Takeda Pharmaceutical Co Ltd (TAK) 2024 Q4 法說會逐字稿

Thank you very much for your participation in the conference call for the financial results for fiscal year 2023 of Takeda Pharmaceutical Company Limited. My name is O'Reilly, Head of Investor Relations.

非常感謝您參加武田藥品工業株式會社 2023 財年財務績效電話會議。我叫奧萊利，投資人關係主管。

First, I would like to explain about language settings. There are language section bottom -- at the bottom of the Zoom window. If you wish to listen in Japanese, please select Japanese. If you wish to listen in English, please select English, or if you wish to listen to the original audio, please select off.

首先，我想解釋一下語言設定。底部有語言部分——在縮放視窗的底部。如果您想聽日語，請選擇日語。如果您想聽英語，請選擇英語，如果您想聽原聲，請選擇關閉。

Before starting, I would like to remind everyone that we'll 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. The factors that could cause our actual results to differ materially are discussed in our most recent Form 20-F and in our other SEC filings.

在開始之前，我想提醒大家，我們將討論 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。我們最新的 20-F 表格和其他 SEC 文件中討論了可能導致我們的實際結果出現重大差異的因素。

Please also refer to the important notice on Page 2 of the presentation regarding the forward-looking statements and our non-IFRS financial measures, which will also be discussed during this call.

另請參閱簡報第 2 頁上有關前瞻性陳述和我們的非國際財務報告準則財務措施的重要通知，這些資訊也將在本次電話會議中進行討論。

Definitions of our non-IFRS measures and reconciliations with comparable IFRS financial measures are included in the appendix to the presentation.

我們的非國際財務報告準則衡量標準的定義以及與可比較國際財務報告準則財務衡量標準的調整表包含在簡報的附錄中。

I would like to move on to the presentation. Christophe Weber, President and CEO; Andy Plump, President of R&D; and Milano Furuta, Chief Financial Officer, will make a presentation. After that, we will have a question-and-answer session.

我想繼續演講。克里斯托夫‧韋伯 (Christophe Weber)，總裁兼執行長； Andy Plump，研發總裁；財務長 Milano Furuta 將發表演講。之後，我們將進行問答環節。

Now we'd like to begin.

現在我們要開始了。

Thank you, Chris. Thank you all for joining our fiscal year 2023 earning call. It's really a pleasure to be with you all today.

謝謝你，克里斯。感謝大家參加我們的 2023 財年財報電話會議。今天很高興和大家在一起。

In fiscal year 2023, we continued to demonstrate our ability to discover and deliver life-transforming treatments. This vision, along with our values is central to our strategy and daily execution.

2023 財年，我們繼續展示我們發現和提供改變生活的治療方法的能力。這個願景以及我們的價值觀是我們策略和日常執行的核心。

I will now review our full year performance and our priorities ahead. First, fiscal year 2023. To summarize fiscal year '23, it was a well managed but tough year. Despite significant generic headwinds, our top line performance exceeded management guidance, with core revenue growth of plus 1.5% at constant exchange rate. This growth was driven primarily by the performance of our Growth & Launch Products, which increased 12.8% year-over-year and now represent 43% of our total revenues.

我現在將回顧我們的全年業績和未來的優先事項。首先是 2023 財年。儘管存在重大的一般阻力，但我們的營收業績超出了管理層的指導，按固定匯率計算，核心收入增長了 1.5%。這一成長主要是由我們的成長和推出產品的表現所推動的，該產品年增 12.8%，目前占我們總收入的 43%。

Our core operating profit declined 13.3%, which was in line with management guidance and reflect the loss of exclusivity for high-margin products, including VYVANSE and our continued investment in R&D and data, digital and technology.

我們的核心營業利潤下降了 13.3%，這與管理層指導一致，反映了高利潤產品（包括 VYVANSE）的獨家經營權的喪失以及我們對研發和數據、數位和技術的持續投資。

Core EPS declined 15.7%, which was above our projected low 20s percentage decline.

核心每股收益下降 15.7%，高於我們預期的 20 多歲的下降百分比。

We made significant progress in our pipeline in fiscal year '23 with 3 new therapies approval in the U.S., FRUZAQLA for metastatic colorectal cancer, ADZYNMA for congenital thrombocytopenic purpura and EOHILIA for eosinophilic esophagitis.

我們的產品線在23 財年取得了重大進展，有3 種新療法在美國獲得批准：用於治療轉移性結直腸癌的FRUZAQLA、用於治療先天性血小板減少性紫斑症的ADZYNMA 和用於治療嗜酸性粒細胞性食道炎的EOHILIA。

We also expanded our existing portfolio with several important life cycle management approvals. Takeda received U.S. FDA approval for ENTYVIO PEN in ulcerative colitis in September and in Crohn's last month.

我們也透過多項重要的生命週期管理批准擴大了現有的產品組合。武田的 ENTYVIO PEN 於 9 月和上個月獲得美國 FDA 批准用於治療潰瘍性結腸炎和克隆氏症。

We also received approval in the U.S. for our PDT therapies, HYQVIA and GAMMAGARD LIQUID in chronic inflammatory demyelinating polyneuropathy, or CIDP.

我們的 PDT 療法 HYQVIA 和 GAMMAGARD LIQUID 治療慢性發炎性脫髓鞘多發性神經病變 (CIDP) 也在美國獲得批准。

And our dengue vaccine, QDENGA, is now approved in more than 20 countries, including where the disease is endemic.

我們的登革熱疫苗 QDENGA 現已在 20 多個國家獲得批准，其中包括該疾病流行的國家。

In addition, we progressed 2 important potential clinical therapies, TAK-279 and TAK-861 into advanced stage of development. TAK-279, now also known as zasocitinib, has moved into Phase III for psoriasis and Phase II for ulcerative colitis and Crohn's disease. We expect to initiate a Phase III trial in psoriatic arthritis soon.

此外，我們將兩種重要的潛在臨床療法TAK-279和TAK-861推進到後期開發階段。 TAK-279（現在也稱為 zasocitinib）已進入治療乾癬的 III 期以及治療潰瘍性結腸炎和克隆氏症的 II 期。我們預計很快將啟動銀屑病關節炎的 III 期試驗。

TAK-861 is a lead molecule in our orexin franchise, met primary and secondary endpoint in a Phase IIb trial in narcolepsy type 1, and we plan to present the trial data at a Sleep Conference in June this year. We are in discussion with the FDA to advance to Phase III in the first half of fiscal year '24.

TAK-861 是我們食慾素系列產品的主要分子，在 1 型發作性睡病的 IIb 期試驗中達到了主要和次要終點，我們計劃在今年 6 月的睡眠會議上展示試驗數據。我們正在與 FDA 討論在 24 財年上半年推進到 III 期。

Including zasocitinib and TAK-861, we expect to have up to 6 programs with high revenue potential in Phase III development in fiscal year '24.

包括zasocitinib和TAK-861，我們預計在24財年的III期開發中將有多達6個具有高收入潛力的項目。

But among -- amid this strong progress, we had some setback too. We made the tough decision based on the fruitful analysis of the data, and we discontinued development of 3 Phase II pipeline program in oncology, modakafusp alfa, subasumstat and TAK-007. We also initiated the voluntary withdrawal of EXKIVITY globally and took the decision not to pursue regulatory filing for ALOFISEL in the U.S.

但在這一強勁進展之中，我們也遇到了一些挫折。基於對數據的富有成效的分析，我們做出了艱難的決定，我們停止了腫瘤學、modakafusp alfa、subasumstat 和 TAK-007 三個 II 期管道項目的開發。我們也發起了在全球範圍內自願撤回 EXKIVITY 的行動，並決定不在美國對 ALOFISEL 進行監管備案。

These decisions are not easy, but they are part of the journey of innovative drug discovery. They are also a reminder of the importance of financial resilience, agile data-driven decision-making and rigorous prioritization.

這些決定並不容易，但它們是創新藥物發現之旅的一部分。它們也提醒我們財務彈性、敏捷的數據驅動決策和嚴格的優先順序的重要性。

Turning to the next slide. I will discuss how we return to sustainable revenue and profit growth beginning in fiscal year 2025 and the path to delivering on our margin expansion target.

轉到下一張投影片。我將討論我們如何從 2025 財年開始恢復可持續的營收和利潤成長，以及實現利潤率擴張目標的路徑。

We expect fiscal year '24 to be the final year of significant headwinds from VYVANSE loss of exclusivity in the U.S. This is reflected in our management guidance for the year, where we expect revenue to be flat to slightly declining, core operating profit to decline approximately 10% and core EPS will decline in the mid-10s percent at constant exchange rate.

我們預計 24 財年將是 VYVANSE 失去美國獨家經營權而面臨重大阻力的最後一年。匯率計算，核心每股盈餘將下降10%，核心每股盈餘將下降10% 左右。

Milano will speak in more detail about our full year outlook in his presentation.

米蘭將在他的演講中更詳細地談論我們的全年展望。

After VYVANSE, we expect no significant generic exposure until the early 2030s. In fact, the total generic exposure we expect over the coming 7 years is less than the impact from VYVANSE decline in the 2 years of fiscal year '23 and '24. That is important because we also project that our Growth & Launch Products will continue to deliver double-digit percent growth at constant exchange rate in fiscal year '24. So we are very confident that we can return to sustainable revenue growth from fiscal year 2025.

在 VYVANSE 之後，我們預計到 2030 年代初期不會出現重大仿製藥曝光。事實上，我們預計未來 7 年的仿製藥總風險敞口小於 VYVANSE 在 23 財年和 24 財年這兩年下降的影響。這很重要，因為我們也預計我們的成長和推出產品將在 24 財年繼續以固定匯率計算實現兩位數的成長。因此，我們非常有信心從 2025 財年開始恢復收入的可持續成長。

This will support stabilization and a slight improvement in our gross margin, which has been impacted by generic erosion of high-margin therapies. This is a welcome progress following 2 very tough years of generic headwinds in fiscal year '23 and '24.

這將支持我們的毛利率穩定並略有改善，毛利率受到高利潤療法仿製藥侵蝕的影響。繼 23 財年和 24 財年經歷了兩年非常艱難的總體逆風之後，這是一個可喜的進展。

However, we have to do more to ensure that Takeda is future-ready and can deliver long-term growth. As I mentioned, in fiscal year 2024, we expect to have up to 6 programs in Phase III development with significant revenue potential. And while we will increase our R&D budget moderately this year, rigorous prioritization will allow us to both contain our R&D budget increase while developing these late-stage programs.

然而，我們必須採取更多措施，確保武田為未來做好準備並能夠實現長期成長。正如我所提到的，在 2024 財年，我們預計將有多達 6 個處於第三階段開發的項目，具有巨大的收入潛力。雖然我們今年將適度增加研發預算，但嚴格的優先順序將使我們能夠在開發這些後期項目的同時控制研發預算的增加。

Furthermore, we are implementing a significant multiyear efficiency program to support our target of delivering 100 to 250 basis points margin improvement each year beginning fiscal year 2025 to build towards our low to mid-30s percent core operating profit margin target.

此外，我們正在實施一項重要的多年效率計劃，以支持我們從 2025 財年開始每年實現 100 至 250 個基點利潤率改善的目標，從而實現我們 30% 中低的核心營業利潤率目標。

I will provide more detail on the program on the following slide. But first, I will say that we are confident in our ability to execute because we have been preparing our data and technology foundation over the past 5 years.

我將在下面的幻燈片中提供有關該計劃的更多詳細資訊。但首先，我要說的是，我們對自己的執行能力充滿信心，因為過去 5 年我們一直在準備我們的數據和技術基礎。

So our long-term outlook is bright, and our cash flow generation is strong. In line with our capital allocation policy, we are committed to grow an attractive shareholder return. In fiscal year 2024, we are proposing an increase to our annual dividend to JPY 196 per share, consistent with our progressive dividend policy of increasing or maintaining the dividend each year.

因此，我們的長期前景是光明的，我們的現金流產生也很強勁。根據我們的資本配置政策，我們致力於增加有吸引力的股東回報。在 2024 財年，我們建議將年度股利增加至每股 196 日圓，這與我們每年增加或維持股利的漸進式股利政策一致。

Moving to the next slide. As I prevised on the prior slide, Takeda has initiated a price-wide program to drive efficiencies and deliver 100 to 250 basis points core operating profit margin improvement each year beginning fiscal year 2025. This program focuses on 3 key areas: first, organizational agility; two, procurement savings; three, leveraging data, digital and technology.

轉到下一張投影片。正如我在上一張幻燈片中所預見的那樣，武田啟動了一項全價格計劃，以提高效率，並從2025 財年開始每年將核心營業利潤率提高100 至250 個基點。 3 個關鍵領域：首先，組織敏捷性;二、採購節約；三是利用數據、數字和技術。

First, we are simplifying our business by removing layers, broadening roles and refining operating models to improve our agility across the enterprise. Second, we are initiating procurement-led savings to optimize our external spend and materially reduce our cost. And third, we are continuing our investment in data, digital and technology to be better, faster and increase productivity. I will provide more information on our progress in data, digital and technology on the next slide.

首先，我們透過消除層級、擴大角色和完善營運模式來簡化業務，以提高整個企業的敏捷性。其次，我們正在啟動以採購為主導的節約，以優化我們的外部支出並大幅降低成本。第三，我們將繼續對數據、數位和技術進行投資，以更好、更快地提高生產力。我將在下一張投影片上提供有關我們在數據、數位和技術方面取得的進展的更多資訊。

In fiscal year '24, we are estimating restructuring expenses of JPY 140 billion, primarily for the implementation of the efficiency program. This is a significant investment, and it underscores the significance of this program for Takeda and the impact it will have on the company.

在 24 財年，我們預計重組費用為 1,400 億日元，主要用於實施效率計劃。這是一項重大投資，凸顯了該計劃對武田的重要性及其對公司的影響。

We believe that efficiencies gained from the program will enable us to allocate resources towards our [latest] pipeline and new product launches and offset inflation headwinds.

我們相信，從該計劃中獲得的效率將使我們能夠將資源分配給我們的[最新]管道和新產品發布，並抵消通貨膨脹的不利因素。

So we will continue to integrate data, digital and technology throughout our operation and value chain to help us develop and deliver medicines to patients more efficiently. We are talking -- we are taking very bold steps to execute this once-in-a-lifetime opportunity. For example, we have now migrated 100% of our applications and 96% of all our data to the cloud, allowing us to leverage this data fully.

因此，我們將繼續在整個營運和價值鏈中整合數據、數位和技術，幫助我們更有效地開發藥物並向患者提供藥物。我們正在談論——我們正在採取非常大膽的步驟來抓住這個千載難逢的機會。例如，我們現在已經將100%的應用程式和96%的資料遷移到雲端，使我們能夠充分利用這些資料。

We are creating innovation capability centers, which are, in fact, Takeda tech centers, which will develop data and technology solutions. We have 3 centers in Bratislava, Mexico and Bangalore in India, each with eventually hundreds of computer engineers.

我們正在創建創新能力中心，實際上就是武田技術中心，它將開發數據和技術解決方案。我們在墨西哥布拉迪斯拉發和印度班加羅爾設有 3 個中心，每個中心最終都有數百名電腦工程師。

We are leveraging artificial intelligence, real-world evidence and digital tools to speed clinical trial recruitment and regulatory filing. For example, the U.S. FDA approval of GAMMAGARD LIQUID for the treatment of CIDP in January 2024 was based, in part, on the real-world evidence study using database licensed by Takeda. This approach taken in place of a randomized control trial amounted to considerable cost savings and several years of production and development time line.

我們正在利用人工智慧、現實世界證據和數位工具來加速臨床試驗招募和監管備案。例如，美國 FDA 於 2024 年 1 月批准 GAMMAGARD LIQUID 用於治療 CIDP，部分基於使用武田授權的資料庫進行的真實世界證據研究。這種方法取代了隨機對照試驗，節省了大量成本，並節省了數年的生產和開發時間。

In manufacturing and quality control, we are using sensors and digital cameras generating big data, which is then analyzed by artificial intelligence to improve our efficiency, for example, in predictive maintenance, root cause analysis, deviation analysis. And I could carry on with many other examples across our value chain.

在製造和品質控制中，我們使用感測器和數位相機產生大數據，然後透過人工智慧進行分析，以提高我們的效率，例如在預測性維護、根本原因分析、偏差分析中。我還可以舉出我們價值鏈中的許多其他例子。

Moving to Slide 8 on our Growth & Launch Products. We expect revenue from this portfolio to grow at double digits at constant exchange rate and account for approximately half of total company revenue in fiscal year 2024.

前往關於我們的成長和發布產品的幻燈片 8。我們預計，以固定匯率計算，該投資組合的收入將以兩位數成長，並約佔 2024 財年公司總收入的一半。

Some updates to highlight since we presented this slide in February are the addition of EOHILIA and the removal of EXKIVITY and ALOFISEL.

自從我們二月展示這張投影片以來，需要強調的一些更新是添加了 EOHILIA 以及刪除了 EXKIVITY 和 ALOFISEL。

While we do not currently have a Growth & Launch Product in neuroscience, we have an exciting pipeline, most notably with TAK-861 and soticlestat in late-stage development.

雖然我們目前在神經科學領域沒有成長和推出產品，但我們有一個令人興奮的管道，最引人注目的是後期開發的 TAK-861 和 soticlestat。

From fiscal year '24, we will present vaccines as a stand-alone business area, reflecting the strong demand for our dengue vaccines, QDENGA and present PDT holistically instead of separating out PDT immunology.

從 24 財年開始，我們將把疫苗作為一個獨立的業務領域來展示，反映對我們的登革熱疫苗、QDENGA 的強勁需求，並整體展示 PDT，而不是分離 PDT 免疫學。

Turning to the next slide. I will provide an update on ENTYVIO, our #1 product by revenue. ENTYVIO continues to outperform the IBD market with strong double-digit volume growth, partially offset by price erosion, resulting in revenue growth of plus 6.6% in fiscal year '23.

轉到下一張投影片。我將提供有關我們收入排名第一的產品 ENTYVIO 的最新資訊。 ENTYVIO 的表現持續優於 IBD 市場，銷售成長強勁，兩位數成長，部分被價格侵蝕所抵消，導致 23 財年營收成長 6.6% 以上。

Importantly, ENTYVIO has been able to maintain the #1 market position in the U.S. for IBD bio-naïve new starts, with competitor launch primarily competing in later lines of treatment or impacting alternative mechanism of actions.

重要的是，ENTYVIO 能夠在美國 IBD 生物新產品方面保持第一的市場地位，而競爭對手的推出主要是在後期治療領域進行競爭或影響替代作用機制。

ENTYVIO subcutaneous or ENTYVIO PEN formulation have now launched in more than 50 markets globally, including the recent launch in the U.S. and are driving incremental growth. A key point I want to highlight is that 30% of ENTYVIO PEN prescribers in the U.S. are either new to ENTYVIO or had not prescribed ENTYVIO for more than one year before prescribing the PEN. This is a strong signal that this formulation is encouraging prescribers back to ENTYVIO and attracting new prescribers. And this is very significant because subcutaneous therapies are estimated to represent approximately 35% to 40% of the total U.S. IBD market.

ENTYVIO 皮下注射劑或 ENTYVIO PEN 製劑現已在全球 50 多個市場推出，包括最近在美國推出的產品，並正在推動增量成長。我想強調的一個關鍵點是，美國 30% 的 ENTYVIO PEN 處方者要么是新使用 ENTYVIO，要么在開 PEN 處方之前一年多沒有開過 ENTYVIO。這是一個強烈的信號，表明該配方正在鼓勵處方者回到 ENTYVIO 並吸引新的處方者。這非常重要，因為皮下療法估計約占美國 IBD 市場總量的 35% 至 40%。

Our recent U.S. FDA approval in Crohn's provides further opportunity to reach this patient population with greater flexibility on shots.

我們最近獲得美國 FDA 對克隆氏症的批准，為我們以更大的注射彈性接觸到這群患者提供了進一步的機會。

Turning now briefly to Slide 11. Our PDT business continues to achieve double-digit growth driven by strong global demand for immunoglobulin products and expansion of subcutaneous therapies. We'll focus on maintaining this growth trend through targeted incremental investment in capacity expansion across our collection and manufacturing network as well as in PDT R&D and PDT transformation.

現在簡單轉向幻燈片 11。我們將重點放在透過有針對性的增量投資來維持這一成長趨勢，包括我們的收集和製造網路的產能擴張以及 PDT 研發和 PDT 轉型。

The PDT business has been steadily improving its core operating profit margin since the first half of fiscal year '23, which will continue to drive expansion of Takeda's overall core operating profit margin as PDT account for a growing share of total company revenues.

自23財年上半年以來，PDT業務的核心營業利潤率一直在穩步提高，這將繼續推動武田整體核心營業利潤率的擴大，因為PDT在公司總收入中所佔的份額越來越大。

In closing, we are confident about the path we are on. We continue to deliver on our financial commitment to progress our pipeline and to create long-term value for our stakeholders.

最後，我們對我們所走的道路充滿信心。我們繼續履行我們的財務承諾，以推進我們的管道並為我們的利害關係人創造長期價值。

With that, I will now turn the call over to Andy to update you on our pipeline. Thank you.

現在，我將把電話轉給安迪，向您通報我們管道的最新情況。謝謝。

Thank you very much, Christophe, and hello to everyone on today's call.

非常感謝你，克里斯托夫，並向參加今天電話會議的所有人問好。

If we can go to the next slide, please. As Christophe mentioned, we've had a very successful year with significant maturation of our pipeline while delivering 3 new molecular entity approvals in the U.S., FRUZAQLA, ADZYNMA and EOHILIA, in addition to important indication expansions of key products.

請轉到下一張投影片。正如Christophe 所提到的，我們度過了非常成功的一年，我們的產品線顯著成熟，同時在美國獲得了3 個新的分子實體批准：FRUZAQLA、ADZYNMA 和EOHILIA，此外還擴展了關鍵產品的重要適應症。

The ENTYVIO PEN, a convenient at-home administration option for patients, was approved in the U.S. for maintenance therapy in both ulcerative colitis and Crohn's disease, as Christophe mentioned.

正如 Christophe 所提到的，ENTYVIO PEN 是一種方便患者在家給藥的選擇，在美國被批准用於潰瘍性結腸炎和克隆氏症的維持治療。

QDENGA, our dengue vaccine, continues a steady cascade of approvals across the globe.

我們的登革熱疫苗 QDENGA 在全球持續獲得穩定的批准。

HYQVIA, our facilitated subcutaneous immunoglobulin treatment, received a key approval as maintenance therapy for CIDP in both the U.S. and Europe. HYQVIA offers the potential for once-monthly infusion, which can positively impact patient lives and elevate the standard of care.

我們的促進皮下免疫球蛋白治療 HYQVIA 在美國和歐洲獲得了作為 CIDP 維持治療的重要批准。 HYQVIA 提供每月一次輸注的可能性，這可以對患者的生活產生積極影響並提高護理標準。

In addition, as you heard from Christophe, a series of positive Phase IIb readouts and partnering activity continued to enhance the strong momentum across our new molecular entity pipeline fueling our growing late-stage portfolio.

此外，正如您從 Christophe 那裡聽到的，一系列積極的 IIb 期數據和合作活動繼續增強我們新分子實體管道的強勁勢頭，推動我們不斷增長的後期投資組合。

A few examples. Our potential best-in-class TYK2 inhibitor, zasocitinib's Phase III LATITUDE psoriasis trials are enrolling beyond our forecasts. They're doing this by leveraging novel digital approaches.

舉幾個例子。我們潛在的同類最佳 TYK2 抑制劑 zasocitinib 的 III 期 LATITUDE 乾癬試驗的入組人數超出了我們的預測。他們透過利用新穎的數位方法來做到這一點。

Zasocitinib's positive Phase IIb data in psoriatic arthritis was presented at the American College of Rheumatology and the Phase III LATITUDE psoriatic arthritis studies are expected to begin in the second half of this fiscal year.

Zasocitinib 在乾癬性關節炎的 IIb 期陽性數據已在美國風濕病學會公佈，III 期 LATITUDE 乾癬性關節炎研究預計將於本財年下半年開始。

Our lead oral orexin agonist, TAK-861, read out positive Phase IIb data in narcolepsy type 1 and just received FDA Breakthrough Therapy designation. These very exciting data will be presented at the Sleep conference in June, and we will hold an analyst call after the presentation to review the data for those who cannot attend live. TAK-861 will begin Phase III development in the first half of this fiscal year.

我們主要的口服食慾素激動劑 TAK-861 在 1 型發作性睡病方面取得了 IIb 期陽性數據，並剛獲得 FDA 突破性療法認定。這些非常令人興奮的數據將在六月的睡眠會議上公佈，我們將在演示結束後召開分析師電話會議，為無法現場參加的人回顧這些數據。 TAK-861將於本財年上半年開始III期開發。

In March, we announced positive Phase IIb data for mezagitamab in immune thrombocytopenia, or ITP. The Phase III start is planned for the second half of this fiscal year. And today, we are happy to announce that mezagitamab has also demonstrated positive proof of concept in immunoglobulin A nephropathy, commonly known as IGAN. We will review these exciting data later in this presentation.

今年 3 月，我們宣布了 mezagitamab 治療免疫性血小板減少症 (ITP) 的 IIb 期陽性數據。第三階段計劃於本財年下半年啟動。今天，我們很高興地宣布，mezagitamab 在免疫球蛋白 A 腎病（通常稱為 IGAN）方面也得到了積極的概念證明。我們將在本演示的後面部分回顧這些令人興奮的數據。

Rusfertide is a first-in-class synthetic hepcidin mimetic being developed in collaboration with Protagonist Therapeutics for the treatment of polycythemia vera, a chronic blood disorder characterized by excessive production of red blood cells, leading to an increased risk for thrombotic events. In February, compelling Phase II data were published in The New England Journal of Medicine. The ongoing VERIFY Phase III trial has almost completed enrollment, with a potential filing in fiscal year 2025.

Rusfertide 是一種一流的合成鐵調素模擬物，正在與 Protagonist Therapeutics 合作開發，用於治療真性紅血球增多症，這是一種慢性血液疾病，其特徵是紅血球生成過多，導致血栓事件風險增加。二月份，令人信服的 II 期數據發表在《新英格蘭醫學雜誌》。正在進行的 VERIFY III 期試驗已接近完成註冊，可能會在 2025 財年提交申請。

And finally, our partner, Neurocrine, recently announced positive Phase IIb data for TAK-653 in patients with an inadequate response to major depressive disorder. We are looking forward to discussions with regulatory authorities and outlining the next steps.

最後，我們的合作夥伴 Neurocrine 最近宣布了 TAK-653 在對重度憂鬱症反應不足的患者中的 IIb 期陽性數據。我們期待與監管機構進行討論並概述後續步驟。

Now building on the success of these pipeline achievements, let's now turn our attention to how these developments are shaping the future of patient care and driving value for our stakeholders. Next slide, please.

現在，在這些管道成就的成功基礎上，讓我們將注意力轉向這些發展如何塑造患者護理的未來並為我們的利害關係人帶來價值。請下一張投影片。

In addition to the approvals of ADZYNMA and FRUZAQLA, that continue to progress through important life cycle management activities, our late-stage pipeline now has 6 programs that are in or about to begin Phase III development. These 6 programs could significantly impact patient care and drive value for Takeda.

