DAIICHI SANKYO CO., LTD. Sunao Manabe President and CEO June 8, 2021
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ASCO 2021 Highlights DAIICHI SANKYO CO., LTD. Sunao Manabe President and CEO June 8, 2021 1 Forward-Looking Statements Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward looking statements were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are various inherent risks as well as uncertainties involved. As such, please note that actual results of Daiichi Sankyo may diverge materially from Daiichi Sankyo’s outlook or the content of this material. Furthermore, there is no assurance that any forward-looking statements in this material will be realized. Regardless of the actual results or facts, Daiichi Sankyo is not obliged and does not have in its policy the duty to update the content of this material from the date of this material onward. Some of the compounds under discussion are investigational agents and are not approved by the FDA or any other regulatory agency worldwide as a treatment for indications under investigation. Efficacy and safety have not been established in areas under investigation. There are no guarantee that these compounds will become commercially available in indications under investigation. Daiichi Sankyo takes reasonable care to ensure the accuracy of the content of this material, but shall not be obliged to guarantee the absolute accuracy, appropriateness, completeness and feasibility, etc. of the information described in this material. 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Daiichi Sankyo assumes no responsibility for any damages resulting from the use of this material or its content, including without limitation damages related to the use of erroneous information. 2 Progress since ASCO 2020 EnhertuⓇ Dato-DXd HER3-DXd Strategic alliance with AZ delivering: ◆ Formed strategic alliance with AZ ◆ Strong market introduction/penetration ◆ Accelerating clinical development through ◆ Initiated NSCLC 3L pivotal trial aiming for ➢ Addition of launched countries for the alliance earliest launch through in-house HER2 positive breast cancer 3L development ➢ NSCLC 2/3L ◆ New indications ◆ Initiated other NSCLC / CRC studies Initiate pivotal trial ➢ HER2 positive gastric cancer 3L (Japan), 2L (US) ➢ Ph1 TNBC cohort ◆ Steady progress for clinical development Acquired interim data ➢ Initiated nine studies for broad ➢ Initiated three other NSCLC studies cancer types CRC: colorectal cancer, NSCLC:non-small cell lung cancer,TNBC: triple negative breast cancer 3 5-Year Business Plan (FY2021-FY2025) for Sustainable Growth Under ESG management, we will realize our 2025 Vision, Global Pharma Innovator with Competitive Advantage in Oncology, 2030 Vision and will shift to further growth toward our 2030 Vision Innovative Global Healthcare Company Contributing to the Sustainable Development 5-Year of Society Business2021-2025 Plan (FY2021第5期中計-FY2025) ◆ Global top 10 in Oncology 持続的 ◆ Additional growth pillars being 年ビジョンを source of revenue and profit 2025Realize 2025 Vision ◆ New products being source of As of FY2020 and成長実現し shift to profit in each business unit ◆ Oncology business 成長ステージへfurther Growth ◆ Contributing to sustainable launched development of society ◆ Edoxaban growing through our business ◆ Regional value being enhanced ◆ AZ strategic alliance ◆ Increased RD investment 4 Strategic Pillars for the 5-Year Business Plan (FY2021-FY2025) Realize 2025 Vision and Shift to Further Growth Profit growth for current Identify and build Create shared value Maximize 3ADCs business and products pillars for further growth with stakeholders ◆ Maximize ENHERTU and ◆ Maximize Lixiana profit ◆ Identify new growth ◆ Patients: Contributing to Dato-DXd through drivers following 3ADCs patients through “Patient ◆ Grow Tarlige, Nilemdo, etc. Centric Mindset“ strategic alliance quickly ◆ Select and advance with AstraZeneca promising post DXd-ADC ◆ Shareholders: Balanced ◆ Transform to profit investment for growth and ◆ Maximize HER3‐DXd modalities structure focused on shareholder returns without a partner patented drugs ◆ Society: Environment load ◆ Expand work force and ◆ Profit growth for reduction across the value supply capacity flexibly American Regent and chain, and actions against pandemic risks depending on changes Daiichi Sankyo Healthcare around product potential ◆ Employees: Create one DS culture through fostering our core behaviors ◆ Data-driven management through DX, and company-wide transformation through advanced digital technology ◆ Agile decision making through new global management structure *3ADCs:1) ENHERTU, Trastuzumab deruxtecan(T-DXd, DS-8201) , 2) Datopotamab deruxtecan(Dato-DXd、DS-1062 ) and 3) Patritumab deruxtecan(HER3-DXd、U3-1402) 5 Cash Allocation for the 5-Year Business Plan (FY2021-FY2025) Prioritize R&D and capital investments for 3ADCs and pay dividends taking account of profit growth Image for cash allocation R&D Expense Prioritized investment for 3ADCs Operating Source for approx. Cash Flow cash allocation 1.5 Tr JPY before during 5-year R&D expense business plan during 5-year business plan CAPEX approx. Investment focused on enhancing ADC supply capabilities Investment Growthfor Investment 500.0 Bn JPY approx. Flexible allocation depending on pipeline progress 2.8 Tr JPY Flexible for 1) investment to build pillars for further growth Allocation - (in-house/external); and 2) acquisition of own shares Current cash in hands* Stable dividends and approx. Dividends Share holder 400.0 Bn JPY Returns dividend increase that take account of profit growth *Cash in hands excluding working capital 6 Financial Targets for the 5-Year Business Plan (FY2021-FY2025) Achieve significant revenue/profit growth ◆Revenue after investment for 3ADCs, and shift to a 1.6 Tr JPY new stage for realizing 2030 vision ➢ Oncology > 600.0 Bn JPY Revenue 960.0 Bn JPY ◆ Operating Profit* ratio % 303.0 before R&D expense: 40 Bn JPY Operating Profit* ratio before R&D expense: 32% ◆ ROE > 16% FY2020 Estimate FY2025 Target FY2016-FY2020 5-Year Business Plan (FY2021-FY2025) ◆ DOE > 8% Investment for 3ADCs Profit Growth *Excluding special items (gains and losses related to sale of fixed assets, restructuring, impairment, litigation, etc.) FY2025 Currency rate assumptions: 1 USD=105 JPY, 1 EUR=120 JPY 7 Focusing on the 2030 Vision and beyond Selection of post Research activities taking DXd-ADC advantage of our Identifying modalities strength in cutting-edge growth science and technology drivers following Steady global Maximizing 3ADCs development bringing 3ADCs Sustainable promising products Growth A strong leader that can effectively lead both “R” and “D”, and can assess/judge our next growth drivers is the key for sustainable growth 8 Leading Daiichi Sankyo to a New Phase 9 ASCO 2021 Highlights DAIICHI SANKYO CO., LTD. Ken Takeshita, MD Global Head of R&D June 8, 2021 10 Agenda 1 Introduction 2 ENHERTU®: New data & development plan 3 Dato-DXd: New data & development plan 4 HER3-DXd: New data & development plan 5 Future news flow 11 My Educational & Professional History Led full-scale global drug development programs across multiple tumor types panitumumab axi-cel romidepsin brexu-cel lenalidomide 12 Why Daiichi Sankyo Became My Destination What I saw from the outside, looking in… • Very strong internal research • Courage to change – ➢Cardiovascular to oncology ➢Japan focus to global focus • Early successes in regulatory approvals 13 My view and vision on our R&D To be a true global pharmaceutical company… Optimize the organization and cultivate human resources globally ◆ Competitiveness ➢Build upon our strengths to continually enhance our Science & Technology beyond 3ADCs • Cutting-edge science: next generation ADCs, mRNA, AAV, etc. ➢Implement unique modality strategies ◆ R&D unity ➢Research activities based on the right clinical questions, strong working relationship with development functions ➢Enhance smooth transition from research to development ◆ Global development ➢Strengthen clinical capabilities globally to accelerate the overall development speed ➢Grow and hire global talent 14 Daiichi Sankyo R&D Strategy ◆ 3 and Alpha strategy ➢ Prioritize investment and resource allocation to 3ADCs ➢ Alpha focuses on changing SOCs 3ADCs & Alpha Specialty ENHERTU® Dato-DXd HER3-DXd Oncology Vaccine Medicine Swift expansion into broader cancer Identify competitive assets using types & treatment lines reliable assessment capabilities and allocate appropriate resources 15 Our goals