Takeda Pharmaceutical Co Ltd (TAK) 2025 Q1 法說會逐字稿

(interpreted) Thank you very much for taking time out of your very busy schedule to join us for this first quarter earnings call by Takeda for FY24. I'm the master of ceremony today. My name is O'Reilly from IR, I'm the Head of IR.

（解釋）非常感謝您在百忙之中抽空參加我們召開的武田 2024 財年第一季財報電話會議。我是今天的司儀。我叫 IR 的 O'Reilly，是 IR 的主管。

I would like to explain the language setting first. Please find the language button at the bottom on the Zoom window. If you wish to listen in Japanese, please select the Japanese; if English, please select the English. If you want to listen to the original, please turn them off.

我想先解釋一下語言設定。請在“縮放”視窗底部找到語言按鈕。如果您想聽日語，請選擇日語；如果是英文，請選擇英文。如果您想聽原版，請關閉它們。

Before starting, I would like to remind everyone that we'll be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in the most recent Form 20-F and in our other SEC filings.

在開始之前，我想提醒大家，我們將討論 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。實際結果可能與今天討論的結果大不相同。可能導致我們的實際結果出現重大差異的因素在最新的 20-F 表格和我們的其他 SEC 文件中進行了討論。

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

另請參閱簡報第 2 頁上有關前瞻性陳述和我們的非 IFRS 最終措施的重要通知，這些內容也將在本次電話會議中進行討論。我們的非國際財務報告準則措施的定義及其與可比較國際財務報告準則財務措施的調整表包含在簡報的附錄中。

Now without further ado, we would like to move on to the presentation of the day, which will be given by Christophe Weber, President and CEO; Milano Furuta, Chief Financial Officer; and Andy Plump, R&D President. Following the presentations, we have the time for Q&A. Now let us begin.

現在，閒話少說，我們想進入當天的演講，由總裁兼執行長 Christophe Weber 進行； Milano Furuta，財務長；和研發總裁 Andy Plump。演講結束後，我們有時間進行問答。現在讓我們開始吧。

Christophe, over to you.

克里斯托夫，交給你了。

Thank you, Chris and thank you, everyone, for joining us today. It's a pleasure to be with you all.

謝謝克里斯，謝謝大家今天加入我們。很高興和大家在一起。

Overall, we had a very positive start to fiscal year 2024. In the first three months, revenue grew 2.1% at constant exchange rate. Performance was driven by the continued strong momentum of our Growth & Launch products, which grew 17.8% at constant exchange rate, and they now represent 46% of our total revenue.

整體而言，我們 2024 財年有一個非常積極的開始。前三個月，以固定匯率計算，營收成長2.1%。業績是由我們的成長和推出產品持續強勁的勢頭推動的，按固定匯率計算，這些產品增長了 17.8%，目前占我們總收入的 46%。

ENTYVIO growth has started to accelerate since last quarter with the launch of ENTYVIO Pen in the US. Still early days as we are getting full access coverage but encouraging. We also saw robust growth of our immunoglobulin portfolio, TAKHZYRO, QDENGA and FRUZAQLA. We are also managing actively the life cycle of our Growth & Launch portfolio. In Q1, we further expanded our main product geographic reach with approval of LIVTENCITY in Japan and FRUZAQLA in Europe.

自上個季度以來，隨著 ENTYVIO Pen 在美國的推出，ENTYVIO 的成長開始加速。雖然我們正在獲得全面的訪問覆蓋，但仍處於早期階段，但令人鼓舞。我們也看到我們的免疫球蛋白產品組合 TAKHZYRO、QDENGA 和 FRUZAQLA 的強勁成長。我們也積極管理我們的成長和發布產品組合的生命週期。第一季度，我們進一步擴大了主要產品的地域覆蓋範圍，並獲得了日本 LIVTENCITY 和歐洲 FRUZAQLA 的批准。

In the first quarter of the fiscal year, our core operating profit margin was at 31.6%, benefiting from phasing of R&D investment, reduction in other OpEx and temporarily lower-than-anticipated generic erosion of VYVANSE in the US. Over the remainder of the fiscal year, we expect multiple pipeline programs to progress into Phase 3, and we are awaiting our R&D investment towards future quarter accordingly. We also expect VYVANSE generic erosion to come back in line with projection.

本財年第一季度，我們的核心營業利潤率為 31.6%，受益於研發投資的分階段、其他營運支出的減少以及美國 VYVANSE 仿製藥侵蝕暫時低於預期。在本財年剩餘時間內，我們預計多個管道專案將進入第三階段，我們正在相應地等待未來季度的研發投資。我們也預計 VYVANSE 通用侵蝕將恢復與預測一致。

We continue to be very focused on improving our core operating profit margin through our multiyear efficiency program. This program is focused on three areas of opportunity: increasing organizational agility, improving procurement savings and strengthening how we leverage data, digital and technology across Takeda. Our progress on this program is on track. In Q1, we took concrete steps to improve organizational agility, for example, in R&D and in our US commercial organization.

我們繼續非常注重透過多年效率計劃來提高我們的核心營業利潤率。該計劃重點關註三個機會領域：提高組織敏捷性、改善採購節省以及加強我們在整個武田利用數據、數位和技術的方式。我們在該計劃上的進展已步入正軌。在第一季度，我們採取了具體措施來提高組織敏捷性，例如在研發和美國商業組織中。

We also identified and executed new procurement-led efficiencies. For example, we have been using data, technology and AI to optimize our supplier selection process. We believe that our investment in data, technology and AI will yield productivity and efficiency gain across our value chain. For example, in manufacturing and quality, our goal is to accelerate the release of drug batch, which will improve our working capital and our ability to supply it.

我們也確定並執行了新的採購主導的效率。例如，我們一直在使用數據、技術和人工智慧來優化我們的供應商選擇流程。我們相信，我們對數據、技術和人工智慧的投資將為我們整個價值鏈帶來生產力和效率提升。例如，在製造和品質方面，我們的目標是加快藥品批次的發布，這將改善我們的營運資金和供應能力。

We also took steps to further enrich our pipeline. We signed two option agreements for mid- and late-stage programs: one with Ascentage for olverembatinib for chronic myeloid leukemia and other hematological concerns; the other with AC Immune for ACI-24.060, an active immunotherapy designed to delay or slow Alzheimer's disease progression. Agreements such as these complement our existing pipeline and portfolio and all promise for enriching our pipeline in the future.

我們也採取措施進一步豐富我們的產品線。我們簽署了兩項中期和後期計畫的選擇協議：一項是與Ascentage 合作開發olverembatinib，用於治療慢性粒細胞白血病和其他血液學問題；另一項是與Ascentage 合作開發olverembatinib，用於治療慢性粒細胞白血病和其他血液學問題；另一個是針對 ACI-24.060 的 AC Immune，這是一種主動免疫療法，旨在延遲或減緩阿茲海默症的進展。此類協議補充了我們現有的產品線和產品組合，並承諾豐富我們未來的產品線。

We also made notable advancements in our organic pipeline, too, and Andy will discuss this in more depth in his presentation. In closing, we are very pleased with the progress we made in this first quarter, which reinforced our ability to deliver on our mission to transform the life of patients while driving long-term business growth and profitability.

我們在有機管道方面也取得了顯著的進步，安迪將在他的演講中更深入地討論這一點。最後，我們對第一季的進展感到非常滿意，這增強了我們履行改變患者生活的使命的能力，同時推動長期業務成長和獲利能力。

I will now hand over to Milano to discuss our financial results. Thank you.

我現在將請米蘭討論我們的財務表現。謝謝。

Thank you, Christophe, and hello, everyone. This is Milano Furuta speaking.

謝謝你，克里斯托夫，大家好。我是米蘭諾古田。

And slide 6 summarizes our Q1 financial results. Revenue was just over JPY1.2 trillion, an increase of 14.1% or 2.1% at constant exchange rate, we call it CER. Top line performance of CER was driven by our Growth & Launch Products with some upside from milder-than-anticipated VYVANSE generic erosion.

第 6 投影片總結了我們第一季的財務表現。營收略高於 1.2 兆日元，成長 14.1%，以固定匯率（我們稱之為 CER）計算成長 2.1%。CER 的營收表現是由我們的成長和推出產品所推動的，其中一些上漲來自於比預期溫和的 VYVANSE 仿製藥侵蝕。

Core operating profit, or core OP, was at JPY382.3 billion, a year-on-year increase of 17.1% or 4.5% at CER. This core OP growth benefited from phasing of R&D investments, which we expect to be weighted more heavily in the remainder of the year. Reported operating profit was JPY166.3 billion, a decline of 1.3%, including the impact of restructuring expenses for the cost efficiency program and the impairment of soticlestat after the Phase 3 study readouts.

核心營業利潤（核心OP）為3,823億日元，較去年同期成長17.1%，以固定匯率計算成長4.5%。這項核心營運成本的成長得益於分階段的研發投資，我們預期研發投資將在今年剩餘時間內得到更大的重視。報告營業利潤為 1,663 億日元，下降 1.3%，其中包括成本效率計劃重組費用的影響以及第三階段研究結果後 soticlestat 的減值。

Core EPS and reported EPS were JPY176 and JPY61, respectively. Operating cash flow was JPY170.3 billion, primarily driven by core OP improvements. And adjusted free cash flow was JPY23.7 billion, reflecting almost JPY100 billion of business development activity in Q1 and including the in-licensing of rusfertide from Protagonist and our option agreement with AC Immune. Please note that we have introduced the term adjusted free cash flow in fiscal year '24, but the calculation is exactly the same as we used for free cash flow in our presentations last year.