除了 ADZYNMA 和 FRUZAQLA 的批准（透過重要的生命週期管理活動繼續取得進展）外，我們的後期管道現在有 6 個專案正在進行或即將開始第三階段開發。這 6 個項目可能會顯著影響患者護理並提升武田的價值。

We will have an R&D event later this year where we will discuss and contextualize the promising clinical data for zasocitinib, fazirsiran, mezagitamab, rusfertide, soticlestat and TAK-861. During this meeting, we will also outline the significant value these medicines can bring to millions of patients.

我們將在今年稍後舉辦研發活動，屆時我們將討論 zasocitinib、fazirsiran、mezagitamab、rusfertide、soticlestat 和 TAK-861 的有前途的臨床數據並對其進行背景介紹。在本次會議期間，我們還將概述這些藥物能為數百萬名患者帶來的重大價值。

Now while our rare genetic and hematology therapeutic area unit was discontinued last year, following our decision to leave AAV gene therapy, we continue to maintain an operationally efficient rare disease development team within our R&D gastrointestinal inflammation therapeutic area in order to support our Rare Diseases business in a streamlined manner.

現在，雖然我們的罕見遺傳和血液學治療領域部門去年停產，但在我們決定退出AAV 基因治療後，我們繼續在研發胃腸道發炎治療領域內維持一支高效運作的罕見疾病開發團隊，以支持我們的罕見疾病業務以精簡的方式。

This focused team is realizing the full potential of ADZYNMA by continuing development in immune-mediated thrombotic thrombocytopenic purpura or ITTP. ADZYNMA will have proof-of-concept data later this fiscal year in ITPP, which would greatly expand the number of patients who could benefit from this therapy.

這個專注的團隊正在透過免疫介導的血栓性血小板減少性紫斑症或 ITTP 的持續開發來實現 ADZYNMA 的全部潛力。 ADZYNMA 將在本財年稍後在 ITPP 中獲得概念驗證數據，這將大大增加可以從該療法中受益的患者數量。

This small dedicated team also coordinates Takeda's responsibility for rusfertide, where the majority of development today is managed by our partner, Protagonist.

這個小型專業團隊也協調武田對 rusfertide 的責任，目前該專案的大部分開發工作均由我們的合作夥伴 Protagonist 管理。

With this exciting late-stage momentum in mind, let's explore how we have significantly restructured and prioritized our pipeline over the last year through data-driven and strategic decisions to sharpen our focus on the most promising programs. Next slide, please. To fund our maturing and exciting Phase III pipeline, 25 data-driven and strategic decisions were made across the portfolio this past year to refocus efforts on the expanding late-stage portfolio.

考慮到這一令人興奮的後期勢頭，讓我們探討一下去年我們如何透過數據驅動和策略決策對我們的管道進行重大重組和優先排序，以加強我們對最有前途的項目的關注。請下一張投影片。為了為我們成熟且令人興奮的第三階段管道提供資金，去年我們在整個投資組合中做出了 25 項數據驅動的策略決策，以重新將工作重點放在不斷擴大的後期投資組合上。

We had 2 key negative Phase III data sets in the year, as Christophe has mentioned, ALOFISEL in the U.S. and the confirmatory frontline data for EXKIVITY. As I have highlighted though, our overall pipeline momentum was positive, especially for our highest-value programs. We can click for the bill, please.

正如 Christophe 所提到的，今年我們有 2 個關鍵的負面 III 期資料集，即美國的 ALOFISEL 和 EXKIVITY 的驗證性第一線資料。正如我所強調的，我們的整體管道勢頭是積極的，特別是對於我們最高價值的項目。請點選查看帳單。

I would like to now take a moment to review our efforts in Oncology. While, of course, we're disappointed by recent setbacks, let me assure you that Takeda is fully committed to oncology as a key component of our strategy and long-term growth and remains a core therapeutic area of our business.

我現在想花點時間回顧我們在腫瘤學方面的努力。當然，我們對最近的挫折感到失望，但我向您保證，武田完全致力於腫瘤學，將其作為我們策略和長期成長的關鍵組成部分，並且仍然是我們業務的核心治療領域。

We have a long history of institutional knowledge, development expertise and strong relationships in the oncology ecosystem. We fully intend to leverage our internal capabilities to accelerate and augment our oncology pipeline. Going forward, we will explore a broad range of modalities and mechanisms as we seek to advance the most promising science and ultimately, address the highest areas of patient need.

我們在腫瘤生態系統中擁有悠久的機構知識、開發專業知識和牢固的關係。我們完全打算利用我們的內部能力來加速和擴大我們的腫瘤學管道。展望未來，我們將探索廣泛的模式和機制，尋求推動最有前途的科學並最終解決患者需求的最高領域。

We have a new R&D Head of Oncology, P.K. Morrow, who is a practicing oncologist at MD Anderson Cancer Center before taking on leadership roles at 2 large biotechnology companies. She brings strong development capability and will guide the building and replenishment of our oncology pipeline through internal and external innovation.

我們任命了新的腫瘤學研發主管 P.K. Morrow 是 MD 安德森癌症中心的執業腫瘤學家，之後在兩家大型生物技術公司擔任領導職務。她帶來了強大的開發能力，將透過內部和外部創新來指導我們腫瘤產品線的建造和補充。

Now early green shoots of progress include the successful approval and launch of FRUZAQLA, early stage-ups of internal programs like dazostinag, TAK-676, our first sting agonist to enter of the clinic and TAK-012, our first gamma-delta T cell therapy as well as our recent licensure from Kumquat therapeutics, which brought a promising immuno-oncology asset into our preclinical pipeline. We look forward to sharing our progress in the months ahead.

現在，早期進展包括FRUZAQLA 的成功批准和啟動、dazostinag 等內部計畫的早期階段、TAK-676（我們第一個進入臨床的刺激動劑）和TAK-012（我們的第一個γ-δ T 細胞）療法以及我們最近獲得的 Kumquat Therapy 許可，這為我們的臨床前管道帶來了一種有前途的免疫腫瘤學資產。我們期待在未來幾個月分享我們的進展。

Next slide, please. Now here, I'd like to highlight the strength and potential of our early- to mid-stage pipeline, which is poised to address unmet patient needs and contribute in the near term to our growing late-stage portfolio.

請下一張投影片。現在，我想強調我們早期到中期管道的實力和潛力，這些管道將解決未滿足的患者需求，並在短期內為我們不斷增長的後期產品組合做出貢獻。

In our emerging celiac disease franchise, we will have an important readout for TAK-227 over the next 12 months. TAK-227, a transglutaminase 2 inhibitor, has already demonstrated reductions in gluten-induced intestinal pathology as published in the June 2021 New England Journal of Medicine.

在我們新興的乳糜瀉系列中，我們將在未來 12 個月內獲得 TAK-227 的重要讀數。 TAK-227 是一種轉谷氨酰胺酶 2 抑制劑，已證明可以減少麩質誘導的腸道病理，正如 2021 年 6 月《新英格蘭醫學雜誌》上發表的那樣。

As Christophe mentioned, we are pivoting development of TAK-007, our CD19 CAR-NK cell therapy, from oncology to autoimmune diseases, where there is exciting autologous cell therapy data emerging with long-lasting effects in refractory autoimmune diseases. Relative to CAR-T therapy, our CAR-NK platform has a favorable safety profile and an off-the-shelf manufacturing process that will deliver therapy on demand at a significantly lower cost of goods. And while a very competitive area for autologous cell therapies, there are a few allogeneic programs in the mix.

正如Christophe 所提到的，我們正在將TAK-007（我們的CD19 CAR-NK 細胞療法）的開發從腫瘤學轉向自身免疫性疾病，其中出現了令人興奮的自體細胞療法數據，對難治性自身免疫性疾病具有長期效果。相對於 CAR-T 療法，我們的 CAR-NK 平台具有良好的安全性和現成的製造工藝，可以顯著降低的商品成本提供按需治療。雖然自體細胞療法是一個競爭非常激烈的領域，但也有一些同種異體療法。

In addition, our expanded orexin franchise continues to progress well. We expect a proof-of-concept readout for danaverexton in post-anesthesia recovery later this year. TAK-360, our next-generation oral orexin agonist, has started recruiting in Phase I. We will advance TAK-360 quickly using our deep understanding of orexin biology and industry-leading expertise with orexin agonists to accelerate development in narcolepsy type 2 and idiopathic hypersomnia. TAK-360 has already been awarded a Fast Track designation by FDA.

此外，我們擴大的食慾素特許經營權繼續進展順利。我們預計今年稍後將公佈 danaverexton 在麻醉後恢復中的概念驗證結果。我們的下一代口服食慾素激動劑TAK-360 已開始第一階段招募。型嗜睡症和特發性睡病的開發嗜睡症。 TAK-360 已獲得 FDA 的快速通道指定。

Next slide, please. Let us now focus on upcoming milestones that are expected to make a significant impact in the near future. We eagerly await the soticlestat Phase III readout in Dravet syndrome and Lennox-Gastaut syndrome, or LGS, both due in the first half of this fiscal year. Soticlestat has a novel mechanism of action and has been well tolerated in clinical studies. We believe approval of soticlestat could lead to a reimagining of care for patients with these pediatric epilepsies.

請下一張投影片。現在讓我們專注於即將到來的里程碑，這些里程碑預計將在不久的將來產生重大影響。我們熱切地等待 Dravet 症候群和 Lennox-Gastaut 症候群（LGS）的 soticlestat III 期結果，這兩種疾病均將於本財年上半年公佈。 Soticlestat 具有新穎的作用機制，並且在臨床研究中具有良好的耐受性。我們相信 soticlestat 的批准可能會導致對這些小兒癲癇患者的護理進行重新思考。

Other upcoming milestones included the start of Phase III development for TAK-861 in narcolepsy type 1 and the completion of enrollment for zasocitinib's Phase III LATITUDE psoriasis trials in the second half of fiscal year 2024.

其他即將到來的里程碑包括開始針對 1 型發作性睡病的 TAK-861 III 期開發，以及在 2024 財年下半年完成 zasocitinib 的 III 期 LATITUDE 銀屑病試驗的入組。

Given the strong momentum of our mid- to late-stage pipeline, we plan to host an R&D event later this year to provide an update on our strategy, present deep dives into our potentially transformative late-stage programs and share more about our data, digital and technology efforts. Specific details of the event will be shared soon.

鑑於我們中後期管道的強勁勢頭，我們計劃在今年晚些時候舉辦一次研發活動，以提供我們戰略的最新信息，深入探討我們潛在的變革性後期項目，並分享更多有關我們的數據的信息，數位和技術方面的努力。活動的具體細節將很快分享。

With these milestones on the horizon, I'm particularly excited to share more about mezagitamab. Let's dive into the details of this promising therapy and its potential for use across a range of immune-mediated disorders.

隨著這些里程碑的到來，我特別高興能分享更多有關美札吉他單抗的資訊。讓我們深入了解這種有前景的療法的細節及其在一系列免疫介導疾病中的應用潛力。

Next slide, please. Mezagitamab is an anti-CD38 antibody that has a lower affinity for platelets and red blood cells than the leading marketed CD38 antibody. Our data on file shows robust immunoglobulin reductions across multiple antibody subtypes. In addition to depleting antibody-producing plasma cells, mezagitamab has shown an ability to substantially reduce a range of other cells involved in inflammatory processes, leading to a rapid onset of response and a long-lasting immunomodulating effect.

請下一張投影片。 Mezagitamab 是一種抗 CD38 抗體，與市場上領先的 CD38 抗體相比，它對血小板和紅血球的親和力較低。我們的存檔數據顯示多種抗體亞型的免疫球蛋白顯著降低。除了消除產生抗體的漿細胞外，美札吉他單抗還表現出顯著減少參與發炎過程的一系列其他細胞的能力，從而導致快速反應和持久的免疫調節作用。

The lowering of immunoglobulin G is on par or less than that seen with anti-FcRns. And yet, we have seen more robust rapid and sustained platelet responses in ITP relative to these agents.

免疫球蛋白 G 的降低與抗 FcRns 的降低相當或更少。然而，與這些藥物相比，我們發現 ITP 患者的血小板反應更為強烈、快速且持續。

This suggests that mezagitamab's mechanism of action goes beyond the effects of lowering immunoglobulin. We look forward to sharing our ITP data at an upcoming major hematology conference later this year.

這顯示美札吉他單抗的作用機制超出了降低免疫球蛋白的作用。我們期待在今年稍後即將舉行的大型血液學會議上分享我們的 ITP 數據。

In IgAN, mezagitamab's host of immunomodulating effects, including reductions in galactose-deficient IgA by 62%, leads to robust benefits on proteinuria.

在 IgAN 中，美紮吉他單抗的一系列免疫調節作用，包括將缺乏半乳糖的 IgA 減少 62%，對蛋白尿產生了巨大的益處。

Mezagitamab thus has the potential to modify the disease path for these patients. Our proof-of-concept data suggests a very competitive profile in IgAN despite a crowded development landscape. We look forward to discussions with health authorities on our Phase III program. We will share the IgAN data at a medical conference later this year.

因此，美札吉他單抗有可能改變這些患者的疾病路徑。我們的概念驗證數據表明，儘管開發環境擁擠，但 IgAN 仍具有非常有競爭力的特徵。我們期待與衛生當局就我們的第三階段計劃進行討論。我們將在今年稍後的醫學會議上分享 IgAN 數據。

Thank you. At this point, I'll turn it over to Milano.

謝謝。現在，我將把它交給米蘭。

Thank you, Andy. Hello, everyone. It's my pleasure to present FY '23 results and financial outlook for FY '24 and onwards.

謝謝你，安迪。大家好。我很高興介紹 23 財年的業績以及 24 財年及以後的財務前景。

FY '23 revenue was over JPY 4.2 trillion, an increase of 5.9% on an actual FX basis or 1.5% at constant exchange rates, or CER. This result exceeded our management guidance of low single-digit decline at CER, mainly due to [Mauda] generic penetration of VYVANSE on top of continued momentum of our Growth & Launch Products.

23 財年營收超過 4.2 兆日圓，以實際外匯計算成長 5.9%，以固定匯率 (CER) 計算成長 1.5%。這一結果超出了我們的管理指導，即 CER 的低個位數下降，這主要是由於 [Mauda] VYVANSE 的仿製藥滲透以及我們的成長和推出產品的持續勢頭。

Core operating profit, core OP, was JPY 1,054.9 billion, a year-on-year decline of 13.3% at CER, in line with management guidance for low 10 percentage decline. This decline mainly reflects the LOE of high gross margin products, transactional FX impacting COGS and increased investment in R&D and data, digital technology, let me call it, DD&T.

核心營業利潤（核心OP）為10,549億日元，以固定匯率計算年減13.3%，符合管理階層指引的低10%的下降幅度。這種下降主要反映了高毛利率產品的 LOE、影響 COGS 的交易性外匯以及對研發和數據、數位技術（讓我稱之為 DD&T）投資的增加。

Reported operating profit was JPY 214.1 billion, a decline of 56.4%, including higher impairment losses based on study readouts of ALOFISEL and EXKIVITY as well as higher restructuring and litigation-related expenses.

報告營業利潤為 2,141 億日元，下降 56.4%，其中包括基於 ALOFISEL 和 EXKIVITY 研究結果的較高減損損失，以及較高的重組和訴訟相關費用。

Core EPS was JPY 484, a 15.7% decline at CER. It landed better than our management guidance, low 20s% decline, due to more favorable core tax rate. Reported EPS was JPY 92, a 54.9% decline with lower financial income than prior year, offset by a reduction in tax expense.

核心每股收益為 484 日圓，以固定匯率計算下降 15.7%。由於更優惠的核心稅率，它的下降幅度比我們的管理層指導要好，下降了 20%。報告的每股收益為 92 日元，下降 54.9%，財務收入低於上年，但被稅收費用的減少所抵消。

Operating cash flow and free cash flow was JPY 716.3 billion and JPY 283.4 billion, respectively, which I will explain later.

營運現金流和自由現金流分別為7163億日元和2834億日元，稍後我將對此進行解釋。

Let's look at the year-on-year revenue dynamics in Slide 21. Our Growth & Launch Products grew by 12.8% at CER, representing now 43% of total revenue in FY '23, which was almost entirely offset by the impact of LOEs.

讓我們看看投影片 21 中的年收入動態。

Growth of other products more than compensated for lower COVID-19 vaccine sales and total revenue landed with 1.5% growth at CER.

其他產品的成長足以彌補 COVID-19 疫苗銷售下降的影響，總收入以固定匯率計算成長 1.5%。

The depreciation of the yen versus major currencies increased the revenue, resulting in total growth of 5.9% on actual FX basis.

日圓兌主要貨幣貶值增加了收入，導致實際匯率總成長5.9%。

Slide 22 shows year-on-year operating profit dynamics. You can see how LOEs and the lower COVID-19 vaccines revenue are having a larger impact on profit due to their higher gross margins.

投影片 22 顯示了年比營業利潤動態。您可以看到 LOE 和較低的 COVID-19 疫苗收入如何因毛利率較高而對利潤產生更大的影響。

On the investment side, we continue to allocate resources to DD&T and R&D. On a CER basis, R&D spend increased by over 8%, slightly ahead of our forecast due to wind-down costs associated with program terminations.

在投資方面，我們持續向DD&T和研發配置資源。以固定匯率計算，研發支出增加了 8% 以上，略高於我們的預測，原因是與專案終止相關的逐步削減成本。

I want to spend a moment to elaborate major factors behind the 4.8 percentage points core operating profit margin drop. The biggest factor was gross margin decline. This was caused by a combination of 2 elements: one, product mix between Growth & Launch Products and LOE-impacted product; and second, transactional FX impact on COGS. These 2 components almost equally affected the gross margin decline.

我想花點時間來闡述核心營業利潤率下降4.8個百分點背後的主要因素。最大的因素是毛利率下降。這是由兩個因素共同造成的：一是成長和發布產品與受 LOE 影響的產品之間的產品組合；其次，交易性外匯對銷貨成本的影響。這兩個因素對毛利率下降的影響幾乎相同。

Then the next factor is an extra spend in R&D and DD&T, as I already mentioned. The last factor is translational FX impact. The depreciation of yen increased revenue and core OP by JPY 176.9 billion and JPY 24 billion, respectively, which pushed further down our core OP margin.

正如我已經提到的，下一個因素是研發和 DD&T 方面的額外支出。最後一個因素是匯率的平移影響。日圓貶值使收入和核心營業利潤分別增加了 1,769 億日圓和 240 億日圓，進一步壓低了我們的核心營業利潤率。

Next Slide 23 shows reported operating profit bridge versus prior year. In addition to the core OP decline, we booked impairments of intangible assets in FY '23, totaling JPY 130.6 billion, mainly around ALOFISEL and EXKIVITY. Impairment reversal in Q4 for EOHILIA was offset by several additional impairments related to the discontinuation of the modakafusp alfa, TAK-007 and others.

下一張投影片 23 顯示了報告的營運利潤與上一年的比較。除了核心OP下降之外，我們在23財年計入了無形資產減值，總計1306億日元，主要圍繞ALOFISEL和EXKIVITY。 EOHILIA 第四季的減損逆轉被與 modakafusp alfa、TAK-007 等產品停產相關的幾項額外減損所抵銷。

Other operating expenses increased due to litigation provisions and restructuring costs and the revaluation of contingent considerations. Translation effect was further headwind to a reported operating profit because many of our noncore expenses, such as amortization, impairments, and legal provisions, are booked in foreign currency. All these items combined led to the reported operating profit decline of 56.4%.

由於訴訟準備金和重組成本以及或有對價的重估，其他營運費用有所增加。換算效應進一步阻礙了報告的營業利潤，因為我們的許多非核心費用，例如攤銷、減損和法律撥備，都是以外幣記帳的。所有這些項目加起來導致報告的營業利潤下降 56.4%。

Next is our cash flow analysis on Slide 24. Operating cash flow for FY '23 was JPY 716.3 billion, lower than prior year mainly due to the decline in core operating profit and a onetime cash payment related to litigation.

接下來是我們對幻燈片 24 的現金流量分析。

Free cash flow was JPY 283.4 billion, reflecting total CapEx of JPY 480 billion. This is below our full year forecast of JPY 400 billion to JPY 500 billion, mainly because of litigation-related payments and higher working capital.

自由現金流為 2,834 億日元，反映資本支出總額為 4,800 億日圓。這低於我們 4,000 億至 5,000 億日圓的全年預測，主要是因為訴訟相關費用和營運資金增加。

Moving to our outlook for FY '24. Let me start with our management guidance on the righthand side of the slide. As explained earlier, the impact of generics on VYVANSE is shifting to FY '24. However, we still anticipate strong momentum of our Growth & Launch Products, in particular, ENTYVIO and immunoglobulin, which will largely alleviate this headwind to result in flat to slightly declining revenue on a CER basis.

轉向我們對 24 財年的展望。讓我從幻燈片右側的管理指南開始。如前所述，仿製藥對 VYVANSE 的影響正在轉向 24 財年。然而，我們仍然預計我們的成長和推出產品的強勁勢頭，特別是 ENTYVIO 和免疫球蛋白，這將在很大程度上緩解這一不利因素，導致以固定匯率計算的收入持平或略有下降。

Core OP is expected to decline by approximately 10% at CER, because of high profitability of VYVANSE and a modest increase in R&D and DD&T. Core EPS is expected to decline by mid 10s percentage by -- with a normalization of our core tax rate to around 20%.

由於 VYVANSE 的高盈利能力以及研發和 DD&T 的適度增長，預計核心 OP 按固定匯率計算將下降約 10%。隨著我們的核心稅率正常化至 20% 左右，核心每股盈餘預計將下降 10 % 左右。

Our forecast on an actual FX basis assumes JPY 150 to the U.S. dollar and JPY 160 to the euro. We expect revenue to be JPY 4.35 trillion, which is a 2% increase versus prior year at actual FX.

我們基於實際匯率的預測假設日圓兌美元為 150 日圓，日圓兌歐元為 160 日圓。我們預計營收為 4.35 兆日元，以實際匯率計算較上年增長 2%。

Core OP forecast is JPY 1 trillion. Reported operating profit forecast is JPY 225 billion, including JPY 140 billion of restructuring costs. Core EPS and reported EPS are expected to be JPY 431 and JPY 37, respectively.

核心OP預測為1兆日圓。公佈的營業利潤預測為 2,250 億日元，其中包括 1,400 億日圓的重組成本。核心每股盈餘和報告每股盈餘預計分別為 431 日圓和 37 日圓。

Our adjusted free cash flow forecast is JPY 350 billion to JPY 450 billion. This reflects the reduction in cash flow from VYVANSE, higher cash restructuring expenses as well as a continued envelope for targeted in-licensing opportunities.

我們調整後的自由現金流預測為 3,500 億日圓至 4,500 億日圓。這反映了 VYVANSE 現金流的減少、現金重組費用的增加以及目標許可機會的持續增長。

Finally, according to the capital allocation policy we updated last year, we are announcing a dividend increase for the second successive year by a further JPY 8 to JPY 196 per share.

最後，根據我們去年更新的資本配置政策，我們宣布連續第二年將股利進一步增加每股 8 日圓至 196 日圓。

Slide 26 picturizes the dynamics impacting our revenue outlook for FY '24, which actually I explained mostly.

投影片 26 描繪了影響我們 24 財年營收前景的動態，實際上我對此進行了大部分解釋。

Slide 27 shows a similar waterfall for FY '24 cooperating profit. The dynamics look similar to FY '23, but there are 2 differences I want to point out. First, gross margin deterioration is expected to be less in FY '24. Second, we expect savings in other OpEx to start offsetting our incremental strategic investments in R&D and DD&T. The net impact is a core OP decline of about 10% at CER.

幻燈片 27 顯示了 24 財年合作利潤的類似瀑布。動態看起來與 23 財年相似，但我想指出兩個差異。首先，預計 24 財年毛利率惡化幅度將較小。其次，我們預期其他營運支出的節省將開始抵銷我們在研發和 DD&T 方面的增量策略投資。淨影響是核心營運成本以固定匯率計算下降約 10%。

Although we are guiding for FY '24 to be another year of profit decline, we expect to bottom out this year. We implement enterprise-wide program to drive efficiencies across the value chain with JPY 140 billion of restructuring costs in FY '24 as well as some additional lower costs in the next couple of years. Through this program, we generate significant gross cost savings. While much of this will be reinvested for growth, we are committed to make concrete steps on improving core OP margin toward the low to mid-30s.

儘管我們預計 24 財年將是利潤下滑的另一年，但我們預計今年將觸底。我們實施了企業範圍內的計劃，以提高整個價值鏈的效率，24 財年的重組成本為 1,400 億日元，並在未來幾年進一步降低成本。透過該計劃，我們顯著節省了總成本。雖然其中大部分將用於再投資以促進成長，但我們致力於採取具體措施，將核心營運利潤率提高到 30 多歲至 30 多歲。

On this slide, I would like to give a bit more color on how we see the P&L evolving from FY '25 onwards. Firstly, it is very important to emphasize our return to sustainable revenue growth after the VYVANSE LOE is behind us. This will be enabled by the current Growth & Launch Products, new launches from our pipeline and with limited further generic exposure, it's negated.

在這張投影片上，我想進一步說明我們如何看待 25 財年以來損益表的演變。首先，非常重要的是要強調在 VYVANSE LOE 過去之後我們恢復了可持續的收入成長。這將透過當前的成長和推出產品、我們管道中的新推出以及進一步有限的通用曝光來實現，它被否定了。

We expect our gross margins to bottom out with the VYVANSE LOE with a gradual improvement due to expansion of ENTYVIO and other high-margin products as well as efficiencies in manufacturing and supply chain and continued margin improvement in PET.

我們預計，由於 ENTYVIO 和其他高利潤產品的擴張、製造和供應鏈的效率以及 PET 利潤率的持續改善，我們的毛利率將隨著 VYVANSE LOE 觸底反彈並逐步改善。

For SG&A, we plan to hold expenses flat to slightly declining on an absolute basis, offsetting investments and inflation. By managing SG&A spend, we should see the ratio of SG&A as a percentage of revenue decline as the top line grows, resulting in a majority of core OP margin improvement.

對於SG&A，我們計劃將絕對支出持平或略有下降，以抵消投資和通貨膨脹。透過管理 SG&A 支出，我們應該會看到 SG&A 佔收入的百分比隨著收入的成長而下降，從而導致大部分核心營運利潤率改善。

In R&D, we are rigorously prioritizing our pipeline to fund late-stage programs. Through disciplined cost management, we intend to progress that pipeline with broadly neutral impact on margins. In other words, we will manage R&D incremental investments broadly in line with revenue growth from FY '25.

在研發方面，我們嚴格優先考慮我們的管道，以資助後期專案。透過嚴格的成本管理，我們打算在對利潤率產生大致中性影響的情況下推進該管道。換句話說，我們將根據 25 財年的營收成長來管理研發增量投資。

As a result of all these dynamics, we plan to deliver 100 to 250 basis points core OP margin improvement each year. We are very confident in our execution of the extensive program and cost management, but to be transparent, there are also some important assumptions behind this outlook such as VYVANSE erosion timing and FX rate. For example, slower erosion would set a higher starting point in FY '24 or, as we experienced in FY '23, significant currency volatility might cause a headwind to our margin improvements.

由於所有這些動態，我們計劃每年將核心營運利潤率提高 100 至 250 個基點。我們對廣泛計畫和成本管理的執行非常有信心，但為了透明起見，這個前景背後還有一些重要的假設，例如 VYVANSE 侵蝕時間和匯率。例如，較慢的侵蝕將為 24 財年設定一個更高的起點，或者正如我們在 23 財年所經歷的那樣，重大的貨幣波動可能會對我們的利潤率改善造成不利影響。

Before handing back to Christophe, for closing remarks, I just want to reiterate our capital allocation policy that we updated last year. We continue to prioritize investment for growth in our pipeline, new product launches and expanding our PDT business while delivering attractive returns to our shareholders. I also emphasize that we remain committed to maintaining solid investment-grade ratings.

在回到克里斯托夫做結束語之前，我只想重申我們去年更新的資本配置政策。我們繼續優先投資於我們的產品線成長、新產品發布和擴大我們的 PDT 業務，同時為股東提供有吸引力的回報。我還強調，我們仍然致力於維持穩健的投資等級。

With this year's JPY 8 increase, we believe our dividend payout ratio in core EPS becomes more in line with our industry peers. Going forward, under our progressive dividend policy, we will decide the dividend according to long-term profit growth outlook and financial capacity in cash flow and balance sheet.

隨著今年每股盈餘增加 8 日圓，我們相信我們的核心每股盈餘派息率將與業界同業更加一致。展望未來，在我們的漸進式股利政策下，我們將根據長期利潤成長前景以及現金流和資產負債表的財務能力來決定股利。

Thank you for your attention, and I'll hand it back to Christophe to close the presentation.

感謝您的關注，我會將其交還給 Christophe 以結束演示。

Thank you, Andy, and thank you Milano. As I said at the beginning, I would describe fiscal year '23 as a well-managed tough year. In a very challenging environment, we met or exceeded our management guidance and made significant progress in our pipeline and marketed therapies.

謝謝你，安迪，謝謝你米蘭。正如我一開始所說的，我將 23 財年描述為管理良好的艱難一年。在一個非常具有挑戰性的環境中，我們達到或超越了我們的管理指導，並在我們的管道和上市療法方面取得了重大進展。

Looking ahead, we believe that we have 1 final year in 2024 of significant headwinds from VYVANSE loss of exclusivity before a long period with minimal loss of exclusivity exposure, a period during which we will fully benefit from the growth generated by our Growth & Launch Products.

展望未來，我們相信，在很長一段時間內，我們將在2024 年最後一年面臨VYVANSE 失去獨家經營權帶來的重大阻力，而獨家經營權的損失最小，在此期間，我們將充分受益於我們的成長和推出產品帶來的成長。

In our late-stage pipeline in fiscal year '24, we expect to have up to 6 promising programs with high revenue potential, and we are committed to the rigorous prioritization needed to maximize their potential for success.

在 24 財年的後期管道中，我們預計將有多達 6 個具有高收入潛力的有前途的項目，並且我們致力於嚴格確定優先順序，以最大限度地發揮其成功潛力。

Our return to revenue growth combined with a significant efficiency program we introduced today, give us a clear path to delivering 100 to 250 basis points core operating profit margin improvement each year from fiscal year '25 towards our low to mid-30s percentage target.

我們的營收成長回歸與今天推出的重大效率計劃相結合，為我們提供了一條清晰的道路，從25 財年開始，核心營業利潤率每年提高100 至250 個基點，實現我們30 多歲的低至中百分比目標。

Finally, we remain committed to delivering an attractive return to our shareholders and feel confident in proposing an increase to our annual dividend again this year.

最後，我們仍然致力於為股東提供有吸引力的回報，並對今年再次提議增加年度股息充滿信心。

We look forward to the opportunities that lie ahead.

我們期待未來的機會。

Thank you for your continued support and confidence in Takeda. I will now hand it back to Chris. Thank you.

感謝您對武田的持續支持與信任。我現在將把它交還給克里斯。謝謝。

Now we'd like to entertain questions from you. In addition to Christophe, Andy and Furuta, we have Ramona Sequeira, President of Global Portfolio division; Julie Kim, President of the U.S. business unit; Giles Platford, President, PDT Business Unit; Teresa Bitetti, President, Global Oncology Business Unit joining in the Q&A.

現在我們願意回答您的問題。除了 Christophe、Andy 和 Furuta 之外，我們還有全球投資組合部門總裁 Ramona Sequeira； Julie Kim，美國業務部總裁； Giles Platford，PDT 業務部總裁；全球腫瘤業務部總裁 Teresa Bitetti 參與問答。

(Operator Instructions) So we'd like to move on to the first question. Jefferies, Steve Barker.

（操作員說明）所以我們想繼續討論第一個問題。傑弗里斯，史蒂夫·巴克。

Yes, it's Steve Barker. So my first question is about your restructuring. You plan to book a charge of JPY 140 billion this year. I'd be interested if you could share any details about what this is going to entail and the scope of any planned redundancies, which divisions that's going to focus on?

是的，他是史蒂夫·巴克。我的第一個問題是關於你們的重組。您今年計劃預訂 1,400 億日圓的費用。如果您能分享有關這將涉及什麼以及任何計劃裁員的範圍以及將重點關注哪些部門的任何詳細信息，我很有興趣？

And then my second question regarding the vaccine business. Christophe's comments, I think it seems to indicate a more enthusiastic commitment to the vaccines business based upon the success of QDENGA. But you only have 1 global product. Should we understand that your new plan could involve adding vaccines to your portfolio potentially through acquisitions.

然後是關於疫苗業務的第二個問題。 Christophe的評論，我認為這似乎表明基於QDENGA的成功，對疫苗業務更熱情的承諾。但您只有 1 個全球產品。我們是否應該理解您的新計劃可能涉及透過收購將疫苗添加到您的投資組合中。

Thank you, Steve. So the first question on restructuring and more details on the program. And then the second question on our strategy in the vaccines business. I'd like to ask Christophe to answer both of those questions.

謝謝你，史蒂夫。第一個問題是關於重組和該計劃的更多細節。然後是關於我們疫苗業務策略的第二個問題。我想請 Christophe 回答這兩個問題。

Thank you, Steve. So the first question, the efficiency programs does include some redundancy and in many different areas of the company. It's -- it will impact differently different departments, but we are looking at a more agile organization, streamlining organization, gaining more efficiency data with data technology and AI. The pipeline prioritization also will create some reorganization. So there is an element of redundancy in this provision. It's not 100% that, but it's a significant part.

謝謝你，史蒂夫。所以第一個問題，效率計劃確實包括一些冗餘，並且涉及公司的許多不同領域。它會對不同的部門產生不同的影響，但我們正在尋找一個更敏捷的組織，精簡組織，透過數據技術和人工智慧獲得更有效率的數據。管道優先級也將進行一些重組。因此，該規定存在冗餘的成分。雖然不是 100%，但它是一個重要的部分。

Regarding the vaccines development, we are very excited about QDENGA for sure. I mean, it's -- first, it's a great vaccine, it's very efficacious. And, unfortunately, dengue prevalence is increasing very significantly in endemic countries.

關於疫苗的開發，我們對 QDENGA 確實感到非常興奮。我的意思是，首先，這是一種很棒的疫苗，非常有效。不幸的是，登革熱流行國家的盛行率正在顯著增加。

On the other hand, for future vaccines development, we are looking for a strategic partner. We don't want to do it alone by ourself. We are missing many strategic components in vaccines. So we want to -- ideally, we would like to find a vaccine strategic partner to potentially develop more other vaccines, if you like, after QDENGA.

另一方面，為了未來的疫苗開發，我們正在尋找策略夥伴。我們不想獨自完成這件事。我們缺乏疫苗中的許多戰略成分。因此，理想情況下，我們希望在 QDENGA 之後找到一個疫苗策略夥伴，如果您願意的話，可以開發更多其他疫苗。

How would that sort of strategic partnership work? What role would Takeda play in such a partnership?

這種策略夥伴關係將如何運作？武田將在這樣的合作關係中扮演什麼角色？

I will not give you detail at this stage because I cannot disclose the type of discussion that we are having. So there are many different types of potential model of strategic partnership. But basically, we think that if we could find a good partner, it will strengthen our capability in vaccines development. It will also reduce our financial exposure. Developing new vaccines is very expensive, very, very long, which is fine, but we are also missing some core capabilities. So there are many different models. If we -- of course, at one stage, if we are able to do a strategic partnership, we will share with you the details.

現階段我不會向您提供詳細信息，因為我無法透露我們正在進行的討論類型。因此，策略夥伴關係的潛在模式有很多種。但基本上，我們認為如果我們能找到一個好的合作夥伴，它將增強我們在疫苗開發方面的能力。它還將減少我們的財務風險。開發新疫苗非常昂貴，時間非常非常長，這很好，但我們也缺少一些核心能力。所以有很多不同的模型。當然，如果我們能夠在某個階段建立策略夥伴關係，我們將與您分享詳細資訊。

[Interpreted] Next question from Yamaguchi-san, Citi, please.

[解釋]下一個問題是花旗山口先生提出的。

This is Yamaguchi from Citi. The two questions. The first one is regarding PDT business. The PDT business is growing faster than the industry, and you seem to have a good condition of course, as well and operating margin is now improving. Can you give us a guidance what kind of gross margin you're looking for, for this fiscal year compared to last fiscal year? That's the first question.

我是花旗銀行的山口。兩個問題。第一個是關於PDT業務。 PDT 業務的成長速度快於行業，當然，您的狀況似乎也很好，而且營業利潤率現在正在提高。您能否告訴我們，與上一財年相比，您希望本財年的毛利率是多少？這是第一個問題。

Second question is regarding narcolepsy project. On the abstract of sleep at the TAK-861, and congratulations on the PDT, but the placebo adjusted time is around 26 minutes. I think it's between 3 to 5 milligrams, if I remember correctly, which is great. But it's a little bit weaker than 994 and also, this is only for NT1. So can you give us any impressions of why it is a little bit less efficacious compared to 994 because of dosage things? And also, why did you do only for the NT1 and giving up NT2 and IH for that?

第二個問題是關於發作性睡病項目。關於 TAK-861 的睡眠摘要，並祝賀 PDT，但安慰劑調整時間約為 26 分鐘。如果我沒記錯的話，我想它在 3 到 5 毫克之間，這很好。但它比 994 弱一點，而且，這僅適用於 NT1。那麼您能否給我們一些印象，為什麼由於劑量問題，它與 994 相比效果稍差一些？還有，為什麼只做NT1而放棄​​NT2和IH呢？

Okay. Thank you, Yamaguchi-san. So the first question on our PDT business, I'd like to ask Giles to comment. And then the second question, on TAK-861 for Andy to answer that one. Thank you.

好的。謝謝你，山口先生。關於我們 PDT 業務的第一個問題，我想請 Giles 發表評論。然後是關於 TAK-861 的第二個問題，由安迪回答。謝謝。

Thank you, Chris, and Yamaguchi-san for the question. We do expect the PDT business to continue growing high single digits in fiscal '24, with the immunoglobulin portfolio growing 5% to 15% and single-digit growth from our albumin portfolio. We don't give guidance around gross margin or COP by division. But what I can show you is that we continue to see positive momentum in margin expansion for the PDT business, driven by better value recognition, better portfolio mix, particularly uptake of our innovative subcutaneous IG portfolio, supported also by the recent approval for IQVIA in the U.S. and Europe for treatment of CID patients -- CIDP patients, but also supported by continued investment in DD&T transformation across the value chain, which is helping to drive efficiencies in productivity. Thank you.

謝謝克里斯和山口先生的提問。我們確實預計 PDT 業務將在 24 財年繼續實現高個位數成長，免疫球蛋白組合將成長 5% 至 15%，白蛋白組合將實現個位數成長。我們不會按部門提供有關毛利率或 COP 的指導。但我可以向您展示的是，我們繼續看到PDT 業務利潤率擴張的積極勢頭，這得益於更好的價值認可、更好的投資組合，特別是我們創新的皮下IG 投資組合的採用，以及最近IQVIA 的批准。謝謝。

Yamaguchi-san, this is Andy. Firstly, with respect to 861 and type 1 narcolepsy, the good news is that in 3 weeks, you'll have an opportunity to see the full-day set as it's presented at Sleep. And as I mentioned, we'll host there and [IR] can go deeper into the -- into your questions and share more of the data.

山口先生，這是安迪。首先，關於 861 和 1 型發作性睡病，好消息是 3 週後，您將有機會看到 Sleep 上呈現的全天場景。正如我所提到的，我們將在那裡主持，[IR] 可以更深入地探討您的問題並分享更多數據。

Just -- so at this point, just a few brief comments. Just a general comment, which is I think it will be hard to get a profile that will be more -- that will be better than TAK-861 in type 1 narcolepsy. It will be hard to create a profile that's going to be better. And I wouldn't look at a small number, numeric differences in a highly artificial endpoint like MWT as relevant.

只是——所以在這一點上，我只是做一些簡短的評論。只是一般性評論，我認為很難獲得比 TAK-861 在 1 型發作性睡病方面更好的資料。很難創建一個更好的個人資料。我不會將 MWT 等高度人為的終點中的微小數字差異視為相關。

What will be very important for you to see is the efficacy across the multiple different aspects of type 1 narcolepsy, excessive daytime sleepiness, cataplexy, nighttime sleep architecture and then measures of patient functional quality of life. We've looked extensively across all of these. And I can tell you that the profile for 861 is quite transformative. And for many of these patients, we're functionally curing their type 1 narcolepsy.

對您來說非常重要的是要看到 1 型發作性睡病、白天過度嗜睡、猝倒、夜間睡眠結構以及患者功能生活品質的多個不同方面的療效。我們對所有這些都進行了廣泛的研究。我可以告訴您，861 的設定檔具有相當大的變革性。對於其中許多患者，我們正在功能性地治癒他們的 1 型發作性睡病。

In addition, there's a therapeutic index that's important to thread the needle. So dose becomes quite important in managing efficacy with therapeutic index. And we think that we have threaded that needle with TAK-861 and you'll see the data in a few weeks.

