I am Okuda, President and CEO. I will provide a summary of our 2025 performance and the outlook for 2026.

Please refer to slide five. Regarding our full-year results for 2025, revenues, operating profit, and net income all reached record highs on a core basis.

Revenue reached ¥1,257.9 billion, exceeding our initial forecast by 5.7%. This was primarily driven by higher-than-expected exports of Actemra and Hemlibra to Roche.

Operating profit surpassed the ¥600 billion mark for the first time, representing our ninth consecutive year of profit growth. Operating profit margin also hit a record high of 49.5%.

Moving to our 2026 earnings forecast, we anticipate another year of record-breaking results. We are projecting a revenue of ¥1,345 billion, up 6.9% year-on-year, and core operating profit of ¥670 billion, up 7.5% year-on-year, fueled by growth in domestic product sales, royalty income, and other revenue streams.

At the same time, we expect to maintain a high operating profit margin. The next slide illustrates our revenue trends.

We expect revenue to increase by ¥87.1 billion, or 6.9%, compared to 2025. Domestic product sales are projected to raise by ¥25.6 billion as steady growth of new and mainstay products outweighs the negative impacts of NHI price revision and generic competition.

Overseas product sales are expected to remain flat year-on-year, while Nemluvio and Hemlibra will continue to grow. These gains will be offset by lower export unit prices and a decline in Actemra sales due to biosimilar entry.

In contrast, other revenues is set to increase significantly, driven by higher royalty and profit share income from Nemluvio and orforglipron and Hemlibra, alongside an increase in milestone payments. Next is page eight.

I will discuss our dividend policy. Reflecting our strong 2025 performance, we plan a year-end dividend of ¥147 per share.

This includes an ordinary dividend of ¥72, up ¥22 from our initial forecast, and a 100th anniversary commemorative dividend of ¥75. Combined with the interim dividend of ¥125, the total annual dividend will be ¥272 per share.

For 2026, consistent with our policy of targeting an average dividend payout ratio of 45% based on core EPS, we plan to increase the ordinary dividend by ¥10 from 2025, bringing the forecast annual dividend to ¥132 per share. Page nine: moving on, I would like to review our 2025 management policies and priority items.

Under strengthening Red functions and value creation, we successfully confirmed proof of concept for NXT007. Furthermore, we accelerated our focus strategy by deciding to collectively discontinue five in-house development projects and making go/no-go decisions on six others.

Open innovation also progressed steadily, as evidenced by the conclusion of 12 new research and technical collaborations. Within maximizing value of lifecycle management projects, despite the delay in Elevidys launch, we achieved several key milestones.

This includes the successful Phase 3 result and subsequent filings for orforglipron, and continued growth of domestic mainstay and new products, and the strategic in-licensing of sparsentan from a third party. Regarding strengthening the foundation, while we faced some challenges in meeting our 2030 mid-term environmental goals, overall progress was smooth.

Key highlights include the rollout of our new HR system and the launch of a company-wide initiative to accelerate business transformation using AI. This slide details the progress of our R&D projects.

In early in-house development, MINT91 and mid-size molecule OP001 transitioned to Phase 1, while GIM329 for obesity moved into Phase 2. Late-stage development also saw significant progress for products expected to drive future domestic growth, including the addition of sparsentan, the transition of trontinemab to Phase 3, and positive trial data for giredestrant.

Additionally, we have successfully obtained regulatory approval for Elevidys. As our project portfolio expanded through the Red shift, we prioritized the selection and concentration of early-stage projects through collective discontinuations and rigorous go/no-go assessments.

Consequently, the number of Phase 1 projects was reduced from 21 at the end of 2024 to 15, allowing us to focus our resources on high-priority candidates. With nine projects in Phase 2 and 28 in Phase 3, we continue to maintain a robust and healthy pipeline.

Three projects are currently under regulatory review, with approvals expected within this year. Next, page 11: we're going to review priority items for strengthening the hemophilia franchise, development of Hemlibra auto-injector progressed, and we confirmed proof of concept for NXT007.

For DON52, we confirmed biological proof of concept and are steadily progressing toward initiating Phase 2 studies. Regarding Elevidys, Chugai's first gene therapy product, following a fatal case of acute liver failure in an overseas non-ambulatory patient, we strengthened safety measures while maintaining close coordination with relevant authorities.

We aim for a prompt launch following reimbursement approval for ambulatory patients aged 3 to 7 years. Regarding the new HR system launched last January, over 20% of all employees volunteered, and proportion of job postings in annual personnel transfers exceeded initial target, reaching over 60%.

We'll continue to promote employee autonomy in career development. Page 12: we will explain progress in the first five years of our 10-year TOP I 2030 plan.

Regarding the first pillar, realizing global first-in-class drug discovery, drug discovery projects and mid-size molecule pharmaceuticals made steady progress. We also accelerated external partnerships and investments to drive further innovation, including CVF investments and introduction of tiny pill technologies.

For the second pillar, building futuristic business model, we reorganized the value delivery functions of sales, medical, and safety. On the production front, we successfully supplied products to meet rapid demand fluctuations and established our own production infrastructure for the future.

Simultaneously, we advanced company-wide DX, including projects for the launch of Aspire. Page 13: based on the progress over the past five years, we defined five targets for the latter half of TOP I 2030.

To achieve annual launches of Chugai-originated global products, we will enhance early-stage development capabilities, including pharmaceuticals, while collaborating with partnering functions in Japan, US, Europe, and Singapore to pursue further drug discovery innovation. In production, we'll establish a stable supply system considering geopolitical risks to prepare for increased supply responsibilities accompanying the growth of in-house global products.

Furthermore, in the newly entered CVM field and metabolism field, we will build systems and capabilities to enable advanced development, project management, safety, medical affairs, and sales activities that respond to the distinct characteristics of this field and changes in external environment, thereby maximizing the value delivered to patients. To achieve these goals, we will advance the utilization of AI across the entire value chain and drive business transformation.

We present the management policies and priority items for 2026, the first year of the latter five-year period. The management policies are enhancing Red functions and creative value, maximizing value of LCM projects, and strengthening business foundations.

The priority items are shown on the right; there are four of them. We'll continue to strengthen our hemophilia franchise by advancing development toward application for the Hemlibra auto-injector and initiating Phase 3 studies for NXT007.

We also anticipate the highest number of domestic applications to date. These initiatives are expected to drive short- to medium-term growth in domestic sales.

In particular, for Lunsumio, one of the products expected to achieve large-scale growth, we aim for early market penetration in combination therapy with Polivy. We'll also ensure the successful launch of our new ERP system, Aspire, and promote the company-wide utilization of AI.

Now, looking at the average annual trend in the number of Chugai-originated global products launched since 2001, the number has steadily increased in the past. Particularly over the last five years, the number of launches of in-house global products has increased, and these products will drive profit growth in the short to medium term.

Furthermore, we anticipate that achieving the annual launch of in-house global products target set in TOP I 2030 will lead to further profit growth thereafter. Moving forward, we'll continue to leverage Chugai's unique drug discovery approach to advance drug discovery, including mid-size molecules, and develop new modalities, thereby expanding the creation of innovative new drugs that only Chugai can deliver.

Through these efforts, we'll achieve the TOP I 2030 goals and realize sustainable growth beyond them. The next slide, page 16: last but not least, regarding the opening of our US partnering office, we opened the Chugai US partnering office in South San Francisco, commencing operations this month.

It will explore, identify, evaluate, and promote collaborations with US academia and venture companies. In addition to the US, we will strengthen our partnership network connecting Tokyo, London, and Singapore to advance global open innovation.

Page 17, the last page: this shows the summary of what I said, and that concludes my presentation.

Thank you. I am Kusano.

I am with Project & Lifecycle Management Unit. Please refer to page 20 of the slides.

This looks at our fourth-quarter topics. I will go through these starting from the top.

We secured two approvals. Tecentriq obtained an indication expansion for unresectable thymic cancer.

Lunsumio was approved for a new subcutaneous injection formulation. On the filing side, there were also two key developments for our in-house product orforglipron.

Eli Lilly has filed an application in the United States for its use as an obesity treatment. Regarding Tecentriq, we filed an application yesterday for its use as adjuvant therapy in MRD-positive bladder cancer.

We also initiated three Phase 3 trials for Roche products: trontinemab for Alzheimer's disease, zilebesiran for hypertension, and divarasib for first-line non-small cell lung cancer. Additionally, divarasib received orphan drug designation last December for KRAS G12C mutation-positive unresectable advanced or recurrent NSCLC.

There were two pipeline deletions. Based on the data accumulated to date, we have decided to discontinue the development of praynstat for chronic diseases.

Furthermore, the development of Tecentriq for perioperative NSCLC was discontinued following the results of the IMpower030 trial. Details regarding recent publications, new contracts, and investments by Chugai Venture Fund are summarized on this slide.

Moving on to the second page of topics, for our in-house product PiaSky, we achieved positive results for Phase 3 trial for atypical hemolytic uremic syndrome. Orforglipron also met its primary endpoint in a switching trial following the administration of injectable incretins.

Furthermore, I am pleased to announce that Enspryng met its primary endpoint in the Phase 3 trial for myelin oligodendrocyte glycoprotein antibody-associated disease. Based on recent trial data, we plan to file for Gazyva, giredestrant, danvatirsen, and sparsentan within 2026.

Regarding academic conferences, there were three presentations. I will provide a more detailed update on giredestrant later in this session.

This is a summary of our major R&D events in 2025. The changes from the previous updates are underlined and shown in bold fonts.

While a few items have been carried over to the next fiscal period, we consider these results to be generally highly satisfactory. In particular, looking back, the confirmation of POC for our in-house product NXT007, a major milestone, and the decision to advance it to Phase 3 represents a significant progress.

Next, I will discuss the major milestones for 2026. A key readout for our in-house portfolio is the Phase 3 trial of Enspryng for MOGAD, which, as recently announced, successfully met its primary endpoint.

Regarding GIM329, we will now refer to it by its international nonproprietary name, INN, emugrobart. We plan to announce results for three Phase 2 trials for emugrobart this year.

For SMA and FSHD trials, the data have already been collected, and we look forward to sharing the results with you soon. For Roche products, pivotal trial readouts are scheduled for divarasib, giredestrant, Lunsumio, and cebarastrant.

Regarding trial starts, we have listed those that have already been publicly disclosed. For NXT007, we have scheduled three Phase 3 trials, including head-to-head comparison with Hemlibra.

We also plan to initiate a Phase 2 trial for DON52 in celiac disease. Now, I will present the results from two trials for giredestrant.

First is the evERA trial for hormone receptor-positive, HER2-negative breast cancer in patients previously treated with a CDK4/6 inhibitor. Although these results were presented at last year's ESMO Congress, I would like to review them with you today.

Giredestrant is an oral selective estrogen receptor degrader, or SERD, designed to inhibit the estrogen receptor signaling regardless of ESR1 mutation status. It is expected to show efficacy even in tumors that have developed resistance to conventional endocrine therapies, including previous generation SERDs.

In in vitro studies, it demonstrated higher cell proliferation inhibitory activity compared to other oral SERDs. Furthermore, the combination of giredestrant and mTOR inhibitor everolimus is expected to provide superior antitumor activity compared to monotherapy by simultaneously inhibiting two key signaling pathways involved in hormone receptor-positive breast cancer proliferation and endocrine resistance.

In the evERA trial, this combination significantly improved investigator-assessed PFS, the primary endpoint, in both the ESR1 mutation-positive and ITT populations. The therapy reduced the risk of disease progression or death by 62% in ESR1 mutation-positive group and 44% in the ITT population.

These results suggest that giredestrant plus everolimus could become a valuable new oral treatment option for patients previously treated with CDK4/6 inhibitors, a segment with limited effective alternatives, regardless of their ESR1 mutation status. Regarding giredestrant, I would like to introduce the lidERA study, which targeted adjuvant therapy for hormone receptor-positive, HER2-negative early-stage breast cancer.

This data was also presented at last year's San Antonio Breast Cancer Symposium. Giredestrant demonstrates stronger growth inhibitory effects than estradiol, E2 depletion, or tamoxifen in ESR1 wild-type cell models with high estrogen receptor signaling activity and endocrine therapy sensitivity, as shown by non-clinical data.

Furthermore, in the Phase 2 study of neoadjuvant therapy for early breast cancer, giredestrant demonstrated superior proliferation-inhibiting effects compared to aromatase inhibitors or tamoxifen. Based on these results, an interim analysis of the lidERA, comparing giredestrant monotherapy with standard endocrine therapy as adjuvant therapy for hormone receptor-positive, HER2-negative early breast cancer, showed a significant improvement in the primary endpoint of invasive disease-free survival, or IDFS, compared to standard endocrine therapy.

In the interim analysis, this reduced the risk of recurrence or death by 30%. These results demonstrate that giredestrant offers the first benefit in approximately 20 years for a new endocrine therapy in early-stage breast cancer, demonstrating the potential to become the new standard of care for adjuvant therapy in hormone receptor-positive, HER2-negative early-stage breast cancer, which accounts for over 70% of early-stage breast cancer cases.

Based on evERA and lidERA studies, we plan to file for approval for each this year and look forward to delivering new treatment options to patients. Next, I want to introduce three examples of our efforts to promote open innovation for expanding our drug discovery engine.

The first is our collaboration with Gero. Gero excels at identifying targets for age-related diseases using a platform that combines physics-based machine learning models with human dataset analysis.

By combining Gero's identified targets with our proprietary antibody engineering technologies, we aim to create first-in-class therapies for age-related diseases. The second is Araris.

We have entered into a joint research and license option agreement with Araris. Their AraLink technologies features high stability in blood, preserves the inherent properties of antibodies including pharmacokinetics, and can carry two or three payloads.

By combining this with our antibody technologies, we aim to create highly differentiated ADCs that achieve a broader therapeutic window and enhanced efficacy. Third is Rani Therapeutics.

The company possesses technologies enabling oral administration of biological products, featuring painless drug delivery within the intestinal tracts, high drug delivery efficacy, and bioavailability comparable to subcutaneous injections. By combining this again with our various antibody technologies, we also aim to realize biological products with high convenience through weekly or monthly oral administration with efficacy comparable to intravenous, subcutaneous injections.

We will accelerate innovation by collaborating with partners possessing target discoveries and modality technologies that synergizes with our own. Now, this slide shows market sales for major projects.

Global sales are based on guidance from Roche or Galderma. There are no updates from previously disclosed figures.

Within the domestic sales, the upper orange section represents our in-house products, while the lower blue section represents Roche products. This slide shows the status of our portfolio across each modality.

We continue to hold a robust pipeline of in-house-developed projects, all progressing steadily. We're also pleased to announce that we have named our drug discovery technologies for mid-size molecules, our third pillar focus, SNIPEtide.

SNIPE embodies the characteristics of our mid-sized molecules: high-precision binding to intracellular targets via oral administration. Tide evokes the peptides that form the basis of this technology, while also expressing our aspiration for it to become a new trend in peptide drug discovery.

We'll continue to focus on the continuous creation and development of our proprietary products or in-house products, including mid-sized molecule drugs, to address unmet medical needs. Last but not least are projected submissions.

Projects marked with light blue stars are newly added ones. Projects marked with green stars have changed since the previous update.

Specifically, for giredestrant, we are advancing the application for adjuvant therapy based on the lidERA study that I mentioned to this year. The following slides are attached as reference materials.

That concludes my presentation. Thank you.

Next, we will have from Taniguchi presentation on FY2025 consolidated financial overview. We will pause at the very beginning of the presentation, those of you who wish to take a capture, please use this opportunity to do so.

Hello, I'm Taniguchi. I look forward to working with you today.

I would like to describe the full FY2025 consolidated financial review. As was mentioned by Dr.

Okuda, I'm pleased to report that cumulative revenue through the fourth quarter reached ¥1,257.9 billion, up 7.5% year-on-year. Core operating profit also grew to ¥623.2 billion, a 12.1% increase.

