Daiichi Sankyo Co Ltd Ord

Thank you for waiting. We are going to start Daichi Sankyo's FI2025 financial results announcement and FI2026 FI2035 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. Please click the interpretation icon at the bottom of your Zoom screen and choose Japanese, English or the original audio. If you choose the original audio, you can listen to the original sound. On 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 and the IR library Financial Results Presentation Material or IR Presentation Material section. Please download the files if necessary. Today, five members are in attendance. Representative Director, President and CEO, Hiroyuki Okuzawa, Senior Executive Officer, CFO, Tomohiro Kodama, Director, Head of Oncology Business Unit, Ken Keda, Head of Global R&D, John Tsai, and Senior Executive Officer, Head of R&D Division, Yuki Abe. Today, after FY2025 financial results announcement, we will present FY2026 to FY2030 five-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 Ten minutes past eight. Please note that this meeting is being recorded. Thank you for your understanding. We are starting FI 2025 financial results announcement. Okuzawa-san, please. Okuzawa speaking. Thank you very much for joining Daiichi Sankyo's FI 2025 financial results announcement and five-year business plan presentation and discussion out of a very busy schedule today. First, we'd like to sincerely apologize for rescheduling the date of FA2025 financial results announcement and five-year business plan presentation and causing you inconvenience and concern. Due to the financial results forecast revision we explained the other day, We thought that explaining FI 2025 financial results and five-year business plan together would be the best way to help you understand the current situation of a company and a future strategy properly, so we decided to reschedule the dates. Today, we will explain FI 2025 consolidated results first, and then the five-year business plan. We will entertain your questions at the end, after the two presentations. Now, our new CFO, Kodama, will explain FY2025 consolidated results. Kodama-san, please. Kodama speaking. Please turn to page 5.

Kodama speaking.

These are the topics we are going to cover today. R&D 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 FI 2025 consolidated results. Revenue increased by 236.8 billion yen or 12.6% year-on-year to reach 2,123,000,000 yen. Cost of sales increased by 25.6 billion yen from the previous year. It generated expenses rose by 134.8 billion yen. and earned expenditure increased by 29.3 billion yen year-on-year. As a result, cooperating profit increased by 47.1 billion yen, or 15.1% year-on-year, to reach 360 billion yen. Operating profit, including temporary gains and losses, decreased by 102.8 billion yen, or 31% year-on-year, to 229.1 billion yen. Profit attributable to owners of the company decreased by 35.9 billion yen or 12.1% year-on-year to reach 259.9 billion yen. You can find the actual currency rates on the slide. Please start to page 8. From here, let me explain positive and negative factors for revenue compared to the previous year. Revenue increased by 236.8 billion yen year-on-year. I will explain its breakdown by business unit. First, Japan business unit. Sales increased for anti-cancer agent , direct oral or rather pain treatment , direct oral anticoagulant , etc. On the other hand, revenue decreased for influenza treatment , in addition We booked realized gains on unrealized gains of inventory for Daichi Sankyo EFTA in EFTA 2024, so Japan business revenue increased by 3.2 billion yen in total. Next, let me explain our overseas business units. Here, work's impact is excluded. In oncology business, revenue increased by 152.2 billion yen, due to the growth of Enhert and Datorre sales. As for American Regent, revenue declined by 32.8 billion yen due to the impact of generic entry on iron deficiency anemia treatment and Venofar, and the impact of price competition on Injectafar and generic injectables. Revenue for EU specialty business increased by 21.7 billion yen as sales grew for hypercholesterolemia treatment Nidamdo Mustendi. In Asuka business responsible for Asia's South and Central American regions, revenue rose by 38.1 billion yen due to the growth of Enherd mainly in China and Brazil. As for upfront payment and regulatory and sales milestone, etc. related to alliance with AstraZeneca and U.S. Merck, we looked at revenue, sales milestones, etc. we received from AstraZeneca in the fourth quarter, so revenue increased by 32.5 billion yen. Forex impact increased the revenue by 21.8 billion yen in total.

Slide 9 shows the factors behind the change in core operating profit. I will explain the 47.1 billion yen increase by item. As explained earlier, revenue increased by 236.8 billion yen, including a positive foreign exchange impact of 21.8 billion yen. Next, I will explain cost of sales and expenses excluding foreign exchange impact. Cost of sales increased by ¥19.9 billion primarily due to the revenue growth and inventory valuation losses recorded in the second quarter for products including NHER2. Selling general and administrative expenses increased by 133.3 billion yen due to an increase in profit sharing with AstraZeneca, as well as investments in DX 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 29.4 billion yen due mainly to increased R&D investments associated with the progress of development of the five DXC ADCs. The negative impact of foreign exchange totaled 7.1 billion yen, and the underlying increase in core operating profit excluding foreign exchange effects was 32.4 billion yen. Next, I will explain the changes in profit for the period on slide 10. Core operating profit increased by 47.1 billion yen, 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 one-time income. In the current fiscal year, Although there were litigation-related gains associated with former Rambaxi shareholders and gains from the liquidation of Ambit, which has been acquired as a subsidiary upon the in-licensing of Queen's Antinous, a profit decreased slightly year-on-year due to the absence of gain recorded in the previous fiscal year. For one-time expenses, a negative impact of 149.9 billion yen 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 Odawa plant, environmental remediation costs for 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 FY2035 decreased by ¥103.8 billion year-on-year on ¥229.1 billion. Finance income and expenses had a positive profit impact of ¥10.9 billion, mainly due to improvements in foreign exchange gains and losses. Income taxes decreased by ¥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 35.9 billion yen year-on-year to 259.9 billion yen. 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 four-year dividend forecast previously announced, with the annual dividend per share expected to increase by 18 yen year-on-year to 78 yen. 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 200 billion yen share repurchase authorization in April last year and ultimately repurchased 91.8 billion yen worth of shares. All shares acquired through this repurchase program will be cancelled on June 10th. Next, I will provide a business update. Please turn to slide 14. This slide shows the sales performance of NHER2. Global product sales and FI-2025 increased by 145.5 billion yen year-on-year to 698.4 billion yen. Combined revenue recognized by Daisan Kyo and AstraZeneca outside Japan reached 5 billion dollars. triggering a sales milestone payment of $537.5 million, and we received 86 billion yen. 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 number one share of new patients, starts in major countries and regions, and cells continue to grow steadily. Global product sales for FY2026. are forecast to increase by 162.9 billion yen year-on-year to 861.3 billion yen. In addition to product sales, we expect to receive a sales milestone payment of $625 million upon combined revenue recognized by Daisankyo 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 self-performance of natural wave. Please turn to slide 15. Global product sales in FY2025 increased by 46.2 billion yen year-on-year to 47.6 billion yen. In addition to the steady market penetration of the breast cancer indication in Japan and the United States, the rapid market penetration of the lung cancer indication 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 1.6 times higher than at the end of the previous 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 the R&D update. The presentation will now be handed over to Ajahn Sy, Global Head of R&D.

Thanks, Kadamasan. My name is Ajahn Sy, 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 five 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 into the slide here. Let's go on the current slide here. So, in HER2-demonstrated robust data in breast cancer in HER2-positive and HER2-ultralow 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 DV11 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-neonadjuvant setting from DB05, we saw clinically meaningful improvement in invasive disease-free survival versus TDM1 in high-risk HER2 breast cancer in the post-neonadjuvant setting. This indication is currently under review in the US, 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 DESTINY 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 INHER2-DB11 in the neoadjuvant setting. As we said earlier, this was already approved in China. What we saw from DB11 is that four cycles of INHER2 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 INHER2. 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 were waiting for results. The post-nea adjuvant, DB05, has been accepted in the U.S., Japan, and EU. We also received two additional approvals in Japan, HER2-positive gastric cancer and the PAN tumor HER2-positive approval in Japan. Lastly, in the IHC3-plus tumor in the HER2-positive patient population, DB05, 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 we'll turn into looking at Datchaway and the progress that was made there. Datchaway 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 Datchaway was obtained for EGFR-mutated patients from the Trope 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 non-squamous patient population, more than the squamous. And importantly, what we also saw was the value of the TROP2 biomarker. Based on the results that we found from Tropion01, We've updated tropion lung 05 to add the tropion to trope 2 biomarker NMR positive to the primary endpoint for progression-free survival and overall survival. In addition to this, we also added the trope 2 NMR biomarker to tropion lung 08, and that was in PD-L1 high positive patients. We added this to the secondary endpoint for PFS and OS. Also in the lung space, we started tropion lung 17 in the trope 2 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 tropion breast 02 in first-line triple negative breast cancer. These are in 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 Datchaway, we expanded into other tumor types. You can see that we expanded into urethelial carcinoma in the Phase 2-3 trial, which is urethelial 03. This was started in October, where we will see Datchaway plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin. There was significant progress, as you can see here, made with Datchaway. As we look into the additional VXD 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 IDXD where we saw robust data from the ID8 lung 01 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 three studies that were started in May and June of last year. For the area of RDXD, there was positive results presented at ESMO last year from the Rejoice Ovarian 01 study. This was a phase two dose optimization study for platinum-resistant patients. who had CDH6 expression, and we were granted breakthrough designation for this specific indication. Lastly, for the DXP platform, we also started the first in human study for DS3790. This was first in human start for the indication of relapsed and refractory B-cell lymphoma. Looking beyond the DXD-ADC platform, we have new modalities in oncology, and we started a number of new firsts in human studies. For DX3610, this is an ADC with sting agonist as the payload. This was started in November of last year. For DS5361, 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, DS9051. 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 IDXT as we are seeking our first approval for IDXT based on the results of ID8-0-2 study in 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. Go to the next slide, please. Beyond oncology, we continue to make progress. There's new programs in the immunology space with a plan first in human start in the first half of this year for DS2001, an anti-ORA1 antibody for autoimmune disease. ORA1 is a major poor-forming subunit of crack 1 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 in 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 two of them here. Daiya Kairona won the 2026 Pharmaceutical Society of Japan Award This was based on the first made-in-Japan mRNA vaccine for COVID-19. In addition, Valmatastat, or Ezeharmia, received the 2025 Pharmaceutical Chemistry Division Award, and this was based on the first dual inhibitor of EZH1 and 2, and provides a new treatment option for all of those patients with a high unmet need with adult T-cell lymphoma. Let's go to 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, Destiny 05, in the post-neonadjuvant HER2-positive breast cancer area, we're expecting the regulatory decision in July of this year. For Datchaway TMVC first line, we're expecting that to do for date in June of 2026. And for IDXT 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 beta readouts this year. We're looking forward to in HER2 DESTINY lung 04 study in the first half of 2026. And in the first half of this year, we expect to get the results of tropion lung 07, tropia lung 15, and Avanzar. These are all in the first-line patient population. We also expect to get results from RDXT, where we have regulatory submission. and we are evaluating the submission of Rejoice01. While we saw positive results, we're awaiting the expansion of the Phase 2 data in order for the full submission. With that, you can also see some of the presentations that we will be sharing at ASCO 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.

From here on, Kodama will explain FY2026 forecast based on the page 27. 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 FY2027 at Taichi Sankyo Group in anticipation of the impacts of this adoption. The definition of core operating profit is to be changed starting in FY2026 when the sixth five-year business plan begins. You can find the table below to compare the previous definition and the new definition. CMO compensation fees and write-down of inventories, which were recorded as temporary expenses in FY2025, are included in core operating profit under the new definition. Regarding the impact on FY2025 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 FI2026 forecast. Changing the definition of core operating profit, which I explained earlier, is reflected onto FI2025 results and FI2026 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 increase due to market penetration of Enhart and Datoray, especially in the United States. So we are forecasting revenue to increase by 7.4%, 157 billion yen, and are able to reach 2,280,000,000 yen. Cost of sales are increasing due to revenue expansion. But cost ratio is improving due to changes in our product mix. and CMO compensation fees are declining, so we are expecting cost of sales to decrease by 80.3 billion yen. CMO compensation fees of 80 billion yen we are recording as cost of sales for FY2026 is the current estimate, expected to additionally arise by the end of FY2026 due to short-term differences between a supply plan and the minimum purchase obligations to CMOs. Specifically, this will be for 2028 to be included in FY2026 as the new firm order period. With regards to co-operating profit, expenses are expected to rise due to sales expansion of Enhard and Atterway, which will likely lead to increased profit share payment to AstraZeneca. On the other hand, gross profit increase is projected. so we are forecasting co-operating profit to increase by 27.5% to 77.6 billion yen to reach 360 billion yen. Due to changing the definition of co-operating profit, amortization expenses of intangible assets related to products will be classified as non-core expenses. In addition, we are expecting EU specialty business unit restructuring expenses, but non-core expenses are going to decline year-on-year, so operating profit will go up by 37.5%. or 85.9 billion yen to reach 315 billion yen, according to a forecast. Pre-tax profit is expected to rise, but corporate tax will increase. And due to the stock transfer of DAI's essential healthcare, profit attributable to non-controlling interests is expected. So, we are forecasting profit attributable to owners of the company to be 260 billion yen at a level similar to the previous year. Our forecast assumptions are 150 yen against the US dollar and 180 yen against the euro. Please stand through page 29. Here, let me explain FR2026 annual dividend forecast. Under the 6th 5-year business plan, stable dividend forecast, 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 ¥100 per share up by ¥23 22 yen from 78 yen in FY2025 is found in FY2026, marking the fifth consecutive year of dividend increases. Towards further growth under the 65-year business plan, we will continue to enhance shareholder return. That's all for the results. Next, we are moving on to the Six five-year business plan presentation and discussion. Observe them, please. Let me explain the six five-year business plan. Please turn to page 46. First recap of the fifth five-year business plan. Under the fifth five-year business plan, we raised, maximized three ADCs, profit growth for current business and products, identify and build pillars for further growth, and create shared value with stakeholders of four strategic peers, 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 a summary for maximizing three ADCs. The oncology business achieved significant growth driven by NHERT and data rates. 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. NHERD transformed standard of care in HER2-positive breast cancer and has established HER2-low and ultra-low breast cancer as a new therapeutic area. DATRAWAY provided new treatment options to patients with limited treatment options. and also updated LAMP cancer strategies by implementing novel biomarker based on learnings from Tropion LAMP-01 study. As for the subsequent three ADC products, we revised the timing to launch HER3-DXD, but we are accelerating iDXD and RDXD development through our collaboration with USMARC. ROSE is making progress for the DXD-ADC portfolio as a whole. Regarding manufacturing and supply, we revised the supply plan and optimized the global supply chain. In addition, we resolved patent dispute with Seagen Inc., confirming DFDABC as Daichi Sankyo's proprietary technology. Please turn to page 48. Next, I will recap the progress for three strategic pillars and business foundations. In the current business, specialty medicine such as Vixiana grew, while profit declined in the iron supplementation business by American regent. Also, we advanced transformation toward an innovative medicine business structure through the transfer of shares in Daichi Sankyo ESSA and Daichi 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 five-year business plan, and the final results as of March 2026. Over the last five years, oncology business grew substantially. FY2025's revenue was 2 trillion 123 billion yen, and revenue in oncology was 954 billion yen. 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 FY2024, above the target, but was 15.8% in FY25, as CMO confidential fees were recorded. GOE 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 cooperating 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 sixth five-year business plan between FY2026 and FY2030.

Next, we will explain the sixth midterm business plan. Please turn to slide 51. We have set forth our 2035 vision as becoming a trusted healthcare 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 of our sixth midterm management plan We aim to become an advanced global healthcare company that contributes to the sustainable development of society. The sixth midterm business plan covering FY2026 through FY2030 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 toward the realization of our Vision 2035, a trusted healthcare innovator. By 2035, we aim to become a global top-five company in the oncology field, with the new BGTs following DXDABC's 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 quantitative targets for FI 2030. We're targeting revenue of more than 3 trillion yen, operating profit of more than 600 billion yen, and EPS of more than 260 yen. During the period of the sixth 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 sixth midterm business plan and its quantitative targets. The first strategy is to be a global top five oncology company by 2035, leveraging the strength over DXC ADCs. We aim to become a global top five 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 a 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 DXDAVCs 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 two 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 toward 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 benefits. with conventional treatment, and by delivering high-value information to healthcare 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 healthcare innovator. Please turn to slide 56. Through strategic collaborations with AstraZeneca and Merck in the United States, our oncology business has achieved significant growth. Through obtaining more than 10 indications for oncology products such as N-HER2 and Deltralase across more than 95 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 954 billion yen in FY2025. Under our growth strategy, Inher2 and Dr. Ray will continue to drive revenue growth over the next five years, with the aim of achieving oncology revenue of more than 2.3 trillion yen 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 three pillars, RDE excellence to support development activities, business excellence to drive commercialization, and an optimized global supply chain. First, under RD 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 five years and will 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 over expanded ADC portfolio, enable the rapid launch of BGP 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 RD excellence. Please turn to slide 59. In order to build development capabilities at the level of a global top-flag oncology company, improving development speed is essential. Within HER2, the period from first in-human clinical entry to initial approval was achieved in four years and three months, representing one of the fastest approval timelines ever achieved globally. To replicate the highly competitive approval speed achieved with NHAR2 for our subsequent in-house pipeline asset, we will shorten the timeline from non-clinical 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 and 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 DXDA-DC products. More than 20 pivotal studies or data readouts are expected over the next five 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, and we need to realize rapid market penetration for products. Throughout the product lifecycle, we will develop pricing and reimbursement strategies 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 five years. We are assuming that $2 to $6 billion total peak sales potential readouts will continue every year for the next five years.

From 2026 to 2027,

FY 2030, this is going to occur every year to contribute to the self-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 NHERT and DATRAWAY, we have established a leadership position in breast cancer. For 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 N-HEART and dactyrate. Especially for dactyrate, 10 phase 3 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 DFDAGC business is growing substantially with peak sales potential of 3 trillion yen or more. We will not only invest in the five DHC ADCs where we are collaborating with our partners, but also invest actively in DS3939 and DS3790, etc. In early developments with blockbuster potential, we will aim to maximize the value of our ADC portfolio, including LCM strategies such as indication expansions. Furthermore, to realize sustainable growth, we will identify multiple next BGTs with potential to match that of TFT ADCs by the year 2030. With 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 next BGTs. Please turn to page 64. We define BGT based through generating technology as 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 will establish end-to-end integrated capabilities from research and development to manufacturing to accelerate delivery of new innovative medicines to patients. GFT-ADC is a good successful example. Clinically validated technologies are being leveraged in the next programs. By now, Enherd and Daturae are already launched, and five others are in development stage. Identifying the next BGT programs is going to be our target during the 6th 5-year business run. Please turn to page 65. On this page, I will talk about three modalities as ADC-based BGT candidates. First, ADC using cytotoxic payloads. As a leading top-1 inhibitor innovator, we will leverage our knowledge and clinical insights accumulated so far to develop next-generation cytotoxic payloads to overcome cancer with TXT-ADC resistance. We are planning to start phase 1 study for ADC with new payloads in FY2027. 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, ES3610 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 trucks through combinations with diverse ADC technologies we have. For this type of ADC, we are planning to start the first Phase 1 study in FY2027. Please turn to page 66. Here, I will talk about three non-ADC BJT 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, this one study is ongoing. We will 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 unjogable targets. This will accelerate TPD molecule creation with higher precision, by integrating a long-standing medicinal chemistry with AR drug discovery. As we mentioned in previous results announcement briefing sessions, DS9051 Phase 1 study is ongoing right now. Last but not the least, siRNA, as a culmination of years of research in nucleic acid therapeutics, we have leveraged decades of our nucleic acid expertise, such as research on Dicerona, By integrating novel chemical modification technologies with DDS technologies, we will create nucleic acid therapies targeting multiple organs. We plan to start phase 1 study for the first program by the end of FY2026. On page 67, I will introduce our programs in immuno-oncology. As is shown in the figure, we are broadly researching key mechanisms of cancer immunology. In each step, we are identifying promising assets. At present, many phase 1 studies are ongoing. By 2030, we are expecting clinical signals from 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 six five-year business plan up to FY2025, through DFT ADCs positioned as the first BGT, we achieved expansion of our business and presence in oncology. For DFT ADCs, also during the six five-year business plan period, multiple data results from large-scale clinical trials were expected, leading to education expansions. In addition, from the six BGT candidates I talked about today, as well as IO breakthrough assets. We will identify promising growth pillars for NGFT ADCs and aim to unlock greater business potential.

Please turn to page 69. This slide introduces the expansion of our drug discovery research platform that supports the continuous creation of BGT. through three 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 craftsmanship 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 three research institutes in Europe and the US, we plan to further strengthen our initiatives. Please turn to slide 70. Here, as examples of the outcomes over science and technology, we would like to introduce some of our licensed compounds currently being developed by other companies. These innovative assets are reaching clinical practice through licensing partnership. Talitholectinib. 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 demonstrates a strength over science and technology capabilities and 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, which serves as the business foundation supporting our two strategies, be a global top five oncology company, and identify next BGTs. Please turn to slide 71. In April, we established a new business transformation organization directly under the CEO. By implementing company-wide operational excellence initiatives over the next five years, we will optimize our cost structure and strengthen our profit-generating capabilities. As a specific initiative, we will expand the scope beyond routine tasks to include non-routine 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 conventional tasks, through these efficiency gains, we will formulate and execute HR strategies that combine capability transformation through re-skilling with optimal talent allocation, thereby advancing talent allocation from the company-wide optimization perspective. In addition, we will further reduce costs by optimizing 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 200 billion yen over the five years period of the sixth mid-term 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 a 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 medicine 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 organization 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 over 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 toward 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 gross investments and shareholder returns. During the period of the sixth midterm business plan, as gross investments, we will expand the oncology business while prioritizing our R&D and capital expenditures aimed at identifying new BGPs 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 five-year period is expected to total approximately 3.85 trillion yen, which together with proceeds from asset sales and financing activities will serve as the source of the funds. Of this amount, approximately 3.9 trillion yen will be allocated to R&D expenses while approximately 700 billion yen will be allocated to capital investments, primarily for strengthening the global ADC supply 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 27 yen in FY 2021 when the first midterm business plan began. and has increased to 78 yen in FY 2025 as we have continued to provide stable shareholder returns in line with profit growth. During the period of the sixth 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 FY2026, we plan to increase the annual dividend per share by ¥22 to ¥100. Next, I will discuss our quantitative target for FY2030 and the outlook toward FY2035. Please turn to slide 76. Looking toward FY2030, in addition to challenges such as the loss of exclusivity for Lexiana, The completion of NHER2 sales, milestone receipts, and declining revenue from the iron business. We will also face revenue reduction impacts from the transfer of Daishinkyo Healthcare beginning in FY2027. However, through the steady execution of the strategies outlined today in our six mid- business plan, along with maximizing the value of our DSC-ADC portfolio centered on HARTU and DACHO way, we expect continued revenue growth throughout the planned period and aim to achieve revenue of more than 3 trillion yen in FY2030. On the profit side, while multiple challenges will converge in FY2027, the transfer of diet-sensitive 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 DXDABC's portfolio, we will strengthen our earnings generating capabilities through operational excellence. As a result, we aim to significantly accelerate profit growth by 2030, targeting operating profit of more than 600 billion yen and EPS of more than 260 yen. 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 dividends and further enhance shareholder returns. R&D expenses are planned to increase gradually, and during the sixth midterm business plan period, we will invest approximately 2.9 trillion yen, an increase of about 1 trillion yen compared with the fifth 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 MSN. As for tariffs, We currently believe that their impact on business performance during the period of the six 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 venture too, while maximizing the value of DXC ADCs and driving business contributions from new BGPs, that follow DXC ADCs, thereby positioning ourselves to target operating profit on the scale of 1 trillion yen in the early 2030s. To achieve this, we will leverage the oncology expertise cultivated 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 a summary. Please turn to slide 77. So today, based on a review of the fifth midterm business plan, we explained the sixth midterm business plan aimed at realizing our vision 2035, which defines where we aspire to be in 10 years. The sixth midterm business plan is a critical plan that will enable us to move into the growth of the future global top five on Koji Company. We will view the rapidly changing business environment as an opportunity, and by combining the strengths we have built over time with new challenges. We will realize sustainable value creation and contribute to the development of sustainable society as we grow into an advanced global healthcare company. We look forward to your continued support and expectations for our future growth. This concludes my presentation.

From here on, we are moving on to a Q&A session for investors and analysts. You can ask questions either in Japanese or in English. If you have multiple questions, please ask one by one. Each person can ask up to two questions. Please mention first whom your question goes to. If you have questions, please press the raise hand button at the bottom of your screen. First, Mr. Yamaguchi from City Group Securities, please.

Can you hear me?

Yes, we can hear you. Thank you. Yamaguchi from Citigroup Securities. Thank you very much for the presentation. My first question is about the five-year business plan and also the FY2026 forecast. So it's in between the two. So maybe the question goes to Odama-san regarding CMO compensation fee. On Friday last week, there was a compensation in Japan. So you said that there can be a provision also for FY2026. You mentioned this is for 2028. So until when this will continue, that's something I'd like to know. It's not included in the five-year business plan figures. CMO compensation fees will continue until when, although the amount is going to decline over time. So, could you explain?

Thank you for your question.

So, I'd like to respond. Your question is about CMO compensation fees. In FY2026, 80 billion yen is included. How much or how long this is going to continue? So, you need some guidance on this. According to my understanding, regarding your contracts with CMOs, there are multiple contracts. Longer ones would be up to SIE 2030 or up to the mid-2030s. For specific data, I'd like to refrain from commenting in detail. So, as a range, you can check this kind of a duration. Regarding the amount and the size, as we communicated on Friday last week, over time, the various measures are going to turn effective. So this year, in FY2026, 80 billion is planned, and the amount is going to decline over time. In the five-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.

Okay, understood. And the second point, I'm going to focus on the natural waste. 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 that's the way I would assume that that is the biggest contribution. Aranza included how that's going to come into this assumption for this year and mid to long term. I would like to ask for your take on the situation. Thank you for your question. So that's your way. And the numbers? So for us, we do you have for the adjustment based on the adjustment of risk? So, including and 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 a function, 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 26 expectations and the six 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.

Thank you. Next question. Next question. USB securities. Mr. Seki, please. Seki from UBS. I thank you for the presentations. 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 are you going to use DOE with dividends? There's no signaling of undervalue for the stock price. If you add the figures, it's already 3.9 billion yen. Are you going to do factoring? That's my first question to you. Thank you for your question. Page 74. Regarding the dividends and shareholder return, you try to know our way of thinking and fundraising philosophy is also part of the question. Regarding shareholder return, acquisition of own shares and dividends, how are we going to do this? Using the two, for the time being, during these six, five year business plan, we try to ensure profit generation and we have commitments to this and we also need to have confidence from the profit. We try to pay dividends to return to shareholders. That's why we are doing this adjusted DOE. This time it's adjusted DOE from the fifth five-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 five-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 a business. Given that situation, 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 try to consider this possibility more actively. And also fundraising, you have calculated and you are right. If you add up the left and the right, the right-hand side is going to be bigger. So compared to, in addition to asset sales, we will also do this for fundraising. You mentioned suffering. We are not considering this possibility more specifically, but we try to study and research broadly. If there is an appropriate thing, we try to work on that as well. Thank you very much. My second question.

So on slide 76, I'd like to direct a question to Mr. Kodama. So you're going to accelerate this. So by R&D, 600 billion yen or so, as it is written here. So I would assume that SGA is going to be reduced tremendously and OP 600 billion yen will be achieved. Is my understanding correct? And if that's the case, So how would be the driver for this robustness of this acceleration? So now forecasting governance is in check, although you do not have the U.S. gap. 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 so uh to um deduct the expense for uh 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 toward the latter. And as for the expense, so for the business transformation, which we have talked about, the size of 200 billion yen to reduce that expense, I 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 that Thank you very much.

Next question. Mr. Hashiguchi from Daiwa Securities, please. Hashiguchi from Daiwa Securities.

Thank you very much.

My question goes to Mr. Okuzawa or somebody you think is appropriate. On page 63, DXT-ADC, potential will be 3 trillion or more next BGT with potential to match that of 50 ADC, anything you can say so will be identified by 2030. You plan to identify multiple BGTs by then. ENHEART entered the clinical studies, if my memory is correct, it was around 2015. And you have been able to say that it had this much potential at around the start of the 5-year business plan, like 2020. at the earliest point, or you might have took longer than that. It might have taken more than five years. If I calculate based on this, you talked about multiple BGT candidates today, but they haven't entered the clinical stage yet. If there is one in 2027, then the likelihood may be very low to reach that goal by 2030. Those already in the clinical stage must have very strong signals. Otherwise, they would not be able to have the potential to match that of ADHD ADC by 2030. It can be difficult. Is my understanding correct or wrong? If there's anything with such strong signals, I'd like to have some comments from you. Hashiguchi-san, thank you very much. In the six, five-year business plan, major strategic pillar is to identify multiple BJTs, as we mentioned. So, thank you for your question on this. Global Research Head of R&D, Abe is going to respond. Hatsuguchi-san, thank you for your question. As you said, the FDADCs, where I was involved in research since 2010. We started research from 2010, and in 2015, Seiki-man started. In 2019, approval was granted. So, we created the oncology business and such. Today, we presented on the six technologies. In the fifth five-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. My boss, Agatsuma, when he was still here, the FDAGC, successful expenses, our use of the basis, are to proceed with a BGK approach, so we are making good results based on that. The timing to contribute to our business in 2030, we don't think we can achieve it in 2030 yet. If I explain, by 2030, Hashibuchi-san mentioned strong signals. We are going to identify strong signals, and multiple VTTs will be identified. So that's the goal setting shown on the right. By 2030, we will identify these BGT candidates, and these groups of assets will enter into 2035 to flourish. So that's the timing. If the ADC business will grow, the new drug assets will generate new business. So that's the nature of the strategy. Did I answer your question? 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 Friday's briefing, so you have factored in such risks.

So that has been embedded into the plan.

And as for the sales, so PDFA is in scope for this.

And depending on the data that may be published, so where would be the focus for R&D? So I would assume that we need to be very flexible. So your midterm plan 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 600 billion or 2.9 trillion yen, how did these figures come out? So R&D cost management, so John would like to respond to that.

Thank you for your question regarding the spends on R&D. As Avishan outlined, we will have a number of identified VGTs 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 VGTs, 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 for the costs associated with moving these BGTs forward. Thank you.

Thank you very much.

That's all for me. Next question. B of A Securities. Manegano-san, please. Next, SMBC Nikko Securities. Wadasan, please. Sorry, next. Yes, Wadasan, please. I have a question on the five-year business plan. First of all, in FY2025, we're operating COVID before R&D, was below 40%. What's the reason why in the next five-year business plan, what would be the factors for you to achieve 40%? And also, for operating profit, you changed the focus. What's the reason behind? Kodama-san, please.

Thank you for your question.

First, FY2025 core operating profit ratio under 40%. And what are the factors behind? And number two, KPI for the fifth, sixth five-year business plan. What's the background for changing from operating profit to operating profit? First, FY2025 core operating profit ratio before R&D. below 40%. And why? What's your question? Cost of goods sold in the second quarter Enhat associated. A write-down of inventories were incurred as losses. And Echirona 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 six five-year business plan are the change of KPIs. Operating profit ratio before R&D target is 40%. In the fifth 5B business plan, by having this target, we 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 sixth 5B business plan, in our business, 5DXD ADCs, specifically Enhert, Datoray, and three products, we are working together with Mark, US mark, and the proportion of these products is getting larger. As you know, regarding the five products, profit share is a mechanism for collaboration, so in terms of the profit ratio, there are some difficulties. And secondly, in the end, profit for the time, and the operating profit, tools that go for various elements included, we have to secure profits. We should focus more on these. So, non-core items as well, we decided to look at them as the responsibility of the management team, so we decided to use the operating profit as an indicator or KPI.

Thank you. I would like to ask about the potential of BGT.

On page 65, on page 66, there was a summary. You have uniqueness here. IO payload, I think, is unique. Sting agonist is the topic of my question.

This is the reason why it is not a medicine. This is the reason why it is not a medicine.

So this legend, has that been overcome? So if you bind with the antibody, you will be able to maintain this?

So then there may be such fillability.

Improve the fillability of the compound. I would like to ask you to elaborate about the property. Yes, exactly the point. So STING, so ADCs, well, we have been able to accomplish this. So how it is going to be bind 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 policy is not being able to explain in this detail, but for us to overcome this. And this is the IOADC. Understood. Thank you very much.

Next question is from Tony Ren-san, Makkori. Please go ahead.

Hello. I think that's going to be.

Yes, we can hear you.

Okay, perfect. Thank you for taking my questions. My first question is about the CMO compensation. That's probably to either Okuzawa-san or Kodama-san. The CMO compensation fee you guys booked this year, 169.5 billion yen, roughly about a little over 1 billion U.S. dollars. This is really very large. We, you know, I happen to cover several CDMOs myself, including ones that specialize in antibody drug conjugates. They said, you know, my contacts in the industry tell me that this basically is equivalent to canceling contracts on drug sales of roughly about 850 billion Japanese yen, or roughly about 5.4. 5.4 billion U.S. dollars. So I just want to understand why are we looking at such large CMO compensation, especially given what Longza said last Friday. Last Friday during their first quarter briefing, they said that they do not expect much cancellation fee this year. So that's my first question. Thank you.

I don't know if that was

Kodama-san, please. Thank you for your question. FY 2025 results, we booked the provision for CMO compensation fees, and you are asking the 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 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 targets and goals, a sufficient amount and high-quality CMO lines must be secured, so long-term commitments and contracts were signed with long-term commitments. For example, results of DEA past clinical studies and future forecasts, including risk assessment, 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 has differences and variance. So I hope you understand our situation.

Okay, I understand very well. Yeah, thank you very much. My second question is either to Abhisam or John. This is about your SRNA platform. Can you tell us a little bit about your SRNA platform? You know, would it be hepatic delivery of SRNA? Would it be extra hepatic? What type of molecular targets would you be looking for, looking at? What diseases or indications are you exploring? Yeah, thank you. Hi.

Thank you very much for your question. SRRNA and the research, I believe your question is related to that. And this time, we have presented to you one of the three BGT candidates on slide 66. So this is, we have multiple BGTs for development candidates. 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 non-hepatic, you have asked the question. So including hepatic and non-hepatic for targeting multiple organs, so SRNA, We were certainly like to deliver, and we have been engaging in the series of development. We have been able to advance this, so therefore we have been able to identify a multiple candidate compound. And we have been doing this when we conduct the phase one 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.

Yes, yeah, thank you very much. Next. Mr. Wakao from JP Morgan Securities, please.

Wakao from JP Morgan Securities.

Thank you very much for naming me. I also have two questions. First, in order to achieve more than 3 trillion yen in 2030, what is going to be needed? According to my understanding, that away length cancer success is a prerequisite. Avanza, TL07, TL08, and also 15 as well. Main is TL 07 and 08 and Avanza studies. Which one? How many of these studies should be successful for you to achieve your goal? Avanza may be successful. TL 07, 08, successful. That would be the best scenario. Avanza may not be successful. 07 alone may be successful. So which one 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. Any data we haven't seen yet, although you may have such data in the background, Avanzar, TL0708, similar to 02 and 04, Are you seeing updates which are not published yet? Are you increasing confidence? Sorry for my long answer. In addition, you want to build rank transfer leadership. That's a very high hurdle to clear because Merck, Prop2, is one competitor. Pfizer has ADCs. But antibodies are being developed by several companies.

So, why?

Thank you very much for the question.

So I'll put my answer in context to what our CEO, Oka Zeller, 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 Datraway, it's important to remember that Avanzar is just one of four first-line non-small cell lung cancer trials. So Avanzar will be the first one to read out, but then we've got TLO7, as you mentioned, TLO8, and TLO10. And so when we look at the first-line opportunity, which is very, very large, it's one of the largest in all of oncology, very high unmet need, we've got at least four 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 01, 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 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 the Vansar. 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. I think one 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.

Thank you.

U0402 update. Data not available for you, and you haven't seen it yet. Understood.

So for the second point, I would like you to tell us about the five-year ahead over time and our visibility there. And perhaps relating to JP Morgan's question, so then there is a bottom for 2027. Is my understanding correct? So 2027, so 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, then 2028, if it is going to be impacting the profits, do you have any plan B or any other options to... Thank you very much for your question. So I know that back in January conference, I did talk about that. I know that that's one of the reasons why it comes 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 NHER2, a milestone, will... So no further sales milestones for NHER2. That will give us a... will be impacted tremendously. And also, for milestones, close to 100 billion yen. So that will be straightforwardly impacting the bottom line. So... So against the backdrop, for OP, slightly decline. This is for 2027, for core OP, and also divestment of Daishankyo Healthcare. So conversely, this would be recognized in 2027 as a profit. So by looking at this upturned profit, so conversely, core OP drops, and we'll be able to supplement for the losses. As we have put it, so Lexiana LOE, so in 2028 or 2029, 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 2026, 2027, by Europe, by each respective countries, LOE impact of Lixiana LOE may be impacted. Conversely, in Japan, there is a prolongment of the patent duration, so the impact in Japan in 2029 or after 2029, so including Asuka 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 kodama ceo have explained so when it comes to our operational excellence this is an old company effort for the past five years so in this five years we are going to put that at our forefront and as the positive impact uh will be garnered toward the end of the five-year plan so therefore after 2027, and 2028 and 2029, we can steadily recover the profits, and then we'll be able to make it very high, higher than 3 trillion in 2030. Very understandable. So if that's the case, and so 2028, you do not have any plans to sell of other assets. That understood. Thank you very much.

Next, Matsubara-san from Nomura Securities, please. Matsubara from Nomura Securities. Thank you for the presentation. My first question is about the cost reduction. 200 billion yen in the five years. Every year it's going to be larger according to the earlier comment. Thank you. You can achieve this if you take time. What about the probability of achieving this goal?

Thank you for your question.

We think there is sufficient possibility that we can achieve this goal and achieve the results. From FY26, 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 as CEO. There are two major missions. First, from last fiscal year, in Europe, US and Japan, one by one, global one instance ERP is launched one after 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 and 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 we 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 freed can be allocated to more advanced work. AI resources can be considered together with human resources to optimize the headcount as well.

In

the six five-year business plan, we want to achieve a big growth. And regarding the talent demand in the conventional headcount plan, the human resources just increase gradually over time, but by leveraging AI effectively, headcount wise, and 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 two pillars to implement business transformation.

Thank you very much.

Thank you very much. With high accuracy. So the second part of my question is for a strategy for sales. So what you have made a comment earlier about this five ABCs and beyond that, it is going to be in-house sales. Any take on the situation, please? So thank you for your question. So this time, therapeutic area. So we have the oncology. conventionally, and also specialty. So we have two pillars. We have categorized them into two pillars, and then we have been designing ourselves a team as well. And in the fifth midterm, so in U.S. and Europe, so oncology team, we wanted to encompass those areas and thereby reinforcing our oncology unit accordingly. On the other hand, So they know discovery research team, not dedicated to this oncology alone. So therefore, in the sixth midterm, so some specialty to contribute to the business, we do not foresee that. In the seventh midterm, we can foresee, and there's a potential for that in health. So therefore, we have a redundant asset for oncology development and also the early stage specialty asset that resides in the five-year for the sixth midterm. So we would like to have an incorporated inter-portfolio management. So therefore, oncology and specialists as a sales team actively rolled out, respectively, but rather under the auspices of one chief commercial officer to oversee the the activities across the board, oncology or non-oncology, and the values of the assets can be identified to optimize the portfolio. So this is what we would like to consolidate the sales activities. And as you have put it, beyond that point, the commercialization from you know, are in-house. That is certainly in the scope.

Others are still raising hands, but we are running over. So with this, we'd like to close. Thank you. 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. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.

Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. © transcript Emily Beynon Thank you.

Thank you.

