Eisai Co Ltd

Thank you very much. financial results. For those of you who are attending in person and those who are virtually attending, please refer to those materials on our website. The presenter is Mr. Haruo Naito, representative corporate officer and CEO.

Now, we'd like to begin our presentation on the Q2 results for fiscal year 2024. First, let us share with you the P&L. Revenue grew by 3% year-on-year to reach 385 billion yen. And if you look at the breakdown of the revenue, The pharmaceutical business grew by 5% year-on-year from the previous year. Steady growth was shown. But there were one-time revenue recorded last year in larger amount. Therefore, revenue decreased. In the other business, so at the 67% year-on-year, the gross profit increased by 3% year-on-year. R&D expenses accounted for... The ratio, which was down by one percentage point in terms of ratio to the revenue, of course, while we are making proactive investment in development of our Rekembe business, we have been able to enhance the efficiency in investment in R&D activities. SG&A expenses increased significantly. There were two reasons for the increase, as you see below that. Because of the strong LENVIMA business performance, therefore, there were increased expenses regarding the shared profit of LENVIMA Paid-to-Partner, which increased. And it can be it's still in the midst of being launched into the market. Therefore, due to these, S&G and expenses increased. As a result of this, operating profit was 27.8 billion yen, 87% of the previous year's level. Profit for the period was 21.7 billion yen, which was 94% of the previous year's level. Next. Now, if I look at the breakdown of the revenue migration, the pharmaceutical business... increased by 13.5 billion yen from a year earlier, as you see on the right-hand side. Recently, what we call three Ls, Renvima, Devigo, whose generic name is Rembolexant, and Rekembe. These three global brands are driving the growth. In total of those three ELs, the revenue exceeded 200 billion yen, which was a 21% up increase from the previous year. The largest increase was driven by Le Canvii. which grew by, increased by 15.9 billion yen year on year. When it comes to the one-time income, which was decreased from a year earlier, therefore, the revenue stayed at the level which was up 3% year on year. Next, turning to the operating profit, pharmaceutical business last year increased by 2.7 billion yen with the more efficiency in R&D investment which led to the factor to increase the profit by 2.7 billion yen. As I said earlier, the expenses of the profit of shared profit of Renvima to partner decreased the factor by 3.9 billion yen and also one time decreased the profit by 5.1 billion yen to reach 27.8 billion yen and there is no change to the full-year forecast. We are going to put more focus on the three Ls, and we would like to control the costs increase within the increase of the growth of the gross profit in order to achieve the increase in both the revenue and the profits. And 80 yen per share as the interim dividend was resolved at the Board of Directors meeting held today. Going forward, I will put focus on Rekembe in my report to you today. This is to recap. For a long time, I think I have been discussing Rekembe, and I feel that a long time has passed since launch of Rekembe. But actually, The first market where we launched Lecambi for the first time, at that market, the accelerated approval was granted in January last year. After that, in July in the same year, full approval, traditional approval was obtained. And since then, we could begin the full-scale sales activities. until the end of this first half, only the 15 months have passed since the launch. And in Japan, the approvals were obtained in September 2023, and it was launched in December. And therefore, the 10 months have passed as of the end of September. And in China, Lecambi was approved in January this year and launched in June this year. Therefore, now in all of these three markets, Lecambi is still in the midst of being launched into these markets. Given this backdrop, when we say Lecambi treatment, I believe that the treatment with Lecambi has been established. So what do I mean by this? As you see below, the early initiation and continued treatment, even after plaque removal, continued to sustain the slowing of clinical decline or improvement with expanding effects. And the accumulation of data in real world has progressed. Therefore, incidence of ARIA in Japan as well as in the U.S. has been contained within the range described in the package insert. Therefore, it can be administered while ensuring safety. So in the meantime, there can be a treatment that has been established during this period. And there are several data sets which are supporting this statement. And core data is as shown here, because I believe that this is the core data. And Chris Van Dyke presented this data at the CETAD, which was recently held. So what I would like to say is over the period of 36 months, When the treatment was provided, on the left-hand side, the 18-month core period under Clarity AD study, and on the right-hand side, you see the open-label extension study. The period is shown here, and there are three lines. The top line shows in the CLARITY-80 study, from the outset of the study until the end of the study, 18 months, active treatment was provided to this group. And even after that, the patients continued to receive active treatment. The line in the middle shows the group which received the placebo treatment in the core period. In the OLE study, everyone was shifted to active arm. Therefore, they received the active treatment in the OLE. The bottom line shows the ADONI cohort, a population with the same baseline or very close to the baseline of the clarity ADE. and over the 36-month period. If you could compare the bottom line and the bottom line in the middle up until the 18 months, you can see almost overlapping each other. So ADONI cohort can be recorded as placebo or control arm in a core period of the clarity AD. If you compare the first line and second line, the second line means that this was the population which started to receive active treatment from 18 months onward, and there seems to be efficacy. However, the gap between the first line and the second line has not shrunk. So that means that the earlier the initiation of treatment was, the greater the benefit was. So that is the interpretation we can drive from comparison of the first and the second line. And after the end of core period, plaque was significantly removed, in my opinion. And even after that, the active treatment was continued, comparing the top line and the bottom line. At the month 18, CDR-SB, a slowdown of the decline was 0.45, which was expanded to 0.95 in terms of the gap between the two lines. Like ABDMT, the causal materials or substance continued to be removed. That means that the longer the treatment gets, the greater the benefits will be. So that is shown here. At the end of a core period, plaque was already removed, but even after that, the active treatment was continued, and then the efficacy was supposed to be expanded further. So continued treatment seems to be very important. That is the message we can get from this data. In terms of pharmaceutical agents, Suppose that there is efficacy in the product and with the safety secured, and then the continued treatment forms the maximum footfall for growth of the product. In that sense, we have made success. That is what I wanted to report to you today first. Now, turning to the actual results in sales for the first half of this fiscal year, comparing Q1 and Q2, the global total sales was 16.3 billion yen globally, and there was the quarter-on-quarter growth was 160%. and 128% increase in U.S., and 186% in Japan, and green at the top consists mostly of China. In Israel, there was an advanced treatment made. However, that is included as a fraction, but most of this portion is from China. Quarter-quarter growth was increased in terms of sales by 7.8 folds. So... we have been able to grow that can be exceeding our business plan. Having said that, as regards to pathway, particularly in the United States, there are some new movements that are emerging. Therefore, I'd like to share with you what they