Astellas Pharma Inc. — Call Transcript 2025

Thank you very much for joining this Q2 YTD FY 2025 earnings call by Astellas. I would like to serve as a moderator for today. I'm Chief Communications and IR Officer, Kato. Thank you for this opportunity today. First of all, we would like to give you the presentation and after that we'll have Q&A session. On our website, presentation material is available and in line with that we are going to make a presentation including Q&A. We will provide you the simultaneous interpretation service between Japanese and English. For simultaneous interpretation service, we are not going to guarantee the accuracy of it when it comes to the language. For this meeting, you can select from the Zoom webinar screen and if you select original then you can listen to the original voices without hearing the interpretation voices. These are some notes. This material or representation by representatives for the company and answers and statement by representatives for the company in the Q&A session includes forward looking statements based on assumptions and beliefs in light of the information currently available to management as subject to significant risks and uncertainties. Actual financial results may therefore differ materially depending on a number of factors. Please do understand about this. They contain information on pharmaceuticals including compounds under development, but this information is not intended to make representations or out of that regarding the efficacy or effectiveness of these preparations, promote an approved uses in any fashion or provide medical advice of any kind. Now I'd like to introduce you participants here. Representative Director, President and CEO Naoki Okamura, Chief Research and Development Officer Tadaaki Taniguchi, Chief Commercial and Medical Affairs Officer Claus Zeiler, Chief Financial Officer Atsushi Kitamura. We have these four representatives here. Now, first of all, Okamura is going to start the presentation. Hello everyone, I'm Naoki Okamura from Astellas Pharma, Inc. Thank you very much for joining our FY 2025 second quarter year-to-date financial results announcement meeting out of a very busy schedule today.This is a cautionary statement regarding forward-looking information as this was explained by Kato earlier. I'm not going to read this page. On page three I will explain the highlights of FY 2025 second quarter year-to-date financial results. Overall we have made exceptional progress at performing expectations. We have made a significant upward revision of our full-year forecast driven by continued strong growth of our strategic brands. Revenue increased significantly year-on-year with underlying growth of 12% year-on-year excluding forex impact. As for SG&A expenses, thanks to the robust progress of SMT, Sustainable Margin Transformation company-wide cost optimization initiative, SG&A ratio improved by 3.1 percentage points year-on-year. Due to the growth of strategic brands and robust cost management through SMT, core operating profit rose significantly year-on-year with underlying growth of 57%. Core operating profit margin increased by 7.9 percentage points year-on-year to reach 27.4%. Based on this exceptional progress exceeding our expectations, we revised our full-year forecast upward by JPY 100 billion for revenue and by JPY 80 billion for both core and full operating profit respectively. Regarding pipeline progress for PADCEV, we have unprecedented EV-303 study data in MIBC, muscle invasive bladder cancer, and our BLA for additional indication was accepted in the United States. As for focus area approach, we obtained promising initial data with ASP3082 and ASP2138 and registration-enabling studies are now under preparation. Page four is the agenda for today. From the next page I will explain these topics. Page five shows FY 2025 second quarter year-to-date financial results. Revenue, core and full operating profit all increased by about JPY 100 billion year-on-year. Let me explain main items. Revenue reached JPY 1,030.1 billion, up by 10.1% year-on-year. Core operating profit rose to JPY 282.6 billion, up by 54.4% year-on-year. The forex impact is shown on the right-hand side of the table. Forex had a negative impact on both revenue and core operating profit. Underlying growth excluding this impact was 12% for revenue and 57% for core operating profit, demonstrating a stronger growth. The bottom half of this page shows our full basis results. Operating profit was JPY 199.4 billion, up by 112.8% year-on-year. Profit increased to JPY 147.6 billion, up by 100.8% year-on-year. Page six shows FY 2025 second quarter year-to-date results of our main brands. Strategic brands grew substantially, driven primarily by strong growth in PADCEV and VYLOY. For second quarter year to date, sales of five strategic brands driving Astellas Pharma's growth, namely PADCEV, IZERVAY, VEOZAH, VYLOY and XOSPATA, exceeded JPY 220 billion in total, substantially up by JPY 66.2 billion or 43% year-on-year. Underlying growth excluding forex impact was 47%, showing a strong growth. Due to high profitability of these brands, they not just contributed to revenues but also made a great contribution to profit growth on a consolidated basis. As a whole, we are expecting this strong growth momentum to continue in the second half of FY 2025. Next I will explain individual strategic brands and XTANDI. Part 7 global sales increased to JPY 102.5 billion, up by JPY 27.1 billion or 36% year-on-year. Robust global growth has been continuously driven by strong first line MUC demand momentum. Regional expansion in the first line indication is also making steady progress. First line MUC approval expanded to 25 countries. We are expecting further expansion of countries with approval as well as an increase in the number of countries where reimbursement will start, mainly based on the robust progress in the United States and Europe. In the FY 2025 second half outlook, we revised our forecast upward by JPY 10 billion to expect JPY 210 billion on a full year basis. Next growth opportunity is expected from potential MIBC indication approval. EV-303 study in cis-ineligible MIBC presented at ESMO the other day demonstrated extremely promising results exceeding our expectations. Based on these results, we already filed a submission in the United States. We are expecting contribution to sales post approval. Furthermore, based on this exceptional data exceeding our expectations, we are analyzing the possibility of any upside to our sales forecast including peak sales. Also taking into account the status of EV-304 study for cis-eligible MIBC. We.Will share our latest outlook as soon as we complete our analysis. As for IZERVAY, sales rose to JPY 34.1 billion, up by JPY 6 billion or 21% year-on-year on a quarterly basis. Double-digit growth is continuously maintained, but patient affordability headwinds weighed on new patient starts and sales, so progress was lower than initially expected. Based on the second quarter year-to-date progress and FY 2025 second half outlook, we revised our forecast downward by JPY 25 billion and are expecting JPY 80 billion on a full-year basis. We revised our full-year forecast downward, but we are expecting continuous also from now on. One factor behind this: new patient starts recovery. Although it's moderate, we are seeing signs of recovery in new patient starts from August. The share is also improving from the lower 50% level in June to the upper 50% level in August. Another factor is the use of GATHER2 open-label extension study data presented at AAO, American Academy of Ophthalmology, this month. Over 3.5 years post IZERVAY dosing, increased benefit was demonstrated according to long-term efficacy data. In addition, favorable long-term data was obtained also in terms of safety and tolerability as well. By broadly disseminating this kind of data in the market, we will aim to further increase the awareness of the importance of treating IGA and the benefit of IZERVAY. You can find GATHER2 extension study data on page 34 and 35 in the Appendix for your reference. Please refer to those pages at your leisure. We believe in the mid to long-term potential of IZERVAY, and we are expecting that we can reach the peak sales forecast range. We have high expectations on IZERVAY as an important growth driver for Astellas Pharma also into the future. Global sales of VEOZAH increased to JPY 22.9 billion, up by JPY 8.1 billion or 55% year-on-year, demonstrating a solid growth continuous. We are anticipating this steady growth trajectory ahead in the second half of FY 2025. With regards to VYLOY, global sales reached JPY 26.6 billion. Its outstanding performance is exceeding expectations due to active awareness campaign. We were able to realize exceptional coding 18 testing rate penetration and lower treatment discontinuation through appropriate information provision activities on adverse event management. Regional footprint is expanding steadily with approval in 47 countries and launches in 26 countries by now. Based on this strong global momentum as a whole, we have made a substantial upward revision of our full year forecast from JPY 40 billion-JPY 60 billion, which is 1.5x compared to the initial forecast regarding XOSPATA. Global sales reached JPY 34.4 billion. There are some regional differences, but overall performance is largely on track. We are anticipating a moderate growth trend within the current indication of relapsed or refractory AML as a future growth driver. Top line results for the additional indication in newly diagnosed AML are anticipated in the first half of FY 2026. If approved, we can offer a treatment option to a new patient population, so we are hoping for contribution to sales. Last but not least, XTANDI global sales increased to JPY 477 billion, up by JPY 25.3 billion or 6% year-on-year. Sales expanded in all regions, reflecting strong global performance as a whole. We revised our full year forecast upward. Page seven is about cost items. The SMT initiative made more progress than our expectations. We realized cost optimization of about JPY 16 billion in total for SG&A expenses, earned expenditure and cost of sales combined, excluding U.S. Extended Core Promotion fees. The SG&A ratio improved by 3.1 percentage points year-on-year. Let me explain a specific breakdown of SG&A cost and R&D expenditure. SG&A expenses fell by 1.3% year-on-year, trending at a similar level compared to the previous year. The SG&A ratio was 26.9%. As SMT progressed, we realized cost optimization of about JPY 7 billion through continuous global organizational restructuring, reduction of mature products related expenses, and streamlining IT infrastructure, etc. In addition to investments to maximize the potential of strategic brands driving our future growth, we will continue to make investments needed for SMT execution in order to realize further cost optimization. The expenditure decreased by 16.9% year-on-year as a main factor behind. In addition to forex impact, we made progress in outsourcing cost reduction through insourcing development capabilities including clinical trials, etc. under SMT, which led to cost optimization of about JPY 7 billion. Furthermore, due to the completion of large clinical studies for strategic plans, clinical development cost decreased by about JPY 6 billion. In addition, one-time co-development cost payment booked in FY 2024 was another factor for cost decrease year-on-year. In the second half of FY 2025 onwards, we are expecting expansion of investments aligned with primary focus progress. In April this year, we implemented R&D organizational restructuring enabling active research to development all throughout. By pursuing operational efficiency, we are creating a cycle of making investments needed for the future continuously. Page eight is about the revision of FY 2025 full year forecast. Based on the robust progress exceeding our initial forecast up to the second quarter, we have made a significant upward revision of revenue, core, and full operating profit. We are expecting core operating profit margin of 24.1%, improving by 2.9 percentage points compared to the initial forecast. We revised our full year forecast forex assumptions to JPY 145 against the U.S. dollar and JPY 170 against the euro. From the third quarter onwards, we are assuming forex rates of JPY 144 against the dollar and JPY 172 against the euro. We have made an upward revision of revenue forecast by JPY 100 billion, including JPY 20 billion for VYLOY, JPY 10 billion for PADCEV, and JPY 70 billion for XTANDI. We are expecting revenue of JPY 2.03 trillion, exceeding the JPY 2 trillion mark for the first time since the establishment of Astellas. We are expecting SG&A expenses excluding U.S. external promotion fees to decline from the initial forecast. If we exclude forex impact reflecting robust progress of SMT, we are expecting JPY 586 billion. As for R&D expenditure reflecting operational efficiency in R&D reorganization, we are expecting JPY 322 billion. Reflecting the strong progress in our core business. Core operating profit is revised upward by JPY 80 billion from the initial focus, now expected to be JPY 490 billion. Hubei's operating profit is also revised upward by JPY 80 billion from the initial focus, now projected to be JPY 240 billion. We continue to incorporate a certain amount into the focus for other expenses to prepare for risks such as impairment losses. Next, I will explain the progress of our pipeline. Page 10 shows the progress of key events expected in FY 2025 for our strategic brands. A particularly significant development, as shown in the center of the slide, is the successful completion of the PADCEV EV-303 trial and acceptance of its supplemental BLA in the U.S. Details are provided on the next page. IZERVAY was approved in Japan in September for the indication of suppression of GA growth in atrophic AMD. Aiming to rapidly deliver this treatment for severe GA with a high unmet need to Japanese patients, the development team engaged in constructive discussions with the authorities. This led to a submission based on overseas clinical trial results using the conditional approval system, resulting in approval just seven months later. Furthermore, as noted and outside of the table, approval was obtained in Australia in October as well. We'll continue to pursue further submissions in other countries and regions with the aim of delivering IZERVAY to patients worldwide. In addition, we presented efficacy and safety data from the GATHER2 open-label extension study covering up to 3.5 years after administration of IZERVAY at the AAO. In October, the final analysis results of the phase II GLEAM trial of VYLOY in pancreatic ductal adenocarcinoma, or PDAC, became available and the primary endpoint was not met. We are currently analyzing the detailed data as part of the lifecycle management of VYLOY. The phase III LUCENE trial evaluating its combination with pembrolizumab and chemotherapy in gastric cancer is ongoing. Page 11 shows the latest status parts of MIBC development. For details, please refer to the materials from last week's online briefing on our oncology pipeline. The EV-303 trial yielded unprecedented data suggesting that PADCEV has the potential to become a new standard of care for cisplatin-ineligible MIBC. EV-303 trial compared the efficacy and safety of PADCEV plus pembrolizumab as neoadjuvant therapy before and after radical cystectomy, the current standard of care in patients with MIBC who were ineligible for or declined cisplatin-based chemotherapy versus surgery alone. The figure shows the efficacy results from the first interim analysis. The left panel displays the primary endpoint event-free survival or EFS, and the right panel shows the key secondary endpoint overall survival or OS compared to surgery alone. The combination therapy group or arm showed a hazard ratio of 0.40 for EFS, representing a 60% reduction in the risk of tumor recurrence, disease progression, or death, and a hazard ratio of 0.50 for OS, indicating a 50% reduction in the risk of death. Subgroup analysis confirmed consistent improvements in EFS and OS regardless of age, sex, or PD-L1 expression status. The safety profile of the combination therapy arm was consistent with the previously reported trials with no new safety concerns identified. Following the top-line results in August, we rapidly advanced the process for additional indications within just over two months. The U.S. BLA was accepted and granted priority review designation with a target PDUFA date set for April 7th, 2026. We are also progressing discussions with regulatory authorities in other regions for other submissions. Furthermore, the phase III EV-304 trial for cisplatin-treated MIBC is ongoing with interim analysis data anticipated in the latter half of fiscal year 2025. Page 12 for Focus Area approach, I will explain the progress on flagship programs ASP3082 targeted protein degradation and ASP2138 immuno-oncology, present promising clinical trial data in October. While details were already explained during last week's online briefing, the following slides briefly recap the current status. Clinical trials for OTA-4/5 in genetic regulation and ASP7317 in blindness and regeneration are progressing as planned, with POC assessment still scheduled for the second half of FY 2025. The current status of other programs is summarized on slide 41 in the appendix. Page 13 explains the progress of ASP3082 and the primary focus, targeted protein degradation. Specifically, ASP3082 has presented promising data in NSCLC or non-small cell lung cancer, and we have initiated preparations for registration studies targeting PDAC and NSCLC. ASP3082 has achieved POC in both PDAC and SCLC. This time we presented clinical data for its monotherapy in second line analytic treatment settings for NSCLC at an October Congress. Last week's online briefing preceded the Congress presentation, so we provided an explanation aligned with the abstract. Today, however, we will use the data presented at the Congress. As shown in the figure on the right, NSCLC has a high unmet medical need. The objective response rate with the existing standard of care in the second line and beyond is reported to be in the single digits, reaching at a maximum of around 18%. ASP3082 monotherapy demonstrated significantly superior anti-tumor activity compared to standard of care, achieving an ORR of 37.5% across our second line and beyond and 42.9% specifically in second and third line. Furthermore, the median duration of response was 9.72 months and a median progression free survival or PFS in second and third line was 8.25 months, confirming sustained efficacy. The safety profile showed no major concerns with no treatment-related adverse events leading to discontinuation observed at the data cutoff date. Development of ASP3082 across various tumor types is progressing. For PDAC, preparations are underway to initiate a pivotal trial for first line treatment in the latter half of FY 2025 with data presentation also targeted for the latter half of FY 2025. For NRCOC, planning is ongoing to initiate restoration of studies as early as possible. For CRC, colorectal cancer, the POC judgment remains targeted for the second half of FY 2025. Furthermore, research and development for follow-on programs is advancing. ASP5834, upon KRAS degradation targeting diverse KRAS variants, achieved its first subject dosing in August. Under the new R&D structure launched in April, the team achieved its first subject dosing in a record 27 days after the FDA IND clearance. Thanks to close cross-functional collaboration, we will provide progress updates as data becomes available. From clinical trials, page 14 details progress on ASP2138 and primary focus seminar oncology specifically. ASP2138 is demonstrating the benefit of subcutaneous administration in combination with the standard of care, steadily progressing toward POC achievement. Phase 1 trials are currently underway for gastric and gastroesophageal junction adenocarcinoma or GGE as well as PDAC. These trials evaluate ASP2138 as a monotherapy in combination with standard of care IV and subcutaneous across multiple treatment lines. Data presented at ESMO in October showed no major safety or elaborated concern concerns and support a combination with current standard of care. Furthermore, the ORR, when combined with the standard of care by a convenient biweekly subcutaneous administration, demonstrated high antitumor activity in gastric cancer at a 2000 microgram dose: 62.5% in first line and 37.5% in second line. In the figure above right, the values indicated in red represent the CLDN18.2 expression levels for each subject by low IT targets patients with high expression 75 N and above. This data confirms efficacy not only in high expression patients but also in those with moderate to low expression levels, suggesting the potential to expand the patient population eligible for this treatment. A POC judgment is planned for the latter half of FY 2025. Given the compelling data obtained thus far, we have initiated discussions on the development plan to enable the prompt execution of the Restoration trial following POC achievement for CLDN18.2 targeted therapy. We aim to provide treatment options to a broader patient population. To strengthen our leading position, we are advancing the development of the antibody drug conjugate as in addition to ASP2138, research and development of follow-on programs are also progressing. Multiple programs utilizing a similar mechanism of action including the clinical stage ASB1002 are advancing including bispecific. Additionally, a research advantage toward clinical trials for IADC immunostimulatory antibody drug conjugate utilizing new antibody modification technologies. We will provide updates including updated explanations as progress is made in each program. Page 15 shows today's key takeaways. The second quarter delivered exceptional financial results. PADCEV and VYLOY led the way with strategic brands demonstrating strong growth. SMT progressed well, achieving robust cost optimization. Based on this strong progress in our core business, we have reversed our full year revenue forecast upward by JPY 100 billion and both core and full operating profit by JPY 80 billion. Our pipeline also showed robust progress. PADCEV showed unprecedented data in the EV-303 trial, significantly advancing its development for MIBC in the focus area approach. Promising data was obtained for ASP3082 and ASP2138 and preparations are underway to conduct registration trials throughout FY 2025. We will aim for further profit growth and enhanced pipeline value at the end. I would like to announce upcoming events. On Tuesday, December 9th, we plan to hold a discussion session with outside directors. At this session, we will explain the evolution of Astellas governance structure. Additionally, directors newly appointed in June will share their perspectives on joining the Astellas Board of Directors as well as their experiences and impressions from their first 150 days in office. We encourage your participation. That concludes my presentation. Thank you very much for your attention. Hey Sei Kato, that's all. As a presentation, we are going to entertain questions from the audience. If you have questions, please press the raise hand button at the bottom of your Zoom screen. If you are joining from your smartphone, if you tap details, the raise hand function will be shown, so please press it. I will name you one by one. If your name is called, please unmute yourself on your screen, mention your name and your affiliation, and then ask questions. We now would like to open the floor for questions. The first, Mr. Yamaguchi from Citigroup. Mr. Yamaguchi, please, can you hear me? I'm Yamaguchi from Citigroup. Yes, we can hear you. Thank you. First, about PADCEV, the data was better than you expected. Global sales are going to be JPY 400 billion-JPY 500 billion. MIBC is ineligible or data was better than expected in this area. What is going to be the potential impact? How better compared to your initial expectations? Thank you for your question. I will respond briefly and then regarding sales forecast class may add and the data per se where necessary can be explained by Taniguchi. First of all, as I showed on. The slide 303 study results, even we non-experts see the separation in the Kaplan-Meier curve and the hazard ratio is 0.4 or 0.5. We don't see these numbers so often. We presented this at ESMO in the first line of settings, we said the same. We made a presentation at Congress and there was a standing ovation naturally in the audience. We think we had unprecedented data. This great data exceeded our expectations. Is this going to lead to the sales forecast directly? Not necessarily. MIBC and after metastasis in the urothelial cancer MUC, it's not clearly separated completely in the current indication. Some part is covered in the United States if the additional indication is approved. How much we can expand the target patient population? It's difficult for us to say clearly how much we can expand. CIS ineligible patient population was studied in 303 study. Patients on cisplatin 3 or 4 study is ongoing and we'd like to look at the distribution of these patients in detail. To share our sales forecast with you first, Taniguchi-san, anything from you. Thank you very much. For me, regarding this data, I'd like to add a bit. As Okamura explained at ESMO, there was a very good response from the audience. First, the primary endpoint EFS hazard ratio was 0.40. This is unprecedented in terms of the risk reduction. Secondary endpoint overall survival consistently 0.5. Regarding secondary endpoint, whether we could meet this in the interim analysis, we made this much reduction. There was a statistically significant difference. Clearly, number three, PCR ratio was 57% or even exceeding that level and 8.6% are for the control group. This much pathological CR was seen at such a high probability. Such a drug is unprecedented.This was highly evaluated as well. These are the three effects. As for safety, the pembrolizumab combination was consistent in terms of safety. In that regard, this data is very innovative and unprecedented. Says ineligible was the indication unfit population, at high risk or with a variety of complications. The drug could be utilized in such patient population. There are high expectations because of this. Yes, so the question that you asked is how this translates into a sales forecast. There are a few considerations. Clearly, clearly such an unprecedented data will help us convince physicians that this should be the new standard of care in the labeled indication of locally advanced and then after approval also in the MIBC indication. There is, however, a difference between the two. If you look at the clinical trial in MIBC, there are two parts to it. There is the so-called neoadjuvant use, so you give it before you do the cystectomy, the removal of a bladder, and then you have the adjuvant use, which is after the surgery has been done. In clinical practice, these two parts are likely to be different from the clinical trial setting. We need to observe carefully exactly how the market adopts the usage of PADCEV and Pembro in these two different phases of the MIBC. Those are things we still have to learn, and I think once we have more data points, we can make a more efficient, accurate sales forecast. Thank you very much. Next question, a brief question again. This time performance was really good. However, from the midterm perspective, we are going to face the cliff of the patent and next year and afterwards a new midterm plan is going to be presented. Toward that, your foundational businesses are quite improved. Toward the next fiscal midterm plan, this performance level and also SMT included, how do you view about it? Would you give us a comment? Thank you very much. We are still in the middle of the discussion about this, so I think it is inappropriate to come into the details about this here. However, the XTANDI and MIBC, where the patent is expired, and we are going to extend their lives. In order to cover the loss of those sales, we will do something including business development or BD, that's not something like that. Rather than that, we have the strategic brands in our hands, those are getting stronger. We would like to maximize its strength. That is going to be the focus of the next midterm plan. That's what we expect. Meaning that from the outsider's perspective, the breakdowns of the products are not really matters. Rather, the sales of the products will be reduced. That is one thing. However, we are already having the three important strategic brand products in the growth phase. We would like to maximize the value of that. That focus is going to be incorporated into the next midterm plan and also focus area approach, key products achieving their clinical POC or coming to the phase of the POC judgment. For the next five years, those flagship going to get into the late phase of the development and on top of that the original focus area benefit, that is when initial compound is successful. Then with the same triangle, we come up with the following programs. We introduce some of the follow-on programs today. That will happen. We have the five strategic brands and on top of that, further ahead of the growth. Growth can be expected in these approaches and if that is recognized in that way or so, it's going to be the one key aspect of the midterm plan. The current product sales increase is a job needed to be done by Okamura and next preparation is Taniguchi's job. Kitamura, who is here, needs to think about changing the company with appropriate financial discipline in terms of the operation of this company based upon such background information. Thank you very much. Thank you very much. Now I would like to move on to the next question, that is JPMorgan, Mr. Wakao, please. JPMorgan, Wakao is my name. Can you hear me? Yes, I can hear you now, please. Thank you very much. Regarding strategic brands, how do you assess those products? As of now you made an upward revision, but extending the mirror background before in the previous upward revision, if you look at the total sales, the JPY 470 billion, although the breakdown is different, you are progressing according to your initial forecast. EV-303 is successful and there are other factors as well. What is your current assessment? Also, the future outlook of strategic brands is of how it's going to go up. That might be part of the question as well. Thank you for your question. I'd like to give you a rough overview where necessary. Claus can add as I mentioned before, how Astellas Pharma is going to be from now on. Extending mirror background such immature products, how we can increase their value from now on is one question. We made an upward revision. If you look at the face value, these two may be covering the majority of the upward revision at a glance. IZERVAY unfortunately on a dollar basis, $750 million was revised downward to $550 million. That reduction is covered by PADCEV and VYLOY. Because of their good performance, we are more than offsetting that decline. In total there is no change in the strategic brands. You may say so from outside, but there are special circumstances for IZERVAY and it may be difficult to perform as expected. Are we going to reduce the strategic brands? No, we would like to cover more than offset this decline and Astellas in the mid to long term needs to grow. To that end, this is going to be very important. In the world of pharmaceuticals, regulations may change and there can be something unexpected. We often see such events in this sector. Instead of saying that this is what we can do only if there is something negative, we'd like to offset the negative and we can recover in the top line figures. Also, we'd like to do our best to control the cost and we would like to achieve core operating profit, the bottom line. That's our discipline and how our management of the company should be. Anything additional from Claus about individual products? I think, Naoki, you've summarized it very well. I think the five strategic brands as a group have the potential to replace XTANDI and maybe even grow beyond that. I personally think the total potential is beyond that of XTANDI as a single brand. Now, the different brands will vary and also in their phases. We see VEOZAH as a primary care, pretty much primary care product with a much slower trajectory than an oncology drug, which has a very, very fast uptake. We've seen that both with PADCEV and with VYLOY now. I think each therapeutic area has its own dynamic. As a group, the potential of these products is, as I said, in my estimation, at least the size of XTANDI. Thank you very much. Secondly, SMT initiative status is something I'd like to know more. In the second quarter, cost reduction was achieved and I'm very surprised. Regarding your plan, OP margin is to improve. I think this was great and SMT is making very good progress as of now. OP 30% or higher. What do you think in terms of this progress? You may have other hurdles to clear or are you approaching the achievement? You may need to invest in R&D for some of the products. What is the current progress? Thank you very much. In the end, operating profit was revised upward. If you look at the guidance, 24.1% for operating profit margin. Are we satisfied? No, we are not completely satisfied yet. Still, in FY 2027 we are targeting to achieve 30%. Towards that goal, we are beginning to solidify our basis. That's how I feel. It's not easy to improve just 5% overnight. There are many things we have to do. As you pointed out, development cost would go back to the original number. We shouldn't sacrifice the development cost. We have to do something else elsewhere. Anything to add from. Thank you very much. Regarding SMT, in the past, I've already made an explanation as saying that this is not their single year short period of time of activity, this is the regular activities. I've mentioned that it's going to be JPY 120 billion to JPY 150 billion. At the time of the announcement, it's clear that for the 70%, yes, we will do that and we execute the plan and the remaining 30% idea is going to be generated. That was the approach and currently it is JPY 150 billion. Internally, we accumulated our ideas and they are going to be executed. That's the next phase. That's the current status. Thanks to SMT, JPY 40 billion of the impact was realized. This fiscal year, throughout the year, we are expecting to be JPY 20 billion. For two years, it will be JPY 60 billion. In the first half, it is JPY 16 billion. Against the target of JPY 20 billion, I think we are doing quite well. As has been mentioned by Okamura, this is not the easy road. We have to steadily execute the plans. We have to have that in our mind. As long as we do what we need to do, we definitely can see the result. Therefore, we have a commitment, we have a confidence about it. Under Sir KU Leali. Thank you very much. Thank you very much. Next, Goldman Sach Securities. Mr. Weda, please. Goldman Sachs Weda is my name. My first question is about the follow-up question, is the currently discussed point, so R&D for this fiscal year, you changed the presumption for the Forex, meaning that there's a wide range of review or revisit during the quarter. What did you do to come up with these big changes? Also, in the current new plan, compared to the initial plan, the accuracy was increased. Would you please make your explanation for these two points. Thank you very much. First of all, in my presentation, as I've already mentioned, in terms of year-on-year, the major clinical trials of the strategic brands completed as their first phase. From year-on-year perspective, in the last year first quarter, one of cost increase was canceled. Because of that, seemingly there was a decrease. Overall flow depending on that, because of that, the cost is reduced. Toward the second half of 2025, the focus program achieved, the POC will come to the later phase of the development and this will come back. This portion will come back. That's why we have this guidance. On top of that, of course we are doing the continuous work. This time, within the SMT and strategy discussions, portfolio prioritization started to be more and more rigorous. With that, selected projects with the keen eyes will receive more and more investment. Our R&D investment usage is shown in that way. Also, clinical trials overall relied on the external CRC, but those are currently conducted more and more internally. Outsourcing cost is reduced and that is replaced as the internal expenses. Seemingly, you see that the subtraction calculation leads to this reduction level as a number. However, with a long-term perspective, having this approach, we can realize more effective clinical trials, which leads to the shorter period of time of the study. A clinical study design is going to be further precise. With our execution of the studies, we can make the fine tuning during the study. I think that's the way it should be for conducting clinical trials. I believe we can realize that. Under Taniguchi, the R&D and R&D were separated, but now it's merged as one organization. Research division and development divisions, those exchange between these two business units became smooth. Outsourcing changed to insourcing. It was just a simple deduction. Come up with this number. You see only this because it's just started, but for a longer time thinking about the next plan, business plan, I think it's going to be more financially reflected into our actual business way of doing. Can you miss them, please? Thank you. Thank you very much. Most of the things already explained by Okamura. If I may add one thing, insourcing of clinical trials. Through insourcing we can reduce outsourcing costs. We paid before and then we should develop our own system. AI and automation is fully leveraged for further cost reduction. Also, the speed of enrollment. Where are the patients and how much, which institutions we should go to. We want to roll this out globally. By doing this, further business and clinical trial efficiency can be enhanced as well as the acceleration of the speed. We can reduce a further cost reduction as well. We're expecting an increase in the late stage development costs would also rise. As much as possible, we'd like to enhance the cost efficiency so that we can cover. Thank you very much. As a follow up question, originally, compared to the initial forecast, in terms of the gap compared to the initial forecast. Overall, all the items are progressing smoothly. Should I understand that way? Basically that understanding is fine. Okay, understood. Thank you very much. Secondly, regarding the U.S. business environment, how do you see it right now? Up until now, regarding the tariff, the situation is still unclear and it was difficult for you to comment. As I said before, right now you have a large exposure to the United States, including the risk of being imposed a tariff. How are you addressing the situation or how are you planning to address the situation from now? Also, including MFN, the drug prices, how do you see the risk factors? I'd like to hear from you. Thank you very much. First, as for the tariff, at one point in time, we didn't know what could happen. From there, the situation is settling a lot. I shouldn't say that's our assessment, but we are feeling relieved. As we said before, from your perspective as that as revenue times U.S. ratio, times COGS times tariff, it's going to be a huge amount. You may say so, but in reality, what we sell in the United States, majority of those products are manufactured in the United States. As we said before, if that's the case, the denominator is small where tariff is going to be imposed. It's not going to be a huge amount. That's a response. The tariff might be imposed. There can be such announcement into the future. We have a supply chain. By understanding our supply chain, if there's going to be any grave impact, as I said before, our profit should not decrease. If the profit may decrease, where are we going to recover? Elsewhere, we should start such discussions. Also, the MFN pricing, most favored nation pricing. As you might have heard in the press report, 17 companies received letters. This does not include a status.In particular, Pfizer reached agreement with the authorities or the government. According to the media report, we didn't receive such a letter. We don't know what are the contents of the letter. In the industry through a variety of routes, what is being communicated in the letter is captured by us. Regarding the agreement with the government and Pfizer, we don't know the details, but we can assume and imagine what's going on and what's being done before we receive a letter. Nothing will be done by us or overreaction and doing a lot of things too much in advance. Rather, monitoring the situation to take necessary action where necessary. Of course, experts in the company gather to form a team and they are monitoring the situation all the time. If we need to take action, if it's time to take action and move forward, the team will come to the executives management team so that we can discuss and take the best action. Understood. Thank you very much. That's all from me. Thank you very much. Thank you very much. Next question, Nomura Securities. Mr. Matsubara, please. Thank you. Matsubara speaking. Can you hear me? Yes, we can hear you. Now, Please start. First question. That is about SMT. In the previous discussions, SMT is exerting its strength and if that is so, then this fiscal year we are going to see further cost reduction. Thank you very much. Originally, JPY 20 billion is our plan and to the second quarter we came to the JPY 16 billion and can you achieve JPY 32 billion? The calculation is not in that way. What is decided is steadily being conducted, that's one thing. However, we've been always looking for what else, other, something else we can do. If we make a certain evaluation for a certain idea, even if a certain advanced investment is necessary, then still we try to secure commitment. In the first two quarters, what's being planned is already realized and you came up with the cost reduction, but at the same time you can think about the investment to the next idea. We have to take the balance of reduction and investment, so that is going to be final end of FY 2025. Of course, the planned JPY 20 billion, that is something we would like to secure, but at the same time, something it might go beyond. Is that going to be reflected into the profit? It's not necessarily so, so please do understand in that way. Kitamura-san, please. What Okamura mentioned is exactly right. Again, this is the repetition. SMT is not a singular year but rather multiple, so there are some things should be done with a short period of time and mid to long term, those ongoing in a parallel manner. If time, things can be realized in an accelerated manner, then we can get the benefit in earlier phase, that's true. Understood very well. Thank you very much. Next question is about VEOZAH on slide page six. It is true that the competition is available, so that is the market competition considered, but the competitor has less, not necessary to do the blood testing and specific for the driving in the case of the design attendant, and what do you think about it? Yes, of course there's an advantage for the predecessor. Our level is not perfect, but we've been doing our activities, so definitely there are advantages as the first comer or pioneer for this. Within just one sentence, what I wanted to say is that another company or the competitor, rather, is very strong in this treatment area, and we are not really so. Compared to us doing the business in this field alone, together with them, the two companies toward the same targeted patients with the same efficacy products, we can do the patient educational awareness increase activities. With that, I think we can increase the awareness more. However, they are very strong in this field. Till then, we are the just player in the market, but now we have two, and they have experience, so the share is going to obviously be smaller. To what extent we can have, to what extent of the market share we can have, that is of course something that we can tell from the data. Clinical data is well controlled. Total number of the subjects are controlled. The competitor launches their products, and what kind of data will be available in the actual market or real market, I think that really determines, besides the competitive situation of these two companies. Claus? Yes, I think two points. One Naoki already made very, very well, which is this is a market we have to develop. Two companies developing a market is always much better than a company doing it alone. I think in that sense the entry of a competitor actually helps grow the class. The other point I would make is that the label that elinzanetant has received in the U.S. takes into account the fact that this particular molecule acts on two receptors, the NK1 and the NK3. They have a warning on inducing sleep. We will not know how the market will react to that. That is not something that's in our label. You pointed out that they have less liver monitoring. That is true, but that's what we also had when we began this journey. What real world evidence will then produce over time? Because remember, these liver incidences are very, very rare. You don't see them in clinical trials, you only see them in real world practice. Only time will tell how that really plays out in the marketplace. Yes, very clear. Thank you very much. Thank you very much. Next we'd like to receive questions from UBS Securities. Mr. Sakai, please. Sakai from UBS speaking. Initially, sorry if a negative question, but VYLOY didn't work in a PDEC. You are now examining the details of your data. CLOVER 18.2 and any learnings are in association with CLOVER 18.2 as the reason for the failure of the study. ASP2138. This is also CLOVER 18.2 targeting PDEC. You are planning a clinical development including these compounds. Could you give us an update on this? That's my first question. Thank you very much. It's technical and expert, so I shouldn't say too much. I'd like to hand over to Taniguchi from the beginning. Thank you very much. First of all, VYLOY GLEAM study for PDAC. It was a phase two study, but a randomized trial in phase two. If the results are good, it could be registrational so that we can file a submission. That's how we were discussing with the regulatory authorities in this study. VYLOY and first line pancreatic cancer chemotherapy combination and chemo monotherapies were compared. This was close to POC study. We are analyzing the results of the study through the analysis in what kind of patients there was a good response and in what kind of patients no response. We can know more details by analyzing, so in the GLEAM study we haven't made public the results yet. Once we are able to analyze the details with a deeper understanding, then we'd like to share. Regarding the results of the study, ASP2138 targeting Claudin 18.2, this is a bispecific antibody. This is CD3 of T cell engager is also added to this bispecific antibody. ASP2138 in PDAC, how does any potential impact on PDAC with this compound CD3 T cell engagement portion. How it's going to affect a PDAC in clinical studies phase 1b. Right now we are studying that part. We haven't published the data yet, but in the near future once we collect the data. We will announce the results including our future outlook. This bispecific antibody and VYLOY, the differences between the two can also be examined. Once we have the data, I will explain such a perspective as well. Cloning 18.2, so you haven't changed your way of thinking in the development concept. As a concept, the GLEAM study, ASP2138, any direct impact? I could say no impact. Understood. Thank you very much. Another question is about your response of the mid-term plan. Okamura-san, you mentioned that the very reinforced the strong or something like that. If that is the case, the number you come up with might be drastic. That is a bit of the concern that I feel. You are working on making the numbers so you would not probably disclose anything specific, but the comment you made a little while ago is probably your honest thinking. Based upon that, we have to also come up with the focus or our numbers. Do you think is it okay that we approach in this way? Thank you very much. We get learnings every day. For example, CSP 2021 review is currently ongoing and based upon that we are going to come up with a next plan. Frankly speaking, overpromise, underperform, that such criticism is what we've already accepted, and so that we can avoid the repetition of that, we can place a more disciplined and well-balanced corporate plan that is going to be announced. In that sense, Kitamura is looking at the numbers with a perspective and Claus as well, being based upon that number is calculated and coming up with. You can feel safe about that as well. Understood. Thank you very much. Thank you. Next, Morgan Stanley. Mr. Fuji. Mr. Muraoka, please. Thank you very much. Muraoka from Morgan Stanley. I think almost all the questions are covered already, but just one question. It was like this last year, so it'll be okay this year. This might be a bit mean question, but that is about IZERVAY impairment loss risk is the question. Last year in the second quarter it was okay in Europe, but in the third quarter impairment loss was incurred, and this time the U.S. sales is a relatively bigger reduction. Looking at this number, thinking about the future value, impairment loss triggered risk is likely to be higher compared to three months ago. I wouldn't say. Of course, you cannot say. It's all right, no problem. However, how can we evaluate these potential risks? Thank you very much. The valuation base is the sales prediction and forecast that Claus is going to make additional comment if necessary. The way of my description is that when evaluation is conducted, the underlying uncertainty is increased. That's the kind of status. If you ask me, impairment loss is higher. At this moment, I wouldn't think that impairment loss risk is higher, but for the valuation compared to what we've originally considered, kind of situation is lower. That is true. If this is going to be recovered or ultimately this will decide the trajectory of IZERVAY, that's something we have to always have sharp eyes. Just like Claus mentioned, peak sales, we do not think that we have to revisit it right away. There is undoubtedly in the U.S. market a dynamic on the affordability part where a part of the patients can't afford the co-pay that they need to contribute for their injections. That is different from when we look at the peak potential and the size of the market that we can still develop in this disease. One is a timing effect, the other is effective. The question is what's the potential of this agent in the geographic atrophy market. I'm very confident that the long-term potential for IZERVAY is intact. The question of how we solve the current dynamic in the U.S. is a tactical problem that we are working through. We hope to find solutions in tactical to come. Kitamura also has a comment. Thank you very much. May I add? Sorry? Yes, please. Last year regarding IZERVAY and impairment loss, the trigger was whether we can get the approval or not. It was about that probability. Now, as you know, IZERVAY intangible assets in the U.S. and outside of the U.S., as we are registering U.S. intangible because of the launching in the United States already, we are going to sell it out, including the competitors. Our drug is also a new treatment. How to develop the market is the main task force. It's our job. Claus is going to do a good job according to him. We think we can do it. Of course, there is a big asset number on the balance sheet. I have to evaluate and assess it. I will do so. The company stance has not changed, and we had impairment loss which was incurred last year, but the root cause is different. Please understand. Thank you very much. One more question if I may. Earlier you talked about CSP mid-term business plan. I know you would say don't ask so many questions on this. Regarding the dividend, I understand the message that there can be a decrease. The dividend level during the course of the next CSP on an absolute basis, do you think you can maintain the amount? Can we feel assured? Sorry, what do you mean by decline? Which, what are you talking about? The top line may decrease on a temporary basis. If you are talking about it, yes, you are right. That may not necessarily lead to a decline in the bottom line. Regarding the specific numbers, in May next year, CSP 2026 will be announced according to plan. Please wait till then. I think this is Tamra's scope of responsibilities, but I also have my own views, so allow me to speak. Regarding the dividend, just increasing the dividend would not happen. Also, even if the company's overall performance is good or bad, it's not something we should change dramatically. I'm talking about the dividend for the past few years. By now, intentionally the dividend level may be too low, and to increase it to a competitive level, we increased the dividend at quite a fast pace. From now on, for the company's growth in the longer term, we'd like to gradually increase the dividend in line. That's Astellas's basic stance. In the next five years, with the next CSP, there's going to be some dip in revenues. We have no intention to decrease the dividend because of that. In that sense, you can feel assured. Kitamura-san, please. As Okamura said, I may be repeating myself, but a stable return to shareholders is an important factor as part of the capital allocation. According to understanding, we are doing this already, so it's not going to change in my view. On the other hand, when it comes to dividend, how much profit do we have? Cash flow is better or balance sheet is better. Are we working on this meticulously? Whatever is going to happen, we should have funds for investments, for stable growth, and we have to have a stable return to shareholders. This is my, including my personal view. I think this is an important factor. It's not going to change substantially according to my assumptions. Understood. Thank you very much. That's all from me. Thank you very much. Next, Macquarie Capital Securities. Tony Renson, please. Tony Ren from Macquarie. Can you guys hear me? Yes, we can. Okay, perfect. Thank you very much for the opportunity. The first question is a simple one on gross profit margin. Your cost of sales in the first half appears to be increasing faster than revenue, which probably suggests that the gross margin is declining a little bit. I just wanted to understand why that might be the case. Thank you. I think the simple answer to your question is the change in the product mix. If you would like to know a little bit more in detail, I will pass the baton to Atsushi. Yeah, it's all about product mix. Okay. Okay, perfect. Understood. The second question and my last question is about your ASP2138. It appears to me that you guys are really pursuing this clinical asset as part of combination therapies, but not as monotherapy. At ASMO 2025, which I attended, I think the monotherapy response rate was fairly modest. The KOLs who I spoke to also think that the duration of response was good, but probably not something that knocked it out of the park. What's your thinking about using ASP2138 either as combination or as a monotherapy? Thank you. Thank you very much for the question. I will ask Taniguchi-san to answer those questions. Thank you. Question. As you describe, if you take a look at therapy of ASP2138, the ORR is relatively modest. It's around the 15% range. I think this is quite consistent with what we see in other CPI such as PD1 or PD-L1 inhibitors. It's also seen a very similar tendency that we see once tumor actually responded, the duration of response is longer. This is exactly what we see in other immuno-oncology products. I think that this is also quite encouraging data from monotherapy by saying that if you're thinking about PD1, most of the cases are actually coming to the earlier line in combination with other agents like chemotherapy or ADC as you see in PADCEV and pembrolizumab. What we believe is that thinking about the development of ASP2138, we believe that it makes sense for us to go into the earlier line in combination with the current standard of care. That's what we believe. This is the space that we can actually work on. I think that this is also based on the data coming up from phase one, current ongoing phase one. Please wait. The data is coming up, but I think we believe that these data we are actually showing in ESMO is quite encouraging. Okay, understood. You have a very clear combination in earlier line with other current standard of care. Thank you very much. Thank you. Thank you very much. Because of the time, we would like to ask the next question as the last question. Sanford C. Bernstein, Mr. Sogi, please. Thank you very much. MIBC commercial potential. How do you feel about that? I would like you to explain more details. To simply put, the patient number times market share times duration of therapy times price. It seems it's not that simple. Listen to you, first line treatment overlapping and actual clinical practice, adjuvant, neoadjuvant usage differentiation seems also complicated. Could you be a little bit more specific about this? Also, on top of that, this adjuvant, neoadjuvant for MIBC regarding first line and second line, the number of the patients including their China major markets number were disclosed. For MIBC, China is excluded according to the description here. Is this significant? Would you please explain about these two points? Your first question, your understanding is correct. We do research. We should be able to respond with responsibility. We would like to respond to your question. Please give us some more time till then. I don't know the background of the second question. Claus, do you know the background for the second question? He would have to come back on China. Yes, I would have to come back. Sorry. Among the participants today, we do not have a full understanding of the background. We would come back to you through our IR team at a later date. Okay, next, about IZERVAY. I have a question about IZERVAY. Of course, you're going to expand the market from now on. You're still on the way. On the other hand, this year from the first half, Good Day is a charity foundation for patients on Medicaid. Patient support funding is no longer available, and there was such an impact on your business. What's the current status right now? Yeah, you're absolutely right. The drying up of the foundation support in the United States is causing some patients to drop off from therapy because they simply can't afford the co-pay that the foundations picked up in the past. We see that both in the geographic atrophy market and in the wet amount. What we see the retina clinics doing in the U.S. is trying to adjust to that new situation. Remember, it's not all the patients who can't afford the co-pay. There's still 70% or something like that. It's an estimate, but it's at least 60% of the patients who can afford the co-pay. I think it's a question for the clinics now to understand when they accept patients, how do they deal with a patient that can afford versus what support mechanisms are available for patients who can't afford. That's the turbulence in the market that we're seeing right now. We believe also on the basis of past analogs that the market will learn how to triage that and how to provide the right solution for different patient types. How long that will take and what the curve after that will be, that is the part that I'm still exactly struggling with. That's why we've been more cautious to take down the projections for this year. Great. Thank you. If we did have enough funding this year, would that fill the gap that you currently lowered in your guidance? It would for the coming quarters, but we have lost time. I don't think the original forecast is realistic simply because of the timing element that we have within a fiscal year. Thank you very much. Now time has come. With this, we'd like to close today's explanatory meeting. Thank you very much for joining us today.

