Good afternoon to you. This is Okuzawa speaking. Thank you very much for your joining this financial result representation of Daiichi Sankyo. I would like to explain to you, based on the material of the unconsolidated financial result of the second quarter of FY 2025, which was announced externally at 1:00 P.M. Japan Standard Time today. This is slide three. I would like to first cover the fiscal year 2025 second quarter financial result and fiscal year 2025 forecast, business update, and then R&D update. In this order, I'd like to present and ask to the R&D update. I would like to ask Dr. Takeshita, the Global Head of R&D, to explain, and we will be entertaining your question at the end. Please now look at slide four. This slide shows the outline of the FY 2025 second quarter financial result. The revenue was JPY 975.4 billion, increased by JPY 92.6 billion, or 10.5% year- on- year. Cost of sales increased by JPY 25.8 billion. SG&A expenses increased by JPY 51.3 billion, and R&D expenses had a JPY 23.5 billion increase year- on- year. As a result, core operating profit was JPY 158.6 billion, declined by JPY 8 billion, or 4.8% year- on-ye ar. Operating profit, including the one-time profit and loss, was JPY 144.2 billion, declined by JPY 42.7 billion, or 22.8% year- on- year. The profit attributable to the owner of the company was JPY 130.8 billion, declined by JPY 15.9 billion, or 10.8% year- on- year. As to the result of the exchange rate, one dollar is JPY 146.04, and this is the 6.5% appreciation year- on- year. One euro was JPY 168.6, and the yen depreciation by JPY 2.13 year- on- year. This is slide five. Now I'd like to talk about the factors contributing to the increase or decrease year- on- year. Revenue increased by JPY 92.6 billion year- on- year. Now I'd like to show you the breakdown by the business units. Let me begin by Japan business unit and others. The Belsomra for insomnia, Datroway, which is the anti-tumor drug, Lixiana, direct oral anticoagulant, Talion for pain, and Enhertu for anti-tumor effect, increased their sales. This absorbed the realized sales for unrealized gains for Daiichi Sankyo SPA, that was JPY 11.2 billion. Also, the decline by the vaccine business shrinkage, that was JPY 6.1 billion. We had the overall increase by JPY 1.6 billion totally. Now let me talk about the overseas business units. Here we have excluded the impact by the foreign exchange. Oncology business increased by JPY 69.7 billion due to the growth of Enhertu and also the contribution of the sales by Datroway. American Regent experienced a decline by the sales by JPY 7.7 billion for the decline of Injectafer and Venofer for iron deficiency and anemia. EU specialty business increased by JPY 16.9 billion due to the growth of Nilemdo and Nustendi, which are hypercholesterolemia treatment increase. In ASKA business, which is in charge of Asia and Central and South America, there was a growth of Enhertu in China and Brazil mainly, and that experienced JPY 22.9 billion of increase. The upfront payment and regulatory and sales milestone, et cetera, related to AstraZeneca and U.S. Merck, increased by JPY 5.6 billion, thanks to development milestone income with U.S. EGFR-mutated non-small cell lung cancer of Datroway and also upfront payment of the agreement of the strategic alliance with U.S. Merck for DXd- ADCs booked. We have also received the second upfront payment of JPY 750 million from Merck USD for U.S. for DXd. From third quarter this fiscal year through the end of expected exclusive period, it will be booked as revenue. The forex impact was JPY 17.1 billion negative. Slide six shows the factors contributing to the change in core operating profit. I will explain about the background of JPY 8 billion profit. As I explained earlier, sales decreased by JPY 17.1 billion due to the FX impact. Revenue increased by JPY 92.6 billion. Next, I will explain cost of sales and expenses, excluding the impact of FX. Cost of sales increased by JPY 28.3 billion due to inventory write-down on Daiichi Sankyo and unqualified products. In addition, sales increased by JPY 109.7 billion in real value, excluding the impact of FX rate. SG&A increased due to increased profit sharing with AstraZeneca. This represents an increase of JPY 61.8 billion. As for R&D expense, due to the progress of development of DXd- ADCs, R&D investment have increased by JPY 30 billion. Total cost reduction due to exchange rate effect was JPY 19.4 billion. Actual decrease in core operating profit, excluding the FX impact, was JPY 10.4 billion. Next, on slide seven, I will explain the change in net income. Core operating profit, as explained earlier, decreased by JPY 8 billion, including FX impact. Regarding one-off income and expenses, in the same period last year, a gain of the sale of Daiichi Sankyo SPA shares was recognized as one-off gain. However, this was no longer such impact. From this fiscal year, revenue decreased despite income related to the litigation with former Ranbaxy shareholders. In addition, due to the CMO compensation fee following the change in the launch date of DS-3939 and the write-down of inventory for Datroway and DS-3939, profit declined by JPY 34.6 billion. Financial income and expenses increased by JPY 13.3 billion due to improvement in FX gains. Corporate tax declined by JPY 13.5 billion due to a decrease in profit before tax and decrease in effective tax rate compared to the same period last year. As a result, profit attributable to the parent company for the period decreased by JPY 15.9 billion year- on- year to JPY 130.8 billion. Next, I will talk about our financial forecast for fiscal 2025. Please refer to slide nine. Revenue is revised upward by JPY 100 billion from the April forecast to JPY 2.1 trillion. This revision incorporates lower sales of Injectafer and Venofer at American Regent and decreased milestone income for Enhertu while reflecting the positive impact of weaker yen. Anticipated sales growth primarily driven by Datroway in Japan and U.S., and Enhertu in the United States. Cost of sales is expected to grow by JPY 30 billion due to higher expenses from the upward revision in revenue forecast and FX impacts, as well as inventory valuation losses for Daiichi Sankyo and unqualified products. SG&A are expected to increase by JPY 65 billion due to FX impact and higher profit sharing with AstraZeneca associated with increased sales. R&D expenses are expected to increase by JPY 5 billion, primarily due to FX impact. As a result, core operating profit is projected to be JPY 350 billion unchanged from the April forecast. OP is expected to decrease by JPY 15 billion- JPY 335 billion, reflecting the recognition of gains and expenses through the second quarter. Profit before tax and net income attributable to owners of the parent, reflecting the revision to OP, are projected to be JPY 355 billion and JPY 288 billion, respectively. The FX rate assumptions for the third quarter and onward are JPY 150 per U.S. dollar and