Daiichi Sankyo Company, Limited (TYO:4568)
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May 13, 2026, 3:30 PM JST
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Earnings Call: Q4 2026

May 11, 2026

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

Thank you for waiting. We are going to start Daiichi Sankyo's FY 2025 financial results announcement and FY 2026-FY 2030 5-year business plan presentation and discussion. I'm delighted to serve as emcee today. I'm Ari Fujishiro from the Investor Relations and Shareholder Relations Department. First, about the language. In this briefing session, we are 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 our presentation material in Japanese. We have posted our presentation in both Japanese and English on our corporate website under 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 Keller, Head of Global R&D, John Tsai, and Senior Executive Officer, Head of R&D Division, Yuki Abe. Today, after FY 2025 financial results announcement, we will present FY 2026 to FY 2030 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 8:00 P.M. We will take questions from members of the media from 10 minutes past 8:00 P.M. Please note that this meeting is being recorded. Thank you for your understanding. We are starting FY 2025 financial results announcement. Okuzawa-san, please.

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

Okuzawa speaking. Thank you very much for joining Daiichi Sankyo's FY 2025 financial results announcement and five-year business plan presentation and discussion out of a very busy schedule today. First, we would like to sincerely apologize for rescheduling the dates of FY 2025 financial results announcement and five-year business plan presentation and causing you inconvenience and concern. Due to the financial result forecast revision we explained the other day, we thought that explaining FY 2025 financial results and five-year business plan together would be the best way to help you understand the current situation of our company and the future strategy properly, so we decided to reschedule the dates. Today, we will explain FY 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 FY 2025 consolidated results. Kodama-san, please.

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Kodama speaking. Please turn to page five. 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 six. This is the summary of the financial results. I will explain the details on the following pages. Please turn to page seven. I will explain an overview of FY 2025 consolidated results. Revenue increased by JPY 236.8 billion, or 12.6% year-on-year, to reach JPY 2,123 billion. Cost of sales increased by JPY 25.6 billion from the previous year. SG&A expenses rose by JPY 134.8 billion, and R&D expenditure increased by JPY 29.3 billion year-on-year.

As a result, core operating profit increased by JPY 47.1 billion, or 15.1% year-on-year, to reach JPY 360 billion. Operating profit, including temporary gains and losses, decreased by JPY 102.8 billion, or 31% year-on-year, to JPY 229.1 billion. Profit attributable to owners of the company decreased by JPY 35.9 billion, or 12.1% year-on-year, to reach JPY 259.9 billion. You can find the actual currency rates on the slide. Please turn to page 8. From here, let me explain positive and negative factors for revenue compared to the previous year. Revenue increased by JPY 236.8 billion year-on-year. I will explain its breakdown by business unit. First, Japan Business Unit.

Sales increased for anticancer agent, Datroway, direct oral pain treatment, Tarlige, direct oral anticoagulant, Lixiana, et cetera. Revenue decreased for influenza treatment, XOFLUZA. We booked realized gains on unrealized gains of inventory for Daiichi Sankyo Espha in FY 2024. Japan business revenue increased by 3.2 billion JPY in total. Let me explain our overseas business units.

Here, FOREX impact is excluded. In oncology business, revenue increased by JPY 152.2 billion due to the growth of ENHERTU and Datroway sales. As for American Regent, revenue declined by JPY 32.8 billion due to the impact of generic entry on iron deficiency anemia treatment on Venofer, and the impact of price competition on Injectafer and generic injectables. Revenue for EU Specialty business increased by JPY 21.7 billion as sales grew for hypercholesterolemia treatment, Nilemdo and Nustendi. In ASCA business responsible for Asia, South and Central American regions, revenue rose by JPY 38.1 billion due to the growth of ENHERTU mainly in China and Brazil. As for upfront payment and regulatory and sales milestones, et cetera, related to alliance with AstraZeneca and U.S. market, we booked as revenue sales milestones, et cetera, we received from AstraZeneca in the fourth quarter, so revenue increased by JPY 32.5 billion.

FOREX impact increased our revenue by JPY 21.8 billion in total. Slide 9 shows the factors behind the change in core operating profit. I will explain the JPY 47.1 billion increase by item. As explained earlier, revenue increased by JPY 236.8 billion, including a positive foreign exchange impact of JPY 21.8 billion. Next, I will explain cost of sales and expenses excluding foreign exchange impact. Cost of sales increased by JPY 19.9 billion, primarily due to the revenue growth and inventory valuation losses recorded in the second quarter for products including ENHERTU. Selling general and administrative expenses increased by JPY 133.3 billion due to an increase in profit sharing with AstraZeneca, as well as investments in 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 JPY 29.4 billion, due mainly to increased R&D investments associated with the progress of development of the 5-DXd ADCs. The negative impact of foreign exchange totals JPY 7.1 billion, and the underlying increase in core operating profit excluding foreign exchange effect was JPY 32.4 billion. Next, I will explain the changes in profit for the period on slide 10. Core operating profit increased by JPY 47.1 billion including the impact of foreign exchange. As for the temporary income in the previous fiscal year, gains on the transfer of shares of Daiichi Sankyo Espha were recorded as one-time income.

In the current fiscal year, although there were litigation related gains associated with former Ranbaxy shareholders and gains from the liquidation of Ambit, which had been acquired as a subsidiary upon the in-licensing of quizartinib, 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 JPY 149.9 billion on profit was recorded due to the recognition of costs including compensation for losses incurred by CMOs, as previously explained, impairment losses and compensation related to the discontinuation of investment in the Odawara 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 of operating profit of FY 2025 decreased by JPY 102.8 billion year-on-year on JPY 229.1 billion.

Finance income expenses had a positive profit impact of JPY 10.9 billion, mainly due to improvements in foreign exchange gains and losses. Income taxes decreased by JPY 56.5 billion due to a decline in profit before tax, as well as an increase in R&D tax credits. As for result, profit attributable to owners of the parent decreased by JPY 35.9 billion year on year to JPY 259.9 billion. Please turn to slide 11. This slide shows the full year dividend forecast for FY2025. Although operating profit for FY2025 decreased year on year, profit growth continued on core operating profit basis. Therefore, we will maintain the full year dividend forecast previously announced, with the annual dividend per share expected to increase by JPY 18 year on year to JPY 78. Please turn to slide 12. This slide shows the results of our share repurchase program.

In order to respond flexibly while comprehensively considering factors such as share price levels, we established a JPY 200 billion share repurchase authorization in April last year and ultimately repurchased JPY 91.8 billion worth of shares. All shares acquired through this repurchase program will be canceled on June 10th. Next, I will provide a business update. Please turn to slide 14. This slide shows the sales performance of ENHERTU. Global product sales in FY 2025 increased by JPY 145.5 billion year-on-year to JPY 698.4 billion. Combined revenue recognized by Daiichi Sankyo and AstraZeneca outside Japan reached $5 billion, triggering a sales milestone payment of $537.5 million. We received JPY 86 billion.

As for new indications obtained in the fourth quarter, in Japan we launched the promotion activities in March for second-line treatment of HER2-positive gastric cancer and HER2-positive multiple solid tumors. In China, we obtained approval in January for second-line treatment of HER2-positive gastric cancer. 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 sales continue to grow steadily. Global product sales for FY 2026 are forecast to increase by JPY 162.9 billion year-over-year to JPY 861.3 billion.

