Takeda Pharmaceutical Co Ltd (TAK) 2025 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Thank you very much for taking time out of their busy schedule to join our earnings announcement for FY24 for Takeda. I'm the master of ceremony, Head of IR. My name is O'Reilly. Thank you for this opportunity. (Event Instructions)

    (翻譯) 非常感謝您在百忙之中抽空參加我們武田 24 財年的收益公告。我是司儀、投資者關係主管。我的名字是奧萊利。感謝您給我這個機會。(活動須知)

  • And before starting, I'd 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 the most recent Form 20-F and 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》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。可能導致我們的實際結果出現重大差異的因素已在最新的 20-F 表格和我們向美國證券交易委員會提交的其他文件中進行了討論。

  • Please also refer to the important notice on Page 2 of the presentation regarding forward-looking statements and our non-IFRS financial measures, which will also be discussed during this call. Definitions of our non-IFRS measures and the reconciliation with the comparative IFRS financial measures are included in the appendix in the presentation. Please also refer to Page 2 for important reference.

    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,這些內容也將在本次電話會議中討論。我們的非國際財務報告準則 (IFRS) 指標的定義以及與比較國際財務報告準則 (IFRS) 財務指標的調節包含在簡報的附錄中。另請參閱第 2 頁以取得重要參考。

  • Moving on to today's presentation. Today, we have President and CEO, Christophe Weber; Chief Financial Officer, Milano Furuta; President, R&D, Andy Plump presenting to you today. And this will be followed by question-and-answer. Let us get started. Christophe, over to you.

    繼續今天的演講。今天,我們請到了總裁兼執行長 Christophe Weber;米蘭古田財務長;研發總裁 Andy Plump 今天要為大家演講。接下來是問答環節。讓我們開始吧。克里斯托夫,交給你了。

  • Christophe Weber - President, Chief Executive Officer, Representative Director

    Christophe Weber - President, Chief Executive Officer, Representative Director

  • So Thank you, Chris, and thank you, everyone, for joining us today. If we go to the first slide, yes, our fiscal-year 2024 performance was driven by a combination of factors, significant generic impact from VYVANSE loss of exclusivity, strong momentum in our Growth and Launch Product portfolio, which more than offset the generic impact, and robust OpEx control, which helped grow our core operating profit margin.

    所以謝謝你,克里斯,也謝謝大家今天加入我們。如果我們看第一張投影片,是的,我們 2024 財年的業績受到多種因素的推動,VYVANSE 失去獨佔權對仿製藥產生了重大影響,我們的成長和發布產品組合勢頭強勁,足以抵消仿製藥的影響,以及強大的營運支出控制,這有助於提高我們的核心營業利潤率。

  • We also demonstrated the potential of our pipeline with accelerated progress in late-stage programs. Looking at our financial results, fiscal-year '24 core revenue grew 2.8% at constant exchange rate, driven by our Growth and Launch Product, which grew 14.7%. This portfolio of product now accounts for 48% of Takeda total core revenue.

    我們也透過後期專案的加速進展展示了我們管道的潛力。從我們的財務表現來看,24 財年核心營收以固定匯率計算成長了 2.8%,這得益於我們的成長和發布產品成長了 14.7%。該產品組合目前佔武田核心總收入的48%。

  • Our core operating profit for the full year was JPY1.2 billion, representing growth of 4.9% at constant exchange rate. Core EPS fell slightly short of our upgraded guidance due mainly to higher-than-anticipated tax expense.

    我們全年核心營業利潤為12億日元,以固定匯率計算成長4.9%。核心每股盈餘略低於我們上調的預期,主要原因是稅費高於預期。

  • Core operating profit margin was 25.4%. This was more than 2 percentage points above our original expectation and represent growth of 65 basis points compared with the previous fiscal year or 270 basis points if we exclude VYVANSE impact. Significant OpEx savings resulting from our multiyear efficiency programs were an important driver of core operating profit and margin growth.

    核心營業利益率為25.4%。這比我們最初的預期高出 2 個百分點以上,與上一財年相比增長了 65 個基點,如果不考慮 VYVANSE 的影響,則增長了 270 個基點。我們多年的效率計劃帶來的大量營運支出節省是核心營運利潤和利潤率成長的重要驅動力。

  • Milano will provide an update on the efficiency program in his presentation. In addition, we continue to progress our late-stage pipeline in fiscal-year '24, supporting our future growth. We now have six Phase 3 programs underway across our core therapeutic areas.

    米蘭諾將在演講中提供有關效率計劃的最新資訊。此外,我們在 24 財年將繼續推動後期研發管線,以支持我們未來的成長。目前,我們在核心治療領域有六個 3 期研究計畫正在進行中。

  • In March, we read out positive and highly promising top line results from a Phase 3 study of rusfertide in Polycythemia Vera, a rare form of blood cancer. During fiscal-year 2024, we also completed Phase 3 enrollment for zasocitinib in psoriasis and oveporexton in narcolepsy type 1.

    3 月份,我們讀到了 rusfertide 治療真性紅血球增多症(一種罕見的血癌)的 3 期研究的積極且極具前景的頂線結果。在 2024 財年,我們也完成了 zasocitinib 治療乾癬和 oveporexton 治療 1 型嗜睡症的 3 期臨床試驗招募。

  • These are on track for data readout in this year with target filing date in fiscal-year '25 and '26. We are excited by the opportunities in our pipeline. This differentiated product has the potential to transform the life of patients in each of our therapeutic focus areas. Turning to slide 5. We achieved strong performance across our Growth and Launch Product portfolio.

    這些數據將在今年內公佈,目標提交日期為 25 和 26 財年。我們對於我們面臨的機會感到非常興奮。這種差異化產品有可能改變我們每個治療重點領域的患者的生活。翻到幻燈片 5。我們的成長和發布產品組合均取得了強勁的業績。

  • This life-transforming treatment now account for 48% of our revenue and achieved double-digit revenue growth of 14.7% at constant exchange rate. TAKHZYRO, an immunoglobulin continued their strong growth at 19% and 12%, respectively, and newly launched products FRUZAQLA and ADZYNMA had impressive uptake exceeding revenue expectation.

    這種改變生活的治療方法目前占我們收入的48%,以固定匯率計算實現了14.7%的兩位數收入成長。免疫球蛋白TAKHZYRO持續保持強勁成長,成長率分別為19%和12%,新推出的產品FRUZAQLA和ADZYNMA的銷售量令人印象深刻,超過了收入預期。

  • QDENGA also continues its excellent launch trajectory with strong demand in both endemic and travel market. Although ENTYVIO revenue performance has been below our expectation in fiscal-year 2024, we are still growing above market, and growth momentum is building with the expansion of ENTYVIO PEN. The reason for this underperformance in the US is that we underestimated the challenge associated with the changing US access landscape.

    QDENGA 也延續了其出色的發布軌跡,在本土市場和旅遊市場均有強勁需求。儘管 ENTYVIO 的營收表現在 2024 財年低於我們的預期,但我們的成長速度仍然高於市場,而且隨著 ENTYVIO PEN 的擴張,成長勢頭正在增強。在美國表現不佳的原因是我們低估了美國接入格局變化所帶來的挑戰。

  • The pen is a new formulation without extra cost for payers but is in a different insurance plan compared to the IV formulation, which has been covered for the past 10 years. As a result, it has taken longer than expected to gain easy access for patients and we are, therefore, still working to improve reimbursement and authorization pathways for patients. On the other hand, prescriber and patient feedback on the pen has been extremely positive, which, once access becomes seamless, will bode well for the future of the pen and ENTYVIO.

    該注射筆是一種新劑型,無需支付額外費用,但與過去 10 年一直受保險覆蓋的靜脈注射劑型相比,其保險計劃不同。因此,為患者提供便利的醫療服務所需的時間比預期的要長,因此,我們仍在努力改善患者的報銷和授權途徑。另一方面,處方醫生和患者對該注射筆的反饋非常積極,一旦實現無縫銜接,這將預示著該注射筆和 ENTYVIO 的未來前景光明。

  • We expect ENTYVIO to maintain its market share leadership and grow faster than the market even as treatment option in the IBD market are increasing. We are, of course, leveraging that -- what we have learned from this experience as we prepare for new pipeline launches.

    我們預計,即使 IBD 市場的治療選擇不斷增加,ENTYVIO 仍將保持其市場份額領先地位,並且成長速度快於市場。當然,我們正在利用從這次經驗中學到的知識來為新管道的推出做準備。

  • Albumin growth in fiscal-year '24 was impacted by plan upgrade to manufacturing operation as well as lower demand in China, but we anticipate a return to growth trajectory of high single digit in fiscal-year '25. We expect overall this Growth and Launch Product portfolio to support revenue and profit resilience through the final year of substantial VYVANSE erosion in fiscal-year '25, and continue to drive our growth agenda through the end of the decade. Turning to slide 6.

    24財年的白蛋白成長受到製造營運計畫升級以及中國需求下降的影響,但我們預計25財年將恢復高個位數的成長軌跡。我們預計,總體而言,這一成長和發布產品組合將在 25 財年 VYVANSE 大幅下滑的最後一年支持收入和利潤的恢復,並繼續推動我們的成長議程直至本世紀末。翻到幻燈片 6。

  • I will discuss our position within the recently evolving tariff landscape. Note that our fiscal-year '25 guidance does not include potential tariff impact on pharmaceutical products. This is because while the situation remained dynamic, based on what we know today, we believe that our likely potential exposure to US and China tariff is limited. Tariff exposure is determined by how much of total revenue comes from imports, manufacturing site location and country of origin, and transfer pricing policy.

    我將討論我們在最近演變的關稅格局中的立場。請注意,我們的 25 財年指引不包括關稅對藥品的潛在影響。這是因為,儘管情況仍在動態變化,但根據我們目前所了解的情況,我們認為我們受到美國和中國關稅影響的可能性有限。關稅風險取決於總收入中有多少來自進口、製造地點和原產國以及轉讓定價政策。

  • This map illustrates Takeda internal global manufacturing footprint. We have 20 manufacturing sites that supply the US, which are shown in bold on the map. Seven of these sites are located in the United States. The others are in Europe, Japan and Singapore. Our strategic contract manufacturers, which we use for about 20% of our production, are distributed across the US, Europe and Japan.

    這張地圖展示了武田內部的全球製造足跡。我們有 20 個為美國供貨的製造基地,在地圖上以粗體顯示。其中七個站點位於美國。其餘的則位於歐洲、日本和新加坡。我們的戰略合約製造商分佈在美國、歐洲和日本,約占我們生產的 20%。

  • And approximately 70% of our global CMOs cost is with US-based CMOs. Our own manufacturing facility in China supports only our business in China. You can see from the map that we have historically invested significantly in the US, and our investments are not limited to manufacturing.

    我們全球 CMO 成本的約 70% 來自美國的 CMO。我們在中國自己的製造工廠僅支持我們在中國的業務。從地圖上可以看出,我們歷來在美國進行了大量投資,而且我們的投資不僅限於製造業。

  • We also have a vast network of BioLife Plasma donation center as well as the majority of our R&D spend and functions located in the US Note that based on our current strategy alone, we currently plan to invest about USD30 billion in the next five years in the US.

    我們還擁有龐大的 BioLife 血漿捐贈中心網絡,而我們的大部分研發支出和功能都位於美國。請注意,僅基於我們目前的策略,我們目前計劃在未來五年內在美國投資約 300 億美元。

  • This reflects the fact that the US is the world's leading market for a biopharmaceutical innovation-focused company like Takeda, and I hope that will continue. To roughly quantify the scope of our business -- of our US business subject to potential tariff, please note that while approximately 50% of total revenue is from the US, the custom value of import into the US is only about 8% to 10% of our total US revenue.

    這反映出美國是武田等專注於生物製藥創新的公司在全球領先的市場,我希望這種情況能持續下去。粗略量化我們的業務範圍——我們的美國業務可能受到關稅的影響,請注意,雖然約有 50% 的總收入來自美國,但進口到美國的關稅價值僅占我們美國總收入的 8% 至 10%。

  • Of note, our largest product by revenue in the US, ENTYVIO, is 100% US country of origin. The custom value of US origin product that we ship to China is about 12% to 15% of our China revenue.

    值得注意的是,我們在美國收入最高的產品 ENTYVIO 100% 原產於美國。我們運往中國的美國原產產品的海關價值約占我們中國收入的 12% 至 15%。

  • But while China is a very important business in our overall business, it is growing rapidly. China revenue today is still a significantly smaller percentage of overall company revenue at approximately 4%. We continue to monitor the global tariff situation closely.

    儘管中國市場是我們整體業務中非常重要的市場,但它的成長速度非常快。目前,中國市場收入占公司整體收入的比例仍然很小,約 4%。我們將繼續密切關注全球關稅情況。

  • Until more is known, it will be difficult to predict the total impact with certainty. But like all global company, we are looking across our global supply chain and taking mitigation measures for import that may be subject to potential tariff impact.

    除非了解更多信息,否則很難準確預測整體影響。但與所有全球性公司一樣,我們正在審視我們的全球供應鏈,並針對可能受到潛在關稅影響的進口採取緩解措施。

  • Turning to the next slide. We are excited for the future and expect '25 to be a pivotal year for Takeda as we advance our late-stage pipeline and prepare for new launches. Key milestone already include very positive top line results for a Phase 3 study of rusfertide.

    翻到下一張投影片。我們對未來充滿期待,並預計 25 年將成為武田的關鍵一年,因為我們將推進後期產品線並為新產品的推出做好準備。關鍵里程碑已經包括 rusfertide 第三階段研究的非常積極的頂線結果。

  • Andy will introduce the top line results later, but the efficacy was at the high end of what we had been hoping for, with a tolerable safety profile. This reinforces our optimism about peak revenue potential of $1 billion to $2 billion that we introduced at our R&D Day last year.

    安迪稍後會介紹最重要的結果,但其療效已經達到了我們所希望的高端,並且具有可容忍的安全性。這加強了我們在去年研發日上提出的 10 億至 20 億美元高峰收入潛力的樂觀情緒。

  • In 2025, we'll review one-year safety and durability of response data prior to submitting this very promising therapy for FDA review. During fiscal-year '24, we also completed Phase 3 enrollment for zasocitinib and oveporexton, which are on track for data readout this year.

    2025 年,我們將在提交這種非常有前景的療法供 FDA 審查之前,審查一年的安全性和反應持久性數據。在 24 財年,我們也完成了 zasocitinib 和 oveporexton 的 3 期臨床試驗招募,預計今年公佈數據。

  • Oveporexton is on track to be a first-in-class orexin agonist to address the underlying orexin deficiency that causes Narcolepsy Type 1. It has a potential to deliver a new era of care with transformative outcomes for people living with Narcolepsy Type 1. Phase 3 recruitment completed ahead of projection, and data readout is expected in the first half of fiscal-year '25.

    Oveporexton 有望成為一流的食慾素激動劑,以解決導致 1 型嗜睡症的潛在食慾素缺乏症。它有可能為患有 1 型嗜睡症的人們帶來具有變革性結果的全新護理時代。第三階段招募工作提前完成,預計 25 財年上半年公佈數據。

  • This could be a $2 billion to $3 billion peak revenue product in narcolepsy type I. Next, zasocitinib is a highly selective oral TYK2 inhibitor that could offer a great treatment option for patients with psoriasis, psoriatic arthritis and other immune-related inflammatory disease. Currently, we are conducting Phase 3 trial of psoriasis and psoriatic arthritis with the first dosing for psoriatic arthritis starting in March this year.

    這可能是 I 型嗜睡症治療領域中收入高峰為 20 億至 30 億美元的產品。其次,扎索替尼是一種高選擇性口服 TYK2 抑制劑,可以為牛皮癬、銀屑病關節炎和其他免疫相關發炎疾病患者提供極佳的治療選擇。目前,我們正在進行銀屑病和銀屑病關節炎的 3 期試驗,針對銀屑病關節炎的首次給藥將於今年 3 月開始。

  • We are looking forward to sharing the top line results of our Phase 3 trial for psoriasis later this year, followed by a regulatory submission in fiscal year 2026. Shifting to our financial outlook for '25 -- fiscal-year '25, we expect broadly flat revenue, core operating profit and core EPS at constant exchange rate.

    我們期待在今年稍後分享牛皮癬 3 期試驗的最終結果,並在 2026 財年提交監管提交。轉向我們對 25 財年的財務展望,我們預計以固定匯率計算,營收、核心營業利潤和核心每股盈餘將基本持平。

  • Our revenue outlook reflects continued momentum in our Growth and Launch Product, offsetting the carryover of VYVANSE decline into fiscal-year 2025. This should be the final year of significant impact from VYVANSE generics.

    我們的營收前景反映了我們成長和推出產品的持續勢頭,抵消了 VYVANSE 下滑對 2025 財年的影響。這應該是 VYVANSE 仿製藥產生重大影響的最後一年。

  • Our profit guidance reflects anticipated gain from our efficiency program as well as increased investment in R&D, data on technology and new launch preparation for our late-stage pipeline program. Finally, in line with our progressive dividend policy, I am pleased to announce a further dividend increase to JPY200 per share.

    我們的利潤預期反映了我們效率計劃的預期收益,以及對研發、技術數據和後期管道計劃新發布準備的增加的投資。最後,根據我們的漸進式股利政策,我很高興地宣布股利進一步增加至每股 200 日圓。

  • With that, I will turn the call over to Milano to review our financial performance and guidance in more details.

    接下來,我將把電話轉給米蘭諾,讓他更詳細地審查我們的財務表現和指導。

  • Milano Furuta - Chief Financial Officer, Director

    Milano Furuta - Chief Financial Officer, Director

  • Thank you, Christophe. Hi, everyone. This is Milano Furuta speaking. So slide 10 summarizes our financial results for FY 2024. Reported revenue was JPY4.58 trillion with growth of 7.5% versus prior year. Core revenue, which includes a small adjustment related to divestiture of Takeda-Teva JV in Japan grew 7.4% at actual FX or 2.8% at CER or constant exchange rate.

    謝謝你,克里斯托夫。大家好。我是 Milano Furuta。投影片 10 總結了我們 2024 財年的財務表現。報告收入為4.58兆日元,較上年增長7.5%。核心收入(包括與日本武田-梯瓦合資公司剝離相關的小幅調整)以實際匯率計算成長 7.4%,以 CER 或固定匯率計算成長 2.8%。

  • Core operating profit or core OP was JPY1.16 trillion, a year-on-year increase of 10.2% at actual FX or 4.9% at CER. Our core operating profit margin was 25.4%, improving versus prior year despite gross margin pressure from VYVANSE loss of exclusivity. This reflects OpEx discipline through an enterprise-wide efficiency program. Reported operating profit was JPY342.6 billion, which grew 60%.

    核心營業利潤或核心營業利潤為 1.16 兆日元,以實際匯率計算年增 10.2%,以固定匯率計算成長 4.9%。我們的核心營業利潤率為 25.4%,儘管 VYVANSE 失去獨家經營權給毛利率帶來壓力,但比去年有所提高。這透過企業範圍的效率計劃反映了 OpEx 紀律。報告的營業利潤為3426億日元,成長60%。

  • Core EPS and reported EPS were JPY491 and JPY68, respectively, with both impacted by higher tax expenses compared to the prior year. Operating cash flow was over JPY1 trillion, and adjusted free cash flow was JPY769 billion.

    核心每股盈餘和報告每股盈餘分別為 491 日圓和 68 日圓,均受到與前一年相比更高的稅費的影響。經營現金流超過1兆日圓,調整後自由現金流為7,690億日圓。

  • Our strong cash flow performance reflected core OP growth, lower cash taxes and less business development spend compared to the prior year. Slide 11 shows our performance versus management guidance. We upgraded our guidance twice during the fiscal year to reflect the product momentum, including VYVANSE and OpEx management through our efficiency program.

    我們強勁的現金流表現反映了核心營業利潤的成長、現金稅的降低以及業務開發支出與去年相比的減少。幻燈片 11 展示了我們的業績與管理指導。我們在本財政年度兩次上調了我們的指導方針,以反映產品勢頭,包括 VYVANSE 和透過我們的效率計劃進行的 OpEx 管理。

  • Compared to our latest guidance from Q3, core revenue delivered as planned, and core operating profit was at the high end of our guidance due to continued OpEx efficiency. Core EPS, while ahead of our original guidance, landed slightly below the latest guidance mainly because of higher-than-anticipated tax expenses. This was due to several factors including an increase in the US international tax provision and the lower-than-anticipated R&D tax credits. Slide 12.

    與我們第三季的最新預期相比,核心收入按計劃實現,並且由於持續的營運支出效率,核心營業利潤處於我們預期的高端。核心每股盈餘雖然高於我們最初的預期,但略低於最新預期,主要是因為稅金高於預期。這是由於多種因素造成的,包括美國國際稅收準備金的增加以及研發稅收抵免低於預期。幻燈片 12。

  • Last year, we initiated an enterprise-wide program to drive efficiencies across the organization. Its execution has been fully on track, and we have captured approximately JPY200 billion in annualized savings to date. About 65% of savings are from compensation and benefits, with 3,000 positions impacted to date approximately as well as further efforts to optimize organizational agility.

    去年,我們啟動了一項企業範圍的計劃,以提高整個組織的效率。該專案的執行情況已完全步入正軌,迄今為止我們已實現年化節省約2000億日元。約 65% 的節省來自薪資和福利,迄今為止約有 3,000 個職位受到影響,同時也進一步努力優化組織敏捷性。

  • About 20% of savings came from procurement initiatives across the value chain. The remaining 15% is from other areas such as rationalization of activities across sales and marketing through R&D, and savings in facilities and equipment with site optimizations, including the San Diego research site.

    約 20% 的節省來自整個價值鏈的採購措施。剩餘的 15% 來自其他領域,例如透過研發合理化銷售和行銷活動,以及透過場地優化(包括聖地牙哥研究基地)節省設施和設備。

  • Restructuring costs for the year were JPY128.1 billion, slightly below our forecast of JPY140 billion. This efficiency program enabled us to reduce OpEx spend in FY24 and frees up resources to advance our pipeline, prepare for new product launches and further build our digital technology capabilities. From Slide 13, I'll explain more about year-on-year growth dynamics in FY24. First, revenue. Our Growth and Launch Products, which grew 14.7% more than offset the loss of exclusivity impact mainly from VYVANSE and ADDERALL XR in the US

    全年重組成本為 1,281 億日元,略低於我們預測的 1,400 億日元。這項效率計劃使我們能夠減少 24 財年的營運支出,並釋放資源來推進我們的產品線,為新產品的發布做準備,並進一步建立我們的數位技術能力。從第 13 張投影片開始,我將詳細解釋 24 財年的年成長動態。第一,收入。我們的成長和上市產品成長了 14.7%,抵消了主要來自美國 VYVANSE 和 ADDERALL XR 的獨家經營權損失的影響

  • and AZILVA in Japan. Net positive growth in other brands such as GATTEX, TRINTELLIX, ADCETRIS and ICLUSIG also contributed to 2.8% revenue growth at CER. On actual FX basis, yen depreciation gave additional revenue lift by JPY195 billion. Finally, this year, we recognized JPY1.7 billion of deferred revenue related to the divestiture of Takeda-Teva JV in Japan. This is noncore income that we adjust out of our core revenue results.

    以及日本的 AZILVA。GATTEX、TRINTELLIX、ADCETRIS 和 ICLUSIG 等其他品牌的淨正成長也促進了 CER 2.8% 的營收成長。以實際匯率計算,日圓貶值使收入額外增加1,950億日圓。最後,今年我們確認了與日本武田-梯瓦合資企業剝離相關的17億日圓遞延收入。這是我們從核心收入結果中調整出來的非核心收入。

  • Slide 14 shows the year-on-year bridge for core operating profit. Gross profit slightly increased with momentum across our portfolio, offsetting the LOE impact of high-margin products such as VYVANSE. Moving to OpEx.

    投影片 14 顯示了核心營業利潤的年比變化。隨著我們整個產品組合的強勁成長,毛利略有增加,抵消了 VYVANSE 等高利潤產品的 LOE 影響。轉向 OpEx。

  • You can see that we have already realized savings from the efficiency program in FY24, gross savings of approximately JPY150 billion. We are directing those savings toward investments in our late-stage pipeline, new product launch preparations and offsetting inflationary increases.

    您可以看到,我們已經透過 2024 財年的效率計劃實現了節省,總節省額約為 1500 億日元。我們將把這些節省下來的資金用於後期研發線的投資、新產品的發布準備以及抵消通貨膨脹的影響。

  • Overall, core OP grew by 4.9% at CER or 10.2%, including the benefit from FX. Next, reported operating profit. In addition to core OP growth, the 60% increase was due to lower impairment cost and net benefit in other operating income and expenses, and then FX.

    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 4.9%,即成長了 10.2%。接下來是報告的營業利益。除了核心營業利潤成長外,60% 的成長還歸因於其他營業收入和支出中的減損成本和淨收益降低,以及外匯影響。

  • Next is our cash flow analysis on Slide 16. Free cash flow was JPY769 billion, reflecting strong operating cash flow of over JPY1 trillion, approximately JPY350 billion of CapEx and JPY57.6 billion of proceeds from the sale of the Takeda-Teva JV.

    接下來是投影片 16 上的現金流分析。自由現金流為 7,690 億日元,反映出超過 1 兆日圓的強勁經營現金流、約 3,500 億日圓的資本支出以及出售武田-梯瓦合資企業所得的 576 億日圓收益。

  • This exceeded our forecast of JPY550 billion to JPY650 billion due to lower CapEx and cash taxes on top of higher core operating profit. Our free cash flow comfortably covered our dividend and interest payments with excess cash put toward debt paydown and share buyback. This chart reflects JPY51.9 billion on buybacks completed by the end of March. In April, we also finished the rest of the JPY100 billion buyback announced at Q3 earnings. Slide 17 shows our change in adjusted net debt.

    由於資本支出和現金稅降低以及核心營業利潤增加,這一數字超過了我們預測的 5,500 億至 6,500 億日圓。我們的自由現金流輕鬆覆蓋了股息和利息支付,多餘的現金用於償還債務和回購股票。該圖表反映了截至 3 月底完成的 519 億日圓回購。四月份,我們也完成了第三季財報中宣布的剩餘1,000億日圓回購計畫。投影片 17 顯示了我們調整後的淨債務的變化。

  • Our strong cash flow performance and EBITDA growth led to an improved leverage ratio of 2.8 times as of March 2025. Next, our latest debt maturity ladder. In quarter four, we prepaid JPY313.5 billion and USD1.5 billion of syndicated loans using a combination of cash on hand, commercial paper and short-term loans.

    我們強勁的現金流表現和 EBITDA 成長使截至 2025 年 3 月的槓桿率提高至 2.8 倍。接下來是我們最新的債務到期階梯。第四季度,我們利用庫存現金、商業票據和短期貸款預付了 3,135 億日圓和 15 億美元的銀團貸款。

  • We plan to refinance our short-term funding with leverage-neutral debt this fiscal year. Our debt profile remains very manageable with 100% of our debt at fixed rates with a weighted average of approximately 2% interest rate.

    我們計劃在本財政年度利用槓桿中性債務為我們的短期融資進行再融資。我們的債務狀況仍然非常可控,100%的債務都是固定利率,加權平均利率約為 2%。

  • Moving to our outlook for fiscal 2025. Our management guidance at CER is for broadly flat core revenue with FY25 expected to be the final year of significant VYVANSE generic headwind. We also expect core OP and core EPS to be broadly flat year on year, reflecting savings from our efficiency program and investment ahead of new launches from the late-stage pipeline. Our free cash flow outlook is stable at JPY750 billion to JPY850 billion. And in line with our progressive dividend policy, we plan to increase the annual dividend to JPY200 per share.

