Thank you very much for taking your time out of your busy schedule. It is now time. We would like to begin financial results presentation for the first quarter fiscal 2023 of Eisai Co., Ltd. Today's session will be held in a hybrid format, at this venue in person, as well as, virtually online. Please find the materials, circulated to you, for those of you who are in this, hall. For those of you who are participating online, please continue to watch the screen. Let me introduce the directors present from Eisai Co., Ltd. Mr. Mitsuru Shomon, Chief Financial Officer. Dr. Ove Takashi, Chief Scientific Officer. Global AD Officer, Naito, Keisuke Naito. Mr. Shomon, please start your presentation. My name is Shomon, I am CFO. I'd like to give you the financial results presentation for the first quarter, fiscal year 2023. During the quarter under review, Lenvima and Dayvigo grew, and R&D expenses and SG&A expenses were controlled, and we achieved increase in revenue and operating profit, making a good start for fiscal year 2023. Revenue was JPY 196.9 billion, which was up 7% from a year earlier. Below that, you can see the breakdown of revenue. Organic business or in pharmaceutical business, revenue was JPY 181.7 billion. Lenvima and Dayvigo grew, overcoming the negative factors, staying at 100% of the previous year. In other business, revenue, by executing, executing strategic options and also receipt of the one-time payment, JPY 50.2 billion was recorded as a revenue, 541%. Cost of sales was JPY 43.9 billion, accounting for 22.3% of the sales. Through product mix improvement and increase in the one-time payments received, the ratio has been reduced by 3.4 percentage points from 25.7% in the previous year. Gross profit was JPY 153 billion. A double-digit growth of 12% was achieved. Expenses. R&D expenses was JPY 41.1 billion, up 7% from a year earlier, accounting for 20.9% of the sales, the same level as last year's. R&D expenses, including partners' reimbursement, was for JPY 55.2 billion, which was 99% of the previous year. Next, SG&A expenses. There was a shared profit of Lenvima paid to Merck, JPY 32.3 billion, and the shared profit of Leqembi received from Biogen, JPY 4 billion included, and JPY 86.1 billion was recorded, which was 93% of the previous year, accounting for 43.7% of the sales, and down by 6.4 percentage points from the previous year's 50.1%. As has been already reported, due to change in agreement with Biogen, the company ceased to incur anyhow-related expenses by the end of December 2022, leading to significant reduction of expenses. For financial disciplines, expenses in total were at 98%, controlled below the increase of gross profit at 112% of the level a year earlier. Operating profit was JPY 26 billion, which was 350% of the previous year. Profit for the period was JPY 20.9 billion, because there was a repayment of paid-in capital from a U.S. sub last year, leading to decrease in corporate income tax. Therefore, year-on-year change was 75% ROE, although this was the reference value for the first quarter, was 9.9%. Net DER showing financial health was -0.19. We have remained debt-free, and equity ratio was 64.7%, showing the strong financial structure. Next slide. On this slide, we can show you the breakdown of revenue migration. Mainly in the United States, Lenvima grew and Dayvigo grew in Japan, and in pharmaceutical business, revenue was increased. On the left-hand side, at the top, as you see, during the first quarter, fiscal year 2022, revenue was JPY 184.3 billion. For the first quarter 2023, in organic business or pharmaceutical business, Lenvima grew JPY 4.4 billion from a year earlier, achieving 7% year-on-year growth. Dayvigo grew JPY 2.9 billion, which was 145% of the previous year's level, exceeding the impacts of the transfer of rights of Leqembi in the United States and a drug price revision in Japan, revenue grew by JPY 0.4 billion. In addition, in our other business, due to the transfer of all future economic rights for LSS grant, JPY 12.3 billion was recorded. Therefore, for the first full quarter of FY 2023, revenue was increased by JPY 20.7 billion year-on-year, up 7% year-on-year, to reach JPY 196.9 billion. Next slide, please. On this slide, you can see the breakdown of operating profit migration. We made a proactive investment in Leqembi, and increase on operating profit was achieved through increased revenue, as well as cost reduction and reallocation. In the top left, during the first quarter of fiscal year 2022, OP was JPY 7.4 billion. During the first quarter of this year, in pharmaceutical business, OP increased due to the following factors: growth of Lenvima and Dayvigo, decreasing Fycompa related expenses, and reversal of lecanemab-related expenses received from Biogen. We made productive investment as Dupixent-related expenses. The ratio of segment profit to revenue increased to 51.3% from 50% in the previous year, segment profit was increased by JPY 2.5 billion. Next, ex- R&D expenses. Aduhelm-related expenses was decreased by JPY 2.3 billion, increased the Dupixent-related expenses. There was a regulatory milestone payment of JPY 3.2 billion for Lenvima, received from Merck in the previous year. The OP increased by JPY 2.6 billion. Ratio of R&D expenses to revenue is 20.9%, the same level as previous years. Next, group headquarters, management costs, and other expenses. In here, Aduhelm-related expenses or losses and shared profit to Lenvima to Merck are included here. Aduhelm related expenses were decreased by JPY 4.6 billion, R&D and A expenses were reduced. The shared profit of Lenvima to Merck increased by JPY 2.6 billion as a proactive investment into this. The profit increased by JPY 6.1 billion through appropriate cost control while making proactive investments. So far, these accounted for a JPY 6 billion increase in OP. In addition, in other business, as I have explained earlier, there was a transfer of all future economic rights for Elacestrant of JPY 12.3 billion, a 1-time in revenue income. As a result, the total R&D and SD and the expenses invested in the Dupixent at the level of JPY 20 billion. Still, the OP for the first quarter, 2023, was JPY 26 billion, increased by JPY 18.6 billion, 350% year-on-year. Next page. This is the last page. Here is the fiscal year 2023 consolidated financial forecast. The full year forecast has remained unchanged. We will accelerate proactive investment in the Dupixent while continuing cost control. This concludes the financial part. I'd like to ask Dr. Ohwa to explain oncology part next. This is Ohwa speaking. I would like to explain oncology part. First, I'd like to share with you the current status of revenue for Lenvima. With six indications in five cancer types, Lenvima has established a very firm backbone therapy position, and it is still continuing the further growth. On the left-hand side, as you can see in these graphs, for fiscal year 2023, during the first quarter, global revenue for Lenvima reached JPY 70.8 billion, which was 107% of the previous year's level. Very strong growth has been shown. Furthermore, this was the highest Q1 revenue ever on a quarterly basis, and we are making steady start toward achieving the fiscal year full year forecast of JPY 261 billion. In the largest market, the U.S., Lenvima revenue grew 125% of the previous year and are driving