Thank you very much. This is the FY `2022 first quarter financial results announcement. I'm Ikeda from Corporate Advocacy and Relations. I would like to serve as moderator for this session. For this meeting, live streaming and telephone participation is possible, but questions can be asked only through the telephone line. You cannot ask questions from the streaming line. The materials for this presentation will be available in our website. Those participating here on a phone, please prepare presentation materials from the website. The participants here, Minoru Kikuoka, CFO, Bernie Zeiher, our Chief Medical Officer, and Yukio Matsui, our Chief Commercial Officer. There are three of them here. Bernie Zeiher is joining with us from the United States via phone. All sessions can be translated into English, but accuracy of the interpretation cannot be guaranteed. This material and representations by representatives for the company and the answers and statements by representatives in Q&A session include forward-looking statements based on assumptions, beliefs in light of the information currently available to management and 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 representations or advertisements regarding efficacy or effectiveness of these preparations, promote unapproved use in any fashion, nor provide medical advice of any kind. Now, let's start the presentation. Kikuoka-san, please start. Hello, everyone. I am Minoru Kikuoka from Astellas Pharma Inc. Thank you very much for joining our FY 2022 first quarter 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 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. On page four, let me first explain the significant impact of Forex and one-time factors on our first quarter results. Due to the sharp depreciation of the yen in the first quarter, we were affected by the significant Forex impact, including the Forex impact on elimination of unrealized profit. There were also one-time factors as well. When these impacts are excluded, our financial results are on track. Our actual business is progressing steadily. First, as you can see in the middle column, Forex had a positive impact of JPY 35.5 billion on our revenue. On the other hand, Forex impact increased each cost item. There was a negative impact on our core operating profit. This time, particularly for COGS, in addition to the cost increase due to Forex impact in proportion to sales amid the yen's depreciation, Forex impact on the elimination of unrealized profit was JPY 9.1 billion on group consolidated basis due to the sharp rise of foreign currencies near the end of June, mainly the rise of the US dollar. Four point two billion yen, mainly due to the sharp rise of the Russian ruble on sub-consolidation basis in Europe. This doubled towards the end of the period. The total was JPY 13.3 billion, substantially up by JPY 12.3 billion compared to JPY 1 billion in the previous fiscal year. Excluding the Forex impact and the elimination of unrealized profit, core operating profit was JPY 62.7 billion at the same level year-on-year. For full basis operating profit, Forex impact was positive due to the booking of net foreign exchange gains as other income. Full basis operating profit was JPY 26.5 billion excluding this impact. Next, as you can see on the right, we had one-time factors such as the booking of JPY 1.8 billion as extended royalty payment adjustment for prior year and JPY 13.1 billion as one-time expenses of R&D expenditure. Excluding the Forex impact and these one-time factors, core operating profit was JPY 77.6 billion, progressing in line with our initial assumption. For full basis operating profit, we booked as other expenses JPY 13.6 billion of increased fair value of contingent consideration for fezolinetant in the first quarter when we submitted our filing. We didn't factor this into our full year forecast because of uncertainty whether this will occur or not at the beginning of the fiscal year. This booking of expenses was a reflection of the results of positive progress in development. Excluding this impact, full basis operating profit was JPY 55 billion. With regards to Forex impact, the elimination of unrealized profit is a one-time factor. Based on the assumption that the current Forex rate levels will continue with the yen's depreciation, we are expecting a positive impact on our core operating profit on a full year basis. As there are no items beyond our expectations, we decided to keep our full year forecast as is. This time, due to a very big Forex impact on the elimination of unrealized profit, let me explain the background and our philosophy in more detail. If you have been watching Astellas from before, you may know this. For a company with a big rate of internal transactions overseas, mainly in Ireland for us, due to IP or production strategies, in case of big Forex fluctuations resulting in a big difference between the average rate during the period and the term end rate, the elimination of unrealized profit is a temporary phenomenon to occur with appropriate accounting processing. This time, in addition, amid geopolitical risks, we were securing proper inventory in Russia in executing the most important mission for us as a pharma company to ensure the delivery of drugs to patients. Came the sharp appreciation of the Russian ruble, leading to similar events on sub-consolidation basis in Europe for the first time. It's impossible to predict these events in advance. We cannot hedge them in our business operation as usual. Costs are booked in relation to the term and processing, and this is not related to cash at all, so personally, I don't think we should hedge. We appreciate your understanding. On page 23 in the appendix, you can find a brief explanation and impact on group consolidation and sub-consolidation in Europe. Please refer to that page later. Having said so, with appropriate accounts settlement processing, JPY 55.3 billion core operating profit and JPY 33.1 billion underlying operating profit we announced today are the correct figures. In account settlement, there are always one-time factors, and they were unusually standing out this time. It's up to the judgment by investors in the end. We wanted to explain to you our first quarter profit and loss in our actual business as we understand. That's why we included this slide at the beginning of the presentation. Recently, as you know, we often see volatile movements of the stock price of not only our company, but also others soon after the announcement due to system trading using algorithm, et cetera. Therefore, next time and beyond, so that we can announce our results and explain our thinking behind to the market and investors without much time difference, we'd like to announce our results and organize this kind of a meeting at 3:00 P.M. or later when the Tokyo Stock Exchange closes its trading session for the day. We appreciate your understanding. Please turn to page five. Revenue increased year-on-year in the first quarter. Revenue was on track when Forex impact was excluded. Sales of Xtandi and strategic products increased 26% year-on-year, contributing to the revenue increase. As was explained on the previous page, COGS ratio rose year-on-year. SG&A expenses were on track and decreased year-on-year, excluding Forex impact. R&D expenditure increased year-on-year, but was on track and used in line with expectations. As a result, core operating profit progressed as expected, excluding Forex impact. Full basis operating profit decreased year-on-year. Next, on page six, I will explain FY 2022 first quarter results. Revenue increased to JPY 381.8 billion, up by 17.1% year-on-year. Progress against the full year forecast was 26.5%. Core operating