Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Investor Day (March 2026)
40 slides from Astellas Pharma's investor day presentation, Mar 31, 2026
Slide 1: Astellas R&D Day
Astellas R&D Day Pioneering science to change tomorrow March 31, 2026 1 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 2: Cautionary statement regarding forward-looking information
Cautionary statement regarding forward-looking information In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These state
Slide 3: Contents
Contents From CSP2021 to Today – I Presenters Delivering VALUE to Patients Transforming Our R&D Organization and II Capabilities to Deliver for Patients Faster Naoki Okamura President and CEO III Advancing Our Pipeline to Pioneer Tomorrow's Science Tadaaki Taniguchi, MD, PhD Looking Ahead: Chief Res
Slide 4: On the forefront of healthcare change to turn innovative science into VALUE
On the forefront of healthcare change to turn innovative science into VALUE for patients Outcomes that matter to patients VALUE = Cost to the healthcare system of delivering those outcomes 4 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 5: Our unique Focus Area approach drives innovation at Astellas
Our unique Focus Area approach drives innovation at Astellas BIOLOGY MODALITY / Unlocking new ways to Understanding the TECHNOLOGY treat challenging biology of disease diseases where patient Harnessing the most and impact on patients' lives advanced science and need is the greatest a versatile toolb
Slide 6: Four flagship assets with breakthrough potential from our Primary Focuses
We are advancing four flagship assets with breakthrough potential from our Primary Focuses IMMUNO- BLINDNESS AND ONCOLOGY R E G E N E R AT I O N ASP2138 – a T-cell engager with the ASP7317 – one of the first ever potential to be a first-in-class therapy in ophthalmic cell therapy derived from notori
Slide 7: This disciplined, focused approach is delivering VALUE for patients
This disciplined, focused approach is delivering VALUE for patients CSP2021 enabled us to focus on accelerating higher-quality science, with stronger execution discipline and sustainable productivity Accelerated the pipeline • 12 Phase 1 FSD NMEs • 1 Phase 3 study initiated on an NME • 4 PoCs*, vali
Slide 8: We are building on this momentum as we inflect to growth
We are building on this momentum as we inflect to growth Astellas is managing its transition with focus and control Illustrative Maximize Revenue Elevate the peak and flatten the dip Pipeline XTANDI REVENUE Accelerate Pipeline Expected sales contribution in 2030s Strategic Brands Operational Efficie
Slide 9: Enabled by our end-to-end model with patient VALUE at the center
Enabled by our end-to-end model with patient VALUE at the center From discovery through development to delivery, aligned around patient VALUE Patient Axis VALUE Creation VALUE Delivery Innovation Customer Engine Engagement Research & Commercial & Development Medical Affairs VALUE Enablement Corporat
Slide 10: Our Focus Area approach is translating into early clinical progress
Our Focus Area approach is translating into early clinical progress Key Modalities Pre-PoC PoC achieved In market Disease Areas Primary Focuses VIR-5500 ASP5541 Genitourinary Prostate cancer cancers • Protein ASP2998 degraders Lung cancer • T-cell ASP1002 ASP5834 ASP3082 engagers Gastrointestinal •
Slide 11: For those living with serious diseases, science can change everything
For those living with serious diseases, science can change everything From treating the toughest cancers, freeing people from the limits of chronic illness, to reimagining life after organ transplant, scientific breakthroughs are changing lives every day But too many patients are still waiting 11 ©2
Slide 12: We are delivering VALUE at global scale
We are delivering VALUE at global scale Our transformative therapies in oncology, ophthalmology, urology, women’s health and immunology have improved millions of lives Astellas’ products We’re broadening access and unlocking new have reached possibilities across earlier and more extensive more than
Slide 13: Translating scientific innovation into patient benefit across multiple diseases
Translating scientific innovation into patient benefit across multiple diseases with high unmet needs Adding nearly 3 Helping patients with Delaying prostate extra months of life Slowing bladder cancer live First-in-class cancer progression by in gastric cancers geographic twice as long non-hormonal