In addition to product sales, we expect to receive a sales milestone payment of $625 million upon combined revenue recognized by Daiichi Sankyo and AstraZeneca outside Japan reaching $6 billion. Going forward, we also expect to obtain approvals in the U.S. for neoadjuvant HER2-positive breast cancer and post-neoadjuvant HER2-positive breast cancer indications, which we hope will enable us to contribute to the treatment of patients with early-stage breast cancer. Next, I will explain the sales performance of Datroway. Please turn to slide 15. Global product sales in FY 2025 increased by JPY 46.2 billion year-over-year to JPY 47.6 billion.

In addition to the steady market penetration of the breast cancer indication in Japan and the U.S., the rapid market penetration of the lung cancer indication in the U.S. 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 year quarter. Regarding the NCCN guideline update for first-line treatment for triple-negative breast cancer, the recommendation level was upgraded from Category 2A, other recommended, to preferred. Next is the R&D update. The presentation will now be handed over to John Tsai, Global Head of R&D.

John Tsai
Head of Global R&D, Daiichi Sankyo

Thanks, Kodama-san. My name's John Tsai, it's a pleasure to be here with you today. I started my role at the beginning of April, I've been in this role for over five weeks, I look forward to working with you. 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, you'll be hearing about those as I go through the R&D update. As we move forward, I'd like to share with you the progress that's been made in 2025 also share looking forward what will be happening in 2026. Let's dive into the slide here. Let's go on the current slide here.

In HER2, demonstrated robust data in breast cancer in HER2 positive and HER2 low, ultra-low going into 2025. In 2025, there was expansion into earlier lines and also into additional indications. In the earlier lines of treatment in fiscal year 2025, we expanded into 1st-line HER2 positive breast cancer from DB09. This was approved by the FDA in December of 2025, and this indication is under review currently in Japan, EU, and China. Going into earlier lines in the neoadjuvant setting, everyone saw the results of DB11 that demonstrated clinically meaningful improvement in pathological complete response in high-risk HER2 positive early breast cancer. This led to the approval in China, which was in March, and this is currently under review in the U.S.

Furthermore, in post-neoadjuvant setting from DB05, we saw clinically meaningful improvement in invasive disease-free survival versus T-DM1 in high-risk HER2 breast cancer in the post-neoadjuvant setting. This indication is currently under review in the U.S., Japan, EU, and China. With these indications, we also look to expand into earlier lines and into other tumor types. In 2025, we expanded into other tumor types, such as in gynecological cancers. From DESTINY-Ovarian01, this trial was started in December of 2025. We also started DESTINY-Endometrial01 and DESTINY-Endometrial02 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 ENHERTU 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 ENHERTU followed by THP versus the standard of care showed an 11.2% improvement in pathological complete response and a trend toward event-free survival. This was demonstrated in patients with high risk of recurrence and includes a high number of patients who are hormone receptor-positive, who generally have lower pathological complete response rates. As I said, this is under review in the U.S. Let's go to the next slide. Here is a summary of the current regulatory status for ENHERTU. We already heard that first-line DB09 was approved in the U.S. The neoadjuvant approval was already approved in China. We have additional approvals that we're waiting for results. The post-neoadjuvant DB05 has been accepted in the U.S., Japan, and EU.

We also received two additional approvals in Japan, HER2-positive gastric cancer and the pan-tumor HER2-positive approval in Japan. Lastly, in the IHC 3+ tumor in the HER2-positive patient population, the file has been accepted in April in China. This is under priority review. This gives you a good snapshot of all of the progress that was made in HER2. Now we'll turn into looking at Datroway and the progress that was made there. Datroway also made significant progress. 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 Datroway was obtained for EGFR-mutated patients from the TROPION-Lung05 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 TROPION-Lung01 study, where we saw benefits more in the non-squamous patient population, more than the squamous. Importantly, what we also saw was the value of the TROP2 biomarker. Based on the results that we found from TROPION-Lung01, we've updated TROPION-Lung05 to add the TROP2 biomarker NMR positive to the primary endpoint for progression-free survival and overall survival. In addition to this, we also added the TROP2 NMR biomarker to TROPION-Lung08, and that was in PDL1 high positive patients. We added this to the secondary endpoint for PFS and OS.

In the lung space, we started TROPION-Lung17 in the TROP2 positive metastatic non-small cell second-line patient, and that trial was started in January of this year. In the area of breast cancer, we demonstrated positive results at ESMO, just last year, where we showed strong results from TROPION-Breast02 in first-line triple-negative breast cancer. These were in patients who were not eligible for PD-1 and when we saw the combined positive score less than 10. This filing is under review in the U.S., Japan, and in China. In addition to earlier lines for Datroway, we expanded into other tumor types. You can see that we expanded into urothelial carcinoma in the phase II/III trial, which is TROPION-Urothelial03. This was started in October, where we will see Datroway plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin.

There was significant progress, as you can see here, made with Datroway. As we look into the additional DXd ADCs, we made significant progress in these area 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. In addition to that, we did see progression and also progress for I-DXd, where we saw robust data from the IDeate-Lung01 study for extensive stage small cell lung cancer on or after platinum therapy. Not only did we see this, we also expanded into additional indications for I-DXd for esophageal and prostate cancer. These were phase III studies that were started in May and June of last year. For the area of R-DXd, there was positive results presented at ESMO last year from the REJOICE-Ovarian01 study.

This was a phase II dose optimization study for platinum-resistant patients who had CDH6 expression, and we were granted breakthrough designation for this specific indication. Lastly, for the DXd platform, we also started the first-in-human study for DS-3790. 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, we started a number of new first-in-human studies. For DS-3610, this is an ADC with STING agonist as the payload. This was started in November of last year. For DS-5361, this is a small molecule NMDA inhibitor which activates by increasing neoantigens, this was started in October. We also started a targeted protein degradation program, DS-9051. That was in November of last year. Next slide, please.

As I shared those results, I'd like to also share with you the progress that was made with I-DXd as we are seeking our first approval for I-DXd based on the results of IDeate-Lung02 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. We expect a PDUFA date in October of this year. Also, IDeate-Lung02 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 planned first-in-human start in the first half of this year for DS-2001, an anti-ORAI1 antibody for autoimmune disease. ORAI1 is a major pore-forming subunit of CRAC channel in immune cells, and this is in the area of immune diseases, as I stated earlier. 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. Daichirona won the 2026 Pharmaceutical Society of Japan Award. This was based on the first made in Japan mRNA vaccine for COVID-19.

In addition, Valemetostat, or EZHARMIA, received the 2025 Pharmaceutical Chemistry Division Award. This was based on the 1st dual inhibitor of EZH1 and EZH2 and provides a new treatment option for all of those patients in 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. If we look at 2026, there are a number of regulatory decisions that we're looking forward to this year. As you heard, DESTINY-Breast05 in the post neo-adjuvant HER2-positive breast cancer area, we're expecting the regulatory decision in July of this year. For Datroway TNBC 1st line, we're expecting that PDUFA date in June of 2026.

For I-DXd, for extensive small cell lung cancer second line, we're expecting the results and the feedback from the FDA in October of this year. In addition to the regulatory readouts, we also have a number of data readouts this year. We're looking forward to ENHERTU DESTINY-Lung04 study in the first half of 2026, and in the first half of this year, we expect to get the results of TROPION-Lung07, TROPION-Lung15, and AVANZAR. These are all in the first-line patient population.

We also expect to get results from R-DXd, where we have a regulatory submission, and we are evaluating the submission of REJOICE-Ovarian01. While we saw positive results, we're awaiting the expansion of the phase II data in order for the full submission. You can also see some of the presentations that we will be sharing at ASCO later on at the end of this month. These are all the accomplishments and what we will be looking forward to in 2026. I will turn it back to Kodama-san for the fiscal 2026 forecast. Thank you.

