Thank you very much for taking your time out of your busy schedule to attend the financial results presentation session by Eisai Company Limited. We would now like to begin the meeting to present financial results from fiscal 2023. This will be held in hybrid format. Those of you who are in this room, please find four presentation materials, including the presentation deck, flash report, and press release that was announced today and start of the rolling submission for subcutaneous injection, and change in the personnel or rather announcements of new appointments. I would now like to introduce the presenter, Mr. Haruo Naito, Representative Corporate Officer and CEO. Mr. Naito, the floor is yours. Let me start my presentation on the financial results for fiscal year 2023. Firstly, please look at the statement of income. Revenue stayed almost flat from a year earlier. The cost of sales has reduced by 3 percentage points. This is due to the ongoing efforts for reducing costs and also the improvement of the product mix. As a result, gross profit was up 4% year-on-year, and profitability has improved by 3 percentage points. As regards to expenses, such as R&D expenses, which accounted for 22.8% of the revenue, that was the reduction by about 0.5 percentage points over the past two years or so. Oncology and neurology, business group R&D have been integrated. Human biology-based integrated approach has adopted for integration, and as a result, the benefits are now arising as the effect of such integration. Now, for SG&A expenses, which have increased, the major driver for the increase was, one thing, due to the expansion of Lenvima. Therefore, there was an increase of expenses regarding shared profit of Lenvima paid to partner. And currently, we are making utmost efforts in development of Leqembi. So with these two major positive investments, we are making SG&A expenses increased. However, if you look at expenses in total, which was 1% up from a year earlier, so these have been controlled within the increase of gross profit. Therefore, operating profit was JPY 53.4 billion, up 33% increase, which was a significant increase year-on-year, and the profitability has improved as well. Profit for the year has decreased. However, in the previous year, there was the repayment of paid-in capital from a consolidated US subsidiary. Therefore, there was the reduction of the tax expenses in the previous year. Excluding that impact, profit for the year should have increased. Therefore, there is no change to the sound structure of the financials. Given these, now take a look at the revenue migration. As you see in the headline, 3 Ls: Lenvima, Dayvigo, because the generic name of Dayvigo is Lemborexant. Therefore, L is taken at the Leqembi. With these 3 Ls, which I believe have contributed to the expansion of pharmaceutical business, Lenvima increased by JPY 48 billion year-on-year, Dayvigo by JPY 12.4 billion, and Leqembi increased by JPY 4.2 billion from a year earlier. Therefore, pharmaceutical business increased by JPY 7 billion in its revenue. There was some decrease in the one-time income. However, overall, revenue was almost flat. Now, a breakdown of operating profit migration is provided here on this page. The profitability of pharmaceutical business was increased from 47.6% to 49.7%. There was an improvement in the profitability because of the adjustments in headcounts in various areas and also better efficiency of spending. And R&D expenses, as I said earlier, integration of the areas of R&D activities have given rise to the more efficiency, and JPY 8 billion in pharmaceutical and JPY 4 billion in the more improved efficiency R&D activities. So these were the contributing factors for improving the operating profit. And the offsetting in the decrease in the one-time income, operating profit increased by JPY 13.4 billion, which was up 33% year-on-year. There was a significant increase in operating profit. As you see in the bottom right, for Leqembi, total investment in R&D and SG&A expenses were at the JPY 110 billion level as planned. Now, today, I would like to put focus on Leqembi in my presentation. Now, Eisai has been rolling out globally with what mission as a pharmaceutical company we are rolling out our business operations worldwide. That is shown here. Eisai has paved the way as a pioneer in the treatment of Alzheimer's disease worldwide, and it will continue to play this role. 1997 by Aricept, exactly 25 years ago, with Aricept as the first-ever treatment for Alzheimer's disease, has been provided to the world. And 2023 by Leqembi, and about one-quarter of a century later, again, similar pioneering role is played by us. At the very bottom, you can see we are aiming for more treatments for more pathologies, including tau and other various pathologies that are being addressed in the pipeline. Now, as pioneer, we are and have been paving the way, but this is not merely drawing a beautiful picture on a white canvas. It's not like that. You needed to remove large rocks. You have to build a bridge over a large river, and you needed to dig a tunnel into a mountain. So you needed to do such enormous, huge work. The poem written by Takamura Kōtarō called Dōtei, which I read many times recently, "There is no way before us, but there will be a way after us," as the poem says. Particularly in today's world, diagnosis and care for AD has progressed a lot. There are a lot more tests to be conducted, and also nuclear medicine is used, and nuclear medicine is used for monitoring of the ARIA. So a very important pathway needs to be established in today's treatment for AD. So pathway establishment is very important today. As a pioneer, we have put ourselves into such areas of work, particularly in the United States. Over the past one year, we have been working on this. So first of all, what we are doing and have been doing, I would like to seek your understanding of what we have been working on. For fiscal year 2023, in the past one year, what about the revenue of Leqembi in the global market, which was JPY 4.26 billion? There may be various opinions saying this is a lot or small, but here you can see the trend of revenue on a quarterly basis. During the fourth quarter of last year, compared to the immediate last quarter, it has sharply increased by 2.7x. This trend, the angle of the increase has become sharper from the beginning of this fiscal year. I would say the sales have been increasing. So looking at these trends, now I would like to talk about the current status of Leqembi in the US, Japan, and China. First, in the United States, we are moving towards a new phase. That is to say, the pathway establishment has seen a certain level of progress. And now, at last, on this pathway, the patients will be able to smoothly follow the path of a treatment, therefore reaching the prescription expansion phase. And then appropriate go-to-market structure for prescription expansion phase needs to be established in the field. The front line should be strengthened. The Leqembi in the U.S. has entered such new phase. Similarly, the Leqembi revenue in the United States for fiscal year 2023 is shown here. If you compare Q3 and Q4 as gain, you can see the rapid expansion. And on the right, you can see the number of vials sold to medical institutions on a weekly basis. As you see, again, week by week, in an accelerated manner, the number of vials sold to sites has been increasing in an accelerated manner. The foundation, including the pathway, has been almost established and reaching a certain level. And on the left, you can see the map of the United States, although this seems to be very busy. But you can see the areas where prescribing facilities, the established pathway, are located with our field people are located. Therefore, you can see the very dense map. This pink-shaded area covers almost the entire nation. Therefore, in most parts of the United States, the prescriptions have been initiated. On the right-hand side, from three aspects, we are showing the status of pathway establishment. First, we identified important targets, IDN. If you could turn to the bottom of the page, IDN is Integrated Delivery Network. Large-scale hospital group had such a system to provide healthcare. For example, Washington University in St. Louis, perhaps have dozens of hospitals under it sharing the common policy or protocol to provide healthcare services. There are such IDNs like that. In the United States, they are playing very important roles in providing healthcare service in a business model. Most of the top 100 target IDNs have established pathways. The target physicians in the second box, they are the physicians or neurologists who belong to IDNs and also other physicians who are providing care in the community practice. In the ordinary communities, there are neurology clinics or hospitals. Those physicians who have experience in AD consultations and treatments, whom we understand very well, and asking them whether their pathway for prescription has been established or not. 100% of them said that they have their pathway ready for treatment. Another is AIC. You may not be familiar with this term, but this stands for Ambulatory Infusion Center. In the neighborhood of where patients live, this is the facility dedicated for infusion. They are not dealing with patients with AD, but also patients with immunology and oncology as well. So they are one of the very important medical institutions which are providing infusion. Most of them are managed and run by companies. The 82% of AICs or infusion centers said that they are ready for infusion of Leqembi. Therefore, the establishment of foundation is largely completed, in our opinion. Given these circumstances, what we are trying to do now is provided here. We call this system as a go-to-market structure in the United States, but frontline people in the sales in Japan. In the second bucket box, there are NAS, ARM, and HSAE. You may not be familiar with this, but if you could look at the bottom footnotes, NAS stands for Neurology Account Specialists, MRs, medical reps specializing in neurology. They are playing a central role in go-to-market structure. ARM stands for Access and Reimbursement Manager, including IDN and all medical institutions in the United States. Are meant to make profits. Therefore, AD-related treatment or healthcare services need to be reimbursed. They needed to confirm in detail whether their services are reimbursed. What should be done is advised. They are seeking such advice from us. These are the people, ARMs are deployed all over the nation to provide such support. The next HSAE stands for Health System Account Executives. They are responsible for thinking about how established the pathway can be made more efficient. It has taken two months for starting treatment. How this can be shortened to one month. It has taken a lot of time for first a referral. How can it be shortened further? They are the ones who are providing information and advice on these. They are rolled out throughout the country. If you could look at the left-hand side, this NAS is going to be increased by 30%. And half of them are going to be the staffers of Biogen's. Where we can have key accounts with greater potential have been already identified by us. So we are collaborating with them. And ARM who are providing advice on the reimbursement and then FTEs of ARM will be doubled, increased. And also the HSAE personnel will be also doubled. And on the right, you can see 3 bullets. We have been targeting 100 IDNs so far, but we are going to expand the target IDNs to 150. And particularly under pathway, from diagnosis to the start of treatment, it used to take a lot of time. And the larger IDN used to take 8 months. That has been shortened to 2 months. Therefore, with various IDNs, we would like to adopt a similar shortening of the duration. Given the increased number of patients, we needed to refer the nearby infusion center or a patient assistant program or support for reimbursement because the need for support is increasing as well. Therefore, we have to strengthen our patient support system. Now, by this, a go-to-market structure in the US is going to be strengthened so that we will be able to achieve the expansion of the prescription. Next is about omnichannel marketing. This is quite a well-known, widely known marketing method nowadays, and it is being used widely. Omnichannel marketing was first used in oncology or lymphoma in the United States over the past three years. We have seen a great effect of this. Simply put, what we are aiming to do is as follows. On the left, you can see Data Lake. Proprietary Data Lake is going to be established, which will contain the digital promotion information for healthcare professionals or patients and consumers and information about in-person contact in the field and information about the major academic societies. If Amyloid Beta test or APOE4 tests are required or ordered, such information are all put into Data Lake, and the AI is used for comprehensive analysis, as you see in the right bottom corner. In the end, they will come up with a recommendation on the next best action. Among recommended actions, in-person field force will be given the recommendation on what the promotion for Dr. A or IDN, what kind of actions need to be taken. Rather than having in-person contact, peer-to-peer healthcare providers communication should be conducted. Or without time, you needed to rely on SNS. Such a recommended action package will be provided. This, I believe, will enhance the efficiency, not depending on the share of voice, and more efficient marketing will become possible in our salesforce activities. We would like to accelerate this. Next, direct-to-patient campaign is something that I would like to explain now. Now we see pathways being established. Therefore, we now believe that we have to directly communicate with the patients and families. The slogan here is, "You still can be with Leqembi." Please look at the bottom. You still can be social with Leqembi. You still can be authentic with Leqembi. You still can be relatable with Leqembi. You still can be empowering with Leqembi to raise awareness for earlier visit to physicians' diagnosis. As you can see at the website, omnichannel or digital marketing, and video or display or print advertisements in waiting rooms, these messages will be carried. A DTP campaign was rolled out and started from February. Disease awareness can be raised, and we can encourage the patients to seek earlier consultation with physicians. Another point I would like to ask you to understand here is the progress we are making in enhancing the value of Leqembi by adding new dosage form and also maintenance therapy on top of initial treatment. Early AD and clinical AD are shown. For early AD, if you look at the right-hand side chart, IV initial treatment with 10 milligrams per kilogram biweekly dosing, this has been already approved. This is the treatment regimen in Japan, the U.S., and China. In other jurisdictions or countries where review is ongoing, submission has been already made. Submission is going to be made for this IV initial treatment. In the middle, IV maintenance treatment, 10 mg per kg monthly, with half dose, which will be used for maintenance treatment, the submissions have been filed. So before maintenance treatment, what about initial treatment? This will be consulted with regulatory agencies. Today, we made a press release. SC-AI subcutaneous auto-injector maintenance treatment submission has been initiated. The Fast Track designation has been granted for this SC-AI maintenance treatment, and rolling submission is allowed. Therefore, we immediately started submission. We are aiming for maintenance treatment with 360 mg weekly dosing. This is going to be manufactured by Terumo pen-type auto-injector. This is prototype rather. This is almost the drug product, but without any label indicating the name of the therapy. So please understand that this is a model. And the Terumo made AI dosage form has benefits. Having one thing, tapered needle. Tip of the needle is tapered. Therefore, this reduces pain a lot. And the syringe itself is made of plastic. Therefore, at home and at nursing care facilities, this is not made of glass. Therefore, this does not break, not causing any injury to patients or caregivers. This is very safe. And this syringe, in order to make it smoother, usually silicone oil is applied to silicone, but this does not use that at all. Therefore, it is difficult to have any aggregation of drug substance. And administration shall be done within 15 seconds. Therefore, this shows it is very usable at home and at nursing care facilities. Patients themselves or carers are able to safely administer the drug with this syringe. There are several patents obtained by Terumo in this auto injector. Current IV, under the current formulation, the patients have to go to infusion center. In the case of the United States, some patients have to drive car by 1.5 hours. Therefore, it will be very burdensome for patients to visit the center. Recommended infusion time is 1 hour. Therefore, pre-treatment process and also post-treatment time for monitoring the condition of the patients, you needed to have nurses to monitor and take care of patients. It is also burdensome for nurses. Considering all this, SC-AI formulation may potentially reduce such burdens significantly. We believe that it is very important to continue treatment with ADDMT. In order to realize long-term administration, we believe that this is going to be a mainstay formulation or dosage form going forward. As you see at the bottom, for both initial and maintenance treatment, we would like to replace the current dosage form with SCAI. We are preparing such programs. We aim to obtain approval by FY 2026 for this. And in the left bottom, you can see preclinical AD. As you know, this is the stage before MCI development. Therefore, patients will not feel subjective symptoms. But if you conduct an amyloid beta test and the position of amyloid beta is about to start or is starting, so AHEAD 3-45 study, phase 3 study is ongoing for patients with such status. And the duration of treatment is long. And it was expected to have difficulties to enroll patients. However, with enormous speed, we have been able to enroll a lot of patients. We are targeting enrolling 1,400 patients, which we think that will be completed by the end of this fiscal year. And even one step before MCI, that initiation of treatment can be earlier than MCI. Therefore, we can expect an enormous effect of this. Now, safety. I would like to share with you the current status of ARIA in the United States. Please look at the first bullet. The reports of ARIA from real-world clinical practice were consistent with what was observed in the clinical trials or as described in the U.S. package insert. Most reports of ARIA in real-world clinical practice in the U.S. are known, serious, asymptomatic, and occur early in treatment. Reported symptoms, as you see here, include headache and others, as you see. Given these, in the real-world clinical practice in the US, prescribing doctors are following the instructions concerning monitoring and the performing of MRI for symptoms described in USPI and the management of such conditions. At Eisai, we are providing a website called Understanding ARIA, where we provide educational materials. This website has been already accessed by over 15,000 healthcare professionals. Therefore, attention has been drawn duly to ARIA, and healthcare providers are following such instructions. Therefore, we believe that safely, Leqembi is being administered in the real-world setting. Now, turning to Leqembi in Japan. Establishment of the pathway has been fast in Japan, faster than we expected. Diagnosis and treatment for eligible patients are progressing faster than expected. Within four months of launch, this is what has been achieved. Bar chart includes pale purple bars in almost 600 facilities. Diagnostic and treatment pathway establishment has been completed, and treatment has been initiated in all of 47 prefectures in Japan. Optimal usage guidelines, OUG as noted at the bottom of the page, and all-case surveillance are being complied to as we are expanding the entry of Leqembi in the market. On the right side, cumulative sales is shown. About 600 million yen of sales was recorded cumulatively by April. In May, the pace is further picking up. We are seeing progress, which is faster than we expected. In Japan, we are making efforts by the entire Japan team. What are we doing? Left side pyramid shows that we are layering facilities in Japan to four layers. OUG has stringent requirements for facilities initiating Leqembi treatment. There are facilities that qualify by satisfying such requirements are at the top two layers. Facilities initiating Leqembi treatment at top layers are led by many top key opinion leaders. We have specialized medical reps, including Biogen's reps, approaching these top two layers of facilities. These two layers at the top of Leqembi, as well as the bottom two layers of the pyramids, who are PCPs, are important. PCPs are playing a very important role of referring patients to the facilities initiating treatment. PCPs are greater in number. Initiating treatment is for six months. Follow-up after the initiating treatment can be given not at the top layer treatment facilities, but in facilities qualifying at the bottom two layers. Therefore, information communication among these facilities is very important. Around 650 MRs, who are regional cooperation MRs, are supporting the communication coordination among these facilities. Referral, initial treatments, and follow-up flow is established by specialized medical reps and regional cooperation medical reps and are achieving results. Another characteristic in Japan is that we have a history of Aricept. We are able to leverage that history made through Aricept. This year, we already have organized 2 large-sized academic symposiums on Leqembi, the second one in red, Academic Symposium