Speaker 6: Thank you very much for joining this Q2 YTD FY 2025 earnings call by Astellas. I would like to serve as a moderator for today. I'm Chief Communications and IR Officer, Kato. Thank you for this opportunity today. First of all, we would like to give you the presentation and after that we'll have Q&A session. On our website, presentation material is available and in line with that we are going to make a presentation including Q&A. We will provide you the simultaneous interpretation service between Japanese and English. For simultaneous interpretation service, we are not going to guarantee the accuracy of it when it comes to the language. For this meeting, you can select from the Zoom webinar screen and if you select original then you can listen to the original voices without hearing the interpretation voices. These are some notes. Thank you very much for joining this Q2 YTD FY 2025 earnings call by Astellas. thank you very much for joining this q2 ytd fy 2025 earnings call by astellas I would like to serve as a moderator for today. i would like to serve as a moderator for today I'm Chief Communications and IR Officer, Kato. i'm chief communications and ir officer kato Thank you for this opportunity today. thank you for this opportunity today First of all, we would like to give you the presentation and after that we'll have Q& A session. first of all we would like to give you the presentation and after that we'll have q& a session On our website, presentation material is available and in line with that we are going to make a presentation including Q& A. on our website presentation material is available and in line with that we are going to make a presentation including q& a We will provide you the simultaneous interpretation service between Japanese and English. we will provide you the simultaneous interpretation service between japanese and english For simultaneous interpretation service, we are not going to guarantee the accuracy of it when it comes to the language. for simultaneous interpretation service we are not going to guarantee the accuracy of it when it comes to the language For this meeting, you can select from the Zoom webinar screen and if you select original then you can listen to the original voices without hearing the interpretation voices. for this meeting you can select from the zoom webinar screen and if you select original then you can listen to the original voices without hearing the interpretation voices These are some notes. these are some notes This material or representation by representatives for the company and answers and statement by representatives for the company in the Q&A session includes forward looking statements based on assumptions and beliefs in light of the information currently available to management as subject to significant risks and uncertainties. Actual financial results may therefore differ materially depending on a number of factors. Please do understand about this. They contain information on pharmaceuticals including compounds under development, but this information is not intended to make representations or out of that regarding the efficacy or effectiveness of these preparations, promote an approved uses in any fashion or provide medical advice of any kind. Now I'd like to introduce you participants here. Representative Director, President and CEO Naoki Okamura, Chief Research and Development Officer Tadaaki Taniguchi, Chief Commercial and Medical Affairs Officer Claus Zeiler, Chief Financial Officer Atsushi Kitamura. We have these four representatives here. Now, first of all, Okamura is going to start the presentation. This material or representation by representatives for the company and answers and statement by representatives for the company in the Q& A session includes forward looking statements based on assumptions and beliefs in light of the information currently available to management as subject to significant risks and uncertainties. this material or representation by representatives for the company and answers and statement by representatives for the company in the q& a session includes forward looking statements based on assumptions and beliefs in light of the information currently available to management as subject to significant risks and uncertainties Actual financial results may therefore differ materially depending on a number of factors. actual financial results may therefore differ materially depending on a number of factors Please do understand about this. please do understand about this They contain information on pharmaceuticals including compounds under development, but this information is not intended to make representations or out of that regarding the efficacy or effectiveness of these preparations, promote an approved uses in any fashion or provide medical advice of any kind. they contain information on pharmaceuticals including compounds under development but this information is not intended to make representations or out of that regarding the efficacy or effectiveness of these preparations promote an approved uses in any fashion or provide medical advice of any kind Now I'd like to introduce you participants here. now i'd like to introduce you participants here Representative Director, President and CEO Naoki Okamura, Chief Research and Development Officer Tadaaki Taniguchi, Chief Commercial and Medical Affairs Officer Claus Zeiler, Chief Financial Officer Atsushi Kitamura. representative director president and ceo naoki okamura chief research and development officer tadaaki taniguchi chief commercial and medical affairs officer claus zeiler chief financial officer atsushi kitamura We have these four representatives here. we have these four representatives here Now, first of all, Okamura is going to start the presentation. now first of all okamura is going to start the presentation

