Q2 2025 Takeda Pharmaceutical Co Ltd Earnings Call

Chris: まず、言語設定についてご説明いたします。Zoomウィンドウの下の方に言語が選択できるボタンがございます。日本語でお聞きになりたい方は日本語、英語でお聞きになりたい方は英語、または生の音声でお聞きしたい方はオフにしていただければ幸いです。本日のコールでは、米国の1995年民事証券訴訟改革法で規定される将来に関する見通し情報を議論させていただくことを皆様にお伝え申し上げます。実際の結果は、本日議論される結果と大きく異なる場合があります。実際の結果を大きく異なるものにする可能性のある要因については、最新のForm 20-Fおよびその他のSECへの提出書類に記載されております。なお、本日のコールでは、国際会計基準に準拠しない財務指標も議論することがございます。この指標の定義および調整表につきましては、プレゼンテーションのAppendixをご参照ください。本日のプレゼン資料の2ページの重要な注意事項もご確認お願い申し上げます。それでは、本日のプレゼンテーションに移りたいと思います。社長CEOのクリストフ・ウェバー、チーフフィナンシャルオフィサーのフルタ・ミラノ、R&Dプレジデントのアンディ・プランプ、グローバルオンコロジービジネスユニットプレジデントのテレサ・ビテティ、オンコロジー疾患領域ユニットヘッドのPKモロよりプレゼンをさせていただきます。その後、質疑応答の時間を設けております。それでは始めたいと思います。Christophe, please go ahead.

Speaker #1: Zoom window . Gozaimasu ! Nihongo de ni nihongo . Eagle . Eagle . The often side by this . The peacock . No .

Speaker #1: Thank . An . Mitoshi . Joho . Yajima . Okegawa . Honjitsu . Kato . Okiku naru . Okiku . Mizuno no aru .

Christophe Weber: Ken, now Honjito Presentation, no appendix. Sorry, Honjito Presentation. CEO, no Christophe Weber. Chief Financial Officer, no Milano Furuta. R&D President, Andy Plump. Global Oncology Business Unit President, no Teresa Bitetti. Oncology, Christophe, please go ahead.

Speaker #1: Join . Nishikawa . Saishin . No form 20 F Oyabe sono hoka no sec . No ni . Now . Honjitsu . Kokusai shiki shinai mo gozaimasu .

Speaker #1: Kono shiono oyobi cho se to presentation no appendix or . No . No . Onegai . Honjitsu presentation . Ni shacho CEO . No .

Speaker #1: Christophe Weber . Chief Financial officer . No . Fujita . Mirano R&D president . Andy . Global oncology business unit . President . No .

Speaker #1: Teresa Bitetti , oncology unit . Know peak Motoyoshi present was sono ATO shitsuji no jikan . Hajime Christoph . Please go ahead .

Speaker #2: 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 .

Milano Furuta: 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 products grew 5.3% at constant exchange rate, and we expect this growth to accelerate in H2. ENTYVIO is growing, albeit at a slower pace, as the brand is growing 20% quarter to quarter in the U.S. but still represents only 9% of ENTYVIO volume in the U.S. 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 profitability.

Christophe Weber: Thank you, Chris, and thank you everyone for joining us today. Our fiscal year 2025 H1 results confirm our expected business dynamics 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. ENTYVIO is growing, albeit at a slower pace, as the pen is growing 20% quarter-to-quarter in the US, but still represents 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.

Speaker #2: 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 .

Speaker #2: Growth and launch products grew 5.3% at constant exchange rates , and we expect this growth to accelerate in H2 . 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 Ontario volume in the US .

Speaker #2: Our PDT business is expected to grow at mid-single digits this year , with immunoglobulin and albumin growing high . Single digit . We will continue to maintain very tight opex control through efficiency improvement , supporting profit .

Christophe Weber: We will continue to maintain very tight OpEx control through efficiency improvement, supporting profit. 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 H1. 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.

Speaker #2: Our decision to update full-year management guidance for 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.

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

Speaker #2: Our updated reported forecast, including our EPS forecast, reflects a non-tax deductible impairment loss booked in the first half. From fiscal year 2026 onwards, Takeda will be in a new business cycle with the Vyvanse generic impact mainly behind us.

Giles Platford: From.

Milano Furuta: Fiscal year 2026 onwards. Takeda will be in a new business cycle with VYVANSE generic impact mainly behind us. Potentially three new product launches for Risvertide, Over Brixton, and Zazocity NIB, 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. Milano will discuss our financial results and expected results in more detail in a moment, and then Andy will present our pipeline advancements with exciting data on mezagitamab. Later on this call, Teresa Bitetti and Piquet Moreau will discuss our partnership with Innovent Biologics and will focus on two new late-stage molecules. With that, I hand it over to Milano to walk us through the financials. Milano, thank you Christophe, and hello everyone, this is Milano Furuta speaking. Slide 7 summarizes our first half financial results.

Speaker #2: Potentially three new product launches for respiratory over Preston and the NIB, and an evolving late-stage pipeline. Now enriched by our strategic partnership with Innovent Biologics.

Speaker #2: Our leadership in leveraging technology and AI will further transform the company , which will be led by Julie . Milano will discuss our financial results , unexpected results in more detail in a moment , and then Andy will present our pipeline advancement with exciting data on Mab .

Christophe Weber: 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 Resagutimab. Later on this call, Teresa Bitetti and P.K. Morrow will discuss our partnership with Innovent Biologics and will focus on two new late-stage molecules. With that, I hand it over to Milano to walk us through the financials. Milano.

Speaker #2: Later on this call , Theresa Bitetti and Pcmu will discuss our partnership with Innovent Biologics and we'll focus on two new late stage molecules .

Speaker #2: With that , I'll hand it over to Milano to walk us through the financials . Milano . Thank you , Christoph and hello everyone .

Milano Furuta: Thank you, Christophe. Hello everyone. This is Milano Furuta speaking. Slide 7 summarizes our first half financial results. Overall, core business performance is tracking as we planned. As anticipated, this period was significantly impacted by LOE as we lost approximately JPY 100 billion of VYVANSE revenue. Meanwhile, we have been focused on driving OpEx savings, which has partially offset the impact to core operating profit. We expect H1 to be the peak of VYVANSE generic impact, and we expect a better growth outlook for the full year. Revenue in H1 was just over JPY 2.2 trillion, a decrease of 6.9% or -3.9% at constant exchange rates or CER.

Speaker #2: This is Milano Furuta speaking . Slide seven summarizes our first half financial results . Overall , our business performance is tracking as we planned as anticipated , this period was significantly impacted by low as we lost approximately ¥100 billion of Vyvanse revenue .

Milano Furuta: Overall, core business performance is tracking as we planned. As anticipated, this period was significantly impacted by LOE as we lost approximately ¥100 billion of VYVANSE revenue. Meanwhile, we have been focused on driving OPEX savings, which has partially offset the impact to core operating profit. We expect H1 to be the peak of VYVANSE generic impact, and we expect a better growth outlook for the full year. Revenue in H1 was just over ¥2.2 trillion, a decrease of 6.9% or minus 3.9% at constant exchange rate, or CER. Core operating profit was ¥639.2 billion, a year-on-year decrease of 11.2% at actual FX or 8.8% at CER. Reported operating profit was ¥253.6 billion, a decline of 27.7% due to larger impairment losses this fiscal year. Core EPS was ¥279 and reported EPS was ¥72.

Speaker #2: Meanwhile , we have been focused on driving OpEx savings , which has partially offset the impact to corporate and profit . We expect H1 to be the peak of Vyvanse generic impact , and we expect a better growth outlook for the full year revenue in H1 was just over ¥2.2 trillion , a decrease of 6.9% , or minus 3.9% at constant exchange rates or KRW corporate profit group was ¥639.2 billion .

Milano Furuta: Core operating profit, core OP, was JPY 639.2 billion, a year-on-year decrease of 11.2% at actual FX or 8.8% at CER. Reported operating profit was JPY 253.6 billion, a decline of 27.7% due to larger impairment losses this fiscal year. Core EPS was JPY 279. Reported EPS was JPY 72. The 40% decline in the reported net profit and EPS reflects the impairment of cell therapy, which is non-deductible from taxable income. Cash flow was very strong this period, with adjusted free cash flow of JPY 525.4 billion, including improvements in working capital. Slide 8 shows our growth on launched products, which represent over 50% of revenue. In H1, this portfolio grew 5.3% at CER.

Speaker #2: A year on year decrease of 11.2% at actual FX or 8.8% at KRW . Reported operating profit was ¥253.6 billion , a decline of 27.7% due to larger impairment losses .

Speaker #2: This fiscal year . Was ¥279 and reported EPs was ¥72 . The 40% decline in reported net profit and EPs reflects the impairment of therapy , which is non deductible from taxable income .

Milano Furuta: The 40% decline in reported net profit and EPS reflects the impairment of cell therapy, which is non-deductible from taxable income. Cash flow was very strong this period with adjusted free cash flow of ¥525.4 billion, including improvements in working capital. 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. In GI, ENTYVIO growth was 5.1% across. We are encouraged to see increasing numbers of active ENTYVIO PEN patients in the U.S., and we are also making progress with expanding formulary access. That said, revenue growth has been slightly below expectation and we are revising our full year forecast for ENTYVIO to 6% at CER.

Speaker #2: Cash flow was very strong this period , with adjusted free cash flow of ¥525.4 billion , including improvements in working capital . Slide eight shows our growth and launch products , which represents over 50% of revenue in H1 .

Speaker #2: This portfolio grew 5.3% at KRW. This modest growth includes the impact of phasing of certain products, and we anticipate a higher growth rate in the second half. In GI, Entyvio growth was 5.1% at KRW.

Milano Furuta: This modest growth includes the impact of phasing of, for certain products, and we anticipate a higher growth rate in the H2. In GI, ENTYVIO growth was 5.1% of CR. 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 expectation, and we are revising our full-year forecast for ENTYVIO to 6% at CR. In rare disease, TAKHZYRO continues to grow steadily as a market leader in HAE prophylaxis with 5.9% growth at CR. Our PD portfolio growth reflects several factors which were built into our guidance and fully in line with expectation. IG growth was 3.1%.

Speaker #2: We are encouraged to see increasing numbers of active Entyvio pen patients in the U.S., and we are also making progress with expanding formulary access.

Speaker #2: That said , revenue growth has been slightly below our expectations and we are revising our full year forecast for Entyvio to 6% at KRW in rare disease , Takhzyro continues to grow steadily as the market leader in high prophylaxis , with 5.9% growth at KRW .

Milano Furuta: In rare disease, TAKHZYRO continues to grow steadily as a market leader in HAE prophylaxis with 5.9% growth at CER. Our PDT portfolio growth reflects several factors which were built into our guidance and fully in line with expectations. IG growth was 3.1% while Medicare Part Redesign is impacting several products in the U.S. this year. One of the most impacted products is GAMMAGARD LIQUID and we expect this to normalize in Q4. Our SCIG portfolio is growing at the 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 confirmed the growth outlook of high single digit for both IG and albumin.

Speaker #2: Our PDT portfolio growth reflects several factors that were built into our guidance and is fully in line with our expectations. IG growth was 3.1%, while Medicare Part D redesign is impacting several products in the U.S. this year. One of the most impacted products is Gammagard Liquid, and we expect this to normalize in Q4.

Milano Furuta: While the 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. Our SCIG portfolio is growing at a 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 digits for both IG and albumin. In oncology, Perjeta 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.

Speaker #2: Our portfolio is growing at double-digit rates, and we expect this to continue. Albumin declined slightly in H1 due to the timing of shipments to China and foreseen cost containment measures.

Speaker #2: Meanwhile , we have also secured additional sustainable tender markets outside of China , and we expect a performance to accelerate in H2 . Therefore , we confirmed the growth outlook of high single digit for both IgG and albumin in oncology continues to expand as we roll out global launches .

Milano Furuta: 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 estimates. Another factor impacting the growth rate of QDENGA is transaction effects, mainly due to the strength of the Euro versus the Brazilian real. On slide nine you can see how the growth in launch products and the VYVANSE loss of exclusivity contributed to total revenue performance. FX was also a headwind this quarter due to appreciation of the Japanese yen against major currencies. As we expect growth in 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.

Speaker #2: Finally , in vaccines , we have reallocated supply of Qdenga based on market needs , which has pushed some shipments . Timing into later this fiscal year .

Speaker #2: However , we expect annual demand to remain in line with our original estimates . Another factor impacting the growth rate of Qdenga is transactional effects , mainly due to the strength of the euro versus the Brazilian real .

Milano Furuta: Another factor impacting the growth rate of QDENGA is transaction effects, mainly due to the strength of the euro versus the Brazilian real. On slide 9, you can see how the growth on launched products and the VYVANSE loss of exclusivity contributed to total revenue performance. FX was also a headwind this quarter due to appreciation of the Japanese yen against major currencies. We expect growth on launched 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. 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 broad initiatives to capture efficiencies across the R&D value chain.

Speaker #2: On slide nine, you can see how the growth and launch of products, as well as the Vyvanse loss of exclusivity, contributed to total revenue performance.

Speaker #2: FX was also a headwind this quarter due to the appreciation of the Japanese yen against major currencies. We expect growth and product launches to deliver higher growth in H2, and the year-on-year decline of Vyvanse to moderate.

Speaker #2: We project more favorable year on year growth dynamics in H2 . Next , an update on efficiency program that we initiated in April 2020 for .

Milano Furuta: Next, an update on the 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 broad initiatives to capture efficiencies across the R&D value chain. Restructuring cost in H1 was ¥27.4 billion and we are focused on further driving additional OPEX savings. 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 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. Within this decline at CER we had a negative impact from transaction FX which accounts for about 1/3 of the decline. Let me take a moment to explain how this is impacting our P&L.

Speaker #2: We continued to make progress with initiatives in H1 this year, including additional organizational changes impacting 600 positions. Further optimization of real estate and the broad initiatives to capture efficiencies across R&D and the value chain.

Speaker #2: Our suctioning costs in H1 were ¥27.4 billion, and we are focused on further driving additional opex savings, as we show on slide 11.

Milano Furuta: Restructuring costs in H1 were JPY 27.4 billion, we are focused on further driving additional OpEx savings. 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% of core OP. Within this decline at core OP, we had a negative impact from transaction 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 a FX fluctuation between the currency paid for product and the currency of the entity where revenue is booked.

Speaker #2: These operational efficiencies are contributing to a reduction in R&D and snda expenses in this bridge . For core operating profit . You can see that low of high margin Vyvanse was the main reason for the year on year decline of 8.8% of KRW .

Speaker #2: Within this decline , at KRW , we had a negative impact from transaction FX , which accounts for about one third of the decline .

Speaker #2: 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 the product and the currency of the entity.

Milano Furuta: 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. 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. 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 impairments of intangible assets.

Speaker #2: We revenue is booked . This is exactly what is impacting Qdenga sales today . For example , because our European entity books revenue in Euro for its sales to Brazil .

Milano Furuta: This is exactly what is impacting Qdenga sales today, for example, because our European entity books revenue in euro 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. 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 impairments of intangible assets. The main item was a JPY 58.2 billion expense related to our recent decision to discontinue cell therapy efforts. Our updated full-year outlook on slide 13.

Speaker #2: In Brazil and real cost of goods can be impacted to when products are imported from other countries . For example , when the European states , commercial entities outside Europe have to recognize higher Cogs when importing products to sell locally .

Speaker #2: As you know, Takeda has a large manufacturing footprint in Europe, so we are particularly sensitive to euro currency volatility. Next, reported operating profit on slide 12.

Speaker #2: This decreased by 27.7% versus the prior year, mainly due to the decline in corporate profit and higher impairments of intangible assets. The main item was a ¥58.2 billion expense related to our recent decision to discontinue sell therapy efforts.

Milano Furuta: The main item was a ¥58.2 billion expense related to our recent decision to discontinue cell therapy efforts. Next, our updated full year outlook on slide 13 starting with management guidance. Although we have reduced our forecast for ENTYVIO and VYVANSE, we expect total revenue to stay in the range of 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 transaction 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 the Core EPS from broadly flat to low single digit percentage decline. The bottom part of the slide shows our reported and core forecasts. These reflect our latest FX assumptions including translation FX and items booked in H1 that will impact the full year results.

Speaker #2: Next , our updated full year outlook on slide 13 , 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 .

Milano Furuta: 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 broad mix. However, the transaction FX dynamic that I just described is having a larger impact on profits. Therefore, we are slightly lowering our guidance for operating profits and core EPS from broadly flat to low single-digit percentage decline. The bottom part of the slide shows our reported and core forecasts. These reflect our latest FX assumptions, including translation 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 $1.2 billion US dollar payment to Innovent Biologics for our recently announced in-licensing deal.

Speaker #2: We expect higher OPEX savings to fully mitigate the impact from unfavorable changes in product mix. However, the transaction FX dynamic that I just described is having a larger impact on profits.

Speaker #2: Therefore, we are slightly lowering our guidance for corporate profit and core EPS from broadly flat to a low single-digit percentage decline. The bottom part of the slide shows our reported and core forecasts.

Speaker #2: These reflects our latest FX assumptions , including translation , 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 1.2 billion US dollar payment to innovate Biologics for our recently announced In-licensing deal .

Milano Furuta: We have also revised our adjusted free cash flow forecast to include a $1.2 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 ¥200 per share for the full year. On slide 14 we show more details about the updated Core 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 translation FX, is a ¥10 billion reduction in our operating profit forecast to ¥1.13 trillion. 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 fiscal year. Meanwhile, we remain focused on cost discipline to deliver our guidance while investing for future growth. Thank you for your attention.

Speaker #2: This payment will be funded by cash on hand. Our dividend outlook remains ¥200 per share for the full year. On slide 14, we show more details about the updated operating profit forecast.

Milano Furuta: This payment will be funded by cash on hand. Our dividend outlook remains JPY 200 per share for the full year. 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 translation FX, is a JPY 10 billion reduction in our operating profit forecast to JPY 1.13 trillion. 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. Thank you for your attention. I will now hand over to Andy for more details on the pipeline updates.

Speaker #2: You can see the relative magnitude of transactional effects and impact. While OpEx savings compensate for unfavorable product mix, the net impact of all these moving parts, including translation and FX, is a ¥10 billion reduction in our corporate profit forecast to ¥1.13 trillion.

Speaker #2: In summary, our business fundamentals are tracking as planned. While H1 growth was largely impacted by low performance, we expect better growth rates for the full fiscal year.

Speaker #2: Meanwhile, we remain focused on cost discipline to deliver our guidance while investing for future growth. Thank you for your attention. I will now hand over to Andy for more details on the pipeline updates.

Milano Furuta: I will now hand over to Andy Plump for more details on the pipeline updates.

Speaker #3: Thank you very much . Milano and hello to everyone on today's call . Next slide please . Fiscal year 2025 . As you just heard from Christoph , 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 .

Andrew Plump: 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 2 for 2 with positive Phase 3 studies for both Ruspertide and Ovaprexin, with zazacitinib Phase 3 data in psoriasis expected by the end of this calendar year. In a few minutes, Teresa Bitetti and P.K. 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.

Andrew Plump: Thank you very much, Milano, and hello to everyone on today's call. Next slide, please. Fiscal year 2025, as you just heard from Christoph, 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 2 for 2 with positive phase III studies for both rusfertide and oveporexton, with zasacitinib phase III data in psoriasis expected by the end of this calendar year. In a few minutes, Teresa Bitetti and P.K. Morrow will walk you through the details of our recently announced partnership with Innovent Biologics, which upon closing will expand our oncology pipeline.

Speaker #3: We are two for two with positive Phase 3 studies for both Protide and Over. Preston has Phase 3 data in psoriasis expected by the end of this calendar year.

Speaker #3: In a few minutes , Theresa Bitetti and PK Mauro 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 .

Andrew Plump: With two highly differentiated late-stage oncology assets in development for multiple solid tumors, this deal has the potential to transform our oncology pipeline. First, I'm going to highlight some recently presented phase III data for oveporexton and long-term IgA nephropathy data for mezagitamab that we are particularly excited about. 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 2 receptor agonist that treats the underlying orexin deficiency in patients with narcolepsy type 1. We believe that the data presented at the World Sleep Congress last month establishes a new standard of care for NT1.

Speaker #3: This deal has the potential to transform our oncology pipeline. But first, I'm going to highlight some recently presented Phase 3 data for over paroxetine and long-term IgA nephropathy data for Mab that we are particularly excited about.

Andrew Plump: This deal has the potential to transform our oncology pipeline. First, I'm going to highlight some recently presented Phase 3 data for Ovaprexin and long term IgA nephropathy data for mezagitamab that we are particularly excited about. 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 Ovaprexin on the next slide. Ovaprexin is on track to be the first in class and potentially best in class orexin 2 receptor agonist that treats the underlying orexin deficiency in patients with narcolepsy type 1. We believe that the data presented at the World Sleep Congress last month establishes a new standard of care for NT1.

Speaker #3: 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 over Preston on the next slide.

Speaker #3: Brexit is on track to be the first in class and potentially best in class . Orexin two receptor agonists that treats the underlying orexin deficiency in patients with narcolepsy .

Speaker #3: Type one . We believe that the data presented at the World Sleep Congress last month establishes a new standard of care for nt1 in one of the largest , most comprehensive phase three development programs for Nt1 to date .

Andrew Plump: 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 Ovaprexin has a profound effect on daytime symptoms like excessive daytime sleepiness and cataplexy, nighttime symptoms, and cognitive symptoms. 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. Ovaprexin sets a high bar with the new standard of care, which will be hard to beat. Feel and function were assessed using multiple objective and subjective measures. Based on these strong Phase 3 data, we plan to file for U.S.

Andrew Plump: In one of the largest, most comprehensive phase III 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. 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 a new standard of care which will be hard to beat. Feel and function were assessed using multiple objective and subjective measures.

Speaker #3: 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 over paroxetine has a profound effect on daytime symptoms like excessive daytime sleepiness and cataplexy.

Speaker #3: Nighttime symptoms and cognitive symptoms . 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 over Preston sets a high bar with the new standard of care , which will be hard to beat , feel and function were assessed using multiple objective and subjective measures .

Speaker #3: Based on these strong Phase 3 data, we plan to file for U.S. approval in NT1 as quickly as possible later this year, with regional filings to occur simultaneously or shortly thereafter.

Andrew Plump: Based on these strong phase III 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. Our orexin franchise is making rapid progress beyond oveporexton. The next generation orexin 2 receptor agonist, TAK-360, is rapidly enrolling phase II studies for narcolepsy type 2 and idiopathic hypersomnia. Results for these trials are expected to be read out by early fiscal year 2026. Next slide, please. 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. 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.

Andrew Plump: approval in NT1 as quickly as possible later this year with regional filings to occur simultaneously or shortly thereafter. Our orexin franchise is making rapid progress beyond orexin. The next generation orexin 2 receptor agonist TAK-861 is rapidly enrolling Phase 2 studies for narcolepsy type 2 and idiopathic hypersomnia. Results for these trials are expected to be read out by early fiscal year 2026. Next slide please. 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. 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.

Speaker #3: Our franchise is making rapid progress beyond over Preston . The next generation orexin two receptor agonist , Tak 360 is rapidly enrolling phase two studies for narcolepsy type two and idiopathic hypersomnia results for these trials are expected to be read out by early fiscal year 2026 .

Speaker #3: Next slide please . We previously presented compelling 48 week proof of concept data for our Anti-cd38 antibody Mab in IGA nephropathy . This includes consistent and supportive trends in decreased IGA , IgG , IgG , and galactose deficient iga1 levels , reflecting the selective targeting of Cd38 on plasma cells , which produce pathological antibodies .

Speaker #3: 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.

Speaker #3: Mesigyna Mab treated patients show persistent reductions in proteinuria or upcr . Nearly 18 months after the last dose , suggesting sustained efficacy beyond the treatment period .

Andrew Plump: 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. 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 enrolling well. Next slide please. The Phase 3 VERIFY study of rusfertide, a potential first-in-class synthetic hepcidomimetic 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.

Andrew Plump: 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. 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 III IgA nephropathy study is open and enrolling well. Next slide, please. The phase III 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.

Speaker #3: Importantly, the estimated glomerular filtration rate (eGFR), which is the regulatory gold standard for measuring renal function, remains stable at 96 weeks. This is significant as it is the first IgA nephropathy therapy to demonstrate stable renal function.

Speaker #3: 18 months after dosing , we look forward to presenting the full data at ASN . ASN Kidney Week next month . Our phase three IGA nephropathy study is open and enrolling well , next slide please .

Speaker #3: The Phase 3 VERIFY study of the 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.

Speaker #3: Updated 52 week data will be available at an upcoming medical congress this quarter , we received Breakthrough Therapy designation , which speaks to the exceptional practice changing data presented at Asco 2025 .

Andrew Plump: 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. Looking ahead to our next major pipeline milestone, we expect TAK-279 Phase 3 psoriasis data later this calendar year. Based on the data seen in Phase 2, we believe TAK-279 will provide an important and very attractive oral option for patients. I'm also excited to report that the head-to-head study of Zazacitinib versus Ducravacitinib in psoriasis is expected to complete enrollment in the next few weeks. As you can see here, psoriasis is the first of many diseases where Zazacitinib 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.

Andrew Plump: 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. Looking ahead to our next major pipeline milestone, we expect zasocitinib phase III psoriasis data later this calendar year. Based on the data seen in phase II, 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. As you can see here, psoriasis is the first of many diseases where zasocitinib can benefit patients.

Speaker #3: And increases the probability of priority review for frustrated , which we intend to file this fiscal year . Looking ahead to our next major pipeline milestone , we expect Dasatinib phase three psoriasis data later this calendar year .

Speaker #3: Based on the data seen in phase two , we believe Dasatinib will provide an important and very attractive oral option for patients . I'm also excited to report that the head to head study of Dasatinib versus Deucravacitinib in psoriasis is expected to complete enrollment in the next few weeks .

Speaker #3: As you can see here , psoriasis is the is the first of many diseases where dasatinib can benefit patients . With that , I will now turn it over to Teresa and PK to provide more details on the event partnership , which has the potential to catapult Takeda into an industry leading oncology company .

Andrew Plump: 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. Thank you.

Speaker #3: Thank you .

Speaker #4: Thank you, Andy. Good morning, good afternoon, and good evening. We're 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.

Teresa Bitetti: Thank you, thank you Andy. Good morning, good afternoon and good evening. We're 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. Our collaboration with Innovent involves three differentiated assets, each with unique mechanisms. IBI363 is a potentially first-in-class PD-1/IL-2 alpha bias bispecific. IBI343 is a next-generation Claudin 18.2 ADC and we're also receiving the exclusive option to license IBI3001, which is another ADC targeting EGFR and B7H3. 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, and finally an option to license a potential best-in-class bispecific ADC.

Teresa Bitetti: Thank you, Andy. Good morning, good afternoon, good evening. We're 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. Our collaboration with Innovent involves 3 differentiated assets, each with unique mechanisms. IBI363 is a potentially first-in-class PD-1/IL-2 alpha bias bispecific. IBI343 is a next generation claudin 18.2 ADC. We're also receiving the exclusive option to license IBI3001, which is another ADC targeting EGFR and B7-H3. 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.

Speaker #4: Next slide . Our collaboration with Innovent involves three differentiated assets , each with unique mechanisms three six , three is a potentially first in class PD one , IL two alpha biased bispecific three 43 is a next generation claudin 18.2 .

Speaker #4: ATC and we're also receiving the exclusive option to license 3001 , which is another ADC targeting EGFR and B7-h3 . This deal is strategically important because it adds cutting edge anchor assets to our pipeline .

Speaker #4: First , a bispecific with the potential to be an I o backbone therapy across a broad range of indications , lung included . Second generation ADC with potential to address difficult to treat cancers , including gastric and pancreatic .

Speaker #4: 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 .

Teresa Bitetti: 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. Next slide. Let me spend a little time sharing how we've structured this deal and what it brings to the Takeda portfolio. For IBI363, which is the PD-1/IL-2α-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 IBI363 with a 60/40 Takeda-Innovent profit or loss split. Takeda will have the exclusive right to commercialize and manufacture outside of Greater China.

Teresa Bitetti: 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. Next slide. Let me spend a little time sharing how we've structured this deal and what it brings to the Takeda portfolio. For IBI363, 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 U.S. co-commercialization of IBI363 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. For IBI343, the Claudin 18.2 ADC, Takeda will have the right to develop, manufacture and commercialize worldwide outside of Greater China. Finally, we will have the option for IBI3001, which is the EGFR/B7H3 ADC currently in phase one.

Speaker #4: Our commitment to patients has the potential to be a significant growth driver for the Takeda enterprise post-2030. So, next slide.

Speaker #4: Let me spend a little time sharing how we've structured this deal and what it brings to the Takeda portfolio . So for 3.63 , which is the PD one , IL two alpha bispecific , Takeda will lead the co-development of this asset globally using a 6040 to keta innovent cost split .

Speaker #4: Takeda will also lead us in co-commercialization of 3.63, with a 60/40 split for profit or loss. Additionally, Takeda will have the exclusive right to commercialize and manufacture outside of Greater China for 343.

Teresa Bitetti: For IBI343, the claudin 18.2 ADC, Takeda will have the right to develop, manufacture, and commercialize worldwide outside of Greater China. Finally, we will have the option for IBI3001, which is the EGFR B7-H3 ADC currently in phase I. If we choose to exercise the option, we will have global rights to develop, manufacture, and commercialize outside of Greater China. 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 3 disease areas and 3 modalities. As we have highlighted here in the red box, the programs included in this partnership fits squarely within our strategy. Now I'm gonna turn it over to PK to explain more about the science behind these programs.

Speaker #4: The Claudin 18.2 ATC . 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 B7-h3 ADC currently in phase one .

Speaker #4: If we choose to exercise the option, we will have global rights to develop, manufacture, and commercialize outside of Greater China. Next slide.

Teresa Bitetti: If we choose to exercise the option, we will have global rights to develop, manufacture and commercialize outside of Greater China. 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 fit squarely within our strategy. Now I'm going to turn it over to PK to explain more about the science behind these programs.

Speaker #4: 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.

Speaker #4: And as we have highlighted here in the red box, the programs included in this partnership fit squarely within our strategy. So now I'm going to turn it over to PK to explain more about the science behind these programs.

Speaker #5: 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.

P.K. Morrow: 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. 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.

P.K. Morrow: Thank you, Teresa. I am 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. 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 anti-tumor immune response.

Speaker #5: At Takeda . I will start with Ibi 363 , IV 363 . As you can see , here is a bispecific with a unique mechanism that has the potential to become an immuno oncology or IO backbone .

Speaker #5: Specifically , Ibis 6363 is what I would call an IO . Io molecule , meaning that it is designed to block the PD one Pd-l1 pathway and selectively activate IL two alpha signaling while attenuating IL two beta gamma signaling .

Speaker #5: As you can see on the left hand side of this slide , this differentiated IL two alpha biased approach has been shown to activate tumor specific T cells that express both PD one and IL two alpha receptor within the tumor microenvironment , thereby unleashing a more effective anti-tumor immune response .

Speaker #5: Ibi 363 thereby supercharges tumor specific T cells , resulting in apoptosis of the cancer cell and by blocking the PD one pathway . Ibi 363 ensures that these T cells continue to stay activated and it reduces the risk of T cell exhaustion .

P.K. Morrow: 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. 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. 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.

P.K. Morrow: IBI363 thereby supercharges tumor-specific T cells, resulting in apoptosis of the cancer cell. 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. 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. While median overall survival is immature at the higher doses, it already shows a positive trend even at these lower doses. 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.

Speaker #5: Ibi 363 has now dosed more than 1200 patients and has demonstrated very encouraging results . 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 .

Speaker #5: And while median overall survival is immature at the higher doses, it already shows a positive trend even at these lower doses. The results you see on the screen were just shared as oral presentations at this year's ASCO.

Speaker #5: They are encouraging data , especially when indirectly compared to results from standard of care chemotherapy on the right . The safety profile of Ibi 363 is considered tolerable , with the most common adverse events related to IV 363 being rash and arthralgia discontinuations .

P.K. Morrow: On the right, 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. 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. 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.

P.K. Morrow: The safety profile of IBI 363 is considered tolerable, with the most common adverse events related to IBI 363 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. The high caliber of these data is reinforced by the FDA's granting of a Fast Track designation in non-small cell lung cancer. 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. Next slide. To maximize the potential of IBI 363, we have three very clear objectives, which are built on the efficacy that we've seen thus far.

Speaker #5: Due to these events, they 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.

Speaker #5: The high calibre of these data is reinforced by the FDA's granting of a fast track , fast track designation , and non-small cell lung cancer .

Speaker #5: 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.

Speaker #5: Next slide. To maximize the potential of Ibai 363, we have three very clear objectives, which are built on the efficacy that we've seen thus far.

Speaker #5: First is to establish foundational efficacy in tumors that have progressed as IO therapies. Second is to penetrate into early reliance as either monotherapy or in combination.

P.K. Morrow: 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. 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. That's why, as shown on this slide, we're initially establishing the 5 phase III trials, including 2 trials in IO-refractory squamous and non-squamous non-small cell lung cancer, 2 in front line non-small cell lung cancer, and 1 in microsatellite stable colorectal cancer. We also have a series of lifecycle management trials that we're discussing with Innovent, which will help to build upon proof of concept data as it evolves. Next slide. Now I'll walk you through IBI343.

P.K. Morrow: 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. That's why, as shown on this slide, we're initially establishing the 5 phase 3 trials, including 2 trials in IO-refractory squamous and non-squamous non-small cell lung cancer, 2 in frontline non-small cell lung cancer, and 1 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. 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.

Speaker #5: 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.

Speaker #5: 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, and two in frontline non-small cell lung cancer.

Speaker #5: And one in microsatellite-stable colorectal cancer. We also have a series of life management trials that we're discussing with Innovent, which will help to build upon proof of concept data as it evolves.

Speaker #5: Next slide. Now I'll walk you through IV 343. This Claudin 18.2-targeted ADC is seamlessly harmonized with our oncology strategy to diversify its novel ADC platform.

P.K. Morrow: 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. 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 sulfone-linked spacer increases the stability, solubility, and potential bystander effect, allowing the ADC to result in a more efficient apoptosis of the cancer cell.

Speaker #5: And second, it's demonstrated efficacy in GI cancers. When examining the image on the left, I will walk you through the platform from left to right.

P.K. Morrow: 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 ETSI silencing. This ETSI silencing is important because it reduces the risk of off-target toxicity and increases the tolerability of this Claudin targeting molecule. 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 sulfamate spacer increases the stability, solubility, and potential bystander effect, allowing the ADC to result in a more efficient apoptosis of the cancer cell. It also supports a homogeneous drug to antibody ratio of approximately 4, which many of us believe is a favorable ratio for ADCs. Finally, this potent exotecan payload inhibits topoisomerase 1, so it fits seamlessly into many standard of care regimens. Next slide.

Speaker #5: First , on the very left , Ibi 343 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 .

Speaker #5: 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 sulfimide spacer increases the stability , solubility , and potential bystander effect , allowing the ADC to result in a more efficient apoptosis of the cancer cell .

Speaker #5: And it also supports a homogeneous drug to antibody ratio of approximately four , which many of us believe is a favorable ratio for ADCs .

P.K. Morrow: It also supports a homogeneous drug-to-antibody ratio of approximately 4, which many of us believe is a favorable ratio for ADCs. Finally, this potent exatecan payload inhibits topoisomerase I, so it fits seamlessly into many standard care regimens. Next slide. IBI343 has been dosed in more than 340 patients. 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, IBI343 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.

Speaker #5: And finally , this potent Exatecan payload inhibits topoisomerase one , so it fits seamlessly into many standard of care regimens . Next slide 343 has been dosed in more than 340 patients .

P.K. Morrow: IBI343 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 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. 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. Next slide.

Speaker #5: And, as shown during oral presentations at this year's ASCO, IBI 343 has demonstrated encouraging activity in pancreatic and gastric cancers compared to the standard of care.

Speaker #5: 343 has more than doubled the response rate and more than doubled the overall survival as compared to standard of care chemotherapy . Thus far .

Speaker #5: 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.

Speaker #5: All of this makes us very excited to continue advancing this asset in GI cancers with critical unmet needs. And as with 363, these results were also reinforced by a Fast Track designation by the FDA for pancreatic ductal adenocarcinoma.

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

Speaker #5: Next slide . We also have an ambitious development plan for 343 and Claudin 18.2 expressing GI cancers as its topoisomerase inhibition enables us to fit seamlessly into the frontline treatment of pancreatic cancer .

P.K. Morrow: We also have an ambitious development plan for 343, including 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, we will leverage this data from this study and add a single arm study in the U.S. 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. Finally, I will review with you IBI3001, for which we have the exclusive option to license at a potential future date.

Speaker #5: And the second line of the chart , you can see that Innovent has an ongoing study , which is well underway in China and Japan , and the third line setting in gastric cancer .

Speaker #5: 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 .

Speaker #5: 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 .

P.K. Morrow: 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. 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, two 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 IBI343. 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.

Speaker #5: Next slide. And finally, I will review with you Ibi 3001, for which we have the exclusive option to license at a potential future date.

Speaker #5: IPA 3001 is truly a novel molecule , which is both a bispecific and an ADC . It targets EGFR and B7-h3 , two 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 .

