Eisai Co., Ltd. ($4523)

It is now time. We would like to now begin the briefing session on the financial results and business update of Eisai Co., Ltd. Today, we will be conducting the briefing session in hybrid format, including in-person attendance and online live streaming. For those of you who are attending in person, we have distributed consolidated financial report, reference data and financial results presentation. If you are attending online, please refer to these materials on our website. Let me now introduce the speakers today, Mr. Haruo Naito, Representative Corporate Officer and CEO; and Mr. Takuya Oyama, Vice President, CFO and Chief IR Officer. First, Mr. Oyama, CFO, will present the financial results. After which, Mr. Naito, CEO, will report on the overall business. Mr. Oyama, CFO, please.

Thank you very much for taking time out of your busy schedule to participate in this earnings call. Let me first share with you the financial highlights for fiscal year 2025. Next page. Revenue for fiscal year 2025 reached JPY 825.4 billion, up 4.6% year-on-year. Pharmaceutical business, which is our organic business delivered strong growth, driving consolidated revenue to a record high. Operating profit was JPY 44.1 billion, down 18.8% year-on-year. Although there was a significant increase in the contribution of the pharmaceutical business to operating profit [indiscernible] declined due to factors such as decisions to forego product out-licensing or divestiture and the recognition of expenses related to structural reforms in Europe. For fiscal year 2026, we are projecting increased revenue and profit with revenue of JPY 883.5 billion and operating profit of JPY 70 billion. Regarding investments for growth, we have made 2 product in-licensing investments to support further growth. Furthermore, we plan to diversify our funding sources for future investments, including issuance of corporate bonds. Next page, please. This page provides details about our consolidated statement of income for fiscal year 2025. Revenue from the pharmaceutical business contributed significantly to the record high consolidated revenue of JPY 825.4 billion. Cost of sales was JPY 191.2 billion, and the cost of sales revenue ratio was 23.2%, up 1.8 points from the previous year. This increase was due to the changes in the product mix and the absence of out-licensing and divestitures that did not involve the cost of sales in the previous year, but it was largely controlled within the planned range. As a result, gross profit JPY 634.2 billion, a 2.2% increase year-on-year. R&D expenses decreased by 7.6% from a year earlier to JPY 158.7 billion as the cost for clinical trials for [ Lakemba ] passed their peak. SG&A expenses totaled JPY 435.3 billion, up 6.7% year-on-year. This increase was due to factors such as proactive investment in [indiscernible] and the recognition of expenses related to structural reforms in Europe. As a result, operating profit was JPY 44.1 billion, down 18.8% from a year-on-year, and the profit for the year was JPY 38.6 billion, down 17% year-on-year, both showing a decline in profits. As I will explain in a later slide, we are now disclosing core operating profit. Core operating profit has expanded significantly due to the contribution of our organic business to operating profit. Next page. This page shows the revenue increase or decrease factors. As shown by the light blue bar, second from the left, our main product, 3Ls, LENVIMA, [indiscernible] and LEQEMBI grew by JPY 68.3 billion from the previous year, absorbing JPY 6. 6 Billion decrease in revenue due to factors such as [indiscernible], LOE and others, resulting in a significant expansion of revenue in our Pharmaceutical business. In other businesses, revenue decreased by JPY 25.8 billion due to the absence of the upfront payment and others related to the transfer of rights for period in China, which took place in fiscal 2024. As a result, revenue reached a record high of JPY 825.4 billion, an increase of JPY 36 billion year-on-year. Next page, please. This page shows the breakdown of operating profit transition. Due to strategic decisions to forgo product out-licensing or divestitures as well as inventory valuation losses resulting from the discontinuation of [ tasveric ] sales also which partially offset the effect of the growth of 3L products. Gross profit increased by no more than 13 R&D expenses decreased by JPY 13.6 billion due to the fact that LEQEMBI clinical study expenses have peaked and are now declining as well as the cost optimization resulting from structural reforms in the U.S. implemented in fiscal year 2024. SG&A expenses increased by JPY 27.3 billion due to a proactive investment in LEQEMBI and onetime expenses related to structural reforms, mainly in Europe. Other income resulted in a decrease of JPY 9.5 billion, mainly due to the absence temporary profit following the end of a global strategic collaboration with BMS, which was recorded in fiscal year 2024. As a result, operating profit amounted to JPY 44.1 billion. In the third quarter of fiscal year 2025, we reported operating profit of JPY 54.5 billion. At the time, we had anticipated a profit for the fourth quarter expecting that income from product out-licensing or divestiture would offset the onetime expenses related to structural reforms in Europe. However, following the third quarter -- after the third quarter earnings call, we decided to forego product out-licensing and divestitures in light of changes in the domestic and international business environment, additional restructuring costs, primarily in Europe, exceeded expectations, and we incurred an inventory valuation losses following the discontinuation of Tazverik sales. Consequently, for the fourth quarter resulted in a loss of JPY 10.3 billion. As will be explained in the later slide, core operating profit for fiscal year 2025, excluding temporary income and expense items was JPY 50.1 billion, more than doubling compared to the previous year. In the fourth quarter of fiscal year '25 alone, it improved by JPY 5 billion year-on-year. Next page shows the background and details regarding the introduction of core operating profit. In our third quarter financial results, we refer to the profit from our organic business as a measure of normal or ordinary earnings power. However, we did not clearly define how to treat temporary income and expenses nor did we disclose specific figures. We have now decided to disclose core operating profit as an indicator of our fundamental earnings. In preparing this disclosure, we have refined the practices of our industry peers and clarified a definition from the perspective of objectivity and comparability. We exclude 5d items of temporary income and the expense items, not directly linked to future earnings from operating profit. For fiscal year 2024 and '25, we have identified 3 items subject to exclusion, product [indiscernible] sensing or divestiture, disposal of tangible fixed assets and the termination benefit costs and have calculated a figure after excluding them. As a result of these adjustments, core operating profit was calculated at JPY 23.8 billion for fiscal 2024 and JPY 50.1 billion for fiscal 2025, representing more than a twofold increase in establishing a solid earnings base for fiscal year '26 onwards. Next page. In conjunction with the introduction of core operating profit, we are also reviewing our capital efficiency indicators. While the company has previously disclosed ROE targets, we are introducing adjusted R-O-I-C, ROIC, as a metric that is more closely linked to medium- to long-term corporate value. Adjusted ROIC is calculated using after-tax core operating profit. Excluding the impact of foreign currency translation adjustments, which are not directly linked to operating activities and adding net interest bearing debt. Since foreign currency translation adjustments account for approximately 30% of the company's equity, which had been undermining the comparability of ROE, we have excluded them from the calculation of adjusted ROIC. We estimated this figure to be 6.8% for fiscal 2025, and we aim for a range of 8% to 10% over the medium to long term, which we will monitor alongside ROE. Next page, please. This page represents -- presents our consolidated financial forecast for fiscal 2026. We continue to pursue organic business growth centered on the 3L products, and we plan for a revenue to reach a record high of JPY 883.5 billion. While R&D expenses will increase due to forecast allocation of resources to our next-generation pipeline, we will control overall expenses at a rate in the high teens percent. Although we anticipate an efficiency improvement from structural reforms implemented in previous fiscal years, SG&A expenses are expected to increase slightly due to higher expenses regarding shared profit associated with the enhanced profitability of LEQEMBI. Our FY '26 plan does not include onetime revenue. As a result, we are targeting operating profit and core operating profit of JPY 70 billion each. Furthermore, we target -- our target for capital efficiency is the adjusted ROIC of 8.7%. Next page. To support further business growth, we executed 2 in-licensing investments in the oncology area during FY 2025. Preparations for the submission and the market launch are proceeding smoothly for both projects. Furthermore, to diversify our funding sources for future strategic investments, we are proceeding with preparations to issue corporate bonds. We completed the shelf registration for bond issuance in March of this year and plan to issue bonds at an appropriate time and scale, timing taking into account market conditions. This concludes my part. CEO Naito, will now provide you a business update.

Regarding the overall business, we would like to report to you. As we have heard 3L several times, what does this mean? This means LEQEMBI, [indiscernible] generic name of this is lemborexant, taking from this, and LENVIMA. These are the products which are supporting our business overall globally, taking acronym from these 3 product names. We are calling this as 3L. For your information, logo names since [ Aricept ], we always started the 7 English alphabets constituting brand names since [ Arcep ]. So what kind of products are we talking about? For LEQEMBI, it is expected to be global #1 anti-amyloid treatment. Actually, this is the global #1 [ AAG ]. [indiscernible] is global #1 in [indiscernible] category, [indiscernible] stands for [indiscernible] receptor antagonist. And LENVIMA is now approved in the 5 cancer types. In these 5 types of cancer, this is the #1 tyrosine kinase inhibitor. For all these 3 products, these are all global or world leaders currently and all of these have been in-house developed, which we take as we take a pride in this fact that these have been in-house developed. Now recapping LENVIMA, this is an in-house developed oral multikinase inhibitor with 7 indications in 5 cancer types, expanding with monotherapy and combination therapies with KEYTRUDA trade et cetera. And it has been 10 years since its launch and it has contributed to approximately 620,000 patients in 81 countries and territories in the world. Please look at the left-hand side chart. JPY 342.5 billion was recorded as revenue, up 4% year-on-year from the previous year in fiscal year 2025. It has become a top brand for Eisai. The key markets are the U.S. On the right-hand side, in all regions. However, for FY 2025, it has been able to grow, particularly in the RCC advanced renal cell carcinoma has driven the growth in the United States. It was the -- including the DTC, which was launched for the first -- as the first indication in all the cancer types in the United States, LENVIMA could expand. [ Light Spark 11 ], starting on the combination therapy for of [indiscernible] LENVIMA for RCC. In this study, we have obtained a favorable results for the improvement in the PSS and ORR. And it has shown to reduce the risk of disease progression or [indiscernible] by 30%. And on or after treatment with an anti-PD-1 or PD-L1 therapy, it is expected as a treatment for patients with ARCC, whose disease has progressed after the prior treatment. In the -- for U.S. FDA, PDUFA action date is set for October 4, 2026. For Japan, we have also submitted and this year, JPY 345 billion about 1% year-on-year growth is as expected for this fiscal year. Next year, [indiscernible]. This is also to recap. The natural biological regulation of sleep and wakefulness is done by orexin. Substance called orexin was found by Dr. [ Yanagisawa ] of [ Scooba ] University in Japan. As a target, the orexin receptor once it is inhibited, it will induce sleep. Orexin receptor is once organized, then wakefulness will be naturally induced. So that is the nature of this target. [indiscernible], is the antagonist for orexin receptor. Of course, from [ Scooba ] laboratories, we developed this in-house, and this treatment has been approved in 27 countries worldwide. If you look at the graph on the left-hand side, for FY 2025, revenue was JPY 64.3 billion globally, which was up 20% year-on-year, in key markets, in Japan, our country. For this fiscal year, we expect to see continue to have -- we expect to have the continued double-digit growth. What is happening in Japan? The number -- we have been #1 in share in terms of both the sales as well as the number of patients who are receiving this treatment. And we have generic agents available in the market, however, including that for the insomnia treatment, including those generics. [Indiscernible] is #1 in share of the market. And now the disease awareness campaign is being launched with -- in collaboration with Pokemon [ sleep ]. As you can see for all generations of population, it is said that the Japanese people are not sleeping very well. Therefore, if we can invite more patients with insomnia to seek the medical consultation, we are currently collaborating with Pokemon Sleep and it has expanded steadily in Canada, China, Thailand as well. In the United States, this is not relaunching, However, we are going to initiate new initiatives. This is called [ TeleHealth ], utilizing so-called IT technologies to replace real in-person face-to-face services in order to provide medical consultation and treatment and diagnosis in more than 30 states in the United States. Utilizing this, we are constrained on conducting relaunching of the product. In Europe as well in the U.K. and EMA, we plan to submit for approval. Turning to LEQEMBI. Needless to say, it is a treatment for Alzheimer's disease. It is an anti-amyloid beta antibody for long-term treatment for early AD. The polymer of amyloid bema neurotoxic amyloid beta [ protofibrils ] as well as plaque both of which are targeted by this treatment. And these are continued to be removed by these drugs. This is the only anti-amyloid treatment for suppressing both of these. For early AD, it has been approved in 53 countries and territories in the world. The track record, please look at the bar in the middle, global revenue was JPY 88 billion, achieving almost a double growth, JPY 44.6 billion in the U.S., JPY 24.4 billion in Japan and JPY 12.4 billion in China and JPY 6.6 billion in the rest of the world. For this fiscal year, we plan to have achieve JPY 143.5 billion in revenue with 63% growth year-on-year, including the U.S. and other regions, we believe that there will be continued robust growth. Now regarding LEQEMBI. LEQEMBI is the #1 AAT anti-amyloid treatment. It is the top brand. In comparison to this second brand, more than double sales is achieved in Japan. In the United States, approximately 1.5x as much sales is achieved. It is the major AAT. Once again, I would like to reiterate this in July 2023, in the United States, it was fully launched it was a little less than 3 years ago. It has been a long time, and it has been a short time over the past 3 years, but it has only been 3 years after the full launch. In the meantime, we have pursued a mission, which is shown in this these 2 lines, early initiation and long-term continuation of treatment. These are considered essential for slowing disease progression in the current AD treatment framework. It is considered to be the only way. And we would like to improve awareness of this amongst specialists and HCPs and others. We have spent all our efforts in the past 3 years on improving such awareness. And I asked, I believe that there is a strong agreement to this. I have covered this a number of times, but -- this thinking is supported by important information, which I would like to cover once again. First, [ Clarity AD ] open-label extension or 48 months active drug is given for extended period of time for 48 months, and we have data. The top line is LEQEMBI Group. The bottom 2 lines are natural progression groups, if you will, these are data from [ DME ] in the U.S. and [ biofinder ] in Europe. As you can see here, after 48 months, slowing of decline effect is sustained and the gap between the natural progression or effect size is expanding. Steadily, the target toxic substance is being removed from the brain. As shown by this data, we are arguing for long-term continuation of treatment, and this is an important supporting information in the middle shows that earlier initiation is better. The center left graphs are from the same [ Clarity AD ] or [indiscernible] showing the results for low [indiscernible] population with smaller accumulation of [indiscernible] MCI early stage, if you will. Looking at this, [ CDRSP], no decline. Cognitive function deterioration is not seen in 69%. In the lower graph, [ CDRSB ] improvement. There are patients of 56% -- of the patients showed improvement in cognitive function. Early initiation of treatment will bring about important treatment effect as shown by these data. On the right side, prespecified biomarker endpoint is shown. [ Amyloid PET ] data, the [indiscernible] -- how much block was removed is shown. The point I would like to convey here is that there can be efficacy onset is quite early. The [ rail ] left side, the red bar, this is after 3 months. After 3 months, in 24% of the patients receiving the can they have turned a beta negative state. The toxic substance has already been removed. They have reached that stage. Placebo group is shown in gray in comparison to placebo group, this is a significant improvement. LEQEMBI has early onset of efficacy, as shown by this data. On the right side, on the far right, long-term continuation of the study. But in real world, how long are patients staying with LEQEMBI Lakemba treatment? The top is the data from the U.S. after 18 months, close to 80% of the patients are continuing with LEQEMBI treatment. At 20 months, more than 70% are continuing with LEQEMBI after 2 years. As much as 67% of the patients are staying with LEQEMBI treatment. Long-term continuation of treatment is realized in the real world as well. At the bottom, the data of Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology shows that in Japan, 84% of the patients are continuing LEQEMBI treatment at 18 months. Now the topic today, the major topic today is the initiation of fundamental transformation in AD diagnosis and treatment started by LEQEMBI. There are 2 types of technological innovations, [ BBand-based ] biomarker confirmatory usage, a beta confirmatory testing using BBM. Such technological innovation is 1 and the other is LEQEMBI [ iClick ] rather than infusion, which was a conventional method, auto-injector self-administration, that can be [indiscernible]. Technological innovation. These 2 technological innovations will be implemented in the society almost at the same time, and that is the fundamental transformation. In the past on several occasions, as I have stated on those occasions, within the AD treatment pathway, there are 2 rate limiting factors or 2 bottlenecks. One is a beta confirmatory diagnosis, how to give confirmatory diagnosis. And once treatment starts, infusion uses lot of health care resources. So these 2 were bottlenecks. How do we remove these bottlenecks? On several occasions, I have discussed this with the 2 technological innovations, these 2 key bottlenecks are removed. The pathway has been improved fundamentally in both speed and capacity, enabling more patients to receive treatment through simpler procedure with greater convenience. This, I believe, is revolutionary. A beta confirmatory diagnosis using BBM. This is now available with that, what kind of value is created? Simplicity. Conventional methods, PET and CSF and new BBM confirmatory diagnosis. These 3 are compared in terms of economic burden, invasiveness and ease of access. PET is not invasive, but it is quite expensive as a diagnostic method. Medical institutions that have PET are also limited in number, which limits access. There will be a waitlist or PET is also used in oncology diagnosis. So it will have to be allocated. CSF, lumber puncture is used to collect CSF. So this is invasive. Economically, it is moderately burdensome. This medical technology technique can be used in by health care professionals or in medical institutions that are limited in number, limiting access whereas [ BBM ] is low in terms of economic burden, and it is now covered by insurance reimbursement in the United States. And only [indiscernible] sample is strong, so invasiveness is quite low. Access is available in large sized diagnostic companies. They are adding BBM in the list of their confirmatory test. So there is a good access clinical diagnosis has become very simple and there will be a greater flow of patients seeking that can be treatment. That is how we see this. I would like to show some actual data on the left side, a [ beta 40 to 40 ][indiscernible]. How many tests of these were conducted are shown, prescreening, triage and confirmatory both are included in the number of BBM tests shown in this graph from January '24 to January '26. In just 2-year period, the number of tests increased by twofold. In half year interval from '24 -- January '24, every 6 months, it is doubling. So at a very rapid pace, BBM is increasing its penetration. In the second bullet, a beta confirmatory test. [ CMS the 3G ] for insurance reimbursement formerly included BBM in the anti-amyloid therapy registry and reimbursement has already started. And [ AAIC ] guideline also recommends confirmatory BBM testing. If you could refer to the right side, out of all [ abeta ] confirmatory diagnosis, how much is done with BBM? That is shown in orange color. According to our estimate, about 50% was already BBM in fiscal 2025. In this fiscal year, we believe that more BBMs for confirmatory diagnosis will be approved by the DA. So we believe there will be acceleration. And by fiscal 2028 or there around, we believe that more than half of all Abeta diagnosis will be done with BBM. At the right bottom, for 1 year, the number of patients receiving AAT in 1 year has increased by 1.8-fold. There are numerous factors is carried out and in effectiveness evidence is also playing a role. But without doubt, BBM, age and confirmatory diagnosis usage has provided tailwind. And we believe that full scale growth of the AAT market has started. The simplicity is the value that is acquired from BBM. And to recap, a beta confirmatory diagnosis using PBM can significantly expand accessibility and its cost effectiveness would greatly simplify AD diagnosis. Next, as for the treatment innovation or transformation, we have [indiscernible]. With [indiscernible], the value that will be brought about is convenience. Conventional administration is IV infusion and the [ fall ] is shown above. Patients will have to visit medical institutions. Currently, around 1.5 hours to 2 hours of driving is required to visit medical institutions in the United States. Oftentimes, caregivers are driving the car to take patients to the medical institution. And infusion takes about 1 hour, and this is followed by 30 minutes of follow-up. In the meantime, nurses are allocated to monitor infusion-related reaction. And to go home the same amount of time driving car is required. And this is every 2 weeks for initiation stage and every 4 weeks during the maintenance period. Now what is the convenience that will be brought about by [indiscernible]? Throughout the whole duration of treatment at home, self-administration is possible, be it by patients themselves or by caregivers safely comfortably at home or at nursing homes, et cetera, it will be possible to receive administration, self-administration. And the 360-milligram auto-injector, on auto-injector once a week is used for maintenance and approximately 15 seconds is the average injection time per injection. In initiation treatment, when this starts will require 250 milligrams of 2 auto injectors, auto indexers of 250 milligrams, but it will also be 15 seconds per injection, improving convenience by a wide margin. [ I click ] maintenance therapy. This was approved in August of 2025. And what has been the effect of that approval that is shown in the 2 graphs. The point I would like to emphasize here is that IV and [indiscernible] can complement each other. Patients who are receiving IV may be switched to [indiscernible] or [indiscernible] patients maybe switched to IV treatment with a