Hello, I'm Manabe. Thank you for joining us today at the Daiichi Sankyo ENHERTU Business Briefing. We at Daiichi Sankyo are committed to continuously create innovative drugs and provide medicines that meet diverse medical needs. Our goal is to become one of the top 10 global companies in the oncology field by 2030. ENHERTU, an anticancer drug discovered and developed by our proprietary DXd-ADC technology, is contributing to the treatment of breast cancer and many other cancer patients in the United States, Europe, Japan, Asia, and Latin America, as well as other countries and regions. Today, Ken Keller, Head of Oncology Business Unit, will explain the expectations for further growth, including the maximization of the product value of ENHERTU through the acquisition and the promotion of new indications. In fiscal 2024, starting this April and beyond, we will launch several DXd-ADC products following ENHERTU, and we are preparing for the start of sales promotion. Through the continuous launch of products that address unmet medical needs, we will expand opportunities to contribute to the treatment of cancer patients, which will be explained today. Our fifth midterm business plan is from 2021 to 2025, and next month, we will be entering the fourth year. Our efforts to date to maximize the product value of ENHERTU and the development of ADC products to follow ENHERTU have progressed beyond our expectations, and we are more confident that we will achieve our goal of FY 2025 of the midterm business plan to become an advanced global drug discovery company with strength in cancer. We will continue to challenge ourselves to bring our innovative products to more patients in need of new treatment options as quickly as possible. That's all from me. Now I will turn the floor over to Ken Keller. Thank you very much, Manabe-san. Please go to the next slide. As Manabe-san mentioned, my name is Ken Keller. I'm the Global Head of the Oncology Business Unit within Daiichi Sankyo. It is my pleasure to share an update on our progress and to provide you with our expectations for the future. Next slide, please. Daiichi Sankyo is rapidly transforming itself into a global oncology leader. Our foundation is strong and getting stronger with ENHERTU as its base. ENHERTU's revenue exceeds $2.5 billion per annum. The Global Oncology Business Foundation has been established across the world. We now have excellent talent and capabilities in place in all regions with sales, medical affairs, access, payer professionals, government affairs, regulatory, manufacturing, and safety teams, among many others, all working together as one to deliver ENHERTU to patients across the globe, and to develop our pipeline ADCs quickly and bring them to patients as fast as possible. Our teams are executing at a high level of performance, as demonstrated by ENHERTU having achieved the market leadership position in all four of its indications in every country it has been fully launched in. We are delivering continued growth in our early launch countries, which have high market penetration, and we are accelerating growth rates in later launched countries which are in the earlier stages of launch and have lower penetration rates. We have multiple major and highly meaningful growth opportunities maturing in the next three years and beyond. We are prepared to optimize these near and long-term growth opportunities. These new ENHERTU growth catalysts begin with ENHERTU's tumor-agnostic indication, which is currently under review at the FDA with the PDUFA date of May 30, 2024. This follows receipt of the breakthrough therapy designation, which was granted in 2023. We have completed enrollment and are expecting top-line results this calendar year for two new indications in large patient populations with high unmet need, who would benefit from earlier use of ENHERTU. The first one is HER2-low post-endocrine therapy. This is based on the results of DESTINY-Breast06. The The second one is our HER2 first-line metastatic breast cancer, based on DESTINY-Breast09. If successful, these two new indications are expected to be obtained in fiscal year 2025. In addition to the multiple ENHERTU growth catalysts, we have an expanding near-term oncology portfolio. The patritumab deruxtecan, which is our HER3-DXd ADC, the application has been submitted and accepted for review by the FDA for EGFR mutated non-small cell lung cancer. Our team in the U.S. is currently preparing for the launch of HER3-DXd, along with our partner, Merck. Preparation has been going very well, and we look forward to bringing this drug to patients who urgently need new treatment options, assuming FDA approval. Dato-DXd, our TROP-2 DXd ADC, has been submitted and accepted for review by the FDA and EMA in second-line metastatic non-small cell lung cancer and metastatic breast cancer. In non-small cell lung cancer, the PDUFA date is December 20th, 2024. We are seeking these approvals based on the TROPION-Lung01 and TROPION-Breast01 trial results, which were presented at ESMO in 2023. If approved, Dato-DXd would be the first TROP2-directed antibody drug conjugate approved for the treatment of lung cancer. Next slide. Since ENHERTU's first approval in 2019, we have experienced rapid adoption across all indications in all countries across the globe. This reflects ENHERTU's impressive clinical data, the boldness of our clinical trial program, and strong commercial execution. Coupling these three drivers together has resulted in ENHERTU achieving number one market share in all four of these indications in all countries. We have accomplished this in a matter of months, not years, once access has been obtained in each country. Today, ENHERTU is recognized as a transformative medicine and standard of care in all of its indications. ENHERTU is now available in over 55 countries. Year-over-year growth is over 70%. In fiscal 2023, revenue will exceed $2.3 billion, with the U.S. and Europe leading the way. Additionally, excellent growth is also reported in Japan and our ASCA regions. Most importantly, we have brought new hope and more time to over 80,000 patients across the globe. This is a testament to ENHERTU's best-in-class efficacy and the effectiveness of the teams at Daiichi Sankyo and our partner, AstraZeneca. ENHERTU is a remarkable medicine, and our ongoing clinical program is designed to further expand its clinical utility and help more patients live longer, better quality lives in multiple tumor types and in earlier lines of therapy. Next slide, please. We have reported impressive global net revenue growth in 2020, 2021, 2022, and 2023. This growth continues in all regions. Global net sales have exceeded JPY 100 billion per quarter for the first time last quarter. Overall, global net sales in Q3 fiscal year 2023 were JPY 102.6 billion. That's +12% sequentially, quarter-over-quarter growth, driven by ASCA and Europe. In the U.S., Q3 fiscal 2023 revenue was JPY 57 billion, +5% versus prior quarter, +JPY 12.5 billion, 28% growth versus the prior year. In Europe, Q3 fiscal 2023 revenue was JPY 25.5 billion, +19% versus prior quarter, +JPY 16.9 billion, or 196% versus the prior year. We expect continued ENHERTU growth in its current indications as opportunities remain to help more patients in all four indications. I will explain these growth opportunities for the two largest indications in the next two slides. Next slide, please. Significant growth opportunities remain in the current HER2 positive second line metastatic breast cancer indication. In this setting, ENHERTU's adoption curve is strikingly similar throughout the world. As I mentioned earlier, ENHERTU rapidly becomes the market leader once access is obtained. Its growth trajectory is steep as it reaches 50%-60% market share of the HER2 positive second line metastatic breast cancer patient population. Once it reaches this high adoption level, the growth continues at a less steep trajectory. Today, we have a few countries with market share now approaching or above 70%, which we view as obtainable in many other countries. Today, we have three broad categories of countries in different stages of this adoption curve. Category one is high adopter countries, in which ENHERTU is the dominant market leader. In these countries, oncologists rate ENHERTU as most efficacious treatment option. Real-world experience matches the impressive clinical trial results. Experience has strengthened the oncology community's confidence in managing the safety profile of ENHERTU, and these oncologists report that they expect to use more ENHERTU in the future. Access in this category is supportive of appropriate use, and these countries include the U.S., France, and Italy. Category two is growth mode countries. In these countries, ENHERTU is also the market leader, but they are in the steep part of the adoption curve. The majority of these countries are in the earlier phase of product launch compared to high adopters, and this is usually due to the timing of when they obtained access. Their experiences are universally positive, and oncologists expect, expect much greater use in the future. We expect these countries will follow the same trajectory path of high, high adopters, and Japan, Germany, Spain, and the U.K. are in this category. In category three, these are the recent or not launched yet countries, and securing access is necessary, and it can be slower than in other countries. Oncologists in these countries are eagerly awaiting ENHERTU's availability. Once access is secured, adoption will increase. We have seen that the countries launching later actually experience an even steeper and faster adoption curve than earlier countries. We understand this is due to the greater comfort these oncologists have after having watched their peers across the world embrace ENHERTU, and they leverage their global peers' real-world experiences. Next slide, please. Now I will talk about the HER2-low indication. The HER2-low indication follows a similar pattern. In high adopter countries, use of ENHERTU in post-endocrine therapy, post CDK 4/6 inhibitors and chemotherapy, that is the standard of care. Patients routinely receive two lines of endocrine therapy prior to moving to chemotherapy. Oncologists perceive first-line chemotherapy after endocrine therapy as really suboptimal, and they are eager to see the results of DESTINY-Breast06, which is expected later this year. The U.S. falls into this high adopter category. In growth mode countries, these generally have obtained market access more recently, and hence are in the earlier part of the adoption curve. A distinguishing characteristic of some of the oncologists in this segment is that they routinely cycle through multiple lines of endocrine therapy, sometimes two and three, prior to chemotherapy. Early experiences are positive, and the expectation of oncologists is a far greater use in the future. We expect to see all the countries in the growth mode category. We expect them to reach the levels of the high adopting country. It's just a matter of time. Japan, France, and Germany fall into this category. Recent or not launched yet countries, here, securing access is necessary, and the speed of obtaining access varies country by country. So today, there are countries that have not yet obtained access for ENHERTU in their HER2-low indication. We are confident in our ability to secure appropriate, appropriate access in these countries in 2024. In fact, we have multiple countries in the final stages of access negotiations. Oncologists in these countries are eagerly awaiting ENHERTU's availability. Once access is secure, adoption will increase quickly. Italy and Spain fall into this category. Now, there are also specific patient types that have more opportunity to penetrate in the future. Today, there is hesitation amongst a minority of oncologists to treat more elderly patients and patients with slow-progressing disease. We will continue to educate these physicians based on ENHERTU's clinical trial results, which demonstrate a consistent magnitude of benefit across all patient segments. We believe greater experience in the real world will further motivate use in these patient segments. Next slide, please. ENHERTU, we'll realize multiple growth catalysts in the near term, beginning in 2024. Our supplemental BLA for ENHERTU has been accepted and granted priority review in the U.S. for the treatment of adult patients with unresectable or metastatic, HER2-positive immunohistochemistry, IHC 3+ solid tumors, who have received prior treatment or who have no satisfactory alternative treatment. This supplemental BLA is based on data from the DESTINY-PanTumor02, phase 2 trial, where ENHERTU demonstrated clinically meaningful and durable responses, leading to clinically meaningful survival benefit in previously treated patients across the HER2-expressing metastatic solid tumor landscape, including biliary tract, bladder, cervical, endometrial, ovarian, and other tumors. If approved, ENHERTU would become the first HER2-directed therapy and antibody drug conjugate with a tumor-agnostic indication, providing patients with a potentially new treatment option. Fiscal 2025 is going to be a monumental year for ENHERTU.... Few drugs in their whole lifetime obtain the number of indications we may obtain in just the year 2025. ENHERTU may have up to 5 new indications. Number 1, HER2-low post-endocrine therapy, metastatic breast cancer, based on the results from DESTINY-Breast06. Number 2, HER2-positive first-line metastatic breast cancer, based on DESTINY-Breast09. Number 3, HER2-mutant first-line non-small cell lung cancer, based on DESTINY-Lung04. Number 4, HER2-positive neoadjuvant breast cancer, based on DESTINY-Breast11. Number 5, HER2-positive second-line metastatic gastric cancer, based on DESTINY-Gastric04. In fiscal year 2026, HER2-positive high-risk adjuvant breast cancer, based on DESTINY-Breast05. In total, there are 7 potentially standard of care-changing indications for ENHERTU in the next three years, which would bring the total number of ENHERTU indications to 11. Next slide, please. If all approved, new indications for ENHERTU will more than double the patients eligible for ENHERTU in 2026. Now I'll talk a little bit about each of these. DESTINY-PanTumor02 study included biliary tract cancers, bladder, cervical, endometrial, ovarian, and pancreatic. In all patients, the overall response rate was 37.1%. The duration of response was 13 months. In patients with HER2 IHC 3+ expression, the overall response rate was 61.3%, and the duration of response was 22 months. The median progression-free survival was 11.9 months. The oncology community find these data highly compelling, and if approved, we believe it will be a major shift in how the oncology community thinks about cancer care. There are approximately 10,000 patients in the major markets. HER2-low post-endocrine treatment based on DESTINY-Breast06, if successful, may displace chemotherapy and move ENHERTU one line up in therapy sequence. Oncologists are eager to embrace ENHERTU in this earlier line of treatment, and we expect rapid adoption if successful, based on their positive experiences with the current HER2-low post-chemotherapy indication. The number of patients is approximately 18,000 patients. The next indication is our HER2-positive first-line metastatic breast cancer. This is based on a phase 3 global, multicenter, randomized trial investigating ENHERTU with or without pertuzumab versus a taxane, trastuzumab, and pertuzumab, THP is the acronym, in first-line HER2-positive metastatic breast cancer. THP, which is docetaxel, a chemotherapy agent, trastuzumab, and pertuzumab, has been the standard of care since the original New England Journal of Medicine publication in 2025. This indication would add approximately 8,000 patients to the patients ENHERTU can help. The next indication is HER2-positive, high-risk adjuvant breast cancer based on DESTINY-Breast05. HER2-positive early breast cancer patients, these are patients with residual disease following neoadjuvant therapy and inoperable HER2 breast cancer presentation. This is our largest trial to date, enrolling 1,600 patients. Patients receive 14 cycles of ENHERTU. The primary endpoint is iDFS, which is invasive disease-free survival, and there are approximately 10,000 patients in this indication. The next indication is HER2-mutant, first-line, non-small cell lung cancer. This is based on DESTINY-Lung04 trial, in which we randomized ENHERTU versus platinum-based chemotherapy, plus immunotherapy in first line HER2-mutant, non-small cell lung cancer. The number of patients is approximately 2,000. The next indication is for HER2-positive breast cancer, neoadjuvant indication, and this is based on our DESTINY-Breast11 study. This is a phase 3 randomized open label trial investigating neoadjuvant ENHERTU monotherapy or ENHERTU, followed by THP versus AC plus THP. AC is chemotherapy in patients with high risk, HER2-positive, early-stage breast cancer. The primary endpoint is pathological complete response, which means the absence of active cancer cells prior to therapy, prior to surgery. There are approximately 27,000 patients in this indication. The last new indication we may receive in fiscal 2025 is HER2-positive second-line metastatic gastric cancer. This is based on DESTINY-Gastric04, with approximately 3,000 patients. These indications represent a large opportunity for ENHERTU to help more patients and change the standard of care many, many times very quickly. Next slide, please. The eligible patient opportunity for ENHERTU will grow to more than 100,000 patients in 2026, assuming these trials are successful. And that is in a single year. This is approximately a four-fold increase from fiscal year 2023. So we are going to be very busy, and we're going to be ready. The potential of ENHERTU to help patients is so great, we all at Daiichi Sankyo feel a sense of urgency and accountability to deliver, and we will. That is the ENHERTU plan for the next three years, but that is only the start of the Daiichi Sankyo oncology story. Next slide, please. We have 13 new portfolio growth catalysts in the next three years. In addition to ENHERTU, we have filed the BLA for our HER3-DXd, and it has been accepted for review by the FDA. This is based on the HERTHENA-Lung01 trial in third-line patients post TKI therapy and chemotherapy. As I mentioned earlier, the PDUFA date is in May of this year. In 2026, the second indication for our HER3-DXd is expected based on the results of our HERTHENA-Lung02 trial. This trial compares patritumab deruxtecan, HER3-DXd, to platinum chemotherapy in metastatic EGFR-mutated non-small cell lung cancer post TKI therapy. So similar to DB zero six, where we move from post chemo to displacing chemo. In this trial, we move from the initial indication in the U.S., post chemo, to then displacing chemotherapy. These data for HERTHENA-Lung02, if successful, would be the basis of a regulatory filing in Europe as well. Then we have Dato-DXd's non-small cell lung cancer indication, which we are seeking approval in the U.S. at the end of this year, and breast cancer at the beginning of fiscal 2025. Both the TROPION-Lung01, which is the non-small cell lung cancer trial results, and the HER2 posi-- the HR positive, HER2 negative TROPION-Breast01 trials, those results were presented at ESMO in 2023. These two indications for Dato-DXd will be followed by a third indication in triple-negative breast cancer.... Our teams are working diligently to prepare to bring all these new indications to the oncology community, along with our partners at AstraZeneca and Merck. For the three drugs I just mentioned, I will share more details on the marketplace and our expectations in the next few slides. Next slide, please. So first, I'd like to talk about our HER3-DXd and the HERTHENA-Lung01 trial. This trial is in patients with advanced EGFR mutated non-small cell lung cancer, previously treated with an EGFR TKI. The standard of care is osimertinib and platinum-based chemotherapy. After disease progression on an EGFR TKI therapy, patients are usually treated with platinum-based chemotherapy. Salvage therapy after disease progression has very limited efficacy. Recent retrospective and real-world analysis of salvage therapy in patients with EGFR mutated non-small cell lung cancer after TKI failure reports median progression-free survival in the range of 2.8-3.3 months. Within with our HER3-DXd, which is given every three weeks, we demonstrated a confirmed overall response rate by BICR of 29.8%. The duration of response was 6.4 months. Median progression-free survival was 5.5 months, and median overall survival was 11.9 months. Impressively, in patients with non-irradiated brain metastasis at baseline, the confirmed CNS overall response rate was 33.3%, a finding that oncologists find highly compelling and are enthusiastic about adding to their treatment options. Next slide, please. Here, I'm gonna talk about Dato-DXd and the TROPION-Lung01 opportunity. A significant unmet need exists in second-line non-squamous, non-small cell lung cancer patients, as the current standard of care chemotherapy in this setting provides modest benefits at best. Unfortunately, progress in improving upon this suboptimal standard of care, which has been docetaxel for over a decade, has been very difficult. Over the past few years, there has been seven failed studies of many different agents versus docetaxel in this setting. The BLA for Dato-DXd in non-small cell lung cancer is based on the results from the pivotal TROPION-Lung01 phase 3 trial, which was presented at the Presidential Symposia at ESMO in 2023. In this trial, Dato-DXd is the first ADC to demonstrate a statistically significant improvement for the primary endpoint of progression-free survival compared to docetaxel, the current standard of care. For the dual primary endpoint of overall survival, interim results numerically favored Dato-DXd over docetaxel in the overall population. However, results did not reach statistical significance at the time of the data cutoff. In patients with non-squamous, non-small cell lung cancer, Dato-DXd showed a clinically meaningful progression-free survival benefit and a numerically favorable overall survival trend. Dato-DXd demonstrated a 5.6 months progression-free survival compared to three point seven months, a hazard ratio of 0.63 compared to docetaxel. Dato-DXd overall response rate was 31.2% versus 12.8%. Dato-DXd demonstrated fewer Grade 3 severe adverse events, and the interim overall survival findings favored Dato-DXd, and this trial is continuing to the final analysis. In the major markets, this opportunity represents 80,000 patients. Next slide, please.... Now I'm gonna talk about Dato-DXd TROPION-Breast01 opportunity, and this is in HR-positive, HER2-negative, and HER2-low patients. There remains unmet need in the HR-positive, HER2-negative breast cancer population, who progress on endocrine therapy and who were treated with chemotherapy. The marketed TROP2 ADC is currently indicated for later lines of therapy, patients with two or more lines of therapy. In this study, TROPION-Breast01, we enrolled 732 patients with inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer, who experienced disease progression on or who are unsuitable for endocrine therapy, and who had previously received one or two lines of chemotherapy. Patients were randomly assigned to receive Dato-DXd every three weeks or the investigator's choice of chemotherapy. Dual primary endpoints were progression-free survival by blinded, independent, central review and overall survival. In this trial, Dato-DXd significantly improved progression-free survival over standard chemotherapy. Median progression-free survival was 6.9 months with Dato-DXd versus 4.9 months with chemotherapy, a hazard ratio of 0.63. The response rate was 36.4% with Dato-DXd and 22.9% with chemotherapy. Overall survival is not mature, but a trend favoring Dato-DXd, the hazard ratio of 0.84, was observed. Dato-DXd demonstrated a favorable safety profile with no new safety signals. In general, we saw the rate of grade three adverse events were lower in the Dato-DXd arm, less than half as compared to the control arm, 21% versus 45%. Additionally, the rate of treatment interruption was lower with Dato-DXd at 12% versus 25% for the control arm. If approved, we are confident Dato-DXd will be viewed as a valuable addition to the oncologist treatment options. Next slide, please. Our expanding portfolio will dramatically increase our opportunities to help patients with cancer. As our portfolio drugs enter the lung cancer space, which is one of the most common cancers worldwide, the number of patients we can benefit grows dramatically. Dato-DXd's approval, based on TROPION-Lung01, can address approximately 80,000 patients. Dato-DXd's approval in HR-positive, HER2-negative patients, based on the TROPION-Breast01 data, adds 55,000 patients. HER3-DXd's approval, based on HERTHENA-Lung01, adds 10,000 patients. DXd's ADCs number four and five, which both have shown promising results in earlier trials, if successfully developed in their initial indications, which is small cell lung cancer and platinum-resistant ovarian cancer, will add approximately 13,000 and 8,000 patients to the overall number of patients that we can help. These indications are the planned first ones, with plans for other cancers in development with our partner, Merck. Next slide, please. If all therapies are successful, our opportunity to help patients grows to over 500,000 patients, with all the ENHERTU indications I mentioned, adding Dato-DXd and our HER3-DXd alone. If we go to the next slide, what I'd like to do is talk briefly about ADCs number four and five. So the first one I'll speak about is I-DXd. This is a specifically designed, potentially first-in-class, B7-H3-directed DXd antibody drug conjugate. I-DXd has potential in multiple tumor types that have broad expression of B7-H3.... It has shown promising durable tumor response in patients with several types of heavily pretreated cancers, including lung, prostate, and esophageal cancer. In small cell lung cancer patients, I-DXd demonstrated an overall response rate of 52.4%, which was observed in 21 patients with advanced stage small cell lung cancer. Based on these impressive responses, we have accelerated development in the small cell lung cancer second-line setting. Small cell lung cancer is an area with significant unmet need, with poor patient prognosis, and there's been limited advancements in second line for many, many years. Small cell lung cancer is usually first treated with chemotherapy combinations. Typically, patients do respond to first-line chemotherapy, but the duration of response is not satisfactory. When relapses occur, treatment is highly fragmented, and responses are infrequent, and unfortunately, they usually don't last very long. R-DXd is our fifth DXd-ADC. It targets cancers that express CDH6. R-DXd is specifically engineered and a potentially first-in-class CDH6 directed DXd-ADC, and is jointly being developed by Daiichi Sankyo and our partner, Merck. Approximately 70%-80% of patients diagnosed with ovarian cancer will have a recurrence of disease following standard treatment with platinum-based chemotherapy regimens. An estimated 65%-85% of patients with ovarian cancer have expression of CDH6, which is associated with poor prognosis. We previously reported encouraging efficacy data and confirmed objective response rate of 46% in a subgroup of 50 patients in our phase 1 trial. Median duration of response was 11.2 months, and median progression-free survival was 7.9 months, and responses were observed in patients with a range of tumor CDH6 expression. Despite treatment advances, an unmet need remains in the second line setting in platinum-resistant ovarian cancer. In addition to this, there is an opportunity to expand R-DXd by moving it from second line, which are our initial studies, into earlier lines of therapy. Next slide, please. By 2030, Daiichi Sankyo could have five marketed antibody drug conjugates in over 30 indications, in over a dozen different cancer types, and benefiting nearly 400,000 patients. Next slide. In our midterm plan, as Manabe-san mentioned earlier in his opening remarks, we stated our intent to grow Daiichi Sankyo to be a top ten oncology company by 2030. In calendar year 2023, we've made significant progress. Today, Daiichi Sankyo ranks number 15. Next slide, please. Of the top 20 largest companies in oncology, Daiichi Sankyo is the fastest growing oncology company. So today, we're number 15 and we're the fastest growing top 20 oncology company in the world. Next slide. We remain highly confident that we will reach our goal of becoming a top 10 oncology company by 2030. Thank you very much for allowing me to share our plans and expectations with you, and I'll, I'll turn it back over to Ken. We'll now take questions. The first question is from Yamaguchi-san, from Citi. Hello, can you hear me? Yes. Okay, thank you. So this is Yamaguchi from Citi. I have a few questions. First of all, thank you very much for providing us the number of the patients, which is very good at the building models. Among those things, I have a specific question on Dato-DXd TROPION-Lung01 penetration speed. You mentioned on the HER2 the reaching 50%-60% in a very quick way. That was very impressive, but... Do you see the same sort of penetration speed because it's only chemo space, is expected from the TROPION-Lung01 data or indications once it's approved by the end of this year? Can you give us any feedback, if you have, from the lung cancer community about the expectation on the Dato-DXd on the TROPION-Lung01? That's the first question. Thank you. Thank you very much for the question. So, the way that we're thinking about this, and what I'm hearing from the investigator community and the broader oncology community, is that in the non-squamous non-small cell lung cancer setting, doctors have been using docetaxel, basically monotherapy, for over a decade, even longer, probably closer to 15, 20 years. As I mentioned, many drugs have tried to improve the outcomes compared to docetaxel, but everyone's failed until we shared our TL01 data. Doctors believe that docetaxel is suboptimal. They see it as a very difficult drug for their patients to tolerate. We believe that the data that we shared with the improvements in progression-free survival, and as we look at our overall survival as that matures, and we look at the safety profile and the tolerability profile that we saw in this study, we believe that the oncology community will quickly embrace Dato-DXd, and I believe it will displace chemotherapy rather quickly. That's why you, it's fair to assume that, the quick penetration ramp-up speed is kind of the same as ENHERTU situation. Is that correct? I'll answer it this way. I think it will become the standard of care, and I think it will become the standard of care in, you know, within certainly the first 15-18 months. Thank you. Quickly, second question is that, basically, you have done a great job on the breast cancer community, the marketing. Then you have to expand into lung cancer in general, as far as the big kind of oncology space is concerned. Are you already sort of making enough investment or staff to be ready for the lung cancer strong expansion from now on, rather than breast cancer? Yep. As far as the marketing organization is concerned. Thank you. Yep. Thank you for the question. Yes, you know, one of the, one of the benefits of having such a, an attractive DXd ADC platform is, over the past few years, the science of our DXDs and the success of ENHERTU has allowed us to attract very talented people. And so we've built up our marketing, our sales team, medical affairs, really development across the organization, and today we've got a fully staffed, highly capable team. What we've also done is we've taken... We've already have a lung team, right? So we've been building it out based on the smaller indication of ENHERTU, ENHERTU mutant lung cancer. So they are getting to know the lung cancer community as we speak today. I will also add that, you know, with Dato-DXd, which is what we're talking about, we have the benefit of working with a terrific partner, AstraZeneca, who is very well known and very strong with the lung cancer physicians. So between their strength and the strength we're building, I feel very confident. Lastly, I have one question to Dr. Manabe. You now rank fifteenth and are aiming for top ten. Given your potential, you can aim for top five rather than top ten, perhaps. Of course, there are competitors, but what's your image of the relative ranking? Can you aim higher than top ten? Thank you for your question. Originally, we have been talking about top ten, so we are keeping that wording as is without any revision, but including ENHERTU, we are making growth higher than we expected. So we try to consider once again how far we can aim for. That's all for me. Thank you very much. Next question is from Wakao-san, J.P. Morgan. Wakao