are. First, there has been an increase in amyloid beta confirmatory testing. As you know, utilizing either PET or CSF for confirmatory testing on amyloid beta. So this shows the heaviest portion of the pathway. At the outset, we thought that this could be the bottleneck in the entire pathway, but this confirmatory testing on amyloid beta is not a limiting factor. To the contrary, there has been a significant increase in the number of amyloid beta confirmatory tests in the United States recently. For the fiscal year 2024, from January through to September, there was approximately 40,000 cases of the tests conducted, and it is predicted to reach approximately 60,000 cases, approximately four times that of the previous year. Therefore, we can say that the amyloid beta testing, PET testing, is increasing significantly in number. And the main factor for this is, as you see in the next bullet, CMS, Centers for Medicare and Medicaid Services, responsible for reimbursement, lifted the upper limit on the number of A-beta PET tests to be reimbursed. That was announced in October last year. So with this, immediately, the number of PET tests increased significantly. In addition to this, again, recently, CMS announced that The fees for reagents and the procedure fees for scanning, there used to be the upper ceiling on that. However, starting from next January, CMS announced that that ceiling will be lifted as well. So as regards to the PET tests, we believe that the number of tests for confirmatory testing will continue to increase in the United States. Similarly, in CSF testing during the first half from April to September, the number of tests performed was approximately 10,000 cases, almost double that of the same period of the previous year. So the amyloid beta confirmatory testing cases are increasing significantly and rapidly in the United States. A possible factor for that is because of the blood-based biomarker which is described at the bottom of this page. Before going through the PET or CSF testing, BBM is widely used for prescreening purposes. What kind of effects can we see from this? Patients with amyloid beta negativity is already identified. at the time of prescreening, therefore they will not be referred to receive the PET or CSF testing. Therefore, amyloid beta confirmatory testing efficiency has been improved with a higher positive rate. The efficiency has been improved significantly. With this tailwind, amyloid beta confirmatory testing is not a limiting factor or a bottleneck in the United States along the pathway, but rather this has become the gateway for patients to be sent to the next steps in the gateway or pathway. So with the increased efficiency in the confirmatory testing and with the 50% positivity, we believe that it used to be about a 30% positivity rate, but it has been increased to about 50%. Therefore, in the early AD, the patients with amyloid beta positivity is about 25,000, which consists of 20,000 people examined by PET and 5,000 people by CSF. After confirming amyloid beta positivity, as you see in the middle, the tests will continue further. Before starting treatment, baseline MRI tests is conducted to confirm the history of cerebral hemorrhage. So after having this test, then patients will go through APOE for testing to see whether they are heterozygous or homozygous or APOE for non-carrier. And after that, attending physician will explain the treatment and then provide informed consent. At IC, there are about 20,000 patients. And as you know, in the United States, after that, there needs to be a step to confirm the reimbursement eligibility because different individuals have different coverage. Medicare Advantage is widely used for most patients, however. The coverage scope and... is deferred from a person to another. Therefore, there needs to be a step to confirm the coverage or eligibility with payers. In Japan, this kind of work is not necessary in most cases. However, actually, this is a quite cumbersome and burdensome process in the United States. After confirming the reimbursement eligibility, then the patients are ready to be infused So during the first half, there are approximately 10,000 people who are ready to start treatment. And those who have received... Approximately 4,000 people have started to receive the treatment, but the remaining 6,000 people are supposed to be waiting for the start of treatment because of the shortage of the infusion capacity, which is deemed to be almost fully occupied. So there are about 6,000 people who are waiting for the treatment. So once again, I would like to give you the overview of the pathway in the United States. Starting from top left, if someone finds any abnormality in daily lives, they will visit the family doctor or primary care physician, and simplified cognitive testing can be used. As you see at the top, primary care physician, family doctors will see and consult with the patients. At this stage, there are approximately 600,000 people who sought the consultation with PCP at the end of September this year. This number has almost doubled from last year. and media coverage about Rekembe was quite active in terms of publicity and the journal and reporting in the media were very active. In the meantime, therefore, The awareness about AD as a disease has been enhanced quite significantly. The number of people who sought a consultation with PCP has almost doubled. And to the right, those people who are referred to neurologists amounted to about 500,000 people. And those people who are going through full-fledged cognitive testing and received amyloid beta confirmatory testing or referred to A-beta testing, about 50,000 people are referred to the test. And basically, MRI is... 25,000 people, CSF will be taken by 20,000 people, and 5,000 people will receive MRI. And based upon the CMS reimbursement data, inclusive of some estimates, we are showing these numbers. Therefore, we believe that these numbers are quite reliable. And now reaching the informed consent, there are about 20,000 people after taking the reimbursement with payers. And now coming to the stage where people are ready to start the treatment on cumulative basis for the first half, there are 10,000 people. And as you see in the blue There are 4,000, about 4,000 people who newly started treatment. And comparing to the above number, 10,000 people and cumulative 10,000, cumulative basis, these two numbers are very different. In fusion stage people, 10,000 people, as of the end of September, those are the people who are receiving the treatment. Therefore, the infusion capacity could accommodate 10,000 people at that time. So out of 10,000 people capacity, why only 4,000 people could receive new treatment? That means that the 6,000 people were continuing on their treatment, which they can be. Therefore, out of the 10,000 people capacity, 6,000 people equivalent capacity was already used. Therefore, at the Therefore, there are about 6,000 people who are waiting on the pathway. Area monitoring is conducted as per the package insert. So capacity along the pathway needs to be expanded, and how? the number of patients who are going through pathway is increasing rapidly. Therefore, there needs to be an increase in the healthcare professionals and also systems or medical tools for managing the pathway is getting more and more important. And number one, we need to support the infusion capacity expansion. There are two measures to be taken. Firstly, We will focus on IDN, as you see at the bottom. IDN stands for Integrated Delivery Network, which are playing major roles in providing treatment in AD. And they are a very huge group, one group. We are negotiating with about 200 IDN, but on the average, one IDN can accommodate 50 to 80 hospitals or infusion centers or sites within one group. They are all huge. For example, Mayo Clinic is either one of the largest IDNs in the United States and covering nationwide. under one unified management policy, they are running these hospitals and sites. So once a policy on the AD treatment is determined, and all the hospitals and sites under the umbrella will conduct the treatment in the same policy. Therefore, the number of hospitals that can administer Lecambi infusion needs to be increased, or infusion centers within the same group needs to be increased. and the infusion capacity needs to be expanded. These are the two measures that are being carried out. And number two is the AIC, Ambulatory Infusion Center, which spreads throughout the United States. There are large companies who are managing hundreds of the infusion centers, and with over 30 companies as such, we have concluded contracts. We are expanding the number as well, and a GPO, group purchasing organization, which also has the huge infusion capacity. We are going to expand the infusion, such contracts, as well as reviewing the contracts with them. By doing these, as I said earlier, we are assuming that 10,000 people equivalent infusion capacity as of today shall be extended, expanded to 18,000 or 19,000 by the end of this fiscal year. We have already concluded the contracts for increasing the number to that level already. Therefore, those patients who are waiting, as I said earlier, will proceed to the stage of infusion by the end of this fiscal year. And as you see in the bottom half, In the pathway or IDN, the duration of the process within the IDN network can be shortened or not, and how we will be able to support the increase of the healthcare professionals in IDN. The example at the top, also an example of a huge IDN. Starting from the testing to start of the treatment, the duration of that process has been shortened to five days in this IDN. And why was it possible? The hotel covered by this IDN is offered for patients to stay for a week. In the meantime, all the necessary tests and, if necessary, a treatment can be initiated during the week. So such pathway is rolled out through this IDN. Or if you look at the second example, this is the university hospital-centered IDN in the south of America. They have a team, multidisciplinary conference is held in order to, team is formed in order to provide a centralized management of patient information. And we'd like to share these good examples with other IDNs and so forth. At the bullet at the bottom, for... There has been a platform developed by a company which is specializing in the development of such a management platform covering the testing and consultation and medication. We are offering this to medical institutions at no cost and the management of the schedule of the patients and the duration of such processes could be shortened at such IDNs. Once again, I'd like to go back to the actual numbers. Regarding the sales from wholesalers to accounts or medical institutions, this graph shows the number of vials sold. This is not the sales numbers, but the sales numbers could be in terms of accounting for or recording in the book. But this shows the monthly number of vials delivered to medical institutions in the U.S. Therefore, this shows the actual trend of the expansion of Lecambi in the field. So if you take a look at this, since the full-fledged launch was made, steady growth has been shown. And recently, we have seen sharper increases exceeding 50,000 vials monthly delivered to medical institutions. This is going through the cold chain. Therefore, medical institutions do not have a lot of stocks. Therefore, at the time of delivery, the vials are used, and we achieved the highest monthly sales of vials in October. So based upon this, We have made the 16 billion yen as the forecast for the second half of this fiscal year in the United States. The full year forecast amounted to 26.5 billion yen for the United States. This means... Compared to the earlier guidance, this means that there was a decrease by 17 billion yen. So what do we mean by the decrease by 17 billion yen? The 6,000 people who are waiting for the initiation of the treatment, suppose that these patients will steadily, if they could proceed to the treatment in the first half, and then the number could have been achieved or almost achieved. And as I said earlier, infusion capacity can accommodate 10,000 people as of the end of September this year. So 10,000 patients on treatment was the number that should have been achieved by the end of last year. Therefore, because of the shortage of capacity for infusion, so there has been this delay by six months in the progress towards our goal in the United States. So now turning to the next page, which shows the key factors in the near future, SCAI and the BBM. SCAI stands for subcutaneous autoinjector. In a pharmaceutical market, obesity drugs are also administered as SCAI formulation. Therefore, this can be easily utilized. Therefore, SCAI formulation has gained a lot of attention. And BBM, blood-based biomarker, which I have been telling you,

First, about new formulation and administration regimen, SCAI, this is game-changer one. But before getting into the discussion of SCAI, as we have discussed before, regarding IV maintenance treatment, we have already filed... Where is initiation treatment? Where does maintenance treatment start? That may be a question, but this is to be reviewed by FDA, and we cannot casually make the distinction. But a clarity AD study ran for 18 months, and I think that can be one of the yardsticks. And for example, let's say that There can be a switch to new maintenance treatment. And instead of biweekly treatment so far, monthly treatments may become possible for maintenance treatment, meaning it will be reduced in frequency by half. Long hours of drive, frequency will be reduced, and the requirement in terms of number of nurses and resource will also be reduced. The second point is about the SCAI first. maintenance treatment to be covered initially with IV can be replaced by SCAI eventually. This is formulation of 360 milligram SCAI for weekly dose, allowing for self-administration at home or outside of care. And as shown at right bottom, pteromine SCAI will be used this is an excellent device in our view first regarding needle the tip of the needle is tapered and it is tapered both on the inside and outside reducing pain significantly and syringe is made of plastic so breakage or safety issues are reduced And the part that moves does not use silicon, and that prevents drug clumping due to use of silicon oil. And it can be given, administered within 15 seconds, whereas it takes one hour for IV infusion. This is by far a very short duration, and there are fewer administration reactions, infusion reactions, according to the data. We believe that this is going to greatly contribute to streamlining the AD diagnosis and treatment pathway. Rolling submission is the type of submission we have been undertaking, and recently this was completed, and we expect approval in the first half of fiscal 2025. And then SCAI for initiation treatment. we will be preparing to file submission for that to be granted approval. And in fiscal 2025, we are aiming to obtain approval in fiscal 2025. And if that becomes a reality, we can cover all of the treatment phases with SCAI Visiting hospital for infusion at the time can be reduced. Manpower, infusion risk, all of these can be reduced. And pathway can be shortened substantially. and AD treatment can become more universal and standard. It will be a major step towards that, and we believe the biggest game changer will be the SCAI formulation. Next, about blood-based biomarker, this is game changer two, or key factor two. Currently, more than 8,000 BBM tests are already conducted each month, And mostly, as I mentioned earlier, mostly these are for pre-screening, to screen out A-beta negative people to prevent them from moving to the next step. testing companies have already initiated LDT. PTAU217 is also included in the test, and this is a highly accurate blood biomarker. And not only for prescreening, but for confirmatory testing, PTAU217 testing might make it possible for confirmatory testing. So this is expected to be such a good BBM. And I believe that is also one of the reasons why BBM test number is increasing. And as noted in the middle, Alzheimer's Association in the U.S., a very prestigious group, which is an organizer of AIC, is expected to issue a clinical BBM guideline in the In Q4 of fiscal 2024, for prescreening such and such biomarker to be used and for confirmatory such and such biomarker to be used may be shown in the guidelines and threshold for use of biomarkers may also be shown. That is more or less decided. With such guidelines in place in clinical settings, for both prescreening