？

Sure, sure. Thank you very Muraoka-san, It's Christophe. Regarding ENTYVIO, there is more -- we do see more activity of development of biosimilar for sure. But as far as we see for serious market, we still believe that it's -- that biosimilar entry will be between 2030 and 2032. We have quite a strong set of patent expiry in 2032. So we'll see what happened when there is a litigation around this patent.

當然，當然。非常感謝村岡先生，我是克里斯托夫。關於 ENTYVIO，我們確實看到更多生物相似藥的開發活動。但就我們對嚴肅市場的觀察而言，我們仍然相信生物相似藥的進入將在 2030 年至 2032 年之間。我們有相當多的專利將於 2032 年到期。因此，我們將看看當圍繞這項專利發生訴訟時會發生什麼。

But just doing the development plus the litigation process takes a lot of time. So if you are optimistic about our strength of our patent, you take an assumption of 2032. If you are not optimistic, you take an assumption of 2030 plus between the two. I think that always has been how we describe the situation.

但僅僅進行開發加上訴訟過程就需要花費大量時間。因此，如果您對我們的專利實力感到樂觀，您可以假設是 2032 年。如果你不樂觀，你可以假設2030年以及兩者之間的差距。我想我們一直都是這樣描述情況的。

We believe that it's 2032 because we believe into our patent set, but might not. So for now, no change in our solution regarding biosimilar entry, especially in the US. In Europe, it's a slightly different legal system, depending on the country. But for US, it's -- our position is very clear. Thank you.

我們認為是 2032 年，因為我們相信我們的專利，但也可能不是。因此目前，我們關於生物相似藥進入的解決方案沒有改變，特別是在美國。在歐洲，不同國家的法律體系略有不同。但對美國來說，我們的立場非常明確。謝謝。

Thank you very much.

非常感謝。

(interpreted) JPMorgan, Wakao-san.

（譯）摩根大通，Wakao 先生。

(interpreted) Wakao from JPMorgan. Have two questions. First is about share buyback. So could you explain the background behind the decision to implement the share buyback this time? Is it simply because the share price was very low.

（譯）摩根大通的 Wakao。有兩個問題。首先是關於股票回購。那麼能否請您介紹一下此次實施股份回購的背景？難道只是因為股價太低嗎？

What is the message of this decision? And could you elaborate on the -- could you tell me the timing of Phase III data readout for TAK-861 and TAK-279, (inaudible).

這項決定傳達了什麼訊息？您能否詳細說明一下——您能告訴我 TAK-861 和 TAK-279 第三階段資料讀取的時間嗎？

Thank you, Wakao-san. So the first question on thinking behind the buyback, I'd like to ask Milano to comment on that. And then the second question, Andy, any further detail you can provide on timing of Phase III for TAK-861 and TAK-279?

謝謝你，若尾先生。因此，第一個問題關於回購背後的想法，我想請米蘭諾對此發表評論。然後第二個問題，安迪，您能提供有關 TAK-861 和 TAK-279 第三階段時間安排的更多細節嗎？

Thank you, Wakao-san. So we updated. If you remember, we updated the capital allocation policy two years ago. And we set the framework that within -- given that we keep the investment grade credit rating, basically, the two primary pillars for our capital allocation is investment for growth and then show the return. So with the current performance, this year, we are generating more cash flow than we originally had planned.

謝謝你，若尾先生。因此我們進行了更新。如果你還記得的話，我們兩年前更新了資本配置政策。我們設定的框架是－假設我們保持投資等級信用評級，基本上，我們資本配置的兩個主要支柱是投資成長，然後顯示回報。因此，以目前的表現來看，今年我們產生的現金流比我們最初計劃的要多。

And we have been allocating this cash. And then as you have seen, we have done a few (inaudible) deals very selectively. And then we are kind of adding in the pipeline, and we are now focusing on developing this in the late stage pipeline.

我們一直在分配這筆現金。然後正如你所看到的，我們非常有選擇地做了一些（聽不清楚）交易。然後我們正在添加管道，現在我們專注於在後期管道中開發它。

And then it comes to the shareholder return. And with this, the upside, we thought this is the good timing or appropriate to do these share buybacks, allocate almost half of the incremental cash flow in terms of the upgrade of the guidance. So the -- we think it's appropriate to do that according to the capital allocation policy.

然後談到股東回報。有了這個，好的一面是，我們認為這是進行這些股票回購的好時機或合適時機，以升級指引的方式分配幾乎一半的增量現金流。因此，我們認為根據資本配置政策，這樣做是適當的。

Wakao-san, this is Andy on timing of each of the studies. So as you know, from the R&D Day, we have three major Phase III readouts coming this year for rusfertide, oveporexton and zasocitinib. We haven't disclosed specific timing for those studies for oveporexton. For rusfertide, we're expecting top line data this quarter. So we're very excited about that.

Wakao-san，我是 Andy，負責每項研究的時間安排。如您所知，從研發日開始，我們今年將有三個主要的 III 期臨床試驗結果，分別為 rusfertide、oveporexton 和 zasocitinib。我們尚未透露針對 overporexton 的研究的具體時間。對於 rusfertide，我們預計本季將公佈營收數據。我們對此感到非常興奮。

For oveporexton, we have two ongoing Phase III studies in narcolepsy, and enrollment for each of those studies has exceeded our forecast. And while we haven't given exact dates, we're hoping to have data mid-2025.

對於 oveporexton，我們正在進行兩項針對發作性睡病的 III 期研究，每項研究的招募人數都超出了我們的預期。雖然我們沒有給出確切的日期，但我們希望獲得 2025 年中期的數據。

And then for zasocitinib, we have two primary registration-enabling studies. As I mentioned earlier, those have completed screening and enrollment as of November of last year. We have a third study that's a study to garner additional safety, that study continues to enroll.

對於扎索替尼，我們有兩個主要的註冊研究。正如我之前提到的，這些申請者已於去年 11 月完成篩選和入學。我們還有第三項研究，旨在獲得額外的安全性，研究仍在繼續招募。

So you can kind of do the math on what we would expect either from the first two pivotal studies. And then as Christophe alluded to earlier, we'll be starting a head-to-head study against to cravacitinib sometime midyear. That study won't be part of our original filing. Our hope is to have data from that study available to support the launch.

因此，您可以計算一下我們對前兩項關鍵研究的預期結果。然後，正如克里斯托夫之前提到的，我們將在年中某個時候開始對克拉伐替尼進行面對面的研究。該研究不會成為我們原始文件的一部分。我們希望該研究的數據能夠支持此次發布。

(interpreted) Okay, very good. Thank you.

（翻譯）好的，非常好。謝謝。

(interpreted) SMBC Nikko, Wada-san.

（翻譯）SMBC日興，和田先生。

(interpreted) Yes, this is Wada, SMBC Niiko. Can you hear me?

（譯）是的，我是 Wada，SMBC Niiko。你聽得到我嗎？

Yes.

是的。

(interpreted) Thank you. Just one question, IRA on price negotiation. 2028, I think ENTYVIO might be included. What is your read on the situation? Do you think ENTYVIO will be included?

（翻譯）謝謝。只有一個問題，IRA 關於價格談判。2028，我認為 ENTYVIO 可能會包括在內。您對此情況有何看法？您認為 ENTYVIO 會被包括在內嗎？

The possibility of ENTYVIO included in IRA in 2028. Christophe, if you'd like to comment on that?

ENTYVIO 有可能在 2028 年納入 IRA。克里斯托夫，你願意對此發表評論嗎？

Wada-san, it's a possibility. That's why actually we kept our peak range between [7.509]. Initially, we had this range because it was -- we are not sure that we will launch a PENN, you know that we had a CRL, et cetera, but we land a PENN. But then we kept that range to include the possibility of an IRA inclusion in the future. So it's a possibility. That we have in mind, yes. Thank you.

和田先生，有這種可能。這就是為什麼我們實際上將峰值範圍保持在[7.509]。最初，我們有這個範圍，因為——我們不確定是否會發射 PENN，你知道我們有一個 CRL 等等，但我們登陸了 PENN。但是我們保留了該範圍以包含未來納入 IRA 的可能性。所以這是有可能的。是的，我們確實這麼想。謝謝。

(interpreted) That's clear. That's all for me.

（解釋）這很清楚。對我來說這就是全部了。

(interpreted) Hashiguchi-san, Daiwa Securities.

（譯）大和證券的橋口先生。

Hashiguchi speaking. Thank you for taking my question. In the US, and the business environment changes and how that impacts your business, I would like to have your idea not limited to pharma industry, but in various industry teams some new policies, recently shown from various players.

我是橋口先生。感謝您回答我的問題。在美國，商業環境的變化以及這對您的業務的影響，我希望您的想法不僅限於製藥業，還包括各行業團隊最近從各個參與者展示的一些新政策。

And by that kind of change, how that could impact your business, including opportunities and risks. For example, PBM may be redesigned and that could impact your pricing? What's about that? Thank you.

這種變化將如何影響您的業務，包括機會和風險。例如，PBM 可能會被重新設計，這會影響您的定價嗎？那又怎麼樣？謝謝。

Thank you, Hashiguchi-san. So Christophe, would you like to answer that question on the potential impact of changes in the US environment.

謝謝你，橋口先生。那麼克里斯托夫，您願意回答有關美國環境變化的潛在影響的問題嗎？

Yeah, Hashiguchi-san, I mean, there will be some changes in the US environment. Healthcare is one of the topic that for any administration will focus on. The Trump administration just announced that they are committed to carry on with IRA. That's one point.

是的，橋口先生，我的意思是美國的環境會有些改變。醫療保健是任何政府都會關注的議題之一。川普政府剛剛宣布他們致力於繼續維持愛爾蘭共和軍。這是一點。

And therefore, this pricing system will carry on for now. It might be adjusted in the future, we will see that that's something to take into consideration. On the other hand, keep in mind that as part of the IRA, there was also for Medicare patients and out-of-pocket cap, which is a positive in -- for many diseases, but especially oncology. So there are plus and minus, if you like.

因此，這個定價制度暫時也將繼續實施。將來可能會進行調整，我們會看到這是需要考慮的事情。另一方面，請記住，作為 IRA 的一部分，也為醫療保險患者提供自付上限，這對許多疾病，尤其是腫瘤學來說，是有積極作用的。所以如果你願意的話，就有優點和缺點。

We believe that the US country will remain absolutely vital for innovative company and R&D-driven-company like Takeda. This is the country where new innovative medicine have the fastest launch. And this is where we have the highest level of innovation recognition and reward for innovation.

我們相信，對於像武田這樣的創新公司和研發驅動型公司來說，美國仍然至關重要。這是新創新藥物推出最快的國家。這也是我們對創新給予最高水準的認可和獎勵。

It's very important, especially as we are contemplating the launch of our new product. But yes, the environment is changing like in other countries. Another element that we are also watching are more geopolitics.

這非常重要，特別是當我們考慮推出新產品時。但確實，環境正在像其他國家一樣改變。我們關注的另一個因素是地緣政治。

Will there be tariff, for example, impacting pharmaceutical medicines. It could be. And obviously, at Takeda, we have a manufacturing network focused on US, Europe, Singapore, and Japan. So it has been -- it's a global network, which was built on the premise of free trade. If there are more forces against free trade, (technical difficulty) Thank you.

例如，關稅是否會影響藥品？有可能。顯然，武田擁有專注於美國、歐洲、新加坡和日本的製造網絡。所以它是一個建立在自由貿易前提下的全球網絡。如果有更多力量反對自由貿易，（技術困難）謝謝。

(spoken in foreign language)

（用外語說）

(interpreted) Sogi-san, Bernstein.

（翻譯）Sogi 先生，伯恩斯坦。

Can you hear me? This is Miki from Bernstein.

你聽得到我嗎？這是來自伯恩斯坦的 Miki。

Yes, we can hear you.

是的，我們能聽到你的聲音。

Great. Thank you very much. I have two questions. First of all, ENTYVIO, we recently saw a report saying that the ENTYVIO listing price was increased by 8%. So could you tell me that listing price increase, what is the impact to the actual net price that is more relevant to your actual net sales? And also does it have any consequence in terms of the rebate for government, because it's higher than the -- significantly higher than the inflation rate. So that's the first question.

偉大的。非常感謝。我有兩個問題。首先是ENTYVIO，我們最近看到一個報導，說ENTYVIO上市價格上調了8%。那你能告訴我，上市價格上漲對與實際淨銷售額更相關的實際淨價有什麼影響嗎？而且這對政府回扣是否有任何影響，因為它高於——明顯高於通貨膨脹率。這是第一個問題。

And the second question is the R&D spending, we understand that R&D spending, despite this the POS trial drug, the cost we moved to the other expense. It's still -- the spending is seemed to a slower than we had expected. But is it still the plan that you will be spending more on the fourth quarter so that you reach the budget that you have shared with us.

第二個問題是研發支出，我們了解研發支出，儘管這是 POS 試驗藥物，但我們將其成本轉移到其他費用。但仍然——支出似乎比我們預期的要慢。但您是否仍計劃在第四季度增加支出以達到與我們分享的預算？

Thank you, Miki. So the first question on ENTYVIO price increase, I'd like to ask Christophe to comment. And then the second question on the R&D budget and progress towards the full year forecast. Milano, if you could please comment on that.

謝謝你，Miki。因此，關於 ENTYVIO 價格上漲的第一個問題，我想請 Christophe 發表評論。第二個問題是關於研發預算和全年預測的進度。米蘭諾，請你對此發表評論。

Thank you, Miki. Yeah. This price increase is more a reflection of the rebate mechanism that is happening in the US market. In order to be competitive, you need to give rebate, and that's really the mechanic. So you don't see this increase on the net price.

謝謝你，Miki。是的。此次漲價更多是體現美國市場正在發生的返利機制。為了保持競爭力，你需要提供回扣，這才是真正的技巧。因此你不會看到淨價上漲。

And government price is calculated on the net price. So I think that's really the effect of the rebate mechanism. And by the way, this is something we think should be fixed. And there is a lot of discussion right now about PBM and rebate. We are voting for this rebate to be replaced (inaudible) mechanism. Thank you.

政府價格是按照淨價計算的。所以我認為這確實是回扣機制的效果。順便說一句，我們認為應該解決這個問題。目前有很多關於 PBM 和回扣的討論。我們投票支持用這種回扣（聽不清楚）機制來取代。謝謝。

Hi Sogi-san. So thank you. Thank you for the question about now on the spending. So the -- just to be clear, we are not seeing any slowness in operation. Actually, we're accelerating. We are gearing up the R&D operations development.

你好，Sogi 先生。所以謝謝你。感謝您提出有關目前支出的問題。所以——需要明確的是，我們沒有看到任何操作緩慢的情況。事實上，我們正​​在加速。我們正在加緊研發業務的發展。

We are driving these -- the development with a very like operational efficiency mindset since we have had efficiency program, since the beginning of this fiscal year. And in the quarter -- fourth quarter, we always have that little bit seasonality increase in R&D spending in the fourth quarter.

自從本財年開始我們就有效率計劃，因此我們一直以非常類似於營運效率的思維來推動這些發展。在第四季度，我們的研發支出總是會出現一點季節性成長。

But on top of that, we are expecting -- actually, we are starting two Phase III programs for the (inaudible) PSA and the mezagitamab for the ITP. So actually with these two new programs or clinical trials, we also anticipate gearing up the R&D spend.

但除此之外，我們預計——實際上，我們正​​在啟動兩個針對（聽不清楚）PSA 和 ITP 的 mezagitamab 的 III 期專案。因此實際上透過這兩個新項目或臨床試驗，我們也預期會增加研發支出。

Great. Thank you very much. Very clear. Thank you.

偉大的。非常感謝。非常清楚。謝謝。

(interpreted) UBS, Sakai-san.

（譯）瑞銀，坂井先生。

(spoken in foreign language) Thank you very much. Two questions. This is more like a general question for (inaudible) IRA has started impacting the industry and likely it remained for some time, and the industry screaming about the squeezing the low molecule development.

