Takeda Pharmaceutical Co Ltd (TAK) 2023 Q3 法說會逐字稿

[Interpreted] Thank you for taking time out of your very busy schedule to join us for the FY '22 Q3 earnings announcement by Takeda. My name is O'Reilly, Head of IR. I'll be the master of ceremony today. (Operator Instructions)

[已解讀] 感謝您在百忙之中抽出時間來參加我們的武田公司 22 財年第三季度收益公告。我叫 O'Reilly，IR 主管。今天由我主持。 （操作員說明）

Before starting, I'd like to remind everyone that we'll be using forward-looking statements in 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 the 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，我們將使用 1995 年《私人證券訴訟改革法案》含義中的前瞻性陳述。實際結果可能與今天討論的結果大不相同。在最近的 20-F 表格和我們提交給美國證券交易委員會的其他文件中討論了可能導致實際結果出現重大差異的因素。

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

另請參閱演示文稿第 2 頁上有關前瞻性陳述和我們的非 IFRS 財務措施的重要通知，這也將在本次電話會議期間進行討論。我們的非 IFRS 措施的定義以及與可比 IFRS 財務措施的對賬包含在演示文稿的附錄中。

Now we would like to move to the presentation and the presenters are Christophe Weber, President and CEO; Andy Plump, President of R&D; Costa Saroukos, Chief Financial Officer. And after the presentation, we will have time for Q&A. Let us start.

現在我們要進行演示，演示者是總裁兼首席執行官 Christophe Weber；研發總裁 Andy Plump； Costa Saroukos，首席財務官。演示結束後，我們將有時間進行問答。讓我們開始吧。

Thank you, Chris. Thank you, everyone, for joining us today. It's a real pleasure to be with you. I'm pleased to report that Takeda has delivered another strong quarter, and we are reinforcing our long-term growth through pipeline advancements and two targeted acquisitions. These developments are well aligned with our vision to discover and deliver life-transforming treatments guided by our commitment to patients, our people and the planet. This purpose-led approach is at the core of our strategy for global growth and long-term value creation for our stakeholders.

謝謝你，克里斯。謝謝大家今天加入我們。很高興和你在一起。我很高興地報告，武田（Takeda）又交付了一個強勁的季度，我們正在通過管道改進和兩次有針對性的收購來加強我們的長期增長。這些發展與我們的願景完全一致，即以我們對患者、我們的人民和地球的承諾為指導，發現和提供改變生命的治療方法。這種以目標為導向的方法是我們為利益相關者實現全球增長和長期價值創造戰略的核心。

In order to do that, we aim to create a diverse, equitable and inclusive working environment for Takeda colleagues. Our focus on creating an exceptional people experience has been critical in allowing us to maintain and develop talent, especially during the recent challenges of the pandemic.

為了做到這一點，我們的目標是為武田同事創造一個多樣化、公平和包容的工作環境。我們專注於創造卓越的人員體驗，這對於我們保持和培養人才至關重要，尤其是在最近的大流行病挑戰期間。

I'm very proud that these efforts continue to be recognized. Last month, for the sixth consecutive year, we were 1 of only 15 companies to achieve global top employer certification for 2023. In addition to this global certification, Takeda was recognized as a top employer across 22 countries.

我很自豪這些努力繼續得到認可。上個月，我們連續第六年成為獲得 2023 年全球最佳雇主認證的 15 家公司之一。除了這一全球認證，武田還在 22 個國家/地區被公認為最佳雇主。

If now we move on the next slide. We have again delivered strong revenue and profit growth as we continue to execute on our strategy. Let me take you through some of our recent highlights. In Q3 year-to-date, core revenue was almost JPY 3.1 trillion, with growth of 4.5% at a constant exchange rate. Our top line continued to be driven by great momentum from our Growth and Launch Products, which now represents 39% of total revenue and grew at 20% year-to-date at a constant exchange rate.

如果現在我們轉到下一張幻燈片。隨著我們繼續執行我們的戰略，我們再次實現了強勁的收入和利潤增長。讓我帶您了解一下我們最近的一些亮點。今年第三季度，核心收入接近 3.1 萬億日元，按固定匯率計算增長 4.5%。我們的收入繼續受到我們的增長和發布產品的強勁勢頭的推動，這些產品現在佔總收入的 39%，並且以固定匯率計算今年迄今增長了 20%。

Core operating profit was JPY 954.7 billion, enabling us to maintain a competitive core operating profit margin of 31.1%. And core earnings per share was JPY 456 with growth of 17.1% at a constant exchange rate.

核心營業利潤為 9,547 億日元，使我們能夠保持 31.1% 的具有競爭力的核心營業利潤率。每股核心收益為 456 日元，按固定匯率計算增長 17.1%。

This result very clearly keep us on track to deliver our management guidance of low single-digit core revenue growth and high single-digit core operating profit and core EPS growth on a constant exchange rate basis. And in fact, we are tracking toward the high end of some of these metrics.

這一結果非常清楚地使我們能夠在固定匯率的基礎上提供低個位數核心收入增長和高個位數核心營業利潤和核心 EPS 增長的管理指導。事實上，我們正在追踪其中一些指標的高端。

Moving now to the right-hand side of the slide. We are progressing on our journey to build one of the most exciting and diverse pipeline in the industry. In December, we achieved a significant milestone as our dengue vaccine, QDENGA, was approved for use in the European Union against any serotype in individuals 4 years of age and older. This followed a positive CHMP opinion in October recommending approval in the EU and in dengue-endemic countries participating in the parallel EU medicine for all procedure. We reached a further crucial milestone late last year when the U.S. FDA accepted our dengue vaccines candidate for priority review.

現在移到幻燈片的右側。我們正在努力建設業內最令人興奮和多樣化的渠道之一。 12 月，我們實現了一個重要的里程碑，我們的登革熱疫苗 QDENGA 獲准在歐盟用於 4 歲及以上人群的任何血清型。此前，CHMP 在 10 月份發表了積極的意見，建議在歐盟和登革熱流行國家批准所有程序的平行歐盟藥物。去年底，美國 FDA 接受了我們的登革熱候選疫苗進行優先審查，我們達到了另一個重要的里程碑。

We also had three positive late-stage trial readouts since our last quarterly update. In January, we announced favorable safety and efficacy results for TAK-755 from the first and only Phase III trial in CTTP, an ultra-rare disease with limited treatment options. Based on this data, we plan to submit TAK-755 for marketing authorization.

自上次季度更新以來，我們還獲得了三個積極的後期試驗讀數。 1 月，我們宣布了 TAK-755 在 CTTP 中的第一個也是唯一一個 III 期試驗的良好安全性和有效性結果，CTTP 是一種治療選擇有限的超罕見疾病。基於這些數據，我們計劃提交 TAK-755 以獲得上市許可。

In addition, the reason from our Phase III oral trial for LIVTENCITY, maribavir, were encouraging, demonstrating evidence of durable antiviral efficacy and confirming the favorable safety profile despite not meeting the primary endpoints of non-inferiority at 8 weeks. Full data results will be submitted to a peer-reviewed journal and are being shared with regulatory agencies. Andy will share additional information on these two studies later in the presentation.

此外，我們對 LIVTENCITY maribavir 進行的 III 期口服試驗的原因令人鼓舞，證明了持久抗病毒療效的證據並證實了良好的安全性，儘管在 8 週時未達到非劣效性的主要終點。完整的數據結果將提交給同行評審的期刊，並與監管機構共享。 Andy 將在稍後的演講中分享有關這兩項研究的更多信息。

In January, together with our partner, Arrowhead, we announced positive Phase II data for fazirsiran in alpha-1 antitrypsin deficiency associated liver disease. Takeda is responsible for taking this program into a Phase III study, which we expect to begin very soon.

1 月，我們與我們的合作夥伴 Arrowhead 一起公佈了 fazirsiran 在 alpha-1 抗胰蛋白酶缺乏症相關肝病中的陽性 II 期數據。武田負責將該項目納入 III 期研究，我們預計該研究很快就會開始。

Moving to the mid-stage pipeline. TAK-861, our orexin agonist for narcolepsy has met our prespecified criteria to advance the program into two Phase IIb studies in narcolepsy type 1 and type 2. We have been proactively planning these studies and we'll be able to move very quickly. Both Phase IIb trials are currently enrolling patients.

轉移到中期管道。 TAK-861，我們用於發作性睡病的食慾素激動劑，已達到我們預先指定的標準，可以將該項目推進到 1 型和 2 型發作性睡病的兩項 IIb 期研究。我們一直在積極規劃這些研究，我們將能夠非常迅速地採取行動。兩項 IIb 期試驗目前都在招募患者。

To supplement this positive development in our pipeline, we are making strategic investments in long-term growth in line with our capital allocation policy. In December, we announced a major agreement with Nimbus Therapeutics to acquire a potential best-in-class TYK2 inhibitors to be known as TAK-279 after closing. This acquisition is fully aligned with our strategy and adds another important licensed therapy to our pipeline.

