We would like to begin Investor Day corporate strategy. This is held in hybrid format, including in-person attendance and virtual attendance. Those of you who are attending in person, we have distributed presentation materials. For those of you who are participating online, please find materials on our website. Today, there will be simultaneous interpretation between Japanese and English. Those of you who are attending virtually and also in person, please select the language of your preference. Let me introduce the presenters. Mr. Keisuke Naito, COO and Chief Growth Officer. Dr. Katsutoshi Ido, Chief Scientific Officer. Mr. Takuya Oyama, Chief Financial Officer and Chief IR Officer. First, COO, Mr. Naito, will discuss long-term vision and the 3-year plan, which is based on the long-term vision, which will be followed by presentation by Dr. Ido, Chief Scientific Officer, to discuss a drug discovery R&D that supports long-term growth.
Mr. Oyama, Chief Financial Officer, will discuss business growth and value creation, which are supported by new financial policy. At the end, Mr. Naito, COO, will summarize the three-year plan. Mr. Naito, COO, please.
Hello, everyone. I am Keisuke Naito, COO for Eisai. Thank you very much for gathering to participate in this Investor Day on corporate strategy of Eisai Company Limited. Today, I'd like to talk about the long-term vision based upon how this company is supposed to spend under this long-term vision for the coming three years. Next slide, please. First of all, we at Eisai, how Eisai has advanced the drug discovery in the field of Alzheimer's disease and how our understanding of AD has evolved. This is what I'd like to explain using this slide.
By advancing the drug discovery from Aricept to LEQEMBI, we have pioneered an era of addressing dementia through medical care and have further moved toward an era in which AD is understood not merely a set of symptoms, but as a disease entity defined by biomarkers. In the 1960s, dementia was not well understood, and patients were treated as misunderstood and isolated individuals. Descriptions of this harsh reality can still be found in books from that era. Later in the 1980s, the acetylcholine hypothesis was proposed, and in 1983, we began our drug discovery efforts. In 1996, Aricept was approved in the United States. Aricept was a major step forward in pioneering an era where dementia is addressed through medical care. Against the backdrop of these medical advances, society's understanding of dementia also evolved, and in 2004, the term was changed from senility to dementia.
At the same time, the challenge of addressing the underlying pathology of AD was extremely difficult. In 1992, the amyloid beta hypothesis was proposed, and a drug discovery for AD disease-modifying therapies began. However, since then, 117 development projects have failed worldwide, with a cumulative total of $42.5 billion invested in research and development. Despite this, Eisai did not give up on the challenge, and in 2023, LEQEMBI was approved. This marks a major step toward an era where we can address the underlying pathology of dementia. Also, in 2023, the Basic Act on Dementia was enacted, advancing efforts to realize an inclusive society where people with dementia can live with hope.
From Aricept to LEQEMBI, through the evolution of drug discovery, Eisai has pioneered an era of addressing dementia through medicine and has further advanced toward an era where AD is understood not merely as a set of symptoms, but as a pathophysiology defined by biomarkers. We will continue to contribute to the evolution of medical care for dementia. Next, please. Now, I have mentioned that AD is now regarded as a set of biomarkers to define the disease and ATN. Now this ATN is regarded as very important in viewing the disease dementia as a set of biomarkers describing it. Now, in AD, we believe that it is a pathological condition that progresses continuously even before symptoms manifest, and it is crucial to view AD not as a disease that is recognized only after symptoms appear.
In AD, amyloid beta first accumulates abnormally in the brain, forming senile plaques. This appears quite early in the pathological progression of AD and is considered an upstream event that promotes downstream tau pathology and neurotoxicity. Biomarkers such as amyloid beta 42/40 and p-tau217 are crucial for detecting this amyloid beta pathology. Next is tau pathology. Tau is a protein that normally stabilizes microtubules, but in AD, it undergoes abnormal phosphorylation within neurons and accumulates as neurofibrillary tangles. It is believed that the spread of tau pathology correlates more strongly with cognitive decline and symptom progression than amyloid beta itself. Here, biomarkers such as p-tau205 and eMTBR-tau243 serve as clues for assessing tau pathology. Further downstream, neurodegeneration progresses, leading to synaptic dysfunction, neuronal injury, and brain atrophy. This is the pathological process most directly linked to cognitive decline.
NfL and neurogranin are biomarkers used to assess such neurodegeneration and synaptic dysfunction. Thus, our treatment strategy is based on the premise of viewing AD as a continuum of amyloid beta pathology, tau pathology, and neurodegeneration, and monitoring each of these stages using biomarkers. Next, please. The Brain Health Panel , the data bank, based upon the data captured through our trials and relationship with the patient so far. By utilizing the BHP, we aim to capture the pathophysiology of dementia earlier and more objectively through liquid biomarkers. As I said, we assess amyloid beta pathology using amyloid beta 42/40 and p-tau217, tau pathology using p-tau205 and eMTBR-tau243, and neurodegeneration and synaptic dysfunction using NfL and neurogranin. Building on this, we are advancing ATN, amyloid beta, tau, and neurodegeneration as a treatment strategy targeting these. At the core of this strategy is LEQEMBI, an anti-amyloid beta antibody.
In the preclinical study stage of AD, before symptoms appear, it aims to prevent the accumulation of amyloid beta and ultimately prevent the onset of AD. Furthermore, even in stages where amyloid beta has already accumulated, it aims to slow disease progression by removing the pathology. Next is etalanetug, an anti-tau antibody. It seeks to halt the progression of AD by inhibiting the propagation of tau pathology. Furthermore, E2511, a synaptic regenerant, aims to restore cognitive function by promoting the regeneration of synaptic function through TrkA stimulation. In this way, BHP visualizes the pathological mechanisms of AD, and through LEQEMBI, etalanetug, and E2511, we intervene in stages targeting A-beta, tau, and neurodegeneration. Under this treatment strategy, we will continue to strive to realize and make AD a curable disease. Next, please. This challenge to address the AD continuum is at the core of our long-term vision.
Eisai will integrate biomarkers, data technology, and ecosystems centered on the drug discovery technologies we have cultivated to date. Through this, we aim to detect the diseases earlier and control them more precisely. In AD, starting with LEQEMBI, we will strive to detect the disease before symptoms appear, slow its progression, and ultimately move towards making it a treatable condition. In oncology, we are committed to reducing patient anxiety and recurrence and expanding the possibilities of a cure because anxiety about recurrence has continued to be a concern or anxiety for patients for many years. Furthermore, through the control of neurological conditions that end up being brain health, we will contribute not only to treating the disease itself but also to improving the quality of life and the time people can spend living as their true selves.
Our goal is to reduce the time taken away by illness and expand the time each individual can spend living their own lives. This is our long-term vision and the underlying philosophy for the three-year plan we will explain now. Next, please. In order to realize this long-term vision, how we are going to spend fiscal years 2026-2028. You can see the simple summarization. As I said earlier, long-term vision, for example, make AD a curable disease. E2511 will be developed. It will take time and cost. With that, now sustainable growth of the company is going to be very crucial for us over the coming three years. Building on the growth of LEQEMBI, we will continue to invest in our priority pipeline while strengthening our management base under new financial policy. First, the business growth, product development, and third, strengthening our management base.
These are the main pillars of our plan under this three-year plan, creating a base for sustainable growth. On the business front, we will focus on organic growth centered on our three L products: LEQEMBI, LENVIMA, and DAYVIGO. In product development, we will work to strengthen our pipeline in the neurology and oncology field in drug discovery, as well as expand our non-drug discovery efforts. Regarding our management base, we will improve profitability and capital efficiency by enhancing cost competitiveness, strengthening headquarters functions, and introducing new financial policy. For fiscal year 2028, we are targeting revenue of JPY 1 trillion and a core operating profit of JPY 90 billion. Starting in fiscal year 2029 and onwards, we will drive growth through the next-generation products following LEQEMBI and LENVIMA, as well as the expansion of our pipeline. Next, please.
It is very important for us to review what was last year's performance, FY 2025. If you look at the top left, this is what we presented at the 2004 information meeting. There are various milestones. An assumption for the business milestones and how these milestones have progressed are shown here. This is a very busy slide, so let me summarize. Overall, we made significant progress in strengthening our growth foundation and advancing structural transformation. The three products led by LEQEMBI drove growth and accelerated a shift to an organic revenue model that does not rely on one-time income. At the same time, we implemented structural reforms focused on R&D expenses, internalized and standardized core IT operations through the establishment of a GCC, Global Capability Centre, and pursued disciplined balance sheet management. We also achieved several key milestones in our business.
LEQEMBI grew steadily across all regions, achieving full-year revenue approximately double that of the previous fiscal year. We announced efficacy and safety data up to 48 months, obtained U.S. approval of and launched IQLIK for maintenance treatment, filed applications for initiation treatment in the U.S., Japan, and China, and there was advancement in the diagnostic environment using blood-based biomarkers. Regarding LENVIMA, we grew and maintained sales across all regions, exceeding our full-year forecast for FY 2025. In the U.S., we achieved revenue growth while absorbing the impact of the IRA. Looking ahead, we anticipate adding a new indication of second-line treatment for renal cell carcinoma based on the LITESPARK-011 study. In our pipeline, phase III trials for lecanemab and etalanetug are progressing smoothly, and we achieved LPI in the phase II study of etalanetug for sporadic Alzheimer's disease.
We have also initiated a phase II study for lemborexant. In oncology, we have strengthened our pipeline through the in-licensing of two products. Next. Here, we will discuss our long-term vision, as I have already explained. Regarding the three-year plan that is positioned or designed to put this long-term vision into action. We will prioritize enhancing our execution capabilities to achieve the long-term vision, managing the businesses flexibly based on multiple scenarios, and ensuring highly transparent financial management and progress monitoring. Furthermore, given the significant changes in the business environment, we will not view the plan as fixed, but will update and roll forward annually in an optimal flexible manner, taking into account changes in the external environment. The main point that I'd like to share with you is for the three-year plan covering 2026 through to FY 2028, how we are going to spend hree years.
Regarding this plan, which is expected to be rolled forward and updated every year. Next, please. As I mentioned earlier, out of the three main pillars, I'd like to explain one after another. Regarding the business growth, we will position the three products, LEQEMBI, LENVIMA, and DAYVIGO, as the core of our growth and achieve steady revenue expansion from our existing businesses. In FY 2025, revenue was JPY 825.4 billion, and core operating profit was JPY 50.1 billion. We aim for JPY 1 trillion level in revenue and JPY 90 billion in core operating profit in FY 2028 through the growth of the three products. What we believe is important is the quality of profit growth. We aim to increase our core operating profit significantly. Organic growth, not depending on the one-time growth or income.
Furthermore, the share of three products in total revenue is expected to rise from about 60% in FY 2025 to approximately 70% in FY 2028. By maximizing the value of these three products, we will achieve both top-line growth and improved profitability, thereby strengthening the foundation for sustainable growth. From now on, I will explain the growth outlook for each of the three products and the business milestones that support them. First, I will discuss LEQEMBI, which serves as the starting point for our growth. LEQEMBI is an anti-amyloid beta antibody eligible for long-term treatment. It slows the progression of AD by removing amyloid beta protofibrils and amyloid plaques, which have been reported to be neurotoxic, and slows the decline in cognitive and daily functioning.
Revenue for fiscal year 2025 was JPY 88 billion. By fiscal year 2028, we expect that the prescribing physician base is expected to expand through the broader use of SC-AI BBM for confirmatory diagnosis and the accumulation of real-world evidence. As a result, we expect to establish a position as the standard of care in the AAT, anti-amyloid therapy market, and a project sales of JPY 300 billion level. As a business milestone for SC-AI, we expect it will be used for initiation treatment in at home and care facility settings across many regions, advancing the home administration environment. Additionally, we aim for it to be listed in the formularies with the majority of insurance companies under Medicare Part D in the U.S. In terms of diagnosis and treatment pathways, we will promote the adoption of confirmatory diagnosis using BBM for amyloid beta testing with insurance reimbursement in major countries.
Through DTC awareness activities, advancement in digital cognitive assessment, and confirmatory diagnosis using BBM, diagnosis in primary care setting will be expanded, and by standardizing MCI treatment, earlier consultation and referral will be facilitated. We expect to obtain top-line results from a AHEAD 3-45 study targeting preclinical AD to confirm the value of earlier treatment intervention. Next, DAYVIGO. DAYVIGO is an orexin receptor antagonist developed from an in-house drug discovery platform targeting the orexin pathway, which is involved in regulating sleep and wakefulness. Revenue for fiscal year 2025 was JPY 64.3 billion. We aim to establish it as a blockbuster product, generating JPY 100 billion level revenue by fiscal year 2028. As the blockbuster product. To achieve this, we will maintain our position as the leading brand in the insomnia treatment market in Japan. In the Americas, including Canada, we will drive growth through commercial strategies centered on digital initiatives.
In China, we anticipate a significant expansion in sales volume following inclusion in the NRDL, National Reimbursement Drug List. In addition, we will expand into new markets such as Europe, South Korea, and Brazil, broadening our growth drivers overseas in addition to Japan. Finally, LENVIMA. LENVIMA is an in-house developed oral multi-kinase inhibitor with seven indications in five cancer types. We have expanded patient contribution with monotherapy and combination therapies with KEYTRUDA. Revenue in fiscal 2025 was JPY 342.5 billion. In fiscal 2028, even after taking into account LOE in various countries and impact from healthcare policies, we aim to achieve JPY 250 billion level revenue. There are two factors behind maintaining growth. The first is potential additional indications in advanced RCC based on LITESPARK-011 study. Secondly, favorable court decisions and settlement agreements related to high purity compound patent in the U.S.
Generic versions of LENVIMA are not expected to launch in the U.S. until at least July 1, 2030, unless certain other conditions occur. On the other hand, in the U.S., the impact of IRA price reduction in the U.S. is factored in. In multiple countries across Europe and Asia, sales share is expected to decline due to LOE. After taking these impacts into account, we will continue to maximize the value of LENVIMA. Next, the second pillar, product development, in particular, strengthening of R&D pipeline. Leveraging human biology, integrating data in AI, we have developed common platform. Using that advantage, we will achieve both increased success probability in drug discovery and faster development speed. With that, we will strengthen R&D platform supporting sustainable growth. We will steadily build regulatory approval submission, clinical introduction by fiscal 2028 by redeveloping pipeline to strengthen growth foundation.
In particular, neurology and oncology are strategic areas, and we will leverage the strength of both to advance development. Especially in neurology, we will pursue a next-generation drug discovery in additional indication of LEQEMBI and by utilizing abnormal protein and orexin knowledge. In oncology, LENVIMA value will be maximized, and in-licensing development will be promoted to enhance pipeline. We will also strengthen external collaboration and exploratory work. We will also achieve improved success probability in drug discovery and enhance pipeline by utilizing AI and data foundation. It is also important to achieve growth investment and improved efficiency. Through partnering and by optimizing development capability and resource allocation, necessary investment will be made, and cost will be appropriately controlled to improve productivity in R&D. In the non-pharmacological R&D, non-drug R&D, in each area, there are different anxieties.
In cognitive area, in each stage of healthiness in healthy state at high risk. After incidence, treatment, nursing care, and prognosis. We are focused on these anxieties that cannot be eliminated simply with pharmacology. These anxieties that cannot be eliminated with a drug will be confronted in our three-year plan. Across healthcare, nursing care, and daily living, ecosystem will be built as a platform.
Promote elderly welfare domain to expand value in nursing care and home care. In ecosystem platform, cognitive function check, treatment support, data collaboration will be utilized to assist early noticing of changes, consultation, access of care, and treatments. In doing so, we will develop environment where there will be timely, easy access to medical care for people who need such care. In elderly welfare domain, we will increase touchpoints with care facilities and home and accumulate daily living information to improve quality of care and improve operational efficiency to detect changes in daily life early on to facilitate access to medical care. We will utilize these data and touchpoints to visualize quality of disease and achieve tailored care and drug discovery insights.
In the future, it will not be limited to cognitive dementia area, but including sleep area, personalized medicine, boosting pharmacological businesses, and new creation of revenue will be aimed at. Next, to strengthen management of business, we will enhance profitability through cost structure reform. Namely, under MQT, manufacturing quality and technology, CMC integrated strategy will be promoted to reform production structure and enhance supply strategy. In doing so, production efficiency will be improved, and structural cost reduction will be achieved, especially focusing on LEQEMBI. Manufacturing process will be improved, and production efficiency will be enhanced to improve cost competitiveness of antibody medicine. High quality, stable supply, cost competitiveness will be achieved at the same time to support higher earnings power and sustainable growth. Next, we will optimize management foundation. Three L, further maximization of value will be promoted through global portfolio management structure.
In the past years, in 2024, 2025, global structure reform was implemented. In leveraging that impact, we will further optimize regional organization and operational structure. Eisai Knowledge Centre, India has GCC IT core operation in-housing. Standardization will be used, leveraging GCC to advance company-wide operations. Financial policy is also revamped to advance capital allocation and investment decisions. Company-wide decision-making capabilities and capital efficiency will be improved. This is a busy slide. This is the summary of overall picture. As I've mentioned at the outset, we consider the next three years to be the period of solidifying foundation for long-term growth. Starting from LEQEMBI growth, we are investing in strategic pipeline. We will also pursue new financial policy. Through this, we will strengthen management foundation to achieve sustainable growth as drug discovery company. This is the period for solidifying foundation.
The uniqueness of and strength of Eisai includes our past development in the area of AD. Such distinctive challenges have been taken on by Eisai, and we will continue to do so by further strengthening our competitive edge over long term. That will be what we will be pursuing the next three years. As for numerical targets in fiscal 2028, on a consolidated basis, JPY 1 trillion in revenue, JPY 90 billion in core operating profit are the targets. In organic business for LEQEMBI, by utilizing SC formulation and BBM for confirmatory diagnosis, we aim to solidify the position as standard of care in AD market and aim to achieve JPY 300 billion in sales. DAYVIGO aims to achieve its position as blockbuster product to achieve JPY 100 billion revenue. Through continuous patient contribution, we aim to maintain JPY 250 billion level for LENVIMA.
In next generation pipeline, LEQEMBI preclinical AD indication, etalanetug, ledasorexton, strong development will be accelerated so that we can aim to file submission in fiscal 2028. In E2511, brain function recovery will be aimed at. Orexin platform will be utilized to normalize brain function. Utilizing in-licensed assets in oncology and also MRD focused in-house assets, we will enhance pipeline. To support a sustainable corporate value enhancement, we will also diversify financing methods and strengthen our balance sheet management and refresh the financial policy, including revamped indicators for financial management. Next, CSO.
This is Ido, CSO. I am Ido, and from here on, I will explain how we plan to build our next growth pipeline in the neurology and oncology areas based on Eisai's deep understanding of human biology cultivated over many years. Our R&D team will aim at continuously generating submissions, approvals, and clinical launches through fiscal 2028, thereby evolving and expanding our pipeline. In the neurology field, our goal is to control brain pathology and function to support brain health in the era of a 100-year lifespan. At the core of this is Make AD a Curable Disease. With LEQEMBI, we aim to prevent the disease onset by developing SC-AI and initiating initial treatment at an earlier stage in preclinical AD. Furthermore, we will tackle the challenge of controlling tau, one of the two major pathologies alongside amyloid beta, to halt the disease progression.
Furthermore, we will expand our drug discovery efforts to include the restoration of neurological function and accumulation of abnormal proteins such as alpha-synuclein. We are also working on the control of neurological function based on sleep and wakefulness. Building on the orexin platform established with lemborexant, we have created ledasorexton, an orexin 2 receptor agonist. Leveraging this foundation, we will advance the creation of next-generation novel drugs. In the oncology field, we view cancer as a continuum and aim for medical care that encompasses everything from prevention to treatment. In addition to expanding the indications for LENVIMA, we are advancing drug discovery centered on minimal residual disease, MRD, microscopic residual lesions that remain at levels undetectable by imaging after treatment. To achieve these goals, we will concentrate resources on priority areas and combine in-house drug discovery with product in-licensing and strategic partnerships.
We will explain how we view AD and where we plan to intervene in order to realize Make AD a Curable Disease. The figure below illustrates the progression of AD from left to right. Amyloid beta protofibrils, which form due to amyloid aggregation, trigger a tau cascade involving downstream tau aggregation. Subsequently, tau aggregates mature, and MTBR-tau seeds propagate throughout the brain, causing neurodegeneration and resulting in cognitive decline. We have been working to visualize this continuum. Using the brain health panel, which combines blood-based biomarkers, we aim to determine which stage of AD a patient is in and which pathological processes are active so that we can deliver the appropriate treatment at the right timing. We intervene in this AD continuum in four ways, as you see above. Approach one involves early administration of lecanemab in preclinical AD to prevent the onset of the disease.
Approach two uses lecanemab, which is currently approved to slow disease progression. After the onset of the disease, approach two through four come. Number three is an approach that uses the anti-MTBR-tau antibody etalanetug to suppress tau propagation and halt the disease progression. The fourth approach focuses on restoring neural function and enhancing brain resilience. One of the assets that will realize this concept is E2511, a small molecule designed to enhance signaling through the neurotrophic factor receptor TrkA and reactivate the damaged neural function. We view AD as a pathological cascade involving amyloid and tau, visualize the pathology, including neurodegeneration, and intervene based on the patient's condition. This is the path towards Make AD a Curable Disease, transforming AD into a more treatable disease. Next, I will explain etalanetug, the compound on which we are focusing our efforts in tau-targeting drug discovery.
In AD, the spread of tau pathology within the brain is strongly correlated with cognitive decline and the progression of clinical symptoms, as shown in the figure on the left. The key process is the propagation in which tau aggregates, forms neurofibrillary tangles, and spreads to surrounding neurons. The key to this process is MTBR-tau. The regions labeled R1 through R4 in the figure on the right represent the microtubule binding region, MTBR, which serves as the core of tau aggregates and plays a critical role in the propagation of the pathology. etalanetug is an antibody that targets pathogenic tau seeds containing this MTBR. While tau fragments of various lengths exist outside of nerve cells, only a limited number of tau species contribute to the spread of pathology.
For example, fragments from the N-terminal end on the far left to the middle region are not believed to play a major role in propagation activity, and targeting them alone may not be sufficient to suppress propagation. etalanetug, on the other hand, aims to directly suppress propagation between neurons by targeting the core that is released extracellularly and spreads tau pathology. Its key feature is that it targets the specific steps of pathological propagation without reducing total intracellular tau, thereby leaving physiologically necessary tau unaffected. As we reported last year, in a phase I-B trial involving patients with DIAD, dominantly inherited AD, we confirmed the reductions in multiple tau pathology-related biomarkers, including eMTBR-tau243, which is included in Alzheimer's Association's revised criteria, as well as a decrease in tau PET levels, thereby achieving proof of mechanism.
A phase II trial targeting sporadic AD is currently underway, and we expect to obtain top-line data during fiscal year 2027.
I would like to turn to the orexin drug discovery, which focuses on wakefulness and sleep. Orexin is an important neurotransmitter that supports wakeful state. Narcolepsy has a strong drowsiness because of the insufficient function of this. Ledasorexton E2086 is an agonist stimulating orexin 2 receptor. Lemborexant suppresses orexin signal to induce sleep, whereas ledasorexton aims to enhance awakeful signal during the day. The graph on the right shows type 1 narcolepsy patient to see how long patients were able to stay awake in a sleep-conducive environment. Vertical white bar is placebo, black bar is modafinil. Against placebo and modafinil, significant sleep latency was extended, especially in 10 mg and 25 mg, more than 30 minutes of wakefulness was maintained, showing strong arousal promotion effect. In once daily administration, we aim to develop this as a drug that can support wakefulness during the day.
Far, hepatic function disorder or visual disorder have not been observed. For over 20 years, Eisai has developed orexin biology, achieving clinical PoM for insomnia with suvorexant and narcolepsy with ledasorexton. We will link this knowledge with brain function regulation, supporting daytime activities and neurodegeneration to lead to the next discovery of new drug. I will now turn to modalities and technologies supporting Eisai's R&D. In this slide, I will introduce in-house developed brain penetrant shuttle that will expand the possibilities of antibody drug discovery in CNS area. Through LEQEMBI, we have shown that we can intervene in the AD pathology with antibody. Going forward, we will further advance antibody drug discovery so that with smaller dose, effect will be delivered to targets in the brain more efficiently, hence proceeding with brain penetrant shuttle technology development and project development.
The shuttle antibody utilizes biological mechanism of RMT or receptor-mediated transcytosis of the living body, as shown on right in the blood vessel, and at the top is blood vessel. Inside the blood vessel, they will be binding with receptor and then will be taken up in the cells and will be dissociated within endosome rapidly before released to the brain side. Efficiently antibody is shuttled. As a delivery platform of antibody drug targeting CNS, we aim to create projects. Another is a small molecule drug. Small molecule drug discovery is increasing in value once again as a result of technological innovations in recent years. Proximity-inducing molecules and RNA-targeted small molecules are examples of areas where new drug discovery potential is increasing. In CNS area, a long-term administration is necessary to reduce burdens on the patients.
Small molecule which can be available orally is quite important. We believe that small molecule will continue to be at the core of drug discovery. Eisai has strength in small molecule drug discovery and was the first company to discover the function of molecular adhesive in disulam and has accumulated expertise in this area. After Aricept, we also have experienced launching eight in-house small molecule drugs. In addition, in CNS, we have data accumulated over many years, which led to proprietary AI and exploration of new mechanism of action to become able to target heretofore difficult to target areas. For AD, orally available small molecule disease modifier, the ultimate modality realization is aimed in our ongoing research. Leveraging such strengths, we aim to create new treatment value through small molecule drug discovery.
The strength supporting Eisai's drug discovery includes clinical development capabilities and reverse translation capability, which uses human data obtained in clinical research to the next drug discovery. At the core of this is molecular profiling. Eisai has the world's highest analytical technology that can detect trace biomarkers that reflect amyloid and tau pathology in the brain. With this technology, we are able to develop eMTBR-tau243, which is plasma biomarker reflecting tau pathology in the brain, which before was able to be measured only with tau PET, and this marker is now used in clinical research. We are also analyzing human biospecimen with a mass spectrometry-based proteomics. The data obtained from large clinical studies are analyzed in this way to understand at molecular level effect of drugs on pathology.
We are comprehensively analyzing in-house clinical study samples to realize a pharmacological value and identify targets and pathway that lead to pharmacological effect to improve success probability of next generation drug discovery. Another is AI usage supported by in-house clinical trial to support clinical development capabilities. An algorithm that is clinically applied to predict blood biomarker in AD pathology at the etalanetug targets tau, in the clinical trials, positive tau pathology patients have to be enrolled. Tau PET was necessary, which was time-consuming and costly. LEQEMBI clinical trial data was utilized to predict in-brain amyloid path based on blood biomarker p-tau217. Tau PET positive tau propagating stage patients are screened with our proprietary algorithm, which is now used in etalanetug study.
Molecular profiling and AI are used for high precision patient selection, dose setting, and progression prediction to eliminate waste and conduct design of the study in efficient way, which is our strength. Turning to oncology. In oncology, as next generation drug discovery, we are targeting MRD or minimal residual disease. We decided to focus our efforts on this area, so I would like to introduce that. As shown in the diagram at the bottom, at the time of the diagnosis, detectable volume of cancer cells exist in the body. After surgery and pharmacological therapy, cancer cells will be diminished greatly, but a complete elimination is not achieved. In a level not detectable in imaging testing, minuscule volume of cancer cells remain, which is MRD. This proliferates and will become a clinically detectable recurrence and metastasis. MRD will inhibit a cure in early stage cancer.
After metastasis, it will lead to faster progression of the disease. Hence, very important biology. Eisai is looking at this MRD biology, which became understandable through long-term treatment data of LENVIMA. We would like to elucidate why MRD survives and how it acquires treatment resistance to identify a target and hypothesis. ctDNA and other biomarker analysis, in-house clinical data, human biology will be utilized to develop treatment hypothesis targeting MRD. In addition to in-house research, in-licensing, co-research, joint research will be utilized to enhance next generation MRD pipeline. This slide shows the progression of stage of major pipeline projects from fiscal 2026 to fiscal 2028. White box shows the current status, and colored boxes are status that we aim to achieve in fiscal 2028. In neurology, towards Make AD Curable, at each stage of AD continuum, there will be interventions in this multi-layered pipeline.
In amyloid, we aim to achieve top line in lecanemab preclinical AD, and new amyloid projects should be in phase I for small molecule and brain penetrant antibody. In tau, etalanetug, DIAN-TU phase II/III study on DIAD. Top line results are aimed to be obtained in sporadic AD. We also aim to steadily progress phase III in neurodegeneration. E2511 is to be advanced to phase II to make concrete development in the approach of neural function recovery. In orexin, targeting regulatory submission of ledasorexton, and also through new projects. We would like to expand our efforts to neural state regulation, not only sleep and wakefulness, but daytime functions. In oncology, taletrectinib and serplulimab approval are included in our targets. In addition to clinical team promotion focusing on MRD biology, we would like to start in-house project in the clinical stage and through structural partnering, develop a next generation pipeline.
This is my final slide. In the next three years, starting with AI chemo biology, we will develop next-generation pipeline and grow them to sustainable growth drivers. For that, in-house clinical data, molecular profiling, and drug discovery, clinical development capabilities, modality creation capabilities cultivated in oncology and neurology area will be brought to bear. We will steadily achieve regulatory submission, approval, and clinical introduction to lead to growth beyond fiscal 2028. New financial policies will be presented by Mr. Oyama.
Myself, I, as the CFO, Oyama is going to explain financial section. First, on this page, I will explain our consolidated profit and loss targets for fiscal year 2028. In fiscal year 2028, driven by the growth of the three L products centered on LEQEMBI, we aim to achieve record high revenue of JPY 1 trillion.
We project the cost of sales at JPY 300 billion and a cost of sales ratio to revenue of 30%. Although the cost ratio is expected to rise due to changes in the product mix, we will mitigate the increase through cost reduction measures centered on LEQEMBI. We project R&D expenses at JPY 170 billion. While actively investing in next generation priority development products, we will control overall expenses in the high teen percentage range through cost optimization. We expect SG&A expenses to be JPY 440 billion. Although these expenses will fluctuate due to the profit sharing for LENVIMA and LEQEMBI, we will control them at a level comparable to fiscal 2026 by transitioning to a more efficient cost structure through structural reforms carried out primarily in Europe and the U.S. in fiscal 2024 and 2025. Our FY 2028 targets do not include one-time gains.
We aim for both operating profit and core operating profit to reach JPY 90 billion, targeting sustainable growth through our organic business and the establishment of profit base for the future. As for capital efficiency metrics, we estimate an adjusted ROIC of 9% based on a net debt of JPY 100 billion. While we will utilize debt for growth investments, we will control it within the target range. Next. From now on, I will explain our new financial policy, which was partially introduced at our recent earnings call.
The diagram illustrates the concept behind the new financial policy. As a general principle, we will use operating cash flow to fund our own R&D, capital expenditures, and shareholder returns while allocating financial cash flow to investments in product in-licensing and M&A. We will use financing to support our growth strategy and enhance corporate value. On this page, I will first explain how we are diversifying financing sources. While the company has historically relied primarily on bank loans for funding, we are now promoting the diversification of funding sources to finance investments in in-licensed products and other initiatives aimed at further business growth. As part of this effort, we plan to issue domestic straight bonds. In preparation for our first bond issuance in 18 years since 2008, we have filed a shelf registration and made an announcement regarding the bond offering.
We plan to offer bonds with maturities of five, seven, and 10 years for a total issuance amount of JPY 50 billion, with pricing expected to be finalized early June at earliest. We are also considering multiple options, including senior and subordinated bonds denominated in yen and foreign currencies. Going forward, we will continue to secure investment funds in a stable and flexible manner through diverse financing methods in response to market conditions and investment opportunities. This page explains the redesign of our performance indicators. Regarding core operating profit, while we have previously referred to profit from organic business as representing ordinary profitability, we have not clearly defined this term or disclosed the specific figures. Therefore, we have decided to define core operating profit as an indicator of ordinary profitability and to disclose it.
We will exclude five temporary income and expense items not directly attributable to future earnings from operating profit. In addition, with the introduction of core operating profit, we are also reviewing our capital efficiency metrics. While we have previously disclosed a target ROE, we are introducing adjusted ROIC as a metric more closely linked to medium to long-term corporate value and will use it alongside ROE to monitor medium to long-term capital efficiency. 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 the translation adjustments account for about 30% of our equity, which was impairing the comparability of ROE, we exclude it from the calculation of adjusted ROIC.
For fiscal 2028, we aim for core operating profit of JPY 90 billion and target an adjusted ROIC of 9%, assuming net debt of JPY 100 billion. Turning to strengthening of balance sheet management. While utilizing debt, financial soundness will be maintained. Through three measures and actions, we aim to enhance capital efficiency. First, global cash management system will be made use of even more to improve efficiency of the funds and eliminate the concentration of funds via dividends and others. Second is improvement in cash conversion cycle of Eisai. This has become prolonged, mainly due to LEQEMBI. Inventory level optimization will be promoted to shorten the cycle. Third is compression of translation adjustment. Foreign currency translation adjustment has become large and accounts for more than 30% of equity capital. Using measures such as net investment hedges, we will curb increase and promote reductions.
Financial soundness KPI targets are within 0.3 net DER and within 3 x Net Debt-to-EBITDA, based on the assumption that debt will be used for growth investments. Regarding capital efficiency, through the measures and actions I mentioned earlier, we target 8% ROE and adjusted ROIC of 8%-10% in the mid to long term to optimize capital efficiency. This slide describes capital allocation for three years from fiscal 2026. In terms of capital allocation funds, our plan is JPY 800 billion level of operating cash flow before R&D expenses, JPY 80 billion level of net cash, and JPY 300+ billion level of debt capacity, assuming the issuance of senior bonds. As for debt capacity, in addition to straight bonds we are planning to issue in Japan, hybrid bonds are considered for the use in case of large-scale M&A.
Based on this funding, JPY 500 billion in in-house R&D and JPY 500 billion in pipeline enhancement for a total of JPY 1 trillion investment is planned. No specific budget is allocated for M&A, but if there are high-quality deals that will contribute to the growth of Eisai, we will proactively consider executing M&A. In regard to shareholder return, consolidated performance, payout ratio, and free cash flow will be taken into account comprehensively to pay out dividends sustainably and stably. This is the summary of my part. To drive sustainable corporate value enhancement, we will strongly support the R&D and business growth strategies with the new financial policy.
At the end, Mr. Naito will summarize the presentation.
This is the final summary. Eisai positions the three years starting from FY 2026 as a phase to accelerate its transformation into a sustainable growing company. As noted in the articles of incorporation, supporting the lives of the people, that long-term vision remains unchanged. In order to realize this over long term, sustainable growth must be achieved. As a major part of that, we have to ensure business growth. SC-AI, BBM, RWE will be leveraged starting with LEQEMBI. We will establish its position as the standard treatment in the AD market and drive organic growth together with DAYVIGO and LENVIMA. By fiscal 2028, we aim to achieve consolidated revenue of JPY 1 trillion and core operating profit of JPY 90 billion.
In drug discovery R&D, we will focus on key pillars including the AD continuum, A-beta, tau, restoration of brain function, orexin, and MRD, continuously generating regulatory filings, approvals, and clinical implementations, and nurturing the next generation pipeline into future growth drivers. Together with non-drug discovery R&D, we will alleviate people's anxiety and maximize the corporate value, which is a very important area of efforts. Under the new financial policy, we will balance growth investment and capital efficiency through diversification of funding methods, balance sheet management, and the redesign of management control indicators. Over this three-year period, Eisai will further evolve as a drug discovery company with distinctive strength, transforming into an organization that captures diseases earlier, controls them more effectively, and reduces the time people may lose due to illness. That concludes our presentation. Thank you very much for your kind attention.
Now, we would like to open the floor for Q&A session. We would like to invite analysts and investors who are attending in venue. Next, we would like to ask online participants from analysts and investors. Also next, media who are attending in person and the media people who are attending online are expected to ask questions. Please mention your name and affiliation before you are asking questions. Due to the time constraint, and also in order to invite as many people as possible to ask questions, we would like to ask you to limit the number of questions per person at one time to one. Those in the venue, could you please raise your hand if you have any questions?
My name is Hashiguchi. I am from Daiwa Securities. Regarding cash allocation to enhance strengths and pipeline, a JPY 500 billion level will be spent over the coming three years. In specific area or field are you going to put focus on in order to explore the opportunities for investment, could you please elaborate on this? Neurology and oncology, respectively. What is going to be the split between the two areas from early to late stages, or what can be immediately solved? Maybe different opportunities are sought after in neurology and oncology. Could you please give us your broad take on how the investment is going to be split?
Thank you very much for your question. How are we going to invest? We have focus priority areas, as I said earlier, the neurology and oncology. This remains unchanged. As you said, how are we going to allocate investments is going to be changed a little bit, particularly in AD area, which is the area where we have specialty from Dr. Ido, who explained we have a very robust technology capabilities in-house. As regards to oncology, we needed to take on the challenge to prevent the metastasis and the recurrence utilizing the capabilities. As you can see, the opportunities in the later stage and development pipeline, we'd like to also continue to invest. We continue to make a significant contribution in the oncology area, which we believe is very important.
Therefore, we needed to continue investment in order to make it sustainable. For enhancing the pipeline and M&A, these are separated. As you see in the above, the investment to enhance the pipeline. What can be sold now or close to be launched? What is available now for sale or the things in the phase close to the business realization? I think that this is the types of investment we can consider when it comes to enhancing the pipeline. As we mentioned earlier, orexin platform. We have drug discovery platform, which needs to be enhanced through the approaches, including the opportunities of M&A.
We would like to stay alert on exploring those opportunities. Are there any comments from Dr. Ido or Mr. Oyama?
Thank you very much for your question. As has been mentioned, we are focusing on the neurology and oncology areas. Regarding this, first, for oncology, which will continue to be our focus area, and later-stage development or assets close to being approved. Yes, these are the focus areas, and R&D before POC assets are also included in our consideration. In order to enhance the solid pipeline, we will follow up on those assets as well. M&A is also clearly one of the options. Particularly, the exploratory research platform is also considered to be very important going forward. Thank you.
Thank you very much.
Next question, please.
Wakao from JP Morgan. Fiscal 2028 plan, revenue JPY 1 trillion and JPY 90 billion of core operating profit. I have a question on these. In this just described three-year plan, is that you will be reviewing the current state of the business, and you have built a plan which is very realistic and achievable. The point of my question is that in the past, you had certain assumptions. In comparison to the past assumptions, how do these numbers compare? You did not indicate numbers for FY 2028, but according to presentation last year, in FY 2027, OP margin of 10% or above is to be achieved without one-time revenue. Looking at that, based on that, it seems that you have revised the numbers downward. That is my impression. Could you address this? If there were modifications, specifically, what did you revise?
Thank you for your question. Our policy is to strengthen organic business to improve profitability. That policy remains unchanged. We discussed in reviewing fiscal 2025 that we have, including core operating profit, our own capabilities for organic business. In terms of organic business, we believe that we are achieving solid growth. As for medium to long-term growth, we would like to enhance pipeline further, it's not that we will be licensing out without any careful plan. Based on both of these concepts, rather than pursuing just short-term profitability based on one-time revenues, we'll be strengthening organic business. I would like to ask Mr. Oyama if there are any additional comments.
Thank you for your question. JPY 1 trillion and JPY 90 billion targets were determined based on recent conditions, including progress in LEQEMBI and reimbursement status in Europe. As we discussed in earnings presentation session in Europe, we have developed a more conservative plan for the next fiscal year. Based on that, we have reviewed the plans. In comparison to what you have seen in the past, when we look at the numerical values, there may have been some that might have appeared inferior. Given the current situation, we have developed these plans, which are more feasible in terms of achievement.
Thank you. As a follow-up, I believe that towards best scenario, you have the next three years. LEQEMBI SC approval may be delayed than expected. I believe there were a number of factors. Additionally, I would like to ask you regarding your views on peak sales of LEQEMBI. Has it not changed?
We would like to limit the number of questions to one per person.
I will withdraw my question. Thank you.
Next question, please.
This is Seki speaking from UBS Securities. Thank you. Regarding your projection of profits for medium to long term, for the growth in the future, you are going to build the management base, you are going to make a steady investment over the three years. After the three years, LENVIMA will come early, come in 2026, Antag may be launched at the time. You may be working through the partnership, therefore, you may suffer from lower profitability. In the first and second year, the profitability may be compromised. You mentioned the dramatic growth. Of course, the top line should be growing. What is the expectation level should we have regarding the profitability level?
Thank you very much for your question. Well, in generation of the profit, one of the most important points is the reduction of costs. This antibody drug will continue to be the important treatment. E2511 is a small molecule, though. We needed to increase our skills when it comes to manufacturing the antibody drugs. That is where we have expectation. In relation to this, if you have any supplementary comments, Mr. Oyama, please.
Yes. Let me make a supplementary comment. I believe that LEQEMBI is going to make contribution to profitability going forward. As we said last month, in FY 2026, excluding R&D expenses, we said that we are going to turn it around into the profitable business in FY 2026. Going forward, blood-based biomarkers and SC-AI are coming from now on, and showing the cost over sales ratio will be shown, and LEQEMBI itself is expected to grow dramatically.
In addition, we have tau and the narcolepsy treatment will contribute. The oncology, I'm sure that LENVIMA sales are going to decline, so this will be made up for by the management efforts. LEQEMBI's contribution itself is expected very much for when it comes to the contribution to the future profit level.
Thank you.
Moving on to the next question, please.
I'm Ueda from Goldman Sachs. Regarding fiscal 2028 and KPIs, I also have question. I especially would like to ask about cost of goods and cost of manufacturing related to cost. Cost will be increased, and I believe the assumption is a rapid increase in cost of production. For LEQEMBI, is fiscal 2028 going to be the peak? As for R&D spending, in comparison to when LEQEMBI was in development, I believe it is at a lower level, but there will be more late-stage products and there may be in-licensed products, including upfront investment. Should we expect some upward adjustment possibilities? How will we control cost?
Regarding R&D spending, CSO Dr. Ido will explain, and Chief Business Officer Mr. Iike, who is also responsible for production, will address question regarding cost of production.
Thank you for your question. Regarding R&D spending, recently, lecanemab, LEQEMBI-related R&D expenditure is now peaking out, and that is a very large factor. In next generation etalanetug and for ledasorexton , there will be reallocation to these products in the three-year plan that was just presented. Within the amounts that were indicated, we expect the R&D investment to remain. There will be further peaking out of LEQEMBI. In the next five years or so, we will continue with this plan.
Next, about cost, I would like to respond. This is Iike speaking. Product mix will be shifting from that centering around LENVIMA to that centering around LEQEMBI in the next three years. We will see a transition of top product or shift of top product. In terms of cost of goods, small molecule LENVIMA and antibody drug LEQEMBI are different. This change in the product mix is the biggest factor. Cost of goods ratio. Cost ratio, however, can be changed with improved efficiency in antibody production and through control of production cost, and volume will also increase. LEQEMBI cost ratio is to be controlled. That is the assumption. Because of the product mix change, that is why we have these numbers as indicated before.
Thank you.
Are there any questions? We'd like to invite the online participants. Muraoka-san from Morgan Stanley Securities, please unmute yourself and start asking your questions.
Yes, thank you very much. This is Muraoka of Morgan Stanley Securities.
I also would like to ask question about the costs, because up to 30%, the cost ratio is going to increase to 30%, so the cost ratio of LEQEMBI should be above 35%. Royalty in single digit, though, maybe this is the other side of the same coin. Efforts to reduce costs. This is to be manufactured and produced by Biogen. I think there is a limit to what you can do. Also, the U.S. government's policy and the manufacturing ratio in the U.S. must be increased, and that may affect the cost ratio as well. Sorry, digressed a little bit. My question is about this cost ratio. To improve margin of LEQEMBI, working on the reduction of cost of LEQEMBI, what specifically Eisai can do? What is going to be asked to Biogen for their cooperation? Could you please elaborate more specifically?
Yes. Thank you very much. As Eisai, the production efficiency and the packaging, we are considering utilizing our own in-house plants, increasing the utilization ratio of our plants in order to improve the manufacturing costs through collaboration between Eisai and Biogen. We would like to realize that. Mr. Iike, do you have anything to add?
Yes. Thank you very much for your question, Muraoka-san. As you said, regarding the antibody part of LEQEMBI is made by Biogen now. The culture and the purification or improvements or processes are based upon our discussion, of course, led by Biogen, but these will be implemented as an improvement. When it comes to the formulation and the packaging, these will be outsourced to other companies, or we are utilizing our in-house capabilities, which will be further improved. SC or IQLIK, we are working with Terumo.
We ask Terumo to manufacture this device. This will be scaled up through investment by Terumo. This will contribute to the better control over costs.
Understood. Any visible improvements? Do we have to wait until five years, or do you think this can be realized within five years?
No, not so long. We have already seen. We have been already conducting these activities. We will continue to do so.
Thank you very much.
Next, Mr. Yamaguchi from Citigroup Securities, please.
Thank you. This is Yamaguchi from Citi. Can you hear me?
Yes, we can.
Thank you. I have one question. About LEQEMBI, you have given an update. Last fiscal year, JPY [880], and now JPY 143.5 billion. JPY 250 billion-JPY 280 billion, and now JPY 300 billion in FY 2027. It looks like this trajectory is understandable if we exclude the FY 2027 number. Should we look at only 2026, 2027, 2028? The fiscal 2027 number, it seems that this number is off in terms of assumptions from the other numbers. It is a three-year plan, so should we not pay too much attention to the middle year, fiscal 2027, and look at the three year as a whole?
Thank you for your question. On a rolling basis, we will be reviewing the plan, as I have mentioned earlier. For example, amyloid, other BAAT market development will be taken into account. European reimbursement situation in terms of LEQEMBI will also be taken into consideration in describing the outlook in this trajectory. That is the background of the change, as I have explained.
Thank you. I see that you will be revisiting the plan on a rolling basis every year.
Yes.
Thank you.
From Macquarie Capital Securities, Mr. Tony Ren, could you please unmute and ask your question, please?
Hello.
Yes.
Hello, Tony Ren from Macquarie. Can you hear me? Okay, perfect. Thank you for taking my question. On slide 28, you guys mentioned. This is probably a question for Ido-san. You mentioned using MRD, minimal residual disease, for solid tumors based on experience with LEQEMBI. MRD is usually used in slow-progressing indolent blood cancers. In most solid tumors, we would usually look at the overall survival and sometimes together with progression-free survival. Could you explain to us which cancer types do you have in mind with your MRD or ctDNA approach? For example, would it be in colorectal cancer? Would it be in bladder cancer? How do you think this would be used as an endpoint? Would it be added to overall survival or progression-free survival as an endpoint using clinical trials? Thank you.
Thank you very much for your question. As you pointed out, this MRD is particularly utilized for hematological cancer. This is discussed a lot in hematology, but we are not sticking to that. Actually, we have been utilizing the knowledge accumulated in the solid tumor so that we can focus on this MRD in solid tumors as well. As we explained, MRD, perioperative, adjuvant, before or after adjuvant, not only with that, but there are two significance. First one is resectable cancer. The surgery and after the local treatment, MRD will still remain, and that will be removed in order to prevent recurrence and also another advanced progressing cancer, the drug-resistant, treatment-resistant, residual gun. Drug-tolerant persister cancer cells. MRD remains and then this will deteriorate the prognosis. Looking at our data, that has been shown. Particularly regarding LENVIMA, RCC or HCC.
Looking at the data and including the biomarkers of the ctDNA, such data have been analyzed together with other companies. Utilizing such knowledge, we have been able to identify the targets, and therefore, we have decided to run the project, and we would like to enter into the clinical stage over the three years to come. Thank you.
Thank you very much. Appreciate it.
Next. From Bernstein Securities, Ms. Sogi, please.
Thank you. About LEQEMBI IQLIK. Gross margin, I have a question. IQLIK and IV, if you compare the two, antibody volume per patient will be much larger after August. Beyond August, when IQLIK, after approval, I think [LAK] will become identifiable. According to the current pricing strategy, gross margin may be much lower. After fiscal 2028, do you expect gross margin to improve?
Mr. Iike, CBO, will answer.
Ms. Sogi, thank you very much for that question. Regarding gross margin, not today, but in the near future, we would like to discuss gross margin. Prices are different. Distribution channels are also different. It is difficult to make an apple-to-apple comparison. Gross margin that is not too inferior is what we are targeting at. We hope to be able to discuss this at a future timing. Thank you.
After fiscal 2028, on a continuous basis, how do you envision? Do you think that gross margin will continue to improve even beyond fiscal 2028?
Between IV and SC formulation, the volume, and how it is distributed in a country, it all depends on these. I would like to respond at a later date. Thank you.
From SMBC Nikko Securities, Wada-san, please unmute and ask your questions.
Yes. This is Wada of SMBC Nikko Securities. Can you hear me?
Yes, we can.
Thank you very much. I have a question about R&D. Next-generation small molecule drugs. Molecular glue was mentioned in your explanation. Is there any pipeline project which is in the clinical stage? It's a simple question. Is there something, a molecular glue can be made into a platform? I don't think that there are many players globally who are able to roll out horizontally the platform of a molecular glue. Have you established such a molecular glue platform?
Thank you very much. Regarding the clinical pipeline, this is to be utilized for the next-generation development over the coming three years. It's included in the pipeline for the three year.
Ind isulam, which has been developed in oncology, this was found to be molecular glue. Starting from that, we have continued to accumulate our knowledge. This is not something that we are trying to do in-house. Through collaboration with the University of Dundee and utilizing the synthesis capabilities and know-how combined together with them. Also, we have a collaborative research project with startups. To make it into a platform and for running the studies, and not only the chemistry, but including the biology. The compounds will be synthesized in large volume on the plates, and then the biological activity will be studied, and the SAR will be taken in short term, and our chemistry capabilities of Eisai will be combined with it so that we can make it into a platform or pipeline, more visible assets in pipelines.
I hope that we can share with you more updates going forward.
Thank you very much.
Thank you. From the members of the media who are attending in person, we would like to take questions. If you have a question, please raise your hand.
Yes, please. I'm [Itakura] from [Yakuji Nippo]. Innovative clinical trial. I have a question on this. I think this question is addressed to Dr. Ido. AD continuum treatment strategy mentions synapse E2511, synapse regeneration. Synapse regeneration, it's not limited to AD continuum, but a wide-ranging diseases may be applicable, that seems to be the case for amateur, a layperson. Earlier, as a security analyst discussed MRD, question was raised. I understand that this is still not in the clinical development stage, but what kind of drug is this going to be? What do you have in mind?
Thank you for your question. E2511, for the first time, we have presented in detail at this time. Let me introduce the background. This is a TrkA NGF receptor activation synapse, similar to synapse. This is axon, which is a pathway for electricity and protein. This axon may be weak in cells, but a cholinergic neuron expressing a receptor, including that there will be revitalization. The concept is to revitalize that cholinergic activation part including synapse and axon. AD, I think, will be the most suitable disease as an initial target. The underlying philosophy is that biology is common. With the same biology, we can apply same biomarkers and define a disease. What is near to AD is DLB, Lewy body dementia, included other dementia, may be potential targets.
Beyond that, as you've mentioned, based on biology, we would like to expand the target diseases where this can be effective. As for the second part of the question, MRD. In in-house drug discovery, we believe we can utilize our strength in development in MRD. Small molecule, of course, will be targeted. Thank you for your question.
Is this going to be an injectable MRD drug? What is going to be the formulation?
Perhaps at a later date, we hope to be able to provide more detailed information. Orally administered drug will be more convenient for patients, we will target that. Based on mechanism, it may differ, we would like to discuss more in at the future timing.
Any other questions?
My name is Horiguchi. I'm from Nikkan Yakugyo. Thank you very much for your explanation today. If possible, I would like to ask Mr. Naito, COO, the succession of COO. Earlier, CEO Naito suggested that they like to see the dramatic generation change to much younger generation. Currently, including the succession plan, what kind of discussion do you have internally now? If you have anything that you are able to share with me, please.
Thank you very much. We are the company with outside independent directors, so this is not the kind of discussion which can be concluded only among the people inside the organization. I hope you can understand that first. The representative director and senior executive officer, as well as Mr. Iike, who also shares the similar title, and it used to be called the Information Meeting, and now it is called the IR Day on Corporate Strategy. Usually, CEO has been leading the sessions. Today, we are representing the company. Three of us are speaking on the company. We are trying on different styles.
I hope that you get the signs of such next generation management style, which the whole management team is trying to explore. That is what I believe can be shared today. Thank you very much.
We would like to take up the next question, please.
Yeah. Thank you. I'm Tomoaki from Yakuji Nippo. It was not discussed during the presentation today, but if I may, I have a question since I believe this is related to management strategy. 10% of domestic pharmaceutical business is accounted for by generic OTC drug. What is the positioning of OTC business in the next years? Daiichi Sankyo in April said that it will focus on new drug development, and it announced a sales divestiture of OTC business. In addition to pursuing new drug development, you are also engaged in OTC business. What is the benefit? Any recent challenges that you see in OTC business as well?
Thank you for your question. This is an event that was formerly called Information Meeting, and as much as possible, we would like to focus on what was presented in the presentation. On the other hand, I believe that a non-drug R&D is also very important. If I may share my view with you, first, this is the business that Eisai started with in the beginning, and OTC is very important as a contact point for consumers. E2511 was discussed earlier, but in a way, Alzheimer's disease or most diseases are abnormalities, roughly speaking. More broadly, anti-aging is a theme that we can pursue. From that perspective, OTC business is a very important theme. It will continue to be important for Eisai. Thank you.
Any other questions?
We'd like to invite a person, Mochizuki-san from Mix, who is participating online. Could you please unmute yourself and ask a question? Because of the closing time, we would like to make it the last question. Mochizuki of Mix, can you hear me?
Yes. Regarding the management base, I have a question. MQT under the new institutional system, what is the aim of making it a new system and the efficiency improvements, and what is going to be the integrated strategy? By improving the manufacturing efficiency, it is expected to contribute to the profitability of the company. Could you please give us your view on the strategy?
Thank you very much for your question. My response may be overlapping with what we responded, but again, I'd like to ask Iike-san, Chief Business Officer, to respond to your question. Thank you for your question.
So far at Eisai, we say CMC, the API, and formulation, R&D division, and the commercial production division were separate. The corporate officer in charge was also different. Currently, Ms. Akiko Nakahama is leading both manufacturing API formulation, starting from R&D phase through getting approval until the commercial production, all managed under one umbrella. Particularly regarding biologics or antibodies, including LEQEMBI and etalanetug is going also antibody drug. We need to have a continuum. Otherwise, there may be inconsistency, which may lead to inefficiency. Organizationally, that's what we'd like to avoid. Q, meaning quality, is also under the same organization so that we can take integrated manner to eliminate waste and establishment of supply chain from R&D through commercial production, we can adopt the consistent approach.
Do you have any specific numbers as target when it comes to improvement of manufacturing efficiency, for example, some percentage points and so forth?
It will also depend on the product mix. The mixture of cost ratio have been presented by Mr. Oyama today. Of course, we have a much more detailed analysis internally, but what we are able to present to you today is based upon the mixture of different cost ratios of different products.
Thank you very much. Understood.
With this, we'd like to conclude today's Investor Day. If you have any follow-up question, additional question, please contact PR or IR departments of the company. We would like to conclude today's Investor Day on corporate strategy. Thank you very much for taking time out of your busy schedule to participate today. Thank you.