of the Japan Academy for Alzheimer's Disease. This academy was established at the time when Aricept was launched. It was launched in 2000. It was attended by 290 people when the first symposium was organized. St. Marianna University's Professor Kazuo Hasegawa was the leader of this academy. Professor Hasegawa is known as the father of Alzheimer's disease in Japan. For 24 years, efforts have continued steadily. This year, more than 500 physicians were attending in person as well as those attending virtually. The number of members has grown to about 4,800. Physicians have contributed to the activities of the academy. This is playing a very core role in AD care. We believe that a very important role was played by this Japan Academy for Alzheimer's Disease. Various topics are discussed. But every year, patients of Alzheimer's Disease, especially in younger age, also appear as speakers. These days, dementia patients are caring dementia patients. Peer-to-peer care is the most modern type of care. This is set to be a most invigorating treatment for patients. We have a program that aims for inclusive society by inviting AD patients as speakers. That has been the feature of the academic symposium from the very beginning. In each medical region, we also have smaller-sized gatherings organized. In Japan, this has served as a major backbone. As noted at the bottom of the page, we have a solid, strong relationship of trust with dementia specialists. We take pride in having established such a relationship. Leqembi introduction is faster than planned or expected. The important background factor is this history made through Aricept. In Japan as well, we are promoting efficient omnichannel marketing, which will be contributing in a similar manner in Japan. Now, as for Leqembi in China, we are planning for launch in July. A pathway that differs from Japan and the U.S. is aimed to be established. The characteristics include industry collaboration and digital technology. With the next page, I would like to describe. The headline says, "Pathway Establishment through Online Merger/Offline Strategy." The next line, "Screening Stage, Diagnosis Stage, and Treatment Stage," has a major role, which is that commercial insurance, private health checkup, and private nursing home will be playing that role. Commercial insurance, quite soon, benefit card insurance will be launched. AD prescreening opportunities can be provided under the insurance. There will be also a recommendation to seek physician consultation for people at high risk. It also has an element of reducing the economic burden of patients. This will be on sale quite soon. The private health checkup includes cognitive function tests and APOE4 tests and MRI. At nursing home, there is also early screening. As a result of these screenings, patients at risk can seek diagnosis through two different channels. First, it's direct referral to hospitals. There is another channel shown below. We have Yifangtong, which we started with the JD Group. This is a dementia online health platform. On this platform, already, more than 400,000 people have become members. There are 6,000 AD specialists registered. This is a very active platform. On this platform, referrals can be made. Memory Map is one example of an app. In the neighborhood of the person using the app, hospitals, specialists, doctors can be identified and recommended. ABETA test sites can also be identified, infusion centers as well. Our pointing upwards indicates that there will be a switch from online to offline. Diagnosis in China is such that PET and CSF are not so widely available. From the beginning, we are developing a diagnosis model mainly using BBBM. We are establishing a diagnostic network with ICL, DT and IVD companies. In Yifangtong, in the middle, there is a patient care package as shown in this diagram. Online consultation and service to accompany patients can also be provided. Once there is a definitive diagnosis, it will be shifting to right-side treatment. Infusion itself will be, of course, offline with diverse options for Leqembi administration. There are potential sites for Leqembi administration. It can be accessed or ARIA monitoring. This is also done offline. But guidance can be given by Yifangtong in Yifangtong. And using a long-term management app, Memory Care Center from Yifangtong, at what infusion center, what ARIA monitoring is provided, such information can be accessed. And an ARIA monitoring reminder can also be sent as a service on this app. By merging online and offline, we are going to provide a platform from the very beginning in China. As a result of these efforts, we estimate JPY 56.5 billion to be revenue from Leqembi, about JPY 43.5 billion from the US, JPY 10 billion from Japan, and JPY 3 billion from the rest of the world, mainly China. Now, this is the core message of my presentation today. Thus far, we have established the value of Leqembi. I would like to take time to describe the value of Leqembi. As noted in the first bullet, Leqembi possesses potentially one of the most extensive treatment datasets on early AD. Represented by Clarity AD, we have a wealth of information from clinical trial data. Open label extensions are run in these clinical trials. Day by day, the data is expanding. After accelerated approval for about 18 months, real-world data has been accumulated. We have a very large volume of data, extensive data. As for early AD indication for Leqembi, well, Leqembi is not looking at a subset of patients, for example, stratified by tau. But to a broader group of early AD patients, safety and efficacy have been demonstrated. This is a distinct characteristic, setting Leqembi apart from other AD/DMT. As for the number of patients with MCI, we are unparalleled. In the low tau group in MCI, when we look at the improvement of cognitive function or including the improvement of cognitive function, we have outstanding data. This suggests a greater benefit for early stage of the treatment. This brings about hope for patients. We also have a growing volume of data for long-term administration. We have seen sustained treatment up to 30 months and enhancement of treatment effect. Early AD is a progressive neurodegenerative disease. Continuous treatment is important. This goes without saying. And that importance, once again, is demonstrated from this long-term treatment data. Early start of the treatment and continuous treatment will provide the best outcome for Early AD patients, as shown by Leqembi data. Thus far, we have established the value of Leqembi. In this way, we believe this is the greatest value of Leqembi. And the second value is that value from dosage and administration. And we are continuously improving the dosage and administration. For example, IV maintenance is under submission. And those are less frequent by half. And SC-AI, as I mentioned earlier, will provide a reduction of burden on caregivers and patients substantially. And it will make it more convenient to continue treatment with Leqembi. And we are continuously expanding value through developing various dosage and administration groups. The third bullet, as I mentioned a little bit earlier, is that we have started 25 years ago. The treatment initiation was at the stage of mild AD. At that time, there was no concept of MCI. 25 years later, MCI is now posed as a condition to be treated by anyone. MCI is now the stage where treatment is initiated, as shown in the approval. With that, treatment effect is expanded. Preclinical AD will be an earlier stage where treatment may be started earlier. If that becomes possible, AD treatment landscape can dramatically change. In some cases, cure may be within our vision. In the real world, the last bullet point, the status of ARIA seems to be within the range described in the package insert. Appropriate monitoring is ensuring safety. That is also an important point in terms of value of Leqembi. This one page shows the status of Lenvima already, as you may be aware of, currently, regarding high purity Lenvima patent. This is a substance patent or material patent. We have a very strong patent. We are challenged by other generic manufacturers. We have pending lawsuits in the United States. The key company in that litigation, one of which is Sun Pharma, and we have entered into a settlement agreement with Sun Pharma. Under the Lenvima brand, there is a possibility to continue to contribute to patients in the medium to long term. We consider this to be an important step forward. LOE, how long will LOE be extended? The details I'm not able to comment since there is still an ongoing litigation with other companies. I would like to report that there has been an important step forward. As shown in the second bullet point, we would like to further expand indications. We have three LEAP studies that may lead to expanded indication: upper gastrointestinal cancer, HCC, and esophageal carcinoma. For two of these, LPI is already achieved. We are adding values to Lenvima. Capabilities to add value to Lenvima from these results will be great. The last bullet point is about RCC. Currently, in multiple indications of Lenvima, RCC is the fastest growing indication. First choice drug, Lenvima as a first choice drug for RCC is what we would like to establish and strengthen. To strengthen that position, LIGHTSPARK studies, two studies are underway. Merck's HIF2 alpha inhibitors will be given in combination with Lenvima in these studies. In these two studies, we have achieved LPIs last patients in. As a result, if these are successful, then we believe that it will have a very positive impact on the performance as LOE may be extended. Going forward, we would like to continue to contribute to patients in the mid- to long-term, as well as continue to generate JPY 300 billion level revenue. Going back to 3Ls in fiscal 2024, revenue forecast is 18% over JPY 400 billion with 3Ls in terms of revenue. Today, at the board, acquisition of own shares was resolved. This will be up to 6.5 million shares. It will be 2.3% as a percentage of total number of issued shares. Total amount of acquisition cost is up to JPY 30 billion. It will be from May 16, 2024, to November 15, 2024. The background of this is that so far, we have focused on cash return and dividend in terms of shareholder returns. But we will be entering the phase of expanding revenues, growing revenues. We have to also be mindful of equity capital ratio as we continue to provide returns to shareholders. From the point of equity capital management, we believe that acquisition of own shares is the simplest method to realize shareholder return. Therefore, we are implementing this measure as a one-dimension higher level method of providing return to shareholders. KPI improvements will be what we will continue to work on. Our determination to increase shareholder value remains unchanged. The final page is the consolidated financial forecasts. We will now open the floor for questions. We will have about 20 minutes of Q&A for analysts before opening the floor to members of the media. If you have a question, please give us your name and affiliation before your question. From analysts, investors, if you have a question, please raise your hand. Thank you for your presentation. My name is Wakao. I am from J.P. Morgan. My first question is for this fiscal year, 2024, revenue plan for Leqembi, assumptions for the forecast, as well as the reasons why you believe such target can be achieved by region. For the United States, $300 million, I think. And the number of vials growing in a linear way, achievable to reach this target number? Or do you have more rapid expansion, such exponential growth, inclusive of the number of potential eligible patients, the patients receiving treatment? Please. And in Japan, it seems that you are performing well. According to the MHLW materials last year or this year, Eisai has shown the potential assumed growth of the quarterly number of patients. By region, Mr. Haruna and Mr. Yusa are going to explain. Thank you very much. I am in charge of the commercial aspect of Leqembi in the United States. My name is Haruna. I would like to give you the status of the Leqembi in the United States. First, as for forecast, current trend, as well as what we explained today, the effect of the rolling out of our strategy being considered. And the forecast is going to be with high probability. And for the months of May, we believe that the performance is exceeding our plan. Therefore, we are very confident in achieving the plan. If I may supplement, for FY 2023, we focused on the establishment of pathways. Now, we are transitioning to prescription expansion phase. As was explained in today's presentation, let me share with you some examples on what we explained. At the site in Midwest in the United States, over 200 patients have received treatment. About a little less than 200 patients are also currently under screening. Therefore, growth is continuing and in an even more accelerated manner. In the so-called Loyalist base, the sites with 50 or more patients are expanding in number. There are also an increasing number of potential loyalist candidate sites. Last week, we could have an opportunity to talk with a patient who is undergoing the Leqembi treatment. Before initiation of the treatment, that person said that he was very frustrated because of the worry or fear of losing memory and also lowering of the ADL or activity level, lowering. That was felt strongly by the patient himself. But after initiation of Leqembi, his ADL could be improved. And also, he could start to see or feel zest for living. And he was pleased to have such changes. As regards to the infusion, to visit the hospital has become a routine of his daily living. And this person has continued treatment with Leqembi for longer than one year. And with this, we believe that we are very confident that this target can be achievable with high probability. Thank you for your question. Now, Mr. Yusa, who is responsible for Leqembi in Japan, thank you very much, Mr. Wakao. As you said, in Japan, as has been already published in the press, the size of the market. Also, if we can achieve the number of patients by quarter, we believe that and we are confident in achieving JPY 10 billion in Japan, particularly for this fiscal year, 2024. So far, we have established a very strong relationship with KOLs. And that's why we have been able to successfully start the initial stage. But for this fiscal year, 2024, first, for patients with MCI, we needed to raise awareness about the disease. The number of patients receiving a prescription exceeds 70% in Japan. And there are some sites which have already treated 80 patients or over. And we have touched on the potential number of patients in Japan. And by adding the education to raise awareness of the disease, and I think that the mild AD and MCI patients will start to seek treatment. With increased number of patients at each site where a pathway will be established and capacity will be increased by such efforts. For this fiscal year, 2024, there will be patients who will be receiving treatment for over six months, then at the sites where they started the initial treatment and also follow-up facilities or sites where Leqembi will be dosed to patients. That means that even with the existing patient pool, capacity for treatment will be expanded. Therefore, with these in mind, we are very much confident in achieving the target in Japan in revenue. Thank you very much. I would like to ask for further follow-up on the US and Japan as well regarding the trend of the number of patients receiving Leqembi in the US. As of quarter three, there are potentially 8,000 patients. What about the update? The 10,000 was also mentioned earlier. What is the current status, Wakao-san, regarding the number of patients? We would like to refrain from talking about the number of patients because it is quite difficult to accurately grasp the number of patients. If the reimbursement claims starter is available, that may be possible. But calculating backward from the number of vials shipped, we cannot reach an accurate number of patients on treatment. For example, the number of vials shipped or real sales starter, these are real figures. Therefore, we would like to utilize such real data, real numbers to discuss. If you could understand this, I don't know whether you agree with me. But that's our position. Understood. All right. Needs in the United States are increasing. If you could give us your gut feeling, I would like to seek your comment on that. Then for Japan, patients who are receiving treatment for over six months, are there enough sites for receiving such patients? Okay. The gut feeling regarding the United States, Mr. Haruna is going to respond. Thank you for your question. I am in charge of Leqembi in the United States. My name is Haruna. Regarding the needs and also expectation for Leqembi going forward, we believe that it is rising. As has been introduced by our CEO, we are seeing an increase in revenue week by week. That has been obvious and shown in data. And on a weekly basis, there is an ongoing upward trend. Therefore, as gut feeling, we believe we are feeling very powerful growth. Thank you for your question. Thank you for your question. In Japan, follow-up sites for accepting receiving patients who are receiving treatment for longer than six months? Yes, of course. In each region or area, we have started the discussion in order to prepare follow-up facilities. We are going to make adjustments as necessary in some regions. As you see in this diagram, regarding the area where we are going to establish follow-up facilities, we will hold the regional lecture meetings. Initiating the sites as well as the follow-up facilities, how to refer the patients and to follow-up facilities. That explanation briefing session is being held throughout Japan. Therefore, I think that we will be ready to prepare follow-up facilities responding to those who are on treatment for over six months. Thank you very much. I don't think that you have explained this. Regarding the changes of the Representative Corporate Officer, there will be two Representative Corporate Officers. That has been released today. What is the background for this at this timing? Although it was mentioned in the press release, but why now? As the candidate to be the CEO, after the current CEO, is this the plan for the company to consider the most powerful candidate as the next CEO, Keisuke Naito, considering the business model and the networking and the hiring of talents? These are very fundamental aspects of the company's business. We needed to change dramatically the conventional way of doing business. This is not something applicable only to Eisai, but applicable commonly to all the companies in all industries. We also believe that there is a necessity to do so. Therefore, for the succession of a CEO means that the generational change. So tens of age should be the magnitude of a change in succession. So in consultation with the board of directors, we are making thorough preparation for the change, as a part of which it's as announced today to appoint a new representative corporate officer. Did you ask when the CEO is going to be changed? Are you asking about that as well? I am not able to respond to that question. We are now entering in the very important expansion phase for Leqembi and also the patent extension period for Lenvima as well. Therefore, at such a crucial period, we would like to refrain from making any comment on when the CEO is going to be changed. Thank you. Next question from the attendee is seated at the front of the room. I am Hashiguchi from Daiwa Securities. I have two questions on Leqembi. First, about the impact from the competitive product. What is your expectation? How is that taken into account in the plan? The competitor's product may be approved in Japan as well as in the United States, even within this month. What is the estimated impact in terms of volume and value? The responses may be long, but Keisuke Naito will respond first. This is Keisuke Naito, responsible for global Leqembi. He will be speaking at some length. There is no direct comparison between Leqembi and Donanemab. Clinical protocols are different. I believe it is difficult to make a head-to-head comparison. But in order to evaluate the available data, there are certain characteristics of Leqembi that we consider to be important. First, regarding in the broad group of EAD patients, consistently, safety and efficacy have been demonstrated. Rather than selecting a most responsive patient group that is most likely to respond, we consider it important to consistently show safety and efficacy in large groups of EAD subjects. There has been no tau stratification. Irrespective of tau level, clinically significant results are shown. Leqembi, not only in subset based on tau level, but in broad subject group of broad patient group of EAD, safety and efficacy have been demonstrated. The second is a clinical benefit is suggested for people who are receiving early treatment. We saw that last fall in Tau PET subgroup. Based on that data, according to our definition in low tau patient, 60% of such patients, CDRSB improvement included, a very favorable clinical outcome was published. We see that Alzheimer's disease is progressive and irreversible neurodegenerative disease. Earlier the diagnosis and earlier the start of the treatment, the greater potentially the benefit. And therefore, in early stage in low tau patient, favorable data was shown. And that is a uniqueness of Leqembi. In addition, in low tau patient, in order to identify low tau patient, we are also focused on biomarker research, a liquid biomarker. We believe it will be enhancing the value of Leqembi. And the third is a favorable safety profile. There's no data comparing head-to-head Leqembi and other drug. But ARIA incidence and timing, we consider to be different from drug to drug. And that is also noted in the U.S. package insert. ARIA mostly caused by Leqembi occur in early stage of the treatment and mostly asymptomatic and non-serious. And that is shown in actual clinical usage. And in ADPD 2024 held in spring this year, Professor Lars Lannfelt presented the results using human sample that showed lower binding of lecanemab to CAA than other anti-amyloid beta antibody. We believe that this scientifically supports the clinical study results. The fourth is the efficacy safety-related point. AD is progressive, chronic, and neurodegenerative. Even after the removal of Aβ, the disease continues to progress. We believe that this is very important in considering the treatment period. In case of Leqembi, until the completion of Clarity AD study, treatment emergent ADA incidence was 10%. There is no effective immunogenicity on efficacy, safety, and pharmacokinetics. It is suggested that ADA is not a limiting factor for continued treatment. Regarding the efficacy and safety in case of continuous treatment over 18 months with Leqembi, Clarity AD open-label extension study, 24-month data was presented at CTAD last autumn. We expect to be able to present even longer-term results in future academic congresses. In order to reduce burden for the patients and caregivers, we are also developing SC-AI, which will be less burdensome on patients. We believe that because of these, we can be confident that Leqembi is the drug of choice for patients and HCPs. We anticipated the launch of Donanemab and have taken that into consideration to a certain degree in the revenue level of Leqembi going forward. The four characteristics that I've discussed about Leqembi can be a very important advantage for Leqembi, as CEO discussed earlier. In establishing pathway, we have made tremendous efforts on a daily basis with HCPs and infusion centers, CMS payers, advocacy groups, and various other stakeholders. With them, we have been able to build very strong relationships. Through commercial activities every day after the launch, we have continued to make efforts. We are confident of the evaluation of Leqembi in actual clinical use. And of course, we do anticipate that at a gradual pace, Donanemab may increase share. But we are also confident that Leqembi will be able to maintain its strong share in the immediate quarters. Second question, between initial treatment and maintenance treatment, what is the distinction between the two in your submission? After how many doses will it be a maintenance dose? Or what is the degree of reduction of amyloid plaque that is required to switch to maintenance dose? That question will be addressed by Dr. Lynn Kramer. Yes. Thank you. I'm Dr. Lynn Kramer. I'm the Chief Clinical Officer at Eisai. We are discussing with health authorities the duration that would be needed with initial therapy before converting to maintenance therapy. We expect that to be in the 18-24-month time frame. But that's a review issue related to discussions with health authorities, which would include PMDA, for example, and FDA. Thank you. Thank you. はい、ご質問ある方、3列目の1番前の方お願いします。 The person in the third row, please. My name is Sakai from UBS Securities. I'm sorry. I still wanted to ask a question about Leqembi. You have shown us numbers for Leqembi spending JPY 110 billion for this fiscal year, considering the SG&A expenses and R&D as a total. And then this accounts for 20% of the total SG&A and R&D expenses. So do you want to continue this level of spending? Pathway has been established, and SC will be introduced. And the remainder of work is how the drug is going to be used. Expansion of indications and monitoring on their safety will remain. And then the investment or expenditure is expected to reduce. Or do you need to maintain a certain level of investment? You touched upon competitors. Competitors are making a lot of money with different drugs. So maybe they can double, but they can invest double the amount of Eisai's investment in the initial year after launch. So maybe you don't have to talk about if. But if you are making excessive investment into Leqembi, some analysts and investors may be concerned. So that's why I think it's hovering down, dragging your share price down. How do you think? Mr. Sakai, you always ask us a very difficult question to answer. So I am wondering what to offer in my answer. For example, in fiscal year 2025, product P&L of Leqembi in the United States will be turned into the black ink. The global product P&L, Leqembi product P/L, will be achieved in 2026. Of course, we have to be careful in investing resources. For example, manpower resources in the United States has reached almost maximum level. In my opinion, therefore, we do not intend to further increase more than today's. And in Japan as well, we do not intend to increase further than the current level. In other major areas, which is Europe, in Europe as well, by relocating the manpower from oncology to neurology, we do not intend to increase the total manpower. Therefore, we do not think that there will be further expansion of SG&A expenses. I believe that we are at the peak in expenditures for SG&A for this fiscal year. In R&D expenses, preclinical AHEAD 3-45. Now, once we see the completion of last patient in in these studies, then the R&D expenditures will end the peak. Therefore, I think that this fiscal year is going to be the peak for both SG&A and R&D expenditures. In 2025, we would like to turn into the black ink in the United States. In the following year, we would like to turn profitable in global market. Understood. You have not taken into account the sales in Europe. But SAG, Science Advisory Board, Neurology, once review is done, and then approval is expected. However, regarding the reimbursement, which may be delayed, therefore, you do not incorporate the number in the revenue for this fiscal year, right? I think this has been already published, so I can say this. SAG was held once. However, because of the review of other drugs, European Court of Justice, because of the background of reviewers, some of them had the experience of getting involved in the review of competitors' products. Thus, there was a rule not acceptable. Therefore, the members of the SAG were reviewed again. Then it was found to be problematic. Therefore, the result of the previous SAG meeting was canceled. With new members, again, SAG-N will be held again. We have not heard of the date yet. Inclusive of that, for EMA, in the first half of this fiscal year 2024, towards the end of the first half of this fiscal year, the result will be provided. The result of the review will come around at the end of the first half. In Israel, for example, the sales are being generated, although it is minor. The drugs are purchased in the United States. That is included in number for Europe. Massive recording of the sales is not included in this number. Understood. Thank you. Next question, please. First question is about your plan and your assumption for cost of goods sold. This year, this fiscal year, you assume that cost of goods sold will increase. Are there one-time factors leading to that? Or for this year, I think there will be an increase in Leqembi. Is there an impact from changing product mix? That question will be addressed by Mr. Tamura. I am Tamura, responsible for production. Thank you for your question. As you rightly mentioned, in this fiscal year, Leqembi sales and cost of goods sold are estimated here. And in comparison to the actual from last fiscal year, cost of goods sold is higher this fiscal year. And that is because of a slight deterioration in the mix. Thank you for your question. Thank you. As a follow-up, in the future, as volume increases, do you expect substantial improvement? Once again, Tamura speaking. Going forward, regarding the cost of Leqembi, large part of the cost is accounted for by drug substance and partner Biogen. We have been working on reduction of cost through various different measures. I would like to cite some examples. Right now, drug substance is a manufacturer that switched plant of Biogen. This plant is highly automated. By continuing to produce drug substance at some scale, we expect cost reduction. Yield improvements may be also achieved through process improvement. We are making efforts towards that end. The trend we anticipate is a declining cost over medium to long term. As for formulation, the second CMO is already launched as a second place of production. We expect the initiation of production. That will also be reducing cost over the medium to long term. With these efforts, we are reducing cost of goods sold. Thank you. In the interest of time, we would like to now turn to media for their questions. If you have any questions in the media, please raise your hand. We do not see any hand raised in this venue. So we are receiving questions from those participating online. Mr. Muraoka of Morgan Stanley, please unmute yourself. Thank you very much. My name is Muraoka. I am from Morgan Stanley. Regarding expenses for Leqembi, you said that this fiscal year is the peak in expenditure. How much is included in the guidance for this fiscal year? Actual result was JPY 110 billion and JPY 60 billion before that and JPY 150 billion in total of two companies. So how much is included in the budget? Could you please give us a ballpark? Mr. Yasuno is going to respond to that question. My name is Yasuno. I am in charge of planning. Regarding the concrete numbers, we would like to refrain from disclosure. But SG&A expenditure will be over the level recorded in last fiscal year. So SG&A expenses will be up, but R&D expenditure will be down. Is this correct? We would like to refrain from specifying numbers. But SG&A's expenditures are expected to be more than the recorded in last fiscal year. Understood. Thank you very much. I would like to ask you another question, if I may, please. Regarding the subcutaneous rolling BLA submissions have been initiated. But if you continue and then approval of the subcutaneous formulation in the United States, when can we expect to get that? Before summer next year or even earlier than that? What is the image? Dr. Lynn Kramer is going to respond. Yes. Thank you for the question. I'm Lynn Kramer, Chief Clinical Officer. As you recognized, the subcutaneous autoinjector maintenance therapy rolling submission was initiated a day ago. In that submission, we have requested a priority review. We won't know whether a priority review is granted until we hear from the FDA that the dossier is formally accepted, which takes about 60 days. At that time, we would know whether we have a priority review or not. If we are granted priority review, that would mean we would expect approval approximately 6 months after that. That's all I can say at this time. Various modules will be submitted in rolling manner. The final submission will come in October. Then the time schedule, as has been explained now, is expected for the completion of the review. Well, it was harder to hear. By October, rolling submission will be completed. Within two months, the priority review will be confirmed. Then six months will kick off from that. Please check with the secretariat later. Are there any questions from the members of the media? I'm Banno from Nikkei Newspaper. Thank you for taking my question. I have a question on China. This fiscal year, do you expect JPY 3 billion revenue? Under other, PET, CSF are not widely available in China. But you still expect this level of revenue. How will BBBM be used? And who will be the patients that will be able to receive treatment? Mr. Okada will respond. I'm Okada, responsible for China business. Thank you for your question. As for the figure, JPY 3 billion, this is a number in the pie chart presented by Mr. Naito, CEO. Mostly, JPY 3 billion is from China. That also includes Europe. So China, per se, is smaller than JPY 3 billion. As presented today using these slides, centering on BBBM screening will be carried out in China. That is the plan that we are pursuing. There are three approaches to screening. Patients who actually come to hospitals, in comparison to those healthy, high-end patients, are targets for screening. Then, as a result of the screening, there will be a pathway to seek consultation and care at the medical institutions. PET and CSF are not so widely available. Therefore, we are preparing for BBBM. As for scientific validity of BBBM as a screening method with Chinese KOLs, including retrospective data, we are preparing a paper publication. It is not that what we are doing in China is exceptional. Based on scientific data, we are making efforts to establish BBBM as a scientifically valid screening method. Who will be the target? It will not be covered under NRDL immediately after the launch. So it will be out of the pocket. And therefore, drug price will be high at around JPY 3 million. So in China, I believe the initial target will be high-end people, people who are living in the cities on the coastal regions. Such high-end people will be the initial targets. And that is already sufficient. And we have begun activities. And potentially, we expect a very large number of potential target patients. One more point, if I may. And this is a clarification question. Subcutaneous switch. By 2026, I thought Mr. Naito, CEO, mentioned that you expect switching to be completed by fiscal 2026. Do you mean that approval is expected by 2026? Launch and approval are being pursued with a target timing of fiscal 2026. Thank you. Kagaku Kogyo Nippo Watanabe-san, could you please unmute yourself? My name is Watanabe. I am from Kagaku Kogyo Nippo. Can you hear me? Yes. As a follow-up on the question of the previous person regarding manufacturing system, the plant in Switzerland and the second site for production, CMO has been contracted. I'm sorry. I may have misheard. I would like to clarify. So that means that the CMO, drug substance, will be produced as well. Or filling into vials will be conducted by the second site at CMO. Is this correct? This is my first question. And the name of the specific CMO may not be disclosed. But Japanese company? Or is it foreign capital affiliated? Or in each region, the production will be conducted? Could you please share with us such information? Mr. Tamura is going to respond. Thank you very much for your question. My name is Tamura. I am in charge of manufacturing. For drug substance, the U.S. plant of Biogen is being developed as the second site for drug substance. For drug product, CMO in Europe is going to be utilized. And it is being ramped up. Thank you for your question. Unfortunately, we have run out of time. We would like to conclude the financial results presentation session. If you have further questions, please contact IR or PR of Eisai. With that, we would like to end today's presentation session. We thank your attendance.