Speaker 12: Hello everyone, I'm Naoki Okamura from Astellas Pharma, Inc. Thank you very much for joining our FY 2025 second quarter year-to-date financial results announcement meeting out of a very busy schedule today.This is a cautionary statement regarding forward-looking information as this was explained by Kato earlier. I'm not going to read this page. On page three I will explain the highlights of FY 2025 second quarter year-to-date financial results. Overall we have made exceptional progress at performing expectations. We have made a significant upward revision of our full-year forecast driven by continued strong growth of our strategic brands. Revenue increased significantly year-on-year with underlying growth of 12% year-on-year excluding forex impact. As for SG&A expenses, thanks to the robust progress of SMT, Sustainable Margin Transformation company-wide cost optimization initiative, SG&A ratio improved by 3.1 percentage points year-on-year. Due to the growth of strategic brands and robust cost management through SMT, core operating profit rose significantly year-on-year with underlying growth of 57%. Hello everyone, I'm Naoki Okamura from Astellas Pharma, Inc. hello everyone i'm naoki okamura from astellas pharma, inc Thank you very much for joining our FY 2025 second quarter year-to-date financial r esults announcement meeting out of a very busy schedule today. thank you very much for joining our fy 2025 second quarter year-to-date financial r esults announcement meeting out of a very busy schedule today This is a cautionary statement regarding forward-looking information as this was explained by Kato earlier. this is a cautionary statement regarding forward-looking information as this was explained by kato earlier I'm not going to read this page. i'm not going to read this page On page three I will explain the highlights of FY 2025 second quarter year-to-date financial results. on page three i will explain the highlights of fy 2025 second quarter year-to-date financial results Overall we have made exceptional progress at performing expectations. overall we have made exceptional progress at performing expectations We have made a significant upward revision of our full-year forecast driven by continued strong growth of our strategic brands. we have made a significant upward revision of our full-year forecast driven by continued strong growth of our strategic brands Revenue increased significantly year-on-year with underlying growth of 12% year- on- year excluding forex impact. revenue increased significantly year-on-year with underlying growth of 12% year- on- year excluding forex impact As for SG&A expenses, thanks to the robust progress of SMT, Sustainable Margin Transformation company-wide cost optimization initiative, SG&A ratio improved by 3.1 percentage points year- on- year. as for sg&a expenses thanks to the robust progress of smt sustainable margin transformation company-wide cost optimization initiative sg&a ratio improved by 3.1 percentage points year- on- year Due to the growth of strategic brands and robust cost management through SMT, core operating profit rose significantly year-on-year with underlying growth of 57%. due to the growth of strategic brands and robust cost management through smt core operating profit rose significantly year-on-year with underlying growth of 57% Core operating profit margin increased by 7.9 percentage points year-on-year to reach 27.4%. Based on this exceptional progress exceeding our expectations, we revised our full-year forecast upward by JPY 100 billion for revenue and by JPY 80 billion for both core and full operating profit respectively. Regarding pipeline progress for PADCEV, we have unprecedented EV-303 study data in MIBC, muscle invasive bladder cancer, and our BLA for additional indication was accepted in the United States. As for focus area approach, we obtained promising initial data with ASP3082 and ASP2138 and registration-enabling studies are now under preparation. Page four is the agenda for today. From the next page I will explain these topics. Page five shows FY 2025 second quarter year-to-date financial results. Revenue, core and full operating profit all increased by about JPY 100 billion year-on-year. Let me explain main items. Revenue reached JPY 1,030.1 billion, up by 10.1% year-on-year. Core operating profit margin increased by 7.9 percentage points year -on- year to reach 27.4%. core operating profit margin increased by 7.9 percentage points year -on- year to reach 27.4% Based on this exceptional progress exceeding our expectations, we revised our full-year forecast upward by JPY 100 billion for revenue and by JPY 80 billion for both core and full operating profit respectively. based on this exceptional progress exceeding our expectations we revised our full-year forecast upward by jpy 100 billion for revenue and by jpy 80 billion for both core and full operating profit respectively Regarding pipeline progress for PADCEV, we have unprecedented EV-303 study data in MIBC, muscle invasive bladder cancer, and our BLA for additional indication was accepted in the United States. regarding pipeline progress for padcev we have unprecedented ev-303 study data in mibc muscle invasive bladder cancer and our bla for additional indication was accepted in the united states As for focus area approach, we obtained promising initial data with ASP3082 and ASP2138 and registration-enabling studies are now under preparation. as for focus area approach we obtained promising initial data with asp3082 and asp2138 and registration-enabling studies are now under preparation Page four is the agenda for today. page four is the agenda for today From the next page I will explain these topics. from the next page i will explain these topics Page five shows FY 2025 second quarter year-to-date financial results. page five shows fy 2025 second quarter year-to-date financial results Revenue, core and full operating profit all increased by about JPY 100 billion year-on-year. revenue core and full operating profit all increased by about jpy 100 billion year-on-year Let me explain main items. let me explain main items Revenue reached JPY 1,030.1 billion, up by 10.1% year-on-year. revenue reached jpy 1,030.1 billion up by 10.1% year-on-year Core operating profit rose to JPY 282.6 billion, up by 54.4% year-on-year. The forex impact is shown on the right-hand side of the table. Forex had a negative impact on both revenue and core operating profit. Underlying growth excluding this impact was 12% for revenue and 57% for core operating profit, demonstrating a stronger growth. The bottom half of this page shows our full basis results. Operating profit was JPY 199.4 billion, up by 112.8% year-on-year. Profit increased to JPY 147.6 billion, up by 100.8% year-on-year. Page six shows FY 2025 second quarter year-to-date results of our main brands. Strategic brands grew substantially, driven primarily by strong growth in PADCEV and VYLOY. Core operating profit rose to JPY 282.6 billion, up by 54.4% year-on-year. core operating profit rose to jpy 282.6 billion up by 54.4% year-on-year The forex impact is shown on the right-hand side of the table. the forex impact is shown on the right-hand side of the table Forex had a negative impact on both revenue and core operating profit. forex had a negative impact on both revenue and core operating profit Underlying growth excluding this impact was 12% for revenue and 57% for core operating profit, demonstrating a stronger growth. underlying growth excluding this impact was 12% for revenue and 57% for core operating profit demonstrating a stronger growth The bottom half of this page shows our full basis results. the bottom half of this page shows our full basis results Operating profit was JPY 199.4 billion, up by 112.8% year-on-year. operating profit was jpy 199.4 billion up by 112.8% year-on-year Profit increased to JPY 147.6 billion, up by 100.8% year-on-year. profit increased to jpy 147.6 billion up by 100.8% year-on-year Page six shows FY 2025 second quarter year-to-date results of our main brands. page six shows fy 2025 second quarter year-to-date results of our main brands Strategic brands grew substantially, driven primarily by strong growth in PADCEV and VYLOY. strategic brands grew substantially driven primarily by strong growth in padcev and vyloy For second quarter year to date, sales of five strategic brands driving Astellas Pharma's growth, namely PADCEV, IZERVAY, VEOZAH, VYLOY and XOSPATA, exceeded JPY 220 billion in total, substantially up by JPY 66.2 billion or 43% year-on-year. Underlying growth excluding forex impact was 47%, showing a strong growth. Due to high profitability of these brands, they not just contributed to revenues but also made a great contribution to profit growth on a consolidated basis. As a whole, we are expecting this strong growth momentum to continue in the second half of FY 2025. Next I will explain individual strategic brands and XTANDI. Part 7 global sales increased to JPY 102.5 billion, up by JPY 27.1 billion or 36% year-on-year. Robust global growth has been continuously driven by strong first line MUC demand momentum. Regional expansion in the first line indication is also making steady progress. First line MUC approval expanded to 25 countries. We are expecting further expansion of countries with approval as well as an increase in the number of countries where reimbursement will start, mainly based on the robust progress in the United States and Europe. For second quarter year to date, sales of five strategic brands driving Astellas Pharma's growth, namely PADCEV, IZERVAY, VEOZAH, VYLOY and XOSPATA, exceeded JPY 220 billion in total, substantially up by JPY 66.2 billion or 43% year-on-year. for second quarter year to date sales of five strategic brands driving astellas pharma's growth namely padcev izervay veozah vyloy and xospata exceeded jpy 220 billion in total substantially up by jpy 66.2 billion or 43% year-on-year Underlying growth excluding forex impact was 47%, showing a strong growth. underlying growth excluding forex impact was 47% showing a strong growth Due to high p rofitability of these brands, t hey not just contributed to revenues but also made a great contribution to profit growth on a consolidated basis. due to high p rofitability of these brands, t hey not just contributed to revenues but also made a great contribution to profit growth on a consolidated basis As a whole, we are expecting this strong growth momentum to continue in the second half of FY 2025. as a whole we are expecting this strong growth momentum to continue in the second half of fy 2025 Next I will explain individual strategic brands and XTANDI. next i will explain individual strategic brands and xtandi Part 7 global sales increased to JPY 102.5 billion, up by JPY 27.1 billion or 36% year-on-year. part 7 global sales increased to jpy 102.5 billion up by jpy 27.1 billion or 36% year-on-year Robust global growth has been continuously driven by strong first line MUC demand momentum. robust global growth has been continuously driven by strong first line muc demand momentum Regional expansion in the first line indication is also making steady progress. regional expansion in the first line indication is also making steady progress First line MUC approval expanded to 25 countries. first line muc approval expanded to 25 countries We are expecting further expansion of countries with approval as well as an increase in the number of countries where reimbursement will start, mainly based on the robust progress in the United States and Europe. we are expecting further expansion of countries with approval as well as an increase in the number of countries where reimbursement will start mainly based on the robust progress in the united states and europe In the FY 2025 second half outlook, we revised our forecast upward by JPY 10 billion to expect JPY 210 billion on a full year basis. Next growth opportunity is expected from potential MIBC indication approval. EV-303 study in cis-ineligible MIBC presented at ESMO the other day demonstrated extremely promising results exceeding our expectations. Based on these results, we already filed a submission in the United States. We are expecting contribution to sales post approval. Furthermore, based on this exceptional data exceeding our expectations, we are analyzing the possibility of any upside to our sales forecast including peak sales. Also taking into account the status of EV-304 study for cis-eligible MIBC. In the FY 2025 second half outlook, we revised our forecast upward by JPY 10 billion to expect JPY 210 billion on a full year basis. in the fy 2025 second half outlook we revised our forecast upward by jpy 10 billion to expect jpy 210 billion on a full year basis Next growth opportunity is expected from potential MIBC indication approval. next growth opportunity is expected from potential mibc indication approval EV-303 study in cis-ineligible MIBC presented at ESMO the other day demonstrated extremely promising results exceeding our expectations. ev-303 study in cis-ineligible mibc presented at esmo the other day demonstrated extremely promising results exceeding our expectations Based on these results, we already filed a submission in the United States. based on these results we already filed a submission in the united states We are expecting contribution to sales post approval. we are expecting contribution to sales post approval Furthermore, based on this exceptional data exceeding our expectations, we are analyzing the possibility of any upside to our sales forecast including peak sales. furthermore based on this exceptional data exceeding our expectations we are analyzing the possibility of any upside to our sales forecast including peak sales Also taking into account the status of EV-304 study for cis-eligible MIBC. also taking into account the status of ev-304 study for cis-eligible mibc We.Will share our latest outlook as soon as we complete our analysis. As for IZERVAY, sales rose to JPY 34.1 billion, up by JPY 6 billion or 21% year-on-year on a quarterly basis. Double-digit growth is continuously maintained, but patient affordability headwinds weighed on new patient starts and sales, so progress was lower than initially expected. Based on the second quarter year-to-date progress and FY 2025 second half outlook, we revised our forecast downward by JPY 25 billion and are expecting JPY 80 billion on a full-year basis. We revised our full-year forecast downward, but we are expecting continuous also from now on. One factor behind this: new patient starts recovery. Although it's moderate, we are seeing signs of recovery in new patient starts from August. The share is also improving from the lower 50% level in June to the upper 50% level in August. We. we Will share our latest outlook as soon as we complete our analysis. will share our latest outlook as soon as we complete our analysis As for IZERVAY, sales rose to JPY 34.1 billion, up by JPY 6 billion or 21% year-on-year on a quarterly basis. as for izervay sales rose to jpy 34.1 billion up by jpy 6 billion or 21% year-on-year on a quarterly basis Double-digit growth is continuously maintained, but patient affordability headwinds weighed on new patient starts and sales, so progress was lower than initially expected. double-digit growth is continuously maintained but patient affordability headwinds weighed on new patient starts and sales so progress was lower than initially expected Based on the second quarter year-to-date progress and FY 2025 second half outlook, we revised our forecast downward by JPY 25 billion and are expecting JPY 80 billion on a full-year basis. based on the second quarter year-to-date progress and fy 2025 second half outlook we revised our forecast downward by jpy 25 billion and are expecting jpy 80 billion on a full-year basis We revised our full-year forecast downward, but we are expecting continuous also from now on. we revised our full-year forecast downward but we are expecting continuous also from now on One factor behind this: new patient starts recovery. one factor behind this new patient starts recovery Although it's moderate, we are seeing signs of recovery in new patient starts from August. although it's moderate we are seeing signs of recovery in new patient starts from august The share is also improving from the lower 50% level in June to the upper 50% level in August. the share is also improving from the lower 50% level in june to the upper 50% level in august Another factor is the use of GATHER2 open-label extension study data presented at AAO, American Academy of Ophthalmology, this month. Over 3.5 years post IZERVAY dosing, increased benefit was demonstrated according to long-term efficacy data. In addition, favorable long-term data was obtained also in terms of safety and tolerability as well. By broadly disseminating this kind of data in the market, we will aim to further increase the awareness of the importance of treating IGA and the benefit of IZERVAY. You can find GATHER2 extension study data on page 34 and 35 in the Appendix for your reference. Please refer to those pages at your leisure. We believe in the mid to long-term potential of IZERVAY, and we are expecting that we can reach the peak sales forecast range. We have high expectations on IZERVAY as an important growth driver for Astellas Pharma also into the future. Another factor is the use of GATHER2 open-label extension study data presented at AAO, American Academy of Ophthalmology, this month. another factor is the use of gather2 open-label extension study data presented at aao american academy of ophthalmology this month Over 3.5 years post IZERVAY dosing, increased benefit was demonstrated according to long-term efficacy data. over 3.5 years post izervay dosing increased benefit was demonstrated according to long-term efficacy data In addition, favorable long-term data was obtained also in terms of safety and tolerability as well. in addition favorable long-term data was obtained also in terms of safety and tolerability as well By broadly disseminating this kind of data in the market, we will aim to further increase the awareness of the importance of treating IGA and the benefit of IZERVAY. by broadly disseminating this kind of data in the market we will aim to further increase the awareness of the importance of treating iga and the benefit of izervay You can find GATHER2 extension study data on page 34 and 35 in the Appendix for your reference. you can find gather2 extension study data on page 34 and 35 in the appendix for your reference Please refer to those pages at your leisure. please refer to those pages at your leisure We believe in the mid to long-term potential of IZERVAY, and we are expecting that we can reach the peak sales forecast range. we believe in the mid to long-term potential of izervay and we are expecting that we can reach the peak sales forecast range We have high expectations on IZERVAY as an important growth driver for Astellas Pharma also into the future. we have high expectations on izervay as an important growth driver for astellas pharma also into the future Global sales of VEOZAH increased to JPY 22.9 billion, up by JPY 8.1 billion or 55% year-on-year, demonstrating a solid growth continuous. We are anticipating this steady growth trajectory ahead in the second half of FY 2025. With regards to VYLOY, global sales reached JPY 26.6 billion. Its outstanding performance is exceeding expectations due to active awareness campaign. We were able to realize exceptional coding 18 testing rate penetration and lower treatment discontinuation through appropriate information provision activities on adverse event management. Regional footprint is expanding steadily with approval in 47 countries and launches in 26 countries by now. Based on this strong global momentum as a whole, we have made a substantial upward revision of our full year forecast from JPY 40 billion-JPY 60 billion, which is 1.5x compared to the initial forecast regarding XOSPATA. Global sales reached JPY 34.4 billion. Global sales of VEOZAH increased to JPY 22.9 billion, up by JPY 8.1 billion or 55% year-on-year, demonstrating a solid growth continuous. global sales of veozah increased to jpy 22.9 billion up by jpy 8.1 billion or 55% year-on-year demonstrating a solid growth continuous We are anticipating this steady growth trajectory ahead in the second half of FY 2025. we are anticipating this steady growth trajectory ahead in the second half of fy 2025 With regards to VYLOY, global sales reached JPY 26.6 billion. with regards to vyloy global sales reached jpy 26.6 billion Its outstanding performance is exceeding expectations due to active awareness campaign. its outstanding performance is exceeding expectations due to active awareness campaign We were able to realize exceptional coding 18 testing rate penetration and lower treatment discontinuation through appropriate information provision activities on adverse event management. we were able to realize exceptional coding 18 testing rate penetration and lower treatment discontinuation through appropriate information provision activities on adverse event management Regional footprint is expanding steadily with approval in 47 countries and launches in 26 countries by now. regional footprint is expanding steadily with approval in 47 countries and launches in 26 countries by now Based on this strong global momentum as a whole, we have made a substantial upward revision of our full year forecast from JPY 40 billion- JPY 60 billion, which is 1.5x compared to the initial forecast regarding XOSPATA. based on this strong global momentum as a whole we have made a substantial upward revision of our full year forecast from jpy 40 billion- jpy 60 billion which is 1.5x compared to the initial forecast regarding xospata Global sales reached JPY 34.4 billion. global sales reached jpy 34.4 billion There are some regional differences, but overall performance is largely on track. We are anticipating a moderate growth trend within the current indication of relapsed or refractory AML as a future growth driver. Top line results for the additional indication in newly diagnosed AML are anticipated in the first half of FY 2026. If approved, we can offer a treatment option to a new patient population, so we are hoping for contribution to sales. Last but not least, XTANDI global sales increased to JPY 477 billion, up by JPY 25.3 billion or 6% year-on-year. Sales expanded in all regions, reflecting strong global performance as a whole. We revised our full year forecast upward. Page seven is about cost items. The SMT initiative made more progress than our expectations. We realized cost optimization of about JPY 16 billion in total for SG&A expenses, earned expenditure and cost of sales combined, excluding U.S. There are some regional differences, but overall performance is largely on track. there are some regional differences but overall performance is largely on track We are anticipating a moderate growth trend within the current indication of relapsed or refractory AML as a future growth driver. we are anticipating a moderate growth trend within the current indication of relapsed or refractory aml as a future growth driver Top line results for the additional indication in newly diagnosed AML are anticipated in the first half of FY 2026. top line results for the additional indication in newly diagnosed aml are anticipated in the first half of fy 2026 If approved, we can offer a treatment option to a new patient population, so we are hoping for contribution to sales. if approved we can offer a treatment option to a new patient population so we are hoping for contribution to sales Last but not least, XTANDI global sales increased to JPY 477 billion, up by JPY 25.3 billion or 6% year-on-year. last but not least xtandi global sales increased to jpy 477 billion up by jpy 25.3 billion or 6% year-on-year Sales expanded in all regions, reflecting strong global performance as a whole. sales expanded in all regions reflecting strong global performance as a whole We revised our full year forecast upward. we revised our full year forecast upward Page seven is about cost items. The SMT initiative made more progress than our expectations. page seven is about cost items. the smt initiative made more progress than our expectations We realized cost optimization of about JPY 16 billion in total for SG&A expenses, earned expenditure and cost of sales combined, excluding U.S. we realized cost optimization of about jpy 16 billion in total for sg&a expenses earned expenditure and cost of sales combined excluding u.s Extended Core Promotion fees. The SG&A ratio improved by 3.1 percentage points year-on-year. Let me explain a specific breakdown of SG&A cost and R&D expenditure. SG&A expenses fell by 1.3% year-on-year, trending at a similar level compared to the previous year. The SG&A ratio was 26.9%. As SMT progressed, we realized cost optimization of about JPY 7 billion through continuous global organizational restructuring, reduction of mature products related expenses, and streamlining IT infrastructure, etc. In addition to investments to maximize the potential of strategic brands driving our future growth, we will continue to make investments needed for SMT execution in order to realize further cost optimization. The expenditure decreased by 16.9% year-on-year as a main factor behind. In addition to forex impact, we made progress in outsourcing cost reduction through insourcing development capabilities including clinical trials, etc. Extended Core Promotion fees. The SG&A ratio improved by 3.1 percentage points year-on-year. extended core promotion fees. the sg&a ratio improved by 3.1 percentage points year-on-year Let me explain a specific breakdown of SG&A cost and R&D expenditure. let me explain a specific breakdown of sg&a cost and r&d expenditure SG&A expenses fell by 1.3% year-on-year, trending at a similar level compared to the previous year. The SG&A ratio was 26.9%. sg&a expenses fell by 1.3% year-on-year trending at a similar level compared to the previous year. the sg&a ratio was 26.9% As SMT progressed, we realized cost optimization of about JPY 7 billion through continuous global organizational restructuring, reduction of mature products related expenses, and streamlining IT infrastructure, etc. In addition to investments to maximize the potential of strategic brands driving our future growth, we will continue to make investments needed for SMT execution in order to realize further cost optimization. as smt progressed we realized cost optimization of about jpy 7 billion through continuous global organizational restructuring reduction of mature products related expenses and streamlining it infrastructure etc in addition to investments to maximize the potential of strategic brands driving our future growth we will continue to make investments needed for smt execution in order to realize further cost optimization The expenditure decreased by 16.9% year-on-year as a main factor behind. the expenditure decreased by 16.9% year-on-year as a main factor behind In addition to forex impact, we made progress in outsourcing cost reduction through insourcing development capabilities including clinical trials, etc. in addition to forex impact we made progress in outsourcing cost reduction through insourcing development capabilities including clinical trials etc under SMT, which led to cost optimization of about JPY 7 billion. Furthermore, due to the completion of large clinical studies for strategic plans, clinical development cost decreased by about JPY 6 billion. In addition, one-time co-development cost payment booked in FY 2024 was another factor for cost decrease year-on-year. In the second half of FY 2025 onwards, we are expecting expansion of investments aligned with primary focus progress. In April this year, we implemented R&D organizational restructuring enabling active research to development all throughout. By pursuing operational efficiency, we are creating a cycle of making investments needed for the future continuously. Page eight is about the revision of FY 2025 full year forecast. Based on the robust progress exceeding our initial forecast up to the second quarter, we have made a significant upward revision of revenue, core, and full operating profit. under SMT, which led to cost optimization of about JPY 7 billion. under smt which led to cost optimization of about jpy 7 billion Furthermore, due to the completion of large clinical studies for strategic plans, clinical development cost decreased by about JPY 6 billion. furthermore due to the completion of large clinical studies for strategic plans clinical development cost decreased by about jpy 6 billion In addition, one-time co-development cost payment booked in FY 2024 was another factor for cost decrease year-on-year. in addition one-time co-development cost payment booked in fy 2024 was another factor for cost decrease year-on-year In the second half of FY 2025 onwards, we are expecting expansion of investments aligned with primary focus progress. in the second half of fy 2025 onwards we are expecting expansion of investments aligned with primary focus progress In April this year, we implemented R&D organizational restructuring enabling active research to development all throughout. in april this year we implemented r&d organizational restructuring enabling active research to development all throughout By pursuing operational efficiency, we are creating a cycle of making investments needed for the future continuously. by pursuing operational efficiency we are creating a cycle of making investments needed for the future continuously Page eight is about the revision of FY 2025 full year forecast. page eight is about the revision of fy 2025 full year forecast Based on the robust progress exceeding our initial forecast up to the second quarter, we have made a significant upward revision of revenue, core, and full operating profit. based on the robust progress exceeding our initial forecast up to the second quarter we have made a significant upward revision of revenue core and full operating profit We are expecting core operating profit margin of 24.1%, improving by 2.9 percentage points compared to the initial forecast. We revised our full year forecast forex assumptions to JPY 145 against the U.S. dollar and JPY 170 against the euro. From the third quarter onwards, we are assuming forex rates of JPY 144 against the dollar and JPY 172 against the euro. We have made an upward revision of revenue forecast by JPY 100 billion, including JPY 20 billion for VYLOY, JPY 10 billion for PADCEV, and JPY 70 billion for XTANDI. We are expecting revenue of JPY 2.03 trillion, exceeding the JPY 2 trillion mark for the first time since the establishment of Astellas. We are expecting SG&A expenses excluding U.S. external promotion fees to decline from the initial forecast. If we exclude forex impact reflecting robust progress of SMT, we are expecting JPY 586 billion. We are expecting core operating profit margin of 24.1%, improving by 2.9 percentage points compared to the initial forecast. we are expecting core operating profit margin of 24.1% improving by 2.9 percentage points compared to the initial forecast We revised our full year forecast forex assumptions to JPY 145 against the U.S. dollar and JPY 170 against the euro. we revised our full year forecast forex assumptions to jpy 145 against the u.s dollar and jpy 170 against the euro From the third quarter onwards, we are assuming forex rates of JPY 144 against the dollar and JPY 172 against the euro. from the third quarter onwards we are assuming forex rates of jpy 144 against the dollar and jpy 172 against the euro We have made an upward revision of revenue