P.K. Morrow: IBI3001 is truly a novel molecule which is both a bispecific and an ADC. It targets EGFR and B7H3, two targets that are highly expressed in many solid tumors, including lung cancer, colorectal cancer, and head and neck cancer. It is linked to the same potent ExoTecan payload as 343. 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, and with that, I'm delighted to turn it back to Teresa to talk about the immense promise of this collaboration for patients.

Speaker #5: In event has rapidly progressed this asset into the clinic already producing data . As you can see on the right hand side , the shows encouraging efficacy in even in highly refractory solid tumors .

Speaker #5: We look forward to following the progress of this trial, which is moving at speed. And with that, I'm delighted to turn it back to Teresa to talk about the immense promise of this collaboration for patients.

P.K. Morrow: We look forward to following the progress of this trial, which is moving at speed. With that, I'm delighted to turn it back to Theresa to talk about the immense promise of this collaboration for patients.

Speaker #4: 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 .

Teresa Bitetti: Thank you, PK. 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.

Teresa Bitetti: Thank you, PK. 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. 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. 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 IBI363, we're looking at lung and CRC.

Speaker #4: So as you can see highlighted in red , the tumors in our initial development plan are not only prevalent but difficult to treat .

P.K. Morrow: As you can see highlighted in.

Teresa Bitetti: 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. 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. In lung, we will be focusing on the iorefractory 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. In colorectal cancer, we'll focus on the frontline patients with MSS. In aggregate, the initial plan focuses on a potential combined addressable market of over $40 billion. Next slide.

Speaker #4: And our initial plans . We can address four of these cancers and make a meaningful difference for patients . Next slide . As I mentioned at the start , this partnership will serve as a significant potential growth driver for Takeda .

Speaker #4: When we look at the market opportunity for our initial development plans for 363, we're focusing on lung cancer and colorectal cancer (CRC) in the lung. We will be concentrating on the immuno-oncology (IO) refractory second-line setting, where the majority of patients will have already been treated with a PD-1 or PD-L1 inhibitor. Then, we will move rapidly into the front-line setting as a monotherapy or part of a combination regimen.

Teresa Bitetti: In lung, we will be focusing on the IO refractory 2nd-line setting, where the majority of patients will have already been treated with a PD-1 or PD-L1, then move rapidly into the 1st-line setting as a monotherapy or part of a combination regimen. In colorectal cancer, we will focus on the 1st-line patients with MSS CRC. In aggregate, the initial plan focuses on a potential combined addressable market of over JPY 40 billion. Next slide. Now let's look at the market potential for IBI343. Globally, gastric cancer affects around 1 million people, with 35% to 55% expressing the claudin 18.2 biomarker. In pancreatic, the global incidence is approximately 500,000, with 30% to 60% of patients expressing claudin 18.2.

Speaker #4: And in colorectal cancer , we'll focus on the front line patients with MSS , CRC . So in aggregate , the initial plan focuses on a potential combined addressable market of over 40 billion .

Speaker #4: Next slide . Now let's look at the market potential for 343 globally gastric cancer affects around a million people with 35 to 55% expressing the Claudin 18 biomarker in pancreatic .

Teresa Bitetti: Now let's look at the market potential for 343. Globally, gastric cancer affects around a 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 five-year survival rates are very low, highlighting the urgent need for innovative treatments. Altogether, 343 offers a potential combined addressable market of approximately $8 billion. We expect this market to grow as we and other novel agents enter. As you can see across both assets, there's an enormous potential to make a significant impact for patients. Next slide. In closing, we are incredibly energized by this extraordinary strategic partnership that brings great value for both patients and for Takeda.

Speaker #4: 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 five year survival rates are very low , highlighting the urgent need for innovative treatments altogether .

Teresa Bitetti: The current standard of care in these tumor types centers on chemotherapy, and the five-year survival rates are very low, highlighting the urgent need for innovative treatments. Altogether, IBI343 offers a potential combined addressable market of approximately JPY 8 billion, although we expect this market to grow as we and other novel agents enter. As you can see, across both assets, there's an enormous potential to make a significant impact for patients. The next slide. 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. It brings forward unique and truly differentiated programs that will overcome many of the challenges of currently available therapies.

Speaker #4: 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.

Speaker #4: So, as you can see across both assets, there's an enormous potential to make a significant impact for patients. So, next slide.

Speaker #4: 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 .

Teresa Bitetti: This agreement with Innovent will enable us to address critical treatment gaps in some of the most prevalent and difficult to treat cancers. 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. In short, this collaboration is incredibly meaningful both for us and for patients. Thank you for your attention. I'm going to hand back to Chris to open the Q&A.

Speaker #4: 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 .

Teresa Bitetti: It adds anchor assets to our solid tumor pipeline with the potential to be future growth drivers for Takeda. In short, this collaboration is incredibly meaningful both for us and for patients. Thank you for your attention. I'm gonna hand back to Chris to open the Q&A.

Speaker #4: With the potential to be future growth drivers for Takeda . So , in short , this collaboration is incredibly meaningful both for us and for patients .

Speaker #4: So, thank you for your attention. I'm going to hand back to Chris to open the Q&A.

Chris: それでは皆様からのご質問をお受けしたいと思います。回答者としまして、Christophe、Milano、Andy、Theresa、PKに加え、CEO就任よてGlobal Portfolio Division Interim HeadのJulie Kim、PDT Business Unit PresidentのGiles Platfordも参加しております。ご質問のある方はZoomの挙手ボタンでお知らせください。日本語ラインでご参加されている方は日本語でご質問いただき、英語ラインで参加されている方は英語で、ライブの音声で聞いていただいている方はどちらの言語でも結構です。なお、ご質問はお一人二問までとさせていただきたいと思います。よろしくお願いします。それでは最初のご質問はシティの山口様、どうぞミュート解除してご質問ください。

Speaker #1: Kato Satoshi . Krzysztof Mirano Andy . Theresa . Peak , Nicole , CEO , Global Portfolio Division , Interim head , not Judy Kim , PDT Business Unit president .

Christophe Weber: CEO Shunning.

Speaker #1: Gyles . Zumino Kiyoshi Desai , Nihon katawa Nihon tadaaki Ogura , San Diego the ribbon on CD kit demo . Keiko . This now more or history states title .

Milano Furuta: Business Unit President, can you hear me?

Speaker #1: Yamaguchi-san. Tokai. Just say.

Speaker #6: Can you hear me ?

Speaker #1: Yes, we can hear you.

Yamaguchi: Can you hear me?

Speaker #6: Thank you . So thank you very much for taking my question . This is Yamaguchi City . The first question regarding to innovate deal .

Christophe Weber: Yes, we can hear you.

Chris: Yes, we can hear you.

Yamaguchi: Thank you. Thank you very much for taking my question. This is Yamaguchi from Citi. The first question regarding to Innovent deal. I understand the potential of this product is pretty big. At the same time, Takeda itself has not really involved in a solid tumor for a while after ALUNBRIG. Investor have a lot of question on this one, how much you need to spend on R&D for next few years, where you have to balance the operating margin. R&D investment, even though you're going to split, but solid tumor first line seems to be very costly.

Milano Furuta: Thank you. Thank you very much for taking my question. This is Hidemaru Yamaguchi from Citi. The first question regarding Innovent, I understand the potential of this product is pretty big, but at the same time, Takeda has not really been involved in solid tumor for a while after ALUNBRIG, and investors have a lot of questions on this one. How much do you need to spend on R&D for the next few years where you have to balance the operating margin? R&D investment, even though you're going to split, but solid tumor first line seems very costly. Can you give me some elaboration on how you are going to run this clinical trial to compete with the global companies on the R&D and trying to finance your R&D and the potential impact on the margins? That's the first question.

Speaker #6: I understand the potential of this product is pretty big, but at the same time, Takeda sales has not really been involved in a solid tumor for a while after Anabolic, and the investors have a lot of questions on this one.

Speaker #6: How much do you need to spend on R&D for the next few years, where you have to balance the operating margin so R&D investment, even though you're going to split? But solid tumor first-line seems to be very costly.

Speaker #6: So, can you give me some insight into how you are going to run this clinical trial to compete with the global players in R&D, and how you plan to finance your R&D? Additionally, what is the potential impact on margins?

Yamaguchi: Can you give me some elaboration how you are going to run this clinical trial to compete with the global guys on the R&D and trying to, how to say, finance your R&D and the impact, potential impact to the margins? That's the first question. The second question regarding to the earnings change, even though there's only a slight change on a CR basis, on the interior and the rivals, but seem to have a big change on the currency things. This year might be a unique year, but is there any way in the future trying to avoid those changes or through some other transaction trying to prevent or this year it's hard to escape from this currency related to earnings revisions? Thank you.

Speaker #6: That first question , the second question regarding to the earnings change , even though there are only a slight change on the basis on the Entyvio and the Vyvanse , but you have a big change on the currency .

Milano Furuta: The second question regarding the earnings change, even though there's only a slight change on the CL basis, on the ENTYVIO and the VYVANSE, there seemingly have been big changes on currency things, and this year might be a unique year, but is there any way in the future.

Speaker #6: Things and this year might be 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's ?

Giles Platford: Trying to avoid those changes or through.

Milano Furuta: Some other transactions trying to prevent this year. It's hard to escape from this currency related to earnings divisions.

Speaker #6: It's hard to escape from this currency related to earnings divisions ? Thank you . That's the second question . Thank you .

Giles Platford: Thank you.

Milano Furuta: That's the second question. Thank you.

Yamaguchi: That's the second question. Thank you.

Speaker #1: 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.

Christophe Weber: Thank you. Yamaguchi-san, 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. Perhaps PK can just comment briefly 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. For the second question on this transactional FX impact, I'd also like to ask Milano to comment on that please.

Chris: Thank you, Yamaguchi-san. The first question was around how we're going to run the trials for the Innovent assets and what that means for our R&D expenses. 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. For the second question on this transactional effects impact, I'd also like to ask Milano to comment on that, please.

Speaker #1: So perhaps PK Kan , 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 .

Speaker #1: And then for the second question on the transactional effects impact , I'd also like to ask Milano to comment on that . Please .

Speaker #5: 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 .

P.K. Morrow: Yes, thank you. 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. It's a little premature for us right now to comment on outlook for R&D spend and margins for fiscal year 2026. 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.

P.K. Morrow: Yes. Thank you. 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. 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.

Speaker #5: 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 .

Speaker #5: It's a little premature for us right now to comment on the outlook for R&D spend and margins for fiscal year 2026, but I can assure you we are very committed to achieving our margins in the mid to long term, which are driven by top-line growth and optimizing our cost structure.

Speaker #2: Thank you . PK . And then hello Yamaguchi , not much things to add . What Zeke said already , but I think you can see the we have been managing quite effectively or in some areas we are even reducing R&D expenses beyond our initial expectations by , you know , the efficiency program .

Milano Furuta: Thank you, P.K. Hello, Yamaguchi-san. Not much things to add what P.K. said already. I think you can see we have been managing quite effectively or in some areas we are even reducing our expenses beyond our initial expectations by, you know, the efficiency program, also the, you know, continuous with continuous cost discipline. That's one. The second one is we are very mindful about this, the incremental R&D investment as well. That's why you see this, you know, cost split of the 60/40 for this three sixty-three compound. At the same time, as you might be aware, we have been arranging some cost sharing program, the partnership with Blackstone for mezagitamab.

Milano Furuta: Thank you, PK. Hello, Emma Gutsan. Not much 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 our expenses beyond our initial expectations by the efficiency program. Also, with continuous cost discipline, that's one. The second one is we are very mindful about the incremental R&D investment as well. 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, we have been arranging some cost sharing program, the partnership with Blackstone for mezagitamab. Through those kinds of arrangements, we are very consciously managing incremental investments. In the end, we want to invest for growth while optimizing OpEx. Eventually, that's going to be top line growth, which should be the main driver toward the long-term corporate margin improvements.

Speaker #2: Also , the continuous with continuous cost discipline , that's one . And then the second one is we are we are very mindful about this .

Speaker #2: The incremental R&D investment as well . So that's why you see this cost split of the 6040 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 Mab .

Speaker #2: So that's kind of through those kind of arrangements . We are very consciously managing incremental investments . But in the end , we want to invest for growth while optimizing opex .

Milano Furuta: That's kind of through those kind of arrangements, we are very consciously managing incremental investment. But in the end, we want to invest for growth while optimizing OpEx. Eventually that's going to be, you know, top line, growth should be the main driver toward the long-term corporate margin improvement. Second question about transaction effects. This is very hard to answer, as it is very difficult to predict the currency fluctuation. But this transaction effect in Takeda's case, as I commented during the presentation, the euro volatility is quite have big impact in this year. This is because of relatively we have large footprint in the manufacturing operation in Europe. We have to see how currencies goes.

Speaker #2: Eventually . That's going to be , you know , top line growth should be the main driver for the long term corporate margin improvements .

Speaker #2: Second question about transaction effects . This is very hard to answer as it's very difficult to predict the currency fluctuation . But this transaction effects in Takeda's case , as I commented during the presentation , the euro volatility is quite have a big , big impact in in this year .

Milano Furuta: Second question about transaction effects. This is very hard to answer as it is very difficult to predict the currency fluctuation. This transaction effect in Takeda's case, as I commented during the presentation, the Euro volatility has quite a big impact this year. This is because we have a relatively large footprint in the manufacturing operation in Europe. We have to see how currencies go, but in the long run, if we want to mitigate, then maybe in the long run somehow we have to rebalance the manufacturing footprint. That's a long-term strategic plan. It's not that we take actions depending on a one-year currency volatility. We have to take a bit long.

Speaker #2: This is because of relatively we have large footprint in the manufacturing operation in Europe . So the we have to see how currencies goes .

Speaker #2: But in the wrong if we have if we want to mitigate then we have to maybe in the long run somehow we have to the rebalance the manufacturing footprint .

Milano Furuta: In the long run, if we want to mitigate, then we have to maybe in the long run, somehow we have to rebalance the manufacturing footprint. That's a kind of course, a long-term strategic plan. It's not we take actions depending on the 1 year currency volatility. We have to take a bit long-term stance on that. Thank you.

Speaker #2: But that's a kind of of course , a long term strategic plan . It's not , you know , the we take an actions depending on the one year currency volatility .

Speaker #2: We have to take a bit long term stance on that .

Andrew Plump: Term stance on that. Thank you.

Speaker #7: Thank you . Thank you .

Milano Furuta: Thank you.

Yamaguchi: Thank you.

Chris: ありがとうございました。それでは次のご質問は野村證券の松原様、ミュート解除してご質問ください。

Speaker #1: Nomura okay . No . Matsubara sama . I . Onegai Shimasu . . Pain . No !

Matsubara: はい、野村證券の松原と申します。聞こえますでしょうか。

Chris: はい、聞こえてます。

Matsubara: ご説明いただきありがとうございます。では二点お願いします。一点目がENTYVIOなんですけども、ご説明いただいたようにPenの浸透が進んでいるということなんですが、現状での保険カバー率であったり、このPenの浸透をさらに進めるためにはどういった施策を今足元やられているのかというところをお伺い願えますでしょうか。二つ目が、御社が提携したAI創薬のNabla Bioなんですけども、こちらまだ非臨床というところで、表に出てきていないと思いますが、これを活用することによってR&Dがどのように加速するのか、また中長期で見たときのパイプラインの増加であったり、ポテンシャルというところをどのように評価しているのかというのをお伺いできますでしょうか。

Speaker #8: Hockey . She told . You . You the mega Osaka AI . So . Nomura . The . No pipeline . No . The potential .

Speaker #1: Okay , so thank you for your questions . Matsubara . So the first on Entyvio . What is the state of insurance coverage ?

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

Chris: Okay, thank you for your questions, Matsubara-san. 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. 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.

Speaker #1: 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.

Speaker #1: Perhaps Andy can add some comments on what we're doing in terms of utilizing in drug discovery. Julie.

Speaker #4: Yes, thank you for the question.

Teresa Bitetti: Julie, yes, thank you for the question. 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. That being said, we continue to work on access at various different levels. One, in terms of the, I would.

Speaker #9: And in regards to Entyvio pen access , as you heard from Christoph 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 .

Julie Kim: Yes, thank you for the question. In regards to ENTYVIO Pen access, as you heard from Christoph 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 coverage. I think you are all aware that we have 2 out of the 3 big contracts signed for quite some time now, and we continue to work on the CVS piece.

Speaker #9: Now , that being said , we continue to work on access at very at various different levels . One , in terms of the I would say the highest level 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 on the CVS piece for the other levels of access .

P.K. Morrow: Say the highest level coverage.

Teresa Bitetti: 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 for the other levels of access. When you look at the way that the U.S. market is structured, actually there's a lot of localization even with the way that we have the big three PBMs. We continue to improve.

Julie Kim: 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. 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. Hopefully that gives you a sense that we're working across multiple different levels on the access continuum in the US.

Speaker #9: 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 .

Speaker #9: 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.

P.K. Morrow: At.

Teresa Bitetti: 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. Hopefully that gives you a sense that we're working across multiple different levels on the access continuum in the U.S.

Speaker #9: In addition to what we're doing at the overall coverage level . So hopefully that gives you a sense that we're we're working across multiple different levels on the access continuum in the US .

Speaker #3: And thank you . Thank you , Julian Matsubara . And thanks for the question . We're quite excited about the partnership with Nabla Biosciences .

Andrew Plump: Thank you. Thank you, Julian Matsubara, 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. 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 Futures. 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.

Andrew Plump: Thank you. Thank you, Julie and Matsubara-san, thanks for the question. We're quite excited by the partnership with Nabla Bio, 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. We're positioning Takeda to be at the leading edge of application of advanced technologies in research. 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 Futures.

Speaker #3: 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.

Speaker #3: We see we see , we see discovery in the biopharmaceutical industry changing quite , quite rapidly . And we're we're positioning to cater to be at the leading edge of application of advanced technologies in research 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 futures and the the intent of this lab is to enable a workflow in discovery that can both improve our probabilities of success , success , and also greatly accelerate the time that it takes to move molecules through discovery .

Andrew Plump: 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, one in five, one in four 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. The partnership with Nabla Bio 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.

Speaker #3: Today, 1 in 5 and 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.

Andrew Plump: 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 by in silico technology. 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 two years now, and we had 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. We were quite excited about that, and that's what led to the collaboration that you see at hand. Hi, thank you for taking my questions.

Speaker #3: 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 .

Speaker #3: We've worked with them for over two years now, and we had three pilot experiments that each were successful: two accelerated programs and a third one that actually took us to a novel space that we wouldn't have gotten to with traditional approaches.

Andrew Plump: We've worked with them for over 2 years now, and we had 3 pilot experiments that each were successful, 2 accelerated programs, and a third one actually took us to a novel space that we wouldn't have gotten to with traditional approaches. We were quite excited about that, and that's what led to then the collaboration that you see at hand.

Speaker #3: So we were quite excited about that, and that's what led to then the collaboration that you see at hand.

Speaker #8: As Osama .

Speaker #10: Said .

Chris: ありがとうございます。ありがとうございました。次はJP Morganの若尾様、どうぞミュート解除してご質問お願いします。

Speaker #1: Arigatou gozaimasu to J.P. Morgan, Wakao-sama, Yutaka, onegaishimasu.

Speaker #11: I . Arigato gozaimasu . Thank you for taking my questions . This is Wakao from J.P. Morgan . I have two questions . Firstly , regarding gross margin trend and revised guidance .

Seiji Wakao: は い 、 あ り が と う ご ざ い ま す 。Thank you for taking my questions. This is Wakao from JP Morgan. I have two questions. Firstly, regarding the gross margin trend and revised guidance. When comparing the initial guidance along with the revised full year guidance, the gross margin has deteriorated 66% to 64.7%. Should we understand this primarily as an FX impact from the euro? If there are other contributing factors, could you elaborate on this point? Also, if FX is indeed affecting the gross margin, the Q2 gross margin is relatively solid compared to the FX levels. I'd like to know this point and why do you expect it to deteriorate in H2? Second question about Innovent event partnerships.

Milano Furuta: This is Seiji Wakao from J.P. Morgan. I have two questions. Firstly, regarding gross margin trend and device guidance. When comparing the initial guidance from with.

Speaker #11: When comparing the initial guidance plan with the revised prior guidance, the gross margin has deteriorated from 66% to 64.7%. Three understand this.

Andrew Plump: The revised three-year guidance, the gross.

Milano Furuta: Margin has deteriorated from 66% to 64.7%.

Speaker #11: Is this primarily as an FX impact from the euro ? If there are other contributing factors , could you elaborate on this point ?

Andrew Plump: Should we understand this? Is this primary adjust affects impact from the euro?

Milano Furuta: If there are other contributing factors, could you.

Speaker #11: And also, if FX is indeed affecting 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?

Andrew Plump: you elaborate on this point?

Milano Furuta: 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.

Andrew Plump: Why do you expect it to deteriorate in the second half? A second question about IV in.

Speaker #11: And the second question about our invented partnerships: When is the next date for IP 3666 expected? On page 27, regarding the ongoing first line and second line NSCLC studies, will we be able to see data in 2026?

Milano Furuta: Event partnerships, when is the next data?

Seiji Wakao: When is the next data update for IBI363 expected? Page 27. Regarding the ongoing first-line and second-line NSCLC studies, will you be able to see data in 2026? In addition, when is the global phase III trial expected to start, Toshi?

Andrew Plump: Update for IBI343 expected?

Milano Furuta: Page 27 regarding ongoing first run and second run NSCLC studies, we will.

Andrew Plump: Be able to see data in 2026. In addition, when is the global phase C trial expected to start the date.

Speaker #11: In addition , when is the global phase three trial expected to start ? That's it .

Speaker #1: Thank you . 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 .

Christophe Weber: Thank you. Wakao-san, 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. The second question on the next data point to come for IBI363 and whether we can give any indication of starting phase three studies, I'd like to ask PK to comment on that please.

Chris: Thank you, Wakao-san. 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. The second question on the next data point to come for IBI363, and whether we can give any indication of starting phase III studies, I'd like to ask PK to comment on that, please.

Speaker #1: And the second question on the next data point to come for EBI-3, 6, 3, and whether we can give any indication of the starting of phase three studies.

Speaker #1: I'd like to ask PK to comment on that, please.

Speaker #2: Of thank you . Thank you for the question . You asked about , you know , the the bridge from , you know , initial forecast , updated forecast at the same time , the how , what how the H2 second half gross margin would be lower .

Milano Furuta: Wakao-san, thank you. Thank you for the question. You asked about, you know, the bridge from, you know, initial forecast, updated forecast. At the same time, how the H2 gross margin will be lower. Actually, the answer would be the basically same. If we compare the May forecast and revised forecast, as you said, gross margin is expected to be lower by about 1.4 percentage points. About half is coming from the transaction effects, and the other half is also coming from kinda product mix change. We are reducing the Vyvanse revenue and the ENTYVIO revenue. These two revision has a negative impact on the gross margin.

Milano Furuta: Wakao-san, thank you for the question you asked about the bridge from initial forecast to updated forecast at the same time how the H2 second half gross margin would be lower. Actually, the answer would be basically the same. If we compare the May forecast and revised forecast as you said, gross margin is expected to be lower by about 1.4%. About half is coming from the transaction effects and the other half is also coming from kind of product mix change. We are reducing the VYVANSE revenue and the ENTYVIO revenue and then these two revisions have a negative impact on the gross margin. That's contributing to this gross margin update in the two forecasts and actually these dynamics explain in the second half because this is more about the second half sales.

Speaker #2: Actually the answer would be the basically same . The if you compare if we compare the the may forecast and revise the forecast , as you said , the gross margin is expected to be lower by about 1.4 percentage points .

Speaker #2: About half is coming from the the transaction effects and the other half is also coming from kind of product mix change . So we are reducing the vyvanse the revenue and the revenue .

Speaker #2: And then these two revision has a negative impact on the gross margin . So that's the the the contributing . This gross margin updates in in the two forecast .

Milano Furuta: That's the contributing this net gross margin updates in the 2 forecast. Actually, these dynamics explains in H2 because this is more about H2 sales. Also, we are updating the currency forecast for H2. Those two impacts will contributing lower gross margin in H2.

Speaker #2: And actually this explains this dynamics explains in in a second half because this is more about the second half sales . Also we are updating the currency forecast for H2 .

Milano Furuta: Also, we are updating the currency forecast for H2 so those two impacts will contribute to lower gross margin in H2.

Speaker #2: So those two impacts will contributing lower gross margin in H2 .

Speaker #12: Okay .

Speaker #5: Thank you . Bolano . And perhaps to address the other two questions that were asked related to the incident collaboration . The first is to say that we , like you , are very enthusiastically monitoring the data with both three , six , three and 343 .

Chris: Okay.

P.K. Morrow: Thank you, Milano. 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 IBI363 and IBI343. We are not yet releasing when we will disclose further data in the coming year. We will be following this closely as we determine when the appropriate data inflection will be in order to release more data at a public forum. 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 is expected to begin in the coming months. As you saw from the slides, we will also be looking towards moving and initiating additional studies at speed. Thank you.

P.K. Morrow: Thank you, Milano. 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 IBI363 and IBI343. 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 at a public forum. The second question you had was related to the start of the phase III studies. We have noted that the phase III study in second-line squamous non-small cell lung cancer we expect to begin in the coming months.

Speaker #5: 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 at a public forum.

Speaker #5: The second question you had was related to the start of the phase three studies, and we have noted that the phase three study in second-line squamous non-small cell lung cancer is expected to begin in the coming months.

Speaker #5: And as you saw from the slides , we will also be looking towards moving and initiating additional studies at speed . Thank you .

P.K. Morrow: As you saw from the slides, we will also be looking towards moving and initiating additional studies at speed. Thank you.

Speaker #11: Okay .

Speaker #12: Thank you .

Andrew Plump: Okay, thank you.

Seiji Wakao: Okay. Thank you.

Speaker #1: Arigatou gozaimasu . Geoffrey is not Stephen Barker . Thank Steve . Please go ahead .

Milano Furuta: Adegato was.

Christophe Weber: I must stop. Stephen Barker. Steve, please go ahead.

Chris: Steven Barker, san. Steve, please go ahead.

Speaker #13: Yes . Steve Bark from Jefferies . Thanks for taking my questions . The first question is about Entyvio and the second question is about your collaboration with Innovent , starting with Entyvio .

Milano Furuta: Yeah, Stephen Barker from Jefferies. Thanks for taking my questions. The first question is about ENTYVIO and.

Stephen Barker: Stephen Barker from Jefferies. Thanks for taking my questions. The first question is about ENTYVIO, and the second question is about your collaboration with Innovent. Starting with ENTYVIO, 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. Secondly, regarding your deal with Innovent, certainly the China data published to date on IBI363 is impressive, but there have been several cases where impressive data in China has not been replicated in international studies. I was wondering if you could share your view on if that's, you know, that apparent trend or phenomenon is real or not.

Giles Platford: The second question is about your collaboration.

Milano Furuta: With Innovent, starting with ENTYVIO.

Speaker #13: 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 .

Giles Platford: You've cut your estimated current growth rate at constant exchange rates from 9%.

Milano Furuta: To 6% due to competitive pressures.

Giles Platford: I was wondering if you could give.

Milano Furuta: Us more details of those competitive pressures.

Giles Platford: The implications for growth going forward.

Speaker #13: As in next year and beyond . And secondly , regarding your deal with Innovent , certainly the the China data published to date on three , six , three is impressive , but there have been several cases where impressive data in China has not been replicated in international studies .

Milano Furuta: As in next year and beyond. Secondly, regarding your deal with Innovent Biologics, certainly the China data published too.

Giles Platford: Data on IBI363 is impressive. There have been several cases where impressive data in China has not been replicated in international studies. I was wondering if you could share your view on if that's you.

Speaker #13: So I'm wondering if you could share your view on if that's you know , that apparent trend or phenomenon is real or not .

Milano Furuta: Know that apparent trend or phenomenon is real or not, and more specifically, how confident are you.

Speaker #13: And more specifically, how confident are you that you can replicate the impressive China data in international trials? Thank you.

Stephen Barker: More specifically, how confident are you that you can replicate the impressive China data in international trials? Thank you.

Giles Platford: That you can replicate the impressive China data in international trials?

Speaker #1: Thank you, Steve. 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.

Andrew Plump: Thank you.

Christophe Weber: Thank you, Steve. 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, I'd like to ask PK to comment on that, please.

Chris: Thank you, Steve. 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. The second question on data replicability of the China studies in a more global population, I'd like to ask PK to comment on that, please.

Speaker #1: And the second question on data replicability of the China studies. In a more global population, I'd like to ask PK to comment on that.

Speaker #1: Please .

Speaker #9: Thanks for the question , Stephen . On 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 .

Teresa Bitetti: Thanks for the question, Stephen, on ENTYVIO. 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. 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. 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.

Julie Kim: Thanks for the question, Steve, and on ENTYVIO. 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. 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. 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.

Speaker #9: 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 .

Speaker #9: 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.

Speaker #9: 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 despite the other factors that are impacting the top line.

Speaker #9: There are a few things . One is Milano mentioned in his talks . It is about the channel mix . We've particularly had an increase in 340 B population , as well as an increase in Medicare Part D redesign impact .

Teresa Bitetti: We've particularly had an increase in 340B population as well as an increase in Medicare Part D redesign impact. 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. 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.

Julie Kim: We've particularly had an increase in 340B population as well as an increase in Medicare Part D redesign impact. Beyond that, the pen conversion, as we've mentioned, is moving a bit slower than we anticipated. While we are resolving those access hurdles, it has impacted the top line thus far. 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.

Speaker #9: 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 .

Speaker #9: 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 .

Speaker #5: Thank you Julie , and to answer the second question , I'll say two points . One is , as you allude 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 .

P.K. Morrow: Thank you, Julie. To answer the second question, I'll say two points. One is, as you allude 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 the U.S., and we are continuing to monitor that data as well as its applicability. 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 radiologist in order to evaluate many of the impact images that were seen of the patients, as well as determining the correlation with our response criteria that is RECIST, and we saw a very strong correlation there. Thank you.

P.K. Morrow: Thank you, Julie. To answer the second question, I'll say two points. One is, as you allude 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. We are continuing to monitor that data as well as its applicability. The second element is the fact that we actually endeavored on very significant due diligence during the evaluation for this collaboration. That included bringing our own Takeda radiologist in order to evaluate the many of the images that were seen of the patients, as well as determining the correlation with our response criteria, i.e., RECIST. We saw a very strong correlation there. Thank you.

Speaker #5: And we are continuing to monitor that data as well as as applicability . 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're seeing of the patients , as well as determining the correlation with our response criteria , i.e. , resist .

Speaker #5: And we saw a very strong correlation there. Thank you.

Speaker #13: Understood. Thank you very much.

Giles Platford: Understood.

Stephen Barker: Understood. Thank you very much.

Milano Furuta: Thank you very much. I do demo's estimation.

Speaker #1: SMB Nik Kershaw no .

Chris: それでは次のご質問は、SMBC日興証券の和田様、どうぞミュート解除してご質問お願いします。

Speaker #11: This .

Wada: SMBC日興証券の和田です。私もイノベントのパイプラインについてお伺いできればと思っています。IBI363ですね、作用機序のお話をお伺いしたいんですけど、IL-2のアルファバイアスにしている意図というのをお伺いしたいです。ロシュとかがやっているのはというか、いわゆるそのIL-2自体は、腎細胞がんとかメラノーマとか承認されていて、あまりこう適応が広がらなかった要因としては、アルファをアクティベートしてしまうとTregが活性化してしまうので、それによって免疫抑制かかってしまうみたいなところが言われていたかなと思うんですけど。なので、アルファをアクティベートするという、そのIBI363の意図というのはどこにあるか、今臨床で得られているデータも含めて、ご意見いただければと思うんですがいかがでしょうか。

Speaker #10: No . Us I . I Alpha bias still Ito you know this it or . I know you no I . Cyborg . Are also activates Kishimoto t .

Andrew Plump: IL-2 alpha bias.

Speaker #10: On the monkey . Or the alpha activate through the . You of IBS unlocks and . No , it .

Speaker #14: Thank you .

Speaker #1: Yeah. PK, would you like to take that question?

P.K. Morrow: Thank you.

P.K. Morrow: Thank you.

Speaker #5: Yes , absolutely . So it's a great question . And we also ask the same question in in interrogated that data with Innovent and discuss this in depth .

Christophe Weber: Yeah, PK, would you like to take that question?

Chris: Yeah, PK, would you like to take that question?

P.K. Morrow: Yes, absolutely. It's a great question. We also asked the same question and interrogated that data with Innovent and discussed this in depth. 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. That's why our focus has been on this IL-2 alpha bias with attenuation of the beta gamma pathway. With that in mind, we have seen that the IL-2 alpha bias approach has been able to target specifically tumor-specific T cells that are addressing both or express both PD-1 and IL-2 alpha. It's been a very precise and effective activation within the tumor microenvironment. 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.

P.K. Morrow: Yes, absolutely. It's a great question, we also asked the same question and interrogated that data with Innovent and discussed this in depth. 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, and that's why our focus has been on this IL-2 alpha bias with attenuation of the beta gamma pathway. With that in mind, we have seen that the IL-2 alpha bias approach has been able to target specifically tumor-specific T cells that are addressing or express both PD-1 and IL-2 alpha. It's been a very precise and effective activation within the tumor microenvironment.

Speaker #5: 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, and that's why our focus has been on this IL-2 alpha bias with attenuation of the beta gamma pathway.

Speaker #5: And with that in mind , we have seen that the IL two alpha bias approach has been able to target specifically tumor specific T cells that are addressing both or expressed both PD one and IL two alpha .

Speaker #5: So it's been a very precise and effective activation within the tumor microenvironment . 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 , and we have not actually seen activation of T Treg cells , which would have resulted , of course , in a decrease in the immune response .

P.K. Morrow: 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. We have not actually seen activation of Treg cells, which would have resulted, of course, in a decrease in 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.

P.K. Morrow: We have not actually seen activation of Treg red 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 irofractory as well as in earlier lines. Thank you.

Speaker #5: 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 Iowa , refractory as well as in earlier lines .

Speaker #5: Thank you .

Speaker #10: Thank you very much . Thank you . All sorry . Plus IO you my initial . The PD one on head to head to the phase three data .

Christophe Weber: Thank you very much.

Wada: ありがとうございます。どうぞ。いいですか？

Milano Furuta: It's.

Chris: はい、お願いします。

Wada: 開発の方針なんですけど、難治性のところ、コールドチューマーみたいなところをやられる戦略はよくわかるんですけど、それプラス、IOの有効性が確認されて適応症で、NSCLCの一次治療とかを狙われてるんですけど、これって、PD-1抗体とのヘッドトゥヘッドでフェーズIIIやられる予定ですか？

Speaker #10: This .

Andrew Plump: You'll take this call?

Speaker #5: Yes . Chris , would you like to be to take this ?

P.K. Morrow: Yes, Chris, would you like me to take this?

P.K. Morrow: Yes. Chris, would you like me to take this?

Speaker #1: Oh, yes. Please.

Speaker #5: Okay .

Speaker #1: Sorry .

Milano Furuta: Oh yes, please.

Speaker #5: Yes . Of course . So I think your question was around the development plan related to Ibi 363 and where we see the , the experience with this and the promise of this and agree with you that we actually want to leverage the strong clinical data .

Chris: Oh, yes, please, PK.

Chris: Okay.

P.K. Morrow: Yes, of course. I think your question was around the development plan related to IBI363 and where we see that the experience with this and the promise of this, and agree with you that we actually want to leverage the strong clinical data. 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.

Chris: Sorry.

P.K. Morrow: Yes, of course. 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. Agree with you that we actually want to leverage the strong clinical data. Beyond the two second-line studies in IO refractory squamous and non-squamous NSCLC, 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.

Speaker #5: 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 .

Speaker #5: Both likely in an all-comers population as well as in a TPS high population.

Chris: Thank you very much for your question. Next question, I'd like to call upon Tony Ren from Macquarie. Tony, please unmute and ask your question.

Speaker #1: Thank you very much for your question . Next question . I'd like to call upon Tony Ren from Macquarie . Tony , please unmute and ask your question .

Christophe Weber: Thank you very much for your question.

Milano Furuta: Next question.

Christophe Weber: I'd like to call upon Tony Ren from Macquarie. Tony, please unmute and ask your question.

Speaker #3: Hello .

Speaker #11: Tony , I'm from Macquarie . Can you guys hear .

Speaker #12: Me ?

Andrew Plump: Hello, Tony Ren from Macquarie.

Tony Ren: Hello, Tony Ren from Macquarie. Can you guys hear me?

Speaker #1: Yes, we hear you.

Milano Furuta: Can you guys hear me?

Speaker #11: Okay . Perfect . Yeah . Thank you for taking my questions . Yeah , a couple of questions again on the Innovent transaction for the for the IO to PD .

Christophe Weber: Yes, we hear you.

Chris: Yes, we hear you.

Teresa Bitetti: Okay, perfect. Yeah.

Tony Ren: Okay, perfect. Thank you for taking my questions. A couple questions again on the Innovent transaction. For the IL-2 PD-1 bispecific IBI363, I actually cover Innovent myself. I understand they have a global phase II study. The primary completion, estimated primary completion of this study is March 2026, so really only 4 months away. Did you guys get a chance to look at the data from that phase II 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? That's my first question.

Milano Furuta: Thank you for taking my questions.

Andrew Plump: A couple questions again on the Innovent transaction for the IL-2/PD-1 bispecific IBI363. I understand.

Speaker #11: PD one bispecific Ivi 363 . I , I understand I actually covered in event myself . I understand they have a global phase two study .

Milano Furuta: I actually cover ENTYVIO myself.

Andrew Plump: I understand they have a global Phase 2 study.

Speaker #11: The primary completion estimated primary completion of this study is March 2026, so it is really only four months away. Did you all get a chance to look at the data from that Phase 2 study, which I believe primarily was conducted in the U.S. and is looking to recruit about 178 patients?

Teresa Bitetti: The estimated primary completion of.

Andrew Plump: This study is March 2026, really only four months away.

Milano Furuta: Did you guys get a chance to?

Teresa Bitetti: Look at the data from that phase.

Andrew Plump: The study, which I believe primarily is conducted in the U.S. and looking to recruit about 178 patients. Were the data better or worse than what you've seen in China?

Speaker #11: And if so , were the data better or worse than what you've seen in China ? So that's my first question .

P.K. Morrow: That's my first question.

Speaker #1: PK , would you like to answer that one as well , please ?

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

Christophe Weber: Pk, would you like to answer that one as well, please?

Speaker #5: 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 .

P.K. Morrow: Yeah, absolutely. 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.

P.K. Morrow: Absolutely. Yes, first I would like to say that yes, we have been in constant communication with Innovent related to the evolving data. As you allude to, that data in the global phase II 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.

Speaker #5: And as you allude to that data in the global phase two is progressing or the trial itself is progressing very nicely and it's I can't disclose what obviously the data shows thus far , but we can see that that I would like to just say that the data thus far is fairly encouraging , but I think too early to comment further .

Speaker #11: Okay . Thank you for for addressing that . Also . Innovent is starting is starting the phase three global study . I think it's called Mars Lite 11 trial in immunotherapy resistant Non-squamous non-small cell lung cancer .

Milano Furuta: Okay, thank you for addressing that.

Tony Ren: Okay. Thank you for addressing that. Also, Innovent is starting the phase III global study. I think it's called Mars Light-11 trial in immunotherapy-resistant, non-squamous, non-small cell lung cancer, right? That trial, according to ClinicalTrials.gov, is literally starting today. Also, Dr. Morrow, you said that you're looking to start in the next few months. Are you know, as Takeda is leading the clinical development, right? Are you looking to change the trial design and the conduct of this Mars Light-11 study?

Teresa Bitetti: Also.

Andrew Plump: Innovent Biologics is starting the.

Teresa Bitetti: Phase 3 global study.

Andrew Plump: I think it's called MARS LIGHT 11 trial in immunotherapy-resistant non-squamous non-small cell lung cancer.

Speaker #11: Right . So that trial , according to ClinicalTrials.gov , is literally starting today . But also moral doctor Moreau , you said that you're looking to start in the next few months .

Milano Furuta: Right. That trial according to clinicaltrials.gov is literally starting today.

Andrew Plump: Dr. Morrow, you said that you're looking to start in the next few months.

Speaker #11: So are you . You know , as Takeda is leading the clinical development , right ? Are you looking to change the trial design and conduct of this Mars 11 study ?

Teresa Bitetti: Are you, you know, as Takeda.

Andrew Plump: Is leading the clinical development. Right.

Teresa Bitetti: Are you looking to change the trial?

Andrew Plump: Design and conduct of this MARS LIGHT 11 study?

Speaker #5: So 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 .

Milano Furuta: So.

P.K. Morrow: 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. Related to the Mars Light 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.

P.K. Morrow: What I will say is that we, as I noted, have had great conversations and discussions with Innovent weekly, if not every few days, and related to the Mars Light status as well as these beginning studies, we've also had discussions about whether 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.

Speaker #5: And related to the Mars Lite study as well as these , 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 .

Speaker #5: 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 .

Speaker #11: If you do decide to change the trial design or protocol or conduct , would that require a new FDA clearance ?

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

Andrew Plump: If you do decide to change the.

Milano Furuta: Trial design or protocol or conduct would.

Andrew Plump: That require a new FDA clearance?

Speaker #5: I don't think so .

Speaker #11: Okay , perfect . Great . Thank you very .

P.K. Morrow: I don't think so.

P.K. Morrow: I don't think so.

Speaker #12: Much .

Andrew Plump: Okay, perfect.

Tony Ren: Okay, perfect. Great. Thank Thank you very much.

Milano Furuta: Great. Thank you very much. My first question is regarding the plasma-derived therapy business. I think in the United States now CSL has been closing some of its plasma collection centers recently. It also appears that Takeda is currently focusing on improving efficiency, such as optimizing utilization rates and implementing digital transformation initiatives, rather than expanding the number of centers. Are there any changes in the business environment in the U.S., such as demand outlook or in the cost structure, that are driving these shifts? Furthermore, I think some other companies seem to be actively investing in collection centers outside the U.S. Could you also let us know whether you are also considering similar types of investments? Tokuniko.

Speaker #1: Arigatou gozaimasu . Sorry . Goldman Sachs no . Ueda sama . Also Onegai Shimasu .

Speaker #10: Gozaimasu .

Chris: Thank you, Ueda-san, for the questions. 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. The second question on the sustainability of the dividend, Milano, if you could kindly answer on that one, please.

Speaker #14: My first question is regarding the plasma derived therapy business . I think in the United States now , CSL has been closing some of its plasma collection 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 .

Speaker #14: Rather than expanding the number of centers, are there any changes in the business environment in the U.S., such as demand outlook or cost structure, that are driving these shifts?

Speaker #14: And furthermore , I think some other companies seems to be actively investing in the collection centers outside the US . So could you also let us know whether you are also considering similar types of investments ?

Speaker #14: So recall . Milano Furuta . Muscle I know EPs . Cannot . Balance sheet and or . Muscle . Took the risk to you .

Christophe Weber: Thank you, Ueda-san, for the questions. The first on the PDT business and specifically on our collection initiatives in the U.S., I think I'd like to ask Giles to comment on that. The second question on the sustainability of the dividend, Milano, if you could kindly answer on that one, please.

Speaker #14: Against the risk . Balance sheet . But . Do you don't you ?

Speaker #1: Thank you for the questions . 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 .

Speaker #1: And then the second question on the sustainability of the dividend . Milano , if you could kindly answer on that one , please .

Speaker #13: Yeah . Thank you , Chris , and thank you , for the question . We have been investing extensively to improve efficiency and productivity across our Biolife collections network .

Giles Platford: Yeah, thank you, Chris, and thank you, Edison, for the question. We have been investing extensively to improve efficiency and productivity across our BioLife Plasma Services network. 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. 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. 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.

Giles Platford: Thank you. Chris, and thank you, Adesan, 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. In particular, we have benefited this year from the accelerated rollout of the personalized nomogram for both our FK and Hematics devices, and that has enabled us to improve volume collection by approximately 10% to 11% on a per donation basis. As a result, we won't be opening as many new centers. We are also benefiting from the ramp-up of the centers that we have opened in the past years.

Speaker #13: And 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 .

Speaker #13: New centers in particular , we have benefited this year from the accelerated rollout of the personalized Nomogram for both our Fdk and Haemonetics devices , and that has enabled us to improve volume collection by approximately 10 to 11% on a on a per donation basis .

Speaker #13: And as a result , we 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 .

Giles Platford: To the second part of your question, we do continuously evaluate opportunities to open up new countries to contribute to global supply of plasma. 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. Thank you.

Giles Platford: To the second part of your question, we do continuously evaluate opportunities to open up new countries to contribute to global supply of plasma. 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. Thank you.

Speaker #13: We do continuously evaluate opportunities to open up new countries to contribute to global supply of plasma . We don't have anything to communicate at this point in time , but it is a big part of our work worldwide to ensure that we are having more countries contributing to sustainable supply of plasma .

Speaker #13: Thank you .

Speaker #2: I know Konichiwa . Ito . High to . Ano ma . To hi . To . Hi to my e.g. . Also no .

Milano Furuta: 上田さん、こんにちは。ご質問ありがとうございます。基本的には配当政策に関しては、以前にもご説明差し上げている通り、基本的には累進配当。つまり配当を維持するか、もしくは増配するかと。そしてそれの判断にあたっては、コアEPS、それからreportedですね、財務上のEPS。それから中長期的にきちっと負債を削減できるかと。この三点、三つのパラメーターを考慮しながら、最終的には年度の意思決定、意思決定というか提案ですね、をしていきたいというふうに考えています。ですので、現時点で確たることは申し上げられませんけれども、基本的にはこの方針に沿って判断をしていきたいと。来期については、また来年の五月頃にまた発表させていただきたいと考えています。

Speaker #2: EPs reported . No . Or EPs . Shock or issue to parameter or to . Mining or or or or . You . The .

Speaker #2: So title like in line . No . No matter . To .

Christophe Weber: Moshe.

Milano Furuta: Title.

Speaker #12: Us . .

Speaker #14: So .

Ueda: 承知いたしました。どうもありがとうございます。私は以上でございます。

Speaker #1: Arigatou gozaimasu to . UBS or Sakai sama .

Chris: ありがとうございました。それでは、次のご質問はUBSの酒井様、よろしくお願いします。

Christophe Weber: Ubsakai Sama.

Speaker #12: You .

Sakai: This is Sakai from UBS. Two questions. One is the same plasma business. Now, CSL issued profit warning. Their reason's very vague, but one of the factor they mentioned is weakening demand of China albumin sales or revenues. Your page, slide 40, you have slide decline China. However, you haven't really changed the guidance for FY 2025. Do you still think that this guidance is achievable? If it's so, can you just give us what's really going on in China market right now? That's first question. The second question is US BIOSECURE Act. When you make a deal with Innovent.

Milano Furuta: Hi, good to see you. Sakai from UBS. Two questions. One is the same plasma business. Now CSL issued profit warning. Their reasons very vague, but one of the factors they mentioned is weakening demand of China or moving sales or revenues, and your page slide 40, you have slight decline in China. However, you haven't really changed the guidance for FY2025. Do you still think that this guidance is achievable? If it's so, can you just give us what's really going on in.

Speaker #11: From UBS. Two questions. One is the same plasma business. Now CSL issued a profit warning. There are reasons, very vague, but one of the factors that I mentioned is the weakening demand of China albumin sales or revenues.

Speaker #11: And your page slide 40. You have a slight decline in China. However, you haven't really changed the guidance for FY 25.

Speaker #11: Do you think still think that this the guidance is achievable ? If so , can you just give us the what's really going on in China market right now ?

Speaker #11: So that's the first question . The second question is us bio secure Act . When you make a deal with Innovent , anything going on in the these days a mystery .

Andrew Plump: China market right now?

Milano Furuta: That's the first question. The second question is U.S. Biosecure Act. When you make a deal with Innovent, anything going on in U.S. these days is a mystery. This act is still pending. Have you considered whatever the political consequences of having China Biotech as a partner? Probably not. If you could update with this Biosecure Act and your business tie-up, I really appreciate that. That's the second question.

Sakai: Anything going on in the US these days is a mystery. This act is still pending. 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.

Speaker #11: But this act is still pending. And have you considered what the political consequences are of having China Biotech as a partner? Probably not.

Speaker #11: But if you could update with this Bio Secure Act and your business tie-up, I would really appreciate that. So, that's the second question.

Speaker #1: Thank you , Sakai . 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 .

Christophe Weber: Thank you, Sakai-san. 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. The second question on the US Biosecure Act vis-à-vis the Innovent deal, I'd like to ask Christophe to answer that question, please.

Chris: Thank you, Sakai-san. 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. The second question on US BIOSECURE vis-à-vis the Innovent deal. I'd like to ask Christoph to answer that question, please.

Speaker #1: And then the second question on us bio secure vis a vis the Innovent deal , I'd like to ask Christoph to answer that question , please .

Speaker #13: Sure . Chris , and thank you for your question . It's true . I'm in portfolio . Did decline marginally by 2% for the first half .

Giles Platford: Sure, Chris. And thank you, Sakasan, 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. I would 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. We do see continued growing demand for albumin worldwide, 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.

Giles Platford: Sure, Chris, and thank you, Sakai-san, for your question. It's true. Our albumin portfolio did decline marginally by 2% for the H1. 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. 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. We have successfully secured a number of tenders in markets ex-China, which will be delivered in the H2, hence accelerating our growth for the balance of the year.

Speaker #13: 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 .

Speaker #13: 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 .

Speaker #13: 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.

Speaker #13: 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 .

Giles Platford: Yes, we remain confident to deliver on our guidance of high single-digit growth for the year for albumin and for our IGE portfolio. Thank you.

Giles Platford: 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.

Speaker #13: Thank you .

Speaker #2: Thank you . This is Christophe here . Obviously , we take into consideration the geopolitical environment when we discuss a deal like our partnership with Innovent Biologics .

Milano Furuta: 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. I will mention two points. One is that we will drive the global development of this asset, guaranteeing that it is meeting all the criteria required by regulatory agencies across the world. That's very important. The second point I will mention is that we will manufacture these molecules in the U.S. We will do a full tech transfer and we'll organize the manufacturing of this molecule in the U.S., and therefore we think that this is also a way to mitigate the potential geopolitical risk. Thank you. Thank you. Can you just—Jaru San, can you just give me the margin update on the PDT business these days?

Christophe Weber: 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. I will mention two points. One is that we'll drive the global development of this asset, guaranteeing that it is meeting all the criteria required by regulatory agencies across the world. That's very important. The second point I will mention is that we will manufacture these molecules in the US. We will do a full tech transfer, and we'll manufacture, we'll organize the manufacturing of this molecule in the US. Therefore, we think that this is also a way to mitigate the potential geopolitical risk. Thank you.

Speaker #2: So I will mention two points . One is that we will do will drive the global development of this asset , guaranteeing that it is meeting all the criteria required by regulatory agencies across the world .

Speaker #2: So that's a 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'll manufacture will organize , will organize the manufacturing of this molecule in the US .

Speaker #2: And therefore we think that this is also a way to mitigate the potential geopolitical .

Speaker #12: Risk . Thank you .

Speaker #11: Thank you . Can you just can you just give me a the margin update on the PTT business these days ?

Sakai: Thank you. Can you just, Jared-san, give me the margin update on the PDT business these days?

Speaker #13: Yeah , absolutely . I can 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 .

Giles Platford: Yeah, absolutely, I can do that. We continue to see our margin recovery year after year, and we expect to deliver continued margin improvement in fiscal, you know, 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. We benefited from strong growth the past couple of years in meeting unmet demand globally. We see that situation now normalizing. We're being a little more selective in terms of tender participation. Very much expected, anticipated, and consistent with the guidance that we gave. 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.

Giles Platford: Absolutely. I can, I can do that. We continue to see our margin recovery year after year, and we expect to deliver continued margin improvement in fiscal 2025. You know, 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. We see that situation now normalizing, so we're being a little more selective in terms of tender participation, ex-US.

Speaker #13: You know, and that's part of the reason why we provided slightly more modest guidance in terms of growth for this year.

Speaker #13: We are seeing more supply on the market . If you remember , Takeda was the first to recover post pandemic . So we've benefited from strong growth for the past couple of years .

Speaker #13: In meeting unmet demand globally . We see that situation now normalizing . So we're being a little more selective in terms of tender participation x us very much expected , anticipated and and consistent with the guidance that we we gave .

Giles Platford: 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. Our innovative subcutaneous IG portfolio has delivered 15% growth for the H1, 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. We have seen gradual improvement in yield, in fractionation and process improvement across our manufacturing network. All of that is contributing to an improvement in margin over time. Thank you, Sakai-san.

Speaker #13: 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.

Speaker #13: We see continued improvement in in product mix . So our innovative subcutaneous IG portfolio has delivered 15% growth for the first half . So that product mix helps in improving margins .

Giles Platford: Our innovative subcutaneous IG portfolio has delivered 15% growth for the first half. 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. We have seen gradual improvement in yield, in fractionation, and process improvement across our manufacturing network. All of that is contributing to an improvement in margin over time. Thank you, Sakasan.

Speaker #13: The Biolife productivity and efficiency efforts are 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 fractionation and process improvement across our manufacturing network .

Speaker #13: So all of that is contributing to an improvement in margin over time. Thank you.

Speaker #11: Okay. Thank you very much.

Speaker #1: Thank you . Sakai , for the next question . I'd like to call on Mike Nedeljkovic from TD Cowan . Please unmute and ask your question .

Milano Furuta: Okay, thank you very much.

Sakai: Okay. Thank you very much.

Christophe Weber: Thank you. Sakai-san. For the next question, I'd like to call on Mike Nedelcovych from TD Cowen. Please unmute and ask your question.

Chris: Thank you, Sakai. For the next question, I'd like to call on Michael Nedelcovych from TD Cowen. Please unmute and ask your question.

Speaker #15: Thanks for your question. Thank you. My first is just a broad question on your celiac disease programs. I'm just curious what the breadth of your ambitions are here.

Milano Furuta: Thanks for the question. 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? 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?

Michael Nedelcovych: Thanks for the question. 2. 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? My second question is on mezagitamab for IGN. 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? Thank you.

Speaker #15: How important could those programs become ultimately, should they make it to the marketplace? And then my second question is on Igen.

Speaker #15: 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 ?

Speaker #15: Or should we be looking for better efficacy ? Thank you .

Speaker #1: Thank you Mike . I think both of those questions on our celiac ambitions and aspirations for Adimab . Andy can answer those .

Andrew Plump: Thank you.

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

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

Speaker #3: Thanks , Chris . Good morning Mike . It's it's Andy . So firstly on the celiac programs . You know we had three programs that were in proof of concept studies .

Andrew Plump: Thanks, Chris. Good morning, Mike. It's Andy. 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 group that failed to show benefits, and 227, which is a transglutaminase 2 inhibitor that's got restricted. Then TAK-101, which is a tolerizing vaccine. 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. We're excited to see data in the coming months and over the next year for both of those programs. I think we can talk more about what the potential long term could look like after we've seen those data.

Andrew Plump: Thanks, Chris. Good morning, Mike. It's Andy. Firstly on the celiac programs, you know, we had 3 programs that were in proof of concept studies. One that we've discontinued, which was TAK-062, which was a orally administered glutenase which failed to show benefits. Two, TAK-227, which is a transglutaminase 2 inhibitor that's got restricted. Then TAK-101, which is a tolerizing vaccine. Both of those are still in phase II 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. We're excited to see data in the coming months and over the next year for both of those programs.

Speaker #3: One that we've discontinued , which was Tak 062 , which was a orally administered glutenase which failed to show benefits . And two 227 , which is a transglutaminase two inhibitor .

Speaker #3: That's gut restricted . And then Tak 101 , which is a tolerizing vaccine . Both of those are still in phase two . Two studies right now .

Speaker #3: Of course , this is a huge unmet medical need with no established standards of care . The bar is is quite high for moving forward in the sciences is quite tough .

Speaker #3: 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 in terms of emicizumab , you know , obviously in your referencing this , it's an incredibly competitive landscape with AB , though , we've got a fairly unique opportunity here .

Andrew Plump: I think we can talk more about what the potential long term could look like after we've seen those data. In terms of mezagitamab, you know, 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, based on the data that we've seen, especially from the APRIL/BAFF agents, I don't think that we expect to see more efficacy. I think the real opportunity with mezagitamab is at least similar efficacy. The 96 data, week data that I referenced that you'll see in the coming weeks at the upcoming ASN Kidney Week meeting is quite extraordinary.

Andrew Plump: In terms of mezagitamab, obviously, and you're referencing this, it's an incredibly competitive landscape. With mezagitamab, 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 April BATH agents, I don't think that we expect to see more efficacy. 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. Secondly, the potential benefits on safety. Thank you.

Speaker #3: I would say that in terms of efficacy, we wouldn't, based on the data that we've seen, especially from the April baff agents.

Speaker #3: I don't think that we expect to see more efficacy. I think the real opportunity with AB is at least similar efficacy.

Speaker #3: The 96 data week data that I referenced that you'll see in the coming weeks at the upcoming ASN week meeting is quite extraordinary .

Speaker #3: I think the real opportunity here is the potential for sustained benefit . After relatively short term dosing . And then secondly , the potential benefits on on safety .

Andrew Plump: 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.

Speaker #12: Thank you .

Michael Nedelcovych: Thank you.

Speaker #1: Saigawa Pansino . Sugiyama also .

Speaker #11: Thank you very much. I have two questions.

Speaker #16: First question is about entyvio . So this is to Julie . So you have mentioned that you know , the evolving competition in the US as well as the increasing the of the change in the channel mix .

Teresa Bitetti: Thank you very much. I have two questions. First question is about ENTYVIO.

Miki: Thank you very much. I have two questions. First question is about ENTYVIO. This is to Julie. You have mentioned that, you know, the evolving competition in the US, as well as the increasing change in the channel mix. I can imagine that those, you know, the dynamics are not really, you know, easily reversible. Should we assume that, you know, this, you know, the slowing down growth rate, you know, as you have, you know, included in the revision from 9% to 6%, is this the kind of trend we should expect for 2026 and beyond? If that's the case, will you be revisiting the peak year sale of ENTYVIO at some point? That's first question.

P.K. Morrow: This is to Julie.

Teresa Bitetti: You have mentioned the evolving competition in the U.S. as well as the increasing change in channel mix. I can imagine that those dynamics are real. It's not really easily reversible. Should we assume that the slowing down of the growth rate, as you have included in the revision from 9% to 6%, is the kind of trend we should expect for 2026 and beyond? If that's the case, will you be revisiting the peak year sale of ENTYVIO at some point? That's the first question. The second question is about the Innovent deal. I have a question about this IBI3001, very interesting product. You know the ADC, a bispecific ADC for this molecule.

Speaker #16: Oh , I can't imagine that those , you know , the , the dynamics are reversed . It's not really easily reversible . So should we assume that , you know , this the slowing down the growth rate , you know , as you have you included in the revision from 9% to 6% ?

Speaker #16: Is this the kind of trend we should expect for 2026 and beyond? And if that's the case, will you be revisiting the peak year of Entyvio at some point?

Speaker #16: The first question . The second question is about the innovent . The the deal . I have a question about this . IBD 3001 .

Miki: The second question is about the Innovent, the deal. I have a question about this IBI3001, very interesting product, you know, the ADC, the bispecific ADC. For this molecule, should we think that, you know, this is kind of gonna work as a 2 ADCs in one molecule, meaning that, you know, it's just kind of working as a EGFR ADC and the B7H3 ADC? If there's any synergy by putting these, you know, the functions in one molecule. Those are 2 questions. Thank you.

Speaker #16: Very interesting product . You know , the ADC , a bispecific ADC for this molecule . Should we think that this is kind of in a work as A22 ADCs in one molecule , meaning that , you know , it's just kind of working as a EGFR , ADC and the B7 ADC or if there's any synergy by putting these , you know , the the functions in one molecule , those are two questions .

P.K. Morrow: Should we think that this is kind?

Teresa Bitetti: 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, you know, the functions in one molecule. Those are two questions.

Speaker #16: Thank you .

Speaker #1: Okay. Thank you. So the first question on Entyvio to Julie, and the second on 3001 to PK, please.

P.K. Morrow: Thank you.

Christophe Weber: Okay, thank you Miki. The first question on ENTYVIO to Julie and the second on IBI3001 to PK please.

Chris: Okay. Thank you, Miki. The first question on ENTYVIO to Julie, the second on IBI3001 to PK, please.

Speaker #9: Thanks for the questions Mickey . In terms of the growth , what I would say is 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 us any predictions about growth and whatnot that will provide for FY 26 .

Teresa Bitetti: 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 FY2026 in May, 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, 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.

Julie Kim: 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. What I would expect, without giving any predictions about growth and whatnot that we'll provide for FY 2026 in May, 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. As I mentioned, where we see the significant competitive challenge is in CD thus far.

Speaker #9: In May . 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 .

Speaker #9: And the strong track record that we have , particularly in in UC , as I mentioned , where we see the significant competitive challenge is in CD thus far in terms of the peak , at this point , we are not changing our overall peak revenue guidance .

Julie Kim: In terms of the peak, at this point, we are not changing our overall peak, revenue guidance.

Speaker #5: Thank you . And to add on related to IBA 301 , happy to to bring this forward . So we we agreed . And when discussing the data and the potential for this molecule with Innovent , it was based upon a few elements .

P.K. Morrow: Thank you. To add on related to IBI3001, happy to bring this forward. 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 two targets specifically. The second element is that we believe that as they actually target two elements and then use the same novel exatecan payload as well as platform, 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. Thank you.

P.K. Morrow: Thank you. And to add on related to IBI3001, happy to bring this forward. 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 two targets specifically. The second element is that we believe that as they actually 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.

Speaker #5: The first is the fact that these targets are very well harmonized with our current disease area strategy, and solid tumors, particularly in GI and thoracic cancers.

Speaker #5: These two target specifically , and the second element is that we believe that as they target to 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 .

Speaker #5: We've seen some elements of that thus far . You know , in the earlier doses , as I noted , and we will continue to monitor as we progress up the dose levels .

P.K. Morrow: We've seen some elements of that thus far, you know, in the earlier doses, as I noted, and we will continue to monitor as we progress up the dose levels.

Speaker #12: Thank you .

Miki: Thank you.

Christophe Weber: Here.