Slide 14: PADCEV is redefining outcomes for patients with muscle-invasive bladder cancer
PADCEV is redefining outcomes for patients with patients with muscle-invasive bladder cancer EV-304: perioperative enfortumab vedotin + pembrolizumab significantly improved EFS and OS and increased pCR vs. neoadjuvant chemotherapy Primary Endpoint: EFS by BICR ITT Population Data presented at ASCO G
Slide 15: We are advancing a focused pipeline in synergy with our Strategic Brands
We are advancing a focused pipeline in synergy with our Strategic Brands As of March 2026 Prostate Cancer Phase Upper GI and Pancreatic Cancer Phase Acute Myeloid Leukemia Phase Solid Tumors Phase XTANDI (enzalutamide) In market VYLOY (zolbetuximab) XOSPATA (gilteritinib) setidegrasib (ASP3082) In m
Slide 16: A clear path to deliver a dynamic, competitive portfolio
We have established a clear path to deliver a dynamic, competitive portfolio to fuel long-term growth 2030-2034 2027-2029 2024-2026 Excel • R&D productivity trending toward top-level industry Enrich the Pipeline performance • Increase quality and coherence of • Deliver consistent high-value, the pip
Slide 17: Transforming Our R&D Organization and Capabilities to Deliver for Patients Faster
Transforming Our R&D Organization and Capabilities to Deliver for Patients Faster 17 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 18: BOLD measures to increase productivity and efficiency
We have taken BOLD measures to increase productivity and efficiency, delivering tangible gains Driving Internal & Accelerating & Accelerating Clinical Fostering a External Maximize our Investing in Talent Trial Execution Data-Driven Culture Collaboration Pipeline 18 ©2026 ASTELLAS PHARMA INC. AND IT
Slide 19: Prioritizing our portfolio with discipline for maximum pipeline value
We are actively prioritizing our portfolio with discipline for maximum pipeline value High Advancement of 3 LCM activities Success Probability Expected shift Key Value Drivers in CSP2026 (“Pearl”) Stable Value Contributors Advancement 3 2 (“Bread and Butter”) 2 of programs 1 Low ROI (“White Elephant
Slide 20: Bringing clinical operations in-house enhanced clinical trial execution
By bringing clinical operations in-house, we have significantly enhanced our clinical trial execution to deliver innovative medicines to patients, faster Clinic Submission Approval • 69% reduction in time from • Median of 115 days from topline • 8 approvals in FY24/25 in IND to First Site Activation
Slide 21: Strategic investments in AI across R&D
Strategic investments in AI will help us improve speed, quality and decision-making across R&D Research Development and Manufacturing AI-enabled Protein Station to Increase Evinova AI-native Study Designer the speed and productivity of biologics platform to design smarter, more discovery patient cen
Slide 22: Research Centers of Excellence drive focused and connected innovation
Our Research Centers of Excellence drive focused and connected innovation to enrich our early pipeline ONCOLOGY RESEARCH CELL AND GENE I N N O V AT I O N L A B S Advancing early-stage cancer therapies THERAPY RESEARCH Harnessing the best external innovation through cutting edge-modalities Developing
Slide 23: Strong partnerships enhance and accelerate our innovation potential
Strong partnerships enhance and accelerate our innovation potential Biotech Collaborations Academic Collaborations Open Innovation 23 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 24: Development-ready supply at scale and with confidence
We can translate innovation into reliable, development-ready supply at scale and with confidence Advanced Technologies Across Resilient Global Network Modalities • Diversified manufacturing sites and • Small molecules and biologics technology centers across Japan, US, • Cell-based therapies Ireland
Slide 25: Advancing Our Pipeline to Pioneer Tomorrow's Science
Advancing Our Pipeline to Pioneer Tomorrow's Science ©2024 ASTELLAS PHARMA INC. AND ITS AFFILIATES. 25 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 26: Primary Focus Targeted Protein Degradation
Primary Focus Targeted Protein Degradation: Leading a new era of medicine by reshaping treatment expectations We are working to target “undruggable” proteins and transform treatment for patients Starting with cancer, we plan to expand to other diseases that need better treatment options Flagship pro
