Takeda Pharmaceutical Co Ltd (TAK) 2026 Q2 法說會逐字稿

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  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Thank you very much for taking time out of your very busy schedule to join Takeda's FY '25 Q2 earnings announcement. I'm the MC today, Head of IR. My name is O'Reilly. Thank you for this opportunity. (Operator Instructions).

    (翻譯)非常感謝您百忙之中抽空參加武田製藥 2025 財年第二季業績發表會。我今天擔任主持人,我是投資人關係主管。我的名字叫奧萊利。感謝您給我這次機會。(操作說明)

  • Before starting, I'd like to remind everyone that we'll be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in our 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》所指的前瞻性陳述。實際結果可能與今天討論的內容有重大差異。可能導致我們實際業績與預期業績有重大差異的因素已在我們最新的 20-F 表格和我們向美國證券交易委員會提交的其他文件中進行了討論。

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

    另請參閱簡報第 2 頁上的重要通知,其中涉及我們對非 IFRS 財務指標的前瞻性陳述,這些陳述也將在本次電話會議中進行討論。本簡報的附錄中包含了我們非 IFRS 指標的定義以及與可比較 IFRS 財務指標的調節表。

  • Now we would like to start with the presentation of the day. We have Christophe Weber, President and CEO; Milano Furuta, Chief Financial Officer; Andy Plump, President, R&D; Teresa Bitetti, President, Global Oncology Business Unit; PK Morrow, Head of Oncology Therapeutic Area Unit.

    現在我們開始今天的專題報告。我們有總裁兼執行長 Christophe Weber;財務長 Milano Furuta;研發總裁 Andy Plump;全球腫瘤業務部總裁 Teresa Bitetti;腫瘤治療領域負責人 PK Morrow。

  • Will provide you with presentation, which will be followed by a Q&A session. We will get started now.

    我會先進行演示,之後是問答環節。我們現在就開始。

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

    Christophe Weber - President, Chief Executive Officer, Representative Director

  • Thank you, Chris, and thank you, everyone, for joining us today. Our fiscal year 2025 first half results confirm our expected business dynamic for fiscal year 2025 with business fundamentals tracking as planned. This is the last year of very significant Vyvanse generic impact, which peaked in H1 and which will be much less of a headwind to our growth from now on. Growth on launch product grew 5.3% at constant exchange rate, and we expect this growth to accelerate in H2.

    謝謝克里斯,也謝謝各位今天蒞臨。我們 2025 財年上半年的業績證實了我們對 2025 財年業務動態的預期,業務基本面按計劃進行。今年是 Vyvanse 仿製藥影響非常顯著的最後一年,其影響在上半年達到頂峰,從現在開始,它對我們的成長造成的阻力將大大減小。以固定匯率計算,首發產品成長了 5.3%,我們預計下半年這一成長速度將加快。

  • Entyvio is growing, albeit at a slower pace as the pen is growing 20% quarter-to-quarter in the US, but still represent only 9% of Entyvio volume in the US. Our PDT business is expected to grow at mid-single digit this year with immunoglobulin and albumin growing high single digit. We will continue to maintain very tight OpEx control through efficiency improvement supporting profit.

    Entyvio 正在成長,儘管成長放緩,因為在美國,鋼筆的銷量每季成長 20%,但仍只佔 Entyvio 在美國銷量的 9%。今年我們的 PDT 業務預計將實現中等個位數成長,其中免疫球蛋白和白蛋白將實現高個位數成長。我們將繼續透過提高效率來維持嚴格的營運成本控制,從而提高利潤。

  • Our decision to update full year management guidance for core operating profit and core EPS was driven by a headwind from transactional foreign exchange, mostly generated by the euro appreciation, which has most notably affected QDENGA. Our updated reported forecast, including our EPS forecast reflect a non-tax deductible impairment loss booked in the first half.

    我們決定更新全年核心營業利潤和核心每股收益的管理預期,主要原因是交易外匯帶來的不利影響,而這主要是由於歐元升值造成的,對 QDENGA 的影響尤其顯著。我們更新後的報告預測,包括我們的每股盈餘預測,反映了上半年計入的不可抵扣稅款的減損損失。

  • From fiscal year 2026 onwards, Takeda will be in a new business cycle with Vyvanse generic impact mainly behind us, potentially three new product launch for rusfertide, oveporexton and zasocitinib and an evolving late-stage pipeline now enriched by our strategic partnership with Innovent Biologics. Our leadership in leveraging technology and AI will further transform the company, which will be led by Julie.

    從 2026 財年開始,武田將進入一個新的業務週期,Vyvanse 仿製藥的影響基本上已經過去,我們可能會推出 rusfertide、oveporexton 和 zasocitinib 這三款新產品,並且我們與信達生物的戰略合作也豐富了我們不斷發展的後期研發管線。我們在利用技術和人工智慧方面的領先地位將進一步改變公司,公司將由 Julie 領導。

  • Milano will discuss our financial results and expected results in more detail in a moment, and then Andy will present our pipeline advancement with exciting data on zasocitinib. Later on this call, Teresa Bitetti, and PK Morrow will discuss our partnership with Innovent Biologics and we'll focus on two new late-stage molecules.

    米蘭諾稍後將更詳細地討論我們的財務業績和預期業績,然後安迪將介紹我們的研發管線進展,並帶來關於扎索替尼的激動人心的數據。在本次電話會議的稍後時間裡,Teresa Bitetti 和 PK Morrow 將討論我們與信達生物的合作關係,我們將重點放在兩種新的後期分子。

  • With that, I'll hand it over to Milano to walk us through the financials. Milano?

    接下來,我將把麥克風交給米蘭諾,讓他為我們講解一下財務狀況。米蘭?

  • Milano Furuta - Chief Financial Officer, Director

    Milano Furuta - Chief Financial Officer, Director

  • Thank you, Christophe, and hello, everyone. This is Milano Furuta speaking. Slide 7, summarizes our first half financial results. Overall, our business performance is tracking as we planned. As anticipated, this period was significantly impacted by LOE, as we lost approximately JPY100 billion of Vyvanse revenue.

    謝謝你,克里斯托夫,大家好。這裡是米蘭諾·富魯塔。第 7 張投影片總結了我們上半年的財務表現。整體而言,我們的業務表現符合預期。正如預期的那樣,這段時期受到了營運中斷的嚴重影響,我們損失了約 1000 億日圓的 Vyvanse 收入。

  • Meanwhile, we have been focused on driving OpEx savings, which has partially offset the impact to corporate profit. We expect H1 to be the peak of Vyvanse generic impact, and we expect a better growth outlook for the full year.

    同時,我們一直致力於降低營運成本,這在一定程度上抵消了對公司利潤的影響。我們預計上半年將是Vyvanse仿製藥影響的高峰期,並預計全年成長前景會更好。

  • Revenue in H1 was just over JPY2.2 trillion, a decrease of 6.9% or minus 3.9% at constant exchange rates or CER. Core operating profit, core OP, was JPY639.2 billion, a year-on-year decrease of 11.2% at actual FX or 8.8% at CER. Reported operating profit was JPY253.6 billion, a decline of 27.7% due to larger impairment losses this fiscal year.

    上半年營收略高於2.2兆日圓,下降6.9%,以固定匯率計算下降3.9%。核心營業利潤(核心 OP)為 6,392 億日元,以實際匯率計算年減 11.2%,以固定匯率計算年減 8.8%。報告顯示,營業利潤為2,536億日圓,年減27.7%,原因是本財年減損損失較大。

  • Core EPS was JPY279 and reported EPS was JPY72. The 40% decline in the reported net profit and EPS reflects the impairment of cell therapy, which is nondeductible from taxable income. Cash flow was very strong this period with adjusted free cash flow of JPY525.4 billion, including improvements in working capital.

    核心每股收益為 279 日元,報告每股收益為 72 日元。報告的淨利潤和每股收益下降 40%,反映了細胞療法的減值,而細胞療法的減值不能從應稅收入中扣除。本期現金流非常強勁,經調整後的自由現金流為5,254億日元,其中包括營運資本的改善。

  • Slide 8, shows our growth and launch products, which represent over 50% of revenue. In H1, this portfolio grew 5.3% at CER. This modest growth includes the impact of phasing of certain products, and we anticipate a higher growth rate in the second half.

    第 8 張投影片展示了我們的成長和上市產品,這些產品佔收入的 50% 以上。上半年,該投資組合以固定匯率計算成長了 5.3%。這一溫和的成長包含了某些產品分階段上市的影響,我們預計下半年成長率將會更高。

  • In GI, Entyvio growth was 5.1% at CER. We are encouraged to see increasing numbers of active Entyvio Pen patients in the US, and we are also making progress with expanding formulary access. That said, revenue growth has been slightly below our expectation, and we are revising our full year forecast for Entyvio to 6% at CER. In rare disease, TAKHZYRO continues to grow steadily as a market leader in HAE prophylaxis with 5.9% growth at CER.

    在GI領域,Entyvio的成長率為5.1%(以固定匯率計算)。我們很高興看到美國活躍的 Entyvio Pen 患者人數不斷增加,並且在擴大處方集覆蓋範圍方面也取得了進展。儘管如此,營收成長略低於我們的預期,因此我們將 Entyvio 的全年預期按固定匯率計算調整為 6%。在罕見疾病領域,TAKHZYRO 作為 HAE 預防領域的市場領導者,持續穩定成長,以固定匯率計算成長了 5.9%。

  • Our PDT portfolio growth reflects several factors, which were built into our guidance and fully in line with expectation. IG growth was 3.1%. While Medicare Part D redesign is impacting several products in the US this year, one of the most impacted product is GAMMAGARD LIQUID, and we expect this to normalize in Q4.

    我們的 PDT 產品組合成長反映了幾個因素,這些因素已納入我們的業績指引,並且完全符合預期。IG成長率為3.1%。雖然今年美國醫療保險D部分改革影響了多種產品,但受影響最大的產品之一是GAMMAGARD LIQUID,我們預計這種情況將在第四季度恢復正常。

  • Our SCIG portfolio is growing at double digits, and we expect this to continue. Albumin declined slightly in H1 due to timing of shipments to China and the foreseen cost containment measures. Meanwhile, we have also secured additional sustainable tender markets outside of China, and we expect albumin performance to accelerate in H2. Therefore, we confirm the growth outlook of high single digit for both IG and albumin.

    我們的SCIG投資組合正以兩位數的速度成長,我們預期這一趨勢將持續下去。由於對華發貨時間以及預期的成本控制措施,上半年白蛋白銷量略有下降。同時,我們也在中國以外獲得了更多永續的招標市場,我們預計白蛋白的業績將在下半年加速成長。因此,我們確認 IG 和白蛋白的成長前景均為個位數高成長。

  • In oncology, FRUZAQLA continues to expand as we roll out global launches. Finally, in vaccines, we have reallocated supply of QDENGA based on market needs, which has pushed some shipments timing into later this fiscal year. However, we expect annual demand to remain in line with our original estimate.

    在腫瘤領域,隨著我們在全球推出FRUZAQLA,其市佔率持續擴大。最後,在疫苗方面,我們根據市場需求重新分配了 QDENGA 的供應,這使得一些產品的發貨時間推遲到了本財年的稍後。然而,我們預計年度需求將與我們最初的估計保持一致。

  • Another factor impacting the growth rate of QDENGA is transactional FX, mainly due to the strength of the euro versus the Brazilian real. On Slide 9, you can see how the growth on launch products and the Vyvanse loss of exclusivity contributed to total revenue performance.

    影響 QDENGA 成長率的另一個因素是交易外匯,這主要是由於歐元對巴西雷亞爾的強勢所致。從第 9 張投影片可以看出,上市產品的成長以及 Vyvanse 失去獨家銷售權對總營收表現的貢獻。

  • FX was also a headwind this quarter due to appreciation of the Japanese yen against major currencies. As we expect growth and launch products to deliver higher growth in H2 and Vyvanse year-on-year decline to moderate, we project more favorable year-on-year growth dynamics in H2.

    本季外匯市場也面臨不利因素,日圓兌主要貨幣升值。由於我們預計下半年成長和上市產品將帶來更高的成長,而 Vyvanse 的同比下降幅度將有所緩和,因此我們預計下半年同比成長動態將更加有利。

  • Next, an update on efficiency program that we initiated in April 2024. We continue to make progress with initiatives in H1 this year, including additional organizational changes impacting 600 positions, further optimization of real estate and the growth initiatives to capture efficiencies across the R&D value chain. Restructuring costs in H1 were JPY27.4 billion, and we are focused on further driving additional OpEx savings.

    接下來,我們將介紹我們在 2024 年 4 月啟動的效率提升計畫的最新進展。今年上半年,我們在各項舉措上繼續取得進展,包括影響 600 個職位的額外組織變革、進一步優化房地產以及旨在提高整個研發價值鏈效率的成長舉措。上半年重組成本為274億日圓,我們正致力於進一步降低營運成本。

  • As we show on Slide 11, these operational efficiencies are contributing to a reduction in R&D and SG&A expenses. In this bridge for core operating profit, you can see that LOE of high-margin Vyvanse was the main reason for the year-on-year decline of 8.8% at CER.

