Slide 1: FY2020 Financial Results Ended March 31, 2021
FY2020 FINANCIAL RESULTS ENDED MARCH 31, 2021 Kenji Yasukawa, Ph.D. President and CEO Astellas Pharma Inc. April 27, 2021
Slide 2: Cautionary Statement Regarding Forward-Looking Information
CAUTIONARY STATEMENT REGARDING FORWARD- 2 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 st
Slide 3: Agenda
AGENDA 3 FY2020 Consolidated Financial Results I FY2021 Forecasts II Initiatives for Sustainable Growth III Review of Corporate Strategic Plan 2018
Slide 4: FY2020 Financial Results
FY2020 FINANCIAL RESULTS 4 Change FY2020 Achieve- (billion yen) FY2019 FY2020 Change (%) FCST ment Revenue 1,300.8 1,249.5 -51.3 -3.9% 1,256.5 99.4% Cost of sales 276.7 246.1 -30.7 -11.1% % of revenue 21.3% 19.7% -1.6 ppt SG&A expenses 499.3 504.3 +5.0 +1.0% R&D expenses 224.2 224.5 +0.3 +0.1% 233.5
Slide 5: FY2020 Financial Results: Year-on-Year Comparison
FY2020 FINANCIAL RESULTS: 5 YEAR-ON-YEAR COMPARISON ⚫ Revenue and Core operating profit decreased, YoY ✓ Sales of growth drivers steadily increased ✓ Sales decreased due to termination of sales and distribution in Japan and loss of exclusivity ✓ Negatively impacted by COVID-19 mainly during Q1/FY202
Slide 6: FY2020 Financial Results: Comparison with Forecast
FY2020 FINANCIAL RESULTS: 6 COMPARISON WITH FORECAST ⚫ Revenue was slightly behind forecast, but achieved when adjusted to exclude FX impact. Core operating profit achieved ✓ FX impact (Revenue: -11.8 billion yen, Core OP: -6.5 billion yen） ✓ Steady performance for main oncology products ✓ In China,
Slide 7: FY2020 Financial Results: Revenue
FY2020 FINANCIAL RESULTS: REVENUE 7 Main oncology products continue to grow strongly FY2020 actual (billion yen) YoY XTANDI 458.4 +58.4 XOSPATA 23.8 +9.6 Total sales of 3 oncology products, YoY PADCEV 12.8 +11.0 +79.0 billion yen Evrenzo 1.1 +0.9 mirabegron 163.6 +2.0 New products in Japan 70.5 +9.3
Slide 8: FY2020 Financial Results: Business Update for Main Products
FY2020 FINANCIAL RESULTS: 8 BUSINESS UPDATE FOR MAIN PRODUCTS Global sales excl. FX impact achieved full-year forecast. US sales were slightly behind forecast due to XTANDI COVID-19 (slowdown of new patients' diagnosis and treatment initiation), but demand grew approx. 20% YoY and continued growth i
Slide 9: FY2021 Forecast
FY2021 FORECAST 9 FY2020 FY2021 (billion yen) Change (%) actual forecast Revenue 1,249.5 1,323.0 +5.9% SG&A expenses 504.3 541.0 +7.3% R&D expenses 224.5 242.0 +7.8% Core operating profit 251.4 270.0 +7.4% Core profit 209.9 213.0 +1.5% <Full basis> Operating profit 136.1 265.0 +94.8% Profit 120.6 20
Slide 10: FY2021 Forecast: Overview
FY2021 FORECAST: OVERVIEW 10 ⚫ Revenue and Profit to increase in FY2021 Core OP margin for FY2021 to be 20% ⚫ Main products and new products continue to grow. Growth to more than offset the impact of the LOE, termination of sales and distribution, transfer of products and NHI price revision ✓ Increa
Slide 11: FY2021 Forecast: Main Growth Drivers
FY2021 FORECAST: 11 MAIN GROWTH DRIVERS FY2021 Forecast FY2021 initiatives and growth factors • Drive market share in earlier stages of prostate cancer XTANDI 557.2 billion yen • Expand sales in the additional indication (M1 CSPC) in Established markets and International markets +98.8, YoY (+21.5%)
Slide 12: Agenda
AGENDA 12 FY2020 Consolidated Financial Results I FY2021 Forecasts II Initiatives for Sustainable Growth III Review of Corporate Strategic Plan 2018
Slide 13: Key Post-PoC Projects: Status Update