Slide 27: setidegrasib (ASP3082): Proof of Concept achieved with clear path to registrational studies
setidegrasib (ASP3082): Proof of Concept achieved with clear path to registrational studies Pancreatic ductal adenocarcinoma (PDAC) Non-small cell lung cancer (NSCLC) • Proof of concept achieved • Proof of concept achieved • Data presented at ASCO GI 2026 • Data presented at AACR-NCI-EORTC meeting O
Slide 28: setidegrasib shows antitumor activity in combination therapy in PDAC
setidegrasib (ASP3082) shows antitumor activity in combination therapy in PDAC Dashed lines at −30% represent PR,, per RECIST version 1.1. Asterisks represent unconfirmed PR per RECIST version 1.1 in patients with ongoing treatment. ORR/DCR analysis included all patients who received at least 1 dose
Slide 29: setidegrasib monotherapy in advanced NSCLC with KRAS G12D mutation
setidegrasib (ASP3082) monotherapy demonstrates deep and durable clinical activity, with no new safety signals, in patients with advanced NSCLC with KRAS G12D mutation Progression Free Survival (PFS) Objective Response Rate (ORR) ORR was 37.5% in the 2L/3L setting Median PFS was 11.2 months in the 2
Slide 30: Primary Focus Immuno-Oncology
Primary Focus Immuno-Oncology: Harnessing the immune system to generate deep and durable responses to prolong survival in patients with cancer We are working to identify, develop and deliver treatments by targeting multiple steps of the cancer immunity cycle Our early-stage platforms are built to tr
Slide 31: Our flagship asset, ASP2138, builds on our expertise from VYLOY
Our flagship asset, ASP2138, builds on our expertise from VYLOY CLDN18.2-expressing ASP2138 is a Claudin 18.2 (CLDN18.2) targeting bispecific antibody, cancer cell helping to activate T-cells and enhance their ability to kill tumor cells CD3+ T cell ⚫ Target disease: Gastric/GEJ (G/GEJ) adenocarcino
Slide 32: Strategic collaboration with Vir Bio to advance VIR-5500
Advancing next-generation modalities in prostate cancer: Strategic collaboration with Vir Bio to advance PSMA-targeting dual-masked T-cell engager VIR-5500* 99% PSA decline; 63% decrease in tumor diameter VIR-5500-V101 First in Human Phase 1 study: and a complete resolution of liver lesions presente
Slide 33: Primary Focus Genetic Regulation
Primary Focus Genetic Regulation: Treating neuromuscular and neurodegenerative conditions by correcting their underlying genetic causes We are focused on making adeno-associated virus (AAV) gene therapies scalable and accessible to more patients, with the ambition to address both rare and common dis
Slide 34: Primary Focus Blindness & Regeneration
Primary Focus Blindness & Regeneration: Realizing a brighter future for people with retinal diseases 1.1+ We are looking to preserve and restore vision with As populations blindness including treatments and regenerative medicines, age,a multi-modality approach of potentially transformative will keep
Slide 35: Looking Ahead: Sustaining Long-term VALUE Creation
Looking Ahead: Sustaining Long-term VALUE Creation 35 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 36: Building an innovation engine for the next generation of breakthrough medicines
We are building an innovation engine to deliver the next generation of breakthrough medicines at Astellas 2030-2034 2027-2029 2024-2026 Excel • R&D productivity trending toward top-level industry Enrich the Pipeline performance • Increase quality and coherence of • Deliver consistent high-value, the
Slide 37: With one goal in mind – creating VALUE for patients
With one goal in mind – creating VALUE for patients Accelerate Flagship Programs and LCM 1 Initiatives • Maximize LCM value • Accelerate Phase 3 start • Enroll faster and more efficiently 2 Focus on Follow-on Programs Take 10 New Molecular • Increase success rate of programs by Entities (NMEs) into
Slide 38: In Summary
In Summary 38 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 39: …to deliver long-term, sustainable growth and VALUE for patients
We have fundamentally transformed our R&D organization and operating model… • Successfully building global, end-to-end capabilities across our transformed R&D organization • Increasing R&D productivity through a disciplined, quality-driven framework • Accelerating and enriching the pipeline by focu
Slide 40: Q&A
Q&A ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.