Eisai Co (OTC:ESAIY). Ltd. (ESALY) reported a stable revenue in fiscal year 2023, with a modest 4% increase in gross profit and a significant 33% rise in operating profit, attributed to cost reduction and product mix improvements. The pharmaceutical giant emphasized its success with key products, especially in the Alzheimer's disease treatment market, with notable revenue increases from their drugs LENVIMA, DAYVIGO, and LEQEMBI. Eisai also outlined ambitious plans for market expansion and efficiency enhancement, particularly in the United States, Japan, and China.
Key Takeaways
- Revenue remained consistent year-over-year, with a 4% increase in gross profit and a 33% increase in operating profit.
- R&D expenses decreased slightly, while SG&A expenses increased due to LENVIMA expansion.
- Significant revenue growth for LENVIMA, DAYVIGO, and LEQEMBI.
- Plans to double the number of Alzheimer's Resource Managers and Health System Account Executives.
- LEQEMBI's launch in China planned for July, with a comprehensive online-merge-offline strategy.
- Eisai to acquire up to 6.5 million of its own shares to enhance shareholder value.
- LEQEMBI revenue forecasts for the US and Japan are $300 million and ¥10 billion for fiscal year 2024, respectively.
- New formulations and dosage forms for LEQEMBI are under development, including a subcutaneous autoinjection.
- The company is focusing on reducing costs through automation, process improvement, and initiating production at a second site.
Company Outlook
- Eisai aims to expand prescription sales and enhance marketing efficiency with a focus on Alzheimer's treatments.
- The company plans to extend its Integrated Delivery Networks target from 100 to 150.
- Revenue projections for LEQEMBI are optimistic, with expectations of growth in the US and Japan.
Bearish Highlights
- SG&A expenditures are anticipated to be higher than the previous fiscal year.
- LEQEMBI will not be covered under an IDL in China and will be priced at around ¥3 million.
Bullish Highlights
- LEQEMBI has seen faster-than-expected progress in Japan with established pathways in nearly 600 facilities.
- The company is confident in LEQEMBI's market share despite the anticipated launch of competitor drug donanemab.
- Plans to achieve profitability for LEQEMBI in the US by fiscal year 2025 and globally by fiscal year 2026.
Misses
- Specific patient numbers for LEQEMBI were not disclosed.
- The company refrained from providing specific expense numbers for LEQEMBI.
Q&A Highlights
- Eisai highlighted LEQEMBI's unique characteristics against competitors, focusing on safety and efficacy.
- The company is preparing for a generational leadership change and business model transformation.
- Eisai did not disclose specific numbers regarding expenses or budget but mentioned efforts to reduce the cost of goods sold for LEQEMBI.
- The subcutaneous formulation of LEQEMBI is expected to receive approval within 6 months post dossier acceptance, with final submission in October.
Eisai Co. Ltd. continues to demonstrate resilience in its financial performance while strategically positioning itself as a leader in Alzheimer's disease treatment. With a clear focus on expanding its market reach and improving operational efficiency, the company is poised to capitalize on the growing demand for its innovative treatments. Despite increased expenditures, Eisai's commitment to shareholder value and cost reduction measures indicates a forward-looking approach to sustainable growth.
Full transcript - None (ESALF) Q4 2024:
Seiji Wakao - JPMorgan:
Kazuaki Hashiguchi - Daiwa Securities:
Fumiyoshi Sakai - UBS:
Akinori Ueda - Goldman Sachs:
Shinichiro Muraoka - Morgan Stanley:
Unidentified Company Representative: Thank you very much for taking your time out of your busy schedule to attend the financial results presentation session by Eisai Co. Ltd. We would now like to begin the meeting to present financial results from fiscal 2023. This will be held in hybrid format. Those of you who are in this room, please find four presentation materials, including the presentation deck, financial report and press release that was announced today and the start of the rolling submission for subcutaneous injection and change in the personnel -- or rather announcements of new appointments. I would now like to introduce the presenter, Mr. Haruo Naito, Representative Corporate Officer and CEO. Mr. Naito, the floor is yours.
Haruo Naito: Let me start my presentation on the financial results for fiscal year 2023. Firstly, please look at the statement of income. Revenue stayed almost flat from a year earlier. The cost of sales has reduced by 3 percentage points. This is due to the ongoing effort for reducing costs and also the improvement of the product mix. As a result, gross profit was up 4% year-on-year and profitability has improved by 3 percentage points. As regards to expenses, such as R&D expenses, which accounted for 22 points of the revenue, that was the reduction by about 0.5 percentage points. Over the past 2 years or so, Oncology and Neurology Business Group R&D have been integrated. Human biology-based integrated approach has adopted for integration, and as a result, the benefits are now arising as the effect of such integration. Now for SG&A expenses, which have increased, the major driver for the increase was one thing due to the expansion of LENVIMA. Therefore, there was an increase of expenses regarding shared profit of LENVIMA paid to partner. Currently, we are making utmost efforts in development of LEQEMBI. So with these two major positive investments, we are making SG&A expenses increase. However, if you look at expenses in total, which was 1% up from a year earlier, so these have been controlled within the increase of gross profit. Therefore, operating profit was ¥53.4 billion, up 33% increase, which was a significant increase year-on-year. Profitability has improved as well. Profit for the year has decreased. However, in the previous year, there was the repayment of paid-in capital from a consolidated U.S. subsidiary. Therefore, there was the reduction of the tax expenses in the previous year. Excluding that impact, profit for the year should have increased. Therefore, there is no change to the sound structure of the financials. Given these, now take a look at the revenue migration. As you see in the headline, 3L: LENVIMA, DAYVIGO because generic name of DAYVIGO is lemborexant therefore l is taken and LEQEMBI. With these 3Ls, which I believe have contributed to the expansion of pharmaceutical business, LENVIMA increased by ¥48 billion year-on-year, DAYVIGO by ¥12.4 billion and then LEQEMBI increased by ¥4.2 billion from a year earlier. Therefore, pharmaceutical business increased by ¥7 billion in its revenue. There were some decrease in onetime income, however, overall, revenue was almost flat. Now a breakdown of operating profit migration is provided here on this space. The profitability of our pharmaceutical business was increased from 47.6% to 49.7%. There was an improvement in the profitability because of the adjustments in head count in various areas and also better efficiency of spending. And R&D expenses, as I said earlier, integration of the areas of R&D activities have given rise to more efficiency and ¥8 billion in pharmaceutical and ¥4 billion in the more -- improved efficiency R&D activities. So these were the contributing factors for improving the operating profit. And the offsetting the decrease in the onetime income, operating profit increased by ¥13.4 billion which was up 33% year-on-year. There was a significant increase in operating profit. As you see in the bottom right, for LENVIMA -- LEQEMBI total investment in R&D and SG&A expenses were at ¥110 billion level, as planned. Now today, I would like to put focus on LEQEMBI in my presentation. Now Eisai has been rolling out globally with what mission as a pharmaceutical company, we are rolling out our business operations worldwide. That is shown here, Eisai has paved the way as a pioneer in the treatment of Alzheimer's disease worldwide and it will continue to play this role. 1997 by Aricept exactly 25 years ago with Aricept as the first-ever treatment for Alzheimer's disease has been provided to the world; and 2023 by LEQEMBI, about 1/4 of a century later. Again, similar pioneering role is played by us. At the very bottom, you can see we are aiming for more treatments for more pathologies, including tau and other various pathologies are being addressed in the pipeline. Now as pioneer, we are and have been paving the way. But this is not merely drawing a beautiful picture on a white canvas, it's not like that. You needed to remove large rocks, you have to build a bridge over a large river and you need to dig a tunnel into mountain. So you needed to do such enormous, huge work. The poem written by Takamura Kotaro called Dotei, which I read many times recently, "There is no way before us, but there will be a way after us," as the poem said. Particularly in today's world, diagnosis and care for AD has progressed a lot. There are a lot more tests to be conducted, and also nuclear medicine is used and -- nuclear medicine is used for monitoring of the ADR. So very important pathway needs to be established in today's treatment for AD. So pathway establishment is very important today. As a pioneer, we have put ourselves into such areas of work. Particularly in the United States over the past one year, we have been working on this. So first of all, what we are doing and have been doing, I would like to seek your understanding of what we have been working on. For fiscal year 2023, in the past one year, what about venue of LEQEMBI in the global market, which was ¥4.26 billion. There may be various opinions saying this is a lot or small, but here you can see the trend of revenue on a quarterly basis. During the fourth last year, compared to the immediate last quarter, it has sharply increased by 2.7x. This trend, the angle of the increase has become sharper from the beginning of this fiscal year. I would say the sales have been increasing. So looking at these trends. Now I'd like to talk about the status of LEQEMBI in the U.S., Japan and China. First, in the United States, we are moving towards a new phase, that is to say, the pathway establishment has seen a certain level of progress. Now at last, on this pathway, the patients will be able to smoothly follow the path of a treatment, therefore, reaching the prescription expansion phase. Then appropriate go-to-market structure for prescription expansion phase needs to be established in the field. The front line should be strengthened. We, the LEQEMBI in the U.S., has entered such new phase. Similarly, the LEQEMBI revenue in the United States for fiscal year 2023 is shown here. If you compare Q3 and Q4, again, you can see the rapid expansion. On the right, you can see the number of vials sold to medical institutions on a weekly basis. As you see, again, week by week, an accelerated manner. The number of vials sold to sites has been increasing in an accelerated manner. The foundation, including the pathway has been almost established and reaching a certain level. On the left, you can see the map of the United States. Although this seems to be very busy, but you can see the areas where prescribing facilities, the established pathway are located with our field people location. Therefore, you can see the very dense map. This pink shaded area covers almost the entire nation. Therefore, in most parts of the United States, the prescriptions have been initiated. On the right-hand side, from three aspects we are showing the status of pathway establishment. First, we identified important targets. IDN, if you could turn to the bottom of the page, IDN is integrated delivery network. Large-scale hospital group had such systems to provide health care. For example, Washington University IDN in St. Louis perhaps have dozens of hospitals under it sharing the common policy or protocol to provide health care services. There are such IDNs like that. In the United States, they are playing very important roles in providing health care service in a business model. Most of the top 100 target IDNs have established pathways. And the target physicians, in the second box, they are the physicians or neurologists who belong to IDNs and also other physicians who are providing care in the community practice. In the ordinary communities, there are neurology clinics or hospitals and those physicians who have experience in AD consultations and treatments whom we understand very well and asking them whether their pathway for prescription being established or not, and 100% of them said that they have their pathway ready for treatment. Another is AIC. You may not be familiar with this term, but this stands for ambulatory infusion center. In the neighborhood of where patients live, this is the facilities dedicated for infusion. They are not dealing with patients with AD, but also patients with immunology and oncology as well. So they are one of the very important medical institutions, which are providing infusion and most of them are managed and ran by companies. 82% of AICs or infusion centers said that they are ready for infusion of LEQEMBI. Therefore, the establishment of foundation is largely completed in our opinion. Given these circumstances, what we are trying to do now is provided here. We call this system as a go-to-market structure in the United States, but front line people in the sales in Japan. In the second target box, there are NAS, ARM and HSAE. You may not be familiar with this, but if you could look at the footnotes, NAS stands for neurology account specialists. MRs, medical reps specializing in neurology. They are playing a central role in go-to-market structure. ARM stands for access and reimbursement manager, including IDN and all medical institutions in the United States are meant to make profits. Therefore, AD-related treatment or health care services need to be reinsured -- reimbursed. They needed to confirm in details whether their services are reimbursed. So what should be done is advised and they are seeking such advice from us. These are the people, ARMs, are deployed all over the nation to provide such support. And the next, HSAE, accounts for -- stands for health system account executives. They are responsible for thinking about how established the pathway can be made more efficient. It has taken 2 months for studying treatment how this can be shortened to 1 month. It has taken a lot of time for first referral how can it be shortened further. So they are the ones who are providing information and advice on these. They are rolled out throughout the country. If you could look at in the left-hand side, this NAS is going to be increased by 30%. Half of them are going to be the staff of Biogen (NASDAQ:BIIB). Where we can have key accounts with a greater potential have been already identified with bias, so we are collaborating with them. ARM who are providing advice on the reimbursement and then FTEs of ARM will be doubled -- increased. Also the HSAE personnel will be also doubled. And on the right, you can see three bullets. We have been targeting 100 IDNs so far, but we are going to expand the target IDNs to 150. Particularly under pathway from diagnosis to the start of treatment, it used take a lot of time and a larger IDN used to take 8 months, that has been shortened to 2 months. Therefore, with various IDNs, we would like to adopt a similar shortening of the duration. Given the increased number of patients, we needed to refer the nearby infusion center or a patient assistance program or support for reimbursement because the need for support is increasing as well. Therefore, we have to strengthen our patient support system. Now by this, go-to-market structure in the U.S. is going to be strengthened so that we will be able to achieve the expansion of the prescription. And next is about omnichannel marketing. This is quite a