Thank you very much for taking your time today out of your busy schedule to attend the information meeting of Eisai. It is now time. We would like to begin the information meeting for March 2025. This is conducted in a hybrid format, combining in-person attendance and virtual attendance. For those of you who are attending in person, the deck of slides is circulated to you. For those of you who are attending virtually, please check our website for the slides. Let me introduce the presenters. Mr. Haruo Naito, Representative Corporate Officer and CEO.
[Foreign language] Representative Corporate Officer, Executive Vice President, COO, and Chief Growth Officer.
[Foreign language]
Thank you. What you see on the screen is a cartoon of a zodiac. I draw a zodiac every year, and this is the zodiac for this year. This year is a Year of the Wood Snake. This is not merely a year of the snake, but this is the year that comes every 60 years. This is a year of zodiac that indicates growth and financial good luck. Despite difficulty, if efforts are exerted, there will be good fortune according to this zodiac. This is a zodiac that suits very well with Eisai. Aricept and LEQEMBI are two of our successful products. In 1997, Aricept was launched in the United States. For more than 30 years, we have developed a number of products, as you see on the body of the snake.
These projects were pursued, and finally, we arrived at the LEQEMBI. E2814 is a promising tau antibody, which will be described later. This is being developed. That is what I try to indicate with this cartoon. Today, I would like to start by presenting the status of the LEQEMBI before medium to long-term outlook is discussed by Mr. Keisuke Naito. Starting with the LEQEMBI, according to recent media reports, in Japan, Alzheimer's disease and other dementia are the leading cause of death in Japan.
[Foreign language]
There is a comparison with 1990 on the left side. Due to advancements in medical technologies, various diseases are becoming less serious. The society is aging, there is demographic change, and Alzheimer's and other dementia have become the leading cause of death in Japan. That was a report in the media.
[Foreign language]
I would like to stress that Alzheimer's disease is a progressive and fatal disease. Due to aging, people may become forgetful, but Alzheimer's disease is different from simple forgetfulness, and it is progressive, and it leads to death. It is a very serious disease. Once again, we need to realize that Alzheimer's is such a serious disease, and this is a disease that should be a target of active treatment. That is a common understanding I would like to establish with you. I would like to show about three sets of data that will support this argument that Alzheimer's is a serious disease needing treatment. Even after A-beta plaques are removed, in progressive Alzheimer's disease, it does not mean cure. The disease continues to progress according to this data. This is from phase II study of LEQEMBI, study 201.
The data is from that study, and as you see the graph below, the core study is the actual study period with the treatment, and it transitioned to open-label extension study. In this study, there was an average of two years of gap period where no treatment was given before the start of OLE. In active RM and placebo RM, no treatment is given during the gap period. A-beta, amyloid beta may turn negative, and after amyloid beta turns negative, what happens can be discerned from this very important data. Amyloid peptide is shown on the left side, looking at amyloid reaccumulation. Gradually, there is reaccumulation that has started during the gap period. On the right side, A-beta 40x 40 ratio is shown.
This is a blood biomarker showing the deposition of A-beta, and at a faster pace, there is a worsening, as you can see from this graph. Treatment suspension reaccumulation of A-beta was shown during treatment discontinuation. Early start of the treatment may sometimes lead to improvement in cognitive function. This was almost a positive surprise, indicated by the data as shown on this slide. This is from Clarity AD study, phase III study, and sub-study from that. The sub-study is called tau PET sub-study. Tau PET is used for assessment and evaluation. The group of patients included here are low tau group, no or low tau group. These are patients who are MCI patients in relatively early stage of MCI. Left side, in 76% of the patients, cognitive function was maintained, and of them, or rather, in 60% of the patients, there was an improvement.
Even AD patients may see improvement in cognitive function when treatment is started early, and for the first time in the world, that was shown with this data indicating the importance of early treatment. Continued treatment, continued administration may provide continued benefit according to this data. This has been shown a number of times. This is also open-label extension up to month 36 from phase III study. The top line is a group that was given active drug throughout the period. The middle line was given placebo during the core period, but active drug switching to active drug during OLE. The bottom red line is at the cohort data, which has the same baseline as a reference. Group that was given active drug throughout the period and the middle group, which switched from placebo to active drug.
If you compare these two groups after the start of the active treatment, the slant of the slope is the same as a group given active drug throughout, but the gap never diminished. This also indicates the importance of early start of the treatment. As for the effect size between placebo group and active drug group, 0.45 in CDRSB was at month 18. At month 36, this has extended to 0.95. You see expansion of effect size or increase of effect size. LEQEMBI is removing the causative material substance of the disease, showing a disease-modifying effect. With early start and continuous treatments, LEQEMBI may lead to sustained suppression of clinical decline with continued benefit. As for the mechanism of action, in the beginning, A-beta cascade understanding, there was certain A-beta cascade understanding, which has since evolved.
Mechanism of action that is necessary for AD drug is slowing of progression, and the center of the LEQEMBI's mechanism of action is to act on soluble A-beta protofibrils that are shown in the diagram above. We believe that this is the toxic species that is at the center of the disease. At the same time, on the right side, after further aggregation, there are insoluble species. There is a process where the fibrils become insoluble, and the plaques are shown. Recently, there is an understanding that diffusible fibrils surround the core of the plaque, and the LEQEMBI also has affinity to diffusible fibrils, and therefore, it also has the action of removing plaques.
Protophibrils shown at the center are key in suppressing the progression of A-beta cascade, but as you see with two arrows pointing downward, it also leads to neurodegeneration, and therefore, there is a blocking effect of neurodegeneration. Protophibril act on membrane destruction protection. On the right side, another important pathology, tau cascade, is shown, and the trigger of tau cascade is also inhibited. Protophibrils also are known to start tau cascade, and LEQEMBI plays an important role in blocking that start of the tau cascade. Another point about AD treatment is that our view is that it needs to be administered for long term, and therefore, safety over long term is needed. A-beta drug safety-related issues is microhemorrhage and microedema known as ARIA, and the main cause of ARIA is shown in the schematic diagram above.
CAAA beta aggregates, cerebral amyloid angiopathy A-beta aggregates that are observed around brain blood vessels. These are said to be causative of ARIA, and regarding CAAA A-beta aggregates, LEQEMBI has low affinity, as it has been demonstrated. As you see at the bottom of the page in the U.S., Japan, and China, according to real-world evidence, ARIA incidence is within the range indicated on the label at low level. Around 6,000 patients are analyzed in all-case follow-up in Japan, and ARIA incidence amongst these about 6,000 cases is 2.5%, 0.25% for symptomatic, ARIA H 2.8%, 0.21% for symptomatic. ARIA incidence in real world has been quite low. In safe environment, the LEQEMBI administration is continuing, and another important characteristic is immunogenicity, which is shown at the bottom of this slide.
By continuing treatments, anti-drug antibodies may be generated, and many of them are neutralizing antibodies, and therefore, the effect of the drugs will be offset by neutralizing antibodies. In case of LEQEMBI, the incidence of such neutralizing antibodies is very low, as also noted on our package insert. LEQEMBI is believed to have safety profile and physical properties essential for long-term administration. I would like to summarize at this point. Early initiation and continued treatment of early AD may slow disease progression and delay decline to the later stages of disease. We believe LEQEMBI has the potential to serve as a standard of care in early AD treatment. Next, I would like to discuss the three points with regard to LEQEMBI's value expansion. First of all, IV, the maintenance regimen. In January, FDA has granted approval.
After 18 months of initial treatment, which required biweekly treatment, but after 18 months of treatment, it can be shifted to bi-monthly dosing. This new option is now added. There are two important implications to this, as indicated on the right-hand side, the first bullet points. Naturally, it would reduce the burden of infusions to half after 18 months. Also for the patients at the hospital visit, the burden has been reduced, and also for the hospitals, the infusion procedures burden is reduced. Actually, it would also have a major effect in further promoting the initiation of the treatment. What it means is that after 18 months, the dosing frequency is halved as a result.
The initial hurdle for the initiation of the treatment would be recognized by the physicians as well as the patient and family members, and that would motivate the patients to start the LEQEMBI treatment, and that is actually the effect that we are seeing in the market. The next point is the introduction of the subcutaneous formulation with autoinjector. We believe that this can be a very important game changer. This requires the separate BLA submission from IV submission, and currently, for this maintenance regimen at 360 mg dose, we are currently working on the rolling submissions under fast track pathway. We have already completed this process, and we expect the announcement for the approval ability to come on August the 31st.
That will be followed by the submission for the initiation dose at 500 mg , and it is to this end that we are getting prepared. For the initiation as well as maintenance, we expect the approval for SC-AI in the first quarter of FY 2026. We believe that, as I said, this can be a game changer for the streamlining of pathway. As indicated on the right-hand side, the treatment would be enabled for the patients at home or at site, and the patient themselves or the care partners can give the administration, which would eliminate the need for the patients to actually go to the infusion centers. Also for the medical institutions, they would no longer have to cope with the infusion capacity problem. Along with that, a nurse burden would be reduced, and this would mean a very important impact.
At the bottom, you see preclinical AG, and we call this study AHEAD 3-45. The protocol for this study is based upon the protocol with the complete agreement with FDA, and this is a pivotal study. In June of last, rather than October of last year, the enrollment is completed. This is a four-year study, and so FY 2028, we are expecting the top line readout, and the study is steadily progressing. There are many different factors to the protocol, especially it includes the BBM in many different stages in this protocol. What is so important about this study is that patients can start the treatment at the stage of MCI, and we have actually recognized the important expansion of the effectiveness.
Now we may be able to advance the initiation of the treatment in one more stage, and then we can expect even greater expansion of the effectiveness on the patients. Therefore, with the approval of the preclinical indications, we expect that the initiation, the timing can be further advanced, and we believe that it would lead to the significant expansion of the effectiveness. Next, I would like to talk about the pathway. In 2023, in July, we received the full approval in the United States, but since then, throughout, we have been working on the improvement of pathway. Through various struggles, we have come today. Throughout this streamlining and optimization of the pathway, we have tried so hard to try to find a way to achieve this. Naturally, we have been supporting the initiatives of the SCPs with overwhelming efforts.
There are three points I would like to discuss here. The first point is targeted DDP. P means patient. It is more like a direct-to-consumer kind of advertisement given to the patients. This is really for the patients who have been already diagnosed for AD, and we want to provide the information like LEQEMBI. This is information provision activities, and through this, for the patient as well as for the family members, we want to support the medical decision-making so that we can see the further increase in the number of patients starting the LEQEMBI treatment. That is something that we are starting in the United States. Also, currently in the U.S., there are some IDNs that are very large scale treating more than 500 of the patients on the LEQEMBI per center.
All these successful IDNs are achieving the very good collaborative relationship with the PCPs in the community, and that is a very important feature. For instance, they may have the fixed referral format so that the patient, the referral form can be sent directly to a certain named doctor, or they would expect the PCP testing to be already done by the PCP. That procedure would have been already educated by IDN, and the whole thing would lead to a very smooth collaboration between the PCP and IDN. In FY 2025, we would like to start our efforts in further strengthening this collaboration between PCP and IDN. The last point is ARIA monitoring done by MRI. There, FDA has granted an approval for AI software to support this. This is called icob rain aria.
When it comes to ARIA readout, it requires the radiologist identifying the very minor changes on the image, but this is the software that would greatly support this process. Through this, ARIA monitoring burden can be reduced. This is a new change observed. The last one, blood-based marker. This BBM-based prescreening is significantly growing. For A-beta negative patients, we would no longer be referred to the further A-beta testing. That is one efficient process. Also, IBD approval for the use of BBM for the complementary testing may possibly come very soon. With this, this very heavyweight medical technology, PET and CSF, would no longer be necessary. Also, the U.S. Alzheimer's Association is expected to come up with the BBM-related clinical guideline. Through this, we expect the wider use of BBM going forward.
This shows several pathways from top as well as to the bottom. There are actually 10 boxes indicated on the slide. In these modern days of the diagnosis and treatment, actually the longest and the heaviest weight kind of pathway that we see today. We have been trying to build this kind of pathway, and at the same time, we have been trying to streamline this. That is exactly what we have been working on in the United States over the past year and a half. At the bottom, you see some actions indicated in the arrow. As a result of the development of some technologies and with the efforts made by SCPs and for the streamlining of this pathway, there have been many measures implemented. On the left top, the PCP has to do the cognitive testing, but now digitalization is progressing significantly.
AI-based testing or through the conversation with the patients to be evaluated by AI, that kind of cognitive assessment tools are being provided, especially the lengthiest are the pathway part. That is the PCP to neurologist, the referral time. Again here, for the very successful IDN, they have been able to significantly save time there through the certain educational efforts they've made. This is where we would like to work towards, for instance, in terms of the educations, what kind of cognitive testing should be carried out by PCP physicians before the patients are referred to the neurologist with the BBM, what kind of testing should be performed before the referral, that kind of agreements they would put in place. As a result of that, we can achieve the significant reduction of this referral time.
As you go to the bottom half, as you can see, that A-beta confirmatory testing would be required. This is a very expensive testing using PET and CSF, very much a heavyweight medical technology. By introducing blood testing, then the patients would no longer have to move into the next stage if they were negative. Actually, up to 80% of the patients are going through this BBM prescreening. Furthermore, as indicated on the right-hand side, just with the blood testing, very soon we should be able to achieve the confirmatory testing, and then PET and CSF, the very expensive heavyweight medical procedures, can now be replaced by the blood-based testing. That would be a major game changer. Also for this patient prescriber decisions, after the confirmatory diagnosis is given, we can provide the information in advance so we can facilitate this process.
On the right of that, you see the humanizing message. That is to say that after the physician explained the safety of the treatment, they would have to explain the efficacy the patient should be expecting. Just explaining CDRSB would not be sufficient. Therefore, the activities of daily living, what kind of improvements can they expect? Better conversation with the family members, can restart hobbies, can start driving cars, can go to the shopping and pay for themselves. That type of humanizing message we are trying to communicate to the patients in many different ways. We have already made some publications at the Medical Congress. Through all of these efforts, we are actively trying to facilitate this process of patient prescriber decisions. Another heavyweight process is the infusion.
As I already mentioned, with the IV maintenance, we have been able to reduce this process to a certain extent. We think that the most important impact would come from SC-AI. As a result, it might even happen that infusion may disappear from this pathway. That would be another major game changer there. Also, AI-supported MRI reading is something that I have already explained. Let me summarize the first bullet point. BBM can definitely confirm A-beta accumulation. The need for the burdensome diagnostic tools may be significantly reduced, simplifying and standardizing the AD diagnosis process. The second bullet point, the potential ability to administer SC-AI for the entire treatment phase may greatly improve the pathway that requires infusion capacity for traditional IV infusion for patients. This means the significant reduction in the time and effort required for hospital visits.
The third one, another very important point, that is the referral time, which is taking a long time. Again, with this IDN and PCPs, the good relationship and by sharing the testing and other burden with PCPs, we should be able to significantly save the time, which is something that we'd like to start from FY 2025. That kind of collaborations and BBM and SC-AI, we expect them all to have the impact by FY 2026. PCP and IDN collaboration, the importance of the medical collaboration is something that I have been discussing today. Actually, in Japan, as mentioned at the bottom, for this initial administration facilities and follow-up facilities, this kind of collaboration system is already progressing, actually already yielding results for the drug. We have more deepened the database, and we are accumulating real-world experience, both in terms of efficacy and safety.
We are gaining further confidence. As for the treatment pathway, over the past one year and a half, we have been making efforts. Finally, we are beginning to see the prospect of further simplifications and streamlining. Now we are beginning to build the pathway that would smoothly introduce the patients to the patients. One last message I would like to share with you. FY 2020 ROE actually has been on a declining trend. One cause of this is AD-related resource investment, which has expanded. In FY 2020 as well as 2021, those were the days when we had to make the significant investment into aducanumab. From FY 2020 to 2024, R&D, SG&As, as well as impairment plus, and approximately JPY 300 billion worth of the investment that we have made at Eisai.
However, Eisai is the company that is making enormous commitment to AD, and this is really the responsibility that we have towards the world. As a result of our efforts, the QOL of the patients as well as the family members have seen the significant improvement. The peak of the investment for lecanemab came in FY 2024. In FY 2025, we expect the lecanemab to achieve break-even level globally. Furthermore, as we continue investment in AD, again, in terms of the shareholders' return, we have never ever slackened our efforts. By saying this, I'd like to conclude my part of the presentation. I would like to ask Mr. Keisuke Naito to give you the mid-to-long-term forecast.
Thank you. Hello everyone. Thank you very much for attending the Eisai information meeting today. I am Chief Operating Officer and Chief Growth Officer. My name is Keisuke Naito.
On fiscal 2027 as the mid-term target up to fiscal 2032, how we plan to achieve medium-to-long-term growth. That is what I would like to share with you today. We have a simulation as of now, and structural reform efforts, drug discovery efforts underway. I would also like to discuss these. This is the executive summary. First of all, in March 2024, we set the revenue aspiration for fiscal 2032. To realize that, we consider fiscal 2027 as a significant milestone, including risk factors. We are disclosing information, and every three years, the plan will be reviewed in a rolling fashion so that for stakeholders, information will be disclosed in a persuasive fashion. Through structural reform, global operation will be optimized. Inclusive of that, excluding one-time income, we aim to achieve a 10%+ operating margin in fiscal 2027.
In three years from fiscal 2025, between in-house R and D and shareholder returns, we aim to balance investments in both. Through partnership investment, we would like to improve efficiency, success probability of drug discovery, and enrich pipeline drug discovery partnership. We will also be making active investment in the non-drug area. I would like to achieve social good and performance through drug and non-drug areas. This is the consolidated revenue simulation. In March 2024, we published the simulation, and this was reviewed more closely. In the near term, up to fiscal 2027, there has been an update. As noted in this slide on the left side, dark blue is LEQEMBI, and the pale blue part that is larger includes Lenvima and Dayvigo. On the right side, these are the assumptions and business milestones. I will start from the top.
For LEQEMBI revenue, it is expected to be JPY 250 billion-JPY 280 billion in fiscal 2027. The delayed uptake in the U.S. market and learnings from launches in each region are reflected. A competitive situation and health policies are also taken into account. Several scenarios have been analyzed. As a result, we believe that this range indicated here is realistic at this point in time. Within the bar graph on the left, others include Lenvima, and Lenvima continues to be a very important drug for Eisai. In various countries, there are policies to reduce medical expenditure, but Lenvima has obtained additional, potentially will be obtaining additional indication, and LOE extension may be possible. We believe that we are able to maintain JPY 250 billion level. LEQEMBI and Lenvima are the major factors, but there are also various events expected in the pipeline.
There are also various expected pipeline status and events. These are important items leading up to fiscal 2027. Please note these as important status and events. We would like to maintain revenue at a certain level up to fiscal 2027 and aim to achieve aspiration target in fiscal 2032. Of course, there are risks as well. In the rolling fashion, every three years, the plan will be reviewed while we continue to make efforts to achieve these objectives. On the other hand, in business, there are various risks as we turn on the offensive. As I mentioned earlier, profitability is also important in supporting our efforts. As CEO mentioned earlier, we are entering into a new phase for global business. Based on this development, we will optimize operation globally. This will not be a mere reduction of expenses.
We will be fundamentally reviewing organization and process to continuously evolve the overall profitability structure of a company. There are two boxes, and we believe that there is a potential in these two areas. First, the resource investment globally. We believe there's a room for optimization. There will be a Chief Business Officer who oversees strategy, planning, finance, and investor relations functions and receives reports from global commercial regions. Around the Chief Business Officer function globally, there will be also improved efficiency of various functions, and resource allocation will be optimized in the operations. On the right side, standardization of systems and processes, IT system and infrastructure were developed in various regions, but for each region, so that operation will be optimal. While maintaining that globally, there will be standardization of IT system and infrastructure to reduce duplicate investments.
By so doing, we will maintain growth investment, and that is how we see the impact of structural reforms. We believe that there is especially room for improvement in SG&A expenses. Structural reforms aim is that in fiscal 2027, excluding one-time income, operating profit margin of 10%+ . Through achieving this, we would like to become profitable without a reliance on one-time income. Structural reforms, business milestones. By achieving these, we should have funding available. This slide shows how we plan to use that funding: resource allocation funds, JPY 1 trillion level. That is what we expect to have. First, evolve a profit structure through structural reform, pursue efficiency, increase profitability. This should allow us to have increased investment capital of JPY 700 billion, plus cash on hand, JPY 300 billion comes to JPY 1 trillion level resource allocation fund.
We would like to achieve both the growth investment and shareholder returns and in-house R and D investment, partnership investment. We will continue to make active investment in major products and areas, meaning mainly in neurology and oncology. That is about the investment. At the same time, we will be strengthening in-house R and D. This is a core activity for a pharmaceutical company. In-house R and D is core. At the same time, partnership is also a part of a very important strategy for us, especially in oncology. There are opportunities for partnership and collaboration. We would like to explore such opportunities widely. In neurology as well, we have various in-house items, and I believe there is also potential for exploring partnership. Partnership potential in oncology can be important. Dementia ecosystem development investment will continue as well.
As for in-house manufacturing of major products, as an R and D-oriented pharmaceutical company, we believe that it is important to have such capabilities. We will also consider capital investment in production capabilities. That is how we plan to spend JPY 1 trillion of funds, allocating that amount appropriately between investment for growth and shareholder returns. Next, about the partnership model that I've mentioned on the previous slide, we have focus areas of neurology and oncology. In the initial stage, we have in-house products, and we are applying the partnership model. Aricept and Halaven, in the earlier years, used a partnership. These led to LEQEMBI and Lenvima, the major products that we have today. Through partnership, the effect that we can expect is, of course, it includes one-time income.
In principle, collaboration with academia and collaboration with other companies should accelerate innovation and cost and risk sharing through joint development and maximization of product value through joint distribution. Innovation may become possible where it is not possible single-handedly through partnerships. Such innovation may become possible. These are areas that we have focused on. We will continue to explore potential partnerships in neurology and oncology. In neurology, we have in-house products, and we would like to enhance values, mainly focusing on in-house products. I would like to add value to that through partnership, potentially. As for oncology, through partnership, we may be able to enrich pipeline. I think that will be one of the main focuses in oncology. In these two important areas, we will be exploring important partnership opportunities as important strategy.
There are three pillars shown here, and you might wonder where the three pillars are since there are many boxes, but there are boxes with numbers at the bottom of structural reforms. This is what I have discussed just now. Operation excellence will be pursued, and the core for Eisai, which is a drug discovery and also development in non-drug areas, these are growth strategies, and they will be supported by structural reforms. I have so far mainly described structural reforms. Above that, there is a drug discovery R and D, progressive R and D, drug discovery, and creation of new area R and D. I would now like to elaborate on these. Regarding drug discovery R and D, we will continue to focus on neurology and oncology, but it is not that we will be pursuing neurology and oncology separately. These two will not be separately developed as separate specialty areas.
What brings the two together is human biology. As for human biology, this is a term that is used quite often in many areas, but I would like to convey that our human biology concept is slightly different. Understand disease pathophysiology to start development. That is the concept of human biology, and that will be applied to neurology and oncology. Different from what we have understood before, we can look at these areas as different groupings based on this concept of human biology. This means it will be cross-process, cross-field effort to apply knowledge in drug discovery. That is the characteristic of Eisai. There are various descriptions on this page. Integrated MedChem part in drug exploration and discovery. This is the cross-functional, cross-area function. MedChem clinical data platform are cross-disciplinary functions. Translational research will be connecting discovery and clinical processes. Translational research will be connecting various processes.
Cross-process, cross-disciplinary knowledge is important in translational research, and therefore it's going to be very characteristic for Eisai. Molecular profiling technology is one of our core technologies. Through these efforts, we aim to reduce development duration and increase precision in our development with the technologies indicated on the box applied. With that capacity, sooner and in a more certain fashion, we will discover drugs. Now, I would like to describe in more depth, more in depth, each field: oncology and neurology. Human biology is applied, and there is also a pipeline that we have. How the concept is brought to bear will be described as I will discuss the pipelines. As for cancer continuum, this means that cancer is a process of early stage onset to recurrence of metastasis, resistance, etc. Each process is involving a different molecular process.
By looking at this as one lump sum, cancer can be understood as a continuum. Across cancer types, development will become possible by understanding cancer as a continuum. There are various descriptions, the first bullet points, in-house products, combination clinical trials to explore potential standard of care. Important proteins for resistance will be also researched, and we will be approaching them with small and medium molecules. This is an oncology pipeline that we have. Lenvima has been discussed extensively before in the past, so I will focus on some other aspects. Next slide. We have in-house developed a pipeline in combination with Lenvima. Lenvima resistance can be overcome by modulating pathway, and that is the concept of E7386. This utilizes organic molecule synthesis technology. This is an approach that is not possible for a company that has only antibodies.
We have a medium-sized molecule technology as well. E7386 is a medium-sized molecule that modulates a Wnt pathway to overcome resistance. Lenvima is one of our flagship products. By developing combination therapy of Lenvima in-house, we can expect to expand Lenvima further. Endometrial cancer phase I study is underway, where we are already obtaining suggestive indications of overcoming resistance. I believe development is underway smoothly. Cancer Big Four, what is known as Cancer Big Four, this was mentioned in earlier earnings call. Beta catenin is one such Cancer Big Four, and that is addressed by this. This can become an important platform, and this is a technology to target what had been difficult to target. We have such technologies. First-in-class, best-in-class in a reproducible fashion will be pursued with the technological platform that we have shown here. Undruggable target to be transformed.
Cancer Big Four are the so-called undruggable targets. Eisai's strength is a small and medium molecule, and these can be applied to oncology targets. There are various difficult technological backgrounds. We have various modalities, and this is one of the in-house approaches that we can apply. Splicing platform. Genetic information is translated by protein, and that will be approached by splicing modulator. IO low-sensitive cancer cells will be made cancer cells with high sensitivity to IO by inducing neoantigen. Targeting refractory solid tumor with low immunogenicity and poor responsiveness to cancer immunology will become possible, which was not possible with the existing technologies before. Proximity-guided compound platform is similar by promoting degradation of undruggable target by bringing the protein closer to proteolytic enzymes or bringing proteolytic enzymes closer to such proteins.
This is needless to say, but undruggable targets are targets that are difficult for drugs to be discovered. By attempting drug discovery, targeting such undruggable targets, we aim to become first-in-class, and we believe that that is possible in this area. IO ADC modifying therapies, first-in-class therapy will be pursued in oncology. In oncology, we have drug discovery platform. We will be utilizing biomarker data obtained from Lenvima, Halaven, interpreting based on human biology concept. We will be creating a backbone therapy applying that concept. Middle and small molecules can be used to transform undruggable target to druggable target in oncology drug discovery platform.
As for small and medium-sized molecules that can act on undruggable targets in the cells that cannot be acted on by the antibodies, where I mentioned in passing before, we believe that these are cross-disciplinary approach in oncology that is only possible for Eisai. We would like to utilize our own technology and expertise, and we will also be exploring partnership opportunities to continue to create innovation in this area. Now, from here on, I would like to discuss neurology, and CEO has already covered part of this. It is about neurodegeneration continuum, A-beta tau neurodegeneration. That means that the progression of AD is regarded as the continuum followed by the biomarker and beyond ATN is also something that we are trying to explore with the tau, and I would like to explain this.
This is our neurology pipeline, and these are the kind of compounds that I'd like to discuss today. Once again, I would like to go over the ATN story. When we look at the pathological change in AD, there is the aggregation of amyloid as well as this tau aggregation. We do see the changes, neurodegeneratory changes, as well as these biomarkers accumulations or the degeneration that we would like to focus on. We would like to put them in this continuum to look at this on the basis of the ATN story. On the left-hand side, you see the natural course of AD continuum. This is the time and biomarker aggregations without any treatment. This is called Jack curve. With the advent of lecanemab, it does modify A-beta, and therefore AD continuum with the AD treatment.
This AD's natural course of the continuum would undergo changes. With lecanemab, after modifying A-beta, what kind of intervention can be achieved? Biomarkers itself would be modified, and then it may act on other biomarkers, and therefore we need to be following up on all of these biomarkers. That is going to be very important. A-beta modified continuum is really the basis of our thinking, and coming up is the combination therapy as indicated in the bottom, at the very bottom here. You see this process showing the aggregation of A-beta, synapse changes, and then that will be reflected in tau, leading to the influence on the neural function, and also how we are trying to approach them, what kind of mechanisms we are trying to bring in that is described on the slide.
We have been trying to approach them, and by combining all of these, we can come up with the combination therapy after removing the A-beta with lecanemab. Then with anti-tau, we can further slow down this cognitive decline. Also, with synapse regeneration, we try to attack from both sides with the enhancement of resilience as well as the neural function recovery. We have the data source and data science in order to combine them. New kinds of mechanisms of action or the most optimal combination is something that we can propose. That is really the part of the concept of neurodegeneration continuum. E2814 anti-tau, and this slide is really trying to explain this mechanism. On the left-hand side, with new biomarkers, AD stages are now being redefined.
That is to say that, first of all, there is this clinical symptoms-based understanding. Also the pathological understanding about the senile, the plaque as well as tau aggregate would be measured. When it comes to the detailed understanding of this, what kind of biomarkers would be interacting to result in these conditions? That is what we are trying to learn. The combination of the biomarkers to understand the activities in the brain, that's what we are really trying to do. The new liquid biomarker, MTBR- tau 243, that we have been able to discover, simply on that, by combining different biomarkers, what kind of degeneration is related to biomarkers with different combinations of biomarkers, we have been able to come up with a biomarker panel. That has greatly supported this MTBR- tau 243.
By defining this AD with these biomarkers, we try to come up with this new drug discovery. Based upon knowledge, we are now able to come closer to this precision medicine in the field of AD. In this way, we do have the brain host panel, and this is the AD-related biomarker panel database. Also, this panel, literature and data science, we try to analyze this. Through this, we do have enough resources to achieve the precision medicine. Brain host panel, which is the biomarker panel, and for the creation of this drug discovery hypothesis, and for the proof of that, this can be applied. Through this, we should be able to shorten the development time period as well as the improvement of the probability of success can be achieved.
I will be discussing VOLOS later on, and that is also based upon this kind of concept. This can be applied for such drug development. Also, in terms of the new kind of biomarker, we can stratify the patients. For each patient population, we can also propose the most appropriate option. That is another thinking behind this. Disease subtypes or the AD continuum, again, as we learn more about AD, we can expect further changes. There, we believe that we would be able to really drive that kind of changes. This is another platform that we have over 20 years. We have been focusing on the orexin as neuropeptide. This is a very important neuropeptide to maintain the wakefulness. Leveraging the orexin platform concept, we came up with the Dayvigo, the orexin receptor agonist.
This is approved for the insomnia treatment that is achieving the top market share in Japan. We do have the technology to be able to develop both agonists as well as antagonists of orexin. This is really unparalleled technology in the world. As a next step, we are coming up with E2086. This is the orexin agonist. For the narcolepsy, type 1 patients with the excessive sleepiness during the day, we are carrying out the study. Phase I proof of mechanism, the study top line is expected to come by the end of 2025. We would also like to keep you updated on this. Now this one, this is the in-house brain delivery by specific antibody. This is quite often called as a brain subtle or brain transporter. We call this as Evolpath. Why Evolpath as a name for this?
In the process of screening, we have applied the molecular evolution method technology. This is also called the phage display method. This kind of technology we have applied. In human biology, lecanemab drives the concept for the ideal antibody that we have to deliver it on then. From the more than 52 billion antibody repertoire, we have been able to come up with the most appropriate antibody. As a result, we call this Evolpath. Simply put, the objective of the brain delivery by specific antibody is to achieve higher efficacy at a lower dose. That is a basic requirement. When it comes to Evolpath of ours, on top of that, in terms of the safety, it is really emphasizing the safety profile of this technology.
Evolpath, as we move into these ATN drugs for various antibodies, we believe that this technology can be applied. This brain delivery by specific antibody is also progressing very well. I would like to also have the future opportunities to keep you updated. The brain health panel platform and also analysis of the brain health panel has been reflected into lecanemab as well as the new degeneration continuum. That has always been the very important resource. By leveraging them going forward, we would like to further drive this ATN continuum and how to combine them all. We think that we will be in a position to be able to propose good options. Also, our excellent platform is very important in order to maintain the continuations of the innovations.
Also, Evolpath is the technology that can be applied into the antibody and others. Therefore, through this, Eisai is working to generate reproducible innovation in neurologies going forward. Now, from here, I would like to discuss ecosystem. Alzheimer's disease is a social issue. There are a lot of life-threatening diseases, but when it comes to the cause of death, this is something that we have to really focus on. That is to say that in terms of the cause of death, it is very high in terms of the cause of death in the world and even getting higher for the high-income countries. It is also true in Japan. As for the social cost, when you look at the global social cost, it is reported to be $1.3 trillion.
Also in Japan, the JPY 17.4 trillion is the social cost in Japan. Actually, out of it, JPY 7.4 trillion is really covered by uncompensated care by the family members. That is called the informal care cost. Therefore, when you think about the fatal disease, of course, it is the challenge for the patient themselves. When it comes to the carers, as well as for the entire society, we have to recognize this to be a very important social challenge. Another important characteristic here is that this is a disease that can be completed just within the framework of Medicare. We do have Aricept. We have launched Aricept, and we still have Aricept. What we have always said is that Aricept is never the panacea. That is to say that this is not something that you can resolve everything just with medications.
Therefore, at the medical institutions, we have really tried to activate the role of medical institutions where all kinds of related issues can be manifested. For the healthy state, for high-risk, onset and treatment, the follow-up and prognosis in different stages, different challenges do exist. We try to address all of these challenges. As we are working on Alzheimer's disease, both with drug development and non-drug approaches, we are really trying to transform this environment. We have been building up on the capabilities to support the dementia ecosystem for Eisai. Non-drug approaches, even from the days of Aricept, we have been working on very hard. As an extension, we have been collaborating with the local governments.
For instance, for the healthy people, the health management service is offered by Arteryex as the dementia portal site management. Also, the data to be really collected in this data platform, which is being offered. Another important core solution in the dementia field that we believe is in the nursing care area and with the non-contact centers. They are really trying to monitor the sleeping activities of facility residents in real time. This is the EcoNaviSta program that is offered by EcoNaviSta. Therefore, building off this, the capability is progressing very smoothly. Through this, we would like to continue pursuing the further partnership in this area. I mentioned healthy, high-risk, onset and treatment, the follow-up and prognosis in different stages. What kind of challenges are there?
Also, for the respective challenges, what kind of solutions are we ready to offer? They have different concerns in different stages. We need to offer the solutions for each and every one of them. The second one, also at the bottom, we need to connect them all with a single platform. We are trying to deploy them all at the same time. At Eisai, when we are engaged in the drug discovery, it is a very important core of activities. It is pretty much focused on onset and treatment. Around that, for the healthy state, Arteryex is offering. We have other collaborations. Database support side would be encompassed in the various technology support site. From healthy to high-risk to onset and treatment, leading to the follow-up and prognosis, we need to really link them all.
We did not have the core solutions to link them all. That is where the EcoNaviSta would come in. With EcoNaviSta, we believe that we now are able to really cover all of these stages. Yet there are some challenges, for instance, some gaps that we do see in the healthy state. We need to do that. With the drug solutions, as well as non-drug solutions, they are in sort of complementary positions. Therefore, we would like to continue working on them. This is my conclusion. There can be businesses transitioning from this initial investment phase to a critical stage of growth expansion driven by BBM and AC formulations.
We aim to maximize our capabilities in drug discovery and product development through cash generated from structural reforms aimed at pursuing efficiency by accelerating the development of in-house pipeline, focused on neurology and oncology, and continuous growth investment. We do have the strength in the drug discovery. We would like to demonstrate capability in a non-drug discovery. In the field of dementia, I mentioned there are four different stages, and we are trying to cover all. We believe that is our obligation. Therefore, we would like to continue with approaching both drug discovery as well as non-drug discovery so that we would like to achieve the social good as well as the business performance through this. We aim to support the people's lives from a healthy state to their final moments.
We believe that that will be really the best business model for us. Thank you very much.
We would now like to open up for questions. We will be taking questions from those attendees in this room attending in person before taking questions from online attendees. Due to time constraints, we would like to ask you to limit the number of questions to one per person so that we can take questions from as many people as possible. If you have a question, please raise your hand. Please also give us your name and affiliation before your question. Attendees seated in the fourth row, please.
I'm Hidemaru Yamaguchi from Citigroup. Since I can ask only one question, I have a question regarding Evolpath. There are various existing technologies for brain delivery. How do you differentiate? Ono Pharmaceutical, I think there will be four-quartet product.
Do you still have some right? Or does Ono still have right? Amyloid beta and tau bispecific antibody, that may be the idea. When will clinical development begin?
That question will be addressed by Mr. Ido.
Thank you for your question. I am a DHBL Discovery Strategy Counselor. My name is Ido. Regarding the first question of how are the Evolpath differentiated from others, efficacy, high brain deliverability, and safety are our focus. Our technology is such that shown here, it is a very high-quality, diverse. It is based on a high-quality, diverse library. We are also combining that with a proprietary brain screening to identify high brain deliverable antibodies. We also have continued drug discovery in AD. What safety issues we should pay attention to, we have very good understanding of that. That is reflected in the design of the antibodies.
That is why we have obtained high-quality candidates. The second question, if I may, right, before quartet, right. There are no rights.
When will clinical development begin?
At the moment, we target 2027. We will make efforts to accelerate that to earlier timing.
Next person. The person on the second column.
JPMorgan, Wakao. Thank you very much for your presentations. FY 2027, LEQEMBI and Lenvima. The basic assumption is something I would like to know more about, but LEQEMBI in FY 2027. You did not give us the number, but I think you are aiming at JPY 500 billion. I think you have made the downward adjustment for us. Based upon the market consensus, it seems to be high. Why did you give this downward revision? Also, how feasible would that be?
As for the Lenvima, you're expecting JPY 300 billion at the end of this fiscal year. The reason for reducing that to JPY 250 billion, is it just the RA? Is that a reason for this downward adjustment for this number?
Iike is going to respond to your questions. Thank you very much for your questions. Iike would like to respond to your questions about the Lenvima.
Compared to the previous version, it's not as if we have reduced our focus. It's more like we have renewed and have come up with a separate forecast. That's how you should be looking at it. You're really the pro of the forecasting. I'm sure that you know how it is, for instance, early AD. There are 14 million patients in the United States. We have to allow some ill. Currently, it is about 10,000.
Therefore, it's only about 0.2%. When we are trying to decide whether to launch or not, we're not able to identify this kind of number. It's not as if we have tried to come up with any stretch goal. Now that we have been in the market for a year and a year and a half, and we now see all these factors, and we have reformulated a model, that's an honest reason. In three years' time, to what extent the BBM would be utilized, and how much of ACAI to be embraced in the market? There is always the range. Therefore, we try to come up with the range forecast. As Mr. Keisuke Naito mentioned, I would like to update this on a rolling fashion. The second question about Lenvima, it's not just about IRS, you have pointed out.
For these thyroid cancers and RCC, new kinds of indications are coming up. Considering all of these impacts, we certainly would like to overachieve this forecast. That is the number that I have.
Thank you for the follow-up question regarding LEQEMBI. The top range and bottom range, do you have any scenarios? What is the impact of IRA?
It is indicated in this slide. BBM penetration depends on how widely it will be penetrated and SC-AI acceptance, and most pronounced way in the U.S. As for the impact of IRA, I would like to refrain from discussing it in terms of percentage. Looking at recent days, weeks, months, not so much. Next year and the year after that, there are certainly risks. We are taking a conservative view. Thank you very much.
Next question, please.
Hashiguchi from Daiwa Securities.
Page 16 pipeline, major neurology pipeline and partnership is also mentioned. For what products? What development stage? In terms of timing, what form of partnership will you be exploring? It depends on who the partners are. It may not turn out as you expect at the moment. Could you elaborate on your idea currently?
Specifically, anti-tau antibody and narcolepsy for these two themes. Lenvima and LEQEMBI. We had a full-fledged partnership for Lenvima and LEQEMBI. We also would like to pursue such partnership for these two themes. In forming partnership, of course, there are necessary data that we have to acquire. When the timing is going to be, I cannot immediately answer. We hope to have such data within one to two years so that we can establish a solid collaborative relationship. Thank you.
Next one, the person seated at the front.
UBS Securities, Sakai. This is my question to CEO. Dementia ecosystem is a wonderful idea. Your social contribution is really demonstrated here. Whereas in this concept, AD, meaning incurable disease, when you think about that, it seems as though this is really the negative cost being deferred to the future. This occurrence of this negative cost, how do you think about this in this system? Would you be able to express this in one way or the other in the future? I do not really mean to ask you about the exact number, but if you can share with me this idea, I would appreciate it. Thank you.
This concept of HCC, that is what we have been trying to achieve with our drug discovery effort. When it comes to drug discovery effort, it takes as long as 20 years.
It is very important. It's a fundamental solution. This remains unchanged. Whereas once we can achieve that, channel sort of the impact expected in all of these directions. This burden that is currently felt, it does not have the direct impact. When we think about the situations and there are different burdens, there are solutions in different ways. For instance, the care burden for the carers. We may be able to achieve some positive impact for dementia. At the same time, we are really trying to offer the solutions to achieve the improvement in all of these areas. Someday, this drug discovery efforts, we believe that will be lead to these fundamental solutions to this dementia. It would take time. We cannot simply be engaged in drug discovery. We are really trying to really cope with the current difficulties.
There are other things we need to do. For instance, the brain health panel. This is something we are trying to create in order to achieve the precision medicine. High-accuracy data we are gathering from here. A digital biomarker that is really linked to such quantitative measure we should be able to come up with. I did mention that they are really in the complementary relationship. What cannot be achieved with the drug discovery alone, we would continue to pursue as well. That would lead to the other findings in different stages as well as the building of the pathway that we can achieve. Sorry to be so quick in my response. Let me try to add. Think about the quality of life. The quality of life for the patients.
In case of the dementia, we also have to think about the quality of life of the caregivers. We have to add them all and then have to try to find a way to try to improve on the overall quality of life. Currently, from the patient's quality of life, now we are really trying to subtract the quality of life of the caregivers and regarding that as a negative quality. However, according to the EcoNaviSta's tool introduction, we know that the quality of life of family members would significantly be improved if it is introduced in patients' homes. This would significantly save the burden of caregiving. We have to look at this as an additive factor rather than deducting this. That is something that we are looking at in terms of these care services.
I may not be responding to your question properly. If you have any kind of data that you can share with us, if you can come up with the kind of data, we would appreciate if you can share that with us.
Next question.
Awesome. Thank you very much. I'm Muraoka from Morgan Stanley. Partnering partnership in neurology. Candidates, the two candidates for a given tau antibody and anti-tau antibody and narcolepsy drug. Regarding tau, you already have established a distribution platform, more or less. You have completed investment. Will you still pursue partnering? I think. I understand that cost can be high, but it may be somewhat wasteful. Do you plan to seek partnership for both or only one of the two?
Muraoka-san, thank you very much for your very valuable input. It is not easy to discuss in further detail.
I will take note of your opinion. Thank you.
The next person on the second row,
hello. Sanford C Bernstein. My name is Sogi. This time, FY 2027 simulation that you have given us in terms of the sales revenue focus for LEQEMBI, when you think about this and F7 2025 to 2026, there will be two years in between. We would like to know the evolution to achieve this number mentioned for FY 2027. SC-AI, BBM, all of these events may naturally be driving this, which is to say that FY 2025 or 2026. When you think about the year-over-year growth rate, are you expecting this to be rather low growth? Are you expecting a much higher growth expected for FY 2027? We would appreciate your input on this.
So far, the process for the patients to reach LEQEMBI treatment, and you have been focusing on how challenging that has always been. However, you have LEQEMBI. Also, Eli Lilly, they have Kisunla. Then as a fundamental challenge when it comes to the value of such treatment, for the majority of the doctors and majority of the patients, they may not necessarily embrace the value of these treatments based upon the data that are presented. However, the pool of the patients is very significant. Even though the majority of people may not accept this, this much of sales we sort of expect that you will be able to achieve. Having said that, it's been like a year and a half since you started selling this product.
Then, especially in the U.S., sort of the doctors' acceptance of the clinical meaningfulness of this treatment, have you witnessed any kind of changes?
With regard to the first part of your questions, the FY 2025, 2026 evolution of LEQEMBI sales, Mr. Iike is going to respond.
As I listen to your questions, I am almost forgetting the first part of your question. Thank you.
Up until FY 2027, we are not anticipating any major changes to come. This is FY 2024. As we try to explain on a yen basis, our focus is JPY 42.5 billion global sales. We are quite certain to achieve this. Now, how about the number for FY 2025? We are expecting higher than double the kind of level that we'd like to aim at.
In that context, we will go through FY 2026 and then reach FY 2027, especially the blood biomarker in the United States. This use of it as a confirmatory biomarker, to what extent this will be accepted? That is certainly reflected into our focus for FY 2027. That certainly would be an important factor. The second part of the questions, the U.S. doctors' acceptance of the clinical meaningfulness.
Thank you very much. I'm Haruna, responsible for LEQEMBI in the U.S. market. I would like to respond to your questions. Currently, LEQEMBI is continuing on the double-digit growth and maintaining close to 90% of the market share. Therefore, our confidence in LEQEMBI remains unchanged and very solid, as Mr. Iike mentioned, in FY 2025 in the United States as well. We are anticipating double-fold growth.
As you have mentioned in your questions about the clinical meaningfulness, at the end of January, IV maintenance regimen was approved. Especially the fact that the patients can move into the maintenance regimen after 18 months of treatment is making it very easy for the patients and family members to accept this treatment. As CEO mentioned, AD is a fatal disease and a chronic disease. Therefore, HCPs and many of the patients want to continue the long-term treatment, especially IV maintenance in starting the treatment. It is making it much easier to convince the patients. For the patients who are under treatment, they see the scores being improved. Also, their activities of daily living are improving. They can now enjoy what they could not do before. ADT or ANN congresses are expected next week.
There, the LEQEMBI's real-world data, especially ADL-based real-world data, we plan to present there. The more specific data would be presented in next week's congress. Again, from the patients, we are getting the input that they are really enjoying the clinical value of this treatment. That data we can publish next week. In that sense, we are making a very significant advancement. I would also like to explain, as you have mentioned, now, LEQEMBI, how the patients would respond to this. CRSP is an improvement of 0.45. If the doctors give that kind of response, it would never be a message for the patients' acceptance. It is more about the improvement of the family relationship. The patients would not become so upset, or they can go out to the shopping and can really pay out of the pocket. Also, their hobbies.
They can enjoy playing violins. They can take care of their pets. Their hobbies they can now enjoy. Also, driving cars. They can continue driving cars as a result. In their average daily life, they do witness the improvement. I mentioned humanizing message. That is something that we are really trying to gather. We would like to publish this in medical congresses or try to communicate this in a peer-to-peer channel in a compliant way. We are really trying to share this kind of message to the patients. I think that is having a major impact, if I may add. As our CEO just mentioned, again, for the SCPs, the meaningfulness of this treatment, they accept this very positively. For the SCP to convince the patients of this meaningfulness, that is really the important point.
Therefore, as a message, we are really trying to send out a humanizing message. That's where we are.
Thank you very much. I understand that you're really trying to gather that kind of data and trying to reflect that into your messages. That was very encouraging. Another point, the doctor's understanding is perhaps not about the clinical meaningfulness, but it's all about the data. Data would know all the clinical data, but would that be truly clinically meaningful? For that, going forward, you need to collect all the examples and also what kind of life the patient can now enjoy. In that sense, I'm very much looking forward to that.
In terms of the clinical meaningfulness, the regulatory authorities would never grant approval unless there is the clinical meaningfulness. FDA or the PMDA or CEDE in China.
Now that they have recognized the clinical meaningfulness, they have granted approval. There is no room for doubt. This is the drug with clinical meaningfulness. Otherwise, we would never have received the regulatory approval.
Maybe I have said this too strongly. I certainly heard your message. I know that you can never compromise on that. Thank you very much.
Are there any other questions? If not, are there any questions from those who are participating online? There is one person who is waiting to ask a question. This will be the final question. Mr. Tony Ren from Macquarie Capital Limited, please. Can you hear me?
Yes. Yeah. Can you hear me?
Yes.
Okay. Perfect. Yeah. Great. Yeah. Thank you. Just a quick two-quick one from me.
On slide number 8, it looks like you guys in Japan are detecting 5% of the patients with ARIA- E or ARIA- H. I just wanted to see how these patients are detected. Most of them appear to be asymptomatic. I just want to get a sense about if you have any update about the European CHMP recommendation update and when you think you can launch in Europe. Thank you.
[Foreign language]
Dr. Lynn Kramer will address that question.
Yes. Thank you for the question. I'm Lynn Kramer, the Chief Clinical Officer. That question has two parts. The first question was about the ARIA rates in real-world evidence. As you have correctly commented, the rates are very low in Japan. The rates in other regions like the U.S. are similar to those that are described in their labels.
In terms of the CHMP, we were very pleased to hear in February that the CHMP has agreed by consensus that no changes were needed to the November 14th positive opinion from LEQEMBI. That was the outcome we had expected. LEQEMBI has now been referred to the European Commission for a decision on the marketing authorization. The EC have clear procedures that they must follow for final steps. These procedures are underway, and we look forward to sharing with you a positive outcome from the European Commission soon. Thank you.
Yeah. I think those Japanese ratio of ARIA is based on official report. We have a mandatory reporting in Japan for all cases. Those are quite precise reports by either neurologists or a jurist, the specialist reports. It is a very, very precise and accurate one.
Yeah. Just on that one. Yeah. Thank you, Naito.
Are the cases of ARIA detected using scans, using clinical assessment? Just want to see how are they detected.
It's based on MRI. MRI.
MRI. Okay. Perfect. Yeah. Thank you.
[Foreign language]The time has come. We would like to conclude the information meeting. Thank you once again for your attendance.