Takeda Pharmaceutical Q3 2026 Takeda Pharmaceutical Earnings Call | AllMind AI Earnings | AllMind AI
Q3 2026 Takeda Pharmaceutical Earnings Call
Speaker #1: Okay.
Speaker #1: Already from, I, uh— お願いいたします。 I would like to explain the
Speaker #2: 安全設定についてご説明します。
Speaker #1: The diagnosis rate is high, and the penetration of prophylaxis treatments has been high as well. So TAKHZYRO continues to be the gold standard for HAE patients.
Speaker #2: ウィンドウの下の方に。 language setting first.
Speaker #1: button Please for the language find the selection bottom at the of window . zoom screen For the , the zoom screen , if you wish to listen in search Japanese .
Speaker #1: Japanese , please If you wish to English , listen in please . Are English . And if you listen to the want to original language , it off please keep .
Speaker #1: And you are correct that we have seen an impact of the launches of the two recent competitive entrants. And so we are seeing an impact in terms of new starts from these new competitive entrants.
Speaker #2: Please select English in the zoom language . Select button .
Speaker #2: 2025。 And
Speaker #1: はい、TAKEDA。
Speaker #1: But I also want to point out that part of the lower growth is also due to the impact of the Medicare Part D redesign. We are experiencing a slightly higher impact from that in the US than anticipated.
Speaker #2: the MC. I would like to explain the language setting first. Please find the button for the language selection at the bottom of your window.
Speaker #1: remind To everyone be that we'll discussing forward looking statements within of the the meaning private Securities Litigation Reform Act of 1995 . Actual results may differ materially from those discussed today .
Speaker #2: screen. If you wish to listen in Japanese, please select Japanese. If you wish to For the Zoom listen in English, please select English. And if you want to listen to the original language, please keep it off.
Speaker #1: Now, when it comes to long-term efficacy, if you look at the real-world evidence that we have for Taxilo, no other product is able to demonstrate the level of efficacy that we have when you look at the data from an attack perspective.
Speaker #1: The factors that could cause our actual results to differ materially are discussed in recent most form , our 20 F , and in our other filings SEC Please also refer .
Speaker #1: Select English in the Zoom language select button. 本日のコールでは、米国の1990。
Speaker #1: to the important notice on two of the page presentation regarding forward looking statements and our non IFRS financial measures , which will also be discussed during this call .
Speaker #2: Before starting, I'd like to remind everyone that we'll be discussing forward-looking statements within the meaning of the private security certification reform act of 1995.
Speaker #1: We have patients that are attack-free for over a year at any given point in time. And so, from an efficacy standpoint, our real-world data for Taxilo can't be beat.
Speaker #1: Definitions of our non IFRS measures and reconciliations with comparable IFRS financial measures are included in the appendix to the presentation .
Speaker #2: Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in our most recent Form 20-F, and in our other SEC filings.
Speaker #2: Aside . Noch need to .
Speaker #1: So, that is something that I would like to highlight. And it's something that we continue to defend and support from a Taxilo standpoint.
Speaker #1: Presentation to start with today's presentation , today we have Christophe Weber . President and CEO Milano Furuta . Chief Financial Officer Andrew Plump .
Speaker #2: Please also refer to the important notice on page 2 of the presentation regarding forward-looking statements and our non-IFRS financial measures, which will also be discussed during this call.
Speaker #6: Thank you very much, Matsubara-san. Matsubara-san, I'd like to answer your second question. At the beginning, as Muraka-san also asked, I mentioned the pressure of overall expenditure increase.
Speaker #2: Definitions of our non-IFRS measures and reconciliations with comparable IFRS financial measures are included in the appendix to the presentation.
Speaker #1: President , R&D and Julie Kim CEO elect will present and this will be followed by Q&A . We'll get right away
Speaker #6: And therefore, I'd like to touch upon the potential contribution of new profit. And this is a general comment—to the products—that whenever new products come out, then in the second year or the third year since its launch, we will see a contribution to the profit.
Speaker #1: . Thank you
Speaker #3: thank you , Chris , and , everyone for joining us today . Our Fiscal year 2025 third quarter results are confirming the strength of the fundamentals and our ability to maintain disciplined cost management and operational efficiency while continuing to focus on innovation and long term sustainable growth .
Speaker #2: Now, we would like to start それでは、本日の。 with today's presentation.
Speaker #1: Christopher Weber,
Speaker #2: President and CEO, Milano Furuta, Chief Financial Officer, Andy Plump, President R&D, and Julie Keene, CEO-Elect. We will present, and this will be followed by Q&A.
Speaker #3: Milano will explain our financial results in detail in his presentation shortly . Fiscal year 25 remains truly a pivotal year for Takeda . We are in a phase of preparing for significant new product launch , making major steps forward in our new growth trajectory .
Speaker #2: We'll get started right away.
Speaker #3: Thank you, Chris, and thank you, everyone, for joining us today. Our fiscal year 2025 third quarter results are confirming the strength of Takeda fundamentals.
Speaker #3: In particular , I would like to focus on our external risk . First , aid and Tinib , which are key assets in our late stage pipeline that we expect to launch over the next 18 months .
Speaker #3: And our ability to maintain disciplined cost management, while continuing to focus on operational efficiency, innovation, and long-term sustainable growth. Milano will explain our financial results in detail in his presentation shortly.
Speaker #3: Over Exton submitted first orexin to the FDA be and has a considerable first mover advantage . Phase three results were statistically significant across all primary and secondary endpoints , demonstrating clinically meaningful improvement on daytime and nighttime symptoms .
Speaker #3: Fiscal year '25 remains truly a pivotal year for Takeda. We are in a phase of preparing for significant new product launch, making major steps forward in our new growth trajectory.
Speaker #3: In particular, I would like to focus on overproduction, risk-fertile, and the society need, which are key assets in our late-stage pipeline that we expect to launch over the next 18 months.
Speaker #3: This reinforces our belief that this medicine can truly transform the life of patients with narcolepsy . Type one . Iodide is an hepcidin mimetic that has demonstrated durable and sustained hematocrit control in patients with polycythemia vera or PV .
Speaker #3: Overproduction is a first-direction agonist to be submitted to the FDA and has a considerable first-mover advantage. Phase 3 results were statistically significant across all primary and secondary endpoints, demonstrating clinically meaningful improvement on daytime and nighttime symptoms.
Speaker #3: Nearly half of PV patients remain untreated in the US today , and those that are treated still have significant challenges in managing their disease .
Speaker #3: The phase three data underscore the potential for risk factors to transform the standard of care . For these patients . We have filed drug a new application with the FDA , unrest overproduction , fertile and are awaiting formal acceptance .
Speaker #3: This reinforced our belief that this medicine can truly transform the life of patients with narcolepsy type 1. Risk-fertile is an exceeding mimetic that has demonstrated durable and sustained hematocrit control in patients with polycythemia vera or PV.
Speaker #3: Finally , at the end of last year , we announced positive phase three psoriasis data for Dasatinib , our highly selective Tyk2 inhibitors .
Speaker #3: Nearly half of PV patients remain untreated in the US today, and those that are treated still have significant challenges in managing their disease. The Phase 3 data underscores the potential for risk-fertile to transform the standard of care for these patients.
Speaker #3: Full details will be disclosed at the upcoming Congress . But this once daily oral therapy offers a compelling profile to help shift the Soyuz's advanced therapy market towards oral treatment .
Speaker #3: We have filed new drug application with the FDA for overproduction on risk-fertile and are awaiting formal acceptance. Finally, at the end of last year, we announced positive phase 3 psoriasis data for azacitinib, our highly selective TIK2 inhibitors.
Speaker #3: Regulatory filing preparations are underway , and we expect to launch the team in the first half of calendar year 2027 . The positive data for all three programs met or exceeded our expectations .
Speaker #3: focused Now we are on preparing for launch . We will update the peak revenue potential for these three programs in the future . Combined , we believe this product could more than the offset anticipated impact of Entyvio biosimilar entry from the early 2030s onwards , and in addition to these three , our transformative late stage pipeline includes five other innovative programs .
Speaker #3: Full detail will be disclosed at the upcoming congress, but this once-daily oral therapy offers a compelling profile to help shift the psoriasis advanced therapy market towards oral treatment.
Speaker #3: Regulatory filing preparation is underway, and we expect to launch azacitinib in the first half of calendar year 2027. The positive data for all three programs met or exceeded our expectations.
Speaker #3: Two of which were recently added through our strategic partnership with Innovent Biologics . Each of our eight late stage the programs has potential to transform the current standard of care , providing and strong sustainable growth drivers Takeda for well into the future .
Speaker #3: Now we are focused on preparing for launch. We will update the peak revenue potential for these three programs in the future. Combine we believe this product could more than offset the anticipated impact of antibiobiosimilar entry from the early 2030s onwards.
Speaker #3: Andy will share more details about our pipeline advancement later in this call . Now I will hand it over to Milano , who will discuss our financial results and the outlook for the rest of the fiscal year .
Speaker #3: And in addition to these three, our transformative late-stage pipeline includes five other innovative programs, two of which were recently added through our strategic partnership with Innovent Biologics.
Speaker #3: Milano , up to you . Thank you . Christoph .
Speaker #4: And hello everyone . This is Milano Furuta speaking . A slide summarizes six our Q3 year to date results . know year we , this the managing As you are significant of impact Vyvanse generic erosion .
Speaker #3: Each of our eight late-stage programs has the potential to transform the current standard of care providing strong and sustainable growth drivers for TAKEDA well into the future.
Speaker #4: However , if you look at the performance quarter by quarter , headwind the Vyvanse from is steadily tapering off as the year goes by and we are maintaining strong cost discipline to limit its impact to profit .
Speaker #3: Andy will share more details about our pipeline advancement later in this call. Now, I will hand it over to Milano who will discuss our financial results and the outlook for the rest of the fiscal year.
Speaker #3: Milano, up to
Speaker #3: Milano, up to you. Thank you,
Speaker #4: Revenue for the nine month period was just over ¥3.4 trillion , a decrease 3.3% , or of minus two point 8% at constant exchange rate or KRW core operating profit group was ¥971.6 billion .
Speaker #1: Christoph, and hello everyone. This is Milano Furuta speaking. Our slide 6 summarizes our Q3 year-to-date results. As you know, this year we are managing a significant impact of vibrant generic erosion.
Speaker #1: However, if you look at the performance quarter by quarter, the headwind from VYVANSE is steadily tapering off. As the year goes by, we are maintaining strong cost discipline to limit its impact. The impact to the nine-month period was just over profit.
Speaker #4: A year on year decrease of 3.4% at both actual effects and KRW . This is a meaningful improvement from our first half results .
Speaker #1: Revenue for the 3.4 trillion yen. A decrease of 3.3% or minus 2.8% at constant exchange rate, or CER. Cooperating profit COOP was 971.6 billion yen, an all-year decrease of 3.4% at both actual effects and CER.
Speaker #4: Reported operating profit was an ¥422.4 billion , increase of 1.2% . Core PS was ¥428 and reported EPs was ¥137 . Cash flow has been very strong this period , with adjusted free cash flow of ¥625.9 billion .
Speaker #4: Even after the upfront payment of 1.2 billion USD to Innovent Biologics in December . Slide seven shows our gross on launched products , which over represents 50% of total revenue and grew 6.7% at constant exchange rate .
Speaker #1: This is a meaningful improvement from our first half results. Reported operating profit was 422.4 billion yen, an increase of 1.2%. Core EPS was 428 yen, and reported EPS was 137 yen.
Speaker #4: This is a steady improvement on the 5% growth rate we saw in Q1 and Q2 in GI and TiVo grew 7.4% at KRW .
Speaker #1: Cash flow has been very strong this period, with adjusted free cash flow of 625.9 billion yen, even after the upfront payment of 1.2 billion US dollars to Innovant Biologics in December.
Speaker #4: Growth in the third quarter was particularly strong . As expected , partially due to a one time gross to net in that threw up .
Speaker #1: Slide 7 shows our Growth and Launch Products, which represent over 50% of total revenue, and grew 6.7% at constant exchange rate. This is a steady improvement on the 5% growth rate we saw in Q1 and Q2.
Speaker #4: Prior year Entyvio pen continues to be the main driver , helping us maintain leadership , share in a competitive IBD market . We are also pleased to report that as of this month , NTV Japan is now on formulary with all three large pharmacy benefit managers with commercial coverage of more than 80% in line with competing products .
Speaker #1: NGI and TVO grew 7.4% at CER. Growth in the third quarter was particularly strong, as expected, partially due to a one-time growth to net through-up in the period prior year.
Speaker #4: With this progress , we are on track to achieve our full year projection of 6% growth in rare diseases . Takhzyro has slowed to at 2.4% growth KRW , although we continue to see strong uptake in markets .
Speaker #1: NTVOPAN continues to be the main driver, helping us maintain leadership share in a competitive IBD market. We are also pleased to report that, as of this month, NTVOPAN is now on the formulary with all three large pharmacy benefit managers, with commercial coverage of more than 80%.
Speaker #4: international This is being offset by the impact of new computing products in US the PDT . In revenue , Q3 growth marked an improvement on the first half .
Speaker #4: said , That we acknowledged some headwinds , particularly in aluminium . IG growth was 4.3% year to date , driven by subcutaneous IG products , which grew double digit IV , IG sales impacted by have been Medicare Part D redesign in the US expect to , which we normalize in Q4 .
Speaker #1: In line with competing products. With this progress, we are on track to achieve our full-year projection of 6% growth. In rare diseases, Taxidra has slowed to 2.4% growth at CER, although we continue to see strong uptake in international markets; this is being offset by the impact of new competing products in the US.
Speaker #4: has returned to Albumin growth of 1.3% , but this is slower than expected due to softening demand in China , which is also putting pressure on other markets .
Speaker #1: In PDT, Q3 revenue gross marked an improvement on the first half. That said, we acknowledge some headwinds, particularly in aluminum. IG growth was 4.3% year-to-date, driven by subcutaneous IG products, which grew double-digit.
Speaker #4: We supply is reallocated . While we anticipate additional tenders in to Q4 support an uptick in growth , there is a possibility we year finished the below our full year forecast .
Speaker #1: ID-IG sales have been impacted US, which we expect to by Medicare Party Redesign in the normalize in Q4. Aluminum has returned to growth of 1.3%, but this is slower than expected due to softening demand in China.
Speaker #4: In oncology continues to expand well as as we roll out global launches . Finally , in vaccines , Qdenga growth has accelerated to 22.1% , driven primarily by Brazil .
Speaker #1: Which is also putting pressure on other markets, where supply is reallocated. While we anticipate additional tenders in Q4 to support an uptick in growth, there's a possibility we finish the year below our full-year forecast.
Speaker #4: On slide eight , you can see how incrementally revenue of growth and launch products and the impact of the vyvanse loss of exclusivity contributed to total revenue performance with each quarter .
Speaker #1: In oncology, Frizacla continues to expand as well. As we roll out global launches, finally, in vaccines, Qdenga growth has accelerated to 22.1%, driven primarily by Brazil.
Speaker #4: The gap is becoming smaller as decline Vyvanse was heavily weighted to the the first half of year , and growth and launch products are performing better in the second half .
Speaker #4: Slide nine shows how near copy performance here you can see that the low of high margin vyvanse was the main reason for the year on year decline of 3.4% at KRW .
Speaker #1: On slide 8, you can see how incremental revenue of growth and impact of the vibrant loss of launch products and the exclusivity contributed to total revenue performance.
Speaker #4: However , we have able to limit the Vyvanse impact through operational efficiencies with R&D and expenses both lower than the prior year . As we explained at the Q2 earnings call , we continue to tighten the belt on expenses .
Speaker #1: With each quarter, the gap is becoming smaller, as the vibrant decline was heavily weighted to the first half of the year. And growth and launch products are performing better in the second half.
Speaker #4: Building on the progress of the cost efficiency program , we started in 2024 . This will be critical as we ramp up investment behind the three new product launches .
Speaker #1: Slide 9 shows year-on-year COOP performance. Here you can see that the LOE of high-margin VYVANSE was the main reason for the year-on-year decline of 3.4% at CER. However, we have been able to limit VYVANSE's impact through operational efficiencies, with R&D and SG&A expenses both lower than the prior year.
Speaker #4: We will not compromise on the necessary investments for long term growth . We also have a multiple programs in the late stage pipeline that will require additional R&D investment in the coming years .
Speaker #4: At the same time , we will continue to pursue opportunities to offset these investments where possible , to minimize the near-term impact on profit .
Speaker #1: As we explained at the Q2 earnings call, we continue to tighten the belt on expenses, building on the progress of the cost efficiency program we started in 2024.
Speaker #4: Next reported operating profit on slide ten . This was flat versus prior year , with a lower restructuring expenses than more offsetting an increasing in impairments of intangible assets main .
Speaker #1: This will be critical as we ramp up investment behind the three new product launches. We will not compromise on the necessary investment for long-term growth.
Speaker #1: We also have multiple programs in the late-stage pipeline that will require additional R&D investment in the coming years. At the same time, we will continue to pursue opportunities to offset these investments where possible to minimize the near-term impact on profit.
Speaker #4: impairment item was booked The in Q2 related to the cell therapy , and there were major new no items in Q3 . Slide 11 shows our updated full year outlook .
Speaker #4: Starting with management guidance . We are revising only revenue guidance to low single digit decline at KRW , primarily due to stronger than anticipated Vyvanse generic erosion in the US .
Speaker #1: Next, reported operating profit on slide 10. This was flat versus prior year, with lower restructuring expenses more than offsetting an increase in impairment of intangible assets.
Speaker #4: However , our commitment to OpEx discipline allows us to offset the gross profit impact from Vyvanse , and we maintain full year guidance for co-op and EPs for our reported and core forecast .
Speaker #1: The main impairment item was booked in Q2, related to the cell therapy, and there were no major new items in Q3. Slide 11 shows our updated full-year outlook.
Speaker #4: We have revised our FX assumptions as a result , our revenue forecast is now ¥4.53 trillion . Co-op forecast is ¥1.15 trillion , and EPs core forecast is ¥486 .
Speaker #1: Starting with management guidance, we are revising only revenue guidance to a low single-digit decline at CER, primarily due to stronger-than-anticipated vibrant generic erosion in the US.
Speaker #4: We have also upgraded our adjusted free cash flow forecasts . On slide 12 , we show more detail about the updated revenue and forecast for revenue .
Speaker #1: However, our commitment to OPEX discipline allows us to offset the gross profit impact from VYVANSE, and we maintain full-year guidance for COOP and COEPS.
Speaker #1: For our reported and core forecast, we have revised our FX assumptions. As a result, our revenue forecast is now ¥4.53 trillion, COOP forecast is ¥1.15 trillion, and COEPS forecast is ¥486.
Speaker #4: latest We are reflecting momentum of Vyvanse and other products , which includes plasma derived therapies and Takhzyro . However , this is more than offset by effects subside , resulting in a net increase of our forecast of ¥30 billion for Corp .
Speaker #1: We have also upgraded our adjusted free cash flow forecast. On slide 12, we show more detail about the updated revenue and COOP forecast. For revenue, we are reflecting latest momentum of VYVANSE and other products, which includes plasma-derived therapies and Takhzyro.
Speaker #4: Continued opex discipline fully offset the impact of Vyvanse . We also have effects benefit for net increase to our forecast of ¥20 billion .
Speaker #4: Thank you and I will now pass Andy over to .
Speaker #5: Thank you . Milano . And hello to today's call . Takeda is entering an exciting new period of growth , powered by our late stage pipeline as Christoph mentioned in 2025 , we were three for three , delivering positive phase three data readouts for over Preston and Dasatinib .
Speaker #1: However, this is more than offset by FX upside, resulting in a net increase of our forecast of ¥30 billion. For COOP, continued OPEX discipline fully offsets the impact of Vibrants; we also have an FX benefit for a net increase to our forecast of ¥20 billion.
Speaker #5: These exciting results are at the end of our expectations . Further strengthening our belief that these new medicines have the potential to fundamentally reshape their respective therapeutic landscapes , bringing transformative benefits to patients in the next 18 months .
Speaker #1: Thank you, and I will now pass over to Andy.
Speaker #2: Thank you, Milano, and hello to everyone on today's call. Takeda is entering an exciting new period of growth powered by our late-stage pipeline. As Christophe mentioned, in 2025, we were three for three, delivering positive phase 3 data readouts for overparexetine, raspartide, and zazoxitinib.
Speaker #5: Let me begin with over our expected first in class orexin two receptor agonist , which can transform the treatment paradigm for narcolepsy . Type one , approximately 85% of patients in the phase three over paroxetine trials saw measurable which improvement , brought them into the normative the range on Epworth Scale Sleepiness The ESS .
Speaker #2: These exciting results are at the high end of our expectations, further strengthening our belief that these new medicines have the potential to fundamentally reshape their respective therapeutic landscapes.
Speaker #5: , or gold standard measure of excessive daytime sleepiness . That means the majority of patients have the possibility of a normal day in both phase three studies .
Speaker #2: Bringing transformative benefits to patients in the next 18 months. Let me begin with overparexetine. Our expected first-in-class orexin-2 receptor agonist which can transform the treatment paradigm for narcolepsy type 1.
Speaker #5: Overall , Brexit achieved clinically and statistically significant improvements across all 14 primary and secondary endpoints , with most participants normative reaching ranges . This normalization across such a broad range of nt1 symptoms , including daytime sleepiness , nighttime symptoms , cataplexy , and cognitive function , is unprecedented over Braxton doesn't just manage symptoms , it addresses the underlying orexin deficiency in nt1 , offering patients a single , well-tolerated oral therapy that could restore a how majority of nt1 patients feel and function have .
Speaker #2: Approximately 85% of patients in the phase three overparexetine trials saw measurable improvement, which brought them into the normative range on the Epworth Sleepiness Scale, or ESS, the gold standard measure of excessive daytime sleepiness.
Speaker #2: That means the majority of patients have the possibility of a normal day. In both phase three studies, overparexetine achieved clinically and statistically significant improvements across all 14 primary and secondary endpoints, with most participants reaching normative ranges.
Speaker #5: We submitted a new drug the application to FDA and are launch working to over Preston . This calendar year . Next is our Hepcidin mimetic for polycythemia vera .
Speaker #2: This normalization across such a broad range of NT1 symptoms—including daytime sleepiness, nighttime symptoms, cataplexy, and cognitive function—is unprecedented. Overparexetine doesn't just manage symptoms; it addresses the underlying orexin deficiency in NT1, offering patients a single, well-tolerated oral therapy that could restore how a majority of NT1 patients feel and function.
Speaker #5: One key data point from the phase three study ability is the to maintain hematocrit control . Below 45% through 52 weeks . Real world data shows that 78% of PV patients experience uncontrolled , fluctuating hematocrit , leading to a four fold increase in the risk of thrombotic events , including stroke , deep vein thrombosis , pulmonary embolism , and acute coronary syndrome targets .
Speaker #2: We have submitted a new drug application to the FDA, and are working to launch overparexetine this calendar year. Next, as for raspartide, our hepcidin mimetic for polycythemia vera, one key data point from the Phase 3 study is the ability to maintain 45% hematocrit control through 52 weeks.
Speaker #5: The biology upstream , offering more stable and durable hematocrit control and fewer variable swings in hematocrit . Durable hematocrit control with impressive safety and tolerability led to also clinically meaningful and statistically significant benefits to patients .
Speaker #2: Real-world data shows that 78% of PV patients experience uncontrolled, fluctuating hematocrit, leading to a fourfold increase in the risk of thrombotic events, including stroke, deep vein thrombosis, pulmonary embolism, and acute coronary syndrome.
Speaker #5: Quality of as life , measured by the promise Fatigue Scale and Myelofibrosis Symptom Assessment form . By reducing fatigue and other key disease related symptoms , as well as the need for phlebotomy , Rutherford Tide enables patients to spend less time managing their disease time and more engaging in everyday activities .
Speaker #2: Raspartide targets the biology upstream, offering more stable and durable hematocrit control with fewer variable swings in hematocrit. Durable hematocrit control with impressive safety and tolerability also led to clinically meaningful and statistically significant benefits to patients' quality of life, as measured by the PROMIS fatigue scale and Myelofibrosis Symptom Assessment Form.
Speaker #5: We have submitted an NDA to the FDA and are working to launch frustrated in PV . This calendar year and finally , we have our next generation Tyk2 for inhibitor amine immune mediated diseases .
Speaker #5: In our phase three psoriasis studies , Zazzo worked fast with significant improvement in Passey 75 within four weeks , patients , of course , want clear skin at week 16 , more Zazzo than on half of patients achieved Pasi 90 or clear skin .
Speaker #2: By reducing fatigue and other key disease-related symptoms, as well as the need for phlebotomy, Raspartide enables patients to spend less time managing their disease and more time engaging in everyday activities.
Speaker #2: We have submitted an NDA to the FDA, and are working to launch raspartide in PV this calendar year. And finally, we have zazoxitinib, our next-generation TIK2 inhibitor for immune-mediated diseases.
Speaker #5: And approximately 30% achieved Pasi 100 or completely clear skin . Pasi scores continue to improve through week 24 . These results are at the very high end of reported results for all therapies in development .
Speaker #2: In our phase three psoriasis studies, zazoxitinib worked fast, with significant improvement in PASI 75 within four weeks. Patients, of course, want clear skin. At week 16, more than half of patients on zazoxitinib achieved PASI 90, or almost clear skin, and approximately 30% achieved PASI 100, or completely clear skin.
Speaker #5: Dasatinib is a once daily well-tolerated pill that does not have any food interactions . We are looking forward to sharing the complete data at a medical conference in the near future , and expect to launch Associate in Psoriasis during calendar year 2027 .
Speaker #5: In addition , we remain confident in future indication expansion opportunities for Zazzo Certinib , including psoriatic arthritis and inflammatory bowel disease . Together over Braxton Tide and represent We three transformative medicines .