    正如我們在第 11 張投影片中所示,這些營運效率的提升有助於降低研發和銷售、管理及行政費用。在這份核心營業利潤的橋樑圖中,你可以看到高利潤率的Vyvanse的營運支出是按固定匯率計算年減8.8%的主要原因。

  • Within this decline at CER, we had a negative impact from transactional FX, which accounts for about one-third of the decline. Let me take a moment to explain how this is impacting our P&L. Revenue can be impacted when there is an FX fluctuation between the currency paid for product and the currency of the entity where revenue is booked.

    在 CER 的下跌中,交易外匯產生了負面影響,約佔下跌幅度的三分之一。讓我花點時間解釋一下這對我們的損益表是如何影響的。當產品支付貨幣與收入確認實體的貨幣之間出現匯率波動時,收入可能會受到影響。

  • This is exactly what is impacting QDENGA sales today, for example, because our European entity books revenue in Europe for its sales to Brazil in Brazilian real. Cost of goods can be impacted, too, when products are imported from other countries. For example, when the euro appreciates, commercial entities outside Europe have to recognize higher COGS when importing products to sell locally. As you know, Takeda has a large manufacturing footprint in Europe, so we are particularly sensitive to euro currency volatility.

    例如,這正是目前影響 QDENGA 銷售的原因,因為我們的歐洲實體在歐洲以巴西雷亞爾計入其對巴西的銷售收入。從其他國家進口產品也會影響商品成本。例如,當歐元升值時,歐洲以外的商業實體在進口產品到當地銷售時,必須確認更高的銷售成本。如您所知,武田製藥在歐洲擁有龐大的生產基地,因此我們對歐元匯率的波動特別敏感。

  • Next, reported operating profit on Slide 12. This decreased by 27.7% versus prior year, mainly due to the decline in core operating profit and higher impairment of intangible assets. The main item was a JPY58.2 billion expense related to our recent decision to discontinue cell therapy efforts. Next, our updated full year outlook on Slide 13.

    接下來,第 12 頁報告了營業利潤。與前一年相比下降了 27.7%,主要原因是核心營業利潤下降和無形資產減損增加。主要支出為 582 億日元,與我們最近決定停止細胞療法研發工作有關。接下來,請看第 13 頁投影片,了解我們更新後的全年展望。

  • Starting with management guidance, although we have reduced our forecast for Entyvio and Vyvanse, we expect total revenue to stay in the range of the broadly flat versus prior year. For profit guidance, we expect higher OpEx savings to fully mitigate the impact from unfavorable change in product mix. However, the transactional FX dynamic that I just described is having a larger impact on profits. Therefore, we are slightly lowering our guidance for core operating profit and core EPS from broadly flat to low single-digit percentage decline.

    首先是管理層指引,雖然我們下調了對 Entyvio 和 Vyvanse 的預測,但我們預計總收入將與去年基本持平。對於獲利預期,我們預期更高的營運支出節省將完全抵銷產品組合不利變化的影響。然而,我剛才描述的交易外匯動態對利潤的影響更大。因此,我們將核心營業利潤和核心每股盈餘的預期從基本持平略微下調至個位數百分比下降。

  • The bottom part of the slide shows our reported and core forecast. This reflects our latest FX assumptions, including transactional FX and items booked in H1 that will impact the full year results. We have also revised our adjusted free cash flow forecast to include a USD1.2 billion payment to Innovent Biologics for our recently announced in-licensing deal. This payment will be funded by cash on hand. Our dividend outlook remains JPY200 per share for the full year.

    投影片的下半部顯示了我們報告的預測和核心預測。這反映了我們最新的外匯假設,包括交易性外匯和上半年入帳的項目,這些都會影響全年的業績。我們也修訂了調整後的自由現金流預測,將向信達生物支付的 12 億美元作為我們最近宣布的引進許可交易的款項。這筆款項將以現有現金支付。我們全年的股利預期仍為每股200日圓。

  • On Slide 14, we show more details about the updated operating profit forecast. You can see the relative magnitude of transactional FX impact, while OpEx savings compensate for unfavorable product mix. The net impact of all these moving parts, including transactional FX, is a JPY10 billion reduction in our operating profit forecast to JPY1.13 trillion.

    第 14 張投影片展示了更新後的營業利潤預測的更多細節。你可以看到交易外匯影響的相對大小,而營運支出節省則彌補了不利的產品組合。所有這些變動因素(包括交易外匯)的淨影響是,我們的營業利潤預測將減少 100 億日元,至 1.13 兆日圓。

  • In summary, our business fundamentals are tracking as planned. While H1 growth was largely impacted by LOE, we expect better growth rates for the full year fiscal year. Meanwhile, we remain focused on cost discipline to deliver our guidance, while investing for future growth.

    總而言之,我們的業務基本面正按計劃進行。雖然上半年的成長很大程度上受到了營運支出的影響,但我們預計全年的成長率會更好。同時,我們將繼續專注於成本控制,以實現我們的業績預期,同時投資於未來的成長。

  • Thank you for your attention. I will now hand over to Andy for more details on the pipeline updates.

    感謝您的關注。接下來我將把發言權交給安迪,讓他詳細介紹管道的最新進展。

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

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

  • Thank you very much, Milano, and hello to everyone on today's call. Next slide, please. Fiscal year 2025, as you just heard from Christophe, is a pivotal year as we advance and accelerate our exciting high-value late-stage pipeline to launch. Today, I am pleased to provide pipeline updates reflecting our growing late-stage portfolio of promising programs powered by our increasingly productive and efficient development engine. We are two for two with positive Phase 3, studies for both rusfertide and oveporexton with zasocitinib Phase 3, data in psoriasis expected by the end of this calendar year.

    非常感謝米蘭諾,也向今天參加電話會議的各位問好。請看下一張投影片。正如克里斯托夫剛才所說,2025 財年是關鍵的一年,我們將推進並加速我們令人興奮的高價值後期研發管線的上市。今天,我很高興地向大家介紹我們不斷成長的後期研發專案組合的最新進展,這些專案都得益於我們日益高效的研發引擎。我們對 rusfertide 和 oveporexton 與 zasocitinib 聯合治療銀屑病的 3 期研究均取得了積極的成果,預計將於今年年底獲得 3 期研究數據。

  • In a few minutes, Teresa Bitetti, and PK Morrow will walk you through the details of our recently announced partnership with Innovent Biologics, which upon closing, will expand our oncology pipeline. With two highly differentiated late-stage oncology assets in development for multiple solid tumors, this deal has the potential to transform our oncology pipeline. But first, I'm going to highlight some recently presented Phase 3, data for oveporexton and long-term IgA nephropathy data for mezagitamab that we are particularly excited about.

    幾分鐘後,Teresa Bitetti 和 PK Morrow 將帶您了解我們最近宣布的與信達生物的合作關係的詳情,該合作一旦完成,將擴大我們的腫瘤產品線。憑藉兩項針對多種實體瘤的、處於後期研發階段的高度差異化的腫瘤資產,這項交易有可能改變我們的腫瘤產品線。但首先,我要重點介紹一些我們特別興奮的、最近發表的 oveporexton 的 3 期數據和 mezagitamab 的長期 IgA 腎病數據。

  • The results of these studies truly represent Takeda's high bar for innovation and the breakthrough benefits we seek to provide patients. Let's start with oveporexton on the next slide. Oveporexton is on track to be the first-in-class and potentially best-in-class orexin two receptor agonist that treats the underlying orexin deficiency in patients with narcolepsy type two. We believe that the data presented at the World Sleep Congress last month establishes a new standard of care for NT1.

    這些研究成果真正體現了武田製藥在創新方面的高標準,以及我們力求為患者帶來的突破性益處。讓我們從下一張投影片上的overporexton開始。Oveporexton有望成為首個也是可能成為同類最佳的食慾素2受體激動劑,用於治療2型嗜睡症患者的潛在食慾素缺乏症。我們認為,上個月在世界睡眠大會上公佈的數據為 NT1 的治療樹立了新的標準。

  • In one of the largest, most comprehensive Phase 3, development programs for NT1 to date, we demonstrated statistically significant and clinically meaningful improvement across all 14 primary and secondary endpoints with most participants within normative ranges. It is clear that oveporexton has a profound effect on daytime symptoms like excessive daytime sleepiness and cataplexy, nighttime symptoms and cognitive symptoms.

    在迄今為止最大、最全面的 NT1 第三階段開發計畫之一中,我們證明了所有 14 個主要和次要終點均有統計意義和臨床意義的改善,大多數參與者的指標均達到正常範圍。很明顯,過量性食慾對白天的症狀(如白天過度嗜睡和猝倒)、夜間症狀和認知症狀有顯著影響。

  • In addition, it significantly impacts how patients with NT1 feel and function. We believe we have created a new standard of care to treat NT1 by treating the entire range of symptoms with a safe, well-tolerated pill. Oveporexton sets a high bar with the new standard of care, which will be hard to beat.

    此外,它還會對 NT1 患者的感覺和功能產生重大影響。我們相信,我們透過安全、耐受性良好的藥丸治療所有症狀,為治療 NT1 創造了新的護理標準。Oveporexton 樹立了新的護理標準,樹立了很高的標桿,很難被超越。

  • Feel and function were assessed using multiple objective and subjective measures. Based on these strong Phase 3, data, we plan to file for US approval in NT1 as quickly as possible later this year with regional filings to occur simultaneously or shortly thereafter.

    採用多種客觀和主觀指標對感覺和功能進行評估。基於這些強勁的 3 期數據,我們計劃在今年稍後盡快向美國提交 NT1 的上市申請,並同時或隨後不久提交區域性上市申請。

  • Our orexin franchise is making rapid progress beyond oveporexton. The next-generation orexin two receptor agonist, TAK-360, is rapidly enrolling Phase 2, studies for narcolepsy type two and idiopathic hypersomnia. Results for these trials are expected to be read out by early fiscal year 2026. Next slide, please.

    我們的食慾素產品線正在迅速發展,超越了Overporexton。下一代食慾素 2 受體激動劑 TAK-360 正在快速進行 2 型嗜睡症和特發性嗜睡症的第 2 期研究。預計這些試驗的結果將於 2026 財年年初公佈。請看下一張投影片。

  • We previously presented compelling 48-week proof-of-concept data for our anti-CD38 antibody, mezagitamab, in IgA nephropathy. This includes consistent and supportive trends in decreased IgA, IgG and galactose-deficient IgA1 levels, reflecting the selective targeting of CD38 on plasma cells, which produce pathological antibodies.

    我們先前已發表了抗 CD38 抗體 mezagitamab 在 IgA 腎病變中令人信服的 48 週概念驗證數據。這包括 IgA、IgG 和半乳糖缺乏型 IgA1 水平持續下降的趨勢,反映了對產生病理性抗體的漿細胞上 CD38 的選擇性靶向作用。

  • I'll now preview the exceptional 96-week results from the proof-of-concept trial that continue to support this promising approach to modifying this disease. Mezagitamab-treated patients show persistent reductions in proteinuria or UPCR, nearly 18-months after the last dose, suggesting sustained efficacy beyond the treatment period. Importantly, the estimated glomerular filtration rate, or eGFR, that is the regulatory gold standard for measuring renal function remains stable at 96 weeks.

    接下來,我將預覽概念驗證試驗中為期 96 週的卓越結果,這些結果繼續支持這種有前景的疾病治療方法。接受 Mezagitamab 治療的患者在最後一次給藥後近 18 個月仍表現出蛋白尿或 UPCR 的持續降低,這表明其療效在治療期後仍能持續。重要的是,作為衡量腎功能的監管金標準的估計腎小球濾過率(eGFR)在 96 週時保持穩定。

  • Mezagitamab is the first IgA nephropathy therapy to demonstrate stable renal function 18-months after dosing. We look forward to presenting the full data at ASN Kidney Week next month. Our Phase 3, IgA nephropathy study is open and has been enrolling well.

    Mezagitamab 是第一個在給藥後 18 個月內證實腎功能穩定的 IgA 腎病治療藥物。我們期待在下個月的 ASN 腎臟週上公佈全部數據。我們的 IgA 腎病 3 期研究正在進行中,目前招募情況良好。

  • Next slide, please. The Phase 3, verify study of rusfertide, a potential first-in-class synthetic hepcidin mimetic in development to treat polycythemia vera was presented at the American Society of Clinical Oncology in a plenary session in June. Updated 52-week data will be available at an upcoming medical congress.

    請看下一張投影片。一項針對 rusfertide 的 3 期驗證研究於 6 月在美國臨床腫瘤學會全體會議上發表。 rusfertide 是一種潛在的首創合成鐵調素類似物,正在開發用於治療真性紅血球增多症。更新後的 52 週數據將在即將召開的醫學會議上公佈。

  • This quarter, we received breakthrough therapy designation, which speaks to the exceptional practice-changing data presented at ASCO 2025 and increases the probability of priority review for rusfertide, which we intend to file this fiscal year.

    本季度,我們獲得了突破性療法認定,這表明我們在 2025 年 ASCO 會議上公佈的具有非凡的、改變實踐意義的數據,並提高了 rusfertide 獲得優先審查的可能性,我們計劃在本財年提交該申請。

  • Looking ahead to our next major pipeline milestone, we expect zasocitinib Phase 3, psoriasis data later this calendar year. Based on the data seen in Phase 2, we believe zasocitinib will provide an important and very attractive oral option for patients. I'm also excited to report that the head-to-head study of zasocitinib versus deucravacitinib in psoriasis is expected to complete enrollment in the next few weeks.

    展望我們下一個重要的研發管線里程碑,我們預計今年稍後將公佈 zasocitinib 治療乾癬的 3 期臨床試驗數據。根據 2 期臨床試驗的數據,我們相信 zasocitinib 將為患者提供一種重要且極具吸引力的口服治療選擇。我很高興地報告,zasocitinib 與 deucravacitinib 在乾癬治療中的頭對頭研究預計將在未來幾週內完成入組。

  • As you can see here, psoriasis is the first of many diseases where zasocitinib can benefit patients. With that, I will now turn it over to Teresa and PK to provide more details on the Innovent partnership, which has the potential to catapult Takeda into an industry-leading oncology company.

    正如您在這裡看到的,銀屑病是 zasocitinib 可以使患者受益的眾多疾病中的第一種。接下來,我將把發言權交給 Teresa 和 PK,讓他們詳細介紹與信達製藥的合作,這項合作有可能使武田製藥成為業界領先的腫瘤公司。

  • Thank you.

    謝謝。

  • Teresa Bitetti - President, Global Oncology, Takeda

    Teresa Bitetti - President, Global Oncology, Takeda

  • Thank you, Andy. Good morning, good afternoon, and good evening. We are pleased to be here today to share more detail about our recently announced partnership with Innovent Biologics and why it's critically important for patients and for Takeda. Next slide.

    謝謝你,安迪。早安,下午好,晚上好。今天我們很高興能在這裡與大家分享我們最近宣布的與信達生物的合作關係的更多細節,以及這對患者和武田製藥來說為何至關重要。下一張投影片。

  • Our collaboration with Innovent involves three differentiated assets, each with unique mechanisms. 363 is a potentially first-in-class PD-1/IL-2 alpha bias bispecific. 343 is a next-generation Claudin 18.2 ADC, and we're also receiving the exclusive option to license 3001, which is another ADC targeting EGFR and B7H3.

    我們與信達生物的合作涉及三項差異化資產,每項資產都有獨特的作用機制。 363 是一種潛在的首創 PD-1/IL-2 α 偏向性雙特異性抗體。 343 是一種新一代 Claudin 18.2 抗體偶聯藥物 (ADC)。此外,我們還獲得了 3001 的獨家授權選擇權,3001 是另一種針對 EGFR 和 B7H3 的 ADC。

  • This deal is strategically important because it adds cutting-edge anchor assets to our pipeline. First, a bispecific with the potential to be an IO backbone therapy across a broad range of indications, lung included. Second, a next-generation ADC with potential to address difficult-to-treat cancers, including gastric and pancreatic.

    這項交易具有重要的戰略意義,因為它為我們的產品線增加了尖端的核心資產。首先,一種雙特異性抗體有望成為包括肺癌在內的多種適應症的 IO 骨幹療法。其次,下一代抗體藥物偶聯物 (ADC) 有望用於治療包括胃癌和胰腺癌在內的難治性癌症。

  • And finally, an option to license a potential best-in-class bispecific ADC. These unique programs, each with differentiated mechanisms further demonstrate our commitment to science, our commitment to patients and have the potential to be significant growth drivers for the Takeda enterprise post 2030.

    最後,也可以選擇授權使用一款潛在的同類最佳的雙特異性ADC。這些獨特的項目,各自擁有不同的機制,進一步證明了我們對科學的承諾、對患者的承諾,並有可能成為武田企業在 2030 年後的重要成長動力。

  • So next slide. Let me spend a little time sharing how we've structured this deal and what it brings to the Takeda portfolio. So for 363, which is the PD-1/IL-2 alpha bias bispecific, Takeda will lead the co-development of this asset globally using a 60-40 Takeda-Innovent cost split. Takeda will also lead US co-commercialization of 363 with a 60-40 Takeda-Innovent profit or loss split. And Takeda will have the exclusive right to commercialize and manufacture outside of Greater China.

    下一張投影片。讓我花點時間分享一下我們是如何建構這筆交易的,以及它能為武田的產品組合帶來什麼。因此,對於 PD-1/IL-2 α 偏向性雙特異性抗體 363,武田將主導在全球共同開發該資產,武田與信達生物的成本分攤比例為 60:40。武田也將主導 363 在美國的聯合商業化,武田與信達生物的利潤或虧損比例為 60:40。武田製藥將擁有在大中華區以外地區進行商業化和生產的獨家權利。

  • For 343, the Claudin 18.2 ADC, Takeda will have the right to develop, manufacture and commercialize worldwide outside of Greater China. And finally, we will have the option for 3001, which is the EGFR/B7H3 ADC currently in Phase 1. If we choose to exercise the option, we will have global rights to develop, manufacture and commercialize outside of Greater China.

    對於 343(Claudin 18.2 ADC),武田將擁有在大中華區以外的全球範圍內進行開發、生產和商業化的權利。最後,我們也可以選擇 3001,這是目前處於第 1 期臨床試驗階段的 EGFR/B7H3 ADC。如果我們選擇行使該選擇權,我們將擁有在大中華區以外進行開發、生產和商業化的全球權利。

  • Next slide. This collaboration further enhances and augments our oncology portfolio and is consistent with our clearly articulated oncology strategy. As a reminder, you can see here on this slide, our strategy is focused on three disease areas and three modalities. And as we have highlighted here in the red box, the programs included in this partnership fits squarely within our strategy.

    下一張投影片。此次合作進一步增強和豐富了我們的腫瘤產品組合,並與我們明確闡述的腫瘤策略一致。再次提醒一下,您可以在這張投影片上看到,我們的策略重點是三個疾病領域和三種治療方式。正如我們在紅色方框中所強調的那樣,此次合作中包含的項目完全符合我們的策略。

  • So now I'm going to turn it over to PK to explain more about the science behind these programs.

    現在我會把麥克風交給PK,讓他來詳細解釋這些程序背後的科學原理。

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • Thank you, Teresa. I'm now going to share more about the three programs in this collaboration and why we are so excited to bring them into our pipeline at Takeda. I will start with IBI363. IBI363, as you can see here, is a bispecific with a unique mechanism that has the potential to become an immuno-oncology or IO backbone. Specifically, IBI363 is what I would call an IO-IO molecule, meaning that it is designed to block the PD-1/PD-L1 pathway and selectively activate IL-2 alpha signaling while attenuating IL-2 beta gamma signaling.

    謝謝你,特蕾莎。接下來,我將詳細介紹此次合作中的三個項目,以及我們為何如此興奮地將它們納入武田的研發管線。我將從IBI363開始。如您所見,IBI363 是一種具有獨特機制的雙特異性抗體,有可能成為免疫腫瘤學或 IO 的骨幹藥物。具體來說,IBI363 是一種我稱為 IO-IO 分子的分子,這意味著它旨在阻斷 PD-1/PD-L1 路徑並選擇性地激活 IL-2 α 訊號傳導,同時減弱 IL-2 β γ 訊號傳導。

  • As you can see on the left-hand side of this slide, this differentiated IL-2 alpha biased approach has been shown to activate tumor-specific T-cells that express both PD-1 and IL-2 alpha receptor within the tumor microenvironment, thereby unleashing a more effective antitumor immune response.

    正如你在這張幻燈片的左側所看到的,這種分化的IL-2α偏向方法已被證明可以激活腫瘤微環境中表達PD-1和IL-2α受體的腫瘤特異性T細胞,從而釋放更有效的抗腫瘤免疫反應。

  • IBI363, thereby supercharges tumor-specific T-cells, resulting in apoptosis of the cancer cell. And by blocking the PD-1 pathway, IBI363 ensures that these T-cells continue to stay activated and it reduces the risk of T-cell exhaustion. IBI363 has now dosed more than 1,200 patients and has demonstrated very encouraging results.

    IBI363 可增強腫瘤特異性 T 細胞的功能,進而導致癌細胞凋亡。透過阻斷 PD-1 通路,IBI363 可確保這些 T 細胞持續保持活化狀態,並降低 T 細胞耗竭的風險。IBI363 目前已對超過 1200 名患者進行了給藥,並取得了非常令人鼓舞的結果。

  • Next slide. We have seen clinically impactful results in trials involving patients with IO refractory squamous and non-squamous non-small cell lung cancer as well as in third-line microsatellite-stable colorectal cancer. And while median overall survival is immature at the higher doses, it already shows a positive trend even at these lower doses.

    下一張投影片。我們在涉及 IO 難治性鱗狀和非鱗狀非小細胞肺癌患者以及三線微衛星穩定型結直腸癌患者的試驗中看到了具有臨床意義的結果。雖然較高劑量組的中位總存活期數據尚不成熟,但即使在較低劑量組,也已顯示出積極的趨勢。

  • The results you see on the screen were just shared as oral presentations at this year's ASCO. They are encouraging data, especially when indirectly compared to results from standard of care chemotherapy on the right.

    您在螢幕上看到的結果只是在今年的ASCO會議上以口頭報告的形式分享的。這些數據令人鼓舞,尤其是與右側標準治療化療的結果進行間接比較時。

  • The safety profile of IBI363 is considered tolerable with the most common adverse events related to IBI363 being rash and arthralgia. Discontinuations due to these events have occurred in a small percentage of patients and a priming dose has been added to the dosing schedule to reduce the risk of immune-related events that may occur with bispecific dosing.

    IBI363 的安全性被認為可以耐受,與 IBI363 相關的最常見不良反應是皮疹和關節疼痛。由於這些事件,少數患者停止了治療,並且在給藥方案中增加了一個啟動劑量,以降低雙特異性給藥可能引起的免疫相關事件的風險。

  • The high caliber of these data is reinforced by the FDA's granting of a Fast Track designation in non-small cell lung cancer. Thus, while this is a competitive environment, we are very encouraged by the data we have seen to date and the potential of this differentiated mechanism.

    這些數據的高品質得到了 FDA 授予非小細胞肺癌快速通道資格的佐證。因此,儘管這是一個競爭激烈的環境,但我們對迄今為止所看到的數據以及這種差異化機制的潛力感到非常鼓舞。

  • Next slide. To maximize the potential of IBI363, we have three very clear objectives, which are built on the efficacy that we've seen thus far. First is to establish foundational efficacy in tumors that have progressed as IO therapies. Second is to penetrate into earlier lines as either monotherapy or in combination. And third is to build on our known data to establish efficacy in immune desert tumors such as microsatellite-stable colorectal cancer in which other IO therapies have not worked.

    下一張投影片。為了最大限度地發揮 IBI363 的潛力,我們制定了三個非常明確的目標,這些目標都是基於我們迄今為止所看到的療效而製定的。首先要確定其在已透過免疫腫瘤療法取得進展的腫瘤中的基礎療效。其次,可以採用單藥療法或合併療法,將藥物滲透到更早期的治療線。第三,要利用我們已知的數據,證明免疫沙漠腫瘤(如微衛星穩定型大腸直腸癌)的療效,因為其他免疫腫瘤療法對這類腫瘤無效。

  • So that's why, as shown on this slide, we're initially establishing the five Phase 3, trials, including two trials in IO refractory squamous and non-squamous non-small cell lung cancer, two in frontline non-small cell lung cancer and one in microsatellite-stable colorectal cancer. We also have a series of life cycle management trials that we're discussing with Innovent, which will help to build upon proof-of-concept data as it evolves.

    因此,如這張投影片所示,我們最初設立了五項 3 期試驗,其中包括兩項針對 IO 難治性鱗狀和非鱗狀非小細胞肺癌的試驗,兩項針對一線非小細胞肺癌的試驗,以及一項針對微衛星穩定型結直腸癌的試驗。我們也正在與信達生物討論一系列生命週期管理試驗,這將有助於隨著概念的演進不斷完善概念驗證資料。

  • Next slide. Now I'll walk you through IBI343. This Claudin 18.2 targeted ADC is seamlessly harmonized with our oncology strategy due to, first, its novel ADC platform; and second, its demonstrated efficacy in GI cancers. When examining the image on the left, I will walk you through the platform from left to right. First, on the very left, IBI343 has a humanized IgG1 with Fc silencing. This Fc silencing is important because it reduces the risk of off-target toxicity and increases the tolerability of this Claudin targeting molecule.

    下一張投影片。現在我將帶你了解 IBI343。這種針對 Claudin 18.2 的 ADC 與我們的腫瘤治療策略完美契合,原因有二:首先,它採用了新型 ADC 平台;其次,它在胃腸道癌症中展現出了療效。在查看左側圖像時,我將從左到右帶您了解該平台。首先,最左邊的 IBI343 具有人源化 IgG1,並抑制了 Fc 訊息傳遞路徑。這種 Fc 沉默非常重要,因為它降低了脫靶毒性的風險,並提高了這種 Claudin 標靶分子的耐受性。

  • This differentiates 343 from other Claudin-targeting agents, which are known to have increased gastrointestinal adverse events. In addition to that, in the middle, the glycan-specific conjugation and sulfamide spacer increases the stability, solubility and potential bystander effect, allowing the ADC to result in a more efficient apoptosis of the cancer cell.

    這使得 343 與其他 Claudin 標靶藥物有所區別,後者已知會增加胃腸道不良事件。此外,中間的糖特異性偶聯和磺酰胺間隔基提高了穩定性、溶解度和潛在的旁觀者效應,使 ADC 更有效地導致癌細胞凋亡。

  • And it also supports a homogeneous drug-to-antibody ratio of approximately four, which many of us believe is a favorable ratio for ADCs. And finally, this potent exatecan payload inhibits topoisomerase one, so it fits seamlessly into many standard of care regimens.

    它還支持藥物與抗體比例約為 4 的均質性,我們許多人認為這是 ADC 的一個有利比例。最後,這種強效的依沙替康有效載荷可抑制拓樸異構酶 I,因此可以無縫地融入許多標準治療方案中。

  • Next slide. 343 has been dosed in more than 340 patients. And as shown during oral presentations at this year's ASCO, IBI343 has demonstrated encouraging activity in pancreatic and gastric cancers. Compared to the standard of care, 343 has more than doubled the response rate and more than doubled the overall survival as compared to standard of care chemotherapy thus far. This, coupled with a favorable and consistent safety profile with manageable GI and hematologic adverse events supports its ability to fit seamlessly into the standard of care.

    下一張投影片。 343號藥物已在超過340名患者身上給藥。正如今年 ASCO 的口頭報告所示,IBI343 在胰腺癌和胃癌中表現出令人鼓舞的活性。與標準治療相比,343 療法使緩解率提高了一倍以上,總存活期也比迄今為止的標準治療化療提高了一倍以上。此外,該藥物具有良好的安全性,胃腸道和血液系統不良反應可控,因此能夠無縫融入標準治療方案。

  • All of this makes us very excited to continue advancing this asset in GI cancers with critical unmet need. And as with 363, these results were also reinforced by a Fast Track designation by the FDA for pancreatic ductal adenocarcinoma.

    這一切都讓我們非常興奮,期待繼續推進這項技術在胃腸道癌症領域應用,以滿足該領域尚未充分滿足的醫療需求。與 363 一樣,這些結果也得到了 FDA 授予的胰腺導管腺癌快速通道資格的證實。

  • Next slide. We also have an ambitious development plan for 343 in Claudin 18.2 expressing GI cancers as its topoisomerase inhibition enables us to fit seamlessly into the frontline treatment of pancreatic cancer. In the second line of the chart, you can see that Innovent has an ongoing study, which is well underway in China and Japan in the third-line setting in gastric cancer.

    下一張投影片。我們還制定了一項雄心勃勃的開發計劃,針對錶達 Claudin 18.2 的 343 型胃腸道癌症,因為其拓撲異構酶抑製作用使我們能夠無縫地融入胰腺癌的一線治療中。從圖表的第二行可以看出,信達生物正在進行一項研究,該研究在中國和日本針對胃癌的第三線治療取得了良好進展。

  • We will leverage this data from this study and add a single-arm study in the US and the EU to move forward towards global registration in the third-line setting. And in the bottom row, you can see that the plans are underway for a frontline study in gastric cancer to address the needs of more gastric cancer patients across lines of therapy. Next slide.

    我們將利用這項研究的數據,並在美國和歐盟進行一項單臂研究,以推進三線治療的全球註冊。在最下面一行,你可以看到,目前正在製定一項針對胃癌的一線研究計劃,以滿足更多接受不同治療方案的胃癌患者的需求。下一張投影片。

  • And finally, I will review with you IBI3001, for which we have the exclusive option to license at a potential future date. IBI3001 is truly a novel molecule, which is both a bispecific and an ADC. It targets EGFR and B7H3, 2 targets that are highly expressed in many solid tumors, including lung cancer, colorectal cancer and head and neck cancer, and it is linked to the same potent exatecan payload as 343.

    最後,我將和大家一起回顧 IBI3001,我們擁有在未來某個時候獨家授權該軟體的選擇權。IBI3001 是一種真正意義上的新型分子,它既是雙特異性抗體,也是抗體藥物偶聯物 (ADC)。它針對 EGFR 和 B7H3,這兩個靶點在許多實體瘤中高表達,包括肺癌、結直腸癌和頭頸癌,並且它與 343 一樣,都含有強效的依沙替康有效載荷。

  • Innovent has rapidly progressed this asset into the clinic, already producing data, as you can see on the right-hand side, that shows encouraging efficacy even in highly refractory solid tumors. We look forward to following the progress of this trial, which is moving at speed.

    信達生物已迅速將該產品推進到臨床階段,並已產生數據(如您在右側所見),數據顯示,即使對於高度難治性實體瘤,也具有令人鼓舞的療效。我們期待關注此次快速推進的審判進展。

  • And with that, I'm delighted to turn it back to Teresa to talk about the immense promise of this collaboration for patients.

    接下來,我很高興把麥克風交還給特蕾莎,讓她談談這項合作對病人的巨大意義。

  • Teresa Bitetti - President, Global Oncology, Takeda

    Teresa Bitetti - President, Global Oncology, Takeda

  • Thank you, PK. So looking at this from a patient perspective against the backdrop of the top tumor types by overall prevalence worldwide, we have the opportunity to make a difference in areas of extremely high unmet need. So as you can see highlighted in red, the tumors in our initial development plan are not only prevalent but difficult to treat. In our initial plans, we can address four of these cancers and make a meaningful difference for patients.

    謝謝你,PK。因此,從患者的角度來看,結合全球患病率最高的幾種腫瘤類型,我們有機會在極度缺乏滿足的需求領域做出改變。正如您在紅色高亮部分所看到的,我們初步開發計劃中的腫瘤不僅很普遍,而且難以治療。在我們的初步計劃中,我們可以攻克其中四種癌症,並為患者帶來有意義的改變。

  • Next slide. As I mentioned at the start, this partnership will serve as a significant potential growth driver for Takeda. When we look at the market opportunity for our initial development plans for 363, we're looking at lung and CRC.

    下一張投影片。正如我開頭所提到的,這項合作將成為武田製藥重要的潛在成長動力。當我們審視 363 的初步開發計劃的市場機會時,我們關注的是肺癌和大腸癌。

  • In lung, we will be focusing on the IO refractory second-line setting, where the majority of patients will have already been treated with a PD-1 or PD-L1 and then move rapidly into the frontline setting as a monotherapy or part of a combination regimen. And in colorectal cancer, we'll focus on the frontline patients with MSS CRC. So in aggregate, the initial plan focuses on a potential combined addressable market of over $40 billion.

    在肺癌方面,我們將重點關注 IO 難治性二線治療,其中大多數患者已經接受過 PD-1 或​​ PD-L1 治療,然後迅速進入一線治療,作為單藥治療或聯合治療方案的一部分。在大腸直腸癌方面,我們將重點放在 MSS CRC 的第一線患者。因此,總體而言,初步計劃著眼於超過 400 億美元的潛在市場。

  • Next slide. Now let's look at the market potential for 343. Globally, gastric cancer affects around 1 million people with 35% to 55% expressing the Claudin 18 biomarker. In pancreatic, the global incidence is approximately 500,000 with 30% to 60% of patients expressing Claudin 18. The current standard of care in these tumor types centers on chemotherapy and the 5-year survival rates are very low, highlighting the urgent need for innovative treatments.

    下一張投影片。現在我們來看看343的市場潛力。全球約有 100 萬人患有胃癌,其中 35% 至 55% 的患者表達 Claudin 18 生物標記。胰臟癌的全球發生率約為 50 萬,其中 30% 至 60% 的患者表達 Claudin 18。目前針對這些腫瘤類型的標準治療以化療為主,5 年存活率非常低,凸顯了開發創新療法的迫切需求。

  • Altogether, 343 offers a potential combined addressable market of approximately $8 billion, although we expect this market to grow as we and other novel agents enter. So as you can see, across both assets, there's an enormous potential to make a significant impact for patients.

    總的來說,343 的潛在市場規模約為 80 億美元,儘管我們預計隨著我們和其他新型藥物的進入,這個市場將會成長。因此,正如你所看到的,這兩項資產都具有巨大的潛力,能夠對患者產生重大影響。

  • So next slide. So in closing, we are incredibly energized by this extraordinary strategic partnership that brings great value for both patients and for Takeda. This agreement with Innovent will enable us to address critical treatment gaps in some of the most prevalent and difficult-to-treat cancers.

    下一張投影片。最後,我們對這一非凡的策略合作夥伴關係感到無比振奮,它為患者和武田公司都帶來了巨大的價值。與信達生物的這項協議將使我們能夠解決一些最常見和最難治療的癌症的關鍵治療缺口。

  • It brings forward unique and truly differentiated programs that will overcome many of the challenges of currently available therapies, and it adds anchor assets to our solid tumor pipeline with the potential to be future growth drivers for Takeda. So in short, this collaboration is incredibly meaningful, both for us and for patients.

    它提出了獨特且真正差異化的方案,將克服目前可用療法的許多挑戰,並為我們的實體瘤產品線增加了核心資產,這些資產有可能成為武田未來的成長動力。簡而言之,這次合作對我們和患者來說都意義非凡。

  • So thank you for your attention. I'm going to hand back to Chris to open the Q&A.

    謝謝大家的關注。我將把發言權交還給克里斯,讓他開始問答環節。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Now I would like to take questions from participants. We have Christophe, Milano, Andy, Teresa, PK, and Julie Kim, CEO Elect Interim Head, Global Portfolio Division and Giles Platford President, Plasma-Derived Therapies Business Unit are joining in the Q&A. (Operator Instructions)

    (翻譯)現在我想回答各位參與者的問題。我們有 Christophe、Milano、Andy、Teresa、PK 和 Julie Kim(全球投資組合部門候任臨時負責人)以及 Giles Platford(血漿衍生療法業務部門總裁)參與問答環節。(操作說明)

  • Yamaguchi-san.

    山口先生。

  • Hidemaru Yamaguchi - Analyst

    Hidemaru Yamaguchi - Analyst

  • So, thank you very much for taking my question. This is Yamaguchi, Citi. The first question regarding to Innovent deal. I understand the potential of this product is pretty big. But at the same time, Takeda sales has not really involved in the solid tumor for a while after ALUNBRIG. And investors have a lot of question on this one, how much you need to spend on R&D for the next few years where you have to balance the operating margin.

    非常感謝您回答我的問題。這裡是山口,花旗銀行。關於Innovent交易的第一個問題。我知道這款產品的潛力非常大。但同時,自從 ALUNBRIG 之後,武田製藥的銷售業務已經有一段時間沒有真正涉足實體瘤領域了。投資人對此有很多疑問,即在未來幾年內,你需要投入多少研發資金才能平衡營運利潤率。

  • So R&D investment, even though you're going to split, but solid tumor first line seems to be very costly. So can you give me some elaboration on how you're going to run this clinical trial to compete with the global guys on the R&D and trying to, I would say, finance your R&D and the impact -- potential impact to the margins? That's the first question.

    所以研發投入,即使你們要分攤費用,但實體腫瘤第一線治療似乎成本很高。那麼,您能否詳細說明一下,您將如何進行這項臨床試驗,以便在研發方面與全球同行競爭,並努力為您的研發籌集資金,以及對利潤率的潛在影響?這是第一個問題。

  • The second question regarding to the earnings change. Even though there's only a slight change on a CL basis on the Entyvio and Vyvanse, seem to have a big change on the currency things. And this year might be a unique year, but is there any way in the future trying to avoid those changes or through some other transactions trying to prevent or this year, it's hard to escape from this currency related to earnings divisions. That's the second question.

    第二個問題是關於收益變化的。儘管 Entyvio 和 Vyvanse 在信用等級方面只有輕微的變化,但在貨幣方面似乎發生了很大的變化。今年或許是特別的一年,但未來是否有辦法避免這些變化,或透過其他交易來阻止這些變化?今年,我們很難擺脫與收益分攤相關的這種貨幣波動。這是第二個問題。

  • Thank you.

    謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Yamaguchi-san. So the first question was around how we're going to run the trials for the Innovent assets and what that means for R&D expenses. So perhaps PK can just comment briefly on -- again, on the development plans we have in place for these programs. And then Milano can add a comment on how that will fit within our R&D budget. And then for the second question on this transactional FX impact, I'd also like to ask Milano to comment on that, please.

    謝謝山口先生。所以第一個問題是,我們將如何對信達生物的資產進行試驗,以及這對研發費用意味著什麼。所以,PK或許可以再次簡單地評論一下我們為這些項目所製定的發展計畫。然後米蘭諾可以補充說明這將如何納入我們的研發預算。關於交易外匯影響的第二個問題,我也想請米蘭諾對此發表評論。

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • Yes. Thank you. So we are very committed to investment both within our oncology portfolio as well as overall in order to support our long-term growth, while continuing to support profitability. In terms of the financial implications of this deal, these have actually been reflected in our revised forecast and guidance.

    是的。謝謝。因此,我們非常致力於在腫瘤產品組合以及整體領域進行投資,以支持我們的長期成長,同時繼續保持獲利能力。就這項交易的財務影響而言,這些實際上已經反映在我們修訂後的預測和指引中。

  • It's a little premature for us right now to comment on outlook for R&D spend and margins for fiscal year 2026. But I can assure you, we are very committed to achieving the margins in the mid-to long-term, which are driven by top line growth and optimizing our cost structure.

    現在對 2026 財年的研發支出和利潤率前景發表評論還為時過早。但我可以向你們保證,我們致力於在中長期內實現利潤目標,而利潤目標的實現將依靠營收成長和成本結構的最佳化。

  • Milano Furuta - Chief Financial Officer, Director

    Milano Furuta - Chief Financial Officer, Director

  • Thank you, PK. Yamaguchi-san, not much things to add to what PK said already. But I think you can see that we have been managing quite effectively or in some areas, we are even reducing R&D expenses beyond our initial expectations by the efficiency program, also the continuous -- with continuous cost discipline. That's one.

    謝謝你,PK。山口先生,PK已經說得很清楚了,我沒什麼要補充的。但我認為您可以看到,我們一直管理得相當有效,或者在某些領域,我們甚至透過效率計劃和持續的成本控制,將研發費用降低到超出我們最初預期的水平。這是其中之一。

  • And then the second one is we are very mindful about this -- the incremental R&D investment as well. So that's why you see this cost split of the 60-40 for this 363 compound. At the same time, as you might be aware that we have been arranging some cost sharing program, the partnership with Blackstone for mezagitamab. So that's kind of through those kind of arrangements. We are very consciously managing incremental investment.

    其次,我們也非常重視這一點──也就是持續的研發投入。所以你才會看到這種 363 化合物的成本分配比例是 60-40。同時,您可能已經知道,我們一直在安排一些成本分攤計劃,與黑石集團就 mezagitamab 展開合作。所以,這大概就是透過這類安排來實現的。我們正在非常謹慎地管理增量投資。

  • But in the end, we want to invest for growth, while optimizing OpEx. Eventually, that's going to be top line growth, should be the main driver to the long-term corporate margin improvement. Second question about transactional FX.

    但最終,我們希望在優化營運支出的同時,進行成長投資。最終,營收成長將成為企業長期利潤率提升的主要驅動力。關於交易外匯的第二個問題。

  • This is very hard to answer, as it is very difficult to predict the currency fluctuation. But this transactional FX in Takeda's case, as I commented during the presentation, the euro volatility is quite -- have a big impact in this year. This is because of -- relatively, we have a large footprint in the manufacturing operation in Europe.

    這個問題很難回答,因為貨幣波動很難預測。但就武田製藥而言,正如我在演講中提到的,歐元波動性在今年會產生相當大的影響。這是因為——相對而言,我們在歐洲的製造業規模較大。

  • So we have to see how currencies goes. But in the long -- if we want to mitigate, then we have to -- maybe in the long run, somehow we have to rebalance the manufacturing footprint, but that's kind of, of course, a long-term strategic plan. It's not -- we've taken actions depending on a 1-year currency volatility. We have to take a bit to long-term stance on that.

    所以我們需要觀察貨幣走勢。但從長遠來看——如果我們想要緩解這種情況,那麼我們就必須——也許從長遠來看,我們必須以某種方式重新平衡製造業佈局,但這當然是一種長期的戰略計劃。並非如此——我們採取的行動是基於一年的貨幣波動性。我們必須對此採取一些長遠的態度。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted)

    (翻譯)

  • Mr. Matsubara, Nomura.

    野村松原先生。

  • Hiroyuki Matsubara - Analyst

    Hiroyuki Matsubara - Analyst

  • (interpreted) Hello, Matsubara from Nomura. I have two questions. First is about Entyvio. As you explained, Entyvio Pen penetration is advancing, but the insurance coverage as of now and to enhance penetration of pen furthermore, what actions are you taking now?

    (翻譯)您好,我是野村證券的松原先生。我有兩個問題。首先是關於Entyvio的。正如您所解釋的,Entyvio Pen 的滲透率正在提高,但目前的保險覆蓋範圍以及為了進一步提高 Pen 的滲透率,您現在正在採取哪些措施?

  • The second question is Nabla Bio that you have partnership with now, and this is nonclinical as of now, and it's not fully disclosed, but by utilizing this R&D acceleration, how does it go? And for mid- to long-term pipeline enhancement and acceleration, how do you see that?

    第二個問題是關於您目前與之合作的 Nabla Bio,目前該計畫還處於非臨床階段,並且尚未完全公開,但透過利用這種研發加速機制,進展如何?那麼,對於中長期管道的改進和加速,您是如何看待的呢?

  • Thank you.

    謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Okay. So thank you for your questions, Matsubara-san. So the first on Entyvio, what is the state of insurance coverage? What are we doing to expand access to pen? I'd like to ask Julie to comment on that. And then the second question was on our recently announced collaboration with Nabla Bio. Perhaps Andy can add some comments on what we're doing in terms of utilizing AI in drug discovery. Julie?

    好的。松原先生,謝謝您的提問。首先,關於Entyvio,保險保障範圍如何?我們正在採取哪些措施來擴大鋼筆的取得途徑?我想請朱莉就此發表一下看法。第二個問題是關於我們最近宣布與 Nabla Bio 的合作。或許安迪可以就我們在藥物研發中利用人工智慧所做的工作發表一些看法。朱莉?

  • Julie Kim - President of the US Business Unit, US Country Head & Interim Head of Global Portfolio Division

    Julie Kim - President of the US Business Unit, US Country Head & Interim Head of Global Portfolio Division

  • Yes. Thank you for the question. And in regards to Entyvio Pen access, as you heard from Christophe in his opening comments, we are continuing to improve our overall position along the access continuum, and we're encouraged by the 20% growth that we're seeing quarter-over-quarter in terms of Entyvio Pen. Now that being said, we continue to work on access at various different levels. One, in terms of the -- I would say, the highest level of coverage. I think you are all aware that we have two out of the three big contracts signed for quite some time now, and we continue to work on the CVS piece.

    是的。謝謝你的提問。至於 Entyvio Pen 的普及情況,正如 Christophe 在開場白中所說,我們正在不斷改善我們在普及過程中的整體地位,Entyvio Pen 的季度環比增長 20%,這讓我們倍感鼓舞。儘管如此,我們仍在各個層面繼續努力改善無障礙環境。第一,就覆蓋範圍而言——我認為是最高等級的。我想大家都知道,我們三大合約中的兩個已經簽署了相當長一段時間,我們正在繼續推進與 CVS 的合作。

  • For the other levels of access, when you look at the way that the US market is structured, it's actually -- there's a lot of localization even with the way that we have the big three PBMs. So while we continue to improve at the local level as well, we are putting in place very specific tactical actions to address the localized challenges in addition to what we're doing at the overall coverage level. So hopefully, that gives you a sense that we're working across multiple different levels on the access continuum in the US.

    至於其他等級的准入,當你觀察美國市場的結構時,你會發現,即使我們有三大藥品福利管理機構 (PBM),也存在著許多在地化現象。因此,在繼續改善本地服務的同時,除了在整體覆蓋層面上所做的工作之外,我們還採取了非常具體的戰術措施來應對本地挑戰。所以,希望這能讓您感受到,我們正在美國醫療服務體系的多個不同層面上開展工作。

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

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

  • And thank you, Julie, Matsubara-san, and thanks for the question. We're quite excited by the partnership with Nabla Biosciences. But maybe I can just dial up for a second and give you some sense of the work that we've been managing in our research laboratories for the last couple of years. We see discovery in the biopharmaceutical industry changing quite rapidly, and we're positioning Takeda to be at the leading edge of application of advanced technologies in research.

    謝謝Julie、松原先生,也謝謝你們的提問。我們對與Nabla Biosciences的合作感到非常興奮。不過,或許我可以抽出一點時間,向您介紹我們過去幾年在研究實驗室裡的工作。我們看到生物製藥行業的發現正在迅速變化,我們正在使武田處於先進技術應用於研究領域的前沿。

  • And in fact, we're in the process of completing a new laboratory in Cambridge, Massachusetts in Kendall Square that we call the lab of the future. And the intent of this lab is to enable a workflow in discovery that can both improve our probabilities of success and also greatly accelerate the time that it takes to move molecules through discovery. Today, 1 in 5, 1 in 4 of our research programs are enabled by in silico technology. By next year, we expect that over 90% of our programs will be enabled by in silico technology.

    事實上,我們正​​在馬薩諸塞州劍橋市肯德爾廣場建造一座新的實驗室,我們稱之為未來實驗室。該實驗室的目標是建立一個能夠提高藥物發現成功率並大幅縮短分子研發過程的工作流程。目前,我們五分之一到四分之一的研究計畫都得益於電腦輔助技術。預計到明年,我們90%以上的項目將藉助電腦模擬技術實現。

  • The partnership with Nabla Biosciences is one example of how we're embracing AI in drug discovery. This is a company that was started by George Church that uses algorithms to optimize sequences of large molecules. We've worked with them for over 2-years now, and we have three pilot experiments that each were successful, two accelerated programs and a third one actually took us to a novel space that we wouldn't have gotten to with traditional approaches. So we were quite excited about that, and that's what led to then the collaboration that you see at hand.

    與 Nabla Biosciences 的合作是我們在藥物研發領域應用人工智慧的一個例子。這是由喬治·丘奇創辦的一家公司,該公司利用演算法來優化大分子序列。我們已經與他們合作超過兩年了,我們進行了三項試點實驗,每一項都取得了成功,其中兩項是加速計劃,第三項計劃實際上將我們帶到了一個全新的領域,這是我們用傳統方法無法到達的。所以我們對此感到非常興奮,這也促成了你們現在看到的合作。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) JPMorgan, Wakao-san.

    (翻譯)摩根大通,若尾先生。

  • Seiji Wakao - Analyst

    Seiji Wakao - Analyst

  • Thank you for taking my question. This is Wakao from JPMorgan. I have two questions. Firstly, regarding gross margin trend and revised guidance. When comparing the initial guidance with the revised full year guidance, the gross margin has deteriorated 66% to 64.7%. Should we understand this is -- this primarily as an FX impact from the euro? If there are other contributing factors, could you elaborate on this point?

    感謝您回答我的問題。我是摩根大通的若尾。我有兩個問題。首先,關於毛利率趨勢和修訂後的指引。與最初的業績指引相比,修訂後的全年業績指引顯示,毛利率下降了 66%,至 64.7%。我們是否應該理解為──這主要是歐元匯率波動帶來的影響?如果還有其他影響因素,能否詳細說明一下?

  • And also, if FX is indeed affecting the gross margin, the second quarter gross margin looks relatively solid compared to the FX levels. I'd like to know this point? And why do you expect it to deteriorate in the second half? And second question about [IVA] innovent partnerships. When is the next data update for IBI363 expected, so Page 27. Regarding ongoing first-line and second-line NSCLC studies, we will be able to see data in 2026. In addition, when is the global Phase 3, trial expected to start? That's it.

    此外,如果匯率確實影響毛利率,那麼與匯率水準相比,第二季的毛利率看起來相對穩健。我想知道這一點?為什麼認為下半場情況會惡化?第二個問題是關於[IVA]創新夥伴關係。IBI363 的下一次資料更新預計是什麼時候? (見第 27 頁)關於正在進行的一線和二線非小細胞肺癌研究,我們將在 2026 年看到相關數據。此外,全球三期臨床試驗預計何時開始?就是這樣。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Wakao-san. So the first question on gross margin trend and the revised gross margin outlook for the full fiscal year. I'd like to ask Milano to comment on that. And the second question on the next data point to come for IBI363 and whether we can give an indication of starting Phase 3, studies.

    謝謝若尾先生。因此,第一個問題是關於毛利率趨勢以及對整個財政年度毛利率的修正預期。我想請米蘭諾對此發表評論。第二個問題是關於 IBI363 的下一個數據點,以及我們是否可以給出開始 3 期研究的跡象。

  • I'd like to ask PK to comment on that, please.

    我想請PK對此發表一下看法。

  • Milano Furuta - Chief Financial Officer, Director

    Milano Furuta - Chief Financial Officer, Director

  • Wakao-san, thank you for the question. You asked about the bridge from initial forecast updated forecast. At the same time, how the H2 second half gross margin will be lower. Actually, the answer would be basically same. If you compare -- if we compare the May forecast and revised the forecast, as you said, gross margin is expected to be lower by about 1.4 percentage points. About half is coming from the transactional FX. And the other half is also coming from kind of product mix change.

    若尾先生,謝謝您的提問。您詢問了根據初始預測和更新後的預測確定的橋樑情況。同時,H2下半年的毛利率將會如何下降?實際上,答案基本上相同。如果比較——如果我們比較五月的預測和修正後的預測,正如你所說,毛利率預計將下降約 1.4 個百分點。其中約一半來自交易外匯。另一半則來自產品組合的變化。

  • So we are reducing the Vyvanse, the revenue and the Entyvio revenue. And then these two revision has a negative impact on the gross margin. So that's the contributing this gross margin update in the forecast. And actually, this explains -- these dynamics explains in the second half because this is more about the second half sales. Also, we are updating the currency forecast for H2. So those two impacts were contributing lower gross margin in H2.

    因此,我們將減少 Vyvanse 的收入和 Entyvio 的收入。這兩項修改會對毛利率產生負面影響。這就是此次預測中毛利率更新的原因。實際上,這解釋了——這些動態在下半年是如何體現的,因為這更多是與下半年的銷售有關。此外,我們正在更新下半年的貨幣預測。因此,這兩個因素導致下半年毛利率下降。

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • Thank you, Milano. And perhaps to address the other two questions that were asked related to the Innovent collaboration. The first is to say that we, like you, are very enthusiastically monitoring the data with both 363 and 343. We are not yet releasing when we will disclose further data in the coming year, but we will be following this closely, as we determine when the appropriate data inflection will be in order to release more data in a public forum.

    謝謝你,米蘭。或許還可以回答與 Innovent 合作相關的另外兩個問題。首先要說的是,我們和你們一樣,都在非常熱情地關注 363 和 343 的數據。我們目前尚未公佈明年何時會披露更多數據,但我們將密切關注事態發展,以確定何時會出現合適的數據拐點,以便在公共論壇上發布更多數據。

  • The second question you had was related to the start of the Phase 3, studies. And we have noted that the Phase 3, study in second-line squamous non-small cell lung cancer, we expect to begin in the coming months. And as you saw from the slides, we will also be looking towards moving and initiating additional studies at speed.

    你的第二個問題與第三階段研究的開始有關。我們注意到,針對二線鱗狀非小細胞肺癌的 3 期研究預計將在未來幾個月內開始。正如您從幻燈片中看到的,我們還將著眼於加快推進和啟動更多研究。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Stephen Barker, Jefferies.

    (譯)史蒂芬‧巴克,傑富瑞集團。

  • Stephen Barker - Analyst

    Stephen Barker - Analyst

  • Steve Barker from Jefferies. The first question is about Entyvio and the second question is about your collaboration with Innovent. Starting with Entyvio. So you've cut your estimated current growth rate at constant exchange rates from 9% to 6% due to competitive pressures. I was wondering if you could give us more details of those competitive pressures and the implications for growth going forward as in next year and beyond?

    來自傑富瑞的史蒂夫·巴克。第一個問題是關於 Entyvio 的,第二個問題是關於您與 Innovent 的合作。從Entyvio開始。因此,由於競爭壓力,您已將以固定匯率計算的預期當前成長率從 9% 下調至 6%。我想請您詳細介紹一下這些競爭壓力以及它們對未來成長(例如明年及以後)的影響?

  • And secondly, regarding your deal with Innovent, certainly, the China data published to date on 363 is impressive. But there have been several cases where impressive data in China has not been replicated in international studies. So I was wondering if you could share your view on if that apparent trend or phenomenon is real or not? And more specifically, how confident are you that you can replicate the impressive China data in international trials?

    其次,關於您與信達生物的合作,當然,363迄今公佈的中國數據令人印象深刻。但也有不少案例表明,中國取得的令人矚目的數據並未在國際研究中重複驗證。所以我想知道您能否分享一下您對這種明顯趨勢或現像是否真實存在的看法?更具體地說,您有多大信心能夠在國際試驗中複製在中國取得的令人矚目的數據?

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Steve. So I think the first question on Entyvio and the reasons for the reduction in the full year forecast. I'd like to call on Julie to answer that. And the second question on data replicability of the China studies in a more global population.

    謝謝你,史蒂夫。所以我認為第一個問題是關於 Entyvio 以及全年預測下調的原因。我想請朱莉來回答這個問題。第二個問題是,中國研究的數據能否在全球人口中複製。

  • I'd like to ask PK to comment on that, please.

    我想請PK對此發表一下看法。

  • Julie Kim - President of the US Business Unit, US Country Head & Interim Head of Global Portfolio Division

    Julie Kim - President of the US Business Unit, US Country Head & Interim Head of Global Portfolio Division

  • Thanks for the question, Stephen, on Entyvio. So let me start by saying that Entyvio has been on the market for 12-years now, and it is still the overall market share leader in IBD when you look at it from a patient demand perspective, and we are holding market share. But as you've noted, there are a few things that are impacting our top line. One is in terms of the intensified competitive activity, and we're seeing that particularly on the CD side, but it is also starting to impact UC.

    Stephen,感謝你提出的關於Entyvio的問題。首先我想說的是,Entyvio 已經上市 12 年了,從患者需求的角度來看,它仍然是 IBD 領域的市場份額領導者,我們保持著市場份額。但正如您所指出的,有一些因素正在影響我們的營收。一方面是競爭活動加劇,我們在 CD 方面尤其看到了這一點,但它也開始影響 UC。

  • But as I said, overall, because Entyvio is still the only gut-selective medicine out there for IBD, we've been able to hold share. The other things that are impacting the top line, there are a few things. One, as Milano mentioned in his talks, it is about the channel mix. We've particularly had an increase in 340B population as well as an increase in Medicare Part D redesign impact.

    但正如我所說,總的來說,由於 Entyvio 仍然是目前唯一一種針對 IBD 的腸道選擇性藥物,我們得以維持市場份額。影響營收的其他因素還有幾點。第一,正如米蘭諾在他的演講中提到的,這是關於頻道組合的問題。特別是 340B 計劃的受益人數增加,同時 Medicare Part D 改革的影響也增加。

  • Beyond that, the pen conversion, as we've mentioned, is moving a bit slower than we anticipated. And while we are resolving those access hurdles, it has impacted the top line thus far. But we do expect as those hurdles are resolved, we will see an acceleration of growth, which is why we do expect to end the year higher than where we are year-to-date.

    除此之外,正如我們之前提到的,鋼筆轉換的進展比我們預期的要慢一些。雖然我們正在努力解決這些准入障礙,但這已經對營收造成了影響。但我們預計,隨著這些障礙的解決,我們將看到成長加速,這就是為什麼我們預計年底的業績將高於年初至今的業績。

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • Thank you, Julie. And to answer the second question, I'll say two points. One is, as you alluded to, initially, Innovent has accrued more patients in China, but over the past few months has now begun to increase the enrollment ex-China, including in US and Australia, and we are continuing to monitor that data as well as its applicability.

    謝謝你,朱莉。至於第二個問題,我只想說兩點。一是,正如您所提到的,信達製藥最初在中國積累了更多患者,但在過去的幾個月裡,該公司已開始增加中國以外地區的患者招募,包括美國和澳大利亞,我們將繼續監測這些數據及其適用性。

  • The second element is the fact that we actually endeavored on very significant due diligence during the evaluation for this collaboration. And that included bringing our own Takeda radiologists in order to evaluate the -- many of the images that we were seeing of the patients as well as determining the correlation with our response criteria, i.e., RECIST. And we saw a very strong correlation there.

    第二個因素是,我們在評估這項合作的過程中,確實進行了非常深入的盡職調查。這其中包括引入我們自己的武田放射科醫生來評估我們看到的許多患者的影像,並確定其與我們的反應標準(即RECIST)的相關性。我們發現兩者之間有非常強的相關性。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) SMBC Nikko Securities, Wada-san.

    (翻譯)SMBC日興證券,和田先生。

  • Hiroshi Wada - Analyst

    Hiroshi Wada - Analyst

  • (interpreted) Thank you very much. Wada from SMBC Nikko Securities. About Innovent pipeline, I have a question. 363, regarding mechanism of action, I want to know IL-2 alpha bias, what's the significance of this? [Roche] has -- well, IL-2 itself is approved for the melanoma and other cancers, but not expanded very much to other cancers. If you activate alpha, Treg may be activated as well.

    (翻譯)非常感謝。SMBC日興證券的Wada。關於信達生物的研發管線,我有個問題。關於363的作用機制,我想了解IL-2α偏向性,這有何意義?[羅氏] IL-2 本身已被批准用於治療黑色素瘤和其他癌症,但尚未擴展到其他癌症領域。如果活化 alpha 細胞,Treg 細胞也可能被活化。

  • And because of that immune response is suppressed, I think that's what was the rationale. So alpha activated mechanism for 363, what's the meaning of that, including the clinical data you have obtained so far. Can you explain that, please?

    正因為如此,免疫反應才受到抑制,我認為這就是背後的原理。那麼,對於 363 而言,α 活化機制的意義是什麼?包括您目前獲得的臨床數據。請問您能解釋一下嗎?

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Yeah, PK, would you like to take that question?

    是的,PK,你願意回答這個問題嗎?

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • Yes, absolutely. So it's a great question. And we also asked the same question and interrogated that data with Innovent and discussed this in depth. And I can tell you that what is actually unique about this particular pathway is the fact that, first, we did learn from the experiences of others within the industry as it relates to IL-2.

    是的,絕對的。這是一個很好的問題。我們也向 Innovent 提出了同樣的問題,並對此數據進行了深入探討。我可以告訴你們,這條特定路徑的獨特之處在於,首先,我們確實從業內其他人的經驗中學習了與 IL-2 相關的知識。

  • And that's why our focus has been on this IL-2 alpha bias with attenuation of the beta-gamma pathway. And with that in mind, we have seen that the IL-2 alpha biased approach has been able to target specifically tumor-specific T-cells that are addressing both -- or express both PD-1 and IL-2 alpha.

    因此,我們的重點一直放在IL-2α偏向性以及β-γ路徑減弱。考慮到這一點,我們已經看到,IL-2 α 偏向方法能夠專門靶向腫瘤特異性 T 細胞,這些 T 細胞既針對 PD-1,也表達 IL-2 α。

  • So it's been a very precise and effective activation within the tumor micro-environment. The other question that you had was related to whether this would actually cause and trigger activation of Tregs, which we also had that question related to.

    因此,它在腫瘤微環境中實現了非常精準有效的活化。您提出的另一個問題與此是否真的會引起並觸發 Treg 細胞的活化有關,我們也曾經有過類似的疑問。

  • And we have not actually seen activation of Treg-cells, which would have resulted, of course, in a decrease in the immune response. Thirdly, I would say that because of this, we think that the clinical data are very consistent with the mechanism of action with findings of very encouraging data in both IO refractory as well as in earlier lines. Thank you.

    我們實際上並沒有觀察到 Treg 細胞的激活,而 Treg 細胞的活化當然會導致免疫反應的下降。第三,我認為正因如此,我們認為臨床數據與作用機制非常一致,在免疫腫瘤難治性患者和早期患者中均發現了非常令人鼓舞的數據。謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you.

    謝謝。

  • Hiroshi Wada - Analyst

    Hiroshi Wada - Analyst

  • (interpreted) May I continue?

    (翻譯)我可以繼續嗎?

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Yes, go ahead.

    好的,請繼續。

  • Hiroshi Wada - Analyst

    Hiroshi Wada - Analyst

  • (interpreted) And for development policy, so refractory cold tumor is the strategy that you want to take. I understand that additional IL-2 NSCLC first line and head-to-head with PD-1 for Phase 3. Is that the plan going forward?

    (翻譯)至於發展政策,那麼,應對難治性冷腫瘤就是你想要採取的策略。我了解到,IL-2 可用於 NSCLC 的一線治療,並與 PD-1 進行頭對頭試驗,以進行 3 期臨床試驗。這就是未來的計畫嗎?

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • Yes. Chris, would you like to be to take this?

    是的。克里斯,你想接這個嗎?

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Yes, please PK.

    是的,請PK。

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • So I think your question was around the development plan related to IBI363 and where we see the experience with this and the promise of this and agree with you that we actually want to leverage the strong clinical data.

    所以我認為你的問題是關於 IBI363 的發展計劃,以及我們從中看到了哪些經驗和前景,我同意你的觀點,我們確實想利用強大的臨床數據。

  • So beyond the two second-line studies in IO refractory squamous and non-squamous non-small cell lung cancer, we will plan to go head-to-head against IO therapy, both likely in an all-comers population as well as in a TPS-high population.

    因此,除了針對 IO 難治性鱗狀細胞癌和非鱗狀細胞非小細胞肺癌的兩項二線研究之外,我們將計劃與 IO 療法進行正面比較,這兩項研究都可能面向所有人群以及 TPS 高人群。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Tony Ren, Macquarie.

    Tony Ren,麥格理集團。

  • Tony Ren - Analyst

    Tony Ren - Analyst

  • Hello, Tony Ren from Macquarie. Thank you for taking my questions. A couple of questions again on the Innovent transaction. For the IL-2 PD-1 bispecific IBI363, I understand -- I actually cover Innovent myself. I understand they have a global Phase 2, study. The primary completion -- estimated primary completion of this study is March 2026.

    您好,我是麥格理集團的Tony Ren。感謝您回答我的問題。關於Innovent的交易,我還有幾個問題。對於IL-2 PD-1雙特異性抗體IBI363,我了解-其實我自己就是信達生物的簽約抗體。據我了解,他們正在進行一項全球性的第二期臨床試驗。主要完成時間-本研究預計主要完成時間為 2026 年 3 月。

  • So really only 4-months away. Did you guys get a chance to look at the data from that Phase 2 study, which I believe primarily is conducted in the US and looking to recruit about 178 patients? And if so, were the data better or worse than what you've seen in China? So that's my first question.

    所以其實只剩下4個月了。你們有沒有機會看一下那項二期研究的數據?據我所知,這項研究主要在美國進行,計劃招募約 178 名患者。如果是這樣,這些數據比你在中國看到的數據好還是差?這是我的第一個問題。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • PK, would you like to answer that one as well, please?

    PK,您也願意回答這個問題嗎?

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • Yeah, absolutely. So yes, first, I would like to say that, yes, we have been in constant communication with Innovent related to the evolving data. And as you allude to, that data in the global Phase 2, is progressing or the trial itself is progressing very nicely and at speed. I can't disclose what obviously, the data shows thus far, but we can see that I would like to just say that the data thus far is fairly encouraging, but I think too early to comment further.

    是的,絕對的。是的,首先我想說,是的,我們一直與 Innovent 就不斷變化的數據保持溝通。正如您所提到的,全球 2 期臨床試驗的數據進展非常順利,或者說試驗本身進展非常迅速。我無法透露目前的數據具體顯示了什麼,但我們可以看到,我想說的是,目前的數據相當令人鼓舞,但我認為現在進一步評論還為時過早。

  • Tony Ren - Analyst

    Tony Ren - Analyst

  • Okay. Thank you for addressing that. Also, Innovent is starting the Phase 3, global study. I think it's called MarsLight-11 trial in immunotherapy-resistant non-squamous non-small cell lung cancer, right? So that trial according to clinicaltrial.gov is literally starting today.

    好的。謝謝你解答這個問題。此外,信達生物即將啟動全球範圍內的第三期臨床試驗。我想它應該叫做 MarsLight-11 試驗,是針對免疫療法抗藥性的非鱗狀非小細胞肺癌進行的,對嗎?根據clinicaltrial.gov網站的信息,這項試驗今天正式開始。

  • But also -- Dr. Morrow, you said that you're looking to start in the next few months. So are you -- as Takeda is leading the clinical development, right, are you looking to change the trial design and the conduct of this MarsLight-11 study?

    另外—莫羅博士,您說過您打算在接下來的幾個月內開始工作。那麼,鑑於武田製藥正在主導臨床開發,您是否打算改變 MarsLight-11 研究的試驗設計和實施方式?

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • What I will say is that we -- as I noted, we have had great conversations and discussions with Innovent weekly, if not every few days. And related to the MarsLight study as well as these beginning studies, we've also had discussions about whether we would need -- we would desire to change or tweak any of the elements of the protocol itself. I would say right now, we have not required any or asked for any significant changes as of today, but we are continuing to have those discussions.

    我想說的是,正如我之前提到的,我們每週都會與 Innovent 進行很好的對話和討論,即使不是每隔幾天一次。針對 MarsLight 研究以及這些初步研究,我們也討論過是否需要——或者說是否希望改變或調整協議本身的任何要素。就目前而言,我們還沒有要求或要求任何重大改變,但我們仍在繼續進行這些討論。

  • Tony Ren - Analyst

    Tony Ren - Analyst

  • If you do decide to change the trial design or protocol or conduct, would that require a new FDA clearance?

    如果您決定更改試驗設計、方案或實施方法,是否需要獲得 FDA 的重新批准?

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • I don't think so.

    我不這麼認為。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) [Ms. Ueda], Goldman Sachs.

    (翻譯)[上田女士],高盛。

  • Unidentified Participant

    Unidentified Participant

  • I am [Ueda], Goldman Sachs. My first question is regarding (inaudible) therapy business. I think in the United States, now CSL has been closing some of its plasma centers recently. So it also appears that Takeda is currently focusing on moving -- improving efficiency such as optimizing utilization rates and implementing the digital transformation initiatives rather than expanding the number of centers.

    我是高盛的上田。我的第一個問題是關於(聽不清楚)治療業務的。我認為在美國,CSL最近一直在關閉一些血漿中心。因此,武田目前似乎更注重提升效率,例如優化利用率和實施數位轉型計劃,而不是擴大中心數量。

  • So are there any changes in the business environment in the US such as like the demand outlook or the cost structure that are driving the shift? And furthermore, I think some other companies seems to be actively investing in the collection centers outside in the US. So could you also let us know whether you are also considering similar types of investments?

    那麼,美國商業環境是否存在某些變化,例如需求前景或成本結構的變化,從而推動了這種轉變?此外,我認為其他一些公司似乎也在積極投資美國境外的收集中心。那麼,您能否也告知我們您是否也在考慮類似的投資類型?

  • (interpreted) I'd like to ask a second question to Milano regarding your dividend increase. Given this -- the downward revision of the guidance, I believe that EPS is going to be also lowered. And you also are able to transfer from the accumulated fund to your hand. However, what is about the potential risk of the impairment loss and how you are confident to continue increasing the dividend payment? I'd like to ask the second question to Milano-san.

    (翻譯)我想就貴公司提高股利一事向米蘭諾提出第二個問題。有鑑於此-業績指引被下調,我認為每股盈餘也會隨之降低。您也可以將累積的資金轉到您的手中。但是,減損損失的潛在風險是什麼?您如何保證能夠持續提高股利支付?我想問米蘭諾先生第二個問題。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • So the first on the PDT business and specifically on our collection initiatives in the US, I think I'd like to ask Giles to comment on that. And then the second question on the sustainability of the dividend. Milano, if you could kindly answer on that one, please.

    首先,關於 PDT 業務,特別是我們在美國的募款活動,我想請 Giles 對此發表一些看法。然後是關於股息可持續性的第二個問題。米蘭,如果您能回答這個問題,那就太好了。

  • Giles Platford - President, Plasma-Derived Therapies Business

    Giles Platford - President, Plasma-Derived Therapies Business

  • Yeah. Thank you, Chris, and thank you, [Ueda-san], for the question. We have been investing extensively to improve efficiency and productivity across our BioLife collections network, and that has positioned us very strongly to be able to meet the growing demand for plasma-derived therapies and to continue to grow our collection volumes without opening to the same extent, new centers.

    是的。謝謝克里斯,也謝謝上田先生的提問。我們已投入大量資金來提高 BioLife 採集網路的效率和生產力,這使我們能夠更好地滿足對血漿衍生療法日益增長的需求,並在不開設同樣規模的新中心的情況下繼續擴大採集量。

  • In particular, we have benefited this year from the accelerated rollout of the personalized nomogram for both our FK and Haemonetics devices, and that has enabled us to improve volume collection by approximately 10% to 11% on a per donation basis.

    尤其值得一提的是,今年我們受惠於 FK 和 Haemonetics 設備個人化列線圖的加速推廣,這使得我們每次捐贈的收集量提高了約 10% 至 11%。

  • And as a result, we won't be opening as many new centers, and we are also benefiting from the ramp-up of the centers that we have opened in the past years. To the second part of your question, we do continuously evaluate opportunities to open up new countries to contribute to global supply of plasma.

    因此,我們不會開設那麼多新中心,同時我們也受益於過去幾年開設的中心逐步發展壯大。關於您問題的第二部分,我們一直在評估各種機會,以開拓新的國家,為全球血漿供應做出貢獻。

  • We don't have anything to communicate at this point in time, but it is a big part of our advocacy work worldwide to ensure that we are having more countries contributing to sustainable supply of plasma.

    目前我們沒有什麼可以公佈的,但確保更多國家為血漿的可持續供應做出貢獻是我們全球倡議工作的重要組成部分。

  • Thank you.

    謝謝。

  • Milano Furuta - Chief Financial Officer, Director

    Milano Furuta - Chief Financial Officer, Director

  • (interpreted) Thank you very much for your question. Basically, regarding our dividend policy, as we explained in the past, it is a progressive policy, meaning we will sustain or increase the dividend. And in order for us to make a decision, we will look at core EPS and reported EPS and mid-term and long-term reduction of interest-bearing liabilities or borrowings. And looking at these three parameters, we make a proposal what to do with the dividend in the next year and going forward.

    (翻譯)非常感謝您的提問。基本上,關於我們的股利政策,正如我們過去解釋的那樣,這是一項漸進式政策,這意味著我們將維持或增加股利。為了做出決定,我們將檢視核心每股收益和報告每股收益,以及中長期減少計息負債或借款的情況。綜合考慮這三個參數,我們提出了明年及以後如何處理股利的建議。

  • Therefore, at this point in time, I cannot say anything definitely, but these are the 3 points, we will base our decisions. And for the next fiscal year, around May time frame, we would like to announce what is the policy of dividend.

    因此,目前我無法做出任何確切的決定,但我們將根據這三點來做出決定。至於下一個財政年度,大約在五月份,我們將公佈股利政策。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) UBS, Sakai-san.

    (翻譯)瑞銀,酒井先生。

  • Fumiyoshi Sakai - Analyst

    Fumiyoshi Sakai - Analyst

  • Thank you very much. Fumiyoshi Sakai from UBS, two questions. One is the same plasma business. CSL issued profit warning. There are reasons very vague, but one of the factors that you mentioned is weakening demand of China albumin sales or revenues.

    非常感謝。我是瑞銀集團的酒井文義,有兩個問題。其中一家是同一家血漿業務公司。CSL發布獲利預警。原因有些模糊,但你提到的一個因素是中國白蛋白銷售或收入需求疲軟。

  • And your page -- Slide 40, you have slight decline in China. However, you haven't really changed the guidance for FY '25. Do you think -- do you still think that this guidance is achievable? If it's so, can you just give us the -- what's really going on in China market right now? So that's the first question.

    還有你的頁面——第 40 頁,你在中國的業務略有下滑。但是,你們並沒有真正改變 2025 財年的指導方針。你認為──你仍然認為這項指導方針是可以實現的嗎?如果情況屬實,您能否直接告訴我們—目前中國市場的真實情況是什麼?這是第一個問題。

  • The second question is US. Biosecure Act when you make a deal with Innovent, anything going on in the US these days is a mystery, but this act is still pending? And have you considered what are the political consequences having China Biotech as a partner? Probably not? But if you could update with this Biosecure Act and your business tie-up, I would really appreciate that. That's the second question.

    第二個問題是關於我們的。在與信達生物達成協議後,美國最近發生的一切都是個謎,但這項生物安全法案仍在審議中?您是否考慮過與中國生技公司合作會帶來哪些政治後果?可能不會?但如果您能提供關於《生物安全法案》和貴公司業務合作的最新信息,我將不勝感激。這是第二個問題。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Sakai-san. So the first question on albumin demand in China and our confidence in the full year outlook, I'd like to ask Giles to comment on that. And then the second question on US. US Biosecure vis-a-vis the Innovent deal. I'd like to ask Christophe to answer that question, please.

    謝謝您,堺先生。那麼,關於中國白蛋白需求以及我們對全年前景的信心,我想請吉爾斯對此發表評論。然後是關於美國的第二個問題。美國生物安全局與信達生物的交易。我想請克里斯托夫回答這個問題。

  • Giles Platford - President, Plasma-Derived Therapies Business

    Giles Platford - President, Plasma-Derived Therapies Business

  • Sure, Chris, and thank you, Sakai-san, for your question. It's true, our albumin portfolio did decline marginally by 2% for the first half. This was a result of the impact of shipment phasing to China, but also related to the continued government-imposed cost controls in the country, both of which were anticipated as well as some effect of tender timing globally.

    當然可以,克里斯,謝謝坂井先生的提問。沒錯,我們的白蛋白產品組合在上半年確實稍微下降了 2%。這是由於分階段向中國發貨的影響,但也與該國政府持續實施的成本控制有關,這兩點都在預料之中,此外,全球招標時間也產生了一定的影響。

  • And I'd like to point out that with a somewhat slower near-term growth outlook for China linked to those government-imposed cost controls, we have been actively working to build sustainable market opportunities for albumin outside of China, and we do see continued growing demand for albumin worldwide.

    我想指出,由於中國政府實施的成本控制措施,中國近期經濟成長前景略顯放緩,我們一直在積極努力在中國以外地區為白蛋白創造可持續的市場機會,而且我們確實看到全球對白蛋白的需求持續增長。

  • And we have successfully secured a number of tenders in markets ex-China, which will be delivered in the second half, hence, accelerating our growth for the balance of the year. So yes, we remain confident to deliver on our guidance of high single-digit growth for the year for albumin and for our IG portfolio. Thank you.

    我們已成功獲得中國以外市場的多個投標項目,這些項目將在下半年交付,加速我們今年剩餘時間的成長。所以,是的,我們仍然有信心實現我們對白蛋白和IG產品組合全年高個位數成長的預期。謝謝。

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

    Christophe Weber - President, Chief Executive Officer, Representative Director

  • Thank you, Sakai-san. This is Christophe here. Obviously, we take into consideration the geopolitical environment when we discuss a deal like our partnership with Innovent Biologics. So I will mention 2 points. One is that we will do -- we'll drive the global development of this asset, guaranteeing that it is meeting all the criteria required by regulatory agencies across the world.

    謝謝您,堺先生。這位是克里斯托夫。顯然,我們在討論像與信達生物這樣的合作計畫時,會考慮到地緣政治環境。所以我提兩點。第一,我們將推動該資產的全球開發,確保其符合世界各地監管機構要求的所有標準。

  • So that's very important. And the second point I will mention is that we will manufacture these molecules in the US. So we will do a full tech transfer and we manufacture -- we'll organize the manufacturing of this molecule in the US. And therefore, we think that this is also a way to mitigate the potential geopolitical risk.

    所以這一點非常重要。第二點我要說的是,我們將在美國生產這些分子。因此,我們將進行全面的技術轉讓,並在美國組織生產這種分子。因此,我們認為這也是降低潛在地緣政治風險的一種方式。

  • Thank you.

    謝謝。

  • Fumiyoshi Sakai - Analyst

    Fumiyoshi Sakai - Analyst

  • (interpreted) Can you just -- Giles-san, can you give a margin update in PDT business?

    (翻譯)吉爾斯先生,您能更新PDT業務的利潤率嗎?

  • Giles Platford - President, Plasma-Derived Therapies Business

    Giles Platford - President, Plasma-Derived Therapies Business

  • Yeah, absolutely. I can do that. So we continue to see our margin recovery year-after-year, and we expect to deliver continued margin improvement in fiscal '25. And that's part of the reason why we gave a slightly more modest guidance in terms of growth for this year. We are seeing more supply on the market. If you remember, Takeda was the first to recover post pandemic. So we benefited from strong growth the past couple of years in meeting unmet demand globally.

    是的,絕對的。我可以做到。因此,我們看到利潤率逐年回升,預計在 2025 財年將繼續提高利潤率。這也是我們今年給出較保守的成長預期的部分原因。我們看到市場上的供應量正在增加。如果你還記得的話,武田製藥是疫情後第一家復甦的公司。因此,過去幾年我們受益於強勁的成長,滿足了全球未被滿足的需求。

  • We see that situation now normalizing. So we're being a little more selective in terms of tender participation ex-US, very much expected, anticipated and consistent with the guidance that we gave, and that's partly because we're trying to calibrate both the need to grow, but also the need to grow profitably and to ensure we're getting value recognition in the process. We see continued improvement in product mix. So our innovative subcutaneous IG portfolio has delivered 15% growth for the first half.

    我們看到這種情況現在逐漸正常化。因此,我們在參與美國以外的投標方面更加謹慎,這完全在意料之中,也符合我們給出的指導方針,部分原因是我們試圖平衡增長的需求,以及盈利增長的需求,並確保我們在這一過程中獲得價值認可。我們看到產品組合持續改善。因此,我們創新的皮下注射免疫球蛋白產品組合在上半年實現了 15% 的成長。

  • So that product mix helps in improving margins. The BioLife productivity and efficiency efforts driven by data digital and technology transformation that I referenced earlier are also helping us to improve margin. And we have seen gradual improvement in yield in fractionation and process improvement across our manufacturing network. So all of that is contributing to an improvement in margin over time.

    因此,這樣的產品組合有助於提高利潤率。我之前提到的,BioLife 在數據數位化和技術轉型驅動下所採取的生產力和效率提升措施,也幫助我們提高了利潤率。我們已經看到,在整個製造網路中,分餾產量和製程改進都得到了逐步提高。因此,所有這些因素都有助於利潤率隨著時間的推移而提高。

  • Thank you, Sakai-san.

    謝謝您,堺先生。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Mike Nedelcovych, TD Cowen.

    邁克·內德爾科維奇,TD Cowen。

  • Michael Nedelcovych - Analyst

    Michael Nedelcovych - Analyst

  • Thanks for the questions. I have two. My first is just a broad question on your celiac disease programs. I'm just curious what the breadth of your ambitions are here? How important could those programs become ultimately should they make it to the marketplace?

    謝謝大家的提問。我有兩個。我的第一個問題是關於你們的乳糜瀉治療計畫的。我只是好奇你在這裡的抱負究竟有多大?如果這些項目最終成功推向市場,它們的重要性究竟會有多大?

  • And then my second question is on mezagitamab for IgAN. When we think about the target product profile for that agent, is it sufficient to have efficacy similar to competitor agents across mechanisms, but with potential treatment holidays? Or should we be looking for better efficacy?

    我的第二個問題是關於美札吉單抗治療IgA腎病變。當我們考慮該藥物的目標產品特性時,是否只要其療效與競爭藥物在作用機制上相似,但允許治療間歇期就足夠了?或者我們應該追求更高的療效?

  • Thank you.

    謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Thank you, Mike. I think both of those questions on our celiac ambitions and aspirations for mezagitamab, Andy you can answer those.

    謝謝你,麥克。關於我們對乳糜瀉的期望和對 mezagitamab 的願景,我認為安迪,你可以回答這兩個問題。

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

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

  • Thanks, Chris. Mike, it's Andy. So firstly, on the celiac programs, we had three programs that were in proof-of-concept studies, one that we've discontinued, which was TAK-062, which was an orally administered glutinase, which failed to show benefits. And two, TAK-227, which is a transglutaminase two inhibitor that's got restricted and then TAK-101, which is a tolerizing vaccine.

    謝謝你,克里斯。麥克,我是安迪。首先,在乳糜瀉治療項目中,我們有三個項目處於概念驗證研究階段,其中一個項目(TAK-062)我們已經停止,它是一種口服谷氨酸酶,但未能顯示出療效。其次,TAK-227 是一種轉谷氨酰胺酶 II 抑制劑,其使用受到限制;然後是 TAK-101,這是一種耐受性疫苗。

  • Both of those are still in Phase 2, studies right now. Of course, this is a huge unmet medical need with no established standards of care. The bar is quite high for moving forward and the science is quite tough. But we're excited to see data in the coming months and over the next year for both of those programs. So I think we can talk more about what the potential long term could look like after we've seen those data.

    這兩項研究目前都還處於二期臨床試驗階段。當然,這是一個龐大的未被滿足的醫療需求,目前還沒有既定的照護標準。要取得進展,門檻很高,科學方面也相當複雜。但我們很高興看到這兩個項目在未來幾個月和一年內的數據。所以我覺得,在看到這些數據之後,我們可以多討論潛在的長期發展前景。

  • In terms of mezagitamab, obviously, and you're referencing this, it's an incredibly competitive landscape. With mezagitamab, though, we've got a fairly unique opportunity here. I would say that in terms of efficacy, we wouldn't -- based on the data that we've seen, especially from the APO/BAF agents, I don't think that we expect to see more efficacy.

    就 mezagitamab 而言,很顯然,正如你所提到的,這是一個競爭極其激烈的市場。不過,有了 mezagitamab,我們就擁有了一個相當獨特的機會。就療效而言,根據我們所看到的數據,特別是來自 APO/BAF 製劑的數據,我認為我們不會期望看到更高的療效。

  • I think the real opportunity with mezagitamab is at least similar efficacy. The 96-week data that I referenced that you'll see in the coming weeks at the upcoming ASN Week meeting is quite extraordinary. I think the real opportunity here is the potential for sustained benefit after relatively short-term dosing. And then secondly, the potential benefits on safety.

    我認為mezagitamab的真正優勢在於至少有類似的療效。我提到的 96 週數據,你們將在接下來的幾週內,在即將舉行的 ASN 週會議上看到,這些數據非常出色。我認為真正的機會在於,相對短期用藥後有可能獲得持續的益處。其次,還有對安全的潛在益處。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Sogi-san, Bernstein.

    (翻譯)Sogi-san,Bernstein。

  • Miki Sogi - Analyst

    Miki Sogi - Analyst

  • I have two questions. First question is about Entyvio. So this is to Julie. So you have mentioned that the evolving competition in the US as well as the increasing -- the change in channel mix. I can imagine that those -- the dynamics are -- it's not really easily reversible. So should we assume that the slowing down the growth rate as you have included in the revision from 9% to 6%. Is this the kind of trend we should expect for the 2026 and beyond? And if that's the case, will you be revisiting the peak year sale of Entyvio at some point? That's first question.

    我有兩個問題。第一個問題是關於Entyvio的。這是給朱莉的。您提到了美國不斷變化的競爭格局以及日益加劇的通路組合變化。我可以想像,這些──其中的動態──並不容易逆轉。所以,我們是否應該假設成長率像您在修訂版中提到的那樣,從 9% 降至 6%?這是我們預期在 2026 年及以後會看到的趨勢嗎?如果是這樣,你們會在某個時候重新考慮 Entyvio 的巔峰年份促銷活動嗎?這是第一個問題。

  • The second question is about the Innovent deal. I have a question about this IBI3001, very interesting product, the ADC -- bispecific ADC. For this molecule, should we think that this is kind of going to work as two ADCs in one molecule, meaning that it's just kind of working as EGFR ADC and the B7H3 ADC? Or if there's any synergy by putting these -- the functions in molecule? Those are two questions.

    第二個問題是關於信達電子的交易。我有一個關於 IBI3001 的問題,這是一款非常有趣的產品,它是一款雙特異性 ADC。對於這個分子,我們是否應該認為它會像兩個 ADC 一樣在一個分子中發揮作用,也就是說,它既是 EGFR ADC,又是 B7H3 ADC?或者,將這些功能組合在一起是否會產生協同效應?這是兩個問題。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • Okay. Thank you, Miki. So the first question on Entyvio to Julie and the second on 3001 to PK, please.

    好的。謝謝你,美紀。所以,第一個問題是關於 Entyvio 的,請問 Julie;第二個問題是關於 3001 的,請問 PK。

  • Julie Kim - President of the US Business Unit, US Country Head & Interim Head of Global Portfolio Division

    Julie Kim - President of the US Business Unit, US Country Head & Interim Head of Global Portfolio Division

  • Thanks for the questions, Miki. In terms of the growth, what I would say is this, as I mentioned earlier, Entyvio has been able to hold share -- patient demand share in overall IBD. And what I would expect without giving any predictions about growth and whatnot that we'll provide for FY '26 in May.

    謝謝你的提問,美紀。就成長而言,我想說的是,正如我之前提到的,Entyvio 已經能夠保持其在 IBD 患者需求方面的份額。至於2026財年的成長等情況,我不會做出任何預測,但我會在今年5月公佈。

  • I would say that our growth is in line with market at this point in terms of patient demand, and we expect to be able to hold our share given the fact that we're still the only gut-selective molecule in IBD and the strong track record that we have, particularly in UC.

    我認為,就目前患者需求而言,我們的成長與市場相符,鑑於我們仍然是 IBD 中唯一一種腸道選擇性分子,並且我們擁有良好的業績記錄,尤其是在 UC 方面,我們預計能夠保持我們的市場份額。

  • And as I mentioned, where we see the significant competitive challenges is in CD thus far. In terms of the peak at this point, we are not changing our overall peak revenue guidance.

    正如我之前提到的,到目前為止,我們看到的主要競爭挑戰出現在CD領域。就目前的高峰而言,我們不會改變整體高峰收入預期。

  • Phuong Morrow - Head, Oncology Therapeutic Area Unit

    Phuong Morrow - Head, Oncology Therapeutic Area Unit

  • Thank you. And to add on related to IBI3001, happy to bring this forward. So we agreed and when discussing the data and the potential for this molecule with Innovent, it was based upon a few elements. The first is the fact that these targets are very well harmonized with our current disease area strategy in solid tumors, particularly in GI and thoracic cancers. These target specifically.

    謝謝。另外,關於 IBI3001,我很樂意提出這一點。因此我們達成了一致,在與信達生物討論數據和該分子的潛力時,我們主要基於以下幾個因素。首先,這些標靶與我們目前在實體腫瘤(尤其是胃腸道和胸部癌症)領域的疾病治療策略非常契合。這些產品有針對性。

  • And the second element is that we believe that, as they should target two elements and then use the same novel exatecan payload as well as platform that they would be able to very specifically harness a payload and result in more encouraging efficacy. We've seen some elements of that thus far in the earlier doses, as I noted, and we will continue to monitor as we progress up the dose levels.

    第二個因素是,我們認為,由於他們應該針對兩個因素,然後使用相同的新型依沙替康有效載荷和平台,因此他們能夠非常具體地利用有效載荷,從而獲得更令人鼓舞的療效。正如我之前提到的,我們在早期劑量中已經看到了一些這樣的跡象,我們將繼續監測,隨著劑量水平的提高,情況也會有所改善。

  • Miki Sogi - Analyst

    Miki Sogi - Analyst

  • Thank you.

    謝謝。

  • Christopher O'Reilly - Global Head of Investor Relations

    Christopher O'Reilly - Global Head of Investor Relations

  • (interpreted) Thank you very much. With this, we'd like to conclude today's webinar. Thank you very much for your participation today. We'd like to ask for your kind continued support. Thank you.

    (翻譯)非常感謝。今天的網路研討會就到此結束。非常感謝您今天的參與。我們懇請您繼續給予支持。謝謝。