Now, we'd like to have a Q&A session for members of the media. I'm delighted to serve as MC for this Q&A. I'm Ogibara from Corporate Communications. If you have multiple questions, please ask one by one. And each person can ask up to two questions. When you ask a question, please mention first Well, your question goes to... If you have questions, please press the raise hand button at the bottom of your screen.

The first question.

Nikkan Kogyo Shimbun, Eskason, please. Can you hear me? Yes, we can hear you. Thank you very much. I'm Yasukawa from Nikkan Kogyo Shimbun 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? Thank you for your question. In FY2026 forecast, cost increase impact is incorporated is a 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. Thank you very much.

Compared with other industries, it has less impact. And my apologies for the follow-up question. So in that, what would be the biggest impact? So whether it's the energy costs and the personnel costs and the logistics costs, among others. Thank you for your question. So when it comes to the overseas operation now, it starts to expand all the more. And personal costs and inflation costs. And also when it comes to the activities, those costs related to the operation globally have risen. Thank you very much. That's all for myself.

Next.

Nihon Keizai Shimpu Newspaper, Nakada-san, please.

Yes, we can hear you.

Nakada from Nikkei Shimbun. I have a question to Mr. Okazawa, CEO. Looking at the subprice, it's now declining.

How do you think about this?

What's your view? Honestly, regarding the stock price level, do you have any measures you're going to take to raise the stock price? Thank you for the question. To think about the stock price was a very strange question from you. Of course, we are not satisfied with the current level of the share price. And our corporate value in trying to recover the stock price in line with the inherent corporate value. So, to that end, the sixth five-year business plan was presented today to you. We have 20-30 financial KPIs, top-line, bottom-line, specific targets and earnings per share and shareholder returns were explained. and a potential is going to go up in the form of a share price. Why we think so? Such a rationale is also being shown with this six five-year business plan. So we will execute the six five-year business plan to the full to increase the stock price. That's our determination. Thank you very much.

So second part of the question, so this may relate to the dividend and payout and shareholder return. So DOE, adjusted DOE that you have put together, so as for the share buyback and the policy in the six-factor business plan, what is your policy for going forward so with regards to this a shareholder return and as a mode of the fundamentals so we are going to have progressive dividend and being on that level so adjust the doe with a target of 10 percent annually or more So this is a progressive dividend. So to the shareholders and the investors, so in five years' time, the dividend, so 100 yen as 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. And I would think that such flexible buyback will be considered at any given time. So as 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. Thank you very much.

Next, Nikkei BP, Kikuchi-san, please.

Kikuchi from Nikkei BP and Nikkei Biotech. Can you hear me? Yes, we can hear you. Thank you very much. This may be a question to Okuzawa-san or John-san. 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 questions from the analysts 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? Thank you for your question. First of all, to contribute to business during the 6th 5-day business plan and beyond, beyond 2030, there's going to be a business contribution. Abe-san, anything to add? Thank you for your question. regarding BJTs. We have six 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'd like to realize the launch of these, and we will promote our R&D activities. I want to response, but any additional questions from you? For example, you had ADC strategy. Is this linked to the conventional ADC technologies or SRNA? Is this something to pave the way for different areas? Please turn to page 65. These are the new BGT candidates based on ADCs. the novel cytotoxic payloads. As you may know, we are leading the TOPO-1 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 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, TOP1 ADC has been developed, and a similar impact can be expected in this technological development IOADC field. It's not turned into product yet by anyone yet. As there was a question, our proprietary IOADC R&D is now underway and novel IO payload ADCs are being researched. ADC's top 1 area has been built by us. Using such insights, 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, multispecific antibodies and other companies are also interested in TPD molecules. This is leveraging our strength in drug discovery. We have multiple development candidates. And srRNA. in non-oncology fields, we are going to pave the way as well. By focusing on these six companies 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 five years, we cut to stop technology development for some, but now we are beginning to focus on these six. Did I answer your question? Yes, thank you very much. That's all from me. Thank you. Thank you very much.

The next question. Asahi Shimbun. Mr. Izawa. 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, MSN. So most favored nation. So how much impact are given? And also in the Japanese market, 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? 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 sixth 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 uh also amongst the couple of the pharmaceutical um drug category and they're going to waive um the tariff on those and among which was adc so our development our core mainstay so for now the u.s uh terrorist uh threat or impact at this point in time we have not gonna need to incorporate into the plan. Having said that, when it comes to the U.S. tariff, the presidential order that came for productivity, to have the production back to the U.S., so with that term, with the executive order that came published in April, so there may be incentives that 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 policy. And for MSN, so for this has to do with the U.S. and they have set forth a series of the policies. And to a certain level, we have factored in to 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, a 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.

In the sixth private business plan, you incorporated the potential impact of MSN to a certain degree. If possible, in what way are you incorporating this element? in the new plan. MFN, reflection onto the further business plan for the specifics. Allow us to refrain from disclosing the details. Understood. Thank you very much.

Next question is Aisha Sharma from Endpoint News. Please go ahead.

Hello, thank you for taking my question. I'm not sure who would be best to answer it, but it's basically about your target to deliver more than 2.3 trillion yen 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.

Thank you for the question. This is Ken Keller. So, when we look at our revenue going forward to deliver that $2.3 trillion, as we mentioned earlier, today within HER2 and Datraway, Daichi Sankyo is one of the leading companies in breast cancer. And when we look at the over 20 key pivotal trials that we'll 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 in HER2 to move into the early stage breast cancer setting where a cure is the goal. And we've got two trials that have already demonstrated success. standard of care-changing data, Destiny Breast 11 and Destiny Breast 05. 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 IDXD that John mentioned earlier, and with all the different lung cancer trials that we have with DactroA, 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 cells 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 six midterm plan, we're going to see tremendous growth in lung cancer. So I hope that answered your question.

There are others who are still raising their hands, but we are running over. With this, we'd 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.