Slide 1: Q3/FY2017 Financial Results
Q3/FY2017 FINANCIAL RESULTS ENDED DECEMBER 31, 2017 Chikashi Takeda Chief Financial Officer Astellas Pharma Inc. January 31, 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 I Q3/FY2017 Financial Results Initiatives to Build Resilience for II Sustainable Growth III Profit Distribution Policy
Slide 4: Q3/FY2017 Financial Results (Core Basis)
Q3/FY2017 FINANCIAL RESULTS (CORE BASIS) 4 On-track toward FY2017 FCST Excl impacts FY17 Achieve- from Fx and （billion yen） Q3/FY16 Q3/FY17 Change business FCST* ment transfer Net sales 1,005.6 999.4 -0.6% 1,297.0 77.1% -1.3% Cost of sales 250.8 238.9 -4.7% % of sales 24.9％ 23.9% SG&A expenses 336.7
Slide 5: Sales Analysis (Year on Year)
SALES ANALYSIS (YEAR ON YEAR) 5 Growth drivers in good shape, slight decrease in net sales due to GEs impacts in Japan (billion yen) Q3/FY16 1,005.6 XTANDI/OAB products Others GEs impacts in Japan, etc. Dermatology business Decrease in transfer * amortisation of deferred revenue Long listed drug tra
Slide 6: Core OP Analysis (Year on Year)
CORE OP ANALYSIS (YEAR ON YEAR) 6 Development costs for late-stage projects, etc. increased (billion yen) Q3/FY16 241.8 Gross profit* Efficient spending and SG&A expenses* optimal resource allocation R&D expenses* Increase in late-stage development Continue to invest in new opportunities Others* Gro
Slide 7: Q3/FY2017 Financial Results (Full Basis)
Q3/FY2017 FINANCIAL RESULTS (FULL BASIS) 7 On-track toward FY2017 FCST Achieve- （billion yen） Q3/FY16 Q3/FY17 Change FY17FCST* ment Core operating profit 241.8 220.5 -8.8% 258.0 85.4% Other income 6.6 10.4 +58.8% Other expenses 17.1 51.2 +198.7% Operating profit 231.3 179.8 -22.3% 222.0 81.0% Financ
Slide 8: Cash Flow Analysis
CASH FLOW ANALYSIS 8 Cash flows from operating activities increased by 16% (YoY) Implemented active business investment and flexible shareholder return Q3/FY16 Q3/FY17 (billion yen) +215.3 +186.4 Acquisition of Ogeda -61.6 -70.8 -93.8 Share buyback -70.7 +12.3 -120.2 -6.8 -143.1 Operating Investing
Slide 9: Sales in Three Key Areas
SALES IN THREE KEY AREAS 9 XTANDI, OAB franchise increase on a global basis (billion yen) Q3/FY16 Q3/FY17 Change CER growth Oncology 232.3 260.8 +12.3% +6.2% XTANDI 189.2 219.9 +16.2% +9.9% OAB in Urology 160.9 171.6 +6.6% +2.1% Vesicare 89.3 78.5 -12.1% -16.0% Betanis/Myrbetriq/BETMIGA 71.6 93.1 +3
Slide 10: Agenda
AGENDA 10 I Q3/FY2017 Financial Results Initiatives to Build Resilience for II Sustainable Growth III Profit Distribution Policy
Slide 11: Achieving Sustainable Growth
ACHIEVING SUSTAINABLE GROWTH 11 (same as Strategic Plan 2015-2017 slide) New products will drive mid-term growth; Sustainable growth will be reinforced by continuous selective investment in innovation and strengthening of the business foundation Maximizing the Creating Innovation Product Value Enhan
Slide 12: Maximize the Product Value
| MAXIMIZE THE PRODUCT VALUE
Slide 13: XTANDI
XTANDI 13 Record-high quarterly sales in each region Sales by region Quarterly sales (local currency) (billion yen) Americas (million USD) 383 (+13%) 219.9 (+16%) 189.2 4.0 US 2.5 (+12%) 79.0 63.1 Asia/Oceania 209 EMEA (million EUR) (+1%) EMEA Americas 116.8 Japan 105.6 50 FY15 FY16 FY17 Q1 Q2 Q3 Q4
Slide 14: OAB Franchise in Urology
OAB FRANCHISE IN UROLOGY 14 Betanis/Myrbetriq/BETMIGA growth enhances OAB Franchise Sales by product Sales composition ratio by (billion yen) product (yen basis) 171.6 (+7%) 160.9 Betanis/Myrbetriq/ 71.6 93.1 54% 46% BETMIGA Vesicare Betanis/Myrbetriq/ BETMIGA 89.3 • The market share of 78.5 Vesicar
Slide 15: Create Innovation: Pipeline
| CREATE INNOVATION PIPELINE
Slide 16: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 16 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, Tab
Slide 17: Steady Progress in Development
STEADY PROGRESS IN DEVELOPMENT 17 SUMMARY OF PROGRAM PROGRESS FROM OCT 2017 TO JAN 2018 Steady progression of pipeline P1 P2 P3 Regulatory Filing* Entry Entry Entry Decision MA-0217 ASP4345 IMAB362 enzalutamide blinatumomab Acute kidney injury Cognitive Gastric and Jan 2018 (US) Jan 2018 (JP) impair
Slide 18: Enzalutamide: Maximize the Value for Prostate Cancer Patients
ENZALUTAMIDE: MAXIMIZE THE VALUE FOR PROSTATE 18 CANCER PATIENTS Application for marketing approval submitted to FDA and EMA for M0 CRPC. PROSPER study data will be presented at ASCO-GU 2018 Localized Castration Anti-Androgens Chemotherapy Therapy* M0 BCR M0 CRPC EMBARK >>> >>> PROSPER -T PSA/ Chemo
Slide 19: Gilteritinib: Treatment Landscape in AML
GILTERITINIB: TREATMENT LANDSCAPE IN AML 19 European Commission granted orphan designation to gilteritinib for the treatment of acute myeloid leukemia (AML) Phase 1 study Ongoing Chemo Maintenance High- intensity consolidation GOSSAMER study induction Transplant Maintenance chemo FLT3 + AML MORPHO s
Slide 20: Gilteritinib: Phase 1 Study in Newly Diagnosed AML
GILTERITINIB: PHASE 1 STUDY IN NEWLY DIAGNOSED AML 20 Encouraging data from on-going Phase 1 study in the FLT3 mutation positive, newly diagnosed AML patients was presented at ASH2017 Study design: Conclusion: • Multicenter, open-label, 3+3 design • Preliminary results suggest that gilteritinib can
Slide 21: IMAB362: Phase 3 Program
IMAB362: PHASE 3 PROGRAM 21 Global Phase 3 studies to support global registration for first-line gastric and gastroesophageal junction adenocarcinoma indication Phase 3:Combination with mFOLFOX6 Phase 3: Combination with CAPOX Study design: Study design: • multicenter, double-blind, randomized • mul
Slide 22: Roxadustat: Robust Phase 3 Program
ROXADUSTAT: ROBUST PHASE 3 PROGRAM TO SUPPORT 22 FILING AND REIMBURSEMENT IN EUROPE AND JAPAN Steady progress of Phase 3 program in dialysis and non-dialysis patients Dialysis Non-dialysis HIMALAYAS: DOLOMITES, vs darbepoetin Incident dialysis, vs epoetin alfa Enrollment completed ALPS, vs placebo S
Slide 23: Expected Key Pipeline Events in FY2017
EXPECTED KEY PIPELINE EVENTS IN FY2017 23 Important milestones from POC through registration *Subject to internal assessment, decision and regulatory consultation, as appropriate Data Readouts Filing* Regulatory Decisions Phase 2 (POC) study Phase 3 study solifenacin/mirabegron enzalutamide Concomit
Slide 24: Potential Growth Drivers
POTENTIAL GROWTH DRIVERS 24 Future growth driven by compounds that already have achieved POC gilteritinib enzalutamide enzalutamide (M0 CRPC) (label expansion) solifenacin/ enfortumab mirabegron vedotin (Combination therapy) IMAB362 evolocumab (Cardiovascular roxadustat outcome study) linaclotide AS
Slide 25: Create Innovation: New Initiatives
CREATE INNOVATION NEW INITIATIVES
Slide 26: Biology: Acquisition of Mitobridge
BIOLOGY: ACQUISITION OF MITOBRIDGE 26 Reinforce the discovery and development of novel drugs that target Mitochondrial functions Programs: Approaches to mitochondrial function MA-0211 • Phase 1 ongoing for duchenne muscular dystrophy MA-0217 • Phase 1 ongoing for acute kidney injury Several other IN
Slide 27: Create Social Value: Initiatives for Access to Health
CREATE SOCIAL VALUE: 27 INITIATIVES FOR ACCESS TO HEALTH Resolve social issues and enhance our enterprise value over the long-term Participation in GHIT Fund replenishment Collaborative development Support of Action on Fistula Access Accelerated agreement for rice-based oral vaccine Collaborative re
Slide 28: Pursue Operational Excellence
PURSUE OPERATIONAL EXCELLENCE
Slide 29: Initiatives to Continuous Strengthening of Management Foundation
INITIATIVES TO CONTINUOUS STRENGTHENING OF 29 MANAGEMENT FOUNDATION Resource allocation from scratch responding to environment changes Investment priority Initiatives in FY2017 • Investment in growth areas and withdrawal from non- growth areas Transfer of long-listed products • Sufficient investme
Slide 30: Agenda
AGENDA 30 I Q3/FY2017 Financial Results Initiatives to Build Resilience for II Sustainable Growth III Profit Distribution Policy
Slide 31: Profit Distribution Policy
PROFIT DISTRIBUTION POLICY 31 Top priority on investment for growth business Dividends to be increased continuously based on mid-and long-term growth Share buybacks to be implemented in a flexible manner （billion yen） 40 250 （yen） Profit for the Dividends per year** (right axis) Share* (Left axis) 2
Slide 32: Realize Sustainable Growth
REALIZE SUSTAINABLE GROWTH 32 Turn innovative science into value for patients on the forefront of healthcare change New technologies/ modalities * Pre-POC projects Post-POC Strategic resource allocation projects -Transfer of dermatology business -Transfer of US manufacturing subsidiary -Transfer of
Slide 33: Schedule
SCHEDULE 33 April 26, 2018: Financial Results for FY2017 May 22, 2018: New Strategic Plan
Slide 34: Appendix
APPENDIX
Slide 35: Q3/FY2017: Sales by Region
Q3/FY2017: SALES BY REGION 35 Q3/FY16 Q3/FY17 Change Japan (billion yen) 380.1 337.3 -11.3% of sales in Japanese market 358.2 309.0 -13.7% Americas (million USD) 2,889 2,926 +1.3% EMEA (million EUR) 2,143 2,023 -5.6% Asia/Oceania (billion yen) 64.5 75.3 +16.8%
Slide 36: FX Rate (Actual)
FX RATE (ACTUAL) 36 Average rate for the period (yen) Currency Q3/FY16 Q3/FY17 Change USD 107 112 +5 EUR 118 129 +11 Change in closing rate from PY end Currency Q3/FY16 Q3/FY17 USD +4 +1 EUR -5 +15 Exchange rate change +: Yen Weakening, - : Yen Strengthening
Slide 37: FY2017 FCST: FX Sensitivity
FY2017 FCST：FX SENSITIVITY 37 Forecast rates from October 2017 onwards: 110 USD/yen, 130EUR/yen Estimated Fx sensitivity (October 2017 and onward) of FY2017 forecasts by 1 yen appreciation* Year-end rate Average rate 1 yen higher than Currency 1 yen higher than assumption assumption Net sales Core O
Slide 38: Balance Sheet/Cash Flow Highlights
BALANCE SHEET/CASH FLOW HIGHLIGHTS 38 (billion yen) FY2016 end Dec. 2017 Total assets 1,814.1 1,933.8 Cash and cash equivalents 340.9 331.7 Total net assets 1,271.8 1,366.9 Equity ratio (%) 70.1% 70.7% (billion yen) Q3/FY16 Q3/FY17 FY2016 Cash flows from operating activities 186.4 215.3 235.6 Cash f
Slide 39: Profit Distribution
PROFIT DISTRIBUTION 39 FY2017 FY2015 FY2016 (forecast) EPS (yen) 89.75 103.69 88.44 Divided per share (yen) 32 34 36 (forecast) ROE 15.0% 17.3% - DOE 5.4% 5.6% - Implemented in a flexible manner 68 million shares 60 million shares Share buyback 49 million shares 119.3 billion yen 91.4 billion yen 70
Slide 40: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE