Daiichi Sankyo Company, Limited

Daiichi Sankyo Company, Limited

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Q4 FY2026 · Earnings Call TranscriptMay 11, 2026

Ari Fujishiro

Thank you for waiting. We are going to start Daiichi Sankyo's FY2025 financial results announcement and FY2026-FY2030 5-year business plan presentation and discussion.

I'm delighted to serve as MC today. I'm Ari Fujishiro from the Investor Relations and Shareholder Relations department.

First, about the language. In this briefing session, 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 a presentation material in Japanese.

We have posted a presentation in both Japanese and English on our corporate website under IR Library, Financial Results Presentation Material, or IR Presentation 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 FY2025 financial results announcement, we will present FY2026 to FY2030 5-year business plan.

At the end, we will have time for Q&A with all the executives. We will entertain questions from investors and analysts until 8:00 p.m.

We will take questions from members of the media from 10 minutes past 8:00. Please note that this meeting is being recorded.

Thank you for your understanding. We're starting FY2025 financial results announcement.

Okuzawa-san, please.

Hiroyuki Okuzawa

Okuzawa speaking. Thank you very much for joining Daiichi Sankyo's FY2025 financial results announcement and 5-year business plan presentation and discussion out of your very busy schedule today.

First, we'd like to sincerely apologize for rescheduling the dates of FY2025 financial results announcement and 5-year business plan presentation and causing you inconvenience and concern. Due to the financial result forecast revision we explained the other day, we thought that explaining FY2025 financial results and 5-year business plan together would be the best way to help you understand the current situation of our company and the future strategy properly, we decided to reschedule the dates.

Today, we will explain FY2025 consolidated results first, and then the 5-year business plan. We will entertain your questions at the end after the two presentations.

Now, our new CFO, Kodama, will explain FY2025 consolidated results. Kodama-san, please.

Tomohiro Kodama

Kodama speaking. Please turn to page 5.

These are the topics we are going to cover today. R&D update will be explained by John Tsai, who has assumed the post of Head of Global R&D since April this year.

Please turn to page 6. This is the summary of the financial results.

I will explain the details on the following pages. Please turn to page 7.

I will explain an overview of FY2025 consolidated results. Revenue increased by ¥236.8 billion or 12.6% year on year to reach ¥2,123 billion.

Cost of sales increased by ¥25.6 billion from the previous year. SG&A expenses rose by ¥134.8 billion, and R&D expenditure increased by ¥29.3 billion year on year.

As a result, core operating profit increased by ¥47.1 billion or 15.1% year on year to reach ¥360 billion. Operating profit, including temporary gains and losses, decreased by ¥102.8 billion or 31% year on year to ¥229.1 billion.

Profit attributable to owners of the company decreased by ¥35.9 billion or 12.1% year on year to reach ¥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 ¥236.8 billion year on year. I will explain its breakdown by business unit.

First, Japan business unit. Sales increased for anticancer agent Dexprami, pain treatment Tarlige, direct oral anticoagulant Lixiana, etc.

On the other hand, revenue decreased for influenza treatment Inavir. In addition, we booked realized gains on unrealized gains of inventory for Daiichi Sankyo Espha in FY2024, Japan business revenue increased by ¥3.2 billion in total.

Next, let me explain our overseas business units. Here, forex impact is excluded.

In Oncology business, revenue increased by ¥152.2 billion due to the growth of Enhertu and Datopotamab sales. As for American region, revenue declined by ¥32.8 billion due to the impact of generic entry on iron deficiency anemia treatment Venofer and the impact of price competition on Injectafer and generic injectables.

Revenue for EU Specialty business increased by ¥21.7 billion as sales grew for hypercholesterolemia treatments Nilemdo, Nustendi. In ASCA business responsible for Asia, South and Central American regions, revenue rose by ¥38.1 billion due to the growth of Enhertu mainly in China and Brazil.

As for upfront payment and regulatory and sales milestone, etc., related to alliance with AstraZeneca and US Merck, we booked as revenue sales milestones, etc., we received from AstraZeneca in the fourth quarter, revenue increased by ¥32.5 billion. Forex impact increased our revenue by ¥21.8 billion in total.

Slide 9 shows the factors behind the change in core operating profit. I will explain the ¥47.1 billion increase by item.

As explained earlier, revenue increased by ¥236.8 billion, including a positive foreign exchange impact of ¥21.8 billion. Next, I will explain cost of sales and expenses, excluding foreign exchange impact.

Cost of sales increased by ¥19.9 billion, primarily due to the revenue growth and inventory valuation losses recorded in the second quarter for products including Enhertu. Selling, general, and administrative expenses increased by ¥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 ¥29.4 billion, due mainly to increased R&D investments associated with the progress of development of the 5 DXd-ADCs. The negative impact of foreign exchange totaled ¥7.1 billion, and the underlying increase in core operating profit, excluding foreign exchange effect, was ¥32.4 billion.

Next, I will explain the changes in profit for the period on slide 10. Core operating profit increased by ¥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 Amber, 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 ¥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 Aldevron plant, environmental remediation costs for former Yasugawa plant, and expenses associated with the next career support program implemented in Japan for the fourth quarter. As a result, operating profit of FY2025 decreased by ¥102.8 billion year on year to ¥229.1 billion.

Financial income and expenses had a positive profit impact of ¥10.9 billion, mainly due to improvements in foreign exchange gains and losses. Income taxes decreased by ¥56.5 billion due to a decline in profit before tax as well as an increase in R&D tax credits.

As for result, profit attributable to owners of the parent decreased by ¥35.9 billion year on year to ¥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 ¥18 year on year to ¥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 ¥200 billion share repurchase authorization in April last year and ultimately repurchased ¥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 FY2025 increased by ¥145.5 billion year on year to ¥698.4 billion. Combined revenue recognized by Daiichi Sankyo and AstraZeneca outside Japan reached $5 billion, triggering a sales milestone payment of $537.5 million, and we received ¥86 billion.

As for new indications obtained in the fourth quarter, in Japan, we launched the promotional activities in March for second-line treatment of HER2-positive gastric cancer and HER2-positive multiple solid tumors. In China, we obtained approval in January for second-line treatment of HER2-positive gastric cancer, and in March, we received the world's first approval for a neoadjuvant indication in HER2-positive breast cancer and launched promotional activities.

In addition, for existing indications, we have maintained the number one share of new patients starts in major countries and regions, and sales continued to grow steadily. Global product sales for FY2026 are forecast to increase by ¥162.9 billion year on year to ¥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 United States for neoadjuvant HER2-positive breast cancer and post-neoadjuvant HER2-positive breast cancer indications, which we hope will enable us to contribute to the treatment of patients with early-stage breast cancer.

Next, I will explain the sales performance of Dato-DXd. Please turn to slide 15.

Global product sales in FY2025 increased by ¥46.2 billion year on year to ¥47.6 billion. In addition to the steady market penetration of the breast cancer indication in Japan and the United States, the rapid market penetration of the lung cancer indication in the United States significantly increased the number of new patients, and the product was prescribed to a cumulative total of more than 4,900 patients globally, approximately 1.6 times higher than at the end of the previous 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

Thanks, Kodama-san. My name's John Tsai, and it's a pleasure to be here with you today.

I started my role at the beginning of April, and I've been in this role for over five weeks, and 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 spend time with them.

I've been really impressed with the innovation that's been coming out of the organization as well as the execution, and you'll be hearing about those as I go through the R&D update. As we move forward, I'd like to share with you the progress that's been made in 2025, also, and also share, looking forward, what will be happening in 2026.

Let's dive into the slide here. Let's go on the current slide here.

Enhertu demonstrated robust data in breast cancer in HER2-positive and HER2-low, ultra-low, going into 2025. In 2025, there was expansion into earlier lines and also into additional indications.

In the earlier lines of treatment in fiscal year 2025, we expanded into first-line HER2-positive breast cancer from DB-09. 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 DB-11 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 US.

Furthermore, in post-neoadjuvant setting from DB-05, 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 US, Japan, EU, and China.

With these indications, we also look to expand into earlier lines and into other tumor types. In 2025, we expanded into other tumor types, such as in gynecological cancers.

From DESTINY-Ovarian01, this trial was started in December of 2025, and we also started DESTINY-Endometrial01 and 02 trials, which, you can see, was started in June and also in December of last year. Let's go to the next slide, where we can go into the details of Enhertu DB-11 in the neoadjuvant setting.

As we said earlier, this was already approved in China. What we saw from DB-11 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 US.

Let's go to the next slide. Here is a summary of the current regulatory status for Enhertu.

We already heard that first-line DB-09 was approved in the US, and the neoadjuvant approval was already approved in China. We have additional approvals that we're waiting for results.

The post-neoadjuvant DB-05 has been accepted in the US, 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, and this is under priority review. This gives you a good snapshot of all of the progress that was made in Enhertu.

Now we'll turn into looking at Dato-DXd and the progress that was made there. Dato-DXd 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 Dato-DXd was obtained for EGFR-mutated patients from the TROPION-Lung05 study after patients had 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-01, 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 PD-L1-high positive patients.

We added this to the secondary endpoint for PFS and OS. Also 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've 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 are not eligible for PD-1 and when we saw the combined positive score less than 10.

This filing is under review in the US, Japan, and in China. In addition to earlier lines for Dato-DXd, we expanded into other tumor types.

You can see that we expanded into urothelial carcinoma in the phase 2/3 trial, which is TROPION-Urothelial03. This was started in October, where we will see Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin.

There was significant progress, as you can see here, made with Dato-DXd. 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 3 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 2 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, and we started a number of new first-in-human studies. For DX-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 NMD inhibitor which activates by increasing neoantigens, and 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-02 study in extensive-stage small cell lung cancer. As I said earlier, the results were shared at the WCLC congress that demonstrated almost 50% reduction in overall response in previously treated extensive-stage small cell lung cancer patients.

This application has been filed with the FDA and given breakthrough designation and given priority review just earlier last month, and we expect a PDUFA date in October of this year. Also, IDeate-02 phase 3 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 CRAC1 channel in immune cells, and this is in the area of immune diseases, as I stated earlier, and this is planned to start this year in the first half.

Go to the next slide, please. Based on all of these advancements, our R&D group has been recognized by the external community through a number of accomplishments, and we highlight two of them here.

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, and this was based on the first dual inhibitor of EZH1 and 2, and provides a new treatment option for all of those patients with a high unmet need with adult T-cell lymphoma. Let's go to the next slide, please.

Looking forward, I've shared with you a number of the progress and advancements made in 2025. If we look at 2026, there are a number of regulatory decisions that we're looking forward to this year.

As you heard, DESTINY-05 in the post-neoadjuvant HER2-positive breast cancer area, we're expecting the regulatory decision in July of this year. For Dato-DXd TNBC first-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. 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 regulatory submission and where we are evaluating the submission of REJOICE-01.

While we saw positive results, we're awaiting the expansion of the phase 2 data in order for the full submission. With that, you can also see some of the presentations that we will be sharing at ASCO later on at the end of this month.

With this, these are all the accomplishments and what we will be looking forward to in 2026. I will turn it back to Kodama-san for the fiscal 2026 forecast.

Thank you.

Hiroyuki Okuzawa

From here, Kodama will explain FY2026 forecast.

Tomohiro Kodama

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 FY2027 at Daiichi Sankyo Group.

In anticipation of the impact of this adoption, the definition of core operating profit is to be changed starting in FY2026, when the sixth 5-year business plan begins. You can find the table below to compare the previous definition and the new definition.

CMO compensation fees and write-down of inventories, which were recorded as temporary expenses in FY2025, are included in core operating profit under the new definition. Regarding the impact on FY2025 results due to change in the definition of core operating profit, please refer to an adjustment table on page 38 in the appendix.

Next, please turn to page 28. Let me explain FY2026 forecast.

Change in the definition of core operating profit, which I explained earlier, is reflected onto FY2025 results and FY2026 forecast figures. As for revenue, decline in 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 Dato-DXd, especially in the United States, we are forecasting revenue to increase by 7.4% or ¥157 billion year on year to reach ¥2,280 billion.

Cost of sales are increasing due to revenue expansions, but cost ratio is improving due to changes in our product mix, and CMO compensation fees are declining, we are expecting cost of sales to decrease by ¥80.3 billion. CMO compensation fees of ¥80 billion we are recording as cost of sales for FY2026 is the current estimate expected to additionally arise by the end of FY2026 due to short-term differences between our supply plan and the minimum purchase obligations to CMOs.

Specifically, this will be for 2028 to be included in FY2026 as the new firm order period. With regards to core operating profit, expenses are expected to rise due to sales expansion of Enhertu and Dato-DXd, which 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 ¥77.6 billion to reach ¥360 billion. Due to change in the definition of core operating profit, amortization expenses of intangible assets related to products will be classified as non-core expenses.

In addition, we're expecting EU Specialty business unit restructuring expenses, but non-core expenses are going to decline year on year, operating profit will go up by 37.5% or ¥85.9 billion to reach ¥315 billion according to our forecast. Pretax profit is expected to rise, but corporate tax will increase.

Due to the stock transfer of Daiichi Sankyo Healthcare, profit attributable to non-controlling interest is expected, we are forecasting profit attributable to owners of the company to be ¥260 billion, at a level similar to the previous year. Our forex assumptions are ¥150 against the US dollar and ¥180 against the euro.

Please turn to page 29. Here, let me explain FY2026 annual dividend forecast.

Under the sixth 5-year business plan, stable dividend will be distributed based on progressive dividends and adjusted DOEs. Adjusted DOE will be calculated based on adjusted shareholders' equity, which excludes items that fluctuate primarily due to share prices and exchange rates from total shareholders' equity.

Increase of dividend to ¥100 per share, up by ¥22 from ¥78 in FY2025, is planned in FY2026, marking the fifth consecutive years of dividend increases. Towards further growth under the sixth 5-year business plan, we will continue to enhance shareholder return.

That's all for the results. Next, we are moving on to the sixth 5-year business plan presentation and discussion.

Okuzawa-san, please.

Hiroyuki Okuzawa

Let me explain the sixth 5-year business plan. Please turn to page 46.

First, recap of the fifth 5-year business plan. Under the fifth 5-year business plan, we raised maximize 3 ADCs, profit growth for current business and products, identify and build pillars for further growth, and create shared value with stakeholders 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 Dato-DXd. Also, we entered into a strategic alliance with US 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. Dato-DXd provided new treatment option to patients with limited treatment options and also updated lung cancer strategies by implementing novel biomarker based on learnings from TROPION-Lung01 study.

As for the subsequent three ADC products, we revised the timing to launch HER3-DXd, but we are accelerating I-DXd and R-DXd development through our collaboration with US Merck. Growth is making progress for the DXd-ADC portfolio as a whole.

Regarding manufacturing and supply, we revised the supply plan and optimized the global supply chain. In addition, we resolved patent dispute with Seagen Inc., confirming DXd-ADC as Daiichi Sankyo's proprietary technology.

Please turn to page 48. Next, I will recap the progress for three strategic pillars and business foundations.

In the current business, specialty medicines such as Lixiana grew, while profit declined in the iron supplementation business by American region. Also, we advanced transformation toward an innovative medicine business structure through the transfer of shares in Daiichi Sankyo 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 5-year business plan and the final results as of March 2026.

Over the last five years, oncology business grew substantially. FY2025 revenue was ¥2,123 billion, and revenue in oncology was ¥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 FY2024, above the target, but was 15.8% in FY2025 as CMO compensation 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 FY2021 and FY2025, 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 5-year business plan between FY2026 and FY2030.

Next, we will explain the sixth mid-term 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 mid-term business plan toward the realization of Vision 2035.

Please turn to slide 53. Under the fifth mid-term 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 mid-term management plan, we aim to become an advanced global healthcare company that contributes to the sustainable development of society. The sixth mid-term business plan covering FY2026 through FY2030 aims to expand the oncology business through the establishment of an efficient and resilient organization, while also advancing the identification of breakthrough generating technologies, or BGTs, as new drug discovery technologies for sustainable growth, thereby driving toward the realization of our Vision 2035, a trusted healthcare innovator.

By 2035, we aim to become a global top five company in the oncology field, with the new BGTs following 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 FY2030.

We're targeting revenue of more than ¥3 trillion, operating profit of more than ¥600 billion, and EPS of more than ¥260. During the period of the sixth mid-term business plan, we will maintain progressive dividends and provide annual dividends with an adjusted DOE of 10% or higher.

Next, I will explain the strategies for achieving the sixth mid-term business plan and its quantitative targets. The first strategy is be a global top five oncology company by 2035.

Leveraging the strength of our 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 capabilities 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, and by delivering high-value information to healthcare professionals, we aim to provide medicines to more than 700,000 target patients annually. By expanding our pipeline and business and growing into a global top 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.

Please turn to slide 56. Through strategic collaborations with AstraZeneca and Merck in the United States, our oncology business has achieved significant growth.