from J.P. Morgan speaking. Thank you very much. First, I'd like to confirm the timing of the data readout from DESTINY-Breast06 and DESTINY-Breast09 studies. The timing is the first half of FY 2024 for DB06 study, but given the original timing, I am assuming somewhere between April and June. No major change from that? And DESTINY-Breast09 study within calendar year 2024. Could you please give us a more specific timing? Okay. Okay. So, I believe the first question was the readout for DB06. We expect that in the first half of fiscal year 2024. And then the second question was, I think, on DB09 and D-DB-. Oh, nine. Okay. So in 2009, we expect that this fiscal year, for DB '09. This fiscal year? This fiscal year. '20 fiscal. By the end of 2024. Sorry, fiscal year 2024. Yeah. I'm ahead of myself. Understood. Thank you. Secondly, I want you to deliberate on ENHERTU sales next fiscal year. On page 13, the number of patients is shown. You mentioned that HER2-low, in particular, is going to grow. As was explained today, should we assume that HER2-low is going to grow in growth mode countries such as Japan, France, and Germany? In the United States, the sales trend up to the third quarter is somewhat reaching a plateau and more difficult to grow. Could you please share your outlook for ENHERTU sales in the United States in 2024? Thank you very much for the question. So I'll address the US first. So the US launched first, it obtained access first. It has very high market share today. However, there's still room to grow in the US. We expect at a different trajectory, but we expect continued growth in the US in a number of areas. There are patients in the US where doctors are withholding ENHERTU because they see these patients as older and frailer, in less good health. We can educate those doctors because in our clinical trials, we demonstrated in all categories, patients over 65, under 65, the magnitude of benefit was very similar. So we believe as doctors get more comfortable, the market share and adoption will continue to increase in the US, but at a slower rate. When we look at other countries that are earlier in the adoption curve, some of the countries that you mentioned, we see, we see all countries getting to that high adopter level, and there we're talking about market share of above 60%. Right. Thank you. One thing to add is, there are a number of countries in Europe where we're still waiting for HER2-low access. That is coming on quickly, and we expect significant growth in Europe in the HER2-low indication. Understood. Thank you. Lastly, on page 21, by 2030, you could have 5 marketed ADCs serving nearly 400,000 patients, according to the graphs. From the perspective of peak sales of each drug, what is going to be the ranking? Based on your image of FY 2030 sales, what would be the ranking? Thank you for the question. I think that, you know, in HER2, if all the trials are successful, we would have 11 different indications. And, you know, today, ENHERTU is already $2.5 billion annum. So I think that gives you an idea of, of what ENHERTU could be. It will be one of the largest breast cancer drugs ever. In terms of others, the lung cancer space is so large in terms of number of patients, and so when you think of our drugs there, whether it be Dato-DXd in the non-squamous, 80,000 patients, I think the opportunity to help the most patients would be in lung cancer. Okay. That's all for me. Thank you very much. Next question is from Muraoka-san, Morgan Stanley. Muraoka from Morgan Stanley speaking. Thank you very much. Can you hear me? Yes. Thank you. I also have questions about the situation of ENHERTU in the United States. During the presentation, you mentioned that there is room to further increase penetration in older patients and patients with slow-progressing disease. Specifically, what kind of efforts are underway right now? In other words, you have already picked up low-hanging fruits, and in order to harvest the segment of older patients and patients with slow-progressing disease, what additional new efforts are you making? That's my question. So there's a number of things we're doing in the US, and I'll kind of list a few of them. So one thing we're doing is physicians that have adopted ENHERTU and are using it in their elderly patients, we're having them connect and educate their peers and sharing their real-world experience. Whenever you have real-world experience that is as positive as we're seeing with HER2, getting physicians to communicate with each other is probably the most effective education we can do. So we're doing that through speaker programs and communications like that. Second thing we're doing is we're going back to our clinical trial data, and with our MSLs and our sales team, we're now cutting that data by those certain patient groups. For example, over 65 and under 65, and we're really highlighting that the efficacy of ENHERTU is the same. The benefits are the same, older or younger, and just by highlighting that education from our sales team to the physicians is helping as well. I think those are two of the big things that we're doing right now, the speaker programs, as I mentioned, and really recutting the data and showing people what that looks like. Thank you. The speaker programs and the data highlight by age group are already beginning to change physicians' prescription behaviors? Or do you need more time, like three months or six months to do so? What do you think? Yeah. I think that it's... It goes doctor by doctor. So, you know, we do speaker programs. We get a dozen physicians together, they hear it from their peers. You know, they don't see a patient that qualifies right away, so it happens incrementally. I don't think it's gonna be just a switch. I think it's at this point, it's more of a slow kind of growth. Understood. Thank you. Also, you mentioned that TROPION-Breast01 based indication will be launched in FY 2025, not in FY 2024. Is there any delay here? Instead of the same timing with lung, if there is any delay compared to lung, is there any reason behind? Could you explain, if any? No, there's no delay in TB-01. This is on track. It's according to the plans that we shared previously. So there's no delay there. You know, I think, it's on track. Understood. Lastly, could you please share the number of the sales force in the United States, if possible? How many for breast cancer right now by Daiichi Sankyo and AstraZeneca, respectively, and how many are you planning to allocate for lung cancer by the two companies, respectively, or are they already put into place? So the makeup, I'll talk about the U.S., and, you know, Europe, those launches are a little bit later, so I'll talk about the U.S. In the U.S., we have about 100 salespeople at Daiichi Sankyo that are doing breast cancer, mainly in HER2 today, right? We've also have about 100 people, I'm including reps and some MSLs, for lung cancer. So we will have two teams, one breast, one lung. The breast team will focus on ENHERTU today, but then, as Dato-DXd gets approved based on TB01, they will also bring that drug to the breast cancer physicians. And in lung cancer, today they're focusing on the HER2-mutant and HER2 approval, but then as Dato-DXd, based on TB-01 and HER3 get approved, that team will cover those drugs. AstraZeneca, for breast cancer, has a similar number of people, and in lung cancer they'll have a similar number of people, okay? And then you add in Merck. Merck will have their own LUNG FORCE. So for these drugs, we've got, in my mind, you know, two of the probably most successful oncology companies in the last decade, AstraZeneca and Merck, working with us to bring these drugs to the oncology community. I think that optimizes the probability of our success. Thank you. There is so much information, so I couldn't catch up completely. For breast cancer, 100 people at Daiichi Sankyo and 100 people at AstraZeneca, and for lung cancer, 100 at each of the two companies. Is my understanding correct? Correct. Understood. That's all from me. Thank you very much. Next question is from Sakai-san, UBS. Thank you very much. I'm Sakai from UBS. I was keeping questions for you, probably. Lung01, Dato-DXd, we're anxiously waiting for OS data toward the end of this year. Now, outcome of this data, how that gonna impact your approval date or probability of approval? Now, we keep hearing result wouldn't really disturb the approval process, because this is dual endpoint trial designed. But I'm not really buying that story 100%. So can you give me some assurance to how confident you are at this moment? That's my first question. Okay. The for Dato-DXd, TROPION-Lung01, it's a dual endpoint, as you rightly pointed out, progression-free survival and overall survival. We are. You know, we've submitted the data. We will soon have dialogue with the FDA. And so I think in terms of what the FDA is thinking at this point, it's really too early for me and premature for me to kind of talk about that. Right. So setting the PDUFA date in December, that is rather long wait. Yeah. That means FDA waiting for OS data? Well, we will have the OS data prior to the PDUFA date, so they will have it in their hands, and I'm sure that will be a consideration for them. Okay, thanks. Second question, DESTINY-Breast06 ENHERTU. If the data didn't hit the primary endpoint, how's that gonna impact your second line, third line, and the future development of ENHERTU? I think, you know, getting the, I mean, everyone's expectation here is you're gonna meet endpoint, because ENHERTU has been so good, right? However, in the trial, anything could happen. So how do you respond to this kind of pushback question? I'm sorry. No, no, that's it. It's appropriate. Well, I share your confidence. We're confident that it's going to deliver, because ENHERTU has such a great track record. I would think... So the DB-04 data, which is what our current indication is, is based on that study has such a outstanding efficacy and safety profile. Just to remind everyone, in that trial, the progression-free survival was 10 months with ENHERTU and 5 months in the control arm, right, the chemotherapy. The hazard ratio was 0.51. In that trial, we showed a 6 months improvement in overall survival. 6 months. I think the hazard ratio was 0.64, if I believe. And so that data is so compelling, and it's already the standard of care. If DB-06 didn't hit the end point, I don't see people changing their mind. I think they would still use DB-04 as they are today. I think it's that strong. And, you know, in terms of future development, you know, every trial you get, you learn from, and, you know, we would incorporate that into our thinking for other trials. But in terms of our current business, I just don't see it changing or hurting us. Are you, are you saying that, people still use... Not still, but are going to use ENHERTU over chemo despite of the DB-06 data? Well, they wouldn't use it. No, I'm sorry. What I meant to say is, if DB-06 was not successful, it would not impact our current DB-04 business- Oh, yeah. The post therapy business. Yeah, I'm sorry to confuse you. Yeah, if it didn't work, I don't think people would move from chemo. Thank you very much. Now, I have a question to Manabe-san. So you are working with AstraZeneca and Merck, which are the world top two oncology companies you are collaborating with. This may be a frequently asked question: Are you going to build your own oncology franchise? Have you expressed such an intention already? Or including these companies, you are going to deepen your experience? Top ten is your goal, or there was a question about the top five instead. To achieve this goal, the size of the revenue and the sales is important, but it's more important to secure profit. Profit sharing all the way will not satisfy the investors. What do you think? Through the collaboration with AstraZeneca and Merck, we have accumulated experience. Sales, revenue, and the profits are also increasing steadily. For the future development, Daiichi Sankyo hopefully would like to do the development on its own. So are you going to spend your own R&D expenditure? You are going to secure profit 100%, am I right? Yes, that's the direction we'd like to head into the future. Understood. Thank you very much. Next question is from Sogi-san, Sanford C. Bernstein. Thank you very much for taking the question. I have three questions. So first of all, in terms of ENHERTU's further development, can we you know we understand that there are a few phase twos ongoing, but can we assume that you know the currently ongoing phase three probably broadly cover the you know the potential of ENHERTU? So that's first question. The second question is Dato-DXd, and also HER3-DXd. So in TL01, you know, TL01 that provided us a quite interesting you know the data on the DXd. And one of the you know the interesting data is about, it's a strong efficacy in the Asian pop- subpopulation. You know, that should then especially you know particularly for EGFR mutated population. We see that, you know, you are already running the phase two in EGFR, EGFR mutated, non-small cell lung cancer, in combination with Tagrisso from AstraZeneca. And, and how are you going to, you know, kind of manage, you know, the, because there's an overlap with HER3-DXd's ongoing, HERTHENA-Lung02, and I'd like to see what is in the current you are thinking around how to manage this, you know, the portfolio overlap. And then thirdly, the you have been mentioning the, you know, the target, the cancer for, cancer types for, the I-DXd and R-DXd in terms of, you know, the expression of the target. You have also mentioned previously that, you know, the HER3 DXd, the indication expansion, that you said that, you know, that you have started looking into, the cancer types regardless of HER3 expression. So we understand that, you know, now we have more understanding of, you know, the how ADC works. Probably, you know, the targeting cancer type just only based on the overexpression of a target, probably isn't- does not really, maximally, the leverage, you know, the efficacy or, you know, the function of ADC. So that, I'd like to understand, what is in the moving forward future targeting strategy of cancer type for these ADCs? Okay, thank you. No, thank you very much. So, the first question is about, if I understood it, you know, are there new clinical opportunities for Enhertu beyond all those different indications that I've mentioned? I think, I think there is, and, I'll give you an example of that. So, you know, we expect to get the tumor-agnostic label for Enhertu in the near future. And based on that data, when you look at, especially the IHC 3+, where you're looking at 61% response rates, very, very impressive. And so we believe there's opportunity now to look at HER2 expression and do like we've done with HER2-low, for example, in metastatic breast cancer. Now, start studying and looking at patients not in third line, pan-tumor, but looking at HER2 expression in second line and first line in tumors like ovarian cancer, in tumors like, biliary tract cancer. And so we believe there's opportunities now that we've seen such compelling data in the tumor-agnostic setting, to look at treating people earlier, in earlier lines. So that's a pretty big opportunity that we're considering right now. So that's my first answer. Second one is, so you rightly point out that when you look at TL01, and you look at the impressive activity in the AGA population, a subgroup of the AGA obviously is the EGFR mutated patients, where we're also studying and, and hopefully will soon be approved for our HER3 drug. The way that we're looking at this, we don't think it's a bad thing that you have multiple drugs in a single setting. You know, for us, unfortunately, you know, even with 50%-60% response rates, there's still unmet need for all of these patients. And so we're gonna let the science dictate where we go. You know, if then you end up with multiple drugs in the same kind of patients, then physicians have more options and choices, and if one drug isn't successful, they can always go to another one. And so I guess our philosophy is: Let the science kind of lead us to where we go, and then, you know, the market will figure it out later on. And the third one is HER3. You rightfully point out, and I'll give you an example of this. With DB-06, I neglected to mention this, but we have patients in the DB-06 study, which is in HER2 low, where we're looking at ultra low expressers in that setting. So that would technically be IHC 0-1, right? And it is what you've mentioned, which is, you know, if an HER2 shows really good activity there, that kind of changes the paradigm of how you think about this, and there's even more opportunity. The way that we're approaching it with I-DXd and R-DXd is, we're doing very robust phase 1 programs in basket studies, where we're studying across a number of different tumor types. And that kind of clinical activity will kind of steer us in the right directions, as much so or more so than just the expression level. So I said a lot. I hope I answered your questions, but please, if I didn't, please ask again. No, thank you very much. This is very clear and comprehensive question. I really appreciate it. Thank you. The last question is from Tony Ren, Macquarie. I, can you guys hear me? Yes. Tony Ren from Macquarie. Okay, great. Yeah, thank you very much. I just wanna go back to the patient. So, on slide, you know, in the slides, slide 12 and 18 in particular, I do have to say that the opportunity in major markets, the numbers look quite large, much larger than at least in my model. Just wanna see how you guys define the eligible number of patients. Do you mean the number of patients treated using your agents? So and also related to that, if you go to slide 13, did I hear correctly that Ken said that there will be four times more patients being treated on in HER2 than in 2026 than in 2023? Just visually looking at the stack, column bars looks more like twice as much. And also, if I'm just extrapolating too much, if it's really four times the number of patients, right now we are running at $2.5 billion a year, right? So are we looking at basically $10 billion a year in peak sales? Okay. So thank you for those questions. So let me clarify. So the number of patients is not the number of... in those slides you mentioned, it's not the number of patients treated with an HER2 or other drugs. It is the patients that we could potentially treat with those indications. So it's our opportunity. All right? So sorry if I confused you there. So it's the opportunity that we could treat those. We're not gonna get 100% of those. Right? So I think that's an important aspect of it. And in terms of HER2 number of patients, again, it's a similar question. It's the eligible patient opportunity. So with those indications, the opportunity for an HER2 would grow to over 100,000 in 2026. So again, it is the opportunity. It's not what I'm suggesting we're gonna get all of that. Does that help? Yeah, definitely. Yeah. Okay. Thank you. I appreciate it. And, are you looking to bring the guidance up to JPY $10 billion? I'll let my boss answer that. Okay. All right. Okay. You know, perhaps just very quickly, if you go to slide number 14, right? Ken, I know that you said that there is no delay on DB0, sorry, TB-06 TROPION-Breast01, sorry, TROPION-Breast01. It is on schedule. Looks like TROPION-Lung01 will come before, the approval will come before TROPION-Breast01. Is that your current understanding as well? Yeah. The PDUFA date in the U.S. is December of this year for- Mm-hmm. For TROPION-Lung. Mm-hmm. And, so that would be earlier. Okay. All right. Perfect. Okay. That's all from me. Thank you. Thank you. We will now conclude Daiichi Sankyo's ENHERTU business briefing. Thank you very much for joining today. Thank you very much.