Daiichi Sankyo Company, Limited ($4568)

[interpreted] Thank you for waiting. We are going to start Daiichi Sankyo's FY 2025 Financial Results Announcement and FY 2026 FY 2030 5-year business plan presentation and discussion. I'm delighted to serve as MC today. I'm Ari Fujishiro from the Investor Relations and Shareholder Relations Department. First, about the language. In this briefing session, you're going to use Japanese and English. Simultaneous translation is available. Ptomoosein Zoom screen and during live streaming, we will show a presentation material in Japanese. We have posted a presentation in both Japanese and English on our corporate website under IR library, financial results presentation material or IR Presentation Materials section. Please download the files if necessary. Today, 5 members are in attendance. Representative Director, President and CEO, Hiroyuki Okuzawa; Senior Executive Officer, CFO; Tomohiro Kodama; Director, Head of Oncology Business Unit, Ken Keller, Head of Global R&D, John Tsai, Senior Executive Officer, Head of R&D Division, Yuki Abe. Today, after FY 2025 financial results announcement, we will represent FY 2026 to FY 2030 5-year business plan. At the end, we will have time for Q&A with all the executives. We will entertain questions from investors and analysts until 8 p.m. We will take questions from members of the media from 10 minutes past 8. Please note that this meeting is being recorded. Thank you for your understanding. We are starting FY 2025 financial results announcement by Okuzawa san, please.

[interpreted] Okuzawa speaking. Thank you very much for joining Daiichi Sankyo's FY 2025 financial results announcement and 5-year business plan presentation and discussion out of your very busy schedule today. First, we'd like to sincerely apologize for rescheduling the dates of FY 2025 financial results announcement and 5-year business plan presentation and causing you inconvenience and concern. Due to the financial result forecast revision, we explained the other day, we thought that explaining FY 2025 financial results and 5-year business plan together would be the best way to help you understand the current situation of the company and and the future strategy properly, so we decided to reschedule the dates. Today, we will explain FY 2025 consolidated results first, and then the Today, we will explain FY 2025 consolidated results first and then the 5-year business plan. We will entertain your questions at the end after the 2 presentations. Now our new CFO, Kodama, will explain FY 2025 consolidated results. Kodama-san, please.

Kodama speaking. Please turn to Page 5. These are the topics we are going to cover today. The update will be explained by John Tsai, who has assumed the post of Head of Global R&D since April this year. Please turn to Page 6. This is the summary of the financial results. I will explain the details on the following pages. Please turn to Page 7. I will explain an overview of FY 2025 consolidated results. Revenue increased by JPY 236.8 billion or 12.6% year-on-year to reach JPY 2.123 billion. Cost of sales increased by JPY 25.6 billion from the previous year. SG&A expenses rose by JPY 134.8 billion, and R&D expenditure increased by JPY 29.3 billion year-on-year. As a result, core operating profit increased by JPY 47.1 billion or 15.1% year-on-year to reach JPY 360 billion. Operating profit, including temporary gains and losses, decreased by JPY 102.8 billion or 31% year-on-year to JPY 229.1 billion. Profit attributable to owners of the company decreased by JPY 35.9 billion or 12.1% year-on-year to reach JPY 259.9 billion. You can find the actual currency rates on the slide. Please turn to Page 8. From here, let me explain positive and negative factors for revenue compared to the previous year. Revenue increased by JPY 236.8 billion year-on-year. I will explain its breakdown by business unit. First, Japan Defense unit. Sales increased for anticancer agent, Zet, direct oral or rather pain treatment of VG, direct oral antoagulant Lixiana, et cetera. On the other hand, revenue decreased for influenza treatment Inavir. In addition, we booked realized gains on unrealized gains of inventory for Daiichi Sankyo Espa in FY 2024. So Japan business revenue increased by JPY 3.2 billion in total. Next, let me explain our overseas business units. Here, ForEx impact is excluded. In Oncology business, revenue increased by JPY 152.2 billion due to the growth of ENHERTU and DATROWAY sales. As for American regions, revenue declined by JPY 32.8 billion due to the impact of generic entry on iron deficiency anemia treatment and Venofer and the impact of price competition on Injectafer and generic injectables. Revenue for EU Specialty business increased by JPY 21.7 billion as sales grew for hypercholesterolemia treatment MirEoSTENI. In A business responsible for Asia, South and Central American regions, revenue rose by JPY 38.1 billion due to the growth of ENHERTU mainly in China and Brazil. As for upfront payment and regulatory and sales milestones, et cetera, related to alliance with AstraZeneca and U.S. Merck, we booked as revenue, sales milestones, et cetera, we received from AstraZeneca in the fourth quarter. So revenue increased by JPY 32.5 billion. ForEx impact increased our revenue by JPY 21.8 billion in total. Slide 9 shows the factors behind the change in core operating profit. I will explain the JPY 47.1 billion increase by item. As explained earlier, revenue increased by JPY 236.8 billion, including a positive foreign exchange impact of JPY 21.8 billion. Next, I will explain cost of sales and expenses, excluding foreign exchange impact. Cost of sales increased by JPY 19.9 billion, primarily due to the revenue growth and inventory valuation losses recorded in the second quarter for products, including ENHERTU. Selling, general and administrative expenses increased by JPY 133.3 billion due to an increase in profit sharing with AstraZeneca as well as investments in DXd-ADCs and IT for medium- to long-term growth, expenses related to strengthening global talent development and strategic investments in human capital. Research and development expenses increased by JPY 29.4 billion due mainly to increased R&D investments associated with the progress of development of the 5 DXd ADCs. The negative impact of foreign exchange totaled JPY 7.1 billion, and the underlying increase in core operating profit, excluding foreign exchange effect, was JPY 32.4 billion. Next, I will explain the changes in profit for the period on Slide 10. Core operating profit increased by JPY 47.1 billion, including the impact of foreign exchange. As for the temporary income in the previous fiscal year, gains on the transfer of shares of Daiichi Sankyo Espa were recorded as onetime income. In the current fiscal year, although there were litigation-related gains associated with former Ramback to shareholders and gains from the liquidation of Ambit, which has been acquired as a subsidiary upon the in-licensing of cinzantinib profit decreased slightly year-on-year due to the absence of gain recorded in the previous fiscal year. For onetime expenses, a negative impact of JPY 149.9 billion on profit was recorded due to the recognition of costs, including compensation for losses incurred by CMOs, as previously explained, impairment losses and compensation related to the discontinuation of investment in the Oldawa plant. environmental remediation costs former Yasugawa plant and expenses associated with the next career support program implemented in Japan for the fourth quarter. As a result, operating profit of FY 2025 decreased by JPY 102.8 billion year-on-year on JPY 229.1 billion. Finance income and expenses had a positive profit impact of JPY 10.9 billion, mainly due to improvements in foreign exchange gains and losses. Income taxes decreased by JPY 56.5 billion due to a decline in profit before tax as well as an increase in R&D tax credits. As a result, profit attributable to owners of the parent decreased by JPY 35.9 billion year-on-year to JPY 259.9 billion. Please turn to Slide 11. This slide shows the full year dividend forecast for FY 2025. Although operating profit for FY 2025 decreased year-on-year, profit growth continued on core operating profit basis. Therefore, we will maintain the full year dividend forecast previously announced with the annual dividend per share expected to increase by JPY 18 year-on-year to JPY 78. Please turn to Slide 12. This slide shows the results of our share repurchase program. In order to respond flexibly while comprehensively considering factors such as share price levels, we established a JPY 200 billion share repurchase authorization in April last year and ultimately repurchased JPY 91.8 billion worth of shares. All shares acquired through this repurchase program will be canceled on June 10. Next, I will provide a business update. Please turn to Slide 14. This slide shows the sales performance of ENHERTU. Global product sales in FY 2025 increased by JPY 145.5 billion year-on-year to JPY 698.4 billion. Combined revenue recognized by Daiichi Sankyo and AstraZeneca outside Japan reached $5 billion, triggering a sales milestone payment of $537.5 million, and we received JPY 86 billion. As for new indications obtained in the fourth quarter, in Japan, we launched the promotion activities in March for second-line treatment of HER2-positive gastric cancer and HER2-positive multiple solid tumors. In China, we obtained approval in January for second-line treatment of HER2-positive gastric cancer. And in March, we received the world's first approval for neoadjuvant indication in HER2-positive breast cancer and launched promotional activities. In addition for existing indicators, we have maintained the #1 share of new patients starts in major countries and regions and sales continue to grow steadily. Global product sales for FY 2026 are forecast to increase by JPY 162.9 billion year-on-year to JPY 861.3 billion. In addition to product sales, we expect to receive a sales milestone payment of $625 million upon combined revenue recognized by Daiichi Sankyo and AstraZeneca outside Japan reaching $6 billion. So going forward, we also expect to obtain approvals in the United States for neoadjuvant HER2-positive breast cancer and post neoadjuvant HER2-positive breast cancer indications, which we hope will enable us to contribute to the treatment of patients with early-stage breast cancer. Next, I will explain the sales performance of NARVAY. Please turn to Slide 15. Global product sales in FY 2025 increased by JPY 46.2 billion year-on-year to JPY 47.6 billion. In addition to the steady market penetration of the breast cancer indication in Japan and the United States, the rapid market penetration in the United States significantly increased the number of new patients and the product was prescribed to a cumulative total of more than 4,900 patients globally approximately 1.6x higher than at the end of the previous year quarter. Regarding the NCCN guideline update for first-line treatment for triple-negative breast cancer, the recommendation level was upgraded from Category 2A, other recommended to preferred. Next is R&D update. The presentation will now be handed over to Jon Sai, Global Head of R&D.

