Ladies and gentlemen, thank you very much for attending the conference on FY 2024 December financial results for Chugai Pharmaceutical. I am acting as the Master of Ceremony for today. My name is Miyata from IR Department. We are holding this session in a hybrid manner. The agenda for today's presentation is shown on the presentation material page 3, as well as the screen in the venue. [Foreign language] However, for those participating through Zoom webinar, you will be able to hear simultaneous translations. Please select the language of your choice by clicking the button at the bottom of your screen. For those who wish to listen to Japanese, please select Japanese. For those who wish to listen to English, please select English. After selecting your preferred language, please click on Mute Original Audio. [Foreign language] At the beginning of each session, we are going to pause for a while for those who want to take a photo of the screen. We are going to take questions at the very end of the presentation. We allocate about 30 minutes for Q&A session. [Foreign language] Audio is muted during the presentation session. Now, Okuda will take you through the summary of year 2024 and outlook into 2025. We are going to pause for a while before the presentation of Okuda, so for those who wish to take screen capture, please do so. [Foreign language] Now, I'd like to start the presentation. I am Okuda, the president. I will explain the summary of 2024 and the forecast for 2025. Please take a look at page 4 of the slides. The full year results of 2024 exceed the revised forecast for revenue, operating profit, and net income, with all figures reaching record highs. Revenue exceeded JPY 1 trillion for the third consistent year, and operating profit exceeded JPY 500 billion for the first time. The operating margin also reached a record high of 47.5%. Regarding domestic sales, the completion of JPY 81.2 billion government supply of Ronapreve in 2023 had a significant impact, while overseas, especially exports of Hemlibra to Roche were particularly strong. In addition, other revenue increased, mainly due to income related to Hemlibra and one-time income. Overseas and other revenue exceeded the decrease in domestic sales, and overall, the revenue increased. Compared to the revised forecast announced on October 25, domestic and overseas sales and revenue or income related to Hemlibra were strong. As a result, the full-year results for 2024 exceeded the upward revised forecast, thus achieving increased revenue and profit. Next, I will explain the forecast for 2025. We expect to achieve record high revenue and profit, mainly due to growth in overseas sales with revenue of JPY 1 trillion 190 billion, or +1.7%, core operating profit of JPY 570 billion, or +2.5%. At the same time, we expect to maintain a very high operating margin. On the next slide, I will show you the trend in sales or revenue. Revenue is expected to increase by JPY 19.4 billion, or 1.7% in 2025 compared to 2024. Sales are expected to increase both in Japan and overseas. In Japan, the impact of NHI drug price revisions and penetration of generics will be more than offset by growth in new products and main products, resulting in a slight increase of JPY 1.4 billion. Overseas, the impact of lower export unit price of Hemlibra will be more than offset by revenue growth due to volume growth and foreign exchange effects, resulting in an increase of JPY 18.7 billion. On the other hand, other revenue is expected to decrease by JPY 700 million due to a decrease in one-time income and Actemra-related income, despite an increase in income related to Hemlibra. Next, I will report on the review and results of our key policies for 2024. First, I will talk about the R&D function for drug discovery and early development. In drug discovery, one project for mid-size molecules, which we are hoping will become our third pillar, has advanced to the preclinical development stage, and we have steadily established manufacturing technology for mid-size molecules, and antibody and small molecule projects have also progressed largely as planned. Next, early stage development. We accumulated experience from our own pre-POC projects, and as our ability to predict human responses improved, we started advancing in phases and developing multiple projects. On the other hand, as a result of the no-go decision, we decided to discontinue the development of ERY974 and discontinue the development of SPY004 in-house, and there were delays in some projects due to changes in the plan. In open innovation, we fully launched the Chugai Venture Fund and made three investments. Regarding R&D projects, at the bottom of the slide, early stage development of in-house products. NXT007, AMY109 advanced to phase II last year, and BRY10 began phase I subcutaneous trials, while GYM-329 began phase I trials for obesity, and RAY-121 began a basket trial for six autoimmune diseases. In addition, in the late stage development, as you can see in the next slide, three of our in-house products, Alecensa, Piasky, and Nemluvio, have achieved approvals, and including all these, 13 approvals and launches were made, including global approvals, and we are expanding our contribution to further treatment of patients. The number of projects in the pipeline, including Roche licensed products, is 21 in phase I, six in phase II, and 29 in phase III, and we continue to have an abundant pipeline. In addition, there are four projects currently under regulatory review, and approvals are expected this year. Next, growth drivers. In Japan, although some products did not reach their targets due to the impact of competing products, Phesgo and Tecentriq grew steadily and more than expected, and also, exports of Hemlibra overseas also grew significantly. Finally, as for the business foundation, we have reviewed materiality in light of changes in the external environment, and we have been working to establish PHC solutions implementation system. Although there are issues with the development and acquisition of highly specialized human resources, the strengthening of our business foundation is progressing smoothly overall. The introduction of ASPIRE is an important company-wide project, and as a result of our policy of making sufficient investments to ensure that there are no delays or problems, progress is on schedule, although the budget has been exceeded. Now, I will explain our management policy for 2025, which consists of three policies. First, with regard to R&D capabilities enhancement and value creation, we will forecast on building technology, a platform, and project creation in addition to executing early judgments for the value of our own pre-POC projects based on the go/no-go criteria and accelerating the development of valuable projects. Next, maximizing the value of lifecycle management projects. In addition to promoting the development of late-stage development projects and maximizing the value of new products and growth driver products, we will evolve our operating model toward an efficient and advanced business model. Finally, strengthening of the foundation. Under the new personnel HR system launched in January this year, we will strengthen our foundation through various measures, including an HR strategy to achieve continuous innovation. These three major policies, we have identified four priority items that we will place particular emphasis on this year. The four are accelerating the maximization of DONQ52 values, strengthening the hemophilia franchise, preparing for the launch and proper use of Elevidys, and the proper operation of the new HR system. Five years have passed since the initial establishment of the materiality, and in response to various changes in the environment, we have reviewed the materiality last year. First, we organized and summarized materiality into 16 items, which are summarized under the three axes of challenge, co-creation, and commitment. In this new value creation model, we've clarified that materiality is the starting point and that we will link it to specific outputs and values provided through our business activities. Created value creation model, Chugai Pharmaceutical aims to realize advanced, sustainable, patient-centered medical care that is a shared value between the company and the society. This year marks the 100th anniversary of Chugai's founding. Since its foundation, Chugai has carried on the idea of creating drugs that benefit the world. By continuously taking on the challenges of new drug discovery technologies from small mid-size molecules, biologics, and antibodies, and by establishing Chugai's unique technology-driven drug discovery approach, we've created innovative new drugs and contributed to solving unmet medical needs in a wide range of diseases. For the next 100 years to come, we'll continue to expand our contribution to the global healthcare community and human health for the sake of the patients. In explaining our medium and long-term growth prospects based on changes from before the start of TOP I 2030 to the present, I would like to make some comments. Four years have passed since 2020, and the revenue structure has evolved dramatically. Please take a look at the graph to your left bottom. With regard to Roche products, biosimilar has penetrated, and we have seen a decline in Avastin, a mature product. New products launched after 2021, such as Polivy, Evrysdi, Vabysmo, and Phesgo, however, have offset such decline, and we continue to provide a stable revenue base. Meanwhile, our own products, mainly Hemlibra, have grown notably on a global basis. Looking ahead into the future from short to medium-term perspective, growth is expected to be driven by the three products that received global approval last year. In addition to this year, we'll mark important milestones for NXT 007 and GYM-329, as well as for the third-party launches such as Orforglipron. These will be our growth drivers in the medium- and long-term. For Roche products, a number of products are in late-stage development, including Lunsumio and Elevidys, which will be approved and launched this year. On the other hand, there are factors contributing to lower sales. For example, NHI price reduction in Japan and overseas, and the impact of biosimilar on Actemra, and appreciation of the yen. Despite these factors, we'll accelerate sustainable growth over the medium to long term through the growth of our own products and continuous launches. Next, I would like to explain our basic policy on capital allocation. In our mission to contribute to the global healthcare through innovative medicines and services, we place highest priority on providing value to patients. At the same time, we consider stable shareholders' return to be also important. To achieve these goals, we carefully consider the balance between investment in growth to create shared value, including the creation and provision of innovative drugs and expansion of our value creation engine, strengthening our drug discovery platform, and shareholder returns such as dividends to ensure optimal capital allocation. We are convinced that this policy will lead to our sustainable growth and enhance our corporate value, and we'll continue to strive for a balance between providing value to patients and returns to shareholders. Next, I would like to explain about the dividend. Reflecting the good performance in 2024, we plan to pay a year-end dividend of JPY 57 per share, JPY 16 higher than the forecast at the beginning of the fiscal year. As a result, together with the interim dividend of JPY 41 per share, the annual dividend will be JPY 98 per share. For 2025, we forecast an annual dividend of JPY 250 per share, consisting of an ordinary dividend of JPY 100 per share and a commemorative dividend of JPY 150 per share to celebrate our 100th anniversary, to express our gratitude to our shareholders for their past support and understanding. We'll continue to strive to deliver innovation to patients around the world. We look forward to your continued support. This is the summary, and that's all from myself. [Foreign language] Next, I'd like to invite Mr. Tanaka to talk about the development pipeline. [Foreign language] at the outset, there will be some still moments where you can take advantage of your screen capture. Thank you. Over to you. I would like to talk about the status of the development pipeline. I am Tanaka, Head of R&D Portfolio Management Department. Please take a look at page 17. This is a summary of the topics of the fourth quarter. All approvals and applications have been already announced. First, we have Nemluvio, which was licensed to Galderma in the US. It received approval for additional indication for atopic dermatitis. In Europe, the EMA's CHMP issued a recommendation for approval for atopic dermatitis and prurigo nodularis. Lunsumio received approval for use in the third-line treatment of follicular lymphoma. Next, we have the applications. We have Avutometinib, which we licensed out to Verastem Oncology. The application for accelerated approval in the U.S. for patients with recurrent low-grade serous ovarian cancer with KRAS mutations was accepted in December 2024. The target date for completion of the review is June 30, 2025. As for the start of the trials, we began the domestic phase III study of Lunsumio for treatment of naive follicular lymphoma. As for the readout, the SKYSCRAPER-01 study of tiragolumab for first-line treatment of non-small cell lung cancer was discontinued, as in addition to failure to meet primary endpoints of PFS, OS had not been met either. Next, I'll present the two-year data from the EMBARK study of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy. The study showed statistically significant and clinically meaningful results in the North Star Ambulatory Assessment, time to rise, and 10-meter walk and run, compared to the pre-specified external control group. In addition, no new safety signals were observed, and it consistently demonstrated benefit. Other items removed from the pipeline are shown here. ERY974 had been undergoing phase I trial for solid tumors and hepatocellular carcinoma, but we have decided to discontinue the trials based on comprehensive evaluation of efficacy and safety to date. At medical conferences, we presented positive four-year data from the phase II clinical trial of Lunsumio in patients with relapsed or refractory follicular lymphoma. Approximately 60% of patients who achieved a complete response were alive and in sustained remission at month 45. In addition, we announced five-year data from the phase III POLARIX study of Polivy in treatment-naive diffuse large B-cell lymphoma. The data showed a favorable trend in OS in the ITT population, reinforcing the new standard treatment position. In spring, we received orphan drug designation for AIE and MOGAD. The review period is expected to be shortened. In the area of open innovation, we have made three investments through the Chugai Venture Fund, which began full-scale operation in Boston last year, and steady progress is being made. As announced in the press release today, and what is not shown here in the slide, as for AID351, GSK Global Health, the Global Health Unit of GlaxoSmithKline in the U.K., we had concluded a collaboration agreement with them to advance development of AID351. I'll explain the details later. This is a summary of the major R&D events for 2024. Changes from the last time are underlined and in bold. Despite some setbacks, such as delays in trials and development discontinuations, we believe that the results were generally satisfactory. We're able to achieve important milestones with our in-house developer products, such as Alecensa, which is one of our current growth drivers, and Tecentriq, which we expect to be a future growth driver. We have made steady progress toward future leap forward. Next, I will explain the major events for 2025. For in-house developer products, we are expecting a readout of the phase III trial for aHUS for Piasky. Readouts for the phase II trials for SMA and FSHD for GYM-329 and for Hemlibra and for NXT 007 are also planned. All of these are important milestones for determining whether to move on to phase III trials or not. In addition, we plan to start a phase II study of GYM-329 for obesity by the end of this year. Next, I'll explain the AID351, which was created at Chugai Pharmabody Research, CPR, a research subsidiary in Singapore. AID351 is an antibody drug for dengue fever, which is one of the neglected tropical diseases. As previously said, we have concluded a collaboration agreement with GSK Global Health to advance the development of this product. Under this agreement, GSK will obtain a non-exclusive license to conduct activities aimed at initiating clinical trials of AID351. Dengue fever is a mosquito-borne fever that affects 400 million people approximately worldwide each year. When it becomes serious, it could be fatal and progress to dengue hemorrhagic fever or dengue shock syndrome, but there is still no established treatment for dengue fever. Every year, 500,000 patients worldwide become seriously ill and require hospitalization and treatment, and there is a high level of unmet medical needs. AID351 is an antibody that can bind to all four different types of dengue viruses that cause dengue fever. With support from Global Health Innovative Technology Fund, or GHIT Fund, the antibody was identified and optimized through collaboration between industry, government, and academia in Singapore, including CPR, and is currently in the preclinical stage or is completed with the preclinical stage. The unique aspect of AID351 is that it is an antibody that combines both safety and efficacy, as it avoids a phenomenon known as antibody-dependent enhancement of infection, which is one of the causes of severe dengue fever, by applying Chugai's proprietary antibody technology while also retaining its ability to eliminate the virus. It is expected to be developed as a treatment for early relief of symptoms of dengue fever and as a prophylactic measure for medical professionals and others who are at the risk of contracting secondary infections during outbreaks or severe cases of the disease. Neglected tropical diseases have threatened the health and livelihoods of many people, but to date, no effective treatments have been established. In order to fulfill our social responsibility in global health, we will work with GSK to develop innovative drugs to address this unmet medical needs. [Foreign language] 2030 [Foreign language] Regarding the five reforms of the Top I 2030 growth strategy, I would like to explain about how to strengthen the go-no-go decision process because this has been a frequently asked question. Chugai Pharmaceutical has been promoting science-based go-no-go decisions, and as a result, many of the projects have processed to the phase III and been brought to the market. In the future, we will achieve both science and speed. We'll continue to find the optimal development pathway for each project, even in the non-clinical stage, and evaluate the drug's potential in the shortest possible time. In addition to an increase in the number of projects due to improved drug discovery capabilities, we are now able to see the potential of a drug earlier and more quickly, and we have improved human predictive capabilities, including the prediction of effective dose and safety profile. These efforts will enable us to maintain our high success rate after phase III, accelerate each project, and strategically allocate resources to ensure that we can continue to deliver the highest quality products to the market. As a result, we'll be able to accelerate the launch cycle and make progress toward achieving TOP I 2030. Specifically, we'll accelerate the high-potential projects and conduct early assessments to minimize development risk. For example, we'll promote efficient phase I study design based on precise dosage prediction, simultaneous development for multiple in early-stage development, and accelerated evaluation of combination therapy. Six months have passed since the elaboration of this TOP I strategy, and we will apply this strategy to new projects to promote speed. We have also applied this strategy to projects that had already started its development. As explained in the review of the priority direction, development of ERY974 was halted based on the clinical trial result, and we have stopped the in-house development of SPY004 due to the result of the clinical trial. In 2025, we plan to make go-no-go decisions for more projects. We'll accelerate early development by making go-no-go decisions that combine science and speed and identify potential drugs in the shortest possible time. This chart shows the market sales of major projects. Of the domestic sales, the orange in the upper row shows the sales of in-house products, and the blue in the lower row shows the sales of Roche products. You see the overseas sales ratio of the in-house products. For domestic sales, the reasons for any changes from the previous disclosure are given in the right-hand column of the table. Of the overseas sales, Galderma expects a net revenue to reach $1 billion per year by the end of 2027, and after that, peak sales are expected to reach $1 billion, and after which peak sales will exceed $2 billion, and this slide shows the status of the portfolio for each modality. We continue to have an abundance of in-house projects, all of which are progressing well. In the third pillar of our focus, mid-size molecules, two projects are in the preclinical phase, and 26 other projects are in the drug discovery phase. As a reference material, we have included a detailed status of low molecular medicine, mid-molecule medicine, and antibody drugs, and cellular genetic medicines. Please refer to them as necessary. Here is a schedule for future filing. The blue star represents newly added projects. This slide, which follows this page, is attached as an appendix, and this is the end of my presentation. Thank you very much for your attention. Now, moving on to Taniguchi, talking about the full year results of 2024 on a consolidated basis. There will be some still moments, so if you wish to make a screen capture, please take advantage of this moment. Now, over to you. Taniguchi, CFO. Thank you very much. I will now explain the full year results for 2024. [Foreign language] These will be all shown in core basis as compared to the previous year, mainly. First of all, 2024 revenue increased by JPY 59.2 billion, or 5.3% year- on- year, to JPY 1 trillion 170.6 billion. Operating profit increased by 23.4% to JPY 556.1 billion. That is the first message that I'd like to convey. Then, let me go into the details of revenue. The main reason for this increase in revenue was the significant increase in export sales of products such as Hemlibra overseas. The sales growth completely absorbed the impact of the loss of sales of Ronapreve, the COVID-19 drug to the Japanese government, worth JPY 81.2 billion, and actually exceeded it. Looking at the breakdown of revenue, first of all, the sales were JPY 997.9 billion, an increase of JPY 23.4 billion, or 2.4%. If you look at the sales by domestic sales and overseas sales, for domestic sales, it decreased by JPY 96.9 billion year on year, or 17.1%. So, as I said, the Ronapreve, JPY 81.2 billion that was reported last year, is now gone, but the decrease would be JPY 15.7 billion excluding Ronapreve, and the main factors were the impact of NHI drug price revisions and penetration of generic products. Overseas, exports products such as Hemlibra were strong, and sales grew by 128.9% and JPY 128.3 billion, or JPY 28.9 billion. Also, other revenue, including royalty income and one-time income, actually increased mainly because of Hemlibra income to JPY 172.7 billion, or an increase of JPY 35.8 billion, or 26.2%. Next, I'd like to move to the cost items. Cost of sales decreased to JPY 338.1 billion year on year by JPY 73.9 billion, or 17.9%. Sales increased, but the cost of sales decreased. Why? The reason for this is that cost of Ronapreve, which had a high cost of sales ratio, has disappeared, and relatively low cost of sales ratio of in-house products has increased in the sales mix. Relative increase and changes in the product mix actually reduced the cost of sales. The cost of sales ratio has improved by 8.4%- 33.9%. Regarding R&D expenses, due to the steady progress of projects in this drug discovery research and early-stage development, it increased by JPY 14.1 billion year on year. SG&A expenses, despite the impact of rising prices and personnel costs, we made efforts to improve efficiency, and the increase was limited to just JPY 200 million year on year. Now, other revenue decreased by JPY 13.4 billion year on year due to the significant decrease in gains on sales of products transferred this year because that was posted in large amounts last year. As a result of these factors, operating profit increased to JPY 556.1 billion, or an increase of JPY 105.4 billion, or 23.4%. Operating margin increased to 47.5%, or 7.0 point increase. Net income was JPY 397.1 billion, an increase of JPY 63.5 billion, or 19% year- on- year. EPS JPY 241, and 0.3, and JPY 38.6 increase year on year. Let me go into the breakdown of changes in sales products. First of all, this is the year-on-year comparison. So, there are Oncology and Specialty Business Units in Japan. As for Oncology, the sales decreased by 4.8%, or JPY 12.5 billion. Sales of Avastin decreased due to the impact of penetration of generic products, JPY 16 billion. The sales of new products first of all increased by JPY 22.8 billion. The Perjeta and Herceptin declined that comprises this FD fixed dose combination, but it has offset by that. The Specialty sales decreased by JPY 84.4 billion. Hemlibra, JPY 82.1 billion. Tamiflu, from around December last year, influenza had been in outbreak, but in 2023, the previous year, there was much more outbreak. Because of that impact of Ronapreve and Tamiflu, it declined, but actually without that, JPY 2.2 billion increase would have been achieved. There was a revision in NHI drug price, but Vabysmo and Phesgo are steadily increasing as new products. And overseas sales, JPY 120.3 billion increase. It was because of Hemlibra and four main products increase. So, and JPY 210.4 billion increase on Alecensa and Actemra that has reached LOE actually avoided the penetration of biosimilar, which was delayed. The next page shows the breakdown of increase in operating profit, JPY 450.7 billion to JPY 556.1 billion. There's a change. There was an impact of NHI drug price revisions, but Ronapreve were the main factors. But on the other hand, there was an increase of JPY 120.3 billion in overseas sales. Hemlibra, the more the sales in the open countries, emerging countries, the cost, the price would be lower. But there are also positive impacts of increase in volume and the positive impact of foreign exchange rate from 2023 to 2024. JPY 66.9 billion impact was seen. Other revenue, the royalty income increased. Hemlibra is the main one, but there are others. Roche local sales increased, and that has increased the royalty income. Expenses, the JPY 73.9 billion in cost of sales declined, but there were R&D expenses increased slightly. Overall, JPY 105.4 billion increase was achieved. The following page shows the trend in profit and loss item for every three months from the fourth quarter 2022. By quarter, there are timing changes in export shipment. In the quarter three, operating profit was quite high, as you can see. Compared to operation of fourth quarter in 2024 and 2023, a JPY 19.4 billion increase was achieved in operating profit, but I will explain in more detail in the next page. In terms of quarter four to quarter four, in other revenue, in between 2023 and 2024, a JPY 13 billion increase was achieved. This is a revenue mix. As you can see, the second quarter and third quarter actually have seen relatively larger sales as compared to the other quarters. The next 2024, the actual results, and as I explained, the revised forecast at the time of earnings results for the third quarter, and JPY 80 billion was upward revision for both revenue and profit, and JPY 20.6 billion in sales and JPY 16.1 billion profit ahead of those revised forecast. JPY 7 billion in sales in domestic market. That was achieved because of the strong sales after the third quarter, so JPY 7 billion domestic sales and JPY 4.9 billion overseas. And as for royalty, in the fourth quarter, Roche sales overseas were ahead of the sales, of the expectations, so Hemlibra income increased. But cost of sales and expenses are mostly as expected, so a JPY 16.1 billion increase. And in the third quarter, the guidance was changed, so compared to that, what was the actual results? A JPY 7 billion increase, a Specialty for JPY 5.3 billion, Hemlibra, Tamiflu, and Vabysmo. Technology also grew and JPY 3.7 billion Hemlibra received. And this shows the effect impact. In 2023, actual FX rate is shown. And then, in terms of the sales, JPY 91 billion positive, and OP basis, we've had a positive impact due to FX rate by JPY 76.4 billion. Exchange rate against the Swiss franc, we have seen one yen depreciation of yen. Next is balance sheet as of the end of 2024. Due to the increase of sales, working capital increased, and we made capital investment, and the net cash went up JPY 257 billion. The total asset was JPY 2 trillion and 208.4 billion. Liability remains almost the same. The net asset has grown up to JPY 1 trillion and 901.5 billion. At the end, net cash increased up to JPY 996.1 billion. Operating free cash flow was + JPY 493.4 billion, reflecting our performance. We did the corporate tax and dividend payment and so on. We have seen increase in cash. Acquisition of tangible fixed asset of JPY 50.4 billion was also recognized. Capital efficiency is quite important. This is a change of ROIC. From 2023, ROIC increased by more than 8%. This is exceeding the 7% threshold. This is the forecast for this fiscal year, which was already explained by Okuda. So, I would like to skip the details, but the revenue is expected to grow by 1.7%, which is JPY 19.4 billion. Overseas and domestic, we have an impact of generic entry and NHI price increase. However, due to the product increase, we are going to make increase and growth. Overseas, Hemlibra is expected to grow, and Nemluvio is also expected to grow. Actemra is impacted by the biosimilar entry. We expect some drop. And cost, R&D, SG&A development fee cost, well, SG&A and R&D cost mainly are expected to stay, but. So, OP expected to be JPY 570 billion. The OP is expected to grow by 2.5%, and net income is expected to be JPY 410 billion. This is in a comparison against the actual of 2024. Domestic plus JPY 1.4 billion. Oncology, we see some impact by generics on Avastin. And Polivy is expected to grow. Specialty product is expected to grow by JPY 9.9 billion. Expected will come from Vabysmo, Phesgo and Hemlibra. Other segments overseas are expected to grow as well. Finally, this is an appendix that you see FY 2025-based financial numbers. JPY 7.9 billion business restructuring costs include SAP implementation. And intangible asset wise, we have in-licensed technology, so we need to incur depreciation. And next page, it shows the major investment and the current plan. And major CapEx approved by the executive meeting are shown here. Now we have added Phesgo, but this is the status of our in-house global products. This shows the actual performance and our local sales and export sales. That's all from myself. Thank you very much for listening. Let's move to the question and answer session. In Q&A, there will be two more people to answer questions. Hidaka, the Vice President of Supervisory Responsibility for Marketing and Sales, and Digital Transformation Unit Head Suzuki. There are three joint releases by three companies, our company, SoftBank, and SB Intuitions today. In order to have as many people as possible asking questions, please let us limit the questions to two per person. Also, the presentation as well as question and answer session will be posted onto the website on a later date of our company. We'll take questions from the people in person in the venue, and then take questions from those who are participating on Zoom webinar. Now, if you have any questions, if you are in the room, please raise your hands. The microphone will be brought to you, so please identify yourself and your affiliation first before asking questions. The person in the first row, please. The microphone will be brought to you. Hashiguchi from Daiwa Securities. The first question is about pipeline. This year, the priority items include DONQ52 phase II initiation and next phase III initiation preparation. And also, in the presentations, you said that GYM- 329 phase II for obesity will be initiated. Of those, for each, to what extent you have seen the decisions made for initiation? The previous phase, which must be the reason for the next phase initiation, has not been disclosed. But as far as you see, to what extent do you have the confidence of being able to initiate actually? And also, is it also part of your wishful thinking? And also, compared to the previously, you said that you are going to accelerate your development. So those you have not decided yet whether to be able to start the next phase. You may also start preparation for the following phase. Is that what is included for each of those? Can you answer that question? Thank you very much for the questions. DONQ52, next, and GYM-329. I think those are the three, the in-house original developed product and milestone that are expected. And has it already been fully decided, or is it just the preparation because of acceleration of development? Well, DONQ52 phase II initiation. Well, at the moment, we are conducting phase I study, and data is coming out. And based on the data, we would do the interpretation and then move on to phase II. So this is the usual steps. In terms of timing, we can start preparation for phase II. As we do so, we can expect the phase I data to come out. As for next, phase 1/2 is also being conducted, and the result will come out. We are at the timing of being able to move to the next phase. The second part of your question, in order to accelerate the speed, you're assuming that the result will be positive. We are starting the preparation, as you have guessed. We're not saying that we know the result, but based on the result that will come out, we would make decisions for the next one. GYM- 329, what about phase II for obesity? Phase I was done last year. With regard to phase II, the combination study is going to be started. Thank you. Then the next question is about dividend. So JPY 250 includes JPY 150 commemorative dividend for this year. If you can look at the other companies, the commemorative dividend is used for increasing dividend, but usually, the following year, the comparable dividend will be paid even though there is no commemorative dividend. So that there will be no decline in the dividend received. So when you increase the dividend, you say this is under the auspices of commemorative dividend, but actually, you would increase further in the following year. So when you look at the cash flow forecast from your company, the JPY 250 dividend per year per share is really an unusual level of dividend because of this 100th anniversary. Or do you think that it's highly probable that you can continue to maintain this level years after that? So let me explain. This commemorative dividend, in total, JPY 250, but JPY 150 out of that is a commemorative dividend, and the ordinary dividend is JPY 100, so if you can distinguish that, that would be appreciated. To celebrate the 100th year and thank the support and cooperation from the shareholders, we are paying JPY 150 more, and then the ordinary dividend would be JPY 100, and we are going to pay a stable dividend, which is about the ordinary dividend. Yes, there is an additional comment from the CFO. No, nothing more. But actually, we're not familiar with the other company's practice, but we do make distinction between these two, but we look at the current financial position. We have made this decision, so we're not able to talk about the future, so 45% payout ratio for the ordinary dividend, but other than that, we're not in a position to comment any other part. Thank you. Please raise your hand if you have any question. Hi, I am from UBS Securities. You are now trying to accelerate drug development. This has been your challenge in the past one to decades. When I look at page 23 and when I look at your news release regarding the collaboration with SoftBank SB Intuitions, I wonder what is the realistic probability of you accelerating the drug development speed. At the same time, I think you are contemplating whether Japanese subject phase I is really necessary. In that case, what will be the expected impact, and is it really viable or not? Can you please comment on the feasibility of this project or impact of this project? By when are we able to start seeing the tangible result of this project? In terms of the acceleration of our development process or enhancement of the go/no-go decision, what Tanaka will answer to that? With regard to the collaboration with SoftBank, I would like to ask Suzuki to respond to your question, and if I have any additional comment, I would like to cut in. Thank you very much for your question. I am Tanaka speaking. The go/no-go decision enhancement. How do we apply our strategy to do so? Existing projects and future new projects who are entering in the clinical development phase. For all of those projects, we are going to apply this strategy. Some of the projects already started early assessment of SC and we have already started efforts to simultaneous development for a multiple number of therapeutic areas. Science-based project decision, what kind of development pathway is most suitable to what kind of project? It's been 10 years since the establishment of translational research division. So we have accumulated know-how from the past clinical research activities. So based on such, the setting up the most optimum timeline for development activities has been now realized. So we would like to continue doing so. What is the timeline in order for us to see the tangible result? Well, as Tanaka mentioned, this criteria has already been applied to the existing projects, and this strategy will also apply to the newly added projects. So as we work on more number of projects, we should be able to see more tangible result. And to your second question in relation to the collaboration with SoftBank, Suzuki would like to respond. Thank you for your question. I am from a digital transformation unit. My name is Suzuki. Collaboration with SoftBank and SB Intuitions, with regard to the basic agreement for the partnership with those companies, I would like to make some comment. How can we shorten the development timeline through this collaboration? Well, when I look at the report issued by METI, by utilizing GenAI, we may be able to shorten the timeline by four years in general, and this year, we are focusing on the clinical development operations to further optimize, so we will start the study and see what will be the probable impact. I think you have asked one more question, which is regarding the necessity of Japanese subjects to be involved in the phase I study, and as Tanaka explained about the Chugai Pharmaceutical original product, so no impact. When it comes to the licensed end product from Roche, we may be able to skip phase I with Japanese population, but it's a project by project, and we need to consult with the authority to see if Japanese phase I is really necessary or can be skipped. My next question, I think it goes to Taniguchi. In the fourth quarter, the probability and the profit sharing number amount increased quite a bit. And I'm sure you will say, "Sorry, we can't comment on that." But indeed, it has gone up. Why? I think it's due to Hemlibra. But in the Roche earnings, they didn't really talk a lot about Hemlibra. They didn't disclose a lot of numbers for Hemlibra. So I would like to ask Taniguchi-san to explain about the reason. Is there any change in the rate, or has there been any change in the threshold? Like a global price should have come down, right? But still, this number is quite big. Roche is holding a conference this evening, but January-December numbers are already available. So if you look at the delta as of the end of Q3 and the end of Q4, you should be able to analyze for Hemlibra. But Q4 was better than our expectation. Again, I cannot comment on specific products, but this is Roche external sales, basically, which performed strong. It's not like we have changed the contract. It's a tiered royalty. So when the number exceeds a certain threshold, the rate will go up. But I can't comment any further on that. But when the volume grows, and then even at the same percentage, numbers can grow. Thank you. Thank you very much. If you have any questions, please raise your hand. For those of you who are in the room, in person, no more questions. Then let's move to the participants through Zoom webinar. If you use PC and tablet PC to participate, please click on the raise hand function at the bottom of the screen. If your turn is here, then your name will be called, and the secretary will ask you to unmute yourself. And please identify yourself and your affiliation before asking questions. If you'd like to cancel the questions, please push the function of lower hand. And if you're participating in telephone, press hash and 9. And if you wish to cancel the questions, also push hash and 9. From JP Morgan, Mr. Wakao, please ask your question. JP Morgan, Wakao desu. Welcome. From JP Morgan, can you hear me? Morgan, Wakao desu. Welcome. From JP Morgan, can you hear me? Morgan, Wakao desu. Welcome. From JP Morgan, can you hear me? Yes. The first question. The third quarter, the changes from the third quarter for the forecast for this year. At the time of third quarter, there is a forecast, but there has been changes. At the time of third quarter, for this year's forecast, JPY 540 billion is the previous one. And you said that this is going to be flat, but the JPY 570 billion for core operating profit guidance. So there is a JPY 30 billion increase. So I'd like to know about this change from the third quarter. If you look at the Roche earnings, Hemlibra, Actemra, and sales, Vabysmo and sales has been strong. So maybe this has been reflected. Am I right? If that is correct, then Hemlibra and Actemra, what sort of level that you're looking at in this year? Thank you very much. Taniguchi speaking. At the time of third quarter, yes, we said JPY 540 billion or around that. That's what Okuda said, and we learned JPY 570 billion. So basically, what is strong is the export sales. So it has been stronger than we had expected. Actemra, Hemlibra. Starting from Actemra, the entry of biosimilar, how you look at that? From October last year, so in our view, of course, our export and local sales from Roche are not exactly consistent, but the inventory is in short supply. So maybe there'll be more in export. But as for Hemlibra, there is a very strong number, especially international sales. So there could be some room for upside. Does that answer your question? Thank you. As for Hemlibra, the follow-up question up to third quarter, international was about inventory build-up. That was the reason for international sales increase. We had thought that in the fourth quarter, the sales could be flat. That's what the equity market had expected. But actually, it has gone to increase this year. Is it only for international, or would it be also seen in the U.S.? I'd like to know. I'd like to know by country breakdown. And also, peak sales that you have shared with us do have room for growth for Hemlibra. So can we expect an increase in export sales for Hemlibra as well? Well, for this year, well, I can't go into details. So there may be some misunderstanding that there is a build-up of inventory behind the international sales. Well, up to third quarter, according to the disclosure of Roche, I think in terms of actual sales, it has been increasing. So there is a pure net increase that we can expect. But it doesn't mean that international sales are weaker. So continuously, there will be some growth in the US, especially. And that has led to our export sales as well. And from next year onward, it's too early to tell. So because we have to look at the competitive environment and to make a comprehensive decision, so I'd like to refrain from commenting further. Thank you. The second question, there are several no-go decisions to be made for several items. So what would be specifically the ones that you're looking at in the document? For example, in 3532, so in antibodies, there are several projects. And of those antibodies, those that are in the clinical studies, those are the go/no-go decision. And LUNA-18, what is the status? And DONQ, from early last year, I think you were engaged in outlicensing activities, but now you're more focused on in-house development. From the outlicensing activities perspective, have they encountered some challenges? With the data that you have, you may not be able to do outlicensing as you had expected, and that's why you are more focused on in-house products. Is that true? I'd like to answer the question on DONQ. Which one is subject to go/no-go decisions? Tanaka will answer the question. As for DONQ, as I explained earlier, phase I clinical trial is underway, and in parallel, outlicensing partners are being looked for, and that has been done since last year. As we look for potential partners, what we've decided is that we on our own can conduct a phase II study to maximize DONQ52 value. Also, by us actually conducting phase II trial, we can accumulate our insights and experiences. Those are the two reasons why we have decided to conduct phase II study on our own. For the second question, Tanaka will answer which one of those projects will be subject to go/no-go decision this year. Tanaka speaking. I was asked to answer this question, but at this moment, we're not in a position to comment on which one will be subject to go/no-go decision. And LUNA-18? As for LUNA-18, the combination dose escalation study and monotherapy study is underway, and we are not in a position to talk about any progress or result. I'd like to refrain from answering that. From 2025, whether you can get POC or not, I think that was the target. This is not part of the milestone for this year, so I would understand that there is not going to be any changes in particular this year. At this moment, we would like to refrain from answering that question. Thank you. Next, Citigroup Securities. This is Mr. Yamaguchi from Citigroup Securities, please. Can you hear me? Yes, I can hear you. Sorry, thank you. The first one. The next question is related to NXT 007. The talk that phase II is coming out. Phase II? The timing of the top line, if possible. Also, there are some academic societies, some characteristic companies. I think there are some major academic societies meeting worldwide to discuss Hemlibra. But discuss Hemlibra. But will you be able to make some presentation based on the phase II result of NXT 007? So I would like to understand when you are planning to present the result of phase II for NXT 007. At this point of time, I cannot comment on the timing of the presentation of phase II study. But I think you are confident in its profile. This has a potential to do better than Hemlibra, right? As a concept, anti-coagulation level [Foreign language]. It should be able to achieve the non-hemophilia level, and that is the concept which remains unchanged. And the second question - oh, sorry, go ahead. [Foreign language]. In the phase I study, we were able to confirm long half-life, which is 10 weeks. My second question is related to go/no-go decision, which has been the focus of today's session. For mid-size molecule, [Foreign language]. Seems like it's taking longer than expected. Not just in LUNA-18, but should we expect some impact as a result of go/no-go decision on mid-sized molecule? [Foreign language]. Thank you for your question. Tanaka would like to respond. Are we applying a go/no-go decision on mid-sized molecule? Well, basically, for any project, we are going to apply this go/no-go decision approach.[Foreign language]. Mid-sized molecule included, right? So you should be able to accelerate the speed of the development for mid-sized molecule, yes. Enhancement of the speed is the goal of science-based go/no-go decision. So yes, that's all from me. Thank you. Oh, this is Taniguchi speaking. For NXT 007, I think you kind of asked the peak sales of NXT 007. So if you look at page 12, it says over CHF 3 billion. That's the category we are referring to. Is this 3 billion? Well, we are saying over 3 billion. 3 billion [Foreign language] So more than CHF 3 billion, yes. Thank you. That's all from me. Next, Jefferies Barker-san, please. Hi, Jefferies. Yes, Stephen Barker from Jefferies. from Jefferies. So this is the company name. This year's. Stephen Barker for the focus for this year and the revenue and profit focus. Nemolizumab export and royalty income. How much you have incorporated in this year's forecast? Taniguchi speaking. Thank you for the question. As for Nemluvio, it has not reached the threshold yet, so it is part of the others in the disclosure. If you look at the data book, there are items like others, the overseas sales. There's others, and that is what includes Nemluvio. But how much of that is Nemluvio? It's not disclosed, and the breakdown information is not subject to disclosure. But the sales in others from this year to next year, there will be more than doubling of increase, and a majority of that is from Nemluvio. Thank you. Other revenue and royalty income. Hemlibra was the main reason, as you said. But for this year, export to Hemlibra, if you look at the value, there is not much increase in royalty income increase. The other revenue is JPY 172.7, or JPY 172.7 is last year. They're not much changed, but actually, mix has changed. I cannot disclose that, but there are products that are slowing down, but there's also one-time income that is included, so there's some increase and decrease. So we cannot talk about which product is growing and which product is slowing down. So Enspryng overseas sales for this year, local sales, what would be that one? Well, in terms of Enspryng, the sales scale is smaller compared to Hemlibra and Actemra, much smaller, and the timing of shipment and export is not happening like every month or every two months, not regularly. So because of the timing of the shipment and export, there were some changes and fluctuations in numbers in the past, but this is also what is happening this year. Thank you. Thank you very much. Next is from Macquarie Capital, Tony Ren, please. Hello, can you hear me? Okay, perfect. Okay, perfect. Yeah, so just a couple from me. So you guys alluded to that in 2025. In terms of exports of Hemlibra to Roche, there will be a unit price reduction. I just want to get some understanding of the magnitude of the unit price reduction here. So if I look at slide 53, you can see that there is a column called year-on-year, year- over-year, year-on-year column. The Hemlibra export appears to be growing at 44.9%. But if you look at the revenue forecast of JPY 324.2 billion, that's about a 5% increase. So would it be correct to assume that there will be roughly a 40%, 39%-40% average price reduction on Hemlibra sold to Roche? This feels quite large of a price reduction. So that's my first question. The second question that you guys alluded to a few times, that GYM329, you will start a combination study in obesity. I just want to see if you have any thinking about what would be the combination partner. Would that be one of the incretin GLP-1s from Roche and Carmot Therapeutics? Yeah, thank you. Thank you very much for your question. Taniguchi would like to respond to your first question. With regard to the Hemlibra, from 2023 to 2024, it has grown by 44.9%, and from 2024 to 2025, we are not expecting that much growth, like 5.4% revenue growth we are expecting from 2024 to 2025. Volume and effects will affect on top of the unit price. And the detailed breakdown is not disclosed. Unit price comes down because the percentage of emerging markets will grow, then unit price will come down. However, for emerging markets, volume will grow. So plus minus net for this fiscal year, we are still expecting a positive growth. The magnitude of the decline of unit price in terms of that we are not expecting a big decline of unit price. And for the GYM329 obesity combination study, what is the combination drug? That's your question. At this point of time, we haven't decided on that, but incretin is one option we are looking into as a combination drug. Okay, if I could, yes, thank you very much on both. If I could just tag on one more. So you guys alluded to that last time that the biosimilar Actemra had some supply chain issues. Now that the whole GLP-1 supply chain issue, particularly with Wegovy, Ozempic, Zepbound, has been resolved, do you have any update on your biosimilar Actemra competitors? Has their supply chain issue been resolved ACTEMRA You're talking about Actemra? Actemra biosimilar. We cannot make a comment on the situation of the other company, but Actemra biosimilar on top of the supply chain issue, there are other factors such as the price of biosimilars and other composite factors are affected, and also in some of the market, Actemra, which is the branded products, are preferred by rheumatologists. So in 2024, the entry of the biosimilar was lower than our expectation, and for 2025, what will be the speed of the entry? I cannot make any comment, but if you look at our sales forecast, well, we are setting up somewhat conservative forecast for 2025, anticipating some entry of biosimilars in 2025. Okay, understood. Yeah, very good. Yeah, thank you. Morgan Stanley MUFG Securities. Mr. Muraoka, please. Thank you very much. Morgan Stanley Muraoka. Can you hear me? Thank you. Now, I'd like to ask about DONQ. Just for clarification, you were looking for partners, but in order to increase value, you are going to conduct phase II on your own. That's how I understood. So POC phase 1c, based on the results of POC and phase 1c, and you showed the results to potential partners, and you decided that you will not be able to find any partners, or on the other hand, you actually thought that it would be more interesting for you to take this up on your own. Okuda speaking. Thank you for the question. We're still conducting phase I that is underway. And also, as for those strategic issues, we'd like to refrain from answering that or commenting. Thank you. In the Roche pipeline, DONQ is part of that. Roche is just showing this as information of the subsidiary. Yes, that is correct. There is no fact that we have licensed out DONQ to Roche. Thank you. Now, the second question. The first quarter that we are now in, how do you look at that? The fourth quarter that was over on a quarter-on-quarter basis. Well, because of the third quarter, on a quarter-to-quarter basis, the numbers dropped. But January to March, there could be some reactionary effect. And also, first quarter, one year before, had a slow start. So this first quarter, you are making steady start, even though the things seem to be flat. Well, I think that probability of hearing that result at the end of the first quarter is high. Would that be correct? Well, January 30th is today. So it's been only one month. So we don't know what is going to happen for the remaining two months. It's very difficult to figure out. And so in terms of the level of probability or confidence, I would like to refrain from commenting on that. Well, the way I put the question was wrong. Well, including the remaining two months, is there anything that you can expect, like changes in inventory or some one-time factors that could be something that we should be mindful of, either positive or negative factors within the information that can be disclosed? Nothing in particular. Okay, thank you. Thank you. Yes, please. I'm in the right channel right now. I have switched to Japanese line. Thank you. I have a couple of questions. First of all, P6, from this year to next year, what is going to be the change? When I look at the overseas sales, export unit price, sales volume impact are shown. The balance seems different from the past. Price reduction impact for export net price seems to be high. My first question is that the impact is coming all from Hemlibra in terms of export unit price and the sales volume? With the Hemlibra seems growing, but in terms of the overall sales, amongst the sales of Hemlibra, the majority of them are coming from the U.S. and Europe. At the end of the day, unit price impact I would assume to be very limited, although there might be some price lowering pressure, but I'm surprised to see this price impact. Export unit price within your scheme of defining export unit price. Is that the sales volume will exceed the impact of export unit price? Taniguchi would respond to this question. This is not only driven by Hemlibra. Percentage contribution of Hemlibra is high, but when you look at the international market, Roche itself has Actemra, which is growing. Alecensa is also growing. All of them are contributing. As long as we have international exposure, this unit price impact will give us some impact. And we have contracts per product, and I cannot comment or disclose the contracts for specific products, but it's not like internally fixed. It's a contract between two parties. So as long as two parties agree, if necessary, we can make amendments or changes. But for the specifics, I cannot comment. The size of this arrow doesn't really have big significance. So I know some people measure the size of this arrow, but it's not really a meaningful thing to do. From 2023 to 2024, compared to the change between those two years, it seems like 2024 to 2025, the size of the change is bigger now. Yes. And with regard to the product development strategy, a valid product drug development strategy, what kind of KPIs do you follow? Do you see that your strategy is functioning well or not? This is Tanaka speaking. I would like to confirm your question. Are you talking about the go/no-go decision KPI? So you are going to promote go/no-go decision. You are going to speed up the right decision-making process. And I was wondering how you measure the effectiveness or success of such go/no-go decision. Is there any KPI? Thank you. With regard to the go/no-go decision, it's not like we have set forth clear KPIs. We don't have such KPIs. When go/no-go decisions are thoroughly executed, our development cycle should see faster speed. So the So the decision on discontinuation of the project can, you know, happen earlier. In that case. That is your. No, we don't have a specific KPI for that. Understood. Thank you. Very much. With that, we'd like to conclude the Chugai Pharmaceutical earnings briefing on the year ending December 2024. Those questions that were left unanswered, please contact Public Relations and IR on a separate basis. There is contact information at the end of the presentation slide in terms of telephone number and email address. Thank you very much for your presence despite your busy schedule today. That concludes our meeting. Thank you. Thank you.