為了補充我們管道中的這一積極發展，我們正在根據我們的資本配置政策對長期增長進行戰略投資。去年 12 月，我們宣布與 Nimbus Therapeutics 達成一項重要協議，以收購一種潛在的同類最佳 TYK2 抑製劑，交易完成後將被稱為 TAK-279。此次收購完全符合我們的戰略，並為我們的管道增加了另一種重要的許可療法。

This therapy has possible indication across a broad range of disease, including psoriasis, psoriatic arthritis, inflammatory bowel disease and lupus. It represents clearly a very significant potential opportunity in this market.

這種療法可能適用於多種疾病，包括牛皮癬、銀屑病關節炎、炎症性腸病和狼瘡。它顯然代表了這個市場中一個非常重要的潛在機會。

We could potentially find this program within the fiscal year '25 to '27 time frame, which means it could be generating significant revenue by the time (inaudible) biosimilar, reinforcing our growth profile into the next decade. We were able to take advantage of this exceptionally rare opportunity because of our financial discipline and our success in deleveraging, which is driving our strong free cash flow. We will maintain that strong financial discipline as we continue to look for opportunities to enhance our pipeline with mid- to late-stage assets.

我們可能會在 25 到 27 財年的時間框架內找到這個項目，這意味著它可能會在（聽不清）生物仿製藥時產生可觀的收入，從而加強我們在下一個十年的增長前景。由於我們的財務紀律和我們在去槓桿化方面的成功，我們能夠利用這個非常難得的機會，這推動了我們強勁的自由現金流。我們將繼續保持嚴格的財務紀律，同時繼續尋找機會來加強我們的中後期資產管道。

In January, we announced an exclusive licensing agreement with HUTCHMED for fruquintinib, a highly selective VEGFR 1, 2, 3 oral tyrosine kinase inhibitor. Fruquintinib offers a potential new treatment option for patients with refractory metastatic colorectal cancer regardless of biomarker status. The agreement will give us exclusive rights to further develop and commercialize fruquintinib worldwide, excluding China, Hong Kong and Macau. We plan to complete regulatory submissions in the U.S., Europe and Japan in 2023.

1 月，我們宣布與 HUTCHMED 就呋喹替尼達成獨家許可協議，呋喹替尼是一種高選擇性 VEGFR 1、2、3 口服酪氨酸激酶抑製劑。無論生物標誌物狀態如何，呋喹替尼都為難治性轉移性結直腸癌患者提供了一種潛在的新治療選擇。該協議將賦予我們在全球範圍內進一步開發和商業化 fruquintinib 的獨家權利，不包括中國、香港和澳門。我們計劃於 2023 年完成美國、歐洲和日本的監管提交。

Including this quarter has reinforced our growth outlook. We continue to deliver on our financial commitment to progress our pipeline and to create long-term value for our stakeholders while we fulfill our purpose of bringing better health for people and a brighter future for the world.

包括本季度在內，加強了我們的增長前景。我們將繼續履行我們的財務承諾，以推進我們的管道並為我們的利益相關者創造長期價值，同時實現我們為人們帶來更好的健康和為世界帶來更光明未來的目標。

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

有了這個，我會把電話轉給安迪，讓你了解我們的管道。謝謝。

Thank you, Christophe, and hello to everyone on the call today. If we go to the next slide, please. Pipeline continues to advance with very strong momentum this quarter and fiscal year. I'm excited to share several important pipeline updates that have been achieved just this quarter.

謝謝你，Christophe，今天向大家問好。請轉到下一張幻燈片。本季度和本財年，管道繼續以非常強勁的勢頭推進。我很高興與大家分享本季度剛剛完成的幾項重要的管道更新。

As Christophe mentioned, Takeda's dengue vaccine, QDENGA, was approved in the EU and received a positive CHMP opinion for endemic countries participating in the EU medicines for all program. In addition, the U.S. filing is complete and QDENGA received priority review. As a result of these efforts, Takeda is on track to provide broad access to this critical vaccine with many additional approvals and launches in the near future.

正如 Christophe 提到的，Takeda 的登革熱疫苗 QDENGA 在歐盟獲得批准，並獲得了 CHMP 對參與歐盟所有藥物計劃的流行國家的積極意見。此外，美國備案已完成，QDENGA獲得優先審評。作為這些努力的結果，武田有望在不久的將來獲得更多的批准和上市，從而提供對這種關鍵疫苗的廣泛使用。

QDENGA is a transformative vaccine that fills a substantial unmet need for individuals in and travelers to warm weather climates. QDENGA has the potential to prevent morbidity and mortality from dengue in endemic regions across the globe, where about half of the world's population lives.

QDENGA 是一種變革性疫苗，可滿足氣候溫暖地區的個人和旅行者的大量未滿足需求。 QDENGA 有可能在全球約一半人口居住的全球流行地區預防登革熱的發病率和死亡率。

Important clinical updates include TAK-755, which at an interim analysis of the Phase III study demonstrated robust efficacy and a strong safety profile compared to the standard of care in congenital thrombotic thrombocytopenic purpura or CTTP. We will file for approval of TAK-755 as the first recombinant ADAMTS13 replacement therapy for cTTP. I'll discuss these data in more detail later in this presentation.

重要的臨床更新包括 TAK-755，在 III 期研究的中期分析中，與先天性血栓性血小板減少性紫癜或 CTTP 的護理標準相比，它顯示出強大的療效和強大的安全性。我們將申請批准 TAK-755 作為 cTTP 的第一個重組 ADAMTS13 替代療法。我將在本演示文稿的後面更詳細地討論這些數據。

LIVTENCITY is up next. In the Phase III AURORA study, LIVTENCITY provided clear evidence of durable antiviral efficacy in hematopoietic stem cell transplant patients with first-line CMV infections. In addition, we confirmed its favorable safety profile versus the standard of care. We are excited to engage regulatory agencies about our filing strategy in the very near future.

接下來是LIVTENCITY。在 III 期 AURORA 研究中，LIVTENCITY 提供了明確的證據，表明在一線 CMV 感染的造血幹細胞移植患者中具有持久的抗病毒療效。此外，我們確認其安全性優於護理標準。我們很高興在不久的將來讓監管機構參與我們的備案策略。

Next, ICLUSIG, our third-generation tyrosine kinase inhibitor designed to block BCR-ABL. ICLUSIG met the primary endpoint in the Phase III PhALLCON study, demonstrating higher rates of minimal residual disease or MRD negative complete response when compared head-to-head with imatinib in frontline Philadelphia chromosome positive ALL.

接下來，ICLUSIG，我們的第三代酪氨酸激酶抑製劑，旨在阻斷 BCR-ABL。 ICLUSIG 達到了 III 期 PhALLCON 研究的主要終點，表明在費城染色體陽性 ALL 一線治療中與伊馬替尼直接比較時，微小殘留病或 MRD 陰性完全緩解率更高。

MRD negativity is associated with improvement in long-term outcomes for patients as reported in the scientific literature. We are discussing these potentially practice-changing data with regulatory agencies and will be the featured abstract in February's ASCO Plenary Series.

正如科學文獻所報導的那樣，MRD 陰性與患者長期結果的改善有關。我們正在與監管機構討論這些可能改變實踐的數據，並將成為 2 月份 ASCO 全體會議系列的特色摘要。

In early January, Takeda, with our partner, Arrowhead, announced positive results for fazirsiran from the blinded Phase II SEQUOIA trial. Fazirsiran is a potential first-in-class RNA interference therapy designed to reduce the production of mutant alpha-1 antitrypsin protein or ZAAT as a potential treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency.

1 月初，武田與我們的合作夥伴 Arrowhead 宣布了 fazirsiran 在盲法 II 期 SEQUOIA 試驗中的積極結果。 Fazirsiran 是一種潛在的一流 RNA 干擾療法，旨在減少突變 alpha-1 抗胰蛋白酶蛋白或 ZAAT 的產生，作為與 alpha-1 抗胰蛋白酶缺乏症相關的罕見遺傳性肝病的潛在治療方法。

Fazirsiran demonstrated a dramatic decrease in circulating median ZAAT as well as liver ZAAT globules. In addition, the percent improvement in portal inflammation and change in fibrosis were consistent with the prior open-labeled Phase II results. We've opened the Phase III study with the primary endpoint of decrease from baseline of at least one stage of histologic fibrosis measured at week 106. We believe that patients who received fazirsiran for 2 years should demonstrate continued therapeutic benefit with improvements in liver fibrosis.

Fazirsiran 顯示循環 ZAAT 中值和肝臟 ZAAT 小球顯著減少。此外，門靜脈炎症的改善百分比和纖維化的變化與之前開放標記的 II 期結果一致。我們已經開始了 III 期研究，其主要終點是在第 106 週測量的組織學纖維化的至少一個階段從基線減少。我們認為接受 fazirsiran 治療 2 年的患者應該表現出持續的治療益處並改善肝纖維化。

Also in January, as Christophe mentioned, we announced the advancement of TAK-861 into two Phase IIb dose-ranging studies for patients with narcolepsy type 1 and narcolepsy type 2. We remain very excited about our orexin franchise. We believe our oral orexin agonist, TAK-861, has the potential to transform treatment for patients suffering from narcolepsy. I will describe the directional criteria used to make this decision shortly.

