Thank you very much for coming despite your busy schedule. It's time. We would like to start the Eisai conference for media and investors on traditional approval for LEQEMBI in the U.S. Today's session is in a hybrid manner, onsite and online. Those who are taking part in the meeting on- site, you have a handout, so please confirm them. Those who are taking part in online, please continue the viewing of the meeting. Let me introduce the presenter and the director, represented by Corporate Officer and CEO, Mr. Haruo Naito. CEO Naito, the floor is yours. LEQEMBI, we obtained at the traditional approval of LEQEMBI. I would like to explain. On 6 July, by the FDA, I am extremely happy to announce that Eisai has received the approval. Since the Aricept research, it's the late 1980s, in the past 40 years, it is a great pleasure for those of us in the pharmaceutical industry, particularly those of us who have interacted with the people living with Alzheimer's disease and their families for many years, to finally offer a treatment that addresses the underlying pathology of Alzheimer's. We will do our utmost to deliver, it is our pleasure. Also that we will do our utmost to deliver this important treatment as soon as possible to more patients in the U.S., for whom it is indicated, in order for patients and their families to fully realize the benefit it may provide. Once again, I would like to give you the recap of the benefit of LEQEMBI. As shown in the phase III, and for the Clarity AD trial, this was the largest global study, we call the CLARITY trial. As you see on this screen, the LEQEMBI demonstrated the efficacy across all endpoints, including a primary and then all key secondary endpoints with a satisfactory, significant result. On the far right, additionally, all the p-value, and then really the robustness of the result for the committees when they accept the p-value, has to be below 0.05. That is the one of the condition. Well, let's say if there is less than 0.1, 0.01, the data itself is quite innovative. Having said that, p-value is, we have four zeros. It is indeed. I've been in this industry for many years. This is unprecedented. This is the really, this is the truly, statistical significance we demonstrated. ARIA, this is the amyloid-related, the imaging abnormalities. This is the, in short, ARIA, the incident rate is low. That's what we understand. Our clinical benefit, this is the aggregate form of the Aβ from the brain that continuously accumulates in AD, we have a robust amyloid beta removal. That will lead to clinical benefit. If you draw your attention to our primary endpoint, CDR-SB, there was a reduction in clinical decline on the primary endpoint, was 27%. For the, all the loss of the orientation and the social activities, there are so many aspects that the physician will test. It's all the accumulation. This is the, one of the assessment scale. This is the most used Alzheimer's assessment scale, here, CDR-SB. 25%, 27% of the decline was demonstrated. That will means that suggesting that the patient remain in the earliest stage for two to three years longer. As discussed by the FDA's advisory committee, the risk benefit profile of the LEQEMBI was established, and also the phase III clinical trial data are considered clinically meaningful. That was the conclusion. Additionally, the key point is that the results show a reduction in the clinical decline in ADCS-MCI-ADL. For the care partners, which is assessed by the care partner, just to observing how the patient is going to grocery shopping. Based on that, so those scaled assessment was clinical decline was at 37%, and also as well as a exploratory QOL-related endpoint, such as daily activities. It's called the EQ-5D-5L. The, really, the, it was a decline by 49%, and also the Geriatric Depression Scale, it was at 38%, and the QOL-AD was 56%. Indicating a reduction of decline in daily activities and the quality of life for patient, this suggests the potential for significant reduction in the... This is the, really, the clinical benefit. Looking at the modern society, now, Alzheimer's disease costs associated with the AD nursing, including family members. Invisible cost, it's not really the cost, it's not substantiated. In Japan, those costs comes to JPY 7 trillion, or looking at the national reimbursement, the half of it would go to for the Alzheimer's disease. This is the really financially and social burden, and also that leads to care partners' burdens are really coming from the AD. This, really, the result suggests to mitigate those burden. As I said before, LEQEMBI is a clinical meaningful. Even for the aspect of the nursing care, the social value we can create through LEQEMBI. Next. Regarding the traditional approval label, I would like to point it out. For our accelerated approval was based on a reduction of the Aβ plaque in the result of phase II study. This time, our traditional approval was granted in accordance with the result of the confirmatory phase III. There was a really with this phase III study, demonstrated the slowing of progression. That is really the key aspect and then difference from the accelerated approval. Indication is for the, LEQEMBI is an indicator for the treatment of Alzheimer's disease. This is the treatment with LEQEMBI should be initiated in patient with a mild cognitive impairment or mild dementia stage of disease. That population in which treatment was initiated in clinical trial, those dosing administration, it is administered. In patient with a confirmed presence of amyloid beta pathology, 10 milligram per kilogram is administered as an intravenous infusion once every two weeks. No titration is required. From the initial dose, and then there is no need to titrate. Regular monitoring of amyloid-related imaging abnormality, also known as ARIA, by MRI, and also. Prior to the fifth, seventh, and 14th infusions, once the treatment started. Compared to placebo, the most common adverse reactions at approximately 10% and higher incidence compare are infusion-related reaction. It's quite mild. As I mentioned before, ARIA, mainly asymptomatic, and then some are symptomatic, such as headache, or it's rare, serious risk, but it's rare. Once again, headache. In addition, that label contains a boxed warning regarding the occurrence of ARIA in regard to anti-amyloid beta antibodies. I would like to talk about, continue to talk about the boxed warning. For this boxed warning, it's for the entire anti-Aβ antibodies to for the ARIA. This is the we have to take a cautionary action. ARIA, the timing of the incident is, we have to be very careful. So it is the, really, the we understand and note that the. It is important to note the genotype of the APOE4 homo patient is about the 10%. APOE4 homozygous. Also that the patient who are APOE4 homo are believed to account for approximately 15% of AD patient, and have a higher risk of ARIA compared to APOE4 heterozygous and non-carriers. Genotype testing should be performed and prior to initiation of the treatment of LEQEMBI to inform the patient potential relative risk of developing ARIA across those APOE4 genotype. Prior to testing, presenting a physician should discuss with the patient the incident of ARIA across genotype and the implication of genetic testing result. After the genetic testing result, the administration decision should be made. After providing the patient with the information about the benefit and relative risk of the treatment. If the patient is found to be APOE4 homozygous, administration should be made after the providing the patient and the family with the information about the consequences, risk, and the benefit of the treatment. It's rare. There is a serious side effect, and that makes sure that the knowing, the understanding, and then make a final decision. In the U.S., it was the first to obtain the traditional approval in the U.S. This is the first anti-amyloid beta drug. This is the, really, the purpose is to reduce the amount of the amyloid beta plaque in the brain. Make sure that the, all the urge, the consideration of the establishment of the benefit of LEQEMBI for the treatment of Alzheimer's disease, and the potential risk of a serious adverse event associated with the ARIA, when deciding where to initiate treatment with the LEQEMBI. Eisai will work with the prescribing physicians to fully communicate any information with a high level of transparency and trust based on our human healthcare concept. An example of this is the development and the deployment of an Understanding ARIA. This is the multifaceted educational initiative to further advance the understanding in healthcare professionals of the real-world management and monitoring of the ARIA, called Understanding ARIA. So far, we received an access of 5,000 times. Understanding ARIA is the imaging expert and core subject matter expert. The clinical study and materials and programs are provided in a real world setting to reduce the risk of ARIA. This program has been significantly contributing for that purpose. For novel innovative track, the having a boxed warning is not the rare case. Referring to the latest example, approved by FDA in 2022, the 12 out of the 32 new drugs, accounting for 32%, particularly including the eight out of 19 first-in-class new drugs, accounting for 42%, have a boxed warning. I would like to talk about the readiness for access expansion after traditional approval in the U.S. After the accelerated approval in January, we have been preparing for expansion of access since then. The diagnosis, infusion, and monitoring, preparations are on progress, so far, 1,200 neurologists are ready to prescribe LEQEMBI. This figure will grow moving forward. Integrated Delivery Network adoption, this is quite important, so we are working towards that proactively. Besides, training for infusion center and facilitate understanding of ARIA, Understanding ARIA program, are proactively implemented for the purpose of a correct use of LEQEMBI. Furthermore, in the field, regional thought leader liaisons, neurology account specialists, market access, medical and MSO, are utilizing digital tools and multi-layer, digitally enabled an approach. Preparing for the launch of the product. As I mentioned earlier, IDN. The important in the IDN in the U.S. are at 200. There has been increasing the number of IDN adapting LEQEMBI prescription. An insurance coverage for LEQEMBI initiated by Medicare. According to CMS, on the day of granting full approval or traditional approval, reimbursement started. That was a common being released, and that was actually practiced. Mild cognitive impairment or early AD patients, LEQEMBI access will be promoted or