great degree of flexibility. Flexible treatment options are offered. At left top, the orange part is [ iClick ] maintenance treatment, incremental portion because of at the convenience, this is increasing, but the IV part, the blue part is not disintegrating. It continues to grow. IV, I click. They are comparable. It is possible to switch between the 2 such flexible treatment options I believe, are welcomed. That is what is shown here. IV or [indiscernible], for both maintenance treatment, we are seeing increasing number of patients who are receiving IV or click maintenance treatment. On the right side, with the [indiscernible] increase in maintenance treatment options, the graph shows that this has led to increase in patients receiving initial treatment using LEQEMBI. After 18 months, of initial treatment, there is a greater degree of freedom regarding the treatment modalities, lowering the hurdle to see [indiscernible] treatment. Currently, with initiation treatment, IV infusion is still used. However, [indiscernible] had the effect of increasing the number of patients receiving initial treatment of LEQEMBI. This is the projected impact of LEQEMBI [indiscernible] initiation treatment in the first year of launch. This is the estimated number of new patients. Between the competitive product, regarding new patient, the share is around 50-50, according to our estimates, with LEQEMBI [indiscernible] initiation treatment after its approval. First, as shown historical #1, we can expect market expansion with [ iClick ] and Circle 2, we can expect increased share with LEQEMBI [indiscernible]. The reason for seeing this is that [ iClick ] by far, is very convenient in comparison to infusion. For initial treatment patients, even lower the hurdle of seeking the B treatment, and it will also offer us a very important competitive edge. Clearly, so this is the expected impact. Currently, LEQEMBI SCAI regulatory status is shown here. For maintenance treatment, as I stated earlier, it was approved by FDA in August 2025. Initiation treatment is [indiscernible] for priority review and we recently received notification that PDUFA date was extended by 3 months as we have informed you. The approval expectation is not of all affected by this, in our view, already, data had already been submitted. And we are not requested to submit additional data. IV and SC switching surrounding the switching between IV and SC, data has already been submitted and labeling words regarding the IVSC, which are being finalized as we understand. And what kind of interpretation is necessary in fixing that language -- those are the inquiries, the types of inquiries that we are receiving, and we are providing information accordingly. This is not about the essence of the -- what is being reviewed. Labeling language adjustment is requiring some time. That is our understanding of the situation. And therefore, we have no concern whatsoever about the approvability of LEQEMBI [indiscernible] for that can be SCAI for initiation treatment. And 3 months is the extension time, but the full duration may not be required. In the second quarter of this fiscal year, we expect approval in Japan and also in China, we anticipate approval in Q4 of this fiscal year. Convenience is the value acquired. And once again, to summarize, [ I click ] for maintenance treatment received FDA approval in August 2025 and has been successfully launched on the market. Currently, the insurance coverage through MAP is about 85% and introduced approximately 600 facilities and PDUFA date action date is extended, but we have no concerns about approvability. Whilst it is approved, all medical institutions are able to provide iClick initiation treatment, lowering the barrier to initiate to with and patients who may have hesitated to receive LEQEMBI treatment -- may seek to receive initial treatment with LEQEMBI. Enhanced convenience is expected to provide a competitive advantage. As for China and EMEA in China, commercial insurance innovative drug list was newly created, which includes LEQEMBI. Based on this, with various commercial insurers, regarding coverage for LEQEMBI, discussions are underway. And these types of insurance are called [indiscernible], under the guidance and support of the local governments commercial insurance, sell insurance and including in Beijing City, in 13 cities, the [indiscernible] on the list of insurance reimbursement. Alipay insurance platform called [ Hao Bao]. LEQEMBI is also included here. This is a commercial insurance covering high-cost medical cost and is available nationwide. As for [indiscernible] covering advanced medical treatments. This also includes LEQEMBI. Then in commercial insurance, mainly through commercial insurance, improvement in access to treatment is achieved in China. As for EMEA, in Germany, the U.K., Spain and Italy, negotiations with authorities for reimbursement is ongoing. This is the overview of the pipeline. Alzheimer's disease is positioned within the new degenerated ATN continuum by Eisai, amyloid tau neurodegeneration, these are 3 [indiscernible]. In all of these pathologies, we have promising pipeline. That is true of only Eisai in the world. LEQEMBI, I have discussed at length and I had preclinical AD ahead of [ 345 ] is underway, and we expect top line data in fiscal 2028, [indiscernible]. This is an excellent anti-antiboantibody in RIs, and we have 2 studies genetic Alzheimer's, hereditary Alzheimer's disease cohort Phase II/III study and sporadic AD Phase II study, both are underway smoothly. And we expect top line data in the years, as indicated here, as for neurodegenerative stage treatment, [ E2511 TRKA], integrated [ Synapsys Regeneron ] study will start. As for Orexin platform, in addition to lemborexant, [indiscernible], the agonist side of orexin for narcolepsy study is underway smoothly. We expect top line data this fiscal year in oncology, LENVIMA [ Light park 11 RCC ] and licensed in [ Talaratinib ] for Europe and for Japan, [indiscernible]. Another licensing product, we expect to file submission in fiscal 2026, respectively, and also expect results for Phase II study this fiscal year. I would like to summarize before I end. In fiscal 2025, driven by growth in the organic business centered on the 3L products, revenue reached a record high and core operating profit increased significantly year-on-year. On the other hand, operating profit decreased due to factors such as decisions to forego product out-licensing and divestitures. In consideration of mid- to long-term corporate value growth as well as recognition of expense related to structural reforms in Europe, et cetera. In fiscal '26, we aim to achieve record high revenue, driven by continued sales growth primarily in the 3 products or LEQEMBI with SCAI and BBM in place. We expect it is entering a true expansion phase, and we aim to enhance business profitability through continued cost control and prioritize SG&A investment in key markets. In addition, we expect improved management efficacy efficiency as a result of structural reforms implemented in prior years, mainly in the U.S. and Europe in R&D, while controlling overall expenses, we will allocate resources to priority pipeline assets including the can be in preclinical AD talent and [indiscernible] and aim to achieve operating profit of JPY 70 billion. In parallel, we will execute proactive financing and promote investments for growth, including product in-licensing mainly in oncology to accelerate pipeline enhancement through [indiscernible] engine of in-house R&D and product in-licensing. Through these initiatives, we aim to achieve revenue expansion driven by organic business and sustainability and have sustainably enhance our corporate value. Now we would like to entertain questions.

We would like to take questions from analysts and investors who are attending in person and then from analysts and investors attending virtually and then those who are attending in person from the media. [Operator Instructions].

This is Wakao from JPMorgan. What I would like to ask you is for the year under review did not achieve the plan. Therefore, could you please why you were not able to achieve the plan? ROE was targeted at 8% level. But in the third quarter results earnings, you mentioned that the level was above the consensus and OP is estimated to be JPY 70 billion. Compared to the third quarter earnings call, it seems to be lower. ROE 8% to be achieved this year or next year. But you said that this is going to be the target for medium to long term. So I think that the projection of the company for the profit growth may have been changed. Could you please explain?

For that question, Mr. Oyama is going to explain.

Thank you very much for your question. Regarding the results below plan for fiscal year 2025. I believe you're asking about that previous fiscal year. And regarding this, it depends on the original plan. Could you please show the Page 2? So if I may, let me explain using this slide. Other income and expenses for the full year forecast, JPY 35.5 billion was planned. In addition, other income and expenses, JPY 9.5 billion was included. At the beginning of the year, the plan was to consider -- take into account the onetime income to some extent. Up until the third quarter, these were not incurred. And the full year results included the other business results, but API sales or sales from subsidiaries are included. So almost 0 excluding those in this line. When we made the announcement of the results for the third quarter, actually, we were in the process of negotiating with the candidates. There were several of them. But due to the changes in the environment, as assumption, we thought that it's better rather than divesting these, but rather, we should continue to keep this. for supporting the business growth from next fiscal year onwards. So onetime income was discontinued, and that is what we decided. And these are the numbers that we have disclosed JPY 8.7 billion related to the structural reforms. -- which was also disclosed in the financial reports. And the plan at the beginning of the year was less than half of this. On the other hand, because of the changes in the situation, actually, the situation in Europe changed significantly. Compared to the original plan, the expense is related to the structural reform or rather the scale of the structural reform there was much larger. So excluding the onetime income as well as the increased more structure reform cost than expectation were the major factors. Regarding your question about ROE. As for this target of 8%, we thought that this should have included the impact of onetime income. When we explained this 8% level target for ROE for FY '25, that's what we explained. And through thorough discussion internally, so secure the onetime. There are some projects that are under the negotiation and there are some potential candidates, but we would like to prioritize what we are able to see visibility in there are some onetime or maybe no onetime rather than explaining it as such to investors, we believe that it is more important for us to go through the more visible plan and going through that process. As a result, ultimately, we had to present this number, not reaching the ROE 8%, but please understand that this commitment to ROA stays unchanged. In addition, compared to the time they actually -- the foreign currency translation gain has increased JPY 310 billion of FX gain was recorded this year. this may have hampered the improvement in ROE. The changes in the ForEx rate cannot be controlled by us. within our plan, but it may have contributed to the target of the companies, which is not reasonable. Therefore, I would like to say that we do not believe that we have changed our message to the market, but organic growth in that business will continue to be achieved in order to support the numbers.

If I may [indiscernible] with you. The gains on the sale, which were in negotiation last year, the probability of realization of those negotiations is decreasing? Or do you think there is any change to the projection of the profit growth, including the onetime impact? So we think you were talking about whether you're able to achieve the 8% ROE. But from next year onward, I believe that you are going to achieve the profit growth inclusive to that?

Regarding the plan for next year onward, there will be another conference to be held on the 25th of this month to explain management strategy, but organic business, we believe that we have secure base for growth, conventionally should -- in order for us to achieve the short-term boats, onetime sale may have been considered for the future growth but rather, we would like to seek the actions which will be surely contribute to the medium- to long-term growth. And please, I'm sorry to say this, but please wait until the explanation on that -- the 25th of May.

That means that there has been a change to the policy of the company, right?

Please wait until the conference. CEO Naito, please.

When it comes to the so-called individual pipeline assets, there are a divestiture or others or existing brand sale or divestiture, we decided to forgo these. But for our growth model, which includes partnering like -- with partnering with [ milk ] for LENVIMA and partnering for LEQEMBI with [indiscernible]. I believe that these are reasonable and good business models that should be adopted by the company for the future growth and reducing the -- having the costs and having the profits. Such model for a pharma company like midsized mid-pharma company like us is a reasonable growth model, in my opinion. We would like to continue to pursue such opportunities proactively. Any revenue or income from these activities will be including some onetime revenue. These are considered to be organic income. So there are 2 separate understandings on these incomes. I am very much looking forward to hearing the management strategy conference, which seems to be very important. Within our pipeline, existing pipeline, there are promising potential items, I would say that there are several of them within the existing pipeline. So we are duly considering these potentials.

Next question. Attendee sitting on the right side, please.

I am [ Hashiguchi ] from [indiscernible]. I can see that you have high expectations regarding [indiscernible]. What is your view regarding the pricing? To the extent that you're able to please comment on the pricing. In maintenance therapy, it is expected that there may be a switch between IV and not all patients may select IQ. And I believe there are several reasons for this. Depending on the insurance plans of the patients, [indiscernible] may lead to higher economic burdens. In some cases, I understand that, that is one of the reasons with the conventional IV in initiation and maintenance treatment, the dose is the same. So on the whole, pricing does not change. But with [ iClick ] in initiation treatment, dosage is larger between IV and SCA foreseeing units of those, if the price is the same, then the economic burden may be felt strongly -- more strongly by switching to [ iClick]. This dosage is complex. And what is your view regarding the pricing?

Mr. Haruna will respond to your question.

Thank you for your question. I'm Haruna, responsible for the U.S. I believe your question was regarding the United States. The concept is price parity. What we have in mind is a concept is price parity, which means that the out-of-pocket payment for patients should be no different between [ iClick ] and IV infusion. You've mentioned drug pricing therapy patients have to pay for infusion procedure. So it is not limited to the cost of the drug itself. We have to take into account total medical cost and keep the economic burden the same for patients. And as CEO, Mr. Naito mentioned earlier, even if there are repeated switches between IV and SC, there should not be any change in the patient's burden. That is what we are keeping in mind.

Any other question? The person in the second row from the front.

This is [ Seki ] from UBS. More promising news Biogen, how Phase II results were announced by Biogen yesterday, [indiscernible] has been demonstrated to improve the cognitive function, [indiscernible] where it's now. What is your view of this? And [ Atlanta 202 ] study compared and except for a small number of patients, what is the possibility of the dose response?

Dr. Ido is going to respond.

I am in charge of R&D. My name is Ido, I'm going to respond to your question. As has been commented by [indiscernible] results are understood positively by us as well, which was a good data. According to the release, primary endpoint, CDR-SB, the dose response was not achieved. But [indiscernible] included that these biomarkers were shown to be significantly reduced and the suppression of [indiscernible] did decline were observed across all those groups. This is going to be announced at the AIC. But including the Atlanta [ anti-tau ] drug development direction of such drug development, including Atlanta, it supported strongly. Our [ Atlantica ] of Eisai has been already explained several times considered to be very important for to aggregation, MTBR core region is the reason to be bounded by this. And so the propagation [indiscernible] will propagate. And that is the most important part of the [indiscernible] pathology hypothesis and also [ Atalanta ] over the high dose and also the safety has been secured, including the high-dose patients and the [indiscernible] to the [indiscernible] is considered to be affecting the cognitive function. But we have deepened our confidence in showing this mechanism to achieve this. And our IV infusion of [indiscernible] biomarker dynamics have been already shared. Based upon the dose response manner, we have been able to see this effect is sold at the diet or the familial Alzheimer's disease patients, severe Alzheimer's disease patients. Last year, the [indiscernible] stabilization or decrease of [indiscernible] were also observed in these patients. Therefore, we have deepened our confidence in this drug. Thank you very much.

Except for the smaller number of patients, are there any dose response effect?

So separate from the biomarker response, yes. Inclusive of the cognitive function as well, we are going to monitor together with the biomarker. He is asking a question about -- so are you asking about the [indiscernible]?

Next, analyst investors who are attending virtually, we will be taking questions. First, Muraoka from Morgan Stanley and please proceed with your question.

This is Muraoka from Morgan Stanley. I have one question about the guidance for this fiscal year. [indiscernible] was extended by 3 months. Does mean that guidance is now JPY 70 billion, slightly lower than your original expectation because of this extension of PDUFA date? That is how I see this favorably. It's not true. And after approval, successfully on August 24, if that is achieved, then do you see a ramp-up from September or from January, what do you currently anticipate?

Mr. Haruna will respond to your question.

Thank you for your question. PDUFA extension by 3 months or within 3 months, but this means that we are able to make for preparations. So we positively consider this. After the actual launch, we believe that we can immediately see the effect. [ iClick ] is already on the market widely with the maintenance therapy. And once [ I click ] initiation therapy becomes available, I believe there can be growth will be accelerated. Regarding the plan, we consider a slight modification possibility, but will be limited.

Do you think that acceleration from January will be bigger than from September?

Regarding iClick, it is already receiving insurance reimbursement. In initial therapy, after launch, through MEP medical exception, we expect the insurance coverage to continue. So irrespective of the timing, we believe that there can be [indiscernible] growth will pick up.

From Citigroup Securities, Mr. Yamaguchi. Please unmute.

This is Yamaguchi of Citi. I have one question regarding [ iClick ] maintenance treatment, accelerating the expansion of [indiscernible] on Page 19. Regarding this government, I would like to ask you a question. As a result, the SC sales -- how much is it now? And for this fiscal year, the initiation of treatment is delayed a little bit as a result sales are going to be increased by that. So could you please disclose the mix between the B and C sales?

For your question, Mr. Haruna is going to respond.

Thank you for your question. If I may, could you please show the next slide? Yes. Thank you very much. Regarding the maintenance treatment for the LEQEMBI [indiscernible] maintenance treatment, exceeding the original plan, it has been strongly performing. And week by week, it is picking up. Therefore, securely the penetration or growth of the sales of [indiscernible] has been growing steadily. And once the initiation treatment is approved and launched, as CEO Naito mentioned earlier, the [indiscernible] will contribute to the expansion of market and also share of the market as well. These are the 2 points. And regarding the mix gradually, ICC ratio will exceed IV. That is what we envision. That is my response. Thank you.

Next, from [ Sanford C. ] Bernstein, Ms. Sogi, please unmute and please start.

Thank you very much. About Alzheimer's market in the future, regarding the expansion of the market, BBM confirmatory usage is important according to the presentation earlier. When we discussed with U.S. neurologists, BBM positioning is screening and often times, they say that it will be difficult to use [ PBM ] for confirmatory testing. 100% -- it's 100% reproducibility in terms of results. There may be overtreatment or under treatment for 5% to 10%. Will there be new data to reduce the gap between PET and [ B ] to lead to greater usage of BBM for confirmatory testing.

Mr. Haruna will respond.

On blood-based biomarker, BBM confirmatory testing, right now around 15% of the patients are using ABM for confirmatory testing. In comparison to last fiscal year, this is an increase of about 5%. And in a beta confirmatory testing, the proportion of PBM is increasing. That is the reality that I would like to emphasize. Going forward, why do we expect BBM proportion to increase? First of all, CMS has officially added BBM in the registry for [ PBM ] as a confirmatory testing is added in the registry. Social implementation will advance and CMS has acknowledged or accepted the BBM confirmatory testing. There is a slight difference between PET and BBM in any of the tests about CMS or AAIC guideline as well BBM as a confirmatory testing is endorsed. In terms of market penetration, there will be newer BBM tests that are expected to be launched for confirmatory testing this year or to be approved this year. So we believe that a confirmatory testing with BBM will surely increase and it will continue to increase.