Thanks, Kodama san. My name is John Tsai, and it's a pleasure to be here with you today. I started my role at the beginning of April, and I've been in this role for over 5 weeks, and I look forward to working with you. So as I start, I've had a chance to work very closely with the R&D organization and spent time with them. I've been really impressed with the innovation that's been coming out of the organization as well as the execution, and you'll be hearing about those as I go through the R&D update. So as we move forward, I'd like to share with you the progress that's been made in 2025, also and also share looking forward, what will be happening in 2026. So let's dive in to the slide here. Let's go on the current slide here. So in ENHERTU demonstrated robust data in breast cancer in HER2 positive and HER2 low ultra low going into 2025. In 2025, there was expansion into earlier lines and also into additional indications. In the earlier lines of treatment in fiscal year 2025 we expanded into first-line HER2-positive breast cancer from DB09. This was approved by the FDA in December of 2025, and this indication is under review currently in Japan, EU and China. Going into earlier lines in the neoadjuvant setting, everyone saw the results of DB11 that demonstrated clinically meaningful improvement in pathological complete response in high-risk HER2-positive early breast cancer. This led to the approval in China, which was in March, and this is currently under review in the U.S. Furthermore, in post neoadjuvant setting from DB we saw a clinically meaningful improvement in invasive disease-free survival versus TDM-1 in high-risk HER2 breast cancer in the post neoadjuvant setting. This indication is currently under review in the U.S., Japan, EU and China. With these indications, we also look to expand into earlier lines and into other tumor types. In 2025, we expanded into other tumor types, such as in gynecological cancers. From DESTINY Ovarian 01, this trial was started in December of 2025. And we also started DESTINE Endometrial 01 and 02 trials, which you can see was started in June and also in December of last year. Let's go to the next slide where we can go into the details of HER2 DB11 in the neoadjuvant setting. As we said earlier, this was already approved in China. What we saw from DB11 is that 4 cycles of in HER2 followed by THP versus the standard of care showed an 11.2% improvement in pathological complete response and a trend toward event-free survival. This was demonstrated in patients with high risk of recurrence and includes a high number of patients who are hormone receptor positive, who generally have lower pathological complete response rates. As I said, this is under review in the U.S. Let's go to the next slide. Here is a summary of the current regulatory status for ENHERTU. We already heard that first-line DB09 was approved in the U.S. and the neoadjuvant approval was already approved in China. We have additional approvals that we're waiting for results. The post-neoadjuvant DB05 has been accepted in the U.S., Japan and EU. We also received 2 additional approvals in Japan, HER2-positive gastric cancer and the pan-tumor HER2 positive approval in Japan. Lastly, in the IHC 3+ tumor in the HER2-positive patient population, the file has been accepted in April in China, and this is under priority review. This gives you a good snapshot of all of the progress that was made in HER2 and now will turn into looking at DATROWAY and the progress that was made there. DATROWAY also made significant progress. And in 2024 was originally approved for HR-positive HER2-negative breast cancer as the first initial indication. In June of 2025, the second approval for Data was obtained for EGFR-mutated patients from the top lung 05 study after patients have been treated with EGFR TKI plus platinum chemotherapy. As we look at learning from some of the studies, we applied some of the learnings as we received the results from TROPION01 study, where we saw benefits more in the nonsquamous patient population more than the squamous. And importantly, what we also saw was the value of the TROP 2 biomarker. Based on the results that we found from TROPION 01, we've updated TROPION-Lung05 to add the TROP2 biomarker. Based on the results that we found from TROPION-01, we've updated TROPION-Lung05 to add the TROPION-2TROP-2 biomarker NMR positive to the primary endpoint for progression-free survival and overall survival. In addition to this, we also added the TROP2 NMR biomarker to TROPION-Lung08 and that was in PD-L1 high positive patients. We added this to the secondary end point for PFS and OS. Also in the lung space, we started TROPIONLung17 in the TROP2-positive, metastatic non-small cell, second-line patient, and that trial was started in January of this year. In the area of breast cancer, we demonstrated positive results at ESMO just last year, where we showed strong results from TROPIONBreast02 in first-line triple-negative breast cancer. These are patients who are not eligible for PD-1 and when we saw the combined positive score less than 10. This filing is under review in the U.S., Japan and in China. In addition to earlier lines for DATROWAY, we expanded into other tumor types. You can see that we expanded into urothelial carcinoma in the Phase II/III trial, which is Urothelial03. This was started in October, where we will see DATROWAY plus carboplatin or cisplatin versus gemcitabine plus carboplatin versus cisplatin. There was significant progress, as you can see here, made with DATROWAY. As we look into the additional DXd ADCs, we made significant progress in these areas also. While we pushed the boundaries for HER3 ADC we saw that the results did not demonstrate positive results in the EGFR-mutated lung cancer area. But in addition to that, we did see progression and also progress for I-DXd where we saw robust data from the IDA Lung01 study for extensive stage small cell lung cancer on or after platinum therapy. Not only did we see this, we also expanded into additional indications for IDXD for esophageal and prostate cancer. These were Phase III studies that were started in May and June of last year. For the area of R-DXd, there was positive results presented at ESMO last year from the Rejoice Ovarian01 study. This was a Phase II dose optimization study for platinum-resistant patients who had CDH6 expression, and we were granted breakthrough designation for this specific indication. Lastly, for the DXd platform, we also started first-in-human study for DS-3790. This was first in-human start for the indication of relapse and refractory B-cell lymphoma. Looking beyond the DXd-ADC platform, we have new modalities in oncology and we started a number of new first-in-human studies. For DX3610, this is an ADC with STING agonist as the payload. This was started in November of last year. For DS-5361, this is a small molecule NMD inhibitor, which activates by increasing neoantigens, and this was started in October and we also started a targeted protein degradation program DS-9051 that was in November of last year. Next slide, please. As I shared those results, I'd like to also share with you the progress that was made with I-DXd as we are seeking our first approval for I-DXd based on the results of 02 study and extensive stage small cell lung cancer. As I said earlier, the results were shared at the WCLC Congress that demonstrated almost 50% reduction in overall response in previously treated extensive stage small cell lung cancer patients. This application has been filed with the FDA and given breakthrough designation and given priority review just earlier last month, and we expect a PDUFA date in October of this year and also ID802 Phase III study is currently ongoing. Going to the next slide, please. Beyond oncology, we continue to make progress. There's new programs in the immunology space with a planned first-in-human start in the first half of this year for DS2001 and anti ORAI-1 antibody for autoimmune disease. ORAI-1 is a major performing subunit of Crackle channel in immune cells, and this is in the area of immune diseases, as I stated earlier, and this is planned to start this year and the first half. Go to the next slide, please. Based on all of these advancements, our R&D group has been recognized by the external community through a number of accomplishments, and we highlight 2 of them here. DIACHIRONA won the 2026 Pharmaceutical Society of Japan Award. This was based on the first made in Japan mRNA vaccine for COVID-19. In addition, Valemetostat or EZHARMIA received the 2025 Pharmaceutical Chemistry division Award, and this was based on the first dual inhibitor of EZH1/2 and provides a new treatment option for all of those patients with a high unmet need with adult T-cell lymphoma. The next slide, please. Looking forward, I've shared with you a number of the progress and advancements made in 2025. And if we look at 2026, there are a number of regulatory decisions that we're looking forward to this year. As you heard, Destiny05 in the post neoadjuvant HER2-positive breast cancer area, we're expecting the regulatory decision in July of this year. For DATROWAY, TNBC first line, we're expecting that PDUFA date in June of 2026. And for I-DXd for extensive small cell lung cancer second line, we're expecting the results and the feedback from the FDA in October of this year. In addition to the regulatory readouts, we also have a number of data readouts this year. We're looking forward to in HER2 DESTINY-Lung04 study in the first half of 2026. And in the first half of this year, we expect to get the results of TROPIONLung07, TROPIONLung15 and AVANZAR, these are on the first-line patient population. We also expect to get results from R-DXd, where we have regulatory submission, and we are evaluating the submission of REJOICD01. While we saw positive results, we're awaiting the expansion of the Phase II data in order for the full submission. With that, you can also see some of the presentations that we will be sharing at ASCO a later on at the end of this month. With this, these are all the accomplishments and what we will be looking forward to in 2026, and I will turn it back to Kodama san for the fiscal 2026 forecast. Thank you.

[interpreted] Kodama, I will explain FY 2026 forecast, please turn to Page 7. With the adoption of IFRS 18, presentation and disclosure in financial statements, the presentation of the consolidated income statement is scheduled to change effective from FY 2027 at Daiichi Sankyo Group in anticipation of the impact of this adoption, the definition of core operating profit is to be changed starting in FY 2026 when the 6 5-year business plan begins. You can find the table below to compare the previous definition on the new definition. CMO compensation fees and write-down of inventories, which were recorded as temporary expenses in FY 2025 are included in core operating profit under the new definition. Regarding the impact on FY 2025 results due to change in the definition of core operating profit, please refer to an adjustment table on Page 38 in the appendix. Next, please turn to Page 28. Let me explain FY 2026 forecast, changing the definition of core operating profit, which I explained earlier, is reflected on to FY 2025 results and FY 2026 forecast figures. As for revenue, declining sales in the iron supplement business in the United States and drug price revision for Lixiana in Japan were negative factors, but there were positive factors, such as revenue increased due to market penetration of ENHERTU and DATROWAY, especially in the United States. So we are forecasting revenue to increase by 7.4% or JPY 157 billion year-on-year to reach JPY 2.280 trillion. Cost of sales are increasing due to revenue expansion but cost ratio is improving due to changes in our product mix. CMO compensation fees are declining, so we are expecting cost of sales to decrease by JPY 80.3 billion. CMO compensation fees of JPY 80 billion, we are recording as cost of sales for FY 2026 is the current estimate. We expect it to additionally arise by the end of FY 2026 due to short-term differences between our supply plan and the minimum purchase obligations to CMOs. Specifically, this will be for 2028 to be included in FY 2026 as the new SAM order period. With regards to core operating profit, expenses are expected to rise due to sales expansion of ENHERTU and DATROWAY, which will likely lead to increased profit share payment to AstraZeneca. On the other hand, gross profit increase is projected, so we are forecasting operating profit to increase by 27.5% or JPY 77.6 billion to reach JPY 360 billion. Due to change in the definition of core operating profit, amortization expenses of intangible assets related to products will be classified as noncore expenses. In addition, we're expecting new specialty business unit restructuring expenses, but noncore expenses are going to decline year-on-year. So operating profit will go up by 37.5% or JPY 85.9 billion to reach JPY 315 billion according to our forecast. Pretax profit is expected to rise, but corporate tax will increase. And due to the stock transfer of Daiichi Sankyo Healthcare, profit attributable to noncontrolling interest is expected. So we are forecasting profit attributable to owners of the company to be JPY 260 billion at a level similar to the previous year. Our ForEx assumptions are JPY 150 against the U.S. dollar and JPY 180 against the euro. Please turn to Page 29. Here, let me explain FY 2026 annual dividend forecast. Under the 6th 5-year business plan, stable dividend will be distributed based on progressive dividends and adjusted DOEs. Adjusted DOE will be calculated based on adjusted shareholders' equity, which excludes items that fluctuate primarily due to share prices and exchange rates. On total shareholders' equity, increase of the dividend to JPY 100 per share, up by JPY 22 from JPY 78 in FY 2025 is planned in FY 2026, marking the fifth consecutive year of dividend increases. Towards further growth under the sixth 5-year business plan, we will continue to enhance shareholder return. That's all for the results. Next, we are moving on to the sixth 5-year business plan presentation and discussion. Okita-san, please.

Let me explain the sixth 5-year business plan. Please turn to Page 46. First, recap of the fifth 5-year business plan. Under the fifth 5-year business plan, we raised maximize 3 ADCs, profit growth for current business and products, identify and build pillars for further growth and create shared value with stakeholders of 4 strategic pillars. We worked hard to realize 2025 goal and shift to further growth. Let me recap the main progress for each, respectively. Please turn to Page 47. This is the summary for maximizing 3 ADCs. The oncology business achieved significant growth driven by ENHERTU and DATROWAY. Also, we entered into a strategic alliance with U.S. Merck as well in addition to AstraZeneca, strengthening the structure for global development and commercialization is ongoing. ENHERTU transformed standard of care in HER2-positive breast cancer and has established HER2 low and ultra-low breast cancer as a new therapeutic area. DATROWAY provided new treatment option to patients with limited treatment options and also updated lung cancer strategies by implementing novel biomarker based on learnings from TROPION-Lung01 study. subsequent ADC products, we revised the timing to launch first-DXd, but we are accelerating DXd. DXd development through our collaboration with U.S. Merck. Growth is making progress for the DXd-ADC portfolio as a whole. Regarding manufacturing and supply, we revised the supply plan and optimize the global supply chain. In addition, we resolved patent dispute with Seagen Inc., confirming DXd-ADC as Daiichi Sankyo's proprietary technology. Please turn to Page 48. Next, I will recap the progress for 3 strategic pillars and business foundations. In the current business, specialty medicines such as LIXIANA grew, while profit declined in the iron supplementation business by American region. Also, we advanced transformation toward an innovative medicine business structure through the transfer of shares in Daiichi Sankyo Esa and Daiichi Sankyo Healthcare. Under the strategic pillar to identify and build pillars for further growth, in-house development of DF9606 was discontinued, but the modified PBD ADC technology was successfully validated, and we generated new platform technology candidates as well. As for shareholder return, we increased dividends annually in line with profit growth, executed flexible share buybacks and achieved DOE of over 8%. Please turn to Page 49. This page shows the financial targets at the time of developing the fifth 5-year business plan and the final results as of March 2026. Over the last 5 years, oncology business grew substantially 2025 revenue was JPY 2.23 billion and revenue in oncology was JPY 954 billion. We achieved our initial target for both. On the other hand, core operating profit ratio before R&D was 38.7%, which fell short of the 40% target. ROE was 17.9% in FY 2024 above the target but was 15.8% in FY '25. CMO competition fees were recorded, ROE was 8.7%, achieving our target. Next, please look at Page 50. This page shows an overview of the recap. Between FY 2021 and FY 2025, both revenue and core operating profit grew substantially and we believe we realized transformation into a global pharma innovator with competitive edge in oncology, which was raised as our 2025 vision. Based on these achievements, we will accelerate further growth under the 6th 5-year business plan between FY 2026 and FY 2030. Next, we will explain the 6th midterm business plan. Please turn to Slide 51. We have set forth our 2035 vision as becoming a trusted health care innovator transforming the lives of people through our science and technology. The next slide shows the positioning of the sixth midterm business plan toward the realization of Vision 2035. Please turn to slide 53. Under the fifth midterm business plan, we transformed into an oncology-focused company and achieved continuous growth. In light of this progress by 2030, the final year over 6th midterm management plan, we aim to become an advanced global health care company that contributes to the sustainable development of society. The 6th midterm business plan covering FY 2026 through FY 2030 aims to expand the oncology business through the establishment of an efficient and resilient organization while also advancing the identification of breakthrough generating technologies or BGTs as new drug discovery technologies for sustainable growth, thereby driving towards the realization of our vision 2035, a trusted health care innovator. By 2035, we aim to become a global top 5 company in the oncology field with the new BGTs following DXd ADCs contributing to our business while establishing an efficient and resilient organization and becoming a trusted partner. Please turn to Slide 54. This slide provides an overview of the quantitative targets and strategies for achieving our 2030 goals. First, let me explain a quantitative targets for FY 2030. We're targeting revenue of more than JPY 3 trillion, operating profit of more than JPY 600 billion and EPS of more than JPY 260. During the period of the 6th midterm business plan, we will maintain progressive dividends and provide annual dividends with an adjusted DOE of 10% or higher. Next, I will explain the strategies for achieving the 6th midterm business plan and its quantitative targets. The first strategy is be a global top 5 oncology company by 2035, leveraging the strength over DXd ADCs. We aim to become a global top 5 company in oncology by 2035. To achieve this goal, we will launch multiple products and indications without delay, thereby providing new treatment options to more patients, while also establishing the capabilities required to independently develop and commercialize products on our own. The second strategy is identifying next BGTs by 2030. To achieve sustainable growth even after the LOE of the DXd ADCs and to deliver products that go beyond current standards of care to patients. We will identify multiple BGTs by 2030. In addition, as a foundation for steadily executing these 2 strategies, we will enhance our profit-generating capability through operational excellence. Furthermore, we will strengthen value creation for diverse stakeholders and enhance our corporate value as a trusted partner. Please turn to Slide 55. From here, we will explain be a global top 5 oncology company. Looking towards 2035, our oncology business aims to provide innovative treatments that bring cancer care one step closer to a cure for patients with serious diseases around the world as well as provide new treatment options through personalized medicine to patients who have not achieved sufficient therapeutic benefit. With convention treatment and by delivering high-value information to health care professionals, we aim to provide medicines to more than 700,000 target patients annually. By expanding our pipeline and business and growing into a global top 5 oncology company, we will be able to provide better treatment options to as many patients as possible, thereby realizing our Vision 2035 of becoming a trusted health care innovator. Please turn to Slide 56. Through strategic collaborations with AstraZeneca and Merck in DI states, our oncology business has achieved significant growth through obtaining more than 10 indications for oncology products such as ENHERTU and DATROWAY across more than 5 countries and regions. We have secured more than 270 reimbursement approvals in total, enabling us to deliver medicines to more than 240,000 patients. In addition to expanding through new product launches and additional indications, we have proactively invested in delivering medicines to a greater number of patients through evidence generation in real-world clinical practice, including more than 400 cumulative studies generating real-world data and the publication of over 100 papers annually. Please turn to Slide 57. Our oncology business grew to revenue of JPY 954 billion in FY 2025. Under our growth strategy ENHERTU and DATROWAY will continue to drive revenue growth over the next 5 years, with the aim of achieving oncology revenue of more than JPY 2.3 trillion by FY 2030. In addition, we will maintain a competitive pipeline and build the capabilities to independently develop and commercialize products in order to maximize their value, thereby achieving sustainable growth in the future. Next, the following slide explains how we will build these in-house capabilities. Please turn to Slide 58. Our in-house capabilities will be built upon 3 pillars: R&D excellence to support development activities, business excellence to drive commercialization in an optimized global supply chain. First, under R&D excellence, we will establish independent development capabilities aligned with pipeline progress by improving development speed through optimization of clinical development processes. In addition, we will leverage technologies such as digital pathology to improve the probability of clinical trial success. We will also promote efficient R&D through the use of AI and digital technologies. Next, under business excellence. We will rapidly launch multiple products and indications in order to maximize product value. We plan to launch more than 20 indications over the next 5 years, and we'll deliver them to patients without delay following regulatory approvals. In addition, through the continuous generation of evidence, we will provide high-value information and secure long-term product value through pricing and reimbursement strategies. Through these initiatives, we will maintain and expand our leadership in the breast cancer field, while also establishing a strong leadership position in the lung cancer field. To support and realize this business growth, we will optimize our global supply chain and build a flexible and stable supply system. As introduced at the recent briefing, based on lessons learned from our past experience, we have revised our strategy to optimize the roles of both our in-house manufacturing capabilities and CMOs. Through this approach, we will secure appropriate capacity over the medium to long term, ensure a stable supply of our expanded ADC portfolio enabled the rapid launch of BGT candidate assets under development and reduce future manufacturing and supply-related risks. Under this new strategic direction, we will build a business foundation that is resilient to changes in the external environment and strive to achieve sustainable growth. Now let me move to the next slide and discuss in more detail, how we are building R&D excellence. Please turn to Slide 59. In order to build development capabilities at the level of a global top 5 oncology company, improving development speed is essential. With ENHERTU, the period from first in human clinical entry to initial approval was achieved in 4 years and 3 months, representing 1 of the fastest approval time lines ever achieved globally. To replicate the highly competitive approval speed achieved with ENHERTU, for our subsequent in-house pipeline asset, we will shorten the timeline from nonclinical development to clinical entry and further streamline each process in clinical development. As a specific initiative, the first is the establishment of a clinical trial network. We have already partnered with more than 20 highly experienced clinical trial sites across over 10 countries and regions, building a global network for conducting Phase I trials. We will continue to actively expand these partnerships and accelerate first-in-human studies. In addition, these Phase I trial sites will share their experience in drug administration and adverse event management with late-stage trial sites around the world. with the aim of accelerating patient enrollment and improving trial quality. The second initiative is the utilization of digital technologies and AI. We will leverage digital technologies and AI for biomarker discovery and research as well as for analysis and utilization of the vast amount of data accumulated internally as well as for improving efficiency in protocol development and site selection, thereby enhancing efficiency through the use of digital technologies in AI across various R&D processes and accelerating the overall development process. Next, we will explain business excellence. Please turn to Slide 60. We will continue to make R&D investments actively for DXd ADC products. More than 20 pivotal studies, data readouts are expected over the next 5 years. To grow our oncology business, after obtaining approval of many indications, we need to launch the products rapidly across the world, including biomarker diagnosis. We need to realize rapid market penetration for products. So that the product life cycle, we will develop pricing and reimbursement strategy from global perspectives. We will also generate data and evidence continuously to secure long-term product value and aim to maximize product value. Please turn to Page 61. I mentioned that more than 20 pivotal studies data readouts are expected over the next 5 years. We are assuming that $2 billion to $6 billion total peak sales potential readouts will continue every year for the next 5 years. In 2026 to FY 2030, this is going to occur every year to contribute to the sales growth. By continuing to invest actively in R&D and delivering new data, we will contribute to more patients. Please turn to Page 62. Through indication expansions for ENHERTU and DATROWAY, we have established a leadership position in breast cancer. Both products, we are implementing more clinical studies to expand their indications. In each treatment stage, we will contribute to more patients with breast cancer. Also in lung cancer, we already obtained indications with ENHERTU and DATROWAY, especially for DATROWAY 10 Phase III studies are ongoing right now. We will promote biomarker research and exploration, identify target patients to deliver the drug appropriately so that we can build leadership in lung cancer as well. Please turn to Page 63. We believe that our DXd ADC business is growing substantially with big sales potential of JPY 3 trillion or more. We will not only invest in the 5 DXd ADCs where we are collaborating with our partners, but also invest actively in DS-3939 and DS-3790, et cetera, in early development with blockbuster potential, we will aim to maximize the value of our ADC portfolio, including OCN strategies such as indication expansions. Furthermore, to realize sustainable growth, we will identify multiple next BGTs with potential too much that of DXd ADCs by the year 2030. These promising pipeline assets, we will aim to be a global top 5 oncology company by 2035 and deliver our medicines to more than 700,000 patients around the world each year. On the next page, I will explain identify NexBGTs. Please turn to Page 64. We define BGT breakthrough generating technology, Daiichi Sankyo's proprietary innovative technology to deliver more innovative medicines to patients faster. Based on this proprietary drug discovery technology, we will advance research and development in multiple diseases and turn this into a platform. First, we will generate multiple drug candidates through innovative technologies to transform standard of care. We will then leverage clinically validated technologies to the next programs to build a high probability portfolio. Then we establish end-to-end integrated capabilities from research and development to manufacturing, to accelerate delivery of new innovative medicines to patients. DXd ADCs are good successful examples. Clinically evaluated technologies are being leveraged in the next programs. By now, ENHERTU and DATROWAY already launched and 5 others are in development stage. Identify the next BGT programs is going to be our target during the 6th 5-year business plan. Please turn to Page 65. On this page, I will talk about 3 modalities as ADC-based BGT candidates. First, ADC using cytotoxic payloads. As a leading Topo 1 inhibitor innovator, we will leverage our knowledge and clinical insights accumulated so far to develop next-generation cytotoxic payloads to overcome cancer with DXd ADC resistance. We are planning to start Phase I study for ADC with new payloads in FY 2027. Next, ADC with IO payloads. By activating the immune system via the STING pathway, we are hoping to drive tumor cell elimination and improve long-term treatment results based on immune memory. As an ADC of this type, DS3610 study is ongoing. Next, antibody engineered ADC. Through novel tumor-selective antibody engineering technologies, we will aim to improve benefit risk balance. We will develop new drugs through combinations with diverse ADC technologies we have. In this type of ADC, we are planning to start the first Phase I study in FY 2027. Please turn to Page 66. Here, I will talk about 3 non-ADC BGT candidates from multi-modality research. First, as an advancement in antibody engineering, we are developing multi-specific antibodies. One example is T cell engagers. As our in-house product DS2243 Phase I study is ongoing. We explore new technology and biology through integration with IO and ADC technologies. Next, as a high-value chemical modality, I will explain targeted protein degradation, TPD molecules. This modality will not inhibit protein functions but degrade target proteins themselves, enabling access to previously undruggable targets. This will accelerate TPD molecule creation with higher precision by integrating a long-standing medicinal chemistry with AI drug discovery. As we mentioned in previous results announcement briefing sessions, DS-9051 Phase I study is ongoing right now. Last but not the least, siRNA as a combination of years of research in nucleic acid therapeutics, we have leveraged decades of our nucleic acid expertise such as research on DAICHIRONA. By integrating novel chemical modification technologies with DDS technologies, we will create nucleic acid therapies targeting multiple organs. We plan to start Phase I study for the first program by the end of FY 2026. On Page 67, I will introduce our programs in immuno-oncology. As is shown in this figure, we are broadly researching key mechanism of cancer immunology. In each step, we identify promising assets. At present, many Phase I studies are ongoing. By 2030, we're expecting clinical signals on these assets. Furthermore, with combination therapies with in-house and external compounds, we will aim to enhance the value of our IO assets. Please turn to Page 68. During the fifth 5-year business plan up to FY 2025 through DXd ADCs positioned as the first BGT. We achieved expansion of our business and presence in oncology. DXd ADCs also during the 6th 5-year business plan period, multiple data results from large-scale clinical trials are expected, leading to education expansions. In addition, from the 6 BGT candidates I talked about today as well as IO breakthrough assets, we will identify promising growth pillars on DXd ADCs and aim to unlock retail business potential. Please turn to Page 69. This slide introduces the expansion of our drug discovery research platform that supports the continuous creation of BGTs. Through 3 perspectives: expansion of the research capabilities at the Shinagawa Research Center research DX and open innovation. We will create an environment that enables us to leverage our craftmanship more effectively than ever before, a new research building in Shinagawa is scheduled for completion by the end of 2027. And we will also strengthen talent acquisition. In addition, DX initiatives in the research field are also advancing and the data-driven drug discovery project that had previously focused mainly on small molecules, can now be applied to multi-modality research. We will continue to leverage AI to improve the efficiency of drug discovery. Regarding open innovation. In addition to establishing 3 research institutes in Europe and the U.S., we plan to further strengthen our initiatives. Please turn to Slide 70. Here, as examples of the outcomes of our science and technology, we would like to introduce some of our license compounds currently being developed by other companies. These innovative assets are reaching clinical this through licensing partnership. Talitolectonife is currently the most successful example among our out-licensed assets, contributing to the treatment of patients with ROS1-positive non-small cell lung cancer in the U.S., Japan and other countries. The growth of these out-licensed assets demonstrate the strength of our science and technology capabilities gives us confidence that we can identify the next generation of BGT candidates based on our drug discovery capabilities. In addition, with respect to these assets, we expect to receive milestone payments and running royalties based on the respective agreements. Next, I will discuss operational excellence. We serve as the business foundation supporting our 2 strategies be a global top 5 oncology company and identify next BGT. Please turn to Slide 1. In April, we established a new business transformation organization directly under the CEO. By implementing company-wide operational excellence initiatives over the next 5 years, we will optimize our cost structure and strengthen our profit-generating capabilities. As a specific initiatives, we will expand the scope beyond routine tasks to include nonroutine operations and improve operational efficiency globally through the use of both general purpose and specialized AI. At the same time, for human resource free from convention tasks through these efficiency gains, and we will formulate and execute our strategies that combine capability transformation through reskilling with optimal talent allocation, thereby advancing talent allocation from the company-wide optimization perspective. In addition, we will further reduce costs by optimizing our procurement processes through the global common ERP platform that has been rolled out sequentially across regions since last fiscal year. Through the execution of these operational excellence initiatives, we aim to optimize costs by a cumulative total of more than JPY 200 billion over the 5 years period of the 6 midterm business plan, thereby enhancing our profit-generating capabilities and utilizing these gains for future growth investments and improved profitability. Please turn to Slide 72. commercialization to achieve strong and sustainable growth, we will establish a new global organization responsible for centrally overseeing commercialization activities across all countries and regions. The entire oncology and specialty innovative medicines business, including marketing, medical affairs and market access. In addition, we will create the position of Chief Commercialization Officer to lead this organization. This will enable us not only to execute our global activities with greater speed and consistency, but also to advance resource allocation and business investment decisions based on strategic priorities including optimization of organizational structures and personnel. This organization is scheduled to become operational in April 2027. Please turn to Slide 73. This slide explains that alongside operational excellence, another foundation supporting the sustainable growth of our business is to be a trusted partner for sustainable society. To maximize our business value, it is essential that we meet the expectation of diverse stakeholders and continue to be a trusted partner. And we believe these ongoing efforts will contribute to a sustainable society. To enable our employees to fully realize their potential. We will foster a culture of patient centricity, thereby creating and delivering medicines that contribute to patients while also fulfilling our commitment to contributing to the medical community based on high ethical standards and providing patients and their families with confidence and safety. Furthermore, as our business continues to expand, we will work to reduce environmental impact across the entire value chain and fulfill our responsibilities as a corporation. Through these initiatives, we will contribute to diverse stakeholders, including patients and their families and work towards the realization of a sustainable society. From the next slide, we will explain our cash allocation and shareholder return policy. Please turn to Slide 74. Our cash allocation policy emphasizes a balance between growth investments and shareholder returns. During the period of the 6th midterm business plan, as growth investments, we will expand the oncology business while prioritizing our R&D and capital expenditures, aimed to identify new BGTs for sustainable growth. For shareholder returns, we will introduce progressive dividends and provide stable dividend payouts. Operating cash flow before deduction of R&D expenses over the 5-year period is expected to total approximately JPY 3.85 trillion, which together with proceeds from asset sales and financing activities will serve as the source of the funds. Of this amount, approximately JPY 2.9 trillion will be allocated to R&D expenses, while approximately JPY 700 billion will be allocated to capital investments, primarily for strengthening the global ADCs supplying network and enhancing research infrastructure. In addition, we will make agile strategic investment, including acquisition of external assets and capabilities to support sustainable growth beyond the mid-2030s. With regards to shareholder returns, we will introduce a progressive dividend policy and prioritize stable dividend payments while considering flexible share repurchases, depending on the circumstances. Please turn to Slide 75. This slide illustrates our shareholder return policy and the outlook for annual dividends. The annual dividend was JPY 27 in FY 2021 when the first midterm business plan began and has increased to JPY 78 in FY 2025 as we have continued to provide stable shareholder returns in line with profit growth. During the period of the 6 midterm business plan, we will introduce a progressive dividend policy and maintain an adjusted DOE of 10% or higher each year as a key indicator while continuing to provide stable shareholder returns through dividends. For FY 2026, we plan to increase the annual dividend per share by JPY 22 to JPY 100. Next, I will discuss our quantitative target for FY 2030 and the outlook towards FY 2035. Please Turn to Slide 76. Looking toward FY 2030, in addition to challenges such as a loss of exclusivity for Lixiana, the completion of ENHERTU sales milestone receipts and declining revenue from the iron business, we will also face revenue reduction impacts from the transfer of Daiichi Sankyo Healthcare beginning in FY 2027. However, through the steady execution of the strategies outlined today in our 6th term business plan, along with maximizing the value of our DXd ADCs portfolio centered on ENHERTU and DATROWAY, we expect continued revenue growth throughout the plan period and aim to achieve revenue of more than JPY 3 trillion in FY 2030. On the profit side, while multiple challenges will converge in FY 2027, the transfer of Daiichi Sankyo Healthcare is expected to offset these impacts at the operating profit level. Furthermore, in addition to sustainable growth driven by maximizing the value of our DXd ADC's portfolio, we will strengthen our earnings-generating capabilities through operational excellence. As a result, we aim to significantly accelerate profit growth by FY 2030, targeting operating profit of more than JPY 600 billion and EPS of more than JPY 260. In addition, by implementing a progressive dividend policy and maintaining an adjusted DOE of 10% or higher each fiscal year, we will pursue more stable dividend and further enhance shareholder returns. R&D expenses are planned to increase gradually. And during the 6th midterm business plan period, we will invest approximately JPY 3.9 trillion, an increase of about JPY 1 trillion compared with the first midterm business plan period as a source of medium- to long-term growth. At the same time, through rigorous project prioritization and portfolio management, we will keep the growth rate of R&D expenses below the rate of revenue growth, with the R&D to revenue ratio expected to be approximately 20% in FY 2030. We have incorporated certain assumptions regarding the impact of MFN. As for tariffs, we currently believe that the impact on business performance during the period of the 6th midterm business plan will be limited, although we will continue to closely monitor policy developments going forward. To realize our Vision 2035, we aim to overcome the patent expiry of ENHERTU, while maximizing the value of the DXd ADCs and driving business contributions from new BGTs that follow DXd ADCs, thereby positioning ourselves to target operating profit on the scale of JPY 1 trillion in the early 2030s. To achieve this, we will cultivate it through our collaborations with AstraZeneca and Merck and strengthen our capabilities to independently develop and commercialize our industry-leading pipeline backed by our science and technology, thereby enhancing our future earnings generating potential. Finally, let me conclude with the summary. Please turn to Slide 77. So today, based on a review of the first midterm business plan, we explained the sixth midterm business plan aim to realizing our Vision 2035, which defines where we aspire to be in 10 years. The 6 midterm business plan is critical plan that will enable us to move into the growth as a future global top 5 oncology company. We will view the rapidly changing business environment as an opportunity. And by combining the strength, we have built over time with new challenges. We will realize sustainable value creation and contribute to the development of a sustainable society as we grow into an advanced global health care company. We look forward to your continued support and expectations for our future growth. This concludes my presentation.

[interpreted] First Mr. Yamaguchi from Citigroup Securities, please.

[interpreted] can you hear me?

Yes, we can hear you.

[interpreted]Yamaguchi from Citigroup Securities. My first question is about the 5-year business plan and also the FY 2026 forecast, so it's in between the two. So maybe the question goes to Kodama san regarding CMO compensation fee. On Friday, last week, there was a consultation, so you said that there can be a provision also for FY '26, you mentioned this is for 2028. Until when this will continue, that's something I would like to know. It's not included in the 5-year business plan figures. CMO compensation fees will continue until when, although the amount is going to decline over time. So could you explain?

[interpreted] Thank you for your question. So I'd like to respond. Your question is about CMO compensation fees. In FY 2026, JPY 80 billion is included. How much or how long this is going to continue, so you need some guidance on this. According to my understanding, regarding the contracts with CMOS, there are multiple contracts. Longer ones would be up to FY 2030 or up to the mid-20s. For specific details, I'd like you're saying from commenting in detail. As a range you can check this kind of a duration. Regarding the amount and the size once we communicated on Friday last week. Over time, the various measures are going to turn effective. So this year, in FY 2026, JPY 80 billion is planned and the amount is going to decline over time. In the 5-year business plan, it's only for 2030 -- up to 2030. But based on assumptions, we have certain figures. We incorporate it for our assumptions. So if you say certain, it's incorporated.

IPD Okay, understood. And the second point, I'm going to focus on the DTY. So this number for this year is very robust, TNBC alone. So in the mid to long term this number, you will not be able to give us the specific figure, but it's indicated from here that, DATROWAY, I would assume that, that is the biggest contribution included. How that's going to come into this assumption for this year and the mid- to long term? I would like to ask for your take on the situation.

[interpreted]Thank you for your question. So that's your way and the numbers. So for us, we do have for the adjustment based on the adjustment of risk -- so including there are such readout of the outcomes for other studies and have been incorporated into the numbers. So TNBC alone have been factored into this as an assumption as a new indication. Is my understanding correct? So yes, for these numbers, Ken would like to explain.

Thank you for the question. So as we look at the fiscal '21 expectations and the 6th midterm plan, we do assume that the triple-negative breast cancer indication will be approved. As you know, the data was reported. It is highly differentiated. We expect that when it is approved and the PDUFA date in the U.S. is pretty soon. It's in May. Everything we're hearing from the oncology community leaves us very confident that the doubling of overall response rate and the fact that it improved overall survival. Physicians are waiting for this drug enthusiastically. And so we expect it will do very, very well.

[interpreted] Next question, UBS Securities, Mr. Sakai, please, from UBS.

