Everyone, thank you very much for your participation of this announcement of the financial result in the FY22, the third quarter. I'm Ikeda from Corporate Advocacy and Relations, serving as the moderator for today. Before starting the financial results announcement, we would like to make some explanation about the Astellas announcement of a change of President and CEO when announced at the 11:30 A.M. Yasukawa is going to make the opening remarks. First of all, that is followed by the explanation by the appointed President as of April 1st, Okamura. Hello, I'm Yasukawa. I would like to thank you for your join. At the board of directors meeting held today, we decided to appoint Mr. Naoki Okamura as CEO effective April 1st. I would like to start by saying thank you for your kind attention. I'd like to begin by explaining the background behind this change in CEO. Astellas has been working on its Corporate Strategic Plan 2018 and Corporate Strategic Plan 2021 since fiscal year 2018, when myself was appointed as President and CEO to realize its vision on the forefront of healthcare change to turn innovative science into value for patients. During this time, Astellas overcame the patent cliff associated with the expiration of products exclusivity that has supported its growth in the past, and revenue has turned upward trend after bottoming out in fiscal year 2020. In addition, Astellas moved away from its past business model of creating products with a focus on specific disease areas and promoted a shift to the Focus Area Approach of determining R&D areas from a multifaceted perspective. It's also making progress in developing new drug candidates that will drive future revenues. Fiscal year 2023 is the right time to go on the aggressive to further accelerate growth, and Naoki Okamura will take over as new President and CEO. Astellas decided it is best for it to consider and implement strategies for achieving CSP '21, which ends in fiscal year 2025, and long-term growth beyond that under the new leadership. The environment surrounding the company is changing rapidly, such as increasing geopolitical risks and changes in the finances and the markets of each country due to the COVID-19 crisis. The new top management has the ability to flexible in response to such changes. Since joining the company in 1986, Mr. Okamura has served as the head of the business development and corporate planning. In 2018, he became CScO and from fiscal 2019, he participated in management as Representative Director and a Vice President overseeing a wide range of business unit and driving the business forward. In addition, he provides leadership in setting direction for organizational health goals and promoting the reorganization of R&D. In a highly uncertain business environment, he's not bound by stereotypes or preconceived notions, but he's also able to make decisions with a bird's-eye view of the entire Astellas organization free from stereotypes. He places great importance on direct dialogue with employees, always speaking to them in his own words and sincerely listening to their voices. He is both logical and passionate, strict and warm, serious and humorous, and has earned the trust of many people within the company. I will assume the position of Representative Director and Chairman of the Board. I will fulfill the roles not for management execution, but of management decision-making and supervision of business execution to ensure that Astellas moves in the right direction to meet the expectations and demands of its stakeholders. I will also focus on advocacy activities to let the public know of what value the pharmaceutical industry brings and how it contributes to society. We look forward to your continued support. Thank you very much. Yasukawa, thank you very much. Next, Okamura-san, please. As of the April first, I'm going to serve as the Representative Director, President and CEO. I'm Okamura. In 2016, I was appointed as the Head of Corporate Planning. For seven years since, I am proud that I was at the center of strategic development and its implementation at Astellas. Being able to assume my responsibility in this way is a great honor for me. We are now at a turning point in a year for CSP2021, but in a bigger framework, there is no change in the priorities raised as strategic organizational health and performance goals. I'm going to continue the management policy and the direction of the business in principle. If you look at each individual goal, the business environment and the progress of the project are changing every day. I will maintain principles and reorganize priorities flexibly so that we can allocate limited management resources appropriately. I'd like to solidify the sustainable growth after LOE of enzalutamide and XTANDI. My mission is to hand over to the next leader by doing so. As is shown in Vision and CSP2021, Astellas is aiming to be a cutting-edge, a value-driven life science innovator. Creating innovations continuously is our lifeline. We should learn from mistakes and failures, take wise risks so that each one of the employees can demonstrate leadership. There is a need to further foster corporate culture aiming for a higher level, as well as Astellas, and we would raise ambitious goals to do our best to achieve the goals, but we'd like to be an outcome-driven companies. Astellas would are working on a regeneration of medicines to improve the root cause of the diseases substantially, like cell therapy and gene therapies. Going into the unknown areas entails business risks, but we give the top priority to the safety for the patients with a sense of urgency that patients are waiting. We'd like to steer the company with a sense of speed. We appreciate your continued support and guidance for the future. Thank you very much. We would like to start the 2022 fiscal year 3rd quarter financial results announcement. For this announcement, Zoom webinar and live streaming are available, questions are accepted only through Zoom webinar, not from live streaming. Today, including Q&A, Japanese and English simultaneous translation is available for those participating through Zoom webinar. From the screen of Zoom, please select your favorable language. When it comes to simultaneous interpretation, we, as a company, do not guarantee the accuracy of that. The participants for today, on top of Yasukawa and Okamura, we have the Atsushi Kitamura, CFO, Yukio Matsui, CCO, Yoshitsugu Shitaka, Chief Scientific Officer, and Tadaaki Taniguchi, Chief Medical Officer. We have four in addition. The presentation material is available on the website, please refer to it. The material or presentation by representatives for the company and answers and statement by them in the QA session includes forward-looking statements based on assumption of beliefs in light of the information currently available to management subject to significant risks and uncertainties. Actual financial results may differ materially depending on a number of factors. They contain information on pharmaceuticals, including compounds under development, but this information is not intended to make any representation, advertisement, or medical advice. Now, I please start, Kikkuoka-san. Yes. Hello, everyone. I'm Minoru Kikuoka, CFO, at Astellas Pharma Inc. Thank you very much for joining our FY 2022 third quarter financial results announcement meeting out of very busy schedule today. This is a cautionary statement regarding forward-looking information shown on page two. This was explained by Ikeda earlier. I'm going to skip this page. This is the agenda for today. I will cover these topics in this order from the next page. Page four is an overview of FY 2022 third quarter financial results. Revenue and profit increased in the third quarter. Revenue increased 17% year-on-year and was in line with our full year forecast revised upward in the second quarter. Sales of XTANDI and strategic products were on track globally. Sales of XTANDI in the United States were in line with our full year forecast, which was revised downward in the second quarter. Sales in Japan and Europe also progressed in line with our full year forecast. Sales of PADCEV were in line with our full year forecast, which was revised upward in the second quarter. I will explain the details of each product on page 6 and page 7. Next on cost items. Cost of sales ratio was as expected. SG&A expenses were on track and decreased year-on-year when Forex impact was excluded. R&D expenses were on track. As a result, core operating profit increased by 6% year-on-year in line with our full year forecast. Full basis operating profit was below our full year forecast due to the booking as other expenses of foreign exchange loss caused mainly by the ruble's depreciation against the euro and the yen's rapid appreciation against the dollar from the 150 yen level to the 120 yen level in just 2 months in the third quarter. On page 5, I will explain FY 2022 third quarter financial results. Revenue increased to JPY 1,164.4 billion, up 17.3% year-over-year. The progress against the full year forecast was 76.2%. Core operating profit was JPY 233.7 billion, up by 6.2% year-over-year. The progress was 80.6% of our full year forecast. You can see the Forex impact on the right-hand side of the table. Revenue increased even when Forex impact was excluded. Core operating profit decreased when excluding the Forex impact. This is partly due to the booking of JPY 24.1 billion gain on divestiture of intangible assets in the third quarter of FY 2021. The bottom half of this page shows our full basis results. In the right bottom of the table, we included other expenses booked so far. In the first quarter, we booked impairment losses on intangible assets in the gene therapy programs and increased fair value of contingent consideration related to fezolinetant. Due to the booking of net foreign exchange losses of JPY 6.7 billion in the third quarter, net foreign exchange gains and losses worsened by JPY 20.6 billion compared to the second quarter. As for a positive event, Xiphos fair value of contingent consideration increased by JPY 4 billion as we reviewed the development plan for Xiphos-derived initial stage program. As a result, operating profit was JPY 181.3 billion, up by 7% year-on-year, progressing at 67.4% of our full year forecast. Profit increased to JPY 144.8 billion, up 9.3% year-on-year. The progress was 69.6% of our full year forecast. On page 6, let me explain the third quarter results and the future outlook of XTANDI. First, global sales reached JPY 511.9 billion in the third quarter, up by 24% year-on-year, and up by 8% when Forex impact was excluded. Global sales are in line with the full year forecast revised in the second quarter. Regarding the future outlook, XTANDI is expected to meet our full year forecast in all regions. Globally, as a whole, we are expecting near double-digit growth. Even excluding Forex impact, XTANDI is expected to achieve big sales of JPY 670 billion in our full year forecast. Let me explain the current situation and the future outlook for each region. In the United States, third quarter sales reached $1.972 billion, growing by 2% year-on-year. This 2% is the growth rate on a local currency basis. Performance is in line with our full year forecast revised downward in the second quarter. Market conditions remain challenging as we included this factor in our forecast. Levels of Patient Assistance Program or PAP ratio and share of Zytiga generic competitors continue to be high. New patient starts have not returned to pre-COVID-19 levels. We don't see any worsening of the situation compared to assumptions reviewed in the second quarter. We are expecting the achievement of full year forecast of over $260 million. Top line results are expected in the fourth quarter for the future growth driver M0CSPC indication from EMBARK study, with which we are aiming to obtain the additional indication. This is expected to drive the growth trend after approval. In established markets, performance is in line with our full year forecast revised significantly upward in the second quarter, contributing the most to global sales increased. In terms of the volume, M1CSPC continues to grow, especially in Germany, Italy and Canada, contributing to strong demand increase by a 22% year-over-year. As of now, we don't see any clear impact of Zytiga generic competitors. We are expecting the achievement of our full year forecast. Commercial segment of Australia was changed from established markets to international markets in the third quarter. Disclosed numbers already reflect this change. Actual results of the same period in the previous fiscal year and forecast figures are slightly changed. In Japan, performance is in line with the full year forecast revised upward in the second quarter. Market share expanded in all approved indications, maintaining number 1 share. In Greater China, performance looks strong. This is due to shipment timing. When this factor is excluded, performance is almost in line with the full year forecast. In international markets, performance looks strong due to big Forex impact, particularly from the ruble, but in line with our full year forecast excluding this factor. There are some regional differences, but globally as a whole, we continue to expect growth in the next fiscal year as well. On page seven, let me explain our strategic products. First, about PADCEV. Global sales were JPY 33.1 billion, in line with our full year forecast revised upward in the second quarter. Strong performance in Europe is expected to offset the slightly underachieving performance of the United States, resulting in expectations to achieve the full year forecast. In the United States, the actual business is progressing in line with our assumptions, and PADCEV is growing steadily. On the other hand, revenue from clinical trial orders are below our expectations. Taking this impact into consideration, we anticipate landing slightly behind our full year forecast. We have already acquired a high market share in the current indication. We're expecting significant sales growth after the approval of the additional indication in the first-line settings. We hope this will be a growth driver in the next fiscal year and beyond. In established markets, led by Germany, market penetration is exceeding our expectations. Performance is also exceeding our full year forecast revised upward in the second quarter. Furthermore, PADCEV was launched in four more countries compared to the second quarter in a total of 20 countries. Reimbursement started in five countries. We are expecting an upside from our full year forecast and further growth into the future. In Japan, progress is in line with our full year forecast revised significantly upward in the second quarter. New patient start continues to show strong trend and market share is expanding steadily. We are expecting landing in line with our full year forecast. In international markets, PADCEV was launched in Singapore in July and in UAE in December last year. We are expecting PADCEV to be launched in more countries in the future, hoping it will contribute to sales. Once again, the key to further growth globally in the future will be the expansion of the current indications and the additional first-line indication. Starting with the approval anticipated in the United States in the next fiscal year, we are hoping for significant sales growth. With regards to Xospata, sales are increasing in all regions where it's launched. The actual business is growing