Eisai Co., Ltd. (4523) Earnings Call Transcript & Summary

Thank you very much for taking your time to attend the conference today. It is now time. We would now like to begin media investor conference for the launch of LEQEMBI in Japan. This is a hybrid presentation, both in person here as well as with attendance online. Those of you who are attending in person, please find the press release. Those of you who are participating online, you are able to download the press release from the chat box. There are English and Japanese versions available. I would now like to introduce the presenter Mr. Haruo Naito, Representative Corporate Officer and CEO. Mr. Naito, CEO, please.

Thank you. At Chuikyou, Central Social Insurance Medical Council, drug price and Optimal Clinical Use Guidelines were approved. On this occasion, regarding the launch of LEQEMBI, we would like to share with you our thinking. Please refer to the material distributed to you as I will be discussing in line with that material. At its general meeting today, the Central Social Insurance Medical Council agreed the addition of LEQEMBI to Japan's National Health Insurance, NHI, drug price list and its optimal clinical use guidelines, OUG. Following this development, we announced today that we will launch LEQEMBI on the same day as the NHI price listing scheduled to take effect on December 20. And we have also announced in the press release in Japan, where this -- LEQEMBI originated, we are to launch LEQEMBI, and we once again realize the responsibility that we shoulder come to think of it. After the launch of Aricept, it has been 24 years, close to a quarter century. In the meantime, regarding AD or Alzheimer's disease, the sciences behind Alzheimer's disease and research in the pathology of AD have advanced significantly. Biomarker research included, there has been a remarkable advance. In AD research, we consider ourselves to be pioneers, and we will once again play a role in paving the way for a new diagnostic and therapeutic paradigm. We will make every effort to ensure that eligible patients have access to LEQEMBI and that its efficacy is demonstrated while ensuring safety in accordance with the approved labeling and the OUG. At the same time, we will continue our efforts to realize dementia inclusive society in cooperation with patient efficacy groups and local governments. First, about the benefits of LEQEMBI. Once again, I would like to review the benefit of LEQEMBI. Amyloid beta is the main pathologies of AD and A beta is a protein. Of A beta LEQEMBI selectively binds to soluble amyloid beta aggregates or protofibrils. And at the same time, LEQEMBI also binds to insoluble amyloid beta aggregates or fibrils thereby reducing both A beta protofibrils and A beta black plaques in the brain. That is the mechanism of action of LEQEMBI. As for A beta plaque, after the removal of A beta plaque, even after the removal, LEQEMBI is installed to continuously support neuronal function by continuously removing highly toxic protofibrils that cause neuronal cell damage and death. In the Phase III Clarity AD study LEQEMBI demonstrated statistically significant efficacy on the primary endpoint and all key secondary endpoints. The primary endpoint, a measure of general clinical AD symptoms, CDR-SB, clinical dementia rating sum of boxes, showed a 27% reduction in clinical decline after LEQEMBI treatment, suggesting that the disease stage remains in an earlier stage 2 to 3 years longer. In addition, LEQEMBI demonstrated less decline in caregiver-rated ADCS-MCI-ADL by 37% and QoL related items, including EQ-5D-5L by 49%, QL-80 by 56% and Zarit Burden Interview by 38%. These results indicate that LEQEMBI has the potential to delay the decline in patients' activities of daily living and quality of life and may significantly reduce increasingly enormous care-related costs, including the burden of family caregiving. In today's modern society families may sacrifice the employment to care for the AD patients or their -- they have to spend time providing care. And such care-related costs may be reduced significantly. In addition to its clinical significance, LEQEMBI has the potential to create societal value by reducing public long-term care costs and the burden of caregiving on families. Next, turning to NHI pricing. At today's general meeting of the Chuikyou, Central Social Insurance Medical Council, the price was determined for LEQEMBI. There are 2 vials. The price is JPY 45,777 per 200-milligram vial and JPY 114,443 per 500-milligram vial. Average weight of 50 kilogram is generally used in calculation in Japan for drug price. And the total annual cost would be about JPY 2.98 million or JPY 2,983,693. Under the high-cost medical expense benefit system for general income earners aged 70 and older with annual incomes between JPY 1.56 million and JPY 3.7 million, the maximum co-pay is JPY 144,000 per year. We understand that the NHI price for LEQEMBI was set based on the Japanese NHI drug pricing standards, namely based on cost accounting method recognizing the innovativeness of LEQEMBI as an additional 45% of usefulness premium. From the outset, and as I have just mentioned, we have proposed that LEQEMBI has not only clinical benefit, but impacts such as reduced burden of care for both the public and the family. And therefore, we have proposed value-based pricing, which takes into account these benefits. Based on AD disease [ similar ] model, quality adjusted for life year increment and willingness to pay WTP thresholds and reduction in total medical and care costs were calculated. These major indicators were calculated to come up with societal value or impact per person. This was quantified to be shown as a numerical monetary value, and that is approximately JPY 4.68 million per year. Societal value per person is approximately JPY 4.68 million per year. And this paper is published by WikiJournal in Japanese [indiscernible] neurology and therapy. Regarding the care part -- care cost part, this was not included in the calculation. We understand that it will be discussed at a future meeting of Chuikyou. And LEQEMBI's NHI price results of JPY 4.68 million of societal value, half of that is returned to public stakeholders, such as patients, families, caregivers, health care professional payers and the governments, according to the current NHI drug pricing and the other half is being allocated to private stakeholders such as Eisai employees and shareholders as net sales after subtracting consumption tax and distribution expenses from sales of products. And the portion of the value assigned to us will be partly committed to reinvestment in, 1, market introduction in full compliance with requirements of the OUG and the all case realized monitoring, #2, future research and development to create new drugs for dementia to follow LEQEMBI and 3, development of safe and secure communities or dementia inclusive society in collaboration with local governments and other industries. As for NHI pricing itself, we filed an appeal and argued for a higher premium. Under the current drug pricing calculation standards for new drugs, in order for a drug to be eligible for innovative premium, which we argue for, the 3 requirements must be met at the same time. 3 requirements are: A, new mechanism of action; B, higher efficacy and safety compared to existing drugs and treatments and C, improved treatment methods. All these 3 requirements are to be satisfied to be eligible for innovative premium. Higher efficacy and safety compared to existing drugs and treatments in direct comparison with existing drugs and treatments. And we understand that this requirement was seen to be not satisfied by Chuikyou. However, there is no existing drug suitable for comparison with LEQEMBI, which has a novel mechanism of action, which acts on the pathology of AD. And therefore, it is difficult to conduct clinical trials to satisfy requirement B in reality. And therefore, due to the lack of data for comparison with existing drug, LEQEMBI was deemed not to meet requirement B. We expect that the eligibility conditions for requirement B to be reviewed going forward. In the future, we hope that the drug price determination of LEQEMBI will serve as an opportunity to advance discussions about a new drug price calculation system that can proactively evaluate drug innovation. I would now like to touch upon OUG, optimal clinical use guidelines. The guidelines for the use of LEQEMBI are set forth in OUG agreed upon today. OUG will be published by MHLW before the NHI drug price listing. The OOG outlines the requirements for patients, facilities and physicians to ensure the safe and appropriate use of LEQEMBI based on a proper understanding of its benefits and risks. We understand that the OUG was established based on the Japanese public policy that when introducing LEQEMBI, the world's first Japanese innovation, it is necessary to have a system in Japan, the birth place of LEQEMBI that can fully ensure its efficacy and safety. Now turning to all-case surveillance. In accordance with the conditions of approval of LEQEMBI, Eisai will conduct a post-marketing special use result survey of all patients who were administered LEQEMBI or all-case surveillance until a certain number of case data are accumulated. Information on patient background, safety and efficacy in daily medical practice will be collected as early as possible and used for safety measures. Background information on ApoE4 will also be collected as much as possible. Next, AD diagnosis and treatment pathway. In AD therapeutic area technology for the diagnosis and treatment of AD is progressing rapidly. However, diagnostic and therapeutic pathways for AD have not been fully established, and we must continue to develop them. We recognize that it is extremely important for health care professionals such as physicians, pharmacists, nurses and clinical psychologists who conduct dementia testing and radiology technicians who give PET and MRI tests and medical office personnel who will be responsible for medical billing and for caregivers, to share the challenges related to the establishment of the shortest, the most optimal diagnosis and treatment pathways for people living with AD and to work together to solve these challenges. We will work together with our stakeholders to address these issues as a top priority. In this diagram, this is the typical anticipated diagnostic treatment pathway shown. First, neighborhood doctor or primary care physician will give consultation and cognitive function test. And patients will be referred by these doctors to specialists. And specialists may give early AD diagnosis, which lead to more detailed dementia tests and generally in majority of the case is MRI to confirm A beta accumulation, PET or CSF will be used. There is also blood-based biomarkers. But in terms of those that are reimbursed by insurance, I think PET and CSF will be used for A beta diagnosis. And ApoE4 tests may be given also at this point in time. After confirming the positivity of A beta, LEQEMBI administration will begin. LEQEMBI infusion is once every 2 weeks as intravenous infusion. Safety monitoring will follow, especially regarding ARIA, MRI will be used for safety monitoring, that means the series of steps comprising diagnosis and treatment pathway. In order to develop this pathway, we will have to make our utmost efforts. And next is about the environment for the amyloid diagnosis. The amyloid PET and CSF tests will begin on the same day in terms of the insurance reimbursement as the NHI price listing of LEQEMBI. Regarding the amyloid PET, the number of facilities with imaging certification was less than 10 at the end of 2020. However, this year, it increased roughly. And as of November this year, it increased to 84 facilities. And according to the Japanese Society of Nuclear Medicine, it is estimated that the number will be over 100 facilities by the end of this year, and the same upward trend is expected to continue in the future. In addition, a system or network for conducting A beta testing is being established through the promotion of collaboration among facilities in geographical regions and medical areas and further progress in the diagnostic system is expected going forward. On the other hand, there are regions where PET testing is not yet accessible. And in such regions, we are promoting the spread of other testing methods such as CSF and the establishment of medical collaboration system for PET testing. Regarding the test procedures, we are providing programs and video-based seminars to support the enhancement of such procedures. By doing so, we expect that the number of CSF tests will increase by approximately 80,000 per year. Through these activities, we aim to minimize the [ regional ] disparities and create an environment in which people indeed can receive A beta assessing smoothly. And we have the sodan.e65 website operated by Eisai will register and regularly update information on legal institution that can perform amyloid PET or a CSF test so that users can search for them any time after the NHI drug price listing. Furthermore, evidence for diagnosis using BBBM or the blood based biomarker is also accumulating. And in the near future an environment will be in place in Japan, where BBBM can be used as a triage test screening. So the triage test might be a new word. However, before going to the PET/CSF, we will be able to screen and do the prescreening so that we would be able to know full or to go forward to the PET or CSF test. And then subsequently, we also would like to establish an environment where the confirmatory test can be done. So in lieu of PET or CSF, utilizing the blood-based biomarkers, we are going to confirm the A beta positivity, and we believe that this kind of environment is going to be spread here in Japan as well. Now the ARIA management. The ARIA is the amyloid-related imaging abnormalities. And this is the specific adverse event for this -- the amyloid-related compound. And we think that it is very important to establish the environment where we will be able to provide the information and to have a coordination system within the hospitals for this ARIA management, and we will continue to do our best to accelerate these activities. LEQEMBI was featured at the annual meeting of the Japan Society for dementia research held recently where the management of ARIA was discussed. And we also conducted a similar title LEQEMBI safety profile and countermeasures focusing on ARIA. And we have already publicized e-learning course on ARIA on our website for health care professionals and plan to post and explanative video before the NHI drug price listing. We will continue to -- our efforts to create an environment where patients can use LEQEMBI as safely as possible. In the United States, the first country to launch LEQEMBI, the online education program understanding ARIA and the management of ARIA had an excess of more than 10,000 times since its release. And now the situation in the United States, after the full approval, we have secured results exceeding the business plans and the go-to-market structure is in full operation and the establishment of diagnostic and treatment pathways at facilities under the IDNs, which is integrated delivery networks. And well, there are about 100 main such IDNs in the United States. But in the IDN facilities, the establishment of this diagnosis and treatment pathway is ongoing. And then also the infusion center is the mainstay in the United States. And in addition to the reimbursement of the infusion technology fees, well, the -- another positive factor is the removal of the limit on the number of amyloid beta PET scans per person on October 13 of this year. So before that, it was okay to take amyloid beta PET scan. However, there was a limit in terms of the number of how many times it is possible to take the PET scan. However, now because of the lift on this limit, it will allow the amyloid beta reimbursement to be secured as often as needed. And also, there is a portal, which [indiscernible] CMS. And through this CMS portal, the number of the patients receiving LEQEMBI is increasing. And we think that we -- in Japan, it is also going to be as -- in the situation in United States. Now I'd like to talk about the preparation for launch in Japan. Well, regarding the structure of information provision activity in Japan, since the grant approval on September 25, 15 specialist MRs have been appointed from Biogen Japan in addition to 42 specialist MRs from Eisai in the field of dementia and initiated the provision of information to specialty doctors. Usually, like Fycompa or [indiscernible] this sleeping related or epilepsy-related drug will be in touch by the joint MRs. However, these general MRs, approximately 600 people, have also initiated activities towards the establishment of the diagnosis and treatment pathway of LEQEMBI in each hospital. And to date, we have already reached approximately 18,000 health care professionals and we have held briefing sessions on LEQEMBI profile at hospitals as well as webinars on safety and biomarkers and lectures aimed at promoting medical care coordination system in each region. Direct seminars have been held 6 times to date and have been viewed by nearly 3,000 health care professionals far exceeding our expectations. Now on dementia ecosystem, we believe that the establishment of a dementia ecosystem will accelerate as we launch the drug that will become the core of this ecosystem. In addition to ascertaining the health condition using Click-Karte, checking brain health using NouKNOW, in collaboration with local government and companies, enhancing disease awareness website, developing AI product treatment effects and visually capturing changes in activities of daily living using the [indiscernible] app, we are collaborating with approximately 165 local governments and patient advocacy groups nationwide and partnering with other industry such as insurance, automobiles, nonlife insurance, banks, food and telecommunications to provide appropriate solutions at each stage of life from the healthy state before the onset of dementia to onset treatment and nursing care. Now I'd like to talk about the development and access with a sustainability-linked loan. As of today, Eisai sustainability linked loan became effective. Sustainability-linked loans are type of loan, which incentivizes the borrowers to achieve sustainability performance targets or SPTs by making borrowing terms and conditions such as interest rate to the achievement of SPTs seeking to drive environmental and social sustainable economic activities and economic growth. In our articles of incorporation, we aim to effectively realize social good and this effectiveness include a procurement of capital and funds. Eisai will use the loan funds raised at low interest rate in 3 areas where positive social impacts are expected. #1, promotion of LEQEMBI's Patient Assistant Program or PAP, for low-income individuals in the United States and developing countries. And #2, establishment of dementia ecosystem, including the realizations of dementia inclusive society in Japan; and #3, the development of drugs to treat disease of poverty, including neglected tropical diseases or NTD, malaria and tuberculosis. And through these activities, we will actively work to realize social growth, including access to LEQEMBI in low-income countries and low-income populations. So lastly, I would like to give concluding remarks. Well, under Eisai's corporate concept, hhc concept, our top priority has been to relieve the anxieties of health of people with AD and their families. All employees spend 1% of their working hours or about 2.5 days per year with patients. Through these efforts, we are proud to say that we have been able to understand the true feelings, the joys and sorrow of the people with AD and their families. And we believe that we were able to build empathetic relationship with them. Well, following the United States, LEQEMBI is now available in Japan, marking a new step towards treatment targeting AD pathology that people with AD and their families have long desired. The paradigm for AD diagnosis and treatment is completely different from those in field where treatment systems have already been established, and we are working towards creating something from scratch. As a pioneer, Eisai is determined to work closely with stakeholders, such as people with AD, their families, caregivers, physicians, pharmacists, nurses, insurers and the government to realize this goal. As a new paradigm for the diagnosis and treatment of early AD begins with LEQEMBI, we are proud to be working together with medical and nursing care professionals on initiatives to relieve the anxieties of people living with AD and their families. Going forward, we will do utmost to further improve treatment methods and diagnostic technologies, including the development of subcutaneous formulations or other injectors and expansions of indication to preclinical AD, the stage before MCI and the introduction of BBBM in the diagnosis, and we strive to realize changing the future of AD.

We would now like to open the floor for questions [Operator Instructions] Yes.

I'm Hashiguchi from Daiwa Securities. About OUG, I have a question. In particular, about facility requirements, a number of requirements or items have been established. And the requirements are different for facilities that are giving LEQEMBI for the initial 6 months and after the initial 6 months. As you expand LEQEMBI, what do you think will be most important in complying with OUG requirements?

The question will be addressed by [ Mr. Yu Sah ], who is responsible for LEQEMBI commercially in Japan.

Mr. Hashiguchi, thank you very much for your question. I am [ Yu Sah ], responsible for LEQEMBI commercial in Japan. Allow me to respond. And as for the OUG, as you rightly mentioned there are facility requirements that are quite in detail. And you may have seen the OUG already. And as for the facility requirements, there are some information that cannot be collected from openly published data, for example, whether the physician has 10 years or more of treating dementia or whether the institution has a multiple full-time specialist doctors. It is difficult to collect information based on public domain information. Facilities have MRIs and doctors who treat dementia in multiple numbers. Given these conditions, we believe that there are about 1,000 medical institutions that will meet such conditions. Now as to how to increase the number of such facilities, there are other requirements. For example, receive training by academic societies and ARIA training by Eisai. We would like physicians to receive these trainings. So we will be very proactive in providing information. And regarding facilities, as you may have seen the OUG within the guidelines, there is also -- it is also noted that OUG will be reviewed in the future. LEQEMBI is to be used safely appropriately, and we have to build such an environment. And by doing so, we believe that OUG will be reviewed. It depends on how it will be reviewed. But depending on the revision of OUG, we believe that it will be increasingly used by increasing number of facilities and physicians. Now we would like to entertain the next up question. So the second in the front.

My name is [ Sakae Ge ] from Nikkan Yakugyo. I would like to pose a question to Mr. Naito. Well, finally, on December 20, the LEQEMBI is going to be launched. But looking at past history and the process, first, how do you think about the LEQEMBI launch on this day?

Well, the Aricept was launched in Japan, that was about 24 years ago. And after that naturally like the R&D people put their priority in the development of the dementia-related compound, the gamma and also the beta [indiscernible] as inhibitor. And then there are 2 small molecules, but there -- it resulted in failure. And then at the helm [indiscernible] Biogen was taking the lead in the development of this. But then in the United States, it was not accepted. And therefore, there was the continuations of failures. And then after repainting the failures, we were able to have a lot of lessons learned. And -- well, we learned that we should not repeat these mistakes and that was the history of the past 20-some years. And then so like we thought that the AD in the therapeutic area is like reading a map of the ocean. So you have to really read the tide of waves as well as the depth of the ocean. And I think Eisai is having the most detailed -- this map or the chart of the details of the oceans. So I think Eisai is possible to bring the ship to the intended land. And I think we do have that kind of capabilities. And I think that was the reasons where we were able to arrive at the success of the LEQEMBI. Of course, we are very happy to see the LEQEMBI launched, but it took 20-some years until we arrived at this stage. And then we had to go through the various failures and mistakes. And that is where we have some reflection. But without these mistakes and failures, we were not able to come up with LEQEMBI. So once again, well, we are really thinking how money effort it takes to do this kind of drug discovery.

Next question, please.

I'm [ Mura Kava from Kudo Press ]. LEQEMBI target population, how large is the population in Japan? And how many people will be receiving LEQEMBI exactly? What is your final estimate? Could you also give us the reasons for making such estimates?

That question will be addressed by Mr. Yu Sah, who is responsible for LEQEMBI commercial activities in Japan.

Thank you for your question. Once again, this is Yu Sah speaking. As for the target patients, including potential patients, that is how I understood your question, according to Japanese publications, the most reliable epidemiological survey covers AD, including MCI and 7.5 million -- the 8 million is the number for 2025 in early 80 and MCI are about 40% of that population, which means that there is about 3 million early 80 and MCIs. These are all dementia patients. And the -- about 67% of dementia patients are set to be Alzheimer's disease dementia patients according to paper publications. So it means that there are 2 million AD patients and amyloid beta pathology will have to be confirmed. And the probability of confirming AD pathology is about 60%, which means that it may be about 1 million to 1.2 million who may be eligible for LEQEMBI. And -- however, as mild the conditions are, it is less likely that they will go to doctors. And there is also OUG impact. All of that taken into account peak patient number is estimated to be 320,000 -- 32,000, 32,000. But regarding OUG, it may be subject to change going forward and 32,000 patient number, the rationale for the calculation. First of all, earlier, as Mr. Naito mentioned in around 2026, we believe that blood-based A beta pathology confirmation will become possible. And that will bring about a major change in treatment and the diagnostic environment. Maintenance therapy and subcutaneous administration are being developed right now. These are not taken into account. According to the current approval and current date OUG, the estimate was made. And in an appropriate fashion without delay, we will be making our most efforts so we can deliver LEQEMBI to those who need LEQEMBI. Now we would like to go on to the next question, please.

My name is [indiscernible]. And I would like to ask Mr. Naito. As for the pricing, the value-based pricing is, I think, that you would like to see and then you try to claim that. But then it seems that the value based is not being taken into consideration on the NHI pricing. However, on the other hand, I think the premium for the usefulness was close to the top. And I think now there is going to be a discussion going on to the cost effectiveness. So do you have any opinion on those points?

Yes. Now I would like to give the responses. So as was discussed, at the present moment, the revenue at the peak is going to be [ JPY 98.6 billion ]. And then so that the -- I think that the total of the compound prime on the NHI is about JPY 1 billion. So it is not the level to give a pressure on the health care costs. And the LEQEMBI in case of -- in the case of Japan, the impact where the value on per person is going to be JPY 4.68 million, and that is how we are calculating. So this JPY 4.68 million, well, was calculated from the WTP, the willing to pay. So it is -- about 15 million of the WTP was utilized. So this is somewhat different from the threshold in the past. So I think into the future, it will be necessary to have due discussions on the gaps of the WTP threshold from the conventional ones. And this NHI pricing as well as the value, if you look from that point, then I think half of that value was allocated to the public stakeholders. So that is the patient and also the families as well as the insurers and government and health care providers or the caretakers. Subtracting the consumption tax and also the logistics or distribution cost, the remainder is going to be allocated to the employees of the Eisai. So in other words, that 1/2 is going to be returned to public. So because of the increase in the quality and also the reductions of the health care-related costs through that, we think that we will be able to contribute to the society here in Japan. On the other hand, as is discussed, the OUG or the all-case surveillance on that, there was a very strict criteria being assigned for the introductions of the LEQEMBI, therefore, the due resources have to be allocated. And then also because there's a strict requirement of where the prescription can take place. So I think that the numbers of the medical institution that can prescribe LEQEMBI is going to be less than what we first assumed. So I think it is very important for us to be thinking very strictly about how to manage this business. Did it answer to your question?

But if you have any expectations to the cost effectiveness discussion, could you please give your viewpoint?

Yes. As for this cost effectiveness, there was a model that has been discussed in the past. And then also, we utilized the AD simulation model in the calculation. And there had been some overlap and some differences. And then also the main indicators, specifically be willing to pay threshold, which one to be utilized was discussed as well. So there were many discussions points, and we hope that this is going to continue, and we are planning to have more discussions. And then by the way, in U.K., the life science council, the life science industry council in Great Britain -- so I participated for more than 20 years as the representative of the industry in the discussions between the public and private. And then [indiscernible] in the U.K., and it is utilizing this cost-effectiveness models. And then vis-a-vis to the great U.K. government, I said that the threshold of the WTP is too low. And I hope that in Japan, we would be able to have this kind of discussions, and we hope that the industry representatives also will be included in such discussions.

We would like to take the next question.

[indiscernible] I have a question for Mr. Naito. Peak time sales is estimated to be close to JPY 100 billion. As a company in the next fiscal year, in fiscal 2024, what is the number that is expected? And under the OUG, strict conditions are given, but what is your prospect of going above JPY 100 billion in sales?

Once again, I would like to ask Mr. [ Yu Sah ] to address that question.

Thank you for your question. In fiscal 2024 -- as for fiscal 2024, we do not expect much change in OUG within fiscal 2024. And in terms of number of patients, we believe that it will be between 4,000 to 5,000 patients. But after we actually start selling LEQEMBI, we will be able to see the development of the situation. And after that, we believe that we will have to revisit our forecast.

I will take the rest of the question.

Yes, please.

As Mr. [ Yu Sah ] just mentioned earlier in treating and diagnosing AD there is a landscape where there are 2 that can be game changers potentially. One is subcutaneous administration with auto injector. Then at home or at nursing care facilities, LEQEMBI can be given without patient having to go to hospitals. It doesn't require infusion. So infusion process can be eliminated. This will increase the convenience of LEQEMBI substantially. That is one potential point. This is not included in our forecast of max peak sales because this has not been submitted for review in Japan yet. We plan to file submission soon in the United States. Another is blood-based biomarkers. If BBBM can be used for confirmatory testing, then PET or CSF can be simplified -- and physicians -- the number of physicians who will treat with LEQEMBI is likely to increase. Auto injection is possible and with blood-based biomarkers, diagnosis is possible. If that becomes a reality, then the heavy requirements under OUG may be relaxed. There is such a possibility. And in around 2025 or 2026, I believe such possibilities may be realized in the society, and this can be a strong upside factor.

So if these 2 are satisfied, what is your expected peak sales? Can you give any indication?

That potential is what we are in the process of calculating. Once we have more firm ideas, we would like to communicate to you.

Now we would like to move on to the next questions. And there are 2 people raising hands. So after this -- entertaining these 2 questions, we would like to move on to the questions from online.

My name is [ Sakata ] from the [ Yakuji Nippo ]. I would like to address my question to Mr. Naito. Well, you have given a look back on the process coming to this LEQEMBI and I believe that it was a very long journey. But despite the failures, you were able to continue. And what was the source of the -- this engine and effective roles do you think you played in this process? And then also, what do you think is going to be your role going forward?

Well, as I mentioned in my presentation, I think that we were able to spend some time with patients and family members. And by doing so, we were able to, well, emphasize with them. And then we also were able to know the true feelings of patients and family members. Also, at the same time, we were able to hear their voices and expectations that they have towards us. And I think that was the source of the energy. And then so if we have this kind of empathy relationship, then we are going to look into the same future. And the future is to have a compound such as LEQEMBI, which address the very cause of the pathology. And then at the very end of the tunnel that the dementia or the AD will be cured completely. And that is the dream, the patient as well as the family members have. And we are having the same aspirations and the dream. So we are developing the LEQEMBI. But then -- so we are targeting [indiscernible]. So we would like to challenge to the multiple target of the pathology and not only for the early AD, but then the preclinic the earlier and then also at the late stage of the AD or dementia. And we would like to continue challenging the development of the compound targeting these disease stages. We don't know until when we can do so. But it's not that we have concluded the treatment of AD with the LEQEMBI. Well, I said that these are the multiple targets and then also this is a progressive pathology. So there are some untapped area in stages of the disease. So our challenge is continuing. And we would like to continue the challenges. And I would like to pass the baton to the next person if the time comes.

Final question from the attendees in this room.

[ Honda ] from Yomiuri Newspaper. About details, I have a question. On Page 6, e-learning is already published. LEQEMBI administration conditions include imaging training. And is this referring to that imaging training. When will that imaging training begin? And is it possible that LEQEMBI is given as early as before the end of this year? What are your expectations?

So first, Mr. Yu Sah will address your question.

Thank you for your question. As Mr. Naito earlier explained, e-learning will be provided. And from medical.eisai.jp, which is a website dedicated to health care professionals, training already -- it is already open. And we have 106 or -- 108 materials PowerPoints are available on the website. A video and explanatory narration will be provided for training, and that will be made available before drug listing. So at the time of the drug listing and launch, it is possible that people have received the training. And as for prescription before the end of the year, in some institutions, they have indicated their willingness to start treating with LEQEMBI before the end of the year. And the contract for all-case surveillance will have to be concluded. And obtaining approval from the facilities for such a contract, we hope that treatment can begin before the end of the year. We will now take questions from those who are participating online.