JPY 170 per euro. The weaker yen against the April forecast is expected to drive revenue by about JPY 68 billion and the core operating profit by approximately JPY 6 billion. With this revision to the forecast, we now expect to achieve four out of the five KPIs for FY 2025, which is the final year of the fifth midterm business plan. Which are revenue, oncology revenue, core operating margin before R&D expense deduction, ROE, and DOE. The exception is core operating margin before R&D expense deduction. Regarding the core operating margin before R&D expenses, while the target was 40%, unfortunately, it is expected to fall slightly short. This is because anticipated timing of receipt of a portion of Enhertu development milestone income is now in fiscal year 2026. We'll continue to make improvement as we move toward the sixth MTP. Next, let me share with you the business updates. Please look at slide 11. This slide shows the Enhertu sales performance. The global revenue of the second quarter of FY 2025 was JPY 318.4 billion, a JPY 57.1 billion increase year- on- year. In all major countries and regions, we have achieved the number one share of the new patients in existing indications such as breast cancer, gastric cancer, and lung cancer. We have established a position as a standard of care, and since the launch, quarterly revenue reached JPY 1 billion for the first time. As to the whole year forecast, penetration in the chemo-naive hormone receptor positive and HER2 low or super low or ultra low expression breast cancer market progressed more quickly than we have expected in the U.S. and Germany. We have updated our forecast to JPY 694.2 billion, increased by JPY 32.1 billion versus April forecast. This indication achieved the number one share of the new patient in Germany. This is a driving force in Germany where it is launched only in Europe. We have started promotion in August in Japan. Next, let me talk about the sales status of Datroway. Please look at slide 12. [Foreign language] Global product sales for Q2 of FY 2025 reached JPY 15.7 billion. Significant sales growth was achieved in the U.S. and Japan for hormone receptor positive, HER2 negative breast cancer with prior chemotherapy, and in the U.S. for EGFR mutated non-small cell lung cancer, exceeding expectations. Globally, the drug has already been administered to over 2,000 patients cumulatively. For both breast and lung cancer, unmet needs are exceptionally high, particularly in the third line and later treatments. Larger than expected number of patients received treatment, and Q2 results significantly surpassed expectations. Therefore, the full-year forecast has been updated to JPY 37.8 billion, up by JPY 16.2 billion from the July forecast. Sales for the breast cancer are progressing steadily in both U.S. and Japan. We are promoting knowledge of preventive care and treatment for side effects such as stomatitis and dry eye through educational activities targeting at HCPs. Furthermore, this indication has already been approved in over 35 countries and regions. For lung cancer indication, following the launch of promotion in the U.S. in June, it has already acquired new patients comparable to breast cancer within just initial three months, demonstrating a very strong sales ramp-up. We will continue to pursue deeper market penetration in existing regions and expand into new countries and regions, while also expanding indications. Our goal is to deliver Enhertu and Datroway to as many patients as possible who are in great need. Next, we will move on to the R&D update. I will now hand over to Takeshita, Head of Global R&D. Thank you very much, Okuzawa-san. It's a pleasure for me to give you an update on important clinical trial data for the last quarter. Many of these clinical trials are ones that are presented at ASCO or sometimes in the World Lung Cancer Conference. The first slide is the DESTINY-Breast11. This trial and the DB05 that you will see next represent a pair of clinical trials that bring Enhertu into early-stage HER2-positive breast cancer in a curative intent setting. For these reasons, these are two important studies. First, on DESTINY-Breast11. This is a neoadjuvant study, and Enhertu followed by TCHP before surgery resulted in a pathologic CR rate of 67.3% compared to the old standard of 56.3%. This is a rather clinically meaningful and large improvement in the pCR rates. We can also see on the right-hand side of the slide an early trend towards improvement in the event-free rate, even though this is a relatively immature set of data at this point, with a hazard ratio already of 0.56. This really represents the first positive global registration trial for a new agent in a neoadjuvant HER2-positive early breast cancer setting in over a decade. Next slide. This is the other part of the pair of clinical trials in early breast cancer, DB05. This is a clinical trial of the post-neoadjuvant setting of Enhertu in patients who remain positive after the treatment with a neoadjuvant therapy. In this clinical trial, we can see that the post-neoadjuvant Enhertu resulted in greater than. Half the decrease in the risk of invasive disease occurrence or death compared to T-DM1 with a hazard ratio of 0.47. This really represents a second positive phase 3 trial demonstrating superiority of Enhertu over T-DM1, the first one being DB03 in a metastatic setting. The safety profile was good, and we believe that between DB05 and DESTINY-Breast11, these two studies bring Enhertu into the HER2-positive post-neoadjuvant setting as a second chance to achieve a cure and a potential for a new standard of care for eligible patients with this residual disease. Next slide. In addition, please note that there were many regulatory achievements in gastric cancer, breast cancer, and pan tumor setting. I also want to make sure to note that we have PDUFA dates coming up, first for the DB09 in January 2026 and DESTINY-Breast11 you just heard about in May 2026. Next slide. This is from the Datroway program, T-B02 clinical trial in the frontline setting for metastatic triple-negative breast cancer. This is a clinical trial in the frontline setting in whom immunotherapy is not an option. We can see that in this clinical trial, we see both positive PFS benefit as well as positive overall survival benefit. Overall survival benefit is with a hazard ratio of 0.79 and improvement by five months compared to the control arm, with experimental arm achieving 23.7 months. This makes Datroway the first and only therapy to significantly improve overall survival versus chemotherapy in this patient population. We believe that this sets the standard for a new potential standard chemotherapy in this patient population. Next slide. This is the results of a clinical trial called BEGONIA. This is an early phase I-B/2 study that was also presented at ESMO. This is the other half of triple-negative breast cancer patients. In this clinical trial, patients who were enrolled regardless of the PD-L1 expression. It is important to note here that there is the addition of Durvalumab in addition to the Datroway in this BEGONIA clinical trial. You can see here that the response rates are very impressive, with a response rate of almost 80%. It is also remarkable that the spider plot shows very durable responses. These are very encouraging. As you know, we do have this exact combination, the double-A combination of Datroway and Durvalumab being tested now in a randomized phase III study in a patient population called TROPION-Breast05. This is an ongoing study. We're very hopeful that we can replicate this outstanding data in a phase III setting. Next slide. We also want to mention that we have initiated a new trial of Datroway in bladder cancer, TROPION-Urothelial03. This is a new trial that just started in October of 2025, this month, in patients with bladder cancer. You can see that the Datroway is really expanding beyond the lung and breast cancers that you are familiar with. Next slide. This is clinical data that was presented not at ESMO, but at the World Congress on Lung Cancer. This is the ID8 Lung 01 clinical trial, a phase II single-arm trial in patients with relapsed refractory small cell lung cancer. This is our first paper study for the I-DXd program. You can see that the response rate, the primary endpoint here, was quite good. We are interested in further pursuing this compound in small cell lung cancer. We are having some conversations now with our regulatory agencies on this particular clinical trial data. Next slide. I do want to mention here that the safety profile of I-DXd in this setting, in the clinical trial that you just saw, was quite good. On the basis of these data, the safety data and the clinical data, the FDA did grant us a breakthrough therapy designation for I-DXd in extended stage small cell lung cancer back in August of 2025. Okay, next slide. This is the results of the Rejoice Ovarian 01 study. This is a phase II III study in which at this point in ESMO, we presented data on various doses of R-DXd in ovarian cancer, patients who have platinum-resistant ovarian cancer. You can see that in all those levels tested, there is very good activity of the drug in ovarian cancer. This allowed us to select the dose of 5.6 as the study for phase III portion of the study based on the combination of the efficacy and safety data that we accumulated in the study that you're seeing here. Next slide. Okay, this is a summary of additional regulatory approvals and clinical trial data. You can see that we have initiated three new studies and also that Datroway was approved in China for the TB01 indication. Next slide. In the next few slides, I want to highlight for you some new trials that are starting in phase I stage. First is the DS-3939 program. This is a clinical trial data that was presented at ESMO. It's a phase I/II trial. This is really intended to understand the safety mostly of the drug. You can also see that there is early activity we can see in patients with various types of cancers, including non-small cell lung cancer and ovarian cancer. This is very encouraging that we are already seeing tumor shrinkage and efficacy in the setting of a dose escalation clinical trial. We are very encouraged and we are hopeful that we can do further with this drug. Next slide. There are a couple of new additional trials that are being started. The next one is DS-3790. This is a DXd- ADC. This is the seventh in our series of DXd ADCs, and this one is directed at a target called CD37. CD37, as some of you may know, is a B cell target. Therefore, we are very interested in studying CD37 in B cell malignancies such as lymphoma. We do intend to start the study in the second half of the current fiscal year. Next slide. DS-9051. This is a new program in solid tumor, and this is Daiichi Sankyo's first targeted protein degrader. This is not an ADC, but it represents a totally different mechanism of action. That is a targeted protein degrader, and we are very interested to initiate this clinical trial. We have not disclosed the target protein, but please do note that it is intended for prostate cancer. Next slide. Finally, the last one is DS-5361. This is a quite unique mechanism of action. This is a small molecule NMD inhibitor. NMD stands for nonsense-mediated messenger RNA decay. Typically, if there is a mutation in the gene that results in a nonsense mutation, that messenger RNA is spontaneously degraded through a mechanism known as nonsense-mediated messenger RNA decay. We have developed a small molecule that inhibits this decay. What this really means is that in many cancers where there are nonsense mutations, frame-shift mutations that result in nonsense mutations, the messenger RNA remains intact and then therefore translated by the cell into proteins and peptides that are typically not expressed by that cell. This results in expression, therefore, of neoantigens that are unique to the tumor cells. Please consider that this small molecule NMD inhibitor, therefore, is an attempt to increase the immunogenicity of tumor cells and therefore is in a class of what we have called immuno-oncology therapy. This is a very exciting, very unique mechanism, and we are very excited to be initiating a study with this compound. Okay, next slide. Okay, so in terms of news flow for the rest of the year, this is shown here. As I mentioned, we anticipate upcoming regulatory decisions with the PDUFA data already decided for DB09 and DB011. In addition, we are expecting data readouts as shown here on the right-hand side. As the data become available, you'll see announcements from us. Okay, that's all from me. Asakura-san, back to you. [Foreign language] On November 28, Japan Standard Time, we have a sustainability meeting. On Monday, December 15, 2025, we are scheduled to have Science and Technology Day. Once the details are decided, we'd like to give you announcements separately later. From here on, we'd like to start Q&A. The first question is Yamaguchi-san for Citig roup. [Foreign language] This is Yamaguchi of Citi. Can you hear me? Yes. This is Yamaguchi of Citi. Let me ask you my first question. This is about the first-half result, especially limiting to Q2 only. As you have explained, the gross profit in relation to vaccine and also manufacturing-related matters, there was the increase of the cost. And also SG&A. [Foreign language] There is an increase excluding the co-promotion-related matters. There are some specific and also very special increase. Excuse me. Core versus the sales, there are a series of costs. [Foreign language] Is it because that there is something which is unexpected, or is it kind of the one-time issue and your main business is going fine or not? That is my first question. Thank you very much for your question. [Foreign language] This is Ogawa speaking. [Foreign language] Yes. Our main business is doing really fine. And how to Datroway. Our major products are doing very nicely. As to SG&A and for Q2, and profit share part, naturally, due to the Enhertu and Datroway, in relation to the profit share, that would be reflected and there is no change at all. In other parts of the SG&A, and we call that others, but you may see this is large. If you look at the whole year for FY 2025, we also reflect the impact by the foreign exchange. At the end of the year, we expect a JPY 30 billion increase. We have JPY 19 billion. Therefore, that would be about JPY 11 billion. It is a slight increase. Therefore, SG&A, as we did before, oncology business to be supported, we need infrastructure for that. Also, investment to the organization and the human resources are continued to be incurred. I also would like to give some additional comment about our costs. Please refer to the supplemental material. There is an adjustment table, and that is the translation from the core to the non-core. This time, we normally do not have an opportunity to ask you to refer to this document. I would like to ask you to refer to that table, taking this opportunity. I would like to explain based on that table. We have one-time cost this time, JPY 18.5 billion on a core base. In a core operating profit, that was a one-time cost, JPY 18.5 billion was booked. This time, on the bottom, especially in this material, in the mid we have some notes here. To show our current profitability, core operating profit is disclosed. This time, especially based on the definition, the one-time but the large amount of the profit and loss is included. There is something which applies to this criteria, for example, in this adjustment table. For example, there is a compensation to CMO loss, and that has been already, that was explained in the presentation. This compensation was JPY 12.7 billion. In addition to that, this compensation, especially for the HER3 study, result-based, the changes and the strategies happened, were made. Therefore, Datroway and HER3 inventory, the impairment or the loss is really due to these changes in strategies. Therefore, those are all regarded as the one-time changes or the repayment. We have JPY 17 billion, that is the largest one, and such a one-time amount is registered here. Therefore, the full base adjustment took place, and that was the SG&A. We have JPY 29.6 billion. This is a huge amount, and this is prior to the cost sharing with the partner. Adjustment after the cost sharing is reflected in that JPY 12 billion or so. We have increase and decreases and the full base and the core base adjustment. There are some adjustment, major amount of the adjustment made. That may be a little bit difficult to understand, but this is what we did. In a core base, in the second quarter, Daiichi Rona and Enhertu. In the case of Enhertu, especially in the manufacturing lots, there are a series of the unqualified lots generated, and those are going to be disposed as from inventory. Those are included in the non-core area. To Enhertu, the cause identified and also the countermeasure has been already taken. This will not give any impact to the plan of the supply. For Daiichi Sankyo, there is a major reduction of the demand. Therefore, we have booked the inventory loss. This has been the lengthy explanation, but that was the thing. I'd like to have another short question. This is about Datroway doing very nicely. Since we have Ken Keller with us, we'd like to understand the situation, competitive situation, especially both in lung cancer and breast cancer situation in the U.S., especially the competitive landscape. Great. Thank you for the question. When we look at Datroway, and I'll talk about the U.S. specifically, we're seeing very good adoption in both the HR-positive, HER2-negative space and also the non-small cell lung cancer space. There are two different dynamics going on. When you look at the lung cancer space, this is a large group of patients where there are not very satisfactory options today. There are many patients who have gone through numerous treatments, and they were waiting for something new. Datroway is filling that space today, and we're seeing very nice uptake and reports of excellent experience. In the breast cancer space, Datroway is also doing well. I think what physicians are seeing is that this is a drug that they are finding they can manage the toxicities. They're seeing that the schedule is advantageous compared to the competitor, and those two factors are really causing people to trial with the drug. As they gain experience, we expect that is going to accelerate. Thank you. Thank you. [Foreign language] Let me move on to the next question. Mr. Hashiguchi from Daiwa Securities, please. Yes, thank you. I am Hashiguchi from Daiwa Securities. Similar question from myself. In terms of the core OP. Inventory write-off? Are we expecting the similar, you know, inventory write-off going forward? And one. Is called non-core, but this is core. So probably, you know, the similar write-off may. Again into the future. With regard to Daiichi Sankyo, depending on the market situation, do you think it is likely to do another write-off of inventory into the future? With regard to Enhertu, I know you have taken action already, but can you explain the background, you know, why that happened and what exactly did you do? Do you have any information that will give me peace of mind? Sorry about that. I was muted. Thank you very much for your question. With regard to Daiichi Sankyo, at this point of time, we have, you know, put this number, I mean, based on the latest information, and when we see some changes in the future, there may be another write-off, but this is based on the latest, best estimate. With regard to Enhertu, actions were taken, and we have already identified the root cause. We have taken measures to prevent the same thing from happening. You can rest assured that the same thing will not happen. I cannot deny the possibility, you know, for sure, but at this point of time, we have taken corrective measures. Now, my second question is regarding Datroway breast cancer. It's progressing better than your expectation. Why is that? What is driving better than expected performance? When you explain about the Enhertu, you oftentimes refer to market share. What about Datroway in breast cancer? What's your market share right now? Drop to ADC, you know, compared to the competitor. Drop to ADC, how do you compare your product? Is there any more room that you can take share away from them? Thank you for that question. To answer your question, yes, there is lots of room to take more market share from the existing competitor, which is a drug called Trodelvy. Datroway is really in its early stages of launching in the breast cancer space. The reasons why people are eager to try this drug is, number one, the efficacy looks, you know, very good in clinical trials. Number two, in the real world, Datroway has a very nice scheduling advantage as it is dosed every three weeks. The competitor is dosed day one, day eight, day 21. You can imagine the inconvenience of going to hospitals or clinics far more often. Number three, the toxicity profile of these two drugs, Datroway and Trodelvy, they're different. There are many physicians and patients who struggle with the toxicity of Trodelvy being neutropenia and difficult diarrhea, which can actually cause febrile neutropenia and place patients at a higher risk for going to the hospital. They see Datroway as a more convenient, potentially an excellent drug, and they want to try it. That's why people are using it more than we thought. I'm happy to report their experience. Is matching their optimism. I think with the data that we shared at ESMO in the triple-negative breast cancer space, that's going to add to the excitement of this product. Thank you very much. That's all from me. Next question. Ueda-san of Goldman Sachs, please. This is Ueda of Goldman Sachs. I would like to also ask you. About the inventory write-down. And a core base. And Daiichi Sankyo and Enhertu were included. What was the specific amount of the money? Without this amount, then core base, the gross profit rate should have been the same as the level of the first quarter or not? Just roughly, what was this impact size? Thank you for your question. As to the sense of the size, was Enhertu about JPY 5 billion and Daiichi Sankyo about JPY 5 billion? That was the rough size. That would be about JPY 10 billion totally. In the second quarter, we have a high cost of the cost ratio, as you understand. With this JPY 10 billion, this is about a 1% increase of the cost ratio. This term, we will not repeat the same situation as we expect. Therefore, in the third quarter and after, we will see the improvement of the cost ratio. The full year, we expect a rate of 21.9%. Thank you. This is a follow-up question of that. In a core base, in the first quarter to the second quarter, the cost ratio seems to be worsening greatly, maybe by 5% or so. The background is that from first to second quarter, there wasn't any, however, the product mix changed greatly. What was the contributor of this worsening by 5%? As far as you see, in the second quarter, vaccine sales were reflected. That's why this contributed to the worsening of the rate of the cost. Understood. Thank you. If that is the case. Excuse me, the second question is about the modification of the plan. The revenue you have raised by JPY 100 billion. The core profit, operating profit hasn't been changed. With the Forex, there will be the increase by about JPY 6 billion. With Enhertu sales increase and so forth, of course, there is an increase of the profit share. In line with this increase, there will be the increase of the profit also at the same time. Are there any offsetting factors? For example, Enhertu, Daiichi Rona may be reflected, but what are the factors to offset so that the cooperating profit would stay flat? Thank you for your question. Yes. Enhertu and Daiichi Rona, cost impact is, yes, the one thing contributing to this. Another thing is the milestone income. There is some shift of the timing. DB05 or 11. I had expected its milestone payment for this fiscal year. However, that would be postponed to the next year. 11, we have some result already, but there is some other shift expected. Excuse me? The milestone on page 38, and how can I interpret the table and Enhertu milestone-wise? Then versus the April forecast, the development milestone was in positive number. How can I understand that? Thank you. Thank you very much for looking into the material very in detail. As of April, there wasn't any, the PB09 was not reflected. However, this is reflected this time. DB09, and based on the PDU for January, we have made some changes. That is the situation. The development milestone-wise, the number is positive. Therefore, rather, the one-time impact of the cost and also the increase expected for the SG&A. These are offsetting the increase by the increase of the sales and profit. That's correct. As I have just, what I have stated was not really wrong. Yes, what I have stated correctly. About JPY 10 billion or so, the milestone payment occurred. However, as of April, when we made the announcement last time, this wasn't announced at the time, but this was reflected already in the forecast at the time. The BDUFA date, however, hasn't been determined. PDO511 milestone wasn't disclosed in the financial documents at the time. However, this time, we are now giving explanation additionally. Yes, so how you understood was correct. Oh, understood. Thank you very much. This is the end of my question. Next question is from UBS Securities. Mr. Sakai, please. Hello, this is Sakai from UBS speaking. One of the income related to the litigation with the former Ranbaxy shareholder, JPY 4.2 billion. IHH, sorry. I think it was Malaysia. Yes, hospital group. The litigation was filed with them. Shares, but. You took some court action to make sure that founder does not sell the shares. Then IHH. JPY 200 billion. He's claiming that they are producing some losses in total of JPY 200 billion. This is positive in terms of income, but this is a legal procedure. I'm not sure if you can comment on this, but JPY 200 billion, this number, when it's misunderstood by the market, that will lead to a scary situation. I just wanted to clarify what's going on. Thank you. IHH. IHH's subsidiary NTK has made a complaint, and this is the amount of the compensation based on their complaint. We believe what they are saying does not have any ground, so we cannot agree with them. We are going to challenge them. We are proceeding with the legal procedures whereby we make a reasonable statement. What they are saying, we believe, is groundless. JPY 4.2 billion income this time. With regard to that, so far, more than JPY 50 billion loss litigation we expected has not come in. The total we expect was JPY 50 billion, and finally we were able to receive JPY 4.2 billion out of JPY 50 billion. This is the income received separate from that litigation. This IHH litigation is now at the Tokyo District Court level. Is that the situation right now? Yes, that's our understanding, yes. Understood. Thank you very much. Another question from myself. Question for Keller-san. It's nice to see Datroway finally taking off. You said third line, fourth line for breast cancer, non-small cell lung cancer, taking some shares from Trodelvy. Given all these comments from you, the fourth line, third line, and fourth line, Datroway is being used regardless of TROP2, positive or negative. Yes, the indication is not TROP2 specific. The indication for breast cancer is HR positive, HER2 negative, regardless of TROP2 expression. Doctors aren't testing for TROP2 expression today, so it's agnostic to that. You're correct. We're getting usage in the third and fourth line. It's growing every week we look at the scripts, and we'll see that adoption continue to grow. The same is true in the non-small cell lung cancer space. We're getting late line use today, and there's no testing for TROP2 in that space as well. That remains to be the use for third line and fourth line use then. Yes, today that's where most people are using it. As they gain experience, I fully expect that it will move earlier and earlier. Just as a reminder, the triple-negative breast cancer data that we shared at ESMO, that's first line metastatic patients, triple-negative. That's first line. I think when people look at that data and they see the safety profile, that's going to really add confidence and assurance to move this drug up earlier and earlier. Right, okay. Thank you very much. Next question. N akao-san of JP Morgan, please. This is Nakao speaking. My first question is about the American Regent situation. Injectafer and Venofer, as you say. In the second quarter, the result was rather poor, and this term, the plan has been downward corrected. What are the factors, and also please tell me the future prospect. Thank you for your question. So far, especially in terms of Injectafer, we had so many challenges to overcome. The one thing was this high dose market itself has very severe competition, and competition is getting severer. With that as a backdrop, Injectafer usage is now on the decline. We have been forced to change the sales forecast. For Venofer, yes, there is a high demand, and also we have some significant share. However, the competition appeared in August. The generics were approved, and the three companies had launched their generics. The impact side so far is still limited, but after the third quarter and onward, there will be the pressure to the volume and price are expected. Considering all those factors, we have decided to make a downward correction of the forecast. Thank you. Listening to your explanation, for the Venofer, there are some generics already available. Therefore, the future is not really bright. For Injectafer, the situation is getting very difficult. Injectafer and Venofer at American Regent expect a decline. For how you can maintain with the generics injectables, would that be the policy? Yes, that is the situation. Further, on behalf of American Regent, we expect to make them as an ADC manufacturing site, and we are making investment towards that. Until the end of fiscal 2027, we plan to start up the manufacturing over there, so it will be having more importance in that area. Thank you. My second question is about the new projects, just briefly. 3790. 3790 and 9051. And 3790 for the DXd advantage to the hematology. And WENSED is target. And 5361 in summer. Y ou said that you are going into the immuno-oncology, and is it one of the immuno-oncology drugs? Yes, so let me answer the quick answer first. 5361, yes, it is part of our immuno-oncology program, for sure, yes. Your second question about the 3790 program, I think the question was, why was this chosen as our target? We did choose this because it is a very specific B-cell target, and it is somewhat different from other types of B-cell targets, such as CD20. It allows us for some differentiation versus other targets. We do think that this is going to be a very interesting one to study with a DXd- ADC platform based on a huge amount of preclinical data that we have generated so far. Also, the fact that there exists already at least one ADC in a B-cell malignancy called Polivy, so there is that precedent also. I think we're very hopeful to see very interesting data with this new compound. Thank you very much. Let me move on to the next question. Sogi-san from Bernstein, please. Thank you. I have a couple of questions to Dr. Takeshita. First of all, you know the Datroway, you have just disclosed that now you are initiating a phase III TROPION-Urothelial03. You presented a very good, strong data in your first line at ESMO, so this totally makes sense. Also, this doesn't appear to include patient selection based on QCS. So far, looking at the different cancer types, it looks like the non-small cell lung cancer is the one that requires the QCS-based patient selection. What is your current hypothesis that, what kind of factor makes the QCS-based patient selection required for the Dato- DXd? Yes, you raise a very interesting biological and clinical question in that, yes, in some diseases like breast cancer, we don't seem to need a biomarker selection, whereas in lung cancer, we are proposing to use this very fancy one called the QCS digital pathology technology. I think your question was, what makes certain cancers require a biomarker and why others do not require? I think that's your question. Yes. Okay, to be very frank, it's a lot of. I don't have a very good biological explanation for this. In fact, what we are doing is that with each indication, we are testing to see whether or not a biomarker is needed or not, and then proceeding to do randomized studies in registration setting once we have that understanding of whether or not a biomarker is required. Thank you. The second question is around new assets beyond ADC. For ADC, we understand that you have a long-term effort to really, you know, improve the modality, and now you're expanding, you know, the assets through that modality. What will be your differentiated strength in these new type of assets? Is it really modality-based, which you have a differentiated modality-based, or something else? Yes, we are a modality company. When I say modality, we're talking about a platform like the ADC platform. Once we are, because we are very good at generating ADCs, we can generate all kinds of ADCs, not just ADC dependent on the payload of DXd, but many other payloads, many other linkers. That is one important part of our longer-term research strategy. In today's presentation, you can also see an emergence of yet another modality. For example, you know, with this TPDs, the targeted protein degraders, that is yet another modality that we are very interested in. It's a modality that other companies have also invested in, but we too are very interested in this part. Then immuno-oncology, you know, the 5361 program, it is an immuno-oncology program, but you can see that it's a very different type of approach to immuno-oncology compared to most other companies in the sense that we are using really a very novel way to increase neoantigen presentation by tumor cells. I do want to mention, therefore, that yes, we have all kinds of ADC modalities. We are expanding to other types of modalities. Thank you. Thank you very much. Next question. Barker-s an from Jefferies Securities. Yes, Steve Barker from Jefferies. I'll ask my question in English, if that's okay. My first question is about capital allocation. In May this year, you got approval to buy back JPY 200 billion of shares, which you haven't executed. My understanding is that you wanted to preserve your cash, for example, for acquiring new assets. It's already October. What's going to happen between now and the end of this fiscal year? Is it possible that you will not buy back the shares and you also will not acquire any new assets? Thank you. Thank you for your question. Let me answer in Japanese. As to the share buyback, that was your question. Is there any possibility that we are executing that or not by the end of the term? As we have explained, it depends upon the stock price level and so forth, and things are decided comprehensively to find the right timing and the right way to do things. If the right timing comes, then we would execute. The important point here is that towards the goal future, we have to make investments, and we have to allocate cash for that. We have to invest to R&D and OpEx, and these should CapEx also, and these should also be carried out in good balance. Acquisition of the external asset could also be one of the options. If opportunity arises, then we also would like to allocate the fund. We will make a comprehensive consideration to decide the timing and to execute the plan. Thank you. My second question is related to R&D. DS-9051, protein degradation. I was wondering if you could talk a little bit about how you see this asset fitting into the bigger picture. Do you see potential for this asset in particular or other protein degradation assets to be combined with your ADCs? Yes. Strategically, we think of this 9051 in two different ways. One is that it is our first one in our series of TPDs, the targeted protein degraders. From that standpoint, it's a very important first step for our TPD program. As I mentioned, there is interest of this compound to target prostate cancer. As you know, we have some additional compounds and assets that are active in prostate cancer. In the longer term, you can imagine various combinations that might be interesting and really also another way for us to establish ourselves in a specific disease such as prostate cancer in a way that we are well established now in breast cancer. You say you have a series of TPD programs, so we should expect to see more programs like this come into the clinic? I think in the future, you can expect to see more, yes. Understood. Thank you. Let me move on. From Morgan Stanley, MUFG Securities, we have Mr. Muraka, please. I am Muraka from Morgan Stanley. I have a question to CEO, Mr. Okuzawa. Mr. Ogawa was commenting on buyback. Based on what I have heard from Mr. Ogawa, I have a follow-up question. Your stock price dropped quite significantly today and is almost the same level as the pre-summer level. I know you are inclined to buy something, but I really appreciate if you can execute another buyback at this timing. Is there anything that you can comment? Mr. Muraka, I understand what you are expecting of us. We investigate all possibilities, and we make a decision of cash allocation. Share buyback is one of the options, but that is not the only option. In terms of the shareholder return, as I have mentioned from previous time, I am committed to DOE 8.5% and more. This is something, this is the commitment that I made as a top management, and that is always sitting in my mind. As I mentioned in my presentation, important KPI, like DOE 8.5% and more. Regardless of the share buyback execution, this is the commitment that we have. I would like to reiterate that once again. Thank you. Thank you very much. JPY 3,600. It's not the level of share price which drives or triggers share buyback. Sorry, I cannot say anything about that. We are not following a short-term up and down of share price. Thank you. One time cost, which is the CMO compensation fee. I think this is related to HER3. You need to pay CMO compensation fee. That, I think I understand. Due to the compromised quality of CMO service, you are not really able to receive approval in a timely manner. Wouldn't it be not fair that you pay compensation fee to CMO? Can you explain? Thank you very much for your question. HERTHENA- Lung 01 study. In this study, we've asked CMO to handle complete response better as a result of the FDA audit. We told you that that issue has almost been resolved. Your point is indeed valid and probably this CMO didn't have a good quality of service. HER3-DXd? It's not approved yet for initial lung cancer. Following confirmatory study, HERTHENA- Lung 03 didn't meet our expectation. That was the major reason. This was unfortunately due to the lack of performance of our compound. CMO and our relationship is as follows. We have certain expectations on technology on CMO, and we have a demand forecast. Based on such, we need them to produce a high-quality product in a timely manner. That's the trust relationship we thought we had. Based on what happened, basically, we thought that we may need to pay cancellation fee as such. That's why we booked this number. This is a Merck partnership with Merck. From Merck perspective, how can we use the same CMO in a different manner? It's a multifaceted discussion that's needed, and we thought that this is the reasonable landing point for all the stakeholders. Thank you. The next question is from Tony Ren from Macquarie. Please go ahead. Hello, Tony Ren from Macquarie. Can you guys hear me? Yes. Okay, perfect. Thank you for taking my questions. First question to Mr. Ken Keller. On slide number 12, the actual way revenue. Wanted to ask you if you could possibly give us a sense of the revenue mix between lung cancer and breast cancer. I think I heard you saying that they are about equal between lung cancer and breast cancer. Just want to confirm that I heard correctly. Yes, thank you for the question. You are correct. When we look at the U.S. marketplace where we have both indications, actual revenue is pretty close to 50/50 at this time. We believe the number of patients are about the same because the length of therapy between those two indications in terms of progression-free survival is about six months for both. We think that is a good proxy since revenue is about equal there. We think it's about a 50/50 split right now. I would say that the early adoption of lung cancer gives me the feeling that we're going to see the lung cancer market grow even more than the HR positive, HER2 negative breast cancer space as we look at the next couple of months at least. Does that answer your question? Yes, it does. Obviously, the breast cancer, you guys have the first line triple-negative coming, right? Yes. My comment was exclusive to the HR positive, HER2-negative. When we get the triple-negative breast cancer indication, based on the profile of the drug, we saw a doubling of overall response rate. The competition today cannot offer that. We saw really impressive progression-free survival. We saw, obviously, the only drug in that space to deliver overall survival. You've got some of the convenience advantages I spoke about earlier. I expect this drug to do very well in that space. Yeah, absolutely. That's a feedback that I heard from ESMO as well. A number of KOLs told me that they think they will switch from Trodelvy to natural weight. Next question to Dr. Ken Takeshita. This is about your new asset in urothelial carcinoma, your TROPION-Urothelial03 