    轉向我們對 2025 財年的展望。我們對 CER 的管理指導是核心收入基本持平,預計 25 財年將是 VYVANSE 仿製藥遭遇重大逆風的最後一年。我們也預期核心營業利潤和核心每股盈餘將與去年同期基本持平,這反映了我們效率計畫的節省以及後期產品線新產品推出前的投資。我們的自由現金流前景穩定在7,500億日圓至8,500億日圓之間。而根據我們的漸進式股利政策,我們計劃將年度股利提高至每股 200 日圓。

  • Please note that our forecast for FY 2025 does not reflect the potential impact of tariffs on pharmaceutical products by the US or other countries. We continue to monitor the situation, and we'll update our forecast if and when appropriate. However, as Christophe explained earlier, based on the current assumptions, we believe our likely potential exposure to US and China tariff is limited.

    請注意,我們對 2025 財年的預測並未反映美國或其他國家對藥品徵收關稅的潛在影響。我們將繼續監測情況,並在適當的時候更新我們的預測。然而,正如克里斯托夫之前解釋的那樣,基於目前的假設,我們認為我們受到美國和中國關稅影響的可能性有限。

  • Slide 20 shows more detail on our FY25 revenue forecast. We expect the continued momentum from our Growth and Launch Products, which should exceed 50% of total revenue this fiscal year. The growth of these products should more than offset the carryover impact from VYVANSE and other loss of exclusivities. Our revenue guidance also takes into consideration Medicare Part D redesign and 340B expansion in the US. Slide 21 further explains our outlook for FY25 core OP.

    投影片 20 顯示了我們對 FY25 收入預測的更多詳細資訊。我們預計成長和發布產品將繼續保持強勁勢頭,預計佔本財年總收入的 50% 以上。這些產品的成長應該足以抵消 VYVANSE 和其他獨家經營權損失的結轉影響。我們的收入指導還考慮了美國醫療保險 D 部分的重新設計和 340B 擴展。幻燈片 21 進一步解釋了我們對 FY25 核心 OP 的展望。

  • Gross profit is expected to improve slightly, while OpEx should see a modest increase versus prior year. We will continue to invest in R&D and data and technology, and in FY25, we expect a meaningful uptick in launch investment for the late-stage pipeline.

    預計毛利將略有提高,而營運支出將比上年略有增加。我們將繼續投資於研發、數據和技術,在 2025 財年,我們預期後期管線的啟動投資將大幅增加。

  • Due to the acceleration of development time lines, we now expect rusfertide, oveporexton and zasocitinib to all be filed in the US in FY25 to '26. We are able to accommodate this with savings generated by the efficiency program.

    由於開發時間表的加快,我們現在預計 rusfertide、oveporexton 和 zasocitinib 都將在 25 至 26 財年在美國提交申請。我們能夠利用效率計劃所產生的節省來解決這個問題。

  • Slide 22 explains our reported operating profit growth. Our reported operating profit forecast benefits from lower amortization expenses mainly due to the conclusion of the VYVANSE amortization in January 2026, lower restructuring expenses and lower impairment cost assumption.

    投影片 22 解釋了我們報告的營業利潤成長。我們報告的營業利潤預測受益於較低的攤銷費用,這主要由於 2026 年 1 月 VYVANSE 攤銷結束、較低的重組費用和較低的減損成本假設。

  • Turning to my final slide, Page 23. The principle of our capital allocation policy remain unchanged. We remain committed to investment -- investing in growth drivers and delivering attractive returns to shareholders through our progressive dividend policy and share buybacks when appropriate.

    翻到我的最後一張投影片,第 23 頁。我們的資本配置政策的原則保持不變。我們將繼續致力於投資——投資成長動力,並透過我們漸進的股利政策和適當時的股票回購為股東帶來可觀的回報。

  • Meanwhile, I would like to clarify our target to reach 2 times adjusted net debt to adjusted EBITDA. We finished fiscal 2024 at 2.8 times, and we aim to further improve the leverage ratio going forward.

    同時,我想澄清一下我們的目標是使調整後的淨債務達到調整後的 EBITDA 的 2 倍。2024財年我們的槓桿率達到2.8倍,我們的目標是進一步提高未來的槓桿率。

  • Thank you, and I'll now hand over to Andy for updates on the pipeline.

    謝謝,現在我將把時間交給安迪,讓他報告管道的最新進展。

  • Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

    Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

  • Thank you very much, Milano, and hello to everyone on today's call. If we go to the next slide, please. 2024 was a very successful year for our R&D organization. As Christophe has already highlighted, we entered 2025 with strong late-stage pipeline momentum.

    非常感謝,米蘭諾,向今天電話會議中的各位問好。請翻到下一張投影片。 2024 年對我們的研發機構來說是非常成功的一年。正如克里斯托夫已經強調的那樣,我們帶著強勁的後期管道勢頭進入了 2025 年。

  • As you can see on the left of this slide, we also had significant events in 2024 for our Growth and Launch Products, delivering on several geographic expansions, including approvals for ENTYVIO subcu in the US for Crohn's disease, FRUZAQLA in the EU and Japan for metastatic colorectal cancer, and ADZYNMA in the EU for congenital TTP.

    正如您在這張幻燈片左側看到的,我們在 2024 年的增長和上市產品方面也發生了重大事件,實現了多個地域擴展,包括在美國批准用於治療克羅恩病的 ENTYVIO 皮下注射劑、在歐盟和日本批准用於治療轉移性結直腸癌的 FRUZAQLA 以及在歐盟批准用於治療先天性 TTPMA 的先天性 TTPMA。

  • We also continued to execute on our global expansion strategy for QDENGA with approvals in Vietnam, Israel and Switzerland. And maralixibat, a regional development program for Japan achieved approval for the treatment of pruritus associated with cholestasis in both Alagille Syndrome and progressive familial intrahepatic cholestasis.

    我們也繼續執行 QDENGA 的全球擴張策略,並獲得越南、以色列和瑞士的批准。日本的區域發展計畫馬拉利昔布獲得批准,用於治療阿拉吉爾症候群和進行性家族性肝內膽汁淤積症中的膽汁淤積相關搔癢症。

  • Now moving to the right-hand side of this slide. You can see that our late-stage pipeline is advancing rapidly with important data readouts coming this year. Now here are a few examples of major milestones achieved in the past fiscal-year 2024.

    現在移到這張投影片的右側。您可以看到,我們的後期研發管道正在快速推進,今年將公佈重要的數據。以下是 2024 財年取得的一些重大里程碑的例子。

  • Our highly selective oral allosteric TYK2 inhibitor, zasocitinib, completed enrollment in two Phase 3 psoriasis trials approximately 7 months ahead of plan with the readout anticipated towards the end of 2025. Oveporexton, our lead orexin 2 receptor agonist, generated positive Phase 2b data in Narcolepsy Type 1 that was presented at the SLEEP 2024 conference.

    我們的高度選擇性口服變構 TYK2 抑制劑 zasocitinib 提前約 7 個月完成了兩項 3 期牛皮癬試驗的招募,預計將於 2025 年底獲得結果。我們的主要食慾素 2 受體激動劑 Oveporexton 在 1 型發作性睡病治療中獲得了積極的 2b 期數據,並在 SLEEP 2024 會議上進行了展示。

  • Two Phase 3 trials of oveporexton in Narcolepsy Type 1 were initiated and completed enrollment in fiscal year 2024. We look forward to data readouts this summer. Our next-generation oral orexin agonist, TAK-360, has also been accelerated, having initiated Phase 2 studies in Narcolepsy Type 2 and idiopathic hypersomnia.

    兩項針對 1 型發作性睡病的 Oveporexton 3 期試驗已啟動,並於 2024 財政年度完成招募。我們期待今年夏天的數據讀數。我們的下一代口服食慾素激動劑 TAK-360 也已加速研發,並已啟動 2 型發作性睡病和特發性嗜睡症的 2 期研究。

  • We presented compelling proof-of-concept data for our anti-CD38 antibody, mezagitamab, in IgA nephropathy at the American Society of Nephrology Kidney Week Meeting this past October, and we plan to initiate Phase 3 development this year. In oncology, we in-licensed elritercept, an activin inhibitor from Keros Therapeutics for the treatment of anemia-associated low and intermediate risk myelodysplastic syndrome, or MDS, and myelofibrosis.

    去年 10 月,我們在美國腎臟學會腎臟週會議上展示了我們的抗 CD38 抗體 mezagitamab 在治療 IgA 腎病方面的令人信服的概念驗證數據,我們計劃今年啟動第 3 階段開發。在腫瘤學領域,我們從 Keros Therapeutics 公司獲得了 elritercept(一種激活素抑制劑)的許可,用於治療貧血相關的低風險和中度風險骨髓增生異常症候群(MDS)和骨髓纖維化。

  • Phase 2b data in MDS was presented at the American Society of Hematology Annual Meeting in December 2024, and the Phase 3 development program is underway. As Christophe mentioned, in March, Takeda and our partner Protagonist Therapeutics announced very impressive Phase 3 data for rusfertide, a first-in-class synthetic hepcidin mimetic being developed for the treatment of polycythemia vera.

    MDS 的 2b 期數據於 2024 年 12 月在美國血液學會年會上公佈,3 期開發計畫正在進行中。正如 Christophe 所提到的,今年 3 月,武田和我們的合作夥伴 Protagonist Therapeutics 公佈了非常令人印象深刻的 3 期臨床試驗數據,rusfertide 是一種一流的合成鐵調素類似物,正在開髮用於治療真性紅血球增多症。

  • This entire sequence of positive Phase 3 and Phase 2b readouts, combined with new strategic partnerships closely aligned with our therapeutic area strategies, continues our strong pipeline progression into fiscal year 2025.

    整個系列的積極的 3 期和 2b 期讀數,加上與我們的治療領域戰略緊密結合的新戰略合作夥伴關係,將使我們在 2025 財年繼續保持強勁的管道進展。

  • Next slide, please. 2025 is indeed a pivotal year for our pipeline. For our six new molecular entity late-stage programs, 3 will have pivotal readouts this year, rusfertide oveporexton and zasocitinib. And we're off to a strong start thanks to the positive Phase 3 results in March from the VERIFY study for rusfertide.

    請看下一張投影片。 2025 年對我們的管道來說確實是關鍵的一年。對於我們的六個新分子實體後期項目,其中三個將在今年獲得關鍵讀數,即 rusfertide oveporexton 和 zasocitinib。由於 3 月 VERIFY 對 rusfertide 進行的第三階段研究取得了積極的成果,我們有一個良好的開端。

  • We'll review the top line data from this 32-week study in the following slide. Next, we have oveporexton. Our Phase 3 program for oveporexton includes two global pivotal studies in Narcolepsy Type 1, which enrolled approximately 10 months ahead of plan.

    我們將在下一張投影片中回顧這項為期 32 週的研究的最重要的數據。接下來我們有 oveporexton。我們的 oveporexton 第 3 階段計畫包括兩項針對 1 型發作性睡病的全球關鍵研究,這兩項研究的入組時間比計畫提前了約 10 個月。

  • Top line data is anticipated in the summer, and we plan to share the full oveporexton data at an upcoming medical conference and target regulatory filing this year. And finally, we have zasocitinib. In the first half of fiscal year 2025, we will initiate a head-to-head trial of zasocitinib versus deucravacitinib in psoriasis that will generate data helping to further demonstrate differentiation and support our commercial launch.

    預計夏季將公佈頂線數據,我們計劃在即將召開的醫學會議上分享完整的 overporexton 數據,並計劃在今年提交監管文件。最後,我們有紮索替尼。在 2025 財年上半年,我們將啟動 zasocitinib 與 deucravacitinib 在銀屑病治療中的頭對頭試驗,以產生有助於進一步證明差異化並支持我們商業發布的數據。

  • Top line data from zasocitinib's two pivotal Phase 3 trials, LATITUDE 3001 and 3002, are expected in the second half of this fiscal year. The rusfertide 32-week top line results were positive, achieving high statistical significance and has been accepted for presentation in early June at ASCO's plenary sessions.

    zasocitinib 的兩項關鍵 3 期試驗 LATITUDE 3001 和 3002 的頂線數據預計將於本財年下半年公佈。rusfertide 32 週頂線結果呈陽性,具有高度統計意義,並已接受於 6 月初在 ASCO 全體會議上進行展示。

  • Let's review the data that has been shared so far. Polycythemia vera is a hematologic cancer characterized by excessive red blood cell production. The primary treatment goal in polycythemia vera is to keep hematocrit below 45%. Why? Because higher levels are associated with increased rates of major thrombosis and potential death from cardiovascular events.

    讓我們回顧一下迄今為止已共享的數據。真性紅血球增多症是一種以紅血球生成過多為特徵的血液系統癌症。真性紅血球增多症的主要治療目標是將血球比容維持在 45% 以下。為什麼?因為較高的水平與主要血栓形成率的增加以及心血管事件導致的潛在死亡有關。

  • Rusfertide more than doubled clinical response rates in the Phase 3 VERIFY study, significantly reducing the primary end point of phlebotomy eligibility when compared to placebo plus standard of care. All key secondary end points met statistical significance, including a three-fold reduction in the proportion of rusfertide-treated patients requiring phlebotomy as well as improvements in hematocrit control.

    在 3 期 VERIFY 研究中,Rusfertide 的臨床反應率提高​​了一倍以上,與安慰劑加標準治療相比,顯著降低了靜脈穿刺資格這一主要終點。所有關鍵次要終點均具有統計學意義,包括接受魯司特治療且需要放血治療的患者比例減少了三倍,且血球比容控制得到改善。

  • Additionally and very importantly, patient-reported outcomes via the PROMIS Fatigue questionnaire and the myelofibrosis symptom assessment form demonstrated improved quality of life. These data represent the most consistent and broad demonstration of patient-reported outcomes in PV patients. This is an interesting data point.

    此外,非常重要的是,透過 PROMIS 疲勞問捲和骨髓纖維化症狀評估表報告的患者結果顯示生活品質有所改善。這些數據代表了 PV 患者報告結果最一致、最廣泛的證明。這是一個有趣的數據點。

  • Throughout the entire 32-week period, 73% of rusfertide-treated patients received zero phlebotomies versus just 22% on placebo plus standard of care, 73% versus 22%. Rusfertide additionally was generally well tolerated with overall adverse events and serious event rates comparable between the two treatment arms.