profit was JPY 55.3 billion, down by 12% year-on-year. Progress against the full year forecast was 19.1%. The bottom half of this page shows our full basis results. In the first quarter, we booked JPY 16.3 billion as other income and JPY 38.4 billion as other expenses. Operating profit was JPY 33.1 billion, down 8.2% year-on-year. Profit was JPY 24.8 billion, down by 19.1% from the previous fiscal year. The progress against our full year forecast is remaining at low levels, but this is due to a big impact of Forex and one-time factors I explained at the outset. On page seven, let me explain the first quarter results for Xtandi and strategic products. Sales of Xtandi, PADCEV, Xospata, and Evrenzo increased by 26% year-on-year, continuing a strong growth. As for Xtandi, global sales increased to JPY 162.4 billion, up by JPY 29.5 billion or 22% year-on-year. I will explain the details, including the situation in the United States on the next page. PADCEV global sales increased to JPY 10.6 billion, up JPY 6.4 billion or 152% year-on-year. Despite some one-time factors, it's progressing well overall. We are expecting an upside from the initial forecast. I will explain the details on the next page together with Xtandi. Xospata global sales increased to JPY 10.5 billion, up JPY 2.2 billion or 26% year-on-year. Global sales are almost in line with our expectations. Based on this progress, we think we can achieve our full year forecast. U.S. was the biggest sales amount, is performing below expectations, but is affected by the high inventory level at the end of the previous fiscal year. This, the actual business is trending as expected. Evrenzo sales reached JPY 0.7 billion, up by JPY 0.1 billion or 19% year-on-year. Sales in Japan and Europe are below expectations due to the factors which haven't changed much from the previous quarter. Continuously, there is an impact of intensifying competition in Japan. In Europe, not much progress has been made yet compared to the assumptions in differentiation from the existing standards of care in Europe. On the other hand, we are expecting reimbursement to start in European countries in the second half of FY 2022, so we are hoping for sales expansion in the future. On page eight, I will explain Xtandi and PADCEV in detail. First, about Xtandi, U.S. performed below expectations, but other regions performed above expectations to offset the downside in the United States. Global sales grew as expected. Also, with a positive Forex impact, a record high quarterly sales were achieved. Share increase mainly from early stage M1 CSPC, metastatic castration-sensitive prostate cancer contributed to sales growth. In the United States, with concern over the slowdown in the previous quarter and a high level of interest from the stock market, we are seeing signs of sales recovery. Regarding Zytiga generic competitors which affected Xtandi in the previous quarter, impact from generic competitor pressure still continues, but we don't see significant expansion of the generics. As for patient access program, called PAP, patient assistance program, which affected our business in the previous quarter, the ratio of PAP is still slightly higher than expected, but there are signs of PAP rates settling from June. For both generic competitors and PAP, inflation and economic recession are factors behind. We think that patients are shifting to cheaper generics and PAP for free drug provision. It's difficult to make an accurate forecast of these elements, so we are continuing to monitor them as a potential risk. On the other hand, new patient starts are in an upward trend, partly due to the achievements from disease awareness activities for new patients we have been implementing since the previous fiscal year. Initial forecast is still challenging, but we are hoping that increasing new patient starts and M1 CSPC prescriptions will lead to sales expansion. Regions other than the United States performed above expectations, especially with big contribution from Europe. In Europe, in M1 CSPC, which was additionally approved in April last year, the number of countries with reimbursement for M1 CSPC increased, including Italy with a big market contributing to volume increase. In the reimbursement negotiations in Germany, higher price than we assumed was agreed upon, so we are expecting this will be an upside factor throughout the current fiscal year. Ex-U.S. regions other than Europe are also performing in line with or above expectations, so we're expecting further expansion in each region in the future. Next, on PADCEV. Sales grew in all regions, and global sales growth is exceeding expectations. In the high-performing United States, the results include revenue from clinical trial orders, but even excluding that factor in the actual business trend, U.S. is performing as expected. Prescription is increasing from second-line therapy, which is contributing to growth. In Japan, sales are increasing at a pace far exceeding our expectations since the launch in November last year. Many prescribing physicians are highly evaluating PADCEV. New patient starts are higher than expected, leading to a higher market share than our forecast. We are hoping for a continuous growth into the future. Also, in Europe, since the approval in April this year, PADCEV has been launched in eight countries including Germany by now. Initial uptake is stronger than expected. We are expecting further increase in launch countries. We are expecting reimbursement to start in the second half of FY 2022 or later. On page nine, I will explain cost items compared to the previous fiscal year and full year forecast. COGS ratio increased by 4.2 percentage points year-on-year. As I explained at the beginning, there was a significant Forex impact on elimination of unrealized profit, which increased COGS ratio by 3.2 percentage points or JPY 2.3 billion year-on-year. Xtandi royalty payment adjustment for prior year also became a factor to increase COGS ratio, increasing COGS ratio by 0.5 percentage point or JPY 1.8 billion. SG&A expenses excluding U.S. Xtandi co-promotion fees rose by 7.4% year-on-year. When Forex impact was excluded, SG&A expenses decreased by JPY 2.4 billion or 2.3% year-on-year and were in line with expectations. Cost decreased by about JPY 3 billion year-on-year due to global optimization of personnel aligned with transformation of product portfolio. We also trying to reduce costs related to mature products such as mirabegron, which decreased our cost by about JPY 2 billion year-on-year. We are making active investments for new product launch readiness, resulting in an increase by about JPY 2 billion from the previous year. We will continue to allocate our resources to strategic products with higher priority. We are making a thorough review of costs which would not contribute to corporate competitiveness and value enhancement. We will continue to control our SG&A expenses stringently. R&D expenditure increased by 26.9% year-on-year. Forex impact increased our R&D costs by JPY 7.5 billion. In addition, we also booked one-time R&D expenses, which increased our R&D expenditure. Due to the booking of JPY 13.1 billion as one-time expenses in the first quarter, the progress versus our full year forecast is high at 29%, but we already factored in this one-time cost into our full year forecast at the beginning of the fiscal year, so we are expecting landing as expected on a full year basis. Let me add one point on this page. In addition to increasing geopolitical risks, which I touched on at the beginning, there is much more uncertainty in business, such as associated increase in material costs, energy and power shortage and inflationary concern. Under these circumstances, we recognize it's becoming more important than ever, not just to control expenses, but also to respond with a BCP for stable continuation of business because we are pharma company. For good readiness against various risks, under the direct leadership of our CEO, Yasukawa, we will address the situation in a structure which enables swift response. Slide 10. Now I'd like to explain about our initiatives for sustainable growth. Page 11. Regarding extended and strategic products, key events expected in FY 2022 will be explained here. Events that have been achieved are marked with a star. For PADCEV, we received top-line results in July from the EV-103 study Cohort K for the first line for metastatic urothelial cancer. Details are explained in the next slide. In addition, we obtained the top-line results in June and July for two cohorts of the EV-202 study, which is being conducted for several solid tumors other than urothelial cancer. We are currently reviewing the status of other cohorts and scrutinizing the future development plan with our partners. We will explain the results of each cohort at an appropriate time. We submitted an application for approval of fezolinetant in the U.S. in June, and the preparation for the submission in E.U. is currently proceeding as planned. The progress of fezolinetant as a whole will be explained in a later slide. Page 12. Page 12 is about PADCEV. I will discuss the top-line results of the EV-103 study Cohort K, which is presented in a press release last week. Cohort K evaluated the combination therapy with the PD-1 inhibitor, that is, pembrolizumab, as first-line therapy in patients with advanced urothelial cancer and cisplatin ineligible. The objective response rate, ORR, the primary endpoint, was 64.5%. The combination of gemcitabine and carboplatin is currently the standard of care for first-line treatment of advanced and cisplatin refractory urothelial cancer. Although head-to-head comparisons are not appropriate due to differences in patient demographics and study design, the ORRs in some previous reports have been in the mid to high 40% range, and we believe that the results of this study demonstrate the high efficacy of the combination of PADCEV and pembrolizumab. The median duration of response cannot be calculated at this time because of the large number of patients who are still responding to treatment. As for safety, there were no unknown findings that are of concern. Overall, the efficacy and safety results are consistent with those seen in the dose escalation cohort and expansion Cohort A of the EV-103 study, which was conducted under the similar protocol in the past. The details of the data is planned to be presented at a future society meeting. Based on the results of the dose escalation cohort and expansion cohort A that I mentioned earlier, we received a Breakthrough Therapy designation from the FDA in February 2020 for this combination therapy. We are planning to discuss with the regulatory authorities aiming at accelerated approval within 2022. Page 13. I will explain the position of EV-103 Cohort K in the overall growth of PADCEV. The figure on the left shows PADCEV's sales forecast for each target patient group. The most significant growth driver is in the middle of the chart. First line treatment of metastatic urothelial cancer indication, which is expected to account for more than half of total sales in the future. Of this first line treatment, the majority of sales will be in the U.S., and we estimate that about half of that will come from the cisplatin-ineligible patient population. That is the target of EV-103 Cohort K. If we are able to file as expected, we expect the growth of PADCEV to further accelerate in the next fiscal year and beyond. Page 14 is the update of fezolinetant. As previously announced, we submitted an NDA for fezolinetant in the U.S. on June 22nd. We are currently waiting for the contact from the FDA on acceptance. Next, we presented the latest data at ACOG, American College of Obstetricians and Gynecologists in May, and the Endocrine Society of America or ENDO in June. At ACOG, we presented 12-week data from SKYLIGHT 1 study. The results of this study were confirmed to be consistent with the 12-week data of the SKYLIGHT 2 study presented last year. At ENDO, we presented 52-week data from the SKYLIGHT 2 trial. We've confirmed that VMS frequency and severity throughout 52-week maintained. Reduction in VMS frequency and severity after re-randomization from 12-week placebo to fezolinetant and consistent safety profile of 56 weeks with that of 12-week placebo-controlled period. The VMS disease education and awareness activities in the U.S. are also making progress. For healthcare professionals, we have sequentially launched a series of online and in-person omni-channel approaches, including the operation of VMS educational or awareness website, internet advertising and booth at academic conferences. To date, we have reached approximately 130,000 healthcare professionals and have made a steady progress in promoting understanding of the mechanisms of VMS and its burden. In addition, for consumers, a disease data awareness campaign will be launched in August. Furthermore, TV commercials will be utilized starting in October to promote understanding of VMS as a disease. Finally, we will introduce upcoming events related to fezolinetant. We are planning to present data from SKYLIGHT 4 study, which evaluates the long-term safety of fezolinetant at the NAMS in October. A conference call will be held on October 17th following the NAMS to provide an update on the status of the study, including the SKYLIGHT 4 and other published data as well, as well as details on disease awareness activities. On page 15, we will discuss the progress in the Focus Area Approach. This slide shows in red the progress made in the past quarter for the projects in the clinical trial with the FA or Focus Area Approach. The following slides provide details on AT845, ASP7317, and ASP3082. Other progress includes ASP2138, our lead project for bispecific immune cell engager in immune-oncology primary focus, which achieved first patient dosing in phase l in June. The right-most column shows the number of projects aiming POC by the end of FY 2025. There was no change from the total number of 24 reported in this April's financial announcement. Slide 16 is the update of AT845. As we have already informed you, FORTIS study is placed on clinical hold by FDA following their reporting of an SAE of peripheral sensory neuropathy in one subject. I would like to begin by briefly explaining the background of the situation. In April, the investigator reported an SAE in a subject who was administered AT845 in November last year. In response to this, we provided information to the authorities and responded to their inquiries several times. On June 23rd, a clinical hold was formally communicated by FDA. On July 20th, we received a clinical hold letter from the FDA. The comments in the letter were in line with our expectations. We are currently developing an overall plan to fully respond to the FDA's comments. Based on this plan, we will proceed with clinical data collection, scientific investigation, and KOL consultation. We expect to submit our response to the FDA by the end of FY 2022. If no new non-clinical studies or sample analysis are required. We are facing various challenges, but we will remain committed to the development of gene therapies, including AT845, which could be an innovative therapy. On page 17, I will explain the latest status of ASP7317. In this project, using human embryonic stem cell-derived retinal pigment epithelial cells, we had been changing the manufacturing process and introducing cutting-edge