同樣在 1 月，正如 Christophe 提到的，我們宣布將 TAK-861 推進到針對 1 型發作性睡病和 2 型發作性睡病患者的兩項 IIb 期劑量範圍研究。我們對食慾素特許經營權仍然感到非常興奮。我們相信我們的口服食慾素激動劑 TAK-861 有可能改變嗜睡症患者的治療方法。我將很快描述用於做出此決定的方向標準。

The last clinical update we would like to share is a new Phase II start for TAK-341, an antibody therapy targeting alpha-synuclein for multiple system atrophy or MSA. MSA is a rare, progressive and fatal neurodegenerative disorder. Our Phase I study showed strong target engagement and a significant reduction of CSF alpha-synuclein. We believe there is a strong biologic rationale that preventing the accumulation of alpha-synuclein could be a disease-modifying approach for MSA patients, for which there are currently no approved therapies.

我們要分享的最後一個臨床更新是 TAK-341 的新 II 期開始，TAK-341是一種針對 α-突觸核蛋白的抗體療法，用於治療多系統萎縮或 MSA。 MSA 是一種罕見的、進行性和致命的神經退行性疾病。我們的第一階段研究顯示了強大的目標參與和 CSF α-突觸核蛋白的顯著減少。我們認為，有一個強有力的生物學原理表明，防止 α-突觸核蛋白的積累可能是 MSA 患者的一種疾病緩解方法，目前尚無批准的治療方法。

And finally, again, as Christophe mentioned earlier, we recently signed (technical difficulty) stage pipeline-enhancing deals that are pending antitrust reviews. We announced our intent to acquire a late-stage potential best-in-class oral allosteric TYK2 inhibitor from Nimbus Therapeutics. Data from a Phase IIb study of this molecule in patients with psoriasis are targeted for presentation in March, just next month. With its unique allosteric mechanism of action, this asset is a potent and highly selective TYK2 inhibitor with exceptional clinical activity, a strong tolerability profile and wide therapeutic margins. We believe it has best-in-class potential across a wide range of immune-mediated conditions.

最後，正如 Christophe 之前提到的，我們最近簽署了（技術困難）階段管道增強交易，這些交易正在等待反托拉斯審查。我們宣布我們打算從 Nimbus Therapeutics 獲得一種後期階段的潛在同類最佳口服變構 TYK2抑製劑。該分子在銀屑病患者中的 IIb 期研究數據將於 3 月，也就是下個月公佈。憑藉其獨特的變構作用機制，該資產是一種有效且高度選擇性的 TYK2 抑製劑，具有卓越的臨床活性、強大的耐受性和廣泛的治療範圍。我們相信它在廣泛的免疫介導條件下具有一流的潛力。

The second deal is a licensing agreement with HUTCHMED that gives Takeda worldwide rights outside of China to fruquintinib, a highly selective oral VEGF receptor tyrosine kinase inhibitor that's already demonstrated a significant overall survival benefit in refractory metastatic colorectal cancer. Our partner, HUTCHMED has started a rolling submissions process with the U.S. FDA. Regulatory submissions are expected to be completed in the U.S., EU and Japan in fiscal year 2023.

第二筆交易是與 HUTCHMED 達成的許可協議，授予武田在中國以外的全球範圍內使用呋喹替尼的權利，呋喹替尼是一種高選擇性口服 VEGF 受體酪氨酸激酶抑製劑，已在難治性轉移性結直腸癌中顯示出顯著的總體生存獲益。我們的合作夥伴 HUTCHMED 已開始與美國 FDA 進行滾動提交流程。預計將於 2023 財年在美國、歐盟和日本完成監管提交。

Next slide, please. Shown here are our 10 late-stage development programs, which continue to advance. Additional progress this quarter includes the LIVTENCITY filing for relapsed refractory CMV in China and a submission of QDENGA in the U.S., which received priority review. As evidenced by the two late-stage deal announcements, Nimbus and HUTCHMED, we continue to look for transformative programs within our therapeutic areas that can add to our late-stage development program and contribute to our marketed portfolio this decade.

請換下一張幻燈片。這裡顯示的是我們的 10 個後期開發項目，這些項目仍在繼續推進。本季度的其他進展包括 LIVTENCITY 在中國提交的複發難治性 CMV 申請和在美國提交的 QDENGA 申請，後者獲得了優先審評。正如兩個後期交易公告 Nimbus 和 HUTCHMED 所證明的那樣，我們繼續在我們的治療領域尋找變革性項目，這些項目可以增加我們的後期開發項目，並為我們這十年的營銷產品組合做出貢獻。

Next slide, please. We are energized by recent developments in our mid-stage pipeline that continues to mature and advance. As mentioned earlier, this quarter, we advanced TAK-861 into two Phase IIb dose-ranging studies for patients with narcolepsies type 1 and 2. This decision was made based on the careful review of preclinical toxicology data, data from the single and multiple ascending dose healthy volunteer cohorts, data from studies of healthy volunteers subject to sleep deprivation and finally, efficacy and safety data for patients with narcolepsy type 1.

請換下一張幻燈片。我們對中期管道的最新發展感到鼓舞，該管道不斷成熟和進步。如前所述，本季度，我們將 TAK-861 推進到針對 1 型和 2 型發作性睡病患者的兩項 IIb 期劑量範圍研究。這一決定是基於對臨床前毒理學數據、單次和多次遞增的數據的仔細審查做出的劑量健康志願者隊列，來自睡眠剝奪的健康志願者的研究數據，最後是 1 型發作性睡病患者的療效和安全性數據。

The prespecified Phase Ib efficacy criteria are equivalent to those used to evaluate our other orexin agonists. The safety review included liver safety assessments for up to 4 weeks of treatment. Our decision to progress was based upon the data for TAK-861 and our extensive datasets from prior orexin agonist development.

預先指定的 Ib 期療效標準與用於評估我們其他食慾素激動劑的標準相同。安全性審查包括長達 4 周治療的肝臟安全性評估。我們決定取得進展是基於 TAK-861 的數據和我們之前開發的食慾素激動劑的廣泛數據集。

In addition, we highlight in green a recent submission to an upcoming conference, promising early data for TAK-925 in healthy volunteers recovering from anesthesia. We hope to share these data with you early in fiscal year 2023.

此外，我們以綠色突出顯示最近提交給即將召開的會議的一份報告，其中承諾 TAK-925 在從麻醉中恢復的健康志願者中的早期數據。我們希望在 2023 財年年初與您分享這些數據。

At our year-end call, we plan to share progress across the mid-stage programs shown here. These programs are the first of many new molecular entities that could emerge from our rich and transformative early to mid-stage pipeline, adding to a growing late-stage portfolio.

在年終電話會議上，我們計劃分享此處顯示的中期計劃的進展情況。這些項目是許多新分子實體中的第一個，它們可能從我們豐富且具有變革性的早期到中期管道中出現，增加了不斷增長的後期產品組合。

Next slide, please. Shown here are select expansion opportunities we have for our major brands. Subcutaneous ENTYVIO was filed in Japan for Crohn's disease earlier than our initial plan. We continue to expect an ENTYVIO subcutaneous U.S. filing in early 2023.

請換下一張幻燈片。這裡顯示的是我們為主要品牌提供的精選擴張機會。皮下注射 ENTYVIO 比我們最初的計劃更早在日本申請克羅恩病。我們繼續預計 ENTYVIO 將於 2023 年初在美國提交皮下注射申請。

The EU filing for the approval of TAKHZYRO to treat pediatric patients is complete, as is the U.S. submission for TAK-880, an IVIG therapy for patients with the sensitivity to immunoglobulin A.

歐盟批准 TAKHZYRO 用於治療兒科患者的申請已經完成，美國提交的 TAK-880 也已完成，TAK-880 是一種針對免疫球蛋白 A 敏感患者的 IVIG 療法。

Next slide, please. As you can see illustrated here, Q3 had many regulatory and Phase III highlights that added to our pipeline momentum. Positive regulatory updates include QDENGA approval in the EU and U.K. LIVTENCITY achieved EU approval this quarter and EXKIVITY was approved in China earlier than our initial target of fiscal year 2023.

請換下一張幻燈片。正如你在這裡看到的那樣，第三季度有許多監管和第三階段的亮點，增加了我們的管道勢頭。積極的監管更新包括 QDENGA 在歐盟和英國的批准。本季度 LIVTENCITY 獲得歐盟批准，而 EXKIVITY 在中國的批准時間早於我們 2023 財年的初始目標。

Lastly, the HyHub device, which is designed to improve the patient experience by reducing the number of steps required to complete an infusion of HYQVIA will now have a regulatory decision in the first half of fiscal year 2023. We have received some end-of-review requests from the FDA that we believe can be satisfied through additional analytical testing.

最後，HyHub 設備旨在通過減少完成 HYQVIA 輸注所需的步驟來改善患者體驗，現在將在 2023 財年上半年做出監管決定。我們已經收到了一些結束-我們認為可以通過額外的分析測試來滿足 FDA 的審查要求。

Now let's look at TAK-755 and LIVTENCITY data. Next slide, please. TAK-755 is our recombinant ADAMTS13 replacement therapy designed to address the underlying cause of congenital TTP. The interim analysis of the first and only Phase III pivotal trial in cTTP patients showed a 60% reduction in the incidence of thrombocytopenic events versus the standard of care, which is plasma derived from fresh frozen plasma or FFP. TAK-755 also showed that a substantially lower proportion of subjects experienced adverse events. These, and many other clinically relevant benefits from this head-to-head trial will be presented at a medical meeting later this year.

現在讓我們看看 TAK-755 和 LIVTENCITY 數據。請換下一張幻燈片。 TAK-755 是我們的重組 ADAMTS13 替代療法，旨在解決先天性 TTP 的根本原因。對 cTTP 患者進行的第一個也是唯一一個 III 期關鍵試驗的中期分析顯示，與標準護理相比，血小板減少事件的發生率降低了 60%，標準護理是從新鮮冷凍血漿或 FFP 中提取的血漿。 TAK-755 還表明，經歷不良事件的受試者比例大大降低。這些以及該頭對頭試驗的許多其他臨床相關益處將在今年晚些時候的醫學會議上展示。

As you can see on the right, we have ADAMTS13 activity plotted versus time at varying doses. The 40 units per kilogram dose was the one used in the Phase III trial and is plotted in green. The gray and shaded area between the 5 and 20 unit curves is representative of the activity we would expect from the plasma standard of care, which typically provides about 10 units per kilogram of activity.

正如您在右側所見，我們繪製了不同劑量下 ADAMTS13 活性與時間的關係圖。每公斤 40 單位的劑量是 III 期試驗中使用的劑量，並以綠色繪製。 5 和 20 單位曲線之間的灰色和陰影區域代表我們期望從血漿護理標準中獲得的活性，通常每千克活性提供約 10 個單位。

These positive results are perhaps not surprising given the higher level and longer duration of ADAMTS13 activity projected. Our recombinant therapy can provide consistent and higher ADAMTS13 replacement with less risk of allergic reactions and no concerns for volume overload. TAK-755 is also being developed in immune TTP, a much more prevalent form of this disease.

鑑於預計 ADAMTS13 活動的水平更高且持續時間更長，這些積極結果也許並不令人驚訝。我們的重組療法可以提供一致且更高的 ADAMTS13 替代，過敏反應風險更低，並且無需擔心容量過載。 TAK-755 也在免疫 TTP 中開發，這是這種疾病的一種更為普遍的形式。

Next slide, please. The AURORA trial was the largest head-to-head comparison of LIVTENCITY versus the standard of care, valganciclovir, in patients undergoing hematopoietic stem cell transplant who develop CMV infections. Despite just missing achievement of noninferiority at the primary endpoint, we believe the durable efficacy and favorable safety profile is clinically meaningful and potentially label enhancing.

請換下一張幻燈片。 AURORA 試驗是 LIVTENCITY 與護理標準纈更昔洛韋在接受造血幹細胞移植並發生 CMV 感染的患者中進行的最大的頭對頭比較。儘管在主要終點上未達到非劣效性，但我們認為持久的療效和良好的安全性具有臨床意義，並可能增強標籤。

I would like to highlight the sustained numerically higher rate of long-term CMV clearance at weeks 12, 16 and 20, showing evidence of durable antiviral efficacy as well as the compelling favorable safety profile, which includes a significantly lower rate of treatment-emergent neutropenia. We will be engaging regulatory agencies shortly about a path forward.

我想強調在第 12、16 和 20 週時長期 CMV 清除率在數值上持續較高，顯示出持久抗病毒療效的證據以及令人信服的有利安全狀況，其中包括顯著降低的治療引起的中性粒細胞減少率.我們將很快就前進的道路與監管機構接洽。

Thank you very much, and I will now turn it over to Costa.

非常感謝，我現在將其轉交給 Costa。

Thank you, Andy, and hello, everyone. This is Costa Saroukos speaking. Today, I'll walk you through the financial highlights of our fiscal 2022 third quarter results. And I'm pleased to say that it has been another strong quarter of growth. Core revenue for the 9-month period was JPY 3.07 trillion or approximately USD 23.3 billion. Despite the entry of VELCADE Generics in May 2022, we continue to deliver solid top line growth, up 4.5% versus prior year at constant exchange rate, driven by our Growth and Launch products. These products now represent 39% of total revenue and grew 20% at constant exchange rate.

謝謝你，安迪，大家好。我是 Costa Saroukos。今天，我將向您介紹我們 2022 財年第三季度業績的財務亮點。我很高興地說，這是又一個強勁的增長季度。前 9 個月的核心收入為 3.07 萬億日元，約合 233 億美元。儘管 VELCADE Generics 於 2022 年 5 月進入市場，但在我們的 Growth 和 Launch 產品的推動下，我們繼續實現穩健的收入增長，按固定匯率計算比上年增長 4.5%。這些產品現在佔總收入的 39%，按固定匯率計算增長 20%。

Reported revenue growth was 13.9%, with business momentum and foreign exchange upside more than offsetting the impact of a JPY 133 billion gain from the sale of the Japan Diabetes business that was booked in Q1 of prior year. Core operating profit grew 9.7% at constant exchange rate to JPY 954.7 billion, and our core operating profit margin was 31.1%, an increase of 1.5 percentage points on a year-over-year basis.

報告的收入增長 13.9%，業務勢頭和外匯上行空間足以抵消去年第一季度入賬的出售日本糖尿病業務帶來的 1330 億日元收益的影響。按固定匯率計算，核心營業利潤增長 9.7% 至 9,547 億日元，核心營業利潤率為 31.1%，同比增長 1.5 個百分點。

This year-on-year margin improvement is an indicator of our financial resilience and our ability to control costs. In fact, at a constant exchange rate, our SG&A spend continues to be lower than last year.

這種同比利潤率的提高是我們財務彈性和控製成本能力的一個指標。事實上，按固定匯率計算，我們的 SG&A 支出繼續低於去年。

Reported operating profit declined 13.1% year-to-date impacted by the sale of our diabetes portfolio last year, but this impact is diminishing as each quarter goes by, and we still expect to end the full year with growth. Free cash flow was very strong at JPY 585.2 billion, and net debt to adjusted EBITDA came down to 2.5x from 2.8x at the start of the fiscal year, even after paying the full year dividend.

受去年出售我們的糖尿病產品組合的影響，今年迄今報告的營業利潤下降了 13.1%，但隨著每個季度的推移，這種影響正在減弱，我們仍然預計全年將實現增長。自由現金流非常強勁，達到 5,852 億日元，淨債務與調整後 EBITDA 之比從本財年開始時的 2.8 倍降至 2.5 倍，即使在支付了全年股息後也是如此。

With regard to the full year outlook, we remain on track to our management guidance for constant exchange rate growth, although we are actually tracking towards the higher end of this guidance on some measures. Our reported and core forecast remain unchanged.

關於全年展望，儘管我們實際上在某些措施上正在朝著這一指導的較高端邁進，但我們仍然遵循我們關於匯率持續增長的管理指導。我們的報告和核心預測保持不變。

Slide 16 shows our first half results in more detail. On the left-hand side are our reported results. As highlighted in previous quarters, the sale of the Japan Diabetes portfolio in Q1 of last year is impacting our reported operating profit growth, but reported EPS is actually up 19.6%, benefiting from a favorable reported tax rate.

幻燈片 16 更詳細地顯示了我們上半年的結果。左側是我們報告的結果。正如前幾個季度強調的那樣，去年第一季度出售日本糖尿病產品組合正在影響我們報告的營業利潤增長，但報告的每股收益實際上增長了 19.6%，這得益於有利的報告稅率。

Focusing on the core numbers on the right. I'm very pleased with the year-to-date growth we are delivering on a constant exchange rate basis with revenue up 4.5%, core operating profit up 9.7% and core EPS growth of 17.1%. On top of that, FX has been a significant tailwind for us this year, resulting in actual core revenue growth of close to 20% and core EPS growth of 37%.

關注右側的核心數字。我對我們在固定匯率基礎上實現的年初至今增長感到非常滿意，收入增長 4.5%，核心營業利潤增長 9.7%，核心每股收益增長 17.1%。最重要的是，外匯今年對我們來說是一個重要的推動力，導致實際核心收入增長接近 20%，核心每股收益增長 37%。

Let me go into more details on the Q3 year-to-date revenue performance versus prior year on Slide 17. On the left is a waterfall chart for reported revenue, which grew at 13.9% year-on-year with business momentum and FX favorability more than offsetting the impact of the JPY 133 billion one-off we booked in Q1 of last year from the sale of the Japan Diabetes portfolio. Core revenue on the right-hand side excludes the impact of the Diabetes portfolio sale in the prior year. You can see our business momentum was driving 4.5% growth at constant exchange rate, with the additional FX tailwind raising total core revenue growth to 19.8%.

讓我在幻燈片 17 上更詳細地了解第三季度年初至今的收入表現與上一年的對比情況。左邊是報告收入的瀑布圖，由於業務勢頭和外匯有利因素，該收入同比增長 13.9%遠遠抵消了我們在去年第一季度從出售日本糖尿病投資組合中一次性獲得的 1330 億日元的影響。右側的核心收入不包括上一年出售糖尿病產品組合的影響。你可以看到我們的業務勢頭以固定匯率推動 4.5% 的增長，額外的外匯順風將核心總收入增長提高到 19.8%。

On Slide 18, you can see that the key driver of top line growth is our portfolio of Growth and Launch products, which generated approximately JPY 1.2 trillion or 39% of total revenue quarter 3 year-to-date with 20% growth at constant exchange rates. Incrementally, these products added JPY 350 billion or USD 2.7 billion of revenue compared to last year. This is the portfolio driving total company growth this year despite the VELCADE loss of exclusivity, and we expect that the continued momentum of these products will allow us to offset VELCADE Generics in fiscal 2023.

在幻燈片 18 上，您可以看到收入增長的主要驅動力是我們的增長和發布產品組合，這些產品產生了約 1.2 萬億日元，佔今年第三季度總收入的 39%，按固定匯率計算增長了 20%費率。與去年相比，這些產品增加了 3500 億日元或 27 億美元的收入。儘管 VELCADE 失去了獨占權，但這是今年推動公司整體增長的投資組合，我們預計這些產品的持續發展勢頭將使我們能夠在 2023 財年抵消 VELCADE 仿製藥。

With our five key business areas; GI, our largest area by revenue, grew at 11% year-to-date on a constant exchange rate basis. This was spearheaded by ENTYVIO, which grew 17% driven by a continued increase in bio-naive patient share. In Rare Diseases, which grew 5%, we see continued demand and geographic expansion for TAKHZYRO, which delivered growth of 25%.

我們的五個關鍵業務領域；地理標誌是我們收入最大的領域，按固定匯率計算，年初至今增長了 11%。這是由 ENTYVIO 帶頭的，由於未接受生物治療的患者份額持續增加，該公司增長了 17%。在增長 5% 的罕見疾病領域，我們看到 TAKHZYRO 的持續需求和地域擴張，實現了 25% 的增長。

We also see early indicators of success with the LIVTENCITY launch, with 87% of transplant centers in the U.S. having now initiated therapy with at least one patient. PDT Immunology continues to be very strong with 18% growth, including 19% growth of immunoglobulin and 20% growth of albumin, reflecting strong demand. We have continued to expand our plasma donation center network, adding 21 centers in the fiscal year to date, bringing our global footprint now to 225 centers.

我們還看到了 LIVTENCITY 推出的早期成功指標，美國 87% 的移植中心現在已經開始對至少一名患者進行治療。 PDT 免疫學繼續保持強勁增長 18%，其中免疫球蛋白增長 19%，白蛋白增長 20%，反映出強勁的需求。我們繼續擴大我們的血漿捐贈中心網絡，本財年迄今增加了 21 個中心，使我們的全球足跡現在達到 225 個中心。

Next is Oncology, which is declining year-on-year as expected, given the VELCADE Generics entered the U.S. market from May this year. Excluding VELCADE, the rest of the portfolio grew 7% driven by ALUNBRIG, EXKIVITY, ADCETRIS and ICLUSIG.

其次是腫瘤學，鑑於 VELCADE Generics 從今年 5 月開始進入美國市場，其同比下降符合預期。不包括 VELCADE，其餘產品組合在 ALUNBRIG、EXKIVITY、ADCETRIS 和 ICLUSIG 的推動下增長了 7%。

Finally, Neuroscience continues to perform very well with growth of 10% driven by VYVANSE and TRINTELLIX, while the other segment is declining due to some regional loss of exclusivities in Japan. The other segment also includes our COVID-19 vaccines in Japan. We are seeing low market demand for NUVAXOVID than expected given the current situation of vaccination in Japan and prevalence of Omicron.

最後，神經科學繼續表現出色，在 VYVANSE 和 TRINTELLIX 的推動下實現了 10% 的增長，而另一部分則由於在日本失去部分區域獨占權而下滑。另一部分還包括我們在日本的 COVID-19 疫苗。鑑於日本目前的疫苗接種情況和 Omicron 的流行，我們看到對 NUVAXOVID 的市場需求低於預期。

On Slide 19, we show the drivers of reported and core operating profit for the quarter. Reported operating profit was JPY 401.9 billion, a decline of 13.1% versus prior year. Again, the decline is predominantly coming from the gain on the sale of the Japan Diabetes portfolio, which contributed JPY 131.4 billion to reported operating profit last year.

在幻燈片 19 上，我們展示了本季度報告和核心營業利潤的驅動因素。報告的營業利潤為 4019 億日元，比上年下降 13.1%。同樣，下降主要來自出售日本糖尿病投資組合的收益，該投資組合為去年報告的營業利潤貢獻了 1,314 億日元。

We also had some one-off items impacting the other column here, such as impairments of intangible assets, which includes NATPARA and higher prelaunch inventory in preparation for future launches.

我們還有一些一次性項目會影響此處的另一欄，例如無形資產減值，其中包括 NATPARA 和更高的上市前庫存，為未來的上市做準備。

On the right side of the slide, you can see the core operating profit was JPY 954.7 billion, with our business momentum driving 9.7% growth at constant exchange rate. Foreign exchange was an additional benefit, resulting in actual core operating profit growth of 26%.

在幻燈片的右側，您可以看到核心營業利潤為 9547 億日元，我們的業務勢頭推動了 9.7% 的固定匯率增長。外匯是一個額外的好處，導致實際核心營業利潤增長 26%。

Moving to cash flow on Slide 20. This slide shows our year-to-date free cash flow of JPY 585.2 billion, comfortably covering the full year dividend and also the net interest payment. We also continue to make progress in reducing our debt with a total amount of JPY 281.6 billion paid year-to-date, including prepayments of higher interest debt maturing in November 2023.

轉到幻燈片 20 的現金流。這張幻燈片顯示了我們今年迄今的自由現金流為 5852 億日元，輕鬆涵蓋全年股息和淨利息支付。我們還在減少債務方面繼續取得進展，今年迄今共支付了 2816 億日元，包括 2023 年 11 月到期的高息債務的預付款。

We closed December with ample cash of JPY 685 billion, and total liquidity of JPY 1.3 trillion or roughly USD 9.5 billion. This gives us the comfort to pay for the TAK-279 acquisition from Nimbus, primarily utilizing cash on hand, pending deal completion, which we hope will occur within this fiscal year.

我們在 12 月結束時擁有 6,850 億日元的充裕現金和 1.3 萬億日元（約合 95 億美元）的總流動性。這讓我們很放心地支付從 Nimbus 收購 TAK-279的費用，主要是利用手頭現金，等待交易完成，我們希望這將在本財政年度內發生。

Slide 21. The net debt balance compared to the end of March demonstrates the continuation of our steady deleveraging progress from 2.8x down to 2.5x. Although we continue to make progress with debt repayment, the amount of debt on our balance sheet in Japanese yen terms increased over the period due to the depreciation of the yen versus the dollar and euro, and this movement is captured within the other bar in the chart.

幻燈片 21. 與 3 月底相比的淨債務餘額表明我們繼續穩步去槓桿化進程，從 2.8 倍降至 2.5 倍。儘管我們在償還債務方面繼續取得進展，但由於日元對美元和歐元貶值，我們資產負債表上以日元計算的債務金額在此期間有所增加，這一變動反映在圖表的另一個欄中圖表。

However, as a reminder, the depreciation of yen also benefited EBITDA, which means the impact of FX on our leverage ratio is minimal. Also, we have structured the currency denomination of our debt to mirror our cash flow, which ensures that over time, we will be able to pay down debt with minimal impact from FX movements.

然而，提醒一下，日元貶值也有利於 EBITDA，這意味著外匯對我們槓桿率的影響微乎其微。此外，我們構建了債務的貨幣面值以反映我們的現金流，這確保隨著時間的推移，我們將能夠在外匯變動的影響最小的情況下償還債務。

On Slide 22, you can see our debt maturity ladder as of December. As demonstrated on the cash flow slide, we have already paid off significant amount of debt this fiscal year, including a total of $1.2 billion of higher interest USD-denominated bonds and EUR 750 million of floating rate bonds. As a result, our debt is now 100% fixed rate, and our weighted average remains around 2%. We remain very comfortable with the debt maturity profile over the coming years.

