Moderator
It is now time. We would like to now begin the briefing session on the financial results and business update of Eisai Company Limited.
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.
Takuya Oyama
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 825.4 billion yen, up 4.6% year-on-year.
The pharmaceutical business, which is our organic business, delivered strong growth, driving consolidated revenue to a record high. Operating profit was 44.1 billion yen, down 18.8% year-on-year.
Although there was a significant increase in the contribution of the pharmaceutical business to operating profit, OP 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 883.5 billion yen and operating profit of 70 billion yen.
Regarding investments for growth, we have made two 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 825.4 billion yen. Cost of sales was 191.2 billion yen, and the cost of sales to revenue ratio was 23.2%, up 1.8 points from the previous year.
This increase was due to 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 was 634.2 billion yen, a 2.2% increase year-on-year.
R&D expenses decreased by 7.6% from a year earlier to 158.7 billion yen, as the costs for clinical trials for Leqembi have passed their peak. SG&A expenses totaled 435.3 billion yen, up 6.7% year-on-year.
This increase was due to factors such as proactive investment in Leqembi and the recognition of expenses related to structural reforms in Europe. As a result, operating profit was 44.1 billion yen, down 18.8% from a year earlier, and profit for the year was 38.6 billion yen, down 17% year-on-year, both showing a decline in profits.
As I will explain in the later slide, we are now disclosing a 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 products, 3Ls—Lenvima, Dayvigo, and Leqembi—grew by 68.3 billion yen from the previous year, absorbing a 6.6 billion yen decrease in revenue due to factors such as Halaven's LOE and others, resulting in a significant expansion of revenue in our pharmaceutical business. In other businesses, revenue decreased by 25.8 billion yen due to the absence of the upfront payment and others related to the transfer of right for Pariet in China, which took place in fiscal 2024.
As a result, revenue reached a record high of 825.4 billion yen, an increase of 36 billion yen year-on-year. Next page, please.
This page shows the breakdown of operating profit transition. Due to strategic decisions to forego product out-licensing or divestitures, as well as inventory valuation losses resulting from the discontinuation of Tazverik sales, both of which partially offset the effect of the growth of 3L products, gross profit increased by no more than 13.6 billion yen.
R&D expenses decreased by 13 billion yen 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 US implemented in fiscal year 2024. SG&A expenses increased by 27.3 billion yen due to proactive investment in Leqembi and one-time expenses related to structural reforms mainly in Europe.
Other income resulted in a decrease of 9.5 billion yen, mainly due to the absence of 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 44.1 billion yen.
In the third quarter of fiscal year 2025, we reported operating profit of 54.5 billion yen. At the time, we had anticipated a profit for the fourth quarter, expecting that income from product out-licensing or divestiture would offset the one-time expenses related to structural reforms in Europe.
However, following 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. Additionally, restructuring costs primarily in Europe exceeded expectations, and we incurred an inventory valuation losses following the unexpected discontinuation of Tazverik sales.
Consequently, OP for the fourth quarter resulted in a loss of 10.3 billion yen. As will be explained in the later slide, core operating profit for fiscal year 2025, excluding temporary income and expense items, was 50.1 billion yen, more than doubling compared to the previous year.
In the fourth quarter of fiscal year 2025 alone, it improved by 5 billion yen year-on-year. Next page shows the background and details regarding the introduction of core operating profit.
In our third quarter financial results, we referred 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 referenced the practices of our industry peers and clarified the definition from the perspective of objectivity and comparability.
We exclude five items of temporary income and expense items not directly linked to future earnings from operating profit. For fiscal year 2024 and 2025, we have identified three items subject to exclusion: product out-licensing or divestiture, disposal of tangible fixed assets, and termination benefit costs, and have calculated the figure after excluding them.
As a result of this adjustment, core operating profit was calculated at 23.8 billion yen for fiscal 2024 and 50.1 billion yen for fiscal 2025, representing more than a twofold increase and establishing a solid earnings base for fiscal year 2026 onward. 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 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 presents our consolidated financial forecast for fiscal 2026. We continue to pursue organic business growth centered on the 3L products, and we plan for revenue to reach a record high of 883.5 billion yen.
While R&D expenses will increase due to focused allocation of resources to our next-generation pipeline, we will control overall expenses at a rate in the high-teens percent. Although we anticipate 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 2026 plan does not include one-time revenue. As a result, we are targeting operating profit and core operating profit of 70 billion yen each.
Furthermore, our target for capital efficiency is the adjusted ROIC of 8.7%. Next page.
To support further business growth, we executed two in-licensing investments in the oncology area during FY 2025. Preparations for the submission and 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 taking into account market conditions.
This concludes my part. CEO Naito will now provide you a business update.
Haruo Naito
Regarding the overall business, we'd like to report to you. As we have heard "3L, 3L" several times, what does this mean?
This means Leqembi, Dayvigo—generic name of this is lemborexant, taking L from this—and Lenvima. These are the products which are supporting our business overall globally, taking acronym from these three products' names.
We are calling this as 3L. For your information, logo names since Aricept, we always started seven English alphabets constituting brand names since Aricept.
What kind of products are we talking about? For Leqembi, it is expected to be global number one anti-amyloid treatment.
Actually, this is the global number one AAT. Dayvigo is global number one in DORA category.
DORA stands for dual orexin receptor antagonist, and Lenvima is now approved in the five cancer types. In these five types of cancer, this is the number one tyrosine kinase inhibitor.
For all these three products, these are all global or world leaders currently, and all of these have been in-house developed, which 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 seven indications in five cancer types, expanding with monotherapy and combination therapies with Keytruda, etc.
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.
342.5 billion yen 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 US. On the right-hand side, in all regions, however, for FY 2025, it has been able to grow.
Particularly in the aRCC, advanced renal cell carcinoma, has driven the growth in the United States, including the RRDTC, which was launched as the first indication in all the cancer types in the United States, Lenvima could expand. LITESPARK-011 studying on the combination therapy of welireg plus Lenvima for RCC, in this study we have obtained favorable results for the improvement in the PFS and ORR and it has shown to reduce the risk of disease progression or death by 30%.
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 this prior treatment. For US FDA, PDUFA action date is set for October 4, 2026.
For Japan, we have also submitted, and this year 345 billion yen, 1% year-on-year growth is expected for this fiscal year. Next year, Dayvigo.
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 Tsukuba University in Japan as a target. The orexin receptor, once it is inhibited, it will induce sleep.
Orexin receptor is once agonized, then wakefulness will be naturally induced. That is the nature of this target.
Dayvigo is the antagonist for orexin receptor. Of course, from Tsukuba 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 64.3 billion yen globally, which was up 20% year-on-year. In key markets in Japan, our country, for this fiscal year we expect to have the continued double-digit growth.
What is happening in Japan? We have been number one in share in terms of both the sales as well as the number of patients for receiving this treatment.
We have generic agents available in the market. However, including that, for insomnia treatment, including those generics, Dayvigo is number one in share of the market.
Now the disease awareness campaign is being launched in collaboration with Pokémon 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 Pokémon Sleep, and it has expanded steadily in Canada, China, Thailand as well. In the United States, this is not a relaunching, however, we are going to initiate new initiatives.
This is called the 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 considering conducting relaunching of the product.
In Europe, as well in the UK 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 beta, neurotoxic amyloid beta protofibrils, as well as plaque, both of which are targeted by this treatment, and these are continued to be removed by this drug. 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 88 billion yen, achieving almost double growth: 44.6 billion yen in the US, 24.4 billion in Japan, and 12.4 billion yen in China, and 6.6 billion in the rest of the world.
For this fiscal year, we plan to achieve 143.5 billion yen in revenue, with 63% growth year-on-year, including the US and other regions. We believe that there will be continued robust growth.
Regarding Leqembi, Leqembi is the number one AAT, anti-amyloid treatment. It is the top brand.
In comparison to the second brand, more than double sales is achieved in Japan. In the United States, approximately 1.5 times 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 three years ago.
It has been a long time and it has been a short time over the past three years, but it has only been three years after the full launch. In the meantime, we have pursued a mission, which is shown in these two 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 three years on improving such awareness, and at last, 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, 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 two lines are natural progression groups, if you will.
These are data from ADNI in the US and BioFinder in Europe. As you can see here, after 48 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 OLE, showing the results for low-tau population with small accumulation of tau, MCI early stage, if you will.
Looking at this, CDR-SB no decline, cognitive function deterioration is not seen in 69%. In the lower graph, CDR-SB improvement, 56% of 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 plaque, how much plaque was removed is shown. The point I would like to convey here is that Leqembi efficacy onset is quite early.
The very left side, the reddish bar, this is after three months. After three months, in 24% of the patients receiving Leqembi, 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 an early onset of efficacy, as shown by this data. On the far right, long-term continuation of the study, but in real world, how long are patients staying with Leqembi treatment?
The top is the data from the US. 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 two 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 major topic today is the initiation of fundamental transformation in AD diagnosis and treatment started by Leqembi. There are two types of technological innovations: BBM, blood-based biomarker, confirmatory usage, A-beta confirmatory testing using BBM.
Such technological innovation is one, and the other is Leqembi Iclick, rather than infusion which was a conventional method, autoinjector, self-administration, Leqembi Iclick, technological innovation. These two 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 two rate-limiting factors or two bottlenecks. One is A-beta confirmatory diagnosis, how to give confirmatory diagnosis, and once treatment starts, infusion uses a lot of healthcare resources.
These two were bottlenecks. How do we remove these bottlenecks?
On several occasions, I have discussed this. With the two technological innovations, these two 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 three 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, it will have to be allocated.
CSF, lumbar puncture is used to collect CSF, this is invasive. Economically, it is moderately burdensome.
This medical technique can be used by healthcare 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 blood sample is drawn, invasiveness is quite low.
Access is available in large-size diagnostic companies. They are adding BBM in the list of their confirmatory test, there is a good access.
Clinical diagnosis has become very simple and there will be greater flow of patients seeking Leqembi treatment. That is how we see this.
I would like to show some actual data. On the left side, A-beta 42/40, p-tau181, p-tau217, 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 two-year period, the number of tests increased by 12-fold.
In half-year interval from '24 January, January '24, every six months it is doubling. A very rapid pace BBM is increasing its penetration.
In the second bullet, A-beta confirmatory test, CMS, the authority for insurance reimbursement, formally 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 A-beta confirmatory diagnosis, how much is done with BBM?
That is shown in orange color. According to our estimate, about 15% was already BBM in fiscal 2025.
In this fiscal year, we believe that more BBMs for confirmatory diagnosis will be approved by the FDA, we believe there will be acceleration, and by fiscal 2028 or there around, we believe that more than half of all A-beta confirmatory diagnosis will be done with BBM. At the right bottom, for one year, the number of patients receiving AAT in one year has increased by 1.8-fold.
There are numerous factors: DTC is carried out and clinical effectiveness evidence is also playing a role, but without doubt, BBM triage and confirmatory diagnosis, the usage has provided tailwind, and we believe that a full-scale growth of the AAT market has started. The simplicity is the value that is acquired from BBM.
To recap, A-beta confirmatory diagnosis using BBM can significantly expand accessibility and its cost-effectiveness would greatly simplify AD diagnosis. Next, as for the treatment innovation for transformation, we have Leqembi Iclick.
With Iclick, the value that will be brought about is convenience. Conventional administration is IV infusion and the flow is shown above.
Patients will have to visit medical institutions. Currently around 1.5 hours to two 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 one hour and this is followed by 30 minutes of follow-up. In the meantime, nurses are allocated to monitor infusion-related reaction.
To go home, same amount of time driving car is required. This is every two weeks for initiation stage and every four weeks during the maintenance period.
Now what is the convenience that will be brought about by Iclick? 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, etc., it will be possible to receive self-administration.
And 360 mg autoinjector, one autoinjector 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 mg of two autoinjectors, two autoinjectors of 250 mg, but it will also be 15 seconds per injection, improving convenience by wide margin.
Iclick maintenance therapy, this was approved in August of 2025, and what has been the effect of that approval, that is shown in the two graphs. The point I would like to emphasize here is that IV and Iclick can complement each other.
Patients who are receiving IV may be switched to Iclick or Iclick patients may be switched to IV treatment with a great degree of flexibility. Flexible treatment options are offered.
At left part, the orange part is Iclick maintenance treatment incremental portion. Because of added convenience, this is increasing, but the IV part, the blue part, is not decelerating.
It continues to grow. IV, Iclick, they are compatible.
It is possible to switch between the two. Such flexible treatment options, I believe, are welcomed.
That is what is shown here. IV, Iclick, for both maintenance treatment we are seeing increase in number of patients who are receiving IV or Iclick maintenance treatment.
On the right side, with the increase in maintenance treatment options, the graph shows that this has led to increase in patients receiving initial treatment using Leqembi after 18 months. Initial treatment, there is greater degree of freedom regarding treatment modalities, lowering the hurdle to seek Leqembi treatment.
Currently initiation treatment, IV infusion is still used. However, Iclick launch had the effect of increasing the number of patients receiving initial treatment of Leqembi.
This is the projected impact of Leqembi Iclick initiation treatment in the first year of launch. This is the estimated number of new patients between the competitor's product.
Regarding new patient, the share is around 50/50 according to our estimate. With Leqembi Iclick initiation treatment after its approval, first as shown in circle number one, we can expect market expansion with Iclick, and circle two, we can expect increased share with Leqembi Iclick.
The reason for saying this is that Iclick, by far, is very convenient in comparison to infusion. For initiation treatment patients, it will lower the hurdle of seeking Leqembi treatment and it will also offer us very important competitive edge clearly.
This is the expected impact. Currently Leqembi SC AI regulatory status is as shown here.
For maintenance treatment, as I stated earlier, it was approved by FDA in August 2025. Initiation treatment is designated for priority review and we recently received notification that PDUFA date was extended by three months, as we have informed you.
The approval expectation is not at all affected by this, in our view. Data had already been submitted and we are not requested to submit additional data.
Surrounding the switching between IV and SC, data had already been submitted, and labeling words regarding the IV/SC switch are being finalized, as we understand, and what kind of interpretation is necessary in fixing that language. Those are the types of inquiries that we are receiving and we are providing information accordingly.
This is not about the essence of 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 SC AI for initiation treatment.
Three months is the extension time, but the full duration may not be required. In the second quarter of this fiscal year, we expect approval, and 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, Iclick 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 at approximately 600 facilities, and action date is extended, but we have no concerns about approvability.
