Takeda Pharmaceutical Co Ltd (TAK) 2023 Q1 法說會逐字稿

[Interpreted] Good evening, everybody, or good morning, everybody. Thank you very much for joining Takeda's earnings conference call webinar for the first quarter FY 2022. I will serve as MC today. My name is Ayako Iwamuro, in charge of Global IR.

[翻譯]大家晚上好，或者大家早上好。非常感謝您參加武田 2022 財年第一季度的收益電話會議網絡研討會。我今天將擔任 MC。我是負責全球 IR 的岩室綾子。

First, I will explain language setup. (Operator Instructions)

首先，我將解釋語言設置。 （操作員說明）

Before starting, I'd like to remind everyone that we will be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today.

在開始之前，我想提醒大家，我們將討論 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。實際結果可能與今天討論的結果大不相同。

The factors that could cause our actual results to differ materially are discussed in our most recent Form 20-F and in other SEC filings of Takeda. Please also refer to the important notice on Page 2 of the presentation.

我們最近的 20-F 表格和武田向美國證券交易委員會提交的其他文件中討論了可能導致我們的實際結果出現重大差異的因素。另請參閱演示文稿第 2 頁的重要通知。

Let's move to the presentation today. We have with us Christophe Weber, President and CEO; R&D President, Andy Plump; and Chief Financial Officer, Constantine Saroukos. They will be presenting. After the presentation, we will have a Q&A session. Please let's start.

讓我們進入今天的演示。我們有總裁兼首席執行官 Christophe Weber；研發總裁，Andy Plump；和首席財務官康斯坦丁·薩魯科斯（Constantine Saroukos）。他們將進行演示。演講結束後，我們將進行問答環節。請讓我們開始吧。

Thank you, Ayako, and thank you, everyone, for joining us today. Our purpose is to create better health for people, brighter future for the world by discovering and delivering life-transforming treatments with a commitment to patients across the world, to our people and to the planet. Needless to say that this purpose is more relevant than ever. It's not only a moral imperative to create shareholder and societal value, but it's also a way to make the company stronger.

謝謝你，綾子，也謝謝大家今天加入我們。我們的目標是通過發現和提供改變生命的治療方法，為世界各地的患者、我們的人民和地球創造更好的健康，為世界創造更光明的未來。不用說，這個目的比以往任何時候都更重要。創造股東和社會價值不僅是道德上的要求，也是使公司變得更強大的一種方式。

Our performance in the first quarter of this fiscal year reinforced our ability to drive long-term business growth. In the first quarter, core revenue was JPY 972.5 billion, with growth at a constant exchange rate of 8.3% driven by our growth and launch products. Core operating profit for the quarter was JPY 319.1 billion, growing at an impressive 17% on a constant exchange rate basis, and core earnings per share grew 15.8% to JPY 145.

我們在本財年第一季度的表現增強了我們推動長期業務增長的能力。第一季度，核心收入為 9725 億日元，在我們的增長和推出產品的推動下，以 8.3% 的固定匯率增長。本季度核心營業利潤為 3191 億日元，按固定匯率計算，增長了 17%，令人印象深刻，每股核心收益增長 15.8% 至 145 日元。

This put us well on track towards our full year guidance for fiscal year 2022 of low single-digit core revenue growth and high single-digit core operating profit and core EPS growth at constant exchange rate.

這使我們朝著 2022 財年全年低個位數核心收入增長和高個位數核心營業利潤和固定匯率核心每股收益增長的目標邁進。

On a reported basis, our strong business performance, coupled with favorable foreign exchange enable us to deliver reported revenue growth of 2.4%. And this is despite the large gain of JPY 133 billion, we booked as revenue in the first quarter of the last year related to the sale of the diabetes portfolio in Japan.

在報告的基礎上，我們強勁的業務表現，加上有利的外匯，使我們能夠實現 2.4% 的報告收入增長。儘管獲得了 1,330 億日元的巨額收益，但我們在去年第一季度將與在日本出售糖尿病產品組合相關的收入計入了收入。

On reported profit basis, this onetime transaction had an impact on the first quarter growth rate, but our full year outlook still anticipate double-digit reported operating profit and EPS growth.

在報告的利潤基礎上，這一一次性交易對第一季度的增長率產生了影響，但我們的全年展望仍預計報告的營業利潤和每股收益增長兩位數。

We continue to see progress in our commercial execution. Our diverse portfolio of growth and launch product grew at an impressive 26% at constant exchange rate, driven by ENTYVIO, TAKHZYRO and our immunoglobulin franchise. At the same times, we are very much focused on our launch excellence as I will detail in a few minutes.

我們繼續看到我們的商業執行取得進展。在 ENTYVIO 、 TAKHZYRO 和我們的免疫球蛋白專營權的推動下，我們多樣化的增長和推出產品組合以恆定匯率增長了 26%，令人印象深刻。同時，我們非常專注於我們的卓越發布，我將在幾分鐘內詳細介紹。

Andy will detail our pipeline progress shortly. So I would like to now give you an update on our most recent launches in the U.S. Let's start with LIVTENCITY, which is redefining the way cytomegalovirus, or CMV, infection is treated.

Andy 將很快詳細介紹我們的管道進展。因此，我現在想向您介紹我們最近在美國推出的產品。讓我們從 LIVTENCITY 開始，它正在重新定義鉅細胞病毒或 CMV 感染的治療方式。

Patients now have access to a therapy that can enable sustained and effective treatment against post-transplant CMV infection, which could save an organ or a life that might otherwise be lost. As CMV is one of the most common and serious post-transplant infection, recent data support the meaningful impact we are seeing.

患者現在可以獲得一種治療方法，可以持續有效地治療移植後 CMV 感染，這可以挽救一個可能會失去的器官或生命。由於 CMV 是最常見和最嚴重的移植後感染之一，最近的數據支持我們所看到的有意義的影響。

At the recent medical meetings, we presented data on a new exploratory analysis showing that patients treated with LIVTENCITY had reduction in hospitalization and length of hospital stay compared to those treated with conventional antiviral therapies.

在最近的醫學會議上，我們提供了一項新的探索性分析的數據，顯示與接受傳統抗病毒治療的患者相比，接受 LIVTENCITY 治療的患者住院和住院時間減少。

We are also seeing promising momentum since the launch in December '21. 56% of the 314 U.S. transplant centers have initiated therapy with at least 1 patient and demand is continuing to grow. Our global expansion plan is underway with an EU approval decision expected in second half of fiscal year 2022.

自 21 年 12 月推出以來，我們也看到了可喜的勢頭。美國 314 個移植中心中有 56% 已開始對至少 1 名患者進行治療，並且需求持續增長。我們的全球擴張計劃正在進行中，預計歐盟將在 2022 財年下半年做出批准決定。

We also anticipate Phase III data for LIVTENCITY, which could extend use in first line. We expect the readout at some point later this fiscal year. We are very proud of the impact of this transformative treatments. Patients who would otherwise be vulnerable to CMV, now have hope and a better quality of life.

我們還預計 LIVTENCITY 的 III 期數據，這可能會擴大在一線的使用。我們預計將在本財年晚些時候的某個時候公佈。我們對這種變革性治療的影響感到非常自豪。原本容易感染 CMV 的患者現在有了希望和更好的生活質量。

I'd like to talk about another launch product, EXKIVITY. EXKIVITY is an important new treatment for adult patients with locally advanced or metastatic non-small cell lung cancer. This is the first and only approved oral therapy designed to target EGFR Exon20 insertion mutation for patients whose disease has progressed on/or after platinum-based chemotherapy.

我想談談另一個發布產品，EXKIVITY。 EXKIVITY 是治療局部晚期或轉移性非小細胞肺癌成年患者的重要新療法。這是第一個也是唯一一個獲批的口服療法，旨在針對鉑類化療期間/或之後疾病進展的患者的 EGFR 外顯子20插入突變。

The very unique and distinct value of this important treatment combined with our launch capability is driving its success. We see it in the continued progress following the launch in the U.S. We are continuing to see better-than-expected new patient starts and have now reached 50% Exon20 market share in U.S. Following approval in the U.S. and the U.K., we continue to receive approval from health authorities around the world, most recently in Switzerland, Australia and South Korea.

這種重要治療的獨特而獨特的價值與我們的發射能力相結合，正在推動其成功。我們在美國推出後的持續進展中看到了這一點。我們繼續看到好於預期的新患者開始，現在已經達到美國 50% 的 Exon20 市場份額。在美國和英國獲得批准後，我們繼續收到獲得世界各地衛生當局的批准，最近一次是在瑞士、澳大利亞和韓國。

However, in the EU, we decided to withdraw the EU marketing authorization application filing in second line non-small cell lung cancer, following discussion with CHMP where the Committee indicated that additional clinical data will be needed to confirm benefit for mobocertinib in the second line. Pending outcome from the Phase III trial in first-line EGFR Exon20 session, non-small cell lung cancer, we plan to pursue approval in the EU. This first-line trial is event driven and is targeted for submission in fiscal year 2024.

然而，在歐盟，在與 CHMP 討論後，我們決定撤回歐盟在二線非小細胞肺癌中的上市許可申請，委員會表示需要額外的臨床數據來確認 mobocertinib 在二線中的益處.在等待一線 EGFR Exon20 階段非小細胞肺癌 III 期試驗的結果之前，我們計劃在歐盟尋求批准。該一線試驗是事件驅動的，目標是在 2024 財年提交。

We remain confident that EXKIVITY offers an effective treatment option for patients suffering from this difficult-to-treat cancer and are hopeful that we will continue to make important progress on bringing this treatment to patients in needs.

我們仍然相信 EXKIVITY 為患有這種難以治療的癌症的患者提供有效的治療選擇，並希望我們將繼續在將這種治療帶給有需要的患者方面取得重要進展。

In closing, this quarter is yet another example of our ability to deliver on our mission to transform the life of patient while driving long-term financial growth. This result reinforce that our strategy is working, specifically the launch of our new innovative products, our deliberate investment in data and digital and also a commitment to sustainability. We have an incredibly exciting time ahead. Patient by patient, we see the impact of our mission to transform life.

最後，本季度是我們在推動長期財務增長的同時實現改變患者生活的使命的又一個例子。這一結果強化了我們的戰略正在發揮作用，特別是我們新的創新產品的推出、我們對數據和數字的刻意投資以及對可持續發展的承諾。我們將迎來令人難以置信的激動人心的時刻。一個接一個的病人，我們看到了我們改變生活的使命的影響。

I now would like to hand over to Andy to introduce our pipeline updates in more detail. Thank you.

我現在想請安迪更詳細地介紹我們的管道更新。謝謝你。

Thank you very much, Christophe, and hello to everyone on the call today. As Christophe mentioned, the impact we are seeing on the lives of patients is the key factor to our success. We see this impact so clearly as we make progress in our pipeline. The opportunity to bring transformative medicines to patients is an inspiring and motivating force for all of our scientists. I think you'll see this today as I walk through a few highlights from the first quarter. Next slide, please.

非常感謝 Christophe，向今天電話會議的每一個人問好。正如 Christophe 所說，我們所看到的對患者生活的影響是我們成功的關鍵因素。隨著我們在管道中取得進展，我們如此清楚地看到了這種影響。將變革性藥物帶給患者的機會對我們所有的科學家來說都是一種鼓舞人心的動力。我想你今天會在我回顧第一季度的一些亮點時看到這一點。請下一張幻燈片。

There's a lot of enthusiasm here about our dengue vaccine. We recently presented the final data for TAK-003 and are very pleased with the long-term efficacy against hospitalizations as well as protection against dengue disease, which was maintained throughout the 4.5 years of our pivotal trial. We will share these results with you shortly.

這裡有很多關於我們的登革熱疫苗的熱情。我們最近公佈了 TAK-003 的最終數據，並對住院治療的長期療效以及對登革熱的保護感到非常滿意，這在我們關鍵試驗的 4.5 年中一直保持不變。我們將很快與您分享這些結果。

We reported positive Phase III data for HYQVIA in CIDP, a chronic autoimmune and inflammatory disease that affects the peripheral nervous system. Most of the patients in the ADVANCE pivotal trial on active treatment received HYQVIA subcutaneously every 4 weeks. This convenient dosing and ability to self-administer at home has the potential to reduce the burden of chronic immunoglobulin treatment. Patients with alpha-1-antitrypsin associated liver disease were treated with fazirsiran, our first-in-class RNAi therapy in an open-label Phase II trial.

我們報告了 HYQVIA 在 CIDP 中的 III 期陽性數據，CIDP 是一種影響周圍神經系統的慢性自身免疫和炎症性疾病。在積極治療的 ADVANCE 關鍵試驗中，大多數患者每 4 週接受一次 HYQVIA 皮下注射。這種方便的劑量和在家自我給藥的能力有可能減輕慢性免疫球蛋白治療的負擔。 α-1-抗胰蛋白酶相關肝病患者接受了 fazirsiran 治療，這是我們在一項開放標籤 II 期試驗中的一流 RNAi 療法。

The strong results were published in the New England Journal of Medicine, and highlights include the regression of fibrosis in 7 out of 12 patients and a median 83% reduction in accumulated Z-AAT protein in the liver. This is the key pathologic aggregate that causes inflammation and can lead to fibrosis and eventual liver transplant. These early results demonstrate the potential for fazirsiran to one day help these patients avoid liver transplant.

強有力的結果發表在《新英格蘭醫學雜誌》上，重點包括 12 名患者中有 7 名的纖維化消退和肝臟中累積的 Z-AAT 蛋白中位數減少 83%。這是導致炎症並可能導致纖維化和最終肝移植的關鍵病理聚集體。這些早期結果表明，fazirsiran 有可能在某一天幫助這些患者避免肝移植。

Completing our clinical updates, TAK-280, a conditional B7-H3 targeted bispecific T cell engager designed to treat solid tumors entered the clinic this quarter. This is the second program that we have entered into the clinic for Maverick Therapeutics, our build-to-buy acquisition completed last year. And as Christophe highlighted earlier, we have in-licensed an exciting hypersialylated immunoglobulin candidate for Momenta Pharmaceuticals. This therapy has the potential to increase potency allowing for significantly lower doses. If you go to the next Slide 10, please.

完成我們的臨床更新，TAK-280，一種有條件的 B7-H3靶向雙特異性 T 細胞接合劑，旨在治療實體瘤，本季度進入臨床。這是我們為 Maverick Therapeutics 進入診所的第二個項目，這是我們去年完成的構建購買收購。正如 Christophe 之前強調的那樣，我們已經為 Momenta Pharmaceuticals 獲得了一種令人興奮的高唾液酸化免疫球蛋白候選藥物的許可。這種療法有可能增加效力，從而顯著降低劑量。請轉到下一張幻燈片 10。

Here are our 10 late-stage development programs. Nuvaxovid was approved early this fiscal year and is now available in Japan, adding to the armament against COVID-19. Modakasfusp alfa is our first-in-class immunocytokine that delivers an attenuated interferon to tumor and immune cells in a highly targeted manner.

以下是我們的 10 個後期開發計劃。 Nuvaxovid 在本財年初獲得批准，現已在日本上市，增加了對抗 COVID-19 的武器。 Modakasfusp alfa 是我們一流的免疫細胞因子，它以高度靶向的方式向腫瘤和免疫細胞提供減毒的干擾素。

Updated results presented at the European Hematology Association for single-agent modakafusp alfa show an overall response rate of 43% with multiple complete responses in heavily pretreated patients, importantly, including those refractory to anti-CD38 therapies. This quarter, we started the first of a series of Phase II trials for modakafusp alfa, our lead innate immune program, which will define its path forward in relapsed or refractory multiple myeloma. Next, Slide 11, please.

歐洲血液學協會公佈的單藥 modakafusp alfa 的最新結果顯示，在經過大量預處理的患者中，包括那些對抗 CD38 治療無效的患者，總體反應率為 43%，具有多次完全反應。本季度，我們開始了 modakafusp alfa 的一系列 II 期試驗中的第一個，這是我們的先天免疫程序，它將確定其在復發性或難治性多發性骨髓瘤中的前進道路。下一張，請看幻燈片 11。

We continue to be excited about our proof of concept readouts to come over the course of the next 2 years. These are the first of many new molecular entities that could emerge from our rich and transformative early-stage pipeline and add to our growing list of late-stage development programs. Next, Slide 12, please.

我們繼續對未來 2 年的概念驗證讀數感到興奮。這些是許多新分子實體中的第一個，它們可以從我們豐富的變革性早期管道中出現，並添加到我們不斷增長的後期開發項目列表中。下一張，請播放第 12 張幻燈片。

Here are select expansion opportunities we have for our major brands. We expect to file TAKHZYRO for the prevention of hereditary angioedema in children ages 2 to 12 in the near future. This filing is based upon the outstanding data presented at the European Academy of Allergy and Clinical Immunology in July.

以下是我們為主要品牌提供的精選擴張機會。我們希望在不久的將來提交 TAKHZYRO 用於預防 2 至 12 歲兒童的遺傳性血管性水腫。該文件基於 7 月份在歐洲過敏和臨床免疫學學會提交的出色數據。

TAKHZYRO demonstrated an approximately 95% reduction in HAE attacks when compared to baseline. Most of these children averaged nearly 2 attacks per month before entering the trial and a majority of them remained attack-free during the full 52-week treatment period, a result not seen with any other agent.

與基線相比，TAKHZYRO 證明 HAE 攻擊減少了約 95%。這些兒童中的大多數在進入試驗前平均每月發作近 2 次，其中大多數在整個 52 週的治療期內保持無發作，這是任何其他藥物都沒有的結果。

And as mentioned, we also expect to file HYQVIA in the U.S. and EU as maintenance therapy for patients with CIDP based upon the positive results announced just this past month. So next Slide 13.

如前所述，我們還希望根據上個月剛剛公佈的陽性結果，在美國和歐盟提交 HYQVIA 作為 CIDP 患者的維持治療。下一張幻燈片 13。

We have some key regulatory approvals and Phase III readouts underway. Before we discuss our exciting data for TAK-003 and HYQVIA, we wanted to highlight upcoming data for -- in Q2 for LIVTENCITY. As Christophe mentioned, we expect the top line Phase III LIVTENCITY data in first-line post-transplant CMV infection to read out in the second quarter. This trial compares LIVTENCITY against the current standard of care, valganciclovir in patient with first CMV infections following hematopoietic stem cell transplant.

我們正在進行一些關鍵的監管批准和 III 期讀數。在我們討論 TAK-003 和 HYQVIA 令人興奮的數據之前，我們想強調即將到來的數據——在第二季度 LIVTENCITY。正如 Christophe 所說，我們預計一線移植後 CMV 感染的 III 期 LIVTENCITY 一線數據將在第二季度公佈。該試驗將 LIVTENCITY 與目前的護理標準纈更昔洛韋在造血幹細胞移植後首次 CMV 感染的患者中進行比較。

In Phase II, LIVTENCITY showed a numerically higher rate of CMV viremia clearance versus valganciclovir with a significantly lower rate of neutropenia at 5% versus 18%. Neutropenia is an independent predictor of mortality in stem cell transplant patients.

在第二階段，LIVTENCITY 顯示 CMV 病毒血症清除率高於纈更昔洛韋，中性粒細胞減少率顯著降低，分別為 5% 和 18%。中性粒細胞減少症是乾細胞移植患者死亡率的獨立預測因子。

LIVTENCITY's favorable safety profile, especially its lack of neutropenia represents a potentially significant therapeutic advance for these patients. The late-stage data readouts shown here will allow for global filing in these indications with future label expansion opportunities to come. So now let's look at some of our data. If we can go to Slide 14, please.

LIVTENCITY 良好的安全性，特別是它沒有中性粒細胞減少症，代表了這些患者潛在的重大治療進展。此處顯示的後期數據讀數將允許在這些適應症中進行全球歸檔，未來標籤擴展機會即將到來。所以現在讓我們看看我們的一些數據。如果我們可以轉到幻燈片 14，請。

As Christophe noted, we are very encouraged by the final 4.5-year data from our dengue vaccine candidate, TAK-003. The analyses are complete, and the new drug application has been submitted in the EU. Dengue is a rapidly spreading mosquito-borne viral illness. It has been defined as a top 10 health problem by the World Health Organization. While mortality from Dengue is relatively low, severe, dengue infection can be devastating for patients, sometimes leading to hospitalization.

正如 Christophe 所說，我們對登革熱候選疫苗 TAK-003 的最終 4.5 年數據感到非常鼓舞。分析完成，新藥申請已在歐盟提交。登革熱是一種迅速傳播的蚊媒病毒性疾病。它已被世界衛生組織定義為十大健康問題。雖然登革熱的死亡率相對較低，但很嚴重，登革熱感染對患者來說可能是毀滅性的，有時會導致住院。

For regions that experienced a dengue epidemic, hospitals can become overrun with patients requiring supportive care. And so the secondary consequences for patients with other diseases can be substantial, not unlike what we have seen with COVID.

對於經歷過登革熱流行的地區，醫院可能會擠滿需要支持性護理的患者。因此，對患有其他疾病的患者的次要後果可能是巨大的，這與我們在 COVID 中看到的情況不同。

There is an incredible unmet medical need, and we are ready to meet that need with a really good vaccine, Our 4.5-year data continue to support sustained efficacy. What we show here with patients at baseline who are seropositive or seronegative is an incredible 84% reduction in hospitalization. Hospitalization is an indicator of severe forms of dengue. As we have seen with COVID, it's not just if you can prevent infection, but if you can prevent severe infection, it's clear that we can do both with our vaccine.

有一個令人難以置信的未滿足的醫療需求，我們已準備好用一種非常好的疫苗來滿足這一需求，我們的 4.5 年數據繼續支持持續療效。我們在此展示的基線時血清陽性或血清陰性患者的住院率令人難以置信地減少了 84%。住院是嚴重登革熱的一個指標。正如我們在 COVID 中看到的那樣，這不僅是您可以預防感染，而且如果您可以預防嚴重感染，很明顯我們可以用我們的疫苗做到這兩點。

Now the efficacy does vary by serotype. We have strong efficacy in serotypes 1 and 2, which are the most common. We have strong efficacy in serotype 3 patients with previous dengue infections. However, we have no efficacy in serotype 3 patients or seronegative. And to date, we do not have enough data in serotype 4 to draw conclusions.

現在療效確實因血清型而異。我們對最常見的血清型 1 和 2 有很強的療效。我們對既往有登革熱感染的血清型 3 患者有很強的療效。然而，我們對血清型 3 或血清陰性的患者沒有療效。迄今為止，我們還沒有足夠的血清型 4 數據來得出結論。

Now allow me to highlight the hospitalization data from the last 18 months of the trial in the lower right. We are most reassured by the 0 hospitalizations seen in the seronegative arm for patients on TAK-003 versus placebo. We believe these data will be reassuring to physicians and importantly regulators. We are currently under review in the EU. We believe these data continue to support a favorable benefit risk profile and are hopeful for a positive decision in the next few months. If we can go to the next Slide 15, please.

現在請允許我在右下方突出顯示過去 18 個月試驗的住院數據。我們對 TAK-003 與安慰劑組患者血清陰性組的 0 次住院感到最放心。我們相信這些數據將使醫生和重要的監管機構放心。我們目前正在歐盟接受審查。我們相信這些數據繼續支持有利的收益風險狀況，並希望在未來幾個月做出積極的決定。請看下一張幻燈片 15。

CIDP is a rare autoimmune and inflammatory disorder that causes demyelination and damage to peripheral nerves. The exact cause is unknown, but patients feel progressive weakness and impaired sensory function in their legs and arms often leading to pain, fatigue and other symptoms. This is a chronic condition that requires long-term therapy.

CIDP 是一種罕見的自身免疫性和炎症性疾病，可導致脫髓鞘和周圍神經損傷。確切原因尚不清楚，但患者感到腿部和手臂進行性虛弱和感覺功能受損，通常會導致疼痛、疲勞和其他症狀。這是一種需要長期治療的慢性病。

The treatment goal is to maintain durable remission with therapies such as IVIG. IVIG, of course, can have its own challenges due to the need for venous access by a health care provider. So a facilitated subcutaneous immunoglobulin like HYQVIA, should help address an important need for patients with CIDP. We are very excited by the positive results in this Phase III study.

治療目標是通過 IVIG 等療法保持持久緩解。當然，由於需要醫療保健提供者進行靜脈通路，IVIG 可能會遇到其自身的挑戰。因此，像 HYQVIA 這樣的促進皮下免疫球蛋白應該有助於滿足 CIDP 患者的重要需求。我們對這項 III 期研究的積極結果感到非常興奮。

In the ADVANCE-1 trial, the HYQVIA arm showed a significant difference in relapse rate compared with the placebo arm when used as maintenance therapy in CID patients with a favorable safety profile. Importantly, most of the patients achieved these results with a once every 4-week dosing regimen using HYQVIA, which is less frequent than any conventional subcutaneous immunoglobulin on the market.

在 ADVANCE-1 試驗中，當用於具有良好安全性的 CID 患者的維持治療時，與安慰劑組相比，HYQVIA 組的複發率存在顯著差異。重要的是，大多數患者通過使用 HYQVIA 每 4 週一次的給藥方案實現了這些結果，這比市場上任何傳統的皮下免疫球蛋白都少。

These data will be presented at an upcoming medical meeting and be used to file for approval in both the U.S. and EU later this fiscal year. So we conclude with 2 exciting data sets that in the near future could bring new therapies and indications to benefit our patients.

這些數據將在即將召開的醫學會議上公佈，並用於本財年晚些時候在美國和歐盟申請批准。因此，我們總結了 2 個令人興奮的數據集，這些數據集在不久的將來可能會帶來新的療法和適應症，從而使我們的患者受益。

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

謝謝，我現在把它交給科斯塔。科斯塔？

Thank you, Andy, and hello, everyone. This is Costa Saroukos speaking. It's my pleasure to explain the fiscal 2022 first quarter financial highlights.

謝謝你，安迪，大家好。這是科斯塔薩魯科斯說話。我很高興解釋 2022 財年第一季度的財務亮點。

We are off to a strong start in fiscal 2022 with core revenue growing at 8.3% at constant exchange rate and 19.1% when factoring in the FX tailwind. This strong performance was driven by global and launch products such as ENTYVIO, TAKHZYRO and immunoglobulin as we delivered growth in all geographic regions.

我們在 2022 財年開局強勁，核心收入按固定匯率計算增長 8.3%，考慮到外匯順風，增長 19.1%。隨著我們在所有地理區域實現增長，這一強勁表現受到全球和推出產品（如 ENTYVIO、TAKHZYRO 和免疫球蛋白）的推動。

In addition, we also are excited with what we've seen so far in the new launches of LIVTENCITY and EXKIVITY. Our reported revenue growth was 2.4% impacted by the JPY 133 billion gain from the sale of the Japan Diabetes business that was booked in Q1 of the prior year. This onetime event is the only difference between reported and core revenue. Our core operating profit, which excludes this divestiture gain, grew 17% at constant exchange rate to JPY 319.1 billion for the quarter.

此外，我們還對迄今為止在 LIVTENCITY 和 EXKIVITY 的新發布中所看到的內容感到興奮。我們報告的收入增長為 2.4%，受去年第一季度出售日本糖尿病業務帶來的 1,330 億日元收益的影響。這個一次性事件是報告收入和核心收入之間的唯一區別。本季度我們的核心營業利潤（不包括此項剝離收益）按固定匯率計算增長 17% 至 3191 億日元。

Our core operating profit margin was 32.8%, an increase of 2.3 percentage points on a year-over-year basis. This was partly because of the resolution of the ENTYVIO shipment phasing that we experienced in quarter 4 and partly a reflection of our broad-based portfolio growth and focus on cost control.

我們的核心營業利潤率為32.8%，同比增長2.3個百分點。這部分是因為我們在第四季度經歷了 ENTYVIO 出貨階段的解決，部分反映了我們基礎廣泛的投資組合增長和對成本控制的關注。

Net debt to adjusted EBITDA remains at 2.8 -- sorry, remains at 2.8x despite the year-end dividend payment. And on all measures, we are on track towards the full year management guidance we provided in May.

調整後 EBITDA 的淨債務仍為 2.8 - 抱歉，儘管支付了年終股息，但仍為 2.8 倍。在所有措施上，我們都在朝著 5 月份提供的全年管理指導邁進。

Let me go into more detail on the Q1 revenue performance versus prior year on Slide 19. On the left-hand side, you can see a waterfall chart for reported revenue, which grew at 2.4% despite the full impact of the JPY 133 billion we booked in Q1 of last year from the sale of Japan Diabetes portfolio.

讓我在幻燈片 19 上更詳細地介紹第一季度的收入表現與上一年的對比。在左側，您可以看到報告收入的瀑布圖，儘管我們的 1330 億日元的全面影響，但仍增長了 2.4%去年第一季度從日本糖尿病產品組合的銷售中預訂。

Core revenue on the right-hand side exclude this. And you can see our business momentum was driving 8.3% growth at constant exchange rate. Foreign exchange has also been a significant tailwind for us due to the depreciation of the yen, adding over 10 percentage points of growth to core revenue in the quarter.

右側的核心收入不包括這一點。您可以看到我們的業務勢頭以固定匯率推動了 8.3% 的增長。由於日元貶值，外匯對我們來說也是一個重要的推動因素，使本季度的核心收入增長了 10 個百分點以上。

On Slide 20, we show the drivers of reported and core operating profit for the quarter. Reported operating profit was JPY 150.5 billion, a decline of 39.4% versus prior year. Again, the decline is predominantly coming from the sale of the Japan Diabetes portfolio last year. However, because that was a one-off event in quarter 1 of prior year, the impact will diminish over the remainder of this fiscal year, and we are forecasting full year reported operating profit growth of 12.8%.

在幻燈片 20 中，我們展示了本季度報告的和核心營業利潤的驅動因素。報告的營業利潤為 1505 億日元，與去年相比下降了 39.4%。同樣，下降主要來自去年日本糖尿病產品組合的出售。然而，由於這是上一年第一季度的一次性事件，其影響將在本財年剩餘時間內減少，我們預計全年報告的營業利潤增長 12.8%。

Core operating profit was JPY 319.1 billion, with our business momentum driving 17% growth at constant exchange rate and foreign exchange, an incremental tailwind of around 11 percentage points.

核心營業利潤為 3,191 億日元，以固定匯率和外匯匯率計算，我們的業務動力推動了 17% 的增長，增加了約 11 個百分點的順風。

On Slide 21, you can see our growth by key business area. We have a balanced growing portfolio. Our growth and launch products continue to be key drivers, generating USD 2.7 billion of revenue in the quarter and delivering 26% growth at constant exchange rate.

在幻燈片 21 上，您可以按主要業務領域查看我們的增長情況。我們擁有平衡增長的投資組合。我們的增長和推出產品仍然是關鍵驅動力，本季度創造了 27 億美元的收入，按固定匯率計算實現了 26% 的增長。

GI, our largest business area by revenue, grew at 15% with growth of ENTYVIO across all markets, driven by continued share growth in bio-naïve patients. In rare disease, which grew 7%, we see continued demand growth and geographic expansion for TAKHZYRO as well as a successful new launch of LIVTENCITY. PDT Immunology continues to be very strong with 18% growth, which I will introduce in more detail on the next slide.

GI 是我們按收入計算的最大業務領域，在所有市場的 ENTYVIO 增長下增長了 15%，這得益於生物初始患者份額的持續增長。在增長 7% 的罕見病中，我們看到 TAKHZYRO 的需求持續增長和地域擴張，以及 LIVTENCITY 的成功推出。 PDT Immunology 繼續保持強勁增長 18%，我將在下一張幻燈片中更詳細地介紹這一點。

You will note that oncology business area is declining year-on-year, as was expected, given VELCADE generics entered the U.S. market from May this year. Neuroscience continues to be strong, driven by VYVANSE and TRINTELLIX. And the other segment has benefited from revenue from our COVID-19 vaccines in Japan.

您會注意到，鑑於 VELCADE 仿製藥從今年 5 月開始進入美國市場，正如預期的那樣，腫瘤業務領域正在同比下降。在 VYVANSE 和 TRINTELLIX 的推動下，神經科學繼續保持強勁勢頭。另一部分受益於我們在日本生產的 COVID-19 疫苗的收入。

I mentioned our strong and sustained performance in plasma-derived therapies where we have successfully navigated pandemic pressures. Looking ahead, we have considerable potential to continue to grow this business and expand the impact of our therapies to new patient populations around the world. This quarter is evidence of that. Our PDT Immunology business delivered revenue growth of 18%, tracking towards the high end of our full year guidance. Within this, our immunoglobulin portfolio grew at 22%, fueled by increased global demand, coupled with steady and growing supply.

我提到了我們在血漿衍生療法方面的強勁和持續表現，我們已經成功應對了大流行的壓力。展望未來，我們有相當大的潛力繼續發展這項業務，並將我們的療法的影響擴大到世界各地的新患者群體。本季度就是證明。我們的 PDT 免疫學業務實現了 18% 的收入增長，接近我們全年指導的高端。其中，我們的免疫球蛋白產品組合增長了 22%，這得益於全球需求的增長以及穩定且不斷增長的供應。

Our primary objective is to maintain continuity of patient supply, which requires consistent plasma volume growth as new patients are brought on to therapy. We have delivered plasma donation volumes above pre-pandemic levels for over 1 year and continue to build on this momentum. The growth of our BioLife network is a key factor. We added 8 donation centers in the U.S. in the first quarter, bringing our global donation network to 212, and we are on track to increase year-on-year donation volumes by 10% to 20% in fiscal year 2022.

我們的主要目標是保持患者供應的連續性，這需要隨著新患者接受治療而持續增加血漿容量。一年多來，我們提供的血漿捐贈量超過了大流行前的水平，並繼續鞏固這一勢頭。我們 BioLife 網絡的發展是一個關鍵因素。我們在第一季度在美國增加了 8 個捐贈中心，使我們的全球捐贈網絡達到 212 個，我們有望在 2022 財年將捐贈量同比增長 10% 至 20%。

The past 2 years have demanded that we do more with less plasma, and we have. We are actively managing costs on a number of fronts to improve margins, including donor compensation. In quarter 1, we reduced donor compensation by approximately 15% compared to a year ago, leveraging new data and analytics capabilities. We are also in position to capture the full benefit of our digital and organization transformation to improve PDT business margins over time.

過去 2 年要求我們用更少的血漿做更多的事情，我們做到了。我們正在多方面積極管理成本以提高利潤，包括捐助者補償。在第 1 季度，我們利用新的數據和分析功能，將捐贈者的報酬與一年前相比減少了約 15%。我們還可以充分利用我們的數字化和組織轉型的優勢，以隨著時間的推移提高 PDT 的業務利潤率。

Slide 23 shows the net balance compared to the end of March. Free cash flow was JPY 42.6 billion, reflecting a step-up in CapEx that captures 2 oncology acquisitions, GammaDelta and Adaptate, which we completed in April this year.

幻燈片 23 顯示了與 3 月底相比的淨餘額。自由現金流為 426 億日元，反映了資本支出的增長，包括我們在今年 4 月完成的 2 項腫瘤學收購 GammaDelta 和 Adaptate。

Also in April, we completed the share buyback initiated last year. And in June, we paid the second half year dividend for fiscal year 2021. Despite the dividend payment, the completion of the buyback and step-up in CapEx, we were able to hold net debt to adjusted EBITDA at 2.8x.

同樣在 4 月，我們完成了去年發起的股票回購。並且在 6 月，我們支付了 2021 財年的下半年股息。儘管支付了股息，完成了回購併提高了資本支出，但我們能夠將淨債務與調整後的 EBITDA 保持在 2.8 倍。

On Slide 24, you can see our debt maturity ladder as of June. We paid down JPY 20 billion of USD-denominated debt in April and still expect to pay down a total JPY 500 billion of debt in fiscal year 2022. I'm very pleased with how we've structured our debt profile with a weighted average interest rate of approximately 2% and importantly, 98% of our total debt at fixed interest rates.

在幻燈片 24 上，您可以看到我們截至 6 月的債務到期階梯。我們在 4 月份償還了 200 億日元以美元計價的債務，但仍預計在 2022 財年償還總額為 5,000 億日元的債務。我對我們如何利用加權平均利率構建債務狀況感到非常滿意大約 2% 的利率，重要的是，我們以固定利率計算的總債務的 98%。

In fact, the only outstanding debt still at floating rate will mature this year. So by the end of fiscal year '22, we expect to be at 100% fixed rate. This gives us strong protection from any potential interest rate hikes. Furthermore, the currency breakdown of our debt very closely matches our cash flows. So we are also protected against major currency fluctuations.

事實上，唯一仍以浮動利率計算的未償債務將在今年到期。因此，到 22 財年末，我們預計將達到 100% 的固定利率。這為我們提供了強大的保護，免受任何潛在的加息。此外，我們債務的貨幣細分與我們的現金流非常接近。因此，我們也受到保護，免受主要貨幣波動的影響。

On Slide 25, we show the guidance we disclosed on May 11. We are on track and make no changes at this point. Our forecast is based on an FX rate assumption of JPY 119 to the U.S. dollar and JPY 132 to the Euro. And if we apply the June end FX rates to the rest of fiscal year 2022, for example, JPY 136 to the U.S. dollar, we would expect to see over 10 percentage points of incremental growth to our forecast for revenue, core operating profit and core EPS.

在幻燈片 25 上，我們展示了我們在 5 月 11 日披露的指導意見。我們正在步入正軌，目前沒有做出任何改變。我們的預測是基於 119 日元兌美元和 132 日元兌歐元的匯率假設。如果我們將 6 月底的外匯匯率應用於 2022 財年剩餘時間，例如 136 日元兌美元，我們預計收入、核心營業利潤和核心利潤的預測將增長 10 個百分點以上。每股收益。

To be precise, core revenue will be growing at around 19%, and our core operating profit and core EPS at 29% and 28%, respectively. We continue to expect to generate JPY 600 billion to JPY 700 billion of free cash flow. And finally, we remain fully committed to our dividend of JPY 180 per share.

準確地說，核心收入將增長 19% 左右，我們的核心營業利潤和核心每股收益分別增長 29% 和 28%。我們繼續預計將產生 6000 億日元至 7000 億日元的自由現金流。最後，我們仍然完全致力於每股 180 日元的股息。

To close out on the presentation on Slide 26, I'd like to reemphasize the key elements of our strategy to deliver sustainable growth and value for our shareholders. We continue to see strong momentum from our commercial portfolio, which enabled us to deliver 8.3% core revenue growth at constant exchange rate.

在結束幻燈片 26 的演示文稿時，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組合中看到強勁的勢頭，這使我們能夠以固定匯率實現 8.3% 的核心收入增長。

While we do face some loss of exclusivity headwinds in the next 2 years, we expect momentum of our growth and launch products to support the top line over that period. Our margins are strong with 32.8% core operating profit margin in Q1, and we delivered core operating profit growth of 17% at constant exchange rate, well on track towards our full year guidance of high single digit.

雖然我們在未來 2 年確實面臨一些排他性不利因素的損失，但我們預計我們的增長勢頭和推出的產品將在此期間支持收入。我們的利潤率強勁，第一季度的核心營業利潤率為 32.8%，按固定匯率計算，我們實現了 17% 的核心營業利潤增長，完全朝著我們高個位數的全年指導目標邁進。

And our success is built on our solid financial foundation with robust cash flow that we will continue to allocate towards growth opportunities, continued deleveraging and competitive shareholder returns. We have abundant liquidity and a well-structured debt profile of 98% fixed rates at an average cost of 2%, which positions us well in the changing macro environment.

我們的成功建立在我們堅實的財務基礎和強勁的現金流上，我們將繼續將其分配給增長機會、持續去槓桿和有競爭力的股東回報。我們擁有充裕的流動性和結構良好的債務狀況，固定利率為 98%，平均成本為 2%，這使我們在不斷變化的宏觀環境中處於有利地位。

In closing, we believe that Takeda is in a position of strength. Our Q1 results demonstrate a strong start to fiscal year 2022, and we are well on track towards our guidance for the full year.

最後，我們相信武田處於強勢地位。我們的第一季度業績表明 2022 財年開局良好，我們正在朝著全年的指導方向邁進。

We look forward to taking your questions, and thank you for your time.

我們期待著回答您的問題，並感謝您抽出寶貴的時間。

[Interpreted] Now we'd like to take questions. And we have Christophe, Andy, and Costa and Masato Iwasaki, Japan General Affairs with us in answering to your questions. (Operator Instructions)

[解釋] 現在我們要回答問題。我們請日本總務部 Christophe、Andy、Costa 和 Masato Iwasaki 一起回答您的問題。 （操作員說明）

And now first, Mr. Yamaguchi of Citigroup, you are raising your hand.

現在首先，花旗集團的山口先生，請舉手。

This is Yamaguchi from Citi. Two questions, please. The first question regarding Q1 situations. You hinted that the full year number will surpass the full year guidance if you use who use the current currency. But can you tell me, even if you use the CER basis, I think your performance Q1 so far looks better than the full year number. So can you give me the comment whether even using a CER, your Q1 may be better than the full year number and why? So that's the first question.

我是花旗的山口。請教兩個問題。關於 Q1 情況的第一個問題。您暗示，如果您使用誰使用當前貨幣，全年數字將超過全年指導。但是你能告訴我，即使你使用 CER 基礎，我認為你 Q1 到目前為止的表現看起來比全年的數字要好。那麼，您能否給我評論一下，即使使用 CER，您的 Q1 也可能比全年數字更好，為什麼？所以這是第一個問題。

And the second question is that regarding 003 dengue vaccine. I understand you hinted that there might be some decision within a few months, which is really a good comment. But can you give me why you think it's a few months? You did have interaction with the EU authorities, then you are now coming up to the conclusion just awaiting the decision from the EU should happen within a few months?

第二個問題是關於003登革熱疫苗。我知道你暗示幾個月內可能會有一些決定，這真是一個很好的評論。但是你能告訴我為什麼你認為這是幾個月嗎？您確實與歐盟當局進行了互動，那麼您現在得出的結論只是等待歐盟的決定應該在幾個月內發生嗎？

[Interpreted] Costa, can you answer to the first question regarding the full year guidance, whether you may be exceeding already in the first quarter.

[解釋] Costa，您能否回答關於全年指導的第一個問題，您是否可能在第一季度已經超過。

Yes. Thank you very much, Yamaguchi-san, for your question. Well, firstly, let me say that we are very happy with the start of the year. Our financials, our growth, even at a constant exchange rate, our margins really, we're doing well. It's a good start to the year.

是的。非常感謝山口先生的提問。好吧，首先，讓我說我們對今年的開始感到非常高興。我們的財務狀況，我們的增長，即使在匯率不變的情況下，我們的利潤，我們都做得很好。這是一年的良好開端。

Having said that, of course, we are continuing to monitor the situation. In particular, the VELCADE generic penetration and erosion in the U.S. is something that we continue to look at. We had generic entry in May, so already in May of this year. So we're monitoring that situation. We've had 7 generics that have already entered into the market in the U.S. We also expect another 10 generics coming in, in the coming weeks.

話雖如此，我們當然會繼續監視局勢。特別是，VELCADE 在美國的通用滲透和侵蝕是我們繼續關注的問題。我們在 5 月有通用條目，所以已經在今年 5 月。所以我們正在監視這種情況。我們有 7 種仿製藥已經進入美國市場。我們還預計未來幾週還會有 10 種仿製藥上市。

So obviously, this is something that we have factored into our forecast for the full year, but we'll continue to monitor. And hopefully, quarter 2 will be another strong quarter, and we can perhaps come back to you and update you accordingly there for the full year guidance.

很明顯，這是我們在全年預測中考慮的因素，但我們將繼續監測。希望第 2 季度將是另一個強勁的季度，我們也許可以回复您並相應地更新您的全年指導。

And Yamaguchi-san, this is Andy. Thank you very much for your question on 003. And I think you essentially answered your own question.

還有山口同學，這是安迪。非常感謝您對 003 的提問。我認為您基本上回答了您自己的問題。

So just to remind everybody, we submitted the original dossier to the special track in the EU called EU Medicines for all. And it's a process whereby countries outside of the EU can actually leverage the opinion, if they choose, they can leverage the opinion from the EU. So it allows the medicine to be made available well beyond the EMEA countries.

因此，為了提醒大家，我們將原始檔案提交給了歐盟名為 EU Medicines for all 的特殊軌道。這是一個過程，歐盟以外的國家實際上可以利用這些意見，如果他們選擇，他們可以利用來自歐盟的意見。因此，它可以使藥物在歐洲、中東和非洲國家以外的地區獲得。

We filed initially based on our 3-year data set. And as we're engaging in discussions with the EMEA, we made the decision to pause the file and include our 4.5-year data set. And as you saw from the data we presented today and has been out in the public domain, the 4.5-year data look quite remarkable and continue to support the overall benefit risk profile of the vaccine. So we've now submitted those data and we're going to do a process of discussions, ongoing discussions with the EU, and we expect to have a CHMP opinion and hopefully, a positive decision later this year.

我們最初是根據我們 3 年的數據集提交的。在我們與 EMEA 進行討論時，我們決定暫停該文件並包含我們 4.5 年的數據集。正如您從我們今天提供的並且已經公開的數據中看到的那樣，4.5 年的數據看起來非常顯著，並繼續支持疫苗的整體收益風險狀況。所以我們現在已經提交了這些數據，我們將進行討論，與歐盟進行持續的討論，我們希望得到 CHMP 的意見，並希望在今年晚些時候做出積極的決定。

(Operator Instructions) Next question, from Nomura Securities, Mr. Kohtani.

（操作員說明）下一個問題，來自野村證券，Kohtani 先生。

This is Kohtani from Nomura talking. Can you hear me?

這是野村的光谷先生在講話。你能聽到我嗎？

Yes, we can here you. Go ahead.

是的，我們可以在這里為您服務。前進。

I have 2 questions, if I may. One is about ENTYVIO. So when we look at the competitive landscape for IBD, it seems like there will be a lot of new entrants in the next 2 years. There's RINVOQ. I think there's SKYRIZI. You see the approval for Crohn's disease in June. And within the next 2 years, there will be SKYRIZI in ultra ulcerative colitis. I think mirikizumab from Lilly launching in ulcerative colitis, etrasimod from Pfizer.

如果可以的話，我有 2 個問題。一是關於ENTYVIO。因此，當我們審視 IBD 的競爭格局時，似乎未來 2 年會有很多新進入者。有 RINVOQ。我認為有 SKYRIZI。你會在六月看到克羅恩病的批准。並且在未來 2 年內，將有 SKYRIZI 用於治療超潰瘍性結腸炎。我認為禮來公司的 mirikizumab 用於潰瘍性結腸炎，輝瑞公司的 etrasimod。

So I understand that none of these drugs have really demonstrated a clear advantage over ENTYVIO. In terms of clinical remission or endoscopic remission or since that actually matter in IBD, I also understand that none of these new entrants are going to report head-to-head result versus Humira, like what ENTYVIO did with VARSITY trial.

所以我知道這些藥物都沒有真正表現出比 ENTYVIO 明顯的優勢。就臨床緩解或內窺鏡緩解而言，或者因為這在 IBD 中實際上很重要，我也明白這些新進入者都不會像 ENTYVIO 對 VARSITY 試驗所做的那樣報告與 Humira 的直接結果。

So we're relatively confident that ENTYVIO will maintain growth, but is Takeda worried about ENTYVIO growth possibly slowing down in the '23 to '24 time frame when VYVANSE is going off that? That's the first question.

因此，我們相對有信心 ENTYVIO 將保持增長，但武田是否擔心 ENTYVIO 的增長可能會在 23 至 24 年 VYVANSE 停止增長時放緩？這是第一個問題。

The second question is about the pipeline. Specifically, modakasfusp alfa and subasumstat because curiously, these -- both of these drugs involve interferon and very interesting. For modakasfusp alfa, there's a trial for combination therapy with KEYTRUDA in solid tumors, specifically melanoma. It says the trial ends in 2023 August. Since interferon's likely to strengthen PD-1 activity, if we see any ORR in primary PD-1-resistant melanoma wouldn't that be considered POC? Why isn't this listed on Page 10 or 11?

第二個問題是關於管道的。具體來說，modakasfusp alfa 和 subasumstat 因為奇怪的是，這兩種藥物都涉及乾擾素，非常有趣。對於 modakasfusp alfa，有一項與 KEYTRUDA 聯合治療實體瘤，特別是黑色素瘤的試驗。它說審判將於 2023 年 8 月結束。由於乾擾素可能會增強 PD-1 活性，如果我們在原發性 PD-1 抗性黑色素瘤中看到任何 ORR，那是否會被視為 POC？為什麼這沒有在第 10 頁或第 11 頁上列出？

For subasumstat, I assume you'll be seeing results in MSS-CRC first and then NSCLC and in cervical cancer later, I couldn't find much scientific evidence to corroborate the involvement of interferon specifically in MSS-CRC. How confident is Takeda in showing activity in this very difficult subset? Those are the 2 questions.

對於 subasumstat，我假設您將首先在 MSS-CRC 中看到結果，然後是 NSCLC，然後在宮頸癌中看到結果，我找不到太多科學證據來證實干擾素在 MSS-CRC 中的作用。武田在這個非常困難的子集中展示活動的信心如何？這是2個問題。

Thank you very much for the question. It's Christophe here. I think you know when the IBD market, I mean ENTYVIO has established a very strong track record of efficacy and safety since its launch more than 7 years ago. We have established also a superiority against TNF-alpha. And the TNF-alpha class still has a very significant market share, and this market, there's still a lot to do.

非常感謝您的提問。這裡是克里斯托夫。我想你知道 IBD 市場時，我的意思是 ENTYVIO 自 7 多年前推出以來已經建立了非常強大的療效和安全性記錄。我們還確立了對抗 TNF-α 的優勢。而且 TNF-alpha 類仍然具有非常重要的市場份額，而且這個市場還有很多工作要做。

And today, we have a leading therapy of choice for bio-naïve patients. So we are very much aware of the competition. It's a very dynamic market. It's -- but we believe that ENTYVIO is extremely well positioned. We have not seen a product which has any demonstration of superiority.

今天，我們為初生生物的患者提供了一種領先的治療選擇。所以我們非常了解競爭。這是一個非常活躍的市場。它是——但我們相信 ENTYVIO 處於非常有利的位置。我們還沒有看到有任何優越性的產品。

So yes, there will be more competition, but this is also a disease where there is a lot of churn among treatment, but still a lot to do to continue to establish the best standard of care, which is ENTYVIO today, when you think that the TNF-alpha class still has a very significant market share in this market.

所以是的，會有更多的競爭，但這也是一種治療中存在大量流失的疾病，但仍然需要做很多工作才能繼續建立最好的護理標準，即今天的 ENTYVIO，當你認為TNF-α類在這個市場上仍然佔有非常重要的市場份額。

So very confident about ENTYVIO. We also plan to launch a subcutaneous formulation in the U.S. in the coming years that will add more dynamic also to the product. So very confident about the continuous growth of ENTYVIO in the future.

所以對ENTYVIO非常有信心。我們還計劃在未來幾年在美國推出一種皮下配方，這也將為產品增添更多活力。所以對ENTYVIO未來的持續增長非常有信心。

And Kohtani-san, thank you very much for the questions about modakasfusp alfa and subasumstat And as you mentioned, these are both agents that work at least in part through an interferon alpha-based mechanism and are representative really of our oncology strategy to focus on innate immune mechanisms.

Kohtani-san，非常感謝您提出有關 modakasfusp alfa 和 subasumstat 的問題 正如您所提到的，這兩種藥物至少部分通過基於乾擾素 α 的機制起作用，並且真正代表了我們專注於腫瘤學的策略先天免疫機制。

Firstly, from modakasfusp alfa, our focus right now is really on melanoma, where we've seen very compelling evidence of clinical activity in highly refractory patients. And so our focus for modakasfusp is in building out that profile in refractory patients and also moving up in lines of therapy through combination therapies. And so we'll be starting over the course of the next few months combination [path], initially it's daratumumab and then with other agents.

首先，從 modakasfusp alfa 開始，我們現在的重點實際上是黑色素瘤，我們已經在高度難治性患者中看到了非常令人信服的臨床活動證據。因此，我們對 modakasfusp 的重點是在難治性患者中建立這種形象，並通過聯合療法提升治療線。因此，我們將在接下來的幾個月中開始組合 [路徑]，最初是 daratumumab，然後是其他藥物。

The studies that you're mentioning in solid tumors are still quite exploratory. We're still in the process of understanding dose safety profile. So we've been hesitant to define a date from when we might have POC because we're still working through a number of issues.

你提到的實體瘤研究仍然是探索性的。我們仍在了解劑量安全性概況。因此，我們一直在猶豫確定我們可能擁有 POC 的日期，因為我們仍在解決許多問題。

With respect to subasumstat, which is also a really exciting mechanism that works at least in part through interferon alpha signaling, and we published quite extensively on the translational data that we've seen in humans in terms of immune activation with this mechanism. Our challenge has been understanding where exactly to target into what tumor.

關於 subasumstat，這也是一個非常令人興奮的機制，至少部分通過乾擾素 α 信號傳導起作用，我們發表了相當廣泛的關於我們在人類中看到的關於這種機制的免疫激活的轉化數據。我們的挑戰一直是了解在哪裡精確定位到什麼腫瘤。

And so we're looking across a range of different tumor types. The 3 that are most actively enrolling right now are combination studies on top of PD-1 inhibitors. The first is in microsatellite stable colorectal cancer. We're also looking in non-small cell lung cancer and, of course, in melanoma.

因此，我們正在研究一系列不同的腫瘤類型。目前最活躍的 3 項是基於 PD-1 抑製劑的聯合研究。第一個是微衛星穩定的結直腸癌。我們也在研究非小細胞肺癌，當然還有黑色素瘤。

The first data set that we'll have readout will be in the microsatellite stable colorectal population. It's a incredibly challenging population to see benefits in. So we'll wait and see what that data set looks like. We actually had some partial responses in our Phase I, Phase II study, which is the -- you asked about rationale, well, that was the rationale for proceeding in that difficult population. I think our focus, given the biology we'll be more on the melanoma and non-small cell lung cancer populations.

我們將讀出的第一個數據集將是微衛星穩定的結直腸人群。這是一個極具挑戰性的人群，要從中受益。所以我們將拭目以待，看看該數據集是什麼樣子的。我們實際上在我們的第一階段、第二階段研究中得到了一些部分的回應，這是 - 你問的基本原理，嗯，這是在那個困難人群中進行的基本原理。我認為我們的重點是，考慮到生物學，我們將更多地關注黑色素瘤和非小細胞肺癌人群。

[Interpreted] Next is Georgi from Cowen.

[解釋] 接下來是來自 Cowen 的 Georgi。

So just a couple on our end. Maybe starting with the positive HYQVIA results in CIDP. Could you discuss the total opportunity and growth prospects in the immunoglobulins -- for immunoglobulins in the space, especially in light with CSL's subcu to (inaudible)? And just in general, how do you see the market being segmented and evolve over time?

所以我們這邊只有一對。也許從積極的 HYQVIA 開始會導致 CIDP。您能否討論一下免疫球蛋白的總體機會和增長前景——該領域的免疫球蛋白，尤其是考慮到 CSL 的 subcu to（聽不清）？總的來說，您如何看待市場隨著時間的推移被細分和演變？

And the second one is on the Arrowhead collaboration. We noticed that the Phase II placebo-controlled study results are expected sometime in the fall client according to clinicaltrials.gov. Do you expect to present these results at an academic conference? And can you just walk us through the next steps of -- towards regulatory filing and the opportunity here?

第二個是關於 Arrowhead 的合作。我們注意到，根據臨床試驗網站，預計秋季客戶的 II 期安慰劑對照研究結果將在某個時候出現。您是否希望在學術會議上展示這些結果？你能引導我們完成下一步的監管申報和這裡的機會嗎？

Thank you very much, Georgi. It's Christophe here. Look, the immunoglobulins are well known to treat CIDP. So this is not a new as such a treatment. But what is new in the case of HYQVIA is that it's one of the most convenient subcutaneous formulation. And we believe that, that will really help patients to -- with their treatment.

非常感謝，喬治。這裡是克里斯托夫。看，眾所周知，免疫球蛋白可以治療 CIDP。所以這並不是一種新的治療方法。但 HYQVIA 的新特點是它是最方便的皮下製劑之一。我們相信，這將真正幫助患者進行治療。

And we don't have the indication of CIDP in the U.S. We don't have it for our IV as well as for our subcu. We believe that nevertheless, our products are used, but we never have the indication. So I think it's really great for us, first, to be able to have this -- to file this indication for HYQVIA. And again, HYQVIA is a very competitive device and a very competitive formulation, very convenient for patients.

而且我們在美國沒有 CIDP 的跡象。我們的 IV 和 subcu 都沒有。我們相信，儘管如此，我們的產品被使用了，但我們從來沒有跡象。所以我認為這對我們來說真的很棒，首先，能夠擁有這個——為 HYQVIA 提交這個指示。再次強調，HYQVIA 是一種非常有競爭力的設備和非常有競爭力的配方，對患者來說非常方便。

So we think that the efficacy combined with this convenience will be a big add and a big plus for the patients. The CIDP indication overall, let me remind you that overall, the CIDP indication represents about 20% of the overall immunoglobulin market globally.

所以我們認為這種功效與這種便利性相結合，對患者來說將是一個很大的加分項和加分項。總體而言，CIDP 適應症，讓我提醒您，總體而言，CIDP 適應症約佔全球免疫球蛋白市場整體的 20%。

And on the -- this is Andy, Georgi-san. On the Arrowhead TAK-999 question, so just again to remind you, just the data that we've seen so far in the open-label study -- ongoing open-label study has been just so remarkable in terms of the percent knockdown. We're seeing 90% knockdown of the mutant alpha-1 antitrypsin RNA. We're seeing almost 85% knockdown of the mutant protein aggregate. We're seeing trends towards reductions in liver function tests.

還有——這是安迪，喬治桑。關於箭頭 TAK-999 的問題，再次提醒您，僅我們目前在開放標籤研究中看到的數據——正在進行的開放標籤研究在擊倒百分比方面非常顯著。我們看到 90% 的突變 alpha-1 抗胰蛋白酶 RNA 被敲低。我們看到幾乎 85% 的突變蛋白聚集體被擊倒。我們看到了肝功能測試減少的趨勢。

And on biopsy, again, noncontrolled setting, but we're seeing actually a regression in fibrosis over a very short time period of 24 and 48 weeks. And so the data that we've seen to date are compelling enough to drive a go decision for a pivotal study.

在活檢中，同樣是不受控制的環境，但我們實際上在 24 和 48 週的非常短的時間內看到了纖維化的消退。因此，我們迄今為止所看到的數據足以推動一項關鍵研究的實施決策。

The placebo-controlled blinded Phase II data that will be coming out later this year, of course, those data will be presented at the Congress. But it's important to note that those -- that study is being run by our collaborator, Arrowhead, so they will be responsible for that presentation.

安慰劑對照的盲法 II 期數據將於今年晚些時候公佈，當然，這些數據將在大會上公佈。但重要的是要注意那些 - 該研究由我們的合作者 Arrowhead 進行，因此他們將負責該演示。

I think that data set will be important in helping us further understand the overall profile of the molecule. But we believe based on the data that we've seen so far that we have enough compelling evidence to move forward.

我認為該數據集對於幫助我們進一步了解分子的整體概況非常重要。但我們相信，根據我們迄今為止所看到的數據，我們有足夠的令人信服的證據來繼續前進。

We strongly believe that we're going to need a full Phase III study to -- for approval. And -- well, our hope is that we'll be starting that Phase III study this year. The specific end points for that study, we're in the process of discussing those with FDA and other agencies.

我們堅信，我們將需要一項完整的 III 期研究來獲得批准。而且 - 好吧，我們希望我們將在今年開始第三階段的研究。該研究的具體終點，我們正在與 FDA 和其他機構討論這些終點。

Very helpful, and congratulations on the progress.

非常有幫助，祝賀你取得了進展。

[Interpreted] The next question, from JPMorgan Securities, Mr. Wakao.

【解讀】下一個問題，來自摩根大通證券Wakao先生。

Wakao from JPMorgan. My first question is about PDT business and the cost structure. Compared to the fourth quarter, this first quarter cost has improved and you showed the donor fee lowered. And when do you expect the result of lower donor fee impacting positively on cost? And this donor fee -- lower donor fee, is that incorporated into your guidance for the year?

摩根大通的 Wakao。我的第一個問題是關於 PDT 業務和成本結構。與第四季度相比，第一季度的成本有所改善，您表示捐贈者費用有所降低。您預計何時降低捐助者費用會對成本產生積極影響？這個捐贈者費用——較低的捐贈者費用，是否包含在你今年的指導中？

And the second question is regarding SG&A. The first quarter SG&A, in spite of cheaper yen is well controlled. That's my impression. I'm aware you are not specifically disclosing SG&A. But can you comment of the current situation against your plan. And there could be some negative impact from yen depreciation going forward. But do you think the first quarter trend in SG&A will continue to the second quarter?

第二個問題是關於 SG&A。第一季度SG&A，儘管日元便宜，但控制得很好。這就是我的印象。我知道您沒有具體披露 SG&A。但是，您能否針對您的計劃發表評論。未來日元貶值可能會產生一些負面影響。但是您認為SG&A一季度的趨勢會持續到二季度嗎？

Thank you very much, Wakao-san, for your question. Now on the first one, on the PDT reduction, and we firstly don't disclose margins, but what I can say is that the reduction in the donor fees has been factored into our full year guidance. So that's one thing.

非常感謝 Wakao 先生的提問。現在是第一個，關於 PDT 的減少，我們首先不披露利潤，但我可以說的是，捐助者費用的減少已納入我們的全年指導。所以這是一回事。

On the SG&A controls, you're right. On the -- we have -- we're seeing a reduction in overall SG&A, predominantly driven by the investments that we've done in the past and currently on data, digital and technology in respect to sales and marketing, where we're leveraging data digital technology, in particular, around omnichannel, targeting with physicians, et cetera.

在 SG&A 控制上，您是對的。在 - 我們已經 - 我們看到整體 SG&A 的減少，主要是由於我們過去所做的投資以及目前在銷售和營銷方面的數據、數字和技術方面的投資，我們在這些方面利用數據數字技術，特別是圍繞全渠道、針對醫生等。

And on the G&A side, we're seeing some significant savings coming through, again, leveraging data digital technology, automation and leveraging our Takeda business solution centers where we are increasing a number of back-office transactional activity, in particular around HR, procurement and finance, and that's helping overall improved productivity and efficiency. So we're very pleased with the progress there, and we'll continue to manage this moving forward.