[interpreted] Sakai from UBS. On Page 74, I have a question on that. There are many things I'd like to ask you on this page. Regarding the dividend, adjusted DOE, 10%, this is a question to Kodama san. Instead of share buyback, why you're going to use DOE with dividends, there's no signaling of under value for the stock price? If you add these figures, it's already JPY 3.9 billion. Are you going to do factoring? That's my first question to you.

[interpreted] thank you for your question. Page 74, regarding the dividends and shareholder return, you'd like to know the way our thinking and fundraising philosophy, is also part of the question regarding shareholder return, acquisition of own shares and dividends, how we're going to do this. Using the 2 for the time being, during the 5-year business plan, we'd like to ensure profit generation, and we have commitments to this, and we also need to have confidence from the profit, we like to pay dividends to return to shareholders. That's why we are doing this adjusted DOE. This time its adjusted DOE from the fifth 5-year business plan, DOE is being used as an indicator. So we will continue to do so. As for the progressive dividends, you can see this progressive dividend in the fifth 5-year business plan, we paid dividends along with the profit increase. So we will continue to do this. As for the share buyback, this will depend on the status of capital and also the size of our business. Given that situation, our working capital is substantially increasing right now. So we have to check the balance. If the situation is appropriate for share buyback in terms of the capital, then we'd like to consider this possibility more actively. And also fundraising, you have calculated and you're right. If you add up the left and the right, the right-hand side is going to be pillar. So compared to -- in addition to asset sales, we will also do this for fundraising. You mentioned factoring. We are not considering this possibility more specifically, but we'd like to study and research broadly. If there is an appropriate things we'd like to work on that as well. Thank you very much.

[interpreted] My second question. So on Slide 6, I'd like to direct your question to Mr. Kodama. So you're going to accelerate this. So by R&D, JPY 600 billion or so as it is written here. So I would assume that SG&A is going to be reduced tremendously and OP, JPY 600 billion will be achieved. Is my understanding correct? And if that's the case, so how would be the driver for this robust -- robustness of this acceleration. So now forecasting governance is in check, although you're not -- do not have the U.S. GAAP.

[interpreted] So for the profit and this building a robust foundation for profit growth and to sharply accelerate profit growth in FY 2030, so your question was about the rationale about this. to deduct the expense from the revenue. And we're going toward 2030, so to improve our profit -- but rather, it is going to be increase in revenue. So the balance will be skewed towards the latter. And as for the expense, so for the business transformation, which we have talked about, the size of JPY 200 billion to reduce that expense have been factored into this. So on average, this isn't something that would be generated every year. It's going to be skewed toward the end of the 2030.

[interpreted] Next question Mr. Hashiguchi from Daiwa Securities, please.

[interpreted] Hashiguchi from Daiwa Securities. My question goes to Mr. Kodama or somebody you think is appropriate. On Page 63. DXd ADC, potential will be JPY 3 trillion or more next DXd ADC potential to match that of DTAC anything you can say so will be identified by 2030, you'd like to identify multiple BGTs by then. And heard enter clinical studies, if my memory is correct, it was around 2015. You have been able to say that it had this much potential. But the around the start of the 5th 5-year business plan like 2020, at the earliest point, you might have took longer than that. It might have taken more than 5 years. If I calculate based on this, you talked about multiple BGT candidates today. But they haven't entered the clinical stage yet. Phase 1 in 2027, then the likelihood may be very low to reach that goal by 2030. Those are already in the clinical stage, must have very strong signals. Otherwise, they would not be able to have the potential to match that of DXd-ADC by 2030, it can be difficult. Is understanding correct or wrong? If there is anything with such strong signals, I'd like to have some comments from you.

[interpreted] Hashiguchi san, thank you very much. In the 6th 5-year business plan, a major strategic pillar is to identify multiple BGTs as we mentioned. So thank you for your question on this. Global Research Head of R&D, is going to respond.

[interpreted] Thank you for your question. As you said, ADCs where I was involved in research since 2010, we started research from 2010 and 2015, Phase I started. In 2019, approval was granted. So we created the oncology business as such. Today, we presented on the 6 technologies. In the 5TH 5-year business plan, there was a lot of growth there. we filed for patents and development candidates are prepared, multiple of them are being prepared by now. Sorry for my long answer, but we took this approach in boss Agata, when he was still here, DXd-ADC successful experiences a use as basis are to proceed with BGT approach. So we are making good results based on that. The timing to contribute to a business in 2030, we don't think we can achieve it in 2030 yet. If I explain by 2030, Pashugut-san mentioned strong signals we are going to identify strong signals and multiple BGTs will be identified. So that's the goal setting shown on the right. So by 2030, we will identify these BGT candidates. And these groups of assets will enter into 2035 to flourish. So that's the timing. The left DXd ADC business will grow and the new drug assets will generate new business. So that's the nature of our R&D strategy. Did I answer your question?

[interpreted] Thank you very much. So the second part of my question is that the plan for the R&D costs, so for this time, so as it was presented in the Fridays, briefing. So you have factored in such risk. So that has been embedded into the plan. And as for the sales. So PDUFA is in scope for this. And depending on the data that may be published, so where would be the focus for R&D? So we -- I would assume that we need to be very flexible. So your midterm plan and with regards to R&D. So there has been such discrepancies. So in all likelihood, is there a possibility for such inconsistency there. So what is the basis for this R&D? So JPY 600 billion or JPY 2.9 trillion, how did these figures come out?

[interpreted] So R&D cost management. So John would like to respond to that.

[interpreted] Thank you for your question regarding the spends on R&D. As Abe-san outlined, we will have a number of identified BGTs moving forward. The specific spends for the R&D expenses have not yet been fully determined, but obviously, if we move forward with a number of promising BGTs, this will be the expenses that are incurred in order for us to achieve the goals. So we're looking forward to the promising agents that are moving forward, and those are the plans that we have in place with the costs associated with moving these BGTs forward.

[interpreted] Next question BoA Securities. Magnus, please. Next, SMBC Nikko Securities,please? Sorry, next.

[interpreted] I have a question on the 5-year business plan. First of all in FY '18 where operating profit before R&D was below 40%. What's the reason why in the next 5-year business plan, what would be the factors for you to achieve 40% SP29085744 And also core operating profit and operating profit, you changed the focus. And what's the reason behind.

[interpreted] Thank you for your question . FY 2025 core operating profit ratio under 40%. And what are the factors behind? And number 2 KPI for the by the business plan. What's the background for changing from operating profit to operating profit? First, FY 2025, core operating profit ratio before R&D below 40%. What was your question? Cost of goods sold in the second quarter. ENHERTU associated write-down of inventories were incurred losses. And on also had write-downs of inventories . So this is what we didn't expect initially, and there was an increase in expenses, and that's a major reason I can mention. And also, secondly, in the 6th 5-year business plan are the change of KPIs. Operating profit ratio before R&D target is 40% in the fifth iBusiness plan, by having this target, we've focused on the improvement of the profit margin, and we showed some effect and it played a certain role to play. When you look at the 6th 5-year business plan in our business, ADCs, specifically, NHT, Data products, we are working together with Mark. U.S. Mark and the proportion of this product is getting larger. As you know, regarding the fly products, profit share is a mechanism for collaboration. So in terms of the profit ratio, there are some difficulties.

[interpreted] And secondly, in the end, Profit for the term and the operating profit towards that goal for various elements.

[interpreted] we should focus more on these. So noncore items as well we decided to look at them as operating profit as an indicator of KPI. Summary, we have uniqueness here. I payload, I think, is unique. [Technical Difficulty] is my -- the topic of my question, exceeding do. Korean channel, ligand. So this ligand has not been overcome. So if you buy with the antibody, you will be able to maintain this work through, so then there may be such ability -- improved the salability of the compound, I'd like to ask you to elaborate about the property. Yes, exactly the point so thin, so ADCs. Well, we have been able to accomplish this -- so how is going to be bid by that? And also how to control the solubility. And with our very stable ADCs and those discharge drug works for the betterment -- and as for the detail property, our apologies not being able to explain in this detail. But for us to overcome this, and this is the IOCs.

[interpreted] next question is from Toni Lanari.

Okay. Perfect. My first question is about the CMO compensation. That's probably to either Kodama, the CMA CMO compensation fee, you guys booked this year, JPY 169.5 billion, roughly about a little over USD 1 billion. This is really very large. We -- I happen to cover several CDMOs myself, including ones that are specializing antibody-drug conjugates. They said, my contacts in the industry tell me that this basically is equivalent to canceling contracts on drug sales of roughly about JPY 850 billion or roughly about USD 5.4 billion. So I just want to understand why are we looking at such large compensation, especially given what Lonza said last Friday, right, last pay during their first quarter briefing, they said that they do not expect much cancellation fee this year, so that's my first question.

[interpreted] Thank you, thank you for your question. FY 2025 results, we booked the provision for CMO compensation fees. And you are asking a question about the size of this amount. On Friday last week, we explained, so I may be repeating myself. Regarding CMO compensation fee and the provision for that initially, according to initial expectations, we had a demand forecast. And we can deliver the products to all patients. And we thought that was the size needed to deliver the products to all patients. So that's why we concluded the contract. In order to achieve our targets and goals, sufficient amount and high-quality CMO lines must be secured, so long-term commitments. -- and contract was signed with long-term commitments. For example, the results of the past clinical studies and future forecast, including risk adjustment, all the studies may not be successful. So we factored in such a reality in the supply plan and variances are occurring. So that's the factor behind. Therefore, regarding the size of the amount, you talked about it. Allow me to refrain from talking about the details here, but our demand of plan, we expected before, and the current estimate have differences and variants. So I hope you understand our situation.

Okay. I understand very well. My second question is either to Abe or John. This is about your sRNA platform. Can you tell us a little bit about your siRNA platform? Would it be hepatic delivery of sRNA, -- would it be extrahepatic, what type of molecular targets would you be looking for, looking at, what diseases or indications are you exploring?

[interpreted] Thank you very much for your question. siRNA and the research, I believe your question is related to that. And this time, what we have presented to you these are 1 of the 3 BGT candidate on Slide 66. So this is -- we have multiple for development and candidate. Today, we will not be able to tell you about the targeted disease. But other than oncology, we are going to -- we would like to fulfill this. And so hepatic or nonhepatic you have asked the question. So including hepatic and nonhepatic from targeting multiple organs. So SRNA, we would certainly like to deliver, and we have been engaging in a series of development, we have been able to advance this. So therefore, we have been able to identify multiple candidate compound. And we -- as we have been doing this when we conduct the Phase I trial. So we would like to explain to you once we get to that -- so sRNA, we are hoping and we have high expectation to fulfill this trajectory. I hope that answers to your question.

[interpreted] Mr. Wakao from JPMorgan Securities.

[interpreted] Wakao from JPMorgan Securities. I also have 2 questions. First, in order to achieve more than JPY 3 trillion in 2030, what is going to be needed. According to my understanding, Data lung cancer success is a prerequisite. Avanza K007-TL08, a and also 15 as well. Main is TL0708 and Avanzar studies, which 1, how many of these studies should be successful for you to achieve your goal? Avanzar may be successful, T0708 successful, that would be the best scenario. Avanza may not be successful. So alone may be successful. So which 1 should be successful for you to achieve this goal? And as of now, you don't have the data yet. It's going to be risk adjusted. But incorporating this means that you are very confident you feel confident. And any data we haven't seen yet, although you may have such data in the background Avanzar similar to 004. Are you seeing updates which are not published yet? And are you increasing confidence? Sorry for my long question. In addition, you want to build lung cancer leadership. That's a very high hurdle to clear because Merck drop 2 is 1 competitor, Pfizer has ADCs. But antibodies are being developed by several companies. So -- why -- you're confident about TROP2 antibody. I want to know, based on the competitive landscape. That's my first question to you. .

[interpreted] So broad question, the topic, Ken and John are going to respond, Ken first, please.

Thank you very much for the question. So I'll put my answer in context to what our CEO, Okasa showed earlier. We've got over 20 pivotal trials that are going to read out over the next few years. And that provides us with many, many shots on goals to help patients and to hit that $3 trillion target. When we specifically look at Data -- it's important to remember that Vans AR is just 1 of 4 first-line non-small cell lung cancer trials. So IVANS will be the first 1 to read out -- but then we've got TLO 7, as you mentioned, TLO 8 and until 10. And so when we look at the first-line opportunity, which is very, very large. It's 1 of the largest in all of oncology, very high unmet need. We've got at least 4 opportunities to help these patients -- so delivering on our target, it's not contingent on any single study. AVanzAr could fail. These others could work, and we will be very confident in our ability to deliver on this forecast.

Just to add on to Ken's comments regarding the advancements that we've made in the lung space. We've made a lot of and gained a lot of understanding from the previous studies that we've conducted and we've been able to use the results of those studies to be able to design the further upcoming studies. So for example, from TROPION Lung 001, what we saw was that in the non-squamous population, we had a doubling of the overall response rate for that specific population and even further, what we were able to do is demonstrate prolonged duration of response and have meaningful response meaningful improvement in progression-free survival. We were able to incorporate those learnings for the AVANZAR study and also based on that, what we were able to do was to advance further and to incorporate the biomarker, which is the TROP2 biomarker. This gives us the confidence from a Vans AR. Now obviously, these are hypotheses, and this is what experiments do is to be able to test these hypotheses based on knowledge that we have. think 1 of the insights that you asked was do we have any additional insights based on our confidence we've not seen any further data. We have no further data because what we have is we share all the information that we have with you. But we are confident based on what we know, and these are the reasons why we test these experiments. And as Ken said, we have a number of first-line studies that will allow us to test these experiments to hopefully get positive readouts, 402 update data not available for you, and you haven't seen it yet understood.

[interpreted] So for the second point, I would like you to tell us about the 5-year ahead over time and our visibility there and perhaps relating to JPMorgan's, so then there is a bottom for 2027. Is my understanding correct? So 2027. or I believe for the full year impact, 2028. So I believe that 2027 does not necessarily be the bottom. So 2027 would be the bottom. Is my understanding correct? And if not 2027 and 2028, if it is going to be impacting the profit, do you have any plan B or any other options to support that?

[interpreted] Thank you very much for your questions. So I know the Bakken January conference, I did talk about that. I know that that's a them reasons why come to this question. So this 2027, it is very challenging. We are very much aware of that in terms of our forecast. So to that end, so ENHERTU, a milestone, so no further sales milestones for ENHERTU. That will give us a will be impacted tremendously and also milestones close to JPY 100 billion. So that would straightforwardly impacting the bottom line. So, so against the backdrop for OP slightly declined. This is for 2027 for core and also divestment of Sankyo Healthcare. So conversely, this will be recognized in 2027 as a profit. So by looking at this operating profit, so conversely, core OP drops, and we'll be able to supplement for the losses. As we have put it, the Lixiana LOE, so in '28 or '29, we are going to be impacted by that. Having said that, there are variabilities of the impact levels based on which region -- it may be so 267 by Europe by each respective countries LOE impact of Lixiana LOE may be impacted. Conversely, in Japan, there's a prolongment of the patent duration. So the impact in Japan in 2029 or after 2029, so including ASCA region, Lixiana LOE impact, so there are differences amongst the regions that also need to be factored in. And that is going to be impacting us steadily and as our CEO have explained. So when it comes to our operational excellence, this is the old company effort for the past 5 years. So in this 5 years, we are going to put that at our forefront. And as the positive impact will be garnered toward the end of the 5-year plan. So therefore, after 2027, and '28 and '29, we can steadily recover the profits. And then we'll be able to make it very, very understandable. So if that's the case, and so 2028, you do not have any plans to sell off other assets.

[interpreted] next, Matsubara from Nomura Securities, please.

[interpreted] Matsubara from Nomura Securities. My first question is about the cost reduction. JPY 200 billion in the 5 years, every year, it's going to be larger according to the earlier comment. Until you can achieve this, it will take time. What about the probability of achieving this goal.

[interpreted]Thank you for your question. We think there is sufficient possibility that we can achieve this goal. -- and achieve the results from FY '26, we had a global reorganization. One of the keys is the business transformation organization function, which is newly established. This is an organization directly under myself, CEO. There are 2 major missions. First, from last fiscal year, in Europe, U.S. and Japan, by one, Global One instance ERP is launched 1 of another in these regions. ERP platform would be leveraged. And globally, highly reliable data can be obtained from our data. So such as procurement, can handle what could not be done before optimization of procurement purchasing globally can be implemented. And another thing is the leveraging AI and there is a progress day by day. In AI, it's evolving and advancing. We have to capture this from the current fiscal year, we have a global project we are newly launching which you are planning to promote from now -- we are going to start this from the current fiscal year. So this is a new initiative and allocation of human resources to enhance efficiency in our work is important and the capacity, which is free, can be allocated to more advanced work resources can be considered together with human resources to optimize the head count as well. The 5-year business plan, we want to achieve a big growth. And regarding the tenant demand in the ntheadcount plan, the human resources just increased red over time. But by leveraging AI effectively, headcount-wise. The quality of the work and the productivity of the work to be done by each person from both perspectives, we can make a dramatic change. So this is a new project. We try to achieve great results. So we have these 2 pillars to implement business transformation with high accuracy.

[interpreted] So the second part of my question is for our strategy for sales. So what you have made a comment earlier about this 5 AGCs. And beyond that, it is going to be in in-house sales any take on the situation, please?

[interpreted] So thank you for your question. So this time therapeutic area. So we have the oncology conventionally and also specialty. So we have 2 pillars. We have categorized them into 2 pillars, and we have been designing our sales team as well. And in the fifth midterm, so in U.S. and Europe to oncology team, we wanted to encompass those areas and thereby reinforcing our oncology unit. Accordingly, on the other hand. So Renal Discovery research team, not dedicated to this oncology alone. So therefore, in the 6 midterm. So some specialty to contribute to the business. We do not foresee that. In the seventh midterm, we can for , and there's a potential for that in-house. So therefore, we have abandoned asset for oncology development and also the early-stage specialty assets. that resides in the 5 years for the 6 midterm. So we would like to have an incorporate into portfolio manage. So therefore, oncology and specialists as a sales team activity rolled out, respectively, but rather under the auspices of 1 Chief Commercial Officer to oversee the activities across the board. Oncology or non-oncology and the values of the assets can be identify side to optimize the portfolio. So this is what we like to consolidate this sales activities. And as we have put it beyond that point, the commercialization from our in-house that is certainly in the scope.

[interpreted] Others are still raising hands but we are running over. So with this, we want to close Daiichi Sankyo's FY 2025 financial results and 5-year business plan presentation and discussions. If you have further questions, please contact our IR team members. After this, from 10 minutes past 8, we will have Q&A of members of the media. Thank you very much for joining today.

[interpreted] Q&A session for members of the media. I'm delighted to serve as MC for this Q&A. I'm Ogawa from Corporate Communication. [Operator Instructions].

Can you hear me?

Yes, we can hear you.

I'm Yasukawa from Nikoyohim newspaper. I have a question to CFO, Kodama-san. Regarding the financial forecast, operating profit and core operating profit are expected to grow both. Cost increase such as raw materials and distribution costs and personnel costs impact are already incorporated in here.

[interpreted] Thank you for your question. In FY 2026 forecast, cost increase impact is incorporated is the question. Recently, material costs are rising. And distribution costs including the geopolitical risks these days are part of the question according to my understanding. Right now, what could be possible as of now, and regarding such cost increases, we are incorporating them to a certain degree. But compared to other industries, such an impact would be relatively smaller compared to other industries.

[interpreted] Compared with other industries have less impact and my apologies for the follow-up question. So in that, what would be the biggest impact? So whether the energy costs and the personnel cost and the logistics cost, among others.

[interpreted] Thank you for your question. So when it comes to the overseas operation, now it starts to expand all the more and personnel costs and inflation costs. And also when it comes to the activities, those costs related to the operation globally have risen.

[indiscernible]. I have a question to Mr. Okuzawa, CEO. Looking at the stock price is now declining. What's your view, honestly, regarding the stock price level. And do you have any measures you're going to take to raise the stock price?

[interpreted] Thank you for the question. How to think about the stock price was a very a straight question from you. Of course, we are not satisfied with the current level of the share price. And our corporate value, we'd like to recover the stock price in line with the inherent corporate value. So to that end, the 6th 5-year business plan was presented today to you. We have 2030 financial KPIs, top line, bottom line, specific targets and earnings per share and shareholder returns were explained and potential is going to go up in the form of share price. Why we think so, -- such a rationale is also being shown with this 5-year 6, 5-year business plan. So we will execute the 6, 5-year business plan to the full to increase the stock price. That's our determination.

[interpreted] So second part of the question, so this may -- this relate to the dividend and payout and the shareholder return. So DOE, adjusted DOE that you have put together. So as for the share buyback and the policy in the 6 5-year business plan, what is your policy going forward?

[interpreted] So with regards to this shareholder return and as a mode of the fundamentals, so we are going to have progressive dividend and being on that level. So adjusted DOE with a target of 10% annually or more. So this is a progressive dividend. So to the shareholders and the investors. So in 5 years' time, the dividend, so JPY 100 serving as a basis for 2026 will stably risen. And I would hope that you can expect that stably. As for the shareholder buyback -- share buyback, so that was also indicated in the fifth business plan. But -- and I would think that such flexible buyback will be considered at any given time. So as a policy of the shareholder return, so we are going to have this progressive dividend and DOE 10% adjusted DOE 10% or higher annually. So we would like to commit to this.

[interpreted] Next Kikuchi-san, please.

[interpreted] Biotech. Can you hear me?

Yes, we can hear you.

This is maybe a question to Okuzawa-san or John Tsai. The philosophy behind BGT, I'd like to know, sorry for the lack of my knowledge. Today, you talked about BGT candidates broadly. And there were a question from the analyst earlier. Until they become after products, it may take a long time according to the question. Any technologies or technological points which can be worth being mentioned as GPT, BGT and how much profit they can generate potentially? Any view from you?

[interpreted]Thank you for the question. First of all, to contribute to business during the 5-year business plan and beyond 2030, there's going to be a business contribution. Abe san, anything to add?

[interpreted] Thank you for your question. Regarding BGTs, we have 6 technologies, and we can get these are patentable and there can be a high impact on treatment. So these are new drug discovery technologies. Towards 2035, we try to realize the launch of these, and we will promote our R&D activities.

[interpreted] I want to response, but there are any additional questions from you?

[interpreted] For example, you had ADC strategy. Is this linked to the conventional ADC technologies or siRNA? Is this something to pave the way for different areas?

[interpreted] Please turn to Page 65. These are the new BGT candidates based on ADCs. And the cytotoxic -- novel cytotoxic payload, as you may know, we are leading the T1 inhibitor isomerase inhibitor as a top innovator such ADCs in the clinical stage had drug resistance and the next drugs are needed because of the resistance. We are anticipating that early on in research, we need a mechanism -- new mechanism of action to overcome the ADC resistance. So the novel cytotoxic payloads can be very innovative, and we can propose innovative ADCs. So T1 ADC been developed and a similar impact can be expected in this technological development IO ADC field is not turned into product yet by anyone yet. As there was a question, our proprietary IO ADC R&D is now underway and novel IO payload ADCs are being researched. ADCs area has been built by us. Using such insights, we try to -- we are engaging in new technology development. That's ADC approach so that we can be top 10 and top 5 oncology company to generate new innovative drugs. So that's why we are showing this. On the next page, non-ADC candidates are shown on this page, as you can see, multi-specific antibodies and other companies are also interested in TPD molecules. This is leveraging our strength in drug discovery. We have multiple development candidates and siRNA in non-oncology fields, we are going to pave the way as well. By focusing on these 6 company like us in terms of the size, you cannot do all different types of research. So we try to focus on these in our R&D activities. Over the past 5 years, we had to stop technology development for some, but now we are beginning to focus on these 6. Did that answer your question?

[interpreted] So next question, Mr. Asahi.

[interpreted] I am Izawa from Asahi. So first -- so in the U.S., so tariff impact, I would like to understand about U.S. tariff impact. What was the size of the impact? And also for this and impacted by the drug price, MFN, so most favorite nation, so how much impact are given? And also in the Japanese market, so in May, there is a concern raised that the innovative drug may not make inroads to the Japanese market. So what is your take on the situation? Do you have any visibility on that?

[interpreted] Thank you for your question. So first, for the tariff impact, so almost hardly no impact is how I would like you to understand what we mean by that for the past year as well in the 6 midterm. So we did not have any particular impact that has not been incorporated into our plan. So back in April, so this is the presidential order in April. And also amongst the couple of the pharmaceutical drug category, and they're going to waive the tariff on those and among which was ADC, so our development, our core mainstay. So for now, the U.S. tariffs are threat or impact at this point in time, we have not -- do not need to incorporate into the plan. Having said that, when it comes to the U.S. tariff, the presidential order that came, so for productivity to have the production back to the U.S. So with that tone, with the executive order that came published in April, so there may be incentives that was -- have been depicted in various areas in the executive order. ADC was not in scope for that. So that is good. But we should not be complacent and we should not feel too optimistic. So we are going to continue to pay close attention to the policy. And for MFN, so for this has to do with the U.S. administration, and they have set forth a series of the policies. And to a certain level, we have factored into our plan when we formulated the sixth midterm. And the impact given to the Japanese market, we started to hear quite often about that. So we are one of the corporations having the global traction. So the impact -- and what kind of impact that may give to Japan and other parts of the world, we are certainly going to pay close attention to the situation. We are originated from Japan, and we have a domestic leading company in Japan. We have always been so. And the medical community, and we have been working closely to the ministry, the regulatory affairs authorities and for the betterment of the patients. So we will certainly continue to provide the treatment to the patients.

[interpreted] In the 5-year business plan, you incorporated the potential impact of MFN to a certain degree. If possible, in what way are you incorporating this element in the new plan?

[interpreted] MFN question on to the 5-year business plan for the specifics, allow us to refrain from disclosing the details.

[interpreted] next question is Sara from Endpoint News.

[interpreted] I'm not sure who would be best to answer it, but it's basically about your target to deliver more than JPY 2.3 trillion in oncology revenue by 2030. I was wondering if you could provide a rough breakdown of how much of this figure you expect to come from breast cancer, how much from lung cancer and how much from sort of other oncology indications, just so I can get a sense of the ratios there.

Thank you for the question. This is Ken Keller. So when we look at our revenue going forward to deliver that JPY 2.3 trillion -- as we mentioned earlier, today, with ENHERTU and DATROWAY, Daiichi Sankyo is one of the leading companies in breast cancer. And when we look at the over 20 key pivotal trials that will read out over the next few years, many of those add to our strength in breast cancer. When we look at 2026, we actually expect ENHERTU to move into the early-stage breast cancer setting where cure is the goal. And we've got 2 trials that have already demonstrated standard of care changing data, DESTINY-Breast11 and DESTINY-Breast05. And I'm confident that this drug will become the standard of care. And hopefully, over time, we can prove that we're curing more women with breast cancer. And then to add to that, with a number of our drugs like I-DXd that John mentioned earlier and with all the different lung cancer trials that we have with DATROWAY, we're going to add to our strength and become a leader in the lung cancer setting as well. Your specific question is about what percent. Today, the majority of our oncology sales are in breast cancer. And given on the strength of our emerging data, I feel it's going to stay that way for at least the next couple of years. And then in the back half of the 6 midterm plan, we're going to see tremendous growth in lung cancer. So I hope that answered your question.

[interpreted] others who are still raising their hands, but we are running over. With this, we would like to close the Q&A session for members of the media. If you have questions, please contact the corporate communications team at the company. Thank you very much for joining us today. [Portions of this transcript that are marked [interpreted] were spoken by an interpreter present on the live call.]