核心每股盈餘和報告每股盈餘分別為 176 日圓和 61 日圓。營運現金流為 1,703 億日元，主要由核心營運改善推動。調整後的自由現金流為 237 億日元，反映第一季近 1000 億日圓的業務開發活動，包括 Protagonist 的 rusfertide 許可以及我們與 AC Immune 的選擇權協議。請注意，我們在 24 財年引入了調整後自由現金流這一術語，但計算方法與我們去年演示中用於自由現金流的計算完全相同。

Let's look at the year-on-year revenue dynamics on slide 7. Takeda's Growth & Launch Products grew 17.8% at CER in Q1, more than offsetting the loss of exclusivity impact such as VYVANSE in the US and AZILVA in Japan. Additionally, net positive growth in other brands contributed to 2.1% revenue growth at CER. The depreciation of the yen versus major currencies was an additional revenue tailwind of JPY127.2 billion, resulting in a 14.1% growth on actual FX basis.

讓我們看看幻燈片 7 上的年比收入動態。武田的成長和推出產品第一季以固定匯率計算成長了 17.8%，遠遠抵消了美國 VYVANSE 和日本 AZILVA 等獨家影響力的損失。此外，其他品牌的淨正成長推動 CER 營收成長 2.1%。日圓兌主要貨幣貶值帶來了 1,272 億日圓的額外收入推動力，導致實際匯率增加 14.1%。

Takeda has a balanced portfolio across 6 key business areas, which are all growing, except neuroscience due to VYVANSE LOE. These are driven by Growth & Launch Products, as Christophe said, which now represent 46% of total revenue and is now growing at 17.8% at CER. All of these products performed broadly in line with expectations in Q1. ENTYVIO growth was 7.6% at CER. We have seen an uptick from the prior quarter supported by the launch of ENTYVIO Pen in the US. As of July, 2 out of 3 patients have an access to ENTYVIO Pen based on US health plan adoption. We expect growth to further accelerate this year with expansion of access.

武田在 6 個關鍵業務領域擁有均衡的投資組合，除 VYVANSE LOE 帶來的神經科學外，這些業務領域均在成長。正如 Christophe 所說，這些都是由成長和推出產品推動的，這些產品目前佔總收入的 46%，並且按固定匯率計算，成長率為 17.8%。所有這些產品第一季的表現基本上符合預期。以固定匯率計算，ENTYVIO 的成長率為 7.6%。我們看到，由於 ENTYVIO Pen 在美國推出，銷量較上一季有所上升。截至 7 月，根據美國健康計劃的採用，三分之二的患者可以使用 ENTYVIO Pen。我們預計，隨著准入範圍的擴大，今年的成長將進一步加速。

TAKHZYRO continues to have a strong momentum with growth of 19.8% of CER. It is capitalizing its leading position in the expanding prophylaxis market in HAE. Within PDT, immunoglobulin grew 21.9%, while albumin declined 14.2% due to anticipated phasing of supply to China. We expect albumin revenue to recover and reaffirm the full-year forecast to single-digit growth at CER.

TAKHZYRO 繼續保持強勁勢頭，以固定匯率計算成長 19.8%。它正在利用其在不斷擴大的 HAE 預防市場中的領先地位。在PDT中，免疫球蛋白增加了21.9%，而白蛋白則因預期分階段向中國供應而下降了14.2%。我們預計白蛋白收入將恢復，並重申全年預測以固定匯率計算將達到個位數成長。

We are happy to see the first launch uptake of FRUZAQLA and QDENGA. For FRUZAQLA, it is still early days, but the first quarter sales are slightly better than we expected with revenue of JPY11.9 million. We expect momentum to continue with EU approval in June and approval in Japan anticipated soon.

我們很高興看到 FRUZAQLA 和 QDENGA 的首次推出。對於 FRUZAQLA 來說，現在還處於早期階段，但第一季的銷售額略好於我們的預期，營收為 1,190 萬日圓。我們預計歐盟將在 6 月獲得批准，日本也將很快獲得批准，這一勢頭將持續下去。

QDENGA, our dengue vaccine, is now available in 21 countries. We see strong demand in both endemic and non-endemic markets. Recently, the WHO added QDENGA to their list of pre-qualified vaccines; and Gavi, the Vaccine Alliance, approved its support for our dengue vaccine program. These acknowledgments should drive further awareness and access for QDENGA going forward.

我們的登革熱疫苗 QDENGA 現已在 21 個國家上市。我們看到地方性和非地方性市場的需求強勁。最近，世界衛生組織將 QDENGA 加入其資格預審疫苗清單中；全球疫苗和免疫聯盟 (Gavi) 批准支持我們的登革熱疫苗計劃。這些致謝應該會進一步推動 QDENGA 的認知和使用。

Slide 9 shows the year-on-year bridge for core operating profit. You can see how LOE had a proportionally larger impact on profit than revenue due to the high gross margin of products like VYVANSE and AZILVA. In Q1, this was offset by phasing of expenses, particularly in R&D. R&D investment in Q1 decreased by 7.7% at CER, but we still expect a modest increase for the full year as multiple programs move into Phase 3 in the coming months.

幻燈片 9 顯示了核心營業利潤的同比橋樑。您可以看到，由於 VYVANSE 和 AZILVA 等產品的毛利率較高，LOE 對利潤的影響比對收入的影響更大。第一季度，這被分階段支出（尤其是研發支出）所抵銷。以固定匯率計算，第一季的研發投資下降了 7.7%，但我們仍預計全年研發投資將小幅成長，因為未來幾個月多個專案將進入第三階段。

In other OpEx, we saw a decline versus prior year benefiting from initiatives, including the rationalization of real estate we executed last year. The cost efficiency program that we announced in May is also progressing on track. We expect savings from this program will ramp up in coming quarters.

在其他營運支出方面，我們看到與去年相比有所下降，這得益於我們去年執行的房地產合理化等措施。我們五月宣布的成本效率計劃也正在按計劃進行。我們預計該計劃的節省將在未來幾季增加。

When it comes to reported operating profit, higher impairment of intangibles, mostly for soticlestat, and higher restructuring costs associated with efficiency program more than offset the core OP growth. Restructuring costs in Q1 totaled JPY40.9 billion, tracking in line with our expectations for the full year. Also, in Q1, we booked a legal provision in other expenses according to our agreement in principle to resolve US product liability litigation related to Prevacid and Dexilant. The full year FY24 outlook is unchanged from what we provided in May.

就報告的營業利潤而言，無形資產減損的增加（主要是針對 soticlestat）以及與效率計劃相關的更高的重組成本遠遠抵消了核心營業利潤的增長。第一季重組成本總計 409 億日元，符合我們對全年的預期。此外，在第一季度，我們根據原則協議在其他費用中計入了法律準備金，以解決與 Prevacid 和 Dexilant 相關的美國產品責任訴訟。2024 財年全年展望與我們 5 月提供的展望相同。

We will continue to monitor the VYVANSE generic erosion alongside performance of the rest of our portfolio and FX rates. We will provide an update at the Q2 earnings in October. A brief update on the financing activities. In June, we issued a new hybrid bond of JPY460 billion. All the proceeds will go towards refinancing the JPY500 billion of hybrid bonds from 2019 that we will call in October 2024. The balance of JPY40 billion will be refinanced with hybrid-backed loans, which will come into effect on the call date.

我們將繼續監控 VYVANSE 的一般侵蝕以及我們其他投資組合的表現和匯率。我們將在 10 月提供第二季收益的最新資訊。融資活動的簡要更新。6月，我們發行了4,600億日圓的新混合債券。所有收益將用於為 2019 年起的 5,000 億日圓混合債券進行再融資，我們將於 2024 年 10 月發行該債券。400 億日圓的餘額將透過混合支持貸款進行再融資，該貸款將於贖回日生效。

In July, we executed USD3 billion of debt financing. We used this to prepay USD1.5 billion of bonds maturing in 2026 and to pay down another USD1.5 billion of outstanding commercial paper. I just want to clarify, as all these are refinancing activities, they are leverage neutral, and they have smoothed out our debt maturity ladder, as you can see. We maintained 100% of our debt at a fixed interest rate, and the weighted average cost is now approximately at 2%.

7月份，我們執行了30億美元的債務融資。我們用這筆資金預付了 2026 年到期的 15 億美元債券，並償還了另外 15 億美元的未償商業票據。我只是想澄清一下，因為所有這些都是再融資活動，它們是槓桿中性的，並且它們已經平滑了我們的債務期限階梯，正如你所看到的。我們將 100% 的債務維持在固定利率，加權平均成本現在約為 2%。

Thank you for your attention, and I'll now pass over to Andy.

感謝您的關注，我現在請安迪發言。

Thank you very much, Milano. Hello to everybody on today's call.

非常感謝你，米蘭。今天電話會議的大家好。

So if we go to the next slide, please, Chris. Thank you. We start with soticlestat, which recently completed Phase 3 trials in two indications: Lennox-Gastaut and Dravet syndrome. As previously communicated, soticlestat failed to demonstrate clinical benefit in Lennox-Gastaut. Soticlestat also failed to meet its primary endpoint in the Dravet syndrome Phase 3 trial, narrowly missing with a p-value of 0.06.

克里斯，請讓我們轉到下一張投影片。謝謝。我們從 soticlestat 開始，它最近完成了兩種適應症的 3 期試驗：Lennox-Gastaut 和 Dravet 症候群。正如之前所傳達的，soticlestat 未能在 Lennox-Gastaut 中證明臨床益處。Soticlestat 在 Dravet 症候群 3 期試驗中也未能達到其主要終點，p 值為 0.06，僅差一點。

However, the totality of data from this study with meaningful effects on key secondary endpoints, combined with the highly significant results from the large Phase 2 study, suggest clear clinical benefits for soticlestat in Dravet patients with a differentiated safety profile. Given the large unmet medical need in Dravet, we are investigating a potential regulatory path forward.

然而，本研究的全部數據對關鍵次要終點具有有意義的影響，再加上大型 2 期研究的高度顯著結果，顯示 soticlestat 對 Dravet 患者俱有明顯的臨床益處，且安全性差異顯著。鑑於 Dravet 存在大量未滿足的醫療需求，我們正在研究潛在的監管路徑。

This quarter, we had important Phase 2b data presented for TAK-861 and mezagitamab that we will describe later in the presentation. FRUZAQLA and LIVTENCITY had additional approvals that expand their geographic reach. Maralixibat was filed in Japan for Alagille syndrome and progressive familial intrahepatic cholestasis.

本季度，我們提供了 TAK-861 和 mezagitamab 的重要 2b 期數據，我們將在稍後的演示中進行描述。FRUZAQLA 和 LIVTENCITY 獲得了額外的批准，擴大了其地理覆蓋範圍。Maralixibat 在日本申請用於治療 Alagille 症候群和進行性家族性肝內膽汁淤積。

In addition, we continue to expand the depth and breadth of our pipeline by signing two option deals, as Christophe mentioned, for mid- and late-stage programs. From percentage Ascentage Pharma, olverembatinib is a third-generation PCR-able tyrosine kinase inhibitor to treat CML and other hematological malignancies. From AC Immune, ACI-24.060 is an active immunotherapy aimed at slowing Alzheimer's disease by targeting toxic amyloid beta. Building on the optionality we have gained with these two deals, let's now turn our attention to the overall momentum we are generating in our pipeline. Next slide, please.

此外，正如克里斯托夫所提到的，我們透過簽署兩項針對中期和後期項目的選擇權協議，繼續擴大我們管道的深度和廣度。olverembatinib是亞盛製藥的第三代PCR酪胺酸激酶抑制劑，用於治療CML和其他血液惡性腫瘤。AC Immune 的 ACI-24.060 是一種主動免疫療法，旨在透過靶向有毒的澱粉樣蛋白 β 來減緩阿茲海默症。基於我們透過這兩筆交易獲得的選擇性，現在讓我們將注意力轉向我們在管道中產生的整體動力。請下一張投影片。

Our rich R&D pipeline continues to advance with two significant opportunities: zasocitinib, our selective TYK2 inhibitor; and TAK-861, our orexin 2 receptor agonist, both poised to deliver near-term Phase 3 readouts. Zasocitinib has the potential to be the leading oral treatment for patients with moderate to severe plaque psoriasis, addressing a significant unmet medical need for patients seeking clear skin. The Phase 3 trials are enrolling rapidly, and we expect to complete enrollment in fiscal year 2024. TAK-861 is also advancing rapidly as we have initiated global Phase 3 trials in narcolepsy Type 1.

我們豐富的研發管線繼續推進，有兩個重大機會：zasocitinib，我們的選擇性 TYK2 抑制劑；和 TAK-861，我們的食慾素 2 受體激動劑，兩者都準備提供近期的 3 期讀數。Zasocitinib 有潛力成為中度至重度斑塊狀乾癬患者的主要口服治療藥物，解決尋求清潔皮膚的患者未滿足的重大醫療需求。第三階段試驗正在迅速招募，我們預計在 2024 財政年度完成招募。隨著我們啟動針對 1 型發作性睡病的全球 3 期試驗，TAK-861 也迅速進展。

We will provide updates on the zasocitinib and TAK-861 pivotal trial designs, our overall program timelines and market potential later this year at our R&D Investor event. Beyond these two programs with significant revenue potential, we have significant depth and breadth in our late-stage program -- pipeline that will further contribute to Takeda's long-term growth. Our partners at Protagonist have been making strong progress with rusfertide, which continues to enroll well with a target filing expected in fiscal year 2025. Fazirsiran continues to advance, and mezagitamab will begin Phase 3 trials for immune thrombocytopenia or ITP in the second half of fiscal year 2024.

我們將在今年稍後的研發投資者活動中提供有關 zasocitinib 和 TAK-861 關鍵試驗設計、我們的整體計劃時間表和市場潛力的最新資訊。除了這兩個具有巨大收入潛力的項目之外，我們的後期項目也具有顯著的深度和廣度——管道將進一步促進武田的長期成長。我們在 Protagonist 的合作夥伴在 rusfertide 方面取得了強勁進展，該藥物的註冊情況繼續良好，預計在 2025 財年實現目標申報。Fazirsiran 繼續推進，mezagitamab 將於 2024 財政年度下半年開始針對免疫性血小板減少症或 ITP 的 3 期試驗。

Near-term Phase II readouts that can expand our growing late-stage pipeline include ADZYNMA in immune thrombotic thrombocytopenic purpura or ITTP and TAK-227 in celiac disease. We have additional data inflections within our early-stage pipeline and intend to continue targeted business development activities to further enhance our maturing pipeline.

近期的 II 期試驗可以擴大我們不斷增長的後期產品線，包括治療免疫性血栓性血小板減少性紫斑症的 ADZYNMA 或治療乳糜瀉的 ITTP 和 TAK-227。我們的早期管道中有更多數據變化，並打算繼續有針對性的業務開發活動，以進一步增強我們成熟的管道。

Now let's review some of the exciting data that was presented this past quarter. Next slide, please, yeah. These transformative Phase 2b data presented at the SLEEP conference demonstrate the potential to revolutionize the treatment of narcolepsy Type 1 or NT1. Unlike existing treatments, by addressing the underlying pathophysiology of the disease, TAK-861 has shown the ability to significantly improve patients' quality of life and, in many cases, normalize the entirety of their symptoms.

現在讓我們回顧一下上個季度提供的一些令人興奮的數據。請下一張投影片，是的。SLEEP 會議上提出的這些變革性 2b 期數據證明了 1 型或 NT1 型發作性睡病治療的潛力。與現有的治療方法不同，透過解決疾病的潛在病理生理學問題，TAK-861 已顯示出能夠顯著改善患者的生活質量，並在許多情況下使患者的整體症狀恢復正常。

Greater than 80% of the NT1 patients on the mid to high twice-daily doses were within the normal ranges for the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test. Weekly rates of cataplexy were driven to near 0. This efficacy was stained over an eight-week treatment period, and 95% of patients rolled over into a long-term extension study with no patients discontinuing due to treatment-related adverse events.

每天兩次中至高劑量的 NT1 患者中，超過 80% 的患者在 Epworth 嗜睡量表和維持清醒測試中處於正常範圍內。每週猝倒率降至接近 0。這種療效在八週的治療期內得到體現，95% 的患者轉入長期擴展研究，沒有患者因治療相關不良事件而中止。

We are observing sustained efficacy in our long-term extension study with no evidence of hepatotoxicity. Over 100 patients have now been treated for at least six months on active therapy and approximately 20 patients for greater than one year. We intend to present long-term efficacy and safety data at a medical conference this fall.

我們在長期擴展研究中觀察到持續療效，沒有肝毒性的證據。目前已有 100 多名患者接受了至少六個月的積極治療，大約 20 名患者接受了一年以上的積極治療。我們打算在今年秋天的一次醫學會議上展示長期療效和安全性數據。

It's worth noting that current NT1 therapies have shown maintenance of wakefulness times ranging from 3 to 10 minutes and Epworth sleepiness scores around 12 to 15, underscoring the unmet need for patients with narcolepsy. We are committed to bringing this exciting therapy to patients as quickly as possible.

值得注意的是，目前的 NT1 療法已顯示出可維持 3 至 10 分鐘的清醒時間，Epworth 嗜睡評分約為 12 至 15，這凸顯了發作性睡病患者未滿足的需求。我們致力於盡快將這種令人興奮的療法帶給患者。

Let's now focus on the mezagitamab immune thrombocytopenia or ITP data. Next slide, please. Mezagitamab is an anti-CD38 antibody which depletes antibody-producing plasma cells as well as impacting a range of other cells involved in inflammatory processes. This leads to a rapid onset of response and a long-lasting immunomodulating effect. The unmet medical need in ITP is high with relatively few approved therapies and as many as one-third of patients not well controlled on existing therapies.

現在讓我們專注於 mezagitamab 免疫性血小板減少症或 ITP 數據。請下一張投影片。Mezagitamab 是一種抗 CD38 抗體，可消耗產生抗體的漿細胞，並影響參與發炎過程的一系列其他細胞。這導致快速起效和持久的免疫調節作用。ITP 未滿足的醫療需求很高，核准的療法相對較少，多達三分之一的患者在現有療法中控制不佳。

In this Phase 2b trial, we assess the efficacy of mezagitamab in a deeply treatment-experienced population of patients with persistent or chronic ITP. The study demonstrated consistent dose response and high response rates at the high doses. There also appears to be the potential for durable and long-term remission after therapy is stopped. The treatment of emergent adverse effects were similar between treatment and placebo arms. We will be starting a Phase 3 program in ITP in the second half of the fiscal year.

在這項 2b 期試驗中，我們評估了 mezagitamab 在經過深度治療的持續性或慢性 ITP 患者群體中的療效。該研究證明了高劑量下的一致劑量反應和高反應率。治療停止後似乎也有可能獲得持久和長期的緩解。治療組和安慰劑組對緊急不良反應的處理相似。我們將在本財年下半年啟動 ITP 第三階段計畫。

Finally, I would like to take this opportunity to invite you to our R&D Day to be held December 12 in the evening, Eastern Standard Time, and the morning of December 13 in Japan. We will review data, development plans, timelines and our assessment of the market opportunities for zasocitinib, TAK-861 and other late-stage pipeline programs. Please save this date in your calendars.

最後，我想藉此機會邀請您參加我們將於 12 月 12 日晚上（東部標準時間）和 12 月 13 日上午在日本舉行的研發日。我們將審查 zasocitinib、TAK-861 和其他後期管道項目的數據、開發計劃、時間表和市場機會評估。請將此日期儲存在您的日曆中。

Thank you very much, and I will now turn it over to Chris to open the Q&A session.

非常感謝，我現在將把它交給克里斯來開始問答環節。

(interpreted) We would like to invite questions. In addition to Christophe, Milano and Andy; Julie Kim, President of US Business Unit, will also join the Q&A. (Event Instructions)

（口譯）我們想請大家提問。除了Christophe之外，還有Milano和Andy；美國業務部總裁 Julie Kim 也將參加問答。（活動須知）

The first question, from Jefferies, we have Barker-san. Steve, please unmute your microphone and ask your question. It looks like he put his hand down. So let's move on to the next question, Matsubara-san from Nomura Security.

第一個問題，來自傑弗里斯，我們有巴克先生。史蒂夫，請取消麥克風靜音並提出問題。看起來他的手已經放下了。那麼，讓我們繼續下一個問題，來自野村證券的松原先生。

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

（解釋）是的，我是野村證券的松原。你聽得到我說話嗎？

(interpreted) Yes.

（解釋）是的。

(interpreted) I have two questions. First question is about VYVANSE. The generic supply will start again in August. So what is the current situation? And in the second quarter, do we see a decline in revenue? Or do we see that in the third quarter? What is your view?

（翻譯）我有兩個問題。第一個問題是關於 VYVANSE 的。仿製藥供應將於八月再次開始。那麼目前的情況如何呢？在第二季度，我們會看到收入下降嗎？或者我們會在第三季看到這一點嗎？你的看法是什麼？

And the second question is about immunoglobulin. I understand that it's growing right now. But donor fee or other measures, maybe you can implement measures to improve OP margin? Are you doing that right now? And have those measures changed since the last quarterly call? Thank you.

第二個問題是關於免疫球蛋白的。我知道它現在正在增長。但是捐贈費或其他措施，也許你可以採取措施來提高OP利潤率？你現在正在這樣做嗎？自上次季度電話會議以來，這些措施是否發生了變化？謝謝。

Okay. Thank you for your question. So the first question on the latest status of VYVANSE in the US and the soticlestat generic supply and when we expect that to accelerate, I'd like to ask Julie to comment on that question. And then the second question about any changes in our plasma business, particularly around donor fees, margin improvements, any commentary on that? I'd like to ask perhaps Christophe to take that question. Julie?

好的。謝謝你的問題。因此，第一個問題是關於 VYVANSE 在美國的最新狀況和 soticlestat 仿製藥供應，當我們預計這種情況會加速時，我想請朱莉對此問題發表評論。然後是第二個問題，關於我們血漿業務的任何變化，特別是在捐贈費用、利潤率提高方面，對此有什麼評論嗎？我想請克里斯托夫回答這個問題。茱麗葉？

Thank you, Chris, and thank you for the question, Matsubara-san. In terms of VYVANSE, as you've noted, we have seen the supply from generics companies improve over the past quarter and, therefore, our VYVANSE demand has declined, although it was above what we were expecting. Quarter over quarter, we do expect the supply situation for the generics to improve, but it is very difficult for us to accurately predict exactly what their supply might be.

謝謝你，克里斯，也謝謝你的提問，松原先生。就 VYVANSE 而言，正如您所指出的，我們看到仿製藥公司的供應在過去一個季度有所改善，因此，我們的 VYVANSE 需求有所下降，儘管高於我們的預期。每個季度，我們確實預期仿製藥的供應狀況會有所改善，但我們很難準確預測其供應情況。

So we are monitoring this closely for VYVANSE. We do not have any supply challenges. And as I said, we do expect the overall supply for the generics to improve quarter over quarter. And so we saw, from a VYVANSE perspective, roughly just over 30% decline versus last year, and we expect our continued erosion of VYVANSE to proceed as planned. Thank you.

因此，我們正在密切關注 VYVANSE 的情況。我們沒有任何供應挑戰。正如我所說，我們確實預計仿製藥的整體供應量將逐季改善。因此，從 VYVANSE 的角度來看，我們看到與去年相比下降了大約 30% 以上，我們預計 VYVANSE 的持續侵蝕將按計劃進行。謝謝。

Thank you, Matsubara-san for the question regarding PDT. A strong quarter indeed in terms of growth. We expect the growth to be slightly lower for the full year, but very strong demand. Our margin has been improving now for a few quarters, starting just after COVID, in fact. This is due to the fact that we are optimizing our supply chain.

謝謝松原先生提出有關 PDT 的問題。就成長而言，確實是一個強勁的季度。我們預計全年成長將略低，但需求非常強勁。事實上，我們的利潤率在幾個季度以來一直在改善，從新冠疫情爆發後就開始了。這是因為我們正在優化我們的供應鏈。

We are growing our revenue using our manufacturing capacity fully. And the donor fee has been stable now for a couple of quarters. So -- and we expect them to remain stable, but we will see how this is evolving. So overall, this is really how we are increasing our margin. We are actively managing donor fee. We are growing our revenue. Our subcu also is growing faster, which is helping our overall margin. And then we are optimizing the utilization of our manufacturing capacity. Thank you.

我們正在充分利用我們的製造能力來增加收入。捐贈費用已經連續幾季保持穩定。因此，我們預計它們將保持穩定，但我們將看到情況如何發展。總的來說，這確實是我們增加利潤的方式。我們正在積極管理捐贈費用。我們正在增加收入。我們的 subcu 成長速度也更快，這有助於我們的整體利潤率。然後我們正在優化我們的製造能力的利用率。謝謝。

(interpreted) Now Jefferies, Mr. Steve Barker, it seems you raised your hand. Please go ahead, Steve.

（翻譯）傑弗里斯，史蒂夫·巴克先生，看來你舉起了手。請繼續，史蒂夫。

Yes. Thank you for giving me this opportunity to ask two questions, both are related to pipeline. Firstly, I was wondering if you could comment on your decision to end your partnership with JCR for Hunter syndrome candidate JR-141.

是的。感謝您給我這個機會問兩個問題，兩個問題都與管道有關。首先，我想知道您是否可以對終止與 JCR 亨特氏症候群候選藥物 JR-141 合作關係的決定發表評論。

And then second question is regarding your deal with AC Immune for Alzheimer's. And given the regulatory challenges that Eisai's LEQEMBI continues to suffer, I think there are questions in people's minds about the amyloid thesis in general, but this deal seems to indicate that Takeda believes that this is a very legitimate target. And I was wondering if you could comment on that topic generally and on this program more specifically. Thank you.

第二個問題是關於你們與 AC Immune 治療阿茲海默症的協議。鑑於衛材的 LEQEMBI 繼續面臨監管挑戰，我認為人們普遍對澱粉樣蛋白理論存在疑問，但這筆交易似乎表明武田認為這是一個非常合法的目標。我想知道您是否可以對該主題進行一般性評論，並更具體地對該計劃發表評論。謝謝。

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

謝謝你，史蒂夫。安迪，你願意回答這兩個問題嗎？

Sure. Steve, it's Andy Plump. So firstly, as you know, we've undergone a very significant prioritization of our pipeline over the last year to increase capacity to support our emerging late-stage pipeline, and the JCR-121 decision was really just a part of that prioritization. So we're quite enthusiastic about the program. We hope for patients and for JCR that that's a successful program.

當然。史蒂夫，我是安迪普拉普。首先，如您所知，去年我們對管道進行了非常重要的優先排序，以增加支持我們新興後期管道的能力，而 JCR-121 決定實際上只是該優先排序的一部分。所以我們對這個計劃非常熱情。我們希望對於患者和 JCR 來說，這是一個成功的計劃。

For the ACI-24.060 program, actually, I have a different -- slightly different take than the one that you just described. I think that the benefits that we've seen with the amyloid beta clearing passively administered antibodies are unequivocal. There's clear clinical benefit. The benefits are modest, which many people believe reflects the timing of intervention. We think that with the active immunotherapy, the vaccine, firstly, we have the potential to generate a safer profile based on the kinetics of raising these antibodies.

實際上，對於 ACI-24.060 計劃，我的看法與您剛才所描述的略有不同。我認為，我們所看到的被動施用的β-澱粉樣蛋白清除抗體的好處是明確的。有明顯的臨床益處。好處是有限的，許多人認為這反映了介入的時機。我們認為，透過主動免疫療法，首先，我們有可能根據產生這些抗體的動力學產生更安全的疫苗。

And secondly, if -- and of course, we need to wait and see the Phase 2 data. We still haven't seen the Phase 2 data. This is a very early program. But if we're seeing the kind of amyloid beta clearing that the passively administered antibodies have seen, we think we have the potential to go in even earlier in these patients with a very convenient administration.

其次，如果——當然，我們需要等待並查看第二階段的數據。我們還沒有看到第二階段的數據。這是一個非常早期的計劃。但是，如果我們看到被動施用抗體所看到的β澱粉樣蛋白清除，我們認為我們有可能透過非常方便的施用更早進入這些患者。

And we and many believe that by going in earlier, you have the potential to significantly increase the level of efficacy. It's clear that the uptake of these antibodies has been slow. But we think that the vaccine has a very different profile that could really potentially transform the treatment of this disease.

我們和許多人都相信，透過儘早介入，您有可能顯著提高療效水準。很明顯，這些抗體的吸收速度很慢。但我們認為該疫苗具有非常不同的特點，可能真正改變這種疾病的治療方法。

Thanks, Andy. Just to follow up on the first topic. Takeda already has the best-selling treatment for Hunter disease, ELAPRASE. And presumably, you thought that the new asset you were developing with JCR had the potential to displace that. Is there something that you've seen in the market performance of -- is cargo in Japan, for example, that made you rethink that view? Do you think that ELAPRASE can continue to be the most popular treatment for Hunter syndrome going forward?

謝謝，安迪。只是為了跟進第一個主題。武田已經擁有最暢銷的亨特病治療藥物 ELAPRASE。想必您認為與 JCR 一起開發的新資產有潛力取代它。您在日本的貨運市場表現中看到的某些東西是否讓您重新思考了這個觀點？您認為 ELAPRASE 未來會繼續成為亨特氏症候群最受歡迎的治療方法嗎？

Well, maybe I'm going to ask Julie to step in here, but maybe just to level set, so there was -- the JCR, the 141 asset actually was unique relative to ELAPRASE that it had a shuttle mechanism that allowed it to traverse the blood-brain barrier. And so our hope and our continued hope for JCR and for patients with this asset was the ability to expand the treatment potential of this replacement enzyme to treat children that have neurological manifestations as well. But Julie, maybe you want to comment as well?

好吧，也許我會請朱莉介入這裡，但也許只是為了水平設置，所以就有了——JCR，141 資產實際上相對於 ELAPRASE 來說是獨一無二的，它有一個穿梭機制，允許它穿越血腦屏障。因此，我們對 JCR 和擁有這項資產的患者的希望和持續的希望是能夠擴大這種替代酶的治療潛力，以治療也有神經系統症狀的兒童。但是朱莉，也許你也想發表評論？

Sorry, just trying to get myself off mute. So yes, in terms of ELAPRASE, we continue to be pleased with the presence of ELAPRASE on the market. And there are a couple of small competitors, as you are aware, in some of our markets for the Hunter patients. And we also had, as you know, another program that we were studying in terms of Hunter that did not meet its endpoints in the Phase 3. So we continue to see that there is interest in developing further treatments for Hunter patients. But at least for now, ELAPRASE continues to serve the needs of those patients. Thank you.

抱歉，我只是想讓自己不再沉默。所以，是的，就 ELAPRASE 而言，我們仍然對 ELAPRASE 上市感到滿意。如您所知，在我們針對亨特患者的一些市場中，存在一些小型競爭對手。如您所知，我們還研究了另一個針對 Hunter 的項目，該項目在第 3 階段並未達到其終點。因此，我們繼續看到人們有興趣為亨特患者開發進一步的治療方法。但至少目前，ELAPRASE 持續滿足這些患者的需求。謝謝。

Thanks very much.

非常感謝。

(interpreted) Moving on to the next question, Morgan Stanley, Mr. Muraoka.

（解釋）繼續下一個問題，摩根士丹利，Muraoka 先生。

(interpreted) Yes. Hello. Good evening. This is Muraoka from Morgan Stanley. Thank you. My first question is about ENTYVIO. I think ENTYVIO Pen is a wonderful story. And the CER for full year is 16%, that's the target. And if you think about the gap against the target, you have to really accelerate the growth in the second quarter. Otherwise, you cannot really achieve the full year target on a constant currency basis.

（解釋）是的。你好。晚安.我是摩根士丹利的村岡。謝謝。我的第一個問題是關於 ENTYVIO 的。我認為ENTYVIO Pen是一個精彩的故事。全年的 CER 是 16%，這是目標。如果你考慮到與目標的差距，你必須真正加速第二季的成長。否則，你無法真正實現以固定匯率計算的全年目標。

Do you believe that you can catch up before the end of the year? And if so, do you have any evidence? Why do you think that? Sorry, that was the first question. And the second question is at the time of our R&D Day, TAK-079, mezagitamab IgAN POC data, can we expect to see that on the R&D Day? That's the second question.

你相信年底前能趕上嗎？如果是的話，你有證據嗎？為什麼你這麼想？抱歉，這是第一個問題。第二個問題是在我們研發日的時候，TAK-079，mezagitamab IgAN POC數據，我們可以期望在研發日看到它嗎？這是第二個問題。

Okay. Thank you for your question. So the first question on ENTYVIO and the confidence in the full year target of 16% growth. Considering the importance of the Pen launch in the US, I'd like to ask Julie to comment on our expectations for the rest of the year for ENTYVIO and the Pen uptake. And then the second question on whether we will see TAK-079, mezagitamab IgAN data at the R&D Day later in the year, I'd like to ask Andy to comment on that.

好的。謝謝你的問題。那麼第一個問題是關於ENTYVIO以及對全年16%成長目標的信心。考慮到 Pen 在美國推出的重要性，我想請 Julie 評論一下我們對今年剩餘時間對 ENTYVIO 和 Pen 的採用的期望。然後第二個問題是我們是否會在今年稍後的研發日看到 TAK-079、mezagitamab IgAN 數據，我想請 Andy 對此發表評論。

Yes. Thank you for the question, Muraoka-san. And in terms of ENTYVIO in the US, as you've noted, the Pen launch has gone well thus far, and we are continuing to increase our access for patients. We've seen 6.5% growth in Q1 in the US. And we do expect, since the Crohn's indication was also just approved a couple of months ago, that we will see further acceleration as we continue to pull through not just the UC indication on Pen, but also the Crohn's indication on Pen.

是的。謝謝村岡先生的提問。就 ENTYVIO 在美國而言，正如您所指出的，迄今為止 Pen 的推出進展順利，我們正在繼續增加患者的使用機會。我們看到美國第一季成長了 6.5%。我們確實預計，由於克羅恩病的適應症也在幾個月前剛剛獲得批准，隨著我們不僅繼續克服Pen 的UC 適應症，而且還克服Pen 的克羅恩病適應症，我們將看到進一步的加速。

As Christophe mentioned in the presentation and Milano as well, we are continuing to increase the access for patients in the US. And with the combination of the two indications, plus improved access, we do expect to see an acceleration in the second half of the year for Pen in the US.

正如 Christophe 在演講中和米蘭提到的那樣，我們正在繼續增加美國患者的就診機會。結合這兩種跡象，再加上准入的改善，我們預計下半年美國筆會加速成長。

I would also note that last year, we had, across the globe, 12% growth in volume, and we do expect to see lower EU claw backs this year, so that will also contribute to our ability to achieve the 16% growth year on year for ENTYVIO, which we acknowledge is ambitious. But we do have positive indications in terms of our ability to achieve that. And as I said, we continue to push in the US and growth in Europe continues to be strong as well. Thank you.

我還要指出的是，去年我們在全球範圍內的銷量增長了 12%，我們確實預計今年歐盟的追回金額將會減少，因此這也將有助於我們實現去年 16% 的增長。 ENTYVIO 雄心勃勃。但就我們實現這一目標的能力而言，我們確實有積極的跡象。正如我所說，我們繼續在美國推動業務，歐洲的成長也持續強勁。謝謝。

Yeah. Muraoka-san, thank you. It's Andy. So obviously, we'll take a deep dive into the mezagitamab program as one of the key areas of focus at the R&D Day in December. It's including ITP, IgAN and other indications that we're considering this, the mechanism of action for this molecule suggests the potential for benefits across a range of indications. We're clearly committed to ITP. We have very robust Phase 1b data in IgAN.

是的。村岡同學，謝謝你。是安迪。顯然，我們將深入探討 mezagitamab 計劃，將其作為 12 月研發日的重點領域之一。它包括 ITP、IgAN 和我們正在考慮的其他適應症，該分子的作用機製表明其在一系列適應症中具有潛在的益處。我們明確致力於 ITP。我們在 IgAN 中擁有非常可靠的 1b 期數據。

IgAN is an extraordinarily competitive field. We think our profile is equal to or better than anything that's been reported, but we're being thoughtful in terms of how we proceed. Our intent right now is to disclose data at a medical conference in the fall and to have that data available to share with you at the R&D Day, but we're also thoughtful of the competitive landscape. And so more to come. Thanks.

IgAN 是一個競爭異常激烈的領域。我們認為我們的資料等於或優於所報導的任何內容，但我們在如何進行方面正在深思熟慮。我們現在的目的是在秋季的醫學會議上揭露數據，並在研發日與您分享這些數據，但我們也考慮到競爭格局。未來還會有更多。謝謝。

Okay. Thank you very much. I'd like to call on the next question, Mike Nedelcovych from Cowen.

好的。非常感謝。我想請來自 Cowen 的 Mike Nedelcovych 回答下一個問題。

Hey. Thank you for the questions. I have two. My first is on TAK-279. So as I'm sure you're aware, another competitor TYK2 inhibitor failed in a mid-stage IBD trial. Relative to deucravacitinib, you have noted in the past that TAK-279 is being tested at higher equivalent doses, and that could make the difference in IBD. Should we apply the same logic when comparing to the Ventyx molecule? Or are there additional factors to consider?

嘿。謝謝你的提問。我有兩個。我的第一個是 TAK-279。我相信您已經知道，另一種競爭對手 TYK2 抑制劑在 IBD 中期試驗中失敗了。相對於 deucravacitinib，您過去已經注意到 TAK-279 正在以更高的等效劑量進行測試，這可能會對 IBD 產生影響。與 Ventyx 分子進行比較時，我們是否應該應用相同的邏輯？或者有其他因素需要考慮嗎？

And my second question relates to guidance. VYVANSE again performed better than expected this quarter and, at least by our estimation, all of your key products as well. So I'm curious if your reiteration of full-year guidance is meant to lean cautious or if there may be headwinds in the rest of the fiscal year that we're not considering?

我的第二個問題涉及指導。VYVANSE 本季的表現再次優於預期，至少根據我們的估計，你們所有的關鍵產品也是如此。因此，我很好奇，您重申全年指引是否意味著要保持謹慎，或者本財年剩餘時間裡是否可能會出現我們沒有考慮到的阻力？

Thanks, Mike. So I think the first question for Andy. And then the second question on guidance, I'd like to ask Milano to comment on that, please.

謝謝，麥克。所以我想第一個問題要問安迪。然後是關於指導的第二個問題，我想請米蘭對此發表評論。

Hi, Mike. Thanks for the question. So of course, we've seen essentially what you've seen with respect to the Ventyx disclosure, which is just a press release. So we don't have all the data in front of us. What we know from that press release is that it was a relatively small study that was running Crohn's disease at doses that were equivalent to the doses that were used in their psoriasis Phase 2 program. We know from the psoriasis program that the data were -- subclinical data were suboptimal relative to our 30-milligram dose in TAK-279, directionally slightly better than deucravacitinib, slightly worse than TAK-279.

嗨，麥克。謝謝你的提問。當然，我們基本上已經看到了您所看到的有關 Ventyx 披露的內容，這只是一份新聞稿。所以我們面前並沒有所有數據。我們從新聞稿中了解到，這是一項相對較小的研究，其治療克羅恩病的劑量相當於其牛皮癬二期項目中使用的劑量。我們從乾癬計畫中得知，相對於 TAK-279 的 30 毫克劑量，亞臨床數據不是最理想的，方向上略好於 deucravacitinib，略差於 TAK-279。

Those are the same doses that were used in IBD. The disclosure for the IBD trial was that they failed in their primary endpoint, which is a very subjective endpoint, very unusual to use this endpoint, which is called the CDAI in a Phase 2 study and that they showed dose-dependent positive effects and a much more robust objective endpoint, which is endoscopy. So of course, we're going to have to wait to see these data. But our internal sense is it's actually encouraging for TAK-279. We continue to have strong belief in the potential in IBD, and both the Crohn's and ulcerative colitis studies are enrolling, and we expect to see them read out in 2026.

這些劑量與 IBD 中使用的劑量相同。IBD 試驗的揭露是，他們在主要終點上失敗了，這是一個非常主觀的終點，使用這個終點非常不尋常，在 2 期研究中被稱為 CDAI，並且它們顯示出劑量依賴性積極作用和更穩健的客觀終點，即內視鏡檢查。當然，我們必須等待才能看到這些數據。但我們內心的感覺是，這對 TAK-279 來說其實是令人鼓舞的。我們仍然堅信 IBD 的潛力，克羅恩病和潰瘍性結腸炎研究都在招募中，我們預計將在 2026 年看到這些研究結果。

Thank you, Mike, and then I'm going to answer to the second question, so the -- about the guidance. So we don't change the guidance. It's not about the headwinds, but rather maybe two components for the both the top line and the expense side as well. So top line, you commented about VYVANSE, but yes, we did have some upside in VYVANSE at the beginning of this quarter. But we do see now VYVANSE generic erosion is coming back to our sort of expectation.

謝謝麥克，然後我將回答第二個問題，即關於指導的問題。所以我們不會改變指導方針。這與逆風無關，而可能與營收和費用方面的兩個因素有關。最重要的是，您對 VYVANSE 發表了評論，但是，是的，我們在本季度初確實看到了 VYVANSE 的一些優勢。但我們現在確實看到 VYVANSE 仿製藥的侵蝕正在回到我們的預期。

And then we do expect that generic erosion is going to be accelerated the coming quarters. And for expense side as well, the R&D investments are weighted toward the rest of the year. So the -- all in all, if you look at the full year, there is not much the big, big component at this moment we think we should change the guidance as of now. But we will monitor the situation, and we will come back at the Q2 announcement in October.

然後我們確實預計未來幾季通用侵蝕將會加速。在費用方面，研發投資也將在今年剩餘時間內加權。因此，總而言之，如果你看看全年，我們認為目前沒有太多重要的組成部分，我們認為我們應該改變目前的指導。但我們會密切關注事態發展，並會在 10 月發布第二季公告時回來。

Great. Thanks so much.

偉大的。非常感謝。

(interpreted) Thank you. Moving on to the next question, JPMorgan, Mr. Wakao, please. Please unmute yourself and ask your question.

（翻譯）謝謝。請轉到下一個問題，摩根大通，若尾先生。請取消靜音並提出您的問題。

(interpreted) Yes, this is Wakao, JPMorgan. I have two questions. My first question is about ENTYVIO. SKYRIZI was approved for the indication of UC recently. Does it impact ENTYVIO's share or revenue in a negative way? That is my question. What is your view on this? And the second question is about the gross profit margin -- gross margin. 65.5%, I think, is the target for the full year, and the first quarter was at 68%. So what are the factors that would lower this number from the second quarter and beyond? That's all. Thank you.

（譯）是的，我是摩根大通的 Wakao。我有兩個問題。我的第一個問題是關於 ENTYVIO 的。SKYRIZI於近期核准用於UC適應症。這會對 ENTYVIO 的份額或收入產生負面影響嗎？這是我的問題。您對此有何看法？第二個問題是關於毛利率－毛利率。我認為65.5%是全年的目標，第一季是68%。那麼，哪些因素會導致第二季及以後的數字下降呢？就這樣。謝謝。

Thank you, Wakao-san, for the question. So the first question on ENTYVIO impact from the approval of SKYRIZI in UC, any impact on market share? I'd like to call on Julie to comment on that. And then second question for Milano on gross margin, 68% in Q1 with an outlook for 65% for the full year. What are the reasons why it will decline in the coming quarters?

謝謝若尾先生的提問。那麼第一個問題是SKYRIZI在UC核准後對ENTYVIO的影響，對市佔率有什麼影響嗎？我想請朱莉對此發表評論。第二個問題是米蘭的毛利率，第一季為 68%，全年展望為 65%。未來幾季會下滑的原因有哪些？

Thank you for the question, Wakao-san. In terms of UC indication, ENTYVIO continues to hold our strong position as market share leader in first line. Where we do see churn in terms of patients is in second line and beyond, and this is where SKYRIZI had their initial impact with CD and that's where we are seeing their initial impact for UC as well. So again, from a mechanism of action perspective, ENTYVIO remains the only gut-selective therapy that's out there for IBD patients, both in UC and CD, and the new entrants seem to be impacting more within the other classes, the other MOAs. Thank you.

謝謝若尾老師的提問。在UC適應症方面，ENTYVIO持續保持第一線市佔率領先者的強勢地位。我們確實看到二線及以上患者流失，這就是 SKYRIZI 對 CD 產生最初影響的地方，也是我們看到它們對 UC 產生最初影響的地方。因此，從作用機制的角度來看，ENTYVIO 仍然是唯一適用於 IBD 患者（無論是 UC 還是 CD）的腸道選擇性療法，而新進業者似乎對其他類別、其他 MOA 產生了更大的影響。謝謝。

(interpreted) Thank you, Mr. Wakao. This is Furuta speaking. In terms of outlook of gross margin, after the first quarter, for the remainder of the year, VYVANSE and AZILVA, high gross margin products will be shrinking, especially VYVANSE. So that's the impact. And also, albumin, lower-margin products, we will see recovery in terms of demand as well as revenue, and this is why we expect the gross margin to lower somewhat. Q1 gross margin is in line with our expectation. So currently, we want to maintain the existing guidance.

（翻譯）謝謝您，若尾先生。我是古田。從毛利率展望來看，第一季之後，今年剩餘時間，VYVANSE和AZILVA等高毛利率產品將會萎縮，尤其是VYVANSE。這就是影響。此外，白蛋白、利潤率較低的產品，我們將看到需求和收入的復甦，這就是我們預計毛利率會下降的原因。第一季毛利率符合我們的預期。因此，目前我們希望維持現有的指導。

(interpreted) Thank you very much for the answer.

（已翻譯）非常感謝您的回答。

Thank you, Wakao-san. Okay. Moving to the next question, I'd like to call upon Tony Ren from Macquarie. Tony, please unmute and ask you question.

謝謝你，若尾桑。好的。轉到下一個問題，我想請麥格理的托尼·任 (Tony Ren) 發言。托尼，請取消靜音並問你問題。

Yeah, sure. Thank you for the opportunity to ask my questions. So I want to ask about your IVIG, your immunoglobulin in CIDP. So we saw some data, some results coming out of argenx. Their VYVGART was approved in CIDP, I believe, quite late in June. And they said the uptake in CIDP is exceptionally strong. I think that's their wording in their transcript. So I just want to see what type of -- are we being -- so we've had competition from them for about a month now. I just want to see, what are you seeing in the market?

好，當然。感謝您給我機會提問。所以我想詢問一下您的 IVIG、CIDP 中的免疫球蛋白。所以我們看到了一些數據，一些來自 argenx 的結果。我相信，他們的 VYVGART 在 6 月底就在 CIDP 中獲得了批准。他們表示 CIDP 的接受度非常高。我認為這就是他們的文字記錄中的措辭。所以我只是想看看我們屬於什麼類型，所以我們已經與他們競爭了大約一個月。我只是想看看，你在市場上看到了什麼？

And then I also want to go back to the market share for ENTYVIO as my second question. If you look at AbbVie's pronouncements and what they say during their earnings about IBD, they are obviously very aggressively targeting the frontline bio-naive IBD setting. And I just want to see your view on that. And also, I believe you guys used to show a longitudinal market share graph of ENTYVIO and its competitors in IBD. I don't believe I've quite seen it in this presentation for the first quarter. I just wanted to see if I'm not missing anything here. So that's my second question. Yeah. Thank you.

然後我還想回到ENTYVIO 的市佔率作為我的第二個問題。如果你看看艾伯維（AbbVie）的聲明以及他們在財報中對 IBD 的看法，你會發現他們顯然非常積極地瞄準了一線生物性 IBD 環境。我只是想看看你對此的看法。而且，我相信你們曾經展示過 ENTYVIO 及其競爭對手在 IBD 中的縱向市佔率圖。我認為我在第一季的演示中還沒有完全看到這一點。我只是想看看我是否錯過了這裡的任何東西。這是我的第二個問題。是的。謝謝。

Thank you, Tony. I think we can call on Julie to answer both of these questions. Julie?

謝謝你，托尼。我想我們可以請朱莉回答這兩個問題。茱麗葉？

Yes. Thank you, Tony, for the questions. So let me start with your first one in regards to CIDP. So in terms of CIDP, our expectations have not changed in terms of the long-term position for IGIV or IGs in general, not just IV, both our GAMMAGARD LIQUID and HYQVIA in CIDP. And so, of course, for patients, it is always a positive situation when they have more choice, especially with the disease area like CIDP where the patients are heterogeneous, and we know that not all patients respond to IG therapy. But IG does remain the gold standard. And we are pleased with our launch of CIDP and HYQVIA over the past several months.

是的。謝謝托尼提出的問題。那麼讓我從您關於 CIDP 的第一個開始。因此，就 CIDP 而言，我們對 IGIV 或整個 IG ​​的長期地位的預期沒有改變，而不僅僅是 IV，我們的 GAMMAGARD LIQUID 和 HYQVIA 在 CIDP 中的地位都沒有改變。因此，當然，對於患者來說，當他們有更多選擇時總是一個積極的情況，特別是像CIDP 這樣的疾病領域，患者是異質的，而且我們知道並非所有患者都對IG 治療有反應。但 IG 確實仍然是黃金標準。我們對過去幾個月 CIDP 和 HYQVIA 的推出感到高興。

Moving to ENTYVIO. So you had a couple of questions on ENTYVIO. So let me see if I remember them correctly. So the first, in terms of ENTYVIO share in first-line vis-à-vis AbbVie. So as I mentioned for first-line bio-naive share, we are still the market share leader both in -- overall. And then when we talk about the market share graph, which I think is your second question. So as you are aware, I'm sure everyone is aware, there was a cyber-situation earlier this calendar year that impacted claims and claims processing.

搬到ENTYVIO。您對 ENTYVIO 有幾個問題。所以讓我看看我是否記得正確。首先，就 ENTYVIO 與艾伯維 (AbbVie) 的一線市佔率而言。因此，正如我提到的一線生物製劑份額一樣，總體而言，我們仍然是市場份額的領導者。然後當我們談論市場份額圖時，我認為這是你的第二個問題。如您所知，我相信每個人都知道，今年早些時候出現了一個影響索賠和索賠處理的網路情況。

And because of that, at this point, we're not able to show the current share data. As soon as that has been sorted and worked through in terms of the claims data in the US, we will be able to revert and show the share data again. But in terms of first-line bio-naive, ENTYVIO is still the market share leader. I hope that addresses your questions. And if I missed something, please ask again.

因此，目前我們無法顯示目前的份額資料。一旦根據美國的索賠資料進行排序和處理，我們將能夠恢復並再次顯示份額資料。但就一線生物原藥而言，ENTYVIO 仍是市佔率領先者。我希望這能解決您的問題。如果我錯過了什麼，請再次詢問。

That's very clear. Thank you very much, Julie.

這非常清楚。非常感謝你，朱莉。

(interpreted) Moving on to the next question, UBS Securities, Haruta-san. Please ask your question.

（解釋）繼續下一個問題，瑞銀證券，Haruta-san。請提出你的問題。

(interpreted) Yes, this is Haruta, UBS Securities. My first question is about R&D organization. Margin improvement program is in place. And within FY24, in terms of headcount, organizational structure, I understand that you'll finish reorganizing, and you mentioned that. I think some of the functions will be centralized and the efficiency will be improved. But with a fewer headcount, how can you improve productivity? And how do you intend to run -- operate the new organization? So that's my first question.

（解釋）是的，這是Haruta，瑞銀證券。我的第一個問題是關於研發組織的。利潤改善計劃已經到位。在 24 財年內，就人員數、組織結構而言，我知道你們將完成重組，你們也提到了這一點。我覺得有些職能會集中起來，效率會提高。但在員工人數減少的情況下，該如何提高生產力呢？您打算如何經營新組織？這是我的第一個問題。

My second question is about the ENTYVIO biosimilar. I think some companies are advancing in the development, not necessarily in all indications, but in '25 or '26, some of the Phase 3 studies will be completed according to my estimation. Now, status of biosimilar development, considering this status, do you think ENTYVIO can protect itself against the biosimilar until 2030, 2032? Do you maintain this assumption? Or do you have any updates on how long you can protect yourself against biosimilars?

我的第二個問題是關於 ENTYVIO 生物相似藥。我認為有些公司正在推進開發，不一定是在所有適應症上，但在'25或'26年，根據我的估計，一些3期研究將完成。現在，生物相似藥的發展狀況，考慮到這種狀況，您認為ENTYVIO可以在2030年、2032年之前保護自己免受生物相似藥的侵害嗎？你維持這個假設嗎？或者您有關於可以保護自己免受生物相似藥侵害多久的最新消息？

Thank you, Haruta-san, for your questions. So the first question on R&D organization, with the restructuring of the organization that's taking place this year, how can we make sure that we are improving productivity through this period of change? And then the second question was on ENTYVIO biosimilar timing. So I think the first question, for Andy, and then second question, I think perhaps, Christophe, if you could comment on our latest biosimilar entry timing assumptions for ENTYVIO.

謝謝春田同學的提問。那麼關於研發組織的第一個問題，隨著今年正在進行的組織重組，我們如何確保我們在這段變革時期提高生產力？第二個問題是關於 ENTYVIO 生物相似藥的時機。因此，我認為第一個問題是安迪提出的，然後是第二個問題，克里斯托夫，我想您是否可以對我們最新的 ENTYVIO 生物仿製藥進入時間假設發表評論。

Thanks, Chris, and thanks, Haruta-san. So we're continually looking at our pipeline. We're continually making data and strategic-driven decisions to prioritize our pipeline, and we're continually looking at how we operate to ensure that we're operating in the most effective and efficient way possible.

謝謝克里斯，謝謝斯普林桑。因此，我們不斷關注我們的管道。我們不斷制定數據和策略驅動的決策，以確定我們管道的優先順序，並且不斷研究我們的營運方式，以確保我們以最有效和高效的方式運作。

We -- over the course of the last year, as I mentioned earlier, we went through quite a significant pipeline prioritization to ensure that we were concentrating our resources as much as necessary to support our growing late-stage pipeline, which now has six programs in it and the potential for more programs to come. As Christophe has mentioned, previously, we've also year-on-year been increasing our R&D budget to ensure that we can support that pipeline.

正如我之前提到的，在去年的過程中，我們經歷了相當重要的管道優先順序，以確保我們盡可能集中資源來支持我們不斷增長的後期管道，該管道現在有六個項目以及未來更多計劃的潛力。正如 Christophe 之前提到的，我們也逐年增加研發預算，以確保我們能夠支援該管道。

So the efficiency program that we've undertaken over the past year, and that's in full swing right now, is really designed to ensure that we have an organization that can drive fully that pipeline forward. Given the prioritization, we feel that we're rightsized to deliver on that pipeline. We're also, as we've mentioned in many different settings, we're also looking to leverage more and more efficiencies in automation from data, digital and technology. And we're starting now to realize some of the benefits of that strategy. Thank you.

因此，我們在過去一年中實施的效率計劃（目前正在如火如荼地進行）的真正目的是確保我們擁有一個能夠全面推動管道向前發展的組織。考慮到優先順序，我們認為我們的規模適合交付該管道。正如我們在許多不同的環境中提到的那樣，我們也希望利用數據、數字和技術的自動化來提高越來越多的效率。我們現在開始認識到該策略的一些好處。謝謝。

Thank you for the question regarding ENTYVIO biosimilars. Look, based on what we know, and we look at, of course, development stage of biosimilars, but also, we look at the defense of our patent set. We don't see any reason to change. Our current assumption is that the earliest biosimilar could enter the market in the US will be 2030 to 2032. So no change to our assumptions so far based on what we know.

感謝您提出有關 ENTYVIO 生物相似藥的問題。看看，根據我們所知，我們當然會專注於生物相似藥的開發階段，而且我們也會關注我們專利集的辯護。我們看不到任何改變的理由。我們目前的假設是，生物相似藥最早進入美國市場的時間是 2030 年至 2032 年。因此，根據我們所知，到目前為止我們的假設並沒有改變。

I will also mention, because we get the question very often, that the ENTYVIO Pen, which is very important right now, as Julie mentioned, it does allow us to keep our leadership in bio-naive patients. We have not seen a market share decline because of the ENTYVIO characteristic. But the ENTYVIO Pen is not allowing us to have a longer protection. So this is why we -- no change to our assumptions when it comes to biosimilar entry. Thank you.

我還要提到，因為我們經常收到這個問題，ENTYVIO 筆現在非常重要，正如朱莉所提到的，它確實使我們能夠在未接受過生物治療的患者中保持領先地位。我們沒有看到市佔率因ENTYVIO特性而下降。但ENTYVIO Pen並沒有讓我們擁有更長久的保護。這就是為什麼我們在生物相似藥進入方面沒​​有改變我們的假設。謝謝。

(interpreted) Thank you.

（翻譯）謝謝。

(interpreted) Next question, from Citi, Yamaguchi-san. Please go ahead.

（解釋）下一個問題，來自花旗山口先生。請繼續。

(interpreted) Can you hear me?

（翻譯）你聽得到我說話嗎？

(interpreted) Yes.

（解釋）是的。

Thank you. This is Yamaguchi from Citi. I have two questions. The first question that might be in the presentation, but I may have missed it, but the QDENGA, the Q1 looks very strong. And is there any kind of one-time factor why this is the kind of basic number for this quarter, which I can think over the 4 times more than this one? So that's the first question, QDENGA situation. The second question is kind of a repeated question, but the progress rate in the Q1 as far as earnings is concerned, except currency, except VYVANSE, is it in line or is it still pretty, looks good as far as the earnings progress is concerned, except currency and then VYVANSE? Thank you.

謝謝。我是花旗銀行的山口。我有兩個問題。第一個問題可能在演示中，但我可能錯過了，但 QDENGA、Q1 看起來非常強大。是否存在任何一次性因素，為什麼這是本季的基本數字，我可以考慮比這個多四倍的數字？這就是第一個問題，QDENGA 的情況。第二個問題是一個重複的問題，但是就收益而言，第一季的進度，除了貨幣，除了VYVANSE之外，它是否符合或仍然漂亮，就收益進度而言看起來不錯，除了貨幣，然後是VYVANSE？謝謝。

Thank you, Yamaguchi-san. So the first question on QDENGA performance, I'd like to ask Christophe to comment on that. And then the second question on Q1 progress rate versus the full year, excluding FX, I'd like to ask Milano to comment on that, please.