study. This is obviously like it's being attempted in the post-platinum and pembro setting. They have roughly about 55% market share in frontline within the U.S. They have roughly about 55% market share in frontline metastatic urothelial carcinoma because it's actually quite a toxic combinatorial regimen, not to mention the financial toxicity, quite expensive regimen as well. Are you guys looking to target the remaining 45% as well, patients who are just using chemo combinations? Yes, thank you for that question. Yes, that's certainly under consideration. Okay, perfect. Thank you. Next question is from SMBC Nikko Securities. Mr. Wada, please. Hello, I am Wada from SMBC Nikko. Thank you. I have a basic question. Your ADC technology. They also have been focusing on ADC, and there are many other Japanese companies developing ADC. You have ADC technology and uncleavable linker technology. Cytospecific conjugation. Can selectively bind. For the rest, I think there are other players who are looking into the same technology. I wonder what's your major point of differentiation. Our research group has been working on ADCs of various sorts for many, many, many years. We have a whole library of linkers, payloads, and binders. Currently, in the DXd ADC program, we are well underway in the development of those DXd ADCs, the first generation ADCs. That has incorporated the best of the linker technology and best of the payload that we have in the DXd series. In addition to that, I have to say that a major differentiator compared to competition has to do with time. I think we are far ahead of what other companies are doing, especially when we look at HER2. In the future generation of ADCs, as I mentioned, we have a whole library of linkers and payloads. Based on all the biology that we understand with these payloads and linkers, we can create new drugs where the linker releases the drug, sometimes not in the cell, sometimes on the cell, sometimes just outside of the cell, sometimes the right microenvironment. We can create all those new different ADCs just simply based on varying the linker. The same thing with the payload. We have a variety of payloads that we can use. Sometimes they are cytotoxic in a way that DXd is, but we have additional biological targets and other targets and other types of payloads that are not necessarily small molecules that we can use to create new entities and new ADCs. I think that's really our major advantage in that we have invested a huge amount of research in the ADC space. This time you have introduced a new program, frame shift heme inhibitor. I was wondering, maybe that kind of triggered the development of this new program. My question is to confirm as follows: through this inhibition, neoantigen, cancer-specific neoantigen. PD-1. That activated. Killer cells so that we can identify the tumor cancer easily. Specifically, we are targeting what we would call frame shift mutations, which are very common in cancers. Frame shift mutations typically result in shifting of the triplet read-through of the amino acid codons, resulting sooner or later, typically in a termination codon. The drug allows read-through of that termination codon to produce additional sequence of amino acids that are not typically coded in a normal genome. These are really the genesis of the neoantigens we're talking about that's very specific to that cancer cell. As noted on that slide, we can also see that combination of this drug with a checkpoint agent such as PD-1 really enhances the immunologic system to recognize and eliminate tumor cells, at least in animal models. Thank you very much. I'm looking forward to the data readout. Thank you. Next is the last question. From J.P. Morgan Asset Management, Sawada-san, please. Hi, JP Morgan Asset's Sawada to moushimasu. This is Sawada of J.P. Morgan Asset. Can you hear me? Yes. I have two questions. The first question is about the numbers. It's rather complicated at the core operating profits. There is some comparison of the challenges. This year, you have JPY 10 billion of the evaluation losses. Last year, you have JPY 12.2 billion of the realization of unrealized profit. Therefore, the JPY 21.2 billion, there is a difference between last term and this term. Am I correct to interpret it that way? Can you please explain such things? That is rather complicated. I'd rather you explain it more in detail. Thank you for your question. Let me apologize that our explanation was not that complete. Unrealized profits in the past fiscal year and this year, in the increase and the decrease of the revenue, there is JPY 11.2 billion in the contributing to the negative growth of the revenue. Yes, that was one of the factors. Versus the previous year, this is really the difference coming from that. Also about the cost of the sales and the core operating profit, in the presentation slides, there is some description on page six. We have an increase of the cost of the sales. In this cost of sales increase, about JPY 10 billion due to HER2 and Daiichi Sankyo evaluation loss included in here. These factors have been explained. These are the factors of the changes or the variabilities in the core operating profits. In other words, I would like to confirm separately, but in the past year, last year, there was a core, but there is a one-time unrealized profit that is JPY 11.2 billion that's included last year. On the contrary, this year, it is a core, but there is some specific loss of JPY 10 billion. Therefore, there are other differences between this year than last year over JPY 21.2 billion. Yes, you are right. Thank you. Another question is about R&D. 37 and 90, and the CD20 is expressed in B cell. Therefore, the review pharma is working on the ADC for DLBCL, as I recall. However, their ORR wasn't that promising. On the other hand, in your case, when I checked at the clinicaltrial.gov, and you are not limiting to DLBCL, but you just say the hematological malignancy. You recruit a very wide variety of the patients. It only says the hematological malignancy assessed, and you do not say DLBCL. It's not limited to DLBCL. Why don't you limit it? Why do you develop? Why can you develop to cover all the range of different hematological malignancies? As a category, it includes not just DLBCL, but many other types of lymphomas, such as follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma. There are many types of B cell malignancies besides just DLBCL. In fact, there's another B cell malignancy called chronic lymphocytic leukemia, which also happens to be CD37 positive. This is the reason why the designation of hematologic malignancy is used in the clinicaltrials.gov listing. Thank you very much. This concludes my question. There are other people raising hands, but unfortunately, we have exceeded the scheduled time. With this, we would like to conclude the Q&A session part one of this financial result reporting. Please contact our IR members so that your question will be answered later.