Through obtaining more than 10 indications for oncology products such as Enhertu and Dato-DXd across more than 95 countries and regions, we have secured more than 270 reimbursement approvals in total, enabling us to deliver medicines to more than 240,000 patients. In addition to expanding through new product launches and additional indications, we have proactively invested in delivering medicines to a greater number of patients through evidence generation in real-world clinical practice, including more than 400 cumulative studies generating real-world data and the publication of over 100 papers annually.

Please turn to slide 57. Our oncology business grew to revenue of ¥954 billion in FY2025.

Under our growth strategy, Enhertu and Dato-DXd will continue to drive revenue growth over the next five years, with the aim of achieving oncology revenue of more than ¥2.3 trillion by FY2030. 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: R&D excellence to support development activities, business excellence to drive commercialization, and an optimized global supply chain. First, under R&D excellence, we will establish independent development capabilities aligned with pipeline progress by improving development speed through optimization of clinical development processes.

In addition, we will leverage technologies such as digital pathology to improve the probability of clinical trial success. We will also promote efficient R&D through the use of AI and digital technologies.

Next, under business excellence, we will rapidly launch multiple products and indications in order to maximize product value. We plan to launch more than 20 indications over the next five years and will deliver them to patients without delay following regulatory approvals.

In addition, through the continuous generation of evidence, we will provide high-value information and secure long-term product value through pricing and reimbursement strategies. Through these initiatives, we will maintain and expand our leadership in the breast cancer field, while also establishing a strong leadership position in the lung cancer field.

To support and realize this business growth, we will optimize our global supply chain and build a flexible and stable supply system. As introduced at the recent briefing, based on lessons learned from our past experience, we have revised our strategy to optimize the roles of both our in-house manufacturing capabilities and CMOs.

Through this approach, we will secure appropriate capacity over the medium to long term, ensure a stable supply of our 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 4 years and 3 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 assets, 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 1 trials. We will continue to actively expand these partnerships and accelerate first-in-human studies.

In addition, these phase 1 trial sites will share their experience in drug administration and adverse event management with late-stage trial sites around the world, with the aim of accelerating patient enrollment and improving trial quality. The second initiative is the utilization of digital technologies and AI.

We will leverage digital technologies and AI for biomarker discovery and research, as well as for analysis and utilization of the vast amount of data accumulated internally, as well as for improving efficiency in protocol development and site selection, thereby enhancing efficiency through the use of digital technologies and AI across various R&D processes and accelerating the overall development process. Next, we will explain business excellence.

Please turn to slide 60. We will continue to make R&D investments actively for DXd-ADC 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 the products rapidly across the world, including biomarker diagnosis, and we need to realize rapid market penetration for our products.

Throughout the product's life cycle, we will develop pricing and reimbursement strategy from global perspectives. We will also generate data and evidence continuously to secure long-term product value and aim to maximize product value.

Please turn to page 61. I mentioned that more than 20 pivotal studies data readouts are expected over the next five years.

We are assuming that $2 billion to $6 billion total peak sales potential readouts will continue every year over the next five years. From 2026 to 20...

FY2030, 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 Dato-DXd, we have established our 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 Dato-DXd. Especially for Dato-DXd, 10 phase 3 studies are ongoing right now.

We will promote biomarker research and exploration, identify target patients to deliver the drug appropriately so that we can build leadership in lung cancer as well. Please turn to page 63.

We believe that our DXd-ADC business is growing substantially with peak sales potential of ¥3 trillion or more. We will not only invest in the 5 DXd-ADCs where we are collaborating with our partners, but also invest actively in DS-3939 and DS-3790, etc., 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 DXd-ADCs 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 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. Then, we will establish end-to-end integrated capabilities from research and development to manufacturing to accelerate delivery of our new innovative medicines to patients.

DXd-ADC is a good successful example. Clinically validated technologies are being leveraged in the next programs by now.

Enhertu and Dato-DXd already launched, and five others are in development stage. Identify the next BGT programs is going to be our target during the sixth 5-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 topo I 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 1 study for ADC with new payloads in FY2027. Next, ADC with IO payloads.

By activating the immune system via the STING pathway, we're hoping to drive tumor cell elimination and improve long-term treatment results based on immune memory. As an ADC of this type, DS-3610 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 1 study in FY2027.

Please turn to page 66. Here, I will talk about three non-ADC BGT candidates from multi-modality research.

First, as an advancement in antibody engineering, we are developing multispecific antibodies. One example is T-cell engagers.

As our in-house product, DS-2243 phase 1 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 the longstanding medicinal chemistry with AI drug discovery. As we mentioned in previous results announcement briefing sessions, DS-9051 phase 1 study is ongoing right now.

Last but not the least, siRNA as a culmination of years of research in nucleic acid therapeutics. We have leveraged decades of our nucleic acid expertise such as research on Daichirona.

By integrating novel chemical modification technologies with DDS technologies, we will create nucleic acid therapies targeting multiple organs. We plan to start phase 1 study for the first program by the end of FY2026.

On page 67, I will introduce our programs in immuno-oncology. As is shown in this figure, we are broadly researching key mechanism of cancer immunology.

In each step, we are identifying promising assets. At present, many phase 1 studies are ongoing.

By 2030, we're 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 5-year business plan, up to FY2025, 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 5-year business plan period, multiple data readouts 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

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 R&D Center, research DX, and open innovation, we will create an environment that enables us to leverage our craftsmanship more effectively than ever before. A new research building in Shinagawa is scheduled for completion by the end of 2027, and we will also strengthen talent acquisition.

In addition, DX initiatives in the research field are also advancing, and the data-driven drug discovery project that had previously focused mainly on small molecules can now be applied to multi-modality research. We will continue to leverage AI to improve the efficiency of drug discovery.

Regarding open innovation, in addition to establishing three research institutes in Europe and the US, we plan to further strengthen our initiatives. Please turn to slide 70.

Here, as examples of the outcomes 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 partnerships.

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 US, Japan, and other countries. The growth of these out-licensed assets demonstrates 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 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 resources freed from conventional tasks through these efficiency gains, we will formulate and execute HR strategies that combine capability transformation through reskilling with optimal talent reallocation, thereby advancing talent allocation from the company-wide optimization perspective. In addition, we will further reduce costs by optimizing procurement processes through the global common ERP platform that has been rolled out sequentially across regions since last fiscal year.

Through the execution of these operational excellence initiatives, we aim to optimize costs by a cumulative total of more than ¥200 billion over the five years period of the sixth mid-term business plan, thereby enhancing our profit-generating capabilities and utilizing these gains for future growth investments and improved profitability. Please turn to slide 72.

Commercialization: to achieve a strong and sustainable growth, we will establish a new global organization responsible for centrally overseeing commercialization activities across all countries and regions, 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 expectations 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 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 mid-term 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 5-year period is expected to total approximately ¥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 ¥2.9 trillion will be allocated to R&D expenses, while approximately ¥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 investments, including acquisition of external assets and capabilities, to support sustainable growth beyond the mid-2030s. With regards to shareholder returns, we will introduce a progressive dividend policy and prioritize stable dividend payments, while considering flexible share repurchases, depending on the circumstances.

Please turn to slide 75. This slide illustrates our shareholder return policy and the outlook for annual dividends.

The annual dividend was ¥27 in FY2021 when the fifth mid-term business plan began, and has increased to ¥78 in FY2025 as we have continued to provide stable shareholder returns in line with profit growth. During the period of the sixth mid-term business plan, we will introduce a progressive dividend policy and maintain an adjusted DOE of 10% or higher each year as a key indicator, while continuing to provide stable shareholder returns through dividends.

For FY2026, we plan to increase the annual dividend per share by ¥22 to ¥100. Next, I will discuss our quantitative target for FY2030 and the outlook toward FY2035.

Please turn to slide 76. Looking toward FY2030, in addition to challenges such as the loss of exclusivity for 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 FY2027.

However, through the steady execution of the strategies outlined today in our sixth mid-term business plan, along with maximizing the value of our DXd-ADCs portfolio centered on Enhertu and Dato-DXd, we expect continued revenue growth throughout the plan period and aim to achieve revenue of more than ¥3 trillion in FY2030. On the profit side, while multiple challenges will converge in FY2027, 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 FY2030, targeting operating profit of more than ¥600 billion and EPS of more than ¥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 mid-term business plan period, we will invest approximately ¥2.9 trillion, an increase of about ¥1 trillion compared with the fifth mid-term 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 FY2030. 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 mid-term 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 ¥1 trillion in the early 2030s.

To achieve this, we will leverage the oncology expertise cultivated through our collaborations with AstraZeneca and Merck, and strengthen our capabilities to independently develop and commercialize our industry-leading pipeline backed by our science and technology, thereby enhancing our future earnings-generating potential. Finally, let me conclude with the summary.

Please turn to slide 77. Today, based on a review of the fifth mid-term business plan, we explained the sixth mid-term business plan aimed at realizing our Vision 2035, which defines where we aspire to be in 10 years.

The sixth mid-term 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 concludes my presentation.

Ari Fujishiro

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

Can you hear me?

Ari Fujishiro

Yes, we can hear you. Thank you.

Hidemaru Yamaguchi

Yamaguchi from Citigroup Securities. Thank you very much for the presentation.

My first question is about the 5-year business plan and also the FY2026 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 FY2026. You mentioned this is for 2028.

Until when this will continue? That's something I'd like to know.

It's not included in the 5-year business plan figures. CMO compensation fees will continue until when, although the amount is going to decline over time.

Could you explain?

Tomohiro Kodama

Thank you for your question. I'd like to respond.

Your question is about CMO compensation fees. In FY2026, ¥80 billion is included.

How much, or how long this is going to continue, you need some guidance on this. According to my understanding, regarding contracts with CMOs, there are multiple contracts.

Longer ones would be up to FY2030 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 FY2026, ¥80 billion is planned, and the amount is going to decline over time in the 5-year business plan. It's only for 2030 up to 2030, but based on assumptions, we have certain figures we incorporated for our assumptions.

If you say certain, it's incorporated.

Hidemaru Yamaguchi

Understood. The second point, I'm going to focus on the Dato-DXd.

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 the Dato-DXd, I would assume that that is the biggest contribution.

Are included, how that's going to come into this assumption for this year and the mid to long term? I would like to ask for your take on the situation.

Tomohiro Kodama

Thank you for your question. Dato-DXd and the numbers, for us, we do have for the adjustment, based on the adjustment of risk, including Dato-DXd, and there are such readouts of the outcomes for other studies, and have been incorporated into the numbers.

Hidemaru Yamaguchi

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

Tomohiro Kodama

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

Ken Keller

Thank you for the question. As we look at the fiscal 2026 expectations and the sixth mid-term plan, we do assume that the triple-negative breast cancer indication will be approved.

As the data was reported. It is highly differentiated.

We expect that when it is approved, and the PDUFA date in the US is pretty soon, it's in May. Everything we're hearing from the oncology community leaves us very confident that the doubling of overall response rate and the fact that it improved overall survival, physicians are waiting for this drug enthusiastically, and so we expect it will do very, very well.

Hidemaru Yamaguchi

Thank you very much.

Ari Fujishiro

Next question. UBS Securities, Mr.

Seki, please.

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 a share buyback, why you're going to use DOE with dividends?

There's no signaling of undervalue for the stock price. If you add these figures, it's already ¥3.6 trillion, ¥3.9 billion.

Are you going to do factoring? That's my first question to you.

Tomohiro Kodama

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.

It's also part of the question regarding shareholder return. Acquisition of own shares and dividends, how we're going to do this using the two.

For the time being, during this sixth 5-year business plan, we'd like to ensure profit generation, and we have commitments to this, and we also need to have confident. 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 has been used as an indicator, we 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, we continue to do this.

As for the share buyback, this will depend on the status of capital and also the size of business. Given that situation, our working capital is substantially increasing right now, we have to check the balance.

If the situation are proper 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're 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 research broadly if there is an appropriate things we'd like to work on that as well.

Thank you very much.

My second question. On slide 76, I like to direct a question to Mr.

Kodama. You're going to accelerate this, by R&D, ¥600 billion or so as it is written here, I would assume that SG&A going to be reduced tremendously, and OP ¥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 forecast and governance is in check, although did not have the US GAAP.

Tomohiro Kodama

For the profit and this building a robust foundation for profit growth and to sharply accelerate profit growth in FY2030, your question was about the rationale about this. To deduct the expense from the revenue, and for going toward 2030 to improve our profit, but 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 ¥200 billion to reduce that expense have been factored into this. On average, this isn't something that would be generated every year.

It's going to be skewed toward the end of the 2030.

Thank you very much. That's all.

Ari Fujishiro

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

Hashiguchi from Daiwa Securities. Thank you very much.

My question goes to Mr. Okuzawa or somebody you think is appropriate.

On page 63, DXd-ADC potential will be ¥3 trillion or more, and next BGT 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 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 5-year business plan, like 2020 at the earliest point, or you might have took longer than that.

It might have taken more than five years. If I calculate based on this, you talked about multiple BGT candidates today, but they haven't entered the clinical stage yet.

Phase 1 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 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

Hashiguchi-san, thank you very much. In the sixth 5-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

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 1 started. In 2019, approval was granted.

We created the oncology business as such. Today, we presented on the six technologies.

In the fifth 5-year business plan, there was a lot of growth. There, we filed for patents, and development candidates are prepared.

Multiple of them have been 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 are used as the basis to proceed with BGT approach, we are making good results based on that. The timing to contribute to 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're 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?

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, and 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 mid-term plan, and as with regards to R&D, there has been such discrepancies.

In all likelihood, is there a possibility for such inconsistency there? What is the basis for this R&D?

So ¥600 billion or ¥2.9 trillion, how did these figures come out? Thank you very much.

Hiroyuki Okuzawa

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

John Tsai

Thank you for your question regarding the spends on R&D. As Abe-san outlined, we will have a number of identified BGTs moving forward.

The specific spends for the R&D expenses have not yet been fully determined. 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.

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

Ari Fujishiro

Next question from BofA Securities, Mamegaya-san, please. Then the next question is SMBC Nikko Securities, Wada-san, please.

Sorry, next. Yes, Wada-san, please.

Wada from Nikko Securities, please. Thank you very much.

Hiroshi Wada

I have a question on the 5-year business plan. In FY2025, core operating profit before R&D was below 40%.

What's the reason why? In the next 5-year business plan, what would be the factors for you to achieve 40%?

Also, core operating profit and operating profit, you changed the focus, and what's the reason behind? Kodama-san, please.

Tomohiro Kodama

Thank you for your question. First, FY2025 core operating profit ratio under 40% and what are the factors behind, and number two, KPI for the sixth 5-year business plan, what's the background for changing from core operating profit to operating profit?

First, FY2025 core operating profit ratio before R&D below 40%, and why was your question. Cost of goods sold in the second quarter, Enhertu-associated write-down of inventories were incurred as losses, and Daichirona 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 5-year business plan, the change of our KPIs, operating profit ratio before R&D target is 40% in the fifth 5-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 5-year business plan, in our business, 5 DXd-ADCs, specifically Enhertu, Dato-DXd, 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

On page 65 and 66, there was a summary. You have uniqueness here.

IO payload, I think, is unique. STING agonist is the topic of my question.

This ligand, has that been overcome? If you bind with antibody, you will be able to maintain this.

Then there may be such solubility, improve the solubility of the compound. I like to ask you to elaborate about the property.

Hiroyuki Okuzawa

Yes, exactly the point. STING, ADCs, what we have been able to accomplish this, how it is going to be bind by that, and also how to control the solubility, and with our very stable ADCs, and this first 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 IO-ADCs.

Hiroshi Wada

Understood. Thank you very much.

Thank you very much.

Ari Fujishiro

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

Tony Ren

Hello, can you guys hear me?

Ari Fujishiro

Yes, we can hear you.

Tony Ren

Perfect. Thank you for taking my questions.

My first question is about the CMO compensation. That's probably to either Okuzawa-san or Kodama-san.

The CMO compensation fee you guys booked this year, a ¥169.5 billion, roughly about a little over $1 billion. This is really very large.

I happen to cover several CDMOs myself, including ones that specialize in antibody drug conjugates. My contacts in the industry tell me that this basically is equivalent to canceling contracts on drug sales of roughly about ¥850 billion, or roughly about $5.4 $5.4 billion.

I just want to 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.

That's my first question. Thank you.

Hiroyuki Okuzawa

Kodama-san, please.

Tomohiro Kodama

Thank you for your question. FY2025 results, we booked the provision for CMO compensation fees, and you are asking a question about the size of this amount.

On Friday last week, we explained, and 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, we factored in such a reality in the supply plan, and variances are 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.

Our demand plan we expected before and the current estimate have differences and variance, I hope you understand our situation.

Tony Ren

Understand very well. Thank you very much.

My second question is either to Abe-san or John. This is about your siRNA platform.

Can you tell us a little bit about your siRNA platform? Would it be hepatic delivery of siRNA?

Would it be extrahepatic? What type of molecular targets would you be looking at?

What diseases or indications are you exploring? Thank you.

Yuki Abe

Thank you very much for your question. siRNA and the research, I believe your question is related to that, and this time, what we have presented to you, one of the three BGT candidate on slide 66, this is 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. SiRNA, we would certainly like to deliver, and we have been engaging in the series of development.

We have been able to advance this, therefore, we have been able to identify multiple candidate compound. We, as we have been doing this, when we conduct the phase 1 trial, we would like to explain to you once we get to that.

SiRNA, we are hoping, and we have high expectation to fulfill this trajectory. I hope that answer to your question.

Tony Ren

Yes, yeah, thank you very much.

Ari Fujishiro

Next, JPMorgan Securities, Mr. Wakao, please.

Wakao from JPMorgan Securities. Thank you very much for naming me.

I also have two questions. First, in order to achieve more than ¥3 trillion in 2030, what is going to be needed?

According to my understanding, Dato-DXd lung cancer success is a prerequisite, AVANZAR, TL-07, TL-08, and also 15 as well. Main is TL-07, 08, and AVANZAR studies.

Which one, how many of these studies should be successful for you to achieve your goal? AVANZAR may be successful, TL-07, 08 successful, that would be the best scenario.

AVANZAR may not be successful, 07 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're very confident.

You feel confident, and any data we haven't seen yet, although you may have such data in the background, AVANZAR, TL-07, 08 are similar to 02 and 04. Are you seeing updates which are not published yet, and 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, Trop-2 is one competitor, Pfizer has ADCs, bispecific antibodies are being developed by several companies. Why you're confident about Trop-2 antibody?

I want to know based on the competitive landscape. That's my first question to you.

Hiroyuki Okuzawa

Wakao-san, thank you very much. It's a broad question with lots of topics.

Ken and John are going to respond. Ken first, please.

Ken Keller

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 going to read out over the next few years, and that provides us with many, many shots on goals to help patients and to hit that $3 trillion target.

When we specifically look at Dato-DXd, 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-07, as you mentioned, TL-08, and TL-10.

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

Just to add on to Ken's comments regarding the advancements that we've made in the lung space, we've 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, and even further, what we were able to do is demonstrate prolonged duration of response and have a meaningful improvement in progression-free survival.

We were able to incorporate those learnings for the AVANZAR study, and also based on that, what we were able to do was to advance further and to incorporate the biomarker, which is the TROP2 biomarker. This gives us the confidence from 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 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.

TL-04, 02 updates,

John Tsai

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

understood. For the second one, I'd like you to tell us about the 5-year ahead of our time and our visibility there, and perhaps relating to JPMorgan's question.

Then there's a bottom for 2027. Is my understanding correct?

I believe for the full year impact 2028, I believe that 2027 does not necessarily be the bottom. So 2027 would be the bottom, is my understanding correct?

If not 2027, in 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

Thank you very much for your question. I know that back in January conference I did talk about that.

I know that that's all the more 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 milestone, no further sales milestones for Enhertu, that would give us a will be impacted tremendously, and also for milestones close to ¥100 billion.

That would straightforwardly impacting the bottom line. Against the backdrop for OP slightly declined, 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 prolongment 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. That is going to be impacting us steadily.

As our Kodama CFO have explained, when it comes to our operational excellence, this is a whole-company effort for the past five years.

Seiji Wakao

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 5-year plan, therefore, after 2027, in 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, and so 2028 you do not have any plans to sell off other assets, that understood.

Thank you very much.

Ari Fujishiro

Next, Matsubara-san from Nomura Securities, please.

Hiroyuki Matsubara

Matsubara from Nomura Securities. Thank you for the presentation.

My first question is about the cost reduction. ¥200 billion in the five years, every year it's going to be larger according to the earlier comment, until you can achieve this if you take time.

What about the probability of achieving this goal?

Hiroyuki Okuzawa

Thank you for your question. We think there's sufficient possibility that we can achieve this goal and achieve the results.

From 20 FY2026, we had a global reorganization. One of the keys is the business transformation organization and function, which is newly established.

This is an organization directly under myself, CEO, the two major missions. First, from last fiscal year in Europe, US, and Japan, one by one, global one instance ERP is launched one after another in these regions.

ERP platform will be leveraged, and 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's 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're going to start this from the current fiscal year, this is a new initiative. Allocation of human resources and 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 head count as well. In the sixth 5-year business plan, we want to achieve a big growth.

Regarding the talent demand in the conventional head count plan, the human resources will just increase gradually over time, but by leveraging AI effectively, head count-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'd like to achieve great results. We have these two pillars to implement business transformation.

Thank you very much.

Hiroyuki Matsubara

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 two pillars. We have categorized them into two pillars, and then we have been designing our sales team as well.

In the fifth mid-term, in US and Europe, oncology team, and we wanted to encompass those areas, and thereby reinforcing our oncology unit. Accordingly,

Hiroyuki Okuzawa

on the other hand, discovery's research team not dedicated to this oncology alone. Therefore, in the sixth mid-term, some specialty to contribute to the business, we did not foresee that.

In the seventh mid-term, we can foresee, and there's a potential for that in-house. Therefore, we have abundant asset for oncology development, and also the early-stage specialty assets that resides in the five-year for the sixth mid-term.

We would like to have and incorporate into portfolio management. Therefore, oncology and specialist as a sales team activity rolled out respectively, but rather under the auspices of one Chief Commercialization 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 our in-house, that is certainly in the scope.

Ari Fujishiro

Others are still raising hands, but we are running over. With this, we'd like to close Daiichi Sankyo's FY2025 financial results and 5-year business plan presentation and discussions.

If you have further questions, please contact our IR team members. After this, from 10 minutes past 8:00, we will have Q&A for members of the media.

Thank you very much for joining today. Now,

we'd like to have a Q&A session for members of the media. I'm delighted to serve as MC for this Q&A.

I'm Ogihara from Corporate Communications. If you have multiple questions, please ask one by one.

Each person can ask up to two 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.

Nikkan Kogyo Shimbun, Yasukawa-san, please.

Can you hear me?

Yes, we can hear you.

Thank you very much. I'm Yasukawa from Nikkan Kogyo Shimbun newspaper.

I have a question to CFO Kodama-san. Regarding the financial forecast, operating profit and core operating profit are expected to grow both.

Cost increase, such as raw materials and distribution costs and personnel costs, in fact, are already incorporated in here?

Tomohiro Kodama

Thank you for your question. In FY2026 forecast, cost increase impact is incorporated is your question.

Recently, material costs are rising and distribution costs, including the geopolitical risks these days, are part of the question according to my understanding. Right now, what could be possible as of now, and regarding such cost increases, we are incorporating them to a certain degree, but compared to other industries, such an impact would be relatively smaller compared to other industries.

Thank you very much. Compared with other industries has 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

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, and also when it comes to the activities, other those costs related to the operation globally have risen.

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

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

Can you hear me?

Yes, we can hear you.

Nakada from Nikkei Shimbun. I have a question to Mr.

Okuzawa, CEO. Looking at the stock price, is now declining.

What's your view honestly regarding the stock price level? Do you have any measures you're going to take to raise the stock price?

Hiroyuki Okuzawa

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 we'd like to recover the stock price in line with the inherent corporate value. To that end, the sixth 5-year business plan was presented today to you.

We have 2030 financial KPIs, top line, bottom line, specific targets, and earnings per share and shareholder returns were explained. 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 5-year sixth 5-year business plan. We will execute the sixth 5-year business plan to the full to increase the stock price.

That's our determination.

Thank you very much. Second part of the question, this may this relate to the dividend and the payout and the shareholder return.

DOE, adjusted DOE that you have put together. As for the share buyback and the policy in the sixth 5-year business plan, what is your policy going forward?

Hiroyuki Okuzawa

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. Adjusted DOE with a target of 10% annually or more.

This is a progressive dividend. To the shareholders and the investors, in five years' time, the dividend, ¥100 as serving as a basis for 2026 will stably risen, and I would hope that you can expect that stably.

As for the 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 returns, we are going to have this progressive dividend and DOE 10%, adjusted DOE 10% or higher annually. We would like to commit to this.

Thank you very much.

Next, Nikkei BP, Kikuchi-san, please.

Takahiro Kikuchi

Kikuchi from Nikkei BP and Nikkei Biotech. Can you hear me?

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

Takahiro Kikuchi

This may be 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, and there were question from the analysts earlier, until they become actual product, it may take a long time according to the question.

Any technologies or technological points which can be worth being mentioned as BGT and how much profit they can generate potentially? Any view from you?

Hiroyuki Okuzawa

Thank you for your question. To contribute to business during the sixth 5-year business plan and beyond, beyond 2030, there's going to be a business contribution.

Abe-san, anything to add?

Yuki Abe

Thank you for your question. Regarding BGTs, we have six technologies, and these are patentable, and there can be a high impact on treatment.

These are new drug discovery technologies towards 2035. We'd like to realize the launch of these, and we will promote our R&D activities.

I want to respond, but there are any additional questions from you?

Takahiro Kikuchi

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

Please turn to page 65. These are the new BGT candidates based on ADCs.

The novel cytotoxic payloads, as you may know, we are leading the topo I inhibitor, topoisomerase I inhibitor, as a top innovator. Such ADCs are in the clinical stage.

Drug resistance and next drugs are needed because of the resistance. We are anticipating that early on in research.

We need a mechanism, new mechanism of action to overcome the ADC resistance. The novel cytotoxic payloads can be very innovative, and we can propose innovative ADCs.

Topo I 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. Novel IO payload ADCs are being researched.

ADC's topo I 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, as shown on this page, as you can see, multispecific antibodies, and other companies are also interested in TPD molecules. This is leveraging our strength in drug discovery.

We have multiple development candidates. SiRNA in non-oncology field, 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'd like 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

Yes. Thank you very much.

That's all for me. Thank you.

Yuki Abe

Thank you very much.

Next question. Asahi Shimbun, Mr.

Izawa.

I am Izawa from Asahi Shimbun. First, in the US, tariff impact, I would like to understand about US tariff impact, what was the size of the impact?

Also for impact by the drug price, MFN, most favored nation, how much impact are given? Also in the Japanese market, 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 that?

Hiroyuki Okuzawa

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 mid-term, 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 a couple of the pharmaceutical drug category, and they're going to waive the tariff on those.

Among which was ADC, our development, our core mainstay. For now, the US tariff 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 US tariff, the presidential order that came, for productivity, to have the production back to the US, with that tone, with the executive order that came published in April, there may be incentives that 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, this has to do with the US administration, and they have set forth a series of the policies, and to a certain level, we have factored in to our plan when we formulated the sixth mid-term. 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 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.

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

Hiroyuki Okuzawa

MFN reflection onto the 5-year business plan for the specifics, allow us to refrain from disclosing the details.

Understood. Thank you very much.

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

Ayisha Sharma

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 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

Thank you for the question. This is Ken Keller.

When we look at our revenue going forward to deliver that ¥2.3 trillion, as we mentioned earlier, today with Enhertu and Dato-DXd, 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 Enhertu to move into the early-stage breast cancer setting, where 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. Then to add to that, with a number of our drugs like I-DXd that John mentioned earlier, and with all the different lung cancer trials that we have with Dato-DXd, we're going to add to our strength and become a leader in the lung cancer setting as well.

Your specific question is about what percent. Today, the majority of our oncology sales are in breast cancer.

Given on the strength of our emerging data, I feel it's going to stay that way for at least the next couple of years. Then in the back half of the sixth mid-term plan, we're going to see tremendous growth in lung cancer.

I hope that answered your question.

There are others who are still raising their hands, but we are running over. With this, we'd like to close the Q&A session for members of the media.

If you have questions, please contact the Corporate Communications team at the company. Thank you very much for joining us today.