Thank you very much for taking your time to attend the conference today. It is now time. We would now like to begin Media Investor Conference for the launch of Leqembi in Japan. This is a hybrid presentation, both in person here as well as with attendance online. Those of you who are attending in person, please find the press release. Those of you who are participating online, you are able to download a press release from the chat box. There are English and Japanese versions available. I would now like to introduce the presenter, Mr. Haruo Naito, Representative Corporate Officer and CEO. Mr. Naito, CEO, please. Thank you. At the Central Social Insurance Medical Council, a drug price and Optimal Clinical Use Guidelines were approved. On this occasion, regarding the launch of Leqembi, we would like to share with you our thinking. Please refer to the material distributed to you. As I will be discussing in line with that material. At its general meeting today, the Central Social Insurance Medical Council agreed the addition of Leqembi to Japan's National Health Insurance, NHI, drug price list and its optimal clinical use guidelines, OUG. Following this development, we announced today that we will launch Leqembi on the same day as the NHI price listing scheduled to take effect on December 20. We have also announced in the press release. In Japan, where this Leqembi originated, we are to launch Leqembi, and we once again realize the responsibility that we shoulder. Come to think of it, after the launch of Aricept, it has been 24 years, close to a quarter century. In the meantime, regarding AD or Alzheimer's disease, the sciences behind Alzheimer's disease and research in the pathology of AD have advanced significantly. Biomarker research included, there has been a remarkable advance. In AD research, we consider ourselves to be pioneers, and we will once again play a role in paving the way for a new diagnostic and therapeutic paradigm. We will make every effort to ensure that eligible patients have access to Leqembi and that its efficacy is demonstrated while ensuring safety in accordance with the approved labeling and the OUG. At the same time, we will continue our efforts to realize dementia-inclusive society in cooperation with patient advocacy groups and local governments. First, about the benefits of Leqembi. Once again, I would like to review the benefit of Leqembi. Amyloid beta is the main pathologies of AD, and A-beta is a protein. Of Aβ, Leqembi selectively binds to soluble amyloid beta aggregates or protofibrils. At the same time, Leqembi also binds to insoluble amyloid beta aggregates or fibrils. Thereby reducing both Aβ protofibrils and Aβ plaques in the brain. That is the mechanism of action of Leqembi. As for Aβ plaque, after the removal of Aβ plaque, even after the removal, Leqembi is thought to continuously support neuronal function by continuously removing highly toxic protofibrils that cause neuronal cell damage and death. In the phase 3 Clarity AD study, Leqembi demonstrated statistically significant efficacy on the primary endpoint and all key secondary endpoints. The primary endpoint, a measure of general clinical AD symptoms, CDR-SB, Clinical Dementia Rating Sum of Boxes, showed a 27% reduction in clinical decline after Leqembi treatment, suggesting that the disease stage remains in an earlier stage two to three years longer. In addition, Leqembi demonstrated less decline in caregiver re-rated ADCS-MCI-ADL by 37%, and QOL-related items, including EQ-5D-5L by 49%, QOL-AD by 56%, and Zarit Burden Interview by 38%. These results indicate that Leqembi has the potential to delay the decline in patients' activities of daily living and quality of life, and may significantly reduce increasingly enormous care-related costs, including the burden of family caregiving. In today's modern society, families may sacrifice the employment to care for the AD patients, or they have to spend time providing care. Such care-related costs may be reduced significantly. In addition to its clinical significance, Leqembi has the potential to create societal value by reducing public long-term care costs and the burden of caregiving on families. Next, turning to NHI pricing. At today's general meeting of the Chuikyo Central Social Insurance Medical Council, the price was determined for Leqembi. There are two vials. The price is 45,777 JPY per 200 mg vial and 114,443 JPY per 500 mg vial. Average weight of 50 kg is generally used in calculation in Japan for drug price. The total annual cost would be about 2.98 million JPY or 2,983,693 JPY. Under the high-cost medical expense benefit system, for general income earners aged 70 and older, with annual incomes between 1.56 and 3.7 million JPY, the maximum co-pay is 144,000 JPY per year. We understand that the NHI price for Leqembi was set based on the Japanese NHI drug pricing standards, namely based on cost accounting method, recognizing the innovativeness of Leqembi as an additional 45% usefulness premium. From the outset, and as I have just mentioned, we have proposed that Leqembi has not only clinical benefit, but impacts, such as reduced burden of care for both the public and the family. And therefore, we have proposed value-based pricing, which takes into account these benefits. Based on AD disease simulation model, quality, quality adjusted for life year increments and willingness to pay WTP thresholds and reduction in total medical and care cost were calculated. These major indicators were calculated to come up with societal value or impact per person. This was quantified to be shown as a numerical monetary value, and that is approximately JPY 4.68 million per year. Societal value per person is approximately JPY 4.68 million per year. This paper is published by Weekly Journal in Japanese by Dr. Igarashi on Neurology and Therapy. Regarding the care part, care cost part, this was not included in the calculation, and we understand that it will be discussed at a future meeting of Chuikyo. Leqembi's NHI price results JPY 4.68 million of societal value. Half of that is returned to public stakeholders such as patients, families, caregivers, healthcare professional payers, and the governments, according to the current NHI drug pricing. And the other half is being allocated to private stakeholders such as Eisai employees and shareholders as net sales, after subtracting consumption tax and distribution expenses from sales of products. And the portion of the value assigned to us will be partly committed to reinvestment in one, market introduction in full compliance with requirements of the OUG and the all-case surveillance monitoring. Number two, future research and development to create new drugs for dementia to follow Leqembi. And three, development of safe and secure communities or dementia inclusive society in collaboration with local governments and other industries. As for NHI pricing itself, we filed an appeal and argued for a higher premium. Under the current drug pricing calculation standards for new drugs, in order for a drug to be eligible for innovative premium, which we argued for, the three requirements must be met at the same time. The three requirements are: A, new mechanism of action; B, higher efficacy and safety compared to existing drugs and treatments; and C, improved treatment methods. All these three requirements are to be satisfied to be eligible for innovative premium. Higher efficacy and safety compared to existing drugs and treatments. In direct comparison with existing drugs and treatments, and we understand that this requirement was seen to be not satisfied by Chugai Pharma. However, there is no existing drug suitable for comparison with Leqembi, Leqembi, which has a novel mechanism of action, which acts on the pathology of AD. And therefore, it is difficult to conduct clinical trials to satisfy requirement B in reality, and therefore, due to the lack of data for comparison with existing drug, Leqembi was deemed not to meet requirement B. We expect that the eligibility conditions for requirement B to be reviewed going forward. In the future, we hope that the drug price determination of Leqembi will serve as an opportunity to advance discussions about a new drug price calculation system that can proactively evaluate drug innovation. I would now like to touch upon OUG, Optimal Clinical Use Guidelines. The guidelines for the use of Leqembi are set forth in OUG, agreed upon today. OUG will be published by MHLW before the NHI drug price listing. The OUG outlines the requirements for patients, facilities, and physicians to ensure the safe and appropriate use of Leqembi based on a proper understanding of its benefits and risks. We understand that the OUG was established based on the Japanese public policy that when introducing Leqembi, the world's first Japanese innovation, it is necessary to have a system in Japan, the birthplace of Leqembi, that can fully ensure its efficacy and safety. Now, turning to all-case surveillance. In accordance with the conditions of approval of Leqembi, Eisai will conduct a post-marketing special use result survey of all patients who were administered Leqembi or all-case surveillance until a certain number of case data are accumulated. Information on patient background, safety, and efficacy in daily medical practice will be collected as early as possible and used for safety measures. Background information on APOE4 will also be collected as much as possible. Next, AD diagnosis and treatment pathway. In AD, therapeutic area, technology for the diagnosis and treatment of AD is progressing rapidly. However, diagnostic and therapeutic pathways for AD have not been fully established, and we must continue to develop them. We recognize that it is extremely important for healthcare professionals, such as physicians, pharmacists, nurses, and clinical psychologists who conduct dementia testing, and radiology technicians who give PET and MRI tests, and medical office personnel who will be responsible for medical billing and for caregivers to share the challenges related to the establishment of the shortest and most optimal diagnosis and treatment pathways for people living with AD and to work together to solve these challenges. We will work together with our stakeholders to address these issues as a top priority. In this diagram, this is the typical anticipated diagnostic treatment pathway shown. First, neighborhood doctor or primary care physician will give consultation and cognitive function test. Patients will be referred by these doctors to specialists. Specialists may give early AD diagnosis, which lead to more detailed dementia tests, and generally, a majority of the cases, MRI. To confirm Aβ accumulation, PET or CSF will be used. There is also blood-based biomarkers, but in terms of those that are reimbursed by insurance, I think a PET and CSF will be used for Aβ diagnosis. APOE4 tests may be given also at this point in time. After confirming the positivity of Aβ, Leqembi administration will begin. Leqembi infusion is once every two weeks as intravenous infusion. Safety monitoring will follow, especially regarding ARIA. MRI will be used for safety monitoring. That is the series of steps comprising diagnosis and treatment pathway. In order to develop this pathway, we will have to make our utmost efforts. Next is about the environments for the amyloid diagnosis. The amyloid PET and CSF tests- Will begin on the same day in terms of the insurance and reimbursement as the NHI price listing of Leqembi. Regarding the amyloid, PET, the number of facilities with imaging certification was less than 10 at the end of 2020. However, this year it increased rapidly, and as of November this year, it increased to 84 facilities. According to the Japanese Society of Nuclear Medicine, it is estimated that the number will be over 100 facilities by the end of this year, and the same upward trend is expected to continue in the future. In addition, a system or network for conducting A-beta testing is being established through the promotion of collaboration among facilities in geographic regions and medical areas, and further progress in the diagnostic system is expected going forward. On the other hand, there are regions where PET testing is not yet accessible, and in such regions, we are promoting the spread of other testing methods such as CSF and the establishment