the global growth. In the middle, here is the revenue by indication. The blue portion, RCC, and the pink-colored endometrial cancer. In these indications, in terms of the number of new patients, it achieves the largest share by region. In China, although there was erosion by generics, compared to the fiscal year 2020, the fourth quarter revenue of JPY 4.8 billion, revenue in China increased by JPY 2.1 billion, JPY 6.9 billion increase. So in RCC and EC, indications, the number of countries where indications are approved and reimbursed is increasing, making it a key factor for growth. This year, we plan to obtain study OS results and potentially file submissions for Lenvima plus Keytruda combination therapy in 3 indications, which are very important, of mSTLC first line, second line, and EC first line in fiscal year 2023. These studies are ongoing, almost in line with our expected timeline. Therefore, we have high expectation to getting these final results. Next slide, please. I would like to share with you the summary of presentation made at this year's ASCO for RCC. The final analysis data, a 4-year follow-up data of phase 3 Study 307, in advanced RCC, as regards to complete response rate, exceeding the 16.1% at time of submission, a CRR of 18.3% was obtained. Survey was conducted on 440 patients with metastatic RCC on their treatment preferences, and it was found that the most important desire for patients was complete response, that is to say, elimination of all evidence of disease. We believe that this final analysis data of 4-year follow-up shall meet this desire of patients. Furthermore, phase 2 study targeting non-clear cell RCC, which has even higher unmet medical needs, favorable RRL, 49%, and PFS of about 18 months. Very favorable results were shown in this study. We believe that we have been able to strengthen the clinical evidence for non-clear cell RCC. Next slide. This is to explain novel anti-HER2 antibody ADC, BB-1701. Here is the update. BB-1701 is being jointly developed with Bliss Biopharmaceutical, and eribulin, our in-house developed anti-cancer drug, is used as payload, and this is bounded to an anti-HER2 antibody through linker. This linker payload was developed at Eisai's U.S. research site, Exton. This is a proprietary technology platform, and it is anticipated to have anti-tumor effects on breast and cancer, and other cancers that express HER2, based upon the clinical study results that have been obtained so far. Here is the waterfall plot. On the left-hand side, here is the efficacy data that was presented from a phase 1 study, which was presented at ASCO this year. As you can see here, in HER2 expressing breast cancers with a prior treatment, there was the efficacy of anti-tumor efficacy was demonstrated in terms of ORR at 70.5% and DCR at 100%. As regards to safety, most commonly reported grade 3 or severe adverse event was peripheral neuropathy. In recent years, it has been reported as problem with other ADCs, interstitial pneumonia or ILD. This particular AE was not clinically reported in this particular study. At the time of our presentation, we plan to initiate a phase 2 study for HER2 expressing breast cancer by the end of this fiscal year. In line with this, last week, IND was achieved in the United States. Based upon the results from phase 2 study and also clinical biomarker data will be collected, and particularly, the clinical biomarkers for non-responders or refractory to existing ADC, human biology data will be focused. Based upon the comprehensive assessment of this data, we may consider exercising option rights for commercialization and development. Next slide, please. Lastly, towards maximizing patient value of Lenvima, we have intellectual property strategy. This slide summarizes our multifaceted initiatives. First is, utilizing our chemistry capability, a highly pure lenvatinib patent. It says international filing date is August 26, 2015. Globally, expiry is 20 years from this date, August 26, 2035. It is valid in the United States, major European countries, Japan, and several other countries. In this patent, the scope of a claim is lenvatinib mesylate that has a very low controlled level of impurity. Patent covers the composition as well as the manufacturing method. Secondly, we have combination patents with pembrolizumab, utilizing our alliance with Merck. Filing date in Japan is March 3, 2016. Expiry in Japan is 20 years from now, on March 3, 2036. This patent covers a lenvatinib mesylate that is used in combination with pembrolizumab. Regarding the combination of the two drugs, already, RCC and in Japan, uterine body cancer are approved as indications. For future indications, the patent also covers the combination therapy. Thirdly, as in preferential measure for rare disease drug. In Japan, reexamination period is extended by as long as 10 years. In Japan, within the Lenvima indication, and the uterine body cancer and the thymic cancer are recognized as rare disease. For these, for this longer exclusivity than the basic patent expiry can be maintained for lenvatinib. Even after basic substance patent expiry of lenvatinib, we are promoting these IP strategies to maximize the value of lenvatinib, to maintain the effectiveness of the rights and to execute the rights. Final part will be presented by Mr. Naito. Good afternoon, everyone. I am Keisuke Naito, appointed as Global AD Officer. I will be promoting dementia ecosystem development globally, including the Leqembi commercial activities. Based on AAIC updates, I would like to review once again the features and characteristics of the solution, Leqembi, and would also like to touch upon commercial situation in the United States. Leqembi received accelerated approval from FDA in the beginning of the year, this year, and at outcome on June 9. Through the discussion of the experts, it was confirmed that Clarity AD study results are clinically meaningful and that the benefit risk profile is positive. After such discussions, Leqembi was fully approved on July sixth. Leqembi is currently the only AD DMT that has received full approval. There were various presentations at AAIC. Other companies' drug may eventually also receive full approval in the United States. As a result, patients will have more options, and I believe that these will be triggers to build wonderful ecosystem in the future. Given such situation, I believe that we now have an environment already where we can discuss more about the uniqueness of Leqembi. Today, once again, I would like to start by touching upon the characteristics of this product. First, about the origin of Leqembi. Leqembi is a drug developed through drug discovery research approach based on A-beta theory, focusing on the aggregation of A-beta, which is observed in Alzheimer's disease patients' brain as the cause of AD. A-beta goes through formation stages of soluble monomer, oligomer, and protofibril, and become aggregated as non-soluble A-beta plaque. Research by Eisai and BioArctic over more than 30 years have shown that the protofibrils have strong neurotoxicity. In the pre-stage of a plaque aggregation, there are protofibrils that are highly toxic, and selective binding of a protofibril is the MOA of Leqembi and characteristic of Leqembi as AD DMT. Next, I would like to discuss the second part in summary. Before for approval, this part of the Clarity AD study was reviewed, mainly reviewed, for approval this time. In, in regards to, to the protocol, there's no tau PET screening. MCI due to AD accounts for 62%, and CDR-SB, which is widely used in actual clinical setting, is set as the primary endpoint. Diverse population is covered similar to real world. With these ideas incorporated in the protocol, to broad range of early AD patients, it, it similar to actual clinical practice, the study was conducted in a design that is scientifically transparent and highly probable, and it was designed in such a way that fair results are obtained. As for clinical efficacy, all primary and secondary endpoints were achieved. From months, set highly statistical significance has been confirmed, and throughout the broad range of endpoints and subgroups, consistent results were obtained. Regarding ARIA, which is a point of discussion in relation to safety of AD DMT, the incidence was within the expected range. FDA has issued clear guidance, and we believe that this is manageable. As for important in-indicator of antibody medicine immunogenicity, ADA positive rate was 10%, neutralizing antibody positive rate was 4%, and it was also confirmed that such immunogenicity does not affect blood concentration and clinical efficacy. That was confirmed through PK/PD study analysis, and we believe that Leqembi can be administered over long term. In summary, the following is the uniqueness of Leqembi as the first-ever AD DMT in the world, or the uniqueness of Leqembi, aside from it being the world's first AD DMT. First, rather than A-beta plaque, the most neurotoxic protofibrils in the stage before A-beta are selectively removed, and consistent clinical significance has been confirmed in broad, diverse range of early AD patients. Secondly, in the U.S. package insert, ARIA-related genetic background monitoring method and method to respond to side effects, such as infusion-related reaction, are described. That is to say, safety treatment management is established by the FDA, and therefore, we believe that Leqembi is a very easy-to-use drug as the first-in-class drug. This is the second characteristic. Third characteristic is confirmation of significant clinical efficacy in low tau group. On this point, at AAIC the other day, a tau PET study results were presented, and I would like to describe the detail on the next slide. The fourth unique point is the ongoing development to maximize the product value through development of subcutaneous formulation and maintenance dosing regime. I will come back to SC formulation later. Based on these uniqueness, we believe that Leqembi is worthy of positioning as the first-line choice. First, about tau PET subgroup results. The top part shows the accumulation in the temporal lobe. This was presented at SITAT. Lecanemab slows the accumulation of tau pathology in temporal lobe. That was confirmed in the data. In the lower part is an update on tau pathology, which was presented at AAIC the other day. This is the analysis result of Clarity AD tau PET substudy. In group with mild accumulation of tau in the brain, CDR-SB, ADAS-Cog 14, and ADCS-MCI-ADL. In all of the indicators, lecanemab group showed a better clinical efficacy than placebo group. That is to say, from these results, Leqembi in early AD group is effective across broad range of endpoints, and in particular, in low tau group, which indicates early stage of AD, significant clinical efficacy is expected. As for 549%, I believe this is eye-catching. In a nutshell, inactive drug group, this shows the positive direction change in cognitive function. The expression used is slowing of deterioration, it can be interpreted that the results were such that cognitive function was improved. Next, about the SC development. Based on the results of the study presented at AAIC, I will explain together. As for dose setting, based on the analysis using PK/PD model, irrespective of the body weight, 770 milligram weekly SC fixed-dose administration achieved a similar level of Cavg as IV administration of 10 milligram per kilogram biweekly, and a lower Cmax in comparison to IV. Efficacy is known to be affected by Cavg. Therefore, based on the results, we believe that SC will bring about amyloid reduction at the same level as IV. Safety indicator ARIA incidence, it is known to depend on Cmax. As shown on the right side, in ARIA-E incidence simulation results, SC incidence and IV incidence of ARIA-E are shown. Cmax of SC is lower than IV, and we expect that safety profile of SC will be better than IV. In summary, towards the submission within fiscal 2023, I would like to say that SC development is smoothly progressing. Currently, within Clarity AD open label extension, SC study results are being analyzed. Update will be presented at SITAD 2023. Finally, I would like to touch upon the market outlook in the United States going forward. After the accelerated approval in January in the United States, in the US, we have implemented limited commercial activities in Leqembi. Treatment of Leqembi will be shown in a journey, as shown in the slide, to the patient. First, patient, starting from number one, a patient will notice that the symptoms and will seek a treatment at the family doctor. Family doctor will refer the patients to specialist. Specialist will give definitive diagnosis and will administer Leqembi or refer the patients to clinic, which is possible to administer the Leqembi. After administration, ARIA, et cetera, will be managed through MRI monitoring. This is the expected journey, and, more or less, the journeys are happening in actual commercial operations. As shown below, in each step, we also recognize that there are challenges to increase the scope. In particular, Leqembi itself included in various pathway, there, or medical technologies in each pathway are not necessarily covered by insurance coverage, and that economic burden is affecting the journey overall. However, triggered by full approval of Leqembi, market environment is changing significantly in the positive direction from A to F. A to G, we have factors. First, A, this was the biggest challenge, insurance coverage of various technologies. We are seeing progress here. First, as for Leqembi, on the same day as the full approval on July 6, CMS started a broad coverage. PET use was restricted in a major way, but the CMS has announced a policy to review this in the direction of lifting the restrictions. Amyloid CSF testing and MRI are already covered by Medicare. APOE4 genetic testing is conducted in clinical practice as a part of assessment of patients. As for PET, insurance reimbursement, with the PET reinsurance, insurance reimbursement, we believe that there will be greater options for diagnosis throughout the United States. The chasm regarding each step, we are seeing progress after full approval. B, enhancement of disease awareness on MCI and mild AD. Regarding this, we have information site on education about the disease and the product information, leqembi.com. After full approval, access number increased to 179%. Regarding screening tests to detect MCI and mild AD, we are implementing measures to make screening tests widely available, including MoCA and other simplified cognitive function screening. As for environmental development to provide Leqembi, as for number of specialists, in a one-stop fashion, about 1,400 neurologists are able to prescribe and administer Leqembi. As for a better environment, currently, 15 integrated delivery networks have seen Pharmacy and Therapeutics Committee pass Leqembi, and more than 700 infusion centers have started training. In terms of administration of Leqembi, prep, there has been much progress. As for reducing the burden on a patient, as earlier mentioned, SC is developed according to the timeline. Is increased understanding of ARIA by medical professionals. ASI is providing education program called Understanding ARIA, and the access number to this program has increased to 125% of before, and interest in this is increasing quite substantially. As I have discussed, after the full approval of Leqembi, stakeholders such as CMS and IDN are taking actions, and this fact shows the expectations towards Leqembi of patients in the United States and medical professionals in the U.S. That there will be most appropriate access to Leqembi, we would like to develop ecosystem. That will be the highest priority. We believe that we are making good progress towards contribution to 10,000 patients. This is the final slide. This is the summary of the message that I wanted to convey today. On July 6th, 2023, Leqembi received a full approval from the US FDA as first AD-DMT. This has the unique MOA targeting highly toxic protofibrils and establish safety profile. We believe that it will be a potential promising first-line therapy option in the future AD DMT ecosystem. Eisai will continue to work with stakeholders to establish an inclusive treatment pathway, aiming that people with dementia can receive treatment with greater peace of mind. AD DMT is a new approach to AD. By disseminating the value of this, we strive to establish dementia ecosystem, which enables people with dementia to have more options, such as novel treatment agents and solutions beyond drugs. Thank you very much for your kind attention, and I will look forward to your questions. We'd like to open the floor for Q&A sessions. If you have any questions, please raise your hand and state your affiliation and name before asking a question. That person in the front row, please have the floor. My name is Yamaguchi. I am from Citigroup. Thank you very much for this opportunity. As for Leqembi, I have several questions. First, well, I haven't been able to locate the information. Toward the end of this fiscal year, you are targeting 10,000 patients to be treated, and the sales and actual number of patients. If you have any updates on the numbers of these status, could you please give them? For your question, Mr. Naito is going to respond. Thank you for the question. Regarding specific numbers, we refrain from disclosing them. As you see here, there are various indicators in addition to them, and also the number of vials under the AA accelerated approval situation. The number of vials has been quadrupled, almost quadrupled. Regarding the number of patients treated, has increased by about fivefold. Looking at this overall trend, we believe that we are making steady progress. Today, from the United States, we have Mr. Toyosaki as the global brand lead. We'd like to ask him to respond to your question in specifics. Thank you. I am global, the Leqembi global, brand lead in the United States. My name is Toyosaki. As has been introduced by Naito, compared to the situation when we saw under the accelerated approval situation, the number of vials shipped and also the number of patients treated have been increased by several folds. Last month, this drug was granted a full approval, IDN, so-called largest scale integrated delivery network, and others, many physicians at a great number of hospitals or clinics who have become ready already, are now starting the actual prescription. Before the expansion of the coverage of the PETs, CSF is mainly used for the making the definitive diagnosis of the amyloid. Even with that, the number of prescriptions has been quadrupled or increased by fivefolds. From physicians, regarding the treatment with Leqembi, there has been a very strong interest shown by patients they are seeing. I believe that, that this can be interpreted as the promising indicator for uptake going forward, and also readiness for prescription and treatment. The formulary approval is increasing, and the IDN among the IDN of our top priority IDN list, and there's 15 IDN have already adopted this Leqembi as their formulary. Now, Leqembi infusion and based upon the discussion with physicians, the number of physicians who are ready for treatment with Leqembi, we have quantified and found that this has reached 1,400. Also, the expanded coverage of CMS. Given these changes in the system, we are seeing the increase of the number, prescription and the patients under treatment are increasing week by week, and even after the PET is covered by reimbursement. We believe that we can say confidently that the number of prescription will even further increase. Thank you very much. Regarding the Lenvima, there was the explanation about the extension of the patent. These one, two, three patents, do you think that trying these patents or IP to block the entry by? I think that the number one in this particular instance, this number one is the strongest in slowing the launching by generics manufacturers. Dr. Ohwa is going to respond to your question. To the question, Mr. Yamaguchi. Regarding the Lenvima patent, the creation and development of lenvatinib is based upon the culmination of the technological capability of Eisai. This efficacy of power of this patent to make high purity lenvatinib, we have a very strong confidence in this entry for this patent. Now, we are in the middle of the litigation regarding this patent in the United States, we'd like to refrain from making any comments regarding this can be utilized as beating the generics manufacturers. If you ask me whether we are confident in doing so, because I am a chemist, chemist, therefore, I would say we are confident utilizing these patents. with the existing indications and new potential indications. We would like to utilize the optimization for maximizing the patent value of Lenvima, even after the expiry of the existing original patents. We would like to continue to utilize this for strengthening the value. Thank you. Next question, audience member in the second row, please. I'm Wakao from JP Morgan. Thank you for the presentation. I have a question regarding subcutaneous formulation. Two questions. First, in simulation, you have said that it is, moving on very well. What is the probability of this being successful in the sub-study? What is your feeling of the possible, probability of success? Next, I believe neuro PET will be an indicator, and amyloid PET will be an indicator, and if, through amyloid PET, a decline is shown, will FDA approve? Is that confirmed with FDA? That question will be addressed by Ms. Ogawa. Neurology, clinical, in Japan, in Asia, that is my responsibility. Thank you for your question. About the simulation, this simulation is in phase 2 of Study 2, or 1 that we conducted. Based on that data, simulation was carried out. According to the simulation regarding efficacy, Cavg. As for ARIA, incidence, it is affected by Cmax. That has been found. Based on that simulation, prediction was made. During the in the sub-study, we are confirming the results of the simulation, but we expect to obtain similar data that is similar to the simulation results. As for FDA discussion consultation, we are still discussing the details, but towards filing of submission, we are in conversation with FDA. Thank you. Second question. Using this SC formulation, longer term administration may be possible, and that, I think, is the strength of lecanemab. As for donanemab, once amyloid beta becomes negative, administration will be stopped. I think that will be the regimen for donanemab. After amyloid beta is negative, administration may be stopped. That is the possibility. With SC formulation, per patient, how long can you extend the administration duration, and how much increase can you achieve in the dosing of times? With the SC formulation, can I simply take it that patients will be longer on the Leqembi treatment? Without amyloid beta accumulation, Alzheimer's disease may progress. Will marketing use and such data become unnecessary, or will you require long-term data, for example, from phase 3? That question will be addressed by Mr. Naito. Thank you for your question. This may be a general answer to your question, but first, as far as a comparison with the donanemab is concerned, there is no head-to-head data right now, so it is difficult to discuss a simple comparison. However, as for the uniqueness of Leqembi, as I mentioned during my presentation, in early AD, broad and consistent results were obtained. From FDA, a safety profile has been established. As you've mentioned, it is highly likely that this drug can be used for longer term administration. As for SC formulation, currently, we are making efforts to increase administration options. As for continuous administration, that is being considered. I would like to ask Toyosaki, Mr. Toyosaki, to provide additional comments. Thank you. I would like to offer some additional comments. First, as for Alzheimer's type dementia, this disease is a progressive, chronic, neurodegenerative disease. After removing a plaque, the disease is understood to continue progression. That is very important as we consider the optimal duration of the treatment. As for Leqembi, during 18 months of administration, neutralizing antibody, this may affect the efficacy of the drug, but neutralizing antibody was 4%, as presented during the earlier presentation. Efficacy, safety, and regarding pharmacokinetics, such as immunogenicity, without defect. From that, the neutralizing antibody is not a limiting factor for Leqembi administration. That has been suggested. Beyond 18 months, over longer-term safety and efficacy, from Quality eighty open label extension study, currently, further evaluation is being carried out. As for continuous treatment beyond 18 months? Whether further benefit can be brought about. We believe that that is a possibility. Evaluation by medical professionals and physicians, and through conversation with our physicians and patients, we hope, we believe that we will be able to consider other treatment options. In that respect, subcutaneous administration will be very important. In addition, we believe that there is another point regarding subcutaneous formulation. Efficient care and other medical resources may be saved through the use of SC formulation. Emphasizing that aspect as well, we are developing SC formulation. Thank you very much. Next, the person by window in the front row, please have the floor. My name is Sakai. I'm from Credit Suisse. I have two questions about Leqembi. Prescriptions and also the sales and revenue, those numbers will become available a little time later. One question. How many patients have started to receive diagnosis based on mainly on CSF tests? Out of which, how many are considered to be MCI or early AD, and definitive diagnosis has been given to such patients, out of which, how many patients are currently have transferred to, migrated to the start of the treatment by Leqembi? If you have such a flow of data, could you please provide them with me? The second question is about the soon-to-be-approved Leqembi in Japan. After Naito-san became this Global AD Officer, I think that you were in charge of the Japanese domestic infrastructure establishment for AD, and I believe that, there will be a stringent supply of the medical resources, inclusive of, the physicians who will be responsible for diagnosis. Could you please give us the current status in the Japanese market infrastructure? For your first question, Mr. Tsurusaki is going to respond. I would like to respond to your first question. For your question, I believe that is a very important point for us. As we have shown in our presentation slide, patient journey is considered in each process. Through which, how many patients will go through each process of the patient journey? Well, actually, we do not have the data on hand as of today, but on the other hand, as important indicators for the uptake of this product, we believe that this data will become crucial. Therefore, we are working on various ways to obtain such data going forward. For your second question, please respond. Thank you very much. Yes, I have been in charge of the Japanese domestic ecosystem establishment. Thank you very much for your question about that. There are various significance to that. Firstly, the in- ecosystem which allow us to have collaboration with other companies, we are increasing the number of alliances we make day by day, and the topic we discussed today about Leqembi. It's not only limited to Leqembi, but we have obtained the accumulated knowledge from Aricept. We have market research team within us, and Yuza-san, who is in charge of that, is going to respond to your question. Thank you very much for your question, Mr. Sakai. I am in charge of the Integrated Dementia Strategy team. My name is Yuza, and in response to your question regarding how the infrastructure has been established in Japan, as Mr. Naito has mentioned, in Japan, HCC, Area Coordinators are available. There are 41 people, and they are mainly engaged in the market research. There are two major parts of the research. First one is, in the dedicated clinical clinics or medical institutions, medical resources, MRI, PETs, and CSF testing, in which quantity and how much capacity will they have in the future for giving such services to patients? With this drug, of course, physicians may ask other medical institutions the CSF, or PET, or MRI. Therefore, it will be necessary to have the local, the collaboration among medical institutions, after the launch, and how these resources will be expanded in each community based upon that market research. As of today, of course, we have to consider when the reimbursement will be approved. For CSF and a PET, we do not believe that there are any problems in terms of the capacity for the future. Thank you very much. Thank you. There is another question. Dr. Ohwa, 1701. Could you please explain how significant this drug is going to be? I believe that you have just touched on breast cancer as that indication, which is a very competitive area. Halaven, I believe that, that this was the product where we had a very high expectation. What is the significance of having this new drug? Dr. Ohwa is going to respond. Thank you very much for your question. For us, through Halaven, we have established a network with key opinion leaders, leaders in breast cancer area in global markets. With the high expectation from such physicians, Reclast or Halaven is still growing and expanding in breast cancer area, showing that it has a depth of excellence of this drug. We have heard such feedback from physicians every day. Also, as a mechanism, the immune modulation and the microenvironment improvements and taxane targeting only the microtubule, which is different from the BB-1701's mechanism. We dare to enter into HER2 area, and with existing drugs cultivating the HER2 area, the prescriptions are expanding. Even with this growth, there are not much complete response achieved. Due to the AE problems, there are many patients who are not able to use therapies for long-term time in the future. Even with a competitive area of our market, best-in-class and eribulin, Halaven data, which shows the uniqueness of Eisai, and they believe that we will be able to deliver meaningful and a significant option of the therapies to healthcare professionals and patients. We have such a belief, and also we are supported by the expectations by the physicians. We are asked frequently by physicians: "Why don't you use the eribulin or Halaven in this area of HER2?" Thank you very much. Next question, please. I'm Hashiguchi from Daiwa Securities. I have 2 questions. First, in Clarity AD study, why was ARIA incidence low in comparison to other amyloid-beta targeting therapy clinical trials? I believe some think that this is due to different patient target patient background. Properties specific to lecanemab, based on the characteristics specific to lecanemab, what do you think led to low incidence of ARIA? That question will be addressed by Mr. Ogawa. Thank you for your question, Mr. Hashiguchi. This is Ogawa speaking. As for the profile of our lecanemab, as it was explained earlier, soluble protofibril, that is, with which the antibody has high affinity. As for ARIA incidence, there are various different theories, on the vessel wall, plaque is adhered to, and removing the plaque may be one of the causes of ARIA. Soluble protofibril is targeted by lecanemab. In that respect, it may have weaker, relatively weaker affinity to the plaque, and it may be less directly involved in that, and that may lead to lower incidence of ARIA. Thank you. The second question is about a highly pure lenabirinib patent and the significance thereof. As for generics, different purity products are often approved as generics in general. Based, the invention, that is the purpose of this patent, by utilizing that invention, how much clinical significance is there? For example, better stability or lower incidence of adverse events. What is the value that will be offered from this invention and from this patent? Dr. Ogawa, Mr. Hashiguchi, your question, that is a very important question, and that is indeed the very point that is being disputed at during the in the patent litigation. By all means, we want to win, and therefore, please understand that we cannot disclose information. Thank you very much. Yes, next question, please. The person in the third row from the front, please have the floor. My name is Susumu Shimoyama, nonfiction novelist. I have two questions I'd like to ask you one by one. On August 21st, the expert committee panel will be held, and lecanemab is expected to be approved in Japan, and that's what I have heard, and that was reported by NHK and others. I have one question about that. The timeline after that, so after the approval is granted, till the reimbursement is granted, do you have any specific date for that? The timing when the price will be determined will be at the same time as the reimbursement approval. In the United States, immediately after the accelerated approval, the marketing activities were started in the United States. When is going to be the launch date of Japan? Is it going to be after the reimbursement is approved in Japan? Could you please explain that? Nakahama-san, perhaps could you please respond? Yes, Ms. Nakahama is going to respond. Thank you for your question. I am in charge of the Japanese regulatory affairs. My name is Nakahama. From approval to reimbursement approval, usually within 60 days, at maximum 90 days, but usually, it is within 60 days as a general rule. After the reimbursement is approved, the timing to launch the product based upon the readiness for shipment, which may be different from a company to another. We would like to proceed in this way as soon as possible. After the reimbursement is approved, launch will be started. That means that at the same time as the reimbursement approval, the insurance coverage will start. As soon as possible, you would like to launch the product, and you mentioned that within 60 days under the Japanese regulations. After approval, the reimbursement will be determined by 60 days. At maximum 90 days, but usually within 60 days after approval, the reimbursement will be determined. Understood. My second question is about on page 12, on this slide, on the left-hand side. It's for low tau group. Once lecanemab is used in terms of CDR-SB, slowing or decline was 549%. I have a question about this data. In the open-label extension, 122 in placebo and 135 in lecanemab arm, this data were obtained, or in Clarity AD study, is this the data that have been measured in the Clarity AD? That is my first question. Mr. Ogawa is going to respond. Thank you for your question. Regarding this tau-related data, in core study or double-blind study of Clarity AD, tau PET were tested, and for these patients, the data was obtained. Top line from 0 to week 78, a subpopulation was reviewed. Okay with that, from Mr. Naito, you used the word improvement in CDRSB. Looking at this data, the blue or green line shows in CDRSB, the numbers seem to improve. Is this the correct way of interpreting? Above 0.4 or in the CDRSB, the point of the CDRSB has been increased by 0.4 points. How to interpret this graph, please? Yes, in the middle line, which shows 0, the below 0 shows the trend towards deterioration. For placebo arm, below 0, showing that there were a deterioration. On the other hand, lecanemab arm made a positive turn, so that means that the group went into the trend towards improvement. If lecanemab arm stayed at the zero line, then the slowing of decline was 100%. However, according to this data, it was above zero. That means that above 100% of slowing of decline rate, Mr. Naito mentioned whether this slowing of decline is appropriate or not, but 549% is shown. CDRSB, what is the full score for CDRSB? 0.4, shown here, How should I interpret this? Overall, out of the global population of 1,795, and a 0.45 was the difference between the lecanemab arm and the placebo arm in the overall population. Is it the case from between zero and up to 0.4, and that's the comparison showing the improvement? Rather, in the lecanemab arm, CDR-SB has been shown to be improving compared to placebo arm. Lecanemab arm, it's not that the lecanemab arm was better by 0.4, but as standalone, lecanemab arm has shown improvement in CDR-SB alone. According to this data, the difference between the two arms, as you see in this graph, 0.59 square was equals 0.59. This is the difference between the two arms. The placebo arm was deteriorated by about 0.1. The lecanemab arm, which have shown the improvement by about 0.4. The difference between the two arm is 0.59. That is how this is shown. Then in Alzheimer's disease, which is known to continue to deteriorate, although the n or sample size is limited, but even at the stage where the symptoms are very mild, but still showing the improvement, based upon only on this data, in these particular arms, there was the trend toward improvement. As you said, our sample size is limited. Depending only on this data, in the mild patient improvement, a trend was shown. We are not able to make a definite comment like that. We just can just say that there was a indication of that trend. Yes. Next question, please. I'm Kurose from Nikkei. About contribution of Leqembi in revenue. First, this is a question for clarification. On page 15, fiscal 2023, contribution to 10,000 patients in the U.S. Does this mean that administration of Leqembi will be administered to 10,000 patients? Is that what it means here? The second question, when will you expect to be able to disclose information on revenue? JPY 1 trillion level revenue simulation in 2030 was presented in information meeting before, but what is the expectations about the revenue? That question will be responded to by Mr. Naito. Thank you for your question. First, regarding 10,000, this is a treatment with Leqembi of 10,000 patients. That is what it means, as you correctly understood. As for the second question about the sales revenue, in as I mentioned our aspiration, this is a drug in a very new category. First, we have to develop a treatment pathway that is safe and secure. That is the first and foremost priority. As I discussed during the presentation, the target of treating 10,000 patients, we are making good progress. That is to say, also, we are making progress towards JPY 1 trillion in 2030, midterm target, we are making good progress. That is the information that I would like to discuss at this point in time. The person in the fourth row from the front, please. My name is Mochiyama. I am from Bloomberg News. I have two questions. Regarding the drug price in Japan, once approval is granted, then that will be covered by reimbursement. When you discuss the reimbursement in the United States, Eisai has published various studies in terms of the economic benefits. For Japan, how you are going to develop the discussion about the drug pricing in Japan? Could you please explain how you are going to promote the discussion on the pricing in Japan? For your question, Ms. Akana is going to respond. I am in charge of drug pricing. My name is Akana. I would like to respond. Regarding the drug pricing in Japan, which is different from U.S., there are rules available for the drug pricing, and based upon that, the MHLW will determine the pricing. On the other hand, similarly, in the United States, this lecanemab is expected to bring about a large impact on the society, not only the medical care fee, but also the long-term care fees. Like in the United States, based upon the simulation model in Japan as well, we have published in papers, a peer-reviewed journal, and in Shuukan Shakai Hoshou in June issue, this paper has been published in Japan. The policymakers and the stakeholders, with them, we are making a very transparent discussion based upon such publication. Now there is- we are at the turning point in drug pricing system in Japan. Cost accumulation method has been made, or similar, drug comparison method has been used in Japan. This kind of, innovative, drug, pricing, it's not compatible with such a conventional method of price- drug pricing. How to, evaluate the innovative drugs is now being discussed. That is included in the basic policies on fiscal and, economic management of the government of Japan. We'd like to, consider how to proceed with such a discussion going forward based upon the developments. Thank you very much. Another question is for Mr. Naito. As of August 1st of this year, congratulations on being appointed as Global ADO Officer. What is your view and your aspiration as Global ADO Officer going forward? Could you please give us your take? Thank you. Mr. Naito is going to respond. Thank you for your question. I think I have mentioned my feeling in the last slide of the slide deck. Leqembi, new AD approach or AD DMT, disease modifying therapy. With this, whether or not we are able to cultivate and develop market for this, and I believe that this will determine the path going forward. In the area of AD DMT, co-existence or inclusive society's definition is expected to further expand. That means that at earlier stages, a patient will find the cognitive function, and then by knowing that, there will be wider options available. By knowing such signs earlier than ever. There hasn't been easily available options for patients. Going forward, Leqembi and other AD DMT categories to be established, there will be a more significant significance of knowing symptoms and signs earlier. Regarding this drug, Leqembi, as well as the category of AD DMT, for all patients with dementia, we are not targeting all the entire patients of dementia. If you ask me whether we are not targeting those patients who are not covered by this category of AD DMT, and then inclusive also the solution beyond the drugs, that's why I use these terms, to cover those patients as well. Now we are not just sticking to the drugs, but also ecosystem and the markets which are not bounded to the drugs, should be developed going forward. As you ask in your question, in the United States, there was the event of getting a full approval, which has triggered various actions of many different stakeholders. On the contrary, there is a high barrier to reach that stage so far in the United States. We have had the teams working on those stages and now transitioning to commercial stage, like in Japan and China or Europe, markets. We will go through similar stages that we have done so in the United States. Globally, we needed to secure the good operation in Japan. I believe that there is a reasonable significance in doing so in Japan. Maybe my answer is not organized well, but that is what I can say now. We would now like to take questions from participants who are participating online for our raising hand. We would like to take 1 question per person. First, Mizuno from Tokyo Asset. Tokyo Marine Asset Management. Can you hear me? Yes, we can. Thank you. Since the number of question is 1, I have a question regarding HER2 ADC. There were earlier responses, and this is for clarification. Ultimately, I believe that you would like to take on the challenge of making your drug first in line. I think you are starting from a niche area where others are not targeting, or are you going to target from the very beginning in a major way, first line? Dr. Ohwa will respond. Thank you, Mr. Mizuno, for your question. HER2 area is seeing very fierce competition. Which line to start with? Well, IND was submitted in the U.S. last week. Without a bias, we will be collecting data under the initiative of ASI and HER2 antibody non-responders, refractive patients. There are various patients who will be entering into our studies. We will be taking a very good look at that data. Based on the data, if our data suggests that we can enter in earlier lines, that will be the direction. If our data suggests that that is difficult, we will pursue later lines, or we will target where our BB1701 is effective. We would like to take a very sure, certain approach. Just to make sure, in our large phase two, you are able to, have a patient pool so that you can run various, sub-analysis? Yes, that is correct. Thank you. From Sanford Bernstein, Sogi-san. Sanford Bernstein, Sogi-san, could you please unmute yourself? Yes, thank you very much. I am allowed to ask 1 question. PET reimbursement or coverage by CMS for Medicare in the United States. CMS, in NCS, NCD, their policy is going to be abolished. I think that, they made a proposal to do so. Before abolishing by of NCE and PET reimbursement will not be become available by Medicare. If that will happen, then how long do we have to wait? In the end, PET or CSF, the usual clinical practice, what is going to be the ratio or mix between the CSF and the PET, if there was no problem with regards to the reimbursement? Mr. Toyosaki is going to respond. Thank you for your question. My name is Toyosaki. First, CMS on July 17th, has announced the policy regarding the addition to the reimbursement covering the amyloid PET. There, there has been a long limitation. On the 6th of July, since Leqembi was fully approved, then about 10 days after that, there was announcement of the policy change. I believe that we take this as a very positive move. As SVP Naito mentioned earlier, and also I explained this earlier, currently the patients are being treated mainly after getting the definitive diagnosis or amyloid positivity through CSF test. On the other hand, if there is, if there is no, more limitation or barrier of the, coverage by the insurance, and then, through amyloid PET, the ratio patient who would be, given the definitive diagnosis through amyloid PET, will be, will be almost equivalent or comparable to that of the CSF. Now most of the patients are being tested based upon CSF, and once, the access to amyloid PET is improved, and also the time, to get access to amyloid PET is shortened, and then there can be access to Leqembi will be further accelerated. As a regards process, we are not able to give you any definitive comment. In usual cases, in mid-July, the policy to abolish current limitation was announced. There is a 30-day public comment period. After that, there will be about 60 days to make a decision after getting public comments. Probably in fall this year, there will be final decision to be announced. That is our expectation. Thank you for your question. Thank you. Okay, Tokyo, please unmute and speak. Thank you. This is Akahane. Thank, thank you for taking my question. One question. Oh, Leqembi patent and China, I had a question, actually I want to ask you about the performance. In the first quarter, revenue increased to 17% operating profit increased by 3.5 fold. Page 3, according to the presentation material, page 3, the Leqembi expenses Leqembi expenses were incurred, in the previous term, Aduhelm expense was incurred, which was about JPY 6.2 billion. One third of the increase in profit is due to no more incurrence of other expense. There's a time-lag effect. Advisory committee was held in June, July, expenses are still not being incurred. Is that the case? A PET and genetic tests are necessary. Are you taking it slow to expand your sales and marketing efforts? Earlier, Aduhelm was led by Biogen, Leqembi is led by Eisai. Is that also affecting the the level of expense, or is it because it is in the first quarter that you are not seeing very large expense? Is there going to be larger expenses for Leqembi in the second and third quarters and onwards? Mr. Shomon will respond. Thank you for your question. This is Shomon speaking. As you rightly mentioned, going forward, we will be accelerating spending in Leqembi. Expenses related to Leqembi will become larger. That is our expectation, and that is why we have not changed our full year forecast. Leqembi and Aduhelm, I believe, are targeted at the same physicians and same target patients. You have suspended Aduhelm and the infrastructure resources that you had before. Can you make a effective use of that? Mr. Akabane, can you repeat your question? With Leqembi, you expect greater expenses in the second and the third quarter. Outside, with Aduhelm, you have built the infrastructure, and since the targeted, the physicians are same, can you make use of the existing infrastructure, so you do not have to incur much cost? Mr. Toyosaki will respond. Thank you for your question. First, regarding Leqembi, Eisai is leading the commercialization efforts. That is how we are carrying out activities. Sales is done in person. Information is provided, education is provided. These channels are also important, but in addition, we also have various different communication channels, including what we call omni-channel, to provide education and communication to the physicians. Would also like to improve awareness of the disease. Thank you for your question. I would like to add, of course, it is not that there's nothing that can be made use of from the past infrastructure. For example, IDN for aducanumab, for example, do we have a infrastructure that we can use for IDN for Leqembi? We do not have such infrastructure, so looking at various indicators, we will have to rebuild our infrastructure once again. That was my additional comment. Thank you. Machino. Machino, could you please unmute your microphone? Sorry, I think you will raise your hand. Understood. Okay, now this is going to be the last question from Morgan Stanley, Mr. Muraoka. Mr. Muraoka of Morgan Stanley, could you please unmute yourself? Hello, this is Muraoka of Morgan Stanley speaking. Can you hear me? Yes, we can. Thank you very much. For clarification and a little bit of request. For clarification, for Q&A, the number of vials and increased by 4 times, and the number of patients increased by a little over 5 times compared to accelerated approval. In 3 or 4 weeks since July, how the 4 times or 5 times increase have been made, achieved. Because the duration of that increase was not clear, could you please clarify that? All right. Mr. Torisaki is going to respond. Thank you for your question. For your point, on July 7th, a full approval was obtained. Up until the recently, the number of vials shipped and also number of patients treated with Leqembi, and during the compared to the mean or average during the accelerated approval period, and that these numbers have increased by 4 or 5 times. Understood. Compared to the average during the 6 months under accelerated approval, and also the days of the average of during the after the full approval were compared, and so apples-to-apples comparison was made. Understood. That question is related to revenue for Leqembi. From the next presentation onward, because full approval has been already granted, could you please specify the numbers? According to your explanation, PET diagnosis may come, become available from October onwards, so it may not be making a full contribution to the revenue this year. We would like to ask you to specify the numbers from the briefing session onward. Thank you very much, Ms. Amarawa. We would like to consider and take action accordingly. Thank you very much. With this, I would like to conclude this financial briefing session today. Thank you very much for taking time out of your busy schedule to participate.