steadily. Performance looks strong, but this is mainly due to high inventory level in the United States. Assuming the leveling off of the inventory level in the fourth quarter, Xospata is expected to meet our full year forecast. As for Evrenzo, performance is below expectations even against downwardly revised full year forecast. Although launch and reimbursement are progressing in Europe, it is slower than expected. Reimbursement was obtained in France in December. We are expecting reimbursement also in Italy and Spain in the near future. We are hoping for sales contribution. On page eight, I will explain cost items. Cost of sales increased by 16.5% year-on-year, along with revenue increase. COGS ratio was down by 0.1 percentage point year-on-year to reach 19.4% in line with our expectations. SG&A costs, excluding extended U.S. co-promotion fees, increased by 11.8% year-on-year. When Forex impact was excluded, SG&A expenses decreased by 1.1% or JPY 3.4 billion year-on-year. The ratio to revenue decreased by 1.4 percentage points year-on-year to 28.6%. The progress against our full year forecast was 73% under full control, in line with our full year forecast. Personnel costs fell by about JPY 8 billion year-on-year with global optimization of commercial related personnel. We are trying to reduce sales promotion costs related to mature products such as Mirabegron, which decreased our cost by about JPY 6 billion year-on-year. On the other hand, we are making active investments for new product launch readiness for PADCEV and fezolinetant. Sales promotion expenses rose by about JPY 8 billion year-on-year. We will continue to allocate our resources to strategic products with higher priorities. R&D expenditure increased by 16% year-on-year, but by 3.1% when Forex impact was excluded. The main reason for this is the booking of one-time expense of JPY 13.8 billion for using a priority review voucher, PRV, in the first quarter for the application of fezolinetant. Excluding this cost, R&D expenditure decreased year-on-year. Ratio to revenue was 17.7%, down by 0.2 percentage point year-on-year. The progress against our full year forecast was 74.1% in line with our full year forecast, including the use of PRV for fezolinetant. On a full basis, we booked net foreign exchange losses of JPY 6.7 billion as other expenses. Net foreign exchange gains were JPY 13.9 billion as of the second quarter, but we booked net foreign exchange losses as expenses, mainly due to the impact of the depreciation of the ruble against for about JPY 10 billion, and the impact of the yen's appreciation against the US dollar for about JPY 9 billion. The net foreign exchange gains and losses worsened by JPY 20.6 billion from the second quarter. Unlike the Forex impact to occur from a special factor elimination of unrealized profit, excluding the impact from the second quarter, we can say this is the most typical Forex impact to occur due to adjustment based on the year-end rate for claims and debts denominated in foreign currency, which are counted as non-operating items according to the Japanese accounting standards. This time, a relatively big impact occurred because of not only for the yen against the dollar, but also for the ruble because of an impact not only from sales amount in ruble, but also from the relatively long payment period for receivables nominated in ruble under special circumstances these days. When the Forex doesn't move much, there is almost no impact on gains and losses. When it fluctuates a lot, there was a big depreciation of the ruble in December, there can be a huge impact to occur like this time. For the future, we would like to consider countermeasures more than before to appropriately manage the impact of Forex fluctuations. Regarding the ruble, which caused a huge impact in the third quarter, I don't go into the details, but there are seasonal factors and special factors as well. In the fourth quarter, claims denominated in ruble are expected to remain high in value. We will work to shrink the exposure for the future as much as possible as Forex hedge costs are high for these currencies. I'd like to explain the outlook for FY 2022 full year on page 9. First, on a core basis, we expect revenue and core OP to be in line with our full year forecast. Our full year forecast remain unchanged and our core OP forecast also remain unchanged at JPY 290 billion. We have revised downward our full year profit forecast. As explained earlier, we booked a net foreign exchange loss of JPY 6.7 billion and a fair value increase of contingent consideration due to review of development plans for Xiphos-derived program, which totaled JPY 4 billion in other expenses in the third quarter. In addition, recent announcement and press release, Zolbetuximab met its primary endpoint in phase 3 studies. If we make decisions for regulatory submission globally in the fourth quarter, we expect to recognize the fair value increase of contingent consideration that is over JPY 40 billion as other expenses in fourth quarter. The same is true for Xiphos-derived development program. The increase in the fair value of the contingent consideration reflects positive development progress for the business. The full basis profit has been revised downward primarily to reflect these events. Operating profit on a full year basis is expected to be JPY 195 billion, a decrease of JPY 74 billion from the previous forecast of JPY 269 billion. Profit is expected to be JPY 150 billion, down JPY 58 billion from the previous forecast of JPY 208 million. In addition to the aforementioned events which are incorporated in this forecast, although not shown on the slide, I would like to explain a few other events that may occur in the fourth quarter and beyond. First, I would like to discuss the possibility of booking an impairment loss on intangible assets of Abirensol. The amount of the impairment loss has now been incorporated in the forecast for FY 2022 full year because it is still undetermined and difficult to estimate the specific amount at this time. The company is currently in the process of obtaining a reimbursement for Abirensol in Europe and plans to revise its future focus in the fourth quarter, taking into consideration the sales in each country. Depending on the outcome of this review, Abirensol may record an impairment loss on intangible assets. In addition, other events are currently under scrutiny to optimize the appropriate cost structure looking ahead to FY 2024 and 2025 in order to achieve the CSD. At this time, we are still in the study stage and have not incorporated the costs to be incurred through this optimization in our forecast for FY 2022, but we may book one-time costs in the future. Again, we haven't incorporated these factors into our full year forecast because they are uncertain at this moment. We have shared these two, information in advance as they may impact the full business profit level if they are booked. These are expectations of the FY 2022 third quarter results and our outlook for the future. I'd like to explain the initiatives for sustainable growth. Page 11 is about extending in strategic products. Key events expected in FY 2022 will be explained. In December, the filing to the FDA was completed for PADCEV for additional indication of first-line locally advanced or metastatic urothelial cancer who are not eligible for cisplatin. This submission received priority review designation and a target date of April twenty-first, 2023 for completion of review. As shown on the bottom of the slide, other updates include the ongoing phase 3 EV-302 study for the global submission for the first-line urothelial cancer completed enrollment in November, and top-line results are expected in 2023. In addition, the EV-202 study evaluating the efficacy and safety of enfortumab vedotin in other solid tumors completed enrollment of all patients in November, and initial data is expected to be disclosed in the first half of 2023. For enfortumab vedotin, we received top-line results from two phase 3 trials in November and December. Details will be explained in the next slide. For AT132, we submitted our initial response to the FDA regarding the clinical hold in the 3rd quarter of this year, and we are still in ongoing discussions with the agency. Details will be explained later again. Page 12 is about the latest status of Zolbetuximab. We have top-line results from two phase 3 studies, SPOTLIGHT and GLOBE studies. The SPOTLIGHT study evaluated the efficacy and safety of Zolbetuximab in combination with mFOLFOX6, a chemotherapy regimen used primarily in the United States and Europe. GLOBE evaluated the efficacy and safety of Zolbetuximab in combination with CAPOX, a chemotherapy regimen used primarily in Asia. In both studies, Zolbetuximab demonstrated statistically significant improvements versus placebo in both the primary endpoint of PFS and the primary secondary endpoint of OS. As we introduced the details of the SPOTLIGHT study at the recent IR meeting, we presented the results at the ASCO GI meeting in January. As shown in the lower right figure, the combination therapy of Zolbetuximab and mFOLFOX6 resulted in long OS over 18 months. Overall, the study was highly evaluated and accepted at the ASCO GI. Based on the results of both studies, we are working for regulatory submission globally and targeting of the first BLA submission in the first half of fiscal 23. In addition, activities are underway to raise awareness of the importance of Claudin 18.2, the drug's target as a biomarker in preparation for its launch. The companion diagnostics needed for patient screening will be marketed by our partner Ventana in conjunction with the timing of marketing of Zolbetuximab. From here, page 13, I would like to talk about focused approach. As for current status of projects and clinical trial, those that made progress in the past quarter are shown in red. In the Genetic Regulation, the FDA's clinical hold on AT845 was lifted in January. The details explained on the next slide. In the area of bispecific immune cell engager in immuno-oncology, ASP1002 has entered the clinical stage and is scheduled to start phase 1 trials in the fourth quarter. The details of the target molecule are not disclosed at this time, but we'll still introduce them at an appropriate time in the future. This is the third project using bispecific antibodies to enter clinical trials following ASP2138, which is positioned as a successor to Zolbetuximab and ASP2074 announced in the previous fiscal results announcement. Based on the Focus Area Approach concept, projects have been continuously generated. On page 14, we describe the progress of the Genetic Regulation programs, AT845 and AT132 towards the resumption of their respective clinical studies. In AT845, we received a clinical hold from the FDA in June 2022, as has been mentioned already. We submitted a response in December based on which the clinical hold was lifted in January. The protocol will be modified to reduce the risk of similar adverse events before resuming clinical trials. One is to exclude participants with a history of or risk factors for neuropathy, and the other is to reinforce the safety monitoring further. We are currently working on the necessary procedures for resumption of dosing with a target resumption date of second quarter of FY 2023. Regarding AT132, its initial response to the clinical hold given by FDA on September 2021 was submitted in the third quarter of the current fiscal year. We have had constructive discussions with the U.S. and European authorities. We plan to continue these discussions with them in the fourth quarter. We will update our overall plan based on feedback from the authorities. At this point, we expect to resume dosing in FY 2024 or later. On page 15, I will explain our collaboration with Selecta Biosciences in relation to the progress of AT-845. First, on the left side of the slide, I will explain about pre-existing immunity or PEI. A certain percentage of people have naturally acquired IgG antibodies that react to adeno-associated virus or AAV. It is difficult to expect such individuals to benefit from gene therapy using AAV capsids sites, and they are excluded from the eligibility criteria in clinical trials and cannot receive treatment. It is estimated that up to 30% of adults have acquired antibodies to AAV8 used in AT845. As shown on the right side of the slide, aiming at dealing with this issue, Selecta has created ZOLC, an IgG protease that specifically and efficiently cleaves human IgG. There are other IgG protease under development by other companies, but most of them are derived from human pathogen, so many patients are considered to have antibodies against AAV. ZOLC, on the other hand, is not derived from human pathogens and is expected to have low cross-reactivity to pre-existing antibodies in human serum, which attenuate the efficacy. Astellas would have the sole and exclusive right to commercialize ZOLC for use with the investigational AT845 in Pompe disease. Through this collaboration, Astellas expects to expand the patient population for AT845. On page 16, I summarize the progress made in the third quarter toward the achievement of CSP2021. In the upper left-hand corner, revenue from XTANDI and strategic products are showing progress in line with the revised full-year forecast. The U.S. sBLA for PADCEV for the first-line treatment of metastatic urothelial cancer, an important growth driver for us, has been accepted and it was designated as priority review. For Zolbetuximab, we obtained top-line results in two phase 3 studies, both of which met their primary endpoints. In the Focus Area Approach on the left bottom, progress was made on AT845, including the lifting of the clinical hold and the new collaboration. In addition, one new immuno-oncology project entered in the clinical phase. In terms of Core OP, while securing proactive investments for new product launches, continued efforts to thoroughly review costs has been made. As a result of G&A expenses excluding the impact of foreign exchange were down year-on-year. In the lower right-hand corner, although I did not explain it today, with respect to sustainability, we have revised our greenhouse gas emission reduction targets and have received approval from the SBT initiative. The details will be explained at the sustainability meeting to be held this month. In addition, again, although not shown on the slide, as announced in the press release today, we have decided to acquire our own shares. The share will be up to 29 million shares to JPY 50 billion, and will be conducted from February seventh through March twenty-fourth. We'll continue our efforts to improve capital efficiency and shareholder return. Page 17. This is the last slide. This is the schedule for upcoming events. We are planning to hold a sustainability meeting on February 17th. We will introduce in depth the initiatives that are unique to Astellas and that are of great interest to investment community. We are also considering holding a meeting on the facility and after it is approved. It is expected to be around March, but we will inform you of the details as soon as they are determined. At the end, to summarize, in the third quarter, the basis of the core business is in line with the forecast. When it comes to business of a full basis, due to the unexpected matters, including the foreign exchange loss against the ruble, it went down. This is considered to be tentative situation. For the full year, our core business is as has been forecast. For the full base business, again, due to the impact of the currency and also the progress of the Zolbetuximab, which are all positive for us, there's likely to be a downward shift. With the value review of Evrenzo and also further optimization of our cost structure, we believe that these are going to work for us. Corporate strength. That's all. Thank you very much. That's all for the presentation. We now would like to entertain questions from the audience. You can ask questions only through Zoom Webinar. If you have a question, at the bottom of the Zoom screen, you can find a Raise Hand button, so please press it. If you're joining from smartphone, if you tap the details, you see the Raise Hand button, so please tap it. The MC is going to name you, so please unmute yourself on your screen, mention your name and affiliation, and then ask questions. Please. Thank you for waiting. First, Credit Suisse Securities, Mr. Sakai, please. Sakai from Credit Suisse Securities. Thank you very much. I have two simple questions. First, today there was no update scan. What is the current status right now? You overcame patent cliff, as was mentioned. As for the scan, it's not against my expectations, but it has a product with quite a big size. I'd like to know. Another question is about XTANDI in the United States. My concern is as follows: pre-pandemic levels of patient, new patient starts have not returned to the COVID-19 pandemic level. Is this because of the competition against generics having an impact? There's going to be an additional indication for the future? You mentioned there's going to be a further growth in the next fiscal year and beyond. I'd like you to explain the situation of XTANDI in the United States once again. Those are my two questions. Thank you very much. Regarding your first question, I'd like to respond. The second question will be explained by Matsui, CCO. As for Lexiscan, right now, in the lawsuit, we applied for the extension of the petition up to the 31st of March. We received the extension. Regarding the impact on the current fiscal year, it's going to be quite limited. In the next fiscal year and beyond, we have to closely monitor the situation. In that respect, in the current fiscal year, there's a smaller likelihood of a decrease in sales. As for the XTANDI, Matsui is going to explain. Sakai, Mr. Sakai, thank you very much for your question. Matsui speaking. As for XTANDI, it's not just about our company, but the diagnosis of cancer for new patients in the United States, companies doing active business in oncology area, you might have heard from them, there's no complete recovery yet. The number of new patients is facing the delayed diagnosis. As for the impact of the generics, there is some impact of generics, but as we mentioned before, in terms of the volume, it's growing. In FY23 and beyond, there's going to be gradual recovery in our view. Our study for the additional indication would be coming in the entire market. What's negatively working is the new patient starts and PAP, P-A-P. Comparing FY 2021 and 2022, just likely there is still some impact of PAP, even more than the previous fiscal year, but we included this in our budget formation. Revised forecast, this is in line with the revised forecast. The ratio is similar to the revised forecast right now. New patient starts and the, together with economic recovery, there's going to be further recovery, we can see a further increase in the new patient starts. That's all from me. Thank you. Thank you. Let me make one confirmation, Kikuoka-san. For Lexiscan, other than what's been presented, there is no new news or the topic in the next, the fiscal year, generic injunction? You go into the generic the generic entering the market, that is also what you have in your mind as the risk? Well, there is a situation with the hospital. Currently we are behind. In that respect, including at-risk launch, a certain risk has to be incorporated in the next fiscal year. However, litigation is still ongoing. The specific number is something I would like to refrain from making comment. Thank you very much. I understand. Thank you very much. Today, Yasukawa and Okamura are still here. Of course, this is the financial announcement meeting. However, if there are any questions, we are ready to answer them as well from them. Citigroup Securities, Mr. Yamaguchi, please. Citi, Yamaguchi is my name. Can you hear me? Yes. Thank you. Next fiscal year, well, the plan's gonna be changed. I don't think this is directly related to it, but has a limit on next fiscal year and afterwards. That is extremely important for your growth in the term plan. Previous meeting, I think you mentioned that from next fiscal year, this product is likely to be further expanded and bigger. Of course, final approval is not really given, and I've heard that the March you are going to give us the some explanation. How do you view about the next fiscal year and afterwards? Are you thinking looking toward making this product big so that it could be the business driving force for you? Would you please make a comment about this? This is a good question made. Matsui is going to give you the comment. Thank you very much for your pointing out. As just you mentioned, the final approval hasn't been given to us, so we need to wait for that. However, so far, information-giving activities for this product, in other words, disease awareness activities have been continuously ongoing. In the United States, the doctors and also consumers are highly reacted to our information that is more than expected. In that way, so that we can make this product bigger, we are honestly working for the effort. One more question. This may be related to the change of the President to CEO. As Dr. Yasukawa mentioned, particularly from the global niche to FA, that's a big change of your strategy, looking from outside. Looking at the pipeline, you explain, I'm sure you are heading into this direction overall. You have to go into this direction for the future. Right now, you are aiming for this. You are making a transformation and a few years have passed since this shift. How this is perceived internally and including the results you're achieving externally, I think your direction is not wrong, but what is your comment on this? Yasukawa speaking. If you look at our initiatives in 2013, it's around nine years since we are working on this. This strategy was incorporated in CSP in 2018. By around 2018, in this way, we wanted to create the backbone of the company. We became confident about it. From that time, their inclusion and exclusion, sometimes five or six, we continue to develop primary focuses. Initially, one by one was kind of independent. But in the past one or two years, cell differentiation and cultural technologies can be used in immuno-oncologies, and gene editing technologies can be used in other areas as well. We think there was a lot of development in this respect. On the other hand, because of the impact of COVID-19, it's not just for Astellas, but also broadly for the entire pharmaceutical industry. Pre-POC clinical studies from the priority for each study site, it was postponed and deferred. We couldn't see progress as we expected. Cells or genes in recent years, assay or analytical technologies also made progress. Very detailed issues we couldn't recognize before are now visible. Because we can see those issues, we have to ensure the safety of the patients and the issues and impurities or abnormalities, which are now visible. If there are some issues with the cells or empty capsids, such technical issues are being improved. As for small molecule studies with the specification studies with FDA and other regulators, we reached agreement with them. That is the past year or so. We made progress, but as I mentioned before, we couldn't achieve POC. That's a regret in my tenure. [Foreign Language]. That's all. Thank you. Next, Daiwa Securities is Mr. Hashiguchi, please. Hashiguchi speaking. There are a couple of questions. The first question, the end of the term, there might be a possibility of additional cost after reviewing the cost structure. Mr. Kikuoka, you've been mention if there is some distortion or situation that happens, you are trying to fill that gap. In FY 2024 and 2025, you mentioned some explanation, but the issue considered this time, well, the FY 2025 profit target is difficult to be achieved, is considered in that way. In order to fill the gap, you are trying to do those countermeasures this time, or in order to add further profit on FY 2025, you are trying to introduce such activities? Thank you. Thank you very much for your question. What I mentioned is that well, for the number-wise, it's still on the stage that we are not able to disclose any specific numbers. Before me joining this company included for various perspectives, so for example, the RP globalization, so that you actively invested, so that the efficiency can be further improved. You prepare the setting for that. For the goal level, the product, there is increase of the cost sometimes. However, it seems that that is started to be offset. We've made an investment beforehand, but thanks to that we started to offset of that. There are some area that is wrapping, so we want to make it further efficient. We are working for the various activities, but especially after I became a CFO, we look at the whole, that perspective in a thorough review approach. While the situation is not particularly difficult compared to the past, but in order to secure the firm result from what I've been making as an effort, just like the CScO mentioned, we would like to grow further. For that purpose, so that we can allocate our investment to the strategic area further, we want to increase the efficiency further. In that perspective for the expenses, well, we are going to come into the details now into the future, but not really booked in FY 2022, and it'll be probably after FY 2024, because in FY 2022 and 2023, we would like to verify the situation and so that we can prepare for FY 2024 where we expect larger expenses. Secondly, about Zolbetuximab. In R&D expenditure, you booked cost for the increase of the commercial production. This time, you are submitting your filing. You have an outlook for filing, so it's going to be deducted from R&D expenditure. When you acquire fezolinetant, with regards to the acquisition of Ogeda, there was a conditional consideration. If you can obtain the approval by mid-February, another possibility of reviewing the fair value again? Yes, you are right. Regarding Zolbetuximab, I talked about the contingency consideration, but by doing this, what we are booking in the R&D expenditure would be seen as product. They would be shifted to the inventory. We are going to book them as assets. We are assuming that possibility. My answer to the first question is yes. As for fezolinetant, there's already a change to the fair value. We are not expecting a further change to the fair value. Zolbetuximab R&D expenditure would be affected. Even including that factor, it's not going to be an impact to affect or have a gap on a full year forecast. Because of the shift and conversion, JPY 6 billion as a short-term profit we are expecting. Okay, thank you very much. Lastly, Xiphos collaboration. Again, the contingent consideration, There's a positive revisit for the development plan. Could you be specific about that? What actually happened, if it is possible? Would you please share that information with us as well? Sorry, it's not a collaboration, it's about the acquisition. Sorry about that. IR is going to give you the answer. Program is a preclinical stage, so detailed programs haven't been really disclosed. We visit, re-visit the study development plan and value went up, and that is Xyphos-derived product. That was disclosed. Thank you. Thank you very much. Thank you very much. Next, Mr. Kotani from Nomura Securities, please. Kotani from Nomura Securities, can you hear me? Yes. First, about Evrenzo. In the end... Sorry to go into the past, Repatha, Lynzos, and if your outlook with extending products, you tend to make a mistake or you tend to be wrong. As for Evrenzo, what was your expectations? What was not achieved? Could you elaborate on that once again to clarify? That's not going to apply to fezolinetant at all. If you don't say that, regarding the accuracy of your forecast, we still have some doubt or question. I would like you to clarify. That's my first question. On this point, Matsui, CCO, is going to respond. Mr. Kotani, thank you for your question, and thank you for your very tough comments. We take it seriously. Regarding Evrenzo, what was different in our forecast? This is an oral agent for CKD-induced anemia, which can be treated with an oral agent. According to our market research, we found a strong need. In reality, intent to use. Asking doctors whether they have intention to use, they do have strong interest. If you look at the response from the physicians on this point, because of the strong comments, skin PPH, HIF-PH, would expand more rapidly. We thought that we can maintain a high market share as a company to enter into this market ahead of the competitors. Unfortunately, in our experience in Japan, in the field of nephrology and treatment of anemia, the healthcare policies are very complicated in a variety of frameworks. From the government, it's strictly controlled by the government. Switching from the existing treatments, it's not going to be changed so quickly, based on the speed we assumed. We think that's the reason for our wrong forecast. What's the difference compared to fezolinetant? In the case of Evrenzo, it was doctor's selection. As for fezolinetant, particularly in the United States, as you know, consumers themselves to be highly engaged in the selection of this drug. In the United States, as we mentioned a bit, fezolinetant and vasomotor syndromes. For fezolinetant, regarding this disease, there are very strong unmet medical needs, and patients themselves are strongly interested in this drug. Particularly for the past half year, we felt it strongly. You may know this, but for example, if you search on the Internet, recently, CBS News spent 5 months to show how women are struggling to advance into society and how much burden they are suffering. There was a talk program for about 5 minutes on CBS. This may be coincidence, but Michelle Obama, the wife of the former President, Barack Obama, also commented on this disease on the Internet. Oprah, she is a very popular MC in the United States, she's also mentioned this disease recently. Regarding this disease and the drug in this field, patients and women's interest are very high. CKD treatment is more specialized and HCPs. As a decision-maker, have a higher proportion. In the case of fezolinetant, patients, particularly in the United States, have a big say in the decision-making process. They have a very high awareness and interest level right now as we observed. In this sense, we are very confident about fezolinetant that we can grow this to a big product. That's our belief. Thank you very much. Sorry, I was in other company's meeting as well. What you just mentioned is also included within the handout material. Maybe? You'd better put that in the material. Oprah Winfrey, Michelle Obama, those have a very strong voice to the female of all the American females. Well, they are not directly talking about fezolinetant, but they are talking about this disease and awareness activities are related. The talk is made by them, right? Yes, that's right. I think that is a very worth information to be put onto the material. About the JPY 40 billion of etacimab, the variation of the fair value, it seems that is larger than expected. This number is a big surprise for you or the pancreatic cancer is also included, that's why the number goes in this way? Thank you. Basically, as for the monetary amount, as been really discussed with the partner, that's why the number is seemingly bigger than we've expected. In the countries where we are aiming at the submission and further concerning the relationship, we come up with a disparate estimate of the possibility of a submission as well to come to this number. This is in line with the our assumption as well. In this fourth quarter, if this really happens or not, in the beginning of the fiscal year, our assumption is, yes, it'll be the next fiscal year. In that perspective, guidance-wise, this is look very sudden information from your perspective. When, from the beginning, we are saying that if we come to that kind of situation, then our fair value, a change will be triggered. That is already in our mind. Looking at these couple of months, we believe that the accuracy and the possibility of the submission goes up, it is likely to be within this fiscal year. In Europe this year, this is going to be a year of the clawback. This year in France, a clawback sales of pharmaceuticals would be regained with excess and a VPAS is rising in UK as well. In Europe, the risk of reduced revenue, what's your view on this? This is my last question. This is related to sales and marketing, Matsui is going to explain. Thank you for the question. You know the details. VPAS in U.K., 5% in 2021 as the ratio, 5% in 2021, 2022, 15%, 2023, 26.5% in the fiscal year 2023, which is a big burden. In France, as you pointed out, unfortunately, Macron introduced such a system, 5% tax, increase, in Germany as well, extending, mainstay products, growth affected by this greatly. We are including this in our outlook. In France and other countries, innovation and Social Security access, they are trying to keep a good balance between the two. In that sense, VPAS and clawback, depending on the economic conditions, can change a lot. Not only for us, but also for the industry association, we are going to appeal to each country. For us, as you pointed out, regarding the three countries you mentioned, we are factoring this in as a risk in our forecast. They have not established yet. They are still under discussions. Somewhere, during this year, they are going to be established? No. Regarding those three countries, starting from January, it's already being applied. Understood. Thank you very much. Thank you very much. Next. Morgan Stanley MUFG Securities. Ms. Muraoka, please. Good afternoon. I'm Muraoka from Morgan Stanley. Thank you very much. Yes, Gasam, thank you very much for your hard work. Okamura-san, thank you for the continuous relationship with the community as well. Now, the first question, it's about this midterm plan. You mentioned about the word of flexibility. There are so many index and there are so many items that you need to look at. However, out of those, I think there are some particular numbers that you definitely like to stick to, 8% revenue or be 30% or something like that. Are there anything specific that you would like to particularly stick to? To achieve, Okamura-san. Thank you very much for the question. If I answer the older numbers, that will be the answer. If you'd say which out of those all. Of course the sales of the revenue has to increase, otherwise we cannot gain the profit for reinvestment. Definitely we would like to increase the revenue. A core OP percentage 30%, that itself is no goal. This is the just assumption for the future and saying 30%. This is definitely have to achieve. This is a must percentage that we need to achieve. As has been mentioned, rather than thinking about FY 25, but my mission is that and, the might patent expiry still, we can continuously grow ourselves. That is what we have to prepare now. Of course, revenue and profit are both important, but, from a Focus Area Approach, we have the product that gives us the profit. That is something I would like to stick to. This, JPY 500 billion for 2023, well, we have to think about that carefully. The further view that I have is 2021, 5 where that we need to see the road of the growth further, otherwise we cannot say that we achieve 2021 CSP. Thank you. Another question to Mr. Okamura to confirm. Last year, I think it was at the time of the second quarter results, Dr. Yasukawa talked about fezolinetant in the initial year. They made dozens of JPY billions to be achieved. Unfortunately, in the market, there are some doubt. I'd like to ask Mr. Okamura to explain this in your own words regarding the numbers mentioned by Dr. Okamura. That's also my belief. How much we explain in our own words repeatedly, the products are going to sell well or there are prescriptions. We have to show evidence and data to you. We are ready in such a stage. Yasukawa and I are kind of united. We are going to believe this, believe in this, and we are going to show it to you. Thank you very much. Thank you. Mitsubishi UFJ Morgan Stanley Securities. Mr. Kumagai, please. Ms. Kumagai, please. Kumagai speaking. Can you hear me? Yes. There are two questions. First, fezolinetant. The disease awareness activities are ongoing that you mentioned. What is the specific activities? What kind of media are you using? Would you please explain about that? Relating to that, fourth quarter pre-launch cost or expenses, that is included within the planned expenses that currently you have as a number. Regarding the expenses, let me answer the second question by myself, and the first question will be answered by Matsui. What you mentioned is probably the cost booking for their launch. That is already incorporated within our financial plan. For the marketing activities, Matsui is going to answer. As has been mentioned, the patient, HCPs, for both hot flash and such as symptom challenges, those are covered by our disease awareness activities. We use TikTok. We use SMS, emails. We utilize a lot of different media. Of course, depending, of course, those 45 to 65-year-older female that is the target for this drug. We are considering the most appropriate media for such a generation. Depending on the situation, we might do the fine-tuning to make it effective. Thank you very much. Secondly, about 8845, the you adding the protocol or change. When ZOKY is going to be available as is shown on page 15, there is going to be an increase in the patient population. How should we see the increase or decrease in the patient population? There are some patient subjects to be enrolled with some limitation. If ZOKY is going to be available, you can expand the patient population regarding 8845. On this matter, Taniguchi is joining remotely, overseas, is going to explain. Thank you for your question. I would like to explain. AT845, as we explained earlier, from FDA, there was clinical hold, which is now lifted by FDA. Continuously, we will discuss with FDA. What kind of protocol amendment is going to be necessary? We are now discussing with FDA. Patients with prior neuropathy or patient at high risk of neuropathy would be excluded from the clinical study. In phase 1 right now, we will accumulate data and in the late stage development, what kind of patients would be our target, and what kind of patients should be excluded from the protocol, we are discussing right now. We have the exclusion criteria in the protocol, and those patients excluded cannot use this drug for the future. We don't know yet. That's one thing. As for Zolgensma, AAV in patients with AAV antibody, that's around 30%. We can make efforts to increase the population. This is not directly linked to the protocol amendment we made. By using Zolgensma AAV, because of the AAV antibody, patients were not eligible for the administration, but could be eligible. This is separate from the protocol amendment. We'd like to make this drug available to a broader patient population into the future. We will make efforts. Understood. Thank you very much. Thank you. Next, Goldman Sachs Securities, Mr. Ueda, please. Ueda from Goldman Sachs. With Zolbetuximab, fair value increase of contingent consideration is something I would like to double-check with you. In your presentation, with the submission and the probability of submission and approval and the launches increased, this probability of success went up, but there is nothing changed about the potential or whatsoever? Yes, your understanding is right. Thank you. Thank you very much. Secondly, about positive sales trend. Right now, sales are growing steadily right now, but this is the expansion in the current indication after the announcement of EV-103 Cohort K. It's not used in the first line yet. It's going to expand after you get the approval for the first line indication. As explained a bit initially, there may be some additional comments. Matsui would like to add. Actually, I don't have much to add, but you are right. According to our observations, off-label use is not so much in principle. In just usage in the current indication, that's the majority of sales right now, according to understanding. Thank you. Third question, the collaboration with Selecta. With the Xork, the efficacy is less likely to be attenuated. For the gene therapy, do you consider about the usage of this technology for the multiple administration of gene therapy? Yasukawa is going to explain about it. Thank you for the question. AAV multiple administration might be possible thanks to this kind of technology. For the collaboration with Selecta this time is only for Pompe. IgG protease, the immunogenicity with disregard is also needed to be observed. Depending on that, there is a possibility of the multiple usage, it will be different. Thank you very much. That's all from me. Thank you very much. Next, J.P. Morgan Securities, Mr. Wakao, please. Wakao from JP Morgan. Thank you for your time. My first question is about your forecast for the next fiscal year. I'd like to get a sense of your company. In February, fezolinetant may be approved. On a full year basis, next fiscal year, fezolinetant is going to contribute to your results. Excluding fezolinetant in your existing business, based on the situation up until now, the existing businesses will grow and then fezolinetant will be on top of that. Rather, according to my own impression, according to my model, rather than that, the existing business may face challenges and fezolinetant growth can offset the stagnant situation of the existing businesses in my view. Right now, what is your future outlook of the existing businesses in the next fiscal year? As a negative factor, the yen's appreciation and the stagnant growth of XTANDI and Mirabegron and the candy generics of Lexiscan. There are some impact of generics. For some products. In the existing businesses, the next fiscal year may be a challenging year. What do you think? I'd like to explain. Right now, we are developing a budget internally for the next fiscal year. In terms of a philosophy here, in XTANDI, we reviewed in the second half. We have to be aware of the mature phase. Still, a high in sales contribution is what we are expecting. Xospata and PADCEV, we are forecasting a steady growth and expansion. In principle, the patent cliff for the future, how to deal with this, is going to be an issue. For next fiscal year, fezolinetant will be launched. That's what we are expecting. Regarding the existing products towards the next fiscal year, difficulties, Lexiscan, we will have a severe outlook for Lexiscan. As a strategic product, we are expecting growth in many of them right now. By adding fezolinetant towards 2026 and 2027, we'd like to be ready. Thank you very much. Second question. PADCEV, first line, will be approved in April. That will contribute throughout the year. That is likely to be the positive factor. On the other hand, there was not much of the explanation about the Mirabegron today. For this, Myfembree, the competitor became available, so situation is getting tougher. I believe you mentioned that. The data basis situation, if I look at that, quarter basis, quarterly basis, yes, it might be a difficult situation for you. Myfembree is not listed on the Medicare Part D from January. Mirabegron is often used for Medicare Part D. Competition is highly likely to be more fierce. My question is that it is likely that situation is a bit fragile for you. That's first thing. Next fiscal year and afterwards, the Mirabegron sales might be negatively impacted because of this competition situation. Well, Matsui is going to answer to this. Thank you very much. Before answering it, your question is only about the U.S.? U.S. market is my question. I see. Regarding the U.S. market, first of all, our observation is that Zynteglo market share is within our we expected. So far, we haven't seen any bigger impact, and we don't see that is a bigger factor causing the difficulty for us. Why this difficult situation for us? Market growth, that is about 2%. Our share is gradually increasing. 24.certain percentage is the current, the market share maintained. In this situation, why is it difficult? That's about the price pressure. That is a negative impact, and that is likely to be continued. The competition is getting fierce, and that might be what would happen in the United States. So far in the United States, the competition of the market share with Zynteglo is not really negatively impacting overall. Sorry, I made a mistake. Thank you very much for correcting it. It is Zynteglo. Yes, there is an impact of the price, the Medicare Part D, if your competitor come into that list, competition is likely to be tougher. It is not happening now, for the future, is it better to expect that it happen? Well, as well, so that we can deal with that situation, with the insurance companies, including the contracts, yes, we are working to prepare for that. We wouldn't say that the situation is further worser than we expected, we're doing the preparation anyway. Thank you. Lastly, briefly about fezolinetant. In the second quarter, you gave us a rough amount of sales. No change since? According to initial plan, in the second quarter, you had a suggestion. We will have the numbers within that range. Should I understand this way? Also in the explanatory meeting on the previously, it was not approved and the price has not been determined yet. Your strategy in detail, numbers were not discussed much. This time, at this timing, the price should be determined and the approval may be determined. I think that we can discuss numbers more. Can we have high expectations for the numbers as well? Yasukawa responded to an earlier question. In principle, we'd like to achieve that level. We will work on that. In that sense, there's going to be no change. This is before the launch. As I said at the end, in March, in as early as March, we'd like to have an explanatory meeting after the launch, where we'd like to explain the details if possible. Thank you very much. I looking forward to that event. Thank you very much. Thank you so much for giving the time to close this meeting. I believe that you are going to join the next other company's call. We have still many questions, with this, I would like to close this meeting here today. Everyone, thank you very much for your participation. With this, I would like to close today's meeting. Thank you.