Slide 1: FY2017 Financial Results Ended March 31, 2018
FY2017 FINANCIAL RESULTS ENDED MARCH 31, 2018 Kenji Yasukawa, Ph.D President and CEO Astellas Pharma Inc. April 26, 2018
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 Review of Strategic Plan I 2015-2017 FY2017 Financial Results and II FY2018 Forecasts Initiatives to Build Resilience III for Sustainable Growth
Slide 4: Review of Strategic Plan 2015-2017 (Financial)
REVIEW OF STRATEGIC PLAN 2015-2017 (FINANCIAL) 4 Achieved profit targets despite net sales behind assumptions Financial overview Net sales (CAGR*)：+1.4% Core OP (CAGR*)：+7.5% R&D investment: 16-17% of net sales / improvement of cost structure Core EPS (CAGR*) ：+13.2% Achieved EPS CAGR exce
Slide 5: Review of Strategic Plan 2015-2017 (Strategic Initiatives)
REVIEW OF STRATEGIC PLAN 2015-2017 (STRATEGIC INITIATIVES) 5 Steady progress in 3 strategic initiatives 戦略課題への取り組み Maximizing the Product Value • Maximized sales of XTANDI in the current indications and steadily progressed development in earlier stages of prostate cancer GEs impacts in Japan • Shift
Slide 6: Agenda
AGENDA 6 Review of Strategic Plan I 2015-2017 FY2017 Financial Results and II FY2018 Forecasts Initiatives to Build Resilience III for Sustainable Growth
Slide 7: FY2017 Financial Results (Core Basis)
FY2017 FINANCIAL RESULTS (CORE BASIS) 7 Excl impacts FY17 Achieve- from Fx and （billion yen） FY16 FY17 Change business FCST* ment transfer Net sales 1,311.7 1,300.3 -0.9% 1,297.0 100.3% -1.2% Cost of sales 320.5 294.2 -8.2% % of sales 24.4％ 22.6% SG&A expenses 470.8 478.3 +1.6% % of sales 35.9％ 36.8
Slide 8: Sales Analysis (Year on Year)
SALES ANALYSIS (YEAR ON YEAR) 8 Growth drivers in good shape despite slight decrease in net sales due to mainly GEs impacts in Japan (billion yen) FY16 1,311.7 XTANDI/OAB products Others GEs impacts in Japan, etc. Dermatology business Decrease in transfer * amortisation of deferred revenue Long list
Slide 9: Core OP Analysis (Year on Year)
CORE OP ANALYSIS (YEAR ON YEAR) 9 Increased operating profit excluding impacts of Fx and business transfers, while increased development costs for late-stage projects, etc. (billion yen) FY16 274.6 Gross profit* (excl. business transfer) Efficient spending and SG&A expenses* optimal resource allocat
Slide 10: FY2017 Financial Results (Full Basis)
FY2017 FINANCIAL RESULTS (FULL BASIS) 10 Booked other expenses for business restructuring and impairment loss Achieve- （billion yen） FY16 FY17 Change FY17FCST* ment Core operating profit 274.6 268.7 -2.1% 258.0 104.1% Other income 9.6 11.9 +23.7% Other expenses 23.3 67.3 +188.7% Operating profit 260
Slide 11: Sales in Key Areas
SALES IN KEY AREAS 11 XTANDI and OAB franchise increase globally FY17 Achieve- (billion yen) FY16 FY17 Change CER growth FCST* ment XTANDI 252.1 294.3 +16.8% +11.7% 291.3 101.0% OAB in Urology 214.9 228.1 +6.1% +2.7% 232.3 98.2% Vesicare 116.1 102.3 -11.9% -15.2% 106.2 96.3% Betanis/Myrbetriq/BETMIG
Slide 12: XTANDI
XTANDI 12 Steadily increasing XTANDI sales in all regions Sales by region 1,404 (+9.2%) 26.1 (+11.4%) 1,286 23.4 Japan Americas (million USD) (billion yen) 823 (+14.6%) 5.8 (+47.3%) 718 +42.4% EMEA Asia/ 4.0 (CER basis) (million euro) Oceania (billion yen) FY2016 FY2017 FY2016 FY2017
Slide 13: OAB Franchise in Urology
OAB FRANCHISE IN UROLOGY 13 Proportion of Betanis/Myrbetriq/BETMIGA sales steadily expanding by shifting resources from Vesicare Sales composition ratio by product (FY2016 vs FY2017:local currency basis) Americas EMEA 36% 31% 37% 51% 49% 64% 69% 63% Japan 50% 50% 45% Betanis/ Myrbetriq/ BETMIGA 55%
Slide 14: FY2018 Forecasts: Summary
FY2018 FORECASTS：SUMMARY 14 Net sales XTANDI & OAB franchise to continue growth on a global basis. Prograf to show steady progress Decrease in sales in Japan due to NHI price revision and GEs impacts Negative impacts on sales due to decrease in deferred revenue of dermatology business transf
Slide 15: FY2018 Forecasts
FY2018 FORECASTS 15 Core basis: Profit for the year and EPS to increase, while operating profit to decrease （billion yen） FY2017 ACT FY2018 FCST Change Net sales 1,300.3 1,278.0 -1.7% R&D expenses 220.8 214.0 -3.1% as % of sales 17.0% 16.7% -0.3ppt Core operating profit 268.7 262.0 -2.5% Core profit
Slide 16: FY2018 Fcst: Net Sales/Core OP
FY2018 FCST: NET SALES/CORE OP 16 Flat net sales and Core OP adjusted for business transfer and Fx impacts despite NHI price revision Net sales Core OP (billon yen) (billion yen) FY2017 1,300.3 FY2017 268.7 XTANDI/OAB 31.1 Excluding Incl. impact of following factors Excluding NHI price revision foll
Slide 17: FY2018 Fcst: XTANDI
FY2018 FCST: XTANDI 17 XTANDI sales to increase in all regions on a local currency basis Sales by region (billion yen) Further penetration in earlier treatment 310.3 (+5.5%) within the current indications 294.3 (+16.8%) 7.7 Utilize solid evidence obtained in 252.1 5.8 clinical trials and our str
Slide 18: FY2018 Fcst: OAB Franchise in Urology
FY2018 FCST: OAB FRANCHISE IN UROLOGY 18 Betanis/Myrbetriq/BETMIGA growth enhances OAB Franchise Sales composition ratio by product Sales by products (billion yen) (FY18 FCST: yen basis) 243.1 (+6.6%) 228.1 (+6.1%) 214.9 Vesicare 60% 40% Betanis/ Myrbetriq/ 98.8 125.7 146.2 BETMIGA Betanis/ Myrbetri
Slide 19: Agenda
AGENDA 19 Review of Strategic Plan I 2015-2017 FY2017 Financial Results and II FY2018 Forecasts Initiatives to Build Resilience III for Sustainable Growth
Slide 20: Initiatives to Build Resilience for Sustainable Growth: Pipeline
INITIATIVES TO BUILD RESILIENCE FOR SUSTAINABLE GROWTH PIPELINE
Slide 21: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 21 Evaluating ~30 new molecular/biological entities as potential drivers of future growth Phase 1 Phase 2 Phase 3 Filed enfortumab vedotin (ASG- enzalutamide enzalutamide ● AGS67E ● (M0 BCR:US/EU/Asia, 22ME) (Urothelial cancer) M1 HSPC:US/EU/JP/Asia,) (M0 CRPC: US/EU) ● A
Slide 22: Steady Progress in Development
STEADY PROGRESS IN DEVELOPMENT 22 SUMMARY OF PROGRAM PROGRESS FROM JAN 2018 TO APR 2018 Steady progression of pipeline P1 P2 P3 Regulatory Decision Entry Entry Filing Entry gilteritinib solifenacin enzalutamide Mar 2018 (JP) Approved in Approved in Mar 2018 (US) Feb 2018 (EU) Feb 2018 (JP) Relapsed
Slide 23: Enzalutamide: Maximize the Value for Prostate Cancer Patients
ENZALUTAMIDE: MAXIMIZE THE VALUE FOR PROSTATE 23 CANCER PATIENTS Acceptance of application from FDA/EMA were received. PDUFA date is Jul 2018. Localized Castration Anti-Androgens Chemotherapy Therapy* M0 BCR M0 CRPC EMBARK PROSPER M1 HSPC >>> >>> PSA/ ARCHES** Tumor volume >>> >>> M1 CRPC M1 CRPC Ch
Slide 24: Enzalutamide: PROSPER Study Results
ENZALUTAMIDE: PROSPER STUDY RESULTS 24 Enzalutamide decreased the risk of metastasis or death by 71% and delayed median metastasis-free survival by approximately 3 years in M0 CRPC patients. Study design: Conclusion: enzalutamide In men with M0 CRPC with rapid PSA doubling (160mg/day) + ADT time (
Slide 25: Enzalutamide: PROSPER Study Results
ENZALUTAMIDE: PROSPER STUDY RESULTS 25 Median MFS was approximately 3 years with enzalutamide compared to 14.7 months for placebo (71% reduction in relative risk of radiographic progression or death) Primary endpoint: Metastatic Free Survival (MFS)* *MFS: a measure of the amount of time that passes
Slide 26: Gilteritinib: Relapsed and Refractory (R/R) AML
GILTERITINIB: RELAPSED AND REFRACTORY(R/R) AML 26 Application for market authorization for R/R AML was submitted to PMDA in Mar 2018 under SAKIGAKE designation. NDA submission in US followed in Mar 2018 AML Patients (~30,000)1 ADMIRAL study mFLT3 ~30% (~10,000) • Enrollment completed • Submission wa
Slide 27: Enfortumab Vedotin: Metastatic Urothelial Cancer
ENFORTUMAB VEDOTIN: METASTATIC UROTHELIAL CANCER 27 FDA granted “Breakthrough therapy designation” for locally advanced or metastatic urothelial cancer (mUC) with prior checkpoint inhibitor (CPI) treatment Target: Nectin-4 Antibody Drug Conjugate (ADC) • Targeting Nectin-4 which is a type I transmem
Slide 28: Roxadustat: Phase 3 Program in Europe and Japan
ROXADUSTAT: ROBUST PHASE 3 PROGRAM TO SUPPORT 28 FILING AND REIMBURSEMENT IN EUROPE AND JAPAN Steady progress of Phase 3 program in dialysis and non-dialysis patients Dialysis Non-dialysis DOLOMITES, vs darbepoetin HIMALAYAS: Enrollment completed Incident dialysis, vs epoetin alfa Data readout plann
Slide 29: Roxadustat: Japanese Studies in Dialysis Patients
ROXADUSTAT: JAPANESE STUDIES IN DIALYSIS PATIENTS 29 Positive results obtained from 2 Phase 3 studies in Japanese dialysis patients Hemodialysis: Correction (ESA-naive) Hemodialysis: ESA-conversion, long-term Study design: multi-center, open-label, Study design: multi-center, open-label, non- ra
Slide 30: Phase 2 Programs: Recent Updates
PHASE 2 PROGRAMS: RECENT UPDATES 30 Making progress and near-term plan for Phase 2 programs ASP4070 reldesemtiv (CK-2127107) Pollinosis caused by Japanese red cedar < Cytokinetics-sponsored study > TLR (preliminary) of POC study obtained SMA Study didn’t meet the primary endpoint Phase 2 study
Slide 31: Expected Key Pipeline Events in FY2018
EXPECTED KEY PIPELINE EVENTS IN FY2018 31 Important milestones from POC through registration *Subject to internal assessment, decision and regulatory consultation, as appropriate Data Readouts Filing* Phase 2 (POC) study Phase 3 study peficitinib Rheumatoid arthritis (Japan) ASP0819 gilteritinib Fib
Slide 32: Potential Growth Drivers
POTENTIAL GROWTH DRIVERS 32 Future growth driven by compounds that already have achieved POC enzalutamide (M0 CRPC) gilteritinib enzalutamide (Relapsed and Refractory AML) (label expansion) solifenacin/mirabegron gilteritinib (Combination therapy) (Other AML patient segments) roxadustat enfortumab v
Slide 33: Initiatives to Build Resilience: Strategic Initiatives
INITIATIVES TO BUILD RESILIENCE FOR SUSTAINABLE GROWTH STRATEGIC INITIATIVES
Slide 34: Modality: Acquisition of Universal Cells
MODALITY: 34 ACQUISITION OF UNIVERSAL CELLS Reinforce focus on cell therapy by acquiring Universal Donor Cell technology Strength of Universal Donor Cell technology Technology to create stem cell therapies that overcome immune rejection Universal Donor Cell technology can be administered to an
Slide 35: Modality: License Agreement with Tottori University
MODALITY: 35 LICENSE AGREEMENT WITH TOTTORI UNIVERSITY Immuno-oncolytic virus with multiple trans-genes to evoke anti-tumor immunity cancer ≠ foreign body cancer ＝ foreign body anti-tumor ⋘ immune suppression immune suppression ⋘ anti-tumor NK cell: Natural Killer cell, DC: Dendritic Cell, APC: Anti
Slide 36: Initiatives to Build Resilience: Pursue Operational Excellence
INITIATIVES TO BUILD RESILIENCE FOR SUSTAINABLE GROWTH PURSUE OPERATIONAL EXCELLENCE
Slide 37: Optimization of Organization / Structure in EMEA
OPTIMIZATION OF ORGANIZATION / STRUCTURE 37 IN EMEA Evolve operating model with changes in external environment R&D activities in Netherlands consolidated in Japan and the U.S. Further improving efficiency of finance function in EMEA through outsourcing and reorganization Enhancing sales & mar
Slide 38: Information Meeting on Strategic Plan May 22, 2018
SCHEDULE 38 Information meeting on Strategic Plan May 22, 2018 2:00 pm – 3:30 pm (JST)
Slide 39: Appendix
APPENDIX
Slide 40: FY2017: Sales by Region
FY2017: SALES BY REGION 40 FY16 FY17 Change Japan (billion yen) 480.8 421.2 -12.4% of sales in Japanese market 452.7 383.4 -15.3% Americas (million USD) 3,805 3,909 +2.7% EMEA (million EUR) 2,785 2,651 -4.8% Asia/Oceania (billion yen) 87.7 102.0 +16.3%
Slide 41: FY2018 Fcst: Sales by Region
FY2018 FCST: SALES BY REGION 41 FY17 FY18 FCST Change Japan (billion yen) 421.2 396.8 -5.8% of sales in Japanese market 383.4 365.3 -4.7% Americas (million USD) 3,909 4,042 +3.4% EMEA (million EUR) 2,651 2,645 -0.2% Asia/Oceania (billion yen) 102.0 112.9 +10.7%
Slide 42: FY2018 Fcst: Sales in Key Areas
FY2018 FCST: SALES IN KEY AREAS 42 (billion yen) FY17 FY18 FCST Change CER growth XTANDI 294.3 310.3 +5.5% +8.4% OAB in Urology 228.1 243.1 +6.6% +9.6% Vesicare 102.3 96.9 -5.2% -3.2% Betanis/Myrbetriq/BETMIGA 125.7 146.2 +16.3% +20.1% Transplantation 198.5 190.7 -3.9% -3.3% Transplantation: Prograf
Slide 43: FY2018 Sales Fcst: XTANDI
FY2018 SALES FCST: XTANDI 43 Sales since launch by region +9% +5% 280 Japan +11% +8% 1400 Americas +1% -11%* ex-US (billion yen) (million USD) 180 900 -2% +7% +4% US 80 400 -20 *+19% excl. NHI drug price cut impacts -100 +12% EMEA +15% 100 Asia&Oceania +35% +31% (million euro) (billion yen) 5x% 4x%
Slide 44: FX Rate (Actual)
FX RATE (ACTUAL) 44 Average rate for the period (yen) Currency FY16 FY17 Change USD 108 111 +2 EUR 119 130 +11 Change in closing rate from PY end Currency FY16 FY17 USD -0 -6 EUR -8 +11 Exchange rate change +: Yen Weakening, - : Yen Strengthening
Slide 45: FY2018 Fcst: FX Rate & FX Sensitivity
FY2018 FCST：FX RATE & FX SENSITIVITY 45 (yen) Average rate for the period Currency FY17 FY18 FCST Change USD 111 105 -6 EUR 130 130 +0 Change in closing rate from PY end Currency FY17 FY18 FCST USD -6 -1 EUR +11 -1 Estimated Fx sensitivity of FY2018 forecasts by 1 yen appreciation Year-end rate Aver
Slide 46: Balance Sheet/Cash Flow Highlights
BALANCE SHEET/CASH FLOW HIGHLIGHTS 46 (billion yen) FY2016 end FY2017 end Total assets 1,814.1 1,858.2 Cash and cash equivalents 340.9 331.7 Total net assets 1,271.8 1,268.3 Equity ratio (%) 70.1% 68.3% (billion yen) FY16 FY17 Cash flows from operating activities 235.6 312.6 Cash flows from investin
Slide 47: Profit Distribution
PROFIT DISTRIBUTION 47 FY2018 FY2016 FY2017 (Forecast) EPS (yen) 103.69 81.11 107.79 Divided per share 34 36 (planned) 38 (forecast) (yen) ROE 17.3% 13.0% - DOE 5.6% 5.7% - 60 million shares 88 million shares Share buyback - 91.4 billion yen 129.9 billion yen Treasury stock 89 million shares 68 mill
Slide 48: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE