Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q1 2018 Earnings Presentation
36 slides from Astellas Pharma's earnings presentation, Jul 27, 2018
Slide 1: Q1/FY2018 Financial Results Ended June 30, 2018
Q1/FY2018 FINANCIAL RESULTS ENDED JUNE 30, 2018 Chikashi Takeda Chief Financial Officer Astellas Pharma Inc. July 27, 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 Q1/FY2018 Consolidated I IV Capital Allocation Financial Results II Pipeline III Initiatives for Sustainable Growth
Slide 4: Q1/FY2018 Financial Results (Core Basis)
Q1/FY2018 FINANCIAL RESULTS (CORE BASIS) 4 FY18 Achieve- Excl. Fx (billion yen) Q1/FY17 Q1/FY18 Change impacts FCST* ment Net sales 322.6 329.1 +2.0% 1,278.0 25.7% +0.8% Cost of sales 79.3 70.7 -10.8% % of sales 24.6% 21.5% SG&A expenses 112.3 112.9 +0.5% % of sales 34.8％ 34.3% R&D expenses 56.5 52.
Slide 5: Sales Analysis (Year on Year)
SALES ANALYSIS (YEAR ON YEAR) 5 Growth of XTANDI and mirabegron contributed to increase net sales despite sales decrease in Japan due to NHI price revision and GEs impact (billion yen) Q1/FY17 322.6 XTANDI OAB products Others GEs impact in Japan, etc. Fx impacts 4.0 329.1 NHI price revision in Japan
Slide 6: Core OP Analysis (Year on Year)
CORE OP ANALYSIS (YEAR ON YEAR) 6 Increased core OP by 29％ with combination of increase sales of main products and optimal resource allocation (billion yen) Q1/FY17 65.1 Gross profit* Efficient spending and SG&A expenses* optimal resource allocation -Decrease due to wind-down of R&D expenses* Agensy
Slide 7: Q1/FY2018 Financial Results (Full Basis)
Q1/FY2018 FINANCIAL RESULTS (FULL BASIS) 7 Achieve- (billion yen) Q1/FY17 Q1/FY18 Change FY18FCST* ment Core operating profit 65.1 84.0 +29.0% 262.0 32.1% Other income 9.7 4.2 -56.3% Other expense 31.3 24.7 -21.0% Operating profit 43.5 63.5 +46.0% 265.0 24.0% Profit before tax 48.5 64.5 +33.1% 266.0
Slide 8: Sales of Main Products
SALES OF MAIN PRODUCTS 8 Main products delivering as forecasted, contributing to increased net sales FY18 Achieve- (billion yen) Q1/FY17 Q1/FY18 Change CER growth FCST* ment XTANDI 67.9 81.2 +19.6% +18.3% 310.3 26.2% OAB products in 51.8 59.3 +14.5% +13.8% 243.1 24.4% Urology Vesicare 24.6 24.9 +1.4
Slide 9: XTANDI
XTANDI 9 Double-digit growth in all regions. Record quarterly sales in Japan, Americas and EMEA Sales by region 390 (+20.8%) 8.5 (+31.4%) 323 Japan 6.5 Americas ex-US (million USD) (billion yen) US 361 301 220 (+10.3%) 200 1.5 (+31.2%) 1,168 Asia/ 1.2 EMEA 1,056 +31.3% (million euro) Oceania (CER ba
Slide 10: OAB Franchise in Urology
OAB FRANCHISE IN UROLOGY 10 Growth of mirabegron due to strategic resource shift driving OAB franchise sales Quarterly sales (Global) (bil. yen) 70.0 Vesicare Mirabegron OAB products total 60.0 50.0 40.0 30.0 20.0 10.0 0.0 Mirabegron (Betanis/Myrbetriq/BETMIGA)
Slide 11: New Products in Japanese Market
NEW PRODUCTS IN JAPANESE MARKET 11 Aiming to restore sales trend by continuously launching and maximizing value of new products Launched in May 2018 Drug combining selective DPP-4 inhibitor (JANUVIA) and selective SGLT2 inhibitor (Suglat) Mar. 2017 Apr. 2016 Apr. 2014 ★ ★ Pipeline (Approved and File
Slide 12: Agenda
AGENDA 12 Q1/FY2018 Consolidated I IV Capital Allocation Financial Results II Pipeline III Initiatives for Sustainable Growth