forecast by JPY 100 billion, including JPY 20 billion for VYLOY, JPY 10 billion for PADCEV, and JPY 70 billion for XTANDI. we have made an upward revision of revenue forecast by jpy 100 billion including jpy 20 billion for vyloy jpy 10 billion for padcev and jpy 70 billion for xtandi We are expecting revenue of JPY 2.03 trillion, exceeding the JPY 2 trillion mark for the first time since the establishment of Astellas. we are expecting revenue of jpy 2.03 trillion exceeding the jpy 2 trillion mark for the first time since the establishment of astellas We are expecting SG&A expenses excluding U.S. external promotion fees to decline from the initial forecast. we are expecting sg&a expenses excluding u.s external promotion fees to decline from the initial forecast If we exclude forex impact reflecting robust progress of SMT, we are expecting JPY 586 billion. if we exclude forex impact reflecting robust progress of smt we are expecting jpy 586 billion As for R&D expenditure reflecting operational efficiency in R&D reorganization, we are expecting JPY 322 billion. Reflecting the strong progress in our core business. Core operating profit is revised upward by JPY 80 billion from the initial focus, now expected to be JPY 490 billion. Hubei's operating profit is also revised upward by JPY 80 billion from the initial focus, now projected to be JPY 240 billion. We continue to incorporate a certain amount into the focus for other expenses to prepare for risks such as impairment losses. Next, I will explain the progress of our pipeline. Page 10 shows the progress of key events expected in FY 2025 for our strategic brands. A particularly significant development, as shown in the center of the slide, is the successful completion of the PADCEV EV-303 trial and acceptance of its supplemental BLA in the U.S. Details are provided on the next page. IZERVAY was approved in Japan in September for the indication of suppression of GA growth in atrophic AMD. As for R&D expenditure reflecting operational efficiency in R&D reorganization, we are expecting JPY 322 billion. as for r&d expenditure reflecting operational efficiency in r&d reorganization we are expecting jpy 322 billion Reflecting the strong progress in our core business. Core operating profit is revised upward by JPY 80 billion from the initial focus, now expected to be JPY 490 billion. reflecting the strong progress in our core business. core operating profit is revised upward by jpy 80 billion from the initial focus now expected to be jpy 490 billion Hubei's operating profit is also revised upward by JPY 80 billion from the initial focus, now projected to be JPY 240 billion. hubei's operating profit is also revised upward by jpy 80 billion from the initial focus now projected to be jpy 240 billion We continue to incorporate a certain amount into the focus for other expenses to prepare for risks such as impairment losses. we continue to incorporate a certain amount into the focus for other expenses to prepare for risks such as impairment losses Next, I will explain the progress of our pipeline. next i will explain the progress of our pipeline Page 10 shows the progress of key events expected in FY 2025 for our strategic brands. page 10 shows the progress of key events expected in fy 2025 for our strategic brands A particularly significant development, as shown in the center of the slide, is the successful completion of the PADCEV EV-303 trial and acceptance of its supplemental BLA in the U.S. a particularly significant development as shown in the center of the slide is the successful completion of the padcev ev-303 trial and acceptance of its supplemental bla in the u.s Details are provided on the next page. details are provided on the next page IZERVAY was approved in Japan in September for the indication of suppression of GA growth in atrophic AMD. izervay was approved in japan in september for the indication of suppression of ga growth in atrophic amd Aiming to rapidly deliver this treatment for severe GA with a high unmet need to Japanese patients, the development team engaged in constructive discussions with the authorities. This led to a submission based on overseas clinical trial results using the conditional approval system, resulting in approval just seven months later. Furthermore, as noted and outside of the table, approval was obtained in Australia in October as well. We'll continue to pursue further submissions in other countries and regions with the aim of delivering IZERVAY to patients worldwide. In addition, we presented efficacy and safety data from the GATHER2 open-label extension study covering up to 3.5 years after administration of IZERVAY at the AAO. In October, the final analysis results of the phase II GLEAM trial of VYLOY in pancreatic ductal adenocarcinoma, or PDAC, became available and the primary endpoint was not met. Aiming to rapidly deliver this treatment for severe GA with a high unmet need to Japanese patients, the development team engaged in constructive discussions with the authorities. aiming to rapidly deliver this treatment for severe ga with a high unmet need to japanese patients the development team engaged in constructive discussions with the authorities This led to a submission based on overseas clinical trial results using the conditional approval system, resulting in approval just seven months later. this led to a submission based on overseas clinical trial results using the conditional approval system resulting in approval just seven months later Furthermore, as noted and outside of the table, approval was obtained in Australia in October as well. furthermore as noted and outside of the table approval was obtained in australia in october as well We'll continue to pursue further submissions in other countries and regions with the aim of delivering IZERVAY to patients worldwide. we'll continue to pursue further submissions in other countries and regions with the aim of delivering izervay to patients worldwide In addition, we presented efficacy and safety data from the GATHER2 open-label extension study covering up to 3.5 years after administration of IZERVAY at the AAO. in addition we presented efficacy and safety data from the gather2 open-label extension study covering up to 3.5 years after administration of izervay at the aao In October, the final analysis results of the phase II GLEAM trial of VYLOY in pancreatic ductal adenocarcinoma, or PDAC, became available and the primary endpoint was not met. in october the final analysis results of the phase ii gleam trial of vyloy in pancreatic ductal adenocarcinoma or pdac became available and the primary endpoint was not met We are currently analyzing the detailed data as part of the lifecycle management of VYLOY. The phase III LUCENE trial evaluating its combination with pembrolizumab and chemotherapy in gastric cancer is ongoing. Page 11 shows the latest status parts of MIBC development. For details, please refer to the materials from last week's online briefing on our oncology pipeline. The EV-303 trial yielded unprecedented data suggesting that PADCEV has the potential to become a new standard of care for cisplatin-ineligible MIBC. EV-303 trial compared the efficacy and safety of PADCEV plus pembrolizumab as neoadjuvant therapy before and after radical cystectomy, the current standard of care in patients with MIBC who were ineligible for or declined cisplatin-based chemotherapy versus surgery alone. The figure shows the efficacy results from the first interim analysis. We are currently analyzing the detailed data as part of the lifecycle management of VYLOY. we are currently analyzing the detailed data as part of the lifecycle management of vyloy The phase III LUCENE trial evaluating its combination with pembrolizumab and chemotherapy in gastric cancer is ongoing. the phase iii lucene trial evaluating its combination with pembrolizumab and chemotherapy in gastric cancer is ongoing Page 11 shows the latest status parts of MIBC development. page 11 shows the latest status parts of mibc development For details, please refer to the materials from last week's online briefing on our oncology pipeline. for details please refer to the materials from last week's online briefing on our oncology pipeline The EV-303 trial yielded unprecedented data suggesting that PADCEV has the potential to become a new standard of care for cisplatin-ineligible MIBC. the ev-303 trial yielded unprecedented data suggesting that padcev has the potential to become a new standard of care for cisplatin-ineligible mibc EV-303 trial compared the efficacy and safety of PADCEV plus pembrolizumab as neoadjuvant therapy before and after radical cystectomy, the current standard of care in patients with MIBC who were ineligible for or declined cisplatin-based chemotherapy versus surgery alone. ev-303 trial compared the efficacy and safety of padcev plus pembrolizumab as neoadjuvant therapy before and after radical cystectomy the current standard of care in patients with mibc who were ineligible for or declined cisplatin-based chemotherapy versus surgery alone The figure shows the efficacy results from the first interim analysis. the figure shows the efficacy results from the first interim analysis The left panel displays the primary endpoint event-free survival or EFS, and the right panel shows the key secondary endpoint overall survival or OS compared to surgery alone. The combination therapy group or arm showed a hazard ratio of 0.40 for EFS, representing a 60% reduction in the risk of tumor recurrence, disease progression, or death, and a hazard ratio of 0.50 for OS, indicating a 50% reduction in the risk of death. Subgroup analysis confirmed consistent improvements in EFS and OS regardless of age, sex, or PD-L1 expression status. The safety profile of the combination therapy arm was consistent with the previously reported trials with no new safety concerns identified. Following the top-line results in August, we rapidly advanced the process for additional indications within just over two months. The U.S. BLA was accepted and granted priority review designation with a target PDUFA date set for April 7th, 2026. The left panel displays the primary endpoint event-free survival or EFS, and the right panel shows the key secondary endpoint overall survival or OS compared to surgery alone. the left panel displays the primary endpoint event-free survival or efs and the right panel shows the key secondary endpoint overall survival or os compared to surgery alone The combination therapy group or arm showed a hazard ratio of 0.40 for EFS, representing a 60% reduction in the risk of tumor recurrence, disease progression, or death, and a hazard ratio of 0.50 for OS, indicating a 50% reduction in the risk of death. the combination therapy group or arm showed a hazard ratio of 0.40 for efs representing a 60% reduction in the risk of tumor recurrence disease progression or death and a hazard ratio of 0.50 for os indicating a 50% reduction in the risk of death Subgroup analysis confirmed consistent improvements in EFS and OS regardless of age, sex, or PD-L1 expression status. subgroup analysis confirmed consistent improvements in efs and os regardless of age sex or pd-l1 expression status The safety profile of the combination therapy arm was consistent with the previously reported trials with no new safety concerns identified. the safety profile of the combination therapy arm was consistent with the previously reported trials with no new safety concerns identified Following the top-line results in August, we rapidly advanced the process for additional indications within just over two months. following the top-line results in august we rapidly advanced the process for additional indications within just over two months The U.S. the u.s BLA was accepted and granted priority review designation with a target PDUFA date set for April 7th, 2026. bla was accepted and granted priority review designation with a target pdufa date set for april 7th 2026 We are also progressing discussions with regulatory authorities in other regions for other submissions. Furthermore, the phase III EV-304 trial for cisplatin-treated MIBC is ongoing with interim analysis data anticipated in the latter half of fiscal year 2025. Page 12 for Focus Area approach, I will explain the progress on flagship programs ASP3082 targeted protein degradation and ASP2138 immuno-oncology, present promising clinical trial data in October. While details were already explained during last week's online briefing, the following slides briefly recap the current status. Clinical trials for OTA-4/5 in genetic regulation and ASP7317 in blindness and regeneration are progressing as planned, with POC assessment still scheduled for the second half of FY 2025. The current status of other programs is summarized on slide 41 in the appendix. Page 13 explains the progress of ASP3082 and the primary focus, targeted protein degradation. We are also progressing discussions with regulatory authorities in other regions for other submissions. we are also progressing discussions with regulatory authorities in other regions for other submissions Furthermore, the phase III EV-304 trial for cisplatin-treated MIBC is ongoing with interim analysis data anticipated in the latter half of fiscal year 2025. furthermore the phase iii ev-304 trial for cisplatin-treated mibc is ongoing with interim analysis data anticipated in the latter half of fiscal year 2025 Page 12 for Focus Area approach, I will explain the progress on flagship programs ASP3082 targeted protein degradation and ASP2138 immuno-oncology, present promising clinical trial data in October. page 12 for focus area approach i will explain the progress on flagship programs asp3082 targeted protein degradation and asp2138 immuno-oncology present promising clinical trial data in october While details were already explained during last week's online briefing, the following slides briefly recap the current status. while details were already explained during last week's online briefing the following slides briefly recap the current status Clinical trials for OTA-4/5 in genetic regulation and ASP7317 in blindness and regeneration are progressing as planned, with POC assessment still scheduled for the second half of FY 2025. clinical trials for ota-4/5 in genetic regulation and asp7317 in blindness and regeneration are progressing as planned with poc assessment still scheduled for the second half of fy 2025 The current status of other programs is summarized on slide 41 in the appendix. the current status of other programs is summarized on slide 41 in the appendix Page 13 explains the progress of ASP3082 and the primary focus, targeted protein degradation. page 13 explains the progress of asp3082 and the primary focus targeted protein degradation Specifically, ASP3082 has presented promising data in NSCLC or non-small cell lung cancer, and we have initiated preparations for registration studies targeting PDAC and NSCLC. ASP3082 has achieved POC in both PDAC and SCLC. This time we presented clinical data for its monotherapy in second line analytic treatment settings for NSCLC at an October Congress. Last week's online briefing preceded the Congress presentation, so we provided an explanation aligned with the abstract. Today, however, we will use the data presented at the Congress. As shown in the figure on the right, NSCLC has a high unmet medical need. The objective response rate with the existing standard of care in the second line and beyond is reported to be in the single digits, reaching at a maximum of around 18%. Specifically, ASP3082 has presented promising data in NSCLC or non-small cell lung cancer, and we have initiated preparations for registration studies targeting PDAC and NSCLC. specifically asp3082 has presented promising data in nsclc or non-small cell lung cancer and we have initiated preparations for registration studies targeting pdac and nsclc ASP3082 has achieved POC in both PDAC and SCLC. asp3082 has achieved poc in both pdac and sclc This time we presented clinical data for its monotherapy in second line analytic treatment settings for NSCLC at an October Congress. this time we presented clinical data for its monotherapy in second line analytic treatment settings for nsclc at an october congress Last week's online briefing preceded the Congress presentation, so we provided an explanation aligned with the abstract. last week's online briefing preceded the congress presentation so we provided an explanation aligned with the abstract Today, however, we will use the data presented at the Congress. today however we will use the data presented at the congress As shown in the figure on the right, NSCLC has a high unmet medical need. as shown in the figure on the right nsclc has a high unmet medical need The objective response rate with the existing standard of care in the second line and beyond is reported to be in the single digits, reaching at a maximum of around 18%. the objective response rate with the existing standard of care in the second line and beyond is reported to be in the single digits reaching at a maximum of around 18% ASP3082 monotherapy demonstrated significantly superior anti-tumor activity compared to standard of care, achieving an ORR of 37.5% across our second line and beyond and 42.9% specifically in second and third line. Furthermore, the median duration of response was 9.72 months and a median progression free survival or PFS in second and third line was 8.25 months, confirming sustained efficacy. The safety profile showed no major concerns with no treatment-related adverse events leading to discontinuation observed at the data cutoff date. Development of ASP3082 across various tumor types is progressing. For PDAC, preparations are underway to initiate a pivotal trial for first line treatment in the latter half of FY 2025 with data presentation also targeted for the latter half of FY 2025. For NRCOC, planning is ongoing to initiate restoration of studies as early as possible. For CRC, colorectal cancer, the POC judgment remains targeted for the second half of FY 2025. ASP3082 monotherapy demonstrated significantly superior anti-tumor activity compared to standard of care, achieving an ORR of 37.5% across our second line and beyond and 42.9% specifically in second and third line. asp3082 monotherapy demonstrated significantly superior anti-tumor activity compared to standard of care achieving an orr of 37.5% across our second line and beyond and 42.9% specifically in second and third line Furthermore, the median duration of response was 9.72 months and a median progression free survival or PFS in second and third line was 8.25 months, confirming sustained efficacy. furthermore the median duration of response was 9.72 months and a median progression free survival or pfs in second and third line was 8.25 months confirming sustained efficacy The safety profile showed no major concerns with no treatment-related adverse events leading to discontinuation observed at the data cutoff date. the safety profile showed no major concerns with no treatment-related adverse events leading to discontinuation observed at the data cutoff date Development of ASP3082 across various tumor types is progressing. development of asp3082 across various tumor types is progressing For PDAC, preparations are underway to initiate a pivotal trial for first line treatment in the latter half of FY 2025 with data presentation also targeted for the latter half of FY 2025. for pdac preparations are underway to initiate a pivotal trial for first line treatment in the latter half of fy 2025 with data presentation also targeted for the latter half of fy 2025 For NRCOC, planning is ongoing to initiate restoration of studies as early as possible. for nrcoc planning is ongoing to initiate restoration of studies as early as possible For CRC, colorectal cancer, the POC judgment remains targeted for the second half of FY 2025. for crc colorectal cancer the poc judgment remains targeted for the second half of fy 2025 Furthermore, research and development for follow-on programs is advancing. ASP5834, upon KRAS degradation targeting diverse KRAS variants, achieved its first subject dosing in August. Under the new R&D structure launched in April, the team achieved its first subject dosing in a record 27 days after the FDA IND clearance. Thanks to close cross-functional collaboration, we will provide progress updates as data becomes available. From clinical trials, page 14 details progress on ASP2138 and primary focus seminar oncology specifically. ASP2138 is demonstrating the benefit of subcutaneous administration in combination with the standard of care, steadily progressing toward POC achievement. Phase 1 trials are currently underway for gastric and gastroesophageal junction adenocarcinoma or GGE as well as PDAC. These trials evaluate ASP2138 as a monotherapy in combination with standard of care IV and subcutaneous across multiple treatment lines. Furthermore, research and development for follow-on programs is advancing. furthermore research and development for follow-on programs is advancing ASP5834, upon KRAS degradation targeting diverse KRAS variants, achieved its first subject dosing in August. asp5834 upon kras degradation targeting diverse kras variants achieved its first subject dosing in august Under the new R&D structure launched in April, the team achieved its first subject dosing in a record 27 days after the FDA IND clearance. under the new r&d structure launched in april the team achieved its first subject dosing in a record 27 days after the fda ind clearance Thanks to close cross-functional collaboration, we will provide progress updates as data becomes available. thanks to close cross-functional collaboration we will provide progress updates as data becomes available From clinical trials, page 14 details progress on ASP2138 and primary focus seminar oncology specifically. from clinical trials page 14 details progress on asp2138 and primary focus seminar oncology specifically ASP2138 is demonstrating the benefit of subcutaneous administration in combination with the standard of care, steadily progressing toward POC achievement. asp2138 is demonstrating the benefit of subcutaneous administration in combination with the standard of care steadily progressing toward poc achievement Phase 1 trials are currently underway for gastric and gastroesophageal junction adenocarcinoma or GGE as well as PDAC. phase 1 trials are currently underway for gastric and gastroesophageal junction adenocarcinoma or gge as well as pdac These trials evaluate ASP2138 as a monotherapy in combination with standard of care IV and subcutaneous across multiple treatment lines. these trials evaluate asp2138 as a monotherapy in combination with standard of care iv and subcutaneous across multiple treatment lines Data presented at ESMO in October showed no major safety or elaborated concern concerns and support a combination with current standard of care. Furthermore, the ORR, when combined with the standard of care by a convenient biweekly subcutaneous administration, demonstrated high antitumor activity in gastric cancer at a 2000 microgram dose: 62.5% in first line and 37.5% in second line. In the figure above right, the values indicated in red represent the CLDN18.2 expression levels for each subject by low IT targets patients with high expression 75 N and above. This data confirms efficacy not only in high expression patients but also in those with moderate to low expression levels, suggesting the potential to expand the patient population eligible for this treatment. A POC judgment is planned for the latter half of FY 2025. Data presented at ESMO in October showed no major safety or elaborated concern concerns and support a combination with current standard of care. data presented at esmo in october showed no major safety or elaborated concern concerns and support a combination with current standard of care Furthermore, the ORR, when combined with the standard of care by a convenient biweekly subcutaneous administration, demonstrated high antitumor activity in gastric cancer at a 2000 microgram dose: 62.5% in first line and 37.5% in second line. furthermore the orr when combined with the standard of care by a convenient biweekly subcutaneous administration demonstrated high antitumor activity in gastric cancer at a 2000 microgram dose 62.5% in first line and 37.5% in second line In the figure above right, the values indicated in red represent the CLDN18.2 expression levels for each subject by low IT targets patients with high expression 75 N and above. in the figure above right the values indicated in red represent the cldn18.2 expression levels for each subject by low it targets patients with high expression 75 n and above This data confirms efficacy not only in high expression patients but also in those with moderate to low expression levels, suggesting the potential to expand the patient population eligible for this treatment. this data confirms efficacy not only in high expression patients but also in those with moderate to low expression levels suggesting the potential to expand the patient population eligible for this treatment A POC judgment is planned for the latter half of FY 2025. a poc judgment is planned for the latter half of fy 2025 Given the compelling data obtained thus far, we have initiated discussions on the development plan to enable the prompt execution of the Restoration trial following POC achievement for CLDN18.2 targeted therapy. We aim to provide treatment options to a broader patient population. To strengthen our leading position, we are advancing the development of the antibody drug conjugate as in addition to ASP2138, research and development of follow-on programs are also progressing. Multiple programs utilizing a similar mechanism of action including the clinical stage ASB1002 are advancing including bispecific. Additionally, a research advantage toward clinical trials for IADC immunostimulatory antibody drug conjugate utilizing new antibody modification technologies. We will provide updates including updated explanations as progress is made in each program. Page 15 shows today's key takeaways. The second quarter delivered exceptional financial results. PADCEV and VYLOY led the way with strategic brands demonstrating strong growth. Given the compelling data obtained thus far, we have initiated discussions on the development plan to enable the prompt execution of the Restoration trial following POC achievement for CLDN18.2 targeted therapy. given the compelling data obtained thus far we have initiated discussions on the development plan to enable the prompt execution of the restoration trial following poc achievement for cldn18.2 targeted therapy We aim to provide treatment options to a broader patient population. we aim to provide treatment options to a broader patient population To strengthen our leading position, we are advancing the development of the antibody drug conjugate as in addition to ASP2138, research and development of follow-on programs are also progressing. to strengthen our leading position we are advancing the development of the antibody drug conjugate as in addition to asp2138 research and development of follow-on programs are also progressing Multiple programs utilizing a similar mechanism of action including the clinical stage ASB1002 are advancing including bispecific. multiple programs utilizing a similar mechanism of action including the clinical stage asb1002 are advancing including bispecific Additionally, a research advantage toward clinical trials for IADC immunostimulatory antibody drug conjugate utilizing new antibody modification technologies. additionally a research advantage toward clinical trials for iadc immunostimulatory antibody drug conjugate utilizing new antibody modification technologies We will provide updates including updated explanations as progress is made in each program. we will provide updates including updated explanations as progress is made in each program Page 15 shows today's key takeaways. page 15 shows today's key takeaways The second quarter delivered exceptional financial results. the second quarter delivered exceptional financial results PADCEV and VYLOY led the way with strategic brands demonstrating strong growth. padcev and vyloy led the way with strategic brands demonstrating strong growth SMT progressed well, achieving robust cost optimization. Based on this strong progress in our core business, we have reversed our full year revenue forecast upward by JPY 100 billion and both core and full operating profit by JPY 80 billion. Our pipeline also showed robust progress. PADCEV showed unprecedented data in the EV-303 trial, significantly advancing its development for MIBC in the focus area approach. Promising data was obtained for ASP3082 and ASP2138 and preparations are underway to conduct registration trials throughout FY 2025. We will aim for further profit growth and enhanced pipeline value at the end. I would like to announce upcoming events. On Tuesday, December 9th, we plan to hold a discussion session with outside directors. At this session, we will explain the evolution of Astellas governance structure. SMT progressed well, achieving robust cost optimization. smt progressed well achieving robust cost optimization Based on this strong progress in our core business, we have reversed our full year revenue forecast upward by JPY 100 billion and both core and full operating profit by JPY 80 billion. based on this strong progress in our core business we have reversed our full year revenue forecast upward by jpy 100 billion and both core and full operating profit by jpy 80 billion Our pipeline also showed robust progress. our pipeline also showed robust progress PADCEV showed unprecedented data in the EV-303 trial, significantly advancing its development for MIBC in the focus area approach. padcev showed unprecedented data in the ev-303 trial significantly advancing its development for mibc in the focus area approach Promising data was obtained for ASP3082 and ASP2138 and preparations are underway to conduct registration trials throughout FY 2025. promising data was obtained for asp3082 and asp2138 and preparations are underway to conduct registration trials throughout fy 2025 We will aim for further profit growth and enhanced pipeline value at the end. we will aim for further profit growth and enhanced pipeline value at the end I would like to announce upcoming events. i would like to announce upcoming events On Tuesday, December 9th, we plan to hold a discussion session with outside directors. on tuesday december 9th we plan to hold a discussion session with outside directors At this session, we will explain the evolution of Astellas governance structure. at this session we will explain the evolution of astellas governance structure Additionally, directors newly appointed in June will share their perspectives on joining the Astellas Board of Directors as well as their experiences and impressions from their first 150 days in office. We encourage your participation. That concludes my presentation. Thank you very much for your attention. Additionally, directors newly appointed in June will share their perspectives on joining the Astellas Board of Directors as well as their experiences and impressions from their first 150 days in office. additionally directors newly appointed in june will share their perspectives on joining the astellas board of directors as well as their experiences and impressions from their first 150 days in office We encourage your participation. we encourage your participation That concludes my presentation. that concludes my presentation Thank you very much for your attention. thank you very much for your attention

Speaker 6: Hey Sei Kato, that's all. As a presentation, we are going to entertain questions from the audience. If you have questions, please press the raise hand button at the bottom of your Zoom screen. If you are joining from your smartphone, if you tap details, the raise hand function will be shown, so please press it. I will name you one by one. If your name is called, please unmute yourself on your screen, mention your name and your affiliation, and then ask questions. We now would like to open the floor for questions. The first, Mr. Yamaguchi from Citigroup. Mr. Yamaguchi, please, can you hear me? Hey Sei Kato, that's all. hey sei kato that's all As a presentation, we are going to entertain questions from the audience. as a presentation we are going to entertain questions from the audience If you have questions, please press the raise hand button at the bottom of your Zoom screen. if you have questions please press the raise hand button at the bottom of your zoom screen If you are joining from your smartphone, if you tap details, the raise hand function will be shown, so please press it. if you are joining from your smartphone if you tap details, the raise hand function will be shown so please press it I will name you one by one. i will name you one by one If your name is called, please unmute yourself on your screen, mention your name and your affiliation, and then ask questions. if your name is called please unmute yourself on your screen mention your name and your affiliation and then ask questions We now would like to open the floor for questions. we now would like to open the floor for questions The first, Mr. Yamaguchi from Citigroup. the first mr yamaguchi from citigroup Mr. Yamaguchi, please, can you hear me? mr yamaguchi please can you hear me

Speaker 1: I'm Yamaguchi from Citigroup. I'm Yamaguchi from Citigroup. i'm yamaguchi from citigroup

Speaker 6: Yes, we can hear you. Thank you. Yes, we can hear you. yes we can hear you Thank you. thank you

Speaker 1: First, about PADCEV, the data was better than you expected. Global sales are going to be JPY 400 billion-JPY 500 billion. MIBC is ineligible or data was better than expected in this area. What is going to be the potential impact? How better compared to your initial expectations? First, about PADCEV, the data was better than you expected. first about padcev the data was better than you expected Global sales are going to be JPY 400 billion- JPY 500 billion. global sales are going to be jpy 400 billion- jpy 500 billion MIBC is ineligible or data was better than expected in this area. mibc is ineligible or data was better than expected in this area What is going to be the potential impact? what is going to be the potential impact How better compared to your initial expectations? how better compared to your initial expectations

Speaker 12: Thank you for your question. I will respond briefly and then regarding sales forecast class may add and the data per se where necessary can be explained by Taniguchi. First of all, as I showed on. The slide 303 study results, even we non-experts see the separation in the Kaplan-Meier curve and the hazard ratio is 0.4 or 0.5. We don't see these numbers so often. We presented this at ESMO in the first line of settings, we said the same. We made a presentation at Congress and there was a standing ovation naturally in the audience. We think we had unprecedented data. Thank you for your question. thank you for your question I will respond briefly and then regarding s ales forecast class may add and the data per se where necessary can be explained by Taniguchi. i will respond briefly and then regarding s ales forecast class may add and the data per se where necessary can be explained by taniguchi First of all, as I showed on. first of all as i showed on The slide 303 study results, even we non-experts see the separation in the Kaplan-Meier curve and the hazard ratio is 0.4 or 0.5. the slide 303 study results even we non-experts see the separation in the kaplan-meier curve and the hazard ratio is 0.4 or 0.5 We don't see these numbers so often. we don't see these numbers so often We presented this at ESMO in the first line of settings, we said the same. we presented this at esmo in the first line of settings we said the same We made a presentation at Congress and there was a standing ovation naturally in the audience. we made a presentation at congress and there was a standing ovation naturally in the audience We think we had unprecedented data. we think we had unprecedented data

Speaker 1: This great data exceeded our expectations. Is this going to lead to the sales forecast directly? Not necessarily. MIBC and after metastasis in the urothelial cancer MUC, it's not clearly separated completely in the current indication. Some part is covered in the United States if the additional indication is approved. How much we can expand the target patient population? This great data exceeded our expectations. this great data exceeded our expectations Is this going to lead to the sales forecast directly? is this going to lead to the sales forecast directly Not necessarily. not necessarily MIBC and after metastasis in the urothelial cancer MUC, it's not clearly separated completely in the current indication. mibc and after metastasis in the urothelial cancer muc it's not clearly separated completely in the current indication Some part is covered in the United States if the additional indication is approved. some part is covered in the united states if the additional indication is approved How much we can expand the target patient population? how much we can expand the target patient population

Speaker 12: It's difficult for us to say clearly how much we can expand. CIS ineligible patient population was studied in 303 study. Patients on cisplatin 3 or 4 study is ongoing and we'd like to look at the distribution of these patients in detail. To share our sales forecast with you first, Taniguchi-san, anything from you. Thank you very much. It's difficult for us to say clearly how much we can expand. it's difficult for us to say clearly how much we can expand CIS ineligible patient population was studied in 303 study. cis ineligible patient population was studied in 303 study Patients on cisplatin 3 or 4 study is ongoing and we'd like to look at the distribution of these patients in detail. patients on cisplatin 3 or 4 study is ongoing and we'd like to look at the distribution of these patients in detail To share our sales forecast with you first, Taniguchi-san, anything from you. to share our sales forecast with you first taniguchi-san anything from you Thank you very much. thank you very much

Speaker 7: For me, regarding this data, I'd like to add a bit. As Okamura explained at ESMO, there was a very good response from the audience. First, the primary endpoint EFS hazard ratio was 0.40. This is unprecedented in terms of the risk reduction. Secondary endpoint overall survival consistently 0.5. Regarding secondary endpoint, whether we could meet this in the interim analysis, we made this much reduction. There was a statistically significant difference. Clearly, number three, PCR ratio was 57% or even exceeding that level and 8.6% are for the control group. This much pathological CR was seen at such a high probability. For me, regarding this data, I'd like to add a bit. for me regarding this data i'd like to add a bit As Okamura explained at ESMO, there was a very good response from the audience. as okamura explained at esmo there was a very good response from the audience First, the primary endpoint EFS hazard ratio was 0.40. first the primary endpoint efs hazard ratio was 0.40 This is unprecedented in terms of the risk reduction. this is unprecedented in terms of the risk reduction Secondary endpoint overall survival consistently 0.5. secondary endpoint overall survival consistently 0.5 Regarding secondary endpoint, whether we could meet this in the interim analysis, we made this much reduction. regarding secondary endpoint whether we could meet this in the interim analysis we made this much reduction There was a statistically significant difference. there was a statistically significant difference Clearly, number three, PCR ratio was 57% or even exceeding that level and 8.6% are for the control group. clearly number three pcr ratio was 57% or even exceeding that level and 8.6% are for the control group This much pathological CR was seen at such a high probability. this much pathological cr was seen at such a high probability Such a drug is unprecedented.This was highly evaluated as well. These are the three effects. As for safety, the pembrolizumab combination was consistent in terms of safety. In that regard, this data is very innovative and unprecedented. Says ineligible was the indication unfit population, at high risk or with a variety of complications. The drug could be utilized in such patient population. There are high expectations because of this. Such a drug is unprecedented. such a drug is unprecedented This was highly evaluated as well. this was highly evaluated as well These are the three effects. these are the three effects As for safety, the pembrolizumab combination was consistent in terms of safety. as for safety the pembrolizumab combination was consistent in terms of safety In that regard, this data is very innovative and unprecedented. in that regard this data is very innovative and unprecedented Says ineligible was the indication unfit population, at high risk or with a variety of complications. says ineligible was the indication unfit population at high risk or with a variety of complications The drug could be utilized in such patient population. the drug could be utilized in such patient population There are high expectations because of this. there are high expectations because of this

Speaker 2: Yes, so the question that you asked is how this translates into a sales forecast. There are a few considerations. Clearly, clearly such an unprecedented data will help us convince physicians that this should be the new standard of care in the labeled indication of locally advanced and then after approval also in the MIBC indication. There is, however, a difference between the two. If you look at the clinical trial in MIBC, there are two parts to it. There is the so-called neoadjuvant use, so you give it before you do the cystectomy, the removal of a bladder, and then you have the adjuvant use, which is after the surgery has been done. In clinical practice, these two parts are likely to be different from the clinical trial setting. Yes, so the question that you asked is how this translates into a sales forecast. yes so the question that you asked is how this translates into a sales forecast There are a few considerations. there are a few considerations Clearly, clearly such an unprecedented data will help us convince physicians that this should be the new standard of care in the labeled indication of locally advanced and then after approval also in the MIBC indication. clearly clearly such an unprecedented data will help us convince physicians that this should be the new standard of care in the labeled indication of locally advanced and then after approval also in the mibc indication There is, however, a difference between the two. there is however a difference between the two If you look at the clinical trial in MIBC, there are two parts to it. if you look at the clinical trial in mibc there are two parts to it There is the so-called neoadjuvant use, so you give it before you do the cystectomy, the removal of a bladder, and then you have the adjuvant use, which is after the surgery has been done. there is the so-called neoadjuvant use so you give it before you do the cystectomy the removal of a bladder and then you have the adjuvant use which is after the surgery has been done In clinical practice, these two parts are likely to be different from the clinical trial setting. in clinical practice these two parts are likely to be different from the clinical trial setting We need to observe carefully exactly how the market adopts the usage of PADCEV and Pembro in these two different phases of the MIBC. Those are things we still have to learn, and I think once we have more data points, we can make a more efficient, accurate sales forecast. We need to observe carefully exactly how the market adopts the usage of PADCEV and Pembro in these two different phases of the MIBC. we need to observe carefully exactly how the market adopts the usage of padcev and pembro in these two different phases of the mibc Those are things we still have to learn, and I think once we have more data points, we can make a more efficient, accurate sales forecast. those are things we still have to learn and i think once we have more data points we can make a more efficient accurate sales forecast

Speaker 1: Thank you very much. Next question, a brief question again. This time performance was really good. However, from the midterm perspective, we are going to face the cliff of the patent and next year and afterwards a new midterm plan is going to be presented. Toward that, your foundational businesses are quite improved. Toward the next fiscal midterm plan, this performance level and also SMT included, how do you view about it? Would you give us a comment? Thank you very much. thank you very much Next question, a brief question again. next question a brief question again This time performance was really good. this time performance was really good However, from the midterm perspective, we are going to face the cliff of the patent and next year and afterwards a new midterm plan is going to be presented. however from the midterm perspective we are going to face the cliff of the patent and next year and afterwards a new midterm plan is going to be presented Toward that, your foundational businesses are quite improved. toward that your foundational businesses are quite improved Toward the next fiscal midterm plan, this performance level and also SMT included, how do you view about it? toward the next fiscal midterm plan this performance level and also smt included how do you view about it Would you give us a comment? would you give us a comment

Speaker 6: Thank you very much. We are still in the middle of the discussion about this, so I think it is inappropriate to come into the details about this here. However, the XTANDI and MIBC, where the patent is expired, and we are going to extend their lives. In order to cover the loss of those sales, we will do something including business development or BD, that's not something like that. Thank you very much. thank you very much We are still in the middle of the discussion about this, so I think it is inappropriate to come into the details about this here. we are still in the middle of the discussion about this so i think it is inappropriate to come into the details about this here However, the XTANDI and MIBC, where the patent is expired, and we are going to extend their lives. however the xtandi and mibc where the patent is expired and we are going to extend their lives In order to cover the loss of those sales, we will do something including business development or BD, that's not something like that. in order to cover the loss of those sales we will do something including business development or bd that's not something like that Rather than that, we have the strategic brands in our hands, those are getting stronger. We would like to maximize its strength. That is going to be the focus of the next midterm plan. That's what we expect. Meaning that from the outsider's perspective, the breakdowns of the products are not really matters. Rather, the sales of the products will be reduced. That is one thing. However, we are already having the three important strategic brand products in the growth phase. We would like to maximize the value of that. That focus is going to be incorporated into the next midterm plan and also focus area approach, key products achieving their clinical POC or coming to the phase of the POC judgment. Rather than that, we have the strategic brands in our hands, those are getting stronger. rather than that we have the strategic brands in our hands those are getting stronger We would like to maximize its strength. we would like to maximize its strength That is going to be the focus of the next midterm plan. that is going to be the focus of the next midterm plan That's what we expect. that's what we expect Meaning that from the outsider's perspective, the breakdowns of the products are not really matters. meaning that from the outsider's perspective the breakdowns of the products are not really matters Rather, the sales of the products will be reduced. rather the sales of the products will be reduced That is one thing. that is one thing However, we are already having the three important strategic brand products in the growth phase. however we are already having the three important strategic brand products in the growth phase We would like to maximize the value of that. we would like to maximize the value of that That focus is going to be incorporated into the next midterm plan and also focus area approach, key products achieving their clinical POC or coming to the phase of the POC judgment. that focus is going to be incorporated into the next midterm plan and also focus area approach key products achieving their clinical poc or coming to the phase of the poc judgment For the next five years, those flagship going to get into the late phase of the development and on top of that the original focus area benefit, that is when initial compound is successful. Then with the same triangle, we come up with the following programs. We introduce some of the follow-on programs today. That will happen. We have the five strategic brands and on top of that, further ahead of the growth. Growth can be expected in these approaches and if that is recognized in that way or so, it's going to be the one key aspect of the midterm plan. The current product sales increase is a job needed to be done by Okamura and next preparation is Taniguchi's job. Kitamura, who is here, needs to think about changing the company with appropriate financial discipline in terms of the operation of this company based upon such background information. For the next five years, those flagship going to get into the late phase of the development and on top of that the original focus area benefit, that is when initial compound is successful. for the next five years those flagship going to get into the late phase of the development and on top of that the original focus area benefit that is when initial compound is successful Then with the same triangle, we come up with the following programs. then with the same triangle we come up with the following programs We introduce some of the follow-on programs today. we introduce some of the follow-on programs today That will happen. that will happen We have the five strategic brands and on top of that, further ahead of the growth. we have the five strategic brands and on top of that further ahead of the growth Growth can be expected in these approaches and if that is recognized in that way or so, it's going to be the one key aspect of the midterm plan. growth can be expected in these approaches and if that is recognized in that way or so it's going to be the one key aspect of the midterm plan The current product sales increase is a job needed to be done by Okamura and next preparation is Taniguchi's job. the current product sales increase is a job needed to be done by okamura and next preparation is taniguchi's job Kitamura, who is here, needs to think about changing the company with appropriate financial discipline in terms of the operation of this company based upon such background information. kitamura who is here needs to think about changing the company with appropriate financial discipline in terms of the operation of this company based upon such background information

Speaker 1: Thank you very much. Thank you very much. thank you very much

Speaker 6: Thank you very much. Now I would like to move on to the next question, that is JPMorgan, Mr. Wakao, please. Thank you very much. thank you very much Now I would like to move on to the next question, that is JPMorgan, Mr. Wakao, please. now i would like to move on to the next question that is jpmorgan mr wakao please

Speaker 8: JPMorgan, Wakao is my name. Can you hear me? JPMorgan , Wakao is my name. jpmorgan wakao is my name Can you hear me? can you hear me

Speaker 6: Yes, I can hear you now, please. Yes, I can hear you now, please. yes i can hear you now please

Speaker 8: Thank you very much. Regarding strategic brands, how do you assess those products? As of now you made an upward revision, but extending the mirror background before in the previous upward revision, if you look at the total sales, the JPY 470 billion, although the breakdown is different, you are progressing according to your initial forecast. EV-303 is successful and there are other factors as well. What is your current assessment? Also, the future outlook of strategic brands is of how it's going to go up. That might be part of the question as well. Thank you very much. thank you very much Regarding strategic brands, how do you assess those products? regarding strategic brands how do you assess those products As of now you made an upward revision, but extending the mirror background before in the previous upward revision, if you look at the total sales, the JPY 470 billion, although the breakdown is different, you are progressing according to your initial forecast. as of now you made an upward revision but extending the mirror background before in the previous upward revision if you look at the total sales the jpy 470 billion although the breakdown is different you are progressing according to your initial forecast EV-303 is successful and there are other factors as well. ev-303 is successful and there are other factors as well What is your current assessment? what is your current assessment Also, the future outlook of strategic brands is of how it's going to go up. also the future outlook of strategic brands is of how it's going to go up That might be part of the question as well. that might be part of the question as well

Speaker 12: Thank you for your question. I'd like to give you a rough overview where necessary. Claus can add as I mentioned before, how Astellas Pharma is going to be from now on. Extending mirror background such immature products, how we can increase their value from now on is one question. We made an upward revision. Thank you for your question. thank you for your question I'd like to give you a rough overview where necessary. i'd like to give you a rough overview where necessary Claus can add as I mentioned before, how Astellas Pharma is going to be from now on. claus can add as i mentioned before how astellas pharma is going to be from now on Extending mirror background such immature products, how we can increase their value from now on is one question. extending mirror background such immature products how we can increase their value from now on is one question We made an upward revision. we made an upward revision If you look at the face value, these two may be covering the majority of the upward revision at a glance. IZERVAY unfortunately on a dollar basis, $750 million was revised downward to $550 million. That reduction is covered by PADCEV and VYLOY. Because of their good performance, we are more than offsetting that decline. In total there is no change in the strategic brands. You may say so from outside, but there are special circumstances for IZERVAY and it may be difficult to perform as expected. Are we going to reduce the strategic brands? No, we would like to cover more than offset this decline and Astellas in the mid to long term needs to grow. To that end, this is going to be very important. In the world of pharmaceuticals, regulations may change and there can be something unexpected. We often see such events in this sector. If you look at the face value, these two may be covering the majority of the upward revision at a glance. if you look at the face value these two may be covering the majority of the upward revision at a glance IZERVAY unfortunately on a dollar basis, $750 million was revised downward to $550 million. izervay unfortunately on a dollar basis $750 million was revised downward to $550 million That reduction is covered by PADCEV and VYLOY. that reduction is covered by padcev and vyloy Because of their good performance, we are more than offsetting that decline. because of their good performance we are more than offsetting that decline In total there is no change in the strategic brands. in total there is no change in the strategic brands You may say so from outside, but there are special circumstances for IZERVAY and it may be difficult to perform as expected. you may say so from outside but there are special circumstances for izervay and it may be difficult to perform as expected Are we going to reduce the strategic brands? are we going to reduce the strategic brands No, we would like to cover more than offset this decline and Astellas in the mid to long term needs to grow. no we would like to cover more than offset this decline and astellas in the mid to long term needs to grow To that end, this is going to be very important. to that end this is going to be very important In the world of pharmaceuticals, regulations may change and there can be something unexpected. in the world of pharmaceuticals regulations may change and there can be something unexpected We often see such events in this sector. we often see such events in this sector Instead of saying that this is what we can do only if there is something negative, we'd like to offset the negative and we can recover in the top line figures. Also, we'd like to do our best to control the cost and we would like to achieve core operating profit, the bottom line. That's our discipline and how our management of the company should be. Anything additional from Claus about individual products? Instead of saying that this is what we can do only if there is something negative, we'd like to offset the negative and we can recover in the top line figures. instead of saying that this is what we can do only if there is something negative we'd like to offset the negative and we can recover in the top line figures Also, we'd like to do our best to control the cost and we would like to achieve core operating profit, the bottom line. also we'd like to do our best to control the cost and we would like to achieve core operating profit the bottom line That's our discipline and how our management of the company should be. that's our discipline and how our management of the company should be Anything additional from Claus about individual products? anything additional from claus about individual products

Speaker 2: I think, Naoki, you've summarized it very well. I think the five strategic brands as a group have the potential to replace XTANDI and maybe even grow beyond that. I personally think the total potential is beyond that of XTANDI as a single brand. Now, the different brands will vary and also in their phases. We see VEOZAH as a primary care, pretty much primary care product with a much slower trajectory than an oncology drug, which has a very, very fast uptake. We've seen that both with PADCEV and with VYLOY now. I think each therapeutic area has its own dynamic. As a group, the potential of these products is, as I said, in my estimation, at least the size of XTANDI. I think, Naoki, you've summarized it very well. i think naoki you've summarized it very well I think the five strategic brands as a group have the potential to replace XTANDI and maybe even grow beyond that. i think the five strategic brands as a group have the potential to replace xtandi and maybe even grow beyond that I personally think the total potential is beyond that of XTANDI as a single brand. i personally think the total potential is beyond that of xtandi as a single brand Now, the different brands will vary and also in their phases. now the different brands will vary and also in their phases We see VEOZAH as a primary care, pretty much primary care product with a much slower trajectory than an oncology drug, which has a very, very fast uptake. we see veozah as a primary care pretty much primary care product with a much slower trajectory than an oncology drug which has a very very fast uptake We've seen that both with PADCEV and with VYLOY now. we've seen that both with padcev and with vyloy now I think each therapeutic area has its own dynamic. i think each therapeutic area has its own dynamic As a group, the potential of these products is, as I said, in my estimation, at least the size of XTANDI. as a group the potential of these products is as i said in my estimation at least the size of xtandi

Speaker 8: Thank you very much. Secondly, SMT initiative status is something I'd like to know more. In the second quarter, cost reduction was achieved and I'm very surprised. Regarding your plan, OP margin is to improve. I think this was great and SMT is making very good progress as of now. OP 30% or higher. What do you think in terms of this progress? You may have other hurdles to clear or are you approaching the achievement? You may need to invest in R&D for some of the products. What is the current progress? Thank you very much. thank you very much Secondly, SMT initiative status is something I'd like to know more. secondly smt initiative status is something i'd like to know more In the second quarter, cost reduction was achieved and I'm very surprised. in the second quarter cost reduction was achieved and i'm very surprised Regarding your plan, OP margin is to improve. regarding your plan op margin is to improve I think this was great and SMT is making very good progress as of now. i think this was great and smt is making very good progress as of now OP 30% or higher. op 30% or higher What do you think in terms of this progress? what do you think in terms of this progress You may have other hurdles to clear or are you approaching the achievement? you may have other hurdles to clear or are you approaching the achievement You may need to invest in R&D for some of the products. you may need to invest in r&d for some of the products What is the current progress? what is the current progress

Speaker 12: Thank you very much. In the end, operating profit was revised upward. If you look at the guidance, 24.1% for operating profit margin. Are we satisfied? No, we are not completely satisfied yet. Still, in FY 2027 we are targeting to achieve 30%. Towards that goal, we are beginning to solidify our basis. That's how I feel. It's not easy to improve just 5% overnight. There are many things we have to do. As you pointed out, development cost would go back to the original number. We shouldn't sacrifice the development cost. We have to do something else elsewhere. Anything to add from. Thank you very much. thank you very much In the end, operating profit was revised upward. in the end operating profit was revised upward If you look at the guidance, 24.1% for operating profit margin. if you look at the guidance 24.1% for operating profit margin Are we satisfied? are we satisfied No, we are not completely satisfied yet. no we are not completely satisfied yet Still, in FY 2027 we are targeting to achieve 30%. still in fy 2027 we are targeting to achieve 30% Towards that goal, we are beginning to solidify our basis. towards that goal we are beginning to solidify our basis That's how I feel. that's how i feel It's not easy to improve just 5% overnight. it's not easy to improve just 5% overnight There are many things we have to do. there are many things we have to do As you pointed out, development cost would go back to the original number. as you pointed out development cost would go back to the original number We shouldn't sacrifice the development cost. we shouldn't sacrifice the development cost We have to do something else elsewhere. we have to do something else elsewhere Anything to add from. anything to add from

Speaker 8: Thank you very much. Regarding SMT, in the past, I've already made an explanation as saying that this is not their single year short period of time of activity, this is the regular activities. I've mentioned that it's going to be JPY 120 billion to JPY 150 billion. At the time of the announcement, it's clear that for the 70%, yes, we will do that and we execute the plan and the remaining 30% idea is going to be generated. That was the approach and currently it is JPY 150 billion. Internally, we accumulated our ideas and they are going to be executed. That's the next phase. That's the current status. Thanks to SMT, JPY 40 billion of the impact was realized. This fiscal year, throughout the year, we are expecting to be JPY 20 billion. For two years, it will be JPY 60 billion. In the first half, it is JPY 16 billion. Thank you very much. thank you very much Regarding SMT, in the past, I've already made an explanation as saying that this is not their single year short period of time of activity, this is the regular activities. regarding smt in the past i've already made an explanation as saying that this is not their single year short period of time of activity this is the regular activities I've mentioned that it's going to be JPY 120 billion to JPY 150 billion. i've mentioned that it's going to be jpy 120 billion to jpy 150 billion At the time of the announcement, it's clear that for the 70%, yes, we will do that and we execute the plan and the remaining 30% idea is going to be generated. at the time of the announcement it's clear that for the 70% yes we will do that and we execute the plan and the remaining 30% idea is going to be generated That was the approach and currently it is JPY 150 billion. that was the approach and currently it is jpy 150 billion Internally, we accumulated our ideas and they are going to be executed. internally we accumulated our ideas and they are going to be executed That's the next phase. that's the next phase That's the current status. that's the current status Thanks to SMT, JPY 40 billion of the impact was realized. thanks to smt jpy 40 billion of the impact was realized This fiscal year, throughout the year, we are expecting to be JPY 20 billion. this fiscal year throughout the year we are expecting to be jpy 20 billion For two years, it will be JPY 60 billion. for two years it will be jpy 60 billion In the first half, it is JPY 16 billion. in the first half it is jpy 16 billion Against the target of JPY 20 billion, I think we are doing quite well. As has been mentioned by Okamura, this is not the easy road. We have to steadily execute the plans. We have to have that in our mind. As long as we do what we need to do, we definitely can see the result. Therefore, we have a commitment, we have a confidence about it. Under Sir KU Leali. Thank you very much. Against the target of JPY 20 billion, I think we are doing quite well. against the target of jpy 20 billion i think we are doing quite well As has been mentioned by Okamura, this is not the easy road. as has been mentioned by okamura this is not the easy road We have to steadily execute the plans. we have to steadily execute the plans We have to have that in our mind. we have to have that in our mind As long as we do what we need to do, we definitely can see the result. as long as we do what we need to do we definitely can see the result Therefore, we have a commitment, we have a confidence about it. therefore we have a commitment we have a confidence about it Under Sir KU Leali. under sir ku leali Thank you very much. thank you very much

Speaker 6: Thank you very much. Next, Goldman Sach Securities. Mr. Weda, please. Thank you very much. thank you very much Next, Goldman Sach Securities. next goldman sach securities Mr. Weda, please. mr weda please Goldman Sachs Weda is my name. My first question is about the follow-up question, is the currently discussed point, so R&D for this fiscal year, you changed the presumption for the Forex, meaning that there's a wide range of review or revisit during the quarter. What did you do to come up with these big changes? Also, in the current new plan, compared to the initial plan, the accuracy was increased. Would you please make your explanation for these two points. Goldman Sachs Weda is my name. goldman sachs weda is my name My first question is about the follow-up question, is the currently discussed point, so R&D for this fiscal year, you changed the presumption for the Forex, meaning that there's a wide range of review or revisit during the quarter. my first question is about the follow-up question is the currently discussed point so r&d for this fiscal year you changed the presumption for the forex meaning that there's a wide range of review or revisit during the quarter What did you do to come up with these big changes? what did you do to come up with these big changes Also, in the current new plan, compared to the initial plan, the accuracy was increased. also in the current new plan compared to the initial plan the accuracy was increased Would you please make your explanation for these two points. would you please make your explanation for these two points

Speaker 12: Thank you very much. First of all, in my presentation, as I've already mentioned, in terms of year-on-year, the major clinical trials of the strategic brands completed as their first phase. From year-on-year perspective, in the last year first quarter, one of cost increase was canceled. Because of that, seemingly there was a decrease. Overall flow depending on that, because of that, the cost is reduced. Toward the second half of 2025, the focus program achieved, the POC will come to the later phase of the development and this will come back. This portion will come back. That's why we have this guidance. On top of that, of course we are doing the continuous work. Thank you very much. thank you very much First of all, in my presentation, as I've already mentioned, in terms of year-on-year, the major clinical trials of the strategic brands completed as their first phase. first of all in my presentation as i've already mentioned in terms of year-on-year the major clinical trials of the strategic brands completed as their first phase From year-on-year perspective, in the last year first quarter, one of cost increase was canceled. from year-on-year perspective in the last year first quarter one of cost increase was canceled Because of that, seemingly there was a decrease. because of that seemingly there was a decrease Overall flow depending on that, because of that, the cost is reduced. overall flow depending on that because of that the cost is reduced Toward the second half of 2025, the focus program achieved, the POC will come to the later phase of the development and this will come back. toward the second half of 2025 the focus program achieved the poc will come to the later phase of the development and this will come back This portion will come back. this portion will come back That's why we have this guidance. that's why we have this guidance On top of that, of course we are doing the continuous work. on top of that of course we are doing the continuous work This time, within the SMT and strategy discussions, portfolio prioritization started to be more and more rigorous. With that, selected projects with the keen eyes will receive more and more investment. Our R&D investment usage is shown in that way. Also, clinical trials overall relied on the external CRC, but those are currently conducted more and more internally. Outsourcing cost is reduced and that is replaced as the internal expenses. Seemingly, you see that the subtraction calculation leads to this reduction level as a number. However, with a long-term perspective, having this approach, we can realize more effective clinical trials, which leads to the shorter period of time of the study. A clinical study design is going to be further precise. With our execution of the studies, we can make the fine tuning during the study. I think that's the way it should be for conducting clinical trials. This time, within the SMT and strategy discussions, portfolio prioritization started to be more and more rigorous. this time within the smt and strategy discussions portfolio prioritization started to be more and more rigorous With that, selected projects with the keen eyes will receive more and more investment. with that selected projects with the keen eyes will receive more and more investment Our R&D investment usage is shown in that way. our r&d investment usage is shown in that way Also, clinical trials overall relied on the external CRC, but those are currently conducted more and more internally. also clinical trials overall relied on the external crc but those are currently conducted more and more internally Outsourcing cost is reduced and that is replaced as the internal expenses. outsourcing cost is reduced and that is replaced as the internal expenses Seemingly, you see that the subtraction calculation leads to this reduction level as a number. seemingly you see that the subtraction calculation leads to this reduction level as a number However, with a long-term perspective, having this approach, we can realize more effective clinical trials, which leads to the shorter period of time of the study. however with a long-term perspective having this approach we can realize more effective clinical trials which leads to the shorter period of time of the study A clinical study design is going to be further precise. a clinical study design is going to be further precise With our execution of the studies, we can make the fine tuning during the study. with our execution of the studies we can make the fine tuning during the study I think that's the way it should be for conducting clinical trials. i think that's the way it should be for conducting clinical trials I believe we can realize that. Under Taniguchi, the R&D and R&D were separated, but now it's merged as one organization. Research division and development divisions, those exchange between these two business units became smooth. Outsourcing changed to insourcing. It was just a simple deduction. Come up with this number. You see only this because it's just started, but for a longer time thinking about the next plan, business plan, I think it's going to be more financially reflected into our actual business way of doing. Can you miss them, please? I believe we can realize that. i believe we can realize that Under Taniguchi, the R&D and R&D were separated, but now it's merged as one organization. under taniguchi the r&d and r&d were separated but now it's merged as one organization Research division and development divisions, those exchange between these two business units became smooth. research division and development divisions those exchange between these two business units became smooth Outsourcing changed to insourcing. outsourcing changed to insourcing It was just a simple deduction. it was just a simple deduction Come up with this number. come up with this number You see only this because it's just started, but for a longer time thinking about the next plan, business plan, I think it's going to be more financially reflected into our actual business way of doing. you see only this because it's just started but for a longer time thinking about the next plan business plan i think it's going to be more financially reflected into our actual business way of doing Can you miss them, please? can you miss them please Thank you. Thank you. thank you

Speaker 6: Thank you very much. Most of the things already explained by Okamura. If I may add one thing, insourcing of clinical trials. Through insourcing we can reduce outsourcing costs. We paid before and then we should develop our own system. AI and automation is fully leveraged for further cost reduction. Also, the speed of enrollment. Where are the patients and how much, which institutions we should go to. We want to roll this out globally. By doing this, further business and clinical trial efficiency can be enhanced as well as the acceleration of the speed. We can reduce a further cost reduction as well. We're expecting an increase in the late stage development costs would also rise. As much as possible, we'd like to enhance the cost efficiency so that we can cover. Thank you very much. thank you very much Most of the things already explained by Okamura. most of the things already explained by okamura If I may add one thing, insourcing of clinical trials. if i may add one thing insourcing of clinical trials Through insourcing we can reduce outsourcing costs. through insourcing we can reduce outsourcing costs We paid before and then we should develop our own system. we paid before and then we should develop our own system AI and automation is fully leveraged for further cost reduction. ai and automation is fully leveraged for further cost reduction Also, the speed of enrollment. also the speed of enrollment Where are the patients and how much, which institutions we should go to. where are the patients and how much which institutions we should go to We want to roll this out globally. we want to roll this out globally By doing this, further business and clinical trial efficiency can be enhanced as well as the acceleration of the speed. by doing this further business and clinical trial efficiency can be enhanced as well as the acceleration of the speed We can reduce a further cost reduction as well. we can reduce a further cost reduction as well We're expecting an increase in the late stage development costs would also rise. we're expecting an increase in the late stage development costs would also rise As much as possible, we'd like to enhance the cost efficiency so that we can cover. as much as possible we'd like to enhance the cost efficiency so that we can cover Thank you very much. As a follow up question, originally, compared to the initial forecast, in terms of the gap compared to the initial forecast. Overall, all the items are progressing smoothly. Should I understand that way? Basically that understanding is fine. Thank you very much. thank you very much As a follow up question, originally, compared to the initial forecast, in terms of the gap compared to the initial forecast. as a follow up question originally compared to the initial forecast in terms of the gap compared to the initial forecast Overall, a ll the items are progressing smoothly. overall, a ll the items are progressing smoothly Should I understand that way? should i understand that way Basically that understanding is fine. basically that understanding is fine

Speaker 12: Okay, understood. Thank you very much. Okay, understood. okay understood Thank you very much. thank you very much Secondly, regarding the U.S. business environment, how do you see it right now? Up until now, regarding the tariff, the situation is still unclear and it was difficult for you to comment. As I said before, right now you have a large exposure to the United States, including the risk of being imposed a tariff. How are you addressing the situation or how are you planning to address the situation from now? Also, including MFN, the drug prices, how do you see the risk factors? I'd like to hear from you. Secondly, regarding the U.S. business environment, how do you see it right now? secondly regarding the u.s business environment how do you see it right now Up until now, regarding the tariff, the situation is still unclear and it was difficult for you to comment. up until now regarding the tariff the situation is still unclear and it was difficult for you to comment As I said before, right now you have a large exposure to the United States, including the risk of being imposed a tariff. as i said before right now you have a large exposure to the united states including the risk of being imposed a tariff How are you addressing the situation or how are you planning to address the situation from now? how are you addressing the situation or how are you planning to address the situation from now Also, including MFN, the drug prices, how do you see the risk factors? also including mfn the drug prices how do you see the risk factors I'd like to hear from you. i'd like to hear from you Thank you very much. First, as for the tariff, at one point in time, we didn't know what could happen. From there, the situation is settling a lot. I shouldn't say that's our assessment, but we are feeling relieved. As we said before, from your perspective as that as revenue times U.S. ratio, times COGS times tariff, it's going to be a huge amount. You may say so, but in reality, what we sell in the United States, majority of those products are manufactured in the United States. As we said before, if that's the case, the denominator is small where tariff is going to be imposed. It's not going to be a huge amount. That's a response. The tariff might be imposed. There can be such announcement into the future. We have a supply chain. By understanding our supply chain, if there's going to be any grave impact, as I said before, our profit should not decrease. If the profit may decrease, where are we going to recover? Elsewhere, we should start such discussions. Thank you very much. thank you very much First, as for the tariff, at one point in time, we didn't know what could happen. first as for the tariff at one point in time we didn't know what could happen From there, the situation is settling a lot. from there the situation is settling a lot I shouldn't say that's our assessment, but we are feeling relieved. i shouldn't say that's our assessment but we are feeling relieved As we said before, from your perspective as that as revenue times U.S. ratio, times COGS times tariff, it's going to be a huge amount. as we said before from your perspective as that as revenue times u.s ratio times cogs times tariff it's going to be a huge amount You may say so, but in reality, what we sell in the United States, majority of those products are manufactured in the United States. you may say so but in reality what we sell in the united states majority of those products are manufactured in the united states As we said before, if that's the case, the denominator is small where tariff is going to be imposed. as we said before if that's the case the denominator is small where tariff is going to be imposed It's not going to be a huge amount. it's not going to be a huge amount That's a response. that's a response The tariff might be imposed. the tariff might be imposed There can be such announcement into the future. there can be such announcement into the future We have a supply chain. we have a supply chain By understanding our supply chain, if there's going to be any grave impact, as I said before, our profit should not decrease. by understanding our supply chain if there's going to be any grave impact as i said before our profit should not decrease If the profit may decrease, where are we going to recover? if the profit may decrease where are we going to recover Elsewhere, we should start such discussions. elsewhere we should start such discussions Also, the MFN pricing, most favored nation pricing. As you might have heard in the press report, 17 companies received letters. This does not include a status.In particular, Pfizer reached agreement with the authorities or the government. According to the media report, we didn't receive such a letter. We don't know what are the contents of the letter. In the industry through a variety of routes, what is being communicated in the letter is captured by us. Regarding the agreement with the government and Pfizer, we don't know the details, but we can assume and imagine what's going on and what's being done before we receive a letter. Nothing will be done by us or overreaction and doing a lot of things too much in advance. Rather, monitoring the situation to take necessary action where necessary. Of course, experts in the company gather to form a team and they are monitoring the situation all the time. Also, the MFN pricing, most favored nation pricing. also the mfn pricing most favored nation pricing As you might have heard in the press report, 17 companies received letters. as you might have heard in the press report 17 companies received letters This does not include a status. this does not include a status In particular, Pfizer reached agreement with the authorities or the government. in particular pfizer reached agreement with the authorities or the government According to the media report, we didn't receive such a letter. according to the media report we didn't receive such a letter We don't know what are the contents of the letter. we don't know what are the contents of the letter In the industry through a variety of routes, what is being communicated in the letter is captured by us. in the industry through a variety of routes what is being communicated in the letter is captured by us Regarding the agreement with the government and Pfizer, we don't know the details, but we can assume and imagine what's going on and what's being done before we receive a letter. regarding the agreement with the government and pfizer we don't know the details but we can assume and imagine what's going on and what's being done before we receive a letter Nothing will be done by us or overreaction and doing a lot of things too much in advance. nothing will be done by us or overreaction and doing a lot of things too much in advance Rather, monitoring the situation to take necessary action where necessary. rather monitoring the situation to take necessary action where necessary Of course, experts in the company gather to form a team and they are monitoring the situation all the time. of course experts in the company gather to form a team and they are monitoring the situation all the time If we need to take action, if it's time to take action and move forward, the team will come to the executives management team so that we can discuss and take the best action. If we need to take action, if it's time to take action and move forward, the team will come to the executives management team so that we can discuss and take the best action. if we need to take action if it's time to take action and move forward the team will come to the executives management team so that we can discuss and take the best action Understood. Thank you very much. Understood. understood Thank you very much. thank you very much That's all from me. Thank you very much. That's all from me. that's all from me Thank you very much. thank you very much

Speaker 6: Thank you very much. Next question, Nomura Securities. Mr. Matsubara, please. Thank you very much. thank you very much Next question, Nomura Securities. next question nomura securities Mr. Matsubara, please. mr matsubara please

Speaker 4: Thank you. Matsubara speaking. Can you hear me? Thank you. thank you Matsubara speaking. matsubara speaking Can you hear me? can you hear me

Speaker 6: Yes, we can hear you. Now, Please start. Yes, we can hear you. N ow, P lease start. yes we can hear you. n ow, p lease start

Speaker 4: First question. That is about SMT. In the previous discussions, SMT is exerting its strength and if that is so, then this fiscal year we are going to see further cost reduction. First question. first question That is about SMT. that is about smt In the previous discussions, SMT is exerting its strength and if that is so, then this fiscal year we are going to see further cost reduction. in the previous discussions smt is exerting its strength and if that is so then this fiscal year we are going to see further cost reduction

Speaker 12: Thank you very much. Originally, JPY 20 billion is our plan and to the second quarter we came to the JPY 16 billion and can you achieve JPY 32 billion? The calculation is not in that way. What is decided is steadily being conducted, that's one thing. However, we've been always looking for what else, other, something else we can do. If we make a certain evaluation for a certain idea, even if a certain advanced investment is necessary, then still we try to secure commitment. Thank you very much. thank you very much Originally, JPY 20 billion is our plan and to the second quarter we came to the JPY 16 billion and can you achieve JPY 32 billion? originally jpy 20 billion is our plan and to the second quarter we came to the jpy 16 billion and can you achieve jpy 32 billion The calculation is not in that way. the calculation is not in that way What is decided is steadily being conducted, that's one thing. what is decided is steadily being conducted that's one thing However, we've been always looking for what else, other, something else we can do. however we've been always looking for what else other something else we can do If we make a certain evaluation for a certain idea, even if a certain advanced investment is necessary, then still we try to secure commitment. if we make a certain evaluation for a certain idea even if a certain advanced investment is necessary then still we try to secure commitment In the first two quarters, what's being planned is already realized and you came up with the cost reduction, but at the same time you can think about the investment to the next idea. We have to take the balance of reduction and investment, so that is going to be final end of FY 2025. Of course, the planned JPY 20 billion, that is something we would like to secure, but at the same time, something it might go beyond. Is that going to be reflected into the profit? It's not necessarily so, so please do understand in that way. In the first two quarters, what's being planned is already realized and you came up with the cost reduction, but at the same time you can think about the investment to the next idea. in the first two quarters what's being planned is already realized and you came up with the cost reduction but at the same time you can think about the investment to the next idea We have to take the balance of reduction and investment, so that is going to be final end of FY 2025. we have to take the balance of reduction and investment so that is going to be final end of fy 2025 Of course, the planned JPY 20 billion, that is something we would like to secure, but at the same time, something it might go beyond. of course the planned jpy 20 billion that is something we would like to secure but at the same time something it might go beyond Is that going to be reflected into the profit? is that going to be reflected into the profit It's not necessarily so, so please do understand in that way. it's not necessarily so so please do understand in that way

Speaker 6: Kitamura-san, please. Kitamura-san, please. kitamura-san please

Speaker 13: What Okamura mentioned is exactly right. Again, this is the repetition. SMT is not a singular year but rather multiple, so there are some things should be done with a short period of time and mid to long term, those ongoing in a parallel manner. If time, things can be realized in an accelerated manner, then we can get the benefit in earlier phase, that's true. What Okamura mentioned is exactly right. what okamura mentioned is exactly right Again, this is the repetition. again this is the repetition SMT is not a singular year but rather multiple, so there are some things should be done with a short period of time and mid to long term, those ongoing in a parallel manner. smt is not a singular year but rather multiple so there are some things should be done with a short period of time and mid to long term those ongoing in a parallel manner If time, things can be realized in an accelerated manner, then we can get the benefit in earlier phase, that's true. if time things can be realized in an accelerated manner then we can get the benefit in earlier phase that's true

Speaker 4: Understood very well. Thank you very much. Next question is about VEOZAH on slide page six. It is true that the competition is available, so that is the market competition considered, but the competitor has less, not necessary to do the blood testing and specific for the driving in the case of the design attendant, and what do you think about it? Understood very well. understood very well Thank you very much. thank you very much Next question is about VEOZAH on slide page six. next question is about veozah on slide page six It is true that the competition is available, so that is the market competition considered, but the competitor has less, not necessary to do the blood testing and specific for the driving in the case of the design attendant, and what do you think about it? it is true that the competition is available so that is the market competition considered but the competitor has less not necessary to do the blood testing and specific for the driving in the case of the design attendant and what do you think about it

Speaker 13: Yes, of course there's an advantage for the predecessor. Our level is not perfect, but we've been doing our activities, so definitely there are advantages as the first comer or pioneer for this. Within just one sentence, what I wanted to say is that another company or the competitor, rather, is very strong in this treatment area, and we are not really so. Compared to us doing the business in this field alone, together with them, the two companies toward the same targeted patients with the same efficacy products, we can do the patient educational awareness increase activities. With that, I think we can increase the awareness more. However, they are very strong in this field. Till then, we are the just player in the market, but now we have two, and they have experience, so the share is going to obviously be smaller. To what extent we can have, to what extent of the market share we can have, that is of course something that we can tell from the data. Clinical data is well controlled. Total number of the subjects are controlled. Yes, of course there's an advantage for the predecessor. yes of course there's an advantage for the predecessor Our level is not perfect, but we've been doing our activities, so definitely there are advantages as the first comer or pioneer for this. our level is not perfect but we've been doing our activities so definitely there are advantages as the first comer or pioneer for this Within just one sentence, what I wanted to say is that another company or the competitor, rather, is very strong in this treatment area, and we are not really so. within just one sentence what i wanted to say is that another company or the competitor rather is very strong in this treatment area and we are not really so Compared to us doing the business in this field alone, together with them, the two companies toward the same targeted patients with the same efficacy products, we can do the patient educational awareness increase activities. compared to us doing the business in this field alone together with them the two companies toward the same targeted patients with the same efficacy products we can do the patient educational awareness increase activities With that, I think we can increase the awareness more. with that i think we can increase the awareness more However, they are very strong in this field. however they are very strong in this field Till then, we are the just player in the market, but now we have two, and they have experience, so the share is going to obviously be smaller. till then we are the just player in the market but now we have two and they have experience so the share is going to obviously be smaller To what extent we can have, to what extent of the market share we can have, that is of course something that we can tell from the data. to what extent we can have to what extent of the market share we can have that is of course something that we can tell from the data Clinical data is well controlled. clinical data is well controlled Total number of the subjects are controlled. total number of the subjects are controlled The competitor launches their products, and what kind of data will be available in the actual market or real market, I think that really determines, besides the competitive situation of these two companies. The competitor launches their products, and what kind of data will be available in the actual market or real market, I think that really determines, besides the competitive situation of these two companies. the competitor launches their products and what kind of data will be available in the actual market or real market i think that really determines besides the competitive situation of these two companies

Speaker 6: Claus? Claus? claus

Speaker 2: Yes, I think two points. One Naoki already made very, very well, which is this is a market we have to develop. Two companies developing a market is always much better than a company doing it alone. I think in that sense the entry of a competitor actually helps grow the class. The other point I would make is that the label that elinzanetant has received in the U.S. takes into account the fact that this particular molecule acts on two receptors, the NK1 and the NK3. They have a warning on inducing sleep. We will not know how the market will react to that. That is not something that's in our label. You pointed out that they have less liver monitoring. That is true, but that's what we also had when we began this journey. What real world evidence will then produce over time? Yes, I think two points. yes i think two points One Naoki already made very, very well, which is this is a market we have to develop. one naoki already made very very well which is this is a market we have to develop Two companies developing a market is always much better than a company doing it alone. two companies developing a market is always much better than a company doing it alone I think in that sense the entry of a competitor actually helps grow the class. i think in that sense the entry of a competitor actually helps grow the class The other point I would make is that the label that elinzanetant has received in the U.S. takes into account the fact that this particular molecule acts on two receptors, the NK1 and the NK3. the other point i would make is that the label that elinzanetant has received in the u.s takes into account the fact that this particular molecule acts on two receptors the nk1 and the nk3 They have a warning on inducing sleep. they have a warning on inducing sleep We will not know how the market will react to that. we will not know how the market will react to that That is not something that's in our label. that is not something that's in our label You pointed out that they have less liver monitoring. you pointed out that they have less liver monitoring That is true, but that's what we also had when we began this journey. that is true but that's what we also had when we began this journey What real world evidence will then produce over time? what real world evidence will then produce over time Because remember, these liver incidences are very, very rare. You don't see them in clinical trials, you only see them in real world practice. Only time will tell how that really plays out in the marketplace. Because remember, these liver incidences are very, very rare. because remember these liver incidences are very very rare You don't see them in clinical trials, you only see them in real world practice. you don't see them in clinical trials you only see them in real world practice Only time will tell how that really plays out in the marketplace. only time will tell how that really plays out in the marketplace

Speaker 4: Yes, very clear. Thank you very much. Yes, very clear. yes very clear Thank you very much. thank you very much

Speaker 6: Thank you very much. Next we'd like to receive questions from UBS Securities. Mr. Sakai, please. Thank you very much. thank you very much Next we'd like to receive questions from UBS Securities. next we'd like to receive questions from ubs securities Mr. Sakai, please. mr sakai please

Speaker 10: Sakai from UBS speaking. Initially, sorry if a negative question, but VYLOY didn't work in a PDEC. You are now examining the details of your data. CLOVER 18.2 and any learnings are in association with CLOVER 18.2 as the reason for the failure of the study. ASP2138. This is also CLOVER 18.2 targeting PDEC. You are planning a clinical development including these compounds. Could you give us an update on this? That's my first question. Thank you very much. Sakai from UBS speaking. sakai from ubs speaking Initially, sorry if a negative question, but VYLOY didn't work in a PDEC. initially sorry if a negative question but vyloy didn't work in a pdec You are now examining the details of your data. you are now examining the details of your data CLOVER 18.2 and any learnings are in association with CLOVER 18.2 as the reason for the failure of the study. clover 18.2 and any learnings are in association with clover 18.2 as the reason for the failure of the study ASP2138. asp2138 This is also CLOVER 18.2 targeting PDEC. this is also clover 18.2 targeting pdec You are planning a clinical development including these compounds. you are planning a clinical development including these compounds Could you give us an update on this? could you give us an update on this That's my first question. that's my first question Thank you very much. thank you very much

Speaker 12: It's technical and expert, so I shouldn't say too much. I'd like to hand over to Taniguchi from the beginning. It's technical and expert, so I s houldn't say too much. it's technical and expert so i s houldn't say too much I'd like to hand over to Taniguchi from the beginning. i'd like to hand over to taniguchi from the beginning

Speaker 7: Thank you very much. First of all, VYLOY GLEAM study for PDAC. It was a phase two study, but a randomized trial in phase two. If the results are good, it could be registrational so that we can file a submission. That's how we were discussing with the regulatory authorities in this study. VYLOY and first line pancreatic cancer chemotherapy combination and chemo monotherapies were compared. This was close to POC study. We are analyzing the results of the study through the analysis in what kind of patients there was a good response and in what kind of patients no response. We can know more details by analyzing, so in the GLEAM study we haven't made public the results yet. Once we are able to analyze the details with a deeper understanding, then we'd like to share. Thank you very much. thank you very much First of all, VYLOY GLEAM study for PDAC. first of all vyloy gleam study for pdac It was a phase two study, but a randomized trial in phase two. it was a phase two study but a randomized trial in phase two If the results are good, it could be registrational so that we can file a submission. if the results are good it could be registrational so that we can file a submission That's how we were discussing with the regulatory authorities in this study. that's how we were discussing with the regulatory authorities in this study VYLOY and first line pancreatic cancer chemotherapy combination and chemo monotherapies were compared. vyloy and first line pancreatic cancer chemotherapy combination and chemo monotherapies were compared This was close to POC study. this was close to poc study We are analyzing the results of the study through the analysis in what kind of patients there was a good response and in what kind of patients no response. we are analyzing the results of the study through the analysis in what kind of patients there was a good response and in what kind of patients no response We can know more details by analyzing, so in the GLEAM study we haven't made public the results yet. we can know more details by analyzing so in the gleam study we haven't made public the results yet Once we are able to analyze the details with a deeper understanding, then we'd like to share. once we are able to analyze the details with a deeper understanding then we'd like to share Regarding the results of the study, ASP2138 targeting Claudin 18.2, this is a bispecific antibody. This is CD3 of T cell engager is also added to this bispecific antibody. ASP2138 in PDAC, how does any potential impact on PDAC with this compound CD3 T cell engagement portion. How it's going to affect a PDAC in clinical studies phase 1b. Right now we are studying that part. We haven't published the data yet, but in the near future once we collect the data. We will announce the results including our future outlook. This bispecific antibody and VYLOY, the differences between the two can also be examined. Once we have the data, I will explain such a perspective as well. Cloning 18.2, so you haven't changed your way of thinking in the development concept. As a concept, the GLEAM study, ASP2138, any direct impact? Regarding the results of the study, ASP2138 targeting Claudin 18.2, this is a bispecific antibody. regarding the results of the study asp2138 targeting claudin 18.2 this is a bispecific antibody This is CD3 of T cell engager is also added to this bispecific antibody. this is cd3 of t cell engager is also added to this bispecific antibody ASP2138 in PDAC, how does any potential impact on PDAC with this compound CD3 T cell engagement portion. asp2138 in pdac how does any potential impact on pdac with this compound cd3 t cell engagement portion How i t's going to affect a PDAC in clinical studies phase 1b. how i t's going to affect a pdac in clinical studies phase 1b Right now we are studying that part. right now we are studying that part We haven't published the data yet, but in the near future once we collect t he data. we haven't published the data yet but in the near future once we collect t he data We will announce the results including our future outlook. we will announce the results including our future outlook This bispecific antibody and VYLOY, the differences between the two can also be examined. this bispecific antibody and vyloy the differences between the two can also be examined Once we have the data, I will explain such a perspective as well. once we have the data i will explain such a perspective as well Cloning 18.2, so you haven't changed your way of thinking in the development concept. cloning 18.2 so you haven't changed your way of thinking in the development concept As a concept, the GLEAM study, ASP2138, any direct impact? as a concept the gleam study asp2138 any direct impact

Speaker 6: I could say no impact. I could say no impact. i could say no impact

Speaker 10: Understood. Thank you very much. Another question is about your response of the mid-term plan. Okamura-san, you mentioned that the very reinforced the strong or something like that. If that is the case, the number you come up with might be drastic. That is a bit of the concern that I feel. You are working on making the numbers so you would not probably disclose anything specific, but the comment you made a little while ago is probably your honest thinking. Based upon that, we have to also come up with the focus or our numbers. Do you think is it okay that we approach in this way? Understood. understood Thank you very much. thank you very much Another question is about your response of the mid-term plan. another question is about your response of the mid-term plan Okamura-san, you mentioned that the very reinforced the strong or something like that. okamura-san you mentioned that the very reinforced the strong or something like that If that is the case, the number you come up with might be drastic. if that is the case the number you come up with might be drastic That is a bit of the concern that I feel. that is a bit of the concern that i feel You are working on making the numbers so you would not probably disclose anything specific, but the comment you made a little while ago is probably your honest thinking. you are working on making the numbers so you would not probably disclose anything specific but the comment you made a little while ago is probably your honest thinking Based upon that, we have to also come up with the focus or our numbers. based upon that we have to also come up with the focus or our numbers Do you think is it okay that we approach in this way? do you think is it okay that we approach in this way

Speaker 12: Thank you very much. We get learnings every day. For example, CSP 2021 review is currently ongoing and based upon that we are going to come up with a next plan. Frankly speaking, overpromise, underperform, that such criticism is what we've already accepted, and so that we can avoid the repetition of that, we can place a more disciplined and well-balanced corporate plan that is going to be announced. In that sense, Kitamura is looking at the numbers with a perspective and Claus as well, being based upon that number is calculated and coming up with. You can feel safe about that as well. Thank you very much. thank you very much We get learnings every day. we get learnings every day For example, CSP 2021 review is currently ongoing and based upon that we are going to come up with a next plan. for example csp 2021 review is currently ongoing and based upon that we are going to come up with a next plan Frankly speaking, overpromise, underperform, that such criticism is what we've already accepted, and so that we can avoid the repetition of that, we can place a more disciplined and well-balanced corporate plan that is going to be announced. frankly speaking overpromise underperform that such criticism is what we've already accepted and so that we can avoid the repetition of that we can place a more disciplined and well-balanced corporate plan that is going to be announced In that sense, Kitamura is looking at the numbers with a perspective and Claus as well, being based upon that number is calculated and coming up with. in that sense kitamura is looking at the numbers with a perspective and claus as well being based upon that number is calculated and coming up with You can feel safe about that as well. you can feel safe about that as well

Speaker 10: Understood. Thank you very much. Understood. understood Thank you very much. thank you very much

Speaker 12: Thank you. Thank you. thank you

Speaker 6: Next, Morgan Stanley. Mr. Fuji. Next, Morgan Stanley. next morgan stanley Mr. Fuji. mr fuji

Speaker 3: Mr. Muraoka, please. Mr. Muraoka, please. mr muraoka please

Speaker 6: Thank you very much. Thank you very much. thank you very much

Speaker 3: Muraoka from Morgan Stanley. I think almost all the questions are covered already, but just one question. It was like this last year, so it'll be okay this year. This might be a bit mean question, but that is about IZERVAY impairment loss risk is the question. Last year in the second quarter it was okay in Europe, but in the third quarter impairment loss was incurred, and this time the U.S. sales is a relatively bigger reduction. Looking at this number, thinking about the future value, impairment loss triggered risk is likely to be higher compared to three months ago. I wouldn't say. Of course, you cannot say. It's all right, no problem. However, how can we evaluate these potential risks? Thank you very much. Muraoka from Morgan Stanley. muraoka from morgan stanley I think almost all the questions are covered already, but just one question. i think almost all the questions are covered already but just one question It was like this last year, so it'll be okay this year. it was like this last year so it'll be okay this year This might be a bit mean question, but that is about IZERVAY impairment loss risk is the question. this might be a bit mean question but that is about izervay impairment loss risk is the question Last year in the second quarter it was okay in Europe, but in the third quarter impairment loss was incurred, and this time the U.S. sales is a relatively bigger reduction. last year in the second quarter it was okay in europe but in the third quarter impairment loss was incurred and this time the u.s sales is a relatively bigger reduction Looking at this number, thinking about the future value, impairment loss triggered risk is likely to be higher compared to three months ago. looking at this number thinking about the future value impairment loss triggered risk is likely to be higher compared to three months ago I wouldn't say. i wouldn't say Of course, you cannot say. of course you cannot say It's all right, no problem. it's all right no problem However, how can we evaluate these potential risks? however how can we evaluate these potential risks Thank you very much. thank you very much

Speaker 12: The valuation base is the sales prediction and forecast that Claus is going to make additional comment if necessary. The way of my description is that when evaluation is conducted, the underlying uncertainty is increased. That's the kind of status. If you ask me, impairment loss is higher. At this moment, I wouldn't think that impairment loss risk is higher, but for the valuation compared to what we've originally considered, kind of situation is lower. That is true. If this is going to be recovered or ultimately this will decide the trajectory of IZERVAY, that's something we have to always have sharp eyes. Just like Claus mentioned, peak sales, we do not think that we have to revisit it right away. The valuation base is the sales prediction and forecast that Claus is going to make additional comment if necessary. the valuation base is the sales prediction and forecast that claus is going to make additional comment if necessary The way of my description is that when evaluation is conducted, the underlying uncertainty is increased. the way of my description is that when evaluation is conducted the underlying uncertainty is increased That's the kind of status. that's the kind of status If you ask me, impairment loss is higher. if you ask me impairment loss is higher At this moment, I wouldn't think that impairment loss risk is higher, but for the valuation compared to what we've originally considered, kind of situation is lower. at this moment i wouldn't think that impairment loss risk is higher but for the valuation compared to what we've originally considered kind of situation is lower That is true. that is true If this is going to be recovered or ultimately this will decide the trajectory of IZERVAY, that's something we have to always have sharp eyes. if this is going to be recovered or ultimately this will decide the trajectory of izervay that's something we have to always have sharp eyes Just like Claus mentioned, peak sales, we do not think that we have to revisit it right away. just like claus mentioned peak sales we do not think that we have to revisit it right away

Speaker 2: There is undoubtedly in the U.S. market a dynamic on the affordability part where a part of the patients can't afford the co-pay that they need to contribute for their injections. That is different from when we look at the peak potential and the size of the market that we can still develop in this disease. One is a timing effect, the other is effective. The question is what's the potential of this agent in the geographic atrophy market. I'm very confident that the long-term potential for IZERVAY is intact. The question of how we solve the current dynamic in the U.S. is a tactical problem that we are working through. We hope to find solutions in tactical to come. There is undoubtedly in the U.S. market a dynamic on the affordability part where a part of the patients can't afford the co-pay that they need to contribute for their injections. there is undoubtedly in the u.s market a dynamic on the affordability part where a part of the patients can't afford the co-pay that they need to contribute for their injections That is different from when we look at the peak potential and the size of the market that we can still develop in this disease. that is different from when we look at the peak potential and the size of the market that we can still develop in this disease One is a timing effect, the other is effective. one is a timing effect the other is effective The question is what's the potential of this agent in the geographic atrophy market. the question is what's the potential of this agent in the geographic atrophy market I'm very confident that the long-term potential for IZERVAY is intact. i'm very confident that the long-term potential for izervay is intact The question of how we solve the current dynamic in the U.S. is a tactical problem that we are working through. the question of how we solve the current dynamic in the u.s is a tactical problem that we are working through We hope to find solutions in tactical to come. we hope to find solutions in tactical to come

Speaker 6: Kitamura also has a comment. Thank you very much. Kitamura also has a comment. kitamura also has a comment Thank you very much. thank you very much

Speaker 13: May I add? Sorry? May I add? may i add Sorry? sorry

Speaker 6: Yes, please. Yes, please. yes please

Speaker 13: Last year regarding IZERVAY and impairment loss, the trigger was whether we can get the approval or not. It was about that probability. Now, as you know, IZERVAY intangible assets in the U.S. and outside of the U.S., as we are registering U.S. intangible because of the launching in the United States already, we are going to sell it out, including the competitors. Our drug is also a new treatment. How to develop the market is the main task force. It's our job. Claus is going to do a good job according to him. We think we can do it. Of course, there is a big asset number on the balance sheet. I have to evaluate and assess it. I will do so. The company stance has not changed, and we had impairment loss which was incurred last year, but the root cause is different. Please understand. Last year regarding IZERVAY and impairment loss, the trigger was whether we can get the approval or not. last year regarding izervay and impairment loss the trigger was whether we can get the approval or not It was about that probability. it was about that probability Now, as you know, IZERVAY intangible assets in the U.S. and outside of the U.S., as we are registering U.S. intangible because of the launching in the United States already, we are going to sell it out, including the competitors. now as you know izervay intangible assets in the u.s and outside of the u.s as we are registering u.s intangible because of the launching in the united states already we are going to sell it out including the competitors Our drug is also a new treatment. our drug is also a new treatment How to develop the market is the main task force. how to develop the market is the main task force It's our job. it's our job Claus is going to do a good job according to him. claus is going to do a good job according to him We think we can do it. we think we can do it Of course, there is a big asset number on the balance sheet. of course there is a big asset number on the balance sheet I have to evaluate and assess it. i have to evaluate and assess it I will do so. i will do so The company stance has not changed, and we had impairment loss which was incurred last year, but the root cause is different. the company stance has not changed and we had impairment loss which was incurred last year but the root cause is different Please understand. please understand

Speaker 3: Thank you very much. One more question if I may. Earlier you talked about CSP mid-term business plan. I know you would say don't ask so many questions on this. Regarding the dividend, I understand the message that there can be a decrease. The dividend level during the course of the next CSP on an absolute basis, do you think you can maintain the amount? Can we feel assured? Sorry, what do you mean by decline? Which, what are you talking about? The top line may decrease on a temporary basis. If you are talking about it, yes, you are right. That may not necessarily lead to a decline in the bottom line. Regarding the specific numbers, in May next year, CSP 2026 will be announced according to plan. Please wait till then. Thank you very much. thank you very much One more question if I may. one more question if i may Earlier you talked about CSP mid-term business plan. earlier you talked about csp mid-term business plan I know you would say don't ask so many questions on this. i know you would say don't ask so many questions on this Regarding the dividend, I understand the message that there can be a decrease. regarding the dividend i understand the message that there can be a decrease The dividend level during the course of the next CSP on an absolute basis, do you think you can maintain the amount? the dividend level during the course of the next csp on an absolute basis do you think you can maintain the amount Can we feel assured? can we feel assured Sorry, what do you mean by decline? sorry what do you mean by decline Which, what are you talking about? which what are you talking about The top line may decrease on a temporary basis. the top line may decrease on a temporary basis If you are talking about it, yes, you are right. if you are talking about it yes you are right That may not necessarily lead to a decline in the bottom line. that may not necessarily lead to a decline in the bottom line Regarding the specific numbers, in May next year, CSP 2026 will be announced according to plan. regarding the specific numbers in may next year csp 2026 will be announced according to plan Please wait till then. please wait till then

Speaker 12: I think this is Tamra's scope of responsibilities, but I also have my own views, so allow me to speak. Regarding the dividend, just increasing the dividend would not happen. Also, even if the company's overall performance is good or bad, it's not something we should change dramatically. I'm talking about the dividend for the past few years. By now, intentionally the dividend level may be too low, and to increase it to a competitive level, we increased the dividend at quite a fast pace. From now on, for the company's growth in the longer term, we'd like to gradually increase the dividend in line. That's Astellas's basic stance. In the next five years, with the next CSP, there's going to be some dip in revenues. We have no intention to decrease the dividend because of that. In that sense, you can feel assured. I think this is Tamra's scope of responsibilities, but I also have my own views, so allow me to speak. i think this is tamra's scope of responsibilities but i also have my own views so allow me to speak Regarding the dividend, just increasing the dividend would not happen. regarding the dividend just increasing the dividend would not happen Also, even if the company's overall performance is good or bad, it's not something we should change dramatically. also even if the company's overall performance is good or bad it's not something we should change dramatically I'm talking about the dividend for the past few years. i'm talking about the dividend for the past few years By now, intentionally the dividend level may be too low, and to increase it to a competitive level, we increased the dividend at quite a fast pace. by now intentionally the dividend level may be too low and to increase it to a competitive level we increased the dividend at quite a fast pace From now on, for the company's growth in the longer term, we'd like to gradually increase the dividend in line. from now on for the company's growth in the longer term we'd like to gradually increase the dividend in line That's Astellas 's basic stance. that's astellas 's basic stance In the next five years, with the next CSP, there's going to be some dip in revenues. in the next five years with the next csp there's going to be some dip in revenues We have no intention to decrease the dividend because of that. we have no intention to decrease the dividend because of that In that sense, you can feel assured. in that sense you can feel assured

Speaker 6: Kitamura-san, please. Kitamura-san, please. kitamura-san please

Speaker 13: As Okamura said, I may be repeating myself, but a stable return to shareholders is an important factor as part of the capital allocation. According to understanding, we are doing this already, so it's not going to change in my view. On the other hand, when it comes to dividend, how much profit do we have? Cash flow is better or balance sheet is better. Are we working on this meticulously? Whatever is going to happen, we should have funds for investments, for stable growth, and we have to have a stable return to shareholders. This is my, including my personal view. I think this is an important factor. It's not going to change substantially according to my assumptions. As Okamura said, I may be repeating myself, but a stable return to shareholders is an important factor as part of the capital allocation. as okamura said i may be repeating myself but a stable return to shareholders is an important factor as part of the capital allocation According to understanding, we are doing this already, so it's not going to change in my view. according to understanding we are doing this already so it's not going to change in my view On the other hand, when it comes to dividend, how much profit do we have? on the other hand when it comes to dividend how much profit do we have Cash flow is better or balance sheet is better. cash flow is better or balance sheet is better Are we working on this meticulously? are we working on this meticulously Whatever is going to happen, we should have funds for investments, for stable growth, and we have to have a stable return to shareholders. whatever is going to happen we should have funds for investments for stable growth and we have to have a stable return to shareholders This is my, including my personal view. this is my including my personal view I think this is an important factor. i think this is an important factor It's not going to change substantially according to my assumptions. it's not going to change substantially according to my assumptions

Speaker 3: Understood. Thank you very much. That's all from me. Understood. understood Thank you very much. thank you very much That's all from me. that's all from me

Speaker 6: Thank you very much. Next, Macquarie Capital Securities. Tony Renson, please. Thank you very much. thank you very much Next, Macquarie Capital Securities. next macquarie capital securities Tony Renson, please. tony renson please

Speaker 9: Tony Ren from Macquarie. Can you guys hear me? Tony Ren from Macquarie. tony ren from macquarie Can you guys hear me? can you guys hear me

Speaker 6: Yes, we can. Yes, we can. yes we can

Speaker 9: Okay, perfect. Thank you very much for the opportunity. The first question is a simple one on gross profit margin. Your cost of sales in the first half appears to be increasing faster than revenue, which probably suggests that the gross margin is declining a little bit. I just wanted to understand why that might be the case. Okay, perfect. okay perfect Thank you very much for the opportunity. thank you very much for the opportunity The first question is a simple one on gross profit margin. the first question is a simple one on gross profit margin Your cost of sales in the first half appears to be increasing faster than revenue, which probably suggests that the gross margin is declining a little bit. your cost of sales in the first half appears to be increasing faster than revenue which probably suggests that the gross margin is declining a little bit I just wanted to understand why that might be the case. i just wanted to understand why that might be the case

Speaker 2: Thank you. I think the simple answer to your question is the change in the product mix. If you would like to know a little bit more in detail, I will pass the baton to Atsushi. Thank you. thank you I think the simple answer to your question is the change in the product mix. i think the simple answer to your question is the change in the product mix If you would like to know a little bit more in detail, I will pass the baton to Atsushi. if you would like to know a little bit more in detail i will pass the baton to atsushi

Speaker 13: Yeah, it's all about product mix. Yeah, it's all about product mix. yeah it's all about product mix

Speaker 9: Okay. Okay, perfect. Understood. The second question and my last question is about your ASP2138. It appears to me that you guys are really pursuing this clinical asset as part of combination therapies, but not as monotherapy. At ASMO 2025, which I attended, I think the monotherapy response rate was fairly modest. The KOLs who I spoke to also think that the duration of response was good, but probably not something that knocked it out of the park. What's your thinking about using ASP2138 either as combination or as a monotherapy? Thank you. Okay. okay Okay, perfect. okay perfect Understood. understood The second question and my last question is about your ASP2138. the second question and my last question is about your asp2138 It appears to me that you guys are really pursuing this clinical asset as part of combination therapies, but not as monotherapy. it appears to me that you guys are really pursuing this clinical asset as part of combination therapies but not as monotherapy At ASMO 2025, which I attended, I think the monotherapy response rate was fairly modest. at asmo 2025 which i attended i think the monotherapy response rate was fairly modest The KOLs who I spoke to also think that the duration of response was good, but probably not something that knocked it out of the park. the kols who i spoke to also think that the duration of response was good but probably not something that knocked it out of the park What's your thinking about using ASP2138 either as combination or as a monotherapy? what's your thinking about using asp2138 either as combination or as a monotherapy Thank you. thank you

Speaker 2: Thank you very much for the question. I will ask Taniguchi-san to answer those questions. Thank you very much for the question. thank you very much for the question I will ask Taniguchi -san to answer those questions. i will ask taniguchi -san to answer those questions

Speaker 7: Thank you. Question. As you describe, if you take a look at therapy of ASP2138, the ORR is relatively modest. It's around the 15% range. I think this is quite consistent with what we see in other CPI such as PD1 or PD-L1 inhibitors. It's also seen a very similar tendency that we see once tumor actually responded, the duration of response is longer. This is exactly what we see in other immuno-oncology products. I think that this is also quite encouraging data from monotherapy by saying that if you're thinking about PD1, most of the cases are actually coming to the earlier line in combination with other agents like chemotherapy or ADC as you see in PADCEV and pembrolizumab. Thank you. thank you Question. question As you describe, if you take a look at therapy of ASP2138, the ORR is relatively modest. as you describe if you take a look at therapy of asp2138 the orr is relatively modest It's around the 15% range. it's around the 15% range I think this is quite consistent with what we see in other CPI such as PD1 or PD-L1 inhibitors. i think this is quite consistent with what we see in other cpi such as pd1 or pd-l1 inhibitors It's also seen a very similar tendency that we see once tumor actually responded, the duration of response is longer. it's also seen a very similar tendency that we see once tumor actually responded the duration of response is longer This is exactly what we see in other immuno-oncology products. this is exactly what we see in other immuno-oncology products I think that this is also quite encouraging data from monotherapy by saying that if you're thinking about PD1, most of the cases are actually coming to the earlier line in combination with other agents like chemotherapy or ADC as you see in PADCEV and pembrolizumab. i think that this is also quite encouraging data from monotherapy by saying that if you're thinking about pd1 most of the cases are actually coming to the earlier line in combination with other agents like chemotherapy or adc as you see in padcev and pembrolizumab What we believe is that thinking about the development of ASP2138, we believe that it makes sense for us to go into the earlier line in combination with the current standard of care. That's what we believe. This is the space that we can actually work on. I think that this is also based on the data coming up from phase one, current ongoing phase one. Please wait. The data is coming up, but I think we believe that these data we are actually showing in ESMO is quite encouraging. What we believe is that thinking about the development of ASP2138, we believe that it makes sense for us to go into the earlier line in combination with the current standard of care. what we believe is that thinking about the development of asp2138 we believe that it makes sense for us to go into the earlier line in combination with the current standard of care That's what we believe. that's what we believe This is the space that we can actually work on. this is the space that we can actually work on I think that this is also based on the data coming up from phase one, current ongoing phase one. i think that this is also based on the data coming up from phase one current ongoing phase one Please wait. please wait The data is coming up, but I think we believe that these data we are actually showing in ESMO is quite encouraging. the data is coming up but i think we believe that these data we are actually showing in esmo is quite encouraging

Speaker 9: Okay, understood. You have a very clear combination in earlier line with other current standard of care. Thank you very much. Okay, understood. okay understood You have a very clear combination in earlier line with other current standard of care. you have a very clear combination in earlier line with other current standard of care Thank you very much. thank you very much

Speaker 6: Thank you. Thank you very much. Because of the time, we would like to ask the next question as the last question. Sanford C. Bernstein, Mr. Sogi, please. Thank you. thank you Thank you very much. thank you very much Because of the time, we would like to ask the next question as the last question. because of the time we would like to ask the next question as the last question Sanford C. sanford c Bernstein, Mr. Sogi , please. bernstein mr. sogi please

Speaker 11: Thank you very much. MIBC commercial potential. How do you feel about that? I would like you to explain more details. To simply put, the patient number times market share times duration of therapy times price. It seems it's not that simple. Listen to you, first line treatment overlapping and actual clinical practice, adjuvant, neoadjuvant usage differentiation seems also complicated. Could you be a little bit more specific about this? Also, on top of that, this adjuvant, neoadjuvant for MIBC regarding first line and second line, the number of the patients including their China major markets number were disclosed. For MIBC, China is excluded according to the description here. Is this significant? Would you please explain about these two points? Thank you very much. thank you very much MIBC commercial potential. mibc commercial potential How do you feel about that? how do you feel about that I would like you to explain more details. i would like you to explain more details To simply put, the patient number times market share times duration of therapy times price. to simply put the patient number times market share times duration of therapy times price It seems it's not that simple. it seems it's not that simple Listen to you, first line treatment overlapping and actual clinical practice, adjuvant, neoadjuvant usage differentiation seems also complicated. listen to you first line treatment overlapping and actual clinical practice adjuvant neoadjuvant usage differentiation seems also complicated Could you be a little bit more specific about this? could you be a little bit more specific about this Also, on top of that, this adjuvant, neoadjuvant for MIBC regarding first line and second line, the number of the patients including their China major markets number were disclosed. also on top of that this adjuvant neoadjuvant for mibc regarding first line and second line the number of the patients including their china major markets number were disclosed For MIBC, China is excluded according to the description here. for mibc china is excluded according to the description here Is this significant? is this significant Would you please explain about these two points? would you please explain about these two points

Speaker 12: Your first question, your understanding is correct. We do research. We should be able to respond with responsibility. We would like to respond to your question. Please give us some more time till then. I don't know the background of the second question. Claus, do you know the background for the second question? Your first question, your understanding is correct. your first question your understanding is correct We do research. we do research We should be able to respond with responsibility. we should be able to respond with responsibility We would like to respond to your question. we would like to respond to your question Please give us some more time till then. please give us some more time till then I don't know the background of the second question. i don't know the background of the second question Claus, do you know the background for the second question? claus do you know the background for the second question

Speaker 2: He would have to come back on China. Yes, I would have to come back. He would have to come back on China. he would have to come back on china Yes, I would have to come back. yes i would have to come back

Speaker 11: Sorry. Among the participants today, we do not have a full understanding of the background. We would come back to you through our IR team at a later date. Okay, next, about IZERVAY. I have a question about IZERVAY. Sorry. sorry Among the participants today, we do not have a full understanding of the background. among the participants today we do not have a full understanding of the background We would come back to you through our IR team at a later date. we would come back to you through our ir team at a later date Okay, next, about IZERVAY. okay next about izervay I have a question about IZERVAY. i have a question about izervay

Speaker 12: Of course, you're going to expand the market from now on. You're still on the way. On the other hand, this year from the first half, Good Day is a charity foundation for patients on Medicaid. Patient support funding is no longer available, and there was such an impact on your business. Of course, you're going to expand the market from now on. of course you're going to expand the market from now on You're still on the way. you're still on the way On the other hand, this year from the first half, Good Day is a charity foundation for patients on Medicaid. on the other hand this year from the first half good day is a charity foundation for patients on medicaid Patient support funding is no longer available, and there was such an impact on your business. patient support funding is no longer available and there was such an impact on your business

Speaker 11: What's the current status right now? What's the current status right now? what's the current status right now

Speaker 2: Yeah, you're absolutely right. The drying up of the foundation support in the United States is causing some patients to drop off from therapy because they simply can't afford the co-pay that the foundations picked up in the past. We see that both in the geographic atrophy market and in the wet amount. What we see the retina clinics doing in the U.S. is trying to adjust to that new situation. Remember, it's not all the patients who can't afford the co-pay. There's still 70% or something like that. It's an estimate, but it's at least 60% of the patients who can afford the co-pay. I think it's a question for the clinics now to understand when they accept patients, how do they deal with a patient that can afford versus what support mechanisms are available for patients who can't afford. Yeah, you're absolutely right. yeah you're absolutely right The drying up of the foundation support in the United States is causing some patients to drop off from therapy because they simply can't afford the co-pay that the foundations picked up in the past. the drying up of the foundation support in the united states is causing some patients to drop off from therapy because they simply can't afford the co-pay that the foundations picked up in the past We see that both in the geographic atrophy market and in the wet amount. we see that both in the geographic atrophy market and in the wet amount What we see the retina clinics doing in the U.S. is trying to adjust to that new situation. what we see the retina clinics doing in the u.s is trying to adjust to that new situation Remember, it's not all the patients who can't afford the co-pay. remember it's not all the patients who can't afford the co-pay There's still 70% or something like that. there's still 70% or something like that It's an estimate, but it's at least 60% of the patients who can afford the co-pay. it's an estimate but it's at least 60% of the patients who can afford the co-pay I think it's a question for the clinics now to understand when they accept patients, how do they deal with a patient that can afford versus what support mechanisms are available for patients who can't afford. i think it's a question for the clinics now to understand when they accept patients how do they deal with a patient that can afford versus what support mechanisms are available for patients who can't afford That's the turbulence in the market that we're seeing right now. We believe also on the basis of past analogs that the market will learn how to triage that and how to provide the right solution for different patient types. How long that will take and what the curve after that will be, that is the part that I'm still exactly struggling with. That's why we've been more cautious to take down the projections for this year. That's the turbulence in the market that we're seeing right now. that's the turbulence in the market that we're seeing right now We believe also on the basis of past analogs that the market will learn how to triage that and how to provide the right solution for different patient types. we believe also on the basis of past analogs that the market will learn how to triage that and how to provide the right solution for different patient types How long that will take and what the curve after that will be, that is the part that I'm still exactly struggling with. how long that will take and what the curve after that will be that is the part that i'm still exactly struggling with That's why we've been more cautious to take down the projections for this year. that's why we've been more cautious to take down the projections for this year

Speaker 11: Great. Thank you. If we did have enough funding this year, would that fill the gap that you currently lowered in your guidance? Great. great Thank you. thank you If we did have enough funding this year, would that fill the gap that you currently lowered in your guidance? if we did have enough funding this year would that fill the gap that you currently lowered in your guidance

Speaker 2: It would for the coming quarters, but we have lost time. I don't think the original forecast is realistic simply because of the timing element that we have within a fiscal year. It would for the coming quarters, but we have lost time. it would for the coming quarters but we have lost time I don't think the original forecast is realistic simply because of the timing element that we have within a fiscal year. i don't think the original forecast is realistic simply because of the timing element that we have within a fiscal year

Speaker 11: Thank you very much. Thank you very much. thank you very much

Speaker 6: Now time has come. With this, we'd like to close today's explanatory meeting. Thank you very much for joining us today. Now time has come. now time has come With this, we'd like to close today's explanatory meeting. with this we'd like to close today's explanatory meeting Thank you very much for joining us today. thank you very much for joining us today