    在整個 32 週期間,73% 的接受 Rusfertide 治療的患者未接受任何靜脈切開術,而接受安慰劑加標準治療的患者中,只有 22% 接受該治療。此外,Rusfertide 整體耐受性良好,兩個治療組的整體不良事件和嚴重事件發生率相當。

  • The most common events were injection site reactions for rusfertide, most of which were mild to moderate in intensity. And very importantly, there is no evidence of an increased risk of secondary cancers in the rusfertide versus placebo-treated patients. These results across a range of patients treated with therapeutic phlebotomy or the majority of patients in the study, phlebotomy plus cytoreductive therapy, are truly transformative.

    最常見的事件是注射魯斯菲特的部位反應,大多數反應強度為輕度至中度。而且非常重要的是,沒有證據顯示接受 Rusfertide 治療的患者與接受安慰劑治療的患者相比,罹患繼發性癌症的風險增加。對於接受治療性靜脈穿刺治療的一系列患者或研究中的大多數患者,靜脈穿刺加細胞減滅療法,這些結果確實具有變革性。

  • Takeda will host an investor call on Sunday evening, June 1 at 7 PM Eastern Time from ASCO. We hope that you can join. Now let's shift to the importance of disciplined decision-making and the connection to pipeline advancement. We continue to make data-driven decisions to main focus -- maintain focus on our most promising pipeline programs, as shown in the bottom half of this slide.

    武田將於美國東部時間 6 月 1 日星期日晚上 7 點在 ASCO 舉行投資者電話會議。我們希望您能加入。現在讓我們來討論嚴謹的決策的重要性以及與管道進步的連結。我們將繼續以數據為依據做出決策,重點關注我們最有前景的管道項目,如本投影片下半部所示。

  • These decisions allow us to pivot resources and rapidly advance development of our six late-stage programs. The deliberate and thoughtful approach we have taken over the last few years has resulted in Takeda's most robust late-stage pipeline in our modern history and is a testament to the successful transformation of our R&D organization.

    這些決定使我們能夠調配資源並快速推進六個後期專案的開發。過去幾年來,我們採取了深思熟慮的方法,使武田擁有了現代歷史上最強大的後期產品線,也證明了我們研發組織的成功轉型。

  • The six programs in our late-stage pipeline have the potential to deliver transformative benefits to patients while contributing to Takeda's long-term growth. We've previously reviewed the major 2025 events for rusfertide, oveporexton and zasocitinib. And now I'd like to highlight some expansion opportunities we are pursuing across these six programs.

    我們後期研發管線中的六個項目有可能為患者帶來變革性益處,同時促進武田的長期成長。我們之前曾回顧過 rusfertide、oveporexton 和 zasocitinib 的 2025 年重大事件。現在我想強調我們在這六個項目中尋求的一些擴展機會。

  • Indication expansions are being explored for zasocitinib with important Phase 2 readouts in 2026 for Crohn's disease and ulcerative colitis; and in addition, a Phase 2 study exploring zasocitinib's potential to treat vitiligo will start in 2025.

    正在探索擴展扎索替尼的適應症,預計 2026 年將獲得針對克羅恩病和潰瘍性結腸炎的重要 2 期臨床試驗讀數;此外,探索 zasocitinib 治療白斑潛力的 2 期研究將於 2025 年開始。

  • Elritercept's proof-of-concept study in myelofibrosis will read out over the next year, and additional expansion opportunities are under consideration. I'm happy to report that the fazirsiran Phase 3 program is enrolling well, and we are on track for data readout and filing as planned.

    Elritercept 在骨髓纖維化方面的概念驗證研究將於明年完成,並且正在考慮其他擴展機會。我很高興地報告,fazirsiran 第三階段計劃的招募進展順利,我們正在按計劃進行資料讀取和歸檔。

  • As I highlighted earlier, fiscal-year 2025 is a pivotal year for Takeda's late-stage pipeline. In addition to the three Phase 3 readouts expected in 2025, we look forward to continuing our strong late-stage development trajectory with the potential to file five additional indications from this late-stage program over the next few years. I am excited to share updates with you as we progress throughout the year.

    正如我之前強調的那樣,2025 財年是武田後期產品線的關鍵一年。除了預計在 2025 年進行的三期 3 期臨床試驗結果公佈外,我們還期待繼續保持強勁的後期研發軌跡,並有可能在未來幾年內從該後期項目提交另外五項適應症。我很高興與您分享我們全年的進展。

  • Thank you very much, and I will now turn it back to you, Christophe.

    非常感謝,現在我將把話題轉回給你,克里斯托夫。

  • Christophe Weber - President, Chief Executive Officer, Representative Director

    Christophe Weber - President, Chief Executive Officer, Representative Director

  • Thank you, Andy. In closing, overall, we are very pleased with what we have achieved in fiscal-year '24. In a challenging period when we are facing significant generic impact, we continue to deliver on our financial commitments, progress our pipeline and create value for our shareholders.

    謝謝你,安迪。最後,整體而言,我們對 24 財年的成就感到非常滿意。在面臨重大仿製藥衝擊的充滿挑戰的時期,我們將繼續履行財務承諾,推進產品線建設,為股東創造價值。

  • The momentum of our current Growth and Launch Product portfolio will continue to drive our growth through the remainder of this decade, a period during which we face only limited generic exposure until the early 2030s.

    我們目前的成長和上市產品組合的勢頭將在未來十年的剩餘時間內繼續推動我們的成長,在此期間,直到 2030 年代初,我們僅面臨有限的仿製藥風險。

  • We are accelerating late-stage therapies with potential to generate significant value, including the 3 new molecular entities with Phase 3 data readout already completed or expected by the end of 2025 that we shared with you today. And we continue to transform the company across our value chain by leveraging data, technology and AI.

    我們正在加速具有產生重大價值潛力的後期療法,包括我們今天與您分享的 3 個新分子實體,其第 3 階段數據已完成或預計將於 2025 年底完成。我們繼續利用數據、技術和人工智慧來改變整個價值鏈中的公司。

  • Strong cash flow support this investment and asset-specific business development to further enhance long-term value and deliver attractive shareholder return. With this strategy, we are laying a strong foundation for Takeda long-term growth and the next chapter in our story.

    強勁的現金流量支持此投資和資產特定業務發展,以進一步提升長期價值並帶來可觀的股東回報。透過這項策略,我們為武田的長期發展和公司歷史的新篇章奠定了堅實的基礎。

  • In closing, we'll navigate the opportunities and challenge ahead from a position of strength, from position of potential with strong core values and our vision to discover and deliver life-transforming treatment guided by our commitment to patients, our people and the planet. These values will guide us well in this fast-moving and challenging environment and generate long-term value for our stakeholders. Thank you.

    最後,我們將以實力、潛力和強大的核心價值迎接未來的機會和挑戰,並以我們對病人、我們的人民和地球的承諾為指導,發現和提供改變生活的治療。這些價值觀將引導我們在這個快速變化和充滿挑戰的環境中前進,並為我們的利害關係人創造長期價值。謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Now we would like you to take your questions. Christophe, Milano, and they will answer your questions and also US Business Unit President Julie Kim; PBT Business Unit President, James Flatwood; and Global Oncology Business Unit President, Talesabiti are also joining to respond (inaudible) -- (Event Instructions)

    (翻譯)現在我們想請您回答問題。Christophe、Milano,他們將回答您的問題,還有美國業務部門總裁 Julie Kim; PBT業務部總裁James Flatwood;和全球腫瘤業務部門總裁 Talesabiti 也加入回應(聽不清楚)-(活動說明)

  • First question from Citigroup. Yamaguchi.

    第一個問題來自花旗集團。山口。

  • Hidemaru Yamaguchi - Analyst

    Hidemaru Yamaguchi - Analyst

  • Do you hear me okay?

    你聽見我說話了嗎?

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Yes.

    (翻譯)是的。

  • Hidemaru Yamaguchi - Analyst

    Hidemaru Yamaguchi - Analyst

  • Thank you very much. I'm Yamaguchi from Citi. I have two questions. The first question is regarding our company guidance, especially two products -- sorry, for the two parts, but ENTYVIO sales growth, 9% [year] basis and also VYVANSE down by 30% for full year. Can you give me some upside and downside risk for this one? Which was the one of the two products, which is going in the different direction compared to your guidance on the last fiscal year?

    非常感謝。我是花旗銀行的山口。我有兩個問題。第一個問題是關於我們公司的指導,特別是兩種產品——抱歉,對於兩個部分,但 ENTYVIO 的銷售增長了 9% [年],而 VYVANSE 全年下降了 30%。您能告訴我這個產品的上行和下行風險嗎?這兩種產品中,哪一種的發展方向與您對上一財年的預期有所不同?

  • That was the first question. The second question is regarding oveporexton. I think that Andy-san was mentioning about the summer data readout. I thought -- it's my understanding was around June, but I may have misunderstood. But can you confirm that -- your top line results timing of a [TAK-869] for the Phase 3, which is summer? And what is the conference you are referring to after summer for the data reads? Thank you.

    這是第一個問題。第二個問題是關於 oveporexton 的。我認為安迪先生提到的是夏季數據讀數。我認為——我的理解是六月左右,但我可能誤解了。但您能否確認-第三階段 [TAK-869] 的頂線結果時間是夏季?您所指的夏季之後的資料讀取會議是什麼?謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Yamaguchi-san. So the first question on specific outlook for ENTYVIO and VYVANSE, Julie can comment on that. And the second question around specific timing of oveporexton data, Andy, could you please comment on that, please?

    謝謝你,山口先生。因此,第一個問題是關於 ENTYVIO 和 VYVANSE 的具體前景,朱莉可以對此發表評論。第二個問題是關於 oveporexton 數據的具體時間,安迪,您能對此發表評論嗎?

  • Julie Kim - President, US Business Unit, and US Country Head

    Julie Kim - President, US Business Unit, and US Country Head

  • Thank you, Yamaguchi-san, for the question. So I'll take them in reverse order, VYVANSE and then ENTYVIO. So with VYVANSE, as you see, we are expecting further erosion of VYVANSE in the US. At this point, we have 15 generics on the market in the US, and we anticipate that the supply challenges that we saw in the first half of last fiscal year, we would not see those sorts of supply challenges in this upcoming fiscal year. So we expect the erosion to occur more smoothly than it happened last year.

    謝謝山口先生的提問。因此,我會以相反的順序服用它們,先服用 VYVANSE,然後服用 ENTYVIO。因此,如您所見,我們預計 VYVANSE 在美國將進一步受到侵蝕。目前,我們在美國市場上有 15 種仿製藥,我們預計上一財年上半年遇到的供應挑戰在即將到來的財年不會再出現。因此,我們預計侵蝕將比去年更加平穩。

  • So that is why we are guiding towards the decrease in VYVANSE, primarily driven by the US situation. We will also start seeing some VYVANSE generics in other geographies, but it's much, much smaller compared to the US.

    因此,我們決定減少 VYVANSE 的銷量,這主要是受美國局勢的影響。我們還將在其他地區看到一些 VYVANSE 仿製藥,但與美國相比,這一數字要小得多。

  • Then when it comes to ENTYVIO, in the US, we expect to see continued above-market growth for ENTYVIO, also driven by ENTYVIO PEN, further increased access across the continuum for ENTYVIO PEN. We continue to see, as you heard from Christophe during the presentation, strong pull-through from patients.

    然後,說到 ENTYVIO,在美國,我們預計 ENTYVIO 將繼續實現高於市場的成長,這也是由 ENTYVIO PEN 推動的,這將進一步提高 ENTYVIO PEN 在整個治療過程中的可及性。正如您在演講中聽到克里斯托夫所說,我們繼續看到患者的強烈支持。

  • And quarter over quarter, we are adding approximately 1,000 new pen writers each quarter. In our other geographies outside of the US, we continue to see strong growth particularly in our European geography, and we expect that to continue. Thank you.

    與上一季相比,我們每季都會增加約 1,000 名新作家。在美國以外的其他地區,我們繼續看到強勁的成長,特別是在歐洲地區,我們預計這種成長勢頭將持續下去。謝謝。

  • Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

    Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

  • (multiple speakers) Sorry, did you want to follow up?

    (多位發言者)抱歉,您想跟進嗎?

  • Hidemaru Yamaguchi - Analyst

    Hidemaru Yamaguchi - Analyst

  • Yes -- no, I'm fine. Please go ahead.

    是的——不,我很好。請繼續。

  • Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

    Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

  • Okay. This is Andy. And I have a big smile, Yamaguchi-san, because, of course, when you say summer, that includes June. But just to be fair, I suspect that the data are not going to come in the early part of June based on just the timing of the trial. So we've just said summer just to give us some room to ensure that we're coming out with the clearest top-line results.

    好的。這是安迪。山口先生,我笑得很開心,因為,當然,當你說夏天時,那也包括六月。但公平地說,僅根據試驗的時間,我懷疑數據不會在六月初出來。所以我們剛才說是夏天只是為了給我們一些空間來確保我們能夠獲得最清晰的頂線結果。

  • We've been moving very quickly with this program and are -- and we continue to drive every step of the process as rapidly as possible. That will include not just the top line disclosure but also presentations at scientific congress. So we will do that as quickly as we can, and we're reluctant at this point to declare which congress because, obviously, we need to have an abstract accepted. And so until that's happened, we won't say that.

    我們正在非常迅速地推進這一計劃,並且我們將繼續盡可能快地推動這一進程的每一步。這不僅包括頂線披露,還包括科學大會上的演講。因此,我們會盡快完成這項工作,目前我們不願意宣布是哪一次大會,因為顯然我們需要一份摘要被接受。所以,在那件事發生之前,我們不會這麼說。

  • But of course, there are relatively limited number of important SLEEP meetings, so you could probably figure it out by just looking at those few meetings that exist. And then the last comment I'll make along these lines just to ensure that expectations are set appropriately, there are essentially three parts that will constitute the filing for oveporexton in Type 1 Narcolepsy.

    但當然,重要的 SLEEP 會議數量相對有限,因此您可能只需查看現有的少數會議就能弄清楚。然後,我將沿著這些思路做出最後評論,只是為了確保期望值得到適當設定,基本上有三個部分構成了 1 型嗜睡症中 oveporexton 的申請。

  • One will be, of course, these two pivotal Phase 3 studies. The second will be the safety database that predominantly will come from the long-term extension study from our Phase 2b study that we presented last year, and then the third will be our CMC package. So right now, we haven't declared precisely when our filing dates and when our expected approval dates would be, but those are the three pieces that will define timing.

    其中之一當然是這兩項關鍵的第三階段研究。第二個將是安全資料庫,主要來自我們去年提出的 2b 期研究的長期擴展研究,第三個將是我們的 CMC 套件。因此,目前我們還沒有確切地宣布我們的提交日期和預計的批准日期,但這三個因素將決定時間表。

  • Hidemaru Yamaguchi - Analyst

    Hidemaru Yamaguchi - Analyst

  • Okay, looking for summer. Thank you.

    好的,期待夏天。謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Thank you very much. Morgan Stanley, Muraoka-san.

    (翻譯)非常感謝。摩根士丹利,村岡先生。

  • Shinichiro Muraoka - Analyst

    Shinichiro Muraoka - Analyst

  • (interpreted) Thank you. This is Muraoka, Morgan Stanley. My first question is about dividends, slight decline in profit, but the dividend is going up by JPY4. We're happy about the increased dividend. But compared to JPY8 increase, this is a smaller increase this time.

    (翻譯)謝謝。我是摩根士丹利的 Muraoka。我的第一個問題是關於股息,利潤略有下降,但股息增加了4日圓。我們對股息增加感到高興。但與8日圓的增幅相比,此次增幅較小。

  • Going forward, if your performance can be, for example, upgraded, would you maybe get closer to JPY8 increase in dividend? Would that be possible? That's my first question. And my second question is in relation with tariffs. Over the next five years, $30 billion investment will be made. I think that's what you said, Christophe, if I heard you correctly.

    展望未來,如果您的業績能夠提升,您的股息是否會接近增加 8 日圓?這可能嗎?這是我的第一個問題。我的第二個問題與關稅有關。未來五年將投資300億美元。克里斯托夫,如果我沒聽錯的話,我想這就是你所說的。

  • Now local production in the United States will be expanded, is that the relationship? And also in terms of total capital allocation, do you think this investment will have a major impact, a big impact or not so big an impact in your assessment? Those are the questions.

    現在美國本土生產會擴大,是這個關係嗎?另外,就總資本配置而言,您認為這項投資會產生重大影響、很大影響還是影響不大?這些都是問題。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Muraoka-san. So the first question on the dividend, why JPY4 and if there is an upgrade to guidance, is there any room to increase that further, I'd like to ask Milano to answer that question. And then the second, on tariffs, Christophe mentioning $30 billion of investment in the US over the next five years, could you please explain a little more in detail what that refers to? Christophe, if you could take that second question.

    謝謝你,村岡先生。因此,關於股息的第一個問題是,為什麼是 4 日元,如果指導有所提升,是否還有進一步增加的空間,我想請米蘭諾回答這個問題。第二,關於關稅,克里斯托夫提到未來五年將在美國投資 300 億美元,您能否更詳細地解釋一下這指的是什麼?克里斯托夫,你能回答第二個問題嗎?

  • Milano Furuta - Chief Financial Officer, Director

    Milano Furuta - Chief Financial Officer, Director

  • (interpreted) Thank you very much, Muraoka-san, for your question. This is Furuta speaking. With regard to dividend, I have to actually repeat myself. Progressive dividend policy is applied, and core EPS, reported EPS and free cash flow, we will monitor those factors and make decisions accordingly.

    (譯)非常感謝村岡先生的提問。我是 Furuta。關於股息,我實際上必須重複一遍。採用漸進式股利政策,以及核心每股盈餘、報告每股盈餘和自由現金流,我們將監控這些因素並據此做出決策。

  • Over the last two years, yes, we increased the dividend by JPY8. And based on the current core EPS, the payout ratio is about 40%, which is quite competitive in this industry. That is our assessment. And reported EPS, well, going forward, we will see shrinkage in amortization, so we expect the number to improve. But currently, we have not really reached the JPY200 level yet.

    是的,在過去兩年裡,我們將股息增加了 80 日圓。並以目前的核心EPS計算,派息率約為40%,在業界具有相當的競爭力。這是我們的評估。並且報告的每股收益,嗯,展望未來,我們將看到攤銷的縮減,因此我們預計該數字會有所改善。但目前我們還沒有真正達到200日圓的水平。

  • So we have to consider all these different factors, and this is why we have decided to increase the dividend by JPY4 this time. Now going forward, how quickly can we move to a further increase in the dividend? Well, core EPS, reported EPS and also free cash flow, specifically cash flow and deleveraging outlook, all of these factors will have to be taken into account, and the decisions need to be made every year accordingly.

    所以我們必須考慮所有這些不同的因素,這就是我們這次決定將股息增加 4 日圓的原因。現在展望未來,我們能多快進一步增加股利?嗯,核心每股收益、報告每股收益以及自由現金流,特別是現金流和去槓桿前景,所有這些因素都必須考慮在內,並且每年都需要做出相應的決策。

  • Christophe Weber - President, Chief Executive Officer, Representative Director

    Christophe Weber - President, Chief Executive Officer, Representative Director

  • Thank you, Muraoka-san, for your questions. As you now understood, we have a very significant presence in the US. This is why we have actually potentially a low exposure to tariffs. We have a massive manufacturing network in the US. We have a very significant presence when it comes to our R&D, for example.

    謝謝 Muraoka 先生的提問。正如您現在所了解的,我們在美國擁有非常重要的業務。這就是為什麼我們實際上可能不太受關稅影響。我們在美國擁有龐大的製造網絡。例如,我們在研發方面佔有非常重要的地位。

  • And so when I said that we will invest $30 billion in the next five years, this is not new. We -- this is to maintain this presence. This is to continue to develop the company. This is to make sure that our manufacturing sites are upgraded up to the best efficiency and productivity. Our R&D, this $30 billion include our R&D spend in the US.

    所以當我說我們將在未來五年投資 300 億美元時,這並不是什麼新鮮事。我們——這是為了維持這種存在。這是為了繼續發展公司。這是為了確保我們的生產基地升級到最佳效率和生產力。我們的研發,這 300 億美元包括我們在美國的研發支出。

  • So this is not a new change of strategy, but it is to illustrate that as a global innovative pharmaceutical company, we have a very strong presence in the US, which is, by far today, the country which is so important for developing biopharmaceutical innovation but also a country very important to reward innovation as well in terms of its market. Thank you.

    因此,這並不是新的策略變化,而是顯示作為一家全球創新製藥公司,我們在美國擁有非常強大的影響力。到目前為止,美國對於發展生物製藥創新非常重要,而且在市場方面也非常重視獎勵創新。謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Stephen Barker, Jefferies.

    (翻譯)傑富瑞 (Jefferies) 的 Stephen Barker。

  • Stephen Barker - Analyst

    Stephen Barker - Analyst

  • Yes, thanks, Steve Barker from Jefferies. My first question is for Andy regarding zasocitinib. Could you please explain your decision to choose vitiligo as the next indication for development, with reference to the unmet need, the competitive environment and mechanistically why a TYK2 inhibitor might succeed in this indication?

    是的,謝謝 Jefferies 的 Steve Barker。我的第一個問題是關於扎索替尼 (zasocitinib) 的,想問安迪 (Andy)。您能否解釋一下選擇白斑症作為下一個開發適應症的決定,參考未滿足的需求、競爭環境以及從機制上講為什麼 TYK2 抑制劑可能在這一適應症上取得成功?

  • And my second question is for Julie Kim, whom I'd like to congratulate on being chosen to become the next CEO. Perhaps you could tell us something about what you expect to be able to bring to this role? Thank you.

    我的第二個問題是針對朱莉金 (Julie Kim) 的,我要祝賀她被選為下一任執行長。也許您可以告訴我們您希望為這個角色帶來什麼?謝謝。

  • Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

    Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

  • It's Andy. So the question about our indication expansion strategy for zasocitinib and why vitiligo, so when we brought the program in, we were committed to the four core indications that are now -- that now we have great momentum behind psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease.

    是安迪。因此,關於我們對扎索西替尼的適應症擴展策略以及為什麼是白斑的問題,當我們引入該計劃時,我們致力於現在的四個核心適應症 - 現在我們在牛皮癬,銀屑病關節炎,潰瘍性結腸炎和克羅恩病方面有著巨大的發展勢頭。

  • We undertook a very extensive effort, a combined effort, obviously, between the R&D organization and our commercial organization looking for indications that would make most sense. And the mechanism is a ubiquitous -- it's a ubiquitous signaling molecule involved in many different inflammatory pathways with very strong human genetics that point too many potential indications. And so we established a rubric by which we have built our decision tree off of.

    我們付出了非常廣泛的努力,顯然是研發組織和商業組織的共同努力,尋找最有意義的跡象。這種機制是普遍存在的——它是一種普遍存在的信號分子,參與許多不同的發炎途徑,具有非常強大的人類遺傳學,指出了太多潛在的跡象。因此我們建立了一個標準,並以此為基礎建構了我們的決策樹。

  • So one is where do we think that we have the greatest likely of scientific success, two, how long and how costly is development, and then three, unmet medical need and commercial opportunity. And so when we sifted through that funnel, we went from literally dozens of very exciting and potentially scientifically interesting indications to a handful of potential indications. And a few have risen to the top. I don't think we'll stop at vitiligo by the way. I think that there'll be more to come, and we'll share with -- those with you later.

    因此,第一,我們認為我們在哪裡最有可能取得科學成功;第二,開發需要多長時間和多少成本;第三,未滿足的醫療需求和商業機會。因此,當我們透過這個漏斗進行篩選時,我們從幾十個非常令人興奮且具有潛在科學意義的跡象變成了少數潛在跡象。其中有些已經晉升至最高位。順便說一句,我認為我們不會止步於白斑症。我認為還會有更多內容,稍後我們會與大家分享。

  • Vitiligo sifted to the top because, a, there's very strong scientific rationale. Both the genetics of this overall pathway suggests a role in vitiligo that we know that interferon signaling, for example, is involved in driving the skin lesions in vitiligo, and TYK2 is a prime mediator of interferon signaling. It's actually a fairly prevalent disease across the world. It's highly unmet in terms of medical need. And it's the kind of disease where -- because there isn't -- there aren't existing therapies.

    白斑之所以被列為首選,是因為其具有非常強的科學依據。此整體路徑的遺傳學特徵顯示它在白斑症中發揮作用,例如,我們知道乾擾素訊號傳導參與驅動白斑的皮膚病變,而 TYK2 是乾擾素訊號傳導的主要媒介。它實際上是一種在世界範圍內相當流行的疾病。就醫療需求而言,它尚未得到滿足。這是一類目前尚無治療方法的疾病。

  • I think we don't realize the amount of lifestyle and health devastation that comes from this disease. So we think that the upside opportunity is quite high. Of course, we have to demonstrate, this is a proof of concept, will be a dose-ranging proof-of-concept study that we're in. So we have to have -- of course, demonstrate benefits, but we're quite excited about the possibility.

    我認為我們沒有意識到這種疾病對生活方式和健康的破壞程度。因此我們認為上行機會相當高。當然,我們必須證明,這是一個概念驗證,將是我們正在進行的劑量範圍概念驗證研究。因此,我們必須——當然,展示出好處,但我們對這種可能性感到非常興奮。

  • Julie Kim - President, US Business Unit, and US Country Head

    Julie Kim - President, US Business Unit, and US Country Head

  • And thank you, Stephen, for your kind comment. It's truly an honor to be the incoming CEO for Takeda. And I will share with you a couple of comments, but obviously, as it's still quite a bit of time away, I won't provide any details until next year.

    謝謝你,史蒂芬,謝謝你的友好評論。能夠擔任武田新任首席執行官,我深感榮幸。我將與大家分享一些評論,但顯然,由於時間還很遙遠,所以我要到明年才會提供任何細節。

  • So first and foremost, as a member of the executive team, I've been involved in all of the strategy discussions to date, and so this is not going to be a situation where there will be a massive overturning of the existing strategy.

    因此,首先,作為執行團隊的一員,我參與了迄今為止的所有策略討論,因此這不會導致現有策略被大規模推翻。

  • My intent is to honor the legacy of Takeda and the legacy that Christophe will be leaving behind next year, but also looking to the future and taking the time to listen to stakeholders, internal, external, to understand what they would like to see from Takeda and incorporate that into what I will share next year as a direction forward for the company. So I guess stay tuned, and you'll hear more from me next year.

    我的目的是尊重武田的遺產和克里斯托夫明年將留下的遺產,同時也展望未來,花時間傾聽內部和外部利益相關者的意見,了解他們希望從武田看到什麼,並將其納入我明年將分享的公司前進方向中。所以我想請繼續關注,明年你會聽到我更多的消息。

  • Stephen Barker - Analyst

    Stephen Barker - Analyst

  • Thanks, Julie and congratulations, and thanks very much, Andy.

    謝謝,朱莉,恭喜你,非常感謝,安迪。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Okay. Thank you, Steve, for your question. TD Cowen, Mike Nedelcovych. Mike, we can't hear you. Mike, are you unmuted?

    好的。謝謝史蒂夫的提問。TD Cowen,Mike Nedelcovych。麥克,我們聽不到你說話。麥克,你取消靜音了嗎?

  • Mike Nedelcovych - Analyst

    Mike Nedelcovych - Analyst

  • Yes, can you hear me now?

    是的,你現在聽得到我說話嗎?

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Yes, okay, we got you. Okay.

    是的,好的,我們明白你的意思了。好的。

  • Mike Nedelcovych - Analyst

    Mike Nedelcovych - Analyst

  • Okay. Apologies. Sorry for that. I have two. One relates to the oveporexton potential launch. I imagine there are only so many prescribers when it comes to narcolepsy and the advantages of orexin replacement should recommend themselves.

    好的。抱歉。很抱歉。我有兩個。其中一個與 overporexton 潛在發射有關。我想,當談到嗜睡症時,開處方的醫生是有限的,而食慾素替代療法的優勢應該是不言而喻的。

  • So my question is whether this could be one of the most successful drug launches in recent history. Assuming Phase 3 replicates what we saw in Phase 2, should we expect oveporexton to take off like a shot and if not, then why not? And then my second question relates to GATTEX. It looks like timing of generic entry is still unknown, and you are forecasting a healthy number for fiscal 2025. How durable do you think this revenue could be? Thank you.

    所以我的問題是,這是否會成為近代史上最成功的藥物上市之一。假設第 3 階段重複了我們在第 2 階段看到的情況,我們是否應該期待 oveporexton 能迅速起飛,如果不是,那為什麼不呢?我的第二個問題與 GATTEX 有關。看起來仿製藥的進入時間仍然未知,並且您預測 2025 財年的數字會很健康。您認為這種收入能維持多久?謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Mike. So the first question on some thoughts on the oveporexton launch trajectory. And then second question on durability of GATTEX. So Julie, could you take both of those questions, please?

    謝謝你,麥克。所以第一個問題是關於 Oveporexton 發射軌跡的一些想法。第二個問題是關於 GATTEX 的耐用性。那麼朱莉,你能回答這兩個問題嗎?

  • Julie Kim - President, US Business Unit, and US Country Head

    Julie Kim - President, US Business Unit, and US Country Head

  • Yes. Thank you, Mike, for those questions. And like before, I will take them in reverse order. So yes, you have noticed that we do expect competition still, but it is delayed. And this is an area where we do believe beyond the actual medicine itself, there is a lot of support needed for this patient population.

    是的。謝謝麥克提出這些問題。和以前一樣,我將按相反的順序進行。是的,您已經注意到我們確實仍然期待競爭,但是競爭被推遲了。我們確實相信,除了實際藥物本身之外,還需要為該患者群體提供大量支持。

  • And so a significant amount of patient services support is critical to supporting the treatment experience. And so we do expect that GATTEX will not have the typical erosion curve once generic comes as well as from competition.

    因此,大量的患者服務支援對於支持治療體驗至關重要。因此,我們確實預計,一旦仿製藥和競爭出現,GATTEX 將不會出現典型的侵蝕曲線。

  • So we do expect there to be longer lasting revenue stream from GATTEX. In terms of oveporexton, I would look at this in a couple of different ways. One, we still have a diagnosis challenge for Narcolepsy Type 1.

    因此,我們確實預期 GATTEX 會帶來更持久的收入來源。就 oveporexton 而言,我會從幾個不同的角度來看這個問題。首先,我們對第 1 型嗜睡症的診斷仍面臨挑戰。

  • So there will be an effort around appropriate diagnosis of Narcolepsy Type 1 because oveporexton will be indicated in type 1, and current therapies are indicated in type 1, type 2 and in IH. So the first aspect is the diagnosis of Narcolepsy Type 1.

    因此,我們將致力於對 1 型發作性睡病進行適當的診斷,因為 Oveporexton 適用於 1 型發作性睡病,而目前的治療方法適用於 1 型、2 型和 IH。因此,第一個面向是第 1 型發作性睡病的診斷。

  • But as you point out, with hopefully Phase 3 replicating the type of data that we saw in Phase 2, we do expect there to be significant demand for oveporexton given the type of efficacy we hope to see. Now that being said, we will have to make sure that we have all of the programs in place to ensure smooth access in this space, and there is a lot of standard therapies that are much cheaper that we will have to work through from an access standpoint. But fundamentally, we are really excited about the opportunity to launch oveporexton, US will be the first market to launch, and we're looking forward to it.

    但正如您所指出的,希望第 3 階段能夠複製我們在第 2 階段看到的資料類型,考慮到我們希望看到的療效類型,我們確實預期對 Oveporexton 的需求會很大。話雖如此,我們必須確保我們已實施所有計劃,以確保能夠順利進入該領域,並且從進入的角度來看,我們必須努力研究許多更便宜的標準療法。但從根本上來說,我們對推出 overporexton 的機會感到非常興奮,美國將是第一個推出的市場,我們對此充滿期待。

  • Mike Nedelcovych - Analyst

    Mike Nedelcovych - Analyst

  • Okay. Thank you very much.

    好的。非常感謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Moving on to the next question, Nomura Securities, Matsubara-san.

    (翻譯)接下來是下一個問題,野村證券的松原先生。

  • Unidentified Participant

    Unidentified Participant

  • (interpreted) Can you hear me okay?

    (翻譯)你聽見我說話嗎?

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Yes, we can.

    (解釋)是的,我們可以。

  • Unidentified Participant

    Unidentified Participant

  • (interpreted) Thank you. I have two questions. First question is about the tariffs. So manufacturing sites, you have disclosed today. I think that gave us some sense of comfort. But is there anything you can comment about IP?

    (翻譯)謝謝。我有兩個問題。第一個問題是關於關稅的。您今天已經披露了製造地點。我認為這給了我們一些安慰。但是您對 IP 有什麼評論嗎?

  • And the second question is about ENTYVIO. So pen is useful. I understand you are increasing the number of new patients, but reimbursement is the bottleneck. So when do you think we will see pen contributing in a great way -- big way? And the [security] is also there. What about second-line market share currently? That's my question.

    第二個問題是關於 ENTYVIO 的。所以筆是有用的。我知道您正在增加新患者的數量,但報銷是一個瓶頸。那麼您認為什麼時候我們才能看到鋼筆發揮巨大作用呢?而且[保全]也在那裡。目前二線市佔率怎麼樣?這就是我的問題。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Okay. So the first question to Christophe around tariffs. Do you have any specific commentary around the location of our intellectual property? And then the second question on ENTYVIO PEN around the reimbursement challenges that Christophe referred to in the call. When do we expect an uptick in reimbursement?

    好的。所以第一個問題是關於關稅的,請問克里斯托夫。您對我們的智慧財產權所在地有什麼具體的評論嗎?然後是關於 ENTYVIO PEN 的第二個問題,涉及 Christophe 在電話中提到的報銷挑戰。我們什麼時候可以預期報銷金額會增加?

  • And how do we see usage being used in the second line given the competitive landscape? I'd like Julie to answer that second question, please.

    考慮到競爭格局,我們如何看待第二線的使用情況?請朱莉回答第二個問題。

  • Christophe Weber - President, Chief Executive Officer, Representative Director

    Christophe Weber - President, Chief Executive Officer, Representative Director

  • Yeah. Thank you, Matsubara-san, for the question. I think it's a very relevant question. You define the potential tariff impact with -- based on your manufacturing network. You have seen that it's located mainly in US and Europe, Japan.

    是的。謝謝松原先生提出的問題。我認為這是一個非常相關的問題。您可以根據您的製造網絡來定義潛在的關稅影響。你已經看到它主要位於美國、歐洲和日本。

  • But also, you're right, where are your economic IP is located, and in our case, it's mainly located in US and Japan. We have never over optimized our economic IP in low tax location where you need also to have a manufacturing site in order to leverage that. We have done it, but we have not done it very, very significantly.

    但是,您說得對,您的經濟知識產權位於哪裡,在我們的案例中,它主要位於美國和日本。我們從未在低稅率地區過度優化我們的經濟智慧財產權,在低稅率地區,您還需要擁有製造基地才能利用這一點。我們已經做到了,但成效還不是非常顯著。

  • That's also why our tax rate is in the low-20s and not in the mid-10s, for example, like some other companies. But this is today helping us in a way to have a lower potential tariff exposure.

    這也是為什麼我們的稅率在 20% 以下,而不是像其他一些公司一樣在 10% 左右。但這今天在某種程度上幫助我們降低了潛在的關稅風險。

  • Julie Kim - President, US Business Unit, and US Country Head

    Julie Kim - President, US Business Unit, and US Country Head

  • Sorry, I had started talking, forgotten to take myself off mute. Your question -- thank you, Matsubara-san -- in terms of ENTYVIO and where we are with reimbursement and whether or not we're targeting second line, I believe, was the other part of your question.

    抱歉,我已經開始說話了,卻忘了取消靜音。謝謝松原先生,您的問題是關於 ENTYVIO 以及我們的報銷情況,以及我們是否以第二線為目標,我相信,這是您問題的另一部分。

  • So for ENTYVIO, we really target first-line usage because of the profile of ENTYVIO, and it's got selective and its safety and efficacy track record. And so really, our focus is on making sure that ENTYVIO is the first choice when moving to advanced therapy in IBD, particularly in UC but also in CD.

    因此,對於 ENTYVIO,我們真正針對的是作為一線用途,因為 ENTYVIO 的特性,並且它具有選擇性以及安全性和有效性的記錄。因此,我們的重點是確保 ENTYVIO 成為 IBD 晚期治療的首選,尤其是 UC 和 CD。

  • And in regards to pen, again, here, this is where we do see patients who are coming on to advanced therapy for the first time that there is a strong preference for moving to pen, and it is about making sure that at the local level, we work through all of the details to make sure that there's smooth experience and transition for the patient.

    關於注射筆,我們再次看到,首次接受高級治療的患者強烈傾向於使用注射筆,而關鍵在於確保在地方層面,我們處理好所有細節,確保患者獲得順利的治療體驗和過渡。

  • And so quarter over quarter, as I mentioned in response to an earlier question, we are seeing an increase in the number of subscribers that we are seeing. And we also have very positive feedback in terms of the patients who do go on to pen and that they have a strong preference for it. So we do expect this to continue to increase, and we are still targeting our overall objective of having 50/50 split in terms of IV and PEN for ENTYVIO. Thank you.

    正如我在回答之前的問題時提到的那樣,我們看到訂閱用戶的數量逐季度增加。我們也從使用筆的患者那裡得到了非常正面的回饋,他們對此有強烈的偏好。因此,我們確實預計這一數字將繼續增加,並且我們仍將總體目標定為 ENTYVIO 的 IV 和 PEN 比例達到 50/50。謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Thank you. Wakao-san, JP Morgan.

    (翻譯)謝謝。JP Morgan 的 Wakao 先生。

  • Unidentified Participant

    Unidentified Participant

  • Thank you. I have two questions. What about, most favored nation policy in US. So there has been discussion of around drug price reductions and the most favored nation policy in US. If such a policy were implemented for Medicare and Medicaid, how do you assess the potential impact of MFL on your US business?

    謝謝。我有兩個問題。那麼,美國的最惠國政策呢?因此,美國一直在討論藥品降價和最惠國政策。如果對醫療保險和醫療補助實施這樣的政策,您如何評估 MFL 對您美國業務的潛在影響?

  • (interpreted) And the second question, I'd like to ask a question to Milano. The fourth quarter, the gross margin rate is higher than my forecast. What is the reasons of the improvement for the fourth quarter number and also the planned number for this fiscal year?

    (翻譯)第二個問題,我想問米蘭諾。第四季度,毛利率高於我的預測。第四季數字以及本財年計畫數字改善的原因是什麼?

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Wakao-san. So the first question on potential impact of most favored nation, Julie can answer about that. And then the second question on gross margin improvement, to Milano, please.

    謝謝你,若尾先生。因此,第一個問題是關於最惠國待遇的潛在影響,朱莉可以回答。第二個問題是關於毛利率提高的,請問米蘭諾。

  • Julie Kim - President, US Business Unit, and US Country Head

    Julie Kim - President, US Business Unit, and US Country Head

  • Thank you, Wakao-san, for the question on MFN or most favored nation. As you have probably seen, it's a very dynamic time here in the US, and this is a significant topic of discussion with the Pharma Board, which met this week and also met last week as well.

    謝謝 Wakao 先生關於 MFN 或最惠國待遇的問題。您可能已經看到,美國正處於一個非常活躍的時期,這是製藥委員會討論的一個重要話題,該委員會本週召開了會議,上周也召開了會議。

  • So this is an area that, when you think about MFN as a concept, it is a very challenging concept to apply in the US, because the health care system here is fundamentally different than the health care system where the pricing is being pulled from. And so basically, it is a price control being applied in the US setting when the US health care system is not set up for that.

    因此,當你將最惠國待遇視為一個概念時,你會發現,在美國應用這個概念非常具有挑戰性,因為這裡的醫療保健系統與定價來源的醫療保健系統有著根本的不同。因此,從根本上來說,這是在美國醫療保健系統尚未建立的情況下實施的價格控制。

  • And there are structural differences and particularly when you look at things like the middlemen with PBMs and with other programs such as 340B. So overall, from an industry perspective, if MFN were applied within the Medicaid setting, which, of course, then trickles through to 340B, that would be an industry impact over 10 years of up to $1 trillion. And so it would fundamentally be a significant challenge for the overall industry, Takeda included.

    並且存在結構性差異,特別是當你查看 PBM 的中間人以及 340B 等其他計劃時。因此,總體而言,從行業角度來看,如果在醫療補助制度中應用最惠國政策,那麼當然,這會滲透到 340B 計劃,這將對產業產生 10 年內高達 1 兆美元的影響。因此,從根本上來說,這對包括武田在內的整個產業來說都是一個重大挑戰。

  • And so when you look at what the US government is trying to do, we think that there are better ways to encourage manufacturing investment in the US, R&D investment in the US, and to support continued innovation through the biopharmaceutical industry in America. And so MFN would not be the appropriate way to do it, and it would be a significantly challenging situation for the whole industry, including us, to manage.

    因此,當你看到美國政府正在嘗試做的事情時,我們認為有更好的方法來鼓勵在美國進行製造業投資、在美國進行研發投資,並支持透過美國生物製藥產業進行持續創新。因此,最惠國待遇並不是合適的做法,對於包括我們在內的整個產業來說,這將是一個極具挑戰性的情況。

  • Milano Furuta - Chief Financial Officer, Director

    Milano Furuta - Chief Financial Officer, Director

  • (multiple speakers) (interpreted) May I comment? Thank you for your question. Regarding the gross margin, first of all, regarding the actual gross margin in the fourth quarter, usually in the fourth quarter, because of the seasonality, we see the trend of a downturn.

    (多位發言者)(翻譯)我可以發表評論嗎?感謝您的提問。關於毛利率,首先關於第四季度的實際毛利率,一般在第四季度,因為季節性的原因,我們看到的是下滑的趨勢。

  • And in FY24 Q4, we saw almost the same trend. And if you compare this number to the numbers up to the third quarter in FY 2024, there have been some cumulative FX impact onto the inventory, and that valuation method has been changed.

    在 FY24 第四季度,我們看到了幾乎相同的趨勢。如果將這個數字與截至 2024 財年第三季的數字進行比較,就會發現外匯對庫存產生了一些累積影響,而且估值方法也發生了變化。

  • Therefore, as a result, compared to the period up to the Q3 and the Q4 numbers, you may thought -- have thought that they look different. But actually, there wasn't much differences and actually, the landing was in line with what we gave guidance.

    因此,與第三季和第四季的數據相比,您可能會認為它們看起來有所不同。但實際上,並沒有太大的差異,而且著陸結果與我們的指導一致。

  • Regarding FY25 forecast, there are 2 points for the potential trend of the gross margin. One is the product mix, and the other is FX. The -- how much impact it will be on to the inventory, we changed the calculation method, as I mentioned earlier.

    對於FY25預測,毛利率的潛在趨勢有2點。一是產品組合,二是外匯。至於它對庫存的影響有多大,正如我之前提到的,我們改變了計算方法。

  • For the first point, the growth of Growth and Launch Products and the VYVANSE LOE offset and relatively speaking, the product mix impact on to the gross margin is going to be neutral, whereas in FY24, we posted the differences from the calculation was sort of changed. Regarding the FX impact onto the inventory and comparing FY24 and '25, this would work to improve the numbers.

    對於第一點,成長和發布產品的成長以及 VYVANSE LOE 抵消,相對而言,產品組合對毛利率的影響將是中性的,而在 FY24,我們發布的計算差異有所改變。關於外匯對庫存的影響以及比較 24 財年和 25 財年,這將有助於改善數字。

  • Unidentified Participant

    Unidentified Participant

  • (interpreted) That's all. Thank you very much. I could understand very well.

    (解釋)就這樣。非常感謝。我非常理解。

  • Julie Kim - President, US Business Unit, and US Country Head

    Julie Kim - President, US Business Unit, and US Country Head

  • And Wakao-san, I just wanted to add one more comment to your question rather than leaving it hanging as I did. Both the Pharma Board as well as individual companies, Takeda included, are putting in significant effort to work with Congress in terms of making sure MFN is not a policy that is included in the reconciliation package.

    還有 Wakao-san,我只是想對您的問題再補充一條評論,而不是像我一樣讓它懸而未決。製藥委員會以及包括武田在內的各家公司都在竭盡全力與國會合作,確保最惠國待遇不包含在和解方案中。

  • There are other pay for that pharma as an industry believe would meet the needs of the government's request here. And at this point, we will continue to support other policies beyond MFN as it is a way to control either pricing and/or provide a pay for in terms of the pill penalty fix, which is what started this initial conversation. Thank you.

    業內人士認為,該製藥公司還有其他薪酬方式可以滿足政府的要求。此時,我們將繼續支持最惠國待遇以外的其他政策,因為這是一種控制定價和/或以藥丸懲罰措施的形式提供報酬的方式,這也是最初對話的開始。謝謝。

  • Unidentified Participant

    Unidentified Participant

  • Thank you very much for your extent answer. I understand it very well. Thank you.

    非常感謝您的詳細回答。我非常理解。謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Wakao-san. Tony Ren, Macquarie.

    謝謝你,若尾先生。麥格理銀行的 Tony Ren。

  • Tony Ren - Analyst

    Tony Ren - Analyst

  • Hello, can you hear me?

    你好,你聽得到我說話嗎?

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Yes, Tony, we hear you.

    是的,托尼,我們聽到了。

  • Tony Ren - Analyst

    Tony Ren - Analyst

  • Okay. Perfect. Yeah. Thank you for the opportunity. Yeah, I -- the first one is for Christophe on going back to the possible impact of tariffs on last slide number 6. I think I heard you saying that customs value in the US, when you compare the customs value to the US revenue, it's about, if you go to slide number 6 here, 8% or so.

    好的。完美的。是的。感謝您提供的機會。是的,我——第一個問題是克里斯托夫關於關稅可能產生的影響,如上一張投影片第 6 段所述。我想我聽到您說過,美國的海關價值,當您將海關價值與美國收入進行比較時,如果您看這裡的第 6 張幻燈片,大約是 8% 左右。

  • This feels -- 8% to 10%, feels a little bit lower than I would have anticipated. Obviously, you guys do not disclose gross profit margin by region. But at the company level, it's about roughly 65%, which implies about 35% COGS as a percentage to revenue. And there was also a question about the IP, which relates to transfer pricing.

    感覺——8% 到 10%,比我預期的要低一點。顯然,你們沒有揭露按地區劃分的毛利率。但在公司層面,這一比例約為 65%,這意味著 COGS 佔收入的百分比約為 35%。還有一個關於智慧財產權的問題,它與轉讓定價有關。

  • So could you help me understand how can I juxtapose COGS transfer price and customs value? So that's a question for slide number 6. Another question is that in your 2025 guidance, you budgeted roughly JPY130 billion worth of negative impact from Medicare Part D redesign and 340B drug price program. This is a pretty big number. So I just want to see what are the drugs that are affected, and if you could just briefly explain mechanistically how you arrived at the JPY130 billion that would be great? Yeah, thank you.

    那麼你能幫助我理解如何並列 COGS 轉移價格和海關價值嗎?這是針對第 6 張投影片的問題。另一個問題是,在您的 2025 年指導中,您預算了 Medicare Part D 重新設計和 340B 藥品價格計劃將帶來的負面影響約為 1300 億日元。這是一個相當大的數字。所以我只是想看看受影響的藥物有哪些,如果您能從機制上簡單解釋一下您是如何得出 1300 億日元這個數字的,那就太好了?是的,謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Tony. So the first question around tariffs and the customs value impact, so Christophe can start that answer. And the second question on impact from Part D and 340B to Julie, but perhaps Milano could also jump in to add any comments as well. Christophe?

    謝謝你,托尼。因此第一個問題是關於關稅和海關價值影響,Christophe 可以開始回答。第二個問題是關於 D 部分和 340B 對朱莉的影響,但米蘭諾也許也可以加入發表一些評論。克里斯托夫?

  • Christophe Weber - President, Chief Executive Officer, Representative Director

    Christophe Weber - President, Chief Executive Officer, Representative Director

  • Yeah. Thank you, Tony. This is exactly why we wanted to disclose this analysis to you guys so that you don't make wrong assumptions. 50% of our total revenue is in the US, but the value of import from Europe, Japan and Singapore, because this is where we can only import drugs from is 8% to 10% of the total US revenue.

    是的。謝謝你,托尼。這就是我們想要向你們透露這項分析的原因,以便你們不會做出錯誤的假設。我們的總收入的 50% 來自美國,但從歐洲、日本和新加坡進口的價值(因為我們只能從這些地方進口藥品)占美國總收入的 8% 到 10%。

  • Why 8% to 10%? Because, one, there are many drugs that we manufacture in the US. So they are not -- they are excluded, if you like, from any import and tariffs. So ENTYVIO is a good example. ENTYVIO's manufacturing is in the US.

    為什麼是8%到10%?因為,首先,我們在美國生產許多藥物。所以它們不是——如果你願意的話,它們被排除在任何進口和關稅之外。ENTYVIO 就是一個很好的例子。ENTYVIO 的製造地在美國。

  • So ENTYVIO is not subject to tariff for example. So you need to exclude all the products, which are manufactured in the US, that's the first thing. And then after that, you need to consider the type of transfer price that exist from Europe to the US for example.

    例如,ENTYVIO 不受關稅約束。因此,你需要排除所有在美國製造的產品,這是第一件事。然後,您需要考慮從歐洲到美國的轉移價格類型。

  • And as we mentioned, our IP mainly is located in US and Japan, so we don't have significant optimization of our tax through a transfer price. So that's why we wanted to share with you this simple math, because you do -- if you want to sort of modelize, what could be a tariff impact, I will see how things are evolving. For example, if you take US, you take 50%. You take the revenue US.

    正如我們所提到的,我們的智慧財產權主要位於美國和日本,因此我們無法透過轉讓價格對稅收進行顯著優化。所以這就是我們想與你們分享這個簡單的數學計算的原因,因為如果你想要對關稅可能產生的影響進行某種建模,我會觀察事情是如何發展的。比如你拿美國的話,你就拿50%。你拿走美國的收入。

  • You multiply by 8% to 10%, and you multiply that by an average tariff, let's say, if it is Europe or Japan. I think that's how you can end up with a number. Same in China. In China, the value of import from the US is 10% to 12% to 15%, why? Because many products that we export to China or that China import come from Japan or from Europe and not from US. So I think this is very important to have this number to sort of scope what could be the tariff impact. And this is why we believe that we have -- we do have a potential exposure but quite limited.

    將其乘以 8% 到 10%,然後乘以平均關稅,比如說,如果是歐洲或日本。我想這就是你最終得到一個數字的方法。中國也一樣。在中國,從美國進口的金額佔比是10%到12%到15%,為什麼?因為我們出口到中國或中國進口的許多產品都來自日本或歐洲,而不是美國。因此,我認為透過這個數字來判斷關稅可能產生的影響非常重要。這就是為什麼我們相信我們確實有潛在的曝光度,但相當有限。

  • Julie Kim - President, US Business Unit, and US Country Head

    Julie Kim - President, US Business Unit, and US Country Head

  • Tony, I'll try to address the question around both Medicare Part D redesign and 340B, and then maybe Milano can jump in to talk about the total impact on the company financial picture because I think that was the other part of your question.

    東尼,我會嘗試回答有關 Medicare D 部分重新設計和 340B 的問題,然後米蘭諾也許可以談談對公司財務狀況的整體影響,因為我認為這是你問題的另一部分。

  • So for Medicare Part D redesign, so this is one of three areas within the Inflation Reduction Act that impacted the pharmaceutical sector. And so for Medicare Part D, just as a quick refresher for everyone, there was a significant shift of the government's responsibility over to payers and manufacturers.

    對於醫療保險 D 部分的重新設計,這是《通貨膨脹削減法案》中影響製藥業的三個領域之一。因此,對於醫療保險 D 部分,我們先讓大家快速回顧一下,政府的責任已顯著轉移到付款人和製造商身上。

  • So that piece that comes over to the manufacturers on the Medicare side, this is what we are now seeing the full-year impact for in our FY25 numbers as that went into effect in January of this year. So that's what you're seeing flowing through.

    因此,醫療保險方面的製造商所面臨的這個問題,就是我們現在在 2025 財年數據中看到的全年影響,因為該政策於今年 1 月生效。這就是你所看到的流動情況。

  • 340B is a program whose initial intent was to help provide support relief, I would say, for hospitals that are taking care of uninsured patients in the US. And this has expanded from the initial roughly 100 hospitals to over 2,000 hospitals that now use this program, and it has turned into a markup program where the hospitals receive the medicines at a very discounted rate, and then they mark it up and keep the difference.

    我想說,340B 是一個最初目的是幫助為美國照顧無保險患者的醫院提供支持救濟的計畫。目前,使用該計劃的醫院已從最初的約 100 家擴大到 2,000 多家,並已轉變為加價計劃,即醫院以非常優惠的價格獲得藥品,然後提高價格並保留差價。

  • This program is growing exponentially. It is the largest and the fastest growing government program of its kind. And so this is having a significant impact on our ongoing revenues as the 340B program continues to expand.

    該計劃正在呈指數級增長。這是同類政府項目中規模最大、發展最快的項目。隨著 340B 計畫的不斷擴大,這對我們的持續收入產生了重大影響。

  • So those are the drivers of those two different components. One is the full-year impact of the Medicare Part D redesign for the first time, and the second is the growth of the 340B program in the US.

    這些就是這兩個不同組件的驅動程式。一是Medicare D部分首次重新設計帶來的全年影響,二是美國340B計畫的成長。

  • Milano Furuta - Chief Financial Officer, Director

    Milano Furuta - Chief Financial Officer, Director

  • So Tony, if I add a little bit, as Julie explained, this both, the 340B expansion and Part D redesign, are working in a way to increase the manufacturers', the pharma companies' contribution or in the form of the rebate.

    所以托尼,如果我補充一點,正如朱莉所解釋的那樣,340B 擴展和 D 部分重新設計都在以某種方式增加製造商、製藥公司的貢獻或以回扣的形式。

  • So this will increase the rebate for the revenue, which are kind of realizing through this Medicare Part D and 340B. So the expansion of these two channels or the incremental rebate through the Part D is going to basically increasing the rebate in gross to net in the US revenue. That's the impact we are projecting if we compare the -- versus FY24.

    因此,這將增加收入的回扣,這些回扣是透過 Medicare Part D 和 340B 實現的。因此,這兩個管道的擴展或透過 D 部分增加的返利將從根本上增加美國收入中的總返利到淨返利。如果我們與 FY24 進行比較,這就是我們預測的影響。

  • It's going to be the 1,000 -- JPY130 billion impact. It's almost like incremental gross to net or the rebate in the US business. That's how the mechanistically or impacted our financials. I just wanted to add one commentary for tariff impact Christophe explained.

    這將產生1000至1300億日圓的影響。這幾乎就像美國業務中的增量毛利到淨額或回扣。這就是它對我們的財務狀況所產生的機械影響。我只是想對克里斯托夫解釋的關稅影響添加一條評論。

  • So even if you do the math, this impact is a potential impact of the annualized impact. So the amount you get by multiplying these factors would be the potential exposure to tariffs, and an actual maybe financial impact even if the tariff be supplied to the -- all the non-US country of origin products, the financial impact would be more or less -- or sorry, less because of the first timing. And then also we have some inventory in the -- on hand. And then we have some mitigation measurements to manage the inventory and the supply chain.

    因此,即使你計算一下,這種影響也是年度化影響的潛在影響。因此,將這些因素相乘得到的金額是潛在的關稅風險,以及實際的財務影響,即使關稅提供給所有非美國原產國的產品,財務影響也會或多或少 - 或者抱歉,由於第一次,財務影響會更少。而且我們手頭上還有一些庫存。然後我們採取一些緩解措施來管理庫存和供應鏈。

  • So the -- please don't translate directly to this that amount you calculate to a potential FY25 impact. This is going to be the potential annualized impact if a tariff becomes applied to all the non-US country of origin products.

    因此 — — 請不要直接將您計算出的 FY25 潛在影響金額轉換為這個。如果對所有非美國原產國產品徵收關稅,這將是潛在的年度影響。

  • Tony Ren - Analyst

    Tony Ren - Analyst

  • Yeah, thank you, Christophe, Judy, and Milano. Just a quick follow-up on the JPY130 billion impact, right, gross to net. Is this number heavily concentrated on a few drugs? Or is it fairly widely dispersed?

    是的,謝謝你,克里斯托夫、朱迪和米蘭諾。簡單跟進一下 1300 億日元的影響,對吧,總額與淨額。這個數字是否主要集中在少數幾種藥物上?或者說其分佈相當廣?

  • Milano Furuta - Chief Financial Officer, Director

    Milano Furuta - Chief Financial Officer, Director

  • It's across the products.

    它涉及所有產品。

  • Tony Ren - Analyst

    Tony Ren - Analyst

  • Okay, very good. Yeah, thank you very much.

    好的,非常好。是的,非常感謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Okay, great. Thank you, Tony. Goldman Sachs, Ueda-san.

    好的,太好了。謝謝你,托尼。高盛,上田先生。

  • Unidentified Participant

    Unidentified Participant

  • (interpreted) Yeah. This is Ueda at Goldman Sachs. I have two questions as well. First question is about R&D expense, level of R&D expense. FY24 year on year, I think yen was weaker, but on yen basis, I think the expense was flat.

    (翻譯)是的。我是高盛的上田。我也有兩個問題。第一個問題是關於研發費用、研發費用水準。與去年同期相比,我認為日圓走弱,但以日圓計算,我認為支出持平。

  • And going forward, do we expect this to stabilize? Progress of clinical program and also the efficiency program, do you have any specific outlook or guidance that you can share about how this may change? The second question is about margin outlook. For FY25 plan, VYVANSE revenue or sales is still remaining. We still have a substantial sales.

    展望未來,我們預期這種情況會穩定下來嗎?臨床計劃和效率計劃的進展,您是否可以分享有關這將如何改變的具體展望或指導?第二個問題是關於利潤率前景。對於 FY25 計劃,VYVANSE 的收入或銷售額仍然剩餘。我們的銷售額仍然可觀。

  • So when do we see the bottom out of margin? When should we expect that? That's my question, so efficiency program and LOE balance. Based on that, core OP of 30%, when do we see this happen? When do you think it will progress to that level? That's my question. Thank you.

    那我們什麼時候才能看到保證金的底部呢?我們什麼時候該期待這一點?這就是我的問題,效率計劃和 LOE 平衡。基於此,核心 OP 為 30%,我們什麼時候會看到這種情況發生?您認為什麼時候才能發展到那個層次?這就是我的問題。謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Ueda-san, for those questions. So the first on the outlook for the R&D budget, and the second on our margin outlook. So, Milano can answer both of those questions. Milano?

    謝謝上田先生提出這些問題。第一個是研發預算的前景,第二個是利潤率的前景。因此,米蘭諾可以回答這兩個問題。米蘭?

  • Milano Furuta - Chief Financial Officer, Director

    Milano Furuta - Chief Financial Officer, Director

  • (interpreted) Thank you, Ueda-san, for your questions. With regard to R&D expenses, what is the current trend, what is the outlook? For FY24, we had multiple factors. As we said before, some programs progressed -- actually, many of them progressed to Phase III. Therefore, the clinical development cost has increased.

    (翻譯)謝謝上田先生的提問。關於研發費用,目前的趨勢如何,前景如何?對於 FY24,我們有多個因素。正如我們之前所說,一些專案取得了進展——實際上,其中許多專案已進入第三階段。因此,臨床開發成本增加了。

  • But at the end of FY23, we did prioritize the programs in R&D. This meant that some of the programs were discontinued, and the expenses went down as well. And for FY24, we also implemented the efficiency program. So these are the three factors resulting in smaller R&D budget in FY24. Now moving to, sorry, FY25 and beyond, as we have explained in our guidance.

    但在 23 財年末,我們確實優先考慮了研發項目。這意味著一些項目被停止,費用也下降了。對於 24 財年,我們也實施了效率計畫。因此,這三個因素導致 24 財年研發預算減少。現在轉向,抱歉,FY25 及以後,正如我們在指導中所解釋的那樣。

  • R&D will accelerate, which means that R&D expense going forward will continue to increase over time. And for FY25, we will continue to implement efficiency program. And there will be some carryover impact of the efficiency programs implemented in FY24.

    研發將會加速,這意味著未來的研發費用將隨著時間的推移而不斷增加。在25財年,我們將繼續實施效率計畫。24 財年實施的效率計畫將會產生一些延續影響。

  • So we want to be able to offset the increase in R&D cost that way. With regard to outlook for margin, as we are a biopharmaceutical company, low to mid-30 -- more than 30% core OP should be our continuous target, and it will be.

    因此我們希望能夠透過這種方式來抵銷研發成本的增加。至於利潤率前景,由於我們是一家生物製藥公司,因此核心營業利潤率應保持在 30% 左右(30% 以上)應該是我們的持續目標,而我們也會這樣做。

  • But in terms of margin improvement, the shape of the curve may look a little bit different from what we saw one-year ago. And there are some reasons behind this. FY24 to begin with was already high in terms of core OP. We landed at high level. And also VYVANSE generic impact was pushed out to FY25.

    但就利潤率改善而言,曲線形狀可能與一年前看到的略有不同。這背後有一些原因。從核心 OP 來看,FY24 一開始就已經很高了。我們降落在高空。此外,VYVANSE 仿製藥的影響也延後至 25 財年。

  • And as somebody else asked earlier, pricing pressure was relatively high as well. So acceleration of development is the biggest factor. In order to continuously improve the margin over time, we need to make sure that new product launches are successful. And this is the most important factor and most important driver. And therefore, we will continue to invest into that.

    正如之前有人問到的,定價壓力也相對較高。因此加速發展是最大的因素。為了持續提高利潤率,我們需要確保新產品的推出能夠成功。這是最重要的因素和最重要的驅動因素。因此,我們將繼續對此進行投資。

  • But, we also want to improve the margin as well, so this is why we want to continue the efficiency program so that we can fund the investment.

    但是,我們也希望提高利潤率,因此我們希望繼續執行效率計劃,以便為投資提供資金。

  • Unidentified Participant

    Unidentified Participant

  • (interpreted) I understand. Thank you very much for your answer. That's all from me.

    (譯)我明白。非常感謝您的回答。我要說的就這些。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Sakai-san, UBS Securities.

    (譯)瑞銀證券的 Sakai 先生。

  • Fumiyoshi Sakai - Analyst

    Fumiyoshi Sakai - Analyst

  • This is Sakai from UBS. Yes. So two questions. The one is that I specifically ask your PDT business. How much this business is based on purely in the US land? Then when you counted the impact of tariffs, did you count those equipment, collection equipment and other machinery tools that your suppliers import from outside Japan -- sorry, not outside, from Japan, outside from US? That's the first question. The second question is for Plump-san, as always.

    我是瑞銀的 Sakai。是的。所以有兩個問題。一是,我專門問了你們的PDT業務。這項業務有多少是純粹基於美國土地的?那麼,當您計算關稅的影響時,您是否計算了您的供應商從日本以外進口的那些設備、收集設備和其他機械工具——對不起,不是從日本進口,而是從美國進口?這是第一個問題。第二個問題一如既往地是問 Plump 桑的。

  • Look at Page 26, I'm sorry if I missed your comment about the zasocitinib development program, but now you are launching this head-to-head, deucra trial ahead of the readout in the second half FY25. Now, I saw the J&J press release.

    請看第 26 頁,如果我錯過了您關於 zasocitinib 開發計劃的評論,我很抱歉,但是現在您正在啟動這場面對面的 deucra 試驗,以便在 2025 財年下半年的讀數之前進行。現在,我看到了強生公司的新聞稿。

  • They've got very good -- I think that was CD23 -- new program, right? And they are launching head to head with injectables. This is oral. Therefore, that change your kind of development strategy here for the zasocitinib going forward? That's my second question.

    他們有非常好的——我認為那是 CD23——新計劃,對嗎?他們正在就注射劑展開正面交鋒。這是口語。因此,這會改變您對 zasocitinib 未來的發展策略嗎?這是我的第二個問題。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Sakai-san. So the first question on PDT geographic footprint and how we thought of that in the tariff impact, so perhaps Giles can begin by -- with an overview of the geographic impact. And then Milano can follow up with any specifics on the tariffs. And then the second question on zasocitinib head to head and future development strategy, Andy can take that question.

    謝謝你,坂井先生。因此,第一個問題是關於 PDT 地理覆蓋範圍以及我們如何看待其對關稅的影響,也許 Giles 可以先概述地理影響。然後米蘭諾可以跟進有關關稅的任何具體細節。然後第二個問題關於 zasocitinib 的正面交鋒和未來的發展策略,Andy 可以回答這個問題。

  • Giles Platford - President, Plasma-Derived Therapies Business

    Giles Platford - President, Plasma-Derived Therapies Business

  • Thank you, Sakai-san for the question. About 60% of our PDT revenues are US domestic sales. And with regards to your question pertaining to the sourcing of equipment ex US, and impact from tariffs, we continue to evaluate that. And we feel confident that we can manage the continued supply of equipment to the US in our current understanding of the tariffs that have been already announced. Thank you.

    謝謝坂井先生提出的問題。我們的 PDT 收入約 60% 來自美國國內銷售。關於您關於美國以外設備採購以及關稅影響的問題,我們將繼續評估。我們有信心,根據我們目前對已經宣布的關稅的理解,我們能夠繼續向美國供應設備。謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Okay. Perhaps to Andy, then for the [zaso] question.

    好的。也許是對安迪來說,然後是[zaso]問題。

  • Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

    Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

  • Yes. Great. And Sakai, thank you very much for the question. So since we brought zasocitinib in, we've been keen to -- we believe, for many reasons, it's truly a best-in-class TYK2 inhibitor based on its selectivity, based on its once-daily dosing with full 24-hour coverage against TYK2, and then, of course, based on the data that we've seen so far in two of our Phase 2b studies. And so we're being keen to demonstrate in a head-to-head study against deucravacitinib that, in fact, we do have the best TYK2 inhibitor.

    是的。偉大的。酒井,非常感謝您的提問。因此,自從我們引入扎索替尼以來,我們一直熱衷於——我們相信,出於多種原因,它確實是同類最佳的 TYK2 抑製劑,基於它的選擇性,基於它每天一次的給藥並且可以對 TYK2 進行 24 小時的全面覆蓋,當然,基於我們迄今為止在兩項 2b 期研究中看到的數據。因此,我們熱衷於透過與 deucravacitinib 的正面交鋒研究證明,事實上,我們確實擁有最好的 TYK2 抑制劑。

  • And we're keen to start that study. And as we've mentioned previously, the two Phase 3 studies in psoriasis will read out later this year. We're in the process of collecting a very substantive safety database to support the filing, and we're preparing for our manufacturing for commercial launch. All of that will be the basis of our filing. The deucra comparator study, head-to-head study will not be a part of the initial package.

    我們熱切地希望開始這項研究。正如我們之前提到的,兩項針對牛皮癬的 3 期研究將於今年稍後公佈。我們正在收集非常實質的安全資料庫來支援申請,並且正在為商業發布的製造做準備。所有這些都將成為我們提交申請的基礎。Deucra 對比研究和頭對頭研究不會成為初始方案的一部分。

  • Our goal is for that to come out at the time of launch to support our overall messaging and differentiation package. I'd like to hand it over to you, Julie. Maybe you can talk a little bit about the access considerations in the competitive landscape?

    我們的目標是在產品發佈時就實現這一點,以支持我們的整體訊息傳遞和差異化方案。我想把它交給你,朱莉。或許您可以稍微談談競爭格局中的進入考量?

  • Julie Kim - President, US Business Unit, and US Country Head

    Julie Kim - President, US Business Unit, and US Country Head

  • Sure. Thank you for the question around the head to head. So first, as Andy said, we do believe that it is important to have a head to head with deucra to be able to demonstrate the differentiated profile within the TYK2 space.

    當然。感謝您提出有關面對面的問題。首先,正如安迪所說,我們確實認為與 deucra 進行正面交鋒非常重要,這樣才能展示 TYK2 領域內的差異化概況。

  • But as you pointed out, their -- the J&J compound is also looking at head to head, in a different type of head to head. We do believe that having two strong efficacious orals will be a benefit to growing the oral segment within the psoriasis treatment landscape. And so, we will continue to address and look at the different ways of differentiating zasocitinib, so that we can best support it at launch.

    但正如你所指出的,強生公司也在進行不同類型的正面交鋒。我們確實相信,擁有兩種強效口服藥物將有利於擴大牛皮癬治療領域的口服藥物市場。因此,我們將繼續解決並研究區分 zasocitinib 的不同方法,以便我們能夠在產品發佈時為其提供最佳支援。

  • Fumiyoshi Sakai - Analyst

    Fumiyoshi Sakai - Analyst

  • Okay. So [JJ] compound, [IL-26] sorry, I missed that. And just to confirm, I mean, everything in budget, right, everything in this year's budget, this head to head going forward?

    好的。所以 [JJ] 化合物,[IL-26] 抱歉,我錯過了。只是為了確認一下,我的意思是,預算中的所有內容,對吧,今年預算中的所有內容,接下來會如何進行?

  • Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

    Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director

  • It's -- that's correct.

    這是——正確的。

  • Fumiyoshi Sakai - Analyst

    Fumiyoshi Sakai - Analyst

  • All right. Thank you very much.

    好的。非常感謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Thank you very much. With that question, we are reaching the time to close. So much for Q&A, and with this, we would like to close today's webinar. Thank you very much for joining us today in spite of your busy schedule. We hope that you continue to support Takeda. Thank you.

    (翻譯)非常感謝。帶著這個問題,我們就要結束談話了。問答環節就到這裡,我們想結束今天的網路研討會。非常感謝您百忙之中抽空參加今天的活動。我們希望您繼續支持武田。謝謝。

  • Editor

    Editor

  • 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。