此外，還有一個治療指數對於穿針很重要。因此，劑量對於透過治療指數管理療效變得非常重要。我們認為我們已經用 TAK-861 解決了這個問題，幾週後您就會看到數據。

With respect to type 2 narcolepsy and idiopathic hypersomnia, there's clearly a dose response element, and we made the calculated decision that we wanted to focus type 1 narcolepsy with 861 and part of that decision was the data that we had seen in our Phase IIb studies, part of that decision was, as you know, our intent to really go forward with the lowest efficacious dose possible for 861 given the history with TAK-994. And then perhaps most importantly was the momentum that we were generating with TAK-360, which is now in the clinic. Our intent for TAK-360 is to move forward very rapidly in type 2 narcolepsy and other way sleep cycle disorders.

關於2 型發作性睡病和特發性嗜睡症，顯然存在劑量反應因素，我們經過深思熟慮後決定，希望將861 重點用於1 型發作性睡病，該決定的一部分是我們在IIb 期研究中所看到的數據如您所知，該決定的一部分是考慮到 TAK-994 的歷史，我們的意圖是真正以 861 可能的最低有效劑量繼續前進。也許最重要的是我們透過 TAK-360 產生的動力，該產品現已投入臨床。我們對 TAK-360 的目的是在 2 型發作性睡病和其他睡眠週期障礙方面快速取得進展。

Thank you, Yamaguchi-san. So for the next question, I'd like to call on Cowen, Mike Nedelcovych.

謝謝你，山口先生。對於下一個問題，我想請考恩邁克·內德爾科維奇 (Mike Nedelcovych) 來回答。

I have two. The first is on ENTYVIO. You note that newly launched ENTYVIO competitors appear to be gaining share from other drug classes, but AbbVie's IL-23 is approved in Crohn's while only filed for UC, and Lilly's IL-23 was approved in UC only 6 months ago with Crohn's approval pending. So I'm curious how confident are you that this dynamic will persist in ENTYVIO's favor?

我有兩個。第一個是ENTYVIO。您注意到，新推出的ENTYVIO 競爭對手似乎正在從其他藥物類別中獲得份額，但艾伯維(AbbVie) 的IL-23 在克羅恩病中獲得批准，但僅申請用於UC，而禮來(Lilly) 的IL-23 僅在6 個月前獲得了在UC 中的批准，但克羅恩病的批准仍在等待中。所以我很好奇，您對這種動態對 ENTYVIO 持續有利的信心有多大？

And then my second question is on TAK-007. You kindly outlined the differentiated features of TAK-007 relative to competitors pursuing cell therapy for autoimmune disease, but why is this approach superior to, for example, CD19 or CD20 directed T cell engaging antibodies? And where might TAK-O07 have limitations relative to other modalities?

我的第二個問題是關於 TAK-007 的。您親切地概述了 TAK-007 相對於尋求自體免疫疾病細胞療法的競爭對手的差異化特徵，但為什麼這種方法優於 CD19 或 CD20 定向 T 細胞接合抗體等？相對於其他方式，TAK-O07 可能有哪些限制？

Thank you, Mike. So the first question on ENTYVIO market share performance, particularly in late lines of therapy. I'd like to ask Julie to comment on that. And then on TAK-007 in immune disorders, Andy can comment on that.

謝謝你，麥克。所以第一個問題是關於 ENTYVIO 市場佔有率的表現，特別是在晚期治療領域。我想請朱莉對此發表評論。然後關於免疫失調中的 TAK-007，安迪可以對此發表評論。

Thanks, Chris, and thanks for the question, Mike. When it comes to ENTYVIO's performance in the U.S., I think being 10 years on the market and able to grow demand faster than the market and maintain our market share leader position in first line, both in IBD overall and bio-naïve starts demonstrates the strong track record that ENTYVIO has being a gut selective option for HCPs to use with their patients in both UC and CD.

謝謝克里斯，也謝謝麥克的提問。當談到ENTYVIO 在美國的表現時，我認為在市場上已有10 年的歷史，能夠以比市場更快的速度增長需求，並保持我們在一線的市場份額領先地位，無論是在IBD 整體還是生物幼稚啟動方面都表明了這一點ENTYVIO 已成為 HCP 治療 UC 和 CD 患者的腸道選擇性選擇的良好記錄。

So we do believe that in first line, we'll be able to hold our market share position given the track record that I just mentioned. And where we see the new entrants gaining share is in second line and beyond. So we expect the -- as new products continue to gain the different indications, whether it's CD or UC, that that's where we will see them take hold when they launch.

因此，我們確實相信，鑑於我剛才提到的業績記錄，我們將能夠在第一線保持我們的市場份額地位。我們看到新進業者獲得份額的領域是二線以上。因此，我們預計，隨著新產品不斷獲得不同的適應症，無論是 CD 還是 UC，我們將看到它們在推出時佔據一席之地。

Mike, it's Andy for -- with respect to TAK-007, we, of course, don't want to get out ahead of ourselves here. This is just an extraordinarily exciting and competitive landscape right now and we're really learning as we're moving forward.

麥克，我是安迪，關於 TAK-007，我們當然不想在這裡超出自己的範圍。現在這是一個非常令人興奮和競爭激烈的局面，我們在前進的過程中確實在學習。

The profile for TAK-007 fits very well with autoimmune diseases. It's an off-the-shelf agent. Manufacturing is quite simple. We have a cryopreserved formulation that we can ship anywhere in the world. The cost of goods are a fraction of what it costs to make an autologous cell therapy.

TAK-007 的特徵非常適合自體免疫疾病。這是現成的代理。製造非常簡單。我們有冷凍保存的配方，可以運送到世界任何地方。商品成本只是自體細胞療法成本的一小部分。

Our experience in oncology is that the safety profile is better than what we've seen with autologous cell therapies, and it's quite potent. So it lends itself very nicely, as you can imagine, to patients with autoimmune diseases relative to patients with cancer.

我們在腫瘤學方面的經驗是，其安全性比我們在自體細胞療法中看到的要好，而且非常有效。因此，正如你可以想像的那樣，與癌症患者相比，它非常適合患有自體免疫疾病的患者。

Of course, there's a lot for us to understand. We feel quite confident based on the activity of TAK-007 that we'll see efficacy similar to what's been seen with the other cell therapy agents in these diseases, but that's something that we still need to sort through. We also need to sort through what conditioning regimens will look like, what dose will look like. So there's still a lot to learn.

當然，我們還有很多需要理解的地方。基於 TAK-007 的活性，我們非常有信心，我們將看到與其他細胞治療藥物在這些疾病中所觀察到的功效相似的功效，但這仍然是我們需要解決的問題。我們還需要整理調理方案、劑量。所以還有很多東西要學習。

Your question though around how it compares to non-cell therapies, I think the answer to the question is we just don't have proof of principle for any other type of agent having the kind of truly remarkable, transformative efficacy perhaps curing these diseases. And actually, the experience to date with depleting antibodies like CD19 naked antibodies or CD20 naked antibodies suggests that you can significantly eradicate circulating B-cell populations, see modest to significant benefits over a short term, but then rebound of disease. And for reasons that I don't think the field fully understands, the cell therapies have been much more active and not driving significant initial responses, but sustained responses over years. So I think the jury's still out as to whether other agents are going to be as effective, let's say, as the cell therapies.

你的問題是它與非細胞療法相比如何，我認為問題的答案是，我們只是沒有任何其他類型的藥物的原理證明，具有真正顯著的、變革性的功效，也許可以治愈這些疾病。事實上，迄今為止使用 CD19 裸抗體或 CD20 裸抗體等耗盡抗體的經驗表明，您可以顯著消除循環 B 細胞群，在短期內看到適度到顯著的益處，但隨後疾病會反彈。由於我認為該領域尚未完全理解的原因，細胞療法更加活躍，並沒有帶來顯著的初始反應，而是多年來持續的反應。因此，我認為對於其他藥物是否與細胞療法一樣有效，目前還沒有定論。

And then lastly, you're asking about the liabilities of TAK-007. It looks quite good. I guess the 1 kind of challenged a bit right now is that you still require conditioning. We don't know if you can just purely give a cell therapy without actually conditioning the bone marrow to allow for reconstitution with the cell therapy, but it's certainly something, an area that we'll be exploring, which will be less severe conditioning regimens.

最後，你問的是 TAK-007 的責任。看起來相當不錯。我想現在面臨的第一個挑戰是你仍然需要調節。我們不知道是否可以純粹進行細胞治療，而不實際調節骨髓以允許透過細胞治療進行重建，但這肯定是我們將探索的一個領域，這將是不太嚴格的調節方案。

Okay. Thank you. So moving on to the next question, I'd like to call on Muraoka-san from Morgan Stanley.

好的。謝謝。接下來，我想請摩根士丹利的村岡先生來回答下一個問題。

[Interpreted] This is Muraoka, Morgan Stanley. My first question is about the core OP margin recovery. You mentioned 100 to 250 basis points improvement a year is expected. And if it is actually following the plan, then I think probably in 2030, FY, the target will be attained from the current 29.7%. And then I think that it may be reaching to sort of high-level ones, but it may be declining after that. Is that the right understanding? And also this improvement will come from the improvement of the gross margin. That's my first question.

[解說]我是摩根士丹利的村岡。我的第一個問題是關於核心營運利潤率的恢復。您提到預計每年將改善 100 至 250 個基點。如果它確實按照計劃進行，那麼我認為可能到 2030 年（財年），目前的 29.7% 的目標就會實現。然後我認為它可能會達到某種高水平，但之後可能會下降。這是正確的理解嗎？而這種改善也將來自於毛利率的改善。這是我的第一個問題。

Second question is about PDT. There are other competitors' compounds, and there seems to be in trouble now. And Takeda, in terms of the collection centers is that -- be any chances that you will have more business opportunities, for instance, to more relatively easily get a collection center?

第二個問題是關於PDT。還有其他競爭對手的化合物，現在似乎遇到了麻煩。武田，就收集中心而言，您是否有機會獲得更多商業機會，例如，更相對容易地獲得收集中心？

So I'd like to ask the second question on PDT to be answered by Giles around whether there are any opportunities to acquire more centers. And then the first question on margin, I'd like to ask Milano to comment, and then if Christophe has anything to add. Thank you.

所以我想問 Giles 回答的關於 PDT 的第二個問題是關於是否有機會獲得更多中心。然後是關於邊際的第一個問題，我想請米蘭發表評論，然後克里斯托夫是否有什麼要補充的。謝謝。

[Interpreted] Muraoka-san, thank you very much for your question. As you said, the starting point is about 23%. And then annually, 100% -- 100 to 250 basis point improvement is expected. And then in order to reach 30% it takes time and that time period that you mentioned is more or less correct. And that may be overlapping with the ENTYVIO timing. However, there will be new pipeline coming out and making contributions to the profit. Therefore, I think the profit profile will be different. So after ENTYVIO LOE, what will be our profit rate? It is difficult at this stage to estimate, but we also have to expect the contribution from new products as well. Thank you.

[譯]村岡先生，非常感謝您的提問。正如你所說，起點大約是23%。然後每年預計會有 100%——100 到 250 個基點的改善。然後為了達到 30%，需要時間，你提到的那個時間段或多或少是正確的。這可能與 ENTYVIO 時序重疊。不過，還會有新的管道出現，為利潤做出貢獻。因此，我認為利潤狀況會有所不同。那麼ENTYVIO LOE之後，我們的利潤率是多少？現階段很難估計，但我們也必須期待新產品的貢獻。謝謝。

Giles?

賈爾斯？

Muraoka-san, thank you very much for the question on PDT. We are always looking at both organic and inorganic opportunities to continue to expand our capacity, both in our collections network that you referred to, as well across our manufacturing network. We have committed to expand our capacity by 50% over the next 5 years, up to fiscal '28. We have opened over 100 new collection centers over the past 4 years. So doubling the size of our collections network.

Muraoka-san，非常感謝您在 PDT 上提出的問題。我們一直在尋找有機和無機機會，以繼續擴大我們的產能，無論是在您提到的我們的收集網絡中，還是在我們的製造網絡中。我們承諾在未來 5 年內（直至 28 財年）將產能擴大 50%。過去 4 年來，我們開設了 100 多個新的收集中心。因此，我們的收藏網絡規模擴大了一倍。

We're very excited about the ramp-up that we're now seeing over the coming years that will help to gain in efficiency and productivity, particularly with data and digital. We've made reference in the slide deck to the commencement of the rollout of our personalized nomogram program, which will be effective in 35 centers across the U.S. by the end of fiscal '24, and we will continue rollout across our entire network in fiscal '25, along with other data, digital and technology investments, which will support further capacity expansion. Thank you.

我們對未來幾年的成長感到非常興奮，這將有助於提高效率和生產力，特別是在數據和數字方面。我們在幻燈片中提到了開始推出我們的個人化列線圖計劃，該計劃將於 2024 財年末在美國 35 個中心生效，我們將在 2020 財年繼續在整個網絡中推出。數據、數位和技術投資，將支持進一步的產能擴張。謝謝。

Thank you very much. Okay. The next question, I'd like to call upon Wakao-san from JPMorgan.

非常感謝。好的。下一個問題，我想請摩根大通的若尾先生來回答。

[Interpreted] Wakao-san from JPMorgan. Two questions. One, in TPO FY '24, JPY 964 billion. Can you elaborate on that? FY '23 CER base was 6.6% growth but you now expect 16% for FY '24. That's a big growth. Do you see some trend in the (inaudible) to say that you can have that improvement?

[解釋]摩根大通的若尾先生。兩個問題。一是 TPO 24 財年為 9,640 億日圓。能詳細說明一下嗎？ 23 財年 CER 基數成長 6.6%，但您現在預計 24 財年將成長 16%。這是一個很大的成長。您是否看到（聽不清楚）有一些趨勢表明您可以取得這種改進？

And then IgAN POC data, can you explain it and add some color. As you mentioned, development is rather competitive. TAK-079 POC compared to other competitors' products, do you have competitive data available already? Can you explain that, please?