and confirmatory BBM usage will be promoted. Rather than using one biomarker, composite of multiple biomarkers and ratios of biomarkers are used to allow for more accurate BBM and academic presentations have been made by two companies, one of which has already filed with FDA, and the other is expected to file shortly. And one is already given breakthrough device designation. With such more accurate BBM diagnostic test, it becomes more likely that BBM can be used for confirmatory testing. And rather than PET and CSF, BBM may be used more for confirmatory testing. As shown at the bottom of the page, in fiscal 2025, BBM is expected to be incorporated for confirmatory use in A-beta testing in the pathway. These are the game changers or key factors, and as a result, we have near future outlook. Next fiscal year, wide usage of IV maintenance and adoption of guideline and increased adoption of VBM are expected, and we believe that pathway is expected to be streamlined. and the two key factors, SCA formulation and BBM confirmatory testing, are expected to be ready in fiscal 2026. At this point in time, the long pathway can be reduced significantly. cognitive testing, A-beta confirmatory testing with BBM and ApoE4 testing. All of these can be done at the level of PCP's family doctors. As for MRI, this part may not change much, but as for drug administration, it can be at home or at the site of care, and the burden of visiting an infusion center can be significantly reduced. So at the risk of repeating myself, a pathway can be streamlined substantially and PCPs will be involved on a full-fledged basis in AD diagnosis and treatment. That is quite imminent, leading to further expansion of the AD market. Turning to the situation in Japan, as you are already aware of, In Japan, OUG, optimal clinical use guidelines, are in place. Under the OUG framework, physician requirements, patient requirements, site requirements are established by the government in Japan, and that leads to standardized pathway in Japan. There is also mandatory all-case surveillance. Already, at more than 600 sites in Japan, Pathway has already been established. As for real-world area incidents, it is within the range described in the package insert. After the launch, it has been more than six months for some of the patients who are receiving treatment, and the number of such patients is increasing. And at OUG, as per OUG, in the neighborhood, dementia disease medical centers, medical institutions with dementia specialists, these follow-up facilities can give treatment to patients who have been given Lecambi for more than six months. and approximately 800 such facilities have agreed to treat patients. And the collaboration is promoted between such facilities and physicians throughout Japan. So standardization and universalization of the pathway in Japan may be accelerating and may be moving slightly ahead of that in the U.S. And from November 15 on TV, direct-to-consumer MCI awareness campaign will start, which will promote early consultation and diagnosis. and as a result, we expect more people will be coming onto the pathway. We are establishing foundation in Japan, and this establishment of foundation in Japan continues to evolve, and it can be expected to enter further expansion phase. Pathway is shown. Around 200,000 people are visiting family doctors. Around 50,000 people are visiting specialists. Around 5,000 are receiving treatment. Patients waiting to receive treatment is not so large in number. And on the very right side, there is a follow-up facility. Follow-up facilities in the neighborhood are beginning to be involved in the treatment in Japan. There is another market, China. There are three characteristics in this market. First is that it is a private market or self-pay market. It is not a reinsurance, reimbursed market, but out-of-pocket market where Lecambi is being introduced. In 30 provinces, in 93 cities, in 240 hospitals, Lecambi is already distributed and is being administered. As for self-pay market, the patients use private insurance. They also have opportunities of receiving private health examinations, and the number of people who receive BBM tests is increasing. And around 3,000 people are expected to receive a Lecambria treatment this year, and we expect an increase by five-fold by 2026. The second characteristic is usage of BBM in China. This is based on solid scientific evidence, AIC. And the other day, in Tokyo, there was an AA conference, and it was noted that BBM data in China, or there were many presentations of BBM in China, There is academic research and physician-led cohort studies nationwide on BBM. And as shown here, top five independent clinical laboratories have established a nationwide diagnostic network. The third characteristic is infanton, Azi and Jindon Health. has a joint venture business which provides a full-scale AD digital platform. Already 610,000 users are on the platform and 6,000 physicians are registered. I would like to further elaborate on this. As I have noted, in the self-pay market, people are purchasing commercial insurance, and including treatment and drug expenses, insurance provides coverage. Private health checkup and private nursing homes are also accessible by these people. So BBM testing and diagnosis is available more frequently. AD and potential AD patients, potential early AD people may go to offline testing for web testing or may seek treatment through ePhantom platform. And main two, BBM, are shown in the middle. is offered under a desire model, what is called a desire model, which I also heard presentation of at AAIC. BBM, APOE4 test, and MCAR combined, and there was a comparison of BBM and PET and CSF. BBM in that combination at AAIC, high level of accuracy, it can offer results. Clear AD study, this is covering six regions in China. It is a very large cohort study, and that data was also presented recently in Tokyo. BBM use in China is backed up by scientific evidence. As for e-phantom, our joint venture is connected, one of them, and a blood drawing site can be introduced to patients. And infusion is given in hub and spoke model. Initial, a few infusions are given at hub sites, and then in the neighborhood infusion sites, patients can continue to receive a treatment. Family doctor selection, testing site selection, infusion site selection. The most convenient location for each can be selected by patients by using eFantone. And there are also apps to confirm the effectiveness of the treatment on a daily basis. And that allows patients to ask questions of doctors. Also, as for full year forecast globally, 42.5 billion yen is the global revenue forecast. Between the first half and the second half, year on year, 161%. 153% in the U.S., 184% in the U.S., and in China, 152%. That is the growth from the first half to the second half. As I have discussed earlier, in the U.S., because of the delays, there was a decrease by 17 billion yen overall. 2 billion in Japan, 1 billion in Japan will be offsetting that negative 17 billion in the U.S. And from the number that I've mentioned earlier, it is down by 14 billion yen in terms of this folio forecast. This is a message. For the first time in the world, we have launched a first-in-class drug that addresses the root cause of A.D., There's no one before us. It has been one year and three months since the U.S. full-scale launch, 10 months since the Japan launch, and four months since the China launch. And that can be in the midst of market introduction. And in the U.S., as I've mentioned earlier, there has been about six months of delays in the progression of sales results. And We regret this, but the reason is quite clear. This is a bottleneck of infusion capacity. It is not a structural reason or any reason due to manufacturing. 6,000 patients are waiting to receive treatment. should be able to receive an infusion since we have already concluded contracting for additional infusion capacity to cover that people who are waiting. And we are progressing with addressing current issues as well as we are taking initiatives to expand the new future market and we recognize the great potential for market expansion ahead. As for regulatory updates, U.S., Japan, China, South Korea, UAE, Hong Kong, Israel, United Kingdom. In these eight countries, we have been granted approval. And in Europe and in other regions, regulatory review is underway in 17 countries. As for EMA, European Medicines Agency, currently re-examination process is underway. The first evaluation resulted in rejection. In the meantime, a very large number of European Alzheimer's disease-related organizations and key opinion leaders have called for approval. on EMA, specialist organizations, radiologist organizations, very large number of people, leaders have called for EMA approval. Even after Brexit, the UK is a major country in Europe, and UK has given approval. Indication is for patients excluding ApoE for homozygous carriers and post-authorization safety study was mandated. That is the approval given in the U.K., This month, there will be CHMP meeting of EMA. We believe that can be will be discussed. And as soon as we know the results, we would like to update you and we await with much expectation. I would like to share with you some more data. First, I had 345. This is a stage before MCI, preclinical AD stage, targeted phase 3 study. What kind of stage of disease is that? Cognitive function is normal, but borderline amyloid accumulation in the brain, as shown in the middle on the left side, cognitive function normal but positive for amyloid accumulation in the brain. These are the target subjects. And recently, on October 15, 1,620 subject enrollment was completed. Treatment will be for four years. Topline data is expected in 2028. So we are moving according to the schedule or slightly ahead of the schedule. At the recent CTAD, there was a presentation as shown here, of prescreening using BBM. The trial uses BBM for prescreening. This results in much higher PET positivity rates, and it has improved the PET screening fail rate. Black line is before BBM prescreening. This shows a PET screening fail rate. 75% was fail rate, meaning 25% was the positivity rate. But with BBM prescreening, fail rate is 25%, 75% is the positivity rate. Screening success rate has increased substantially, resulting in much greater efficiency. Next is E2814. This is anti-MTBR tau antibody. As shown at the top, ASI is aiming to overcome the two major pathologies, A beta and tau. And regarding tau pathology, our flagship drug is E2814. This antibody... From the very beginning, there is a cohort of dyad, dominantly inherited Alzheimer's disease, a patient cohort, which is managed by And there is a very large number of patients who are registered here. And this group has evaluated the cohort of patients. And part of the data is shown here. And another important piece of information is NIA-AA. This is National Institute on Aging, NIA, and the earlier mentioned Alzheimer's Association. Jointly, the two organizations are looking at tau pathology, and they are recommending tau pathology-related biomarkers, three biomarkers, CSFP tau 217 and MTBR tau 243 and tau PET, using these three. That is recommended. And as a result of such assessment, As presented at CITAD, the red line at the top is ZIAD observation group without any treatment intervention, and the bottom is a group that is given E2814. These are two biomarkers, CSF biomarkers. It suggests a significant decrease in these biomarkers. Tau accumulation in the cells, it shows that there was decrease of tau accumulation in the cells. On the right side, it is a very small number of patients, three patients, but this is world's first data. Please look at the image. Red part shows accumulation of tau. And there is patients one, two, three. In the right side, there is a graph. This is quantification of using tau PET or SUVR, and it shows the trend for each patient. The top patient at the baseline did not have much tau accumulation. In such a patient, the top blue line, there is no deterioration observed. So it suggests that deterioration was suppressed. And the bottom two patients have more red regions at the baseline. And the red region is decreasing much in the image after the beginning, the start of the treatment. And as shown on the right side in the graph, there is also a marked reduction of tau. Diode. data and NIA recommended biomarkers were applied to DIAC patients and pharmacodynamic effect of E2814 is being observed and now we are moving on to initiation of a new phase 2 study expanded to sporadic ADE. We have presented data which can be a very strong driving force. I would just like to use one slide to share with you the current status on oncology. Revenue, 164.9 billion yen, increase of 9% year-on-year. We had strong results in the first half and are primarily driven by the performance in the U.S. 115.9 billion yen, 17% year-on-year. That was a strong growth in the Americas in all of the 10 cancer types. The results exceeded the previous year same period, especially as shown on the right side, RCC. For both clear cell and non-clear cell, we have first-line indication, which is included in the NCCN recommendation. We also have a LEAP-01 study, which is jointly conducted with Merck. Lenvima plus pembrolizumab plus TACE. So TACE plus these two drugs. The presentation was made at ESMO, primary endpoint PFS. is already achieved, and the other primary endpoint, OS, is showing positive trend. Data is now being accumulated. NCCN guideline inclusion application has been completed. RCC HIF-2-alpha inhibitor combination trial called LightSpark Phase 3 study is also steadily ongoing. In conclusion, I have a long paragraph, long paragraphs, and this is written in passion, so please allow me to read this out. Alzheimer's disease AD diagnosis and treatment pathway is being created by Lekembe. In the United States, the first country in the world to launch Lecambi, the issue regarding reimbursement of A-beta confirmatory testing has been resolved. The utilization of BBM has increased, and we are seeing a large demand being created. This has led to an increase in patients waiting for their treatment, making it important to secure infusion capacity and effectively deploy medical staff. We know a great passion and enthusiasm of the relevant medical professionals who are working diligently with us. In fiscal 2026, we expect wide usage of BBM for A-beta confirmatory testing in medical community and coverage of Lecambi SCAI as an option for the entire treatment period, from initiation to maintenance. Through these efforts, PCPs, family doctors will play a crucial role in the AD diagnosis and treatment, and AD diagnosis and treatment pathway is expected to be further simplified. The can-be treatment will become a much more common and popular medical practice. In Japan, the initial introduction facilities are expanding simultaneously at the follow-up facilities, which cover the patients after six months' treatment. PCPs as well as local dementia medical centers have started to participate in the treatment. The generalization of AD diagnosis and treatment is progressing, and we are seeing an increase in sales. In China, with AD digital platform, Market introduction is progressing steadily, and we expect rapid increase in demand. Regarding regulatory status, we believe EMA re-examination process is in its final stages. Opinions advocating strongly, there can be approval from European patient organizations and leading AD experts have been shared. Approval by the UK authority has already been granted. We are aiming to successfully tackle the two major AD pathologies, A, beta, and tau, and continue with a robust pipeline for this purpose. MTBR tau antibody E2814 has confirmed its pharmacodynamic evidence by using the most modern biomarkers in tau research. In addition, a HED345 study with Lekembe phase 3 study is steadily ongoing, aiming to start treatment in preclinical AD stage. ASI will continue to commit to function as a pioneer at the forefront of the world in the field of AD, and we further collaborate with medical professionals and, above all, with patients' families to realize today that AD will be changed to a curable disease as soon as possible. I would like to open the floor for questions. First, we will entertain questions from analysts and investors before taking questions from the press. If you have a question, please give us your name and affiliation before your question. If you have a question, please indicate by raising a hand. Yes, attendee seated in the second row, please.

Excuse me.

This is Yamaguchi of Citi. Thank you for this opportunity today. Regarding the current marketing for Lecambi, thank you very much for ample supply of data. Please do not withdraw it. On this basis, we'd like to continue discussion with you. And one question I have regarding U.S. market about infusion center. That has been discussed earlier as well. And this time, you have mentioned specific numbers like 10,000, which will be increased to 20,000. And based upon the IV, of course, once SC is introduced, the status will be changed. But for the coming... One year, do you think that the 10,000 can be increased to 20,000? This can be a bottleneck again. And then based upon the 20,000, the sales trend will be estimated and assumed on this basis? Earlier, I mentioned towards the end of this fiscal year, 19,000 infusion capacity has been already secured by contracting. And in fiscal year 2025, the number will be exceeding 26,000 in terms of the infusion capacity to be secured by introducing an IV maintenance therapy and infusion capacity will be allocated more towards initial treatment. and increased sales will be supported by infusion capacity. By 2025, we believe that the likelihood of securing enough capacity is already established. And then in the equation, I think Kesena is also considering the same thing. I believe that they will try to secure the infusion center capacity. So you mentioned that the 19,000 or 26,000 are already secured. Do you think that taking into account the competitors' movement? Thank you for your question. Yes, we have taken into account the movements by competitors in terms of securing the infusion capacity. Thank you very much. And SC is going to be very important. And SCAI maintenance submission has been already completed and you are just waiting for the approval to be given and then SCAI initiation treatment it is to be going to be approved but have you completed the submission if you have any timeline for submission please share it with us Excuse me, I forgot to mention this. SCAI is the new BLA. because of the biologic license application, which is different for filing for IV. So it is equivalent to the submission for a new product. So independent submission has been filed. And a Part D of Medicare will be granted. Currently, it is included in the Part B. But Part D means that the distribution will go through the pharmacies. So new pricing will be considered for SCAI. As I mentioned briefly, the value will be much higher than the value of IV formulation. Therefore, from the standpoint of the value-based pricing, the price can be set upwardly, which is supported by enough logic. Therefore, for SCAI formulation, New BLA in the new category for new pricing will be progressed. So that is what we assume for SCAI. Regarding the submission and registration, I believe that includes the initiation treatment for SCAI filing. Nakama-san or Owa-san, could you please respond to the question? Thank you very much for your question. My name is Nagahama. I am responsible for RA, regulatory affairs. SCAI initiation submission has not been done yet. But for initiation, we are steadily progressing in the discussion with FDA. We are exploring the optimal dose. We are discussing on this with FDA. And SCAI maintenance treatment, We expect that approval will be granted in the first half of next year. After getting that approval, immediately we will file the submission for SEAI initiation. Thank you for your question. So let me clarify. After getting approval for the maintenance, and then you will start filing for the initiation? Well, we have already commenced consultation with the regulatory authorities and the PKPD monitoring data. and SCAI real world or the administration data will be combined in submission. Therefore, almost the same methodology for filing will be done with the SCAI maintenance. Therefore, the preparations are almost done, but the timing for the submission is after getting approval for SCAI maintenance. We will switch to the initiation fighting, but we are aiming at getting approval by the end of fiscal year 2025. Understood. Thank you very much.

Yes, next. Attendee seated in the front row. I'm from JP Morgan. Thank you for taking my question. I also have a question regarding infusion centers. To begin with, up until the first quarter, I believe the progress was according to the plan, but this time, infusion center is the rate limiting factor. Infusion center contract was delayed. Is that the reason why? Or looking at the past three months, infusion capacity is the limiting factor, and you have confirmed that. There is a need to increase infusion capacity. At the end of the fiscal year, it will be 18,000 to 19,000 capacity, and next fiscal year, 26,000 capacity. How many patients can you administer annually? At that point in time, we should be able to administer Lecambi to 26,000 patients. And as I presented, the overall demand is stimulated at a very fast pace. And if infusion capacity is not a limiting factor, more and more patients will be coming onto the pathway. And Wakao-san, as for your first part of the question... In the end, right now, at IDN large institutions, there are more sites that are treating about 300, as many as 300 patients per site. And infusion capacities are at full capacity. And we began to recognize this. Recently, relatively recently. Mr. Haruna, could you supplement? Thank you. I'm responsible for the Canby in the U.S. My name is Haruna. So your first question. Regarding your first question, at IDN, more patients are being prescribed Lecambi. And we also hear from IDNs about their desire to have off-site prescriptions outside of their sites since last summer. And we have begun to enter into contracts with more. We were able to complete that quickly, and patients who are waiting are now beginning to receive infusion. And so these are the most recent developments. Thank you. If that is the case, 26,000 infusion capacity, meaning 26,000 patients, I think that is still far short of what you're targeting. With the increasing demand, are you able to increase at a certain rate infusion center number or... Unless maintenance therapy or auto-injection are approved, is it going to plateau at a certain point in time? I think infusion capacity is used most by oncology. Most oncology patients receive infusion. Next is RA. RA. And it's vying for allocation of infusion capacity with these therapeutic areas. AICs are for-profit organizations, and if Lecambi Infusion ensures greater profit, then it's possible that there may be more allocation for Lecambi. Inclusive of that, we are reviewing contracts, revising contracts, and entering into new contracts. So you expect to be able to increase infusion capacity. About the revised forecast, my final question, the Canby sales was lowered in your forecast and the VIMA increased, but fixed cost others have remained unchanged. There may be an increase, there can be a decrease. When I look at these, there can be gross profit. I think it's possible to be guessed. And that's the same as what I guessed earlier. in the beginning of the fiscal year, but I think it's lower than the ordering antibody drugs. I would like to understand if my estimate is correct. And next fiscal year onward, with increasing demand, do you expect improvement in margin in manufacturing? I think there was a comment before on the past occasion. I would like to seek clarification this time again. globally, that can be, will start to contribute to profitability from fiscal 2026. as I have discussed before, and the U.S. will be turning profitable in fiscal 2025, but unfortunately, there is not a certainty. There has been a delay, as I've described. So in the U.S., we believe that it will be turning to profitability in fiscal 26, but in China and in Japan, we will be turning to profitability in fiscal 2025. fiscal 2025, there can be overall profitability in comparison to fiscal 2024 should be much improved. Globally, also in the United States, in fiscal 2025, We had full field force deployment in fiscal 2023 and 2024, but after the establishment of the pathways and we have... completed most of the efforts needed to establish the pathway, and we believe that we will be able to reduce resources for that. And therefore, in fiscal 2025, we can be more selective in resource expenditure and investment. And therefore, in fiscal 2025, China, Japan profitable, and in the U.S., unfortunately, one year later, but profitability should be improving, and in fiscal 26, we expect to turn profitable, including in the U.S. and globally. As for OP margin, I think there will be improvement, but about gross margin, or can I expect improvement in cost of goods? manufacturing cost? I take it that that is your question. As for manufacturing, well, drug substance, drug product, as for drug substance, biogen is producing, and as for drug product or formulation, we use a part of biogen as a plant, but After expansion of volume, we are able to use a third-party facility, and we expect to be able to use a third-party facility about the cost reduction in a very rough manner. Could you elaborate on that? I'm Tamura, responsible for manufacturing. As CEO mentioned, regarding drug substance, Right now, in Solzhen, Switzerland, at Biogen plant, drug substance is produced, and this is a highly automated facility, and cost is being reduced by averaging. yield improvement is expected based on the new process that is being developed. And we expect to be able to produce at lower cost. As for drug product, as CEO commented, we have concluded a contract with European CMO. Manufacturing has been started. By using such CMO, we believe we should be able to control cost even better. As for drug substance, as Mr. Tamura mentioned, at the cutting-edge factory in Solzhen, Switzerland, it is being produced and the facility is run at full capacity. Also in North Carolina, Biogen has a factory in Research Park Triangle, Research Triangle Park, and we are planning to be able to use that. And that North Carolina facility has been depreciated, and therefore cost is lower. And we would like to be able to increase the volume of batch produced there so that overall cost can be reduced. As for formulation of the third party, I think it's a German CMO. We already have contract with that CMO, so we believe we should be able to substantially decrease costs for drug product. Thank you very much.

The person in the front row, please, have the floor. My name is Hashiguchi. I'm from Daiwa Securities. Regarding your explanation about the status in the U.S. of the Lecambi, and you mentioned that the amyloid beta testing is not a limiting factor, and the BBM could be a key factor. And for those people who will receive the treatment, an impact on the cells will not be dramatically significant. Is this correct understanding? And in Japan, you have already established a structured organization. And out of those people who saw the consultation with the doctor, there is only 3% or so of the patients who have initiated treatment. And the fusion capacity... limiting factor is resolved. And in order for you to increase the sales further, and then top left of the page 10, and 600,000 people, how you are able to increase that size further. For example, you may want to consider DTC usage. At which timing, what kind of measure are you going to implement? Hashigoshi-san, regarding your first half of your question, have you ever received a PET test? No, I have gone through PET tests many times. I do not intend to be confirmed on the amyloid beta negativity. But anyway, PET test is really burdensome, particularly for elderly people. And of course, there is issue of exposure to radiation. So considering this risk and the cost considered, PET has been quite burdensome on the pathway. And turning to CSF, which could be invasive because you needed to stick needle and procedure can be done by a limited number of operators. So for the current amyloid beta confirmatory testing, PET-CSF have become the burdensome procedures on the pathway. Therefore, it is significant to reduce and streamline that part. And if the diagnosis can be done by PCP, If I may dare to refer to the currently popular obesity drugs, that is a CAI drug, and the prescribers are mostly PCPs, and specialists are not prescribing. And PCPs or nurse practitioners in the United States... A part of the nurses are allowed to prescribe. Therefore, that drug is prescribed by those professionals. And then the drugs can spread so quickly as we saw. So there is such a significance. And regarding the second half of your question, as you said, now it has doubled to 600,000 and it stucked. and this bottleneck will be resolved soon. And what do we need to do? There are two things. First is for PCPs in the United States. we need to support their increased knowledge or awareness about this disease. And at the level of PCPs, they will be able to do certain level of diagnosis, Alzheimer's or Lewy body type of or cerebrovascular type of dementia. They will be able to diagnose to that level. And I think that the The level of PCPs needs to be enhanced. That effort will be started from next fiscal year. The approach to PCPs will be started in the United States. Once PCPs can obtain certain level of knowledge, and then DTC will be considered, for example, through SNS social networks, utilizing such media, we may consider direct consumer campaign from 2026 onward, and PCP approach will be started from FY25. And in fiscal year 2026, we will consider starting DTC in the United States. Thank you very much. I have another question. With SC initiation treatment, a little earlier, A smaller size trial was published and there was an impression shown by the data suggesting that slight increase in the area incidence and the efficacy of SEAI is the equivalent to IV infusion. And before approval is granted in 2025, for such clinical question, Do you think that there can be additional clinical trial data to respond to such clinical questions? Ogawa-san, would you please respond to this question? My name is Ogawa. I am in charge of the clinical development in Japan and Asia. Thank you very much for your question. Please speak up. Can you hear? Thank you for your question. Regarding the SC initiation dosing in the clinical trials, this for the administration is being tried. And in early next fiscal year, before submission is filed, we'll be able to summarize the data and based upon which we will file for submission and then so that we can secure the delivery of the new formulation to patients. Thank you very much.

I also have a question regarding pathway in the U.S. and regarding the number of patients. You have shown that the number of patients is increasing, but up to the PCP level, from PCP level to the time that it takes from PCP to the patient receiving administration, it seems that it takes about six months. But your efforts, how shorter can that be made? And from informed consent to patients who are being administered, and there is also reimbursement procedures. and other issues that need to be addressed. But can you broaden the funnel? From PCPs to neurologists, the patients who are referred, and it takes about six months for this referral process. This process has been a time-consuming process, and there hasn't been much change here. Quite a large number of patients who visited PCPs are being referred to neurologists. Actually, referral rate in Japan is much lower. So the flow is such that it is left up to the specialists. And in AD diagnosis and treatment, we would like to utilize more PCPs, more PCPs. Because of this referral, neurologists are busier. We are also looking at referral duration. There has not been much improvement yet. From informed consent to actual infusion, was your question about simplifying this process. Mr. Haruna, can you address that question? Thank you for your question. I am Haruna, responsible for Lecambi in the U.S. There are 20,000 patients who have given informed consent. And then 10,000 patients have gone through reimbursement check with payer. This is cumulatively from January to September. And there are also patients who are given informed consent who have yet to go through reimbursement check with payers. So the 10,000 people who have gone through reimbursement check, that number should increase. I cannot give the number for the month of October, but we have seen much increase. And in October, also, a larger number of patients are receiving drug, starting a new treatment. It is not that 10,000 have dropped off. From informed consent to reimbursement check, there are still patients who are transitioning phase between the two. Thank you very much. Second question is about CHMP status in Europe. After a new reporter is named, do you think that you can expect things to be more positive? In the UK, excluding for Homozygous patients, indication was approved. And do you expect that That direction may also be reviewed in positive fashion by Europe and could also discuss other regulators. With EMA, we have very good communication and we have been exchanging data. APOE for HOMO patients, if they are excluded, how will data look, including that, and also new data for long-term treatment and what is happening in the real world. We are in close communication with EMA and sharing that information, and we are responding to inquiries from EMA. That is the current situation. Understood. Thank you.

We would like to receive questions from the media. If you have any questions, please raise your hand. All right. The person in the third row from the front, please have the floor. My name is Asusumu Shimoyama. I am a nonfiction writer. On page 10, regarding the 80 pathways in the United States, on this diagram... First, people will seek consultation with PCP and then easy cognitive testing will be conducted and then referred to neurologist. 500,000 people will be referred to neurologist and MMSE and CDR testing will be conducted and then the number of people will be reduced to approximately 50,000 people and the remaining, the 450,000 people are supposed to proceed, progress to the moderate severity. So those people with moderate severity have seen PCPs in the first stage. Cerebrovascular dementia or DLD. Well, so this 500,000 people include patients with various types of dementia. And out of which we narrow down to the patients with early AD, the number of people has reduced to this level. But cerebrovascular type or dementia with lower body can be screened. Without PET-CSF, I believe that PET-CSF must be conducted to screen them out. So the reduction here to 500,000 people to 50,000 people, the progress, the disease stages have progressed to later stages. The neurologists are capable of differentiating among those different types of dementia. You mean the progression? No, cerebrovascular, the dementia with Lewy body, NAD. Haruna-san, do you have any comments to add? Yes, thank you very much for your question. So all of these are mild and moderate, and the progress, the patients are not included in these 500,000 people. Yes, all of these 500,000 people are patients with mild diseases. But as I said earlier, dementia with Lewy body and cerebrovascular type of dementia are included. Therefore, because PCP... cannot differentiate them. Therefore, at the cognitive testing, the first stage after referral to neurologist and other types of tests are conducted here. Therefore, differential diagnosis is given. And then if the Alzheimer's disease, it was the diagnosis and then amyloid beta confirmatory testing will be conducted. So Alzheimer's disease is Therefore, that's why the number has significantly reduced here. I'm sorry again. Alzheimer's disease is diagnosed after the confirmation of the accumulation of amyloid beta through PET or CSF. After confirming the accumulation of amyloid beta and then Alzheimer's disease can be definitively diagnosed here. In my understanding, so according to your explanation, the decrease from 500,000 to 50,000 amyloid, before amyloid beta confirmatory testing is done, is it possible to see whether patients are diagnosed, should be diagnosed with the amyloid, the Alzheimer's disease? Right, amyloid beta confirmatory testing. to screen and narrow down the eligible patient for treatment. No, I understand that that test is conducted to find the patients with Alzheimer's disease. But MMSE or CDR, the amyloid, the Alzheimer's disease can be a definitive diagnosis. BBM can be also utilized. All right. Because of the BBM utilization. I see. Understood. Thank you. Would there be any other questions?

Yes. Participants seated in the back of the room, please. I'm Honda from Yomiuri newspaper. Thank you very much for the presentation. page 19 around page 18 or 19 in the pathway in Japan according to what was presented earlier There are about 600 in early AD diagnosis and treatment, and 804 facilities have agreed. Is this moving out of the initial expectation, or is this progressing according to your expectation? How should I understand the situation in Japan? OUG, optimal clinical use guidelines. Under the guidelines, it is almost in line with our expectation or slightly ahead of our expectations. We have to follow OUG, but without OUG, the pace could have been quicker. But there is no use saying that. And Mr. Yusa, responsible for Japan business, could you make additional comment? Thank you. I'm Yusa, responsible for Lecambi in Japan. CEO Mr. Naito responded, and as he responded, under OUG, optimal clinical use guidelines, first, Regarding the size of the patient population this year, in comparison to what we have reported to MHLW, it is slightly ahead or almost in line. As for 600 facilities that are administering, there can be 800 follow-up facilities. That number is also almost according to the plan. But every day, that number of facilities is increasing, and it's close to 904 facilities as of October. So the number of facilities is also increasing every day. I forgot to ask this, but not just a number of sites, but a number of patients is also trending according to the plan. It is slightly ahead of the plan or expectations. Thank you.

The person in the back row, please, have the floor. My name is Sakata of Yakujinippo. I have a similar question. You mentioned that you are progressing in line with the plan, 800 follow-up sites. They have consented to receiving patients. So receiving patients, there may be some bottlenecks. Could you please give us your take on potential bottlenecks? Thank you very much for your question. Yusa is going to respond regarding a reception of the patients. Are there any bottlenecks, as you pointed out? Not all the hospitals or sites are ready to receive patients for follow-up. It takes a burdensome workload, and once you receive one person, there needs to be one person to be assigned to follow-up. watch and for general practitioners particularly they needed to do some preparations and to healthcare professionals we are asking them to bear the burden with the passion to treat patients with dementia therefore they agreed to receiving patients for follow-up and the The ratio between the GP and the hospitals who are open to receiving the follow-up patients are 50 to 50. Therefore, so many GPs are ready to receive those patients. So as you pointed out, there are some issues, but we have specializing MRs or sales reps in the field. Therefore, they are trying to resolve the issues one by one in order to better the situation. Thank you very much. So you mentioned that the number of hospitals, 800, has been increased to 900. So are there any things that they need to prepare or having those requirements, they are ready to receive patients? Right. For patients to be increased, we would like to see triple the number of sites who can receive. And towards that goal, we are making steady progress. And throughout the nation, if you look at some areas, and there are some areas where we needed to do more in follow-up for such specific areas, we will talk to the doctors who will be responsible for follow-up and those who are responsible for initiation. As the CEO mentioned earlier, we would like to have the exchanges of information through visits by the sales reps. Thank you very much.

We have gone overboard with the time. We would like to take one final question. Are there any other questions? If not, we would like to end today's financial results presentation session. Thank you very much once again for your attendance.