（外語）非常感謝。兩個問題。這更像是一個普遍的問題，因為（聽不清楚）IRA 已經開始對產業產生影響，而且這種影響可能會持續一段時間，而產業大聲疾呼擠壓低分子開發。

Do you think that, that is going to impact your pipeline strategy going forward, especially I'm interested in the (inaudible) life cycle management, extra indication strategy. Can you comment anything interesting on this topic? That's my first question.

您認為這會影響您未來的管道策略嗎？您能對這個主題發表一些有趣的評論嗎？這是我的第一個問題。

The second question is Weber-san, thanks for your service, I must say. But Julie Kim, is she going to be stationed in Tokyo, is that going to be must condition for her to be appointed as CEO, my second question?

第二個問題是韋伯先生，我必須說，感謝您的服務。但是 Julie Kim，她會駐紮在東京嗎？

Thank you, Sakai-san. So the first question to Andy on IRA impact on pipeline strategy, specifically on zasocitinib. And then second question to Christophe, on Julie where should be located?

謝謝你，堺先生。因此，第一個問題是關於 IRA 對管道策略的影響，特別是對 zasocitinib 的影響，問 Andy。然後第二個問題是問克里斯托夫，朱莉該位於哪裡？

Thank you very much, Sakai-san. It's a great question to end the call on. So I mean, I can't say that IRA won't affect the R&D strategies across the industry. Of course, it has an effect on R&D strategies. I would say that the strategy that we've adopted for our organization Takeda withstands the IRA in the sense that we've always focused on innovation and high unmet medical need in everything that we do.

非常感謝，坂井先生。這是一個結束通話的好問題。所以我的意思是，我不能說 IRA 不會影響整個產業的研發策略。當然，它對研發策略有影響。我想說的是，我們為武田公司採取的策略能夠抵禦 IRA，因為我們在所做的每一件事中始終專注於創新和大量未滿足的醫療需求。

I think that in order to be competitive in the world of IRA, those are two features that every company will need to focus on innovation and high unmet medical need. With respect to zasocitinib, I would say that yes, IRA has effects how we strategically approach zasocitinib.

我認為，為了在 IRA 領域具有競爭力，每家公司都需要專注於創新和高度未滿足的醫療需求這兩個特徵。關於扎索替尼，我想說，是的，IRA 會影響我們如何策略性地對待扎索替尼。

This is a molecule with the potential for many indications. Historically, companies might have approached a program like this strategically in a more sequential way. We're approaching it in a parallel way. As you know, we have four ongoing indications today, psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease. And we're in the process of looking at additional indications. And over the course of the coming months, you'll hear more of our strategy to expand for zasocitinib.

這是一種具有多種用途潛力的分子。從歷史上看，公司可能會以更具連續性的方式從策略上實施此類計劃。我們正在以平行的方式處理這個問題。如您所知，我們目前有四種正在進行的適應症，即牛皮癬、銀屑病關節炎、潰瘍性結腸炎和克隆氏症。我們正在研究其他跡象。在接下來的幾個月裡，您將會聽到更多關於我們擴大札索替尼的策略。

Sakai-san, thanks for your questions. First, I would like to say that I started a few years to be based in Tokyo, the majority of the time, and in Boston. So I am between these two locations because our global hub in Boston is so important. So I want to stress that out. So my location today is Tokyo and Boston, and Julie is very much committed to also have this Tokyo, Boston location. That's part of the agreement if you like. Yeah. Thank you.

坂井先生，感謝您的提問。首先，我想說的是，過去幾年我大部分時間都在東京和波士頓工作。所以我在這兩個地點之間徘徊，因為我們在波士頓的全球樞紐非常重要。所以我想強調這一點。所以我今天所在的位置是東京和波士頓，而朱莉也非常致力於在東京和波士頓設立這個辦公室。如果你願意的話，這就是協議的一部分。是的。謝謝。

Thank you. Thank you very much.

謝謝。非常感謝。

(interpreted) Thank you very much for your participation in this pretty schedule, and we look forward to your continued support. Thank you.

（翻譯）非常感謝您參與這個美好的日程，我們期待您繼續支持。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.

本記錄中標記（翻譯）的部分是由現場通話中的翻譯人員說的。翻譯由贊助此活動的公司提供。