Slide 13: Steady Progress in Development
STEADY PROGRESS IN DEVELOPMENT 13 SUMMARY OF PROGRAM PROGRESS FROM APR 2018 TO JUL 2018 Steady progression of pipeline P1 P2 P3 Regulatory Decision Filing Entry Entry Entry (Approval) ASP1948/ enfortumab peficitinib solifenacin/ fidaxomicin PTZ-329 vedotin May 2018 (JP) mirabegron Jul 2018 (JP) Urot
Slide 14: Enzalutamide
ENZALUTAMIDE 14 FDA approved enzalutamide for M0 CRPC in US in July 2018 PROSPER study results published in New England Journal of Medicine Approved in US P3: PROSPER study M0 CRPC Placebo-controlled, combination with ADT Under regulatory review Non-metastatic CRPC in EU M1 HSPC P3: ARCHES study Met
Slide 15: Gilteritinib
GILTERITINIB 15 NDA accepted for priority review in US with PDUFA date on Nov 29, 2018 Relapsed or refractory Open-label, randomized, Enrollment completed P3: ADMIRAL study 1st relapsed or refractory, monotherapy vs salvage chemo (2:1), n=371 (Study on-going) FLT3 mutation positive P2/3: 1st line in
Slide 16: Enfortumab Vedotin
ENFORTUMAB VEDOTIN 16 Data readout of Cohort 1 (platinum-pretreated) in Phase 2 study planned in 1H/2019 enfortumab vedotin (EV) Metastatic urothelial cancer (mUC) EV: ADC* targeting Nectin4 • Approximately 233,000 new patients are diagnosed as urothelial cancer Nectin4: Type I transmembrane protein
Slide 17: Enfortumab Vedotin
ENFORTUMAB VEDOTIN 17 Updated data of Phase 1 study presented at ASCO2018 Efficacy: EV has demonstrated a clinically meaningful confirmed ORR of 41% in heavily pretreated locally advanced or metastatic urothelial cancer patients Although OS data are still maturing, the preliminary median OS of 1
Slide 18: Zolbetuximab (IMAB362)
ZOLBETUXIMAB (IMAB362) 18 Phase 3 SPOTLIGHT study (combination with mFOLFOX6) initiated Gastric and gastroesophageal junction (GEJ) Target: Claudin18.2 adenocarcinoma Claudin is a major structural component of tight Target patient population: locally advanced and junctions and seals intercellula
Slide 19: Roxadustat
ROXADUSTAT 19 Filing in Japan for anemia associate with CKD (dialysis) planned in 2H/2018 Dialysis Non-dialysis HIMALAYAS: Incident dialysis, vs epoetin alfa DOLOMITES: vs darbepoetin Enrollment completed Enrollment completed Data readout planned in 4Q/2018 Data readout planned in 4Q/2018 SIERRAS: S
Slide 20: Fezolinetant
FEZOLINETANT 20 A potential first-in-class, non-hormone replacement therapy treatment for MR-VMS MR-VMS: Unmet medical needs Phase 2b study: TLR in 3Q/2018 Women’s Health Initiative (WHI) Study1 Target patient • The data contraindicated chronic treatment with • Post menopausal women suffering from a
Slide 21: Reldesemtiv
RELDESEMTIV 21 Phase 2 study results in SMA patients were presented at CureSMA conference Phase 2 study in SMA patients Study status of other indications Currently the detail data analysis is on-going < Cytokinetics-sponsored study > The 2018 annual CureSMA conference ALS Study design: double-blind,
Slide 22: Expected Key Pipeline Events in FY2018
EXPECTED KEY PIPELINE EVENTS IN FY2018 22 Important milestones from POC through registration Gray out indicates the achieved milestone Data Readouts Filing* peficitinib roxadustat Phase 2 (POC) study Phase 3 study Rheumatoid arthritis (Japan) Anemia associated with CKD, Dialysis pts (Japan) ASP0819
Slide 23: Potential Growth Drivers
POTENTIAL GROWTH DRIVERS 23 Future growth driven by compounds that already have achieved POC Filed/Expected filing Current FY2018 FY2019-FY2020 FY2021 - enzalutamide enzalutamide enzalutamide (M1 HSPC) (M0 HSPC) (M0 CRPC: EU) gilteritinib enfortumab vedotin gilteritinib (Metastatic urothelial cancer
Slide 24: Agenda
AGENDA 24 Q1/FY2018 Consolidated I IV Capital Allocation Financial Results II Pipeline III Initiatives for Sustainable Growth
Slide 25: Pursue Operational Excellence
PURSUE OPERATIONAL EXCELLENCE 25 Continue zero-based review of all activities from various aspects Capability Operating model evolution Focus on Differentiating Capabilities Review operational process and and Competitive Necessities organization -Restructuring of operations in Japan -Optimization of
Slide 26: Initiatives for Access to Health
INITIATIVES FOR ACCESS TO HEALTH 26 Contribute to Access to Health, leveraging Astellas capability MucoRice-CTB: Starting Phase 1 study targeting prophylaxis of diarrhea caused by Vibrio cholerae Characteristics ・Rice-based oral vaccine Genetically expressing antigens and suppressing the endogenous
Slide 27: Agenda
AGENDA 27 Q1/FY2018 Consolidated I IV Capital Allocation Financial Results II Pipeline III Initiatives for Sustainable Growth
Slide 28: Capital Allocation
CAPITAL ALLOCATION 28 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 29: Appendix
APPENDIX
Slide 30: Q1/FY2018: Sales by Region
Q1/FY2018: SALES BY REGION 30 (billion yen) Q1/FY17 Q1/FY18 Change Japan 114.2 100.2 -12.3% Americas 101.6 112.9 +11.2% EMEA 83.4 90.8 +8.9% Asia/Oceania 23.4 25.2 +7.5%
Slide 31: FX Rate (Actual)
FX RATE (ACTUAL) 31 Average rate for the period Currency Q1/FY17 Q1/FY18 Change USD 111 109 -2 EUR 122 130 +8 Change in closing rate from PY end Currency Q1/FY17 Q1/FY18 USD -0 +4 EUR +8 -3
Slide 32: FY2018 FCST: FX Rate & FX Sensitivity
FY2018 FCST：FX RATE & FX SENSITIVITY 32 Estimated Fx sensitivity of FY2018 forecasts by 1 yen appreciation Year-end rate Average rate 1 yen higher than 1 yen higher than assumption assumption Currency Net sales Core OP Core OP USD Approx. -5.1 bil yen Approx. -1.2 bil yen Approx. +0.6 bil yen EUR Ap
Slide 33: Balance Sheet/Cash Flow Highlights
BALANCE SHEET/CASH FLOW HIGHLIGHTS 33 (billion yen) FY17 end Jun. 2018 Total assets 1,858.2 1,866.6 Cash and cash equivalents 331.7 309.7 Total net assets 1,268.3 1,275.9 Equity ratio (%) 68.3% 68.4% (billion yen) Q1/FY17 Q1/FY18 FY17 Cash flows from operating activities 59.5 37.2 312.6 Cash flows f
Slide 34: Details of Shareholder Returns
DETAILS OF SHAREHOLDER RETURNS 34 Profit for the (billion yen) Dividends per 40 Share* (Left axis) year** (right axis) 250 (yen) 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 35: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 35 Phase 1 Phase 2 Phase 3 Filed ● AGS67E ● AGS-16C3F (Renal cell carcinoma) enzalutamide enzalutamide (M0 HSPC:US/EU/Asia, (M0 CRPC: EU) ● bleselumab (ASKP1240) M1 HSPC:US/EU/JP/Asia,) ● AGS62P1 (rFSGS) gilteritinib (ASP2215) ● gilteritinib (ASP2215) ASP4070 (Pollinosis
Slide 36: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE