Slide 1: FY2018 Financial Results Ended March 31, 2019
FY2018 FINANCIAL RESULTS ENDED MARCH 31, 2019 Kenji Yasukawa, Ph.D. President and CEO Astellas Pharma Inc. April 25, 2019
Slide 2: Cautionary Statement Regarding Forward-Looking Information
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING 2 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 sta
Slide 3: Agenda
AGENDA 3 FY2018 Consolidated Financial Results I FY2019 Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 4: FY2018 Financial Results (Core Basis)
FY2018 FINANCIAL RESULTS (CORE BASIS) 4 FY18 Achieve- (billion yen) FY17 FY18 Change CER growth FCST* ment Revenue 1,300.3 1,306.3 +0.5% 1,300.0 100.5% +0.8% Cost of sales 294.2 292.0 -0.7% % of revenue 22.6% 22.4% SG&A expenses 478.3 490.3 +2.5% % of revenue 36.8% 37.5% R&D expenses 220.8 208.7 -5.
Slide 5: Revenue Analysis (Year on Year)
REVENUE ANALYSIS (YEAR ON YEAR) 5 Sales increase in XTANDI, mirabegron and new products sales (billion yen) FY17 1,300.3 XTANDI OAB products XOSPATA New products in Japan -Decrease in long-listed drugs Others (incl. Micardis) and Tarceva Fx impacts -4.6 FY18 1,306.3 OAB：Overactive bladder OAB produc
Slide 6: Core OP Analysis (Year on Year)
CORE OP ANALYSIS (YEAR ON YEAR) 6 Increased core OP by 4% through steady growth of main products (billion yen) FY17 268.7 Gross profit* -Increase in XTANDI US co-promotion fee SG&A expenses* -Launch costs for new products -Increase investments to key late-stage R&D expenses* pipeline and new area /
Slide 7: FY2018 Financial Results (Full Basis)
FY2018 FINANCIAL RESULTS (FULL BASIS) 7 FY18 Achieve- (billion yen) FY17 FY18 Change FCST* ment Core operating profit 268.7 278.5 +3.7% 270.0 103.2% Other income 11.9 14.2 +19.2% Other expense 67.3 48.8 -27.6% Operating profit 213.3 243.9 +14.4% 234.0 104.2% Profit before tax 218.1 249.0 +14.1% 236.
Slide 8: FY2019 Forecasts
FY2019 FORECASTS 8 (billion yen) FY18 ACT FY19 FCST Change Revenue 1,306.3 1,224.0 -6.3% R&D expenses 208.7 211.0 +1.1% % of revenue 16.0% 17.2% +1.2ppt Core operating profit 278.5 240.0 -13.8% Core profit 249.3 194.0 -22.2% Core EPS (yen) 129.07 102.87 -20.3% Operating profit 243.9 229.0 -6.1% Prof
Slide 9: FY2019 Forecasts: Revenue
FY2019 FORECASTS: REVENUE 9 Revenue to decrease due to LOE of major products. Main products continue to grow and new products contribute throughout the year (billion yen) FY18 1,306.3 XTANDI mirabegron XOSPATA New products in Japan LOE impact of Vesicare/Tarceva Others and transfer of sale and distr
Slide 10: FY2019 Forecasts: Core OP
FY2019 FORECASTS: CORE OP 10 Securing investments to maximize product VALUE while reviewing cost structure (billion yen) FY18 278.5 Gross profit -LOE impact of Vesicare and Tarceva -Transfer of sale and distribution in Japan -Increase in XTANDI US co-promotion fee SG&A with sales expansion expenses
Slide 11: Progress Towards the Strategic Plan 2018 Guidance
PROGRESS TOWARDS THE STRATEGIC PLAN 2018 11 GUIDANCE (billion yen) FY20 Indicators FY17 ACT FY18 ACT FY19 FCST Guidance Revenue 1,300.3 1,306.3 1,224.0 FY2017 level More than R&D investment 220.8 208.7 211.0 200.0 billion yen 268.7 278.5 240.0 Core OP margin Core OP 20.7% 21.3% 19.6% 20% Core EPS 10
Slide 12: Agenda
AGENDA 12 FY2018 Consolidated Financial Results I FY2019 Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 13: Review of FY2018
REVIEW OF FY2018 13 Initiatives aiming at 3 Strategic Goals advancing as planned Strategic Goal 1 Strategic Goal 2 Strategic Goal 3 Maximizing Product VALUE and Evolving How We Create VALUE Developing Rx+TMprograms Operational Excellence -With Focus Area Approach- Maximizing Product VALUE Progress
Slide 14: Maximizing Product VALUE and Operational Excellence
Strategic Goal 1 Maximizing Product VALUE and Operational Excellence
Slide 15: Main Growth Drivers: XTANDI and Mirabegron
MAIN GROWTH DRIVERS: XTANDI AND MIRABEGRON 15 XTANDI +9% • FY2018: XTANDI revenue increased in all regions due to +13% penetration in earlier stage of prostate cancer • FY2019: Enhance market access and further penetration of urologists in the M0 CRPC indication FY2019 forecast：364.2 billion yen • R
Slide 16: New Product: XOSPATA
NEW PRODUCT: XOSPATA 16 FIRST FLT3 INHIBITOR FOR R/R AML WITH FLT3 MUTATION Launched in Japan and US as new treatment option for AML • Patients with AML with activating FLT3 mutations have short survival and high relapse rates. No standard of care established for R/R AML with FLT3 mutation. • The NC
Slide 17: New Products in Japan
NEW PRODUCTS IN JAPAN 17 Sales increase due to launch of new products and additional indications Strategic plan 2018 Guidance: Exceed 100.0 billion yen in early 2020’s Additional indication Dec. 2018 Approx. 45.0 Launched in (billion yen) 26.2 Additional indication Aug. 2018 May 2018 14.7 Launched i
Slide 18: New Commercial Structure as of April 2019
NEW COMMERCIAL STRUCTURE AS OF APRIL 2019 18 New sales and marketing structure aims to maximize product VALUE on a global basis Reorganization from the 4 unit commercial structure to 5 unit structure • In addition to US as single division, independence of China where further market expansion to be
Slide 19: Enhancement of Initiatives in China (1)
ENHANCEMENT OF INITIATIVES IN CHINA (1) 19 Expecting further market expansion by promoting innovation in addition to economic growth External environment and business opportunities Continued market growth from rising income levels due to economic growth and aging society Potential for accelerate
Slide 20: Enhancement of Initiatives in China (2)
ENHANCEMENT OF INITIATIVES IN CHINA (2) 20 Invest sufficient resources to accelerate development of innovative medicines in top-tier market Enhancement of development and regulatory functions Late-stage projects M1 CRPC Establishing drug development enzalutamide (XTANDI) Filed in Mar. 2018 Regulat
Slide 21: Enhancement of Initiatives in China (3)
ENHANCEMENT OF INITIATIVES IN CHINA (3) 21 Enhancement of commercial functions to support continuous launch of new products into growth market Enhancement of Government affairs function Enhancement of Marketing function • Market expansion through disease awareness activities • Access enhancement
Slide 22: Pursue Operational Excellence
PURSUE OPERATIONAL EXCELLENCE 22 Progress as planned against profit improvement plan of over 30.0 billion yen announced in Strategic plan 2018 Prioritize advertising and sales promotion expenses Progress in FY2019 Prioritize R&D expenses Strengthen global procurement Review costs not contributing to
Slide 23: Continued Progress on 6 Post-POC Projects Since Apr 2018
CONTINUED PROGRESS ON 6 POST-POC PROJECTS 23 SINCE APR 2018 Development advancing as intended in Strategic Plan 2018 Progress since April 2018 Completion/readout occurred since April 2018 Indication P1 P2 P3 Filed Approved enzalutamide M0 CRPC US, EU M1 HSPC M0 HSPC gilteritinib Relapsed or refracto
Slide 24: FY2018 Achievements and Status Update
FY2018 ACHIEVEMENTS AND STATUS UPDATE 24 (Underline: Updates since Q3/FY2018 Announcement) enzalutamide gilteritinib enfortumab vedotin M0 CPRC FLT3 mut+ R/R AML mUC with prior CPI treatment • US: Approved in July 2018 • ADMIRAL study: Results obtained • Cohort 1 in Phase 2 study • EU: Approved in O
Slide 25: Enzalutamide: Results of Phase 3 ARCHES in M1 HSPC
ENZALUTAMIDE: 25 RESULTS OF PHASE 3 ARCHES IN M1 HSPC Enzalutamide significantly improved rPFS Filing for M1 HSPC in US/EU/Japan planned by mid-2019 ENZA + ADT 100 PBO + ADT 90 Free of rPFS event (%) 80 70 60 50 ENZA + ADT PBO + ADT 40 (n=574) (n=576) 30 Median, months NR 19.4 20 (95% CI) (NR, NR) (
Slide 26: Gilteritinib: Results of Phase 3 ADMIRAL in R/R AML
GILTERITINIB: 26 RESULTS OF PHASE 3 ADMIRAL RESULTS IN R/R AML Gilteritinib significantly improved survival compared with salvage chemotherapy US sNDA to include OS and MAA in EU submitted in Feb 2019 • Compared with salvage chemotherapy, gilteritinib was generally associated with lower toxicity dur
Slide 27: Gilteritinib
GILTERITINIB 27 Plan to start 2 head-to-head studies in newly diagnosed patients FLT3 mut+ AML patients • In a Phase 1 study in combination Low-intensity chemo High-intensity induction with high intensity chemotherapy, LACEWING chemo gilteritinib showed a CRc rate of Newly diagnosed *1 ≥90% in patie
Slide 28: Enfortumab Vedotin
ENFORTUMAB VEDOTIN 28 Obtained positive results from Cohort 1 of Phase 2 study. BLA submission in US planned later this year Characteristics Status update • First and only ADC targeting Nectin-4, which EV-201 study is highly expressed in bladder cancer and has • Single-arm, pivotal phase 2 study lim
Slide 29: Roxadustat
ROXADUSTAT 29 Readout of all Phase-3 studies ongoing, MAA planned in 2H/2019 Initiated development for additional indication Characteristics Status update Novel mechanism of action • Obtained TLRs of 6 Phase 3 studies to Orally administered support EU filing and reimbursement Reduces the need
Slide 30: Fezolinetant: Efficacy in Phase 2b
FEZOLINETANT: EFFICACY IN PHASE 2B 30 Statistically significant improvement across all four co-primary endpoints in most cohorts; comparable efficacy and treatment effect size for BID and QD Frequency of moderate and severe VMS per 24 hours with fezolinetant BID/QD *P<0.05 for all pairwise compariso
Slide 31: Fezolinetant: Safety in Phase 2b and Next Step
FEZOLINETANT: 31 SAFETY IN PHASE 2B AND NEXT STEP Fezolinetant was generally well tolerated; Phase 3 preparation ongoing Safety Status update • Overall TEAE rates were similar across • End of Phase 2 Meeting is being held cohorts; TEAEs were mostly mild or with FDA; incorporating their moderate. fee
Slide 32: Expected Key Events in FY2019
EXPECTED KEY EVENTS IN FY2019 32 Continued progress on important milestones for 6 post-POC projects Regulatory enzalutamide M1 CRPC (China) decisions gilteritinib Relapsed/refractory AML (EU) Label update to include OS data (US) roxadustat Anemia associated with CKD, dialysis (Japan) Regulatory enza
Slide 33: Evolving How We Create VALUE - With Focus Area Approach
Strategic Goal 2 Evolving How We Create VALUE -With Focus Area Approach-
Slide 34: Focus Area Approach
FOCUS AREA APPROACH 34 Focusing on the areas to turn innovative science to VALUE for patients Our efforts in current and potential Focus Area approach Primary Focus • Exploring multiple sets of combinations of Primary Focus Biology, Modality/Technology and Disease • Prioritize investment in 4 Primar
Slide 35: Acquiring and Partnering External Capabilities
ACQUIRING AND PARTNERING 35 EXTERNAL CAPABILITIES Incorporate game changing technology and cutting-edge science Primary Focus Regeneration & * * Harvard Medical blindness School * Immuno-oncology ASIM biology Mitochondria biology Potential future Primary Focus * * Genetic regulation Note) This chart
Slide 36: Regeneration & Blindness (1/2)
REGENERATION & BLINDNESS (1/2) 36 Established research and manufacturing platform for cell therapy PSC Donor (iPSC/ESC) Cell bank Desired Drug cells substance Logistics Development 1 Patients Commercialization 3 4 5 2 Research Manufacturing Supply chain Development Commercial ➊ ➋ ➋ ➌ ➍ ➍ ➍ ➎ Post-Oc