of medical collaboration system for PET testing. Regarding the test procedures, we are providing programs and video-based seminars to support the enhancement of such procedures. By doing so, we expect that the number of CSF tests will increase by approximately 80,000 per year. Through these activities, we aim to minimize the regional disparities and create an environment in which people in need can receive A-beta testing smoothly. We have the Soudan e-65, a website operated by Eisai, will register and regularly update information on medical institutions that can perform amyloid PET or CSF tests, so that users can search for them anytime after the NHI drug price listing. Furthermore, evidence for diagnosis using BBM or the blood-based biomarker is also accumulating, and in the near future, an environment will be in place in Japan, where BBM can be used as a triage test screening. So the triage test might be a new word. However, before going to the PET or CSF, we will be able to screen and do the pre-screening, so that we would be able to know who are to go forward to the PET or CSF tests. Then subsequently, we also would like to establish an environment where the confirmatory test can be done. So, in lieu of PET or CSF, utilizing the blood-based biomarkers, we are going to confirm the A-beta positivity. And we believe that this kind of environment is going to be spread here in Japan as well. Now, the ARIA management. The ARIA is the amyloid-related imaging abnormalities, and this is the specific adverse event for this, the amyloid-related compound. And we think that it is very important to establish the environment where we will be able to provide the information and to have a coordination system within the hospitals for this ARIA management, and we will continue to do our best to accelerate these activities. Leqembi was featured at the annual meeting of the Japan Society for Dementia Research, held recently, where the management ARIA was discussed. And, we also conducted a seminar, titled Leqembi Safety Profile and Countermeasures, Focusing on ARIA. And we have already publicized the e-learning course on ARIA on our website for healthcare professionals, and plan to post an explanatory video, before the NHI drug price listing. We will continue to our efforts to create an environment where patients can use Leqembi as safely as possible. In the United States, the first country to launch Leqembi, the only online education program understanding ARIA on the management ARIA had an access of more than 10,000 times since its release. And now the situation in the United States, after the full approval, we have secured results exceeding the business plans, and the go-to-market structure is in full operation. And the establishment of diagnostic and treatment pathways at facilities under the IDNs, which is Integrated Delivery Networks. And well, there are about 100 main such IDNs in United States. But in the IDN facilities, the establishment of this diagnosis and treatment pathway is ongoing. And then also, the infusion center is the mainstay in the United States. And in addition to the reimbursement of the infusion technology fees. Well, the another positive factor is the removal of the limit on the number of amyloid beta PET scans per person on October 13 of this year. So before that, it was okay to take amyloid beta PET scan. However, there was a limit in terms of the number of how many times it is possible to take the PET scan. However, now because of the lift on this limit, it will allow the amyloid beta PET reimbursement to be secured as often as needed. And also, there is a portal which calls that CMS, and through this CMS portal, the number of the patients receiving Leqembi is increasing. And we think that in Japan, it is also going to be as is in the situation in United States. Now, I'd like to talk about the preparation for launch in Japan. Well, regarding the structure of information provision activity in Japan, since the grant of approval on September 25, 15 specialist MRs have been appointed from Biogen Japan, in addition to 42 specialist MRs from Eisai in the field of dementia, and initiated the provision of information to specialty doctors. Usually, like for Belsomra or Dayvigo, it is a sleeping related or Alzheimer's-related drug, will be in charge by the general MRs. However, these general MRs, approximately 600 people, have also initiated the activities toward establishment of the diagnosis and treatment pathway of Leqembi in each hospital. And to date, we have already reached approximately 18,000 healthcare professionals, and we have held briefing sessions on Leqembi profile at hospitals, as well as webinars on safety and biomarkers, and lectures aimed at promoting medical care coordination system in each region of it. Seminars have been held 6 times to date and have been viewed by nearly 3,000 healthcare professionals, far exceeding our expectations. Now, on dementia ecosystem, we believe that the establishment of a dementia ecosystem will accelerate as we launch the drug that will become the core of this ecosystem. In addition to the asserting, ascertaining the health condition use Easiit, checking brain health using NouKNOW, in collaborations with local government and companies, enhancing disease awareness website, developing AI, predict treatment effects, and visually capturing changes in activities of daily living using the Sasaell app. We are collaborating with approximately 165 local governments and patient advocacy groups nationwide, and partnering with other industry, such as insurance, automobiles, non-life insurance, banks, food, and telecommunications, to provide appropriate solutions at each stage of life, from the healthy state before the onset of dementia, to onset, treatment, and nursing care. Now, I'd like to talk about the development and access with a sustainability linked loan. As of today, Eisai's sustainability linked loan became effective. Sustainability linked loans are a type of loan which incentivizes the borrowers to achieve sustainability performance targets, or SPTs, by linking borrowing terms and conditions, such as interest rate, to the achievement of SPTs, seeking to drive environmental and social sustainable economic activities and economic growth. In our articles of incorporation, we aim to effectively realize social good, and this effectiveness include the procurement of capital and funds. Eisai will use the loan funds raised at low interest rate in three areas where positive social impacts are expected. Number one, promotion of Leqembi's Patient Assistant Program, or PAP, for low-income individuals in the United States and developing countries. And number two, establishment of dementia ecosystem, including the realizations of a dementia-inclusive society in Japan. And number three, the development of drugs to treat disease of poverty, including neglected tropical disease, or NTD, malaria, and tuberculosis. Through these activities, we will actively work to realize a social good, including access to Leqembi in low-income countries and low-income populations. So lastly, I would like to give a concluding remarks. Well, under Eisai's corporate concept, the hhc concept, our top priority has been to relieve the anxieties over health of people with AD and their families. All employees spend 1% of their working hours, or about 2.5 days per year, with patients. Through these efforts, we are proud to say that we have been able to understand the true feelings, the joys and sorrow of the people with AD and their families, and we believe that we were able to build empathetic relationship with them. Well, following the United States, Leqembi is now available in Japan, marking a new step toward the treatment targeting AD pathology that people with AD and their families have long desired. The paradigm for AD diagnosis and treatment is completely different from those in field where treatment systems have already been established, and we are working towards creating something from scratch. As a pioneer, Eisai is determined to work closely with stakeholders such as people with AD, their families, caregivers, physicians, pharmacists, nurses, insurers, and the government to realize this goal. As the new paradigm for the diagnosis and treatment of early AD begins with Leqembi, we are proud to be working together with medical and nursing care professionals on initiatives to relieve the anxieties of people living with AD and their families. Going forward, we will do our utmost to further improve treatment methods and diagnostic technologies, including the development of subcutaneous formulations or, or the injectors, and expansions of indication to preclinical AD, the stage before MCI, and the introduction of BBM in a diagnosis. We strive to realize changing the future of AD. We would now like to open the floor for questions. First, we will take questions from attendees who are attending in person in this room before taking questions from online attendees. Please limit the number of questions to one per person initially, and if time allows, we would like to see if people who have asked questions already have additional questions. Microphone will be brought to you, and please give us your name and affiliation before your question. Please, we would appreciate if you could take off your facial mask so we can hear you clearly. If you have questions, please raise your hand. Yes. I am Hashiguchi from Daiwa Securities. Thank you for the presentation today. About OUG, I have a question. In particular, about facility requirements, a number of requirements or items have been established. And the requirements are different for facilities that are giving Leqembi for the initial six months and after the initial six months. As you expand Leqembi, what do you think will be most important in complying with OUG requirements? The question will be addressed by Mr. Yusa, who is responsible for Leqembi commercially in Japan. Mr. Hashiguchi, thank you very much for your question. I'm Yusa, responsible for Leqembi commercial in Japan. Allow me to respond. As for the OUG, as you rightly mentioned, there are facility requirements that are quite in detail. You may have seen the OUG already. As for the facility requirements, there are some information that can not be collected from openly published data. For example, whether the physician has 10 years or more of treating dementia, or whether the institution has multiple such full-time specialist doctors. It is difficult to collect information based on public domain information. Facilities have MRIs and doctors who treat the dementia in multiple numbers. Given these conditions, we believe that there are about 1,000 medical institutions that will meet such conditions. Now, as to how to increase the number of such facilities, there are other requirements. For example, receive training by academic societies and ARIA training by Eisai. We would like physicians to receive these trainings, so we will be very proactive in providing information. And regarding facilities, as you may have seen the OUG, within the guidelines, there is also, it is also noted that OUG will be reviewed in the future. Leqembi is to be used safely, appropriately, and we have to build such an environment. And by doing so, we believe that OUG will be reviewed. It depends on how it will be reviewed, but depending on the revision of OUG, we believe that it will be increasingly used by increasing number of facilities and physicians. Now, we would like to entertain the next up question. So the second in the front. My name is Sakabe from Nikkan Kogyo. I would like to pose a question to Mr. Naito. Well, finally, on December 20, the Leqembi is going to be launched. But in looking past the history and the process, how do you think about the Leqembi launch on this day? Well, the Aricept was launched in Japan. That was about 24 years ago. And after that, naturally, like, the R&D people put their priority in the development of the dementia-related compound, the gamma and also the beta, the secretase inhibitor. And then there are two small molecules, low, but they are resulted in failure, and then the, the helm or outcome, the Biogen was taking the lead in the development of this. But then in the United States, it was not accepted, and therefore, there it was, the continuations of failures. And then after repeating the failures, we were able to have a lot of lessons learned. And, well, we learned that we should not repeat these mistakes, and that was the history of the past 20-some years. And then, so like, we thought that the AD in the therapeutic area is like reading a map of the ocean. So you have to really read the tidal waves as well as the depth of the ocean. I think the Eisai is having the most detailed map or the chart of the details of the oceans. So I think the Eisai is possible to bring the ship to the intended land, and I think we do have that kind of capabilities. And I think that was the reasons where we were able to arrive at the success of the Leqembi. Of course, we are very happy to see the Leqembi launch, but it took 20-some years until we arrived at this stage. And then we had to go through the various failures and mistakes, and that is where we have some reflection. But without these mistakes and failures, we were not able to come up with this Leqembi. So once again, well, we are really thinking how many efforts it takes to do this kind of drug discovery. Next question, please. I am Murakawa from Kyodo Press. Leqembi target population, how large is the population in Japan, and how many people will be receiving Leqembi exactly? What is your final estimate? Could you also give us the reasons for making such estimates? That question will be addressed by Mr. Yusa, who is responsible for Leqembi commercial activities in Japan. Thank you for your question. Once again, this is Yusa speaking. As for the target patients, including potential patients, that is how I understood your question. According to Japanese publications, the most reliable epidemiological survey covers AD, including MCI, and 7.5 million, the million is the number for 2025, and early AD and MCI are about 40% of that population, which means that there's about 3 million early AD and MCIs. These are all dementia patients, and about 67% of dementia patients are said to be Alzheimer's disease dementia patients, according to paper publication. So it means that there are 2 million AD patients, and amyloid beta pathology will have to be confirmed. The probability of confirming AD pathology is about 60%, which means that it may be about 1-1.2 million who may be eligible for Leqembi. However, as mild the conditions are, it is less likely that they will go to doctors, and that there is also OUG impact. All of that taken into account, the peak patient number is estimated to be 320,000, 32,000. 32,000. But regarding OUG, it may be subject to change going forward. And the 32,000 patient number, the rationale for the calculation. First of all, earlier, as Naito, Mr. Naito mentioned, in around 2026, we believe that a blood-based A beta pathology confirmation will become possible, and that will bring about a major change in treatment and diagnostic environment. Maintenance therapy and subcutaneous administration are being developed right now. These are not taken into account. According to the current approval and current OUG, the estimate was made. And in an appropriate fashion without delay, we will be making our most efforts, so we can deliver Leqembi to those who need Leqembi. Now, we would like to go on to the next question, please. My name is Mochizuki from the Mix, and I would like to ask Mr. Naito. As for the pricing, the value-based pricing is, I think, that you would like to see, and then you try to claim that. But then it seems that the value based is not being taken into considerations on the NHI pricing. However, on the other hand, I think the premium for the usefulness was close to the top. I think now there is going to be a discussion going on to the cost effectiveness. So do you have any opinion on those points? Yes, thank you. Now I would like to give the responses. So as was discussed, at the present moment, the revenue at the peak is going to be JPY 198.6 billion. And then so that, I think that the total of the compound price on the NHI is about JPY 1 billion. So it is not a level to give a pressure on the healthcare cost. And the Leqembi, in case of Japan, the impact or the value per person is going to be JPY 4.68 million, and that is how we are calculating. So this JPY 4.68 million well was calculated from the WTP, the Willingness to Pay. So it is about JPY 15 million of the WTP was utilized. So this is somewhat different from the threshold in the past. I think into the future, it will be necessary to have due discussions on the gaps of the WTP threshold from the conventional ones. This NHI pricing, as well as the value, if you look from that point, then I think half of that value was allocated to the public stakeholders. That is the patient and also the families, as well as the insurers and government and healthcare providers or the caretakers. Well, subtracting the consumption tax and also the logistics or distribution cost, the remainder is going to be allocated to the employees of the Eisai. In other words, that one half is going to be returned to public. So, because of the increase in the quality and also, the reductions of the healthcare-related cost, through that, we think that we will be able to contribute to the society here in Japan. On the other hand, as is discussed, the OUG or the all-case surveillance, on that, there was a very strict criteria being assigned for the introductions of the Leqembi. Therefore, the due resources have to be allocated. And then also, because, there's a strict requirement of where the prescription can take place. So I think, that the numbers of the medical institution that can prescribe the Leqembi is going to be less than what we first assumed. So I think, it is very important for us to be thinking very strictly about how to manage these business. Did it answer to your question? But if you have any expectations to the cost-effectiveness discussion, could you please give your viewpoint? Yes. As for this cost-effectiveness, there was a model that has been discussed in the past, and then also we utilized the AD simulation model in the calculation. And there had been some overlap and some differences. And then also the main indicators, specifically the Willingness to Pay threshold, which one to be utilized, was discussed as well. So there were many discussion points, and we hope that this is going to continue, and we are planning to have more discussions. By the way, in the U.K., the Life Science Council, the Life Science Industry Council in Great Britain, so I participated for more than 20 years as the representative of the industry in the discussions between the public and private. And then there's a NICE in the U.K., and it is utilizing this cost-effectiveness models. And then vis-à-vis to the Great U.K. government, I said, I said that the threshold of the WTP is too low. And I hope that in Japan, we would be able to have this kind of discussions, and we hope that the industry representatives also will be included in such discussions. We would like to take the next question. Hasegawa from Yakukeizai. I have a question for Mr. Naito. Peak time sales is estimated to be close to JPY 100 billion. As a company, in the next fiscal year, in fiscal 2024, what is the number that is expected? Under the OUG, strict conditions are given, but what is your prospect of going above JPY 100 billion in sales? Once again, I would like to ask Mr. Yusa to address that question. Thank you for your question. In fiscal 2024, as for fiscal 2024, we do not expect much change in OUG within fiscal 2024. And, in terms of number of patients, we believe that it will be between 4,000 to 5,000 patients. But after we actually start selling Leqembi, we will be able to see the development of the situation, and after that, we believe that we will have to revisit our forecast. I will take the rest of the question. Yes, please. As Mr. Yusa just mentioned earlier, in treating and diagnosing AD, there is a landscape where there are two that can be game changers, potentially. One is subcutaneous administration with auto-injector. But then, at home or at a nursing care facilities, Leqembi can be given without patient having to go to hospitals. It doesn't require infusion, so infusion process can be eliminated. This will increase the convenience of Leqembi substantially. That is one potential point. This is not included in our forecast of max peak sales because this has not been submitted for review in Japan yet. We plan to file submission soon in the United States. Another is blood-based biomarkers. If a BBM can be used for confirmatory testing, then PET or CSF can be simplified. And physicians, the number of physicians who will treat with Leqembi is likely to increase. Auto-injection is possible, and with blood-based biomarkers, diagnosis is possible. If that becomes a reality, then the heavy requirements under OUG may be relaxed. There is such possibility, and in around 2025 or 2026, I believe, such possibilities may be realized in the society, and this can be a strong upside factor. So if these two are satisfied, what is your expected peak sales? Can you give any indication? That potential is what we are in the process of calculating. Once we have more firm ideas, we would like to communicate to you. Now, we would like to move on to the next questions, and there are two questions, people raising hands. So after this, entertaining these two questions, we would like to move on to the questions from online. My name is Sakata from the Yakuji Nippo. I would like to address my question to Mr. Naito. Well, you have gave a look back on the process coming to this Leqembi, and I believe that it was a very long journey. But despite the failures, you were able to continue, and what was the source of this engine? And what roles do you think you played in this process? And then also, what do you think is going to be your role going forward? Well, as I mentioned in my presentation, I think that we were able to spend some time with our patients and our family members. And by doing so, we were able to, well, emphasize with them, and then we also were able to know the true feelings of patients and family members. Also, at the same time, we were able to hear their voices and what expectations they have towards us. And I think that was the source of the energy. And then, so if we have this kind of empathy relationship, then we are going to look into the same future. And the future is to have a compound, such as Leqembi, which address the very cause of the pathology. And then at the very end of the tunnel, that the dementia or the AD will be cured completely. And that is the dream the patients, as well as the family members, have. And we are having the same aspirations and the dream. So we are developing the Leqembi, but then, so we are targeting tau and microglia and synapse. So we would like to challenge to the multiple target of the pathology, and not only for the early AD, but then the preclinical, the earlier, and then also at the late stage of the AD or dementia. And we would like to continue challenging the development of the compound targeting these disease stages. We don't know until when we can do so, but, it's not that we has concluded, the treatment of AD with AD, Leqembi. Well, I said that these are the multiple target, and then also this is a progressive pathology, so there are some untapped area and stages of the disease. So our challenge is continuing, and we would like to continue the challenges, and I would like to pass the baton to the next, person if the time comes. Final question from the attendees in this room. Honda from Yomiuri Newspaper. About details, I have a question. On page six, e-learning is already published. Leqembi administration conditions include imaging or training, and is this referring to that imaging training? When will that imaging or training begin? And is it possible that Leqembi is given as early as before the end of this year? What are your expectations? First, Mr. Yusa will address your question. Thank you for your question. As Mr. Naito earlier explained, e-learning will be provided, and from medical.eisai.jp, which is a website dedicated to healthcare professionals, training already exists. It is already open, and we have 106 or 108 materials. PowerPoints are available on the website. A video and explanatory narration will be provided for training, and that will be made available before drug listing. So at the time of the drug listing and launch, it is possible that people have received the training. And as for prescription before the end of the year, in some institutions, they have indicated their willingness to start treating with Leqembi before the end of the year. And the contract for all-case surveillance will have to be concluded. Obtaining approval from the facilities for such a contract, we hope that treatment can begin before the end of the year. We will now take questions from those who are participating online. If you have any questions, please click the raise hand button. So JP Morgan, Mr. Wakao, please. Yes, my name is Seiji Wakao from JP Morgan. Thank you very much. I would like to give a confirmation and then followed by question. About the SC, the filing to January and to March, so there is no change on this timing after that the FDA confirmation? Because I think in the November explanation, you said that if you're going to have a FDA meeting. So if after the talk with FDA, still the January to March is okay. And then also China and Europe, I think there are, you are yet to launch. And however, in the U.S. and also in Japan, you have the price. But then when do you think that the business of the Leqembi is going to be in alignment? And then I think, like, you were spending about JPY 70 billion for the R&D, but do you think in the next term, you will be able to turn the ink in black? Well, first, about the confirmation or clarification. So, Mr. Ogawa, from the Clinical Development Department. Yes, my name is Ogawa from. I'm the head of the Japan and Asia Clinical Development Department. As for the SC administration, we did have a meeting with the FDA, and there are some confirmation items that we have to come back to. But then, we would think that we will be able to launch within this end of this fiscal year. And the second question was about when you are planning to. When are you expecting the profit? Whether it is going to be the next fiscal year. So, the Keisuke Naito, the Global AD Officer, is going to respond. So are you saying, including the Asia business? Yes, I am asking about globally, when can you expect a profitability? Well, as early as possible, or, of course, preferably next fiscal year. That is what we would like to do. But, I would like to add, FY 2024 we have to invest a lot of resources, and that is natural because we are really putting our bets on this Leqembi. But of course, we would like to be very cautious and make all our efforts so that it is not going to give any financial damages to our business. Then the Leqembi R&D and marketing for those areas, we are going to put a priority on Leqembi. In order to observe and in order to have a very good P&L, we are going to put all out efforts. In other words, that you are saying that you are spending certain expenses, but also you are expecting to have an increase in the sales and revenue? Yes, of course, for that, we are putting our utmost efforts, so please, try to observe and have how we are doing. Okay, thank you. Next, Mr. Muraoka from Morgan Stanley, can you hear us? This is Muraoka from Morgan Stanley. Can you hear me? Yes. Thank you for taking my question. Earlier, you've mentioned that in Japan, you expect the patient number to be 4,000-5,000 next year. You've also mentioned that you are making utmost efforts to increase sales. 4,000-5,000 patients in Japan, well, in Japan by March, 10,000. It seems to be a rather ambitious target, but because of that target in the U.S. that you expect to achieve, are you expecting 4,000-5,000 patients in Japan next year? Or is it this aspirational target? Are there any reasons behind these numbers? If you could share those with us, please. Mr. Yusa will first respond to our intentions for Japan, and Mr. Yasuno will address a question regarding the US. Thank you very much for your question. This is Yusa speaking. Earlier, I've mentioned the patient number of 4,000-5,000. Currently, market size estimate is about seven thousand for the fiscal year, and 7,000 is not based on the figures in the United States. As I mentioned earlier, OUG was expected to be stringent, and based on that, we also looked at market and the frequency of receiving tests, consultation by physicians, and the probability of patients migrating onto testing. For two fiscal years, we have calculated the number to be 4,000-5,000. Mr. Yasuno will address the situation in the U.S. Mr. Muraoka, thank you for your question. 10,000 patient number, is it likely to be achieved in the U.S.? Inclusive of that question, I would like to address your question. This is Yasuno speaking. As Mr. Naito explained today, the Leqembi is progressing steadily in the U.S. at a pace higher than the monthly plans. IDNs, integrated delivery networks, and in addition, community neurologists are both our focus areas, and together with healthcare professionals, treatment policies, SOPs, and processes for MCI early AD treatment are being established together as an infrastructure for AD treatment. And we are putting very strong efforts in preparing the environment. Field neurology account specialists and market access teams and clinical educators, these teams, in a multi-faceted fashions, are visiting neurologists, infusion centers, and clerical staff. So, including the diagnostic measures such as dementia scoring and administration method and how to monitor ARIA, and from neurologists to infusion centers, the flow of patients, all of these are being discussed by our people with the healthcare professionals so that our treatment is smooth for our patients. As a result, there are around 100 main IDNs, and out of 100 main IDNs, about 60 IDNs have included Leqembi in formularies after approval from P&T, and we have received our orders. As for number of physicians who are able to prescribe Leqembi, even before full approval, or in comparison to before full approval, the number increased by 2,000 or 2.5 fold. As for insurance coverage, in addition to Medicare, Medicaid and Veterans Affairs insurance are also fully reimbursing Leqembi, and including private insurance, more than 90%, 90%-93% coverage is now achieved. Furthermore, in October, amyloid PET- Amyloid beta PET restriction was lifted, and the number of amyloid beta PET test, the number has increased in comparison to before by significant margin. And according to recent information, it has increased to close to 1,000 tests per month. As a result, at the time of the earnings announcement previously, in comparison to the number announced at that time, in just one month's time, the number of patients has increased almost at a pace where number is doubling. And in October, November in the coming months, in December, January, we believe that there will also be a fast pace of increase of patients receiving Leqembi, and we are more confident that we are able to achieve the patient target number. Thank you. This is question for clarification. I think 800 was the number as of October 27th, and you have suggested that the number is now 1,600 in November. As of the end of last week, it is close to 1,600, and it's almost doubling. Thank you. Then next, Tsuji, Mr. Tsuji from the Asahi Newspaper. Can you hear me? I'm Tsuji from Asahi Shimbun, Asahi Newspaper. Yes. Can you hear me? Yes. Well, it's a detailed question, but I would like to make some kind of clarification. You mentioned that based on the OUG, within six months, the number of the medical facilities where the prescription is possible, I think you said 1,000. So today, for the three months, I think that where you submitted to the Central Social Insurance Medical Council that the prescribers will be 400. So 400 prescribers and 1,000 clinical medication. And then you've mentioned that you're going to give a registration so that it is possible to find where the amyloid PET can be conducted. So, also taking that into consideration, can you give the more accurate number? Mr. Yusa is going to explain. So first of all, about the 1000 institutions and 400 prescribers, well, more in the detail, as I mentioned, like, there's a requirement of the OUG, and to, a nd it is very difficult to assume how many institutions would be possible. But then there is, like, the specialists where they will be certified by this for a society congress. And then that is going to be 1000. And then, so for the coming 3 months, we don't think, or 3 months from the launch, we don't think that it will be adopted for one thous- by the 1000. But then, so, we have to do the all-case surveillance, and then also, we are going to give some training and then prescriptions, and then it is going to be 400 gradually. And then whether it is possible to also search in the net, well, I mentioned, the adoption is going to be gradually, step by- so it is not that we are going to publicize the where it is possible to prescribe at initially. Because then there will be a lot of patients going into that site. So we are not planning to put all the possible prescribers and sites. But then I think, when the patient is going to go into the disease center, there will be some questions asked by the patient. So at that time, we would like to convey also where the patients can go, and we would like to introduce the where the clinical institutions, where the all case surveillance is finished. And that answered to your question? Yes. Shimayama from Sophia University. In the interest of time, can you limit the number of questions to one? Shimayama, can you hear me? Yes, I can hear you. Can you hear me? Yes, please go ahead. This is Shimayama. In the United States, regarding the access to the drug, I understand that there is a regional difference according to what was discussed in the last presentation meeting. In Japan, well, in 2020, amyloid PET facility, there was only 10, and now 84, and by the end of this year, 110 facilities will have amyloid PET equipment. According to your estimate, in terms of 47 prefectures in Japan, regarding this network of institutions for amyloid PET testing, which region is more advanced and which region is lagging behind? Shimayama, thank you for your question. If we specify, identify our regions, we would like to refrain from doing so. Thank you. Understood. Now, Sogi, Mr. Sogi from Sanford C. Bernstein? Yes, I can hear. Can you hear? So, in your presentation, you mentioned about the Biogen MR. There will be 15 Biogen MR who are going to do the promotion here in Japan. But this 15 will serve the same roles as the Eisai's MR, or this Biogen 15 MRs are going to do some different activities from the Eisai MR. And with regards to the collaborations in United States, are you doing the same thing? My understanding is that in the United States, the Biogen promotion, the contribution is low. So what role is Biogen playing in the United States, specifically in terms of the commercial activities? Now, Mr. Yusa is going to answer about the activities in Japan, and Yasuno is going to briefly respond to the activities in the United States. Thank you very much for your question. Well, about the Biogen 15 MRs starting September, they started the activities, and we are doing the activities together. And the roles is exactly the same as the specialist MR in our company. Now, Yasuno is going to respond the activities in United States. At the present moment in United States, the Eisai resources or with the Eisai FD, we are co-conducting the activities. Thank you. Thank you. Well, additional question. So you mentioned that in the United States, the all resources are coming from Eisai. Is it because it is sufficient, or are there any other reasons? Well, at the present moment, as we mentioned, today, that first we have to establish the diagnostic and the treatment pathway, and then also to establish infrastructure, and then also try to do together with a community neurologist. So at the present moment, we think that our resources would be sufficient and appropriate. Thank you. Well, but however, the cost is shared. So, the cost or expenses are shared in equal manner between the two companies, but then the actual activities are conducted by Eisai. Okay, thank you very much. So now, because of the time, we would like to end the Q&A session. And so if you have any further questions, then please contact the IR and PR. And with this, we would like to end today's session. Thank you very much for coming out of your busy schedule.