在 G&A 方面，我們再次看到通過利用數據數字技術、自動化和利用我們的武田業務解決方案中心，我們正在增加一些後台交易活動，特別是在人力資源、採購方面，節省了大量資金和金融，這有助於整體提高生產力和效率。因此，我們對那裡的進展感到非常滿意，我們將繼續管理這一進展。

[Interpreted] Next question, Daiwa Securities, Hashiguchi-san.

[解釋] 下一個問題，大和證券，橋口先生。

[Interpreted] This is Hashiguchi. I have one question. Regarding your COVID-19 vaccine sales, I understand that the full year forecast is JPY 50 billion. And what is the revenue in the first quarter? And the latest forecast, do you think that it's likely that you'll be exceeding JPY 50 billion?

[解釋] 這是橋口。我有一個問題。關於你們的 COVID-19 疫苗銷售額，我了解全年預測為 500 億日元。第一季度的收入是多少？而最新的預測，你認為你有可能超過500億日元嗎？

Thank you very much Hashiguchi-san. It's Costa here. Revenue for the first quarter was JPY 19.4 billion, which is a combination of both [Spikevax] and Nuvaxovid.

非常感謝橋口同學。這裡是科斯塔。第一季度的收入為 194 億日元，是 [Spikevax] 和 Nuvaxovid 的組合。

At this stage, we're holding on the target of the JPY 50 billion. So no further update at this stage, but we're very happy with the start of the fiscal year. So that's where we're tracking JPY 19.4 billion for Q1, and we're maintaining the guidance of JPY 50 billion for the full year.

在這個階段，我們保持著 500 億日元的目標。因此，現階段沒有進一步的更新，但我們對本財年的開始感到非常滿意。這就是我們追踪第一季度 194 億日元的地方，我們維持全年 500 億日元的指導。

[Interpreted] Next question, from Credit Suisse Securities, Mr. Sakai.

[解釋]下一個問題，來自瑞士信貸證券，酒井先生。

This is Sakai speaking from Credit Suisse. So 2 questions. The trend of the LIVTENCITY and EXKIVITY, the first quarter seems to be little bit lower than, well, actually our expectations. And when we're going to see the spike in the sales trend going forward?

這是來自瑞士信貸的Sakai。所以2個問題。 LIVTENCITY 和 EXKIVITY 的趨勢，第一季度似乎有點低於我們的預期。什麼時候我們會看到未來銷售趨勢的飆升？

Now you mentioned about important [fast-track] indications for both drugs, but that's [3] year away. So what's going to be the trigger for the spike in the share -- I mean the sales trend for these 2 important -- supports the important new products? That's the first question.

現在您提到了這兩種藥物的重要 [快速通道] 適應症，但那是 [3] 年之後的事。那麼，什麼是導致份額飆升的觸發因素——我的意思是這兩個重要的銷售趨勢——支持重要的新產品？這是第一個問題。

And second question is, TAK-861, I -- if I'm not mistaken, you are going to have the internal leader of the Phase I data sometime in August. And once you find any new -- well, if it's a good result or a bad result, what do you plan to disclose the outcome of this early bid-out? That's my 2 questions.

第二個問題是，TAK-861，我——如果我沒記錯的話，你將在 8 月的某個時候擁有第一階段數據的內部負責人。一旦你發現任何新的——好吧，如果它是一個好的結果或一個壞的結果，你打算透露這個提前出價的結果？這是我的2個問題。

Thank you, Sakai-san. It's Christophe here. So I think we are not disappointed at all by the Q1 actually. We are very pleased with the update, but you need to -- when you launch a product like LIVTENCITY, first, you need to have the product reference in the different transplant center. I think we have achieved that very well.

謝謝你，坂井同學。這裡是克里斯托夫。所以我認為我們實際上對第一季度並不感到失望。我們對更新非常滿意，但您需要 -- 當您推出像 LIVTENCITY 這樣的產品時，首先，您需要在不同的移植中心擁有產品參考。我認為我們已經很好地做到了這一點。

The majority of the transplant center are now have reference LIVTENCITY, and 56% of the 314 transplant centers in the U.S. have already used it. So it will take a while to translate that into revenue, but it will happen.

大多數移植中心現在都有參考 LIVTENCITY，美國 314 個移植中心中有 56% 已經使用它。因此，將其轉化為收入需要一段時間，但它會發生。

And then, of course, the first line is a key here, the majority of the value will be in the first-line indication. So we'll see it starting next year and the year after. So that's LIVTENCITY.

然後，當然，第一行是這裡的關鍵，大部分值將在第一行指示中。因此，我們將從明年和後年開始看到它。這就是活力。

And keep in mind also that LIVTENCITY overall potential, revenue potential is higher than EXKIVITY as well. And on EXKIVITY, it's also -- the first line is also very critical. The first-line indication is also very critical. This is where there is the highest market value.

請記住，LIVTENCITY 的整體潛力，收入潛力也高於 EXKIVITY。在 EXKIVITY 上，第一行也非常關鍵。一線適應症也很關鍵。這是市場價值最高的地方。

So I think this product will be successful. The early signs are very strong that these 2 product will be very successful. We just need to have the full set of indication to translate that into revenue potential.

所以我認為這個產品會成功。早期跡象非常強烈，這兩種產品將非常成功。我們只需要有完整的指示將其轉化為收入潛力。

And Sakai-san, on TAK-861, just to be clear, and I'm sorry if there was a misunderstanding. We will not have a data set that will enable us to make a decision, a go-no-go decision in August. What we've disclosed is that we'll have a decision, a go-no-go decision by the end of this year. So just so that we're clear in terms of time lines.

還有堺先生，關於 TAK-861，為了清楚起見，如果有誤會，我很抱歉。我們將沒有一個數據集可以讓我們在 8 月份做出決定，一個不通過的決定。我們透露的是，我們將在今年年底之前做出決定，一個不通過的決定。所以只是為了讓我們在時間線方面很清楚。

So end of this year, that's what you're saying right now?

所以今年年底，這就是你現在所說的？

That's right. And that's, I think, what we've been guiding all along. Nothing's changed since we have -- since we made the transition from 994 to 861 in terms of our acceleration. And the data set that will enable this trend, this decision will be healthy volunteer sleep-deprived data and then also Type 1 narcolepsy patients treated for a month. So we're in the process of accumulating that blinded data set now.

這是正確的。我認為，這就是我們一直以來的指導。自從我們在加速方面從 994 過渡到 861 以來，一切都沒有改變。而能夠促成這一趨勢的數據集，將是健康志願者睡眠剝奪數據以及治療一個月的 1 型發作性睡病患者的數據。所以我們現在正在積累那個盲目的數據集。

[Interpreted] Next is Goldman Sachs, Ueda-san.

[解釋]接下來是高盛，上田先生。

I have one question. The question for the narcolepsy franchise. The company decided the discontinuation of the development TAK-994 based on the clinical data. So could you share your thoughts on the factors behind the development suspension for TAK-994? And whether you think those factors will affect the safety profile of TAK-861?

我有一個問題。嗜睡症專營權的問題。公司根據臨床數據決定停止開發TAK-994。那麼您能否分享您對 TAK-994 開發暫停背後的因素的看法？您是否認為這些因素會影響 TAK-861 的安全性？

Thank you very much. So we discontinued TAK-994 because of drug-induced liver injury signal that we don't believe is class-related or mechanism-based but molecule-related.

非常感謝。因此，我們停止了 TAK-994，因為我們不認為藥物誘導的肝損傷信號與類別相關或基於機制但與分子相關。

TAK-861 is a unique molecule with a very different profile to TAK-994. It's a much more potent molecule, and it has a very different exposure profile. So part of what we're doing in the context of our Phase I studies is we're trying to understand what's the overall profile of TAK-861, and whether it's going to have an efficacy and safety profile that's going to be distinct from TAK-994? And that will be what will drive the Go/No Go decision into Phase II.

TAK-861 是一種獨特的分子，其特徵與 TAK-994 截然不同。它是一種更有效的分子，並且具有非常不同的暴露特徵。因此，在 I 期研究的背景下，我們正在做的部分工作是試圖了解 TAK-861 的總體概況，以及它是否會具有與 TAK 不同的功效和安全性概況-994？這將推動 Go/No Go 決策進入第二階段。

[Interpreted] Thank you very much. It's time to close. So with this, we'd like to close today's webinar. Thank you very much for your participation. And when you have further questions, please contact IR members regarding the financial situation.

[解釋] 非常感謝。是時候關閉了。因此，我們想結束今天的網絡研討會。非常感謝您的參與。如果您還有其他問題，請聯繫 IR 成員了解財務狀況。

Thank you very much for your participation today. With this we disclose today's conference call. Thank you.

非常感謝您今天的參與。有了這個，我們公開了今天的電話會議。謝謝你。

Thanks everyone. Bye for now.

感謝大家。暫時再見。

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

[此成績單中標記為 [已翻譯] 的部分由現場通話中的口譯員朗讀。]