Slide 1: FY2019 Financial Results Ended March 31, 2020
FY2019 FINANCIAL RESULTS ENDED MARCH 31, 2020 - Presentation for FY2019 Financial Results Scheduled on May 18, 2020 - Kenji Yasukawa, Ph.D. President and CEO Astellas Pharma Inc. May 14, 2020
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: Efforts Against the Spread of COVID-19 (1/2)
EFFORTS AGAINST THE SPREAD OF COVID-19 (1/2) 3 Continuation of business and maintaining a stable supply of products In order to continue our social mission of ensuring a stable supply of drugs, quality control, managing safety, and providing information, our essential business continues to be carr
Slide 4: Efforts Against the Spread of COVID-19 (2/2)
EFFORTS AGAINST THE SPREAD OF COVID-19 (2/2) 4 Contribution with in-line products and compounds in R&D stage Continue to take appropriate action in response to requests by the government such as providing drugs Provide compounds in response to a request from the Ministry of Health, Labour and We
Slide 5: Agenda
AGENDA 5 FY2019 Consolidated Financial Results I FY2020 Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 6: FY2019 Financial Results
FY2019 FINANCIAL RESULTS 6 Change Change (billion yen) FY18 FY19 CER growth (amount) (%) Revenue 1,306.3 1,300.8 -5.5 -0.4% +2.4% Cost of sales 292.0 276.7 -15.3 -5.2% % of revenue 22.4% 21.3% SG&A expenses 490.3 499.3 +9.0 +1.8% R&D expenses 208.7 224.2 +15.5 +7.4% Amortisation of intangible assets
Slide 7: FY2019 Financial Results: Year-on-Year Comparison
FY2019 FINANCIAL RESULTS: 7 YEAR-ON-YEAR COMPARISON Revenue and Core OP were the same level as previous fiscal year, while both increased when excluding FX impacts Sales increases for XTANDI and mirabegron, as well as new products XOSPATA and EVENITY, offset most of the sales decreases in Vesica
Slide 8: FY2019 Financial Results: Comparison with Forecast
FY2019 FINANCIAL RESULTS: 8 COMPARISON WITH FORECAST FY19 FY19 FY19 Main variance in revenue between (billion yen) initial revised actual and initial forecast Actual forecast* forecast** Exceeded expectations due to focused Revenue 1,224.0 1,256.0 1,300.8 resource allocation to growth drivers Ea
Slide 9: FY2019 Financial Results: Sales of Main Products
FY2019 FINANCIAL RESULTS: 9 SALES OF MAIN PRODUCTS FY2019 sales XTANDI XTANDI sales reached 400.0 billion yen 400.0 billion yen +66.9 (+20%) Significant growth higher than FY19 forecast XOSPATA Contribute throughout the year Launched in Europe in November following 14.3 billion yen +11.7 (+468%) Jap
Slide 10: Accounting Treatment of Business Combination with Audentes
ACCOUNTING TREATMENT OF BUSINESS 10 COMBINATION WITH AUDENTES Booked intangible assets of $2,620 million and goodwill of $391 million <Balance sheet as of Jan 15, 2020* > ($ million) Other assets Other liabilities • In-Process R&D: 389 116 $1,851M To be amortised after Deferred tax liabilities lau
Slide 11: FY2020 Forecast
FY2020 FORECAST 11 FY19 FY20 (billion yen) Change (%) actual forecast Revenue 1,300.8 1,282.0 -1.4% R&D expenses 224.2 239.0 +6.6% Core operating profit 277.8 257.0 -7.5% Core profit 223.2 206.0 -7.7% <Full basis> Operating profit 244.0 252.0 +3.3% Profit 195.4 202.0 +3.4% The impact of COVID-19 is
Slide 12: FY2020 Forecast: Overview
FY2020 FORECAST: OVERVIEW 12 Expect to achieve target for final fiscal year of Strategic Plan 2018 Main products continue to grow and new products will contribute throughout the year to secure revenues of the same level as FY2019, offsetting most of the impact of the LOE, termination of sales an
Slide 13: FY2020 Forecast: Core Operating Profit
FY2020 FORECAST: CORE OPERATING PROFIT 13 Core OP to grow excluding one-off items in FY2019 by growth of major products and pursuing cost efficiency to offset sales decrease in other products and increases in strategic investment • One-off revenue increase items: • Loss of exclusivity Transfer val
Slide 14: Financial Impact Due to COVID-19 Disruption
FINANCIAL IMPACT DUE TO COVID-19 DISRUPTION 14 Impact in FY2019 financial results Impact of COVID-19 on FY2019 financial result was immaterial despite sales increase due to inventry build as well as cost decrease due to lower sales promotion activities, etc. Assumption of FY2020 forecast The imp
Slide 15: Main Growth Drivers: XTANDI, Mirabegron
MAIN GROWTH DRIVERS: XTANDI, MIRABEGRON 15 XTANDI FY2017-FY2020 CAGR forecast: +16% +15% Sales growth exceeded expectations due to penetration in +20% earlier stages of prostate cancer +13% FY2020 initiatives Enhance market access and conduct further engagement with urologists for M0 CRPC an
Slide 16: Launch of Post-PoC Projects
LAUNCH OF 6 POST-POC PROJECTS 16 XOSPATA In addition to Japan and US, expect sales contribution from Europe Available in Japan, US, following launches Established Markets Approved in South Korea and Australia. Filed in Mar 2020 in China Promote XOSPATA to hematologists/oncologists using Phase
Slide 17: New Local Products in Japan
NEW LOCAL PRODUCTS IN JAPAN 17 Sales increased due to launch of new products and additional indications Steady progress against Strategic Plan 2018 target Exceed 100.0 billion yen in early 2020s +26% YoY 61.2 (billion yen) 26.2 14.7 FY17 FY18 FY19 FY20 FCST New products in Japan (Repatha, Suglat-Fam
Slide 18: Progress Towards the Strategic Plan 2018 Guidance
PROGRESS TOWARDS THE STRATEGIC PLAN 2018 18 GUIDANCE Achieve Strategic Plan 2018 target including strategic investments for sustainable growth (billion yen) Indicators FY17 ACT FY18 ACT FY19 ACT FY20 FCST FY20 Guidance (Announced in May 2018) Revenue 1,300.3 1,306.3 1,300.8 1,282.0 FY2017 level R&D
Slide 19: Agenda
AGENDA 19 FY2019 Consolidated Financial Results I FY2020 Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 20: Enhancement of Initiatives in China
ENHANCEMENT OF INITIATIVES IN CHINA 20 Enhancement of development and regulatory functions for late-stage projects Accelerate development and launch of medicines in China as top-tier market Compound Indication Current Status M1 CRPC Approved in Nov 2019 and launched in Mar 2020 enzalutamide M0 CRPC
Slide 21: Post-PoC Projects: Progress in FY2019
6 POST-POC PROJECTS: PROGRESS IN FY2019 21 Achieved many important milestones Phase Project Indication 1 2 3FA * Milestone achieved in FY2019 enzalutamide M1 castration-resistant prostate cancer * Approved in China M0 castration-resistant prostate cancer * Filed in China M1 castration-sensitive pros
Slide 22: Key Post-PoC Projects: Status Update
KEY POST-POC PROJECTS: STATUS UPDATE 22 (Underlined: Updates since Q3/FY2019 announcement in Jan 2020) enzalutamide gilteritinib enfortumab vedotin M0 CRPC Relapsed or refractory Metastatic urothelial cancer • Positive OS data of Phase 3 study acute myeloid leukemia • Previously untreated (first lin
Slide 23: Progress in Focus Area Approach (1/3): Major Events in FY2019
PROGRESS IN FOCUS AREA APPROACH (1/3): 23 MAJOR EVENTS IN FY2019 Biology Project-based Business development-related Immuno- • Phase 1 entry: • License agreement with RIKEN for aAVC programs oncology ASP9801 (oncolytic virus), • Acquisition of Xyphos Biosciences to add CAR-cell ASP7517 (aAVC) therapy
Slide 24: Progress in Focus Area Approach (2/3): New Modality for Immuno-oncology
PROGRESS IN FOCUS AREA APPROACH (2/3): Immuno-oncology 24 NEW MODALITY FOR IMMUNO-ONCOLOGY Further strengthened immuno-oncology platform through collaboration with CytomX Therapeutics for Probody® T-cell engaging bispecific therapies CytomX’s Probody® platform • Probody® masked antibodies remain ina
Slide 25: Progress in Focus Area Approach (3/3): Astellas Assets in Cancer Immunity Cycle
PROGRESS IN FOCUS AREA APPROACH (3/3): Immuno-oncology 25 ASTELLAS ASSETS IN CANCER IMMUNITY CYCLE Astellas’ pre-clinical and clinical research spans full cancer immunity cycle Priming and activation 4 Trafficking of T cells to tumors ASP8374, ASP1951 3 Oncolytic virus (ASP9801) Infiltration of T ce
Slide 26: COVID-19 Impact on Clinical Development
COVID-19 IMPACT ON CLINICAL DEVELOPMENT 26 Changes implementing to our clinical trial operations, to ensure patient safety and alleviate strain on healthcare resources during the COVID-19 pandemic: In countries and regions with continuing spread of COVID-19, we are suspending start-up activities
Slide 27: Progress in Rx+ Program (1/2): FY2019 Progress
PROGRESS IN Rx+TM PROGRAM (1/2): 27 FY2019 PROGRESS Steadily progress to establish a solid ground for business acceleration Formulation of Rx+ Story™ (Strategic direction of Rx+™) Each program is steadily progressing toward commercialization Chronic disease progression prevention New digital hea
Slide 28: Progress in Rx+ Program (2/2): Smartphone Exercise Support Application
Chronic PROGRESS IN Rx+TM PROGRAM (2/2): disease progression prevention 28 SMARTPHONE EXERCISE SUPPORT APPLICATION Moved to the next step toward commercialization Enter into Agreement with BANDAI NAMCO Entertainment to Co-Develop and Co-Commercialize Smartphone Exercise Support Application Imple
Slide 29: Climate Change Mitigation Measures
CLIMATE CHANGE MITIGATION MEASURES 29 Three Astellas’ research and production facilities* in Japan started purchasing electricity generated by renewable energy sources, to reduce the volume of GHG emission Our target Effects of this initiative on GHG emission Astellas’ Environmental Action Plan
Slide 30: Agenda
AGENDA 30 FY2019 Consolidated Financial Results I FY2020 Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 31: Capital Allocation
CAPITAL ALLOCATION 31 Top priority is investment for strategic business growth Dividends to be increased continuously based on mid-and long-term growth Share buybacks to be implemented in a flexible manner Business investment Shareholder return Aiming for steady dividend increase Acquisition during
Slide 32: Appendix
APPENDIX
Slide 33: FY2019 Financial Results: Cost Items
FY2019 FINANCIAL RESULTS: COST ITEMS 33 Core basis: Year-on-Year comparison Cost of sales Decrease due to changes in product mix, etc. (-0.8ppt) % of revenue FX impact on elimination of unrealized gain (-0.3ppt) 1.1ppt decrease Pursue cost efficiency by resource allocation to investment in new
Slide 34: FY2019: Revenue by Region
FY2019: REVENUE BY REGION 34 (billion yen) FY18 FY19 Change Japan 369.5 345.4 -6.5% United States 421.6 443.5 +5.2% Established Markets 300.0 296.1 -1.3% Greater China 62.4 60.4 -3.3% International 122.7 134.8 +9.9% Established Markets: Europe, Canada, Australia Greater China: China, Hong Kong, Taiw
Slide 35: FY2019: Sales of Main Products
FY2019: SALES OF MAIN PRODUCTS 35 FY19 Achieve (billion yen) FY18 FY19 Change CER growth forecast ment XTANDI 333.1 400.0 +20.1% +24.1% 383.9 104.2% XOSPATA 2.5 14.3 +467.6% +478.2% 13.9 102.7% OAB products 242.2 206.3 -14.8% -12.6% 201.0 102.6% mirabegron 147.2 161.6 +9.8% +12.5% 158.8 101.8% Vesic
Slide 36: FY2019 Actual: FX Rate
FY2019 ACTUAL: FX RATE 36 Average rate for the period Currency FY18 FY19 change USD 111 yen 109 yen -2 yen EUR 128 yen 121 yen -8 yen Change in closing rate from PY end Currency FY18 FY19 USD +5 yen -2 yen EUR -6 yen -5 yen <Impact of exchange rate on financial results> 36.7 billion yen decrease i
Slide 37: FY2020 Forecast: FX Rate & FX Sensitivity
FY2020 FCST： FX RATE & FX SENSITIVITY 37 Average rate for the period Currency FY19 FY20 FCST change USD 109 yen 110 yen +1 yen EUR 121 yen 120 yen -1 yen Change in closing rate from PY end Currency FY19 FY20 FCST USD -2 yen +1 yen EUR -5 yen +0 yen Estimated Fx sensitivity of FY2020 forecast by 1 ye
Slide 38: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 38 (billion yen) FY18 end FY19 end Total assets 1,897.6 2,318.2 Cash and cash equivalents 311.1 318.4 Total equity attributable to 1,258.4 1,289.2 owners of the parent 66.3% 55.6% Equity ratio (%) (billion yen) FY18 FY19 Cash flows from operating activities 258.6
Slide 39: Details of Shareholder Returns
DETAILS OF SHAREHOLDER RETURNS 39 (yen) (billion yen) Dividends per Share* (left axis) Profit** (right axis) 250 2,500 40 2,000 200 30 150 1,500 42 20 40 38 100 1,000 10 50 500 0 00 (billion yen) FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20 (FCST) Total dividends 3
Slide 40: Filing Opportunities Announced in Strategic Plan
FILING OPPORTUNITIES 40 ANNOUNCED IN STRATEGIC PLAN As of May 2020 enzalutamide M0 CSPC ✓✓✓: Approved ✓✓: Filed zolbetuximab Gastric and gastroesophageal ✓: Data obtained, enzalutamide junction adenocarcinoma filing under preparation M1 CSPC ✓✓✓ gilteritinib (US) AML (Post-HSCT maintenance) (EU,JP)
Slide 41: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 41 Phase 1 Phase 2 Phase 3 Filed ASP1235/AGS62P1 zolbetuximab enzalutamide enzalutamide (Pancreatic adenocarcinoma) (M0 CSPC, M1 CSPC: China) (M1 CSPC: EU,JP) ASP8374/PTZ-201 ASP1650 (Testicular cancer) gilteritinib enzalutamide ASP1948/PTZ-329 (Earlier-stage AML) (M0 CRP
Slide 42: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 42 Phase 1 entry to approval since Q3/FY2019 financial results announcement in Jan 2020 Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval gilteritinib gilteritinib fidaxomicin Acute myeloid Relapsed or Clostridium leukemia in refractory difficile infection pediat
Slide 43: Enzalutamide: Androgen Receptor Inhibitor
ENZALUTAMIDE: ANDROGEN RECEPTOR INHIBITOR 43 US/EU/JP Definitive Therapy Castration-Sensitive Castration-Resistant ARCHES M1 CSPC newly-diagnosed Initial PREVAIL AFFIRM Surgery M1 CSPC Diagnosis M1 CRPC M1 CRPC recurrent (1st line) (lines 2+) Salvage Launched in US Filed in EU & JP Launched Launched
Slide 44: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 44 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 LACEWING Monotherapy vs salvage Launched in US, JP, and EU Relapsed
Slide 45: Enfortumab Vedotin (EV): Nectin-4 Targeted ADC (1/3)
ENFORTUMAB VEDOTIN (EV): 45 NECTIN-4 TARGETED ADC (1/3) Treatment landscape for metastatic urothelial cancer and clinical studies for EV Platinum or Platinum and mUC patient Previously untreated PD-1/L1 inhibitor PD-1/L1 inhibitor treatment (first line) pretreated pretreated Cis-eligible: Platinum p
Slide 46: Enfortumab Vedotin (EV) (2/3): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/3): CLINICAL STUDIES 46 For urothelial cancer mUC, Platinum and PD-1/L1 inhibitor pretreated; vs. P3: EV-301 n=608 Enrollment completed chemotherapy Locally advanced or mUC, Previously untreated, P3: EV-302 n=1,095 FSFT: Apr 2020 Platinum-eligible; EV + Pembro +/- Platinum
Slide 47: Enfortumab Vedotin (EV) (3/3): Phase 1b/2 EV-103 Study Design
ENFORTUMAB VEDOTIN (EV) (3/3): 47 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 Cohort E 1L or metasta
Slide 48: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: 48 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 49: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 49 US/EU Phase 3 studies: FSFT of all the 3 studies in Aug 2019 2 Pivotal studies Long-term safety study (SKYLIGHT 1, SKYLIGHT 2) (SKYLIGHT 4) Women suffering from moderate to severe Women suffering from VMS VMS associated with menopause * associated with menopa
Slide 50: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): Genetic Regulation 50 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 51: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE