It is now time. We would like to begin fiscal 2020 financial results presentation by Eisai Co., Ltd. Presentation will be live-streamed and will also be distributed over telephone line. Those who are participating via telephone line, please refer to the slides after downloading the slides from our website, and please click to advance the slide. I would now like to introduce the presenter today, Representative Director and CEO, Mr. Haruo Naito. Mr. Naito, please. Thank you. This is Naito speaking. We would like to give you a presentation on the financial results for fiscal year 2020. In the year under review, we have been affected by COVID-19 pandemic in a variety of ways. Given that backdrop, what we have focused on during the year is, as you can see on this page, to secure the product of our products and secure the stable supply of products. Needless to say, pharmaceutical products are directly linked to the lives of patients, therefore, it is never allowed to stop supply. In our case, we have nine manufacturing sites globally where manufacturing is done. Out of which, if even one of nine manufacturing sites is down, then it will impact the stable supply of our products. As shown in this table, plants in Vizag in India and Bogor in Indonesia, they are still suffering from the pandemic. At both plants, operations were suspended for three days or up to 10 days. Regarding other manufacturing sites, utilization rate was kept at 100%. Overall, smooth and stable supply was maintained. That's what I would like to report to you first. That was supported by the securing of the raw material intermediates and final products. Appropriate level of inventory has been maintained. During fiscal year 2020, 6.1 billion tablets in total or up 9% year-on-year. Such a stable supply of so many tablets have been maintained during the year. Turning to the P&L, where I would like to report to the consolidated statement of income. Revenue was JPY 645.9 billion, which was 93% of the previous year, and operating profit was JPY 51.8 billion. We announced a downward revision to our guidance earlier. We believe we have ended up at almost in line with that revised forecast. However, our results ended up well below the original plan, for which I would like to apologize today. Looking at the revenue top line, which was 93% of the previous year. One line below it, other business revenue is presented, which stood at JPY 59.9 billion, which was 51% year-on-year. That means that this out-of-business revenue was almost halved from a year earlier. The products such as LENVIMA were expected to clear a certain threshold to gain the sales-based milestones or one-time payments. That means that these were significantly below the plan or from the previous year. We believe that this was a big factor for delaying the progress in achieving the revenue. Regarding LENVIMA, the sales itself will be explained later, but the sales itself grew steadily with 20% increase from a year earlier. Unfortunately, however, there was a delay against the original plan. In accordance with the plan, sales-based milestones were scheduled or expected and which we could not receive during the year. Revenue in other business halved almost, therefore, resulting in the revenue, as you can see in the top line. By segment information, you can see the sales was increased and also the profit also increased by 3% as well, and the sales increased by 20%. The core businesses have not been hampered or compromised. R&D expenses, JPY 150.3 billion, including the partner's reimbursement, R&D expenses in total was JPY 208.4 billion. LEAP study for LENVIMA and the multiple AD DMT projects are ongoing. That means that we have made ample investments of our resources into these priority projects. SG&A expenses was JPY 281.4 billion, which was 43.6% of revenue, which means the expansion from a year earlier. It includes the shared profits of LENVIMA paid to partner. JPY 60.2 billion was incurred related to the shared profit for LENVIMA in fiscal year 2020. We believe that this was rather productive investment and increasing SG&A expenses for the growth of LENVIMA. For preparation of the environment for launch of AD DMT, we made investment as well. As a result, operating profit was JPY 51.8 billion. Profit for the year was JPY 42.5 billion. ROE was 6.1%. At the bottom, you can see the financial structure. So-called equity ratio was 64.5%. For the first time, equity or shareholders' equity over JPY 700 billion has been obtained. Net DER was -0.27, that means that our business has been run substantively debt-free. Rating has been upgraded from single A to double A minus. Based upon this strong financial integrity, year-end dividend of JPY 80 per share has been resolved at the Board of Directors meeting held today, and the full year dividend is JPY 160 per share. Next, here is the breakdown of changes in revenue by using this waterfall chart. In the middle, the beige-colored box, you can see the increase and decrease in global brands. As a total, there was an increase by JPY 24 billion in the total global brand sales, mainly led by increase by JPY 22 billion or a 20% increase from a year earlier in LENVIMA. FYCOMPA up and HALAVEN down. From this fiscal year, 2020, DAYVIGO was launched during the year under review, and it contributed by JPY 3.1 billion to revenue. By region, in Japan business, which decreased revenue by JPY 15.2 billion because of drug price revision and COVID-19 impact, but in the latter half of the year, there was a market entry of the generics of Lyrica, which is one of our mainstay products. We believe that these were the factors for the decrease. In Americas business through the growth of LENVIMA, this increased the revenue by JPY 14.9 billion. Even with the COVID-19 impact, particularly in the first half of the year, sales and marketing in-person activities could not be done. That was the impact they had in Americas. In China business, revenue was increased by JPY 8.1 billion. China was the country where COVID-19 pandemic broke out first in the world, it was a country which could recover from the pandemic earlier than other countries and contributed to the growth of the business. From March 1st, 2021 LENVIMA and FYCOMPA, these two products have been added to the National Reimbursement Drug List. JPY 8.1 billion has been recorded as the increase because of this effect of the NRDL inclusion. In EMEA or Europe, that has been significantly impacted by COVID-19. Most of the offices continued to be closed, but through the digital utilization, revenue was increased by JPY 1.6 billion. In AGI and Latin America, there was impact of termination sales contract of HUMIRA in Taiwan. As I have been saying, the most or biggest downside or downward impact was brought about by the milestones of payments related to LENVIMA received from partners. As you can see in the pink box, you see the decreasing factors. During fiscal year 2019, what about the LENVIMA-related milestones or payment received? There were option rights related one-time lump sum payments. It depends on the year's business, for fiscal year 2019, there was JPY 21.6 billion, and there were three sales-based milestones acquired or received during 2019. On a calendar basis from January through December, JPY 800 million was received, for the fiscal year, JPY 750 million achievement. There was another threshold of fiscal year, JPY 1 billion achievement. There were three sales-based milestones. All in all, JPY 76.2 billion payments were received. On the other hand, regarding 2020, fiscal year 2020 option rights JPY 12.9 billion and the sales-based milestone on a calendar year base, JPY 1.2 billion, JPY 20.7 billion was received. That was the only sales-based milestone we received. As I said earlier, LENVIMA grew 20% year-on-year, compared to the original plan, which could not be met. In addition to this, there was a calendar year-based milestone, which could not be received in full. Therefore, compared to fiscal year 2019, there was a significant drop in the payment received from partners. Regarding the tazemetostat-related payment, which was according to the contract in 2019, it decreased to JPY 16.4 billion. Therefore, the revenue was JPY 645.9 billion for the year. Next, I would like to explain the breakdown of changes in operating profit from a year earlier. The biggest factor for decrease is in the middle, in the right, of JPY 42.6 billion related to LENVIMA-related payments. This has affected operating profit as a whole, this was the greatest factor for the decreased OP. On the left-hand side, Global Brands added JPY 23.7 billion to operating profit. For DAYVIGO, in the U.S. launch was in June, and in Japan it was in July. Recalling the launch in June in the U.S., actually, that was the timing when the COVID-19 impact was most significant, therefore, our sales reps could not visit clinics at all. After the launch, over 200 reps were newly hired, and we were making such preparations, therefore, preparation-related costs were incurred. Included in this number, adding up to a minus JPY 14.7 billion, LENVIMA-related R&D costs and increase in share of the profit of LENVIMA paid to partner. AD DMT will be explained in detail later, but we have four AD DMT candidates. Alzheimer's disease-modifying therapies are being developed and related to this, preparation for the environment incurred some costs and therefore, in the total, JPY 18.4 billion was spent, and we ended up in JPY 51.8 billion in OP. You can see the R&D expenditures, including the reimbursement from partners on the right-hand