Now, I will provide details of these results. First, on other revenue, the pharmaceutical product sales rose to ¥1,077.8 billion, an 8.0% increase year-on-year.

By region, domestic sales were ¥472.4 billion, up 2.5%. We had strong performance from new and mainstay products, effectively offsetting the impacts of generic penetration and the NHI price revisions.

Overseas sales reached ¥605.4 billion, up 12.8%, continuing to benefit from robust exports of mainstay products through Roche. Those are for product sales.

Other revenues, including royalties in here, increased by ¥7.4 billion year-on-year to ¥180.1 billion. While milestone income from third party declined compared to previous year, this was offset by an increase in Hemlibra royalties from Roche, resulting in an overall year-on-year gain.

Turning to expenses, cost of sales was ¥351.5 billion, up 4.0% year-on-year. If you look at the cost ratio, Actemra, with relatively high ratio, has dropped slightly from previous year, -1%.

Cost of sales ratio for pharmaceutical products improved by 1.3 percentage points to 32.6%. Regarding SG&A expenses, we successfully maintained these at ¥103.2 billion, flat more or less year-on-year, by driving efficiency to offset rising prices and labor costs.

R&D expenses rose by ¥3.2 billion to ¥180.1 billion, primarily reflecting the impact of yen's depreciation. Other operating income saw a modest ¥2.7 billion decrease, mainly due to lower gains from product transfers.

As a result, operating profit grew by ¥67.1 billion to ¥623.2 billion, with the operating profit margin expanding to 2 percentage points to 49.5%. Net income after taxes reached ¥451.0 billion, a 13.6% increase.

Next, on the changes from last year in pharmaceutical sales, starting with domestic, at the very bottom, domestic oncology sales were ¥246.5 billion, a marginal decrease of 0.5% compared to the previous year. Specifically, steady growth in new product, Phesgo, more than offset the decline in Perjeta sales.

Additionally, while Lunsumio is off to a strong start, Avastin sales declined due to generic competition. Specialty sales grew by 5.8% to ¥225.8 billion.

There was, yes, NHI price revisions, but in addition to mainstay products, Hemlibra, Actemra, and Enspryng, and Vabysmo, alongside the new products, PiaSky, all delivered steady growth. Overseas pharmaceutical sales grew 12.8% to ¥608.6 billion, primarily driven by strong exports of Hemlibra and Actemra.

Next summarizes a full-year export status to Roche of Hemlibra and Actemra. First, Hemlibra: fourth-quarter sales, the final quarter, if you look at that compared to last year, rose by ¥35.3 billion year-on-year.

If you look at the full-year cumulative sales, that reached approximately ¥20 billion above our initial ¥318.6 billion forecast. Actemra: since biosimilar penetration has been slower than expected, if you look at just the fourth quarter, we have seen leading to an ¥8.6 billion year-on-year increase on the fourth quarter.

Consequently, for the entire year, Actemra forecast of ¥123 billion was exceeded by approximately ¥30 billion. Though this was increased by about ¥30 billion.

Next, on the changes, this is a factor analysis in changes in operating profit, starting with domestic segment on the left, as noted, there's been an impact of NHI price revision to drive higher operating profit. In the overseas segment, the more we have sales in the emerging markets, the unit price will become lower, and so volume growth significantly outweighed the impact of lower export unit prices, combined with favorable foreign exchange movements.

These factors were key contributors to the growth of operating profit. The revenue also contributed to the profit increase primarily through higher Hemlibra royalties.

This is the breakdown of the increased profitability of ¥672.1 billion. On a quarterly basis, we are comparing P&L trends.

Because of the export timing, there will be more ups and downs. If you focus more on sales, this is by-quarter changes.

As you can see, the export to overseas, again, because of timing of the disease timing, there will be ups and downs. Next is the FY2025 how the outcome actually landed.

How much of a gap there was to what we have expected. As you can see, both sales and the profit, and for each segment, we have exceeded the projection, it was greater than 100%.

For the expenses, there were some pluses, but it's been slightly lower. That led to overachieving the operating profit.

This is seeing by-product sales as compared to the forecast for at the beginning of the year. The inventory situations has changed, and there was slight negative, but everything else, like Actemra overseas, Hemlibra overseas and domestic, overall compared to our forecast, there was a positive number.

Next page is the impact of foreign exchange rate fluctuations on the performance. The actual rate was ¥161.2, including the forward contracts, which is the basis for the sales recording, and ¥173.57, ¥12.50 yen depreciation.

There was an impact in terms of revenue, ¥49.6 billion plus, and ¥44.2 billion operating profit on the positive side. This is actual rate comparison compared to the forecast rate.

In 80% of the contracts are hedged in the previous year, 20% are unhedged, and you use the actual rate. There was change in exchange rate.

As a result, in 2025, there was a further depreciation of yen, of ¥5.6 billion in sales and ¥3.6 billion in plus for operating profit was recorded. The balance sheet, ¥2,468.6 billion, which is ¥260.2 billion increase.

There was a working capital increase and also net asset increase because of investments. Net assets increase by ¥124.2 billion.

Compared to total assets, there was a slight lower increase, but there was some interim payment of dividends and had 82.1%, which is shareholders' equity ratio, which is over 80%. Here you're talking about cash status.

Last year, at the end of 2024, ¥993.3 billion, but now there was a decrease of ¥160.6 billion, and the operating cash flow, ¥452.1 billion. There was further positive size like income tax payment and dividend payments, and ¥170 billion for special dividend was included.

Cash increase was slightly suppressed. In total, this shows the trends in ROIC and ROE, indicators of capital efficiency.

We have been focusing on ROIC so far, but depending on company, the definitions of ROIC may vary. In our case, the denominator doesn't include cash, ROIC has been at the higher level, 43.9% for this year, which is a 1 percentage point increase from the year-on-year.

As for ROE, which is attracting more attention, and definitions are actually universal from company to company for denominator and numerator, and 22.1%, which is an increase from the year before. This is ROE that is way exceeds the capital cost.

This is this fiscal's earnings forecast. As Okuda said, as for revenues, 6.9% increase to ¥1,345 billion, core operating profit to increase by 7.5% to ¥670 billion.

That is our forecast. Domestic sales expected to grow despite the headwinds from drug price revisions and generic penetration.

We are expecting ¥25.6 billion growth because of new products' growth, 2.2% growth, which is exceeding the last year's growth. As for overseas exports for Hemlibra and Nemluvio, they are expected to increase, but there will be further marked impact from the biosimilars in Actemra.

There's ¥3.4 billion slight decrease is expected. For the other revenues, ¥64.9 billion increase is expected from previous year.

There will be some foreign exchange impact. The cost side is not going to change that much, there's going to be a support for profit growth.

This is the slide for the pure product sales aside from the other revenues. Actemra is significantly negative, and Avastin, for various reasons, will remain in the negative territory.

Lunsumio, on the other hand, which is a new product, is expected to grow significantly. Hemlibra overseas will remain on the growth trajectory.

This also, this is a core and non-core adjustment. Previously, the intangible asset impairment and also restructuring cost and ERP business foundation system introduction and research and cost, these are actually items for core and non-core adjustment items.

In the third quarter, there is also discontinuation of five development products that will be recorded. This is the capital investments currently approved internally.

Last page is just for your reference. We have attached details regarding status of our five Chugai-originated global products.

That concludes my presentation. Thank you for your attention.

I would like to first of all ask about the Hemlibra. You said that on the core basis, this grew by double-digit, and based on foreign currency denomination, I think it's also increase, but for this term, if you use that, it's negative.

What are your thoughts about the volume as well as unit price? How will this change from last year?

For volume, I'd like to know what your forecast are for end-user sales and the fluctuations in inventory in Russia?

Thank you very much for the questions. For FY2026 on the whole, you are correct, we expect a positive number.

If we do elemental breakdown analysis at the point in time as for volume and the foreign exchange impact, we are not disclosing this at the moment. Now, at the J.P.

Morgan conference, Roche talked about the single-digit growth, positive growth, which means that we would like to replenish the inventory to our export on the whole. Hemlibra guidance number has been as disclosed.

Thank you. The second question: in Dr.

Okuda's presentation, auto-injector filing for Hemlibra has been mentioned several times. I believe that this is a very important agent in terms of competitiveness.

When do you expect this to become available? Is it very close, or do you still have some issues that needs to be resolved before that can take place?

I would like to know more about the progress of this product.

Thank you very much for asking about Hemlibra AI. We are moving along very steadily in terms of development.

We are not disclosing the dates, but we would like to provide Hemlibra AI to the patients as quickly as possible, we are doing everything possible to move things forward. The person next to him, please.

Yokoyama from Nikkei Medical. Giredestrant is what I'd like to ask about.

Many companies are developing oral SERD drugs, but how do you look at the differentiation from competitors? Inavolisib is going to be a set of those, and this is going to be significant with the combination with inavolisib in breast cancer, but there's no schedule for filing for inavolisib.

How do you see this? Giredestrant question, thank you very much for your question, Yokoyama-san.

Other SERD products, comparison with those, as I said in the slide, in the in vitro test trial, giredestrant, compared to other SERD oral, the proliferation suppression inhibitory activities were shown.

In the evERA study, giredestrant and everolimus, a combination therapy, compared to the conventional standard of care, ESR1-positive patients, in addition to that population, ESR1 non-mutant population, there was a PFS statistically significant achieved. Regardless of ESR1 mutation, there was efficacy that was proven in a SERD oral product.

The previously treated with CDK inhibitor patients had a bad prognosis, there's a higher hopes on that. Giredestrant and everolimus combination therapy, if you look at this, they are both oral drugs, there's no injection to be required, there's high convenience, and two different signal pathways can be inhibited simultaneously.

Compared to monotherapy, there is a higher antitumor effect expected. Also adjuvant, compared to endocrine therapy, standard of care, at the interim analysis, primary endpoint was achieved.

For early breast cancer, as a new endocrine therapy, this is the first one in the last 20 years, a new benefit was brought about. This could become a adjuvant standard of care, there's high hope.

More than 70% of early breast cancer is the target for this study, we are hoping that giredestrant can contribute to many patients. As for inavolisib, there's one study with a combination with inavolisib by Roche, but at the moment, the combination of giredestrant and inavolisib, there's no plan for study with that.

With the study of giredestrant and everolimus, what sort of strategy can worked out will be something that will work with Roche. That's not my question.

ESR can be covered, but CDK4 and 6 has to be suppressed, but there's studies overseas, but Japan has not participated, but Phase 2 study will be done in Japan, and there will be bridging study. At that timing, the inavolisib can be used as for the oral SERD study.

When will it be?

As for inavolisib, as you said, Phase 1 study is now underway, and there will be bridging with overseas study data to file for approval. This moment, I'm sorry, but we're not in a position to disclose that timing.