在幻燈片 22 上，您可以看到我們截至 12 月的債務到期階梯。正如現金流幻燈片所示，我們已經在本財年還清了大量債務，包括總計 12 億美元的高息美元債券和 7.5 億歐元的浮動利率債券。因此，我們的債務現在是 100% 固定利率，我們的加權平均利率保持在 2% 左右。我們對未來幾年的債務到期情況仍然非常滿意。

Next, moving to Slide 23 and our outlook for full year 2022. I'm pleased to say that we are on track to meet our full year management guidance for growth at constant exchange rate, with core revenue growing at low single digit and core operating profit and core EPS growing high single digit. And in fact, we are trending towards the high end of the range for some of these metrics.

接下來，轉到幻燈片 23 和我們對 2022 年全年的展望。我很高興地說，我們有望實現以固定匯率增長的全年管理指導，核心收入以低個位數和核心運營增長利潤和核心每股收益增長高個位數。事實上，對於其中一些指標，我們正趨向於範圍的高端。

For our reported and core forecast, we are keeping our numbers unchanged from the update we gave at Q2. On a reported basis, we still anticipate revenue to be JPY 3.93 trillion, operating profit JPY 530 billion and EPS of JPY 198. On a core basis, revenue is expected to be JPY 3.93 trillion, with core operating profit expected to reach JPY 1.18 trillion and core EPS to reach JPY 525.

對於我們報告的核心預測，我們保持第二季度更新後的數字不變。根據報告，我們仍預計收入為 3.93 萬億日元，營業利潤為 5300 億日元，每股收益為 198 日元。在核心基礎上，收入預計為 3.93 萬億日元，核心營業利潤預計將達到 1.18 萬億日元和核心每股收益達到 525 日元。

With regards to free cash flow, we are keeping our forecast unchanged at JPY 650 billion to JPY 750 billion, although please note that it does not include the impact of the TAK-279 acquisition from Nimbus, which may impact this number if the deal closes within this fiscal year.

關於自由現金流，我們將預測保持在 6500 億至 7500 億日元不變，但請注意，它不包括從 Nimbus 收購 TAK-279 的影響，如果交易完成，這可能會影響這個數字本財年內。

To close out the presentation on Slide 24, I'd like to reemphasize the key elements of our strategy to deliver sustainable growth and value to our shareholders. We continue to see strong momentum from our commercial portfolio, which enabled us to deliver 4.5% core revenue growth at constant exchange rate Q3 year-to-date. This is driven predominantly by our Growth and Launch products, growing at 20% on a constant exchange rate basis, more than offsetting the impact of generic visions of VELCADE that launched in May 2022. Our margins are strong at 31.1%, and we delivered year-to-date core operating profit growth of 9.7% at constant exchange rate, well on track towards full year guidance of high single-digit growth.

為了結束幻燈片 24 的演示，我想再次強調我們為股東提供可持續增長和價值的戰略的關鍵要素。我們繼續從我們的商業投資組合中看到強勁的勢頭，這使我們能夠以今年第三季度的固定匯率實現 4.5% 的核心收入增長。這主要是由我們的增長和發布產品推動的，在固定匯率的基礎上增長了 20%，遠遠抵消了 2022 年 5 月推出的 VELCADE 通用願景的影響。我們的利潤率高達 31.1%，我們交付了一年- 按固定匯率計算，迄今為止核心營業利潤增長 9.7%，有望實現全年高個位數增長的目標。

And our success is built on a solid financial foundation with robust cash flow that we will continue to allocate towards growth opportunities such as the recent new deals with Nimbus and HUTCHMED while continuing to focus on competitive shareholder returns. We have abundant liquidity and a well-structured debt profile of 100% fixed rates at an average cost of 2%, which positions us well in the current macro environment.

我們的成功建立在堅實的財務基礎和強勁的現金流之上，我們將繼續將現金流分配給增長機會，例如最近與 Nimbus 和 HUTCHMED 的新交易，同時繼續關注有競爭力的股東回報。我們擁有充足的流動性和結構良好的 100% 固定利率的債務組合，平均成本為 2%，這使我們在當前的宏觀環境中處於有利地位。

Finally, before we open up to Q&A, I'd like to bring to your attention an upcoming investor call we have scheduled for mid-March focusing on our launch plans and commercial strategy for QDENGA. We look forward to your participation in this event.

最後，在我們開放問答之前，我想提請您注意我們定於 3 月中旬召開的即將召開的投資者電話會議，重點是我們的 QDENGA 啟動計劃和商業戰略。我們期待您的參與。

With that, we can open up the line for questions. Thank you very much.

這樣，我們就可以打開問題熱線了。非常感謝。

Now, we'd like to take questions from the participants. And here in the Q&A session, Ramona Sequeira, President, Global Portfolio division is joining together with Christophe, Andy and Costa. (Operator Instructions)

現在，我們想回答與會者的問題。在問答環節中，全球投資組合部總裁 Ramona Sequeira 與 Christophe、Andy 和 Costa 一起參加。 （操作員說明）

The first question is Yamaguchi-san, Citigroup.

第一個問題是花旗集團的山口先生。

(foreign language)

（外語）

Thank you, Yamaguchi-san, for your question. Let me just refer to your question. More on a year-to-date basis, we typically, given the way the business operates, the seasonality impact and quarter-by-quarter, we prefer to look at the year-to-date. So if you look at year-to-date, the gross profit margin year-to-date -- Q3 year-to-date versus Q3 year-to-date '21, in fact, our gross profit is improving on an actual basis by 0.5% and on a constant exchange basis, it's grown by 0.1%. And the main reason for this, gross profit improvement on a year-to-date basis is because of the strength of our Growth and Launch portfolio.

謝謝山口先生的提問。我來提一下你的問題。更多的是年初至今，我們通常會考慮到業務運營方式、季節性影響和逐季度，我們更願意查看年初至今。因此，如果您查看年初至今，年初至今的毛利率——年初至今的第三季度與年初至今的 21 年第三季度相比，事實上，我們的毛利率在實際基礎上有所改善0.5%，在固定匯率的基礎上，它增長了 0.1%。年初至今毛利改善的主要原因是我們的增長和發布產品組合的實力。

At the same time, if you look at our core operating profit margin, it's improved year-to-date by 1.5% for both actual and constant exchange rate, and again, the main reason is driven by the Growth and Launch products, coupled by our laser focused efforts on managing costs, in particular, SG&A, where you see our SG&A, it's actually favorable. So we're -- it's 1.6% favorable versus prior year year-to-date. So consider the year-to-date numbers and the year-to-date numbers are really looking favorable overall.

與此同時，如果你看一下我們的核心營業利潤率，今年迄今實際匯率和固定匯率都提高了 1.5%，這也是主要原因是由增長和發布產品推動的，再加上我們的激光集中精力管理成本，特別是 SG&A，你看到我們的 SG&A，它實際上是有利的。所以我們 - 與去年年初至今相比有利 1.6%。因此，請考慮年初至今的數字，而年初至今的數字總體上看起來確實不錯。

Thank you, Yamaguchi-san. It's Christophe. Our PDT growth is really driven by volume and demand. It's not a price-driven growth. Our portfolio is growing well. Our SCIG, CUVITRU and IQVIA are growing also well, and there are significant growth driver. We have, in the quarter, by the way, we continue to increase our donation center. We added five new donation centers. So we are on track to expand our network as planned by about 25 centers in fiscal year 2022.

謝謝你，山口桑。是克里斯托夫。我們的 PDT 增長實際上是由數量和需求驅動的。這不是價格驅動的增長。我們的投資組合增長良好。我們的 SCIG、CUVITRU 和 IQVIA 增長也很好，並且有很大的增長動力。順便說一句，我們在本季度繼續增加我們的捐贈中心。我們增加了五個新的捐贈中心。因此，我們有望按計劃在 2022 財年將我們的網絡擴展到大約 25 個中心。

We -- in terms of the donor cost -- donor compensation, as we announced previously, we have been able to reduce slightly the donor compensation and to maintain that level in this Q3. So really, a growth driven by the business fundamental.

我們 - 就捐贈者成本而言 - 捐贈者補償，正如我們之前宣布的那樣，我們已經能夠略微降低捐贈者補償並在第三季度保持這一水平。所以真的，增長是由業務基礎驅動的。

[Interpreted] Moving on to the next question. Nomura Securities, Mr. Kohtani, please.

[解釋] 繼續下一個問題。野村證券，有請 Kohtani 先生。

[Interpreted] Yes. This is Kohtani, Nomura Securities. Can you hear me?

[解釋]是的。我是野村證券的小谷。你能聽到我嗎？

[Interpreted] Yes.

[解釋]是的。

[Interpreted] It seems that I'm in the Japanese channel. TAK-755. I have a question about TAK-755. If my understanding is correct, this is basically caplacizumab or cTTP recurrence is suppressed, similar to that drug. And there is no plasma exchange and the bleeding event is fewer with the 755. That's my understanding. So is that correct? That's my first question.

【解讀】我好像在日語頻道。 TAK-755。我對 TAK-755 有疑問。如果我的理解是正確的，這基本上是抑制了caplacizumab或cTTP的複發，類似於那個藥。而且 755 沒有血漿置換，出血事件更少。這是我的理解。那是正確的嗎？這是我的第一個問題。

And the second question is, I understand that you're going to be filing for this product. It was not part of the press release. But is this only for on-demand? Or does it also include prophylactic use? So please explain that. That's my first question.

第二個問題是，我知道你要為這個產品提交申請。它不是新聞稿的一部分。但這僅適用於點播嗎？或者它是否也包括預防性使用？所以請解釋一下。這是我的第一個問題。

[Interpreted] Could you please ask the second question as well?

[已解讀] 請問第二個問題也可以嗎？

[Interpreted] Yes. My second question is about TAK-341. Alpha-synuclein antibody is my understanding. So in (inaudible) disease, you're doing Phase I. And Mr. Plump mentioned that this short target engagement, and this is, of course, for (inaudible), MSA actually involved of synuclein. So diagnostic criteria for MSA is just symptoms as far as I understand. So can we really include true MSA patients in the clinical trials? How accurate can you be with that enrollment? And starting from this study, the sponsor started to be Takeda, not AstraZeneca. So can you please explain why the sponsor has changed to Takeda? That's my second question.

[解釋]是的。我的第二個問題是關於 TAK-341。 α-突觸核蛋白抗體是我的理解。所以在（聽不清）疾病中，你正在做第一階段。Plump 先生提到了這個短期目標參與，當然，這是因為（聽不清）MSA 實際上涉及突觸核蛋白。所以據我了解，MSA的診斷標準只是症狀。那麼我們真的可以在臨床試驗中包括真正的 MSA 患者嗎？您的註冊有多準確？從這項研究開始，贊助商開始是武田，而不是阿斯利康。那麼能否請您解釋一下為什麼贊助商改為武田？這是我的第二個問題。

So I think these are both for Andy. So the first question on TAK-755. So understanding similar efficacy (inaudible), but without the need for plasma exchange. Is it correct, there's no bleeding events? And then for the filing, would it be on demand? Or is there also a prophylaxis indication possibly?

所以我認為這些都是為了安迪。所以關於 TAK-755 的第一個問題。因此了解類似的功效（聽不清），但不需要血漿交換。這是正確的，沒有出血事件嗎？然後對於歸檔，它會按需嗎？或者是否也可能有預防指徵？

And then the next question on TAK-341, was in Phase I for Parkinson's now moving into a Phase II for MSA. But we -- certainly, we can enroll the right patients given that a lot of the diagnosis is based on symptoms. So are we sure we can correctly enroll these MSA patients? And why is Takeda be taking over leading this trial from AstraZeneca? So I'll hand over to Andy, please.

然後關於 TAK-341 的下一個問題是帕金森氏症的第一階段，現在正進入 MSA 的第二階段。但我們——當然，我們可以招募合適的患者，因為很多診斷都是基於症狀。那麼我們確定我們可以正確地招募這些 MSA 患者嗎？為什麼武田要從阿斯利康手中接過這項試驗的領導權？所以我會交給安迪，請。

Terrific. Thank you very much, Kohtani-san. This is Andy. So firstly, on TAK-755, the data that we've accumulated in our Phase III study is both in prophylactic and in acute settings. cTTP, whether it's congenital or immune mediated is related to either a complete deficiency or a functional deficiency and ADAMTS13 activity. So TAK-755 is quite distinct from any existing therapy. It's a recombinant form of ADAMTS13. And so, we're essentially providing an enzyme replacement therapy. We're placing either the genetic or the acquired deficiency in this enzyme. And the activity that we've seen in the Phase III study in cTTP is quite remarkable.

了不起。非常感謝你，Kohtani 先生。這是安迪。因此，首先，在 TAK-755 上，我們在 III 期研究中積累的數據既有預防性的，也有急性的。 cTTP，無論是先天性的還是免疫介導的，都與完全缺陷或功能缺陷以及 ADAMTS13 活性有關。因此，TAK-755 與任何現有療法都截然不同。它是 ADAMTS13 的重組形式。因此，我們實質上是在提供一種酶替代療法。我們在這種酶中放置了遺傳或獲得性缺陷。我們在 cTTP 的 III 期研究中看到的活動非常顯著。

TTP is a very complex disease. You have both clotting and bleeding. And so, the endpoints are related to both clotting organ damage that you see when you move blood flow to an organ and also bleeding. And we saw benefits across all endpoints in our Phase III study. And we'll be presenting those shortly, and you'll have a chance to see them.

TTP 是一種非常複雜的疾病。你既有凝血又有出血。因此，終點與血液流向器官時看到的凝血器官損傷和出血有關。我們在 III 期研究中看到了所有終點的好處。我們很快就會展示這些，您將有機會看到它們。

With respect to TAK-341, you're correct. MSA is a clinical diagnosis and has many overlaps with Parkinson's disease. There are some distinguishing features. The rapidity of progression is one. And then there are some neuropsychiatric manifestations in MSA, which are different. But it is a diagnosis -- clinical diagnosis. And so, it's possible that some of the patients that we would include in our MSA study may not actually have MSA. I don't think that, that's necessarily important because our expectation is that not only will TAK-341 be effective in MSA, but we have a strong hypothesis to think that TAK-341 could be effective in Parkinson's disease.

關於 TAK-341，您是對的。 MSA 是一種臨床診斷，與帕金森病有許多重疊之處。有一些與眾不同的特點。進步的速度是其中之一。然後在MSA中有一些神經精神表現，這是不同的。但這是一種診斷——臨床診斷。因此，我們將納入 MSA 研究的一些患者可能實際上並未患有 MSA。我不認為那一定很重要，因為我們的預期是 TAK-341 不僅對 MSA 有效，而且我們有一個強有力的假設認為 TAK-341 對帕金森病可能有效。

We're starting with MSA because it's a more streamlined Phase II and Phase III study. We think that we can see efficacy more rapidly in MSA, but we're also considering very seriously moving into Parkinson's disease as well.

我們從 MSA 開始，因為它是一個更精簡的 II 期和 III 期研究。我們認為我們可以更快地看到 MSA 的療效，但我們也非常認真地考慮進入帕金森氏病。

And then finally, this program is a partnership with AstraZeneca. The terms of the partnership were that AstraZeneca would manage the Phase I program, and starting in Phase II and Phase III, Takeda would take over the market authorization application.

最後，該計劃是與阿斯利康的合作夥伴關係。合作夥伴關係的條款是，阿斯利康（AstraZeneca）將管理 I 期項目，從 II 期和 III 期開始，武田（Takeda）將接管市場授權申請。

[Interpreted] Next question is JPMorgan. Wakao-san, please.

[解釋] 下一個問題是摩根大通。 Wakao-san，請。

[Interpreted] Wakao speaking. JPMorgan. I have two questions. First is TYK2 EBITDA. In March, Phase IIb result will be announced. And looking at this Phase IIb results compared to deucravacitinib of Bristol, can we tell that this is superior? Phase II endpoint is, I think PASI 75 and compared to deucravacitinib. Can we consider that it is expected that this Nimbus molecule is superior? That's first question.

[解釋] Wakao 說話。摩根大通。我有兩個問題。首先是 TYK2 EBITDA。 3月，將公佈IIb期結果。看看與 Bristol 的 deucravacitinib 相比的 IIb 期結果，我們能說這是更好的嗎？ II 期終點是，我認為 PASI 75 與 deucravacitinib 相比。我們是否可以認為這種 Nimbus 分子具有優越性？這是第一個問題。

Second question is about 861. You proceeded to Phase II. And in TAK-994, there are some safety setbacks, but can you now believe that it's totally eliminated? Or still there is potentially a possibility of the similar risk in Phase II and you will monitor it? And I think it is for long-acting molecule. However, in terms of the concept, is it the similar sort of molecules?

第二個問題是關於861的。你進入了第二階段。在 TAK-994 中，有一些安全問題，但你現在能相信它已經完全消除了嗎？還是二期仍有可能出現類似的風險，你們會監控？我認為它適用於長效分子。但是，就概念而言，它是同類分子嗎？

I think both these for Andy as well. So the first question on the TYK2 inhibitor. So we'll see Phase IIb data in March. And will that data allow us to see superiority versus the Bristol product in the PASI 75 scores? And then the second question on TAK-861. Does this mean that we've fully overcome the TAK-994 safety issues? Or does that possibility remain in Phase II? And previously, we talked about this -- about having a longer half-life, a longer duration. And is that still the case with TAK-861? Over to you, Andy?

我認為這對安迪來說也是如此。所以關於 TYK2 抑製劑的第一個問題。所以我們將在三月份看到 IIb 階段的數據。這些數據是否能讓我們在 PASI 75 分數中看到與 Bristol 產品相比的優勢？然後是關於 TAK-861 的第二個問題。這是否意味著我們已經完全克服了 TAK-994 安全問題？或者這種可能性是否保留在第二階段？之前，我們談到了這個——關於擁有更長的半衰期，更長的持續時間。 TAK-861 仍然如此嗎？交給你了，安迪？

So the TYK2 Phase IIb psoriasis -- I'm sorry, the TYK2 Phase IIb psoriasis data will -- Nimbus has already disclosed if they intend to present that in March. The hope is that we'll be closing the deal this fiscal year, and we'll be presenting those data -- or presenting those data at a medical meeting. It's important to note the study did not include deucra. This was a study that was increasing doses of what we'll call TAK-279 against placebo. So you have to make cross-study comparisons.

所以 TYK2 IIb 期牛皮癬——對不起，TYK2 IIb 期牛皮癬數據將——Nimbus 已經披露了他們是否打算在三月份公佈。希望我們將在本財政年度完成交易，我們將展示這些數據——或在醫學會議上展示這些數據。重要的是要注意該研究不包括 deucra。這是一項針對安慰劑增加我們稱為 TAK-279 的劑量的研究。所以你必須進行交叉研究比較。

And when we looked at the data during our diligence, we felt that the study data suggested a high likelihood of a best-in-class profile. The best way to understand the potential of this molecule is to go back and look at some of the deucra Phase IIb data, right? And look at what you see in terms of clinical efficacy with increasing doses with deucra and then look at the dose that was chosen for Phase III. So we believe that deucra left efficacy on the table with their Phase III dose, perhaps to optimize the safety profile. But you'll have an opportunity to see all of those data next month.

當我們在盡職調查中查看數據時，我們認為研究數據表明極有可能獲得一流的資料。了解這種分子潛力的最好方法是回頭看看一些 deucra IIb 期數據，對嗎？看看你在增加 deucra 劑量的臨床療效方面看到了什麼，然後看看為 III 期選擇的劑量。因此，我們認為 deucra 的 III 期劑量保留了療效，或許是為了優化安全性。但您將有機會在下個月看到所有這些數據。

With respect to TAK-861, TAK-861 is a distinct molecule to TAK-994. It's more potent. It has a longer half-life. It's a very different set of biophysical properties, and it's dosed at a much lower level than TAK-994 to see equivalent efficacy. We haven't seen any indication of liver toxicity in our clinical studies. Now it's important to note that we've only dosed patients for up to 4 weeks, but we haven't seen any signals, which is quite encouraging. So we're very excited to move forward with the Phase IIb study, which we'll be testing a number of different doses and dose combinations.

關於 TAK-861，TAK-861 是不同於 TAK-994 的分子。它更強大。它的半衰期更長。它具有一組非常不同的生物物理特性，並且它的劑量比 TAK-994 低得多，以達到相同的功效。在我們的臨床研究中，我們沒有發現任何肝毒性跡象。現在需要注意的是，我們只給患者服用了最多 4 週的劑量，但我們還沒有看到任何信號，這非常令人鼓舞。因此，我們非常高興能夠推進 IIb 期研究，我們將在該研究中測試多種不同的劑量和劑量組合。

[Interpreted] Moving on to the next question, Morgan Stanley, Mr. Muraoka, please.

[解讀] 摩根士丹利，請村岡先生進入下一個問題。

[Interpreted] This is Muraoka, Morgan Stanley. I hope you can hear my voice.

[解讀] 我是摩根士丹利的 Muraoka。我希望你能聽到我的聲音。

[Interpreted] Yes, we can hear you.

[翻譯] 是的，我們能聽到你的聲音。

[Interpreted] My first question, in this third quarter, if you look at the expenses, R&D and SG&A, on a quarter-by-quarter basis, they both increased quite a lot. And based on this situation, for the full year, JPY 1.18 trillion of our core profit for the full year. Do we have to worry about achieving this? That's my first question.

[解讀]我的第一個問題，在這個第三季度，如果你看費用，R&D 和 SG&A，按季度計算，它們都增加了很多。基於這種情況，全年我們的核心利潤為 1.18 萬億日元。我們是否需要擔心實現這一目標？這是我的第一個問題。

And the second question is with regard to shareholder return. In the market, there is a heightened expectation for increased dividend by Takeda, and not just once, but continuous increase in dividend. So in FY '23, '24 and '25, is your plan to continue this every year over the long term? What is your general thinking or policy about this? Those are the two questions.

第二個問題是關於股東回報。市場對武田增加股息的預期越來越高，而且不是一次，而是持續增加股息。那麼在 23 財年、24 財年和 25 財年，您是否計劃長期每年都繼續這樣做？您對此有何總體看法或政策？這是兩個問題。

So first question is looking at the quarter-on-quarter costs. So R&D, SG&A tend to be higher in the third quarter. And is there any risk to the full year forecast of JPY 1.18 trillion core operating profit? And then the second question on shareholder returns. What should we think about expectations of a dividend increase? Would it be something continual? And can we have the thoughts on that? So I think both of these will direct to Costa.

所以第一個問題是看季度成本。因此，研發、SG&A 在第三季度往往會更高。全年預測的 1.18 萬億日元核心營業利潤是否存在風險？然後是關於股東回報的第二個問題。我們應該如何看待股息增加的預期？它會是連續的嗎？我們可以對此有想法嗎？所以我認為這兩個都會直接指向科斯塔。

Great. Thank you very much, Muraoka-san. So let me just start again just really drawing your attention to the year-to-date numbers, Q3 versus Q3 2021. So again, quarter-by-quarter, this fluctuation seasonality on a year-to-date, we're comparing the right apples-to-apples baseline.

偉大的。非常感謝，村岡先生。因此，讓我重新開始，只是真正提請您注意年初至今的數字，即 2021 年第三季度與第三季度的數據。因此，再次逐季地，這種年初至今的季節性波動，我們正在比較正確的同類基線。

So on the SG&A numbers, you can see that our SG&A on a constant exchange rate is actually declining versus last year. So it's favorable 1.6%. And again, main driver for that is significant improvement in back office, more the G&A line with leveraging data digital technology, the Takeda business solutions and transactional effectiveness there.

因此，在 SG&A 數字上，您可以看到我們按固定匯率計算的 SG&A 實際上比去年有所下降。所以這是有利的 1.6%。再一次，主要的驅動力是後台的顯著改善，更多的是 G&A 線利用數據數字技術、武田 (Takeda) 業務解決方案和那裡的交易效率。

The R&D line, it's up on a constant exchange basis of 5.3%, slightly above the growth of revenue, which is revenues growing at 4.5%. But a lot of that is driven by some timing of program completion. Overall, to your question on the core operating profit of JPY 1.18 trillion, I can say that we are tracking well towards that on a run rate. You can see our run rate deliverable year-to-date, we're tracking well. And in fact, we're highlighting that the management guidance is at the high single digit and perhaps in the higher range of that high single-digit number. So very pleased with Q3 results, not only on the top line growth, but also on the OpEx and core operating profit overall.

研發線按固定匯率計算增長 5.3%，略高於收入增長 4.5%。但其中很多是由計劃完成的某些時間驅動的。總的來說，對於你關於 1.18 萬億日元核心營業利潤的問題，我可以說我們在運行率上跟踪得很好。你可以看到我們年初至今的運行率交付，我們跟踪得很好。事實上，我們強調的是，管理層的指導意見處於高個位數，而且可能處於高個位數的較高範圍內。對第三季度的結果非常滿意，不僅是收入增長，還有運營支出和整體核心運營利潤。

Regarding dividend increase or share buybacks or -- we haven't changed, we're not changing our capital allocation policy. Again, we're very much focused on investing for growth and growth drivers. We're pleased with the trend of our net debt to adjusted EBITDA coming down even from 2.8x to 2.5x, even after the full year dividend has been made. And we're tracking very well towards getting to our net debt to adjusted EBITDA targets by fiscal year '23. So we're very much focused on that and shareholder returns. So we're very much focused on maintaining our discipline there.

關於增加股息或股票回購，或者——我們沒有改變，我們沒有改變我們的資本配置政策。同樣，我們非常專注於投資增長和增長動力。我們很高興我們的淨債務與調整後 EBITDA 的比率從 2.8 倍下降到 2.5 倍，即使在全年派發股息之後也是如此。我們正在很好地跟踪到我們的淨債務到 23 財年調整後的 EBITDA 目標。所以我們非常關注這一點和股東回報。所以我們非常專注於維持我們在那裡的紀律。

If we were to give an update on the capital allocation policy, we will consider, for sure, looking at something that wouldn't be a one-timer. It will be something that will be consistent moving forward. But right now, it's too early to communicate that.

如果我們要更新資本配置政策，我們肯定會考慮考慮一些不會一次性的東西。這將是始終如一的前進。但現在，傳達這一點還為時過早。

[Interpreted] Thank you. And now, the time has come to close. So I would like to finish the Q&A session. Thank you very much for your participation, taking your precious time out of your busy schedule. If you have any individual follow-up questions, please contact IR. I'd like to ask for your continued support.

[翻譯] 謝謝。而現在，時間到了。所以我想結束問答環節。非常感謝您的參與，讓您在百忙之中抽出寶貴時間。如果您有任何後續問題，請聯繫 IR。我想請你繼續支持。

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

[此抄本中標記為已翻譯的部分是由現場通話中在場的口譯員說的。]