It is now time. We would like to begin information meeting of Eisai Company Limited for fiscal year ending March 2023. There is sufficient distance between the speaker and the audience, therefore, speaker will take off the mask. Today, the meeting is held in person here as well as online. For those of you in this room, slide deck is distributed to you. Those of you who are participating online, we would like to ask you to download the material from our website. After the presentation, we will have Q&A session. Let me introduce the speaker. Mr. Haruo Naito, CEO, Director, Representative Corporate Officer. Mr. Naito, please.
What you see on the screen is a rabbit, since this is the year of the rabbit. Every year, I doodle with the drawing of the zodiac of the year, animal zodiac of the year. Eisai is like a wild rabbit with animal spirit. With Lecanemab, we will jump. Globally, we would like to bring about benefits. That is the meaning I wanted to convey in this drawing. Today, I would like to cover these five topics. First, business model driven by the articles of incorporation, the hhceco model . This is the articles of incorporation of Eisai. Since 2005, corporate philosophy is included in articles of incorporation. Articles of incorporation is like a constitution for a company more than 2/3 majority voting at the AGM or special resolution is required to adapt or change articles of incorporation.
Last year, at the AGM, revision was made to article two of the articles of incorporation, corporate philosophy. What is important is that we go beyond the realm of healthcare, but a stakeholder, the general public, was added. Secondly, under number two, we use the phrase social good. In these days, there is much talk about the purpose of the company or social impact. This is also often talked about under the discussion regarding new form of capitalism, and Eisai version of that is social good. More specifically, we seek to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. We seek to achieve this effectively. Thirdly, company's mission. The mission is to increase the satisfaction of patients and the general public. This remains unchanged.
To empower people in the daily living and medical domains to realize their fullest life through an HHC ecosystem based on collaboration with other industries. Over the whole of the lifespan, we would like to engage with the general public, and we would also like to develop ecosystem-like business model to encompass that through collaboration with other industries. Please refer to one under five. This stipulates the content of the business activities, raising awareness of illnesses and providing information and services. Pharmaceutical products and information related to pharmaceutical products have been provided by Eisai. In addition, we would like to provide information and services utilizing technologies in addition to pharmaceutical technology and that is stipulated here. Eisai HHC Echo model is the business model to achieve this.
This is an example for dementia. We will have hhceco model for each disease area. First, model is to be developed for dementia. Oncology is an area we have been making efforts over many years, including for breast cancer and endometrial cancer. In gynecological cancer, hhceco model can be developed. We believe we have sufficient capability to develop hhceco model for gynecological cancers. Currently, we are in the process of developing hhceco model for dementia. At the outermost rim of this slide. People living with Alzheimer's, with families, caregivers, healthcare providers, payers, government shareholders, and employees are the stakeholders to whom we will be delivering social impact and value.
In return, as shown at the very bottom, there is a potential of funding through sustainable financing with social impact targets as KPIs. This can be one form of the reward for the impact that we deliver. Funding and financing cost for ACIC will be lower in comparison to the situation where no such impact is delivered. Inside of this ecosystem and inside blue dotted line, that is hhceco model . The very important base of that is data. For example, genome data for disease or our proprietary data, meaning data from clinical studies and real world data and personal health record data. These data are the very important premise of our hhceco model . These data will be input into the model to create value, and R&D will play a very important role in creating value.
In addition to the conventional R&D, or rather we are shifting in a major way from conventional R&D, we are now looking at disease as a disease continuum. Dementia starts from preclinical condition to severe condition, and in case of cancer, there is precancerous condition to metastatic disease. There are various stages within a disease. For this disease continuum, we would like to apply human biology, which is becoming more and more clear. There is a better understanding of human biology, based on that understanding, we will engage in drug discovery. This is what we call DHBL, Deep Human Biology Learning structure. This will be playing a central role in value creation within the ecosystem.
From that, various solutions will be emerging as shown in the top part, real world medicine, real medicine or prediction of the progression of the disease, et cetera. These solutions can be provided to the people in various stages. That is the hhceco model and purple circle, circles around our partners. In case of industry collaboration, insurance industry for dementia insurance, and it is said that JPY 160 trillion is the asset owned by dementia patients. We can collaborate with the financial services industry to address that issue, connected car program to be developed with automobile industry collaborating partners to ensure safe driving for elderly people.
To create society that is safe and secure, it is important to work with local governments as shown in inclusion bubble. We are also collaborating with academia and the startups. This is indispensable in relation to data, genome data, public groups. We are working together for monitoring PHR partners are also partners for collaboration in this hhceco mode l. That is the overall picture of this model. This is a busy chart, and I will briefly walk you through this, and this is the dementia version of ecosystem. At the very top shows the stage. It starts from aging, and there is a high-risk stage and preparation for care. Up to that stage, there are various stages. In each of these stages, people have various anxieties.
In HCC project, through HCC projects, we have a deep understanding of what anxieties people have. Anxieties include anxiety about one's health condition and what solutions can we offer. The people may not be aware of the condition called dementia or even people at high risk may hesitate to go to hospital. They may have fear of being diagnosed as having dementia. There are many people who have such anxieties. We need to provide solution to address those anxieties. Dementia is now becoming a disease or dementia has become a disease that can be treated, and we have to communicate that. Cognitive function checking, for example, with NouKNOW, should be made widely available by working with our partners.
Those are included in our solutions. From medical consultation, to treatment, to evaluation and monitoring. In case of medical consultation, clinical diagnosis, no matter where a person may live, it should be possible to seek consultation and diagnosis. Aβ diagnosis environment should be very established in communities. A solution is to provide an environment where consultation and clinical diagnosis are possible wherever one lives. In healthcare sector and otherwise, what is possible to seek, that can become a very important part of the solution. PET equipment may not be available in a nearby facility, but if in a different specialized clinic, it may be available. Where are specialists provide practicing, and how can these specialists work together with family doctors?
That is what we are trying to address in our solutions. As for development of inclusive societies, there are health checkups by local governments, and NouKNOW can be used in ordinary health checkup to identify people at high risk. People at high risk can be referred to medical institutions in the community, and we are implementing these solutions. One of the key in the solution packages is the very bottom row of boxes. Risk prediction AI and treatment-effective AI are some of the things that are mentioned here. Based on our proprietary clinical trial data and proprietary cohort data, based on that data, AI algorithm is developed. In a personalized fashion, prediction can be made for each individual. Within the solution packages, this is a part where we have the most proprietary value.
In addition, on the left side, there's a box called Quick Carté with a smartphone camera. If a health checkup results are photographed in a clearly organized way, information can be organized and be presented in easy-to-grasp fashion. ePRO, electronic patient reported outcomes on the right side between clinical visits. The daily experience of a patient can be input into an app by patient or family to be shared with medical providers. It is known that by using ePRO, there is a better, there is an improvement of a treatment effect. Within such ecosystem, it will be indispensable to use digital technology. This is the model called Infanton, which is used in China. This is a collaboration with JD Health. On the left side, you see screens of a smartphone.
There are more than 94,000 users who are registered as users. This is for online treatment, online health platform for medical treatment. Over 4,800 physicians, including specialists and neurologists, are registered, and users are able to choose a physician and can seek medical consultation online. Last year, in one year, over 2,000 times that this service was used. In a very vast country of China, this will enable providing dementia medical consultation in a uniform fashion, eliminating regional disparities. This is an example from Thailand. We would like to expand lecanemab to Asian countries. When lecanemab is launched in Asian countries, naturally, an important question is who will pay for that cost? As one solution, here we are tying up with Thai Life Insurance.
Thai Life is the second biggest life insurer in Thailand. As noted here, insurance product that covers expenses for the treatment, including cost for drugs, if insurance subscribers are diagnosed with mild to moderate AD. This product was developed. With this product, a part of the cost of lecanemab, we believe can be covered. Within the same group of Thai Life Insurance, there is a bank, and this bank is considering dementia loan at a favorable rate. By tying up with these financial service players, we believe we can provide funding assistance to middle to low-income segments. That will be very important part of our work in HCC ecosystem.
I would like to turn to the next topic, which is we like to aim to replicate what LEQEMBI's success. As you may have known very well, LEQEMBI demonstrated its remarkable p- values, quite astonishing results. We believe that this is a very powerful innovation derived from Japan, which will create a new chapter in the history of drug discovery. Why was it possible in the first place? These are the four patterns of success we believe. First one is in drug discovery, you needed to have hypothesis as the basis for creating new drugs. That is very important. If you have a wrong hypothesis, you are not able to create good drugs. The very rough drug profile will result. Having right hypothesis is absolute necessary condition for success. As I said earlier, this hypothesis needs to be built based upon human information.
The most human information is available in academia. Through collaboration with academia to establish this right hypothesis, which I believe is going to be the first condition to make success. The second condition is what we will be able to obtain from phase II study. Phase II study is in between phase I and phase III. Therefore, people may usually think that they would like to finish this study quickly in order to transition into phase III or pivotal study. That is the mentality of pharma company. In this LEQEMBI case, we had to take six years for phase II study. In this phase, what kind of target population will be most effective? MCI due to AD and mild AD, early AD was obtained as the right target as a result. Dose 10 milligram per kilogram bi-weekly with no titration.
This dosing schedule was found to be most effective. For endpoint, CDRSB was used, but originally it was planned to conduct for 12 months. Rather than that, we decided to opt for 18 months for evaluation of CDRSB. That is derived from the results of the phase II study. Target, dosage, and endpoint all were rightly set up and identified from this phase II, which I believe is another major factor for making LEQEMBI project a success. Third one is robust ability to conduct clinical research. First one under this is clin pharm or clinical pharmacology. As you know, this includes pharmacokinetics, pharmacodynamics simulation is relevant to this. In case of lecanemab, utilizing these technologies, efficacy, it depends or correlated to Cavg, and area is correlated with Cmax. These were found in early course.
This was very effective and useful for setting the right dosage and maintenance dose, which is being studied with less frequent dosing to maintain the efficacy of the treatment. In development of the maintenance dose, this clin pharm capability has been quite useful. This is a very important aspect. Second one here is sophisticated statistics. As I said in this phase II, five doses were compared to placebo. During this period, which was 18 months, 16, as many as 16 interim analysis were conducted. Almost every month IA was conducted. Every time the next cohort is, or patients are assigned to the area, showing the best efficacy. That was the design. This required a very advanced, sophisticated statistical technique. When reaching the phase III study, simply the two-arm comparison with one dose, 1,800 patients were enrolled.
This is a very large scale study with a very sophisticated statistical technique. I think that this very powerful statistical capability was very important. Lastly, a decentralized clinical trial is mentioned here because this period of this study matched the period where the COVID-19 infection spread. Therefore, patients could not come to medical institutions. Diagnosis or visiting have to be done remotely, and remote cognitive assessment and safety should be monitored remotely. Also administration was done, the healthcare providers visited the homes or places of the patient to provide treatment. That was the key in the success of the clinical research going forward and lessening the burden of the patients in order to carry out the clinical research. I think this is going to be a very powerful factor. Number four.
The value of the drug in a particular society needs to be quantified and demonstrated based upon the value pricing was set. We implement the value-based pricing. We need to explain for that with high transparency. By doing so, the drug or therapy would be more acceptable in the society. I would like to raise these four as the patterns of success in drug discovery. The first source of such success is derived from the hypothesis for drug discovery, and it is academia. Patients do not come to medical to pharmaceutical companies. They come to medical institutions, particularly university-affiliated hospitals. Therefore, frontline of human biology is not in the pharma companies. That resides in academia. Therefore, the most human biology data is accumulated in academia. In order to create a human biology-based hypothesis, we needed to collaborate securely with academia.
There is no doubt about that. If you just knock on the door, you are not able to get collaboration from them easily. With these three colleges and universities, we have built very deep and sound long-term collaboration relationship through various activities. In the middle, University College London, which is located in London, where a neurology research is conducted jointly with us over 10 years. In the 1980s, on the campus of UCL, we established a London-based research institute of Eisai. That was the start for collaboration which lasted very long. U.K. dementia research, seven university or college consortium is established in the U.K., and UCL has been playing as a role as a hub. Tau antibody research was derived from the research conducted at UCL.
To your left, EKID is the collaboration with Keio University, which last over for 10 years and funded by AMED, and it is in its sixth year. As you can see here, Keio University has centenarian cohort. 100 and 110, 120 years old, the patients or people are being monitored. At 120 years old, but still healthy and APOE4 carriers, but not at an onset of the dementia. Why can it be possible? Based upon the multi-omics research, they are studying such cohort. The omics data here are for the entire body, such as intestinal flora and also oral flora or bacteria and the details, and also the underlying disease such as complications. All are included in the omics data. Therefore, not simply about the neurodegeneration information, but rather more deeper.
For example, like information about the robustness of the brain is included in the data. It may lead to a clue for the discovery. There are three milestones. First milestone has been cleared, and that is related to the pumping of the removal of the waste from the brain. This was the trigger for creating the new drugs, and that is the first barrier was... The ultimate goal is to reactivate the neurons. That is the ultimate goal. iPS and the organoid of the brain, the cutting-edge technologies, they have such technologies on a world-class level. To your right, WashU, meaning, Washington University in St. Louis. As you are aware, they have a DIAN, the hereditary Alzheimer's cohort. It's being managed by this research group.
Also, the anti-tau antibodies are being tried and the cutting-edge biomarker is being researched here. We have exchange between Eisai's research as well as their research. They are wearing two hats as our researchers as well as their researchers at the university. Such anti-MTBR tau antibody E2814, which is described on the right-hand side. What I'd like to say is that LEQEMBI's origin hypothesis, MOA, and target population. E2814 is following almost the path towards winning, which was followed by LEQEMBI. Regarding the origin. At UCL, which I described earlier, the core of the tau aggregation is found to be MTBR tau. That was discovered. Therefore, this is the propagation species of tau, MTBR tau.
If you are able to capture them in the extracellular space, then we'll be able to remove them in order to prevent the propagation of tau. That was found at the UCL. This anti-tau antibody, particularly binding to these regions called R2 and R4 specifically. This antibody was created. At the same time, at Washington University, hereditary AD patients' CSF MTBR-tau was found to be increased at very early stage. Such human biology evidence was discovered.
This hypothesis based upon the tau propagation specie MTBR tau, if that is removed and then aggregation, accumulation of tau can be prevented. Therefore, it is thought to be able to provide a new therapy for AD. On the right-hand side, although this is very busy, but this contains very important information. This is taken from CU. An AD cadaver brain. Then tau species profiling was conducted. As you see in the right, MTBR region is indicated. Please look at R2 and R4, 299 and then 354. Normal and mild and severe compared. In severe AD, these have been expressed very highly. Not dependent on the dose, but this is correlated to the progression of the disease phases. Very powerful evidence was obtained.
We have very high confidence in this MOA. Currently, DIAD program, this anti-etal antibody, lecanemab is utilized for a treatment of AD, and a phase II plus III study is ongoing. As for sporadic AD patients, of course, they have similar symptoms, therefore, we would like to apply this technology to such patients as well. The pipeline that is shown here. On the horizontal axis, you can see all phases of the disease. On the vertical axis, you can have all pathophysiology, ADNI or ADIN, covering all the stages of the disease and all pathophysiology factors. We are preparing the development of these treatments. We believe that we have the world's best and comprehensive pipeline. Pricing based on societal value or value-based pricing, as shown here.
The thinking illustrated here is that regarding lecanemab, when we set price for lecanemab in each country, we would like to apply this as common way of thinking or common logic. First, every business should generate a social impact. The current administration advocates new form of capitalism, I believe this is in line with that concept. We have to enhance the understanding of stakeholders of this. In order to enhance understanding, social impact must be quantified. The quantification is done using disease model called ADAS model. It is now possible to quantify. By inputting various data into this model, lecanemab annual value or yearly value can be calculated. That value is allocated to public as well as private stakeholders.
As public stakeholders, we have people living with the disease and various other stakeholders, including government and private stakeholders, Eisai shareholders and employees. To all of the stakeholders, to deliver value is important. In the American society, the out of the value generated by lecanemab, 60% will be returned to the public stakeholders, and 40% is to be allocated to private stakeholders. This is a 60-40 split, this split can be different from country to country. This is quite natural. In lower-income countries or in countries where healthcare system or insurance systems are underdeveloped, public allocation should be at a higher percentage. In case of our Soliris, a drug, DEC tablet, this is a public return of 100 since it is priced at zero.
As for the value that is allocated to the private stakeholders, it is not that it will merely be consumed, but it will be reinvested in future research and development and for inclusive community. I discussed this in January press conference, and I would like to review this once again. In the U.S. society, the yearly value of lecanemab is estimated at $37,600 per person, and the price set in the United States per person per year is $26,500. Value and price are different. The value was estimated using this formula. Very briefly. The numerator part, 0.64 multiplied by $200,000 means that the total sum of health delivered to U.S. society by lecanemab. What is the additional gain of total sum of health in monetary value?
That is represented by this. The 3.6 is QALY, quality-adjusted life year. After receiving LEQEMBI, the years lived by the patient is multiplied by indicator, which represents quality of life. The total sum of health, I think is the most appropriate way to describe this. As for $200,000 in the U.S. society, if there is complete freedom from AD, how much is one willing to pay? Willingness to pay. Around $200,000 is typically or oftentimes used as the amount for willingness to pay. This can also mean a price for one QALY, and it increases by 0.64. If you multiply that with $200,000, we can come up with a value that is delivered by LEQEMBI.
$7,415 is how much saving there is in medical cost and long-term nursing care costs, family burden, and hospitalization or institutionalization costs. This is the sum of the offset cost or cost that is saved. This is all represented in present value. To analyze this, 3.6 years is the denominator, or time on treatment is the denominator to arrive at annual value, which is $37,600. 40% of this is to be allocated to Eisai shareholders and employees. That is shown below. First, $37,600 and a time span of 10 years is used to calculate the price. In 10 years in the U.S. society, how much value in total will be brought about by lecanemab.
$37,600 multiplied by a number of patients who will be receiving LEQEMBI in 10 years, then we will be able to have the value in 10 years. Forty percent of that will be net sales to be allocated to private stakeholders. If that is divided by the cumulative number of patients in 10 years, then there will be a net price for each person. This net price will include both the original price as well as price during the maintenance dose phase. Maintenance dose currently is assumed to be monthly, which means the price will be half. When adjusted for that, we can derive a $26,500 in the initial stage before maintenance phase.
This is not exactly 60% to 40%, but in 10 years in maintenance phase, since price will come down, $26,500 will decline and therefore, over 10-year period, the ratio will be 60% to 40%. In Japan as well, we would like to have a same discussion in fair and as transparent as possible fashion. As a premise to that, we have to look at the condition in Japan shown in numbers here. On the left side, there's medical cost and public long-term care insurance finance and how much impact is coming from AD or how much AD is consuming medical cost and long-term care insurance finance. In case of medical cost, it's 2.5%. As for long-term care insurance, about 50% is spent on caring for AD.
It shows how much AD is impacting society as a burden, and in particular, in long-term care. On the right side, it shows that how medical costs and long-term care costs increase in the following stages. In case of medical cost, it will be about double in severe AD in comparison to MCI. But what is surprising is that from MCI to severe AD, long-term care costs increases by about tenfold. Lecanemab, according to the current clinical data, is understood by specialists and researchers to slow the progression of disease by about 3 years. What this means is that in the former stage or in the current stage, patients can remain for 3 additional years.
In these bar graphs on the right side, rather than shifting to the right side, it will remain on the left side, and that effectiveness will be more pronounced in long-term care cost. That is the value of LEQEMBI and value-based pricing. In the context of value-based pricing, I believe that the larger effect, larger savings effect of long-term care cost should be properly reflected in pricing calculation. I believe that that is necessary, and that is the basis of the concept of value-based pricing. ADAS model that was applied in the U.S., if that is applied in Japan, that is being considered, and this is more or less complete. Jointly with academia, we are preparing to submit a paper. We expect the paper to be published in May.
Naturally, this will include the cause of COI is different, and the willingness to pay for one year free of AD that will also be different between Japan and the United States. The cost savings will also be very different between the two countries. Therefore, the results is expected to be different from the U.S. result. A similar argument is possible to be applied in Japan. Value-based pricing as a pricing approach it is possible. The current prime minister evaluated highly LEQEMBI as innovation coming out from Japan. As a worldwide innovation and a new form of capitalism, it is said that companies that bring about social impact should be rewarded.
In the form of a reward for pharmaceutical companies, there should be a reward that is reflected in the pricing for the pharmaceutical products. That is why I wanted to explain this. If such a pricing approach is adopted by Japan, that will very much encourage innovation in life science sector. I believe that it will also help break the sense of stagnation in pharmaceutical industry in Japan. Let me report to you on the update about LEQEMBI. First, the submissions and review processes are being accelerated. On 6 January , we received an AA from FDA in the United States. We submitted for the full approval, and that was accepted on 3 March . Also, this was designated as priority review.
The proof action date is set for 6 July , therefore, a little less than four months away from today. In Japan as well, on the 16 January, we filed submission, and immediately after that, this was designated as a priority review. In Europe, we have completed a submission. In China, in February, from NMPA we have notified of the priority review designation. In major agencies, we believe that review process is being accelerated and steadily ongoing. In the United States, coverage by Medicare in the United States, the status of this is very important. The coverage is managed by a government body called the Centers for Medicare & Medicaid Services, CMS. With CMS, there have been various advocacy activities. More recently, from Congress, letter was sent. That is shown here.
A group of 24 Congress members signed a letter regarding the CED requirements designated by CMS. They asked for review of this for providing the early and broader coverage for lecanemab as requested in the letter. Similar contents were written in a letter from 20 senators' signature, and that was sent out on the 17th of February. This is quite a busy slide, but with CMS, we have been cooperating and communicating with them. The current position of the CMS in our view is as follows. Actually, CMS responded to in a letter to Alzheimer's Association in the U.S. As you know, national coverage determination, which was announced last year, that was the decision made last year by CMS for the entire class of monoclonal antibodies against amyloid. This decision will stay unchanged.
When it comes to individual specific antibodies, out of which if one is granted a full approval from FDA, then immediately after that, coverage with evidence development or CED. There is such a criteria. Under this criteria, the flexible application will be considered in order to provide a broader coverage. That was the statement issued. What is important here is under CED, at the time of NCD last year, the CED coverage is to be relieved. There were three questions to be answered in order to release-
They will relieve these requirements under CED. There are three questions. The first one is, does the anti-amyloid mab, in this case lecanemab, does this improve health outcomes like slowing the decline of communication and function for patients in broader community practice? For this question, with the data from Clarity AD, globally utilized the CDRSB, which covers both cognitive and the day-to-day functional scale. This is comprehensive indicator, and 27% slowing of the decline was demonstrated with the overwhelmingly statistically significant difference. Overall activity, ADCS, MCI-ADL, evaluation by caregivers and a 37% slowing of the decline with statistical significance difference. Also QOL measures of EQ-5D-5L and QOL-AD, 49% less decline and 56% less decline were observed. Very clear difference was observed in the difference against the placebo.
In Clarity AD study, in patients who had a broad range of comorbidities and co-medications and diverse racial and ethnic elderly patient population, that generally reflected that of the U.S. Medicare population, which covers or people over 65 years old. Therefore, we believe that we are able to answer this question one perfectly. Question number two is, do benefits and harms such as brain hemorrhage and edema associated with this drug depend on characteristics of patients treating clinicians and settings? As for benefits, in all prespecified subgroups. Based upon the confirmation in advance with FDA subclasses, the stages of disease, MCI or mild AD and APOE4 status, presence or absence or concomitant approved AD symptomatic medication, region of America or Asia and so forth. Over all these subclasses, we have been able to demonstrate consistent data for benefits.
As for harms, infusion-related reactions were most common adverse events. This was observed across all the subclasses. However, ARIA E and ARIA H were less common in APOE4 non-carriers versus carriers. Comparing APOE4 homozygous against APOE4 heterozygous carriers, higher frequency was observed in homozygous groups. Therefore, harms information based upon the demographics and attributes of the patients were also available. Therefore, we are able to answer this question. Question three, how do the benefits and harms change over time? For benefits, based on the CDR-SB, please recall the gap widening over the period of 18 months, showing the disease-modifying effect. Therefore, benefits can increase or remain stable. When it comes to harms, after three months of the administration, harms decreased and then returned to baseline risk. Therefore, for this question number three, we believe we are able to answer perfectly.
As you see at the very bottom, Eisai believes that the clinical study data of LEQEMBI can fully answer the three questions, so-called high level of evidence touted by CMS. We believe that our answers will qualify for that. Therefore, at the time of obtaining approval, the Medicare coverage will be flexibly and broadly granted. That is our expectation. Another aspect is about the outlook for the amyloid diagnosis. I would like to give you a brief overview. In the United States as well as Japan, capacity for PET test itself over the past three years have been improved. We believe that this capacity is going to be improved in the coming three years. The challenge here is to cover such testing under insurance in the US and Japan as well.
PET and the CSF tests as well are not yet covered by ample insurance coverage. In our communication with authorities at the time of the therapies being approved, PET CSF to be covered under the insurance, I believe that that is what the regulatory authorities are considering. Improvement of the coverage situation at the time of getting approval for lecanemab will be realized. That is our expectation. On the right side, you can find the blood-based biomarker status in the U.S. and Japan. There are several or more than two blood-based biomarker technologies that have been approved. For the time being, blood-based biomarkers will become available in use in real world. The using this technology for screening and then will allow us to accumulate data.
For the use of this technology in the confirmation of the amyloid beta or a definitive diagnosis and in blood-based biomarker or BBB shall be utilized. If that situation is realized, data will be accumulated. By 2025.
I believe that the likelihood of having such situation is very high. Now demography. Demographics showing the prevalence and people potentially treated with AD-DMT are described here. Please look at the pie chart or the circles. The first population, the largest one, which shows the prevalence of early AD in combination of MCI due to AD and mild AD, which is the indication of lecanemab, which is shown in the outer circle. That is the total prevalence of early AD. As I said earlier, some people may wanted to seek the consultation by medical institution. They have to visit first hospitals. Not reaching the stage of using PET or CSF. A CDR will be used for a dementia screening, showing the suspect of the early AD. That diagnosis is necessary.
After that, the physician will tell the patients to go through the amyloid beta test in population three. In population four, they will find that they have positive amyloid beta. They will consult with attending physician, and a physician will introduce this amyloid AD-DMT. "Would you like to have this treatment or not?" They will reach number five as the population eligible patient or treated with AD-DMT. Number one, prevalence. Number five population is AA, the eligible patients. At last, the patients will reach this step or number five. Going through these steps, if you turn to the bar graph in the middle.
Currently, the patients going through one through five steps, and then the AD DMT patients or patients treated with AD DMT is quite a small fraction of the total prevalence. Number of eligible patients accounts for only 0.01% or 0.02% of the total prevalence of early AD. Yellow portion here is going to be expanded, of course, when people's awareness is enhanced about the disease, and then seeking the medical consultation from 2025 onward, when blood-based biomarkers will become available for confirmation. Population three or four will be expanded because they can seek such testing more easily. In 2030 and 2032, I believe that the number of people, patients treated with AD DMT will increase as such. Accounting for about 1.2%.
In Japan or the United States, where environment of healthcare is more advanced, and I believe that the number ratio will be further increased. Clearly, Latin America, Asia and China combined accounting for 70% of the total prevalence. For the long run, in Asia, Latin America and China, this treatment. How access to this therapy can be enhanced is going to be a very important key. I have final three slides to show future scenarios. First, the revenue simulation toward the fiscal 2032 for the next 10 years. The red part is LEQEMBI. Blue is LENVIMA. Yellow is new potential products. Other is including new potential products. As for LEQEMBI, around the 2025 blood-based biomarker expansion is expected.
Since around that time, we expect a rapid increase and will reach about JPY 1 trillion in 2028. It will continue to grow. As for LENVIMA. Correction, JPY 1 trillion to be reached by LEQEMBI by fiscal 2030. LENVIMA may reach peak sales in fiscal 2025. For HCC, RCC, we see strong growth from LENVIMA. LEAP 2 studies, 12 LEAP studies are also underway. That contribution to growth is also taken into account here. As for new potential products, earlier mentioned tau antibody E2814 is included. In oncology, we have MORAb-202. This is a product where we are collaborating with Merck. The C1q beta-catenin inhibitor E7386 are expected to contribute. Two final slides. Management intention.
Eisai is building an ecosystem for each disease that supports end-to people's entire process, from healthy state to high risk, onset treatment, follow-up prognosis by playing the role of a producer. AJC Echo will be enhanced through repeated mutual interactions between data and solutions. Eisai is a corporate entity that achieves social impact through its business of creating data and providing solutions. That is the clear intention of the management. This is the final slide. You may wonder what this is. Actually, this is where the headquarters in the U.S. of Eisai is located. It is in New Jersey. Last we relocated to New Jersey. It's an 11-storey building, and at the topmost floor, there is my office. From my office, we are able to see Manhattan. For some reason, I'm very motivated to work more.
By looking at this view, and that is why I included this photograph. This slide says, "The new chapter for Eisai hhceco model has started by LEQEMBI." With that, I would like to conclude. Thank you for your attention.
Now we would like to open the floor for Q&A session. We would like to take questions from the attendees in the biz new, and we would like to receive questions from those participating online. If you wish to ask questions online, please push the Raise Hand button in Zoom. Although the time is limited, I would like to ask you to limit the number of questions per person to two, and please ask questions one by one. Could you please take off your mask so that everyone here can hear you clearly.
If you have any questions, please raise your hand. I would like to call upon the person to ask a question, and then staffer will bring you a microphone. Please wait for microphone and state your name and affiliation. The person in the first front row, close to the window, please.
This is Yamaguchi of Citi. Thank you very much for the explanation. My first question is about page 25, regarding this diagram about LEQEMBI. In FY 2025 onward, there will be a increase, and toward 2032, where you expect to see JPY 1 trillion level. I have one question. In 2025, when there will be a turning point in the revenue, as you said, blood-based biomarker technology will become available. That's why you think that there will be a jump. JPY 1 trillion in 2032, of course you cannot tell the global average drug price. JPY 300,000-JPY 400,000 will be utilized. That means that 10% penetration from the eligible patient. I think you said that three million, therefore 3.4 million.
That will be used for the price calculation, and then penetration will be estimated as the 10%. What is the ground for estimating that there may further increase from that? Could you please give us your take?
Your first question is, as you rightly pointed out, BBB will become available for the use in a confirmation. We believe that the BBB technology will start to play an important role, so there will be a boost. In 2030, FY 2030, the global brand read is here, so I'd like to let him explain.
Thank you very much. I'm in charge of the global brand read of LEQEMBI. My name is Toyosaki. I am stationed in the U.S. now. Regarding this simulation of the revenue in FY 2030, revenue is expected to reach JPY 1 trillion. How we estimated this number, let me explain. First, the origin is the AD-DMT, the eligible patients. This number is used as the start. In 2030, as I said earlier, AD-DMT eligible patients will reach about 2.5 million. For AD-DMT, there will be other drugs that then LEQEMBI will be launched. Therefore, we have taken into account the market share. For us, LEQEMBI will obtain the largest share of the market of AD-DMT. We are confident, we have considered a certain share of the market in here.
Out of which throughout the year, a number of patients to be treated is estimated for LEQEMBI. For a certain period of time, the LEQEMBI treatment will be continued. During the treatment period, drop-out rate or discontinuation rate is considered in order to calculate the patients to be treated. For the current year, the new patients will be added, and the number of patients treated with LEQEMBI is estimated for the year. In 2030, globally will reach about 0.9 million. That is our estimate. As you said, the pricing in the United States per person year, $26,500. Because of the introduction of the monthly regimen of the maintenance and the maintenance period, this price will be halved.
Currently, SC, subcutaneous formulation is being developed which may be priced differently. For prices other than U.S., which is not determined yet, in addition to the medical value and the social value will be added, and the therapy's value and affordability for patients and also healthcare systems' sustainability in each different country is factored in in setting this price. As I said, AD-DMT eligible patients are the starting point for calculating the simulation of the revenue for LEQEMBI. We have taken a conservative view. In China and in Asia and globally.
In around 2030, this LEQEMBI is expected to reach JPY 1 trillion in revenue. We believe that there is such a sufficient likelihood. Thank you very much.
My next question is simple. For your company, you have shown us various numbers. From next fiscal year onward, on the ground, marketing costs in the United States and how many MRs or sales reps will be rolled out. Or Biogen as a partner, I don't think that you have mentioned anywhere in this slide deck this time. What about the partnership with Biogen? Well, in the near future, strategies of the marketing in the United States. Do you have any comments you are able to make?
For this current question, global AD officer, I'd like to invite Ivan Cheung to respond.
Thank you for the question. This is Ivan Cheung. As of this moment, we are at the first stage of the launch under Accelerated Approval. As you know well, our primary goal is to get the patient journey and the health system readiness in place so that when a second stage of launch, which is post traditional approval and post CMS reimbursement, then the full launch will be ready. At this moment, in the United States, in, at the current stage, Eisai is taking the lead with the launch with support from Biogen, of course. At the full launch stage, Eisai will continue to play the role leading the launch with Biogen's support.
As of this moment, in the United States, across all the functions, meaning sales and marketing, medical, market access, government affairs, all the key functions together, we have over 150 people dedicating to getting this stage of the launch in shape. At the next stage, at the full launch stage, of course, we will ramp up the number of individuals dedicating to the full launch of LEQEMBI because we are obviously, as you heard from CEO Naito, are optimistic about the traditional approval by the FDA and the granting of broader access by the CMS. Thank you.
Thank you very much.
We would like to entertain next question.
As for our collaboration with Biogen, it is quite smooth. There's no problem with Mr. Chris Viehbacher . I have known him for quite some time. With Chris, I maintain good communication. Commercial area of collaboration with respect to that as well. There is good agreement between the two parties, and we are making progress. Things are moving smoothly.
We would like to entertain the next question. Please take off your mask.
I'm Kotani from Nomura Securities. I have two questions. The first, Mr. Naito, CEO, I have a simple question. Lecanemab, Aβ antibody, you had a Clarity AD study where you had very strong results. This is carried in New England Journal of Medicine.
As noted in one of your slides, U.S. Congress members are signing letters asking for coverage. Scientists also signed a letter, 270 scientists signed a letter supporting LEQEMBI. With blood testing, on the other hand, there is also progress, including a blood-based biomarker by Sysmex. I think that this is the first time that a drug as well as a diagnosis are led by Japanese companies. Your share price is not reacting to this much. There should be strong expectations given this situation, but why is stock price not reacting?
I am certain that stock price it will rise. In the past, through PR, IR, every time we carry out events, we communicate information.
We have been communicating positive information, including the latest communication regarding a variety decision by FDA and lecanemab certainty and potential. With respect to that, there is no negative information. Looking into the future, we do not expect bad news. At least as far as I can see, I do not expect any bad news. Advisory committee under FDA is also welcome. In a transparent fashion, a discussion can take place and data can be acknowledged by the advisory committee. We positively welcome this because we think that this will lead to increased awareness of LEQEMBI. Most likely, we believe that the CMS will be responding in a way that we expect.
I believe that we are in very good condition, and we are having a very good journey at a cruise speed. I'm very certain that market will evaluate this.
Thank you. Second question is on page 25. This is about the yellow part. I believe this is increasing from 2028 to 2030 because of tau antibody E2814. Since this is going to be likely an orphan drug and maybe priced high, higher as to be given to DIAD targeted population. Yesterday you've mentioned that there will be a study for sporadic Alzheimer's patients. Will this product be considered an orphan drug? Can this be priced at high price if a DIAD is successful in sporadic as well?
It can be considered that it will be successful. As for tauopathy, MTBR, different types of dementia, involving base cerebral part and other types of dementia, are you going to look into developing this product for different types of dementia?
Ivan Cheung will address the question.
Thank you very much to your question. I believe there are two parts to your question. With regard to the first part, you are correct. In addition to studying E2814 in the DIAD population, we will also study E2814 in the, of course, much larger sporadic AD population, because we believe E2814 is specifically designed for Alzheimer's disease.
As you see on the slide, on slide 11 right now, as we disclosed previously, In addition to the DIAN-TU phase II/III study, we are also wrapping up the phase I-B/II-A study also in DIAD subjects, which we will read out the important biomarker information this year in terms of early tau pathology biomarkers, late tau pathology biomarkers, ranging from tau PET to various species of CSF and plasma tau biomarkers. These information will be very important for us to design the phase II/III registrational study in sporadic AD in terms of the right dose and more importantly, the right population. This is the goal for E2814. To your question about orphan drug.
In sporadic AD, of course, this will not be an orphan drug. DIAD, of course, is orphan drug, but sporadic AD is not. From a pricing perspective, similar to what you heard from CEO Naito about how we are pricing LEQEMBI, same concept we will apply. What is the societal value for E2814? How much we gonna give back to the society and how we're gonna price E2814, considering other factors such as health system sustainability and patient affordability. To your second part of your question with regard to other dementia types.
As I mentioned earlier, E2814, as you heard from CEO Naito, the mechanism, this is very specific to catching the propagation of tau seeds from cell to cell in Alzheimer's disease brain. We believe this is important because as you look at other anti-tau antibodies being studied by other companies, studying those more general anti-tau antibodies without being disease specific. Meaning applying that across different disease areas may not be as effective and efficient as E2814. We believe, given how this is specifically designed for Alzheimer's disease from the early collaboration with UCL, we are gonna be focusing in the Alzheimer's disease space first and foremost, including the synergistic complementary approach in combination with LEQEMBI. Thank you.
[inaudible]
That's the goal. Yes, that's the goal for this year. Not only engagement, we will also have biomarker results that we believe are surrogates for efficacy. That's our goal this year. Both target engagement and efficacy surrogates.
Next question is from the person in the front row, please.
Thank you much. My name is Wakao, I am from JP Morgan. With the presentation, I have been able to understand clearly your ecosystem as well as the R&D strategy. You said that you are expecting to see the rise in the stock price. You seems to be confident. Going forward, as I said, AdComs and the donanemab results will become available. For both of these, I would like to seek your opinion and a take from CEO. AdComs, I think you have touched upon briefly. You said that you are very confident. In the first place, AdCom will be held. What is the ground for having such AdComs? What was the cause for them to decide to hold AdComs? What is the rationale for you to be so confident?
You have shown us a very excellent data, and also the points raised by CMS are important as well. You have already said that you are able to answer those questions. AdComs, I believe that there shouldn't be any problem in holding this. From an outsider's view, I think that it is quite uncertain or there are some points which are not clear to us as outsider. Could you please explain?
Before me making comments about AdCom, I'd like to invite Ivan Cheung to introduce general view about AdCom, and then I'd like to follow. Okay, I would like to ask Ivan Cheung to respond first.
Yes. Thank you very much for the question. As you heard from CEO Naito, as you all know very well, since our Clarity AD data presentation at CTAD last year, and a simultaneous publication in the New England Journal of Medicine, Eisai continues to uphold our principle to gain public trust in lecanemab through our clinical data transparency. We very much welcome the FDA advisory committee meeting to be another productive occasion to share the highly statistically significant and clinically meaningful efficacy data, as well as the consistent safety data from Clarity AD. Specific of your question about the rationale behind the advisory committee for this application.
As you know well, this is really the first time in this class, and actually any potential disease modifying therapy for Alzheimer's disease. This is the first medicine going through that full traditional approval process. I think to gain public trust, and given the fact that the Clarity AD data is so robust, we believe this is a win-win situation to have an advisory committee meeting for many stakeholders, for the public, for the FDA, for Eisai, for everyone involved. I think this is in our belief a good move to go down this path. Thank you.
I myself agree with Ivan in principle. What kind of issues to be reviewed? Well, I cannot think of any specific issues. The submission for full approval has been accepted by FDA, and I believe that they have thoroughly reviewed that, and they have granted a priority review status. If there are any specific issues in the review, are they going to ask the opinions from the AdCom members about those issues? We do not know. The schedule or date of the AdCom is not specified yet. If AdCom is going to be held, we would like to take it rather positively with higher transparency, and we can be more convincing to the general public. We believe that that will provide us such opportunity.
Understood clearly. Thank you very much. My second question is about donanemab.
Regarding the peak sales you mentioned, you said that you are going to be taking the largest share without the data from donanemab being available. You are saying that you will be able to get the top share. Because of the data available, I think that you have become confident enough, but based upon the data from donanemab, you do not think that donanemab will become a threat to you. Why do you think your product will take the largest share? What kind of data are you expectin g from donanemab? As far as you can, please mention them.
Our view is amyloid beta reduction based on the data from Clarity AD study at 18 months turning into negative side. After that, through the OLE study, A-beta deposition data were shown.
There are some patients with a completely suppressed, and there are some other patient who have shown this slight increasing trend in the amyloid. The bi-weekly turning to monthly dosing with less frequent dosing, and then turning into the maintenance period, and therefore patients will continue to treat. We would like to establish such regimen or schedule of treatment. I believe that, when we consider patient journey and welfare of patients, I think that, this is the appropriate dosing regimen taking into such aspects into account. Of course, in maintenance period, the dose will be halved, therefore the price will be halved as well, and the burden will be reduced. With such dosing, we are confident. We have a core and a gap and also oily.
During the gap period in between the two study periods, we have understood what happened to the patients. Based upon that, we believe that the treatment needs to be continued. I wonder if I am answering your question. This is what I can say now. The data itself from donanemab, I don't think I am in a position to mention any specific comments, so I'd like to refrain from making any comments.
Thank you very much.
We would like to take the next question.
I'm Muraoka from Morgan Stanley. Thank you for taking my question. In January, you've commented on this. What is the timing of turning profitable? There was a discussion of 150 or so sales reps in the latter half of the second year to the third year, or latter part of 2024 was the answer last time. JPY 200 billion of sales by 2024. According to this, it might seem that it is possible to turn profitable in the second year in the latter part of 2024. How should we understand this? Can you share with us your thinking including scenario?
Internally, we are conducting a very detailed review, and we would like to achieve what Mr. Muraoka, you exactly said.
profitable in 2024?
Towards the very end o f 2024.
I would like to remember that you pointed out that possibility.
Thank you. I think that is important for stock price. That is my comment.
This is Muraoka from Morgan Stanley speaking. Second question. In the media presentation session yesterday, it was mentioned that there was a question regarding a succession. It seems that you've commented that there will be rejuvenation, change of generation. Does that mean that a successor can be in his or her 30s?