Once it is approved, all medical institutions are able to provide Iclick initiation treatment, lowering the barrier to initiate treatment with Leqembi, 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.
These types of mutuals are called Huiminbao, under the guidance and support of the local governments, commercial insurance selling insurance, and including in Beijing City, in 13 cities, Leqembi is on the list of insurance reimbursement. Alipay has insurance platform called Hao Yibao, and Leqembi is also included here.
This is a commercial insurance covering high cost medical cost and is available nationwide. As for Sui Xin Bao, this is Guangzhou-based program covering advanced medical treatments.
This also includes Leqembi. Mainly through commercial insurance, improvement in access to treatment is achieved in China.
As for EMEA, in Germany, the UK, Spain, and Italy, negotiations with authorities for reimbursement is ongoing. This is the overview of the pipeline.
Alzheimer's disease is positioned within the neurodegenerative AD continuum by Eisai: amyloid, tau, neurodegeneration. These are three pathologies.
In all of these pathologies, we have promising pipeline, and that is true of only Eisai in the world. Leqembi, I have discussed at length.
Preclinical AD, AHEAD 3-45 is underway, and we expect top-line data in fiscal 2028. Tau, E2814, this is an excellent anti-MTBR tau antibody in Phase 1, and we have two studies: hereditary Alzheimer's disease cohort Phase 2/3 study, and sporadic AD Phase 2 study.
Both are underway smoothly, and we expect top-line data in the years as indicated here. As for neurodegenerative stage treatment, E2511, TrkA, we will start clinical study for this.
Orexin platform, in addition to lemborexant, the agonist side of orexin for narcolepsy study is underway smoothly. We expect top-line data this fiscal year.
In oncology, Lenvima LITESPARK-011, RCC, and in-licensed taletrectinib for Europe and for Japan, serplulimab, another licensed-in product, we expect to file submission in fiscal 2027, 2026, respectively, and also expect results for Phase 2 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 Europe, etc.
In fiscal 2026, we aim to achieve record high revenue driven by continued sales growth primarily in the 3L products. For Leqembi, with SC AI and BBM in place, it is entering a true expansion phase, and we aim to enhance business profitability through continued cost control and prioritized SG&A investment in key markets.
In addition, we expect improved management efficiency as a result of structural reforms implemented in prior years, mainly in the US and Europe. In R&D, while controlling overall expenses, we will allocate resources to priority pipeline assets, including Leqembi in preclinical AD, E2814, and [unclear], and aim to achieve core operating profit of 70 billion yen.
In parallel, we will execute proactive financing to promote investments for growth, including product in-licensing mainly in oncology, to accelerate pipeline enhancement through dual engine of in-house R&D and product in-licensing. Through these initiatives, we aim to achieve revenue expansion driven by organic business and 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.
When you have a question, please give us your name and organization name before your question, and we would like to take as many questions as possible, and in the interest of time, please limit the number of questions to one per person.
Moderator
Now, I would like to ask if you have a question, please raise your hand.
Seiji Wakao
This is Wakao from J.P. Morgan.
Thank you very much for your presentation. What I would like to ask you is for the year under review did not achieve the plan.
Therefore, could you please explain why you were not able to achieve the plan? ROE was targeted at 8% level, but in the third quarter earnings, you mentioned that the level was above the consensus.
OP is estimated to be 70 billion yen, 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.
I think that the projection of the company for the profit growth may have been changed. Could you please explain?
Moderator
For that question, Mr. Oyama is going to explain.
Takuya Oyama
Thank you very much for your question. Regarding the results below plan for fiscal year 2025, I believe you are asking about that previous fiscal year, and regarding this, it depends on the original plan.
Could you please show the page two? If I may, let me explain using this slide.
Other income and expenses for the full-year forecast, 35.5 billion yen was planned. In addition, other income and expenses 9.5 billion yen was included.
At the beginning of the year, the plan was to take into account the one-time income to some extent. Up until the third quarter, these were not incurred.
The full-year results included the other business results, but API sales or sales from subsidiaries are included, almost nil 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. 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.
One-time income was discontinued, and that is what we decided. These are the numbers that we have disclosed: 8.7 billion yen related to structural reforms, which was also disclosed in the financial reports.
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 scale of the structural reform there was much larger. Excluding the one-time income as well as the more structural reform costs than expectation were the major factors.
Regarding your question about ROE 8%, as for this target of 8%, we thought that this should have included the impact of one-time income. When we explained this 8% level target for ROE for FY 2025, that's what we explained.
Through thorough discussion internally, there are some projects that are under negotiation and there are some potential candidates, but we'd like to prioritize what we are able to see, visibility, explaining there are some one-time or maybe no one-time, rather than explaining as such to investors, we believe that it is more important for us to go through the more visible plan. 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 ROE 8% stays unchanged.
In addition, compared to that time, actually the foreign currency translation gain has increased. 310 billion yen 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 company's, 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 the business will continue to be achieved in order to support the numbers.
Seiji Wakao
If I may check 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 one-time impacts?
Takuya Oyama
We think you are talking about whether you are able to achieve the 8% ROE, but from next year onward, I believe that you are going to achieve the profit growth inclusive of 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.
For organic business, we believe that we have secure base for growth. Conventionally, in order for us to achieve the short-term goals, one-time 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.
Please, I'm sorry to say this, but please wait until the explanation on the 25th of May.
Seiji Wakao
That means that there has been a change to the policy of the company, right?
Moderator
Please wait until the conference. CEO Naito, please.
Haruo Naito
When it comes to the so-called individual pipeline assets, their divestiture or others, or existing brand sale or divestiture, we decided to forego these. For our growth model, which includes partnering with Merck for Lenvima and partnering for Leqembi with Biogen, I believe that these are reasonable and a good business models that should be adopted by the company for the future growth and having the costs and having the profits.
Such model for a mid-sized pharma company like us is a reasonable growth model in my opinion. We'd like to continue to pursue such opportunities proactively.
Any revenue or income from these activities will be including some one-time revenue. These are considered to be organic income.
There are two separate understandings on these incomes. I am very much looking forward to hearing at the management strategy conference, which seems to be very important.
Within our existing pipeline, there are promising potential items, I would say that there are several of them within the existing pipeline, we are duly considering these potentials.
Moderator
Next question. Attendee seated in the front row on the right side, please.
Kazuaki Hashiguchi
I'm Hashiguchi from Daiwa Securities. I can see that you have high expectations regarding Iclick.
What is your view regarding the pricing? To the extent that you're able to, please comment on the pricing.
Haruo Naito
In maintenance therapy, it is expected that there may be switch between IV and SC. Not all patients may select Iclick, and I believe there are several reasons for this.
Depending on the insurance plans of the patients, Iclick 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, on the whole pricing does not change. With Iclick in initiation treatment, dosage is larger between IV and SC.
If forcing a unit of dose, if the price is the same, then the economic burden may be felt 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.
Katsuya Haruna
Thank you for your question. I'm Haruna, responsible for the US.
I believe your question was regarding the United States. The concept is price parity.
What we have in mind as 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 the pricing.
IV therapy patients have to pay for infusion procedure, 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.
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.
Kazuaki Hashiguchi
Thank you very much, that was very helpful.
Moderator
Any other question? The person in the second row from the front.
Atsushi Seki
This is Seki from UBS. Thank you very much for explanation.
More promising news, Biogen tau ASO Phase 2 results were announced by Biogen yesterday. Tau pathway has been demonstrated to improve the cognitive function.
Epoch-making news was announced. What is your view of this?
E2814 202 study compared, and except for the small number of patients, what is the possibility of the dose response?
Moderator
Dr. Ido is going to respond.
Katsutoshi Ido
I am in charge of R&D. My name is Ido.
I'm going to respond to your question. As has been commented by you, BIIB080 results are understood positively by us as well, which was a good start.
According to the release, primary endpoint, CDR-SB, the dose response was not achieved, but tau PET, CSF tau included that these biomarkers were shown to be significantly reduced, and the suppression of cognitive decline were observed across all dose groups. This is going to be announced at the AAIC.
Including the E2814, anti-tau drug development, direction of such a drug development, including E2814, is supported strongly. E2814 of Eisai has been already explained several times.
Considered to be very important for tau aggregation, MTBR core region is the region to be bounded by this, and so the propagation tau seed will propagate, and that is the most important part of the tau pathology hypothesis. Also E2814, over the high dose, and also the safety has been secured, including the high-dose patients.
The tau propagating to the cortex, cerebral cortex, it's considered to be affecting the cognitive function, but we have deepened our confidence in showing this mechanism to achieve this. Our IV infusion of E2814 and biomarker dynamics have been already shared based upon the dose-response manner.
We have been able to see this effect. At the DIAN or the familial Alzheimer's disease patients, severe Alzheimer's disease patients, last year the tau PET, the stabilization or decrease of tau PET were also observed in these patients.
Therefore, we have deepened our confidence in this drug. Thank you very much.
Atsushi Seki
Except for the smaller number of patients, are there any dose-response effect?
Katsutoshi Ido
Separate from the biomarker response, yes. Inclusive of the cognitive function as well, we are going to monitor together with the biomarker.
Haruo Naito
He's asking the ASO. A question about ASO.
Are you asking about the E2814?
Moderator
Next, analysts, investors who are attending virtually, we will be taking questions. First, Muraoka-san from Morgan Stanley.
Please unmute and please proceed with your question.
Shinichiro Muraoka
Thank you. This is Muraoka from Morgan Stanley.
A question regarding the guidance for this fiscal year. SC Iclick, PDUFA was extended by three months.
The guidance is now 70 billion, slightly lower than your original expectations because of this extension of PDUFA date. How do you assess this?
Probably is that true? After approval, successfully August 24, if that is achieved, then the acceleration around September or from January, what do you currently anticipate?
Takuya Oyama
Mr. Haruna will respond to your question.
Katsuya Haruna
Thank you for your question. PDUFA extension by three months, or within three months, right, this means that we are able to make a thorough preparation, we positively consider this.
After the actual launch, we believe that we can immediately see the effect. Iclick is already on the market, widely used for maintenance therapy, and once Iclick initiation therapy becomes available, I believe Leqembi growth will be accelerated.
Regarding the plan, we consider a slight modification possibility, but it will be limited.
Shinichiro Muraoka
Do you think the acceleration from January will be bigger than from September?
Katsuya Haruna
Thank you for that question. Regarding Iclick, it is already receiving insurance reimbursement in initial therapy.
After launch through MAP, medical exception, we expect the insurance coverage to continue. Irrespective of the timing, we believe that Leqembi Iclick growth [unclear].
Shinichiro Muraoka
Thank you very much.
Moderator
From Citi Group Securities, Mr. Yamaguchi, please unmute.
Hidemaru Yamaguchi
Hello, this is Yamaguchi of Citi. Can you hear me?
Moderator
Yes, we can. Thank you.
Hidemaru Yamaguchi
I have
Katsuya Haruna
one question
Hidemaru Yamaguchi
regarding Iclick,
Moderator
maintenance treatment,
Takuya Oyama
expansion of
Katsuya Haruna
Leqembi on page 19. Regarding this, I would like to ask you a question.
As a result, the SC sales, how much is it now? For this fiscal year, the initiation treatment is delayed a little bit.
As a result, how SC sales is going to be increased by that? Could you please disclose the mix between the IV and SC 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 Leqembi, Iclick maintenance treatment, exceeding the original plan, it has been strongly performing, and week by week it is picking up.
Therefore, securely, penetration or growth of the sales of Iclick has been growing steadily. Once the initiation treatment is approved and launched, as CEO Naito mentioned earlier, the Iclick will contribute to the expansion of market and also share of the market as well.
These are the two points. Regarding the mix, gradually Iclick ratio will exceed IV.
That is what we envisioned. That is my response.
Thank you. Thank you very much.
Next from Sanford C. Bernstein, Ms.
Soki, please. 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 US neurologists, BBM positioning is screening and oftentimes they say it is difficult to use BBM for confirmatory testing. 100% PET and CSF, it's not 100% reproducibility in terms of results.
There will be over-treatment, under-treatment for 5% to 10%. Will there be new data to reduce the gap between PET and BBM to lead to greater usage of BBM for confirmatory testing?
For your question, Mr. Haruna will respond.
Thank you for your question. Blood-based biomarker, BBM confirmatory testing, right now around 15% of the patients are using BBM for confirmatory testing.
In comparison to last fiscal year, this is an increase of about 5%. In A-beta confirmatory testing, the proportion of BBM is increasing.
That is the reality that I would like to emphasize. Going forward, why do we expect BBM proportion to increase?
CMS has officially added BBM in the registry for BBM 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, but CMS or AAIC guideline as well, BBM as a confirmatory testing is endorsed. In terms of market penetration, there will be new BBM tests that are expected to be launched for confirmatory testing this year or to be approved this year, we believe that confirmatory testing with BBM will surely increase and will continue to increase.
Thank you.
Moderator
Next, from Macquarie Capital Securities, Tony Ren. Could you please unmute and start asking question?
Tony Ren
Hi, Tony Ren from Macquarie. Thank you for taking my question.
I would like to also stay on the previous page on blood-based biomarkers, slide number 16. This is a very informative slide of slide number 16.
When I look at this slide, what struck me on the left-hand side was the very fast uptake of p-tau217, and basically not p-tau181 not growing much. Could you explain to us why the p-tau217 experienced so much rapid growth, and also which companies are the vendors of this test?
Thank you.
Moderator
For your question, Mr. Haruna is going to respond.
Katsuya Haruna
Thank you very much for your question. On the left-hand side, BBM tests and p-tau217 is growing so rapidly.
This is partly because of the Fujirebio's p-tau217 was launched, so that has peaked. That has contributed to the peak.
That is one reason. When it comes penetration into the market, p-tau217 single, it's simple, and therefore it is increasing.
The data source is LabCorp and Quest, but Mayo and other institutions are not included in this data, actual uptake should have been more than what is shown here in terms of the uptake in the market. We have high expectation to this, and going forward BBM confirmatory test, p-tau217 related tests will become available.
Therefore, we think that the penetration in this part will be accelerated further. That is my answer.
Thank you.
Tony Ren
Very clear. Thank you very much.
Next
Moderator
from SMBC Nikko Securities, Mr. Wada, please.
Hiroshi Wada
Thank you. This is Wada from SMBC Nikko Securities.
My question is on Leqembi in fiscal 2026, whether it will be profitable in fiscal 2026. In fiscal 2026 guidance, how much Leqembi Iclick will be making the big contribution in increase in revenue and that SG&A and R&D are contained and double-digit growth in profitability.
I understand that. What I am concerned about is the last year, in the plan for fiscal 2025, SG&A has grown up more, and this may be partly due to the proactive investment in Leqembi.
If it is similar this year, it may offset the increase in profit. Is that a possibility?
Moderator
Mr. Oyama will respond.
Takuya Oyama
Thank you for your question. First, Leqembi in fiscal 2026, whether Leqembi will turn profitable, the original plan was that excluding R&D to achieve profitability, including R&D we foresee profitability in Leqembi.
Regarding your question of increase in SG&A, please turn to page four once again. As shown on this page, proactive investment in Leqembi expense is 20 billion yen, 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 in Leqembi profitability in fiscal 2026.
I cannot give exact numbers at this juncture, however. Thank you.
Next,
Moderator
Tokai Tokyo Intelligence Lab, Yoshida-san, please unmute.
Thank you. Tokai Tokyo, Yoshida speaking.
Thank you for this opportunity for me to ask question. 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 CSF for FY 2025 will account for about half of the total number of tests performed in the US.
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. What I'd like to say is on page 15, favorable aspects of BBM are arranged from this table.
Then if that is the case, I believe that the ratio of BBM tests will be getting larger, replacing the CSF or PET. More optimistically, and physicians are unexpectedly a large number of physicians still prefer PET imaging based diagnosis, or setting aside those physicians, the triage will be the main usage of the BBM, and then for the confirmatory testing, PET and CSF will still remain.
What is the reason?
Moderator
For your question, Mr. Haruna is going to respond.
Katsuya Haruna
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, the situation.
Going forward, what we assume as a company is PET will continue to stay flat, and BBM will be accelerated. As you pointed out, BBM is less expensive and less invasive and good access is provided, going forward we believe that BBM is going to the mainstream test method.
On the other hand, at hospitals, utilizing PET, they will be able to see and confirm the effects of the treatment through imaging. By conducting CSF test, 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 PET, CSF demand will still remain to some extent.
Therefore, at PCP or home doctors or neurologist clinic, BBM is expected to expand. At the teaching hospitals, PET, CSF, and BBM will continue to be utilized in combination while we see increase in all of them.
Thank you.
Understood very well. Thank you very much.
Moderator
Next, those of you who are in person from the media, if you have question, please raise your hand. Then attendee seated in the front row.
I'm Kozaki from Kokusai Yakuhin Joho. Thank you for the presentation.
About lecanemab treatment, cognitive function improvement, I think, is the ultimate objective. Cochrane report the other day said that, and this is not limited to lecanemab, but regarding amyloid antibody, amyloid antibody reduces amyloid, but cognitive function improvement is not sufficient according to this Cochrane report.
In the future, what is your strategy? Will you try to see more improvement in cognitive function?
Does that mean that preclinical intervention or tau modality used in combination? What is your outlook?
Could you share with us how you see the current situation and what your future outlook is?
Haruo Naito
I'm not aware of the report that you've mentioned. Lecanemab, currently I've shown 48-month data earlier.
As shown in that data, progression is suppressed and that is seen pathologically. Plaque is removed, but A-beta protofibril is still toxic and therefore neurodegeneration will advance in the presence of that.
A-beta reduction and A-beta pathology, regarding these, we believe that lecanemab 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 possibilities and preclinical usefulness.
It may also offer preclinical usefulness, switching to such oral modality may be required in the future. As you're aware of, the disease is a complex disease and another major pathological factor is tau.
Tau pathology part is also examined with E2814 in our case, and we believe that this is important in the propagation. Tau pathology trigger is A-beta protofibril.
A-beta polymers may be also triggering tau pathology. In that case, lecanemab and E2814 in combination may turn out to be useful.
Going forward, we would like to pursue these in our consideration.
Moderator
I would like to also ask Dr. Ido to offer additional response.
Katsutoshi Ido
Thank you. If I may, I would like to offer one additional comment regarding the Cochrane review that you've mentioned.
Not only successful antibodies, but in the initial stage, solanezumab included, those targeting monomers, all of the antibodies were included in the analysis. As CEO Mr.
Naito explained, our lecanemab has shown significant efficacy in Phase 3 based on human biology, and we would also like to consider translating these results in small molecules in the future. Thank you very much.
Moderator
Are there any questions? The person in the second row.
The fifth row from the front, please.
This is Suzuki from Nihon Keizai, Nikkei. President Trump, MFN program, regarding this, what kind of impact would you see on your business?
What kind of scenario are you envisioning regarding this matter?
Moderator
For your question, Mr. Yasuno is going to respond.
Tatsuyuki Yasuno
Thank you very much for your question. I am in charge of US business.
This is Yasuno speaking. Regarding MFN pricing, right?
Yes. Far, Trump administration in the United States has announced plans including Medicare Part B, so-called GLOBE, and for Part D, GUARD, and for Medicaid, they have come up with some program.
For Medicaid, it's a voluntary participation basis. For GLOBE and GUARD, they just announced their plan or ideas.
Therefore, currently 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 US government's plan, we are preparing for such potential initiatives.
Therefore, we do not believe that there will be any immediate impact from those plan. We are preparing in order to avoid any immediate impact.
For Medicaid, do you think that you are going to participate in that?
Tatsuyuki Yasuno
In and 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. Thank you very much.
Next question, please.
I am Horiguchi from Nikkan Yakugyo. Thank you for the presentation.
The term ending March 2026, operating profit decline, I would like to ask question for clarification as to the reason why. Structural reform cost in Europe was larger than expected.
What are the reasons that the structural reform cost increased? As for foregoing the strategic decision to divest a product, If you could, could you specify what product?
Moderator
Mr. Oyama will respond.
Takuya Oyama
Thank you for your question. As for structural reform cost in Europe, in the beginning of the fiscal year and then since then, there were many changes, including reimbursement, and there were also uncertainties.
What size to implement there are diversity in labor environment and legal system in each country, it was very difficult to estimate this very accurately. There was difficulty and also because of the differences in situations that led to bigger than expected structural reform cost.
As for out-licensing and 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, there would have been significant impact.
Some were postponed, some were foregone completely. Thank you.
Moderator
It's close to the ending time, we are going to take the one last question. All right, those of you who are raising hand now will be addressed.
The first person, please have the floor.
Thank you very much. From Yakuji Nippo, Tomioka is speaking.
If I may go into details in the reference material, on page 3 and page 9 of the reference slides, for FY 2025 actual results, for pharmaceutical business main products revenue in Japan, relatively speaking and looking at the top ranking, Jyseleca, Movicol are listed here. Jyseleca, compared to a year earlier, seems to be growing very significantly.
It has been included in the top three. If you look at page 9, I cannot find Jyseleca here.
Why is it? Movicol, for FY 2025 actual results was ranked number six, but forecast for FY 2026 it is improved to top three.
135.3% increase in profitability. Could you please explain why these are the case?
Takuya Oyama
Mr. Yusa is going to explain.
Excuse me, Mr. Iike is going to answer your question.
Terushige Iike
Regarding Jyseleca, let me answer your question about Jyseleca. In Japan, we have a partner, Gilead.
We are co-promoting this drug with them. Far, we have been reporting track record, actual results.
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, could you please teach me?
Terushige Iike
When we disclose the forecast for some products which can be determined by Eisai alone, but others by Eisai not alone, we are able to disclose actual results. However, we are not able to disclose any forecast because of the partnering.
Understood. Another question is about Movicol.
Based on the forecast, it has been increased to the top ranking of products. How do you analyze, and what is the reason for this?
Moderator
Mr. Yusa is going to respond.
Toshihiko Yusa
Sales of Movicol is increasing, and are you asking about the reason why we see such increase? Yes, I am in charge of Japanese business, Yusa is saying.
Regarding constipation market, GOOFICE and Movicol, both grew for fiscal year 2025. The market itself grew significantly, and both of the drugs, compared to competitors' drugs, were very efficacious and a safety profile was more favorable, so that is highly evaluated.
Movicol, at the time of testing, Movicol is utilized together with the testing agent. Therefore, the market is increasing, and compared to other companies' products, Movicol is increasing.
Sorry again, for it is utilized in combination with test, could you please explain?
Toshihiko Yusa
The lower digestive tract, Movicol, colorectal colonoscopy, patient have to excrete. In such case, Movicol is utilized for removing the feces, so that's why we are seeing the increase in the sales.
Thank you very much. Another question, for the main body of the slide deck, could you please open page 8, serplulimab.
For future development in Japan, by the end of fiscal year 2026, ES-SCLC, small cell lung cancer, the submission is planned for FY 2026 in Japan. Could you please give us timeline for this?
If possible, when do you expect to launch this product?
Moderator
For your question, Mr. Yusa is going to respond.
Toshihiko Yusa
Thank you very much for your question. In Japan, regarding serplulimab, schedule for getting approval is not disclosed yet.
Having said that, for the first part of your question about the lung cell cancer, ES-SCLC, we have obtained favorable data already, in early course, we believe we will be able to proceed with a development for this indication. Thank you very much.
Moderator
Yes, next question, please.
I'm Izawa from Asahi Shimbun. There was an earlier question, a follow-up question about N-MFN price in the US.
What is the impact? Is there going to be an impact of drug loss where there will be fewer new drugs launched in Japan as a result of MFN in the US?
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 MFN price policy in the US? What is your outlook, please?
Haruo Naito
I am not sure if I understood your question. If you could speak up, I would appreciate it.
Sorry, I am Izawa from Asahi Shimbun. I have a question regarding MFN price in the US.
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 US? Do you have any policies to address this?
Haruo Naito
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 an 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 UK, as a result of bilateral negotiations, the view of the UK about the consideration for innovation has undergone 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?
Yes, thank you. In Japanese NHI...
Moderator
We are conscious of time, 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.
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