accelerated. Registry portal is quite simple and easy to use. The information requiring input is within the conventional range of the required information on the medical record, so burden is limited. Actually, this morning, I viewed CMS video by getting access to the portal site, particularly reviewing the instruction video, and the total length was less than 10 minutes. It was very easy to understand instruction. The input required time. When you get used to it, then it should be completed by five minutes. HCPs and staff members require five to 10 minutes to input necessary information. As for information input, that is now to be done at once in every six months. Information update will be made in every six months, so no complex input is required. J-code, and now this is quite important to reimbursement. The invoicing code is attached. This is already assigned, so from today, reimbursement is available. Practically, it is now quite in a practical registry in a portal that can be used and from the day one. In conclusion, allow me to serve you as Eisai. Under the corporate concept of HHC, we have been working to relieve the anxieties of AD patients and their families as our priority. All employees spend 1%, which is approximately 2.5 days in a year, of their working hours on spending time with patients. Through this, we have gained a deeper understanding of the true feelings of the patients and their families, and build relationships based on empathy. Now, we are proud to offer LEQEMBI and the traditional approval in the U.S., providing these patients as important AD treatment option, which they have been anxiously waiting for. We are committed to closely collaborating with patients, their families, care partners, physicians, nurses, payers, and the governments to ensure that LEQEMBI achieves its maximum impact in helping the AD community. Last but not least, we appreciate the collaboration with our global partner, Biogen and BioArctic. Thank you. Thank you. We would like to move on to a Q&A session. Please ask one question per person. If the time allows, you may ask another question. First, we would like to take question from the floor. We have a runner to present the microphone. Make sure to you address your company and name, and then please take off your face mask for the volume purpose. Let's the second from the window side, the person in the front on the right-hand side. My name is Zaki of Asahi Shimbun. Since I have one question, so how did U.S. inform the update back in 2021 accelerated approval, and this time, as I led for this approval? Back in 2021, for the accelerated approval. What worked well, and then what worked better compared to 2021? Just looking into this traditional to approval, if you can share your comment. Mr. CEO. Early this morning, I think it was 4:15 A.M., Ivan Cheung in the U.S. and also Lynn Kramer, Chief Clinical Officer, they informed me for the obtaining traditional approval. Label discussion has continued with the FDA. At the end, we, the FDA, granted the traditional approval. I was nervous, and I was anxiously waiting for the result. I am relieved, or I could really achieve my mission. The previous approval, just to compare with the previous approval, Clarity AD study, this is the phase III study. This is, just to think back, during the pandemic, COVID-19. The peak of the pandemic, that was when the phase III study was running. They centralized the clinical trial. The most of them were diagnosed remotely. Assess, confirm clinically, and then assess safety. Of course, that we obtained the permission from FDA, and also administration. HCPs won't visit the patient residence. However, we really increased the number of the enrollment because of that, but we could follow our timeline to complete the study. All the endeavors get together, that went to our Clarity AD study. That just came to my mind. Clarity study result, as I said before, it was in my opinion, that was a perfect result. This was the robust data we obtained. It tells the entire story. The LEQEMBI, we would like to offer as many as possible. That is the, what the label is saying. Also the CMS reimbursement endeavors, that's all the really the result of the all the different aspect. Let's move on to the next question. There was a second row by the windows. Thank you. JP Morgan, Watanabe. Congratulations on receiving the traditional approval. This is a symbolic event for Japanese pharma industry. I have a question on diagnosis. Gene testing and PET are used. As for gene testing, I think this is a newly recommended one. Gene testing, penetration into the marketplace, would you play the proactive role for the better penetration? Amyloid beta, when the reimbursement timing, would you anticipate? As for gene testing, there are a number of approaches available. PCR, immune assay, those are the conventional approaches. Multiple companies are offering this service, as well as in the reimbursed. Under the accelerated approval environment, after conducting gene testing and infusion took place, that's the majority case. By doing so, whether the infusion decreased or not, actually, that is not the case. Through the introduction of gene testing, there will be huge economic burden. This will not cause the huge economic burden for the patients. As for the subject population, for infusion, no major impact on the figure. As for PET. In the current reimbursement environment, CMS is announcing to relax their current environment, but the substance hasn't been announced yet. Having said that, at the next chance or next opportunity, not too distant future, I hope, PET reimbursement condition is anticipated to be mitigated. Alzheimer's disease diagnosed and treatment, the situation will be hugely improved. That's our assumption. Thank you very much. In several months' time, could you give us a sense? That's the point we want to know, we're eager to know. No, that is a decision, to be made by CMS, so it's hard to anticipate, but we hope as early as possible. Thank you very much. Let's move on to the next question. Second person, the second row. My name is Muraoka of Morgan Stanley. First I would like to extend a big congratulations for the approval. This drug, in order for to offer this product as many patient possible for the subcutaneous and also the study result of the maintenance dose. For the, at this point, for the subcutaneous indication, do you have any timeline, the timing? If you have any update, would you please share with us? We have already announced there is no change. W e are going to submit NDA filing within the end of this year, that means that the next March, can we expect anything from at the CTAD? Are you talking about the data? Now I would like to hand it over to Ivan Cheung in order to answer to that question, please. Ivan? Thank you very much for your question. We are indeed planning to share more data about the subcutaneous auto-injector formulation at CTAD later this year. As you know, in the current open label extension study of Clarity AD, we have the subcutaneous auto-injector cohort enrolling both patients converting from IV into subcutaneous in the open label extension, as well as the de novo patients newly recruited into the subcutaneous cohort. We can see the data of subcutaneous in both settings. Thank you. Thank you for that. Moving on to the next question. Person sitting in the front row. The second from the front. My name is Sakai from Credit Suisse. Since the accelerated approval in the U.S. hospitals, LEQEMBI has been utilized inclusive of the reimbursement. I think at the military hospital, this LEQEMBI has been utilized on a almost a full-fledged basis. Now, how is the progress of the prescription in the U.S. so far? At the last session, Mr. Ivan Cheung mentioned the accumulated number of the patient as of March, it was in the 10,000. Are you on track of that? I also would like to invite, Mr. Ivan Cheung, to respond to the question. Thank you for the question. We believe to get to that exit number of 10,000 individuals, the work starts now, with the traditional approval, and most importantly, the broad access by the CMS, as you heard from CEO Naito earlier. The past six months under accelerated approval, yes, of course, we have patients on LEQEMBI, but the primary goal in the past 6 months have been to get these health systems across the country ready for the patient journey. We've made good progress, so, starting tonight, tomorrow, we will be working very hard, to start, helping health systems across the country to bring these patients onto LEQEMBI. Thank you very much. Uh, VA. VA. VA. VA. Ivan, could you please, touch on the VA? Yes. With regard to the VA, as you know, the VA allows use of LEQEMBI under a criteria that the VA has published. Similar to other health systems across the country, the VA is working towards setting up the patient journey in different VA hospitals across the country. Thank you. [Foreign language] Next one, the third from the front, by the window. My name is Harada of the Credit Suisse. Congratulations on the traditional approval. This time, according to the Nikkei paper, in the U.S., you are equipped with a 400 MR in place. What is really the magnitude of the commercial activities? Not just the MR, but all the medical or the market access in total. You mentioned that the 400 in the past. What is really the U.S. organization, but what is really the 400 personnel can really equip at the magnitude of the commercially? If you can explain, please. Ivan. [Foreign language] Yeah. Perhaps this is for the translation. Yes. Ivan? Yes, this is Ivan. Thank you very much for the question. The 400 number you mentioned covered different teams that you heard from CEO Naito earlier. Not only the MRs, but also different market access teams, the thought leader management team, also the medical teams. In the United States for this launch, the key is to get all the health systems ready for the patient journey. We believe a different model is required, not only based on the MRs, but a multidisciplinary, multifunctional approach is what we will be deploying, which has seen a good success so far, and we will now be expanding that model, and the 400 number is the total. Thank you. Person who is sitting on the corridor side, and the second from the front. Corridor side. I'm Murakawa, the reporter of Kyodo News. After receiving U.S. approval, of course, now there will be increasing expectation in the Japanese market. Now, what is the approval schedule in Japan and opportunity? Could you comment on that? On that question, Japanese AD medical affairs person Nakahama will respond. Thank you for the question. I'm Nakahama. I'm in charge of regulatory affairs in Japan. Japanese, the review situation has been making smooth progress in the amyloid PET testing drug. Additional indication for MCI, we are making on track progress. It's not still under review, so I apologize that, and I'm not enabled to disclose the details, but, we are at the final phase. In the committee and then the meeting by the Minister of New Health. When the meeting is in held, a month in the prior to the announcement timing, I think, and you can get to know the details. By September, we are hoping to receive approval. The AD patients and family members who are waiting to receive prescription and testing, we want to deliver drugs as early as possible. Thank you. On to next question, the second and then third from the front. My name is Shimoyama of the Nonfiction Writer. Congratulations. Regarding the boxed warning explanation, I have a question on this. According to your explanation, prior to testing, physicians, genetic testing. Undergo genetic testing, and then have a discussion with the patient. Having that result, the patient, they have a right not to go through receiving a genetic testing. That is correct. ARIA, depending on the genotype, the incident rate different from the genotypes. However, patient or a patient family, "Well, I understand that, but no, I do not wish to receive the genetic testing." Even for that situation, they can receive LEQEMBI. For the Alzheimer's genetic testing in Japan, I think the same goes for the same in the U.S. There was really the series of the genetic testing to receive the treatment, but for the APOE4, that's not really follow that patient flow. Once that patient is informed by the physician, and then you can take any options. Well, that's according to part label. Physicians and the patient have a discussion on both end and then come to conclusion. There was no genetic counseling personnel? No. That's Ivan Cheung, would you please give me answer? Thank you. As CEO Naito explained, patient autonomy needs to be respected, and the FDA understands this point very well. Thank you. Ivan, I think in the prior to the prescription, they need to discuss with the patient what is the meaning of the result of the genotype testing, right? Could you please explain that? Correct. As you can see in the box warning, the FDA is asking prescribers, before any testing, prescribers need to talk to the patients about the implications of genetic testing results. Thank you. [Foreign language] Is it necessary for genetic counselor to intervene that process? Lynn Kramer? Michael. Yeah, Lynn. Lynn or Michael. Lynn or Michael, could you please answer to the question? Yeah, Lynn, please. Thank you. There is not a need for a genetic counselor. There is a need, as it says, for first, a discussion, as Ivan said, between the caregiver and the patient in terms of the potential implications of the outcome of the genetic test. After the discussion between the caregiver and the patient, there is a determination whether the patient would like to have the genetic test or not. If the genetic test is not performed, the patient can still get LEQEMBI, but a genetic counselor is not required. Thank you. Okay, thank you. [Foreign language] The person who is sitting in the third row and on the corridor side. My name is Imanaka from Sankei Shimbun. Congratulations on the traditional approval. I'm sorry to ask a rough question. Looking ahead now towards 2013, you target to generate a revenue of lecanemab in the global market at JPY 1 trillion. In the U.S., after receiving full approval, once again, how much in economic benefit would you expect out of lecanemab? The sales projection is, of course, depending upon the eligible patient number. With this assumption in mind, first, the prevalence figure comes first, so millions of the population is available. Learn how many people receive diagnosis, after going through CSF or the PET, or the blood-based biomarker, Aβ confirmation is done. After that, if the Aβ is positive, after consulting with attending doctor, come to the decision to prescribe LEQEMBI. As the time goes by, then the subject population will decrease. Ultimately, from prevalence down to subject, we are currently estimating at 1% to 2%. Such eligible patient number is assumed in mind and multiplied by the certain figure, is the basis of our sales projection. As you referred to, after 2030 until 2032, we are aiming to realize that revenue level on a global basis. Let's move on to next question. My name is Yasukawa of the Nikkan Kogyo. For the Japan approval, I have a question, please. Regarding a price, so value-based pricing, that was mentioned before. For the all the impact on the care, patient care, there was really In order to pursue the premium for the innovativeness, innovation, what is your take on this? As I said before, the product, just like LEQEMBI, the value of the. There was really the medical aspect of the value at the same time. There was a really reduced the burden for the caretakers and also for the patients' families. The family may lose the working opportunities. Used to work five days a week, now working twice a week because of the care for the patient. These are happening. In order to really mitigate that, those situation, that is the value from the LEQEMBI or impact. We should really regard it. Innovative medicine, premium assessment, we have to include that aspect in order to. That we would like to have a discussion when setting a price. Without any rationale? No. In fact, so value-based price, so there was a U.S., $26,500. There was the paper published. Based on that, those, we really with the utmost transparency, this is the U.S. price. In Japan, lecanemab, but the social value can we quantitative. We have already published the article. We have a concise version of the paper. Shukan Shakai Hosho, that is the that was the journal in the beginning of May, of the volume that have already published. I'd like for you to take a look at the article. lecanemab, creating the value creation in Japan. That's it. Those article relatively really explain to the point with this, really the how much you can really extend the life expectancy. What about the quality of life? This comes to the very core. That is the part of the calculation in the article. There's a multiple by the payment. In Japan, it's general, it was JPY 5 million or JPY 5.7 million per year. If you are free from that disease, how much you are willing to pay, or how much that with the worth and to be in the society. There was a really the quality of life, so you can convert it to amount. Also reduction of the healthcare cost, and those are also added, and then divided by the treatment period. That result is featured in a Dr. Igarashi. This is the Yokohama City University Hospital. He's the expert in HEOR, authored this article. This is the one of the rationale. We would like to have a discussion for Japan. Next question. Person who is in the front row. My name is Azuma from Yomiuri Shimbun. Congratulations. I think they just like overlap with the previous question. Subject in the U.S., estimated at $1 million. Target patient is $1 million, but actually prescribed eligible figure is 1%-2% out of the total preference. What is the biggest barrier of the screening and reaching to under 1%-2%? How about the situation in Japan? How much would you estimate an eligible population in Japan? The biggest one is the rate of receiving medical consultation or coming to the hospital. Those who do not wish to be diagnosed as Alzheimer's disease, that's a typical mindset of the people. Early detection and early treatment may lead to the totally different outcome. That is the message we would like to signal clearly by doing so. For example, the people coming to the hospital for hypertension or cardiology diseases or GI diseases. People can feel, I mean, they're relaxed in coming to the hospital, and for the diagnosis and of the Alzheimer's disease. The biggest barrier so far is the people are not coming to the hospital, and for the diagnosing on Alzheimer's disease. Another, the hurdle is the testing, PET or the CSF. Now, the subject is not insurer, then they have to pay a high cost. Aβ confirmation is the term we refer to. Aβ confirmation is a major hurdle. There we will have the big screening of the eligible population. Those are the major barriers from prevalence down to eligible population. The re-estimated ratio is much like the same in Japan as well, as I often say, blood-based biomarker, Aβ confirmation approach, has been making remarkable progress and, partially, and then such approach has been submitted now for approval. If this approach is penetrated, then PET testing hurdle is reduced quite significantly. As a result, eligible population will increase. As for the timing, it should be around 2025 or 2026. That is our projection. Thank you. PET testing, if not that is reimbursed, then would you anticipate having a bigger eligible population? Just to follow up, the genetic testing as a part of a boxed warning. If the same condition is applied now for the Japanese and the patient, that is that going to be perceived as another major hurdle? This is to be responded by Ms. Nakahama, PET reimbursement and genotype testing. Thank you for the question. I'm Nakahama. As for PET testing, additional, the indication expansion and the covering MCI has been filed. We are seeking to receive an approval for the expansion and to be reimbursed as well. Genotype testing, currently it is not approved, so not reimbursed. That said, gene risk testing, we have to provide a thorough explanation, and gene counseling and support now through counseling are recommended. Without not having a structure in place and simply conducting testing, then we need to be carefully examining about the approach. Now we are still under review in Japan. At this point in time, that is our current and the temporary idea to share with you. Thank you. Earlier, Naito talked about the weekly journal. The edition is on the fifth of June. Interest of time, we take a three raise hand, and then all the waiting, Mr. Yamaguchi, waiting online. The first row on the window side. My name is Zawa of the Nikkan. Congratulations. Regarding for the Shakai Hosho, the value of the amount, the maximum is JPY 4.6 million. Naito CEO, according to the article, in that, within that range, what do you think that which will be the figure will fit to the medical facility in Japan? Weekly Shakai Hosho, remember there was a chart. There was a few parameters of the payments, and then there was a three scenario, depending on the type of the payment. There are some options. In Japan, from. If, let's say, if you are free from AD, how much would you put in price? That is the one discussion point. Nursing care, it's a quite broad. Nursing cost, how much you will incorporate it in that payment? When it comes to the incorporated in the reimbursement, we will be able to have a very constructive discussion. Anything else, I would like to further discussion in the foreseeable future. The person who is in the seating in the second row, please. There can be approval. Congratulations on that. The sales projection. My name is Sogi from Bernstein. The sales projection moving forward. This year, targeted number of the population is 10,000 in the U.S. Honestly speaking, I thought it's a rather conservative figure. Against that, is there any rationale of providing an estimated figure of 10,000? For example, PET scan capacity may be the reason. Is there any rationale behind? In Q2 and Q3, according to the announcement, May, this morning, I think there will be the clarity that provided actually the how many the populations receiving the LEQEMBI. How many prescribers and how many patients in the being prescribed? Could you share that figure? On that question, to be responded by Ivan Cheung. Ivan, please. Thank you very much for the question. We believe the exit patient number of 10,000 individuals is a very good number that will show a very strong trajectory going into the next two, three years. As of this moment, we believe we have about 1,000 prescribers who are ready to put patients on LEQEMBI in terms of understanding exactly how to do amyloid confirmation testing, and also how and where to infuse the patients, as well as how and where to do monitoring. For the patients, we believe that 1,000 prescribers number at this moment who are ready, will continue to grow quite rapidly over the next few months within this fiscal year, as the ACI Teams continue to work with health systems across the country to get their patient journeys ready. We believe we will be making very good progress over the next three quarters in this fiscal year. Thank you. Thank you very much. Just to supplement, if I may. Under the accelerated approval, of course, LEQEMBI has been prescribed and without the reimbursement. Then, through the patient assist program, LEQEMBI, they're being prescribed within free of charge. Those who receive LEQEMBI, they on their own. There are the two options. The free of charge, the patients are double than the patients who are paying on their own. The free of charge patients, we believe now they are the quite important ones, because they don't have the sufficient insurance coverage, or due to financial reasons, they don't have affordability, but they need LEQEMBI treatment. Therefore, in terms of ensuring drug access, we need to make sure to appropriately deliver our product. That is the important mission of our modern pharma company. We are taking proactive measures on that. These figures have been indicated. In the U.S. society, the total value to be provided to the U.S. society is not just to be based on the fee being paid, we are offering value which is not charged. Aggregate value has been described on the academic paper in the journal, namely, $37,600. This is the value that we offer. Multiply by the total number of the subject, eligible patients. Multiply by the $37,600. This is the value we created to the U.S. society. That's something we would like to make sure to indicate this, and not just depend on the revenue, but how much total value we created is something that we would like to seek the assessment on that or evaluation on that. Last, from the, from the venue. My name is Watanabe of Nikkan Kogyo Shimbun. Congratulations. My question is the production capability. For the commercialization, is it really responsible by Biogen, or are you going to use the CMO? What is the system you are considering? Once you are commercialized through the approval, are you going to proprietary have a production site? Anyone from the manufacturing? Currently, production API is done by Lonza in Biogen, and also the DP is at the ET. We need to ramp up the production capability. That means they don't have a capability. That means we have to look into the third production side, has been agreed with Biogen. Moving on to online participant. First, I mentioned that there's one person, but actually there are three persons waiting to ask a question. Starting from Mr. Yamaguchi of the Citi. Can you hear me? Mr. Yamaguchi? Mr. Yamaguchi, can you hear? All right. Moving on to the next. Kimura San of Asahi Shimbun. Can you hear me? Moving on. Oka San of NHK. Yes, I can hear you. Mr. Oka, please. To CEO Mr. Naito. Mr. Oka, there is, we can't hear you. Can you hear me? Sorry. We have a difficulty hearing your voice. Medicaid. Can you hear me? Now we can hear you. Could you repeat the question? If this is not workable, I will put my question in chat box. An application or the coverage of the Medicaid now has been announced. Now what is the impact on the Japanese reimbursement? That's a question to CEO. The free of charge in the offering of the medication, even with the reimbursement, there may be the certain number of the population who will give up receiving of the treatment due to the financial reasons. How would you perceive that situation? In Japan, on the drug pricing system, offering with the free of charge, we can't take that option.