There has been rejuvenation by about 30-40 years of age when there was a change of guard. Now I'm 75, so it would mean that people in their 30s-40s. This is quite delicate, and I find it difficult to answer.
Thank you. I will read between the lines.
I'd like to take next question. The person in the second row from the front, please have the floor.
My name is Ueda. I'm from Goldman Sachs Securities. I would like to ask only one question because of the interest of time. On page 15, your concepts behind the pricing. Looking at this formula and going forward, the long-term data will become available and after accumulation of the evidence. Is it possible for you to consider raising the price slightly? In the Q&A session and SC formulation, you are considering different pricing. I think you commented that. Could you please explain what is going to be your view on the pricing?
Yes. As you said, from time to time, we needed to continue evaluation. I think that is important.
Of course, the quality may change and the cost offset portion may change, therefore we needed to continue updating this. By doing so, we will be able to respond to the pricing flexibly. Taking this opportunity, because you asked this, about this, I'd like to say, in the United States, a free of charge provision, patient assistance program called PAP, is being used in the United States. Going forward, when we roll out this product in Asia, PAP is going to play a key role. PAP does not generate any revenue for us. Yearly value terms, the PAP portion can be reflected on the yearly value. Impact-weighted accounting is now being the, a buzzword. For both, we would like to continue to report on both aspects. Regarding the SSC, subcutaneous formulation. Yes, for SSC formulation.
This is going to be a separate filing with a different setting of the price.
Understood.
Yes. For SC, I believe SC will carry higher value.
Thank you. Understood.
Would there be any other questions from those of you in the room? If not. Oh.
[inaudible]The national coverage decision rule will be. Specifically, how can coverage be expanded? Current NCD would mean that unless there are participation clinical trials, coverage cannot be increased. Our large-scale clinical trial would need to bring a larger number of people, or without a clinical trial, while abiding by the current NCD rule, do you think that without going through clinical trial, you can increase coverage?
The question will be addressed by Ivan Cheung.
Thank you for the question. This is Ivan Cheung. If you look at the CED document, it is very clear that each antibody will be judged on its own merits. Each antibody has to answer those three CED questions, which we believe the LEQEMBI data, including both the Clarity AD data and the phase II plus phase II long-term extension data, fully answered of those three questions. What does that mean? That's your question. If you look at the NCD document, which you see on this slide, we believe LEQEMBI can be qualified for so-called high level of evidence in the NCD document. In that scenario, it's likely that the CMS could lift the CED requirement for LEQEMBI, meaning there's no access restriction. That's one scenario.
The other scenario could be that these data from LEQEMBI almost fully answered all the questions. As a result, a very light CED may remain in place. That's also a possibility. That's not a clinical trial, as you mentioned. In the NCD document, the CMS used the phrase registry, which can mean many things in terms of different ways of collecting any type of information in the real world. Again, as of this moment, our interactions with the CMS and our data sharing with the CMS, Eisai's position is that we fully answered all three CED questions, qualified for high level of evidence, and we believe the CED for LEQEMBI should be lifted for the benefits for American seniors. Thank you.
That's very clear. Thank you.
There is another person who is asking a question online. This is going to be the last question. From Sanford Sogi-san. Sogi-san, are you hearing me? Could you please unmute yourself and ask your questions?
Hello. Thank you very much for calling me. Sanford, my name is Sogi. On page 23, the patients to be treated with AD-DMT, could you please explain this hypothesis? I have a question about this. When we have discussion or interview with physicians in the United States, beta amyloid diagnosis, as well as the beta after the amyloid diagnosis and whether or not patients will seek the treatment, actually patients may not feel like going to the treatment stage. There are many such patients, and particularly those senior patients going to seek the consultation at the hospital.
That itself is difficult. Also it requires infusion. The efficacy of LEQEMBI, of course, can slow the progress of the disease. It is meaningful, medically meaningful. However, this is not a cure from the perspective of a patient. It does not mean improvement. When it comes to the actual confirmation of the beta amyloid, then patients may seek to proceed to the medical consultation and treatment. What is the challenge? I believe based upon the hypothesis that you have presented, out of the patients who have the beta amyloid positive status, then how are they going to transfer it to the actual receipt of the treatment and the current status? Do you think that this situation can be changed, or are there any plans of your company's activities in order to change the situation?
Regarding this question, Yusa-san, who is preparing for the launch in Japan. Mr. Yusa is going to respond.
I am preparing for the LEQEMBI launch in Japan. My name is Yusa. I'm going to respond. Thank you for your question. Okay. Let me answer your question from the perspective of the Japan situation.
I am asking the situation in the U.S. actually.
Yes. Toyosaki-san. In charge of LEQEMBI global lead. Toyosaki is going to respond.
My name is Toyosaki. I am the global lead for LEQEMBI. Let me respond. As you pointed out, in the U.S. as well, after positivity of amyloid beta is confirmed, well, not everyone with positivity will seek the treatment with LEQEMBI. We believe that a certain percentage, which I do not know, have at hand. However, I would say that not every patient with positivity amyloid will seek the treatment with LEQEMBI.
Having said that, the clinical meaningfulness of this LEQEMBI is to the effect that the decline of the cognitive function for patients and their families and what benefits or impacts will be brought about by this LEQEMBI. We need to explain fully to them or asking the physicians to explain that fully to patients and their families, and then that will impact the acceptance of this drug. We would like to enhance the acceptance by doing so.
Let me supplement his explanation. As you asked in question, after confirming the positivity of amyloid-beta and then becoming the eligible patients to be treated with AD-DMT, in between the two processes, there is another step.
As you pointed out, you needed to consult and discuss with attending physician to determine whether they would like to be treated with this drug or not. That is taken into account. The number of patients treated with LEQEMBI was calculated.
That is one thing that I wanted to ask. Can I see the ecosystem chart in terms of in Japan?
This is it. At the very bottom, in the middle, at the very bottom, you can see the LEQEMBI efficacy prediction AI. After treatment with LEQEMBI and the efficacy of the treatment for patients can be visualized and such visualized screen can be shared with the physician. We would like to prepare such system. For patients, then by seeing this, then it may be one key motivation for patients.
they may feel like receiving a treatment with LEQEMBI.
Thank you very much.
Are there any other questions? If not, we would like to conclude the information meeting today. If you have further questions, please.