analytical methods in order to respond to recent technological advances in the field of cell medicine. Due to the time required to study the manufacturing process, quality testing, and the establishment of quality standards, as well as to provide data to the FDA, Astellas has been voluntarily putting on hold the enrollment of new subjects in clinical trials since last year. Through these activities, we have established the capabilities enabling supply of cells that meet high quality standards. There are three of them. Manufacturing technology to improve the ratio of cells with the desired characteristics. Analytical technology for quality testing with high sensitivity and reproducibility. And specification setting based upon the various preclinical data and the rationale. The necessary steps have now been completed, and subject screening is anticipated to resume in August. In some cases, similar issues were identified early in other cell therapy programs, leading to smooth responses. We hope that the capabilities established this time will be utilized in subsequent programs to accelerate the research and development of cell therapies. Next. New project, ASP3082. First of all, an undruggable target. Undruggable target is a molecule that is considered hard to be a target of conventional compounds. Even if a compound can bind to an undruggable target, it is difficult to control its function by itself and cannot exert sufficient action. We have focused on protein degrader, utilizing an intrinsic mechanism in the body as a technology to access undruggable targets. The protein degrader we are currently developing has a structure with a site that binds to the target protein and a site on the opposite side that binds to E3 ligase, which is a ubiquitin ligase. This brings the target protein into close proximity to the E3 ligase, where it undergoes ubiquitination. The target protein is then degraded by the proteasome, an enzyme that selectively degrades ubiquitinated proteins. Once this technology is established, we believe it can be applied to a variety of undruggable targets by converting the binding site to the target protein. The target protein of ASP3082 is KRAS G12D mutant. As shown in the table on the right, it is one of the most frequent cancer driver gene mutations found in various types of cancer, but has been considered an undruggable target. Astellas has long been strong in chemical synthesis and was able to create a compound that binds to KRAS G12D at an earlier stage. However, the problem was that simply binding to KRAS G12D did not fully control its function and did not produce the expected effect. Therefore, we created ASP3082, which induces selective degradation of KRAS G12D by utilizing the mechanism of protein degrader. This is expected to have a growth inhibitory effect on cancer cells with KRAS G12D mutations. Next, I will explain the progress of our Rx+ program. The top of the chart. Well, in June, we began pilot sales of EG Holter, a single-use ECG for the ECG testing service that we are considering in collaboration with Nitto Denko and M. Heart. This service aims to provide a total solution combining a highly convenient ECG testing with the EG Holter designed and developed by Nitto Denko, and data analysis with MYHOLTER II jointly developed by M. Heart and Astellas, leading to early detection and appropriate treatment of AF and others. This is the first time for Astellas' Rx+ program to sell its products on an e-commerce site. After verifying the business model through these pilot sales, we will consider full-scale development as well. Page 20. This summarizes the progress made in the first quarter in line with the CSP2021. On the top left, Xtandi and strategic products showed sales growth on track. We also achieved important development milestones with PADCEV and fezolinetant. In the Focus Area approach, left bottom. We made progress in clinical trials for our oncology projects with an aim of being first-in-class. In the cell therapy and gene therapy projects, we continue to build capability by resolving the various challenges we face in tackling cutting-edge science. In terms of operating income or profit, top right, by thoroughly reviewing and rigorously controlling costs and the resource allocation, SG&A expenses, excluding the impact of foreign exchange fluctuations, decreased year-on-year, while we continue to aggressively make necessary investments. Overall, we made progress as expected toward achieving the performance targets of CSP2021. This is the last slide. This is the schedule of upcoming events for securities analysts and institutional investors. We are planning to hold our fezolinetant meeting on October seventeenth. We are also planning to hold a meeting on the data from the EV-103 study cohort K of PADCEV after Congress presentations. Details will be announced at a later date. We would like to continue to hold meetings on topics of high interest from the stock markets. If you have any requests, please contact our IR department. The presentation is finished with this. At the end, appendix. Here. I'm not going to talk about the details, but for those who are not familiar with this situation, let me explain about this, why this situation happened. When the cost of sales is calculated, as you know, the left top, the beginning inventory and the purchase and cost added for the calculation of the cost of sales. Out of this, as you see, left at the time of the consolidation. For example, from the manufacturing site, it would have profitability if the goods are sold to the group company. For example, 30 cost of goods is sold with a 70, then internal profit would be 70. At the time of consolidation process, this is posted as the cost of sales. As you find on the left, this is what is unavoidable. That is unrealized profit. That is a flow. In place of the booking in the mid of the fiscal term, the beginning inventory and the ending inventory, that is a VS item. Therefore, the term and rate is applied for this elimination proportion. As you see that the JPY 7,700-JPY 8,400 with the yen depreciation greatly, then cost of sales to be offset is eliminated, is bigger. Therefore, the COGS is larger. In the case of the stronger yen, then the recorded COGS is smaller. This time, the US dollars and has impact. At the same time, the drastic increase of the Russian rubles. As has been found at the bottom, the cost of sales group consolidation, JPY 91 billion, and sub-consolidated in Europe, cost of sales is positive JPY 42 billion. That is all from me. Thank you very much. Thank you very much. That's all our presentation. Next, we'd like to entertain your questions. You can ask questions through teleconference system. You cannot ask questions through live streaming system. If your time comes, the operator will name you, so please wait on the phone if you requested for a question. If you want to ask a question, please press zero one. If you have a question, please press zero one. The operator will name you one by one, so please wait. If you want to cancel your question, please press zero two. Thank you for waiting. Please connect with the person who is going to ask the first questions. First, Mr. Yamaguchi from Citigroup Securities. Mr. Yamaguchi, please. Hello, Yamaguchi from Citigroup. Can you hear me? Yes, we can hear you. Thank you. I have a few questions. You explained the details about the elimination of unrealized profit. I'd like to confirm. In the first quarter, you had this much impact, and Forex is not going to fluctuate. The first quarter impact will remain in the second quarter and the third quarter, and it's going to be diluted. This JPY 13 billion or so is going to remain without a fluctuation of the Forex. The elimination of unrealized profit, this is a cash, so you're not ignoring this. This amount is going to remain, but there's going to be positive impact on the top line because of the yen's depreciation, and you can absorb the impact, correct? Yes, you are right. From the end of the previous fiscal year, there is a difference, and we had unrealized profit. If the inventory level is going to trend at the same level, then the same amount is going to stay. We cannot identify what is going to happen to the Russian ruble by saying it's going to be offset. How much this is going to remain, it's not clear yet. On the other hand, as you pointed out, if it's going to trend at the same level this time as well, unrealized profit and in areas other than unrealized profit, in proportion to sales, our cost would go up. The profit margin in local currency would not change. The positive impact of Forex will only emerge. The Forex impact is going to be diluted into the future, as you said. For us, on a full consolidated basis. The net foreign exchange gains could be expected in some cases. Core operating profit on full basis operating profits. The yen's depreciation level is going to continue at the current level. If that's the assumption, we will have a positive impact into the future. Understood. Second, Xtandi. I had a good understanding about that, thanks to your explanation. You explained about the U.S. situation. Full year U.S. CER increase of the revenue is looked at, so there has to be the acceleration in the U.S. business. There are several positive factors. Q1, I understood very well, but Q2, Q3 afterwards, your forecast is very aggressive. How are you going to try to catch up with that? Matsui-san, could you make a comment about this? That was what I was planning. Matsui is going to talk about it. Yamaguchi-san, thank you very much for your question. Q2, Q3, the challenges are just like explained by Kikuoka. The PAP percentage is difficult to predict. Also new patients. To what extent we can enjoy the increase of new prescriptions, that matter. PAP, that's untouchable. We cannot do anything on that. With regards to the increase of the patients, well, as has been mentioned in the past as well, currently together with Pfizer, we are working so that the patients go to the hospitals to get the diagnosis. In order to educate for that, we are working for the communication activities together with them. We will enhance such activities further so that the patients can have earlier access to this drug, so that they can use our drug in an earlier phase. Through these activities, we would like to catch up the forecast of Q2, Q3. There are many activities we are planning, but what I mentioned is considered to be the one of the largest. You have been doing these activities from some time ago. There had been some impact of COVID-19, but are you beginning to feel some effect in your collaboration with Pfizer? Internal assessment for these investments and ROI within marketing mix is being seen. How effective these activities have been based on certain assumptions we are assessing. In such an evaluation, we are finding a positive impact. We'd like to continue to collaborate with Pfizer in this respect. Thank you. Around the R&D, that is a one time or the temporarily, but there is a bit of the gap. More specifically, what actually happened? Well, I didn't mention clearly about that in the presentation, so please do understand the situation. As of now, what we can say is that we would explain about that at an appropriate timing. Thank you very much for your understanding. Understood. Thank you very much. That's all from me. Thank you. Thank you very much. Next person, please. Next. Mr. Hashiguchi from Daiwa Securities. Mr. Hashiguchi, please. Hashiguchi speaking. Thank you very much. My first question, on page 18, ASP3082 and about this technology. You have entered the clinical stage, but primary focus candidate is still the stage for that. Why it's still a candidate? And regarding this targeted protein degradation, what is going to be the possible application of this technology? There is a circle and diamonds figure. Any difference compared to typical small molecules? What about the features of this modality as far as you can comment? This is an early development project, Bernie. Hopefully we'll comment on this, please, Bernie. For the question first, I believe there's two components. The first part of the question relates to why is this a primary focus candidate. Our primary focus area is, when we declare something to be a primary focus area, it means that we have confidence in the platform and can produce multiple candidates. This is the first one, as was mentioned, using this protein degrader technology. As we gain more confidence that we can continue to use this technology to target other proteins, we're going to consider upgrading it. It doesn't really change, you know, than any individual project. It's just more of an internal decision as to at what point we, you know, devote more resources and continue to, you know, work on other proteins that, where it may be appropriate to pursue this technology. The second part of your question, I think you were asking what's different about this versus a, you know, a typical small molecule inhibitor. I think the main difference here, as shown on slide 18, is the fact that, typically with a small molecule, you're binding to one protein. You're usually binding either in an active site or in a other site that actually changes the conformation of the protein. In this case, the molecule that we've developed has two binding sites. One of those will bind to KRAS, and specifically the mutated KRAS G12D, and the other is gonna bind to E3 ligase. Which makes it a somewhat larger small molecule, but it is still a synthetically produced small molecule, but that is the difference versus a normal approach. By binding to that E3 ligase, it targets the protein for degradation. In that way, it's a different mechanism by which it's inhibiting KRAS. Because ultimately, what you're doing is removing the protein from the cell so that it can no longer contribute to the cancer phenotype. Hi. Thank you so much. Now, the second question, that is about the promotion of the Dansharism. That is one of the theme for this fiscal term. We just finished the first quarter or one quarter, so there might be less to talk about here. So far, what kind of experience do you have? What kind of opportunities you have? Do you see any challenges? If there is any new information, would you please share that with us? Thank you very much for the question. Just like you mentioned, this is about the change of the mindset. That's the starting point. Actually employees giving us their very positive response about the Dansharism from the individual base to function base. There are coming a new plan for their activities in the business as well. From July 15th to August 5th, the Dansharism Challenge Program has been conducting. We are starting activities of sharing the programs that we are going to do, we are currently doing. Each business unit group or teams will have opportunities of discussions. This is also called as the g rassroots activities, so that we are trying to make the rules and new mindset. Well, for Dansharism itself is to create the white space for the employees through nurturing the mindset. We would like to have the environment for the innovation and improve the intellectual productivity. At this moment, it's very early to talk about the cost impact, but I think this is well-rooted in the environment of the work for our employees working. As the grassroots activities, it's now prevailing. We are trying to avoid unnecessary process or procedures. If some voice is raised without regards, the management needs to listen to them. This is the employee level information, but from the management and also head office perspective as well, we need to look at the situation where that, for example, reportings are quite complicated, like the finance and corporate planning. We are issuing multiple reports, and if there are something overlapping, we should simplify them or we reduce the time necessary for the meetings. Like that, we would like to introduce the efficiency in corporate and that is part of the management responsibility. There are things that is taking place in the field or employee level and also top-line initiatives. With those in combination, we would like to continuously work on that. Thats all. That's all from me as well. Thank you very much. Next person, please. Mr. Koutani from Nomura Securities. Mr. Kotani, please. Koutani from Nomura Securities, can you hear me? Yes. I have a lot of questions. I'd like to focus on three questions. First, about Xtandi. Due to inflation, there may be some impact due to inflation. But honestly speaking, I'd like you to elaborate on that point because Johnson & Johnson is a competitor. ERLEADA is a competitor. It's a similar drug with, there's a difference in the indication. It's performing well and the drug price is not so much. So it should have been affected by the inflation. So I wonder why Xtandi alone is affected by inflation. If you look at the prescription trend, I don't see signs of recovery. So how are you judging that it's going to recover? Looking at the end customer level, inventory, you are judging that it's recovering. Matsui, would you like to explain? Thank you for the question. First, the impact of inflation may not be seen for other competitors. It may be seen just with Xtandi. The impact of inflation we are seeing is as follows. In the oncology area, cancer fund, this is our guess and we cannot say anything clear. Probably since January this year, usually cancer fund support could be extended to patients. The number of such patients is decreasing, resulting in an increase in PAP, according to our guess. Is this seen just with Xtandi? Also with other drugs like Pfizer's product, the same thing is happening as well, as we have confirmed. PAP right now for Johnson & Johnson drug, you took it up as an example. I haven't captured all the drugs situation, but for some cancer-related drugs in the first quarter calendar basis since January, it's increasing, affecting the revenue and profits. We heard some reports by other companies as well. For us, macroeconomic aspect, from that perspective, support related to funds and the funding in the foundation are also part of the issues. PAP program by companies in order to enable access to the drugs are patients applying for that. That's one impact. Under these circumstances, why access is difficult? Because there are many elderly patients in prostate cancer. If the average age is 65 years old, because of their job and because of their income level, they may no longer be working. Slight inflation or the drug price because of the increase of out-of-pocket can be very difficult for some patients. They want to have an option to minimize their out-of-pocket payments. That's why there's an increase in generics. That's part of the current situation. Secondly, prescriptions are recovering according to analysis. It depends on which period to look at. We don't see a dramatic growth yet, so the volume is just a slight increase in trend. In a worst case scenario, prescriptions will not go up for a long time into the future. We don't think so. We are confirming an upward trend according to the data we have internally. We look at the long-term prescription patterns internally. This is how we are interpreting on our end. That's all from us. Cancer Fund. By the way, cancer fund, the reasons for that is from donation and inflation has negative impact onto that as well? Well, that is, this is just our assumption. It's inflation or macro economy might be the reason for that. Regardless, pharmaceutical companies with several reasons, the donation from various sources might have been reduced. That's what we assume. Although there is no proof for that. Understood. Second, EV-202 study. The initial top-line result is available now. That's what I've learned, but I don't know if you make success or not. How should we interpret the situation? Those enrolled in this study have already received the SOC standard of care for each cancer types. After that, there is progress. ORR 23% is a good result. Once the result is again, you are going to have the placebo control study as well. What's your plan for this? That's the question about PADCEV. Bernie, could you answer these questions? Yes. Koutani-san, thank you for your question about EV-202. We apologize we don't have more data to share at this time, but please understand this is a complicated study with six different tumor types that are being explored, and we've received top-line data from two of the tumor types. Now we're analyzing that data. We also need to consider, you know, standard of care, which you need to, in every tumor type continues to evolve. We are having discussions with our partner, Seagen, on what might be the path forward or whether we would proceed with a particular tumor type. We hope to be able to explain that in the not too distant future. You know, in many cases, as you said, we will need to perform placebo control or, you know, standard of care controlled trials, but there may be opportunity for open label studies to also enable us to do accelerated approval. It really just depends on the magnitude of the results and the specific tumor type. For each of these, as we gain clarity on, you know, the results and potential path, we will have appropriate disclosures and share that information with you. That's the end of my answer. Understood. Thank you very much. Next, about ASP3082. This is the first KRAS G12D drug for ASP3082. There is a high selectivity for KRAS G 12D, so it would bind to the CTC like G12C. Lumakras as a monotherapy is effective enough. Amgen's Lumakras has been approved. What about ASP3082? It's a very hot mechanism, protein degradation. G12D alone is not enough in animal studies, or selectivity is not so high, so that's why you have to do this selectively. I'd like to know why. This question will also be answered by Bernie. Yes. Thank you, Kotani-san, for the question. You mentioned KRAS is a very, well, it's a target that the industry has pursued for many years, but not with much success. Amgen and Mirati had some breakthroughs. Theirs is a different mechanism using, you know, covalent binding at the active site. The protein degradation approach that we're taking to G12D, we think has the potential to have monotherapy activity. Obviously, that's the thing that we are evaluating in our initial trials. Much like, you know, other KRAS programs, you know, there may be potential to combine in the future. You know, we are looking at this stage for monotherapy type activity. I'm sorry. I don't think the question got through in translation. Just let me repeat in English. I think the why did you add ProTAC? You know, this ASP3082, if the KRAS G12D of the inhibition itself should be enough, why add ProTAC? Was there a signal in the animal model that showed- Sorry about this. Because the line is separated, the Bernie, your English is not really communicated to Bernie. Bernie was not able to hear Kotani-san's English directly. We are now adjusting the channel. Please wait for a moment. Thank you. Koutani-san, so sorry. It seems that it's difficult to have the communication line. We will double-check about this and let you know later. Thank you. That's all from me. Thank you very much. Next person, please. J.P. Morgan, Wakao-san, please. Wakao-san? J.P. Morgan, Wakao. There are two questions. Xtandi U.S., we understand that the volume and the price this time, it's difficult to increase the price, but the price. Is it okay to understand that you think the price increase is very difficult? XzerO, the study, it was successful, and if you gain the indication for that, is it possible for you to increase the price? The price perspective, I would like to know your focus for extending in the US. The Lexiscan, your sales is suspended and there is such a request and what happened to that? Matsui is going to answer that. Thank you for your question, Wakao-san. The first question is about the extended price increase and the possibility of that for the future. Environment-wise, as you know, in the United States, the price sensitivity is quite enhanced. Therefore, increase of the price is quite difficult. That's for sure. Having said that, the less than inflation rate level, the level of the price increase is ongoing, not only with us, but other companies as well. We are not going to deny wholly the price increase from the strategic perspective as well. We cannot say that we would increase or we would not increase. From my perspective, under this current environment compared to the past, yes, it is difficult to increase the price. However, for the future indications, depending on the profile and also value, increase of the price is also possible even in the US market. The second is the Lexiscan. What was your question? That is about the litigation? I think you requested for the suspension of the sales and the result will be available around July, I believe you mentioned. Yes. Thank you very much. Yes. This preliminary injunction, that is actually what we've done. The result, for example, the local courts, we believe that the response or the answer will be given to us from the local court. So far, we haven't received anything from them. Suppose that we have a negative result out of this, as has been communicated from our team already. We already appealed to the federal court, and their injunction request is planned to be applied. So far, that is where we are. From the local court, decision was communicated to you? The answer is no for that. That's all. Thank you. Thank you very much. That's all from me. Thank you. Next person? Next. Mr. Sakai from Credit Suisse Securities. Mr. Sakai, please. Mr. Sakai, we can't hear you. Sorry. Can you hear me now? Yes, we can hear you. Sorry. About Xtandi, I have two questions. First, about Xtandi. At least IMS, IQVIA prescription trend I see, and your quarterly data. The sales in the first quarter, it's difficult to link the two. This has been pointed out from before. As Matsui-san said, the prescriptions you are checking internally according to such trend, there is a recovery, a trend, and also growth. It's not captured by IQVIA for specialty retail, and the volume there still exists a lot for Xtandi. This was mentioned from your background before, so I'd like to know the current status. Matsui is going to respond. Thank you very much. Regarding this capturing, according to understanding, about 30% has not been captured or addressed as of now, according to our estimation. Any impact because of this, I cannot say clearly right now. At least the actual demand and prescriptions, the volume is increasing. The inventory has a certain degree of impact within the normal range. The inventory is still a little less or more at the end of the term. In June, it was little more than usual. Excessive inventory exceeding or deviating from usual not at all, according to understanding. Gross to net assumptions also changing, reflecting the environment. As for prescriptions, it's not growing so much, and this is below our expectations as we explained earlier, but there is an increase. That's what we recognize. Then quarter. That is the previous quarter, the first quarter, the third quarter, fourth quarter in the previous time and this quarter. Is that what you look at? Yes. For each quarter, we are looking at the trend, and we see the gradual trend of the recovery. Understood. Thank you very much. Another question. The question I from time to time ask is the zolbetuximab current status. Claudin 18.2, that is a biomarker. While in the U.S., the gastric cancer and the GE junction cancer adenocarcinoma. While Opdivo is now approved for that indication in the U.S., but the competition situation is getting very severe. But of course, there is the advantage of your product then as you shown in the page 11, SPOTLIGHT and GLOW study. While next year, January and March, the data will be available. I think this is the same as the previous presentation. I believe this is basically the event-driven, but what, how do you see in Claudin 18.2. I believe you have already started the educational or awareness activities. Would you please explain about the current situation with that? Bernie, could you explain about it? Thank you for your question. You know, first to just provide some update on the clinical program. As you said, the SPOTLIGHT and GLOW studies are event-driven studies. We anticipate readouts from both of those in the third to fourth quarter. You know, it's actually unusual to some extent that we will have two studies, two pivotal studies reading out very close together, and that should and these should support global submissions. Often in oncology, well, if you're pursuing accelerated approval, sometimes there's only or you know under something like a breakthrough designation, you may only have open label data. Even if you're seeking full approval, usually you only have one pivotal study. This is actually a very comprehensive program, and we think this should help to address many questions that could come up in gastric cancer, because it's on two different chemotherapy backgrounds. We're hopeful that we're seeing very similar results and that it can offer benefit. As you mentioned, it is a targeted therapy, which is gonna be for patients with tumors that express Claudin 18.2, and there would be a companion diagnostic that would be needed to identify those patients. We think that will also be important. Maybe Matsui-san wants to comment on any educational activities we're doing around Claudin 18.2. Okay. On top of that, let me make just a couple of comments. Well, again, because this is before the approval, awareness activities and educational activities are only what we can do. Not only commercial, but also medical side is currently carrying out such activities. This Claudin 18.2, the interest toward that is on the increase currently amongst the oncology field. Still, our activities haven't been full-fledged. We just partially started the activities. What we feel out of the activities done so far is that the positioning of this Claudin 18.2 is on the increase amongst the specialists and that level is more than we've expected. That's basically the information I have. In that sense, including the result of the clinical results and also, just like Bernie commented, CDx, in other words, companion diagnostics, from that perspective, further, education activities, awareness activities that we would like to reinforce. Thank you very much. To confirm, with the results of the two studies, it's going to be no problem if you have both study results. If you have results just from one study, is it possible to file your submission just based on the results from one study? Is that going to be possible? Bernie, please. Yes. Thank you for the question. Yes, we do believe it's possible to file with just one positive study. Where it could have impact is, you know, geographically, the background chemotherapy that's used in different regions is different. SPOTLIGHT uses the modefied FOLFOX6 as the backbone chemotherapy. That's more common in Western countries. The GLOW study uses CAPOX, which is more common, you know, in Asia. You know, depending on which study is positive, it could influence how, you know, some of the uptake given the differences in usage of the backbone chemotherapy. Understood. Thank you very much. Next person, please. Mr. Muraoka from Morgan Stanley MUFG Securities, please. Hello, I'm Muraoka from Morgan Stanley. Thank you. I want to ask Kikuoka-san this question first. Looking at your PL, there were a lot of elements I understand how it was. Cost management and cost control, are there lessons learned from the January-March period? What is your personal assessment of the first quarter results? Do you think you can give full score, full mark? How you can change this into, or what kind of direction into the future? It's difficult to assess this myself. As I explained, excluding Forex impact year-on-year, it's negative year-on-year. Honestly speaking, in the first quarter of the last fiscal year, there was some impact as well. From the CXO level, we have the so-called division at the division head level. On an individual basis, the budget is given at that level, and we try to have a stringent control, not only myself, but also from finance. Even if they hate us internally, cost ownership and financial discipline are the words we are using to promote this control. We have to avoid any misunderstanding internally because this is the selection and concentration. As I explained during the presentation, strategic areas for the future and cost reductions into the future must be the result from the streamlining investments we have to promote. The costs which are becoming something like a legacy must be prevented as much as possible. In various aspects, we have to control costs in a stringent fashion. We run multiple projects. Even if they can reduce the budget, the money would be, could be used elsewhere. Before, we didn't control so strictly in some cases. Including such areas, I may be repeating myself, but if we are seen like a cost cutter, it may not work so well. Internally in the company, necessary expenses have to be spent, but we try to prevent unnecessary costs. We think that idea is spreading to a certain degree within the company. As is mentioned by Apple, for the future streamlining activities like ERP investments into the future, by rolling this out globally, it's being standardized. Including the ease of use in each region and including education, it took time to stabilize. Finally, we have been able to do this to complete one round. This will lead to higher efficiency for sure. Given the situation is still short in duration, and I have to study and learn more by myself, but I think we achieved a certain degree of achievements. Thank you very much. The regional-wise sales, China, International, they made a greater growth probably due to Xtandi. Can it be explained by Forex or there are other factors? Just a word will be fine. Well, Matsui will answer for that. Muraoka-san, thank you so much for your question. First of all, about China. Well, your question is about quarter on quarter growth that is better than expected. Which way should we answer to your question? I asked you from both perspective. Well, first of all, quarter on quarter compared to last year first quarter, the result is a bit better. That's because in China as a whole, there are two factors. First of all, Xtandi growth. That's one thing. And the second biggest thing factor for this is tacrolimus. Well, due to the COVID impact, the end of last fiscal year, Shenyang factory is where we ship our products. And there, the cluster of COVID took place and the shipment became impossible. The distributed inventory was greatly reduced. In this fiscal year, it's recovered. That's one factor. Also last year, well, last financial year, first quarter, VBP, the volume-based procurement in China targeting the tacrolimus. That what prevailed in the healthcare professionals, therefore the inventory level was greatly suppressed. Those were the major reasons. Compared to the previous fiscal year, there was a great increase. Against the budget this fiscal year, why the progress is better than what we expected? Well, tacrolimus, this drug has just a narrow therapeutic window. Difference between generic and the original products is likely to take place. There is a lot of the concerns about different patients and healthcare professionals. Even after the expiration of the patent, it's still used continuously. National-based volume-based procurement was not covered, not really including the product. In the provincial level, rather, in order to reduce the budget, they are trying to work on the provincial level of VBP. The plan to do this was already opened or disclosed, and that impact was incorporated into the budget this fiscal year. As you know, in China, zero-COVID approach took place. That's why the provincial government does not have to work on this healthcare situation. Rather they spend more time for COVID countermeasures. What's been planned hasn't been really progressed. From these factors, all in all, worked favorably for us. This is the reason why our business in China is good. While international market, big driver for this is just like you mentioned, Xtandi. More exactly what's good about Xtandi, well, Russia, for example, considering the sanction status. Because uncertainty is high, they would like to supply the products as much as possible. Therefore, there is a larger scale of the bid that took place in the first half of the fiscal term that had a positive impact on the shipment. That's the biggest favorable factors for international market. That's all. Understood. Thank you very much. It was quite a differential answer. Thank you very much. Thank you very much. We are running over, but maybe one last person to ask questions before we close. Mr. Ueda from Goldman Sachs Securities. Mr. Ueda, please. Mr. Ueda, we cannot hear you. Sorry. Ueda from Goldman Sachs Securities. Just briefly, I'd like to ask two questions about numbers on page four. Fezolinetant increased fair value of contingent consideration for fezolinetant, which was not planned. What was the progress leading to the increased fair value of contingent consideration for fezolinetant? And secondly, about the elimination of unrealized profit, JPY 13.3 billion on page 23, but on page four, JPY 12.3 billion. So I'd like to know the difference between the two figures. Thank you for your question. Regarding JPY 13.6 billion, we had the filing in this period, so there's a higher likelihood of the launch. Regarding the contingent consideration, there was an arrangement when we purchased this drug based on the calculation formula. This was remeasured. A further increase in the fair value, there can be a little bit, but with this, we have reached almost the upper limit. Secondly, yes, you're right. Actually, I checked with my colleague. On an apples-to-apples basis, in the first quarter of FY 2021, we had JPY 1 billion. How to look at the Forex was a question. In comparison to FY 2021, if you are to look at the budget rate, it's different. Because of the comparison against FY 2021 to be in line, in the previous quarter, in the previous first quarter, we have JPY 12.3 billion because of the JPY 1 billion difference compared to the first quarter of the previous fiscal year. Understood. Thank you very much. That's all from me. Thank you very much. Thank you. I'm sure that you still have questions, but it's time. With this, we would like to close today's earnings call. Thank you very much for your participation. Thank you very much.