side. Next. AD DMT or Alzheimer's disease-related treatments. We are aiming to make changes in AD treatment on this page. Aricept was launched in the U.S. in 1997 and in Japan in 1999. We believe that it was a new historical step in AD treatment. We take pride on that. Dr. Kazuo Hasegawa, who is called the father of treatment of dementia in Japan, according to his book, he said, "With no available treatments for Alzheimer's disease at that time, they felt helpless. However, Aricept provided patients, their families, and doctors a sense of hopeful fulfillment. Overall initiatives in diagnosis, treatment, and care have been advanced a lot. We believe that the benefits for patients and their families have increased. From this fiscal year 2021 and beyond, we believe that we are at the turning point to enter into the era of AD DMT. We are at such a timing. We have four AD DMT compounds in our pipeline. We believe that in the world, Eisai is the only pharmaceutical company which have four AD DMT compounds. We needed to develop them fully, and biomarker research and new modality researches have to be advanced at the same time in order to have a new historical step in the AD treatment again. A core concept in this pathway is brain health panel concept. Concept of Brain Health Panel. Conventionally, Alzheimer's disease was considered to be a snapshot damage or impairment of the cognitive function. This was a target in treating this disease. More recently, Alzheimer's disease may have started even much earlier from a healthy state. Through very long patient journey, disease will continue to progress. This disease is now regarded as a continuum of disease. It is now understood as a new concept. At each phase of disease continuum, there are various pathophysiological aspects or changes in pathophysiology in a continuum. Biomarkers, as explained here, can be utilized for understanding such aspects. This has become the core of the concept of this disease. That is called the concept of Brain Health Panel. Now, turning into the contents. On the left-hand side, genetics information, APOE4, for example, and various genetic polymorphisms related to the cognitive decline rate and amyloid accumulation rates. These have been identified. As a biomarker, these have to capture into Brain Health Panel. On the right-hand side, imaging, PET, amyloid- beta PET, tau PET, and MRI. These all have very high precision and high resolution now. Information taken from imaging should be added to Brain Health Panel. CSF. Today, regarding the changes in the neurodegeneration, a CSF is expected to provide the broadest range of biomarker information. More recently, protofibrils can be measured by CSF. Just focusing on CSF, and a lot of biomarker related information can be captured. On the left-hand side, blood comes. Clearly, by the advance of a blood biomarker development, disease continuum AD can be transformed dramatically. Abeta40, amyloid- beta 42, and p-tau or other tau-related information can be obtained one after another. The items which can be measured through blood are increasing, this constitutes an important portion of brain health panel and EEG and physiological information and a digital or personal health record in daily activities can be registered in Brain Health Panel. The progression in the AD disease continuum, the intervention or treatment can be achieved and brought about through this information. Turning to the first of our AD DMT candidates, aducanumab. FDA in the U.S. had set PDUFA date at June 7th, 2021 it is only less than a month from today, we are just focusing on the outcome on the PDUFA date. Whatever outcome comes, we are preparing to address it, we are putting most priority on that. In EU and Japan, the MAA and the submission have been filed, which are all under review. At the bottom, we are reporting to you that in other markets such as Brazil, Canada, Australia, Switzerland, the MAA has been submitted. The second one is lecanemab BAN2401, anti-amyloid- beta protofibril antibody. Top left. One remaining regulatory study, CLARITY-AD, which is a Phase III study. The summary of the study is provided. CLARITY study, of course, was affected by COVID-19 during fiscal year 2020. For example, some patients could not come to clinics, therefore they could not be administered with the investigational drug. Through consultation with the authorities, we increased the number of patients to be enrolled to 1,795, which have been already completed. Remote diagnosis and other measures were utilized in order to complete the enrollment of expanded number of samples, which has been completed. In accordance with our plan, we expect that a readout of a primary endpoint is targeted for second quarter of FY 2022, next fiscal year. AD continuum or more upstream, preclinical AD, Phase III study together with ACTC, which is an academic consortium in the U.S., with AHEAD 3-45, is being conducted smoothly. Lecanemab is the only AD DMT which is studied in the clinical trial under this consortium. Lecanemab, we conducted Study 201 with over 800 subjects, which was a large-scale placebo-controlled, phase II study, double-blind study. Here is the summary of the results from Study 201 and a redosing study or Study 201 open-label extension study, which has been initiated. On the horizontal axis, this is the time axis. The core study of 201 was 18-month study for core portion. That was followed by about two-year gap period. After that, OLE study was initiated, which started from OLE baseline. The red line shows the active arm, and blue line shows placebo arm. During the two-year gap period, during which the amyloid- beta reduction was maintained in the group, which was administered with the active drug. The gap between the amyloid accumulation between placebo arm and active arm was not narrowed. That means that the AD DMT effect was sustained. At OLE baseline onward, for placebo arm, active drug was administered. Blue line in the OLE study period. In relatively early period at around three months, already a significant or conspicuous amyloid reduction was observed in around 12 months. In 12 months, in about 80% of subjects with the drug, the amyloid level was reduced to negative levels. Therefore, robust effect was confirmed. In the right bottom corner, here is the instance of ARIA-E in the OLE study. Incidence was 8.9%, which was consistent with the rate of 9.9% observed during the 201 core study. The third DMT is related to tau antibody E2814. On the left side is a schematic diagram. Tau antibodies, there are various different tau antibodies, but E2814. Binds to MTBR in tau. MTBR or microtubule binding region. It is a specific antibody. Regarding MTBR tau fragments, as shown in this schematic diagram, will control tau propagation in intercellular space. It is a tau-propagating species, and it is related to tau propagation. As shown in the schematic diagram below, it also promotes accumulation of tau, and this antibody, E2814, specifically engages MTBR region. At right top, phase I study summary is given in dose-dependent manner. E2814-bound MTBR tau is increasing. In two different populations, phase II studies are planned. First is in DIAD, the so-called familial background Alzheimer's disease population, and the other is sporadic AD population. In these two different populations, and the reason for selecting these two different populations are as shown in these diagrams. That is why we've decided to test in these two populations. Regarding DIAN academic consortium, DIAN-TU is managing DIAN population. Therefore, in collaboration with DIAN-TU as the first tau-related therapeutic investigational drug picked up by DIAN-TU, we are preparing for phase II study. The fourth AD DMT is synapse regenerant E2511. This is an orally administered small molecule drug developed in-house, as shown on the left. This compound engages with TrkA. As shown on the left, synapse survival signal will be activated. As shown right, damaged synapse restoration and regeneration will be promoted. In that sense, it is a drug with an epoch-making mechanism. First in class that had never been tried before, may be achieved as a disease-modifying therapy. These are disease-modifying therapies for A-beta, tau, and synapse. With these composite treatments, we hope to make major advances in treatment of Alzheimer's disease. I would like to turn to oncology. We aim to reinforce immuno-oncology treatment. There are three bullet points. First, combination of LENVIMA and Keytruda, and we are conducting LEAP studies. LEAP studies are advancing. We aim to develop LENVIMA and Keytruda combination as cancer backbone therapy. There are cancers that are resistant to the combination treatment of LENVIMA and Keytruda. To overcome that treatment resistance mechanism, we have two in-house developed compounds that we would like to further develop. There are also cancers where IO treatment shows limited efficacy, and we would like to address this with new modality. About LEAP studies, on the very left, 5 approved cancer types are shown. There are 3 monotherapies and 2 combination therapies that are approved. LENVIMA approval was given in 74 countries, number of prescribed patients is over 130,000. In the middle, LEAP studies development that are shown for 14 cancer types, development is underway. In FY 2021, first line for RCC and for endometrial carcinoma, first line for following previous systemic treatment. In HCC first line, we are especially focused on these in FY 2021. The top 2 will be discussed in more detail. HCC Phase III is also underway with a good progress, we believe that we are making full-out efforts so that we can file at the earliest possible timing. In FY 2025, we target to achieve JPY 500 billion from LENVIMA. RCC first-line Phase III study. Full data is shown on this page. Regarding RCC first line in the U.S. from FDA, priority review status was granted. PDUFA date is August 25th, 2021 this year. Data is shown, including PFS, median PFS. LENVIMA Keytruda combination is achieving median PFS of about two years, a very long period of time of progression-free survival. ORR on the right is also showing high rate. CRR is as high as 16%. Complete response rate is 16%, and this shows a possibility of very robust option for RCC treatment. Already it is included in a guideline. Endometrial carcinoma following prior systemic treatment is shown in the bottom half, and in all comer population, the previous treatment was chemotherapy, or control is chemotherapy, but PFS and OS are far superior to results in chemotherapy group. Therefore, in this cancer type as well, it may become a new treatment option that can completely replace chemotherapy. Based on these, I would now like to discuss commercial prospects of LENVIMA. As I mentioned earlier, in fiscal 2020, LENVIMA revenue was JPY 133.9 billion, 120% growth year-on-year. This year's forecast is JPY 172 billion, 28% year-on-year growth. Key drivers of these will be, among others, RCC first-line, which I just explained. This is a combination with Keytruda. We already have indication of combination with everolimus in the second line, and this is also to be transitioned into first line. In NCCN guideline, it is combination with Keytruda in first-line setting is recommended as Category 1 treatment option. In endometrial cancer, conditional approval is already obtained, but based on overall survival, we would like to transition to full approval. In endometrial cancer treatment, especially in the U.S., this is going to be an innovative treatment option for the first time in the U.S. in 50 years. To healthcare professionals, regarding this option, thorough information needs to be provided as to how this drug should be used. In this respect, unfortunately, we were impacted by COVID-19 pandemic last fiscal year, and we may not have been able to fully communicate information related to conditional approval, especially adverse event management guidelines. We have already started to make efforts to thoroughly communicate this information to healthcare professionals. With this, we would like to maintain sufficient time, where patients adhere to LENVIMA regimen. When there are adverse events, there are guidelines for drug holiday or drug withdrawal, and there should be good compliance with that guideline. HCC monotherapy in combination with Keytruda, we are seeing emergence of competition, which is combination of two antibodies. Right now, there is not sufficient evidence of that competition. For example, as shown in the parentheses, TACE refractory BC LC B type and NASH-derived type, which is increasing in the U.S. This is HCC due to non-alcoholic NASH, as shown in footnote. We would like to make a proposal related to these and would also like to convey the benefit of LENVIMA being an orally administered drug to maintain our competitiveness. In combination, first-line study is underway, we would like to continue to make efforts in this area. As for regions, the biggest market, Americas, is the market where we are seeing very rapid progress in terms of vaccination and normalization or returning to new normal life is beginning to be seen. Restriction of visitation to clinics will be gradually lifted. In more full-fledged fashion, we will be able to provide information to healthcare professionals. In Americas, RCC, EC, HCC, DTC, with these four types of cancers, including additional indication, we will continue to make strong efforts. With this, on a full-year basis and on a calendar year basis. In 2021, we would like to make sure to achieve good results. By region, the second-largest region is China. As I mentioned earlier, the drug was listed on a national reimbursement drug list, NRDL, which led to increase in access and supply of the drug is increasing at rapid pace. 44% growth in volume over the previous year is the forecast for fiscal 2021 for China. LENVIMA, Keytruda combination efforts are made, and as we make these efforts, we have come to understand better mechanism of treatment resistance. There are enhanced FGF signal and enhanced WNT signal. Regarding enhanced FGF signal, we have small molecule compound developed in-house, E7090, which received Sakigake designation in Japan. A highly selective small molecule or E7090 can be applied to unlock treatment resistance mechanism. That is what we would like to achieve. Regarding enhanced WNT signal, we have E7386, middle molecule category of drug. This is a CREB-binding protein, beta-catenin inhibitor. This is a protein-protein interaction inhibitor. This is a very difficult chemistry to achieve, development led to this E7386, which is very difficult to obtain chemically. With these two compounds, we believe that we can further strengthen LENVIMA, Keytruda combination therapy. Last topic related to oncology is cancer with low sensitivity to IO treatment, including breast cancer and ovarian cancer. We would like to approach these with new modalities. Shown on left is MORAb-202. This is an ADC, payload is eribulin. Antibody is developed by former Morphotek, farletuzumab. This is anti-folate receptor, alpha receptor antibody. Our in-house developed linker is used. Every component of this ADC was developed by Eisai, this may be the best-in-class ADC using anti-folate receptor, alpha receptor antibody. We will continue to develop this for such cancers as ovarian cancer. On the right side is a drug developed by H3 Biomedicine in Boston, H3B-6545, for estrogen-dependent breast cancer. Right now, there are other compounds in this area, and these are all called SERD degraders. H3B-6545 is not a degrader. It is an antagonist, and it has potent binding through covalent binding to target. This is similar to new modality. This is a product of a very precise organic synthesis. With this, estrogen-dependent breast cancer, we would like to target estrogen-dependent breast cancer, aim to make change in AD treatment, aim to reinforce IO treatment, aim to transform to ecosystem platform model, including DX investment. In fiscal 2021, we will be making robust investment based on long-termism. We aim to maximize corporate value through contribution to people in order to generate sustainable value. This is the forecast PL for fiscal 2021. Revenue, JPY 681 billion. In fiscal 2020, other business revenue declined, but we plan to achieve growth here to achieve the top-line result. SG&A, 47.1%. SG&A expense will grow by that margin. In fiscal 2021, regarding R&D expenses and SG&A expenses, JPY 500 billion for LENVIMA. This is a big fish. There are four AD DMTs that I introduced today. These are also big fish items. We have to be able to catch these big fish. We have to strengthen our capabilities to be able to fish. We are making advanced investments to strengthen our powers. Operating profit, JPY 58 billion, 12% increase. ROE forecast is 6.7%. 5-year average ROE since 2017 was 10.1%. Over medium term, equity spread is ensured. Based on healthy financial condition, JPY 160 annual dividend was approved at today's board meeting. That concludes my presentation. We would now like to enter questions. We will first accept questions from those participating via telephone lines. Please press star and one if you would like to ask question. Please press star and one to ask question. I will call upon you when it's your turn to ask question. We are currently accepting questions. The first person, Mr. Yamaguchi from Citigroup Securities. Mr. Yamaguchi from Citigroup Securities. The floor is yours. Can you hear me? This is Yamaguchi speaking. Thank you. I have two questions. The first question is about the precondition assumptions for your guidance, LENVIMA milestones. Year-over-year, a little less than JPY 40 billion will be recovered. R&D increased by JPY 10 billion or so. SG&A will be increased. The operating margin seems to be rather low. Other than these factors, do you think that there are any factors in profits comparing last fiscal year and this year, like what happened in last year will be lost and so forth? Any changes from last year, could you please share them with us? In SG&A, aducanumab in the U.S., I think costs have been incurred. How much of such costs incurred are included in this SG&A line? These are the two questions. Thank you for your questions. Mr. Yanagi, CFO, is going to respond to your questions. Mr. Yamaguchi, thank you very much for your question. This is CFO Yanagi responding to your questions. First, regarding the fiscal year 2021 company guidance, are there any extraordinary or specific line items which may affect the income or profits? We do not expect any extraordinarily large items, but as you pointed out, which will be included in the other business, including milestones by segment. If you look at the guidelines, over JPY 100 billion was recorded in 2019, but in 2020, a JPY 60 billion level was recorded. Furthermore, in FY 2021, it's going to be a little less than JPY 100 billion. As you pointed out, milestones to be received from Merck will be changed. That is a difference. Having said that, it was less in the fiscal year 2020, but it will be returning to the cruise level or pace in 2021. It's not extraordinary item. Overall, the status of the development, new products and business development beyond budget or adaptive budgeting process, in which we would like to consider the potential of various real options so that we can provide a best estimate as of now. That's what we have presented today. These are not to be considered finalized. Please consider that there are items which are not fixed and others which are already fixed. Another item is, ultimately, which is related to OP margin. As you said, aducanumab-related SG&A expenditures. For this item, as we explained earlier, the real options are being considered in order to maximize our contribution to future patients. We are making the proactive investment to maximize that. For example, which includes the issues related to access and diagnosis, and those preparation-related costs for environment for launch. More specifically, numbers are not disclosed related to line item, but earnings call suggested and fiscal year, calendar year difference is considered as well. It's on the level of the JPY tens of billions, SG&A shall be invested. Overall P&L structure for fiscal year 2021. To maximize the value of LENVIMA, R&D expenditures shall be invested at high level. We think that it may reach the peak, and R&D expenditures for lecanemab will also reach the peak. Therefore, 23.5% of the sales will be spent for R&D expenditures. SG&A as well, for maximization of value of LENVIMA and for next generation AD DMT and maximization of the contribution to patients in the future. We are making proactive investment of 47.1% of the SG&A ratio. In both, it's about 70%. Almost the OP margin is on the single digit, although the double-digit growth is to be planned for the profit growth. The one single-digit growth number is recorded in the profit line. We are going to maximize the value for the medium to long term and SG&A and R&D expenditure ratio. We believe that we are peaking out in fiscal year 2021, and these will be converging to the average of the global pharma and OP margin going towards 20% level. We expect that the OP margin will continue to improve. They're not going into short-termism, but from the medium to long-term perspective, we are making proactive investments to maximize the future corporate value. If I may add further, such proactive investment and stable dividend payment shall be sustained, both based upon the financial integrity. We have maintained such 65% of the equity ratio and JPY 190 billion level on net cash. The credit rating has been improved to AA- and stable dividend and such proactive investment can be sustained, and customer contribution to patients as well as the maximization of the corporate value can be maintained from the medium to long-term perspective. Thank you very much. This is Naito speaking. If I may go into details, I would like to add just one point. For LENVIMA, the full year annual sales-based milestones, we said that we lost some of the expected milestones during fiscal year 2020, but this is not the end. In 2021 as well, we have same target threshold in sales where we will be allowed to try to get those milestones during the year. Thank you very much. Next, Mr. Kohtani from Nomura Securities. Mr. Kohtani from Nomura Securities. Yes, this is Kohtani from Nomura speaking. Can you hear me? Yes, please go ahead. First question regarding LENVIMA. LENVIMA/Keytruda RCC first-line data was shown. I think we shouldn't be comparing with other clinical trials, but in VEGF inhibitor, in combination with a PD-1 antibody, there are four trials including LENVIMA, and patient background is similar. Risk category, gender, and age are quite similar. ORR, CRR, PFS, and DOR, in all of these, your drug LENVIMA exceeds other drugs. In adverse event, hypertension or hand and foot syndrome are less frequently occurring. Is there any factor leading to this? LEAP-002 study for HCC was also discussed, and I think any time interim analysis result is expected. Melanoma LEAP-004 interim analysis, it was at 21% and CBR was 65%. Until the end of the completion of data analysis from the full trial, will submission not be possible? Thank you for your question. Dr. Owa, responsible for oncology, will respond. Thank you, Mr. Kohtani, for your questions. First, about RCC, what you pointed out is correct. If we intentionally find a weakness, we may be able to find a weakness. This may sound boastful, we cannot find a weakness, any weakness, as far as I know. Well, is there any problem with the safety? QOL-related data will be presented one after another at the academic conferences. Please, keep paying attention to these. As for CR, once it is attained, there may be relapse or recurrence of cancer. There is such concern. How CRR is sustained, we are following in detailed fashion, and we will be providing information one after another. Please keep paying attention to what we will be able to provide in terms of information. As for HCC, any time we may have a result from interim analysis, as you correctly pointed out, I'm very much looking forward to seeing that data. Lastly, about melanoma trial. Thank you for raising that. In view of our recent FDA position with ORR data alone, it may not be sufficient to file submission, but LEAP-003 study for first line is underway and is making good progress. In combination with that, we would like to consider melanoma in both first line and the second line setting. Thank you. Follow-up question about the VEGF inhibitor and PD-1 antibody combination. Various other data are also coming out. In RCC, it seems to be very effective, but not so in HCC or melanoma. Is there any scientific reason? The answer. I don't think so. Vascular regeneration, we have scoring biomarkers, at least for cancer types included in LEAP studies. In other TKI that Mr. Kohtani may be aware of, FGFR inhibition in a bound way is not achieved by other drugs in comparison to LENVIMA. I do not have any concern that the effect may be insufficient for these cancer types. I have a question regarding aducanumab, I don't think there will be answer forthcoming. Instead, on 24-01, I have a question, There's donanemab from Lilly. aducanumab safety-related issues, this is because of ARIA-E concern that highest dose was not reached in many patients, There were patients who advanced quickly. I think there is also a lack of reproducibility in CDR-SB. When we look at BAN2401, if we see whether these apply, ARIA-E is 10%, very low, so highest dose is achieved. Second point, at the other day, at the earnings session, it wasn't disclosed, but to fast-advancing patient, it's also applied. The rest is reproducibility of CDR-SB, 0.5 and 1.0. What is 0 and what is 0.5 and what is 1.0? It has to be determined in a very precise manner. Clinician's training will be very important. Eli Lilly's results Added new DRS evaluation item because of some questions about this. How are you training healthcare providers in measuring CDR-SB? This is a question regarding reproducibility of CDR-SB for your drug. Neurology business group President Ivan Cheung will respond. Thank you very much for your question. This is Ivan Cheung. You're correct. Training of all the sites and the staff working at the sites on these endpoints, such as CDR-SB, is a core component to the excellent conduct of any Phase III large-scale trial. That's why we spend a lot of time and effort in, first of all, securing the highest quality sites around the world, and also conduct a very detailed training with all the sites. Last but not least, also having ongoing monitoring efforts to make sure that we don't see any, for lack of a better phrase, outliers or underperforming sites with regard to this matter. We are probably one of the very few companies in the industry who know how to do this, and we are confident in the Clarity- AD trial for BAN2401, for example. Thank you. Thank you very much. Next is Mr. Sakai from Credit Suisse Securities. Mr. Sakai, are you ready? Thank you. I have only one question. Aducanumab PDUFA date scheduled in June, I know everyone is aware of this, the outcome will be given. Reflecting on that, what sort of corporate actions are you envisioning to be taken going forward? Until the outcome is seen, it will be difficult for you to decide on the actions. Based upon the result to be seen going forward, I think that there will be some kind of a release or announcement from the company. What are you currently considering? I know that this is based on the collaboration with Biogen, are there any plans or ideas regarding how you are going to take course going forward? Thank you very much, Mr. Sakai. This is Naito speaking. For instance, for diagnosis and PET and CSF and blood, if we just take the diagnosis portion, there are various players. With these players, we needed to keep close communication so that we can take appropriate regulatory actions and our processes aiming at getting approval for reimbursement. We have to make those preparations. As has been shown by these areas, in various areas, we needed to prepare some foundation with structure or capabilities. We are the company which is dealing with four AD DMT compounds. We believe that this is something that Eisai must cope with, and we are going to cope with these initiatives going forward. Understood. Thank you very much. You are waiting for the results, conclusion from PDUFA date. I am also looking forward to it. Thank you. Now it is time to finish. I'm sorry to call the day, but however, now we'd like to close the conference. We would like to close today's briefing session for the financial results. Thank you very much for taking time.