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

From here, Kodama will explain FY 2026 forecast.

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Please turn to 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 FY 2027 at Daiichi Sankyo Group. In anticipation of the impact of this adoption, the definition of core operating profit is to be changed starting in FY 2026 when the 6th 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 FY 2025 are included in core operating profit under the new definition. Regarding the impact on FY 2025 results due to changing the definition of core operating profit, please refer to an adjustment table on page 38 in the appendix. Please turn to page 28.

Let me explain FY 2026 forecast. Changing the definition of core operating profit, which I explained earlier, is reflected onto FY 2025 results and FY 2026 forecast figures. As for revenue, declining sales in the iron supplement business in the United States and drug price revision for Lixiana in Japan were negative factors, but there were positive factors such as revenue increase due to market penetration of ENHERTU and Datroway, especially in the United States. We are forecasting revenue to increase by 7.4% or JPY 157 billion year on year to reach JPY 2.28 trillion. Cost of sales are increasing due to revenue expansion. 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 JPY 80.3 billion.

CMO compensation fees of JPY 80 billion we are recording as cost of sales for FY 2026 is the current estimate expected to additionally arise by the end of FY 2026 due to short-term differences between our supply plan and the minimum purchase obligations to CMOs. Specifically, this will be for 2028 to be included in FY 2026 as the new firm order period. With regards to core operating profit, expenses are expected to rise due to sales expansion of ENHERTU and Datroway, which will likely lead to increased profit share payment to AstraZeneca. On the other hand, gross profit increase is projected. We are forecasting core operating profit to increase by 27.5% or JPY 77.6 billion to reach JPY 360 billion.

Due to changing the definition of core 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 JPY 85.9 billion to reach JPY 315 billion, according to our forecast. Pre-tax profit is expected to rise, but corporate tax will increase. Due to the stock transfer of Daiichi Sankyo Healthcare, profit attributable to a non-controlling interest is expected. We are forecasting profit attributable to owners of the company to be JPY 260 billion at a level similar to the previous year.

Our Forex assumptions are JPY 150 against the U.S. dollar and JPY 180 against the euro. Please turn to page 29. Here, let me explain FY 2026 annual dividend forecast. Under the sixth five-year business plan, stable dividend will be distributed based on progressive dividends and adjusted DOEs. Adjusted DOE will be calculated based on adjusted shareholders' equity, which excludes items that fluctuate primarily due to share prices and exchange rates from total shareholders' equity. Increase of the dividend to JPY 100 per share, up by 22 yen from JPY 78 in FY 2025 is planned in FY 2026, marking the fifth consecutive years of dividend increases. Towards further growth under the sixth five-year business plan, we will continue to enhance shareholder return. That's all for the results. Next, we are moving on to the sixth five-year business plan presentation and discussion. Ogawa-san, please.

Satoru Ogawa
Head of CEO Chief of Staff Office, Daiichi Sankyo

Let me explain the 6th five-year business plan. Please turn to page 46. First, recap of the 5th five-year business plan. Under the 5th five-year business plan, we maximized 3 ADCs, profit growth for current business and products, identify and build pillars for further growth, and create shared value with stakeholders as four strategic pillars. We worked hard to realize 2025 goal and shift to further growth. Let me recap the main progress for each respectively. Please turn to page 47. This is a summary for maximizing 3 ADCs.

The oncology business achieved significant growth driven by ENHERTU and Datroway. Also, we entered into a strategic alliance with Merck as well. In addition to AstraZeneca, strengthening the structure for global development and commercialization is ongoing. ENHERTU transformed standard of care in HER2-positive breast cancer and has established HER2-low and ultra-low breast cancer as a new therapeutic area. Datroway provided new treatment option to patients with limited treatment options.

Also updated lung cancer strategies by implementing novel biomarker based on learnings from TROPION-Lung01 study. As for the subsequent 3 ADC products, we revised the timing to launch HER3-DXd, but we are accelerating I-DXd and R-DXd development through our collaboration with Merck. Growth is making progress for the DXd ADC portfolio as a whole. Regarding manufacturing and supply, we revised the supply plan and optimize the global supply chain. In addition, we resolved patent dispute with Seagen Inc., confirming DXd ADC as Daiichi Sankyo's proprietary technology. Please turn to page 48. Next, I will recap the progress for 3 strategic pillars and business foundations. In the current business, specialty medicines such as Vixian and Rue, while profit declined in the iron supplementation business by American Regent, Inc.

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

We advanced transformation toward an innovative medicine business structure through the transfer of shares in Daiichi Sankyo Espha and Daiichi Sankyo Healthcare. Under the strategic pillar to identify and build pillars for further growth, in-house development of DS-9606 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 5 years, oncology business grew substantially. FY 2025 revenue was JPY 2,123 billion, and revenue in oncology was JPY 954 billion.

We achieved our initial target for both. On the other hand, core operating profit ratio before R&D was 38.7%, which fell short of the 40% target. ROE was 17.9% in FY 2024 above the target, but was 15.8% in FY 2025 as CMO compensational fees were recorded. DOE was 8.7%, achieving our target. Next, please look at page 50. This page shows an overview of the recap. Between FY 2021 and FY 2025, both revenue and core operating profit grew substantially, and we believe we realized transformation into a global pharma innovator with competitive edge in oncology, which was raised as our 2025 vision. Based on these achievements, we will accelerate further growth under the sixth five-year business plan between FY 2026 and FY 2030.

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 2020, 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 6th midterm business plan covering FY 2026 through FY 2030 aims to expand the oncology business through the establishment of an efficient and resilient organization, while also advancing the identification of breakthrough generating technologies, or BGTs, as new drug discovery technologies for sustainable growth, thereby driving toward the realization of our Vision 2035, a trusted healthcare innovator. By 2035, we aim to become a global top 5 company in the oncology field with the new BGTs following DXd ADCs contributing to our business while establishing an efficient and resilient organization and becoming a trusted partner. Please turn to slide 54. This slide provides an overview of the quantitative targets and strategies for achieving our 2030 goals. First, let me explain our quantitative targets for FY 2030.

We're targeting revenue of more than JPY 3 trillion, operating profit of more than JPY 600 billion, and EPS of more than JPY 260. During the period of the 6th midterm business plan, we will maintain progressive dividends and provide annual dividends with an adjusted DOE of 10% or higher. I will explain the strategies for achieving the 6th midterm business plan and its quantitative targets. The 1st strategy is be a global top 5 oncology company by 2035.

Leveraging the strength in, strength over DXd 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 the capabilities required to independently develop and commercialize products on our own. The second strategy is identify next BGTs by 2030. To achieve sustainable growth even after the LOE of DXd ADCs and to deliver products that go beyond current standards of care to patients, we will identify multiple BGTs by 2030. In addition, as a foundation for steadily executing these 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 five 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 benefit with conventional treatment. 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 five 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.

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Please turn to slide 56. Through strategic collaborations with AstraZeneca and Merck in the U.S., our oncology business has achieved significant growth. Through obtaining more than 10 indications for oncology products such as ENHERTU and Datroway 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 JPY 954 billion in FY 2025.

Under our growth strategy, ENHERTU and Datroway will continue to drive revenue growth over the next five years with the aim of achieving oncology revenue of more than JPY 2.3 trillion by FY 2030. In addition, we will maintain a competitive pipeline and build the capabilities to independently develop and commercialize products in order to maximize their value, thereby achieving sustainable growth in the future. Next, the following slide explains how we will build these in-house capabilities. Please turn to slide 58. Our in-house capabilities will be built upon three pillars: RD 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 technology 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 we'll deliver them to patients without delay following regulatory approvals. In addition, through the continuous generation of evidence, we will provide high value information and secure long-term product value through pricing and reimbursement strategies. Through these initiatives, we will maintain and expand our leadership in the breast cancer field while also establishing a strong leadership position in the lung cancer field. To support and realize this business growth, we will optimize our global supply chain and build a flexible and stable supply system.

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

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 BGT candidate assets under development, and reduce future manufacturing and supply related risks. Under this new strategic direction, we will build a business foundation that is resilient to changes in the external environment and strive to achieve sustainable growth. Now let me move to the next slide and discuss in more detail how we are building R&D excellence. Please turn to slide 59. In order to build development capabilities at the level of a global top five oncology company, improving development speed is essential.

With ENHERTU, 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 ENHERTU 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 expert experience in drug administration and adverse event management with late-stage trial sites around the world with the aim of accelerating patient enrollment and improving trial quality. The second initiative is the utilization of digital technologies and AI. We will leverage digital technologies and AI for biomarker discovery and research, as well as for analysis and utilization of the vast amount of data accumulated internally, as well as for improving efficiency in protocol development and site selection, thereby enhancing efficiency through the use of digital technologies in AI across various R&D processes and accelerating the overall development process. Next, we will explain business excellence. Please turn to slide 60. We will continue to make R&D investments actively for DXdADC products. More than 20 pivotal studies data readouts are expected over the next five years.

To grow our oncology business after obtaining approval of many indications, we need to launch new products rapidly across the world, including biomarker diagnosis, and we need to realize rapid market penetration for products. Throughout the product's lifecycle, we will develop pricing and reimbursement strategy from global perspectives. We will also generate data and evidence continuously to secure long-term product value and aim to maximize product value. Please turn to page 61. I mentioned that more than 20 pivotal studies data readouts are expected over the next five years. We are assuming that $2 billion-$6 billion total peak sales potential readouts will continue every year for the next five years. From 2026 to 20 FY 2030, this is going to occur every year to contribute to the sales growth. By continuing to invest actively in R&D and delivering new data, we will contribute to more patients.

Please turn to page 62. Through indication expansions for ENHERTU and Datroway, we have established a leadership position in breast cancer. 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 ENHERTU and Datroway. Especially for Datroway, 10 phase III studies are ongoing right now. We will promote biomarker research and exploration, identify target patients to deliver the drug appropriately so that we can build leadership in lung cancer as well. Please turn to page 63.

We believe that our DXdADC business is growing substantially with peak sales potential of JPY 3 trillion or more. We will not only invest in the five DXdADCs where we are collaborating with our partners, but also invest actively in DS-3939 and DS3790, et cetera. In early development 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 DXdADCs by the year 2030.

With these promising pipeline assets, we will aim to be a global top five 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 f-64. We define BGT, Breakthrough 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. We will establish end-to-end integrated capabilities from research and development to manufacturing to accelerate delivery of new innovative medicines to patients.

DXd ADCs are good successful examples. Clinically validated technologies are being leveraged in the next programs. By now, ENHERTU and Datroway are already launched, and five others are in development stage. Identify the next BGT programs is going to be our target during the sixth five-year business plan. 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 Top1 inhibitor innovator, we will leverage our knowledge and clinical insights accumulated so far to develop next generation cytotoxic payloads to overcome cancer with DXd ADC resistance. We are planning to start phase I study for ADC with new payloads in FY 2027. Next, ADC with IO payloads. By activating the immune system via the STING pathway, we are hoping to drive tumor cell elimination and improve long-term treatment results based on immune memory.

As an ADC of this type, DS3610 study is ongoing. Next, antibody engineered ADC. Through novel tumor-selective antibody engineering technologies, we will aim to improve benefit risk balance. We will develop new drugs through combinations with diverse ADC technologies we have. For this type of ADC, we are planning to start the first phase I study in FY 2027. Please turn to page 66. Here, I will talk about three non-ADC BGT candidates from multimodality 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, DS-2243 phase I 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 undruggable targets. This will accelerate TPD molecule creation with higher precision by integrating a long-standing medicinal chemistry with AI drug discovery. As we mentioned in previous results announcement briefing sessions, DS-9051 phase I study is ongoing right now. Last but not the least, siRNA as a culmination of years of research in nucleic acid therapeutics. We have leveraged decades of our nucleic acid expertise, such as research on Dai-ChiRona. By integrating novel chemical modification technologies with DDS technologies, we will create nucleic acid therapies targeting multiple organs. We plan to start phase I study for the first program by the end of FY 2026. On page 67, I will introduce our programs in immuno-oncology. As is shown in this figure, we are broadly researching key mechanism of cancer immunology.

In each step, we are identifying promising assets. At present, many phase I 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 fifth five-year business plan up to FY 2025 through DXd ADCs positioned as the first BGT, we achieved expansion of our business and presence in oncology. For DXd ADCs, also during the sixth five-year business plan period, multiple data results from large scale clinical trials are expected, leading to indication expansions. In addition, from the six BGT candidates I talked about today, as well as IO breakthrough assets, we will identify promising growth pillars following DXd ADCs and aim to unlock greater business potential.

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Please turn to page 69. This slide introduces the expansion of our drug discovery research platform that supports the continuous creation of BGTs. 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 multimodality 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 U.S., we plan to further strengthen our initiatives.

Please turn to slide 70. Here, as examples of the outcomes of our science and technology, we would like to introduce some of our out-licensed compounds currently being developed by other companies. These innovative assets are reaching clinical practice through licensing partnership. taletrectinib is currently the most successful example among our out-licensed assets, contributing to the treatment of patients with ROS1-positive non-small cell lung cancer in the U.S., Japan, and other countries. The growth of these out-licensed assets demonstrate the strength of our science and technology capabilities 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 initiatives, 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 convention tasks through these efficiency gains, we will formulate and execute HR strategies that combine capability transformation through reskilling with optimal talent re-allocation, thereby advancing talent allocation from the company-wide optimization perspective.

In addition, we will further reduce costs by optimizing our procurement processes through the global common ERP platform that has been rolled out, sequentially across regions since last fiscal year. Through the execution of these operational excellence initiatives, we aim to optimize costs by a cumulative total of more than JPY 200 billion over the five years period of the sixth midterm business plan, thereby enhancing our profit-generating capabilities and utilizing these gains for future growth investments and improved profitability. Please turn to slide 72. Commercialization to achieve a strong and sustainable growth, we will establish a new global organization responsible for centrally overseeing commercialization activities across all countries and regions, spanning 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 organizational structures and personnel. This organization is scheduled to become operational in April 2027. Please turn to slide 73. This slide explains that alongside operational excellence, another foundation supporting the sustainable growth of our business is to be a trusted partner for sustainable society. To maximize our business value, it is essential that we meet the expectation of diverse stakeholders and continue to be a trusted partner. 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 our shareholder return policy, please turn to slide 74. Our cash allocation policy emphasizes a balance between growth investments and shareholder returns.

During the period of the sixth midterm business plan, as growth investments, we will expand the oncology business while prioritizing our R&D and capital expenditures aimed at identifying new BGTs for sustainable growth. For shareholder returns, we will introduce progressive dividends and provide stable dividend payouts. Operating cash flow before deduction of R&D expenses over the five-year period is expected to total approximately JPY 3.85 trillion, which together with proceeds from asset sales and financing activities will serve as the source of the funds. Of this amount, approximately JPY 2.9 trillion will be allocated to R&D expenses, while approximately JPY 700 billion will be allocated to capital investments, primarily for strengthening the global 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 JPY 27 in FY 2021 when the fifth midterm business plan began and has increased to JPY 78 in FY 2025 as we have continued to provide stable shareholder returns in line with profit growth. During the period of the 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 FY 2026, we plan to increase the annual dividend per share by JPY 22 to JPY 100.

Next, I will discuss our quantitative target for FY 2030 and the outlook toward FY 2035. Please turn to slide 76. Looking toward FY 2030, in addition to challenges such as the loss of exclusivity for Lixiana, the completion of ENHERTU sales, milestone receipts, and declining revenue from the iron business, we will also face revenue reduction impacts from the transfer of Daiichi Sankyo Healthcare beginning in FY 2027. However, through the steady execution of the strategies outlined today in our sixth midterm business plan, along with maximizing the value of our DXd ADCs portfolio centered on ENHERTU and Datroway, we expect continued revenue growth throughout the plan period and aim to achieve revenue of more than 3 trillion yen in FY 2030.

On the profit side, while multiple challenges will converge in FY 2027, the transfer of Daiichi Sankyo Healthcare is expected to offset these impacts at the operating profit level. Furthermore, in addition to sustainable growth driven by maximizing the value of our DXd ADCs portfolio, we will strengthen our earnings-generating capabilities through operational excellence. As a result, we aim to significantly accelerate profit growth by FY 2030, targeting operating profit of more than JPY 600 billion and EPS of more than JPY 260. In addition, by implementing a progressive dividend policy and maintaining an adjusted DOE of 10% or higher each fiscal year, we will pursue more stable dividend and further enhance shareholder returns.

R&D expenses are planned to increase gradually, and during the sixth midterm business plan period, we will invest approximately JPY 2.9 trillion, an increase of about JPY 1 trillion 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 MFN. As for tariffs, we currently believe that their impact on business performance during the period of the sixth midterm business plan will be limited, although we will continue to closely monitor policy developments going forward.

To realize our vision 2035, we aim to overcome the patent expiry of ENHERTU while maximizing the value of DXd ADCs and driving business contributions from new BGTs that follow DXd ADCs, thereby positioning ourselves to target operating profit on the scale of JPY 1 trillion in the early 2030s. To achieve this, we will leverage the oncology expertise cultivated through our collaborations with AstraZeneca and Merck, ROI, and strengthen our capabilities to independently develop and commercialize our industry-leading pipeline backed by our science and technology, thereby enhancing our future earnings-generating potential. Finally, let me conclude with the summary. Please turn to slide 77. Today, based on a review of the fifth midterm business plan, we explained the sixth

Midterm business plan aim to realizing our vision 2035, which defines where we aspire to be in 10 years. The sixth midterm business plan is a critical plan that will enable us to move into the growth as a future global top five oncology company. We will view the rapidly changing business environment as an opportunity, and by combining the strength we have built over time with new challenges, we will realize sustainable value creation and contribute to the development of a sustainable society as we grow into an advanced global healthcare company. We look forward to your continued support and expectations for our future growth. This conclude my presentation.

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

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 Citigroup Securities, please.

Hidemaru Yamaguchi
Analyst, Citigroup Securities

Can you hear me?

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

Yes, we can hear you. Thank you.

Hidemaru Yamaguchi
Analyst, Citigroup Securities

Yamaguchi from Citigroup Securities. Thank you very much for the presentation. My first question is about the five-year business plan and also the FY 2026 forecast. It's in between the two, maybe the question goes to Kodama. Regarding CMO compensation fee, on Friday last week there was a presentation. You said that there can be a provision also for FY 2026. You mentioned it, this is for 2028. Until when this will continue? That's something I'd like to know.

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

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. Could you explain? Thank you for your question. I'd like to respond. Your question is about CMO compensation fees. In FY 2026, JPY 80 billion is included. How much or how long this is going to continue, so you need some guidance on this. According to my understanding, regarding your contracts with CMOs, there are multiple contracts. Longer ones would be up to FY 2030 or up to the mid-2030s. For specific details, I'd like to refrain from commenting in detail. 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. This year, in FY 2026, JPY 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 incorporated for our assumptions. If you say certain, it's incorporated.

Hidemaru Yamaguchi
Analyst, Citigroup Securities

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

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Thank you for your question. Datroway and the numbers. For us, we do have for the adjustment based on the adjustment of risk. Including the van the round, and there are such readout of the outcomes for other studies and have been incorporated into the numbers.

Hidemaru Yamaguchi
Analyst, Citigroup Securities

TNBC alone have been factored into this as assumption, as a new indication. Is my understanding correct?

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Yes. For these numbers, Ken would like to explain.

Ken Keller
Director and Head of Oncology Business Unit, Daiichi Sankyo

Thank you for the question. As we look at the fiscal 26 expectations in the 6th midterm plan, we do assume that the triple-negative breast cancer indication will be approved. As you know, the data was reported. It is highly differentiated. We expect that when it is approved, and the PDUFA date in the U.S. is pretty soon, it's in May. Everything we're hearing from the oncology community leaves us very confident that the doubling of overall response rate and the fact that it improved overall survival, physicians are waiting for this drug enthusiastically. We expect it will do very, very well.

Hidemaru Yamaguchi
Analyst, Citigroup Securities

はい、ありがとうございます。次のご質問です。

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

Next question. UBS証券。 UBS Securities, Mr. Seki, please.

Atsushi Seki
Analyst, UBS Securities

UBSの関です。 Seki from UBS. 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. Instead of share buyback, why you are going to use DOE? With dividends, there is no signaling of under value for the stock price. If you add these figures, it's already JPY 3.9 billion. Are you going to do factoring? That's my first question to you.

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Thank you for your question. Page 74 regarding the dividends and shareholder return, you'd like to know our way of thinking and fundraising. Philosophy is also part of the question.

Atsushi Seki
Analyst, UBS Securities

そうですね。あの、自己株式の取得と配当

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

acquisition of our own shares and dividends, how we are going to do this using the 2 for the time being during these 6 5-year business plan, we'd like to ensure profit generation, and we have commitments to this, and we also need to have confidence. From the profit, we'd like 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 5-year business plan. DOE is being used as an indicator, so we will continue to do so. As for the progressive dividends, you can see this progressive dividend in the fifth 5-year business plan. We paid dividends along with the profit increase, so we will continue to do this. As for the share buyback.

Atsushi Seki
Analyst, UBS Securities

そうですね。

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

This will depend on the status of capital and also the size of a business. Given that situation, our working capital is substantially increasing right now, so we have to check the balance. If the situation appropriate for share buyback in terms of the capital, then we'd like to consider this possibility more actively. 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. In addition to asset sales, we will also do this for fundraising. You mentioned factoring. We are not considering this possibility more specifically, but we'd like to study and research broadly. If there is an appropriate things, we'd like to work on that as well. Thank you very much.

Atsushi Seki
Analyst, UBS Securities

ありがとうございます。

Speaker 21

My second question. On slide 76, I'd like to direct a question to Mr. Kodama. You're going to accelerate this. By R&D, JPY 600 billion or so as it is written here. I would assume that SG&A is going to be reduced tremendously, and OP JPY 600 billion will be achieved. Is my understanding correct? If that's the case, how would be the driver for this robustness of this acceleration? Now forecasting governance is in check, although you're not do not have the U.S. GAAP.