Next from Macquarie Capital Securities, Tony Ren.

Tony Ren from Macquarie. I would like to also say on the previous page on based of our markets. Slide #16. Yes, this is a very informative slide of Slide #16. When I look at this slide, what struck me on the left-hand side was the very fast uptake of [indiscernible] and basically not [ pTau-181 ] not growing much. Could you explain to us why the [indiscernible] experienced so much rapid growth and also who are -- which companies are the vendors of this test?

For your question, Mr. Haruna is going to respond.

Thank you very much for your question. On the left-hand side, BBM tests and [indiscernible] is growing so rapidly. Yes, this is partly because of the [indiscernible] was launched. So that has peaked. That has contributed to the peak. That is one reason. And when it comes to penetration into the market, [indiscernible], single test, it's simple, and therefore, it is increasing. And that requested as is a [indiscernible] and a quest, but for Mayo and other institutions are not included in this data. So actual uptake should have been more than what is shown here in terms of the uptake in the market. So we have a high expectation to this. And going forward, BBM confirmatory test [indiscernible] related tests will become available. Therefore, we think that the penetration in this part will be accelerated further.

Next from SMBC Nikko Securities, Mr. Wada, please.

This is Wada from SMBC Nikko Securities. My question is on LEQEMBI in fiscal '26, whether it will be profitable in fiscal '26. Fiscal '26 guidance was given, and there can be, I believe, will be making the biggest contribution in the increase in revenue and then cost of sales growth are contained and that will lead to growth and profitability, as I see it. What I'm concerned about is last year, in fiscal '25, in comparison to plan SG&A has grown more. This may be partly due to proactive investment in LEQEMBI. If it is similar this year. It may offset the increase in profit. Is that a possibility?

Mr. Oyama will respond.

Thank you for your question. First, LEQEMBI fiscal '26, whether it can be turn profitable. The original plan was that excluding R&D to achieve profitability. So including R&D, we -- our plan does foresee profitability in taken. But regarding your question of increase in SG&A, please turn to Page 4, once again. As shown on this page, proactive investment in LEQEMBI expense is JPY 20 billion, and there is also structural reform cost that has accounted for a large portion, I would like to stress that, once again, in fiscal 2026, excluding R&D, we expect LEQEMBI to become profitable and we believe that there will be substantial improvement LEQEMBI profitability in fiscal 2026. I cannot give the exact numbers at this juncture.

Next, Tokai Tokyo intelligence lab, Yoshida-san, please unmute.

Tokai Tokyo, Yoshida speaking. Thank you for this opportunity for me to ask questions. Please open page 16. I have a question about the same page. On the right-hand side, amyloid beta confirmatory tests performed and PET and the CSF for FY 2025, we will account for about half of the total number of tests performed in the U.S. What is the reason for this? BBM diagnosis will increase in number and it is going to be add-on increase on that -- that is the perception I see. So what I would like to say is on Page 15. BBM favorable aspects of BBM are conveyed from this table. But then if that is the case, I believe that the ratio of BBM tests will be getting larger, replacing the [ CSF ] tests more optimistically. And physicians actually unexpectedly large number of offices still prefer PET imaging-based diagnosis or setting aside those physicians, the Triage will be the main usage of PBM. And then for the confirmatory testing, patency will still remain.

For your question, Mr. Haruna is going to respond.

Thank you very much for your question. Current status regarding CSF is declining slightly. Regarding PET, it stays almost flat since last fiscal year for BBM, as we explained today, and going forward, what we assume as the company is PET will stay -- continue to stay flat. And [ BPM ] will increase will be accelerated. As you pointed out, BBM is less expensive and less inventive and good access is provided. So going forward, we believe that PBM is going to the mainstream base method. But on the other hand, the hospitals utilizing pets, they will be able to see and confirm the effects of the treatment through imaging by conducting CSF tests they will be able to have an access to the more detailed biomarkers, particularly at the teaching hospitals and academic hospitals, not only BBM and TCS demand will still remain to some extent. Therefore, [ PCP ] or home doctors or neurologists, clinic BPM is expected to expand. But the teaching hospitals CSF and BPM will continue to be utilized in combination while we see increase in all of them.

Next, those of you who are in person from the media. If you have a question, please raise your hand. Attendee seated in the front row.

I'm [indiscernible]. Thank you for the presentation. About [ lacalumab ] treatment, [ Cognity ] function improvement, I think, is the ultimate objective. [indiscernible] report the other day said that -- and this is not limited to lecanemab, but regarding amyloid antibody, amyloid antibody reduces amyloid, but quality function improvement is not sufficient according to this coking report. In the future, what is your strategy? Will you try to see more improvement in cognitive function? Does that mean the preclinical intervention or power modality used in combination? What is your outlook? So could you share with us how you see the current situation and what your future outlook is?

I'm not aware of the report that you've mentioned. [ Lecanemab ], currently, I've shown 48-month data earlier, as shown in the data, progression is suppressed, and that is seen pathologically. [ Plug ] is removed, but [ taprotofibril ] is still toxic and therefore, new generation will advance in the presence of that a beta reduction and [ Abeta ] pathology regarding these -- we believe that lecanumab is almost the ultimate drug. As far as modalities are concerned, in the future if small molecule oral drug becomes available, we are also considering such [indiscernible] and preclinical usefulness it may also offer preclinical usefulness. So switching to such oral modality may be required in the future. But as you are aware of, the disease is a complex disease. And another major pathological factors, too. [ taupathology ] [indiscernible] is also examined with Atalanta in our case, and we believe that this is important in the propagation and [indiscernible] pathology trigger is a beta protofibril [ Abeta ] polymers may be also triggering til pathology. In that case, lacanumab and Atalanta in combination, we turn out to be useful. So going forward, we would like to pursue these in our consideration.

I would like to also ask Dr. Ido to offer additional response.

Thank you. If I may, I would like to offer one additional comment. Regarding the [indiscernible] review that you've mentioned, not only successful antibodies, but in the initial stage, [ solanezumab ] included those targeting monomer, all of the antibodies were included in the analysis. As CEO, Mr. Naito explained, our lecanemab, has shown significant efficacy in Phase III. Based on human biology, and we would also like to consider translating these results in small molecules in the future.

Are there any questions? A person in the second row, the [indiscernible] from the front, please.

This is [ Suzuki ] from [ Nihon Keizai Nikkei ]. [ Presenter MFN ] program. Regarding this, what kind of impact would you see on your business? What kind of scenario are you envisioning regarding this model?