Slide 37: Regeneration & Blindness (2/2)
REGENERATION & BLINDNESS (2/2) 37 Building a portfolio of cell therapy, gene therapy and other approaches to address blindness Strategy ASP7317 overview • Provide therapy to regain lost sight or Previous cell line (MA09-hRPE) prevent blindness by cell therapy and • 38 patients were successfully tran
Slide 38: Immuno-Oncology
IMMUNO-ONCOLOGY 38 Building a portfolio of novel immuno-oncology programs 3 clinical projects targeting patients Strategy non-responsive to existing therapies • Harnessing the immune system to treat intractable cancers NK cell Clinical program Projects from Potenza - Started collaboration in 2015 -
Slide 39: ASIM Biology and Mitochondria Biology
ASIM BIOLOGY AND MITOCHONDIRA BIOLOGY 39 Exploring potential of multiple clinical programs ASIM biology Mitochondria biology • Exploring LAMP-Vax platform as a • Develop mitochondria biology-based potential approach to develop immune therapies to address various diseases tolerance in allergic indivi
Slide 40: Developing Rx+ Programs
Strategic Goal 3 Developing Rx+TM Programs
Slide 41: Rx+ Program: Achievements in FY2018
Rx+TM PROGRAM: ACHIEVEMENTS IN FY2018 41 • Established US basis for Rx+™ business • Collaborations with venture capitals • Progress on multiple programs Progress in FY18 Expected key events in FY19 Exercise therapy • Exercise support application: • Exercise support application: Executed an agreement
Slide 42: Agenda
AGENDA 42 FY2018 Consolidated Financial Results I FY2019 Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 43: Capital Allocation
CAPITAL ALLOCATION 43 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 during FY2018-FY202
Slide 44: Appendix
APPENDIX
Slide 45: FY2018 ACT: Revenue by Region
FY2018 ACT: REVENUE BY REGION 45 (billion yen) FY17 ACT FY18 ACT Change Japan 421.2 396.6 -5.8% Americas 433.3 461.5 +6.5% EMEA 343.8 340.3 -1.0% Asia/Oceania 102.0 107.9 +5.8%
Slide 46: FY2018: Sales of Main Products
FY2018: SALES OF MAIN PRODUCTS 46 FY17 FY18 FY18 Achieve- (billion yen) Change CER growth ACT ACT FCST* ment XTANDI 294.3 333.1 +13.2% +13.6% 325.9 102.2% XOSPATA - 2.5 - - OAB products 228.1 242.2 +6.2% +6.5% 245.7 98.6% Vesicare 102.3 95.0 -7.2% -6.8% 96.1 98.8% Mirabegron 125.7 147.2 +17.0% +17.2
Slide 47: FY2019 FCST: Revenue by Region
FY2019 FCST: REVENUE BY REGION 47 (billion yen) FY18 ACT FY19 FCST Change Japan 369.5 316.8 -14.3% United States 421.6 404.7 -4.0% Established Market 300.0 286.8 -4.4% Greater China 62.4 70.9 +13.6% International 122.7 124.4 +1.4% Greater China: China, Hong Kong, Taiwan Established Market: Europe, C
Slide 48: FY2019 FCST: XTANDI Sales by Region
FY2019 FCST: XTANDI SALES BY REGION 48 Sales by region Japan US Established Market (billion yen) +10% (million USD) +10% (million euro) +11% +24% +14% +8% FY17 FY18 FY19 FY17 FY18 FY19 FY17 FY18 FY19 FCST FCST FCST International Greater China 5x% 4x% +24% +42% (billion yen) (billion yen) +30% +42% F
Slide 49: FY2019 FCST: Mirabegron Sales by Region
FY2019 FCST: MIRABEGRON SALES BY REGION 49 Sales by region Japan US Established Market (billion yen) (million USD) +10% +11% +4% +17% (million euro) +20% +11% FY17 FY18 FY19 FY17 FY18 FY19 FY17 FY18 FY19 FCST FCST FCST International Greater China 5x% 4x% +23% +93% (billion yen) (billion yen) +36% +6
Slide 50: FX Rate (Actual)
FX RATE (ACTUAL) 50 Average rate for the period Currency FY17 FY18 change USD 111 yen 111 yen +0 yen EUR 130 yen 128 yen -1 yen Change in closing rate from PY end Currency FY17 FY18 USD -6 yen +5 yen EUR +11 yen -6 yen Fx impact on elimination of unrealized gain: COGs ratio -0.1 ppt
Slide 51: FY2019 FCST: FX Rate & FX Sensitivity
FY2019 FCST：FX RATE & FX SENSITIVITY 51 Average rate for the period Currency FY18 FY19 FCST Change USD 111 yen 110 yen -1 yen EUR 128 yen 125 yen -3 yen Change in closing rate from PY end Currency FY18 FY19 FCST USD +5 yen -1 yen EUR -6 yen +0 yen Estimated Fx sensitivity of FY2018 forecasts by 1 ye
Slide 52: Balance Sheet/Cash Flow Highlights
BALANCE SHEET/CASH FLOW HIGHLIGHTS 52 (billion yen) FY17 end FY18 end Total assets 1,858.2 1,897.6 Cash and cash equivalents 331.7 311.1 Total equity attributable to 1,268.3 1,258.4 owners of the parent 68.3% 66.3% Equity ratio (%) (billion yen) FY17 FY18 Cash flows from operating activities 312.6 2
Slide 53: Details of Shareholder Returns
Details of shareholder returns 53 (yen) (billion yen) 40 Dividends per Profit for the 250 2,500 Share* (left axis) year** (right axis) 2,000 200 30 150 1,500 20 38 40 100 1,000 10 50 500 0 00 FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 (billion yen) (Forecast) Total di
Slide 54: Filing Opportunities Announced in Strategic Plan
FILING OPPORTUNITIES 54 ANNOUNCED IN STRATEGIC PLAN enzalutamide ✓✓✓: Approved M0 HSPC ✓✓: Filed zolbetuximab ✓: Data obtained, enzalutamide ✓ Gastric and gastroesophageal filing under preparation M1 HSPC junction adenocarcinoma enfortumab gilteritinib AML (Post-HSCT maintenance) enzalutamide vedoti
Slide 55: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 55 Phase 1 Phase 2 Phase 3 Filed ASP1235/AGS62P1 zolbetuximab enzalutamide enzalutamide (Pancreatic adenocarcinoma) (M0 HSPC, M1 HSPC) (M1 CRPC, China) ASP8374/PTZ-201 AGS-16C3F (Renal cell carcinoma) gilteritinib gilteritinib (R/R AML: China, Other AML) (R/R AML, EU) ASP
Slide 56: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 56 Phase 1 entry to filing, since Q3/FY2018 financial results announcement in Jan 2019 Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing ASP9801 roxadustat gilteritinib Cancer Chemotherapy-induced Relapsed or Refractory anemia acute myeloid leukemia: EU fidaxomicin Clostr
Slide 57: Enzalutamide
ENZALUTAMIDE 57 Definitive Therapy Hormone or Castration Castration-Resistant Sensitive ARCHES M1 HSPC Initial Surgery newly-diagnosed PREVAIL AFFIRM Diagnosis M1 CRPC M1 CRPC M1 HSPC Salvage (1st line) (lines 2+) recurrent Active Surveillance Radiation EMBARK EMBARK PROSPER M0 HSPC M0 CRPC Data pre
Slide 58: Gilteritinib
GILTERITINIB 58 HOVON, PrECOG Chemo Maintenance High- Salvage therapy intensity consolidation GOSSAMER induction Maintenance ADMIRAL FLT3 mut+ chemo Transplant AML MORPHO Launched (US, JP) patients Low-intensity Filed in EU in Feb. 2019 chemo (accelerated assessment) LACEWING MAA submitted in Feb 20
Slide 59: Enfortumab Vedotin
ENFORTUMAB VEDOTIN 59 Treatment Landscape *Overall treatment flow is similar among regions even though the standard of care and approved drugs varies. 1st line 2nd line 3rd line EV-201 (Cohort 1) cisplatin eligible Gem-Cis EV-301 • CPI • Gem-Carbo • Single agent chemo • Single agent chemo • Clinical
Slide 60: Zolbetuximab
ZOLBETUXIMAB 60 Target: Claudin 18.2 Gastric and gastroesophageal junction (GEJ) adenocarcinoma • Claudin is a major structural component of tight • Target patient population: locally advanced and junctions and seals intercellular space in metastatic gastric and GEJ adenocarcinoma epithelial sheets
Slide 61: Fezolinetant: Efficacy in Phase 2b
FEZOLINETANT: EFFICACY IN PHASE 2B 61 Mean severity of moderate and severe VMS per 24 hours with fezolinetant QD a Week 4: P<0.05 for all pairwise comparisons of fezolinetant doses a Week 4: P<0.05 for all pairwise comparisons of fezolinetant doses vs placebo, vs placebo, without adjustments for mul
Slide 62: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE