Ogawa speaking. Thank you very much for joining Daiichi Sankyo's financial results presentation. I'll have a very busy schedule today. I'm going to explain our FY 2025 first quarter financial results. We announced at 1:00 P.M. on Thursday, July 31st, JST, based on the presentation materials. Please turn to page three. This is the agenda for today. We will cover FY 2025 first quarter consolidated financial results, business update, and R&D update in that order. R&D update will be explained by Yuki Abe, R&D Division Head. We will entertain your questions at the end. Please turn to page four. This is an overview of FY 2025 first quarter consolidated results. Revenue increased by JPY 38.4 billion, or 8.8% year on year, to reach JPY 474.6 billion. Cost of sales decreased by JPY 2.6 billion from the previous year. SG&A expenses rose by JPY 12.4 billion, and R&D expenditure increased by JPY 5.3 billion year on year. As a result, operating profit increased by JPY 23.4 billion, or 32.1% year on year, to reach JPY 96.3 billion. Operating profit, including temporary gains and losses, increased by JPY 3.7 billion, or 4% year on year, to JPY 96.3 billion. Profit attributable to owners of the company increased by JPY 0.1 billion year on year, to reach JPY 85.5 billion. As for the actual currency rates, the U.S. dollar was JPY 144.60. The yen appreciated by JPY 11.29 against the dollar year on year. The euro was JPY 163.81. The yen appreciated by JPY 4.07 against the euro. Please turn to page five. From here, let me explain positive and negative factors for our revenue compared to the previous year. Revenue increased by JPY 38.4 billion year on year. I'd like to explain its breakdown by business unit. First, in Japan business unit, etc., revenue increased by JPY 2 billion, absorbing the revenue decrease of JPY 5.6 billion realized gains of unrealized gains of inventory for Daiichi Sankyo Espha, as sales increased for insomnia treatment, Belsomra, direct oral anticoagulation, coagulant Lixiana, pain treatment, Tarlige, and anti-cancer agent DATROWAY, etc. Next, let me explain our overseas business units. Forex impact is excluded here. In oncology business, revenue increased by JPY 35 billion due to the growth of anti-cancer agent ENHERTU sales and DATROWAY's contribution to revenue. As for American region, sales increased for generic injectables, but sales decreased for iron deficiency anemia treatments, Injectafer, and Venofer. American region revenue decreased by JPY 2.8 billion. Revenue for EU specialty business increased by JPY 6.2 billion, as sales increased for Lixiana and hypercholesterolemia treatment, Nilemdo/ Nustendi. In ASCA business responsible for Asia, South, and Central American regions, revenue rose by JPY 12.5 billion due to the growth of ENHERTU mainly in China. Upfront payment and regulatory sales milestones, etc., related to alliance with AstraZeneca and U.S. Merck, increased our revenue by JPY 4.7 billion due to the booking of regulatory milestone associated with DATROWAY's approval for EGFR-mutated NSCLC in the United States and upfront payment for strategic collaboration with U.S. MRK for three DXd ADCs. Forex impact decreased our revenue by a total of JPY 19.2 billion. Now, please look at slide six. Slide six shows the factors contributing to the increase or decrease in core operating profits. We will explain the JPY 23.4 billion increase in profit by item. As explained earlier, revenue increased by JPY 38.4 billion, including a JPY 19.2 billion decrease due to foreign exchange effects. Next, we will explain cost of sales and expenses, excluding foreign exchange effects. Cost of sales increased by JPY 1.5 billion only due to an improvement in the cost ratio resulting from the change in product mix, such as increased sales of in-house developed products like ENHERTU, whereas a JPY 57.6 billion increase in sales revenue, excluding foreign exchange effects. SG&A expenses increased by JPY 22.3 billion, primarily due to an increase in profit sharing with AstraZeneca. R&D expenses increased by JPY 10.8 billion, primarily due to increased R&D investments with the progress of 5 DXd ADCs development. Foreign exchange effects reduced expenses by a total of JPY 19.6 billion, and core operating profit, excluding foreign exchange impact, increased by JPY 23 billion. Next, I will explain the changes in the profit of the period on slide seven. Core operating profit increased by JPY 23.4 billion, including the impact of foreign exchange, as explained earlier. As to temporary income and expenses, in the same period of the previous fiscal year, a gain on the sales of shares of Daiichi Sankyo Espha was recorded as temporary income. Without such impact in the current fiscal year, there was a decrease of JPY 19.7 billion in profit. In terms of financial income and expenses, etc., due to the deterioration of foreign exchange gains and losses, profit decreased by JPY 8.5 billion, corporate taxes decreased by JPY 4.9 billion due to the decrease in pre-tax profit, as well as a decrease in the effective tax rate compared to the same period last year. As a result, profit attributable to the owner of the company for the current period increased by JPY 100 million, compared to the same period last year, to JPY 85.5 billion. Next time, we talk about business update. Please turn to page nine. This page shows the status