For your question, Mr. Yasuno is going to respond.

Thank you very much for your question. I am in charge of our U.S. business. This is Yasuno speaking. Regarding MF and pricing, right? Yes. So far, Trump administration in the United States has announced plans, including Medicare Part B so-called, growth, for Part D, Guard, and for Medicaid, they have come up with some program. And for Medicaid, it's a voluntary participation basis. for Globe and -- [ GERD], they just announced the plan or ideas. Therefore, currently, they are setting -- they have ended the public comment period and we do not know whether they are going to put forward the final plan. Even in the case they are going to announce the final plan, what is going to be the contents. We are waiting for further information and collecting information on this. Anyway, once we see more visibility on the U.S. government's plan, we are preparing for such potential initiatives. Therefore, we do not believe that there will be an immediate impact from those plans. We are preparing in order to avoid any immediate impact. So for Medicaid, do you think that you are going to participate in that? Under Medicaid, we do not have many products which are utilized heavily under Medicaid. Therefore, we do not think that we are going to participate into Medicaid voluntarily.

Our next question, please.

I am [indiscernible]. The term ending March 2026 operating profit decline. I would like to ask a question for clarification as to the reason why structural reform costs in Europe was larger than expected. What are the reasons that the structural reform cost increased -- as for foregoing the strategic decision to divest our product could -- if you could, could you specify what product?

Mr. Oyama will respond.

Thank you for your question. As for structural reform costs in Europe in the beginning of the fiscal year and then -- since then, there were many changes, including reimbursement, and there were also uncertainties. And what size to implement there are differences in labor environment and legal system in each country. So it was very difficult to estimate this very accurately. There was difficulty and also because of the difficult differences in situations that led to a bigger-than-expected structural reform cost. As for outlicensing in divestiture because these involve potential partners, it's difficult to specify not possible to mention names, but we were considering both in Japan and outside of Japan. And if these are materialized would have been significant impact. Some were postponed, some were foregoing completely.

It's close to the ending time, so we are going to take that one last question. Those of you who are raising hand now will be addressed. So the person, please at the floor.

[indiscernible] is speaking. If I may go into details in the reference material. On Page 3 and Page 9 of the reference slides, for FY '25, actual results for pharmaceutical business, main products revenue in Japan, relatively speaking and looking at the top ranking, [indiscernible] are listed here. [indiscernible] compared to a year earlier, it seems to be growing very significantly. It has been included in the top 3. But if you look at Page 9, I cannot find [indiscernible] here. So why is it [indiscernible], for FY 2025 actual results was ranked number 6 but forecast for FY '26 is increase -- improved to top 3, a 13.3% increase in profitability. So could you please explain why these are the case?

Mr. Yusa is going to explain. Excuse me, Mr. Iike is going to answer your question.

Regarding the [ Zeneca], let me answer your question about Jyseleca. In Japan, we have a partner, [indiscernible]. We are co-promoting this drug with them. So far, we have been reporting track record actual results. But regarding forecast because of the partner, we refrain from making any forecast from us. I'm sorry, my understanding is not clear.

I'm sorry, I haven't been covering a pharmaceutical company for long. So could you please teach me?

When we disclosed the forecast, for some products, which can be determined by [indiscernible], but the others by Eisai alone not. So we are able to disclose actual results. However, we are not able to show any disclosing forecast because of the partnering.

Understood. And another question is about [indiscernible]. Based on the forecast, it has been increased to the top ranking products. So how do you analyze? And what is the reason for this?

Mr. Yusa is going to respond.

Sales of mobile is increasing. And are you asking about the reason why we see such increase. Yes, I am in charge of our Japanese business [indiscernible] saying. Regarding constipation market, [ glofitamab], both grew for fiscal year 2025. The market self grew significantly and both of the trucks compared to competitors' drugs were very efficacious and the safety profile was more favorable. So that is highly evaluated. [indiscernible] at the time of testing molecule is utilized together with the testing agent. Therefore, the market is increasing and compared to other companies' products, [indiscernible] is increasing.

I'm sorry, again, for -- it is utilized in combination with tests. Could you please explain?

The lower digestive tract mobile colorectal colonoscopy patients have to [indiscernible]. So in such case, [indiscernible] is utilized for removing the thesis. So that's why we are seeing the increase in the sales.

Question for the main body of the slide deck. Could you please open Page 8, [indiscernible]. The future development in Japan. By the end of fiscal year 2026, [indiscernible] also lung cancer. The submission is planned for FY '26 in Japan. Could you please give us time line for this, if possible? When do you expect to launch this product?

For your question, Dr. Ido is going to answer. Sorry, Mr. Yusa is going to respond.

Thank you very much for your question. In Japan, regarding [indiscernible], schedule for getting approval is not disclosed yet. Having said that, for the first part of your question about lung cell cancer, [indiscernible]. We have obtained favorable data already. So in early course, we believe we will be able to proceed with the development for this indication.

I'm [indiscernible]. There was an earlier question -- a follow-up question about price in the U.S. What is the impact? Is there going to be an impact of drug class where there will be fewer new drugs launched in Japan as a result of [indiscernible] in the U.S. Most favored nation price, we do not know the final outcome yet, but for Eisai in launching new products in Japan, do you expect any impact from an price policy in the U.S. What is your outlook, please?

I'm not sure if I understood your question. If you could speak up, I would appreciate it.

I am [indiscernible] from [ Asahi Shimbun ]. I have a question regarding MF and price in the U.S., we do not know the final outcome yet, but if [ MFN ] is introduced, does that lead to fewer drugs launched in Japan that is a concern of some -- regarding the introduction of new products in Japan, what effect do you think there will be from MFN in the U.S.? Do you have any policies to address this?

Basically, as shown in our philosophy, so long as there are patients who need drugs, we deliver drugs, that is the mission of pharmaceutical company. And to fulfill that mission, we make all efforts. That is our basic stance. Having said so, regarding life science innovation, the consideration for life science innovation is appropriate consideration being paid. Depending on the government of each country, the consideration paid oftentimes in the form of price setting, whether that is appropriate or not, there is a huge debate right now in Japan as well, similar debate should take place. That is what I believe between the United States and the U.K. as a result of bilateral negotiations, the view of the U.K. about the consideration for innovation has undergone a major change in Japan, including drug price, the consideration for innovation, should be discussed in many ways in my view. Does this address your question? We are conscious of time. So I would like to take this offline later. It is now time to end the briefing session. If you have additional questions, please contact IR or PR section. With that, we would like to end today's presentation session. Thank you once again for your time today.