KEY POST-POC PROJECTS: STATUS UPDATE 13 (Underlined: Updates since Q3/FY2020 Financial Results Announcement in Jan 2021) enzalutamide enfortumab vedotin zolbetuximab M0 CRPC mUC Gastric & GEJ adenocarcinoma • EU: CHMP positive opinion received • Pretreated: • Phase 3 studies ongoing in Jan 2021 for
Slide 14: Enfortumab Vedotin (1/2): mUC Program Regulatory Status
ENFORTUMAB VEDOTIN (EV) (1/2): mUC PROGRAM 14 REGULATORY STATUS Filed in US, EU and Japan ⚫ US: Filed (2 sBLAs) in Feb 2021 and PDUFA set on Aug 17, 2021 a 1. To convert “Accelerated Approval” to “Regular Approval”, based on EV-301 study results 2. To expand the indication to include mUC, PD-1/L1 in
Slide 15: Enfortumab Vedotin (2/2): Phase 3 EV-301 Study Results
ENFORTUMAB VEDOTIN (EV) (2/2): mUC PROGRAM 15 PHASE 3 EV-301 STUDY RESULTS In patients with advanced UC who had previously received platinum-based chemotherapy and a PD-1/L1 inhibitor, ✓ EV monotherapy showed superior OS, compared with chemotherapy ✓ Safety profile was consistent with prior EV studi
Slide 16: Progress in Focus Area Approach: Genetic Regulation
PROGRESS IN FOCUS AREA APPROACH: 16 GENETIC REGULATION To build our position as a global leader in the field of genetic regulation “Astellas Gene Therapies” as Gene Therapy Center of Excellence of Astellas ⚫ Established (effective Apr 1, 2021), integrating our wholly owned subsidiary, Audentes Thera
Slide 17: Key Events Expected in FY2021
KEY EVENTS EXPECTED IN FY2021 17 Regulatory enzalutamide M1 CSPC (EU) decision enfortumab mUC, PD-1/L1 inhibitor pretreated and cisplatin ineligible (US a) vedotin mUC, platinum and PD-1/L1 inhibitor pretreated (US a,b, EU c) mUC, progressed after anti-cancer medication (JP) roxadustat Anemia associ
Slide 18: Progress in Rx+ Program (1/2): AI-Based Program for Holter Analysis Devices
PROGRESS IN Rx+ PROGRAM (1/2): DEVELOPMENT OF AI-BASED PROGRAM FOR 18 HOLTER ANALYSIS DEVICES Developed an AI-based data analysis algorithm for Holter ECG test through research collaboration with M. Heart ⚫ Developed an efficient analytical algorithm with low computer load (patent pending) ⚫ Data de
Slide 19: Progress in Rx+ Program (2/2): Key Events Expected in FY2021
PROGRESS IN Rx+ PROGRAM (2/2): 19 KEY EVENTS EXPECTED IN FY2021 Sphere * Program Expected key event Chronic disease Fitness service for exercise Initiation of pilot marketing for progression prevention support (Fit-eNce) at-home service Smartphone game application Initiation of pilot marketing for e
Slide 20: Sustainability: Access to Health
SUSTAINABILITY: ACCESS TO HEALTH 20 A new collaborative research agreement with TB Alliance to identify lead compounds for the treatment of tuberculosis ⚫ Astellas and TB Alliance have conducted joint research for exploration of new compounds for Mycobacterium tuberculosis since Oct 2017 ⚫ This new
Slide 21: Agenda
AGENDA 21 FY2020 Consolidated Financial Results I FY2021 Forecasts II Initiatives for Sustainable Growth III Review of Corporate Strategic Plan 2018
Slide 22: Review of Corporate Strategic Plan 2018 (Strategic Part)
REVIEW OF CORPORATE STRATEGIC PLAN 2018 22 (STRATEGIC PART) Initiatives aiming at 3 Strategic Goals advancing as planned. Building a foundation to create innovative treatments Strategic Goal 1 Strategic Goal 2 Strategic Goal 3 Maximizing Product VALUE and Evolving How We Create VALUE Developing Rx+
Slide 23: Progress in Post-PoC Projects
PROGRESS IN 6 POST-POC PROJECTS 23 Achieved all the targeted submission goals in Strategic Plan 2018 and obtained the global approvals As of Apr 2021 (Progress since May 2018 ) As of Apr 2021 (No update in phase since May 2018) Phase Project Indication Phase 2 Phase 3 Filed Approved enzalutamide M1
Slide 24: Progress in Focus Area Approach (1/2): Organic Application Among Multiple Primary Focus
PROGRESS IN FOCUS AREA APPROACH (1/2): 24 ORGANIC APPLICATION AMONG MULTIPLE PRIMARY FOCUS Enhanced utilization of innovative platforms among multiple Primary Focus and produced multiple promising projects May 2018 Apr 2021 Quethera Nanna Audentes Immuno- Regener- Mito- Potenza Immuno- Regener- Mito
Slide 25: Progress in Focus Area Approach (2/2): Organic Application of Cell Therapy Platform
Slide for Astellas R&D Meeting in Dec 2020 PROGRESS IN FOCUS AREA APPROACH (2/2): ORGANIC APPLICATION OF CELL THERAPY PLATFORM 25 TO REALIZE MULTIPLE PF STRATEGY Established cell differentiation protocols in multiple projects PF candidate Cell Therapy Platform PF - Blindness & - Immune Homeostasis R
Slide 26: Progress in Rx+ Program
PROGRESS IN Rx+ PROGRAM 26 Steadily progressed to establish a solid foundation ✓ Formulated Rx+ Story (strategic direction of Rx+ business creation) ✓ Established a US base for Rx+ business Successfully advanced multiple programs toward commercialization Chronic disease Service and smartphone applic
Slide 27: Review of Corporate Strategic Plan 2018 (Financial Part) (1/2)
REVIEW OF CORPORATE STRATEGIC PLAN 2018 27 (FINANCIAL PART) (1/2) Revenue was behind original forecast, but achieved Core OP margin including investment for sustainable growth (billion yen) Indicators FY2017 ACT FY2020 ACT FY2020 Guidance (Announced in May 2018) Revenue 1,300.3 1,249.5 ✕ FY2017 leve
Slide 28: Review of Corporate Strategic Plan 2018 (Financial Part) (2/2)
REVIEW OF CORPORATE STRATEGIC PLAN 2018 28 (FINANCIAL PART) (2/2) Product portfolio has changed in 3 years and sales of main products and new products grew significantly. Negative impact from LOE/ transfer of sales and distribution has almost ended. Aiming for mid- to long-term growth trend during t
Slide 29: Appendix
APPENDIX
Slide 30: FY2020: Revenue by Region
FY2020: REVENUE BY REGION 30 (billion yen) FY2019 FY2020 Change (%) Japan 345.4 279.1 -19.2% United States 443.5 473.2 +6.7% Established Markets 296.1 293.2 -1.0% Greater China 60.4 59.3 -1.8% International Markets 134.8 111.1 -17.6% Established Markets: Europe, Canada, Australia Greater China: Chin
Slide 31: FY2020: Sales of Main Products
FY2020: SALES OF MAIN PRODUCTS 31 FY2020 (billion yen) FY2019 FY2020 Change CER growth FCST * XTANDI 400.0 458.4 +14.6% +15.3% 464.6 XOSPATA 14.3 23.8 +67.2% +68.3% 23.1 PADCEV 1.8 12.8 +607.3% - 13.0 Evrenzo 0.2 1.1 - - mirabegron 161.6 163.6 +1.2% +2.3% 167.9 New products 61.2 70.5 +15.3% - in Jap
Slide 32: FY2020 Actual: FX Rate
FY2020 ACTUAL: FX RATE 32 Average rate for the period Currency FY2019 FY2020 Change USD 109 yen 106 yen -3 yen EUR 121 yen 124 yen +3 yen Change in closing rate from previous fiscal year end Currency FY2019 FY2020 USD -2 yen +2 yen EUR -5 yen +10 yen <Impact of exchange rate on financial results> ⚫
Slide 33: FY2021 Forecast: FX Rate & FX Sensitivity
FY2021 FCST： FX RATE & FX SENSITIVITY 33 Average rate for the period Currency FY2020 FY2021 FCST change USD 106 yen 110 yen +4 yen EUR 124 yen 130 yen +6 yen Change in closing rate from the previous FY end Currency FY2020 FY2021 FCST USD +2 yen -1 yen EUR +10 yen +0 yen Estimated FX sensitivity of F