of ENHERTU and DATROWAY performance. First, I'm going to explain ENHERTU. FY 2025 first quarter product sales increased year on year by JPY 25.6 billion, to JPY 155.2 billion, due to sales growth mainly in breast cancer. Across main countries and regions, such as the United States, Europe, ASCA, and Japan, ENHERTU has maintained the number one new patient share in each of the existing indications, including breast, gastric, and lung cancer. It established its position as a standard of care. As for chemo naive HR positive, HER2 low, or ultralow breast cancer, since we started promotion in January this year in the United States, solid progress has been made in market penetration. We have already acquired more than 50% new patient share and maintained the number one market share. In Europe, we obtained approval for the same indication in March and started promotion in April. With regards to HER2 low breast cancer post-chemo, in main countries in Europe, such as Germany, France, Italy, and Spain, we have maintained the number one new patient share. In addition, in France, reimbursement started in public sector in April. In China, sales are increasing steadily following the inclusion in the NRDL National Reimbursement Drug List in January this year for each breast cancer indication. Next, I will explain about DATROWAY. Sales for the first quarter of 2025 reached JPY 5.3 billion. Approved for hormone receptor-positive and HER2 negative breast cancer with a history of chemotherapy, the product was launched in the United States in January and in Japan in March, and sales have been steadily increasing. We have updated our full year forecast to JPY 21.6 billion, an increase of JPY 16.9 billion from the April forecast. For better management of adverse reactions such as stomatitis and dry eyes, we distribute pamphlets to educate patients on preventive care and treatment methods, as well as education activities for healthcare professionals. In Europe, we launched in June following the approval for the same indication. Additionally, in the United States, we have initiated promotion for EGFR-mutated NSCLC with a history of prior treatment with EGFR-targeted therapy and platinum-based chemotherapy. It has been adopted in the NCCN guideline, and we have started promotion in June. We will deepen its penetration where it's already launched and expand further with new launches in other countries and regions. Acquiring approvals on new indications, we will deliver ENHERTU and DATROWAY to as many patients as possible who need them. Finally, even though we haven't prepared slides for this, we would like to provide an update on the setting of the cap on share buybacks we announced in April, as we received many inquiries. Although it's still the period for the buyback, no shares have been acquired to date. We will consider share buyback as to the JPY 200 billion of the cap, comprehensively considering factors such as stock price levels and executed when conditions are met. Although we have prepared for flexible share buyback, we will commit ourselves to achieve DOE of 8.5% of this fiscal year, even if we do not acquire own stocks. We will continue to provide returns to the shareholders through an increase in dividend proportionate to the profit growth and flexible share buyback to enrich the shareholders' value. Regarding U.S. Tariffs and most favored nation treatment for drug prices, in relation to the external environment, we are closely monitoring the situation and taking measures to minimize the impact. Especially in terms of the tariff to minimize its impact, we are trying to expand our own production capabilities in the United States, among other options being considered. We believe the impact to this fiscal year's business performance will be limited at this point, even though it may have been introduced since we have already adjusted the inventory levels for ENHERTU. This concludes my presentation. Now, for the research and development update, I'd like to hand over to Abe-san, Head of Research and Development. Abe speaking. I'm going to talk about R&D update. First, an update on DXd ADCs. Please turn to page 12. As part of the progress of ENHERTU clinical development in HER2 positive breast cancer, I'm going to use two pages to explain DESTINY-Breast09 study we presented at ASCO this year. DESTINY-Breast09 is a phase III study to evaluate the efficacy and safety of ENHERTU with or without pertuzumab versus standard of care THP in first-line HER2 positive advanced or metastatic breast cancer. Primary endpoint is PFS. Secondary endpoints include OS and ORR, objective response rate. At ASCO, we reported interim analysis results. In the ENHERTU monotherapy arm, evaluation is ongoing. On page 13, I will share the data we presented at ASCO. ENHERTU, in combination with pertuzumab, showed statistically significant PFS extension compared to the standard of care THP arm. The median PFS was 40.7 months in the combination therapy arm, with 44% reduction in the risk of disease progression or death compared to the control arm. Clinically meaningful PFS improvement was demonstrated. Safety data in the combination arm was consistent with known profiles of individual treatments. The majority of ILD events were low-grade. Two grade 5 ILD events were reported. Based on the study results, ENHERTU, in combination with pertuzumab, was granted breakthrough therapy designation by U.S. FDA in July. We will share efficacy and safety data with regulatory authorities towards regulatory submission, aiming to establish a new first-line treatment for HER2 positive breast cancer. Please turn to page 14. I will give you an overview of DESTINY-Breast11 study. We are evaluating the efficacy of ENHERTU, followed by THP, in HER2 positive early breast cancer, neoadjuvant settings. ENHERTU THP therapy demonstrated statistically significant and clinically meaningful improvement in the primary endpoint of pCR, pathological complete response, compared to the standard of care ddAC THP therapy. No new safety signals were identified. Safety profile of ENHERTU THP therapy was favorable compared to the standard of care in the control arm. We will present the data at ESMO 2025. On page 15, I will explain our efforts to establish an earlier treatment of HER2 positive gastric cancer with ENHERTU. DESTINY-Gastric04 is a phase III study to evaluate the efficacy and safety of ENHERTU monotherapy versus the current standard of care ramucirumab and paclitaxel combination therapy in second-line HER2 positive gastric cancer and gastroesophageal junction adenocarcinoma. In the interim analysis, ENHERTU demonstrated median OS as primary endpoint of 14.7 months, showing clinically meaningful improvement, with 30% reduction in the risk of death compared to the control arm. ENHERTU is already approved for second-line HER2 positive gastric cancer in the United States and Europe. If the second-line indication is established in Japan based on this data, ENHERTU is expected to become a global standard of care indicated for HER2 positive gastric cancer and gastroesophageal junction adenocarcinoma in the second-line settings and beyond. From page 16, I am going to explain. Two phase III studies as a new challenge ENHERTU is taking on in the field of gynecological cancer. First, DESTINY Endometrial 01 study in HER2 expressing mismatch repair proficient pMMR endometrial cancer. DESTINY PanTumor 02 study, which we presented at ESMO 2023, demonstrated encouraging efficacy signals of ENHERTU in HER2 positive endometrial cancer. Based on that data, we will evaluate the efficacy of ENHERTU in combination with rilvegostomig stomach or ENHERTU in combination with pembrolizumab in primary stage 3, stage 4, or recurrent endometrial cancer in the first-line settings. We initiated the study in June this year. On page 17. I will explain the other phase III gynecological cancer study for ENHERTU. DESTINY -Endometrial 02 study. This is a study to evaluate the efficacy of ENHERTU for adjuvant therapy in high-risk HER2 expressing endometrial cancer, with no evidence of disease post-surgery. Primary endpoint is DFS, disease-free survival. Aiming to cultivate early identification of HER2 expressing endometrial cancer and establish a curative treatment, we are planning to start this study in the second half of FY 2025. Please turn to page 18. As a new formulation of ENHERTU, we initiated the development of a subcutaneous formulation containing hyaluronidase. Currently, ENHERTU is administered intravenously. Subcutaneous formulation is expected to provide a shorter injection time, reduce the burden, and enhance convenience for patients, contributing to better QOL. Phase I study consists of dose escalation and dose expansion parts. In the first half of FY 2025, we plan to initiate the study. Based on this study outcome, a registration study is to follow. From page 19, I will cover DATROWAY. The first indication for DATROWAY was HR positive, HER2 negative breast cancer. In June this year, we obtained DATROWAY's first approval for lung cancer in the United States. DATROWAY was approved for the treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC, previously treated with EGFR-targeted therapies and platinum-based chemotherapy, based on the results of TROPION-Lung05 and TROPION-Lung01 studies. The indication was granted accelerated approval following breakthrough therapy designation and priority review. Right now, TROPION-Lung15 is ongoing as a confirmatory study. On page 20, I will explain the results of clinical study data analysis using a biomarker candidate in NSCLC. QCS is a novel computational pathology approach that precisely quantifies and locates targets. TROP2 NMR by QCS potentially predicts the efficacy of DATROWAY through analyzing the TROP2 expression in the cell membrane relative to total TROP2. TROPION-Lung02, shown here, is a study to evaluate the efficacy and safety of DATROWAY and pembrolizumab with or without platinum chemotherapy in patients with non-actionable genomic alteration NSCLC. In the analysis of first-line treatment as a whole, which we presented at ASCO, both doublet and triplet showed durable antitumor activity. The tolerability of the combination was also good. TROP2 NMR was applied as a biomarker to TROPION-Lung02 study data, and retrospective analysis was performed. In TROP2 NMR-positive patients, improvement of both PFS and OS was observed compared to negative patients. Out of the ongoing phase III studies for DATROWAY, we plan to stratify the patients based on TROP2 NMR as a biomarker in AVANZAR and TROPION-Lung10 studies. On page 21, I will explain HER3-DXd. HER3-DXd has been under development for EGFR-mutated NSCLC as the first indication. Based on HERTHENA-Lung01 study results, a regulatory submission was accepted in the United States in December 2023. Its confirmatory study, HERTHENA-Lung02 study, met primary endpoint PFS without any new safety concern. However, based on the subsequent OS results from HERTHENA-Lung02 study and our discussions with U.S. FDA, our application based on HERTHENA-Lung01 study was voluntarily withdrawn in May this year, as was already announced in a press release. On the left, you can find PFS and OS data from HERTHENA-Lung02 study, which we presented at ASCO this year. HER3-DXd is under broad clinical development across multiple solid tumors, including HERTHENA-Breast 04 study, which I will explain on the next page. The position of HER3-DXd in our pipeline has not been changed. Please now look at slide 22. HERTHENA-Breast04 study is a new phase III study evaluating HER3-DXd for hormone receptor-positive HER2 negative metastatic breast cancer with progression after CDK4/6 inhibitor as the first-line therapy, with BFS and OS as the primary endpoints. As a prerequisite of this study, ICARUS-Breast01, a phase II study, confirmed the efficacy HERTHENA-Breast04 in the setting of post-first-line CDK4/6 inhibitors and chemotherapy. HERTHENA-Breast04 study is scheduled to begin in the first half of this fiscal year. Now, please look at slide 23. We obtained promising data of the IDeate-Lung01 phase II study in April this year, evaluating IDXd's efficacy as a second-line and beyond on extensive stage small cell lung cancer. In this study, we compared 8.0 mg/kg and 12 mg/kg doses, and 12 mg/kg was chosen in the dose extension part. Data will be presented at upcoming congresses. In extensive stage small cell lung cancer, in addition to this study, Ideate-Lang 02 study, a phase III study, a second-line therapy, is ongoing. Slide 23-24 summarizes the progress of other studies and approval status of 5DXd ADCs. We have initiated a phase I/II study of HER3-DXd on refractory pediatric cancers. We have initiated two phase III studies of I-DXd, namely IDeate-Esophageal 01 study on esophageal squamous cell carcinoma as a second-line therapy and IDeate-Prostate 01 study on chemo-naive metastatic castration-resistant prostate cancer. We have begun two I-DXd studies, namely REJOICE- GI 01, a phase II study to explore signals for gastrointestinal cancers, and REJOICE- Ovarian 02, phase Ib/II study, evaluating combination therapy for ovarian cancer recurrent after platinum-based chemotherapy. From slide 25, we will talk about the next wave update. First, please look at slide 26. We have been actively conducting research on immuno-oncology and acquired several candidates for further development. One of these is the IOADC, namely ADC effective on cancer immunity, which we are introducing today. DS3610 is an ADC that combines a STING agonist with an antibody. By delivering our proprietary STING agonist to cancer tissues, it activates anti-tumor immunity locally in the tumor. It employs a novel Fc modification technology, which is expected to diminish systemic cytokine release. In the preclinical research, we have confirmed the activation of immune cells and sustained anti-tumor effects, and combination effects with a variety of therapeutic agents were observed as well. We are planning to begin DS3610 first in human study in the second half of this fiscal year. From slide 27, we will discuss updates on the licensed out products. Now, please look at slide 28. Taretolectinib is an oral ROS1/ NTRK inhibitor we have discovered as DS-6051 and licensed out to AnHeart Therapeutics in 2018, and currently, Nuvation Bio has exclusive rights to develop, manufacture, and commercialize it worldwide. This Taletrectinib received approval in January in China and in June 2025 in the United States, indicated for locally advanced or metastatic ROS1-positive non-small cell lung cancer. We are pleased that the asset we have discovered will be able to contribute to treating patients. Next, we would like to make announcements on IR events associated with WCLC and ESMO. Now, please look at slide 30. We will be hosting IR events in association with WCLC and ESMO. For WCLC, September 18 at 8:00 A.M. Japan Standard Time, and for ESMO on October 21 at 9:00 P.M. Japan Standard Time. Both events will be held virtually. Slide 31 onwards will cover the upcoming news flow. Now, please look at slide 32. As for presentations at major congresses, we plan to present the results of the intracranial efficacy analysis of the TROPION-Lung01 study at WCLC 2025. At ESMO 2025, primary analysis of Destiny Breast 11 study and the data presentation of TROPION-PanTumor 03 study, as well as first data presentation of DS-3939, the next DXd ADC following f5 DXd ADCs, among others. Regarding regulatory review outcomes for the DESTINY- Breast 06 study from Japanese authorities, for TROPION-Breast 01 study from Chinese authorities, we expect to receive review results in the first half of this fiscal year. Regarding the anticipated timing for obtaining key data in the near future, the data of ENHERTU's DESTINY- Breast 05 study is expected to come out in the second half of this fiscal year, and DATROWAY's TROPION-Breast 02 study for triple-negative breast cancer as the first-line therapy in the second half of this fiscal year. Incidentally, the timeline for obtaining data from DATROWAY's AVA NZAR study is now anticipated to be the first half of calendar year 2026. Slide 36 and beyond are the appendices for your later reference. This concludes my presentations. Now we would like to move on to a Q&A session. First question. Mr. Yamaguchi from Citi Group Securities, please. Can you hear me? Yes. Hello, Yamaguchi from Citi Group Securities. Thank you for your time. First, about AVANZAR study, the timing of disclosure would be later this year. Has been postponed from later this year to early next year. It's an open study. At the end of last year, enrollment was completed, as I heard before. The reason for the delay, I think, is because of the events. If there is a delay in general, we feel a bit worried. Any impact on the probability of success? It's not blinded, so I'm sure you know the data. Anything you can share with us? Abe would like to respond. Yamaguchi-san, thank you very much. Regarding AVANZAR study, we are waiting for the results as well, but it's been postponed. AZ is very confident in its development. We don't have any further information on our end, so we will do what we can do. That's our stance. There's no other impact, according to Abe. Understood. I have a question about the I-DXd. Commentary that I just recorded your commentary before, and promising data will be available in April, and I thought you said that at the last time, or is it the very first time you say this? No, this is the first time. Based on that, since you say this is promising, in a very early stage, you may be able to file for approval, or do you have to wait for additional studies? Otherwise, you cannot go to registration. You say the data is promising, and then if it is good enough for the early approval, then I'd like to know that. Thank you. Thank you for your question. Detail of the data will be presented at the congress. At this moment, we just can communicate that we got the promising data. Before going to the filing for the approval, to the timing of the when the filing is accepted by the authority, then we'd like to make announcements separately. You are not really commenting whether you are going to go for the filing or not? No, not yet. That's something we are going to consider going forward. Thank you. It's not in time for WCL--C, so it's difficult for you to say the timing, like when. We are going to present the data within the end of this year at congress. I see. Thank you very much. That's all from me. Next question from Hashiguchi-san of Daiwa Securities, please. [Foreign language] This is Hashiguchi speaking. Good evening. The first question is about the DB-02 study and this result. How will it be reflected to the clinical practice? The doctors, amongst those physicians or clinicians, some of them may continue the combination therapy until the progression of disease, or rather. If they see the response or tumor shrinkage, then they may stop doing HER2 and then switch to other maintenance therapy. For considering the balance with the safety, I believe some physicians are thinking like that. Of course, there's no evidence that that is the better way or right way to do, but if this regimen is approved, and then how will that be actually used? The evidence tells that you can continue until the progression of disease. In most of the cases, the drug will be used in such a way, but are you going to consider that kind of usage going forward? Practically speaking, there is a possibility that there may be many different uses considered. To answer such clinical questions, are you going to collect the evidence? Do you have any plan to collect clinical evidence to answer such questions? Thank you. Thank you, Hashiguchi-san, for your question. You are talking about DB-09, right? Yes. Thank you. Yes, and I would like to point this out to the development departments. At this moment, DB-09 interim results analysis, and then from the evidence, the exacerbation or the adverse events or the desire of the patients in HER2 will be continued. Considering the risk over benefit and the benefit of [exceeds], the risk, but what you have just pointed out is going to be discussed amongst our development team. Thank you for your comment. Thank you. you. Understood. At this moment, [Foreign language] You are not really. [Foreign language] Having any consensus in the clinical practice in terms of the right duration administration, we are going to get the approval in the first-line usage. That's it. Thank you. Secondly, I have a question about DATROWAY. Your sales forecast revision in May, or rather in April, there was a forecast. You made a lot of changes or revisions. Compared to your assumptions, what was different? How did you change your assumptions in what respect? Any specific comment? Thank you for your question. Regarding the changes in the assumptions in detail, there's nothing, unfortunately, we can explain, but with regards to the market penetration, it's not been able to predict the market penetration accurately. That's why there is a big gap, but it's a positive gap. The adoption at institutions is making steady progress. In Japan, U.S., respectively, initial uptake has been positive and strong, particularly in the United States. HR positive, HER2 negative, breast cancer, late-run settings. Share is rising. There. In lung cancer, we have just started. It's going to be seen from now on. In lung cancer, the high unmet medical needs in the target patient population, so there are needs to a certain degree in our view. At any rate, regarding our revised forecast, the proportion in sales of breast cancer has a large proportion. That's all from me. Most of the revision is from breast cancer, right, in the current forecast. That's all from me. Next question is from Wakao-san of J P Morgan, please. [Foreign language] This is Wakao of JP Morgan. Can you hear me? Yes, very clearly. Thank you. Good evening. I have a question. In the first quarter of this year, the gross margin was quite favorable. Are there any special factors, or is it just because of the product mix? That is my first question. Thank you for your question. In principle, it is coming from the product mix, and ENHERTU and Lixiana are selling very nicely. This is the first-quarter result, so this may change going forward. In the latter half of the fiscal year, we will be selling more vaccines, and as the cost ratio, the vaccine may give some impact. The annual cost ratio is as expected, but the major factor is the product mix. Thank you. So ENHERTU and DATROWAY margin didn't change, right? No. No, we do not expect. As a follow-up question, profit share looks small. Any special factors here? Nothing we are aware of. No particularly special background. I heard DATROWAY profit sharing regions based on other sales, and half of the gross profit is booked. Yes? Yes. Nothing coming over the different period. When we consider the tariff impact, then can you eliminate the impact? Of course, we need to consider the duration, and there is a grace period of one year, one and a half years. Some companies are telling that they are going to bring the manufacturing site all over to the United States. Of course, you are considering the manufacturing site in the United States, but if the duration of the grace period is only two years, then how much can you make a transfer? Do you think that you can make a sufficient amount of the transfer during this period? Thank you for your question. Yes, we are still considering that seriously and investigating that. In a timeline, it is told that one and a half years or two years, and we are now considering what we can do in that period. Production location, especially in terms of ADC. We have the. Steps to manufacture, such as the antibody conjugation or whatsoever. What will be done where? Considering the tariff mechanism, we are considering a variety of different scenarios so that we can cope with the situation as much as possible. That actually will depend upon the amount, and also the rate of the tariff should also be considered. Therefore, it really depends upon the tariff rate. On top of that, two-year timeline, how much can we prepare? Apart from that, internally or maybe externally, manufacturing site may be considered, and also what we put in what part of the world in terms of our supply chain, and we are now considering that internally. Thank you. Understood. No problem for this term, but we may expect uncertainty in the next year. Of course, it really depends upon the tariff rate. If the tariff rate is not that high, then you think that you believe that it's manageable? Of course, it really depends upon the rate and also how the tariff is levied in what part. It really depends upon the financial evaluation or the amount will be evaluated. It really depends upon those factors. Therefore, it's so difficult to make any forecast of a specific amount of the financial impact. Thank you. Once the rules are determined, please let us know. That's all from me. Thank you very much. Next question. [BioVie] Securities, [Mamegano-san], please. [Foreign language] Thank you very much. [Mamegano] from [BioVie] Securities. Can yo u hear me? Yes. Thank you. Yamaguchi-san asked a question. There is some overlap with his question. I'd like to know about the data in small cell lung cancer. In the dose expansion part, there's going to be promising data. Does that include dose extension as well? Last year at WCLC, 80 mg was already presented at the congress. For the 80 cases, rather, but the additional 100 cases are included in the data? Yes. There's a mention of dose extension, but dose expansion is included as well. Although the slide says dose extension. Understood. Thank you. I'd like to confirm. In the earlier question, by the end of this year, you're going to present at congress. By the end of December? Yes. Understood. Thank you very much. Other question is about HER3. HERTHENA-Breast03, you mentioned the result. What is the population? Is that TB maybe overlapping with DB-06? Is there any cannibalization you are considering or not? How are you going to market HER3? Thank you for your question. There's no overlap. For TPC, the physician can choose ENHERTU if they like. Therefore, the study is designed in such a way. HER3-DXd with the ICARUS- 01 breast study has a very good result or promising result. HER3-DXd is the area that it covers, and also, we have a different safety profile. Therefore, having more options for the treatment, we would like to focus HER3-DXd in this area. I don't understand what you mean by not overlapping the HER2 negative breast cancer. That is IHC 0, but also 1+ or 2+. You are talking about HER2 low or ultra low are included, right? Am I correct? I would like to explain more. HERTHENA-Breast04 study is CDK4/6 inhibitors and also hormonal therapies, and following that therapy, it will be used. Therefore, there is no direct competition with CD4/6 inhibitor. Let me also repeat, the TPC group and ENHERTU can also be an option so doctors can choose it if they like. That is the situation. As I said, the HER2-DXd is going to be developed in this treatment line. That is the idea. That may be used before the ENHERTU. You are considering that too? Yes. Yes, that's right. Yes, that's why we are designing the study in that way. Next question. Sanford Bernstein, Ms. Sogi, please. Thank you very much. First, at ASCO, you presented on TL02, TL02, QCS analysis. [Foreign language] That data for AVANZAR study? Positive. Results? Results? Can be expected with higher confidence? [Foreign language] On your end? Doublet results were very good. If you look at the patient population and the dose being used, that was different from the triplet cohort. Still, the results were very good. Based on these results, what kind of clinical studies are you going to proceed in lung cancer with DATROWAY? Thank you for your question. You asked two questions. First, biomarker candidate. With the higher possibility or probability of development of DATROWAY in lung cancer in NSCLC, if there is a biomarker, we have a higher probability. That is alarming for us. That's how we see this. That's one answer to your question. Next, doublet and triplet results were available, and recruitment was not so sufficient. We are going to do more, but also learning in both triplet and doublets, there was sustained efficacy we are able to confirm. Treatment option is being expanded. TL07 or 8, based on our ideas, we are proceeding, including AVANZAR. What kind of combination therapies are good? We'd like to discuss based on the results. We'd like to proceed with new clinical studies. Did I answer your question? Thank you. I have another question. ENHERTU subcutaneous formulation is what I'd like to talk about. ENHERTU has a variety of indications right now. Ultimately, the phase III should be carried out by a different indication. Thank you for your question. First, we have to do the clinical study for the subcutaneous formulation. That is the beginning, and then the target population. Thank you. I will be now checking. Yes, for development, that will be discussed going forward. Thank you for the answer. Next, Morgan Stanley, MUFG Securities. Mr. Muraoka, please. Thank you very much. Muraoka from Morgan Stanley speaking. First question. Share buyback. You have not used the limit yet. You haven't reached the criteria yet. If I may, the stock price was in the early JPY 3,000 level, but you don't think that it's a low level. Is my understanding correct? Thank you for your question. No, it's difficult to judge. As for the stock price, there are a variety of factors for the share price. So looking at the stock prices, whether our corporate value is reflected completely, there may be some of the enterprise value which may not be fully reflected in our view. Still, reacting to everything to buy back shares, no, that's not really the case. We have to consider comprehensively. We will look at the stock price level to execute share buyback. That's why we set the limit for share buyback. You may wonder what kind of conditions we have set, but as of now, we will judge comprehensively and be flexible. That's why we have set the limit. Thank you very much. In other words, the stock price of JPY 3,200 or so, if that is that low, you didn't execute that exercise. Once the year has ended, then the DOE. The unused portion could be returned to shareholders or not. Can we see the situation in such a way? The stock price level, of course, it really depends upon that time, the consideration timing, and also it depends upon the background. In April, when we set the cap of the buyback, and it was written in the press release. In the release, considering the stock price level, and we will be operating flexibly. That was stated in the press release. Based on the market condition, we may exercise or we may not exercise a complete amount until the limit. In the financial result, the summary includes the comprehensive decision. We have also made an announcement of the comprehensive decision of our securities and the order. We have to make investment for the long-term growth. Therefore, we have to make CapEx investment, and also we have to invest to R&D. At the same time, the business is expanding, and also operating cash is now expanding. We have to consider these factors. At the same time, we would like to establish a good balance to the return to the shareholders. In terms of the return to the shareholders, our policy is that stable dividend payment. Proportionate to the increase of the profit, we will increase the return. We have committed the DOE of 8.5%. Thank you. Thank you very much for your answer. One more question about DATROWAY. On page 39, there was a future master, TL-07 or 8. By the end of next fiscal year, according to the update. Oh, it's earlier than before. AVANZAR is being delayed. It may become available almost at the same timing or later in the fiscal year, TL-07, TL-08. Do not include biomarkers. QCS is not included in here. Even without QCS, it's going to be fine. What's your rationale? Why do you think so? Thank you for your question. TL-07 or 8. FY 2026, according to our description on the slide. When is that? Please allow us to refrain from commenting on that specifically. The other question was about QCS. It's not included in these studies, but is it going to be fine? What's the rationale behind? Why do you think it's going to be fine? In 07 or 08 studies, we have clinical study results to date. We are proceeding with confidence. Also, QCS NMR for patients is desirable if that's the case. What to do with this? We will do our best in development. We are discussing internally. Regarding how we are going to proceed, it's now under consideration and discussions. TL-07 or 08, we are proceeding with the development with confidence right now. Okay. QCS is not included in both of them. Am I correct? Yes, that's right. Yes, that's correct. Understood. Thank you. That's all for me. Next question. Sakai-san on UBS Securities, please. The time is limited, so I would like to just one question. Abe-san, this is a retrospective question. I'm sorry about that. On page 21, HER 3 data. When I look at OS data. Actually, there's no difference, or rather, placebo or the standard of care versus this seems to be better than the drug. It's so difficult to verify this. What actually is causing this phenomena? Have you analyzed that? Based on such a result, once you get a PFS, you have two endpoints, and you are going to use PFS first for filing, and then you will follow up with the OS data later. Can you do that? Have you discussed that matter with Merck? As a lessons learned for the future, I would like to ask for your comment. Thank you. The most important part is the lessons learned after the clinical trial. What it actually means is now being discussed at the working level. We have also learned that ORR or PFS, when we cannot expect the OS extension, then what data will be required so that we can carry out the clinical trial to get the early and expedited approval. That's now being discussed also. That's what we can tell you right now. Once you conclude the discussions, please give us an educational lecture. Can we ask you? Lessons learned should be shared, so including Congress, in a formal way, we'd like to present. Even in such a format, we'd like to have another opportunity to explain. Thank you very much for your comment. Your comment is heard. Thank you very much. Thank you. The next question is from [Bakarsan] from Jeffries. Please go ahead. Thank you very much. My question is about the share buyback. According to your presentation, the major goal and purpose is the DOE KPI to achieve. I believe this is one of the tools to achieve that. That's my interpretation. Looking at the result, you have more profit than you have originally planned. Without a share buyback, you may be able to achieve DOE. Therefore, there's no necessity for you to buy back the share right now. Am I correct? Thank you for your question. In terms of DOE, as I have just explained, the 8.5% can be achieved without any share buyback. That's how we see it. On the other hand, in terms of the share buyback, considering the stock price level, we would like to be flexible. That's what I have just said, and that's our position right now. Stock price level and the situation in the stock market, we may, we will behave flexibly. Thank you. Understood. The last question is from Tony Renson. Please go ahead. Hi there. Can you hear me? Yes. Okay. Perfect. Yeah. First of all, a quick one. About your effective tax rate on slide number seven, it looks like there is quite a bit of decline in the first quarter compared to previously. Do you think this is sustainable? Thank you for your question. Corporate tax rate. This year in the first quarter, Thank you for your question. Corporate tax rate. This year in the first quarter, Thank you for your question. Corporate tax rate. This year in the first quarter, if you look at the tax rate on a quarterly basis, it's calculated based on the simplified method or abbreviated method. This can be subject to change. The tax rate expected in FY 2025 is 19.9%. We expect it, but this can be subject to further change from now on. Okay. Perfect. I would like to ask about your new STING agonist ADC, DS-3610. First of all, about the mechanism of action here, looking at the cartoon. Historically, all your ADCs have been internalized by the tumor cells, and then the payload's released, right, conditionally within the tumor cells. Looking at the cartoon, it looks like here it's the T cells that's doing the anti-tumor, eliciting the anti-tumor activity. The payloads will be released into the tumor microenvironment. Just want to understand if my understanding is correct. Thank you very much for your question. The detail of this research, in the interest of time, will be explained more in detail in another opportunity. This is our original STING agonist, how it is released, including that information. At the time, we would like to give you the information. We are very glad that you are interested in that. Okay. Perfect. Yeah, we look forward to more information on the antibody linker and the payload. Yeah, thank you. I see more hands, but we have exceeded the scheduled closing time. With this, we would like to conclude today's financial result reporting. If you have more questions, please contact our IR or the Public Relations members. Thank you very much for your attendance and attention.