[Operator Instructions] So JPMorgan, Mr. Wakao please.

Yes. My name is Wakao from the JPMorgan. I would like to give a conformation and then followed by question. About the SC, the filing to January into March. So there is no change on this timing the FDA confirmation because I think in the November explanation, you said that the -- you're going to have a FDA meeting. So after the talk with the FDA still they are January to March is okay. And then also China and Europe, I think there you are yet to front. And however, in the U.S. and also in Japan, you have the price. But then when do you think that the business of the LEQEMBI is going to be in alignment. And then I think like you were spending about JPY 70 billion for the R&D. But do you think in the next term, you will be able to turn the ink in black?

Well, first, about the confirmation or clarification. So Mr. [ Ogawa ] from the Clinical Development Department.

Yes, my name is Ogawa from -- I'm the Head of the Japan and Eisai Clinical Development Department. As for the SC administration, we did -- had a meeting with the FDA, and there are some confirmation items that we have to come back to, but then we would think that we will be able to launch within this -- end of this fiscal year.

And the second question was about when you are planning to -- when are you expecting the profit, whether it is going to be the next fiscal year. So the [ Kase Kanito ], the Global AD Officer is going to respond.

So are you saying including the Asia business?

Yes, I'm asking about globally when can you expect the profitability?

Well, as early as possible, of course, preferably next fiscal year. That is what we would like to do. But I would like to add, FY '24 we have to invest a lot of resources and that is natural because we are really putting our bets on this LEQEMBI. And -- but of course, we would like to be very cautious and make all our efforts so that it is not going to give any financial damages to our business. And then the LEQEMBI R&D and marketing for those areas, we are going to put the priority on LEQEMBI. And in order to absorb and in order to have a very good P&L, we are going to put out all out efforts.

So in other words, that you are saying that you are spending certain expenses, but also you are expecting to have an increase in the sales and revenue.

Yes, of course, for that, we are putting Atmos efforts. So please try to observe how we are doing.

Next, Mr. Muraoka from Morgan Stanley. Can you hear us?

This is Muraoka from Morgan Stanley. Can you hear me?

Yes.

Earlier, you've mentioned that in Japan, you expect the patient number to be 4,000 to 5,000 next year and you are also -- you've also mentioned that you are making utmost efforts to increase sales. 4,000 to 5,000 patients in Japan -- in Japan by March, 10,000, it seems to be a rather ambitious target. But because of that target in the U.S. that you expect to achieve are you expecting 4,000 to 5,000 patients in Japan next year? Or is this aspirational target? Are there any reasons behind these numbers? If you could share those with us, please?

Mr. [ Yu Sah ] will first respond to our intentions for Japan and [indiscernible] will address the question regarding the U.S.

Thank you very much for your question. This is Yu Sah speaking. Earlier, I've mentioned the patient number of 4,000 to 5,000. Currently, market size estimate is about 7,000 for the fiscal year and 7,000 is not based on the figures in the United States. As I mentioned earlier, OUG was expected to be stringent. And based on that, we also looked at market and the frequency of receiving tests, consultation by physicians and the probability of patients migrating on to testing. And for 2 fiscal years, we have calculated the number to be 4,000 to 5,000.

Mr. [ Yasuno ] will address the situation in the U.S.

Mr. Muraoka, thank you for your question. 10,000 patient number, is it likely to be achieved in the U.S. Inclusive of that question, I would like to address your question. This is Yasuno speaking. As Mr. Naito explained today, LEQEMBI is progressing steadily in the U.S. at a pace higher than the monthly plans. IDNs, integrated delivery networks, and in addition, community neurologists are both our focus areas. And together with health care professionals, treatment policies, SOPs and processes for MCI early AD treatment are being established together as an infrastructure for AD treatment. And we are putting very strong efforts in preparing the environment, field neurology account specialists and market access teams and clinical educators. These teams in a multi-faceted fashions are visiting neurologists, and efficient centers and clerical staff. So including the diagnostic measures such as dementia scoring and administration method and how to monitor ARIA and from neurologists to infusion centers, the flow of patients, all of these are being discussed by our people with the health care professionals so that treatment is smooth for our patients. As a result, there are around main 100 IDNs. And out of 100 main IDNs about 60 IDNs have included LEQEMBI in formularies after approval from PMT, and we have received orders. And as for a number of physicians who are able to prescribe LEQEMBI even before full approval or in comparison to before full approval, the number increased by 2,000 or 2.5 fold. And as for insurance coverage, in addition to Medicare, Medicaid and Veterans Affairs insurance are also fully reimbursing LEQEMBI, and including private insurance, more than 90% -- 90% to 93% coverage is now achieved. And furthermore, in October, amyloid PET, amyloid beta PET restriction was lifted. And the number of amyloid beta PET test number has increased in comparison to before by a significant margin. And according to recent information, it has increased to close to 1,000 tests per month. As a result, at the time of the earnings announcement previously, in comparison to the number announced at that time, in just 1 month's time, the number of patients has increased almost a pace where our number is doubling. And in October, November -- in the coming months in December, January, we believe that there will also be a fast pace of increase of patients receiving LEQEMBI, and we are more confident that we are able to achieve the patient target number.

This is a question for clarification. I think 800 was the number as of October 27. And you have suggested that the number is now 1,600 in November.

As of the end of last week, it is close to 1,600, and it's almost doubling.

The next Mr. [ Suji from the Asahi Newspaper]. Can you hear me?

I'm Suji from Asahi Newspaper. Yes, can you hear me?

Yes.

Well, it's a detailed question, but I would like to make some clarification. You mentioned that based on OUG, within 6 months, the number of the medical facilities where the prescription is possible, I think you said 1,000. So today, for the 3 months, I think that where you submitted to the Central Social Insurance Medical Council that the prescribers will be 400. So 400 prescribers and 1,000 clinical mitigation. And then you've mentioned that you're going to give a registration so that it is possible to find where the amyloid PET can be conducted. So also taking that into consideration, can you give a more accurate number.

Mr. [ Yu Sah ] is going to explain.

So first of all, about the 1,000 institutions and 400 prescribers, well more in the detail, as I mentioned, like there's a requirement of the OUG and it is very difficult to assume how many institutions would be possible. But then there are like the specialists where they will be certified by this 4 Society Congress. And then that is going to be 1,000. And then so for the coming 3 months, we don't think our 3 months from the launch. We don't think that it will be adopted by the 1,000. But then -- so you have to do the all-case surveillance. And then also, we are going to give some training and then prescriptions, and then it is going to be 400 gradually. And then whether it is possible to also search in the net. Well, I mentioned the adoption is going to be gradually. So it is not that we are going to publicize where it is possible to prescribe initially because then there will be a lot of patients going into that site. So we are not planning to put all the possible prescribers and sites. But then I think when the patient is going to go into the disease center, there will be some questions asked by the patient. So at that time, we would like to convey where the patients can go. And we would like to introduce the clinical institutions where the all-case surveillance is finished. And that answered to your question?

Yes.

[ Sumaya Masan from Sofia University ]. In the interest of time, can you limit the question -- number of questions to one? Sumaya Masan, can you hear me?

Yes, I can hear you. Can you hear me?

Yes, please go ahead.

This is [ Sumaya Masan ]. In the United States, regarding the access to the drug, I understand that there is a regional difference according to what was discussed in the last presentation meeting. In Japan, in 2020, amyloid facility, there was only 10 and now 84. And by the end of this year, 110 facilities will have amyloid PET equipment according to your estimate. In terms of 47 prefectures in Japan regarding this network of institutions for amyloid PET testing, which region is more advanced and which region is lacking behind?

[ Sumaya Masan ], thank you for your question. If we specify -- identify regions, we would like to refrain from doing so.

Understood.

So Mr. Sogi from Sanford.

Yes, I can hear. Can you hear? So in your presentation, you mentioned about the Biogen MR. There will be 15 Biogen MRs who are going to do the promotion here in Japan. But then this 15 will serve the same role as the Eisai's MR or this Biogen 15 MRs are going to do some different activities from the Eisai's MR? And with regards to the collaborations in United States, are you doing the same thing? My understanding is that in the United States, the Biogen promotion, the contribution is low.

So fact role is Biogen playing in the United States, specifically in terms of the commercial activities. Now. Mr. [ Yu Sah ] is going to answer about the activities in Japan and Yasuno is going to briefly respond to the activities in the United States.

Thank you very much for your question. Well, about the Biogen 15 MRs starting September, they started the activities, and we are doing the activities together. And the roles is exactly the same as the specialists MR in our company.

Now Yasuno is going to respond to the activities in the United States.

At the present moment in United States, the Eisai resources or with the Eisai FTE, we are conducting the activities.

Well, additional question. So you mentioned that in the United States, all resources are coming from Eisai. Is it because it is sufficient? Or are there any other reasons?

Well, at the present moment, as we mentioned today, that first, we have to establish the diagnostic and treatment pathway and then also to establish the infrastructure and then also try to do together with the community neurologist. So at the present moment, we think that our resources would be sufficient and appropriate. But however, the cost is shared. So their costs or expenses are shared in an equal manner between the 2 companies. But then the actual activities are conducted by Eisai.

Okay. So now because of the time, we would like to end the Q&A session. And so if you have any further questions, then please contact the IR and PR. And with this, we would like to end today's session. Thank you very much for coming out of your busy schedule. [Statements in English on this transcript were spoken by an interpreter present on the live call.]