Thank you very much for taking your time out of your busy schedule to attend the financial results presentation for fiscal year ended March 31, 2023 by Eisai. Today, this will be conducted in hybrid format, in person as well as virtually. Those of you who are here, please refer to the circulated materials, including the deck of slides, press reports. Those of you who are participating online, please look at the slides that will be shown on the screen. The presenter is Mr. Haruo Naito, Representative Corporate Officer and CEO. Could I have the slide deck for the fiscal year 2022. Here is the statement of income. As you see in the subtitle, we accelerated investment in the dementia area. In total, the R&D and SG&A expenses, we made a total of approximately JPY 60 billion investment. Here are the results.
If you look on the right-hand side, there is Forex impact. There has been a lot of significant impacts by Forex fluctuations for many lines. Revenue was JPY 744.4 billion, which was 98% of the previous year's level. Gross profit growth was 97% of the previous year. R&D expenses and SG&A expenses were spent as such. The total expenses exceeded a little bit of the increase of gross profit as a result of such investment. Operating profit was about JPY 40 billion. That was the result. Profit for the year increased from a year earlier. This was because of the impact of the payment of paid-in capital from a consolidated U.S. sub. Tax expenses decreased as an effect of that. Next page. Regarding the changes in the revenue, here is the breakdown of the factors.
The business during the last fiscal year in each region, regarding the major brand products that you see in the top half, LENVIMA increased by JPY 57.3 billion. DAYVIGO increased by JPY 12.9 billion. These four global brands grew JPY 77.4 billion. On the left-hand side, you can see this pharmaceutical business grew 11% from a year earlier with the amount of JPY 67.2 billion. Pharmaceutical business can be said that it has achieved significant growth. What was much lower than the level years last year was because of the decreasing one-time income related to the license income. The if you look at the bottom half for the one-time income during fiscal year 2021, there was upfront payment related to MORAb-202, and there were two sales milestone payments related to LENVIMA.
As compared to last year, there was a JPY 79 billion decrease in terms of the one-time income. Therefore, as a result, revenue decreased by JPY 11.8 billion. Similar structure is applicable in operating profit. The JPY 65.7 billion increase or a 25% increase was recorded in the operating profit for the pharmaceutical business. However, because of the impact, minus JPY 82.2 billion as the one-time payment decreased from a year earlier, therefore, the operating profit decreased. Because of the significant decrease in the one-time payment in other business segment, therefore, we resulted in JPY 40 billion in operating profit. Next. For Alzheimer's disease and Leqembi, I would like to report to you current status.
On the 14th of May, there was the G7 Nagasaki Health Ministers Communique. There was a statement specifically referring to dementia that was adopted at the meeting. To the last part of this communique, we will also work to enhance early detection, diagnosis, and interventions, including through the development of a care pathways and capability and capacity building of health and primary care providers by strengthening primary health care. In the field of R&D, we encourage the development of potentially disease-modifying therapies for the various types of dementia, including Alzheimer's disease. In addition, we believe that a development related to early diagnostics, such as biomarkers, should also be noted. We encourage manufacturers to seek to bring effective, safe, and affordable new treatments for dementia to the global market as quickly as possible. Very positive message was adopted at the G7 Health Ministers meeting.
We believe that this message is very encouraging for us. We are working towards value maximization of Leqembi. If you look at the top of this page, we are planning to submit two very important value maximization programs, which will lead to the new usability of Leqembi by the end of this fiscal 2023. First one is subcutaneous administration. As you see on the right-hand side, there is the picture of pen-type auto-injector. This will be utilized for subcutaneous administration. We plan to submit for approval of this dosage form by the end of this fiscal year. Data for this will be taken from open label extension study or sub-study in the OLE of Clarity AD. This data will be utilized for submission for this.
Another one is maintenance dosing regimen, currently bi-weekly infusion during the initial dosing period, and after that, once every 4 weeks is going to be provided. Based upon this interval, maintenance dosing regimen shall be submitted utilizing the data from the sub-study in Study 201 OLE study, and we plan to file submission by the end of this fiscal year. Why do we believe these are very important submissions? For us, treatment of Alzheimer's disease shall not be discontinued after a certain period of time of treatment. That is to say, initial dosing bi-weekly administration will be done. After that, Alzheimer's disease is supposed to continue to progress. For example, amyloid-beta turns into the negative field. However, accumulation of amyloid-beta will take place gradually, and there are various changes in the biomarkers. Changes are going to start.
That has been confirmed in the open label extension study. Therefore, treatment for AD should be continued. That is what we believe. Therefore, we come up with these two value maximization programs, which we believe are very important. If you look at the bottom half, this is the schedule for getting full approvals. As we have already reported in the United States under priority review, PDUFA date is scheduled for July 6th. Before that, on June 9th, advisory committee will be held. In Japan, in the second quarter, EU and China. In the fourth quarter, we anticipate approval to be obtained. By the end of this fiscal year, globally, we anticipate obtaining full approvals. Through Leqembi, we would like to establish simple patient journey. At the top, you can see for patients as well as the consumers, there are various stages they are going through.
By recognizing early signs and make the decision to seek treatment, from that timing to the initiation of the treatment with LEQEMBI. At the very first stage, utilizing apps, simple Cognigram and other testing, or self-check or self-confirmation of the cognitive function will be done. Visiting PCP, primary care physicians, then something like MoCA, simple scale, will be utilized for detection of cognitive impairment. In order to have the clinical definitive diagnosis and amyloid-beta test, more detailed specific scaling shall be utilized, and a PET and a CSF shall be used for confirmation. Then BBBM, blood-based biomarkers, how feasible and usable in the clinical setting BBBM is going to be. That is something we are focusing on. In the Health Minister's communiqué, a statement was made to promote the diagnosis based upon the biomarkers.
In that sense, simple and low-cost BBBM to be adopted more and in so that it will be incorporated into the clinical guidelines. We are having a high expectation to that. After the initiation of the treatment with Leqembi, there is no need for titration with Leqembi. A first dose is effective dose. This, we believe, will bring about a very simple initiation of treatment and then transition into maintenance dosing. Subcutaneous auto-injector will be used, which will allow patients to be administered at the location where they are. We are designing this kind of a simple patient journey. As you see at the bottom, needless to say, ARIA management is going to be very important. After obtaining a accelerated approval, we started education program called Understanding ARIA to promote adoption throughout the United States, and many HCPs have participated in this program.
For ARIA, as well as the diagnosis of it, I believe that the knowledge or awareness has been advanced. What is going to be described in label, MRI confirmation, is very important. There is no room for debate on this. How are we ready towards a full approval in the United States? Cognitive function tests, amyloid-beta tests, and in the United States, in the healthcare supply or provision in the United States, IDN is playing a very critical role. Integrated Delivery Network, which is the network centering on the larger scale hospitals and in the United States. For this kind of a drip infusion formulation, what is most important is infusion centers and also management of area, ARIA is shown here. Regarding the cognitive function tests, which I already explained, then going to amyloid-beta tests, PET CSF.
We are collaborating with diagnostic manufacturers and the reference laboratories very closely for reimbursement as well as the wide use by HCPs. We are aiming at this as soon as possible. For blood-based biomarkers, PrecivityAD by C2N Diagnostics is considered to be most advanced, therefore, we are working more closely with C2N Diagnostics. The use of PrecivityAD, it started in prescreening, but ultimately, confirmation or the definitive diagnosis of amyloid beta needs to be based upon this PrecivityAD. We try to incorporate this into the guideline, but for that, simple and low-cost BBBM method, it should be taken into account for achieving that goal. For IDN, with most of the top 40 IDNs, we completed clinical presentations and we achieved a positive P&T, Pharmacy and Therapeutics decisions at eight key IDNs.
Infusion centers, we already provided over 600 infusion centers with educational sit-in sessions for Leqembi administration. The Association of Infusion Centers, NICA or NICA, National Infusion Center Association, we are working with them to raise awareness of Leqembi for HCPs. When it comes to management of ARIA, educational program, Understanding ARIA provides medical resources. Since AA accelerated approval in January, over 2,900 times of access have been already made, and live webinar by a neurologist or neuroradiologist has been conducted. At AAN, American Academy of Neurology, M-ARIA MRI reader sessions have been conducted many times. We have seen a great advancement and progress in awareness rating. The accelerated approval status has been already obtained, and we are utilizing the advantage of that in order to prepare ourselves for full approval.
The other hand, if you look at field forces, those people in the front line, they are in the market. Well, I wonder whether we can call medical people as market-in people. I would like to share with you our activities for preparation in the field. On the right-hand side, you can see the list of stakeholders, starting from key opinion leaders down. For these stakeholders, corresponding to these, there are various groups within Eisai in a multilayered approach to keep contacts with wide-ranging stakeholders. When it comes to Eisai's group, medical, commercial, market access, these are the three major groups of people within Eisai. For medical, literature and as regards to clinical studies, they are the ones who share information about these. For rolling out to markets and each region, MSL, medical science liaison, these are the main people who are doing these services.
Medical affairs and medical directors, this is also another group in medical team currently with key opinion leaders, neurologists, and a geriatrician. These are the stakeholders they are focusing on in rolling out medical activities. Starting from the second half of this fiscal year, they will start contacting PCP, primary care physicians, as well. Top four on the right-hand side list are contacted and approached by medical groups. Turning to commercial, we have neurology account specialist. The MR or sales reps dedicated to neurology covering whole United States. HCPs and IDN, they are approaching these networks, and also they are conducting educational sessions at infusion centers. Regional thought leader liaison. In each region, the patient advocacy groups and professional societies are existent in each region.
There, it is very important to create networking with them in each region, that is what regional thought leader liaisons are engaged in. Clinical educators. This group of people are educating site of care staff in the field. Infusion-related education or the diagnostics and so forth, site of care staff are being educated by these educators of Eisai. Market access, of course, this is expected to play very critical roles in the U.S. Health systems account executives are focusing on IDN, as I said earlier. About top 100 IDNs, they are focusing on getting approval at P&T for top 100 IDNs. Next one, market access and HEOR group is focusing on the health economics of Leqembi. They are discussing with national level or regional level payers. Next, patient navigators.
This group of people, if you look at the right-hand side, the second from the bottom, all the people who would be treated with Leqembi. They will provide information regarding patient journey that I explained earlier and support them. Patient assistant program, which was explained in January, for financial disadvantaged patients eligible for PAP. The free of charge provision of medication is being conducted. Such PAP is supported by this group of people included in this group of patient navigators. Next, access and reimbursement team. As you see at the bottom, once Leqembi is prescribed, the scope of indication as well as the reimbursement of status will be communicated to payers. The medical institutions and infusion centers, they will explain the scope of the coverage for Leqembi. That is the work done by part of this team.
In total, we have about 400 FTEs. It's the same set of data and same omni-channel approach shall be applied. Data will be input in the data lake, and then AI will support the processing of data in order to get the appropriate guidance out of this. The database, the approach will be utilized in order to further expand the efficient approach. These 400 FTEs, I believe that the... some people may say that this is too, this is large, and some others may say this is small number. But this kind of a breakthrough type of product launching is not relying on the very large scale share of voice. We do not think that we are currently in that era.
Appropriate number of FTEs should be rolled out in order to deploy these approaches efficiently, and that is required by the society nowadays. In that sense, I believe that we are preparing the field workforce in appropriate manner. Next, this is about CMS reimbursement coverage. Recently, attorney generals in nearly half of U.S. states and territories sent a letter to HHS and CMS. Regarding Alzheimer's disease treatment, the important therapy for Alzheimer's disease will be extremely limited or nearly non-existent, and this status should not be considered fair. As soon as possible, fair and a larger scale access to this therapy, it should be realized as soon as possible. That is the letter they sent. At the Congress, as well as the AAN, of course, patient groups and a similar opinion has been sent from various groups, including both.
Given that, in the U.S. Congress, the CMS administrator made these remarks. "The people who will be eligible will be based on the FDA label. A registry in no way limits people from getting access to the drug. When FDA fully approves the drugs for Alzheimer's disease, CMS will cover it more broadly." She made these remarks. In our interpretation, as you see, two bullets are provided at the bottom. It remains the goal of the agency to have coverage operational that people who will be eligible based on the FDA label on the same day of the traditional approval. Registry requirement will not be an obstacle to coverage. These are quite positive statement, I believe, in our interpretation, so we have high expectation because of this. In Japan, for amyloid testing, imaging agents are used, and this shows the submission status.
This is a partial change submission. This is additional indication for NCI. For that submission is being filed or will be filed. Imaging agents, there are two types, tracer production, tracers produced at hospitals and those that are delivered. For these two types, we see development.
The number of manufacturers who have filed submission is increasing. At the time of when Lecanemab is approved, we believe that there will be better environment for PET, amyloid PET. This is the vision for the year ahead. There are three. First, establish a global presence. As I mentioned earlier, Japan, US, EU, and China, we expect to obtain full approval by the end of the fiscal year. We would like to establish position as the first-choice treatment for early AD by ensuring efficacy and safety. Two, simple patient journey. Patient journey should be as simple as possible, as I mentioned. As much as possible, it should be not burdensome, and that there should be diagnosis and treatment of dementia, and efficaciousness should be experienced.
That is the simple patient journey that we aim to achieve. 3, global access. Medicare reimbursement included, as I just mentioned earlier. In each country, we would like to pursue reimbursement. In that respect, earlier, shared with you the communiqué announced by G7 health ministers in each country to promote reimbursement. The communiqué, I believe, has a very strong significance. Patient-assisted program will be enhanced depending on the conditions in each country. These 3 are what we would like to have achieved in 1 year's time. Next, following Lecanemab, the second Alzheimer's disease treatment. The second round, I would say plus ultra therapy. This is 8 anti-MTBR tau antibody, E2814. This adopts a promising approach by Eisai in DHBL-based development.
What I mean by promising approach is that, well, in case of Aβ hypothesis, Aβ protofibril was hypothesized to be the main pathological Aβ. In case of tau, we believe that MTBR tau is the pathological target, and that has been confirmed. Starting from this, we have developed a drug development hypothesis. In that sense, approach for Aβ cascade and this tau pathology are similar-- is similar. DHBL is human-based biology-driven learning process. The data indicated here is based on human biology. All of them are based on human biology. Animal test data or preclinical data, these are not animal data or preclinical data, but human biology-based data. E2814 data were obtained from the studies. Deep human biology learning-based development is exemplified by E2814.
Please refer to the diagram at right top. This explains the hypothesis of drug development. This pathological tau species is considered to be MTBR tau. What is shown at the middle is a synaptic cleft. MTBR tau propagation species in the synaptic cleft are considered to be the main pathological species. MTBR tau in the synaptic cleft can be captured and removed by the antibody to remove them to outside of the brain. This antibody therapy, it will halt progression of tau pathology, resulting in a reduction in cognitive function decline. That is our hypothesis for drug development. Observation from AD brains, MTBR tau extracted was analyzed, and the core of AD tau aggregation was this MTBR tau, according to mass spectrometric analysis of insoluble tau tangle.
MTBR tau exists in DIAN patients, and MTBR tau is trapped by E2814. MTBR tau and E2814 are engaged. That was confirmed. Target engagement was confirmed. This is a very important observation in terms of this drug development hypothesis. Dyad are inherited Alzheimer's disease family of patients. In this mutation, there is an estimated year of onset, the expected timing of symptom onset. In this family of patients, the symptom onset is estimated pretty much accurately. Increased tendency of MTBR tau in CSF, starting 20 years prior to symptom onset, was confirmed in DIAN observation program. What is noted at the bottom of left-hand side are shown on the 2 charts on the right-hand side. 3 A EYO 0, estimated year of onset, 0.
Around this time, within CSF, MTBRtau rate of annual change changes. It was increased. However, around the time of EYO of zero, it turns to decrease. What this means is that MTBRtau decreases in CSF, but rather it is aggregated in the brain. That is what's suggested here. If you turn to 3B, at the same timing, according to tau PET observation, the same thing was also confirmed. Within CSF, MTBRtau rate of increase was slowed at the time of the onset. With tau PET, start of the aggregation in the brain was confirmed. As shown at in red letters, MTBRtau captured by E2814 was indicated to be associated with tau pathology.
E2814 potentially suppresses the progression of tau pathology, as indicated in red in lower left. Turning to oncology, first LENVIMA, as shown in bar charts on the left side. Globally, last year, we were able to achieve substantial growth. This fiscal year, once again, we expect the growth. Blue part is the United States. The main market is the United States. What is happening in the United States is shown in the bar charts in the middle. The two lower segments clearly are driving the growth in Americas. Blue part is RCC and pink part is endometrial cancer. These two new cancer types are expected to continue to drive growth this year. At the top in red letter, targets are shown. At ASCO, various new data for these two cancer types will be reported.
In case of RCC, 30% of new patients and in EC, 45% of new patients. Those are the shares we would like to achieve. In other words, top share. As for LENVIMA, as shown at middle part of right-hand side, we are fully deploying omni-channel marketing. What this means is that, to HCPs, we are adopting various approaches. We are approaching them in many ways. Sales reps are approaching them, and remote channels are also used to approach HCPs. Feedbacks and responses obtained will be all entered into a data lake in an integrated fashion.
Integrated data from data lake will be analyzed by AI, it will suggest or recommend the next action to be taken, including in-person contacts by sales reps or various other approaches using various other pathways. By implementing these, we are able to engage in very efficient sales activities, and this will be applied to all types of cancer. RCC and EC, and at the bottom, HCC is mentioned. These are our thinking for this fiscal year. For RCC, refractory, a non-clear cell RCC, even in that, favorable ORR and PFS were shown. In clear cell RCC and non-clear cell RCC, in both types, there is a clear action indicated, a clear action shown. On the right side, for regulatory purposes, complete response rate is shown, which is 16.1%.
At ASCO, we hope to be able to report results that is better than this. In the middle is EC. For the first time, this is used in off-chemotherapy treatment. Therefore, it is also outstanding in terms of safety. In the middle, in the yellow part, OS, PFS, and ORR are shown. In comparison to chemotherapy, risk of death decreased by 30%, risk of progression or death decreased by 40% or PFS. ORR was approximately 2 times. In regulatory data, in Kaplan-Meier curve, efficacy is shown from early on and in a sustained fashion. At the very bottom, HCC. In the past, mainly the focus was on Child-Pugh A, but Child-Pugh B, sorafenib, is mainly used.
We have favorable data for Child-Pugh B, and in this fiscal year, we would like to develop further this Child-Pugh B. We will be obtaining results from three important cancer types this fiscal year. LEAP-006, NSCLC first line, 008 is the second line, and first line from EC. We will be obtaining results. I would like to say that we are confident about the expected results. The reason for that is that for lung cancer, VEGF antibody bevacizumab is used as add-on in the first line setting. Favorable OS extension is observed. LENVIMA also has a potent anti-VEGF action. In preceding studies, ORR of 69% was observed, which was exceeding 48% reported from control arm in preliminary results.
As for the second line in a similar fashion, VEGFR antibody ramucirumab add-on is used to show OS extension, significant OS extension. Similar effects are expected by adding on LENVIMA from previous trials ORR in comparison to control drug docetaxel exceeded the results. As for the first line for EC, second line approval was obtained as based on the results from Study 309, which was a very large size study with 827 patients. Adjuvant chemotherapy, following adjuvant chemotherapy in the first line, which are quite similar in profile to the second line patients. In comparison to the control, decrease of risk of death of 36% was shown. Second line success, and based on this data, we also are very confident about the success of Study 001.E
Next. This was recently announced. A new HER2, anti-HER2 ADC. We have EZH2. This is the second bullet from the top. This is the former Morphotek site. At EZH2, ADC research is carried out very actively, and MORAb-202 is one such ADC. Eribulin is used as a payload. Linker chemistry, we also have proprietary linker chemistry. Multiple ADCs were developed, and one such ADC is BB-1701. As shown at the right, this is licensed out to Chinese company BlissBio. Favorable results were obtained by a study run by BlissBio. Results are expected to be published at ASCO. Based on this, we have concluded an agreement with SystImmune for joint development.
For HER2 expressing breast cancer, the second phase II study will be conducted. There will be various biomarker research as well. The biomarker change in case of non-responder to other agents or biomarker change in ILB, we would like to conduct research of these as well. This slide shows strong balance sheet of Eisai. There are no concerns. We have no concerns. At the board meeting today for fiscal 2022, a JPY 160 dividend of a full year was approved. In fiscal 2023, the forecasted JPY 160 full year dividend was also confirmed at the board. Sufficient shareholder return and growth investment both can be achieved. This is the PL for this fiscal year. Revenue.
Within the increase of revenue, expense increase will be also contained to ensure that revenue and profit can be grown. Last year, tax expenses decreased, but this fiscal year, we do not forecast such decrease in tax expenses, and that is why we forecast these amounts for profit for the year. Lecanemab-related, JPY 110 billion investment will be made in this fiscal year. More than JPY 110 billion of lecanemab-related investment is planned. There will be a shared burden-sharing with Biogen. About 60% of JPY 110 billion investment is related to market in SG&A. Market, marketing-related SG&A. The remainder is to be invested in ongoing R&D programs.
Such a large investment related to Leqembi and resource allocation related to Leqembi included, we plan to achieve this PL. R&D expenses, SG&A expenses, we will be improving efficiency. At the same time, our biggest mission, the steady introduction in the market of Leqembi, is to be achieved. Steady creation of value is to be achieved. We are determined to make important resource investment this fiscal year. This is my final slide. Full approval of Leqembi is anticipated globally. As I just mentioned, for Leqembi, we remain committed, and we consider this current now to be the time for investment. We aim for dramatic growth in fiscal 2024 and beyond. What we mean by dramatic growth?
Well, towards 20, 32, top line and bottom line, we would like to achieve double-digit growth in both the top line and the bottom line. That is what we mean by dramatic growth. With that, I would like to conclude.
Thank you. Now we would like to open the floor for Q&A session. If you have any questions, please make sure you wait for the microphone, and please state your affiliation and name before asking a question. In order to clearly hear your voice, could you please take off your mask? Due to the interest of time, I would like to ask you to limit the number of the questions to 1 per person. If there is extra time, we would like to make a second round for taking questions. The person in the second row, please.
Thank you. This is Kotani of Nomura Securities.
I have one question. It may be difficult for you to comment on the phase III results for donanemab. In high tau patients, the change in CDR-SB was 36%, suppressing the progression more than placebo, which looks to be better than Leqembi, as it was 27%, though tau was not measured for Leqembi. ARIA-E, 6.1%, and for you, 2.8%. It seems better than donanemab. Considering the right cycle of the drugs, and then efficacy is focused, and then safety comes, and lastly, convenience. From this perspective, I think that efficacy terms, donanemab seems to be better than Leqembi. ARIA-E may be fatal, therefore it is better to have stronger safety, therefore Leqembi might be better. Could you please give us your take on this?
Regarding this, I would like to ask CEO to respond to your question.
As you know, Kotani, at AAIC, more detailed data will become available. Until we see those data, there are many things that are not known to us. According to the current press release, this is my personal take from what I read from the press release. If it is okay, I would like to share with you. First of all, Clarity AD compared to this study, target population seems to be different. That is my impression. For Clarity AD, patients with MCI account for 62% in the population. In donanemab trial, MCI patients account for much less than that. For us, Clarity AD, tau PET was not used for screening the patients.
For patient selection and inclusion, I believe there are differences between the two studies. The second point is the duration of treatment, or rather discontinuation of the treatment. I think that there is a point as a difference. As I said in my presentation today, after ending the initial treatment, the patient may transition into the maintenance dosing period. Even after completing the initial treatment, we needed to continue with maintenance dosing. That is what we have learned with confidence from OLE study. In that sense, development of subcutaneous dosing as well as the maintenance dosing regimen, where we put much focus. Maintenance dosing regimen, it's something indispensable in the treatment of AD. That is one aspect. Well, how long the treatment duration for donanemab is going to be is not known to us.
At least for lecanemab, that is what we believe in. The third point is, as you pointed out, safety profile. ARIA-E incidence for lecanemab is 12.6%. Symptomatic ARIA-E is 2.8%. ARIA-H is 17.3%. I believe that there are differences from the other. That is my impression. Rather, this is my take as my impression. In a nutshell, for those patients with accumulated tau, and then still compared to Clarity AD for more progress or advanced patients are enrolled in their study. In that sense, maybe the patient seems to have responded to their treatment better. Is this what I should interpret? MMSE criteria I looked at, and I think that is what you can take from that as well.
The vision I said earlier that we'd like to establish the first-choice drug. That is what we would like to establish. I believe, starting from the early phase of MCI, treatment can be started, and then, it is expected to get larger response or efficacy of treatment. In that sense, even in the MCI or early AD, I believe that this is the strong point that we recognize as feature of this drug.
Thank you very much.
Next, attendee seated in the front, row, please.
I'm Sakai from Credit Suisse. I also have a question related to tau, in relation to donanemab study. I'm curious about that. As it was just mentioned, in high tau patient, it doesn't seem that donanemab is effective. I believe that is the result. On the other hand, a tau increase or decrease, how much is that linked to improvement in the symptoms? You are developing E2814, and I think that can be an important point going forward. Looking at the data, I'm sure you have looked at the data. Overall, I believe, Mr. Naito, I think you grew more confident about LEQEMBI. Regarding tau, if we look only at tau, how do you interpret the results?
I would like to ask Ivan to add later if necessary. AD...
The initial trigger for AD, I believe, is Aβ pathology. First, Aβ pathology should be targeted from early on. Then I believe that tau pathology, I think there's a potential to weaken tau pathology as a result. If you consider tau pathology to be separate and independent from AD pathology, then that will be a different story. However, we believe that Aβ pathology, within AD pathology, is a major pathology that occurs in the very beginning. To target that from quite early on in the treatment is important. I believe that is always important irrespective of tau. Ivan, if you would like to add, please.
I'm Cheung, Global Alzheimer's Disease Officer. Thank you very much for the question. Let me make 2 points. First point, when you mentioned the donanemab phase III trial. I think everyone's focusing on intermediate tau and high tau. I think 1 point not being mentioned is this trial excluded low tau. Probably more than 20% of amyloid-positive early AD subjects were excluded from that trial. Why you heard from CEO earlier that the Clarity AD and LEQEMBI uniqueness in the efficacy profile is a broad efficacy, including the very early stage of early AD. In a progressive disease, as you heard from CEO, critically important to treat early as a first-choice therapy. I just want to remind everyone about the lack of low tau people in the donanemab phase III trial.
The Clarity AD trial has low tau subjects. Second point on E2814, as you heard from CEO already, amyloid is the early part of the disease cascade that triggers and that impacts early tau pathology. You can think about impacting amyloid, especially when you think about the protofibrils targeting impacts the early tau pathology. E2814 here, as you saw, which we'll present more data later on this year, both at AAIC and CTAD. You see that E2814 has the ability to also impact late tau pathology. Which will expand the utility of E2814 in conjunction of LEQEMBI across a broader continuum of the Alzheimer's disease. We'll show more biomarker data later on this year. Please stay tuned. Exciting time ahead. Thank you.
Thank you. The next question. The person in the third row, please have the floor.
My name is Susumu Shimoyama, nonfiction novelist. I have a question. Compared to donanemab and lecanemab is ahead of donanemab 8 months, in my opinion. The results from phase III trial were obtained 8 months earlier than those from donanemab. Perhaps approval can be obtained globally 8 months earlier than donanemab. This time lag of 8 months. As we mentioned earlier, in order to establish the presence globally, how significant do you think it is going to be? I believe that you explained earlier that you are preparing various things in today's presentation. In the competition in pharmaceutical industry, in order to obtain best-in-class position, getting approval earlier than others, what is the significance in terms of strengths of having earlier approval than others?
It's not only about the earlier acquisition of the results from the phase III study, but for lecanemab, we have the accelerated approval status. This is the drug medication that has been already approved. For example, approaching IDN. To approach the committee deciding on the formulary, we can approach them to ask them to approve the adoption of this medication. We can do such activity. In the field, not only medical, but also commercial group and reimbursement groups. We are talking about already approved drugs, therefore they can be very active and publicly, officially, they can do marketing activities. This is a great advantage of having AA. donanemab, was it granted AA?
Case, they didn't get accepted. Yeah.
Right. In that sense, the density of the activities can be very different by having this status. For us, this lead time is very significant. Thank you very much. Next, I would like to entertain questions from online attendees. From Citigroup Securities, Mr. Yamaguchi. Can you hear me?
Thank you. This is Yamaguchi from Citi. Can you hear me?
Yes, we can. Please go ahead with your question.
Thank you. I was not able to hear very well. This is for clarification. The amount to be invested in Leqembi, did you say JPY 400 billion?
No, JPY 110 billion.
I see. About half of that amount, will be borne by Eisai?
Yes. According to the agreement, this is a 50/50.
What is the sales amount that is expected?
Ivan, if Ivan can address the question.
Thank you for the question. I believe it's the sales for this fiscal year. I think a great question. You heard from our CEO earlier. We are very confident with the FDA traditional approval by July sixth, as well as the approval in Japan in second quarter. Europe and China at the end of the fiscal year will not contribute meaningful in terms of the sales numbers. Of course, with respect to the United States, we are also confident about the CMS granting broad and simple access by July sixth. In the United States, you'll see a rather rapid uptick of the prescriptions and new patients from July onward.
By the end of fiscal year 2023, we do expect about 10,000 patients to be on Leqembi by that time in the United States. Thank you.
Thank you very much.
From J.P. Morgan Securities, Mr. Wakao. Mr. Wakao, can you hear us?
Yes. This is Wakao of J.P. Morgan Securities speaking. I think that many things are going very well. I understood that very well. In the near future, and before the approval, there is advisory committee. As for advisory committee, I don't think that there are any problems or issues, but now we are approaching that date. Once again, could you please give us specific discussions and are there any updates on the preparation for that? For this, I'd like to ask Ivan Cheung to respond.
Thank you for your question. Yes, June 9th is the FDA advisory committee. It's gonna be conducted virtually. The FDA has done this virtually a few times now, this format is very well established. We are very pleased with the FDA's progress on this format. Right now, we are not aware of specific questions to be discussed at the June 9th. At this moment, we are of course confident that the well-conducted, straightforward and robust Clarity AD result will be shared publicly in this very important forum. We are also ready to address any question to be asked by the advisory committee members. Basically, everything is going very well.
We are very prepared. We wish the advisory committee is tomorrow, but it's June ninth. That's fine. We look forward to that date. Thank you.
Thank you very much. Clearly understood.
Next, Mr. Muraoka from Morgan Stanley, please.
Can you hear me? Thank you. I'm conscious of time. I have one question about the balance sheet inventory, increased by about JPY 40 billion, quite substantial. Is this because of the steady progress for launch of the Leqembi? Earlier you've mentioned about 10,000 new patients, and does that mean that considering the unit price, the sales expected for this fiscal year, maybe JPY 1 billion-2 billion?
CFO, Mr. Yasuno will respond.
This is Yasuno, CFO. Thank you for your question. Your understanding is quite correct. Thank you very much. As you rightly understood, this is Lenvima inventory in preparation for a full launch of Leqembi. We are fully prepared by having sufficient inventory of Leqembi. Are you going to increase inventory further? Mr. Muraoka, could you repeat your question? It wasn't clear. Inventory, do you think that you will have to build up inventory significantly from the level at the end of March? We believe that we have sufficient inventory. Please understand that there will not be any excessive increase in inventory.
We can take some further questions if you have any questions. Yes, the person in the second row from the back, please.
My name is Oka. I'm from NHK. At the previous, the last press conference, Mr. Naito, CEO Naito said, "At earliest, approval in Japan may come around in September." In the second quarter, you said in the presentation slide it is expected to come around in the second quarter. Do you think that there is possibility to get approval earlier?
I'd like to ask Ms. Nakahama to respond. If necessary, I would like to supplement. Please.
Thank you very much for your question. Could you please speak louder? Thank you very much for your question. I am in charge of lecanemab review status in Japan. Before submission, we utilized the prior assessment consultation system, therefore everything is moving very steadily. The PET for diagnosis, amyloid PET test, agent or imaging agent, as CEO explained earlier. The review for these agents, Clarity AD data, is provided to support that, the review process. The review of imaging agents are also in going steadily. Is there any potential to see, have the approval earlier than expected? Although we are not able to give you any specific view on that, because we are in the process of being reviewed. At the expert panel of the MHLW, I believe that there will be a review by them.
We have been given the priority review status. Therefore, at latest, the approval can be obtained by September. Towards which we would like to work hard in order to get approval as soon as possible. Prime Minister, in his policy statement, he touched upon this area. Several weeks ago in Japan, biopharmaceutical CEO roundtable was held with CEOs of over 30 companies all over the world. There has been request made to the government of Japan. Prime Minister Kishida attended the meeting. AD treatment, as the first ever in the group, and originated from Japan. This treatment for AD shall be reviewed, and he expect that this will be rolled out and deployed all over the world. In the G7 health ministers meeting, this topic has been taken up and addressed.
Innovation originated from Japan. Innovation starting from Japan, for which review is being conducted very actively. I think this is further accelerated now. That is how I have felt. Understood. Thank you very much. I should have said that, at latest by September. I shouldn't have said, at earliest September. I have other questions, but I will wait.
There are people who are waiting to ask question who are participating online. From Sanford C. Bernstein, Sogi-San, please.
Can you hear me?
Thank you. I'm Sogi from Sanford C. Bernstein. I have a question regarding Leqembi. Recently, results from donanemab were announced. Differences between Leqembi. There may be differences between Leqembi and one such difference, as CEO Naito mentioned, is the treatment duration. Treatment duration is limited for 1 or one and a half years, or continuous treatment in the case of Leqembi. This can be a major difference. Do you believe that continuous treatment is necessary for Alzheimer's disease or rather the need for continuous treatment for Alzheimer's disease? When you communicate with the physicians and the patients, what data do you think will be necessary to explain the need for continuous treatment or are you already preparing such data?
I would like to ask, Ivan Cheung to address that question.
Thank you very much for your question. Let me refresh your memory if I may. In our phase II trial, there is a gap period between the core randomized phase and the open label extension. On average about 2 years, for some patients longer than 2 years. If you look at that gap period, you can see first of all, the amyloid accumulation in terms of the PET scan in the brain does reaccumulate slightly over time, about 3% or so over time. If you look at the other, what you may think of as more leading indicators, such as the CSF or the plasma biomarkers, They reaccumulate even faster during those gap period. Which tells you that this is indeed a chronic disease. As you know, Alzheimer's is a neurodegenerative disease.
It's not just a condition that you tackle one time and it's gone. It's a progressive degenerative disease. Beyond the data for any degenerative disease, when you talk with key opinion leaders and physicians, there's a general understanding for chronic progressive degenerative disease. Some kind of ongoing treatment will be needed to prevent reaccumulation or prevent worsening of the disease. Of course, you may not need the same dose intensity, and that's why you heard from CEO Naito earlier that we're developing the maintenance dosing regimen of less frequent dosing after the initial, for example, 18 months of a more intensive dosing. This is, I believe, a very well-accepted position among many physicians and experts. Thank you.
Thank you.
I believe there are further questions or those people who are waiting for the opportunity to ask questions. We would like to take second round of questions.
My name is Oka, I'm from NHK. This is my second time. If the approval is obtained in Japan, the key point is going to be what kind of a guideline for the optimal use of the drug, how the guideline is going to look like. It will determine the ramp-up speed of the penetration of this drug. I would like to ask for your take. Mr. Naito, what will be the desirable things to see? The prescribers. For prescribers. What kind of a physician should be prescribing this drug? That is the point you're asking. Those physicians who have certain level of experience in treating Alzheimer's disease for a certain period of time, or physicians who have gone through training and education programs.
On condition as such, the prescribers may be determined, and that is the most desirable situation I'd like to see. This is my personal opinion, though. Looking at the G7 Health Ministers' communiqué, they mentioned the importance of PCP. Through the discovery of the through the training as well as the capability, capacity building and then, we needed to enhance the early detection diagnosis intervention. This is not only about specialists or neurologists. For treatment of the dementia, neurologists are not in sufficient supply for providing treatment. We are thinking about PCPs or general practitioners. By having the certain level of experience and also going through the trainings and education, guideline, I hope will permit them as well to prescribe this drug.
That will be the most desirable situation I'd like to see. Thank you very much. Understood.