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

For the profit and this building a robust foundation for profit growth and to sharply accelerate profit growth in FY 2030, your question was about the rationale about this. To deduct the expense or from the revenue and for going toward 2030, to improve our profit. Rather it is going to be increase in revenue. The balance will be skewed toward the latter. As for the expense, for the business transformation, which we have talked about, the size of JPY 200 billion to reduce that expense, have been factored into this. On average, this isn't something that will be generated every year. It's going to be skewed toward the end of that 2030.

Atsushi Seki
Analyst, UBS Securities

ありがとうございます。以上です。

Speaker 21

Thank you very much.

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

次のご質問です。 Next questions from Mr. Hashiguchi from Daiwa Securities, please.

Kazuaki Hashiguchi
Analyst, Daiwa Securities

大和証券、橋口です。

Speaker 21

Hashiguchi from Daiwa Securities. Thank you very much.

Kazuaki Hashiguchi
Analyst, Daiwa Securities

奥澤社長、もしくは奥澤社長が適当と

Speaker 21

My question goes to Mr. Okuzawa or somebody you think is appropriate. On page 63, DXDADCPotential will be 3 trillion or more on XPGT with potential to match that of DXD-ADC. Anything you can say so will be identified by 2030. You'd like to identify multiple BGTs by then. ENHERTU entered the clinical studies, if my memory is correct, it was around 2015. You have been able to say that it had this much potential at around the start of the fifth five-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. Phase I 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 a DXD-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.

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

Hashiguchi-san, thank you very much. In the sixth five-year business plan, a major, strategic pillar is to identify multiple BGTs, as we mentioned. Thank you for your question on this. Global Research, head, of R&D, Abe is going to respond.

Yuki Abe
Senior Executive Officer and Head of R&D, Daiichi Sankyo

Hashiguchi-san, thank you for your question. As you said, DXD-ADCs, where I was involved in research since 2010. We started research from 2010, and in 2015, phase I started. In 2019, approval was granted. We created the oncology business as 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, DXD-ADC successful experiences were used as a basis to proceed with BGT approach, so we are making good results based on that. The timing to contribute to a business in 2030, we don't think we can achieve it in 2030 yet. If I explain, by 2030, Hashiguchi-san mentioned strong signals. We are going to identify strong signals, and multiple BGTs will be identified. 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. That's the timing. The left DXD ADC business will grow, and the new drug assets will generate new business. That's the nature of our R&D strategy. Did I answer your question? </edited_transcript

Speaker 21

Thank you very much. The second part of my question is that the plan for the R&D costs. For this time, so as it was presented in the Friday's briefing, you have factored in such risk, so that has been embedded into the plan. As for the sales, PDUFA is in scope for this. Depending on the data that may be published, where would be the focus for R&D? I would assume that we need to be very flexible. Your midterm plan and as with regards to R&D, there has been such, you know, discrepancies. In all likelihood, is there a possibility for such inconsistency there? What is the basis for this R&D? JPY 600 billion or JPY 2.9 trillion yen. How did these figures come out?

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

R&D cost management, so John would like to respond to that.

John Tsai
Head of Global R&D, Daiichi Sankyo

Thank you for your question regarding the spends on R&D. As Abisan outlined, we will have a number of identified BGTs moving forward. The specific spends for the R&D expenses have not yet been fully determined, but obviously, if we move forward with a number of promising BGTs, this will be the expenses that are incurred in order for us to achieve the goals. 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.

Kazuaki Hashiguchi
Analyst, Daiwa Securities

Hi.

Speaker 21

Thank you very much. That's all from me.

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

Next question from BofA Securities. Mamegano-san, please. Next, SMBC Nikko Securities. Wada-san, please. Sorry, next. Yes, Wada-san? Please. Yes. Wada from Nikko Securities, please. Thank you very much.

Hiroshi Wada
Analyst, SMBC Nikko Securities

I have a question on the five-year business plan. First of all, in FY 2025, core operating profit before R&D was below 40%. What are the reasons why in the next five-year business plan? What would be the factors for you to achieve 40%? Also, core operating profit and operating profit, you changed the focus. What's the reason behind? Kodama-san, please.

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Thank you for your question. First, FY 2025 core operating profit ratio under 40%, and what are the factors behind? Number two, KPI for the fifth, sixth five-year business plan, what's the background for changing from core operating profit to operating profit? First, FY 2025 core operating profit ratio before R&D below 40%. Why was your question. Cost of goods sold in the second quarter enhanced associated a write-down of inventories were incurred as losses.

Uchiura also had write-downs of inventories. This is what we didn't expect initially, and there was an increase in expenses, and that's a major reason I can mention. Also, secondly, in the sixth five-year business plan are the change of our KPIs. Operating profit ratio before R&D target is 40%. In the fifth five-year 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 five-year business plan in our business, five DXd ADCs, specifically ENHERTU, Datroway, and three products, we are working together with Merck, US Merck, and the proportion of these products is getting larger. As you know, regarding these five products, profit share is a mechanism for collaboration.

In terms of the profit ratio, there are some difficulties. Secondly, in the end, profit for the term and the operating profit towards that goal for various elements included, we have to secure profits. We should focus more on these. Non-core items as well, we decided to look at them as the responsibility of the management team. We decided to use the operating profit as an indicator or KPI. Thank you.

Hiroshi Wada
Analyst, SMBC Nikko Securities

On page 65 and 66, there was a summary. You have uniqueness here. IO payload I think is unique. STING agonist is my the topic of my question This ligand, has that been overcome? If you bind with the antibody, you will be able to maintain this? There may be such solubility. Improve the solubility of the compound. I would like to ask you to elaborate about the property.

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

Yes, exactly the point. STING, so ADCs. Well, we have been able to accomplish this. How it is going to be bind by that and also how to control the solubility. With our very stable ADCs and those discharge drug works for the betterment. As for the detail property, our apologies not being able to explain in this detail, but for us to overcome this, and this is the IoADCs.

Hiroshi Wada
Analyst, SMBC Nikko Securities

Understood. Thank you very much.

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

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

Tony Ren
Analyst, Macquarie

Hello. Can you guys hear me?

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

Yes, we can hear you.

Tony Ren
Analyst, Macquarie

Okay, perfect. Yeah, 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, right, JPY 169.5 billion, roughly about a little over $1 billion. This is really very large. You know, I happen to cover several CDMOs myself, including ones that are specializing 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 JPY 850 billion or roughly about $5.4 billion. I just wanna understand why are we looking at such large, CMO compensation, especially given what Lonza said last Friday, right? last Friday during their first quarter briefing, they said that, they do not expect much cancellation fee, this year. Yeah, so that's my first question. Thank you.

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

Kodama-san, please.

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

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. That's why we concluded the contract. In order to achieve our 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, the results of the past clinical studies and future forecast, including risk adjustment, all the studies may not be successful, so we factored in such a reality in the supply plan and variances occurring. That's the factor behind. Therefore, regarding the size of the amount, you talked about it. Allow me to refrain from talking about the details here, but our demand of plan we expected before and the current estimate have differences and variance. I hope you understand our situation.

Tony Ren
Analyst, Macquarie

Okay. Understand very well. Yeah, thank you very much. My second question is either to Abe-san or Zhang. This is about your siRNA platform. Can you tell us a little bit about your siRNA platform? You know, would it be hepatic delivery of siRNA? Would it be extrahepatic? What type of molecular targets would you be looking for, looking at? What diseases or indications are you exploring? Yeah. Thank you.

Yuki Abe
Senior Executive Officer and Head of R&D, Daiichi Sankyo

Thank you very much for your question. siRNA and the research, I believe your question is related to that. this time Well, we have presented to you these, one of the three, BGT candidate on slide 66. We have multiple BGTs for development candidate. Today, we will not be able to tell you about the targeted disease, but other than oncology, we would like to fulfill this. Hepatic or non-hepatic, you have asked that question. Including hepatic and non-hepatic for targeting multiple organs. sRNA, we would 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. As we have been doing this, when we conduct a phase I trial. We would like to explain to you once we get to that. sRNA, we are hoping, and we have high expectation to fulfill, this, trajectory. I hope that answered to your question.

Tony Ren
Analyst, Macquarie

Yes. Yeah. Thank you very much.

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

Next, J.P. Morgan's Seiji Wakao.

Mr. Wakao from J.P. Morgan Securities, please.

Seiji Wakao
Analyst, JPMorgan

Hi. Wakao from J.P. Morgan Securities. </edited_transcript

Wakao from J.P. Morgan Securities, thank you very much for naming me. I also have two questions. First, in order to achieve more than a 3 trillion yen in 2030, what is going to be needed? According to my understanding, Datroway lung cancer success is a prerequisite. Avanzar, TL zero seven, TL zero eight, and also fifteen as well, main is TL zero seven and zero eight and Avanzar studies. How many of these studies should be successful for you to achieve your goal? Avanzar may be successful, TL zero seven, zero eight successful. That would be the best scenario. Avanzar may not be successful. Zero seven alone may be successful. Which one should be successful for you to achieve this goal? As of now, you don't have the data yet.

it's going to be risk-adjusted, but, incorporating this, means that you are very confident. You feel confident and, any data we haven't seen yet, although you may have such data in the background, AVANZAR, TL07, 08, similar to 02 and 04. Are you seeing updates of which are not published yet? Are you increasing confidence? Sorry for my long answer. In addition, you want to build lung cancer leadership. That's a very high hurdle to clear because Merck, TROP2, is one competitor. Pfizer has ADCs. Bispecific antibodies are being developed by several companies. Why you're confident about TROP2 antibody? I want to know based on the competitive landscape. That's my first question to you.

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

Wakao-san, thank you very much. It's a broad question, which was off-topic. Ken and John are going to respond. Ken first, please.

Ken Keller
Director and Head of Oncology Business Unit, Daiichi Sankyo

Sure. Thank you very much for the question. I'll put my answer in context to what our CEO, Okuzawa, showed earlier. We've got over 20 pivotal trials that are gonna read out over the next few years, and that provides us with many shots on goals to help patients and to hit that three trillion dollar target. When we specifically look at Datroway, it's important to remember that AVANZAR is just one of four first-line non-small cell lung cancer trials. AVANZAR will be the first one to read out, but then we've got TL zero seven, as you mentioned, TL zero eight, and TL ten. 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. 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.

John Tsai
Head of Global R&D, Daiichi Sankyo

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. For example, from TROPION-Lung01, what we saw was that in the non-squamous population, we had a doubling of the overall response rate for that specific population. Even further, what we were able to do is demonstrate prolonged duration of response and have meaningful response, meaningful improvement in progression-free survival. We were able to incorporate those learnings for the AVANZAR study. 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 AVANZAR. 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. We are confident based on what we know, and these are the reasons why we test these experiments. 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.

Seiji Wakao
Analyst, JPMorgan

TL 04, 02 updates.

John Tsai
Head of Global R&D, Daiichi Sankyo

Our data are not available for you, and you haven't seen it yet.

Seiji Wakao
Analyst, JPMorgan

Understood.

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 J.P. Morgan's question. There's a bottom for 2027. Is my understanding correct? 2027. For I believe for the full year impact, 2028. I believe that 2027 does not necessarily be the bottom. 2027 would be the bottom. Is my understanding correct? Not 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 support that?

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Thank you very much for your question. I know that back in January conference, I did talk about that. I know that's Otomo reasons why it come to this question. This 2027, it is very challenging. We are very much aware of that in terms of our forecast. To that end, ENHERTU, a milestone, will. No further sales milestones for ENHERTU. That would give us a Will be impacted tremendously and also for milestones close to JPY 100 billion. That would straightforwardly impacting the bottom line. Against the backdrop for OP slightly decline. This is for 2027. For core OP, and also divestment of Daiichi Sankyo Healthcare. Conversely, this would be recognized in 2027 as a profit. By looking at this operating profit, conversely, core OP drops, and we'll be able to supplement for the losses.

As you have put it, Lixiana LOE. 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 country's LOE impact of Lixiana LOE may be impacted. Conversely, in Japan, there's a prolongation of the patent duration. The impact in Japan in 2029 or after 2029, including ASCA region, Lixiana LOE impact. There are differences amongst the regions that also need to be factored in, and that is going to be impacting us steadily. As our Kodama CEO have explained, when it comes to our operational excellence, this is an all-company effort for the past five years.

In this five years, we are going to put that at our forefront. As the positive impact will be garnered toward the end of the five-year plan, 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. If that's the case, 2028, you do not have any plans to sell off other assets.

Seiji Wakao
Analyst, JPMorgan

Understood. Thank you very much.

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

Next, Matsubara-san from Nomura Securities, please.

Hiroyuki Matsubara
Analyst, Nomura Securities

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

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

Thank you for your question. We think there is sufficient possibility that we can achieve this goal and achieve the results. From FY 2026, 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, U.S., and Japan, one by one Global One Instance ERP is launched one after another in these regions. ERP platform would be leveraged. Globally, highly reliable data can be obtained from our data. Such as procurement can handle what could not be done before, optimization of procurement and purchasing globally can be implemented. Another thing is the leveraging AI. 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. This is a new initiative. 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 6th 5-year business plan, we want to achieve a big growth. Regarding the talent demand in the conventional headcount plan, the human resources just increase gradually over time. 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. This is a new project, we try to achieve great results. We have these two pillars to implement business transformation. Thank you very much.

Hiroyuki Matsubara
Analyst, Nomura Securities

Thank you very much with high accuracy. The second part of my question is that for a strategy for sales. What you have made a comment earlier about this 5 ADCs, and beyond that it is going to be in-house sales. Any take on the situation, please? Thank you for your question. This time therapeutic area. We have the oncology conventionally and also specialty. We have 2 pillars. We have categorized them into 2 pillars, we have been designing our sales team as well. In the 5th midterm, in U.S. and Europe, oncology team, we wanted to encompass those areas and thereby reinforcing our oncology unit accordingly.

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

We know discovery research team not dedicated to this oncology alone. In the sixth midterm 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-house. We have abundant asset for oncology development and also the early stage specialty assets that resides in the five-year for the sixth midterm. We would like to have and incorporate our inter-portfolio management. Oncology and specialists as a sales team actively rolled out respectively but rather under the auspices of one Chief Commercial Officer to oversee the activities across the board. Oncology or non-oncology and the values of the asset can be identified to optimize the portfolio. This is what we would like to consolidate this sales activities. as you have put it, beyond that point, the commercialization from, you know, our in-house, that is certainly in the scope.

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

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

Speaker 20

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 Ogihara from Corporate Communications. If you have multiple questions, please ask one by one. Each person can ask up to 2 questions. When you ask question, please mention first whom your question goes to. If you have questions, please press the Raise Hand button at the bottom of your screen. The first question. Yasukawa Yasukawa-san, please.

Speaker 19

Can you hear me?

Speaker 20

Yes, we can hear you.

Speaker 19

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 cost and personnel costs impact are already incorporated in here?

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Thank you for your question. In FY 2026 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 your 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. Compared to other industries, such an impact would be relatively smaller compared to other industries.

Speaker 19

Thank you very much. Compared with other industries, there's less impact and my apologies for the follow-up question. In that, what would be the biggest impact? Whether it be energy costs and the personnel cost and the logistics cost, among others.

Tomohiro Kodama
Senior Executive Officer and CFO, Daiichi Sankyo

Thank you for your question. When it comes to the overseas operation, now it starts to expand all the more, and personnel cost and inflation cost. When it comes to the activities, the, those costs related to the operation, globally, have risen.

Speaker 19

Thank you very much. That's all for myself.

Speaker 20

Next, Nihon Keizai Shimbun newspaper, Nakada-san, please.

Speaker 18

Can you hear me?

Speaker 20

Yes, we can hear you.

Speaker 18

Nakada from Nikkei Shimbun. I have a question to Mr. Okuzawa, CEO. Looking at the stock price, it's now declining. 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?

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

Thank you for your question. How to think about the stock price was a very straight question from you. Of course, we are not satisfied with the current level of the share price and our corporate value. We'd like to recover the stock price in line with the inherent corporate value. To that end, the 6th five-year business plan was presented today to you. We have 2030 financial KPIs, top line, bottom line, specific targets, and earnings per share and shareholder returns were explained. Our 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 five-year, 6th five-year business plan. We will execute the 6th five-year business plan to the full to increase the stock price. That's our determination.

Speaker 18

Thank you very much. Second part of the question, this may, this relate to the dividend and payout and the shareholder return. DOE, adjusted DOE that you have put together. As for the share buyback and the policy in the 6th 5-year business plan, what is your policy going forward?

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

With regards to this, a shareholder return and as a mode of the fundamentals, we are going to have progressive dividend and being on that level. Adjust the DOE with a target of 10% annually or more. This is a progressive dividend. To the shareholders and the investors, in 5 years' time, the dividend, JPY 100 as serving as a basis for 2026 will stably risen. 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. I would think that such flexible buyback will be considered at any given time. As a policy of the shareholder return, so we are going to have this progressive dividend and DOE 10%, adjusted DOE 10% or higher annually. We would like to commit to this.

Speaker 18

Thank you very much.

Speaker 20

Next, Nikkei BP, Kikuchi-san, please. Kikuchi from Nikkei BP and Nikkei Biotech. Can you hear me?

Takahiro Kikuchi
Analyst, Nikkei BP

Yes, we can hear you. Thank you very much.

Ari Fujishiro
Head of Investor Relations and Shareholder Relations, Daiichi Sankyo

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

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

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

Yuki Abe
Senior Executive Officer and Head of R&D, Daiichi Sankyo

Thank you for your question. Regarding BGTs, we have six technologies and we can get these are patentable, and there can be a high impact on treatment. These are new drug discovery technologies. Towards 2035, we try to realize the launch of these, and we will promote our R&D activities. I want to respond, but there are any additional questions from you?

Takahiro Kikuchi
Analyst, Nikkei BP

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

Yuki Abe
Senior Executive Officer and Head of R&D, Daiichi Sankyo

Please turn to page 65. These are the new BGT candidates based on ADCs. The cytotoxic, novel cytotoxic payloads. As you may know, we are leading the topo 1 inhibitor, isomerase inhibitor as a top innovator. Such ADCs are in the clinical stage, had drug resistance, and the next drugs are needed because of the resistance. We are anticipating that early on in research. We need a mechanism, new mechanism action, to overcome, the ADC resistance. The novel cytotoxic payloads can be very innovative

We can propose innovative ADCs. Top 1 ADC have been developed, and a similar impact can be expected in this technological development, IO ADC field. It's not turned into product yet by anyone yet. As there was a question, our proprietary IO ADC R&D is now underway, and novel IO payload ADCs being researched. ADCs at 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. That's why we are showing this. On the next page, non-ADC candidates are shown on this page. As you can see, multi-specific antibodies, and other companies are also interested in TPD molecules. This is leveraging our strengths in drug discovery.

We have multiple development candidates. siRNA, in non-oncology fields, we are going to pave the way as well. By focusing on these six, a company like us in terms of the size, you cannot do all different types of research. We try to focus on these in our R&D activities. Over the past five years, we had to stop technology development for some, but now we are beginning to focus on these six. Did I answer your question?

Takahiro Kikuchi
Analyst, Nikkei BP

Yes. Thank you very much. That's all from me. Thank you.

Yuki Abe
Senior Executive Officer and Head of R&D, Daiichi Sankyo

Thank you very much.

Speaker 20

Next question. Asahi Shimbun. Mr. Izawa.

Speaker 17

I am Izawa from Asahi Shimbun. First, in the U.S., tariff impact, I would like to understand about U.S. tariff impact. What was the size of the impact? Also for this, impacted by the drug price, MFN, Most Favored Nation. How much impact are given? Also in the Japanese market, it may. There's a concern raised that the innovative drug may not make inroads to the Japanese market. What is your take on the situation? Do you have any visibility on data?

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

Thank you for your question. First, for the tariff impact, 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, we did not have any particular impact that has not been incorporated into our plan. Back in April, this is the presidential order in April, and also amongst the couple of the pharmaceutical drug category, and they're going to waive the tariff on those, and among which was ADC. Our development, our core mainstay. For now, the U.S. tariffs threat or impact, at this point in time, we do not 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. With that tone, with the executive order that came published in April, there may be incentives that was the have been depicted in various areas in the executive order. ADC was not in scope for that. That is good. We should not be complacent, and we should not feel too optimistic. We are going to continue to pay close attention to policy. For MFN, for this has to do with the U.S. administration, and they have set forth a series of the policies. To a certain level, we have factored in to our plan when we formulated the sixth midterm.

The impact given to the Japanese market, it started to hear quite often about that. We are one of the corporations having the global traction. 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. In the medical community, and we have been working closely to the ministry, the regulatory affairs authorities, and for the betterment of the patients. We will certainly continue to provide the treatment to the patients.

Speaker 17

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

Hiroyuki Okuzawa
President and CEO, Daiichi Sankyo

MFN reflection onto the five-year business plan for the specifics allow us to refrain from disclosing the details.

Speaker 17

Understood. Thank you very much.

Speaker 20

Next question is Ayisha Sharma from Endpoints News. Please go ahead.

Ayisha Sharma
Analyst, Endpoints News

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.

Ken Keller
Director and Head of Oncology Business Unit, Daiichi Sankyo

Yep. Thank you for the question. This is Ken Keller. When we look at our revenue going forward to deliver that JPY 2.3 trillion, as we mentioned earlier, today within HER2 and Datroway, Daiichi Sankyo is one of the leading companies in breast cancer. When we look at the over 20 key pivotal trials that will read out over the next few years, many of those add to our strength in breast cancer. When we look at 2026, we actually expect in HER2 to move into the early stage breast cancer setting where a cure is the goal. We've got two trials that have already demonstrated standard of care changing data, DESTINY-Breast11 and DESTINY-Breast05.

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. To add to that, with a number of our drugs like I-DXd, that John mentioned earlier, and with all the different lung cancer trials that we have with Datroway, we're gonna add to our strength and become a leader in the lung cancer setting as well. Your specific question is about what %. Today the majority of our oncology sales are in breast cancer, and given on the strength of our emerging data, I feel it's gonna stay that way for at least the next couple of years. In the back half of the sixth midterm plan, we're gonna see tremendous growth in lung cancer. I hope that answered your question.

Speaker 20

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.

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