Astellas Pharma R&D Day Summary Company Overview - **Company**: Astellas Pharma - **Event**: R&D Day - **Key Speakers**: Naoki Okamura (CEO), Tadaaki Taniguchi (CRDO) Core Industry Focus - **Primary Focus Areas**: 1. Immuno-oncology 2. Targeted protein degradation 3. Blindness and regeneration 4. Genetic regulation Key Points and Arguments Vision and Strategy - Astellas aims to transform innovative science into value for patients, focusing on outcomes that matter to patients and the costs to the healthcare system [3][4] - The **Focus Area Approach** is employed to address high unmet medical needs, linking biology, modality, and technology [3][4] R&D Progress - Achieved proof of concept (POC) for three assets: ASP 2138, ASP 7317, and zitidagresib (ASP 3082) [5] - Over the past five years, Astellas accelerated its pipeline, achieving 12 phase II first subject doses and initiating one new phase III trial [5] - Terminated 21 clinical stage programs to reallocate resources to higher value assets, improving overall pipeline quality [6] Financial and Operational Strategy - Focus on maximizing sales of strategic brands to mitigate revenue decline from XTANDI's loss of exclusivity [8] - Implementing a new end-to-end operational model to enhance productivity and integrate research, development, commercialization, and lifecycle management [9] Pipeline Development - Building a robust pipeline with strategic brands, flagship programs, and follow-on programs [9][10] - Examples include the prostate cancer franchise and the acquisition of IZERVAY for geographic atrophy in age-related macular degeneration [10] Specific Program Updates - **Setidegrasib**: A targeted protein degrader for solid tumors with KRAS G12D mutations, showing promising results in pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) [24][25] - ORR of 58.3% in PDAC and 37.5% in NSCLC with ongoing phase III trials [26][28] - **ASP2138**: A bispecific antibody targeting claudin 18.2 in gastric cancer, preparing for phase III trials [30] - **ASP7317**: Achieved POC for severe visual impairment in geographic atrophy, moving towards phase III [34] Future Outlook - Astellas plans to transform its R&D organization and governance structure to enhance productivity from 2024 to 2026, aiming for significant improvements in R&D productivity by 2030 to 2034 [15][36] - Continuous investment in cutting-edge technologies, including AI and robotics, to accelerate drug discovery and clinical trials [20][21] Additional Important Insights - Astellas emphasizes the importance of portfolio discipline, making strategic decisions to discontinue low-value projects [6][45] - The company is actively collaborating with external partners and academia to enhance its R&D capabilities [22] - Astellas aims to maintain a 30% operating margin sustainably while investing in R&D and managing expenses effectively [53][58] This summary encapsulates the key points discussed during Astellas Pharma's R&D Day, highlighting the company's strategic focus, R&D progress, and future outlook in the pharmaceutical industry.

Astellas R&D Day Pioneering science to change tomorrow March 31, 2026 1 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. 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 statements are based on management's current assumptions and beliefs in light of the information c ...

Core Insights - Astellas Pharma is set to present significant clinical data at the ESMO congress, showcasing advancements in its oncology programs, particularly in muscle-invasive bladder cancer and hormone-sensitive prostate cancer [1][2][3] Astellas' Oncology Programs - The company will present ten abstracts, including new data for PADCEV (enfortumab vedotin) combined with pembrolizumab in muscle-invasive bladder cancer, which will be featured in an ESMO Presidential Symposium [1][2] - Final overall survival data for XTANDI (enzalutamide) in high-risk, biochemically recurrent non-metastatic hormone-sensitive prostate cancer will also be shared [1][2] Clinical Trials and Data - The EV-303 trial (KEYNOTE-905) will evaluate enfortumab vedotin plus pembrolizumab as neoadjuvant and adjuvant treatment in patients with muscle-invasive bladder cancer who are not eligible for cisplatin-based chemotherapy [3][4] - Long-term follow-up data from the EV-302 trial will explore the utility of enfortumab vedotin in patients with challenging baseline characteristics, including older patients and those with comorbidities [3][4] - The EMBARK trial will present final data assessing overall survival with enzalutamide in combination with leuprolide and as monotherapy in patients with non-metastatic hormone-sensitive prostate cancer [3][4] Innovative Treatments - Astellas is advancing its investigational bispecific T cell engager ASP2138, targeting CLDN18.2 in solid tumors, with initial clinical data being presented [2][3][5] - The company continues to explore treatment options for gastric and gastroesophageal junction cancers with new clinical data for ASP2138 [2][5]