Slide 34: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 34 (billion yen) FY2019 end FY2020 end Total assets 2,315.2 2,273.6 Cash and cash equivalents 318.4 326.1 Total equity attributable to owners of the parent 1,289.2 1,386.1 Equity ratio (%) 55.7% 61.0% (billion yen) FY2019 FY2020 Cash flows from operating activiti
Slide 35: Details of Shareholder Returns
DETAILS OF SHAREHOLDER RETURNS 35 (yen) (billion yen) 50 Dividends per Share* (left axis) Profit** (right axis) 250 2,500 40 2,000 200 50 30 42 1,500 150 40 20 100 1,000 10 500 50 0 00 (billion yen) FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20 FY21 (FCST) Total div
Slide 36: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 36 Phase 1 Phase 2 Phase 3 Filed ASP1948/PTZ-329 zolbetuximab enzalutamide enzalutamide (Pancreatic adenocarcinoma) (M0 CSPC, M1 CSPC: China) (M1 CSPC: EU) ASP1951/PTZ-522 enfortumab vedotin gilteritinib enfortumab vedotin (Other solid tumors) (mUC, pretreated: US [sBLA],
Slide 37: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 37 Phase 1 Entry to Approval since Q3/FY2020 Financial Results Announcement in Jan 2021 Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP8062 enfortumab vedotin gilteritinib Opioid use disorder Locally advanced or metastatic Relapsed or refractory urothelial
Slide 38: Enzalutamide: Androgen Receptor Inhibitor (1/2)
ENZALUTAMIDE: 38 ANDROGEN RECEPTOR INHIBITOR (1/2) US/EU/JP Definitive Therapy Castration-Sensitive Castration-Resistant ARCHES M1 CSPC newly-diagnosed Initial M1 CSPC PREVAIL AFFIRM Diagnosis Surgery recurrent M1 CRPC M1 CRPC Launched (1st line) (2nd line+) Salvage in US & JP Launched Launched Acti
Slide 39: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): 39 PHASE 3 STUDY DATA BY DISEASE STAGE Continued potential in earlier lines with consistent survival benefit and longer duration of treatment Early stage Late stage Disease Castration-sensitive (CSPC) Castration-resistant (CRPC) stage M1 M1 M0 M1 M0 (pre-chemo) (post-chemo) Phase
Slide 40: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 40 PASHA (HOVON) PrE0905 (PrECOG) Chemo Maintenance ADMIRAL High- consolidation GOSSAMER intensity induction Maintenance chemo Transplant MORPHO Salvage therapy FLT3 mut+ AML Launched Low-intensity chemo Discontinued LACEWING due to the futility Relapsed or refractory Mo
Slide 41: Enfortumab Vedotin (EV): Nectin-4 Targeted ADC (1/9)
ENFORTUMAB VEDOTIN (EV) : 41 NECTIN-4 TARGETED ADC (1/9) For urothelial cancer Primary endpoint (OS) met (data presented at mUC, Platinum and PD-1/L1 inhibitor pretreated; P3: EV-301 n=608 ASCO GU 2021 and published in NEJM). Filed in EV mono vs. Chemo US (sBLA) in Feb 2021, in EU and JP in Mar 2021
Slide 42: Enfortumab Vedotin (2/9): Phase 1b/2 EV-103 Study Design
ENFORTUMAB VEDOTIN (EV) (2/9): 42 PHASE 1b/2 EV-103 STUDY DESIGN Dose Escalation Cohort Dose Expansion Cohorts Recommended Cohort A Cohort D Cohort G EV dose EV + Pembro EV + Pembro EV + Cis, 1L EV + Cis/Carbo Locally Cis-ineligible Cis-ineligible + Pembro advanced 1L or 2L 1L 1L or Cohort E metasta
Slide 43: Enfortumab Vedotin (3/9): Phase 3 EV-301 Study Results - Efficacy
ENFORTUMAB VEDOTIN (3/9): 43 PHASE 3 EV-301 STUDY RESULTS - EFFICACY PFS (Secondary endpoint) Powels T, et al., NEJM. 2021 PFS: Progression-free survival, CI: Confidence interval, NEJM: New England Journal of Medicine
Slide 44: Enfortumab Vedotin (4/9): Phase 3 EV-301 Study Results - Safety