Speaker #2: Passing scores continue to improve through week 24. These results are at the very high end of reported results for all therapies in development. Zazoxitinib is a once-daily, well-tolerated pill that does not have any food interactions.
Speaker #5: to plan to bring patients over the 18 months . next They demonstrate the strength of R&D our engine , the speed and quality of our clinical execution , and our commitment to delivering therapies that meaningfully change how patients live .
Speaker #2: We are looking forward to sharing the complete data at a medical conference in the near future, and expect to launch zazoxitinib in psoriasis during calendar year 2027.
Speaker #2: In addition, we remain confident in future indication expansion opportunities for zazoxitinib, including psoriatic arthritis and inflammatory bowel disease. Together, Overparexetine, Raspartide, and Zazoxitinib represent three transformative medicines we plan to bring to patients over the next 18 months.
Speaker #5: Next slide please . These first three approvals are just the beginning . I want to highlight some additional bright spots within our late stage pipeline building on our success .
Speaker #5: A head to head study Zazzo of versus Deucravacitinib is fully enrolled and on track to readout . In 2026 . These data are not required for filing , but will be insightful to further differentiate from other oral psoriasis medicines .
Speaker #2: They demonstrate the strength of our R&D engine, the speed and quality of our clinical execution, and our commitment to delivering therapies that meaningfully change how patients live.
Speaker #5: Last November at the American Society of Nephrology , Kidney Week , we presented new IGA nephropathy data from a proof of concept study for our Anti-cd38 monoclonal antibody .
Speaker #2: Next slide, please. These first three approvals are just the beginning. I want to highlight some additional bright spots within our late-stage pipeline. Building on our success, a head-to-head study of zazoxitinib versus dacravositinib is fully enrolled and on track to read out in 2026.
Speaker #5: Igan is a progressive autoimmune disease that causes irreversible damage to kidney function . Patients receiving Mab demonstrated durable kidney function for about two years .
Speaker #2: These data are not required for filing, but will be insightful to further differentiate zazoxitinib from other oral psoriasis medicines. Last November, at the American Society of Nephrology Kidney Week, we presented new IgA nephropathy data from a proof-of-concept study for mesagitamab, our anti-CD38 monoclonal antibody.
Speaker #5: This is an incredible 18 months the after treatment initial five month period a disease , suggesting modifying effect sustained long after dosing that could allow for extended treatment .
Speaker #5: Holidays . Very important for patients with this lifelong disease , where many progress to kidney failure within ten years . addition to In over Preston , we are excited about the potential of our second orexin two receptor agonist , Tak 360 , which which is initially focused on patients with normal orexin levels like those with narcolepsy .
Speaker #2: IgAN is a progressive autoimmune disease that causes irreversible damage to kidney function. Patients receiving mesagitamab demonstrated durable kidney function for about two years. This is an incredible 18 months after the initial five-month treatment period, suggesting a disease-modifying effect sustained long after dosing, that could allow for extended treatment holidays.
Speaker #5: Type two and idiopathic hypersomnia . Phase two studies in nt2 and I.h are enrolling well , expect to have data and we three year to inform phase development .
Speaker #5: Next slide please . Turning our attention to oncology late stage highlights include a our activin A B ligand trap that showed compelling data in myelofibrosis presented as at past Ash this meeting .
Speaker #2: Very important for patients with this lifelong disease, where many progress to kidney failure within 10 years. In addition to overparexetine, we are excited about the potential of our second orexin-2 receptor agonist, TAK-360, which is initially focused on patients with normal orexin levels, like those with narcolepsy type 2 and idiopathic hypersomnia.
Speaker #5: Phase two myelofibrosis data showed clinically meaningful improvements in anemia and thrombocytopenia alongside favorable trends in spleen volume and symptoms . When when added to ruxolitinib , a ridership remains a stage late , potentially best in class approach across MDS and myelofibrosis .
Speaker #2: Phase two studies in NT2 and IH are enrolling well, and we expect to have data this year to inform phase three development. Next slide, please.
Speaker #2: Turning our attention to oncology, late-stage highlights include Eritrosept, our active in A/B ligand trapt, that showed compelling data in myelofibrosis as presented at this past ASH meeting.
Speaker #5: And lastly , we recently licensed two new innovative oncology drugs from Innovent Biologics , now called Tak 928 and Tak 921 . Tak 928 is a potential first in class alpha bias IL two , PD one bispecific antibody designed to selectively activate tumor specific cytotoxic T cells through activation of the IL two alpha cd25 receptor .
Speaker #2: Phase 2 myelofibrosis data showed clinically meaningful improvements in anemia and thrombocytopenia, alongside favorable trends in spleen volume and symptoms when added to ruxolitinib. Eritrosept remains a late-stage, potentially best-in-class approach across MDS and myelofibrosis.
Speaker #5: While the risk reducing of exhaustion through immune checkpoint inhibition in early stage clinical studies , Tak 928 has demonstrated encouraging activity in heavily pretreated immunotherapy and chemotherapy refractory lung cancer , as well as in immunologically cold tumors such as microsatellite stable colorectal cancer .
Speaker #2: And lastly, we recently licensed two new innovative oncology drugs from Innovent Biologics, now called TAK-928 and TAK-921. TAK-928 is a potential first-in-class alpha-bias IL-2/PD-1 bispecific antibody designed to selectively activate tumor-specific cytotoxic T cells through activation of the IL-2 alpha CD25 receptor, while reducing the risk of exhaustion through immune checkpoint inhibition.
Speaker #5: We have seen compelling high quality data in well over 1200 Chinese patients and consistent early signals from Ex-china populations . We have completed the rapid transfer of data and materials and are now executing with speed to generate global data sets that will supplement the China data shared last year at Asco .
Speaker #2: In early-stage clinical studies, TAK-928 has demonstrated encouraging activity in heavily pretreated, immunotherapy- and chemotherapy-refractory lung cancer, as well as in immunologically cold tumors such as microsatellite stable colorectal cancer.
Speaker #5: This will allow us to advance Tak a 928 to treat range of broad solid tumors , including non-small cell lung cancer and microsatellite stable colorectal cancer .
Speaker #2: We have seen compelling, high-quality data in well over 1,200 Chinese patients, and consistent early signals from ex-China populations. We have completed the rapid transfer of data and materials, and are now executing with speed to generate global data sets that will supplement the China data shared last year at ASCO.
Speaker #5: These go to phase three decisions will start as soon as 2026 and into 2027 . The shared investment in Tak 928 has a 6040 split within event and is stage gated by .
Speaker #5: These go decisions . Tak 921 is a claudin 18.2 targeted antibody drug conjugate that couples a selective antibody with a silenced FC region to a topoisomerase payload .
Speaker #2: This will allow us to advance TAK-928 to treat a broad range of solid tumors, including non-small cell lung cancer and microsatellite-stable colorectal cancer.
Speaker #5: This approach is designed for potent , tumor specific delivery of this payload preferred to patients with pancreatic and gastric cancers were unmet . Need remains high .
Speaker #2: These go-to-phase-three decisions will start as soon as 2026 and into 2027. The shared investment in TAK-928 has a 60/40 split with Innovent, and is stage-gated by these go decisions.
Speaker #5: The engineered FC silencing reduces off target toxicity in the GI tract and lung , potentially allowing for more robust dosing and the ability to combine with first line regimens .
Speaker #2: TAK-921 is an 18.2-targeted antibody-drug conjugate that couples a selective antibody with a silenced Fc region to a topoisomerase payload. This approach is designed for potent, tumor-specific delivery of this preferred payload to patients with pancreatic and gastric cancers, where unmet need remains high.
Speaker #5: Clinical data shows lower rates of GI adverse events relative to other claudin 18.2 targeted antibodies in development . We plan to develop Tak 921 in first line gastric cancer and first line pancreatic cancer .
Speaker #5: I'd like to And now turn it back to Christoph and Julie for a few closing remarks .
Speaker #2: The engineered FC silencing reduces off-target toxicity in the GI tract and lung potentially allowing for more robust dosing and the ability to combine with first-line regimens.
Speaker #3: Thank you . Andy and Milano , before we start the Q&A , I share that to would like this is my last earnings call as a main presenter , I will be on the full year earnings call , but in a supportive role as Julie Kim , our CEO elect , takes the lead and sets guidance for fiscal year 26 ahead of our formal handover in June .
Speaker #2: Clinical data show lower rates of GI adverse events relative to other clotting 18.2-targeted antibodies in development. We plan to develop TAK-921 in first-line gastric cancer and first-line pancreatic cancer.
Speaker #3: This is part of our intentional and coordinated transition . Starting this month , Julie began taking on more operational responsibilities to ensure that we remain focused on our upcoming launches without interruption .
Speaker #2: And now I'd like to turn it back to Christophe and Julie for a few closing remarks. Thank you, Andy and Milano. Before we start the Q&A, I would like to share that this is my last earnings call as a main presenter.
Speaker #3: I would like to thank all of important for the the dialogue we had over years about business . I am proud of the work we have done to position Takeda among the global R&D driven pharma leaders and poised growth in the years ahead .
Speaker #2: I will be on the full-year earnings call, but in a supportive role, as Julie Kim, our CEO-elect, takes the lead and sets guidance for fiscal year '26 ahead of our formal handover in June.
Speaker #3: There has been a wonderful journey and I am excited about Takeda's future and confident in Julie's leadership . In its next era . Julie , over to you .
Speaker #2: This is part of our intentional and coordinated transition. Starting this month, Julie began taking on more operational responsibilities to ensure that we remain focused on our upcoming launches without interruption.
Speaker #6: Thank you , Christoph , and thank you for your leadership and guidance over the last 12 years . Hello everyone , and thank you for your trust that you're putting in me to lead Takeda's next era of growth .
Speaker #2: I would like to thank all of you for the important dialogue we have had over the years about our business. I am proud of the work we have done to position Takeda among the global R&D-driven pharma leaders and poised for growth in the years ahead.
Speaker #6: As Christoph shared our transition has been incredibly collaborative and one of the benefits of being an internal successor is that we don't have to slow down .
Speaker #2: It has been a wonderful journey, and I am excited about Takeda's future and confident in Julie's leadership in its next era. Julie, over to you.
Speaker #6: We can keep the momentum going and continue to move the organization forward . To that end , you may have seen our posts today about changes to our organizational and executive leadership .
Speaker #3: Thank you, Christophe, and thank you for your leadership and guidance over the last 12 years. Hello, everyone, and thank you for the trust that you're putting in me to lead Takeda's next era of growth.
Speaker #6: We are making effective These changes are designed to position us for competitiveness , growth and speed in the years ahead , particularly as we plan for multiple launches as we implement these changes , we expect that teens will identify opportunities to simplify their work further as they continue to redesign our processes to adopt AI and other advanced technologies .
Speaker #3: As Christophe shared, our transition has been incredibly collaborative, and one of the benefits of being an internal successor is that we don't have to slow down.
Speaker #3: We can keep the momentum going and continue to move the organization forward. To that end, you may have seen our post today about changes to our organizational structure and executive leadership we are making effective April 1.
Speaker #6: Next quarter , I look forward to taking the lead on the earnings announcement and guidance for providing fiscal year 2026 . I value our ongoing dialogue and will stay closely engaged with all of you in the months and years ahead .
Speaker #3: These changes are designed to position us for competitiveness, growth, and speed in the years ahead, particularly as we plan for multiple launches. As we implement these changes, we expect that teams will identify opportunities to continue to redesign our processes to simplify their work further as we adopt AI and other advanced technologies.
Speaker #6: Thank you . And with that , I will turn it back to Chris for Q&A .
Speaker #1: have a If you question , please press the raise hand .
Speaker #3: Next quarter, I look forward to taking the lead on the earnings announcement and providing guidance for fiscal year 2026. I value our ongoing dialogue and will stay closely engaged with all of you in the months and years ahead.
Speaker #2: Button .
Speaker #1: And it's in .
Speaker #2: .
Speaker #1: you're If using Japanese Screen channel , please ask the question in Japanese . And if you're using the English Channel , please ask in English .
Speaker #1: If you're listening to the original language , either language will do , and we would like to limit the number of questions to two per person .
Speaker #3: Thank you, and with that, I will turn it back to Chris for Q&A.
Speaker #1: Now we welcome your questions .
Speaker #4: I'd like to open the floor for それでは、皆様からのご質問をお受けしたいと... questions. If you have a question, please press the raise-a-hand button. If you speak Japanese, please ask the question in Japanese.
Speaker #2: Morgan Stanley Muraoka .
Speaker #1: Muraoka San . Please unmute yourself and ask your . very .
Speaker #1: Thank you Much
Speaker #7: .
Speaker #1: This is I hope you can hear me . Yes , we can hear you . Thank you . Maybe it's too early to .
Speaker #4: And if you're using the English channel, please ask in English. If you're listening to the original language, either language is fine. Limit the number of questions to two per person, please.
Speaker #4: And we would like to person. Now, we welcome your questions. Morgan Stanley, please unmute yourself and ask your question. Thank you very much. This is Muraka, Morgan Stanley.
Speaker #7: Ask .
Speaker #1: But . Mirano San , what are your thoughts about the next fiscal .
Speaker #7: Year ?
Speaker #1: Contribution from the new product is small probably will be , and there spending a lot of marketing expenses for those new launches . I understand that , but violent situation is coming down .
Speaker #1: It's getting better and profit will be . Maybe flat or slight decrease . And I'm thinking that you can continue to increase dividend , but can you give us some suggestions about what will happen in the next fiscal year ?
Speaker #4: I hope you can hear me. Yes, we can hear you. Thank you. Maybe it's too early to ask, but Milano-san, what are your thoughts about the next fiscal year?
Speaker #2: Thank you . Please go ahead .
Speaker #4: Hello . So .
Speaker #4: Contribution from the new product is probably small. They will be using a lot of marketing expenses for those new launches, I understand that. But live and situation is coming down.
Speaker #1: Thank you . Yes , it's a little bit too early . You're .
Speaker #4: Right .
Speaker #1: Our guidance will be provided as usual in .
Speaker #4: May or .
Speaker #4: It's getting better, and profit will maybe be flat or show a slight decrease. I'm thinking that you can continue to increase the dividend. But can you give us some suggestions about what will happen?
Speaker #1: And the next fiscal year budget is being finalized as we speak . So please give us some more time . With regard to the current momentum we can , I give believe that you some more information .
Speaker #4: Fiscal year. Thank you.
Speaker #1: Topline . Well , growth of a growth and launch products versus the low impact . I think it's the balance between the two .
Speaker #3: Thank you, Muraka-san. Yes, it's a little bit too early. You're right. Guidance will be provided as usual in May. And the next fiscal year's budget is being finalized as we speak.
Speaker #1: We expect the growth products and launch products to continue to grow , but as you saw in the numbers in this fiscal year , they are beginning to This mature .
Speaker #1: can not be denied . But the gap between low and the growth and launch products is shrinking . Every quarter . So we need to see how this balance will work out for the next fiscal year .
Speaker #3: So, please give us some more time. With regard to the current momentum, I believe that we can give you some more information. Top line—well, growth of a growth and launch products.
Speaker #1: We are trying to figure that out now , so please give us some more time . As far as expenses are concerned , this fiscal year , the whole company endeavoured on saving the costs and we will this continue to make effort .
Speaker #3: Versus the LOE impact, I think it's a balance between the two. We expect the growth products and launch products to continue to grow, but as you saw in the numbers in this fiscal year, they are beginning to mature.
Speaker #3: This cannot be denied. But the gap between LOE and the growth and launch products is shrinking every quarter. So, we need to see how this balance will work out for the next fiscal year.
Speaker #1: Maruoka San , But like said you , launch costs three products . We launched within one year . This means will be that there some load burden .
Speaker #3: We are trying to figure that out now, so please give us some more time. As far as expenses are concerned, this fiscal year, the whole company endeavored to save costs, and we will continue to make this effort.
Speaker #1: But this uptake is very important for the future growth as well . This is a very important timing for us , so we will be discerning in terms of which are investments and we will not compromise in investing .
Speaker #1: These launches . As far as R&D is concerned . This fiscal year , we have been trying to save the costs and also at the same time , continue to drive various product projects .
Speaker #3: But Muraka-san, like you said, launch costs—three products we launched within one year. This means that there will be some load burden. But this uptake is very important for the future growth as well.
Speaker #1: So the innovation partnership , we have introduced new assets for Japan and for scale development is expected to start considering that impact expenses , R&D are likely to go up .
Speaker #3: This is a very important time for us. So, we will be discerning in terms of which investments are necessary, and we will not compromise.
Speaker #3: In investing these launches. As far as R&D is concerned, this fiscal year, we have been trying to save the costs and those at the same time continue to drive various product projects.
Speaker #1: I think that would be the correct way of reading it . But again , I would like to emphasize that we will continue to tighten the cost wherever we can .
Speaker #4: Or .
Speaker #3: So, with the Innovate Partnership, we have introduced new assets for Japan, and full-scale development is expected to start. Considering that impact, R&D expenses are likely to go up.
Speaker #1: And I hope that you can evaluate that as well . Do you have any comment about shareholder return ? Well , dividend . Yes .
Speaker #1: Progressive dividend is something that we have been talking about for a long time . So this is the basic policy . So either keep it flat or try to increase the dividend .
Speaker #3: I think that will be the correct way of reading it. But again, I would like to emphasize that we will continue to tighten the cost wherever we can.
Speaker #1: This is a base basis . Whether or not the dividend will increase and by how much . Well in order to decide that we have to look at the core EPs .
Speaker #3: And I hope that you can evaluate that as well. Do you have any comments about shareholder return? Well, dividend, yes. Progressive dividend is something that we have been talking about for a long time.
Speaker #1: And also reported EPs as well as cash flow generating power and speed of a reduction of varying debt , interest bearing debts . So we'll pay attention to those and decide , understand .
Speaker #3: So this is a basic policy. So either keep it flat or try to increase the dividend. This is the basis. Whether or not the dividend will increase and by how much, well, in order to decide that we have to look at the core EPS and also reported EPS, as well as cash flow-generating power, and speed of a reduction of debt-bearing interest-bearing debts.
Speaker #1: Thank you very much . I have a great expectations . I have another question about Dasatinib UC CD phase two outcome . When can we expect it ?
Speaker #1: And also , what about dosing phase two for UC was 50mg or 30mg . And what about the psoriasis safety data based safety on that data , can you perhaps comment on this ?
Speaker #3: So, we will pay attention to those and decide. Understand. Thank you very much. I have great expectations. I have another question about the subsidy need.
Speaker #2: the So question on timing for the UC and CD readouts for Tinib and which doses we are using ? Andy , if you could comment on that , please .
Speaker #5: Thanks , Chris . And thanks , Mercaston . So we'll have data from both the UC and Crohn's disease phase two studies . This this year .
Speaker #3: You said CD phase two, and also, what about those outcomes? When can we expect those things? Phase two for UC—was it 50 milligrams or 30 milligrams?
Speaker #5: dose Both are ranging studies . As we've mentioned , we disclosed the precise haven't we've doses , but as mentioned , the 30 milligram dose that we've studied in psoriasis and that will be registering for psoriasis is the low end of the dose range in IBD .
Speaker #3: And what about the psoriasis safety data? Based on that safety data, can you perhaps comment?
Speaker #3: on this? So the
Speaker #5: Question on timing for the UC and CD readouts for Zazasidnib, and which doses we are using? Andy, if you could comment on that.
Speaker #5: We have reason to believe that higher exposures will be necessary for efficacy . And you and Crohn's disease , and we have significant upwards headroom in dose to study .
Speaker #5: please. Thanks, Gretchen.
Speaker #6: Thanks, Muraka-san. So we'll have data from both the UC and Crohn's disease phase 2b studies this year; both are dose-ranging studies. As we've mentioned, we haven't disclosed the precise doses, but as we've mentioned, the 30 milligram dose that we've studied in psoriasis, and that we will be registering for psoriasis, is the low end of the dose range in IBD.
Speaker #5: So those those studies are ongoing . And then your last question was with respect to safety profile for psoriasis . So we've just commented that the top line in December when the phase three studies were read out , will be presenting at a medical conference in the in the near future , you could probably you could probably guess which conference we're targeting .
Speaker #5: And overall the safety profile that we've seen in both phase three studies is very consistent with the profile that we had seen previously in our phase two study .
Speaker #6: We have reason to believe that higher exposures will be necessary for efficacy in UC and Crohn's disease. And we have significant upwards headroom in dose to study.
Speaker #6: So those studies are ongoing. And then your last question was with respect to safety profile for psoriasis. So we've just commented that the top line in December when the phase three studies were read out will be presenting at a medical conference in the near future.
Speaker #3: That .
Speaker #8: Thank you very much .
Speaker #2: Much Thank you very . .
Speaker #1: very much . Next question Thank you is Yamaguchi Sang City , please . Can you hear me ? Yes , we can . Thank you .
Speaker #6: You could probably guess which conference we're targeting. And overall, the safety profile that we've seen in both Phase 3 studies is very consistent with the profile that we had seen previously in our Phase 2 study.
Speaker #9: Thank you very much . So this is Yamaguchi . I have two questions . First of all , the first one is more of a broad question because my and situation or medical policy in the United States seem to be a coming down because the major companies are now settled with the US government or MFN , but Japanese company , including your company , are still excluded from this discussion .
Speaker #5: So Understand.
Speaker #4: Thank you very much. Thank you very much. Next question. Is Yamaguchi-san on the line, please? Can you hear me? Yes, we can. Thank you.
Speaker #9: But what do you think about this sort of activity , which you need to do regarding MFN or US policy in the near future ?
Speaker #4: You. Yeah, I have two questions.
Speaker #9: That the classification ? The second question is regarding the organizational change , which you announced today , especially on the strategic portfolio development , which sounds like you're speed trying to up of the on some activity areas , especially in the US .
Speaker #7: First of all, the first one is more of a broad question, because the MFN situation or medical policy in the United States seems to be coming down, because major companies are now settled with the U.S. government on MFN.
Speaker #9: US marketing is a key for the next few years . And it depends on the products . But your marketing activity in the past are not necessarily executing better than expected , to be honest .
Speaker #7: But the Japanese company, including your company, are still excluded from this discussion. But what do you think about this sort of activity, which you need to do regarding MFN or U.S. policy in the near future?
Speaker #9: But how are you going to change , especially on the US marketing organizations or activities in the near future through the roles ? Or CEO roles in the near future ?
Speaker #7: That's the first question. The second question is regarding the organization change which you announced today, especially strategic portfolio development. You're trying to speed up on the summer marketing activity in those areas.
Speaker #9: Thank you . Two questions .
Speaker #2: Thank you . Yamaguchi . So the first question on on MFN and latest US policy updates . The second question regarding the organizational updates that we announced today .
Speaker #7: Especially in the US, US marketing is a key for the next few years. And it depends on the product, but your marketing activity in the past is not necessarily executing better than expected.
Speaker #2: So I'd like to call on Julie to address both of those questions , please . Julie .
Speaker #6: Yes , thank you , Yamaguchi for the questions . First , in regard to MFN , as you've noted , the number of companies , 17 companies that had originally received the the letters white from House , they have all gone in for a negotiated agreements in regards to how they will approach MFN , how they're going to be managing tariffs with the relief that they received and the further investments in the US .
Speaker #7: To be honest, but how are you going to change, especially on the US marketing organizations or activities, in the near future through Akimu-san's roles or CEO roles in the near future?
Speaker #7: Thank you. Two
Speaker #7: Thank you. Two questions. Thank you.
Speaker #5: Yamaguchi-san. So the first question on MFN and latest US policy updates. The second question regarding the organizational updates that we announced today. So I'd like to call on Julie to address both of those questions, please.
Speaker #5: Julie?
Speaker #6: So since those agreements have been made , there were also releases from the government in terms of the generous model , which details how these agreements can be actually implemented through Medicaid .
Speaker #8: Yes, thank you,
Speaker #8: Yamaguchi-san, for the questions. First, in regard to MFN, as you've noted, the number of companies is 17 companies that had originally received the letters from the White House.
Speaker #8: They have all gone in for negotiated agreements in regards to how they will approach MFN, how they are going to be managing tariffs with the relief that they received, and further investments in the US.
Speaker #6: And there have been a release of the both globe and sorry , globe and Guard CMMi demonstration projects for commentary by the public .
Speaker #6: So at this point , we have assessed both the impact of generous and looking at the potential design of the two CMI products on Takeda and the Takeda portfolio .
Speaker #8: So since those agreements have been made, there were also releases from the government in terms of the Generous Model, which details how these agreements can be actually implemented through Medicaid.
Speaker #6: So we evaluating those impacts and taking necessary steps to address that within within our approach to MFN . But let me end by saying that in general is , MFN not an approach that we support having price controls and importing one component of of healthcare systems that have very , very different structures does not make sense for the US .
Speaker #8: And there have been a release of both GLOBE and GARD CMMI demonstration projects for commentary by the public. So at this point, we have assessed both the impact of GLOBE and are looking at the potential design of the two CMMI products on Takeda and.
Speaker #6: And can impact future innovation . So we are not in favor of MFN , but we will continue to address the challenges that may face Takeda going forward .
Speaker #6: regard In to the organization changes that were announced today , you will see that from a commercial standpoint , there are basically two key structures that we are trying to focus on .
Speaker #6: One is a therapeutic one . And so you will see that the oncology business unit is still a separate business unit . Both Andy and Christophe have talked about the assets that we have brought in , particularly the Innovent ones , will be the key part of our oncology portfolio and we are very much looking forward to launching later this year .
Speaker #6: So maintaining a focus on oncology to drive that growth and potential that we have in our pipeline now is absolutely critical for the .
Speaker #6: upcoming And then launches , creating two primary geographic focus , one in the US , maintaining the US focus . size of Given the the market and the dynamics that exist that we have manage to to , that is part of being able to set ourselves for up success .
Speaker #6: Going forward . In terms of the commercial approach to the US as well as the international markets . So . What may be not as visible through the org are work that we're is the changes that doing announced in terms of our marketing excellence and sales excellence and commercial operations .
Speaker #6: So we are working on all those aspects again to ensure that we are ready and can deliver successful launches going forward . Thank you .
Speaker #9: Okay . Thank you .
Speaker #2: Thank you very much for the next question . I would like to call on Stephen Barker from Jefferies . Steve , please unmute and ask your question .
Speaker #10: Yes . Stephen Barker from Jefferies . Thanks for taking my questions . I have two questions , Entyvio both about . were The third quarter sales very robust .
Julie Kim: That we're doing in terms of our marketing excellence, and sales excellence, and commercial operations. So we are working on all those aspects, again, to ensure that we are ready and can deliver successful launches going forward. Thank you.
Julie Kim: That we're doing in terms of our marketing excellence, and sales excellence, and commercial operations. So we are working on all those aspects, again, to ensure that we are ready and can deliver successful launches going forward. Thank you.
Speaker #10: The global third quarter sales expanded 17% year on year on a reported basis . Much better than the 3% growth reported in the second quarter .
[Analyst]: Thank you.
[Analyst]: Thank you.
Speaker #10: You said that you're now confident that you can achieve your 6% guidance for the full year , but that would imply a 2% decline year on year .
Operator: Thank you very much. For the next question, I would like to call on Stephen Barker from Jefferies. Steve, please unmute and ask your question.
Operator: Thank you very much. For the next question, I would like to call on Stephen Barker from Jefferies. Steve, please unmute and ask your question.
Speaker #10: In fourth quarter sales . So would you agree that your that there's a decent chance at least that you could beat the the current guidance for full year 6% growth and and if you could just talk a little bit more about what's driving the good performance in the third quarter and if it is something that can be sustained into next year , that's the first question .
Stephen Barker: Yes, Stephen Barker from Jefferies. Thanks for taking my questions. I have two questions, both about Entyvio. The Q3 sales were very robust. The global Q3 sales expanded 17% year-on-year on a reported basis, much better than the 3% growth reported in the Q2. You said that you're now confident that you can achieve your 6% guidance for the full year, but that would imply a 2% decline year-on-year in Q4 sales. So would you agree that there's a decent chance, at least, that you could beat the current guidance for full-year 6% growth? And if you could just talk a little bit more about what's driving the good performance in the Q3, and if it is something that can be sustained into next year. That's the first question.
Stephen Barker: Yes, Stephen Barker from Jefferies. Thanks for taking my questions. I have two questions, both about Entyvio. The Q3 sales were very robust. The global Q3 sales expanded 17% year-on-year on a reported basis, much better than the 3% growth reported in the Q2. You said that you're now confident that you can achieve your 6% guidance for the full year, but that would imply a 2% decline year-on-year in Q4 sales. So would you agree that there's a decent chance, at least, that you could beat the current guidance for full-year 6% growth? And if you could just talk a little bit more about what's driving the good performance in the Q3, and if it is something that can be sustained into next year. That's the first question.
Speaker #10: And then second question , a couple of days ago , CMS announced that Entyvio has been chosen as one of the drugs for the third cycle of IRA Price negotiations , meaning that it's likely to get a substantial price Medicare cut from the start of 2028 .
Speaker #10: Any comments on how big that price cut might be ? And if you can still achieve your peak sales guidance of 7.5 to $9 billion , even with the price cut ?
Speaker #10: Thank you .
Stephen Barker: Then second question: a couple of days ago, CMS announced that Entyvio has been chosen as one of the drugs for the third cycle of IRA price negotiations, meaning that it's likely to get a substantial Medicare price cut from the start of 2028. Any comments on how big that price cut might be, and if you can still achieve your peak sales guidance of $7.5 to $9 billion, even with the price cut? Thank you.
Then second question: a couple of days ago, CMS announced that Entyvio has been chosen as one of the drugs for the third cycle of IRA price negotiations, meaning that it's likely to get a substantial Medicare price cut from the start of 2028. Any comments on how big that price cut might be, and if you can still achieve your peak sales guidance of $7.5 to $9 billion, even with the price cut? Thank you.
Speaker #2: Okay . Thank you Steve . So the question on Entyvio sales trend . Impact of IRA inclusion and the implications on peak sales .
Speaker #2: So I'd like to ask Christoph to to start with this one . And perhaps Julie can add some comments as well . Christoph .
Speaker #2: I'm sorry Christoph , I think you might be muted .
Speaker #3: Thank you . Thank you Steve . Obviously Entyvio is operating now in a very competitive market . We know that . But we are pleased by the Q3 performance .
Operator: Okay, thank you, Steve. So the question on Entyvio sales trend, impact of IRA inclusion, and the implications on peak sales. So I'd like to ask Christophe to start with this one, and perhaps Julie can add some comments as well. Christophe? Sorry, Christophe, I think you might be muted.
Operator: Okay, thank you, Steve. So the question on Entyvio sales trend, impact of IRA inclusion, and the implications on peak sales. So I'd like to ask Christophe to start with this one, and perhaps Julie can add some comments as well. Christophe? Sorry, Christophe, I think you might be muted.
Speaker #3: One important point is that we have improved our coverage situation in the US . All the big three now PBM are reimbursing , covering Entyvio pen took a while , but we have now coverage at the level of our competitors .
Speaker #3: Around 80% since January . So it's it's quite recent . So we are hopeful that the pen will continue to progress in the US as it has progressed in other countries .
Christophe Weber: Thank you, Steve. Obviously, Entyvio is operating now in a very competitive market. We know that, but we are pleased by the Q3 performance. One important point is that we have improved our coverage situation in the US. All the big three now, PBMs, are reimbursing and covering Entyvio Pen. Took a while, but we have now a coverage at the level of our competitors, around 80%, since January, so it's quite recent. So we are hopeful that the Pen will continue to progress in the US, as it has progressed in other countries. And long term, we still aim to have a 50/50 split between the IV and the Pen. So overall, good performance in Q3. Long term, we project Entyvio not to gain market share, but to remain stable and to grow at market pace, basically, while the Pen is developing.
Christophe Weber: Thank you, Steve. Obviously, Entyvio is operating now in a very competitive market. We know that, but we are pleased by the Q3 performance. One important point is that we have improved our coverage situation in the US. All the big three now, PBMs, are reimbursing and covering Entyvio Pen. Took a while, but we have now a coverage at the level of our competitors, around 80%, since January, so it's quite recent. So we are hopeful that the Pen will continue to progress in the US, as it has progressed in other countries. And long term, we still aim to have a 50/50 split between the IV and the Pen. So overall, good performance in Q3. Long term, we project Entyvio not to gain market share, but to remain stable and to grow at market pace, basically, while the Pen is developing.
Speaker #3: And long term , we we still aim to have a 5050 split between the the IV and the pen . So overall , you know , a good performance in Q3 long term , the , the the we project gain not to entyvio market share , but to remain to stable and grow at at market pace , basically , while the pen is , is is developing .
Speaker #3: That's our current is you know , But changing the market quite a bit . But good performance for sure . In in Q3 .
Speaker #6: And then Stephen , regards to the IRA selection of of Entyvio , as we've shared in the past , this was anticipated . And so we've been preparing for this eventuality .
Speaker #6: You know , from a timing perspective , we have a period of time in which we have to confirm engagement in the negotiation and then towards the end of the year , we will actually find out what price will be set , as I think you are also aware , it's not really a negotiation , but we will be submitting our best evidence package to support Entyvio .
Christophe Weber: That's our current estimation, but the market is changing quite a bit. But good performance for sure in Q3.
That's our current estimation, but the market is changing quite a bit. But good performance for sure in Q3.
Julie Kim: And then, Steve, in regards to the IRA selection of Entyvio, as we've shared in the past, this was anticipated, and so we've been preparing for this eventuality. As you know, from a timing perspective, we have a period of time in which we have to confirm engagement in the negotiation, and then towards the end of the year, we will actually find out what price will be set. I think you are also aware it's not really a negotiation, but we will be submitting our best evidence package to support Entyvio. If you look at what's been happening over the previous two cohorts, the second cohort had higher price cuts than the first cohort. So it is too early to say whether that trend will continue into the third cohort or whether it will be similar to the second cohort.
Julie Kim: And then, Steve, in regards to the IRA selection of Entyvio, as we've shared in the past, this was anticipated, and so we've been preparing for this eventuality. As you know, from a timing perspective, we have a period of time in which we have to confirm engagement in the negotiation, and then towards the end of the year, we will actually find out what price will be set. I think you are also aware it's not really a negotiation, but we will be submitting our best evidence package to support Entyvio. If you look at what's been happening over the previous two cohorts, the second cohort had higher price cuts than the first cohort. So it is too early to say whether that trend will continue into the third cohort or whether it will be similar to the second cohort.
Speaker #6: If you look at what's been happening over the previous two cohorts , the second cohort had a higher price cuts than the first cohort .
Speaker #6: it is say early to So too whether that will trend continue into the third cohort or whether it will be similar the second to cohort .
Speaker #6: So it really depends on where we land with the final pricing on Entyvio in terms of when that peak sale could , sorry , peak revenue could be , and also if we end up in the 7.5 to to nine or not .
Speaker #6: So we will update later once we understand what our pricing situation will be for Entyvio . Thank you . .
Speaker #10: Understood . Thank you very much .
Speaker #2: Arigatou gozaimasu .
Speaker #1: Next question is from Matsubara Nomura Securities . Please unmute and ask a question . This is Matsubara Securities . Thank you . First question is about takhzyro on a seasonal basis from the second quarter .
Julie Kim: So it really depends on where we land with the final pricing on Entyvio in terms of when that peak sales could, sorry, peak revenue could be, and also if we end up in the 7.5 to 9 or not. So we will update later once we understand what our pricing situation will be for Entyvio. Thank you.
So it really depends on where we land with the final pricing on Entyvio in terms of when that peak sales could, sorry, peak revenue could be, and also if we end up in the 7.5 to 9 or not. So we will update later once we understand what our pricing situation will be for Entyvio. Thank you.
Speaker #1: The growth rate seems to be slowing down and is it affected by competitor the Donzella and the transition from Takhzyro to Donzella and high rate showing some 65% decrease .
[Analyst]: Understood. Thank you very much.
Stephen Barker: Understood. Thank you very much.
Operator: ありがとうございました。それでは次のご質問。
Operator: ありがとうございました。それでは次のご質問。
Speaker #1: So what about the prescription rate in existing patients or new patients ? Could you comment on those ? Second is as Sam mentioned , overproduction .
Hiroyuki Matsubara: Next question is from Matsubara-san, Nomura Securities. Please unmute and ask a question. This is Matsubara at Nomura Securities. Thank you. First question is about Takhzyro. On a CER basis, from Q2, the growth rate seems to be slowing down. Is it affected by the competitor, Donzera? And the transition from Takhzyro to Donzera and HAE attack rate showing some 65% decrease. So what about the prescription rate in existing patients or new patients? Could you comment on those? As Milano-san mentioned, Oveporexton and the associated need will be launched, and also R&D spending, more spending will be necessary. In the mid-term viewpoint, as you try to increase the operating profit, how are you going to take measures?
Next question is from Matsubara-san, Nomura Securities. Please unmute and ask a question.
Hiroyuki Matsubara: This is Matsubara at Nomura Securities. Thank you. First question is about Takhzyro. On a CER basis, from Q2, the growth rate seems to be slowing down. Is it affected by the competitor, Donzera? And the transition from Takhzyro to Donzera and HAE attack rate showing some 65% decrease. So what about the prescription rate in existing patients or new patients? Could you comment on those? As Milano-san mentioned, Oveporexton and the associated need will be launched, and also R&D spending, more spending will be necessary. In the mid-term viewpoint, as you try to increase the operating profit, how are you going to take measures?
Speaker #1: And zastosowanie will be launched . And also R&D spending , more spending will be necessary . And in the mid-term viewpoint . As you try to increase the operating profit , how are you going to take measures .
Speaker #2: For your questions ? So the first around recent zero trends , prescription trends in the US , I'd like to ask Julie to comment on that .
Speaker #2: And then the second question , looking at for over the profit medium term , I'd like to ask comment on that . Milano to Please .
Speaker #2: First , Julie .
Speaker #6: Yes , thank you for the question . Matsubara San . When it comes to Takhzyro , will I share a few comments . First , in terms of the overall market , this is a market that has been maturing .
[Company Representative] (Takeda): Thank you, Matsubara-san, for your questions. So the first around recent Takhzyro trends, prescription trends in the US. I'd like to ask Julie to comment on that. And then the second question, looking at outlook for profit over the medium term, I'd like to ask Milano to comment on that, please. First, Julie?
Operator: Thank you, Matsubara-san, for your questions. So the first around recent Takhzyro trends, prescription trends in the US. I'd like to ask Julie to comment on that. And then the second question, looking at outlook for profit over the medium term, I'd like to ask Milano to comment on that, please. First, Julie?
Speaker #6: The diagnosis rate is high and the penetration of prophylaxis treatments has been high as well . So Takhzyro continues to be the gold standard for high patients .
Speaker #6: And you are correct that we have seen an impact of the launches of the two competitive recent competitive entrants . And so we are seeing an impact in terms of new starts from these new competitive entrants .
Julie Kim: Yes, thank you for the question, Matsubara-san. When it comes to Takhzyro, I will share a few comments. First, in terms of the overall market, this is a market that has been maturing. The diagnosis rate is high, and the penetration of prophylaxis treatments has been high as well. So Takhzyro continues to be the gold standard for HAE patients. And you are correct that we have seen an impact of the launches of the two recent competitive entrants. And so we are seeing an impact in terms of new starts from these new competitive entrants. But I also want to point out that part of the lower growth is also due from the impact of Medicare Part D redesign, that we are experiencing a bit higher impact from that in the US than anticipated.
Julie Kim: Yes, thank you for the question, Matsubara-san. When it comes to Takhzyro, I will share a few comments. First, in terms of the overall market, this is a market that has been maturing. The diagnosis rate is high, and the penetration of prophylaxis treatments has been high as well. So Takhzyro continues to be the gold standard for HAE patients. And you are correct that we have seen an impact of the launches of the two recent competitive entrants. And so we are seeing an impact in terms of new starts from these new competitive entrants. But I also want to point out that part of the lower growth is also due from the impact of Medicare Part D redesign, that we are experiencing a bit higher impact from that in the US than anticipated.
Speaker #6: But I also want to point out that part of the lower growth is also due from the impact of Medicare Part D redesign that we experiencing are a bit higher impact from that in the US than anticipated .
Speaker #6: Now , when it comes to long term efficacy , if you look at the real world evidence that we have for tech zero , no other product is able to demonstrate the level of efficacy that we have .
Speaker #6: When you look at the data from an attack perspective , we have patients that are attack free for over a year at any given point in time .
Speaker #6: And so from an efficacy standpoint , our real world data for tech zero , it can't be beat . So that is something that I would like to highlight .
Julie Kim: Now, when it comes to long-term efficacy, if you look at the real-world evidence that we have for Takhzyro, no other product is able to demonstrate the level of efficacy that we have. When you look at the data from an attack perspective, we have patients that are attack-free for over a year at any given point in time. And so from an efficacy standpoint, our real-world data for Takhzyro, it can't be beat. So that is something that I would like to highlight, and it's something that we continue to defend and support from a Takhzyro standpoint.
Now, when it comes to long-term efficacy, if you look at the real-world evidence that we have for Takhzyro, no other product is able to demonstrate the level of efficacy that we have. When you look at the data from an attack perspective, we have patients that are attack-free for over a year at any given point in time. And so from an efficacy standpoint, our real-world data for Takhzyro, it can't be beat. So that is something that I would like to highlight, and it's something that we continue to defend and support from a Takhzyro standpoint.
Speaker #6: And it's something that we continue to defend . And support from a tech zero standpoint .
Speaker #4: I know .
Speaker #1: Thank you very much . And I'd like to answer to your the at beginning .
Speaker #1: second question As
Speaker #4: .
Speaker #1: Mallorca San also asked , and I mentioned about the pressure of overall expenditure increase and therefore I'd like to touch upon the potential contribution of new products to the profit .
Speaker #1: And this is a general comment that whenever new products come out , then in the second year or the third year , since its launch , we will see a contribution to the profit .
Hiroyuki Matsubara: Thank you very much, Matsubara-san, and I'd like to answer to your second question. At the beginning, as Miraoka-san also asked, and I mentioned about the pressure of overall expenditure increase. Therefore, I'd like to touch upon the potential contribution of new products to the profit. This is a general comment that whenever new products come out, then in the second year or the third year since its launch, we will see a contribution to the profit. It depends on the timing of the launches. Therefore, it is difficult for us to say anything concrete, whether it's going to be next year or the year after the next and how much. But amongst the three products, Oveporexton uptake after the launch is expected to be fast, whereas Zasocetinib will have to play in the very highly competitive market.
Thank you very much, Matsubara-san, and I'd like to answer to your second question. At the beginning, as Miraoka-san also asked, and I mentioned about the pressure of overall expenditure increase. Therefore, I'd like to touch upon the potential contribution of new products to the profit. This is a general comment that whenever new products come out, then in the second year or the third year since its launch, we will see a contribution to the profit. It depends on the timing of the launches. Therefore, it is difficult for us to say anything concrete, whether it's going to be next year or the year after the next and how much. But amongst the three products, Oveporexton uptake after the launch is expected to be fast, whereas Zasocetinib will have to play in the very highly competitive market.
Speaker #1: It depends on the timing of the launches . Therefore , it is difficult for us to say anything concrete , whether it's going to be next year or the year after the next , and how much .
Speaker #1: But amongst the three products of preparations , uptake . After the launch is expected to be fast Zaslow , whereas Sataniv will have to play in the very highly competitive market .
Speaker #1: Therefore , I think for that , I think we need to take time to monitor and with few tide is in between . It is highly innovative product , but at the same time , the market access may not necessarily be so easy .
Speaker #1: Therefore , how that will demonstrate the uptake would like to monitor . But the speed of uptake will be impacting on to the that timing we start to see the product contribution to the profit .
To the profit. And this is a general comment that whenever new products come out, then in the second year or the third year since its launch, we will see a contribution to the profit. It depends on the timing of the launches, therefore, it is difficult for us to say anything concrete—whether it's going to be next year or the year after the next, and how much. But, amongst three products of the products...
Hiroyuki Matsubara: Therefore, I think for Zasocetinib, I think we need to take time to monitor. And Rusfertide is in between. It is a highly innovative product, but at the same time, the market access may not necessarily be so easy. Therefore, how that will demonstrate uptake, we'd like to monitor. But the speed of uptake will be impacting onto the timing that we start to see the product contribution to the profit. And also, not just these three products, but five new pipeline assets readouts are coming, and in forthcoming five or six years, they will continue to be launched. And as a result, overall, I think that the overall profit level should be able to be enhanced. At the same time, not just the core OP, but the reported operating profit is also monitored. For instance, Vyvanse, the intangible asset, the amortization will be complete.
Therefore, I think for Zasocetinib, I think we need to take time to monitor. And Rusfertide is in between. It is a highly innovative product, but at the same time, the market access may not necessarily be so easy. Therefore, how that will demonstrate uptake, we'd like to monitor. But the speed of uptake will be impacting onto the timing that we start to see the product contribution to the profit. And also, not just these three products, but five new pipeline assets readouts are coming, and in forthcoming five or six years, they will continue to be launched. And as a result, overall, I think that the overall profit level should be able to be enhanced. At the same time, not just the core OP, but the reported operating profit is also monitored. For instance, Vyvanse, the intangible asset, the amortization will be complete.
Speaker #1: And also just not these three products , but five new pipeline assets , readouts are coming and in forthcoming 5 or 6 years , they will to continue be launched .
And, uh, we feel TIGHT is in between. It is a highly innovative product, but at the same time, the market access...
Speaker #1: And as a result , overall , I think that the overall profit level should be able to be enhanced at time , the same not just the core or B , but the reported operating profit .
may not necessarily be so easy.
Therefore, how that will demonstrate the uptake, we would like to monitor.
But the speed of uptake.
Speaker #4: Q4 and Vyvanse . No .
Speaker #1: It's also monitored for instance , Vyvanse , the intangible asset , the amortization will be complete and as a result , there will be also a positive contribution in that sense .
Uh, it will be impacting the timing that we started to see the product contribution to the profit.
And, uh, also not just these three products, but, uh, five.
Speaker #1: Thank you .
Speaker #2: Thank you very much for the question . Moving on to the next question , I would like to call on from TD Cowen Michael Nedelcovych .
Speaker #2: Mike , please unmute and ask your question .
New pipeline assets, readouts are coming and, uh, in force in the coming five or six years, they will continue to be launched. And as a result, overall, I think that the overall profit level should be able to be enhanced.
Speaker #11: Great . Thank you so much for the questions . I have two . My first is also related to the IRA impact on Entyvio .
At the same time, not just the core for BE, but the reported operating profit.
Speaker #11: I believe it is Takeda's base case that Entyvio pen will be in the included IRA price But I'm if that is negotiation . a completely curious settled matter or Is there that not .
Hiroyuki Matsubara: As a result, there will be also a positive contribution in that sense. Thank you.
As a result, there will be also a positive contribution in that sense. Thank you.
Speaker #11: any chance ultimately pen is Entyvio excluded from negotiation ? That's my first question . And then my second question relates to the partnered AC immune asset .
Operator: Thank you very much for the question. Moving on to the next question, I would like to call on from TD Cowen, Mike Nedelcovych. Mike, please unmute and ask your question.
Operator: Thank you very much for the question. Moving on to the next question, I would like to call on from TD Cowen, Mike Nedelcovych. Mike, please unmute and ask your question.
Uh, it's also monitored, for instance, violence—uh, the intangible asset—uh, the amortization. We will be complete, and uh, as a result, there will also be a positive contribution in that sense. Thank you.
Thank you very much for the question.
Speaker #11: In Alzheimer's . It looks like data may be anticipated mid this year . Should we expect that to be the time when Takeda decides if it wants to opt in or not ?
Stephen Barker: Thank you so much for the questions. I had two. My first is also related to the IRA impact on Entyvio. I believe it is Takeda's base case that Entyvio Pen will be included in the IRA price negotiation, but I'm curious if that is a completely settled matter or not. Is there any chance that Entyvio Pen is ultimately excluded from IRA price negotiation? That's my first question. And then my second question relates to the partnered AC Immune asset in Alzheimer's. It looks like data may be anticipated mid this year. Should we expect that to be the time when Takeda decides if it wants to opt in or not? And Andy, I'm curious to hear your thoughts more broadly on prospects for Alzheimer's disease prevention or delay based on early amyloid plaque clearance. What are your general thoughts on this approach? Thank you.
Michael Nedelcovych: Thank you so much for the questions. I had two. My first is also related to the IRA impact on Entyvio. I believe it is Takeda's base case that Entyvio Pen will be included in the IRA price negotiation, but I'm curious if that is a completely settled matter or not. Is there any chance that Entyvio Pen is ultimately excluded from IRA price negotiation? That's my first question. And then my second question relates to the partnered AC Immune asset in Alzheimer's. It looks like data may be anticipated mid this year. Should we expect that to be the time when Takeda decides if it wants to opt in or not? And Andy, I'm curious to hear your thoughts more broadly on prospects for Alzheimer's disease prevention or delay based on early amyloid plaque clearance. What are your general thoughts on this approach? Thank you.
Speaker #11: And Andy , I'm curious to thoughts hear your more broadly on prospects for Alzheimer's disease prevention or delay based on early amyloid plaque clearance .
Speaker #11: What are your thoughts on this approach ? Thank you .
Speaker #2: Thank you Mike . I think the first question , Julie , can comment on IRA Entyvio and impact on potential impact on pen , and then the second question to Andy on the AC immune partnership .
Speaker #2: And Adi in general . Julie .
Speaker #6: Hi . Thanks for the question , Mike . And in terms of the negotiation with the IRA , we do expect that pen will be included .
Speaker #5: on the And Mike , AC immune program . So we won't data this have year to drive a decision that will in subsequent come years .
Speaker #5: And and thanks for asking . More generally , of course , I've been working in this industry for almost three decades now , and the first project I worked on was a project in of a gamma secretase inhibitor designed to reduce a-beta production .
Operator: Thank you, Mike. So I think the first question, Julie can comment on IRA, Entyvio impact, potential impact on Entyvio Pen, and then the second question to Andy on the AC Immune partnership and AD in general. Julie?
Operator: Thank you, Mike. So I think the first question, Julie can comment on IRA, Entyvio impact, potential impact on Entyvio Pen, and then the second question to Andy on the AC Immune partnership and AD in general. Julie?
Moving on to the next question. I would like to call on, uh, from TD Cowen, Mike Nadulovic. Mike, please unmute and ask your question.
Great, thank you so much for the questions. I have two. Uh, my first is also related to the IRA impact on antibio. I—I believe it is Takeda's base case that Iniv of Pain will be included in the IRA price negotiation. But I'm curious if that is a completely settled matter or not. Is there any chance that Iniv of Pain is ultimately excluded from price negotiation? That's my first question.
And then my second question relates to the partnered AC Immune asset in Alzheimer's. It looks like data may be anticipated in mid this year. Should we expect that to be the time when Takeda decides if it wants to opt in or not? And Andy, I'm curious to hear your thoughts more broadly on prospects for Alzheimer's disease prevention or delay based on early amyloid plaque clearance. What are your general thoughts on this approach? Thank you.
Speaker #5: It's been one of , to me , one of the most exciting and promising , but also one of the most challenging areas in our industry .
Thank you, Mike. So, I think the first question, uh, Julie can comment on IRA and give you an impact on potential impact on pain. And then the second question to Andy on the AC Immune partnership and AD in general. Julie.
Julie Kim: Hi, thanks for the question, Mike. In terms of the negotiation with the IRA, we do expect that PEN will be included.
Julie Kim: Hi, thanks for the question, Mike. In terms of the negotiation with the IRA, we do expect that PEN will be included.
Speaker #5: I'm a I'm a big believer that if we could clear A-beta plaque early in the in the longitudinal course of Alzheimer's disease , that we could drive even greater benefits than what we see from the from the from the passive antibodies that have been used in demonstrated efficacy .
Hi, thanks for the question, Mike. And in terms of the negotiation with the IRA, we do expect that Penn will be included.
Andrew Plump: And Mike on the AC Immune program. So we won't have data this year to drive a decision. That will come in subsequent years. And thanks for asking more generally. Of course, I've been working in this industry for almost three decades now. The first project I worked on was a project of a gamma secretase inhibitor designed to reduce A beta production. It's been, to me, one of the most exciting and promising, but also one of the most challenging areas in our industry. I'm a big believer that if we could clear A beta plaque early in the longitudinal course of Alzheimer's disease, that we could drive even greater benefits than what we see from the passive antibodies that have been used and demonstrated efficacy. So we're quite excited about the vaccine program.
Andrew Plump: And Mike on the AC Immune program. So we won't have data this year to drive a decision. That will come in subsequent years. And thanks for asking more generally. Of course, I've been working in this industry for almost three decades now. The first project I worked on was a project of a gamma secretase inhibitor designed to reduce A beta production. It's been, to me, one of the most exciting and promising, but also one of the most challenging areas in our industry. I'm a big believer that if we could clear A beta plaque early in the longitudinal course of Alzheimer's disease, that we could drive even greater benefits than what we see from the passive antibodies that have been used and demonstrated efficacy. So we're quite excited about the vaccine program.
Speaker #5: So we're excited quite about the vaccine program , of course , the challenge with the historically with the vaccines has been the threading needle of safety and efficacy .
Speaker #5: think we We have a shot with the with our partners and still working towards that .
Speaker #11: Thank you so much .
Speaker #2: Arigatou gozaimasu .
Speaker #1: Thank you very much .
Speaker #2: JP Morgan .
Speaker #1: , next question is what caused JP Morgan ? Please unmute and ask a question . This is a JP Morgan . Thank you for this opportunity .
Andrew Plump: Of course, the challenge historically with the vaccines has been threading the needle of safety and efficacy. We think we have a shot with our AC Immune partners, and still working towards that.
Of course, the challenge historically with the vaccines has been threading the needle of safety and efficacy. We think we have a shot with our AC Immune partners, and still working towards that.
Speaker #12: JP Morgan I have two questions . Firstly , regarding PDT , how do you assess the Sarcoid progression of PDT compared with your guidance ?
And, and Mike on, um, the AC immune program. So we we, we won't have data this year to drive a decision that will come in, in subsequent years. And, um, and and thanks for asking more generally. Of course, I've been working in this industry for almost 3 decades now. And the first project I worked on was a project in of a gamma secretase inhibitor designed to reduce a beta production. It's been 1 of to me, 1 of the most exciting and promising but also 1 of the most challenging areas in our industry. Um, I'm a I'm a big believer that if we could clear a beta plaque early, um, in the, in the longitudinal course of Alzheimer's disease that we could drive even greater benefits than what we see the from the, from the, um, from the passive antibodies that have been used and demonstrated efficacy. So, we're quite excited about the vaccine program. Of course, the challenge with the historically, with the vaccines has been threading, the needle of safety,
Speaker #12: PDT progress seems to have been somewhat slower and could you share your drug for BDD in fourth quarter and next fiscal year ? This is the first question .
And efficacy. We think we have a shot with the AC, with our AC Immune partners, um, and still working towards that.
Operator: Thank you so much.
Michael Nedelcovych: Thank you so much.
Hiroyuki Matsubara: Thank you very much. Next question is Wakao-san. J.P. Morgan, please unmute and ask a question. This is Wakao, J.P. Morgan. Thank you for this opportunity.
Operator: Thank you very much. Next question is Wakao-san. J.P. Morgan, please unmute and ask a question. This is Wakao, JPMorgan. Thank you for this opportunity.
Speaker #12: And second question is about the associate . Should we expect the associate efficacy data to be presented to aid in March ? If so , what key aspects should we focus on ?
Thank you very much.
Next question. Is there a vocal sound? JP Morgan, please unmute.
Speaker #12: As I and other programs shown have , favorable data ? Also , where do you see the key point of differentiation ?
Seiji Wakao: I have two questions. Firstly, regarding PDT, how do you assess the cited progress of PDT? Compared with your guidance, PDT progress seems to have been somewhat slower. Could you share your outlook for PDT in Q4 and next fiscal year? This is the first question. The second question is about Zasocetinib. Should we expect Zasocetinib efficacy data to be presented at AAD in March? If so, what key aspects should we focus on? As Icotrokinra and Alumis programs have shown favorable data, also, where do you see Zasocetinib's key point of differentiation?
Seiji Wakao: I have two questions. Firstly, regarding PDT, how do you assess the cited progress of PDT? Compared with your guidance, PDT progress seems to have been somewhat slower. Could you share your outlook for PDT in Q4 and next fiscal year? This is the first question. The second question is about Zasocetinib. Should we expect Zasocetinib efficacy data to be presented at AAD in March? If so, what key aspects should we focus on? As Icotrokinra and Alumis programs have shown favorable data, also, where do you see Zasocetinib's key point of differentiation?
Ask a question. This is J.P. Morgan. Thank you for this opportunity.
Speaker #2: Thank you . Okay , so the first question on PDT , business Performance and outlook . I'd like to ask Julie to comment on that .
I have two questions. Firstly, regarding PDT—how do you assess the S code? Could progress not PD compared with your guidance, PD progress? Seems to have been somewhat unsure.
Speaker #2: And the second question on Zazo data , where will it be presented and what should we focus on in that data ? I'd like to ask Andy to comment on that .
Speaker #2: Please .
And could you share your outlook for BDD in FOR scorer? And next? Next fiscal year. This is the first question. And the second question is about Jaso ship.
Speaker #6: Thank the question . you for In regards to PDT , as Milano was sharing in his part of the presentation earlier , we do see some slowdown in demand , particularly in regards to albumin in China .
Speaker #6: As you may be aware , the Chinese government has put in place utilization are guidelines that impacting demand for albumin in China , and it it will has a slowed down the growth and it will take time growth to for return in .
As IoT and Alist programs have shown favorable data, also, where do you see the key point of differentiation?
Operator: Thank you, Wakao-san. So the first question on the PDT business performance and outlook, I'd like to ask you to comment on that. And the second question on Zasocetinib data, where will it be presented and what should we focus on in that data? I'd like to ask Andy to comment on that, please.
Operator: Thank you, Wakao-san. So the first question on the PDT business performance and outlook, I'd like to ask you to comment on that. And the second question on Zasocetinib data, where will it be presented and what should we focus on in that data? I'd like to ask Andy to comment on that, please.
Thank you. So, the first question on the PDT business performance and outlook, I'd like to ask you on that. And the second question on ZAZO data—where will it be presented, and what should we be focused on in that data? I'd like to ask Andy to comment on that, please.
Julie Kim: Thank you for the question, Wakao-san. In regards to PDT, as Milano was sharing in his part of the presentation earlier, we do see some slowdown in demand, particularly in regards to albumin in China. As you may be aware, the Chinese government has put in place utilization guidelines that are impacting demand for albumin in China. It has slowed down the growth, and it will take time for growth to return in China. When you look at the overall outlook for PDT overall, there we still believe we will have mid-single-digit growth for this year, as previously shared, and longer-term outlook is still strong. The quarter to quarter, as you know, because there are lots of variabilities in regard to tender timing, etc., we do, as Milano mentioned, we do believe that there is a possibility we will have a shortfall, particularly in regards to albumin.
Julie Kim: Thank you for the question, Wakao-san. In regards to PDT, as Milano was sharing in his part of the presentation earlier, we do see some slowdown in demand, particularly in regards to albumin in China. As you may be aware, the Chinese government has put in place utilization guidelines that are impacting demand for albumin in China. It has slowed down the growth, and it will take time for growth to return in China. When you look at the overall outlook for PDT overall, there we still believe we will have mid-single-digit growth for this year, as previously shared, and longer-term outlook is still strong. The quarter to quarter, as you know, because there are lots of variabilities in regard to tender timing, etc., we do, as Milano mentioned, we do believe that there is a possibility we will have a shortfall, particularly in regards to albumin.
Speaker #6: When you look at the overall outlook for PDT overall there , we still believe we will have mid-single digit growth for this year as .
Speaker #6: Previously shared and longer term outlook is still strong . The quarter to quarter , as you know , because there are lots of variabilities in regard to tender timing , etc.
Speaker #6: we do as Milano mentioned , we do believe that there is a possibility we will have a shortfall regards to to , particularly in albumin .
Speaker #6: But overall we will be meeting the the forecast for PDT .
Thank you for the question. In regards to PDT, as Milano was sharing in his part of the presentation earlier, we do, uh, see some slowdown in demand, particularly in regards to Alban in China. Uh, as you may be aware, the Chinese government has put in place utilization guidelines that are impacting, uh, demand for Alban in China. And it has, uh, slowed down the growth and it will take time, uh, for growth to return in China. When you look at the overall outlook for PDT overall,
Speaker #5: sorry . Please I'm
Speaker #5: .
Speaker #12: also could you So comment on the immunoglobulin ?
Speaker #6: sure . Oh , Yes . From an immunoglobulin perspective . Again long term growth . We we believe will remain steady a and from short term perspective , we are we are expecting to be on forecast for immunoglobulin .
Speaker #12: Okay .
Julie Kim: But overall, we will be meeting the forecast for PDT.
Julie Kim: But overall, we will be meeting the forecast for PDT.
Speaker #5: And and this is Andy . So thank you for your question on Dasatinib . So we haven't disclosed yet the conference that we'll be presenting at .
There we still believe we will have uh mid single digit growth for the year as previously, shared and longer term Outlook is still strong. The quarter to quarter, as you know, because there are lots of variabilities in regard to Tender timing Etc. Um, we we do as Milano mentioned, uh, we do believe that there is a possibility, we will have a shortfall particularly in regards to to aliment, uh, but overall we will be meeting the the forecast for PBT.
Speaker #5: But but Adi , certainly is like is a possibility . Just to suggest that you watch out for the abstract when they're released in mid mid-February day for a .
Seiji Wakao: I'm sorry, please. So could you also comment on the Immunoglobulin?
Seiji Wakao: I'm sorry, please. So could you also comment on the Immunoglobulin?
I'm sorry, please.
Julie Kim: Oh, sure. Yes, from an Immunoglobulin perspective, again, long-term growth we believe will remain steady. From a short-term perspective, we are expecting to be on forecast for Immunoglobulin.
Julie Kim: Oh, sure. Yes, from an Immunoglobulin perspective, again, long-term growth we believe will remain steady. From a short-term perspective, we are expecting to be on forecast for Immunoglobulin.
Uh, so could you also comment on that?
Oh sure.
Speaker #5: And then in terms of what to look for , it's pretty , pretty straightforward . We it's fast onset of action . It's clear skin and its ease of administration .
Speaker #5: We have a once daily oral pill that's well strong a safety profile . double And then when you click , you'll see that in the two phase three studies we hit on every single primary and secondary endpoint .
Yes, from an immigrant perspective again, long-term growth, we we believe will remain steady, um, and from a short term perspective. Uh, we are, we are expecting to be
Andrew Plump: Okay. And Wakao-san, this is Andy. So thank you for your question on zasocetinib. So we haven't disclosed yet the conference that we'll be presenting at, but AAD certainly is a possibility. Just suggest that you watch out for the abstract when they're released in mid-February for AAD. And then in terms of what to look for, it's pretty straightforward. It's fast onset of action, it's clear skin, and it's ease of administration. We have a once-daily oral pill that's well tolerated with a strong safety profile. When you double-click, you'll see that in the 2 phase 3 studies, we hit on every single primary and secondary endpoint. That's 44 total endpoints. So there'll be a lot of data that will be shared, and we're quite excited to get it out there.
Andrew Plump: Okay. And Wakao-san, this is Andy. So thank you for your question on zasocetinib. So we haven't disclosed yet the conference that we'll be presenting at, but AAD certainly is a possibility. Just suggest that you watch out for the abstract when they're released in mid-February for AAD. And then in terms of what to look for, it's pretty straightforward. It's fast onset of action, it's clear skin, and it's ease of administration. We have a once-daily oral pill that's well tolerated with a strong safety profile. When you double-click, you'll see that in the 2 phase 3 studies, we hit on every single primary and secondary endpoint. That's 44 total endpoints. So there'll be a lot of data that will be shared, and we're quite excited to get it out there.
Uh, on forecast for immunoglobulin.
Okay.
Speaker #5: And that's 44 total endpoints . So there'll be a lot of data that will be shared . And we're quite excited to get it out there .
Speaker #12: All right so what is a competitive advantage .
Speaker #5: Well well it's a it's a it's a has as we mentioned over the over the last hour . It has an efficacy profile that at 16 weeks is at the very high end of what's been seen for oral agents .
And we'll cast on this is Andy. So, thank you for your question on Zaza snib. So we haven't disclosed yet the conference that will be presenting at. But, um, but a these certainly is, is like is a possibility. Just suggest that you watch out for the abstract when they're released in mid mid-February for a day and then in terms of what to look for. Um, it's, you know, pretty pretty straightforward, we
Speaker #5: It's , it's ease of administration without having any , any food effects . It's and it's the overall profile and it's the rapidity with which we generate clear skin in an oral agent .
Speaker #5: You know , we we believe and we think the data will demonstrate that it's as good or better than any other oral option in the moderate to severe plaque psoriasis space
Speaker #5: You know , we we believe and we think the data will demonstrate that it's as good or better than any other oral option in the moderate to severe plaque psoriasis space
Fast onset of action. It's clear skin and its ease of administration. Um, we have a once-daily oral pill that's well tolerated with a strong safety profile. Um, and when you double-click, you'll see that in the two Phase 3 studies, we hit on every single primary and secondary endpoint—that's 44 total endpoints. So there will be a lot of data that will be shared, and we're quite excited to get it out there.
Seiji Wakao: All right. So what is the competitive advantage?
Seiji Wakao: All right. So what is the competitive advantage?
Andrew Plump: Well, it has, as we mentioned over the last hour, it has an efficacy profile that at 16 weeks is at the very high end of what's been seen for oral agents. It's ease of administration without having any food effects. And it's the overall profile, and it's the rapidity with which we generate clear skin in an oral agent. We believe, and we think the data will demonstrate that it's as good or better than any other oral option in the moderate to severe plaque psoriasis space.
Andrew Plump: Well, it has, as we mentioned over the last hour, it has an efficacy profile that at 16 weeks is at the very high end of what's been seen for oral agents. It's ease of administration without having any food effects. And it's the overall profile, and it's the rapidity with which we generate clear skin in an oral agent. We believe, and we think the data will demonstrate that it's as good or better than any other oral option in the moderate to severe plaque psoriasis space.
All right. So, what is a competitive advantage?
Speaker #12: I'm looking forward . Okay , data . Thank you .
Speaker #12: to see
Speaker #2: Okay . Thank you very much . I think we have just time for one final question . So I'd like to call on Tony Ren from Macquarie .
Speaker #2: Toni , please unmute and ask your question . Please .
Speaker #5: Yeah .
Speaker #13: Thanks for the chance to ask the last questions . My first one , and I'll go back to the again for Andy , the Zaslow Sydney regulatory pathway .
Speaker #13: So assuming that you will present the data at AAD in March , the standard FDA review takes about ten months . So do you think you can actually launch it earlier than the 18 months for timeline guided ?
Well, well, it's a, it's a, it's a has. Um, as we mentioned over the, over the last hour, it has an efficacy profile that is 16 weeks. It's at the very high end of what's been seen for oral agents. It's, it's ease of administration without having any food effects. It's, and it's the overall profile, and it's the rapidity with which we generate clear skin in an oral agent. Um, you know, we believe in, and we think the data will demonstrate that it's as good or better than any other oral option in the moderate to severe plexus space.
Okay, I'm looking forward to seeing the data. Thank you.
Operator: Okay. Thank you very much, Wakao-san. I think we have just time for one final questioner. So I'd like to call on Tony Ren from Macquarie. Tony, please unmute and ask your question, please.
Operator: Okay. Thank you very much, Wakao-san. I think we have just time for one final questioner. So I'd like to call on Tony Ren from Macquarie. Tony, please unmute and ask your question, please.
Speaker #13: Are you being a little bit too conservative in estimating the timeline ? So that's my . First question . The second one is probably to Julie about the Entyvio biosimilar .
Okay, thank you very much, Markesan. I think we have just time for one final question or so. I'd like to call on Tony Ren from McQuarrie. Tony, please unmute and ask your question, please.
Tony Ren: Yeah. Thanks for the chance to ask the last questions. My first one, and I'll go back to the, again, for Andy, the Zasocetinib regulatory pathway. So assuming that you will present the data at AAD in March, the standard FDA review takes about 10 months. So do you think you can actually launch it earlier than the 18 months of a timeline guided? Are you being a little bit too conservative in estimating the timeline? So that's my first question. The second one is probably to Julie about the Entyvio biosimilar. Have your thinking about the biosimilar entry changed because of the subcutaneous pen? I noticed that at a recent conference in San Francisco, you guys are now saying 2030 and beyond.
Tony Ren: Yeah. Thanks for the chance to ask the last questions. My first one, and I'll go back to the, again, for Andy, the Zasocetinib regulatory pathway. So assuming that you will present the data at AAD in March, the standard FDA review takes about 10 months. So do you think you can actually launch it earlier than the 18 months of a timeline guided? Are you being a little bit too conservative in estimating the timeline? So that's my first question. The second one is probably to Julie about the Entyvio biosimilar. Have your thinking about the biosimilar entry changed because of the subcutaneous pen? I noticed that at a recent conference in San Francisco, you guys are now saying 2030 and beyond.
Yeah, thanks for the, uh, chance to ask. Uh, the last questions, um, uh, my, uh, first one, and I'll go back to the, uh,
Speaker #13: Have you has your thinking about the biosimilar entry changed because of the subcutaneous pen ? I noticed that at a recent conference in San Francisco , you guys are now saying 2030 and beyond .
Speaker #13: So just want to confirm whether the launch of the pen and the wider adoption of the pen has anything to do with the biosimilar entry .
Um, again, for Andy, the ZASO senator regulatory pathway. Uh, so assuming that you will present the data at, uh, AAD in March, uh, the standard FDA review takes about 10 months. So, do you think you can actually launch it earlier than the, uh,
18 months.
Speaker #13: Yeah . So that's my second question . Thank you very much .
Speaker #2: Okay . Thank you , Tony , for your question . So the first on Dasatinib regulatory potential launch pathway and timing , Andy can comment on that .
First question, um, the second one is probably to Julie about, uh, the interview about similar.
Speaker #2: And then the second question on Entyvio biosimilar entry timing , I think Julie can comment on that . Please . Andy .
Speaker #5: Thanks , Chris . And just to . Put Tony . So just filing perspective on thanks , timeline . So there are three elements that define the timeline for There's filing .
Tony Ren: So I just want to confirm whether the launch of the PEN and the wide adoption of the PEN has anything to do with the biosimilar entry? So that's my second question. Thank you very much.
Tony Ren: So I just want to confirm whether the launch of the PEN and the wide adoption of the PEN has anything to do with the biosimilar entry? So that's my second question. Thank you very much.
Um, have you—have you been thinking about the B similar entry change because of the subcutaneous PAN? Um, I noticed that at a recent conference in San Francisco, you guys are now saying, '23 and beyond.'
Speaker #5: the phase three studies which we've completed . Those are ready to go . There's the overall patient safety database . So we have to accrue safety in about 1000 patients on active drug for a full year .
So, um, just want to confirm whether the launch of the PAN and the wider—the option of the PAN—has anything to do with the, uh, uh, similar entry. Yeah. So that's my second question. Thank you very much.
Operator: Okay. Thank you, Tony, for your question. So the first on Zasocetinib regulatory pathway and potential launch timing. Andy can comment on that. And then the second question on Entyvio biosimilar entry timing. I think Julie can comment on that, please. Andy?
Operator: Okay. Thank you, Tony, for your question. So the first on Zasocetinib regulatory pathway and potential launch timing. Andy can comment on that. And then the second question on Entyvio biosimilar entry timing. I think Julie can comment on that, please. Andy?
Speaker #5: And then the third is the CMC package . So when you put together , Tony , all three of those we're looking at a submission that's likely to occur sometime in the summer .
Speaker #5: And then of course the timeline for the review will be something that will be in dialogue with the FDA . And once we've made that submission .
Andrew Plump: Thanks, Kristen. Thanks, Tony. So just to put perspective on the filing timeline. So there are three elements that define the timeline for filing. There's the phase 3 studies, which we've completed. Those are ready to go. There's the overall patient safety database. So we have to accrue safety in about 1,000 patients on active drug for a full year. And then the third is the CMC package. So when you put all three of those together, Tony, we're looking at a submission that's likely to occur sometime in the summer. And then, of course, the timeline for the review will be something that will be in dialogue with the FDA once we've made that submission.
Andrew Plump: Thanks, Kristen. Thanks, Tony. So just to put perspective on the filing timeline. So there are three elements that define the timeline for filing. There's the phase 3 studies, which we've completed. Those are ready to go. There's the overall patient safety database. So we have to accrue safety in about 1,000 patients on active drug for a full year. And then the third is the CMC package. So when you put all three of those together, Tony, we're looking at a submission that's likely to occur sometime in the summer. And then, of course, the timeline for the review will be something that will be in dialogue with the FDA once we've made that submission.
Speaker #13: Okay , great . Thanks .
Speaker #6: Tony , for Thanks , the question . On the Entyvio biosimilar timing . So we have not really changed our timing expectations here .
Speaker #6: As we've shared previously , do we have patents that cover various different aspects of entyvio out that go But as to 2032 . you are there are biosimilars in development and they could file with legal challenges .
Okay, thank you Tony for your question. So the First on Zaza Zaza sit in the regulatory pathway and potential launch timing, Andy can comment on that, and then the second question on on entity your bio similar entry timing, uh, I think Julie can comment on that, please Andy. That's it. Thanks Chris. And thank you, Tony. So, just just to put perspective on the filing timeline. So there are 3 elements that Define the timeline for filing. There's the phase 3 studies, which we've completed, those are ready to go. There's the overall patients. Safety database. So we have to acrew Safety in about a thousand patients on active drug for a full year and then the third is the CMC package. So when you put all 3 of those together Tony we're looking at a submission that's likely to occur sometime in the summer. And then, of course, the timeline for the review will be something that will be in dialogue with the FDA.
Speaker #6: I'm sorry , they could file and we would then pursue legal challenges . So that's why the timing could be 2030 , 2032 .
Once we've made that submission.
Tony Ren: Okay. Great. Thanks.
Tony Ren: Okay. Great. Thanks.
Okay, great. Thanks.
Julie Kim: Thanks, Tony, for the question on the Entyvio biosimilar timing. So we have not really changed our timing expectations here. As we've shared previously, we do have patents that cover various different aspects of Entyvio that go out to 2032. But as you are also well aware, there are biosimilars in development, and they could file with legal challenges. I'm sorry, they could file, and we would then pursue legal challenges. So that's why the timing could be 2030, 2032, and that's why you hear us saying that. Also, from an overall market attractiveness perspective for Entyvio, as now that Entyvio has been selected for IRA negotiation, the pricing expectations for biosimilars will also be impacted by that. Thank you.
Julie Kim: Thanks, Tony, for the question on the Entyvio biosimilar timing. So we have not really changed our timing expectations here. As we've shared previously, we do have patents that cover various different aspects of Entyvio that go out to 2032. But as you are also well aware, there are biosimilars in development, and they could file with legal challenges. I'm sorry, they could file, and we would then pursue legal challenges. So that's why the timing could be 2030, 2032, and that's why you hear us saying that. Also, from an overall market attractiveness perspective for Entyvio, as now that Entyvio has been selected for IRA negotiation, the pricing expectations for biosimilars will also be impacted by that. Thank you.
Speaker #6: And that's why you hear us saying that also from an overall market attractiveness for perspective Entyvio , as now the Entyvio has been selected for IRA negotiation .
Speaker #6: The pricing expectations for biosimilars will also be impacted by that . Thank you .
Speaker #13: Thank you .
Speaker #2: Thank you , Tony , for your questions . With that , we'd like to bring this call to a close . Thank you all very much for participating in the call today .
Tony Ren: Great. Thank you.
Tony Ren: Great. Thank you.
Thanks, Tony for the question on, um, the antibio biosimilar timing. So we have not really changed our, uh, timing expectations here. As we've shared previously. We do have patents that cover, various different aspects of antibio that go out to 2032, but as you are also well aware there, uh, are uh, biosimilars in development and they could um, uh, file with legal challenges. Uh, I'm sorry they could file and we would, uh, then pursue legal challenges, so that's why the timing um, could be 2030 2032 and that's why you hear us saying that also from a, an overall Market attractiveness perspective for antibio as now. The antibio has been selected for Ira negotiation that the pricing um, expectations for biosimilars will also be impacted by that, thank you.
Operator: Thank you, Tony, for your questions. With that, we'd like to bring this call to a close. Thank you all very much for participating in the call today. This concludes our Q3 earnings call. Thank you. Good night.
Operator: Thank you, Tony, for your questions. With that, we'd like to bring this call to a close. Thank you all very much for participating in the call today. This concludes our Q3 earnings call. Thank you. Good night.
Great. Thank you.
Thank you, Tony, for your questions. Uh, with that, we'd like to bring this call to a close. Thank you all very much for participating in the call today.
This concludes our Q3 earnings call. Thank you. Good night.