The timing of filing has not been disclosed. What you filed for yesterday, the bladder cancer, MRD-positive patients, for all-comers, Nivo can be used, and Durva has been presented as part of the data.

Compared to other products, what would be the superiority of this drug? I'm not sure who this is addressed to.

Tecentriq adjuvant of the muscular invasive bladder cancer, thank you for your question. Compared to PFS in OS, the primary, secondary endpoint, there was a statistically significant benefit that was proven.

In the ctDNA monitoring, we can identify patients that can benefit from atezolizumab. For the there could be over-avoidance of overtreatment, or personalized medicine can be done.

With the ctDNA approach, if the patients with lower risk can avoid overtreatment. That would be the benefit.

Thank you.

Thank you very much. Wakao with J.P.

Morgan. Can you hear me?

First of my question is related to the royalty other than coming from Roche and also other revenues. Royalty from other than Roche is for orforglipron and enoticumab sales or increase thereof, I believe.

Am I right? If that is the case, orforglipron has not been approved, I would like to know how you are incorporating that.

We also expect the sales to grow considerably. I would like to have you comment on this.

This is Taniguchi speaking. Thank you, Wakao-san.

Revenue stream from other than Roche, yes, is expanding in 2026, and you are absolutely right in your understanding. Vast majority comes from those two product royalties.

That's true. Other sales revenue in general terms, this is milestone payment.

Now, as for the content, this still is not disclosed, including of what we are filing today. We have introduced several assumptions and have reflected in what we are saying.

I would like you to tell us about how you incorporate the orforglipron. I think because the product is not out there, you must be exercising conservatism.

Yes, for anything that is uncertain, our basic thinking is to make sure that we will use reasonable assumptions.

Second question is about 45% dividend payout ratio.

The operating profit in a mid- to long-term will lead to greater profit, and you are focus more on ROE, which means that at some point in time in the future, you will raise payout ratio. There are no reasons for you not to.

Are you discussing this internally of raising the payout ratio to above 45%, and if you have decided no, why?

Thank you, Wakao-san, for that question. We have provided last year at this timing our capital allocation policies, and we wanted to target 45% stably.

Dividend payment included is based on that. For the time being, we have no plans of revising or reviewing this, and I'm sure you understand that.

Now, the question is, will we ever consider revisiting? Are we not going to revise this ever?

We cannot say anything definitive at this point in time. We'll be looking at objectively our situation as well as our financial conditions.

Now, ROE, yes, we are looking at our cost of capital, and we have disclosed this. We consider to be about 7%, which means that our ROE is well above that.

It's not that we are going to make active adjustment of the capital. We don't think that we are at the situation where we need to boost ROE today.

In any case, we should continue to maintain and try to strive for improvement of capital efficiency.

Thank you. That's all I have.

Thank you. I'm Muraoka from Morgan Stanley.

Can you hear me?

Thank you. My question is also addressed to Taniguchi-san for the forecast or guidance for more detailed way of interpretation.

The seven slide seven, the forecast by product: so overseas and others, there will be an increase of ¥70 billion, which is significant. Nemluvio export would probably the biggest contributor.

If that's the case, then the royalties from entities other than Roche, the increase of ¥30 billion or compared to Nemluvio, orforglipron would be larger. That's our guess.

Is that something that is valid?

Thank you very much for your question. Taniguchi speaking.

For the breakdown of royalties for the portions that are not from Roche, those two that you mentioned is overwhelmingly important. That's what I can tell you.

As for the allocation between these two, at the moment, we cannot answer that question. Also orforglipron, it has not been launched yet, and you have to look at the timing of launch, which is quite difficult discussion.

We remain undisclosed for the allocation. As for Nemluvio exports, this was recorded in the previous fiscal year, but for this fiscal year, we still continue to expect growth, and that has been incorporated in our guidance that we provided this time.

Does that answer your question? Overseas others, ¥32.6 billion, ¥170 billion, ¥17 billion year-on-year, it is mostly from Nemluvio?

Yes. Also, the breakdown of this page seven, the domestic and specialties and others sales, ¥33.3 billion year-on-year growth of ¥12 billion.

Tamiflu is not going to grow. What's included in this number?

Earlier, you talked about P&L, cost of sales ratio that is assumed to increase. Maybe the products that are included here have higher cost of sales.

Those that are not in the pipeline, but there's something that you are going to start to sell. That's my personal guess, but am I wrong?

Thank you. For the cost of sales ratio compared to 2025, in 2026, there's a positive growth.

The background, there's a lot of factors. If we compare domestic and overseas sales, the cost of sales ratio is much higher in domestic products.

This is related to products. Overseas, there's a ¥3.4 billion decline, but ¥20 billion increase for domestic sales.

Domestic products ratio has increased, and that has brought up the cost of sales overall. As for more details, it is not disclosed.

You mentioned Tamiflu. There are various factors involved.

Products that are not mentioned and that are expected to grow this year that are included in others.

Those that are expected to grow are not in the pipeline or the filing schedule on page 39, those are not included in those schedule?

No. That's not the case.

There are some that are included. All that are expected to be filed are anticancer drugs.

Hidaka from sales speaking. As you said, there's still uncertainty, a lot of uncertainty.

Elevidys, the gene therapy sales are incorporated to some extent, and maybe that would satisfy your question.

Elevidys, okay. Thank you.

That's all. Thank you.

Yes, thank you very much for this opportunity. At the very beginning, about the update of mid-term business plan, you talked about the production efficiency of blockbusters have improved from 0.3 to 0.6.

My understanding, of course, is you are aiming for one. Although there are different risks based on current pipeline, do you think that you are achieving what you can achieve?

What are your thoughts about this 0.6 vis-à-vis 2026 and 2030?

This is Okuda speaking. Thank you, Yamaguchi-san, for your questions.

You're looking at this slide, right? Looking back in the 2000s, it was 0.1, 1 per 20.

In the 2010s, it tripled. If it's in five years since we began the strategy 2030, we have actually launched three.

You talked about, Yamaguchi-san, blockbusters, but this is about global in-house original product being successfully developed and launched. We have focused on antibody plus small molecule that we have achieved launch targets between 2026 to 2030.

In the latter half of TOP I 30, TOP I 2030, we our strategy is to further increase this. We talk about mid-size molecule, middle molecule.

The white will gradually become more purple. If we succeed beyond 2031, this could become like one every year or greater global launch that will further drive growth or even better than that.

With increased modality, this growth will increase because of the mid-sized molecules? Yes, we will look at antibody, small molecule, mid-molecule, and in balance.

We're talking about other modalities. We were discussing this in the TOP I 2030 strategy discussion.

We hope to achieve multi-modality, we want to increase that.

Thank you very much. The other question is giredestrant, which you have explained in length that we have high expectation.

What is your peak sales forecast? Or is it too early?

Thank you for that question. For giredestrant, we are not disclosing that.

What could be the TAM in Japan?

The targeted market size, number of patients, or the existing market size probably quite large, but I would like to know which segment you are targeting. If you don't have that information, if you could provide information later.

Yes, we would like to confirm and get back to you. That's all I have.

Thank you.

Hi there. Can you hear me?

Yes, we

can hear you. Perfect.

Thank you for taking my questions. The first question I would like to ask is about your CapEx.

You commented on the Araris partnership for ADCs, right? My understanding is that the CapEx can be very intensive for ADCs.

In fact, one of your peer companies recently announced a very large CapEx project for their ADCs. I just wanted to see how are you thinking about the CapEx related to the ADC drugs?

Are you building the production capacity internally? Are you using CDMOs?

Are you using facilities from Roche? Is this included in your CapEx budget for 2026?

That's my first question.

Thank you very much for your question, Mr. Tony Ren.

As for the CapEx for the current status, Araris and Chugai Pharmaceutical are now engaged in joint research. We haven't discussed the CapEx.

We're just engaged in joint research. Therefore, as for the 2026 in the CapEx budget, this is not included.

Very good. My second question is on the development of your GIM329, emugrobart in obesity.

The GIMinda Phase 2 trial of emugrobart in obesity, if we look at clinicaltrials.gov, the primary completion is August 2026. Can you confirm that you will be releasing Phase 2 results roughly around that time as well?

GIM329 obesity, Phase 2 trial, thank you very much for your question on that. At the outset, as I said in the presentation, the result of the clinical study is going to be released by the end of this fiscal year.

Very clear. Thank you very much.

I'm Seki with UBS. Can you hear me?

Yes, we can. Thank you very much, and we congratulate you on excellent performance.

In other revenues, this royalty or milestone includes some items that are outside of Chugai's control. If other revenue does not meet your target, what are some avenues that will change, or don't we need to worry about this because you are being very conservative?

Thank you very much, Seki-san. I am Taniguchi.

The latter: we have exercised conservatism. If it is so unexpected happen, we cannot negate the possibility that something will happen outside this.

How this will be absorbed within the entire portfolio, this is something that we will be communicating to you in the quarterly earnings call. We will keep you apprised or updated within the profit planning.

Thank you. The second question has to do with biological POC of DON52, and I would like you to supplement my understanding.

What does this mean? In Phase 1 study, proof of blood monocyte, or are you looking at that kind of response at the cellular level?

Thank you very much for that question about the DON52. We have conducted what we call Phase 1c study.

This is celiac disease patients who are stable. After administering DON52 in such patients, for three days, we challenged them with wheat.

Gluten-dependent immune response is what we are trying to induce. Then we give DON52 to see if the gluten-dependent immune response can be suppressed.

In this study, in addition to PK, we'll be looking at pharmacological action. T-cell activation suppression due to gluten ingestion is also looked into, as well as other biomarkers.

What was the outcome of a three-day challenge study? We are now in the process of analyzing this, and when we are ready to publish data, we would like to do so.

Thank you very much. That's all for me.

Wada-san, are you there? Yes, Wada from SMBC Nikko Securities.

Thank you. I'd like to also ask about DON52.

Licensing-out schedule: how do you look at that schedule and development? As you saw, Phase 2 study is going to be initiated.

As I heard, this is going to be licensed out to other companies. I think that is a main strategy.

Maybe it would be the Phase 2 timing that you're going to do that. Phase 2 is going to be performed on your own.

What would be the timing of Phase 2, as you see it?

Wada-san, thank you very much for your question on DON52. For licensing-out strategy and timing of individual products, we cannot answer those questions.

Phase 2 study that we announced this time would be performed by Chugai Pharmaceutical. Just for clarification, in the Roche pipeline, this is in Phase 1.

You are not aligning with Roche on this particular product, is that correct? Probably this is not described in the Roche material or pipeline.

We don't have the information that they have introduced this. In the Roche pipeline, the Chugai's projects are also described, but this doesn't show that they have licensed in our product.

Thank you. As Yamaguchi-san asked, page 15, TOP I 2030, one per year

global product launch that is target, and I'd like to ask about the strategy of research and development. From 2011 to 2020, 0.3 per year, but '21 to '25, 0.6 per year, it has doubled.

R&D around 2015, ¥80 billion was spent, and in '23, ¥160 billion, this was doubled as well. That's why the number of launches has been increased, I understand that.

Between now and 2030, if you are to launch one per year, then 1.5 times R&D expenses will be required. In order to achieve one launch per year, what is your expectation on the R&D expenses or spending?

Okuda will answer that question first, and then so the future R&D investments, I would like to ask Taniguchi to answer that question.

The R&D expenses and number of launches, whether they are correlated or linked, it's not necessarily the case. The number of launches, what would be the function of this?

Aside from R&D, the cycle time of development, the speed of development, and probability of success, and those will be significant factors. There is a time lag between R&D activities and launch of the products, there is not that simple correlation.

As a principle for R&D activities, high-quality products have to be developed. This has been the case in the past, but with a higher probability of success, we came up with the molecule.

In the Phase 3 development, the first indication had achieved 100% success probability. That quality principle has to be maintained or expanded while engaged in this drug development.

R&D expenses and number of launches are not directly related, necessarily. On the other hand, if you look at R&D expenses, it includes the personnel cost, and this is a very important resources to drive research.

This R&D expenses has been increased in accordance with the profit increase. I'd like to ask Taniguchi to add.

Compared to 2025, 5.5% increase was recorded. That was a fact.

As Okuda said, the productivity increase is something that we give priority, and that is also true for R&D. By utilizing AI and go or no-go decision will be further refined.

We are hoping to enhance productivity.

It doesn't necessarily mean that R&D expenses are going to keep going up rapidly. The target for percentage of R&D expenses, there's no such figure that we have in mind.

As the projects make progress, there could be increase in development expenses. That could be the one that we might end up with.

We are also keeping an eye on productivity and efficiency so that we can maximize our efforts. Thank you.

Thank you very much. About Hemlibra, I have two questions.

The first question is related to overseas sales. This time in 2026, the assumption on Swiss franc, you are expecting 6% depreciation of the yen.

If that is the assumption, Hemlibra, as I understand, the plan is to decrease. Of course, sales in the international market by Roche of Hemlibra going up, you said will lead to lower unit price.

Even if the volume increases, the lower unit price will have greater effect. You're selling more, but is it possible that the yen amount of export come down?

Is that possible?

Thank you very much, Tsugi-san. This is Taniguchi speaking.

Hemlibra forecast for this year, and you ask about breakdown, which, of course, is related to unit price, volume, and foreign exchange factors. I would like to keep from giving you any responses in detail, but it is true that there has been foreign exchange effects positive.

What about the net of that? Then we have unit price multiplied by volume.

Unit price actually has to do with the weighted average in the market previous year applied. We will be looking at market price, and that sort of decides what the export price is going to be.

Volume is something that's updated every term in emerging market, not just the emerging market, but it is possible that volume increase globally. This has happened in the past.

There's no reason to think that this will not happen in the future. That multiplied by unit price will give us the results.

Thank you very much. Also about Hemlibra, and this is related to auto-injector: by launching this, what the level of upside do you expect?

Hemlibra, I believe, has penetrated market, uptake has been great. Who are the patients that have not been able to capture without the auto-injector?

I also would like to understand what Roche has in mind related to this. Thank you very much.

I would like to respond. Auto-injector development for Hemlibra, we have been striving with the aim of raising convenience of our patients.

If we have auto-injector of Hemlibra, we expect the uptake to increase. The Mim8, a competition, could come up with very convenient device.

Please do understand that we're taking a defensive approach to that, too.

Ueda from Goldman Sachs Securities. The first question is about the US partnering office that has been launched.

At the moment, in the previous activities, what were the challenges that you faced to trigger this, and what kind of effects that you're expecting out of this initiative?

Thank you for the question. As for US partnering office, this is located in South San Francisco in West Coast, and they just started operation in Silicon Valley, and there are many bio ventures and universities in the US.

There are numerous universities located there. Of course, we can keep communication from Japan, but by physically locating in the area, bio ventures and academia and venture capitals, we will have closer communication with those parties so that we can achieve open innovation.

The drug discovery capabilities increase is the primary purpose, but there will be effective result that we can expect. That's why we've decided to locate our office in West Coast, South San Francisco.

Ahead of this, there was a corporate venture capital that was established in 2023 in Boston, and it's been already two years since the start of the operation. We went into venture communities, and from venture companies or startup companies, there was a lot of information that we received.

As the technologies reaches maturity, we could have a joint or collaboration with those, and there's a link there as well. It's not just in the US, but in Singapore, there is a similar function, and there's also partnering function in London, and Chugai headquarters, Tokyo headquarters has this function.

By establishing global partnering network, we are hoping to increase our drug discovery capabilities. That's our intention.

Thank you. Thank you for the answer.

I think we have run out of time, I'd like to leave here. Thank you.

Thank you very much. With that, we would like to conclude Chugai Pharmaceutical fiscal year 2025 financial results presentation.

We apologize for the difficulty you experienced at the first half of the presentations. We will provide backup information via web.

If there are any questions that you are not able to ask, please to contact us at the corporate IR. The phone number as well as mail address is shown on the last page of the presentation material.

Thank you very much once again for joining us, taking time out of your very busy schedules.