然後是 IgAN POC 數據，你能解釋一下並添加一些顏色嗎？正如您所提到的，開發是相當有競爭力的。 TAK-079 POC 與其他競爭對手的產品相比，您是否已有競爭數據？你能解釋一下嗎？

Thank you, Wakao-san. So the first question on ENTYVIO performance and outlook for 2024, I'd like to ask Julie to answer this. And then the second question on mezagitamab and the data that we have in IgAN, anything that Andy can comment on its competitiveness at this stage.

謝謝你，若尾桑。那麼第一個問題是關於ENTYVIO的表現以及2024年的展望，我想請Julie來回答這個問題。然後是關於 mezagitamab 的第二個問題以及我們在 IgAN 中擁有的數據，安迪可以對其現階段的競爭力發表評論。

So thank you for the question, Wakao-san. In terms of the ENTYVIO outlook of 16% growth year-over-year, we appreciate that this is an ambitious target, but we do believe that it is achievable. A number of things contribute to the thinking behind this.

謝謝你的提問，若尾先生。就 ENTYVIO 同比增長 16% 的前景而言，我們讚賞這是一個雄心勃勃的目標，但我們確實相信它是可以實現的。許多事情促成了背後的思考。

First, when you look at the growth of ENTYVIO PEN, the subcutaneous formulation for ENTYVIO, we continue to see good signs from the launch in the U.S. You heard Christophe mention some of those statistics in terms of access to new HCPs, new patients as well as the uptake that we've seen in general in UC, and we're very excited about the CD approval that we received last month.

首先，當您觀察 ENTYVIO PEN（ENTYVIO 的皮下製劑）的增長時，我們繼續看到在美國推出後的良好跡象。中普遍看到的那樣，我們對上個月收到的CD 批准感到非常興奮。

In addition, when you look at what's happening from a revenue perspective, we did experience significant clawbacks and rebates in Europe last year in FY '23 that we don't anticipate will be as strong in FY '24.

此外，當你從收入的角度來看正在發生的事情時，我們去年在歐洲確實經歷了 23 財年的重大回扣和回扣，我們預計 24 財年不會如此強勁。

In addition, when you look at the advanced therapy market and the number of patients that still remain on conventional therapy, that there is still an opportunity for us to gain additional patients, particularly with our first-line position in the U.S.

此外，當你看到先進治療市場和仍在接受傳統治療的患者數量時，我們仍然有機會獲得更多患者，特別是考慮到我們在美國的第一線地位。

So all of these combined give us reason to believe that we can achieve the 16% growth in FY '24.

因此，所有這些加起來讓我們有理由相信我們可以在 24 財年實現 16% 的成長。

And Wakao-san, on mezagitamab or TAK-079, there's something quite unique about the depleting activity of this agent that goes far beyond the reductions that we're seeing in immunoglobulin and the best demonstration of that has been in ITP, where, as I mentioned, we see -- we do see reductions in immunoglobulins and -- but those are actually less than what's seen with the anti-FcRns and yet, in ITP, our data set, which we'll present this year and you'll have a chance to see that, is quite different than what's been seen with FcRns, both in terms of the magnitude of response in refractory patients as well as the rapidity of response. So there's no way to explain the rapid rebound in patients' platelet counts based solely on reductions of circulating pathological immunoglobulins. And I'm not sure that we fully understand what's driving that rapid and profound benefit, something that we're investigating.

Wakao-san，對於 mezagitamab 或 TAK-079，這種藥物的消耗活性有一些非常獨特的地方，遠遠超出了我們在免疫球蛋白中看到的減少，最好的證明是在 ITP 中，其中，我提到過，我們確實看到了免疫球蛋白的減少，但是這些實際上比抗FcRns 所看到的要少，但是，在ITP 中，我們的數據集，我們將在今年展示，您會有機會看到，無論是在難治性患者的反應幅度或反應速度方面，這與FcRns 所觀察到的情況有很大不同。因此，無法僅僅因為循環病理性免疫球蛋白的減少來解釋患者血小板計數的快速反彈。我不確定我們是否完全理解是什麼推動了我們正在研究的快速而深遠的效益。

And in refractory ITP, third line and some second-line patients, there really isn't a competitive agent. I think this is a real chance for us to offer significant benefits in a market that's much less competitive.

對於難治性 ITP、第三線和一些二線患者，確實沒有有競爭力的藥物。我認為這對我們來說是一個真正的機會，可以在競爭不那麼激烈的市場中提供顯著的優勢。

The profile of mezagitamab is further supported by what we've seen in IgAN. And there's not much I can share at this point more than what we've said based on the Ib data that we've shown. I can say that it is a very competitive landscape. And the data that we've seen with meza is on par or better than essentially anything that's been presented.

我們在 IgAN 中看到的情況進一步支持了 mezagitamab 的概況。在這一點上，除了我們根據我們展示的 Ib 數據所說的內容之外，我沒有什麼可以分享的。我可以說這是一個競爭非常激烈的環境。我們在 meza 上看到的數據與所提供的任何數據基本上相同或更好。

We're all still looking at relatively early data sets that are focused predominantly on a proxy measure of benefit in IgAN, which is proteinuria. I don't think we fully understand whether proteinuria will translate to preservation of renal function, which is going to be the clinical endpoint that will be most relevant in this patient population, and there are many different mechanisms of action. And we're the only CD38 depleting antibody that's progressing right now in IgAN. So I think that we have a chance to be quite competitive in this space, despite the large number of different agents that are being tested. It's also a relatively large market with very unmet medical need. So there's the potential for multiple different agents. Thank you.

我們仍在研究相對早期的數據集，這些數據集主要關注 IgAN 益處的代理衡量標準，即蛋白尿。我認為我們還沒有完全了解蛋白尿是否會轉化為腎功能的保留，這將是與該患者群體最相關的臨床終點，並且有許多不同的作用機制。我們是目前唯一在 IgAN 領域取得進展的 CD38 耗竭抗體。因此，我認為，儘管正在測試大量不同的代理，但我們有機會在這個領域具有相當的競爭力。這也是一個相對較大的市場，醫療需求尚未被滿足。因此，存在多種不同代理的潛力。謝謝。

Thank you. Moving to the next question, I'd like to call upon Tony Ren from Macquarie.

謝謝。轉到下一個問題，我想請麥格理的托尼·任 (Tony Ren) 發言。

Can you guys hear me?

你們聽得到我說話嗎？

Hi, Tony. Yes, we can hear you.

嗨，托尼。是的，我們能聽到你的聲音。

Okay. Perfect. Yes. So a couple of questions. So first one on your pipeline TAK-279, zasocitinib. It looks like the head-to-head psoriasis trial against so TYK2 is now delayed by about 2 to 4 quarters. I wanted to get some understanding on what's the thinking behind that.

好的。完美的。是的。有幾個問題。因此，您的管道 TAK-279 中的第一個產品是 zasocitinib。看起來針對 TYK2 的頭對頭銀屑病試驗現在推遲了大約 2 到 4 個季度。我想了解一下背後的想法。

In addition, this is a question on ENTYVIO, the effort to extend its loss of exclusivity, we've been seeing -- in the U.S., we've seen that they've been pretty -- getting increasingly tough on drug pricing and patent [ever grainy]. We see FTC taking some pretty tough actions. So how confident are you guys about extending the ENTYVIO loss of exclusivity into the 2030s? So that's the two for me.

此外，這是一個關於 ENTYVIO 的問題，我們一直在努力擴大其獨佔權的喪失，在美國，我們已經看到他們在藥品定價和專利方面變得越來越強硬。我們看到聯邦貿易委員會採取了一些相當嚴厲的行動。那麼，你們對於將 ENTYVIO 的獨家經營權延續到 2030 年代有多大信心呢？這就是我的兩個。

Okay. Thank you, Tony. So the question on zasocitinib, I'd like to ask Andy to comment on that, and then perhaps Ramona could add some color on the market opportunity for this program as well. And then the next question on ENTYVIO and our loss of exclusivity assumptions, particularly in the U.S., I'd like to ask Julie to comment on that. So first, Andy, please?

好的。謝謝你，托尼。關於 zasocitinib 的問題，我想請 Andy 對此發表評論，然後也許 Ramona 也可以為該專案的市場機會增添一些色彩。然後是關於 ENTYVIO 和我們失去排他性假設的下一個問題，特別是在美國，我想請朱莉對此發表評論。那麼首先，安迪，好嗎？

Thanks, Chris. Thanks, Tony. So we're not -- the head-to-head study, the timing of the head-to-head study is not delayed per se. Where -- the head-to-head study will not be necessary for filing. The filing in psoriasis would be based on the 2 LATITUDE Phase III studies. And what we're doing is we're still working the design of the head-to-head study to make it most relevant to physicians and patients to understand the differences between zaso [and ducra]. And we're just timing that study to have the data at the appropriate time point to support the launch of zaso.

謝謝，克里斯。謝謝，托尼。所以我們不是——頭對頭研究，頭對頭研究的時間本身並沒有延遲。其中——頭對頭研究不需要提交。牛皮癬的備案將基於兩項 LATITUDE III 期研究。我們正在做的是，我們仍在設計頭對頭研究，使其與醫生和患者最相關，以了解 zaso [和 ducra] 之間的差異。我們只是對該研究進行計時，以便在適當的時間點獲得數據來支持 zaso 的推出。

And then I'll hand it over to Ramona or Julie to comment on the competitiveness.

然後我會把它交給雷蒙娜或朱莉來評論競爭力。

Yes, I can do -- I can make some quick comments, Tony, on 279 and the plans that we have. And first of all, let me say that, that head-to-head trial remains an important part of our evidence package. So it's not registration enabling. So we -- there's no compromising to our time lines. But at the same time, we know we have a very, very strong product. We know the profile of 279 is 1.3 million fold greater binding for TYK2 versus JAK. And so we know that we can dose for efficacy, achieving favorable side effects, while decreasing the risk of nonselected JAK inhibition.

是的，我可以——托尼，我可以對 279 和我們的計劃發表一些簡短的評論。首先，我要說的是，面對面的審判仍然是我們證據包的重要組成部分。所以它不支援註冊。所以我們——我們的時間表不會妥協。但同時，我們知道我們擁有非常非常強大的產品。我們知道 279 對 TYK2 的結合力比 JAK 高 130 萬倍。因此我們知道我們可以根據療效進行劑量調整，實現有利的副作用，同時降低非選擇性 JAK 抑制的風險。

We saw from our Phase III trials that 1/3 of patients had clear skin in our Phase IIb. So we're pretty excited about moving ahead with our full package psoriasis, psoriatic arthritis, doing our work in UC and CD and the head-to-head versus [ducra] in psoriasis is a big part of that evidence package.

我們從 III 期試驗中看到，在 IIb 期試驗中，1/3 的患者皮膚狀況良好。因此，我們對繼續推進我們的全套銀屑病、銀屑病關節炎、UC 和 CD 方面的工作感到非常興奮，銀屑病方面的頭對頭與 [ducra] 是這個證據包的重要組成部分。

So our time lines are not compromised. We're staging the trials to complete them quickly, and we're moving ahead with that. Thank you.

所以我們的時間安排不會受到影響。我們正在組織試驗以快速完成它們，並且我們正在繼續前進。謝謝。

Tony, in terms of the question on the ENTYVIO LOE, our assumptions here have not changed in terms of when we expect that to occur. And part of this is driven by the patents that we have on ENTYVIO, but part of it is also driven by timing of the clinical trials needed by other companies in order to challenge ENTYVIO with the generic.

東尼，關於 ENTYVIO LOE 的問題，我們的假設在我們預期何時發生方面沒有改變。其中一部分是由我們在 ENTYVIO 上擁有的專利驅動的，但也有一部分是由其他公司所需的臨床試驗時間驅動的，以便用仿製藥挑戰 ENTYVIO。

And so given those combined data points, we believe that the LOE -- or the challenge from a generic would not occur until 2030 at the earliest and 2032 is what we've been communicating.

因此，考慮到這些綜合數據點，我們相信 LOE 或來自仿製藥的挑戰最早要到 2030 年才會出現，而我們一直在溝通的時間是 2032 年。

Thank you, Tony. Okay. Moving to the next question, I'd like to call upon Nomura Securities. I see a hand raised by Maeda-san or Matsubara-san.

謝謝你，托尼。好的。轉到下一個問題，我想請野村證券。我看到前田先生或鬆原先生舉起了手。

[Interpreted] I am Matsubara, Nomura Securities. Can you hear me okay?

[解讀]我是野村證券的松原。你聽得到我說話嗎？

Yes. Thank you.

是的。謝謝。

[Interpreted] The first question is about ENTYVIO. In your previous answer, we understand that ENTYVIO will grow. However, so far, during the COVID-19 pandemic or even after pandemic, the patients are not coming back. And what is the current situation?

【解讀】第一個問題是關於ENTYVIO的。在您先前的回答中，我們了解到 ENTYVIO 將會成長。然而，到目前為止，在 COVID-19 大流行期間甚至大流行之後，患者還沒有回來。目前情況如何？

Second question is about VYVANSE. Generics supply shortage, I think is still going on. And looking at FDA list, in April, May or maybe up to August, some genetics may be shipped out, but still there's a shortage. So this generics impact, how much do you think that it is expected in this new year?

第二個問題是關於VYVANSE的。我認為仿製藥供應短缺仍在持續。從 FDA 的清單來看，四月、五月甚至八月，有些基因可能會被運出，但仍有短缺。那麼這種仿製藥的影響，您認為在新的一年預計會產生多大的影響？

Thank you, Matsubara-san. So first question on ENTYVIO and whether patients are returning after coronavirus. And then the second question on VYVANSE generics and what our expectations are for generic supply in 2024. So I'd like to ask Julie to answer both of these questions.

謝謝你，松原同學。因此，關於 ENTYVIO 的第一個問題以及患者在感染冠狀病毒後是否會返回。然後是關於 VYVANSE 仿製藥的第二個問題以及我們對 2024 年仿製藥供應的預期。

Thank you, Matsubara-san for the questions. First, in terms of ENTYVIO, let me distinguish between ENTYVIO performance versus what the market performance has been. I think that is at the heart of your question.

謝謝松原先生的提問。首先，就ENTYVIO而言，讓我區分一下ENTYVIO的表現與市場表現。我認為這是你問題的核心。

So as we've shared before, when you look at certain factors like diagnosis rates, we do see that diagnosis rates, whether it's for UC, but particularly for CD, are much lower than what they were pre-pandemic. So the market growth overall has been slower than pre-pandemic. We estimate that the market growth for this past fiscal year was roughly just over 4% in terms of demand growth. And so we do expect that the market will continue to grow, albeit at a slower rate than it has historically.

正如我們之前分享的那樣，當你考慮診斷率等某些因素時，我們確實發現診斷率，無論是 UC 還是 CD，都比疫情前低得多。因此，整個市場的成長速度比疫情前還要慢。我們估計，就需求成長而言，上一財年的市場成長率大約略高於 4%。因此，我們確實預期市場將繼續成長，儘管成長速度低於歷史水準。

In terms of ENTYVIO's position within that, as mentioned before, we are holding on to our first -- sorry, our position in first-line in IBD overall as market share leader as well as bio-naïve starts.

就 ENTYVIO 在其中的地位而言，如前所述，我們正在保持我們的第一——抱歉，我們在 IBD 整體上作為市場份額領導者以及生物天然起步的一線地位。

In terms of your second question around VYVANSE generics supply. Let me start by saying we now have 10 generics that are on the market in the U.S. Initially, it started with 7, but now we have 10 generics on the market. The generics companies have experienced some supply challenges as noted on the FDA shortage website. But we do anticipate that going forward, the generics companies should be able to better supply the market.

關於您關於 VYVANSE 仿製藥供應的第二個問題。首先我要說的是，我們現在在美國市場上有 10 種仿製藥。正如 FDA 短缺網站指出的那樣，仿製藥公司遇到了一些供應挑戰。但我們確實預計，未來仿製藥公司應該能夠更好地供應市場。

So from a VYVANSE -- branded VYVANSE perspective, we are not experiencing any supply challenges, and we are able to provide VYVANSE -- branded VYVANSE to meet the demand that still exists in this market.

因此，從 VYVANSE——品牌 VYVANSE 的角度來看，我們沒有遇到任何供應挑戰，我們能夠提供 VYVANSE——品牌 VYVANSE 來滿足這個市場中仍然存在的需求。

Okay. Moving to the next question from UBS, Haruta-san.

好的。接下來轉向瑞銀的下一個問題，Haruta-san。

This is Kasumi Haruta from UBS. Can you hear me?

我是瑞銀集團的春田霞。你聽得到我嗎？

Yes, we can hear you. Please go ahead.

是的，我們能聽到你的聲音。請繼續。

Yes, I have two questions. First one is about the margin improvement program. I guess this program will start for March '26. How should we think about the improvement progress? Earlier timing after the start timing could be drastically changed or latter timing could be better margin improvement? How we should think about the improvement progress going forward?

是的，我有兩個問題。第一個是關於利潤改善計劃。我想這個計劃將於 26 年 3 月開始。我們該如何看待改進進度？開始時間後較早的時間可能會發生巨大變化，或者較晚的時間可能會更好地提高利潤率？我們該如何思考未來的改進進展？

And second one is on TAK-861. If I'm correct, I think Andy-san mentioned those will be the most lowest dose for the Phase III. So is that correct? And I assume from the abstract from the Sleep, there was no dose dependency results from the MWT endpoint. And I would like to know the reason or background of this dose dependency result.

第二個是 TAK-861。如果我是對的，我認為安迪先生提到這些將是第三階段的最低劑量。那麼這是正確的嗎？我從睡眠摘要中假設，MWT 終點沒有劑量依賴性結果。我想知道這種劑量依賴性結果的原因或背景。

Thank you, Haruta-san. So the first question around the margin improvement, I'd like to ask Milano to comment on that. And then Andy, on 861 dosing. Milano?

謝謝你，春田同學。關於利潤率改善的第一個問題，我想請米蘭對此發表評論。然後是安迪，服用 861 劑量。米蘭？

Thank you, Haruta-san. So the -- let me clarify again, the -- so the baseline or starting point for the margin improvement will be FY '24. And then from there and '25 onwards, we are -- we intend to improve 100 to 250 basis points each year. So it's going to -- '25 OP margin will be better than '24 and then onwards. So you can count like that. It's not starting from '26 and onwards. From baseline from '24 and improving from FY '25. Is that clear?

謝謝你，春田同學。因此，讓我再次澄清一下，利潤率改善的基線或起點將是 24 財年。然後從那時起，從 25 年開始，我們打算每年提高 100 到 250 個基點。因此，'25 年的 OP 利潤率將比 '24 年及以後的情況更好。所以你可以這樣算。這不是從26年開始的。從 24 年的基線開始，從 25 財年開始有所改善。明白了嗎？

Yes, it has a range for 100 to 25 drug 250 bps. So I wanted to more know about how skewed that margin improvement is progress or drastically changed from the beginning or latter timing will be more uptick for the improvement?

是的，它的範圍為 100 至 25 個藥物 250 bps。因此，我想更多地了解利潤率改善是如何傾斜的，或者從一開始就發生了巨大的變化，或者後期的改善會更加明顯？

Thank you. So the -- we start program from this fiscal year, and we expect the sort of benefit of this program will gradually increase toward '25, '26. So the reason why we gave EBITDA the range from 100 basis points to 250 basis points is we expect at this moment, EBIT margin improvement will be bigger in FY '26 than FY '25.

謝謝。因此，我們從本財年開始實施該計劃，我們預計該計劃的效益將在 25 年、26 年逐漸增加。因此，我們之所以給 EBITDA 範圍從 100 個基點到 250 個基點，是因為我們目前預計 26 財年的 EBIT 利潤率改善將比 25 財年更大。

And Haruta-san on 861, I didn't mean to suggest that there isn't dose responsiveness in our 861 data and -- but -- so the good news is that in 3 weeks, we'll have a chance to dive deep into all of the data. So I'm not going to really try to unpack that here today. But I will say that -- and I'm not going to comment on -- I can't comment on our Phase III dose at this point. We're still working through the design and having discussions with regulatory authorities. And it's also something that we'll look at as quite competitive. But I will say that our Phase IIb study was designed and we never use the word perfect, but almost perfectly to really help us understand how to move forward into Phase III with the dose that we think will thread the needle in terms of maximal efficacy in type 1 narcolepsy and the best safety and tolerability.

Haruta-san 關於 861，我的意思並不是說我們的 861 數據中沒有劑量反應性，而且——但是——所以好消息是，在 3 週內，我們將有機會深入研究到所有數據中。所以我今天不會真正嘗試在這裡解開它。但我要說的是——我不會發表評論——我目前無法評論我們的第三階段劑量。我們仍在完成設計並與監管機構進行討論。我們認為這也是非常有競爭力的。但我要說的是，我們的IIb 期研究是經過精心設計的，我們從不使用完美這個詞，而是幾乎完美地真正幫助我們理解如何以我們認為將在最大功效方面發揮作用的劑量進入III期。

Okay. I think we have time for one final question. So I'd like to ask SMBC Nikko, Wada-san.

好的。我想我們還有時間回答最後一個問題。所以我想問SMBC日興和田先生。

[Interpreted] Wada-san, SMBC Nikko Securities. Can you hear me?

[解釋]和田先生，SMBC日興證券。你聽得到我嗎？

Yes.

是的。

[Interpreted] Well, there are two questions I'd like to ask. As for research and development pipeline, you have been selective in prioritization. So impairment losses has been completed in fiscal 2023. Is that correct? And how would you plan to have R&D played out for the next 5 years? Are you going to expect this to be flat? That's my first question.

[翻譯]嗯，我想問兩個問題。至於研發管道，你們在優先順序上是有選擇性的。那麼減損損失已在 2023 財年完成。您計劃如何在未來 5 年內開展研發？您預計會持平嗎？這是我的第一個問題。

And second question, 861 successor, 360 positioning. You're aiming for NT2, but 861 is for NT1. So there is a differentiation and you're aiming for NT2 for 360, but in terms of advantage of the agent, is there any evidence that you see that this will be effective in NT2? But NT2, orexin is not that much playing a role, so orexin agonist, is that really effective in addressing NT2? That's my question.

還有第二個問題，861的繼任者，360的定位。您的目標是 NT2，但 861 是 NT1。因此，存在差異化，您的目標是 NT2 for 360，但就代理的優勢而言，是否有任何證據表明您認為這在 NT2 中有效？但NT2，食慾素並沒有那麼大的作用，那麼食慾素激動劑，真的能有效解決NT2嗎？這就是我的問題。

Costs related to R&D prioritization and our R&D expense outlook going forward, I'd like to ask Milano to answer that question. And then the second question on positioning of TAK-360, I'd like to ask Andy to comment what have we seen that suggests that it could work in NT2? And what is the hypothesis behind orexin agonists working in NT2 when these patients already have orexin circulating in their brains? So I'd like Milano first question; Andy, second question, please.

與研發優先順序相關的成本以及我們未來的研發費用前景，我想請米蘭回答這個問題。然後是關於 TAK-360 定位的第二個問題，我想請 Andy 評論一下我們看到了什麼表明它可以在 NT2 中工作？當這些患者的大腦中已經有食慾素循環時，食慾素激動劑在 NT2 中起作用的假設是什麼？我想請米蘭提出第一個問題；安迪，請提出第二個問題。

[Interpreted] Thank you very much for your question, Mr. Wada. For the first question, we have done the implemented program to prioritize the programs and impairment losses were booked and winding down costs were booked in FY '23. Almost all were booked in FY '23. And going forward, for the budget of R&D. in terms of our prospects, gradually, there will be an increasing trend in line with the increase in revenue. So we are mostly in line with the increase in revenue. That's how we are going to manage R&D investments. So in terms of percentage of revenue, or OP margin, it is going to be neutral.

[翻譯]非常感謝和田先生的提問。對於第一個問題，我們已經完成了已實施的計劃，以確定計劃的優先順序，並在 23 財年記入了減損損失和清算成本。幾乎所有訂單均在 23 財年預訂。展望未來，研發預算。從我們的前景來看，隨著收入的增加，逐漸會有增加的趨勢。所以我們基本上是與收入的成長保持一致。這就是我們管理研發投資的方式。因此，就收入百分比或營運利潤率而言，它將是中性的。

[Interpreted] So does that mean that going forward, you are going to see the improvement in margin, OP margin? So that means that you are going to reduce COGS and SG&A?

[解讀] 那麼這是否意味著，展望未來，您將看到利潤率、OP 利潤率的改善？這意味著您將減少 COGS 和 SG&A？

[Interpreted] Yes, that's correct. Thank you.

[解釋] 是的，沒錯。謝謝。

Wada-san, this is Andy. We've -- over the past several years with multiple molecules, we've demonstrated that orexin agonist can be effective in NT1 as well as a range of sleep-wake cycle disorders that are characterized by normal orexin levels. So NT1 is orexin deficient and all of the other indications that we talked about, including type 2 narcolepsy and idiopathic hypersomnia have normal orexin levels. So there's a very different disease etiology and the pharmacology is quite different.

和田先生，這是安迪。在過去的幾年裡，我們透過多種分子證明了食慾素激動劑可以有效治療 NT1 以及一系列以正常食慾素水平為特徵的睡眠-覺醒週期障礙。因此，NT1 缺乏食慾素，而我們討論的所有其他症狀，包括 2 型發作性睡病和特發性嗜睡症，都具有正常的食慾素水平。因此，疾病的病因非常不同，藥理學也非常不同。

We have the most experience with type 1 narcolepsy. And I'll add something I haven't mentioned, which is that we have now an open -- an ongoing open-label extension study with 861 in type 1 narcolepsy. And we've now seen data for most patients up to 6 months and now some patients up to a year and those data will be presented later in the year, but we continue to see sustained, durable, robust efficacy.

我們對第 1 型發作性睡病擁有最多的經驗。我要補充一些我沒有提到的內容，那就是我們現在有一項開放的——一項正在進行的開放標籤擴展研究，涉及 861 名 1 型發作性睡病患者。我們現在已經看到大多數患者長達 6 個月的數據，現在一些患者長達一年的數據，這些數據將在今年稍後公佈，但我們仍然看到持續、持久、穩健的療效。

There's still a lot for us to learn in type 2 narcolepsy in idiopathic hypersomnia. We've seen benefits in short-term therapy. The sustainability of those benefits over time is something that we'll have to demonstrate in clinical trials. And so we've made the decision for 861 to really focus on type 1 narcolepsy. 360 was developed purposefully and is differentiated from 861. And we believe, based on our understanding of its profile preclinically and our translational understanding of this mechanism, that it will be effective in type 2 narcolepsy and idiopathic hypersomnia, and that's what we're focused on is moving as fast as possible to get those data and to accelerate it to patients.

關於特發性嗜睡症的 2 型發作性睡病，我們還有很多東西要了解。我們已經看到了短期治療的好處。隨著時間的推移，這些益處的可持續性是我們必須在臨床試驗中證明的。因此，我們決定 861 真正關注 1 型發作性睡病。 360 是有目的地開發的，與861 不同。我們關注的重點on 正在盡快獲取這些數據並加速將其提供給患者。

Thank you. With that, we've now reached the end of call. Thank you, everyone, for attending. And if you have any follow-up questions, please reach out to the Investor Relations team. Thank you very much, and good night, good day.

謝謝。至此，我們的通話就結束了。謝謝大家的出席。如果您有任何後續問題，請聯絡投資者關係團隊。非常感謝，晚安，美好的一天。

[Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]

[本文字記錄中標記為[已翻譯]的部分是由現場通話中的口譯員朗讀的。