well-known -- widely known marketing method nowadays and it is being used widely. But omnichannel marketing was first used in Oncology or LENVIMA in the United States. Over the past 3 years, we have seen a great effect of this. Simply put, what we are aiming to do is as follows. On the left, you can see data lake. Proprietary data lake is going to be established, which will contain the digital promotion information for health care professional or patients and consumers and information about in-person contact in the field and information about the major academic societies. If amyloid beta test or ApoE4 tests are required or ordered, such information are all put into a data lake and AI is used for comprehensive analysis. As you see in the right bottom corner, in the end, they will come up with recommendation on the next best action. Among recommended actions, in-person field force will be given the recommendation on what the promotion for Dr. A or IDN A, what kind of actions need to be taken. Rather than having in-person contact peer-to-peer, health care providers communication should be conducted, or without time, you needed to rely on [S&S] such a recommended action package will be provided. This, I believe, will enhance the efficiency, not depending on the share of voice. More efficient marketing will become possible in our sales force activity. So we would like to accelerate this. Next. Direct-to-patient campaign is something that I would like to explain now. Now we see pathways being established. Therefore, we now believe they have to directly communicating with the patients and families. The slogan here is, You Still Can Be With LEQEMBI. Please look at the bottom. You still can be social with LEQEMBI. You still can be authentic with LEQEMBI. You still can be relatable with LEQEMBI. You still can be empowering with LEQEMBI. To raise awareness for earlier visit to physician's diagnosis. As you can see at the website, omnichannel or digital marketing and video or display or print advertisements in waiting rooms, this message will be carried. A DTP campaign was rolled out and started from February and disease awareness can be raised, and we can encourage the patients to seek earlier consultation with physicians. Another point I would like to ask you to understand here is the progress we are making in enhancing the value of LEQEMBI by adding new formulation dosage form and also maintenance therapy on top of initial treatment. Early AD and the clinical AD are shown. For early AD, if you look at the right-hand side chart, IV initial treatment with 10-milligram per kilogram biweekly dosing. This has been already approved. So this is the treatment regimen in Japan and the U.S. and China. In other jurisdictions or countries where review is ongoing, submission have been already made -- submission is going to be made for this IV initial treatment. And in the middle, IV maintenance treatment, 10-gram milligram per kilogram monthly. With half dose, which will be used for maintenance treatment, the submissions have been filed. So before maintenance treatment, what about initial treatment? And this will be consulted with regulatory agencies. And today, we made a press release. SC-AI, subcutaneous autoinjection, maintenance treatment submission has been initiated. The Fast Track designation has been granted for this SC-AI maintenance treatment and rolling submission is allowed. Therefore, we immediately started submission. We are aiming for maintenance treatment with 360-milligram weekly dosing. This is going to be manufactured by Terumo pen-type autoinjector. This is prototype, rather this is almost the drug product but without any label indicating the name of the therapy. So please understand that this is a model, and Terumo-made AI dosage form has benefits. Having one thing, tapered needle. Tip of the needle is tapered, therefore, this reduces pain a lot. And syringe itself is made of plastic, therefore, at home and at nursing care facilities. This is not made of glass, therefore, this does not break, not causing any injury to patients or caregivers. This is very safe. This syringe, in order to make it smoother, usually silicon oil is applied to silicon, but this does not use that at all. Therefore, it is difficult to have any aggregation of drug substance. Administration shall be done within 15 seconds. Therefore, this shows it is very usable at home and at nursing care facilities. Patients themselves or carers are able to safely administer the drug with this syringe. There are several patents obtained by Terumo in this autoinjector. Current IV, under the current formulation, the patients have to go to the infusion center. In the case of United States, some patients have to drive a car by 1.5 hours. Therefore, it will be very burdensome for patients to visit center and recommended infusion time is one hour. Therefore, pretreatment process and also posttreatment time for monitoring the condition of the patients, you needed to have nurses to monitor and take care of patients and it is also burdensome for nurses. So considering all these, SC-AI formulation may potentially reduce such burdens significantly and we believe that it is very important to continue treatment with AD-DMT. In order to realize long-term administration, we believe that this is going to be a mainstay formulation or dosage form going forward, as you see at the bottom, for both initial and maintenance treatment, we like to replace the current dosage form with SC-AI. We are preparing such programs. We aim to attain approval by FY 2026 for this. And in the left bottom, you can see preclinical AD. As you know, this is the stage before MCI development. Therefore, patients will not feel subjective symptoms, but if you conduct an amyloid beta test and the position of amyloid beta is about to start or is starting. So AHEAD 3-45 study, Phase III study is ongoing for patients with such status. The duration of treatment is long and it was expected to have difficulties to enroll patients. However, with enormous speed we have been able to enroll a lot of patients. We are targeting enrolling 1,400 patients, which we think that will be completed by the end of this fiscal year. Even one step before MCI, that initiation of treatment can be earlier than MCI. Therefore, we can expect an enormous effect of this. Now safety. I would like to share with you the current status of ARIA the United States. Please look at the first bullet because the reports of ARIA from real-world clinical practice were consistent with what was observed in the clinical trials or as described in the U.S. package insert. Most reports of ARIA in real-world clinical practice in the U.S. are nonserious asymptomatic and it occurred early in treatment. Reported symptoms, as you see here, include headache and others, as you see. Given these in the real-world clinical practice in the U.S., prescribing doctors are following the instructions concerning monitoring and performing of MRI for symptoms described in USPI and the management of such conditions. At Eisai, we are providing a website called understanding ARIA, where we provide educational materials, and this website has been already accessed by over 15,000 health care professionals. Therefore, attention has been drawn duly to ARIA and health care providers are following such instructions. Therefore, we believe that safely LEQEMBI is being administered in the real-world setting. Now turning to LEQEMBI in Japan. Establishment of the pathway has been fast in Japan, faster than we expected. Diagnosis and treatment for eligible patients are progressing faster than expected. Within four months of launch, this is what has been achieved. Bar chart includes a pale purple bars. In almost 600 facilities, diagnostic and treatment pathway establishment has been completed and treatment has been initiated in all of 47 prefectures in Japan. And optimal usage guidelines, OUG, as noted at the bottom of the page, in all case surveillance are being complied to as we are expanding the entry of LEQEMBI in the market. On the right side, cumulative sales is shown and about ¥600 million of sales was recorded. Cumulatively by April and in May, the pace is further picking up and we are seeing progress, which is faster than we expected. In Japan, we are making efforts by the entire Japan team. What are we doing? Left-hand side, the pyramid shows that we are layering facilities in Japan to four layers. OUG has stringent requirements for initiating -- facilities initiating LEQEMBI treatment. There are facilities that qualify by satisfying such requirements are at the top two layers. Facilities initiating LEQEMBI treatment at top layers are led by many top key opinion leaders. We have specialized medical reps, including Biogen's reps, approaching these top two layers of facilities. These two layers at the top of LEQEMBI as well as the bottom two layers of the pyramid who are PCPs are important. PCPs are playing a very important role of referring patients to the initiating -- facilities initiating treatment. PCPs are greater in number, and initiating treatment is for 6 months. And to follow up after the initiating treatment can be given not at the top layer treatment facilities, but in facilities qualifying at the bottom two layers, and therefore, information communication amongst these facilities is very important. Around 650 million MRs who are regional cooperation MRs are supporting the communication/coordination amongst these facilities. Referral, initial treatment and follow-up flow is established by specialized medical reps and regional cooperation medical reps and are achieving results. Another characteristic in Japan is that we have a history of Aricept and we are able to leverage that history made through Aricept. This year, we already have organized two large-sized academic symposiums on LEQEMBI. The second one, in red, Academic Symposium of the Japan Academy for Alzheimer's disease. This academy was established at the time when Aricept was launched. It was launched in 2000 and it was attended by 290 people when the first symposium was organized in St. Marianna University. Professor Kazuo Hasegawa was the leader of this academy. Professor Hasegawa is known as the father of Alzheimer's disease in Japan. For 25 years -- 24 years, efforts have continued steadily. This year, more than 500 physicians were attending in person as well as those attending virtually. The number of members has grown to about 4,800. Physicians have contributed to the activities of the academy. This is playing a very core role in AD care. We believe that a very important role was played by this Japan academy for Alzheimer's disease. Various topics are discussed, but every year patients of Alzheimer's disease, especially in younger age, also appear as speakers. These days, dementia patients are caring dementia patients. Peer-to-peer care is the most modern type of care. This is set to be a most invigorating treatment for patients. We have a program that aims for inclusive society by inviting AD patients as speakers and that has been the feature of the academic symposium from the very beginning. In each medical version, we also have smaller-sized gatherings organized. In Japan, this has served as a major backbone. As noted at the bottom of the page, we have solid, strong relationship of trust with dementia specialists. We take pride in having established such relationship, and LEQEMBI introduction is faster than planned or expected. The important background factor is this history made through Aricept. In Japan, as well, we are promoting efficient omnichannel marketing, which will be contributing in a similar manner in Japan. Now as for LEQEMBI in China, we are planning for launch in July. Pathway that differs from Japan and the U.S. is aimed to be established. The characteristics include industry collaboration and digital technology. With the next page, I would like to describe. The headline says, pathway establishment through online-merge-offline strategy. Next line, screening stage, diagnosis stage and treatment stage. The screening stage has a major role, which is that commercial insurance, private health checkup and private nursing home will be playing that role in commercial insurance. Quite soon, benefit card insurance will be launched. AD prescreening opportunities can be provided under the insurance. There will be also a recommendation to seek physician consultation for people at high risk and it also has an element of reducing economic burden of patients. This will be on sale quite soon. The private health checkup includes cognitive functions and ApoE4 test and MRI. At nursing home, there is also early screening. As a result of these screenings, patients at risk can seek diagnosis through two different channels. First is referral to hospitals. There is another channel shown below. We have Yin Fa Tong, which we started with JD (NASDAQ:JD) group. This is dementia online platform. On this platform already, more than 400,000 people have become members and there are 6,080 specialists registered. This is a very active platform. On this platform, referrals can be made. Memory map is one example of an app. In the neighborhood of the person using the app, hospitals, specialist doctors can be identified and recommended and A beta test sites can also be identified in physician centers as well. Arrow pointing upwards indicates that there will be a switch from online to off-line. Diagnosis in China in such that PET and CSF are not so widely available. From the beginning, we are doing a diagnosis model, mainly using BBBM. We are establishing diagnostic network with ICLDT and IVD companies. In Yin Fa Tong, in the middle, there is patient care package as shown in this diagram. Online consultation and service to company patients can also be provided. Once there is a definitive diagnosis, it will be shifting to right side treatment. Infusion itself will be, of course, off-line with diverse options for LEQEMBI administration. There's potential sites for LEQEMBI administration can be accessed or ARIA monitoring this is also done off-line, but guidance can be given by Yin Fa Tong. Using a long-term management app memory care center from Yin Fa Tong, what infusion center, what we are monitoring is provided. Such information can be accessed and ARIA monitoring reminder can also be sent as a service on this app. By merging online and off-line, we are going to provide a platform from the very beginning in China. As a result of these efforts, we estimate ¥56.5 billion to be revenue from LEQEMBI, about ¥43.5 billion from the U.S., ¥10 billion from Japan and ¥3 billion from the rest of the world, mainly China. Now this is the core message of my presentation today. Thus far, we have established the value of LEQEMBI. I would like to take time to describe the value of LEQEMBI. As noted in the first bullet, LEQEMBI possesses potentially one of the most extensive treatment data set on EAD, early AD. Represented by Clarity AD, we have wealth of information from clinical trial data and open-label extensions are run in these clinical trials. Day by day, the data is expanding. After accelerated approval, for about 18 months, real-world data has been accumulated and we have a very large volume of data, extensive data. As for EAD indication for LEQEMBI, well, LEQEMBI is not looking at a subset of patients, for example, stratified by tau. But to broader group of EAD patients, safety and efficacy have been demonstrated. This is a distinct characteristic setting that can be apart from other AD-DMT. And as for the number of patients with MCI, we are unparalleled. In low tau group in MCI, when we look at the improvement of cognitive function -- or including the improvement of cognitive function, we have outstanding data. This suggests a greater benefit for early start of the treatment. This brings about hope for patients. We also have a growing volume of data for long-term administration. We have seen sustained the treatment up to 3 months -- 30 months and enhancement of treatment effect. EAD is a progressive neurodegenerative disease and a continuous treatment is important, this goes without saying. That importance, once again, is demonstrated from this long-term treatment data. Early start of the treatment and continuous treatment will provide the best outcome for EAD patients, as shown by LEQEMBI data. Thus far, we have established the value of LEQEMBI. In this way, we believe this is the greatest value of LEQEMBI. The second value is that dosage and administration -- value from dosage and administration. We are continuously improving the dosage and administration. For example, IV maintenance is under submission. The dose is less frequent, by half. SC-AI, as I mentioned earlier, will provide reduction of burden on caregivers and patients substantially and it will make it more convenient to continue treatment with LEQEMBI. We are continuously expanding value through developing various dosage and administration routes. The third bullet, as I mentioned a little bit earlier, is that we have started 25 years ago and the treatment initiation was at the stage of mild AD. At that time, there was no concept of MCI. 25 years later, MCI is not opposed as a condition to be treated by anyone. MCI is now the stage where treatment is initiated, as shown in the approval. With that, treatment effect is expanded. Preclinical AD will be an earlier stage where treatment may be started earlier, and if that becomes possible, AD treatment landscape can dramatically change and in some cases cure may be within our vision. In the real world, the last bullet point, the status of ARIA seems to be within the range described in the package insert. Appropriate monitoring is ensuring safety. That is also an important point in terms of value of LEQEMBI. This one page shows the status of LENVIMA. Already, as you may be aware of, currently, regarding high-purity LENVIMA patent, and this is a substance patent or material patent, we have a very strong patent. We are challenged by ANDA generic manufacturers, and we have pending lawsuit in the United States. The key company in that litigation, one of which is Sun Pharma, we have entered into settlement agreement with Sun Pharma. Under LENVIMA brand, there is a possibility to continue to contribute to patients in the medium to long term. We consider this to be an important step forward. LOE. How long will LOE be extended? The details I'm not able to comment since there is still an ongoing litigation with other companies, but I would like to report that there has been an important step forward. As shown in the second bullet point, we would like to further expand indications. We have three LEAP studies that may lead to expanded indication: upper gastrointestinal cancer, HCC and esophageal carcinoma. For two of these, LPI is already achieved. We are adding values to LENVIMA and capabilities to add value to LENVIMA from these results will be great. The last bullet point is about RCC. Currently in multiple indications of LENVIMA, RCC is the fastest-growing indication. First choice drug, LENVIMA as a first choice drug for RCC is what we would like to establish and strengthen. To strengthen that position, LITESPARK studies, two studies are underway. Merck's HIF-2 alpha inhibitors will be given in combination with LENVIMA in these studies. In these two studies, we have achieved LPI plus patients. As a result, if these are successful, then we believe that it will have a very positive impact on the performance as it only may be extended. Going forward, we would like to continue to contribute to patients in the mid- to long term as well as continue to generate ¥300 billion level of revenue. Going back to 3Ls, in fiscal 2024 revenue forecast is 18%, over ¥400 billion with 3Ls in terms of revenue. Today, at the Board, acquisition of own shares was resolved. This will be up to 6.5 million shares and it will be 2.3% as a percentage of total number of issued shares. Total amount of acquisition cost is up to ¥30 billion. It will be from May 16, 2024, to November 15, 2024. The background of this is that, so far, we have focused on cash return and dividend in terms of shareholder returns. But we will be entering the phase of expanding revenues, growing revenues and we have to also be mindful of equity capital ratio as we continue to provide returns to shareholders. From the point of capital -- equity capital management, we believe that acquisition of owned shares is the safest effort to realize shareholder return. Therefore, we are implementing this measure as one dimension higher level method of providing return to shareholders. KPI improvement will be what we will continue to work on. Our determination to increase shareholder value remains unchanged. And the final page is the consolidated financial forecast.
A - Unidentified Company Representative: We will now open the floor for questions. We will have about 20 minutes of Q&A for analysts before opening the floor to members of the media. If you have a question, please give us your name and affiliation before your question. From analysts, investors, if you have a question, please raise your hand.
Seiji Wakao: Thank you for your presentation. My name is Wakao. I am from JPMorgan. My first question is for this fiscal year 2024, revenue plan for LEQEMBI. Assumptions for the forecast as well as the reasons why you believe such target can be achieved by region. For the United States, $300 million, I think. The number of vials growing in a linear way achievable to reach this target number or do you have more rapid expansion, such exponential growth, inclusive of the number of potential eligible patients, the patients receiving treatment, please? And in Japan, it seems that you are performing well. According to the available materials, last year or this year, Eisai has shown the potential assumed the growth of the quarterly number of patients.
Haruo Naito: By region, Mr. Haruna and Mr. [Yusa] are going to explain.
Katsuya Haruna: Thank you very much. I am in charge with commercial aspect of LEQEMBI in the United States. My name is Haruna. I would like to give you the status of the LEQEMBI in the United States. First, as for forecast, current trend as well as what we explained today, the effect of the rolling out of our strategy being considered and the forecast is going to be with high probability. For the month of May, we believe that the performance is exceeding, therefore, we are very confident in achieving the plan. If I may supplement, for FY 2023, we focused on the establishment of pathways. Now we are transitioning to prescription expansion phase. As was explained in today's presentation, let me share with you some example on what we explained. At the site in Midwest in the United States, over 200 patients have received treatment and about -- a little less than 200 patients are also currently under screening. Therefore, growth is continuing. In even more accelerated manner, so-called loyalist bias, the sites with 51 more patients are expanding in number. There are also increasing number of potential loyalist candidate sites. And last week, we could have an opportunity to talk with a patient who is undergoing the LEQEMBI treatment. Before initiation of the treatment, the person said he was very frustrated because of the worry or fear of losing memory and also lowering of the ADL or activity level lowering that was felt strongly by the patient himself. But after initiation of LEQEMBI, his ADL could be improved. Also, he could start to see or fee zest for living, and he was pleased to have such changes. As regards to the infusion, to visit the hospital has become a routine of his daily living and this person has continued treatment with LEQEMBI over -- more than -- longer than one year. With this, we believe that we are very confident that this target can be achievable with high probability.
Haruo Naito: Now [Mr. Yusa], who is responsible for LEQEMBI in Japan.
Unidentified Analyst: Thank you very much, Mr. Wakao. As you said, in Japan, as has been already published in the press, that size of the market and also if we can achieve the number of patients by quarter, we believe that -- and we are confident in achieving ¥10 billion in Japan, particularly for this fiscal year 2024. So far, we have established a very strong relationship with KOLs that's why we have been able to successfully start the initial stage. But for this fiscal year 2024, first, for patients with MCI, we needed to raise awareness about the disease. The number of patients receiving prescription exceeds 70% in Japan. There are some sites, which have already treated AD patients moreover. We have touched about the potential number of patients in Japan. By adding the education to raise awareness of the disease, I think that the mild AD and MCI patients will start to seek treatment. With increased number of patients at each site where pathway will be established, capacity will be increased by such efforts. For this fiscal year 2024, there will be patients who will be receiving treatment for over 6 months then at the sites where they started the initial treatment and also follow-up facilities or sites where LEQEMBI will be dosed to patients, that means that even with the existing patient pool, capacity for treatment will be expanded. Therefore, with these in mind, we are very much confident in achieving the target in Japan in revenue.
Seiji Wakao: I'd like to ask for further follow-up on the U.S. and Japan as well. Regarding the trend of the number of patients receiving LEQEMBI in the U.S., as of quarter 3 there are potentially 8,000 patients. What about the update? And 10,000 was also mentioned earlier, what is the current status?
Haruo Naito: Wakao-san, regarding the number of patients, we would like to refrain from talking about the number of patients because it is quite difficult to actually grasp the number of patients. If the reimbursement claims data is available, that may be possible. But from calculating backwards from the number of vials shipped, we cannot reach accurate number of patients on treatment, for example. The number of vials shipped or sales data, these are real figures. Therefore, we would like to utilize such real data, real numbers to discuss if you could understand this. I don't know whether you agree with me, but that's our position.
Seiji Wakao: Understood. All right. Need in the United States are increasing. If you could give us your gut feeling, I would like to seek your comment on that. Then for Japan, patients who are receiving treatment over -- for over 6 months, are there enough sites for receiving such patients.
Haruo Naito: Okay. The gut feeling regarding the United States, Mr. Haruna is going to respond.
Katsuya Haruna: Thank you for your question. I am in charge of LEQEMBI in the United States. My name is Haruna. Regarding the needs and also expectation for LEQEMBI going forward, we believe that it is rising. As has been introduced by our CEO, we are seeing an increase in revenue week by week. That has been obvious and shown in data. On a weekly basis, there is ongoing upward trend. Therefore, as gut feeling, we believe we are feeling very powerful growth. Thank you for your question.
Haruo Naito: Thank you for your question. In Japan, follow-up sites for accepting or receiving patients who are receiving treatment for longer than 6 months.
Unidentified Analyst: Yes, of course. In each region or area, we have started a discussion in order to prepare follow-up facilities and we are going to make adjustments as necessary in some regions. As you see in this diagram, regarding the area where we are going to establish follow-up facilities, we will hold the regional lecture meetings and initiating the sites as well as the follow-up facilities, how to refer the patients to follow-up facilities, and that explanation briefing session is being held throughout Japan. Therefore, I think that we will be ready to prepare follow-up facilities responding to those who are on treatment for over 6 months.
Seiji Wakao: Thank you very much. I don't think that you have explained this, but regarding the changes of the representative corporate officer, there will be two representative corporate officers. That has been released today. What is the background for this at this timing. Although it was mentioned in the press release, but why now? As the candidate to be the CEO after the current CEO, is this the plan for the company to consider the most powerful candidate as the next CEO, Keisuke Naito.
Haruo Naito: Considering the business model and the networking and hiring of talents, these are very fundamental aspects of the company's business. We needed to change dramatically the conventional way of doing business. This is not something applicable only to Eisai, but applicable to -- commonly to all the companies in all industries. We -- also that there is a necessity to do so. Therefore, for the succession of CEO means the generational change. So tens of age should be the magnitude of change in succession. So in consultation with the Board of Directors, we are making thorough preparation for the change. As a part of which is, as announced today, to appoint a new representative corporate officer. Did you ask when CEO is going to be changed? Are you asking about that as well? I'm not able to respond to that question. We are now entering in the very invention expansion phase for LEQEMBI and also the patent extension period for LENVIMA as well. Therefore, at such a crucial, we'd like to refrain from making any comment on when the CEO is going to be changed.
Unidentified Company Representative: Next question from the attendee seated at the front of the room.
Kazuaki Hashiguchi: I'm Hashiguchi from Daiwa Securities. I have two questions on LEQEMBI. First, about the impact from the competitive product, what is your expectation? And how is that taken into account in the plan? The competitor's product may be approved in Japan as well as in the United States even within this month. What is the estimated impact in terms of volume and value?
Haruo Naito: My response -- the responses may be long, but Keisuke Naito will respond first.
Keisuke Naito: This is Keisuke Naito responsible for global LEQEMBI. I will be speaking at some length. There is no direct comparison between LEQEMBI and donanemab, and clinical protocols are different and I believe it is difficult to make a head-to-head comparison. But in order to evaluate the available data, there are certain characteristics of LEQEMBI that we consider to be important. First, regarding in the broad group of EAD patient as consistently safety and efficacy have been demonstrated. Rather than selecting most responsive patient group that is the most likely to respond, we consider it important to consistently show safety and efficacy in large group of EAD subjects. There has been no tau stratification, and irrespective of tau level, clinically significant results are shown. LEQEMBI not only in subset based on tau level, but in broad subject group of -- broad patient group of EAD, safety and efficacy have been demonstrated. And the second clinical benefit is suggested for people who are receiving early treatment. At least at last the fall in [indiscernible] subgroup, based on that data, according to our definition in low-tau patient, 60% of such patients, CDR-SB improvement included a very favorable clinical outcome was published at CTAD. Alzheimer's disease is progressive and irreversible neurodegenerative disease. And earlier the diagnosis and earlier the start of the treatment, the greater potentially the benefit. Therefore, in early stage in low-tau patient, favorable data was shown and that is the uniqueness of LEQEMBI. In addition, in low-tau patients, in order to identify low-tau patients, we are also focused on biomarker research. A liquid biomarker, we believe, will be enhancing the value of LEQEMBI. And the third is a favorable safety profile. There's no data comparing head-to-head LEQEMBI and other drug, but ARIA incidents and timing we consider to be different from drug to drug and that is also noted in the U.S. package insert. ARIA mostly caused LEQEMBI occur in early stage of the treatment and mostly asymptomatic and nonserious and that is shown in actual clinical usage. In AD/PD 2024 held in spring this year, Professor Lannfelt presented the results using human sample that showed lower binding of lecanemab to CAA than other anti-Abeta antibody. We believe that this scientifically supports the clinical study results. And the fourth is the efficacy, safety-related point. AD is progressive, chronic and neurodegenerative. Even after the removal of plaque, the disease continues to progress. We believe that this is very important in considering the treatment period. In case of LEQEMBI, until the complete on Clarity AD study, treatment-emergent ADA incidence was 10%. There is no effect of immunogenicity on efficacy, safety and pharmacokinetics. It is suggested that ADA is not a limiting factor for continued treatment. And regarding the efficacy and safety in case of continuous treatment over 18 months with LEQEMBI, Clarity AD open-label extension study, 24-month data was presented at CTAD last autumn. We expect to be able to present even longer-term results in future academic congresses. In order to reduce burden for the patients and caregivers, we are also developing SC-AI, which will be less burdensome on patients. We believe that because of these, we can be confident that LEQEMBI is the drug of choice for patients and HCPs. And we anticipated the launch of donanemab and have taken that into consideration to a certain degree in the revenue level of LEQEMBI going forward. But the four characteristics that I've discussed about LEQEMBI can be a very important advantage for LEQEMBI. As CEO discussed earlier in establishing pathway, we have made tremendous efforts on a daily basis with HCPs. Infusion centers, CMS payers, efficacy groups and various other stakeholders, with them, we have been able to build very strong relationship. Through commercial activities every day after the launch, we have continued to make efforts and we are confident of the evaluation of LEQEMBI in actual clinical use. Therefore -- and of course, we do anticipate that a gradual pace donanemab may increase here, but we are also confident that LEQEMBI will be able to maintain its strong share in the immediate quarters.
Kazuaki Hashiguchi: Second question between initial and maintenance treatment, what is the distinction between the two in your submission? After how many doses will it be a maintenance dose? Or what is the degree of reduction of amyloid plaque that is required to switch to maintenance dose?
Haruo Naito: That question will be addressed by Dr. Lynn Kramer.
Lynn Kramer: Yes. Thank you. I'm Dr. Lynn Kramer. I'm the Clinical -- Chief clinical Officer at Eisai. We are discussing with health authorities the duration that would be needed with initial therapy before converting to maintenance therapy. We expect that to be in the 18 to 24-month time frame, but that's a review issue related to discussions with health authorities, which would include PMDA, for example, and FDA. Thank you.
Unidentified Company Representative: The person in the third row, please.
Fumiyoshi Sakai: My name is Sakai from UBS Securities. I'm sorry, I still wanted to ask a question about LEQEMBI. You have shown numbers for LEQEMBI, spending ¥110 billion for this fiscal year considering the SG&A expenses and R&D as a total and then this accounts for 20% of the total SG&A and R&D expenses. So are you -- do you want to continue this level of spending? pathway has been established and SC will be introduced. The remainder of work is how the drug is going to be used. Expansion of indications and monitoring on the safety will remain. Then the investment or expenditure is expected to reduce or do you need to maintain a certain level of investment? You touched upon competitors. Competitors are making a lot of money with different drugs. So maybe they can double, but they can invest, double the amount of Eisai's investment in the initial year after launch. So not maybe -- you don't have to talk about if. But if we are -- you are making excessive investment into LEQEMBI, some analysts and investors may be concerned. So that's why I think is hovering down dragging your share price down. How do you think?
Haruo Naito: Mr. Sakai, you always ask us very difficult question to answer. So I am wondering what to offer in my answer. For example, in fiscal year 2025, product P&L of LEQEMBI in the United States will be turned into the black ink. The global product P&L, LEQEMBI product PL will be achieved in 2026. Of course, we have to be careful in investing resources. For example, manpower resources in the United States has reached almost maximum level. In my opinion, therefore, we do not intend to further increase more than to date. And in Japan as well, we do not intend to increase further than the current level. In other major areas, which is Europe, in Europe, as well, by reallocating the manpower from Oncology to Neurology, we do not intend to increase the total manpower. Therefore, we do not think that there will be further expansion of SG&A expenses. I believe that we are at the peak in expenditures for SG&A for this fiscal year. In R&D expenses, preclinical A3-45, now once we see the completion of last patient in, in these studies, then the R&D expenditures will end the peak. Therefore, I think that this fiscal year is going to be the peak for both SG&A and R&D expenditures. And in '25, we would like to turn into the blank ink in the United States. In the following year, we would like to turn into term profitable in global markets.
Fumiyoshi Sakai: Understood. You have not taken into account the sales in Europe, but SAG, Science Advisory Board, Neurology, once review is done and then approval is expected. However, regarding the reimbursement, which may be delayed. Therefore, you do not incorporate the number in the revenue for this fiscal year, right?
Haruo Naito: I think this has been already published, so I can say this. SAG was held once. However, because of the review of other drugs, European Court of Justice, because of the background of reviewers, some of them had the experience of getting involved in the review of competitors' products, thus it was ruled not acceptable. Therefore, the members of the SAG was reviewed again and then it was founded to be problematic. Therefore, a result of the previous SAG meeting was canceled. With new members again, SAG will be held again. We have not heard of the date yet. But inclusive of that, for EMA in the first half of this fiscal year 2024 -- towards the end of the first half of this fiscal year, the results will be provided. The result of the review will come around at the end of the first half. In Israel, for example, the sales is being generated, although it is minor. The drugs are purchased in the United States and that is included in the number for Europe. But massive recording of the sales is not included in this number.
Unidentified Company Representative: Next question, please.
Akinori Ueda: I'm Ueda from Goldman Sachs. First question is about your plan and your assumption for cost of goods sold. This year -- this fiscal year, you assume that the cost of goods sold will increase. Are there onetime factors leading to that? Or for this year, I think that there will be increase in LEQEMBI, is there an impact from changing product mix?
Haruo Naito: That answer the question will be addressed by Mr. Tamura.
Kazuhiko Tamura: I am Tamura responsible for production. Thank you for your question. As you rightly mentioned, in this fiscal year, LEQEMBI sales and cost of goods sold are estimated here. In comparison to the actual -- from last fiscal year, cost of goods sold is higher this fiscal year and that is because of a slight deterioration in the mix. Thank you for your question.
Akinori Ueda: As a follow-up. In the future, as volume increases, do you expect improvement, substantial improvement?
Kazuhiko Tamura: Once again, Tamura speaking. Going forward, regarding the cost of LEQEMBI, large part of the cost is accounted for by drug substance and partner, Biogen, that we have been working on reduction of costs through various different measures. I would like to cite some examples. Right now, drug substance is a manufacturer, the Swiss plant of Biogen. This plant is highly automated. By continuing to produce drug substance at some scale, we expect cost reduction. Yield improvements may be also achieved through process improvement and we are making efforts towards that end. The trend we anticipate is a declining cost over medium to long term. As for formulation, the second CMO is already launched as a second place of production and we expect the initiation of production. That will also will be -- that will also be reducing cost over the medium to long term. With these efforts, we are reducing our cost of goods sold.
Unidentified Company Representative: In the interest of time, we would like to now turn to media for their questions. If you have any questions in the media, please raise your hand. We do not see any raised being -- hand raised in this venue. So we are receiving questions from those participating online. Mr. Muraoka of Morgan Stanley.
Shinichiro Muraoka: My name is Muraoka, I am from Morgan Stanley. Regarding expenses for LEQEMBI, you said that this fiscal year is the peak in expenditure. How much is included in the guidance for this fiscal year? Actual result was ¥110 billion and ¥60 billion before that and ¥150 billion in total of two companies. So how much is included in the budget. Could you please give us a ballpark?
Haruo Naito: Mr. Asano is going to respond to the question.
Toshitaka Asano: My name is Asano. I am in charge of planning. Regarding the complete numbers, we would like to refrain from disclosure. But SG&A expenditure will be over the level recorded in last fiscal year.
Shinichiro Muraoka: So as SG&A expenses will be up, but R&D expenditure will be down, is this correct?
Toshitaka Asano: We'd like to refrain from specifying numbers, but SG&A expenditures are expected to be more than the record in last fiscal year.
Shinichiro Muraoka: Understood. I'd like to ask you another question, if I may, please. Regarding the subcutaneous rolling BLA submissions have been initiated. But if you continue and then approval of the subcutaneous formulation in the United States, when can we expect to get that before summer next year or even earlier than that? What is the image?
Haruo Naito: Dr. Lynn Kramer is going to respond.
Lynn Kramer: Yes. Thank you for the question. I'm Lynn Kramer, Chief Medical Officer. As you recognized, the subcutaneous autoinjector maintenance therapy rolling submission was initiated a day ago. And in that submission, we have requested a priority review. We won't know whether our priority review is granted until we hear from the FDA that the dossier is formally accepted, which takes about 60 days. And at that time, we would know whether we have a priority review or not. If we are granted priority review, that would mean we would expect approval 6 months after -- approximately 6 months after that. So that's all I can say at this time.
Haruo Naito: Rolling submission was initiated, so various modules will be made in a rolling manner. And the final submission will come in October. So then the time schedule, as has been explained now, is expected for the completion of the review.
Shinichiro Muraoka: Well, it was hard to hear. So by October, rolling submission will be completed. And within 2 months, the rolling priority review will be confirmed, and then 6 months, will kick off from that.
Haruo Naito: Please check with the secretariat later.
Unidentified Company Representative: Are there any questions from the members of the media?
Unidentified Analyst: I'm [Bano] from Nikkei newspaper. I have a question on China. This fiscal year, do you expect ¥3 billion revenue under other. PET, CSF are not widely available in China, but you still expect this level of revenue? How will BBBM be used? And who will be the patients that will be able to receive treatment?
Haruo Naito: Mr. Okada will respond.
Yasushi Okada: I'm Okada responsible for China business. Thank you for your question. As for the figure, ¥3 billion, this is a number in the pie chart presented by Mr. Naito, CEO. Mostly ¥3 billion is from China, but that also includes Europe. So China, per se, is smaller than ¥3 billion. And as presented today using the slides, centering on BBBM, screening will be carried out in China. That is the plan that we are pursuing. There are three approaches to screening. Patients who actually come to hospitals in comparison to those healthy, high-end patients are target for screening. Then as a result of the screening, there will be a pathway to seek consultation and care, the medical institutions. PET and CSF are not so widely available, and therefore, we are preparing for BBBM. As for scientific validity of BBBM as a screening method with Chinese KOLs, including retrospective data, we are preparing a paper publication. It is not that what we are doing in China is exceptional. Based on scientific data, we are making efforts to establish BBBM as a scientifically valid screening method.
Unidentified Analyst: Who will be the target.
Yasushi Okada: Those who will be identified through the screening and it will not be covered under an IDL immediately after the launch. So it will be out of the pocket. Therefore, a drug price will be high at around ¥3 million. So in China, I believe our initial target will be high-end people. People who are living in the cities on the coastal regions, such high-end people will be the initial targets. That is already sufficient, and we have begun activities and potentially we expect a very large number of potential target patients.
Unidentified Analyst: One more point, if I may, and this is a clarification question. Subcutaneous switch. By 2026, I thought Mr. Naito, CEO, mentioned that you expect switching to be completed by fiscal 2026. Do you mean that approval is expected by 2026?
Yasushi Okada: Launch and approval are being pursued with the target timing of fiscal '26.
Unidentified Company Representative: From [Kakoho], Watanabe-san could you please unmute yourself?
Unidentified Analyst: My name is Watanabe, I am from [indiscernible]. Can you hear me?
Unidentified Company Representative: Yes.
Unidentified Analyst: As a follow-up on the question of the previous person regarding manufacturing system, the plant in Switzerland and the second side of production, CMO has been contracted. I'm sorry, I may have misheard. I'd like to clarify. So that means that the CMO, drug substance will be produced as well or filling into vials will be conducted by the second site at CMO. Is this correct? This is my first question. And the name of the specific CMO may not be disclosed, but Japanese company or is it foreign capital affiliated or in each -- which region the production will be conducted. Could you please share with us such information.
Haruo Naito: Mr. Tamura is going to respond.
Kazuhiko Tamura: Thank you very much for your question. My name is Tamura, I am in charge of manufacturing. For drug substance, the U.S. plant of Biogen is being developed as the second site for drug substance. For drug product, CMO in Europe is going to be utilized and it is being ramped up.
Unidentified Company Representative: Unfortunately we have run out of time. We would like to conclude the financial results presentation session. If you have further questions, please contact IR or PR of Eisai. With that, we would like to end today's presentation session. We thank your attendance.
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