ENFORTUMAB VEDOTIN (EV) (4/9): 44 PHASE 3 EV-301 STUDY RESULTS - SAFETY Safety profile was consistent with prior EV studies TRAE No. of patients (%) Any grade in ≥ 20% of patients EV (n=296) Chemo (n=291) and ≥ Grade 3 in ≥ 5% of patients Any grade ≥ Grade 3 Any grade ≥ Grade 3 Any adverse event 278
Slide 45: Enfortumab Vedotin (5/9): Phase 2 EV-201 Cohort Results - Efficacy (1)
ENFORTUMAB VEDOTIN (5/9): 45 PHASE 2 EV-201 STUDY COHORT 2 RESULTS - EFFICACY (1) ORR (Primary endpoint) Patients (%) ORR per RECIST v1.1 assessed by BICR (n=89) Confirmed ORR 52 95% CI (40.8, 62.4) Best Overall Response per RECIST v1.1 Complete response 20 Partial response 31 Stable disease 30 Prog
Slide 46: Enfortumab Vedotin (6/9): Phase 2 EV-201 Cohort Results - Efficacy (2)
ENFORTUMAB VEDOTIN (6/9): 46 PHASE 2 EV-201 STUDY COHORT 2 RESULTS - EFFICACY (2) Change in tumor measurements per BICR Data are not available for 12 subjects due to no response assessment post- baseline (n=5), incomplete assessment of target lesions post-baseline (n=1), or no measurable disease at
Slide 47: Enfortumab Vedotin (7/9): Phase 2 EV-201 Cohort 2 Results - Safety
ENFORTUMAB VEDOTIN (EV) (7/9): 47 PHASE 2 EV-201 STUDY COHORT 2 RESULTS - SAFETY Safety profile was consistent with prior EV studies TRAE No. of patients (%) Any grade in ≥ 20% of patients (n=89) and ≥ Grade 3 in ≥ 5% of patients Any grade ≥ Grade 3 Overall TRAEs 86 (97) 49 (55) ⚫ ≥ Grade 3 TRAEs of
Slide 48: Enfortumab Vedotin (8/9): Study Data by Disease Stage
ENFORTUMAB VEDOTIN (EV) (8/9): 48 STUDY DATA BY DISEASE STAGE Early stage Late stage MIBC mUC Disease Surgery eligible Previously untreated (first line) PD-1/L1 inhibitor pretreated stage Platinum naïve Cis- Cis- Platinum Cis-ineligible and Platinum pretreated eligible ineligible eligible cis-inelig
Slide 49: Enfortumab Vedotin (9/9): Number of UC Patients
ENFORTUMAB VEDOTIN (9/9): 49 NUMBER OF UC PATIENTS MIBC mUC Urothelial Total All stages cancer Post- (Incident Drug treated Drug treated (Incidence) (Annual) cystectomy + Newly (1L) (2L+*) recurrent) US 83,000 20,000 20,700 15,600 8,500 EU5 120,000 32,000 29,600 28,000 13,600 JP 46,000 11,500 10,500
Slide 50: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: 50 ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY Target: Claudin 18.2 Gastric and gastroesophageal junction ⚫ Claudin is a major structural component of tight (GEJ) adenocarcinoma junctions and seals intercellular space in ⚫ Target patient population: locally advanced and epithelial sheets met
Slide 51: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 51 VMS has a significant negative impact on Women’s Health Initiative (WHI) Study 2 quality of life ⚫ Physical symptoms include hot flashes and ⚫ Initial data analyses showed an association sweating/night sweats, which can impact sleep. between chronic HRT use a
Slide 52: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): Genetic Regulation 52 rAAV8-Des-hMTM1 Characteristics of AT132 X-linked myotubular myopathy (XLMTM) ⚫ Lead program in the gene therapy pipeline of ⚫ Rare neuromuscular disease with X-linked, Audentes Therapeutics, acquired by Astellas loss of function mutations in M
Slide 53: Progress in Focus Area Approach: Manufacturing Capability - Cell & Gene Therapy
PROGRESS IN FOCUS AREA APPROACH: 53 MANUFACTURING CAPABILITY - CELL THERAPY & GENE THERAPY Cell Therapy: Astellas Institute for Regenerative Gene Therapy: Astellas Gene Therapies Medicine (AIRM) (Audentes Therapeutics) April 2020 in operation Westborough, South San Francisco, Massachusetts, US Calif
Slide 54: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE