Slide 1: Q2/FY2018 Financial Results
Q2/FY2018 FINANCIAL RESULTS ENDED SEPTEMBER 30, 2018 Kenji Yasukawa, Ph.D President and CEO Astellas Pharma Inc. October 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 Q2/FY2018 Consolidated Financial Results I and FY2018 Revised Forecasts II Pipeline III Initiatives for Sustainable Growth
Slide 4: Q2/FY2018 Financial Results (Core Basis)
Q2/FY2018 FINANCIAL RESULTS (CORE BASIS) 4 FY18 (billion yen) Q2/FY17 Q2/FY18 Change Progress CER growth FCST* Net sales 639.8 647.1 +1.1% 1,278.0 50.6% +0.6% Cost of sales 148.8 143.5 -3.5% % of sales 23.3% 22.2% SG&A expenses 228.3 231.5 +1.4% % of sales 35.7％ 35.8% R&D expenses 107.5 99.6 -7.4% 2
Slide 5: Sales Analysis (Year on Year)
SALES ANALYSIS (YEAR ON YEAR) 5 Growth of XTANDI and mirabegron contributed to increase in net sales despite sales decrease in Japan due to NHI price revision and GEs impact (billion yen) Q2/FY17 639.8 XTANDI OAB products Others GEs impact in Japan, etc. Fx impacts +3.5 NHI price revision in Japan Q
Slide 6: Core OP Analysis (Year on Year)
CORE OP ANALYSIS (YEAR ON YEAR) 6 Increased core OP by 13% with combination of increased sales of main products and optimal resource allocation (billion yen) Q2/FY17 136.4 Gross profit* -Increase in XTANDI US co-promotion fee SG&A expenses* -Efficient spending and optimal resource allocation -Increa
Slide 7: Q2/FY2018 Financial Results (Full Basis)
Q2/FY2018 FINANCIAL RESULTS (FULL BASIS) 7 (billion yen) Q2/FY17 Q2/FY18 Change FY18FCST* Progress Core operating profit 136.4 154.2 +13.1% 262.0 58.9% Other income 10.0 4.7 -53.1% Other expense 50.3 32.0 -36.3% Operating profit 96.1 126.8 +32.0% 265.0 47.9% Profit before tax 101.2 128.3 +26.7% 266.
Slide 8: Sales of Main Products
SALES OF MAIN PRODUCTS 8 Main growth products contributing to increased net sales FY18 (billion yen) Q2/FY17 Q2/FY18 Change CER growth Progress FCST* XTANDI 140.3 164.0 +16.9% +16.3% 310.3 52.8% OAB products in 107.3 116.7 +8.8% +8.5% 243.1 48.0% Urology Vesicare 49.7 48.1 -3.2% -3.8% 96.9 49.6% Mir
Slide 9: XTANDI
XTANDI 9 Steadily increasing XTANDI sales in all regions. Record quarterly sales in Americas 796 (+20.1%) Sales by region 16.8 (+30.4%) 663 Japan 12.9 Americas ex-US (billion yen) (million USD) US 738 615 433 (+6.8%) 3.2 (+25.1%) 406 EMEA 1,168 Asia/ 2.5 +27.2% Oceania (CER basis) (million euro) (bi
Slide 10: OAB Franchise in Urology
OAB FRANCHISE IN UROLOGY 10 Mirabegron growth from novel mechanism of action and product features driving OAB franchise sales Quarterly sales (Global) (bil. yen) 700 70.0 Vesicare Mirabegron OAB products total 600 60.0 500 50.0 400 40.0 60% 30.0 300 20.0 200 40% 10.0 100 0 0.0 Mirabegron (Product na
Slide 11: Revised Forecasts for FY2018 (Core Basis)
REVISED FORECASTS FOR FY2018 (CORE BASIS) 11 Upward revision of initial forecasts for net sales and profit based on Q2/FY2018 results and Fx trend FY18 FY18 (billion yen) Initial Revised Change Forecasts Forecasts Net sales 1,278.0 1,300.0 +22.0 R&D expenses 214.0 216.0 +2.0 as % of sales 16.7% 16.6
Slide 12: Revised Forecasts for FY2018 (Full Basis)
REVISED FORECASTS FOR FY2018 (FULL BASIS) 12 Downward revision of initial OP forecasts based on other income/expenses booked in Q2/FY2018 and estimated ones to be booked by the end of FY2018 FY18 FY18 (billion yen) Initial Revised Change Forecasts Forecasts Net sales 1,278.0 1,300.0 +22.0 Operating
Slide 13: Agenda
AGENDA 13 Q2/FY2018 Consolidated Financial Results I and FY2018 Revised Forecasts II Pipeline III Initiatives for Sustainable Growth
Slide 14: Summary of Program Progress
SUMMARY OF PROGRAM PROGRESS 14 SINCE Q1/FY2018 FINANCIAL RESULTS ANNOUNCEMENT IN JULY Steady progression of pipeline P1 P2 P3 Filing Approval* Entry Entry Entry ASP1951/ ASP1650 evolocumab linaclotide blinatumomab PTZ-522 Aug 2018 (JP) Aug 2018 (JP) Sep 2018 (JP) Testicular cancer Cancer Statin into
Slide 15: Enzalutamide
ENZALUTAMIDE 15 Approved in Europe for high-risk M0 CRPC in Oct. 2018 Amended protocols for ARCHES and EMBARK, accelerating study timeline Definitive Therapy Hormone or Castration Castration-Resistant Sensitive ARCHES M1 HSPC Initial Surgery newly-diagnosed PREVAIL AFFIRM Diagnosis M1 CRPC M1 CRPC M
Slide 16: Gilteritinib
GILTERITINIB 16 Approved in Japan for FLT3mut+ relapsed or refractory AML in Sep. 2018 Obtained full OS data of ADMIRAL study, to be presented at a future medical conference Phase 1 study Chemo Maintenance Salvage therapy High- intensity consolidation GOSSAMER induction Maintenance ADMIRAL chemo Tra
Slide 17: Roxadustat
ROXADUSTAT 17 Filed in Japan for anemia associated with CKD (dialysis) in Sep. 2018 Data readout of all 6 global Phase 3 studies expected by the end of 2018 Dialysis Non-dialysis HIMALAYAS: Incident dialysis, vs epoetin alfa DOLOMITES: vs darbepoetin alfa Data readout planned in 4Q/2018 Data readout
Slide 18: Fezolinetant
FEZOLINETANT 18 TLR obtained from Phase 2b study in MR-VMS, the analysis is ongoing Proceed to Phase 3 study preparation Design TLR obtained Target patient • TLR obtained in Oct. 2018 • Post menopausal woman suffering from at least 50 moderate to severe vasomotors symptoms per week • The detailed an
Slide 19: Program Updates
PROGRAM UPDATES 19 Oncology reldesemtiv enfortumab vedotin Next steps currently under discussion Data readout of Cohort 1 (CPI-pretreated/ COPD platinum-pretreated) in Phase 2 study planned Phase 2 study: TLR obtained. in 1Q/2019 The study did not meet the primary endpoint and secondary endpoi
Slide 20: Expected Key Events in Next 12 Months
EXPECTED KEY EVENTS IN NEXT 12 MONTHS 20 Important milestones from POC through registration Data Readouts Filing* roxadustat gilteritinib Phase 2 (POC) study Phase 3 study Anemia associated with CKD, R/R AML (EU) reldesemtiv roxadustat Dialysis/Non-dialysis (EU) enzalutamide (CK-2127107) EU: Non-dia
Slide 21: Potential Growth Drivers in Our Pipeline
POTENTIAL GROWTH DRIVERS IN OUR PIPELINE 21 Future growth driven by compounds that already have achieved POC Filed/Expected filing FY2018 FY2019-FY2020 FY2021 - gilteritinib enzalutamide enzalutamide (M1 HSPC) (M0 HSPC) (Relapsed or Refractory AML) enfortumab vedotin gilteritinib roxadustat (Metasta
Slide 22: Agenda
AGENDA 22 Q2/FY2018 Consolidated Financial Results I and FY2018 Revised Forecasts II Pipeline III Initiatives for Sustainable Growth
Slide 23: Focus Area Approach
FOCUS AREA APPROACH 23 Adding novel gene therapy programs through acquisition and alliance Acquisition of Quethera Option agreement with Gene Therapy Research Institution Novel gene therapy program for glaucoma at high risk of blindness* GT0001X* for the treatment of sporadic ALS Strengths of Qu
Slide 24: Capital Expenditures for R&D
CAPITAL EXPENDITURES FOR R&D 24 Facilities for the research, development and manufacture of new products with innovative modalities/technologies Center for Active Ingredient for Biopharmaceuticals (provisional name) Relocation and renovation of the AIRM* in Toyama in the US • Manufacture of anti
Slide 25: Developing Rx+ Programs
TM DEVELOPING Rx+ PROGRAMS 25 Steady progress on each program and continuing to capture new business opportunities Image-guided Initiatives to build connections and networks with /Treatment supports precision surgery technology and knowledge from various fields utilizing the • Rx+™ Business: Establi
Slide 26: R&D Meeting - Approaches to Cell Therapy
SCHEDULE 26 R&D meeting -Approaches to cell therapy- Date: December 13, 2018 Time: 14:00-15:30
Slide 27: Appendix
APPENDIX
Slide 28: Q2/FY2018: Sales by Region
Q2/FY2018: SALES BY REGION 28 (billion yen) Q2/FY17 Q2/FY18 Change Japan 213.0 195.3 -8.3% Americas 208.4 227.9 +9.4% EMEA 169.1 172.3 +1.9% Asia/Oceania 49.4 51.6 +4.6%
Slide 29: FX Rate (Actual)
FX RATE (ACTUAL) 29 Average rate for the period Currency Q2/FY17 Q2/FY18 Change USD 111 110 -1 EUR 126 130 +4 Change in closing rate from PY end Currency Q2/FY17 Q2/FY18 USD +1 +7 EUR +13 +2 Fx impact on elimination of unrealized gain: COGs ratio -0.1 ppt
Slide 30: FY2018 Revised Fcst: FX Rate & FX Sensitivity
FY2018 REVISED FCST：FX RATE & FX SENSITIVITY 30 Forecast rates from Q3/FY2018 onwards: 110 USD/yen, 130 EUR/yen Estimated Fx sensitivity (Q3 and onward) of FY2018 revised forecasts by 1 yen appreciation* Year-end rate Average rate 1 yen higher than 1 yen higher than assumption Currency assumption Ne
Slide 31: Balance Sheet/Cash Flow Highlights
BALANCE SHEET/CASH FLOW HIGHLIGHTS 31 (billion yen) FY17 end Sep. 2018 Total assets 1,858.2 1,886.9 Cash and cash equivalents 331.7 306.9 Total net assets 1,268.3 1,282.7 Equity ratio (%) 68.3% 68.0% (billion yen) Q2/FY17 Q2/FY18 FY17 Cash flows from operating activities 115.3 112.1 312.6 Cash flows
Slide 32: Details of Shareholder Returns
DETAILS OF SHAREHOLDER RETURNS 32 (yen) (billion yen) Dividends per Profit for the 40 Share* (Left axis) year** (right axis) 250 200 30 150 20 38 100 36 10 50 0 0 FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 (billion yen) (Forecast) Total dividends 39.3 42.3 55.2 56.9 58.2 5
Slide 33: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 33 Phase 1 Phase 2 Phase 3 Filed ASP1235/AGS62P1 AGS-16C3F (Renal cell carcinoma) enzalutamide gilteritinib (ASP2215) (M0 HSPC:US/EU/Asia, (R/R AML: US) ASP1650 (Testicular cancer) M1 HSPC:US/EU/JP/Asia,) ASP8374/PTZ-201 degarelix (ASP3550) bleselumab (ASKP1240) gilteriti
Slide 34: Enfortumab Vedotin
ENFORTUMAB VEDOTIN 34 Data readout of Cohort 1 (platinum-pretreated) in Phase 2 study planned in 1Q/2019 P3: EV-301 Pts with prior CPI treatment (platinum-pretreated) n=550 First Patient In: Jul 2018 Pts with prior CPI treatment First Patient In: Oct 2017 P2: EV-201 Cohort 1: Platinum-pretreated n=2
Slide 35: Zolbetuximab
ZOLBETUXIMAB 35 FPI achieved for Phase 3 SPOTLIGHT study (combination with mFOLFOX6) and Phase 2 ILUSTRO study (monotherapy, combination with mFOLFOX6) Gastric and gastroesophageal junction (GEJ) adenocarcinoma P3: SPOTLIGHT Combination with mFOLFOX6 vs. placebo, n=550 First Patient In: Oct 2018 P3:
Slide 36: Roxadustat
ROXADUSTAT 36 ASN Kidney Week 2018: JP Phase 3 study (hemodialysis, ESA-conversion) Efficacy Change of average Hb levels (g/dL) from baseline to Weeks 18-24 (△Hb18-24) • In the PPS, the mean (SE) of the average Hb levels of Weeks 18-24 in the roxadustat group was 10.99 (0.06) g/dL; the 95% CI (10.
Slide 37: Roxadustat
ROXADUSTAT 37 ASN Kidney Week 2018: JP Phase 3 study (hemodialysis, ESA-conversion) Safety Roxadustat was well tolerated with a safety profile similar to that of DA and consistent with previous reports. The proportion of patients who reported TEAEs were similar in the roxadustat and DA groups •
Slide 38: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE