使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
(Interpreted) Thank you very much for joining us today for Takeda's 2026 Q2 earnings announcement despite your busy schedules. My name is O'Reilly, Head of IR. I'll be serving as the MC today. Thank you for this opportunity. (Operator Instructions)
(口譯) 非常感謝各位在百忙之中參加武田 2026 會計年度第二季(Q2)財報發布會。我是 O'Reilly,投資人關係(IR)主管,今天將擔任主持人。感謝各位給予這個機會。(接線員指示)
Before starting, I would like to remind everyone that we'll be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in our most recent Form 20-F and in our other SEC filings. Please also refer to the important notice on page 2 of the presentation regarding forward-looking statements and our non-IFRS financial measures, which will also be discussed during this call. Definitions of our non-IFRS measures and reconciliations with the comparable IFRS financial measures are included in the appendix to that presentation.
在開始之前,我想提醒各位,我們將討論《1995 年私人證券訴訟改革法》(Private Securities Litigation Reform Act of 1995)所定義的前瞻性陳述。實際結果可能與今日討論內容有重大差異。可能導致我們實際結果與所述內容出現重大差異的因素,已於我們最新的 Form 20-F 以及其他向美國證券交易委員會(SEC)提交的文件中說明。也請參閱簡報第 2 頁關於前瞻性陳述及我們非 IFRS 財務衡量指標的重要聲明;本次電話會議亦將討論這些指標。我們的非 IFRS 指標定義,以及與可比較的 IFRS 財務衡量指標之調節表,均收錄於該簡報的附錄中。
Now we would like to start today's presentation. We will hear from President and CEO, Julie Kim, Chief Financial Officer, Milano Furuta; and R&D President, Andy Plump. And this will be followed by a Q&A session.
現在我們開始今天的簡報。我們將聽取總裁暨執行長 Julie Kim、財務長 Milano Furuta,以及研發總裁 Andy Plump 的報告。之後將進行問答環節。
Now we'll get started. Julie, please go ahead.
現在我們開始。Julie,請。
Julie Kim - President, Chief Executive Officer, Representative Director
Julie Kim - President, Chief Executive Officer, Representative Director
Thank you, Chris, and thank you all for joining us today for Takeda's second-quarter earnings call for fiscal year 2026. Our goal is to deliver a meaningful impact for patients and lasting value for our shareholders. And in the first half of this fiscal year, I am proud of what we've accomplished towards achieving that. We'll continue delivering impact and value by leading in our therapeutic areas, building portfolio depth through science, innovation and speed from discovery to access.
謝謝你,Chris,也謝謝各位今天參加武田 2026 會計年度第二季財報電話會議。我們的目標是為病患帶來有意義的影響,並為股東創造長期價值。在本會計年度上半年,我為我們在朝此目標邁進所取得的成果感到自豪。我們將持續透過在治療領域保持領先、以科學、創新與從研發到可近性的速度來建立產品組合深度,進一步交付影響力與價值。
Our generational promise to boldly reinvent for a healthier world remains at the heart of everything we do. And I want to thank our colleagues as well as the patients, families and health care professionals who make this progress possible.
我們「勇於重塑、共創更健康世界」的世代承諾,仍是我們一切工作的核心。我也要感謝我們的同仁,以及讓這些進展成為可能的病患、家屬與醫療照護專業人員。
Starting with slide 5. Our fiscal 2026 first half results demonstrate strong execution across our priorities. Let me walk you through the numbers. In the first half, core revenue was just over JPY2.4 trillion, a decrease of 1% at constant exchange rate or CER. This reflects the resilience of our core in-line brands and headwinds in our mature and off-patent portfolio that are not yet fully offset by our recent launches.
先從第 5 頁投影片開始。我們 2026 會計年度上半年業績,展現了在各項優先事項上的強勁執行力。我帶各位看一下數字。上半年核心營收略高於 2.4 兆日圓,以固定匯率(CER)計算下降 1%。這反映出我們核心主力產品的韌性,以及成熟與專利到期產品組合所面臨的逆風,而這些逆風尚未完全被近期新上市產品所抵銷。
Core operating profit was JPY710.6 billion, an increase of 0.7% at CER. And core EPS was JPY308, a decrease of 1.2% at CER. As we outlined in May, core operating profit reflects the investments we're making to support our new launches and our late-stage pipeline. And we're largely offsetting those investments with the savings our transformation program is delivering.
核心營業利益為 7,106 億日圓,以 CER 計算成長 0.7%。核心每股盈餘(EPS)為 308 日圓,以 CER 計算下降 1.2%。如同我們在 5 月所說明,核心營業利益反映了我們為支持新產品上市與後期研發管線所進行的投資。而我們在很大程度上以轉型計畫所帶來的節省來抵銷這些投資。
Overall, our first half results demonstrate that we are on track against our FY 2026 priorities, and we will continue our disciplined execution to deliver on our revised full year forecast and management guidance. The right side of the slide highlights our pipeline and portfolio progress since last earnings. Our first priority in Horizon 1 is to execute successful new product launches. We are pleased that ORZEYFUL launched in Japan and China this month for the treatment of narcolepsy type 1, and we expect to launch in the US in early November following the completion of DEA scheduling. We also launched MIMRYLO in the US in August, a first-in-class new treatment for patients with polycythemia vera. In addition, we secured approval for ELAHERE, which we're commercializing only in Japan for folate receptor alpha-positive platinum-resistant recurrent ovarian cancer.
整體而言,上半年業績顯示我們正按計畫推進 2026 會計年度的優先事項;我們也將持續以紀律性的執行,達成我們修訂後的全年預測與管理層指引。投影片右側重點呈現自上次財報以來,我們在研發管線與產品組合上的進展。Horizon 1 的第一項優先事項,是成功執行新產品上市。我們很高興 ORZEYFUL 本月已在日本與中國上市,用於治療第一型嗜睡症(narcolepsy type 1);並預期在完成美國緝毒署(DEA)排程後,於 11 月初在美國上市。我們也於 8 月在美國推出 MIMRYLO,這是一項同類首創(first-in-class)的新療法,適用於真性紅血球增多症(polycythemia vera)患者。此外,我們也取得 ELAHERE 的核准;該產品我們僅在日本進行商業化,用於治療葉酸受體 α 陽性、對鉑類治療具抗藥性之復發性卵巢癌。
We also made progress with regulatory submissions, reflecting our continued momentum to bring new medicines to patients. The FDA accepted our new drug application for zasocitinib in psoriasis under priority review and the EMA accepted our marketing authorization application. We also filed TAK-881, our 20% hyaluronidase facilitated subcutaneous immunoglobulin program in the US for primary immunodeficiency.
我們在法規申請方面也取得進展,反映出我們持續將新藥帶給病患的動能。美國 FDA 已受理我們的 zasocitinib 乾癬新藥申請(NDA),並以優先審查(priority review)方式審理;歐洲藥品管理局(EMA)也已受理我們的上市許可申請(MAA)。我們也已在美國提交 TAK-881 申請,這是我們以 20% 透明質酸酶(hyaluronidase)促進之皮下免疫球蛋白計畫,用於原發性免疫缺乏症。
Our second priority this year is to advance our late-stage pipeline, where we have made significant progress across other late-stage programs. At the European Society for Medical Oncology Congress last week, we shared positive results from our Phase 3 study of TAK-921 in previously treated advanced gastric cancer. The study met its dual primary endpoints of overall survival and progression-free survival while demonstrating a manageable safety profile. These findings will support our planned regulatory filing in Japan, which we intend to submit during fiscal year 2027.
我們今年的第二項優先事項,是推進後期研發管線;在多個後期計畫上我們已取得顯著進展。在上週的歐洲腫瘤內科學會(ESMO)年會上,我們分享了 TAK-921 用於既往治療後之晚期胃癌的第三期研究正向結果。該研究達成兩項共同主要終點:整體存活期(overall survival)與無惡化存活期(progression-free survival),同時展現可管理的安全性特徵。這些結果將支持我們在日本的法規申請計畫,我們預計於 2027 會計年度期間提交。
In addition, we've initiated a Phase 3 study of elritercept in myelofibrosis. We also remain committed to supporting our core in-line brands, which continue to deliver value for patients and underpin our performance. To this end, we presented positive results from the VERDICT study, adding to the strong body of evidence for ENTYVIO in ulcerative colitis. The study generated compelling evidence that ENTYVIO can achieve deep remission and meaningfully reduce the risk of UC-related complications with sustained benefit over time. Andy will dive deeper into this ENTYVIO study and our pipeline developments later in the call.
此外,我們已在骨髓纖維化(myelofibrosis)啟動 elritercept 的第三期研究。我們也持續致力於支持核心主力產品,這些產品持續為病患創造價值並支撐我們的業績表現。為此,我們發表了 VERDICT 研究的正向結果,進一步強化 ENTYVIO 在潰瘍性結腸炎(ulcerative colitis)上的堅實證據基礎。該研究提供具說服力的證據,顯示 ENTYVIO 可達成深度緩解(deep remission),並在長期持續受益的情況下,顯著降低與潰瘍性結腸炎相關併發症的風險。稍後在本次電話會議中,Andy 將更深入說明這項 ENTYVIO 研究以及我們的研發管線進展。
Lastly, our transformation is progressing well as we continue to strengthen our capabilities and drive efficiencies across the organization. As these initiatives gain traction, the realized savings are funding new launches and late-stage pipeline while protecting core operating profit. Beyond these financial benefits, our transformation is building the agility we need to support Takeda's next phase of growth. Milano will walk through our savings progress later and how we are reinvesting for accelerated growth.
最後,我們的轉型進展良好,並持續強化能力、推動全組織的效率提升。隨著這些措施逐步發揮成效,已實現的節省正用於資助新產品上市與後期研發管線,同時保護核心營業利益。除了財務效益之外,我們的轉型也正在建立所需的敏捷性,以支持武田下一階段的成長。稍後 Milano 將說明節省進度,以及我們如何再投資以加速成長。
Let me now turn to ORZEYFUL and how excited we are about this new class of medicine. ORZEYFUL is a first-in-class oral orexin receptor 2 agonist for the treatment of narcolepsy type 1 or NT1. Unlike treatments that focus on individual symptoms, it is designed to address the underlying orexin deficiency. We believe it has the potential to redefine the standard of care by delivering transformative efficacy across a broad range of NT1 symptoms.
接下來我想談談 ORZEYFUL,以及我們對這一全新藥物類別的高度期待。ORZEYFUL 是同類首創的口服食慾素受體 2(orexin receptor 2)致效劑,用於治療第一型嗜睡症(narcolepsy type 1,NT1)。不同於僅聚焦單一症狀的治療方式,它的設計旨在處理根本性的食慾素缺乏。我們相信它有潛力透過對 NT1 多種症狀展現具變革性的療效,重新定義照護標準。
NT1 diagnosis is a challenge. The diagnosis rate ranges from less than 10% in China to roughly 40% and 50% in Japan and the US, respectively. And in the US, more than half of patients diagnosed with NT1 continue to experience symptoms despite switching treatments or taking multiple medications. In all markets, we will first focus on individuals who have already been diagnosed. At the time of our last call, ORZEYFUL had just been approved in China. And since then, it has also been approved in the US and Japan, all within about 1 month. ORZEYFUL launched simultaneously in Japan and China on October 15, and we're really excited about the potential to fundamentally change how NT1 is managed with great early response from both patients and HCPs.
NT1 的診斷是一項挑戰。診斷率在中國低於 10%,而在日本與美國則分別約為 40% 與 50%。在美國,超過一半已確診 NT1 的病患,即使更換治療或同時使用多種藥物,仍持續出現症狀。在所有市場中,我們將首先聚焦於已經確診的族群。在上次電話會議時,ORZEYFUL 才剛在中國獲批。此後,它也在美國與日本獲得核准,三地皆在約 1 個月內完成。ORZEYFUL 已於 10 月 15 日在日本與中國同步上市;我們對其有潛力從根本上改變 NT1 的管理方式感到非常振奮,且已從病患與醫療照護專業人員(HCPs)獲得良好的早期回饋。
In the US, we've been preparing for launch for more than a year with our medical teams engaging sleep specialists and our specialty pharmacy network and patient support programs now in place. We expect to launch ORZEYFUL through specialty pharmacies as soon as DEA scheduling is complete, which we anticipate by early November. Finally, it makes me extremely proud to share that ORZEYFUL was recently selected as one of TIME Magazine's best inventions of 2026 in the scientific innovation category.
在美國,我們已為上市準備超過一年,醫療團隊與睡眠專科醫師密切合作,並且我們的專科藥局網絡與病患支持計畫現已就緒。我們預期在 DEA 排程完成後,將盡快透過專科藥局推出 ORZEYFUL;我們預估最早在 11 月初完成。最後,我非常自豪地分享,ORZEYFUL 近期獲選為《TIME》雜誌 2026 年最佳發明之一,並入選科學創新類別。
Turning to the next slide. We're also thrilled about the early progress with MIMRYLO, an FDA-approved treatment for erythrocytosis in adults with polycythemia vera. MIMRYLO received FDA approval on August 28 and became commercially available very soon thereafter. This is a first-in-class hepcidin mimetic and is administered once weekly by subcutaneous injection. MIMRYLO provides rapid, stable and durable hematocrit control, the primary goal of PV treatment and has been shown to reduce the burden of phlebotomy and improve fatigue. The prescribing label allows physicians to use MIMRYLO at any point in the treatment paradigm with no box warning, giving us clear differentiation over other advanced therapies approved in this area.
接著看下一張投影片。我們也對 MIMRYLO 的早期進展感到振奮;MIMRYLO 是一項已獲 FDA 核准、用於治療真性紅血球增多症(polycythemia vera, PV)成人紅血球增多症的療法。MIMRYLO 已於 8 月 28 日獲得 FDA 核准,並在不久後即開始商業供應。這是一款同類首創(first-in-class)的 hepcidin 擬似物,採每週一次皮下注射給藥。MIMRYLO 可提供快速、穩定且持久的血比容控制——這是 PV 治療的主要目標——並已證實可降低放血治療的負擔並改善疲勞。其核准標示允許醫師在治療流程中的任何階段使用 MIMRYLO,且無黑框警語,使我們相較於此領域其他已核准的進階療法具備明確差異化。
Also, it is the only PV treatment listed as a category 1 recommendation in the NCCN guidelines for both high- and low-risk patients. This medicine addresses a disease affecting approximately 90,000 people in the United States. We have been educating physicians about the burden of uncontrolled hematocrit and repeated phlebotomy and identifying patients who can benefit from a new treatment option. We are also leveraging our established hematology capabilities, payer relationships and patient support resources to support the launch and build momentum. At this early stage, we are focused on raising physician awareness and securing payer coverage so that appropriate patients can access MIMRYLO. Our goal is to build the foundation for both durable adoption and meaningful patient impact.
此外,它也是 NCCN 指南中,針對高風險與低風險病患皆列為第 1 類建議(category 1 recommendation)的唯一 PV 治療。此藥物所針對的疾病在美國約影響 90,000 人。我們一直在向醫師宣導血比容控制不佳與反覆放血治療所帶來的負擔,並辨識可受益於新治療選項的病患。我們也運用既有的血液學能力、與支付方的合作關係以及病患支持資源,以支援上市並建立動能。在這個早期階段,我們聚焦於提升醫師認知並取得支付方給付覆蓋,讓合適的病患能夠使用 MIMRYLO。我們的目標是為長期採用與具意義的病患影響奠定基礎。
If we go to slide 8, we've talked about ORZEYFUL and MIMRYLO, so let me focus on our third transformative medicine that we expect approval for within this fiscal year, zasocitinib. The FDA has accepted our application under priority review and the EMA has also accepted our application. The clinical data for zasocitinib are compelling, including head-to-head Phase 3 results demonstrating superiority versus deucravacitinib in achieving clear skin. These results further strengthen our confidence in zasocitinib's potential to become a leading oral treatment for people with plaque psoriasis with rapid, durable and consistent skin clearance.
若我們看第 8 張投影片,我們已談到 ORZEYFUL 與 MIMRYLO,接下來我將聚焦於我們預期在本會計年度內獲核准的第三項變革性藥物:zasocitinib。FDA 已以優先審查(priority review)受理我們的申請,EMA 也已受理我們的申請。zasocitinib 的臨床數據相當具說服力,其中包含第 3 期頭對頭試驗結果,顯示在達成皮膚清除方面優於 deucravacitinib。這些結果進一步強化我們對 zasocitinib 潛力的信心;它有望成為斑塊型乾癬患者的領先口服治療選項,提供快速、持久且一致的皮膚清除。
Andy will walk you through details of the head-to-head data shortly. Our payer engagement and field team preparations are well underway. We are positioned for a potential US launch following the FDA approval decision planned in the fourth quarter of fiscal year 2026. For each of these medicines, we are tailoring our launch approach to the market while applying the same proven fundamentals, engaging with physicians and payers establishing specialty pharmacy and patient support programs and preparing our field teams. With ORZEYFUL and MIMRYLO launches already underway, zasocitinib will build on that experience and the experience from across our portfolio.
Andy 稍後將帶各位了解頭對頭數據的細節。我們與支付方的互動以及前線團隊的準備工作正順利推進。在預計於 2026 會計年度第 4 季作出 FDA 核准決定後,我們已就可能的美國上市做好部署。針對每一項藥物,我們都會依市場情況調整上市策略,同時沿用同樣經驗證的基本功:與醫師與支付方互動、建立專科藥局與病患支持計畫,並為前線團隊做好準備。隨著 ORZEYFUL 與 MIMRYLO 的上市已在進行中,zasocitinib 將在此基礎上延伸,並結合我們整體產品組合的經驗。
Today, we are in Horizon 1 of our 2 Horizon strategy, and our focus is clear: transform Takeda for growth. We are building the capabilities we need to lead and establish the foundation for accelerated growth. At the halfway point of this fiscal year, I am encouraged by the progress we have made against our priorities.
今天,我們正處於「雙地平線(2 Horizon)」策略的地平線 1,而我們的重點非常明確:推動武田(Takeda)轉型以實現成長。我們正在建立所需能力,以引領並奠定加速成長的基礎。在本會計年度過半之際,我對我們在各項優先事項上取得的進展感到鼓舞。
Looking ahead, our focus remains on executing successful launches for medicines that are now reaching patients, advancing our late-stage pipeline with speed and quality, ensuring the resilience of our core in-line brands and executing transformation to position Takeda for sustainable, profitable growth. Each milestone we achieve builds our path towards Horizon 2, our growth acceleration phase. At our Capital Markets Day later this year, we will share more details on our progress and provide a lens into our longer-term growth strategy.
展望未來,我們仍將聚焦於:成功執行目前已觸及病患的藥物上市、以速度與品質推進後期研發管線、確保核心在售品牌的韌性,以及推動轉型以使武田達成可持續且具獲利性的成長。我們達成的每一個里程碑,都在為邁向地平線 2——我們的成長加速階段——鋪路。在今年稍晚的資本市場日(Capital Markets Day),我們將分享更多進展細節,並提供我們更長期成長策略的觀點。
With that, I will hand the call over to Milano.
接下來,我把電話會議交給 Milano。
Milano Furuta - Chief Financial Officer, Director
Milano Furuta - Chief Financial Officer, Director
Thank you, Julie, and hello, everyone. Let me walk you through our FY26 first half results and updated full year outlook. Slide 11 summarizes our H1 results. Overall, I'm pleased to say that our financial performance is well on track with our expectations. We have positioned FY26 as a year of investment. We are managing headwinds in our mature and off-patent portfolio while advancing our pipeline and launching new products that will be the drivers of future growth.
謝謝你,Julie,各位大家好。我將帶各位回顧 2026 會計年度上半年(FY26 H1)的業績,以及更新後的全年展望。第 11 張投影片總結了我們上半年的結果。整體而言,我很高興地表示,我們的財務表現與預期相當一致。我們將 FY26 定位為投資之年。在推進研發管線並推出將驅動未來成長的新產品之際,我們也在管理成熟與專利到期產品組合所面臨的逆風。
Revenue in H1 was JPY2.4 trillion, an increase of 8.4% at an actual FX rate or a decline of 1% at constant exchange rates or CER. Core operating profit was JPY710.6 billion, up 11.2% at an actual exchange rate and 0.7% at CER. We are seeing the benefits of the transformation program we initiated this year with savings being reallocated towards investments in new product launches and R&D. Core EPS was JPY308, a decline of 1.2% at CER. Meanwhile, reported EPS was JPY193 with year-on-year growth of 169% at actual FX. This reflects an increase in reported operating profit due to lower amortization and impairment expenses as well as a very low tax rate in H1 this year, partially due to timing of legal entity restructuring, which will be normalized in H2.
上半年營收為 2.4 兆日圓,以實際匯率計成長 8.4%;以固定匯率(CER)計則下降 1%。核心營業利益為 7,106 億日圓,以實際匯率計成長 11.2%,以 CER 計成長 0.7%。我們正看到今年啟動的轉型計畫帶來的效益,節省下來的成本被重新配置,用於新產品上市與研發投資。核心每股盈餘(Core EPS)為 308 日圓,以 CER 計下降 1.2%。同時,報導每股盈餘(reported EPS)為 193 日圓,以實際匯率計年增 169%。這反映了報導營業利益的提升,主因為攤銷與減損費用降低,以及今年上半年稅率非常低,部分原因是法律實體重組的時點因素;該影響將在下半年回歸正常。
Operating cash flow was JPY431.9 billion, and adjusted free cash flow was JPY325.7 billion. This was lower than prior year due to reduction of our trade receivables factoring program as well as a payment to Protagonist related to their decision to opt out of MIMRYLO co-commercialization in the US.
營業活動現金流為 4,319 億日圓,調整後自由現金流為 3,257 億日圓。相較去年較低,原因包括我們縮減應收帳款保理(factoring)計畫,以及因 Protagonist 決定退出在美國與我們共同商業化 MIMRYLO 而支付的一筆款項。
The transformation program started earlier this year, an initiative to strengthen Takeda's competitiveness and accelerate our future growth outlook. In the six months since we started the program, we have made progress across our transformation initiatives such as centralizing and streamlining corporate functions such as HR, finance and communications, reducing layers, particularly in the commercial organizations, bringing leaders closer to patients and customers, strengthening procurement excellence and simplifying processes with digital technologies and expanding our global capability centers.
轉型計畫於今年稍早啟動,旨在強化武田的競爭力並加速未來成長展望。在計畫啟動後的六個月內,我們在多項轉型舉措上取得進展,例如:集中化並精簡人資、財務與傳播等企業職能;減少層級,特別是在商業組織中,讓領導者更貼近病患與客戶;強化採購卓越能力;運用數位技術簡化流程;以及擴大全球能力中心。
Related to the organization design, we have moved with speed to implement changes. As of September 30, approximately 3,000 impacted roles have been communicated. In procurement, to date, we have implemented initiatives resulting in approximately JPY30 billion of annualized savings. This program remains on track to achieve JPY100 billion of gross savings with JPY160 billion of restructuring costs in FY26, JPY10 billion less than our original forecast. Over the next few slides, I'll explain more about our year-on-year performance.
在組織設計方面,我們迅速推動變革落地。截至 9 月 30 日,約有 3,000 個受影響職務已完成溝通。在採購方面,截至目前我們已推行多項措施,帶來約 300 億日圓的年化節省。本計畫仍按進度推進,目標是在 FY26 達成 1,000 億日圓的總節省,並產生 1,600 億日圓的重組成本,較原先預估少 100 億日圓。接下來幾張投影片,我將進一步說明我們的年對年表現。
First, revenue. New launches, which are products that launched in the past five years, still represents only 4% of total revenue today, but are growing well at 17.3% at CER. We look forward to expanding this category significantly in the coming quarters as we launch and drive uptake of ORZEYFUL, MIMRYLO and zasocitinib. Core in-line brands, which includes large established products such as ENTYVIO, immunoglobulin and TAKHZYRO represented 58% of total revenue and grew 0.5% at CER.
首先是營收。新上市產品(即過去五年內上市的產品)目前仍僅占總營收的 4%,但以 CER 計成長表現良好,達 17.3%。隨著我們推出並推動 ORZEYFUL、MIMRYLO 與 zasocitinib 的使用成長,我們期待在未來幾季大幅擴大此類別。核心在售品牌(core in-line brands),包括 ENTYVIO、免疫球蛋白與 TAKHZYRO 等大型成熟產品,占總營收的 58%,以 CER 計成長 0.5%。
The growth of new launches and the core in-line brands partially offset headwinds from loss of exclusivity products such as VYVANSE and a mature portfolio such as hemophilia franchise, resulting in overall revenue decline of 1% at CER. On an actual FX basis, the depreciation of the yen had a positive impact of JPY210 billion, resulting in reported revenue of JPY2.407 trillion, up 8.4% versus prior year.
新上市產品的成長以及核心既有上市品牌,部分抵銷了如 VYVANSE 等失去獨占期產品與如血友病產品線等成熟產品組合所帶來的逆風,使得整體營收以 CER 計算下降 1%。以實際匯率基礎計算,日圓貶值帶來正面影響 2,100 億日圓,使得報告營收達 2.407 兆日圓,較前一年成長 8.4%。
Slide 14 shows the bridge in core operating profit. Overall, growth was 0.7% at CER with OpEx savings from our transformation program helping to fund increased investment behind our growth priorities, including launch preparation for ORZEYFUL, MIMRYLO and zasocitinib and the continued progression of our R&D pipeline. FX was also positive for core operating profit, pushing the growth to 11.2% at an actual exchange rate.
投影片 14 顯示核心營業利益的橋接分析。整體而言,以 CER 計算成長 0.7%,我們轉型計畫帶來的營運費用(OpEx)節省,有助於支應我們在成長優先事項上的加大投資,包括 ORZEYFUL、MIMRYLO 與 zasocitinib 的上市準備,以及研發(R&D)產品線的持續推進。匯率對核心營業利益亦有正面貢獻,使得以實際匯率計算的成長率提升至 11.2%。
Next, reported operating profit on slide 15. The main items driving the 60.4% improvement versus prior year were lower amortization costs due to the conclusion of VYVANSE amortization in January 2026 and lower impairment of intangible assets compared to the prior year, mainly due to a charge in FY25 related to discontinuation of our cell therapy efforts.
接著看投影片 15 的報告營業利益。相較前一年改善 60.4% 的主要驅動因素為攤銷費用下降(因 VYVANSE 於 2026 年 1 月攤銷結束)以及無形資產減損較前一年降低,主要是因 FY25 曾因終止我們的細胞治療投入而認列費用。
Moving now to our updated outlook for full year FY26. Starting with management guidance for CER growth, we maintain our revenue guidance of low single-digit percent decline. We have made some adjustments on a product-by-product basis, which you can confirm in our supplemental materials. This includes reducing our forecast for albumin to reflect ongoing market dynamics, while on the other hand, increasing VYVANSE and TRINTELLIX. We maintain our outlook for immunoglobulin with expectation of a growth rebound in second half, and we will continue to monitor competitive and pricing dynamics.
現在轉到我們更新後的 FY26 全年展望。先從管理層對 CER 成長的指引開始,我們維持營收指引為低個位數百分比下滑。我們已就各產品別做出一些調整,您可在補充資料中確認。其中包括下調白蛋白(albumin)的預測以反映持續的市場動態;另一方面,上調 VYVANSE 與 TRINTELLIX。我們維持免疫球蛋白(immunoglobulin)的展望,預期下半年成長將反彈,並將持續監測競爭與定價動態。
We are raising our management guidance for core operating profit and core EPS to reflect transaction FX benefits. Outside of FX, the underlying business continues to perform very much in line with our initial expectations for the year. The bottom half of the slide shows our forecast on an absolute basis. We are raising our revenue forecast by JPY60 billion and the core operating profit forecast by JPY30 billion, also mainly due to a change in FX rate assumptions.
我們上調核心營業利益與核心每股盈餘(core EPS)的管理層指引,以反映交易匯率(transaction FX)帶來的效益。撇除匯率因素,基本面業務表現仍大致符合我們年初的預期。投影片下半部顯示我們以絕對金額計的預測。我們將營收預測上調 600 億日圓,核心營業利益預測上調 300 億日圓,主要亦是因匯率假設變動所致。
The final slide in my section shows a bridge from our original operating profit forecast of JPY1.16 trillion to the revised forecast of JPY1.19 trillion. As explained on the previous slide, the main reason for the increase is FX. There is some movements by line item in our forecast as a savings target originally in the SG&A budget has been reallocated to opportunities we identified in R&D and cost of goods. Overall, the key message here is that our first half results are on track. We are tightly managing costs across the P&L while still making the necessary investments to drive future growth.
我這部分的最後一張投影片,顯示從原先營業利益預測 1.16 兆日圓到修正後 1.19 兆日圓的橋接分析。如前一張投影片所述,上調的主要原因是匯率。由於原先在銷售、一般及行政費用(SG&A)預算中的節省目標,已重新配置至我們在研發(R&D)與銷貨成本(cost of goods)中所辨識的機會,因此預測中各項目之間出現一些變動。整體而言,關鍵訊息是我們上半年結果符合進度。我們在整體損益表(P&L)上嚴格控管成本,同時仍進行必要投資以推動未來成長。
Thank you for your attention. I will now hand over to Andy for pipeline highlights.
感謝各位的聆聽。接下來我將交棒給 Andy,分享產品線(pipeline)重點。
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Thank you, Milano, and hello to everyone joining us on the call. Today, I would like to focus on three areas: emerging data for our flagship brand, ENTYVIO, that could change clinical practice, pipeline progress with an emphasis on our launch products and exciting new data for TAK-921. Together, these updates demonstrate progress against our Horizon 1 priorities, strengthening the resilience of our core in-line brands, delivering successful launches and advancing our pipeline.
謝謝你,Milano,也向所有參與本次電話會議的各位問好。今天我想聚焦三個面向:我們旗艦品牌 ENTYVIO 的新興數據,可能改變臨床實務;產品線進展,重點放在我們的上市產品;以及 TAK-921 令人振奮的新數據。這些更新共同展現我們在 Horizon 1 優先事項上的進展:強化核心既有上市品牌的韌性、實現成功上市,並推進我們的產品線。
Treat-to-target strategies have improved outcomes across many chronic diseases by moving beyond symptom control towards deeper objective measures of disease control. VERDICT is the first and only prospective treat-to-target trial in both moderate and severe ulcerative colitis patients, evaluating whether treating to more stringent composite endpoints with gut-focused ENTYVIO can improve long-term outcomes. Patients received standard ENTYVIO induction and every eight week maintenance with steroid tapering. Physicians had the option to escalate treatment every four weeks as needed to hit targets.
「以目標為導向治療」(treat-to-target)策略,透過從僅控制症狀進一步轉向更深層、客觀的疾病控制衡量指標,已改善多種慢性疾病的治療結果。VERDICT 是首個且唯一一項前瞻性 treat-to-target 試驗,納入中度與重度潰瘍性結腸炎(ulcerative colitis)患者,評估以腸道靶向的 ENTYVIO 針對更嚴格的複合終點進行治療,是否能改善長期結果。患者接受標準 ENTYVIO 誘導治療,並每 8 週維持治療,同時逐步減量類固醇。醫師可視需要選擇每 4 週加強治療,以達成目標。
The results demonstrate that treating to more stringent endpoints with ENTYVIO reduced the risk of UC-related complications by approximately 70% with this benefit extending up to 80 weeks after target achievement. ENTYVIO has been on the market for over 12 years with over 2 million patient years of therapy and a strong safety profile. It was thus not surprising that the safety was similar across the groups, even with the potential for more frequent dosing. VERDICT also provides compelling evidence that deep remission is achievable with ENTYVIO. More than half of the patients, 52.1% assigned to Group 3, achieved the stringent disease clearance target.
結果顯示,使用 ENTYVIO 針對更嚴格終點進行治療,可將與潰瘍性結腸炎(UC)相關併發症的風險降低約 70%,且在達成目標後,此效益可延續至 80 週。ENTYVIO 上市已超過 12 年,累積治療超過 200 萬病人年,且具備良好的安全性概況。因此,即使可能採用更頻繁的給藥,安全性在各組之間相近也並不令人意外。VERDICT 亦提供有力證據顯示,使用 ENTYVIO 可達成深度緩解(deep remission)。超過一半的患者(分派至第 3 組者為 52.1%)達成嚴格的疾病清除(disease clearance)目標。
These findings reinforce an important shift in our ambition for UC, moving beyond symptom control towards disease clearance. By treating earlier and to more stringent targets with ENTYVIO, we have the potential to reduce future complications and change the trajectory of this progressive disease. These data were very well received at the United European Gastroenterology Week, or UEG, and provide important new evidence supporting the role of ENTYVIO in a treat-to-target approach.
這些發現強化了我們在 UC 治療目標上的重要轉變:從症狀控制進一步邁向疾病清除。透過更早介入並以 ENTYVIO 追求更嚴格的治療目標,我們有機會降低未來併發症並改變此進行性疾病的病程走向。這些數據在歐洲聯合胃腸病學週(United European Gastroenterology Week,UEG)獲得非常正面的回響,並提供重要的新證據,支持 ENTYVIO 在 treat-to-target 治療策略中的角色。
Let me now turn to our rapidly maturing pipeline that we believe can drive Takeda's next phase of growth. As Julie mentioned, we believe these three medicines will change the trajectory of Takeda's growth and importantly, make a meaningful difference for patients. ORZEYFUL is one of the most exciting stories in medical science today.
接下來談談我們快速成熟的產品線,我們相信它能推動武田下一階段的成長。如 Julie 所提到,我們相信這三項藥物將改變武田的成長軌跡,更重要的是,能為患者帶來實質且有意義的改善。ORZEYFUL 是當今醫學科學中最令人振奮的故事之一。
The journey began with Emmanuel Mignot and Masashi Yanagisawa, whose identification of orexin deficiency as the root cause of narcolepsy earned them the 2026 Lasker Basic Medical Research Award. This summer, ORZEYFUL's Phase 3 data were published in the New England Journal of Medicine, the third time orexin biology has been highlighted there.
這段旅程始於 Emmanuel Mignot 與 Masashi Yanagisawa,他們辨識出食慾素(orexin)缺乏是嗜睡症(narcolepsy)的根本原因,並因此獲得 2026 年拉斯克基礎醫學研究獎(Lasker Basic Medical Research Award)。今年夏天,ORZEYFUL 的第 3 期數據發表於《新英格蘭醫學期刊》(New England Journal of Medicine),這也是食慾素生物學第三次在該期刊中受到重點報導。
More recently, as Julie shared, TIME Magazine named ORZEYFUL one of the Best inventions of 2026. Narcolepsy type 1 is a lifelong disorder caused by the loss of orexin signaling, leading to disabling daytime and nighttime symptoms. We have presented groundbreaking Phase 3 results and continue to generate additional data across the broad disease spectrum, which includes daytime symptoms like excessive daytime sleepiness and cataplexy as well as nighttime symptoms, cognitive symptoms, functional improvements and quality of life.
更近期,如 Julie 所分享,《TIME》雜誌將 ORZEYFUL 評選為 2026 年最佳發明之一。第一型嗜睡症(narcolepsy type 1)是一種終身疾病,由食慾素訊號喪失所致,會引發影響生活功能的日間與夜間症狀。我們已發表突破性的第 3 期結果,並持續在廣泛的疾病譜系中產出更多數據,涵蓋日間症狀(如過度日間嗜睡與猝倒)、夜間症狀、認知症狀、功能改善以及生活品質。
ORZEYFUL does more than manage symptoms. It addresses the underlying orexin deficiency in NT1. As a single, well-tolerated oral therapy, it could restore how a majority of NT1 patients feel and function. ORZEYFUL is now available in Japan and China. We anticipate a DEA scheduling decision in the coming days with the US launch to begin immediately thereafter.
ORZEYFUL 不僅是管理症狀。它可處理 NT1 的根本問題——食慾素缺乏。作為單一、耐受性良好的口服治療,它有望恢復多數 NT1 患者的感受與功能表現。ORZEYFUL 目前已在日本與中國上市。我們預期未來幾天內將收到 DEA 的分級(scheduling)決定,並將在其後立即啟動美國上市。
MIMRYLO, our first-in-class hepcidin mimetic, represents a fundamentally different approach to managing polycythemia vera or PV. Rather than relying on repeated phlebotomy to remove excess red blood cells, MIMRYLO mimics the physiologic action of hepcidin, restricting iron availability for erythropoiesis and thereby controlling excessive red blood cell production. In clinical trials, MIMRYLO was able to provide rapid, stable and durable hematocrit control, reduce phlebotomy requirements and improve fatigue.
MIMRYLO 作為同類首創(first-in-class)的鐵調素(hepcidin)擬似物,代表一種在管理真性紅血球增多症(polycythemia vera,PV)上的根本不同方法。它不是依賴反覆放血(phlebotomy)移除過多紅血球,而是模擬鐵調素的生理作用,限制紅血球生成(erythropoiesis)所需的鐵可用性,從而控制過度的紅血球生成。在臨床試驗中,MIMRYLO 能提供快速、穩定且持久的血比容(hematocrit)控制,降低放血需求並改善疲勞。
Following its late August approval, MIMRYLO was rapidly incorporated into the NCCN guidelines in September as the only category 1 option for both low and high-risk PV. Category 1 is reserved for medicine supported by high-level Phase 3 evidence and uniform expert consensus. Encouraging early physician and patient feedback further reinforce the potential for MIMRYLO to change how PV is managed.
在8月下旬獲得核准後,MIMRYLO 於9月迅速被納入 NCCN 指南,成為低風險與高風險 PV 的唯一第1類(category 1)選項。第1類僅保留給具有高等級第三期(Phase 3)證據支持且專家共識一致的藥物。令人鼓舞的早期醫師與病患回饋,進一步強化了 MIMRYLO 有望改變 PV 治療管理方式的潛力。
Zasocitinib is our next-generation, highly selective oral TYK2 inhibitor, which has demonstrated rapid and durable skin clearance in a convenient once-daily pill. We have filed for approval in the US and Europe. We also had new data presented at EADV that makes the profile even more compelling. The Phase 3 LATITUDE Atlas trial directly compares zasocitinib with deucravacitinib using PASI 100 as the primary endpoint.
Zasocitinib 是我們新一代、高度選擇性的口服 TYK2 抑制劑,已在每日一次的便利口服劑型中,展現快速且持久的皮膚清除效果。我們已在美國與歐洲提出核准申請。我們也在 EADV 發表了新的數據,使其整體特徵更具吸引力。第三期(Phase 3)LATITUDE Atlas 試驗以 PASI 100 為主要終點,直接比較 zasocitinib 與 deucravacitinib。
The key takeaway is straightforward. At week 16, 36.5% of patients treated with zasocitinib achieved complete skin clearance. This is the highest rate of skin clearance demonstrated by an oral therapy in psoriasis. For patients, complete clearance is the desired outcome. We also saw improvement in itch in zasocitinib beginning as early as week two.
關鍵結論很明確。在第16週,接受 zasocitinib 治療的病患中有 36.5% 達到皮膚完全清除。這是口服療法在乾癬中所示範的最高皮膚清除率。對病患而言,完全清除是期望的治療結果。我們也觀察到 zasocitinib 對搔癢的改善,最早可自第2週開始出現。
Importantly, the safety profile was consistent with prior trials. Taken all together, these results reinforce our confidence in zasocitinib as a potentially important oral treatment for people living with psoriasis. We are looking forward to updating you on our regulatory progress in the US and Europe. And later this fiscal year, we plan to share additional zasocitinib data, including robust 52 week durability data from our 3003 study. We continue to execute across our broad late-stage portfolio with many important Phase 2 and Phase 3 readouts ahead.
重要的是,其安全性特徵與先前試驗一致。綜合而言,這些結果強化了我們對 zasocitinib 的信心,認為其可能成為乾癬患者一項重要的口服治療選擇。我們期待向各位更新我們在美國與歐洲的法規進展。此外,在本會計年度稍晚,我們計畫分享更多 zasocitinib 數據,包括來自 3003 研究的強而有力之 52 週持久性數據。我們持續推進廣泛的後期研發組合,未來將有多項重要的第二期與第三期(Phase 2/Phase 3)讀出。
Today, I'll focus on two programs that generate frequent questions, zasocitinib in ulcerative colitis and Crohn's disease, and TAK-360 in narcolepsy type two and idiopathic hypersomnia. While we had initially planned to disclose the zasocitinib UC and Crohn's results together, we've decided to share a directional summary of the UC data today. Our expectations have been somewhat more measured in UC given the mechanistic rationale, which we believe may be even stronger in Crohn's disease. Against that backdrop, we found the UC results encouraging.
今天,我將聚焦兩個經常被問到的計畫:zasocitinib 用於潰瘍性結腸炎與克隆氏症,以及 TAK-360 用於第二型嗜睡症與特發性嗜睡症。雖然我們原先規劃同時揭露 zasocitinib 在 UC 與克隆氏症的結果,但我們決定今天先分享 UC 數據的方向性摘要。基於作用機轉的理據,我們對 UC 的預期相對更為審慎;我們認為該理據在克隆氏症可能更強。在此背景下,我們認為 UC 的結果令人鼓舞。
In brief, we've completed our zasocitinib Phase 2 ulcerative colitis study and are pleased with the clinical remission rate observed at week 12. We saw a strong separation from placebo and a nominally significant p-value at one of the two doses tested. Overall clinical remission results are on par with other investigational oral products in Phase 2 UC studies. Safety across all dose arms remain consistent with our experience in previous trials. While we have not observed a dose-dependent efficacy effect, this is not unusual in dose-ranging IBD studies, and we are actively evaluating potential factors that may have contributed to the dose response profile.
簡而言之,我們已完成 zasocitinib 第二期潰瘍性結腸炎研究,並對第12週觀察到的臨床緩解率感到滿意。我們看到與安慰劑之間有明顯差異,且在兩個測試劑量中的其中一個劑量達到名目上顯著(nominally significant)的 p 值。整體臨床緩解結果與其他處於 UC 第二期研究中的口服研發中產品相當。所有劑量組的安全性仍與我們在先前試驗中的經驗一致。雖然我們未觀察到隨劑量增加而提升的療效(dose-dependent efficacy)效果,但這在 IBD 劑量探索研究中並不罕見;我們正積極評估可能導致此劑量反應特徵的潛在因素。
Importantly, the full dose-ranging Crohn's disease study will provide additional data. We expect the Phase 2b Crohn's readout around the end of fiscal year 2026. We are planning for success, and our team is working on Phase 3 scenarios in both indications. And ultimately, our path forward will be based on the totality of evidence across the program.
重要的是,完整的克隆氏症劑量探索研究將提供更多數據。我們預期第二期 b(Phase 2b)克隆氏症讀出約在 2026 會計年度末。我們正以成功為前提進行規劃,團隊也在兩個適應症上研擬第三期(Phase 3)情境。最終,我們的後續方向將以整個計畫的全部證據為依據。
Next, the orexin franchise continues to advance well with ORZEYFUL approved in the United States, Japan and China for narcolepsy type 1. NT1 is the only orexin-deficient disease. In other more heterogeneous patient populations, we are working hard to untangle the biology and determine the right orexin profile for each central disorder of hypersomnolence and for the other potential indications. TAK-360 is being studied in orexin normal populations like NT2 and idiopathic hypersomnia, where we aim to address key symptoms and expect to have results in Q4 of fiscal year 2026.
接下來,食慾素(orexin)產品線持續順利推進,ORZEYFUL 已在美國、日本與中國獲准用於第一型嗜睡症(narcolepsy type 1)。NT1 是唯一一種食慾素缺乏的疾病。在其他更具異質性的病患族群中,我們正努力釐清其生物學機制,並為每一種中樞性嗜睡障礙(central disorder of hypersomnolence)及其他潛在適應症,確定合適的食慾素特徵。TAK-360 正在食慾素正常的族群(如 NT2 與特發性嗜睡症)中進行研究;我們的目標是改善關鍵症狀,並預期在 2026 會計年度第4季取得結果。
Now let me turn to oncology. Oncology continues to execute across its broad portfolio with the approval of MIMRYLO in the US Elritercept has started Phase 3 trials in myelofibrosis and in first-line myelodysplastic syndrome and is enrolling well. TAK-921 had potentially practice-changing data in advanced gastric cancer, which we will review shortly.
現在讓我轉到腫瘤領域。腫瘤事業持續在其廣泛的產品組合上推進,包括 MIMRYLO 在美國獲准;Elritercept 已在骨髓纖維化與第一線骨髓增生異常症候群啟動第三期(Phase 3)試驗,且收案進展良好。TAK-921 在晚期胃癌中取得可能改變臨床實務的數據,我們稍後將進行回顧。
In PDT, we have completed a US regulatory filing for TAK-881, our 20% next-generation facilitated subcutaneous IG for primary immune deficiency, and are on track to complete filings in multiple indications in Europe and Japan later this fiscal year.
在 PDT 領域,我們已完成 TAK-881 的美國法規申請;TAK-881 為我們用於原發性免疫缺乏症的 20% 新一代促進型皮下免疫球蛋白(facilitated subcutaneous IG)。我們也按計畫在本會計年度稍晚完成於歐洲與日本多項適應症的申請。
Let me close our pipeline review with the latest data for TAK-921. TAK-921 is our investigational Claudin 18.2 targeted antibody drug conjugate with an Fc-silenced backbone, delivering a potent exatecan topoisomerase I inhibitor payload to tumors. Last week at ESMO, we presented groundbreaking Phase 3 data for TAK-921 in advanced gastric cancer versus chemotherapy.
讓我以 TAK-921 的最新數據作為研發管線回顧的結尾。TAK-921 是我們的研發中 Claudin 18.2 標的抗體藥物複合體(ADC),採用 Fc 靜默(Fc-silenced)骨架,將具強效的 exatecan 拓撲異構酶 I 抑制劑載荷遞送至腫瘤。上週在 ESMO,我們發表了 TAK-921 對比化療用於晚期胃癌的突破性第三期(Phase 3)數據。
The patients enrolled were refractory to at least three lines of therapy with 30% of patients on their fourth or fifth line, representing an area of true unmet need. In this very sick patient population, TAK-921 delivered an exceptional improvement in objective response rate, statistically significant progression-free survival that hit at the first interim analysis and statistically significant and clinically meaningful overall survival with a hazard ratio of 0.57.
納入的病患對至少三線治療已無反應,其中 30% 的病患處於第四或第五線治療,代表真正未被滿足的醫療需求領域。在這個病情非常嚴重的病患族群中,TAK-921 在客觀反應率上帶來卓越提升;無惡化存活期(PFS)達到統計顯著,且在第一次期中分析即達成;整體存活期(OS)亦達到統計顯著且具臨床意義,風險比(hazard ratio)為 0.57。
The safety also remained differentiated with limited severe gastrointestinal toxicities, including nausea and vomiting. Grade 3 or higher treatment-related adverse events, dose reductions and delays were less frequent than in the chemotherapy arm. We believe TAK-921's Fc-silenced design provides a competitive advantage in gastrointestinal tolerability relative to other Claudin 18.2 targeted therapies. This profile may make it more suitable for combination with current and future standards of care in first-line gastric and pancreatic cancer.
安全性也維持差異化表現,嚴重胃腸道毒性(包括噁心與嘔吐)有限。與化療組相比,3 級或以上治療相關不良事件、減量與延遲給藥的發生頻率較低。我們相信 TAK-921 的 Fc 靜默設計,相較於其他 Claudin 18.2 標的療法,在胃腸道耐受性方面具競爭優勢。此特徵可能使其更適合與目前及未來第一線胃癌與胰臟癌的標準治療進行併用。
We plan on filing for approval in Japan for previously treated advanced gastric cancer in fiscal year 2027. Proof-of-concept studies are ongoing globally for first-line gastric and pancreatic cancer with readouts expected over the next 18 months.
我們計畫於 2027 會計年度在日本就既往治療後的晚期胃癌提出核准申請。針對第一線胃癌與胰臟癌的概念驗證(proof-of-concept)研究正在全球進行中,預期未來 18 個月內將有讀出。
Let me conclude by repeating that this is the best pipeline Takeda has had in the modern era. I have never been more confident in the science, the team behind it or our ability to improve our patients' lives and build a healthier world for generations. We look forward to sharing our continued progress with you.
最後我想重申,這是武田在現代以來最好的研發管線。我從未對科學本身、背後的團隊,以及我們改善病患生活並為世世代代打造更健康世界的能力如此有信心。我們期待與各位分享我們持續的進展。
Thank you. And with that, I'll now turn it back to Julie for closing remarks. Julie?
謝謝。接下來,我把時間交回給 Julie 作結語。Julie?
Julie Kim - President, Chief Executive Officer, Representative Director
Julie Kim - President, Chief Executive Officer, Representative Director
Thank you, Andy. As you've heard today, we are making steady progress across all four of our Horizon 1 priorities. We are building new growth drivers through the ongoing and upcoming launches of three new medicines for ORZEYFUL, MIMRYLO, and zasocitinib. Our late-stage pipeline continues to move through key inflection points, including positive overall survival and progression-free survival data for TAK-921 and the start of a Phase 3 study for elritercept.
謝謝你,Andy。正如各位今天所聽到的,我們在四項 Horizon 1 優先事項上都在穩健推進。我們正透過 ORZEYFUL、MIMRYLO 與 zasocitinib 三款新藥的持續與即將到來的上市,建立新的成長動能。我們的後期研發管線持續邁向關鍵拐點,包括 TAK-921 的整體存活期與無惡化存活期正向數據,以及 elritercept 第三期(Phase 3)研究的啟動。
Our core in-line brands such as ENTYVIO, continue to be resilient and performed broadly in line with our expectations. And our transformation is delivering. It is unlocking new capabilities and generating savings that we are reinvesting in our launches and pipeline. Taken together, this progress gives us confidence in our trajectory. Each milestone strengthens the foundation for Horizon 2 and brings us closer to sustainable, profitable growth and greater impact for patients.
我們的核心在售品牌(例如 ENTYVIO)持續展現韌性,整體表現大致符合我們的預期。同時,我們的轉型也正在產生成效。它正在解鎖新的能力並帶來節省,而我們正將這些節省再投資於新品上市與研發管線。綜合而言,這些進展讓我們對自身的發展軌跡更具信心。每一個里程碑都在強化「Horizon 2」的基礎,並讓我們更接近可持續、具獲利性的成長,以及為病患帶來更大的影響。
With that, I'll turn the call over to Chris for questions.
接下來,我把電話會議交給 Chris 進行問答。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
(Interpreted) Now we would like to start receiving questions. We have Julie, Furuta and Andy and also Rhonda Pacheco, President, US Business Unit, Teresa Bitetti, President, Oncology Business Unit; and Ramy Riad, President, Plasma-Derived Therapies Business Unit as well.
(口譯)現在我們開始接受提問。我們也有 Julie、Furuta、Andy,以及 Rhonda Pacheco(美國事業部總裁)、Teresa Bitetti(腫瘤事業部總裁)和 Ramy Riad(血漿衍生療法事業部總裁)一同參與。
(Event Instructions) Yamaguchi-san, Citi.
(活動指示)山口先生,花旗。
Hidemaru Yamaguchi - Analyst
Hidemaru Yamaguchi - Analyst
I have two questions. The first question is regarding MIMRYLO. The product looks pretty good, but you hinted that it takes some time to get the reimbursement treatment. But can you give me some early launch sort of impressions, number-wise or some other key success factor-wise? That's the first question.
我有兩個問題。第一個問題是關於 MIMRYLO。這個產品看起來相當不錯,但你們提到取得給付(報銷)待遇需要一些時間。不過,能否就早期上市的初步印象,從數字面或其他關鍵成功因素的角度,提供一些分享?這是第一個問題。
And the second questions is that thank you very much for sharing the UC, the top-line data of zaso. And the information you gave me are still a little bit confusing to me, especially the dose dependency issue. And I understand it didn't happen on IBD in the past, but can you clarify out of two doses, which has a good data and which one didn't? And what do you need to understand further to decide whether you can go to the Phase 3 or not because a dose dependency issue, a bit of a question from the investment community at the moment.
第二個問題是,非常感謝你們分享 zaso 在 UC 的頂線數據。但你們提供的資訊我仍覺得有點混亂,特別是劑量依賴性的問題。我理解過去在 IBD 並未出現這種情況,但你們能否釐清兩個劑量之中,哪一個數據表現較好、哪一個沒有?另外,為了決定是否能進入第三期,你們還需要進一步了解什麼?因為目前投資界對劑量依賴性問題有些疑問。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Thank you, Yamaguchi-san, for your questions. So the first question on MIMRYLO launch uptake and reimbursement. So our President of Oncology, Teresa Bitetti, can answer that question. And your second question on the UC top line announcement and what we would need to see for a Phase 3 decision. Andy Plump can comment on that one, please. Teresa?
謝謝你,山口先生,提出這些問題。第一個問題關於 MIMRYLO 上市採用情況與給付。我們的腫瘤事業部總裁 Teresa Bitetti 可以回答。第二個問題關於 UC 頂線公布,以及我們在做第三期決策前需要看到什麼。請 Andy Plump 來回應。Teresa?
Teresa Bitetti - President of the Global Oncology Business Unit
Teresa Bitetti - President of the Global Oncology Business Unit
This is Teresa. Thank you so much for that question. We're very excited around how the launch is going. I'll remind you that MIMRYLO was the first time in over 10 years that we have had a new mechanism in this marketplace that truly addresses the gold standard of treatment for PV, which is keeping that hematocrit level consistently, durably and rapidly below the 45% range. And as we move into this market, we know that 78% of the patients remain above at various points in time, the 45% mark.
我是 Teresa。非常感謝這個問題。我們對上市進展感到非常振奮。我提醒各位,MIMRYLO 是超過 10 年來我們首次在這個市場推出全新機轉的產品,能真正對應 PV 治療的黃金標準:將血比容(hematocrit)水準持續、持久且快速地維持在 45% 以下。而在我們進入這個市場時,我們知道有 78% 的病患在不同時間點仍高於 45% 的門檻。
And if you're above 45%, you're at a 4 times higher risk of death or a cardiovascular event. So we have found the reception. It is early days in the launch. We were approved at the end of August. The reception from the HCP market and from patients has been very excited, very positive. The execution of the launch is going very well. It is early days, so we don't have quantitative measures to share, but I can tell you from what I'm hearing on the ground that there is enthusiasm across the board and things are proceeding exactly as we planned with a real focus on education, awareness as well as ensuring access. So thank you for the question.
若高於 45%,死亡或心血管事件的風險會高出 4 倍。因此我們看到市場反應。目前仍是上市初期。我們在 8 月底獲得核准。醫護人員(HCP)市場與病患端的反應都非常興奮、非常正面。上市執行進展也非常順利。由於仍在初期,我們沒有可分享的量化指標,但我可以告訴你,從第一線回饋來看,各方面都充滿熱情,且一切都依照我們的規劃推進,重點聚焦在教育與提升認知,同時也確保可近性(access)。所以謝謝你的提問。
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Yes, Yamaguchi-san, this is Andy, and thank you very much for the question. We are, of course, expecting questions on the UC zaso disclosure. So you may recall that we had originally disclosed that we would share data together for UC and Crohn's. So we decided to pivot and there are a couple of reasons behind the pivot. One is that there's going to be about a six to seven month delay between the UC data and the Crohn's disease data. So that's a bit longer than what we had hoped for.
是的,山口先生,我是 Andy,也非常感謝你的問題。我們當然預期大家會就 UC 的 zaso 揭露提出問題。你可能記得,我們原先曾表示會把 UC 與克隆氏症(Crohn's)的數據一起分享。我們後來決定調整做法,背後有幾個原因。其中之一是 UC 數據與克隆氏症數據之間會有約 6 到 7 個月的延遲。這比我們原先希望的時間更長一些。
The second is that the UC data were actually more encouraging in many ways than what we had expected. As we've discussed previously, we're quite excited about the broad profile of zasocitinib. We think that this is truly a best-in-class TYK2 inhibitor. We do -- the mechanism in ulcerative colitis has carried a little bit of baggage historically because there's been two failed trials in UC. And mechanistically, the rationale points to, we think, a greater likelihood of success in Crohn's disease -- so we put all that together, our initial plan was to disclose the two data sets as one.
第二個原因是,UC 的數據在許多方面其實比我們預期更令人鼓舞。如同我們先前討論過的,我們對 zasocitinib 的整體特性相當興奮。我們認為這確實是一款同類最佳(best-in-class)的 TYK2 抑制劑。不過,潰瘍性結腸炎的機轉在歷史上背負了一些包袱,因為在 UC 曾有兩項試驗失敗。而從機轉合理性來看,我們認為在克隆氏症成功的可能性更高——因此綜合考量後,我們最初的計畫是把兩組數據一起揭露。
When we saw the UC data set, we were quite pleased with the efficacy at the middle dose. And as I mentioned in the presentation, directionally, the efficacy is on par with what's been seen with other oral agents in ulcerative colitis. And importantly, at both doses, the safety profile was very consistent with the safety profile that we've seen at the 30-milligram dose in psoriasis. The study is a complex study, though, because we don't see a dose response.
當我們看到 UC 這組數據時,我們對中間劑量的療效感到相當滿意。如同我在簡報中提到的,從方向性來看,其療效與潰瘍性結腸炎中其他口服藥物所見的結果相當。而且重要的是,在兩個劑量下,安全性概況都與我們在乾癬 30 毫克劑量所觀察到的安全性概況非常一致。不過,這項研究相當複雜,因為我們沒有看到劑量反應關係。
So we see a robust efficacy at the 50-milligram dose with a strong nominal p-value, but we're not seeing that with the 75-milligram dose. And as I mentioned, it's not uncommon in IBD to see, especially in smaller Phase 2b studies, a lack of a dose response. We're working hard to understand this mechanistically. And in the end, we'll look forward to seeing the Crohn's data and putting those two data sets together to make a decision on whether and how we move forward with Phase 3.
我們在 50 毫克劑量看到強勁的療效,且名目 p 值(nominal p-value)表現良好,但在 75 毫克劑量並未看到同樣結果。如我所提,尤其在較小型的第二期 2b 研究中,在 IBD 看不到劑量反應並不罕見。我們正努力從機轉面理解這個現象。最終,我們會期待看到克隆氏症數據,並把兩組數據合併評估,以決定是否以及如何推進到第三期。
Hidemaru Yamaguchi - Analyst
Hidemaru Yamaguchi - Analyst
Just a little bit of update. You're happy with the 50 milligram, but the 50 milligram, 75 milligram didn't show. So is it fair to say you can go ahead with the 50 milligram or you need a more dose dependency analysis even further?
我只是想再更新確認一下。你們對 50 毫克感到滿意,但 50 毫克有顯示、75 毫克沒有顯示。所以是否可以說你們可以直接以 50 毫克往前推進,還是仍需要進一步做更多劑量依賴性的分析?
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Well, I think that the data as -- the data stands suggests that we have a path forward in IBD. But before we make that decision and before we decide what Phase 3 will look like, we really want to look at the Crohn's disease data and the two data sets together. There's also, I'll say -- and many of you may have seen this from the United European Gastroenterology Week, there's a huge push towards combination therapies, particularly with parenterally administered agents.
我認為就目前數據來看,顯示我們在 IBD 有一條可行的前進路徑。但在做出決策、以及決定第三期試驗設計之前,我們確實希望先看到克隆氏症數據,並把兩組數據一起評估。另外我也想補充——你們很多人可能在歐洲胃腸病學週(United European Gastroenterology Week)已經看到,目前正大力推動合併療法,特別是與經腸外給藥(parenterally administered)的藥物搭配。
But I think that's going to happen more and more with oral agents. And we think given the nature of zasocitinib and the early data that we've seen in UC, we'll wait for Crohn's disease. We think that not only could this be effective as a monotherapy, but this could be a cornerstone of combination therapies potentially in the future.
但我認為這樣的趨勢也會越來越多地出現在口服藥物上。而我們認為,考量 zasocitinib 的特性以及我們在 UC 看到的早期數據,我們會等待克隆氏症結果。我們認為它不僅可能作為單藥治療有效,未來也可能成為合併療法的基石。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
(Interpreted) Thank you. Next. Morgan Stanley, Muraoka-san.
(口譯) 謝謝。下一位。摩根士丹利,村岡先生。
Shinichiro Muraoka - Equity Analyst
Shinichiro Muraoka - Equity Analyst
(Interpreted) Muraoka from Morgan Stanley. My first question is about that UC topic. And in your presentation deck, clinical remission rate compared to other investigational oral drugs, it was comparable. That's 30% and 20% at the doses of 400 milligrams and at 200 milligrams, respectively. And that number was not obtained, but you saw the dose dependency. Is that right understanding?
(口譯) 我是摩根士丹利的村岡。我的第一個問題是關於 UC 的議題。在你們的簡報資料中,與其他研發中的口服藥相比,臨床緩解率是相當的。在 400 毫克與 200 毫克劑量下,分別是 30% 與 20%。雖然那個數字沒有達到(顯著性/目標),但你們看到了劑量依賴性。我的理解正確嗎?
And next question is about NT2. I think the way that you disclosed the data, did you say January through March, it will be press released first and then it will be presented at the medical scientific convention. Is it what you are planning? These are two questions.
下一個問題是關於 NT2。我想你們揭露資料的方式是:你們說 1 月到 3 月會先以新聞稿發布,之後再在醫學科學會議上發表。這是你們的規劃嗎?以上兩個問題。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
So the first, if we could provide any more insight on to the comment around the zasocitinib UC data being on par with other orals in this space? And then the second question on TAK-360. We commented data expected in January to March 2027. What would be the plan in terms of disclosing the top line, whether a press release and/or Congress presentation.
第一個問題:是否能就 zasocitinib 的 UC 資料與此領域其他口服藥物大致相當的評論,提供更多洞見?第二個問題:關於 TAK-360。我們提到預期在 2027 年 1 月到 3 月取得資料。在揭露頂線結果方面的規劃會是什麼,例如發布新聞稿及/或在學術大會發表?
So Andy Plump to take both of those questions, please.
請 Andy Plump 回答這兩個問題。
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Thank you, Muraoka-san. So again, on the zaso UC Phase 2 data, we see a strong nominal p-value at the 50 milligram dose. We see a robust effect size on our primary endpoint clinical remission. We see consistent effects on our secondary endpoints, including objective endoscopic endpoints. And directionally, these are on par with what's been seen with other oral agents. At this point, we don't have additional details to share. When we get the Crohn's disease data, which we anticipate at the end of this fiscal year, we'll have a chance to evaluate those data together and share them as a complete data set.
謝謝你,村岡先生。再次就 zaso 的 UC 第二期資料而言,我們在 50 毫克劑量看到強勁的名目 p 值。在主要終點「臨床緩解」上,我們看到顯著的效果量。在次要終點(包含客觀的內視鏡終點)上也看到一致的效果。就方向性而言,這些結果與其他口服藥物所見大致相當。目前我們沒有更多細節可以分享。當我們取得克隆氏症資料(預期在本會計年度末),我們將有機會把這些資料一併評估,並以完整資料集的形式對外分享。
With regards to TAK-360, two ongoing studies in IH and in type 2 narcolepsy. As we've discussed previously, the design of these studies is adaptive that allows us within the study to rapidly shift from different doses and different dosing administration strategies, which we think is critical to understanding how you thread the needle with dosing in these populations given the potential for efficacy and for some of the tolerability issues.
至於 TAK-360,目前在 IH 與第二型嗜睡症各有兩項進行中的研究。如同我們先前討論過的,這些研究採用適應性設計,使我們能在研究進行中快速在不同劑量與不同給藥策略之間切換;我們認為這對於理解在這些族群中如何精準拿捏劑量非常關鍵,因為同時存在療效潛力以及部分耐受性議題。
The data from those studies will be presented later in the -- we will have the data from those studies later in the fiscal year. How and where exactly we share those data will depend on what those data look like and strategically how we'd like to disclose. We don't have a precise plan at this point.
我們將在本會計年度稍晚取得這些研究的資料。至於要如何、以及在何處分享這些資料,將取決於資料本身的結果,以及我們在策略上希望如何揭露。目前我們還沒有精確的計畫。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Stephen Barker, Jefferies.
Jefferies 的 Stephen Barker。
Stephen Barker - Analyst
Stephen Barker - Analyst
Steve Barker from Jefferies. Two questions again about zaso in UC and MIMRYLO. So regarding zaso in UC, can you clarify if it was the high dose or the low dose, which showed indications of efficacy? And then regarding MIMRYLO, can you give us some indication of what the percentage of covered lives is right now? And how long -- what's the path to broader coverage, please?
我是 Jefferies 的 Steve Barker。兩個問題,同樣是關於 UC 的 zaso 與 MIMRYLO。關於 UC 的 zaso,你能否釐清是高劑量或低劑量顯示出療效跡象?另外關於 MIMRYLO,你能否提供目前涵蓋人群(covered lives)的比例大約是多少?以及要達到更廣泛給付的路徑/進程會是什麼?謝謝。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Thanks, Steve. So again, a question on zaso UC for Andy on the dosing clarification and then MIMRYLO on reimbursement to Teresa again, please?
謝謝,Steve。所以再次,關於 zaso UC 的劑量釐清請 Andy 回答;而 MIMRYLO 的給付/報銷問題請 Teresa 再回答,謝謝?
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Stephen, we saw the robust effect with the strong nominal p-value at the 50-milligram dose, and we didn't see that effect at the 75-milligram dose.
Stephen,我們在 50 毫克劑量看到顯著的效果,且名目 p 值很強;而在 75 毫克劑量並未看到同樣的效果。
Stephen Barker - Analyst
Stephen Barker - Analyst
So as a follow-up, considering that the higher dose didn't reach significance, is there any reason to think that the low dose result is meaningful rather than just by chance?
追問一下,考量到較高劑量沒有達到顯著性,有沒有任何理由認為低劑量的結果是有意義的,而不是只是偶然?
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Well, of course, that's always a concern when you see a study with a lack of a dose responsiveness. There are a few pieces that make us feel that this is a robust result. The first is the magnitude of the result. And again, we're not going to share numbers, but we've said that directionally, it's on par with what's been seen with other agents. This was a well-powered Phase 2b study with approximately 210 patients enrolled over the three arms.
當然,當你看到一項研究缺乏劑量反應關係時,這永遠是一個疑慮。但有幾點讓我們覺得這是相當穩健的結果。第一是結果的幅度。同樣地,我們不會分享具體數字,但我們已表示就方向性而言,與其他藥物所見大致相當。這是一項統計力充足的第二期 b 試驗,三個組別合計約納入 210 名病人。
The second is we see consistency of data across both the clinical endpoints and the objective endoscopic endpoints. And then third, we see -- we have some mechanistic rationale that we're building that might explain why a TYK2 inhibition at higher doses may actually -- one may lose some of the anti-inflammatory and gain some pro-inflammatory effects at higher doses. So we're going to try to put all of that together. But of course, in the end, the Crohn's disease study will be, we think, definitive in terms of understanding the robustness of the UC data and what that path forward will look like.
第二,我們在臨床終點與客觀的內視鏡終點上都看到資料的一致性。第三,我們正在建立一些機轉上的理據,可能可以解釋為何在較高劑量下抑制 TYK2 反而可能——在較高劑量時,部分抗發炎效果可能流失,並增加一些促發炎效果。因此我們會嘗試把這些線索整合起來。但當然,最終我們認為克隆氏症研究將是關鍵,能夠更明確地判斷 UC 資料的穩健性,以及後續前進路徑會是什麼樣子。
Teresa Bitetti - President of the Global Oncology Business Unit
Teresa Bitetti - President of the Global Oncology Business Unit
This is Teresa. Thank you for the question around MIMRYLO. I'll remind you, it's still early days. So the data is coming in. What I can tell you is that given the fact that this is the first time in 10 years that we really have an agent that is consistently addressing the gold standard of treatment, which is maintaining the hematocrit below 45%.
我是 Teresa。謝謝你關於 MIMRYLO 的問題。我先提醒一下,目前仍是上市初期。所以資料仍在陸續回收中。我可以告訴你的是,鑑於這是 10 年來第一次我們真正有一個藥物能夠持續達成治療的黃金標準,也就是將血比容(hematocrit)維持在 45% 以下。
We've also seen sort of that reflected in the fact that we have NCCN Category 1 for both low risk and high risk. So that bodes very well as we move forward in our access discussions. As you would typically see, we expect Medicare to come on first, followed more by the commercial. But what I can tell you right now is that we see scripts that are going through the system with prior auth, and we're feeling very good about the early conversations that we're having with payers who are clearly recognizing the value that we're bringing to patients with this medicine. And of course, that's reflected in the NCCN category 1 listing. So thank you for the question.
我們也看到這點反映在我們同時取得 NCCN 對低風險與高風險族群的第 1 類(Category 1)推薦。這對我們後續在可近性(access)討論上是非常正面的訊號。如同一般情況,我們預期 Medicare 會先到位,之後才會有更多商業保險跟進。但我現在可以分享的是,我們看到處方(scripts)正在系統中透過事前授權(prior auth)流程,我們也對與保險支付方(payers)的早期對話感到非常樂觀;他們顯然認可這個藥物為病人帶來的價值。當然,這也反映在 NCCN 第 1 類的列名上。謝謝你的提問。
Stephen Barker - Analyst
Stephen Barker - Analyst
Just a follow-up. Can you comment on the mix between low-risk phlebotomy patients and those that the high-risk patients already on therapy?
再追問一下。你能否評論目前低風險、以放血(phlebotomy)為主的病人,與已在治療中的高風險病人之間的組合占比?
Teresa Bitetti - President of the Global Oncology Business Unit
Teresa Bitetti - President of the Global Oncology Business Unit
Your high-risk patients are defined by patients that have had 65 years and older or have had one thrombotic event. So I mean, I would say that given that it tends to be a larger population, you probably skew a little bit more towards the high risk. But I mean, I would say rather evenly distributed.
高風險病人的定義是:65 歲以上,或曾發生過一次血栓事件的病人。所以我會說,因為高風險族群通常是較大的族群,你們可能會稍微偏向高風險一些。但整體而言,我會說分布相當平均。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
(Interpreted) Nomura Securities, Matsubara-san.
(口譯) 野村證券,松原先生。
Hiroyuki Matsubara - Analyst
Hiroyuki Matsubara - Analyst
(Interpreted) This is Matsubara. My first question is about zaso UC. So dose dependency is still being analyzed in detail. But how does it compare against ENTYVIO? And in terms of safety, is there any problem, for example, TB? For ORZEYFUL, diagnosis rate and the treatment rate improvement, how is it working? So sales started in Japan and China. Do you have any feedback through the education of the physicians in the United States? How is the initial action?
(口譯) 我是松原。我的第一個問題是關於 zaso 的 UC。劑量依賴性仍在進一步詳細分析中。但與 ENTYVIO 相比表現如何?在安全性方面,是否有任何問題,例如結核病(TB)?另外關於 ORZEYFUL,在提升診斷率與治療率方面,效果如何?日本與中國已開始銷售。你們是否從美國對醫師的教育中收到任何回饋?初期的推動情況如何?
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Any further commentary you can give on efficacy, for example, compared to ENTYVIO or anything in the safety profile worth noting? So Andy can comment on that one.
關於療效方面,您還能提供任何進一步的評論嗎?例如,與 ENTYVIO 相比,或是在安全性特徵上有沒有值得注意之處?那麼這題請 Andy 來評論。
And then the second question on prelaunch activities for ORZEYFUL in the US Any initial feedback from health care practitioners, et cetera? Any detail as we prepare to get the launch underway shortly in the US, Rhonda Pacheco to answer that one, please?
接著第二個問題是關於 ORZEYFUL 在美國上市前的活動:是否有來自醫療照護專業人員等的初步回饋?在我們準備於美國近期啟動上市之際,能否提供一些細節?請 Rhonda Pacheco 回答這題。
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Well, Matsubara-san, thank you very much. So again, the efficacy at the 50 milligram dose looks robust and directionally on par with what we've seen for -- in UC for other oral agents. And unlike in areas like psoriasis, the parenteral agents are typically on par as well. So I would say directionally, and again, we'll have a chance early next year to share these data with you on par with what's been seen with other agents. I think we were particularly pleased to see that at both the 50 milligram and the 75 milligram dose, the safety profile for zasocitinib was very consistent with what we had seen previously in our psoriasis and psoriatic arthritis studies at the 30 milligram dose.
好的,Matsubara 先生,非常感謝。再次說明,50 毫克劑量的療效看起來相當穩健,方向上與我們在潰瘍性結腸炎(UC)其他口服藥物所見大致相當。而且不同於像乾癬這類領域,注射劑通常也大致相當。所以我會說在方向上是相當一致的;同時,我們也會在明年初有機會與各位分享這些數據,與其他藥物所見相當。我想我們特別高興看到,在 50 毫克與 75 毫克兩個劑量下,zasocitinib 的安全性特徵與我們先前在乾癬與乾癬性關節炎研究中、30 毫克劑量所觀察到的結果非常一致。
Rhonda Pacheco - President of U.S. Business Unit & US Country Head
Rhonda Pacheco - President of U.S. Business Unit & US Country Head
Great. I'll jump in here. This is Rhonda. Thank you for the question. I'll start with launch preparation in the United States. We are ready. We are ready across the field, the access and patient support. We have all commercial and medical teams in the field, and we're focused on three things. First is education. We're building that awareness of the NT1 true burden and the role of orexin in NT1 patients for patients and HCPs, making significant investments in supporting disease awareness and education. We initiated the non-branded disease awareness campaign in the US, and we have reached thousands of HCPs across individual meetings, congress participation and supported educational programs. The feedback has been overwhelmingly positive, and they are ready and excited for ORZEYFUL launch.
很好。我在這裡補充一下。我是 Rhonda。謝謝你的提問。我先從美國的上市準備談起。我們已經準備就緒。在前線團隊、給付准入與病患支持方面,我們都已就位。我們已將所有商業與醫學團隊部署到前線,並聚焦三件事。第一是教育。我們正在建立對 NT1 真實疾病負擔的認知,以及食慾素(orexin)在 NT1 病患中的角色,並對疾病認知與教育投入大量資源,面向病患與醫療照護專業人員(HCPs)。我們已在美國啟動非品牌的疾病認知宣導活動,並透過一對一會議、參與學術會議以及支持教育計畫,觸及數千名 HCP。回饋極為正面,他們已準備好並對 ORZEYFUL 的上市感到興奮。
The second that we're focused -- the second topic that we're focusing on is access and patient support. Our payers have been engaged pre-approval to support broad formulary coverage. Our specialty pharmacy distribution is ready, and our patient support program is prepared and committed to helping patients gain access to medication at launch. This is an area where we bring real experience because of our rare disease portfolio.
第二個我們聚焦的——第二個主題是給付准入與病患支持。我們在核准前就已與支付方(payers)互動,以支持更廣泛的處方集(formulary)涵蓋。我們的專科藥局配送已準備就緒,病患支持計畫也已就位並承諾在上市時協助病患取得用藥。這是我們能帶來真正經驗的領域,因為我們擁有罕見疾病產品組合。
Lastly is diagnosis, which we know is important for this launch, improving the accurate and early diagnosis of NT1, we have been leveraging data, digital and technology that aim to accelerate accurate diagnosis and improve the patient journey. For example, we're pursuing digital and fluid biomarker tools to support diagnosing the NT1 from other sleep-wake disorders.
最後是診斷。我們知道這對本次上市很重要:提升 NT1 的準確且早期診斷。我們一直在運用資料、數位化與科技,目標是加速正確診斷並改善病患旅程。例如,我們正在推進數位工具與體液生物標記(fluid biomarker)工具,以支持將 NT1 與其他睡眠—覺醒障礙做出鑑別診斷。
And lastly, partnerships like with EnsoData on developing and validating AI-based PSG algorithms to improve the detection and diagnosis of NT1 during routine sleep lab studies. Lastly, in bottom line, we are ready. We're building that awareness to activation, which means making sure HCPs and patients are aware of our ORZEYFUL through all competitive channels, and we're meeting our customers where they are through direct-to-consumer initiatives.
另外,也包括像與 EnsoData 的合作,開發並驗證以 AI 為基礎的 PSG 演算法,以在例行睡眠實驗室檢查中提升 NT1 的偵測與診斷。總結來說,我們已準備就緒。我們正在把認知轉化為行動,也就是確保 HCP 與病患透過所有競爭性渠道都能認識 ORZEYFUL,並透過直接面向消費者(direct-to-consumer)的措施,在客戶所在之處與其互動。
Thank you for the question.
謝謝你的提問。
Julie Kim - President, Chief Executive Officer, Representative Director
Julie Kim - President, Chief Executive Officer, Representative Director
And Matsubara-san, this is Julie. Let me just add a quick comment about Japan and China. So as I shared during the presentation, we launched in both countries on October 15. So it's only been two weeks, but -- we're very pleased with the initial response. And in terms of targeting, we are also in both Japan and China, targeting patients who have already been diagnosed and are on treatment first, and then we'll have to work on the diagnosis.
Matsubara 先生,我是 Julie。我再快速補充一下日本與中國的情況。如我在簡報中分享的,我們在兩個國家都於 10 月 15 日上市。目前才兩週,但——我們對初期反應非常滿意。在目標族群方面,日本與中國兩地我們也都是先鎖定已確診且正在治療的病患,之後再著手推動診斷。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Thank you, Matsubara-san for the question.
謝謝你,Matsubara 先生,謝謝你的提問。
Mike Nedelcovych, TD Cowen.
Mike Nedelcovych,TD Cowen。
Michael Nedelcovych - Equity Analyst
Michael Nedelcovych - Equity Analyst
I have some clarifying questions on zasocitinib in Crohn's and then a question on TAK-360. So in Crohn's, can you remind us why there is greater confidence for zasocitinib relative to ulcerative colitis? And depending on those Phase 2 data, is it possible you would pursue pivotal trials for zasocitinib only in Crohn's and not in ulcerative colitis? And then just to clarify, what is the reason for the delay that emerged between the two Phase 2 readouts? So those are my zasocitinib questions.
我有一些關於 zasocitinib 在克隆氏症(Crohn's)上的釐清問題,然後還有一個關於 TAK-360 的問題。就克隆氏症而言,你能提醒我們為什麼相較於潰瘍性結腸炎,你們對 zasocitinib 更有信心嗎?並且視第二期(Phase 2)數據而定,是否有可能你們只在克隆氏症、而不在潰瘍性結腸炎中推進 zasocitinib 的樞紐性試驗(pivotal trials)?另外再釐清一下,兩個第二期讀出(readouts)之間出現延遲的原因是什麼?以上是我關於 zasocitinib 的問題。
And then on TAK-360, Management had previously articulated some good reasons why marketing two different products for NT1 and NT2 made commercial sense. But of course, you've now initiated a Phase 2 trial of TAK-360 in both NT1 and NT2. So my question is, why did you change course on that front? It seems to me one possibility is that the company wants to put its best foot forward in all indications and likes what it sees so far from TAK-360. Could that have been part of the reasoning?
接著關於 TAK-360,管理層先前曾闡述過一些很好的理由,說明為 NT1 與 NT2 以兩個不同產品進行行銷在商業上是合理的。但當然,你們現在已在 NT1 與 NT2 都啟動了 TAK-360 的第二期試驗。所以我的問題是:為什麼你們在這方面改變了方向?在我看來,一種可能性是公司希望在所有適應症上都拿出最佳表現,且對目前 TAK-360 所看到的結果感到滿意。這是否可能是部分原因?
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Thank you, Mike, for the questions on zaso and CD rationale and then on TAK-360, NT1 and NT2 studies. So Andy, if you could answer those ones, please.
謝謝你,Mike,關於 zaso 與 CD 研發依據的問題,以及關於 TAK-360、NT1 與 NT2 研究的問題。那麼 Andy,麻煩你回答這些問題。
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Sure. Thank you very much, Mike. So firstly, why do we -- why mechanistically do we believe that there's a greater likelihood for benefits in Crohn's for a TYK2 inhibitor such as zasocitinib in UC? There are two lines of evidence. The first is that agents that signal through TYK2. When you look at medicines that block those agents, they tend to have stronger effects in Crohn's than in UC.
好的。非常感謝你,Mike。首先,為什麼我們——從機轉上——相信像 zasocitinib 這樣的 TYK2 抑制劑在克隆氏症中,相較於在潰瘍性結腸炎(UC)中,更有可能帶來效益?有兩條證據線索。第一是,透過 TYK2 傳遞訊號的那些因子(agents),當你看阻斷這些因子的藥物時,它們在克隆氏症中的效果往往比在 UC 中更強。
And then secondly, when we look at the human genetics, which has been a guidepost for us these years, patients that have heterozygous loss of function in their TYK2 gene are protected from Crohn's, but not from ulcerative colitis. Patients have to have homozygous deficiencies in TYK2 to be protected for ulcerative colitis. So those would be the two reasons we think Crohn's has a stronger rationale.
第二,當我們看人類遺傳學——這些年一直是我們的重要指引——帶有 TYK2 基因雜合性功能缺失(heterozygous loss of function)的病患,對克隆氏症具有保護作用,但對潰瘍性結腸炎則沒有。病患必須是 TYK2 的同型合子缺失(homozygous deficiencies),才會對潰瘍性結腸炎具有保護作用。因此,這兩點就是我們認為克隆氏症具備更強研發依據的原因。
And then the second, you asked about the timing of the two trials. There are really two reasons that create the separation. The first and most importantly is the Crohn's study is a larger study. The UC study has three dose arms and the Crohn's study has four dose arms. The second reason is that right now, Crohn's is an incredibly competitive space to enroll trials in.
接著第二個,你問到兩項試驗的時間點。造成兩者間隔的原因主要有兩點。第一、也是最重要的,是克隆氏症研究規模更大。UC 研究有三個劑量組,而克隆氏症研究有四個劑量組。第二個原因是,目前克隆氏症在試驗收案方面競爭非常激烈。
And to be very frank, we've been working with a disadvantage given the experience of investigators with prior TYK2 inhibitors. As we've said all along, zasocitinib is truly a best-in-class molecule. And we think that now the UC data confirm that, and we'll really look forward to seeing the Crohn's disease data.
坦白說,因為研究者先前對其他 TYK2 抑制劑的經驗,我們在推進上一直處於不利位置。正如我們一路以來所說,zasocitinib 確實是一個同類最佳(best-in-class)的分子。我們認為現在 UC 的數據已經證實了這一點,也非常期待看到克隆氏症的數據。
We'll think, Mike, that having some positive halo behind a TYK2 inhibitor in IBD will help us to really accelerate that Crohn's trial as well. For 360, I wouldn't look too deeply into our decision to run an NT1 study. It's a relatively small proof-of-concept study. We're just, I mean, as you know, we've talked about this many times, we are incredibly enthusiastic about ORZEYFUL and the ORZEYFUL profile, truly believe that it's not just a first-in-class, but it's a best-in-class agent. We're running the Phase 2 study for 360 in NT1 really just to keep our options open.
我們認為,Mike,在 IBD 領域若 TYK2 抑制劑能建立一些正向的光環效應,將有助於我們真正加速那項克隆氏症試驗。至於 360,我不會對我們決定進行 NT1 研究這件事過度解讀。這是一項相對小型的概念驗證研究。我們只是——我的意思是,如你所知,我們已多次談過——我們對 ORZEYFUL 以及 ORZEYFUL 的特性非常、非常振奮,並且真心相信它不僅是同類首創(first-in-class),更是同類最佳(best-in-class)的藥物。我們在 NT1 進行 360 的第 2 期研究,主要只是為了保留選項。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Tony Ren, Macquarie.
Tony Ren,Macquarie。
Tony Ren - Analyst
Tony Ren - Analyst
Tony Ren from Macquarie. Can you guys hear me?
我是 Macquarie 的 Tony Ren。你們聽得到我嗎?
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Yes, Tony, we hear you.
是的,Tony,我們聽得到。
Tony Ren - Analyst
Tony Ren - Analyst
Yes. Okay. Perfect. My first question is on your Claudin 18.2 data presented at ESMO. And then I'll also ask about ORZEYFUL's launch pricing and the strategy. So first, Claudin 18.2. So at ESMO, right, your AstraZeneca presented some data at the -- with their competing Claudin 18.2 at the Presidential Symposium. I think it's probably fair to say that it is generally considered practice changing based on the feedback that I've gathered at the conference. It appears to be slightly ahead of you guys in regulatory time line. They are in the second-line plus setting with a Claudin 18.2 cutoff of 25%. How do you expect to differentiate? Would you say that in a disease setting where the median overall survival is about 10 to 11 months, safety alone may not be a good enough selling point? That's my first question.
是的。好的。太好了。我的第一個問題是關於你們在 ESMO 發表的 Claudin 18.2 數據。接著我也會問 ORZEYFUL 的上市定價與策略。先談 Claudin 18.2。在 ESMO 上,對吧,你們的 AstraZeneca 在總統研討會(Presidential Symposium)上發表了他們競品 Claudin 18.2 的一些數據。根據我在會議上蒐集到的回饋,我想可以說這一般被認為會改變臨床實務。看起來他們在法規時程上略微領先你們。他們是在二線以上的治療情境,Claudin 18.2 的切點(cutoff)為 25%。你們預期要如何做出差異化?你是否會認為,在一個中位整體存活期約 10 到 11 個月的疾病情境中,僅靠安全性可能不足以成為好的賣點?這是我的第一個問題。
And the second one is that you launched ORZEYFUL in both Japan and China. Could you comment on the launch pricing? We recently saw several large European pharmaceutical companies saying that they will carefully consider their ex-US launches because of MFN. And you guys are obviously thinking about this quite differently. So could you explain that as well?
第二個問題是,你們已在日本與中國上市 ORZEYFUL。可否評論一下上市定價?我們最近看到幾家大型歐洲藥廠表示,因為 MFN,他們會審慎考量其美國以外市場的上市。你們顯然是以相當不同的方式在思考。所以也請你們說明一下。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
(Interpreted) Okay. Thank you, Tony, for your questions. So the first on our recently announced data for TAK-921 and how we may differentiate versus other Claudin 18.2 ADCs. So Andy can take that question.
(口譯)好的。謝謝你,Tony,提出問題。第一個問題是關於我們近期公布的 TAK-921 數據,以及相較於其他 Claudin 18.2 ADC 我們可能如何做出差異化。Andy 可以回答這個問題。
And then the second question on ORZEYFUL pricing ex-US in the markets where we've already launched. Julie can take that question.
第二個問題是關於 ORZEYFUL 在美國以外、我們已上市市場的定價。Julie 可以回答這個問題。
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Thank you, Chris. And then I'll also ask if Teresa may want to add to the 921 discussion. But Tony, thank you very much. We're, I mean, incredibly excited by the data that we presented for 921 at ESMO. And we think that it has -- when you look at all the endpoints, OS, highly significant effects in PFS and overall response rate as well as safety and tolerability, we think that this is a best-in-class profile.
謝謝你,Chris。另外我也想問 Teresa 是否願意補充 921 的討論。不過 Tony,非常感謝。我們——我的意思是——對我們在 ESMO 發表的 921 數據感到非常興奮。我們認為,當你檢視所有終點時,包括 OS、在 PFS 與整體反應率上高度顯著的效果,以及安全性與耐受性,我們認為這是一個同類最佳(best-in-class)的特性。
Remember that this is an extremely refractory third line plus population. In fact, 30% of the patients enrolled in this study were fourth line or fifth line. So this is really a very high unmet medical need, very sick patient population. And to see overall survival rates of over 10 months median is really just extraordinary. Remember that this is an Asian study that was enrolled in China and Japan and will be filed and eventually launched in those two countries.
請記得,這是一個極度難治的三線以上族群。事實上,本研究納入的病人中有 30% 是四線或五線。因此這確實是高度未被滿足的醫療需求、病情非常嚴重的病人族群。而能看到中位整體存活期超過 10 個月,確實非常非凡。請記得,這是一項在中國與日本收案的亞洲研究,將在這兩個國家申報,並最終在這兩個國家上市。
We don't have the intent of bringing the program into highly refractory settings in US and Europe. Our goal is to rapidly move towards a first-line study, and we're evaluating a number of different combinations with established standards of care chemotherapy regimens as well as now KRAS agents. So we think that this data sets us up extremely well to be highly competitive in the first-line setting.
我們並沒有打算把這個計畫帶到美國與歐洲的高度難治治療情境。我們的目標是快速推進到一線研究,我們正在評估多種不同的合併療法,包括與既有標準治療的化療方案合併,以及現在也包括 KRAS 藥物。因此我們認為,這些數據讓我們在一線治療情境中具備非常強的競爭力。
Teresa Bitetti - President of the Global Oncology Business Unit
Teresa Bitetti - President of the Global Oncology Business Unit
Yes. And Andy, if I could just add on to that, Tony, thanks for the question. We're actually feeling very confident because when you look at our data, indeed, the safety was something outstanding and very reflective of the mechanism that we have with Fc-silenced linker as well as the fact that we have a TOPO1 payload, which is very strong, very low on the GI tox. So we do stand out there.
是的。Andy,如果我可以補充一下,Tony,謝謝你的問題。我們其實非常有信心,因為當你看我們的數據時,安全性確實非常出色,也非常反映我們的作用機轉——包括 Fc 靜默化(Fc-silenced)連接子——以及我們使用的是 TOPO1 載荷(payload),效力很強、腸胃道毒性(GI tox)非常低。所以我們在這方面確實很突出。
But the efficacy, when you look at what we delivered in what was a very sick patient population, we're feeling very confident in terms of our ability to compete on both efficacy and safety, and we're looking forward to moving at speed to get TAK-921 into frontline studies.
但在療效方面,當你看我們在一個病情非常嚴重的病人族群中所交出的結果,我們對於在療效與安全性兩方面的競爭能力都非常有信心,也期待加速推進,讓 TAK-921 進入一線研究。
So thank you for that question.
所以謝謝你的提問。
Julie Kim - President, Chief Executive Officer, Representative Director
Julie Kim - President, Chief Executive Officer, Representative Director
And Tony, I'll take your question about pricing for ORZEYFUL in both Japan and China. So for China, let me clarify that for NRDL reimbursement, there's only one opportunity per year to submit for NRDL reimbursement, and we received approval for ORZEYFUL after that date.
Tony,我來回答你關於 ORZEYFUL 在日本與中國定價的問題。先談中國:我想澄清的是,NRDL 報銷每年只有一次提交 NRDL 報銷申請的機會,而我們是在那個日期之後才取得 ORZEYFUL 的核准。
So right now, we are selling via the private market. And so we do not have the NRDL listing yet. So we will be submitting that next summer, and then we should have NRDL listing, hopefully, in January of '28. For Japan, we have received pricing in Japan, as you may be aware, and the equivalent in US dollars is roughly about $100,000 on an annualized basis.
因此目前我們是透過自費市場(private market)在銷售。所以我們尚未取得 NRDL 收載。我們將在明年夏天提交申請,之後希望能在 2028 年 1 月取得 NRDL 收載。至於日本,如你所知,我們已在日本取得藥價;換算成美元,年化大約是 10 萬美元左右。
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
(Interpreted) Wakao-san, JPMorgan.
(口譯)Wakao 先生,JPMorgan。
Seiji Wakao - Analyst
Seiji Wakao - Analyst
(Interpreted) This is Wakao from JPMorgan. First, about zaso IBD in our Capital Markets Day. I understand you show our true colors in December at Capital Market Day. Is there a Phase 3 development strategy for zaso in IBD has not yet been finalized until the Capital Markets Day. How will you reflect that opportunity and its uncertainty in the outlook? Also given the encouraging efficacy signal at the 50 milligram UC, is it fair to say that we should not be overly pessimistic about the lack of dose response?
(口譯)我是 JPMorgan 的 Wakao。首先,關於我們資本市場日(Capital Markets Day)提到的 zaso IBD。我理解你們會在 12 月的資本市場日展現真正的全貌。是否表示 zaso 在 IBD 的第 3 期開發策略在資本市場日之前尚未最終定案?你們將如何在展望中反映這個機會及其不確定性?另外,鑑於 50 毫克 UC 的療效訊號令人鼓舞,是否可以說,我們不應該因為缺乏劑量反應而過度悲觀?
And second about product performance. Could you provide some more color on the second quarter performance and second half outlook for ENTYVIO and PDT? ENTYVIO delivered strong result in second quarter. What were the key driver of this performance? And do you expect this positive momentum to continue into the second half, giving you confidence in achieving your revised full year guidance? In PDT world, second quarter was weak. What were the main reason for the weakness? What is your outlook for the second half? And how confident are you in achieving your full year guidance?
第二個問題是關於產品表現。你能否就 ENTYVIO 與 PDT 的第二季表現及下半年展望提供更多說明?ENTYVIO 在第二季交出強勁成果。這項表現的關鍵驅動因素是什麼?你是否預期這股正向動能會延續到下半年,讓你們對達成上修後的全年財測更有信心?在 PDT 方面,第二季表現疲弱。疲弱的主要原因是什麼?你對下半年的展望為何?你們對達成全年財測的信心有多高?
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Christopher David O'Reilly - Global Head of Investor Relations & Global Finance
Thank you, Wakao-san. So the first question around whether we'll have any further updates on zasocitinib in IBD by Capital Markets Day in December. And again, a question around how we should think about the lack of dose response. So Andy, call on you again for that question.
謝謝你,Wakao 先生。第一個問題是關於在 12 月資本市場日之前,我們是否會就 IBD 適應症的 zasocitinib 提供任何進一步更新。以及同樣關於我們應如何看待缺乏劑量反應的問題。Andy,我再請你回答這個問題。
Next, a couple of product-specific questions on sort of Q2 performance and rest of the year outlook. So first one, ENTYVIO. Perhaps Rhonda can take that one to talk a little bit about the US performance. And then on our IBD portfolio, Ramy can comment on that one, please.
接下來,有幾個針對特定產品的問題,關於第二季的表現以及今年其餘時間的展望。首先是 ENTYVIO。也許請 Rhonda 來談談美國市場的表現。然後關於我們的 IBD 產品組合,請 Ramy 也評論一下。
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Andrew Plump - President of Research & Development, Vice President of Subsidiary, Director
Great. Thank you very much, Wakao-san. And if you could see me, I have a big, big smile because we knew that there would be a lot of questions on the UC zaso data. So maybe if I may, let me dial up for a second and just paint the picture for zasocitinib. So this is a best-in-class TYK2. It's a once-daily conveniently administered oral agent. We've just filed for psoriasis with really truly best-in-class data. We've just completed a head-to-head study against deucravacitinib that shows the strongest PASI 100 data in psoriasis that any agent has ever seen. We are incredibly excited to get this launched in psoriasis.
很好。非常感謝您,Wakao 先生。如果你們看得到我,我現在笑得很開心,因為我們知道大家一定會對 UC 的 zaso 數據有很多問題。所以如果可以的話,讓我先退一步,簡單描繪一下 zasocitinib 的全貌。這是一款同類最佳(best-in-class)的 TYK2,為每日一次、方便口服給藥的藥物。我們剛以真正同類最佳的數據提交了乾癬適應症的申請。我們也剛完成一項與 deucravacitinib 的頭對頭研究,顯示在乾癬中,任何藥物迄今所見最強的 PASI 100 數據。我們對於在乾癬領域推出上市感到非常振奮。
Next year, we'll have Phase 3 data in psoriatic arthritis. Our Phase 2b results that we presented last year are very compelling. We have four Phase 2 studies. The UC is the first to read out. We'll have Crohn's reading out at the end of the fiscal year. And then next year, we'll see data from HS and very excitingly, vitiligo, and both of those studies are enrolling extremely well. We are very enthusiastic about the potential for zasocitinib.
明年我們將取得乾癬性關節炎的第三期數據。我們去年發表的第二期 b(Phase 2b)結果非常有說服力。我們有四項第二期研究。UC 是第一個讀出結果的。克隆氏症(Crohn's)將在本財政年度末讀出。接著明年,我們會看到 HS 的數據,以及非常令人興奮的白斑症(vitiligo)數據,而這兩項研究的入組進展都非常順利。我們對 zasocitinib 的潛力非常樂觀。
Now drilling down on UC and what we'll present at Capital Markets Day. We will not share the UC data at Capital Markets Day. As I mentioned, our intent would be to share the UC and Crohn's disease data sets together, and we'll see those data towards the end of this fiscal year. We're sharing the data today because we were encouraged, to be frank, by the data. It's a complex data set. Any time you have a lack of dose response and a stronger effect in a middle dose versus a higher dose, it creates some complexity.
現在聚焦到 UC,以及我們在資本市場日(Capital Markets Day)會呈現的內容。我們不會在資本市場日分享 UC 數據。如我所提,我們的意圖是將 UC 與克隆氏症的數據集一起分享,而我們會在本財政年度接近年底時看到這些數據。我們今天分享數據,坦白說,是因為這些數據讓我們受到鼓舞。這是一組複雜的數據集。任何時候若缺乏劑量反應(dose response),且中等劑量的效果反而強於高劑量,都會帶來一些複雜性。
But given the robustness of those data directionally in line with what other agents have seen, other oral agents and even many parenterally administered agents and the robustness of the nominal p-value, we felt it was important to get those data out there. We think that this will change the mindset around TYK2 and IBD. And in the end, we'll look forward to seeing the Crohn's disease data to see what that overall data set will look like.
但鑑於這些數據的穩健性,且方向上與其他藥物(其他口服藥,甚至許多注射給藥的藥物)所見一致,再加上名目 p 值(nominal p-value)的穩健性,我們認為有必要把這些數據公布出來。我們認為這將改變外界對 TYK2 與 IBD 的看法。最後,我們也期待看到克隆氏症的數據,以了解整體數據集會呈現什麼樣貌。
Rhonda Pacheco - President of U.S. Business Unit & US Country Head
Rhonda Pacheco - President of U.S. Business Unit & US Country Head
Thank you for the ENTYVIO question. A couple of points on ENTYVIO performance. ENTYVIO is performing in line with our expectations, and we remain on track against the plan we laid out for 2026. That is driven by sustained demand growth and a favorable comparison to a softer Q4 fiscal year '25. ENTYVIO is in its 13 year on the market and continues to deliver sustained growth.
謝謝關於 ENTYVIO 的提問。關於 ENTYVIO 的表現有幾點說明。ENTYVIO 的表現符合我們的預期,我們也仍按計畫朝著我們為 2026 年所制定的目標推進。這主要由持續的需求成長,以及相較於 2025 財年第四季較疲弱基期的有利比較所帶動。ENTYVIO 已上市第 13 年,仍持續帶來穩健成長。
As you see in Q2, global growth was 2.7% at constant exchange rates. The brand is growing with the market in first line, which is where our strategy is, supported by our continued uptake of the pen formulation across different regions. Specifically in the US, again, in line with our expectations with overall demand continuing to grow. So in summary and to conclude, we remain confident in our ENTYVIO's guidance for 2026.
如各位在第二季所見,以固定匯率計算(constant exchange rates),全球成長為 2.7%。該品牌在第一線治療市場與市場同步成長,這正是我們的策略重點,並由我們在不同地區持續提升筆型注射劑(pen formulation)的採用所支持。特別是在美國,同樣符合我們的預期,整體需求持續成長。因此總結來說,我們對 ENTYVIO 2026 年的指引仍然充滿信心。
Thank you for the question.
謝謝您的提問。
Ramy Riad - President of Plasma-Derived Therapies Business Unit
Ramy Riad - President of Plasma-Derived Therapies Business Unit
So thank you for the PDT question. So I will start with IG first for Q2 IG. Overall, we have a very solid underlying demand that continued to grow by mid-single digits. For the H1 results, it's in line with our expectation. SCIG continued to grow by double-digit growth at 17% growth, supported by our broad differentiated portfolio. For IV, we declined versus the last year first half as a result of the phasing as well as market and price dynamics.
謝謝關於 PDT 的問題。我先從 IG 開始,談第二季的 IG。整體而言,我們有非常穩健的基本需求,並持續以中個位數成長。就上半年(H1)結果而言,符合我們的預期。SCIG 持續以雙位數成長,成長率為 17%,這得益於我們廣泛且具差異化的產品組合。至於 IV,因時點因素(phasing)以及市場與價格動態影響,相較去年上半年有所下滑。
H2, we expect the SCIG, the subcutaneous IG to sustain its strong growth. IVIG growth, we expect it to accelerate, driven by the momentum of the large contracts in the US specifically. And this time, we are continuing to monitor the market because we are in a supply-demand dynamic change emerging. However, we are also balancing our short-term growth of profitability and margin expansion with revenue growth.
下半年(H2),我們預期 SCIG(皮下 IG)將維持強勁成長。IVIG 的成長我們預期會加速,主要由美國大型合約的動能所帶動。同時,我們也持續監測市場,因為供需動態正在出現變化。不過,我們也在短期獲利成長與毛利率擴張,和營收成長之間取得平衡。
For albumin to continue the PDT portfolio, albumin for PDT continue to be a very important product for our portfolio. For the first half of the year, it's impacted by phasing in US specifically and stronger-than-expected cost containment measures in China. China remains our largest market for albumin and the underlying demand remains very positive and strong. We expect China to return to growth in the near term as cost containment policies settle and demand rebounds. At the same time, we are diversifying the growth by building sustainable markets ex-China, securing tenders outside China, where we started to already deliver in and it's contributing to our performance side. Thank you.
接著談 PDT 產品組合中的白蛋白(albumin)。白蛋白對我們的產品組合仍是非常重要的產品。上半年表現受到影響,主要是美國的時點因素(phasing),以及中國超出預期的成本控制措施。中國仍是我們白蛋白最大的市場,而基本需求仍然非常正向且強勁。我們預期隨著成本控制政策趨於穩定、需求回升,中國在短期內將恢復成長。同時,我們也透過建立中國以外(ex-China)的可持續市場來分散成長來源,在中國以外取得標案(tenders);我們已開始交付,並對我們的業績表現有所貢獻。謝謝。
Julie Kim - President, Chief Executive Officer, Representative Director
Julie Kim - President, Chief Executive Officer, Representative Director
Thanks, Ramy, and thank you, everyone, for your questions. Apologies, we ran a few minutes over, but hopefully, you've seen that we've made notable progress in the first half of the fiscal year. And our focus now is on continued disciplined execution, bringing these medicines to patients, supporting access and driving adoption.
謝謝你,Ramy,也謝謝各位的提問。抱歉我們超時了幾分鐘,但希望各位已看到我們在本財政年度上半年取得了顯著進展。我們目前的重點是持續以紀律執行,把這些藥物帶給病患,支持可近性並推動採用。
At the same time, our transformation is strengthening the capabilities and agility we need to lead in every therapeutic area where we operate and sustain long-term growth. We look forward to connecting today's progress with our longer-term ambition at our Capital Markets Day on December 11, where we will share more details on our growth strategy and how we will build sustainable leadership in our core therapeutic areas.
同時,我們的轉型正在強化我們所需的能力與敏捷性,使我們能在所涉足的每個治療領域中保持領先並維持長期成長。我們期待在 12 月 11 日的資本市場日,將今天的進展與我們更長期的願景連結起來,屆時我們將分享更多關於成長策略的細節,以及我們將如何在核心治療領域建立可持續的領導地位。
Thank you, and have a good rest of your day or evening.
謝謝,祝各位今天或今晚剩餘時間愉快。
Editor
Editor
Statements in English on this transcript were spoken by an interpreter present on the live call. The interpreter was provided by the company sponsoring this event.
本逐字稿中的英文陳述由現場電話會議中的口譯員口述。該口譯員由主辦本活動的公司提供。