謝謝你，山口先生。關於 QDENGA 效能的第一個問題，我想請 Christophe 對此發表評論。然後是關於第一季進度與全年進度（不包括外匯）的第二個問題，我想請米蘭對此發表評論。

Thank you, Yamaguchi-san. Look, I think QDENGA is off for a strong start. We see a very significant demand where it is -- I mean, in endemic countries as well as countries where there is a travel market. We are ramping up our manufacturing capacity. This is a limiting factor right now. The demand is way greater than our supply capacity. We are expanding this supply capacity. So yeah, we are very pleased with the takeoff. I don't think there is any special case in here.

謝謝你，山口先生。看，我認為 QDENGA 已經有了一個好的開始。我們看到了非常巨大的需求——我的意思是，在流行國家以及有旅遊市場的國家。我們正在提高我們的製造能力。這是目前的限制因素。需求遠大於我們的供給能力。我們正在擴大這種供應能力。所以，是的，我們對起飛感到非常滿意。我認為這裡沒有什麼特殊情況。

There is -- there will be in the future, by the way, because there is a private market that is quite predictable and linear, if you like, but more and more because we are going into public immunization programs. They are not obviously phased, if you like, depending on the order, on the supply that we can provide to a government. But really, product is off to a fantastic start. And as we all know, dengue is a major issue in many countries. Thank you.

順便說一句，將來還會有，因為如果你願意的話，有一個相當可預測和線性的私人市場，但越來越多，因為我們正在進行公共免疫計劃。如果你願意的話，它們沒有明顯的分階段，取決於訂單，取決於我們可以向政府提供的供應。但實際上，產品已經有了一個美好的開始。眾所周知，登革熱是許多國家的一個主要問題。謝謝。

Thank you, Yamaguchi-san, for the question. So the -- overall, I think on the top line side, we are -- we think it's on track. It's according to our expectation. And VYVANSE indeed have some upside at the beginning -- especially beginning of the quarter. But we do expect it's coming back -- that generic erosion, will come back to our expectation level going forward.

謝謝山口先生的提問。因此，總的來說，我認為在營收方面，我們認為一切都步入正軌。這符合我們的預期。VYVANSE 在開始時確實有一些優勢——尤其是在本季初。但我們確實預期它會回來——那種普遍的侵蝕，將回到我們的預期水平。

For the expense side, the -- there was some phasing in R&D. So we spent less in R&D for the first quarter. And then those development costs are weighted toward the rest of the year. So it's going to ramping up. So the -- yes, we did have less expense in Q1, but it will catch up. So all in all, according to our expectation, and then that's why we don't change the guidance at this moment. Thank you.

在費用方面，研發工作已分階段進行。因此，我們第一季的研發支出減少了。然後這些開發成本會被加權到今年剩餘的時間。所以它將會加速。所以——是的，我們第一季的支出確實減少了，但它會迎頭趕上。總而言之，根據我們的預期，這就是我們目前不改變指導的原因。謝謝。

Thank you very much.

非常感謝。

Thank you, Yamaguchi-san. I think we have time for just one final question, so I'd like to call on Miki Sogi from Bernstein. Miki, please unmute and ask your question.

謝謝你，山口先生。我想我們只有最後一個問題的時間，所以我想請伯恩斯坦的 Miki Sogi 來回答。Miki，請取消靜音並提問。

Yes. Thank you very much for giving me the opportunity. So first question is the TAKHZYRO and immunoglobulin. It seems like these two products had a really strong growth in first quarter. Is there any market dynamics that -- can you explain this -- the growth? And also, is this something you are expecting to sustain over the year?

是的。非常感謝您給我這個機會。第一個問題是 TAKHZYRO 和免疫球蛋白。看來這兩種產品在第一季的成長非常強勁。是否有任何市場動態——你能解釋一下——成長嗎？而且，您預計這一年會持續下去嗎？

Thank you, Miki. Julie --

謝謝你，米基。茱麗葉--

On the second -- okay. Maybe I should have asked the second question --

第二個——好吧。也許我應該問第二個問題--

(multiple speakers)

（多個發言者）

Yes, exactly. And so for the second question is the -- so TYK2 from the BMS. We have been hearing that these products, TYK2 inhibitor, the first-in-class has been -- its launch has been quite underwhelming. And this is due to the fact that the payer coverage has been quite slow. I just wanted to see, is it the kind of fate that your TYK2 inhibitor would also have? Or if not, what would you do differently?

對，就是這樣。第二個問題是來自 BMS 的 TYK2。我們聽說這些產品，TYK2抑制劑，是一流的——它的推出一直相當平淡。這是因為付款人的覆蓋速度相當緩慢。我只是想看看，你的TYK2抑制劑是否也會有這樣的命運？或者如果沒有，你會採取什麼不同的做法？

Great. Thank you, Miki. So Julie, would you like to comment on both of those questions?

偉大的。謝謝你，米基。朱莉，您想對這兩個問題發表評論嗎？

Okay. So the first one, in terms of TAKHZYRO and the immunoglobulin growth, I'll speak primarily to the growth in the US versus rest of world. I'd make a couple of comments on that. But in terms of US, what we continue to see for TAKHZYRO is a very strong growth in terms of patients year over year. And so even though the product has been on the market for quite a number of years and we've had new entrants like orals come on, we continue to see a strong growth in patients.

好的。因此，第一個，就 TAKHZYRO 和免疫球蛋白的成長而言，我將主要談論美國與世界其他地區的成長。我想對此發表幾點評論。但就美國而言，我們繼續看到 TAKHZYRO 的患者數量逐年強勁增長。因此，儘管該產品已經上市很多年，我們已經有了口服藥物等新產品，但我們仍然看到患者數量的強勁增長。

So for example, in Q1 of this year, we had roughly 25% of our start forms come from prescribers who are writing TAKHZYRO for the first time. So we're quite pleased with the continued growth of TAKHZYRO in the US. And outside of the US, we continue to see further patient growth as well as launches in our markets outside of the US. So that's what's driving the strong growth for TAKHZYRO.

例如，今年第一季度，我們大約 25% 的起始表格來自首次使用 TAKHZYRO 的處方者。因此，我們對 TAKHZYRO 在美國的持續成長感到非常滿意。在美國以外的地區，我們繼續看到患者數量的進一步增長以及在美國以外市場的上市。這就是推動 TAKHZYRO 強勁成長的原因。

In terms of the immunoglobulins in the US, we've had, as I mentioned in an earlier answer, the approval of our CIDP indication for HYQVIA and GAMMAGARD LIQUID. And we've had very strong growth overall for our IGs in general because of the continued ramp that there is in terms of diagnosis and optimization of treatment in primary immune deficiency and now with the addition of the CIDP indication, strong growth in the US. Outside of the US, there continues to be more demand than supply, which is contributing to growth outside of the US.

就美國的免疫球蛋白而言，正如我在先前的回答中所提到的，我們的 HYQVIA 和 GAMMAGARD LIQUID 的 CIDP 適應症已獲得批准。由於原發性免疫缺陷的診斷和治療優化方面的持續增長，加上現在 CIDP 適應症的增加，我們的 IG 整體成長非常強勁，在美國的成長強勁。在美國以外的地區，需求仍然大於供應，這有助於美國以外的地區的成長。

And Chris, remind me of the second question? Apologies, I've -- it slipped my mind.

克里斯，提醒我第二個問題嗎？抱歉，我——我忘了​​。

Thoughts on the TYK2 uptake in the US and implications for TAK-279.

關於 TYK2 在美國吸收的思考以及對 TAK-279 的影響。

Sure. On the TYK2 uptake, so look, it's not our place to comment on our competitors' performance. But as you heard from Andy, in terms of TAK-279, we believe in the differentiated profile that we've seen thus far for TAK-279. And from a commercial perspective, if that data bears out in Phase 3, that will give us a very strong position from a commercial standpoint to launch successfully against the existing products in the space in psoriasis as well as vis-à-vis the existing TYK2 product as well. Thank you.

當然。關於 TYK2 的採用情況，我們沒有資格評論競爭對手的表現。但正如您從 Andy 那裡聽到的，就 TAK-279 而言，我們相信迄今為止我們所看到的 TAK-279 的差異化概況。從商業角度來看，如果該數據在第 3 階段得到證實，那麼從商業角度來看，這將使我們處於非常有利的地位，能夠成功推出針對牛皮癬領域的現有產品以及現有的 TYK2產品也是如此。謝謝。

Thank you.

謝謝。

Sogi-san, sorry, maybe let me add some comments around IG. So yes, the IG's growth in Q1 was pretty strong comparing to our annual guidance, but the growth rate in a quarter-by-quarter growth rate of PDT can fluctuate a bit. So the -- we expect to stay the full-year growth would be within the guidance, which is in the 5% to 15%.

Sogi-san，抱歉，也許讓我在 IG 上添加一些評論。所以，是的，與我們的年度指導相比，IG 在第一季的成長相當強勁，但 PDT 的季度成長率可能會略有波動。因此，我們預計全年成長將保持在 5% 至 15% 的指導範圍內。

Thank you very much for your explanation. That's great.

非常感謝您的解釋。那太棒了。

Great. Thank you, Sogi-san. With this, we've reached the end of the call. So thank you, everyone, for joining us today, and we wish you all the best. Thank you very much.

偉大的。謝謝你，索吉桑。至此，我們的通話就結束了。謝謝大家今天加入我們，祝福你們一切順利。非常感謝。

Portions of this transcript that are marked (interpreted) were spoken by an interpreter present on the live call. The interpreter was provided by the company sponsoring this event.

此文字記錄中標記（翻譯）的部分是由現場通話中的口譯員說出的。口譯員由贊助本次活動的公司提供。