Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q1 2019 Earnings Presentation
43 slides from Astellas Pharma's earnings presentation, Jul 30, 2019
Slide 1: Q1/FY2019 Financial Results Ended June 30, 2019
Q1/FY2019 FINANCIAL RESULTS ENDED JUNE 30, 2019 Chikashi Takeda Chief Financial Officer Astellas Pharma Inc. July 30, 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 I Q1/FY2019 Consolidated Financial Results II Initiatives for Sustainable Growth III Capital Allocation
Slide 4: Q1/FY2019 Financial Results (Core Basis)
Q1/FY2019 FINANCIAL RESULTS (CORE BASIS) 4 FY19 (billion yen) Q1/FY18 Q1/FY19 Change Progress CER growth FCST* Revenue 329.1 334.1 +1.5% 1,224.0 27.3% +3.1% Cost of sales 70.7 70.5 -0.3% % of revenue 21.5% 21.1% SG&A expenses 112.9 117.5 +4.1% % of revenue 34.3% 35.2% R&D expenses 52.1 53.5 +2.6% 21
Slide 5: Revenue Analysis (Year on Year)
REVENUE ANALYSIS (YEAR ON YEAR) 5 Sales increase in XTANDI, XOSPATA, mirabegron and new products in Japan offset the LOE impacts of Vesicare and Tarceva (billion yen) Q1/FY18 329.1 XTANDI XOSPATA mirabegron New products in Japan Others -LOE impacts of Vesicare/Tarceva, etc Fx impacts -5.1 Q1/FY19 33
Slide 6: Core OP Analysis (Year on Year)
CORE OP ANALYSIS (YEAR ON YEAR) 6 Steady growth of main products/new products. Resource allocation to growth investment for new product launches and R&D while implementing cost optimization (billion yen) Q1/FY18 84.0 Gross profit -XTANDI US co-promotion fee: Increase with sales expansion SG&A expens
Slide 7: Q1/FY2019 Financial Results (Full Basis)
Q1/FY2019 FINANCIAL RESULTS (FULL BASIS) 7 FY19 (billion yen) Q1/FY18 Q1/FY19 Change Progress FCST* Core operating profit 84.0 84.7 +0.8% 240.0 35.3% Other income 4.2 4.5 +6.7% Other expense 24.7 12.2 -50.8% Operating profit 63.5 77.1 +21.3% 229.0 33.7% Profit before tax 64.5 76.5 +18.7% 230.0 33.3%
Slide 8: Agenda
AGENDA 8 I Q1/FY2019 Consolidated Financial Results II Initiatives for Sustainable Growth III Capital Allocation
Slide 9: Sales of Main Products: XTANDI, XOSPATA, Mirabegron
SALES OF MAIN PRODUCTS: 9 XTANDI, XOSPATA, MIRABEGRON Q1/FY18 Q1/FY19 (billion yen) • Record quarterly sales • Steady growth in all regions due to XTANDI 81.2 96.0 penetration in earlier stage of (+18%) prostate cancer • M1 HSPC additional indication filed in US and EU • Label update to include OS d
Slide 10: New Products in Japan
NEW PRODUCTS IN JAPAN* 10 Sales doubled with continued launches of new products (billion yen) Q1/FY18 Q1/FY19 YoY Total of 6.3 12.8 +103% New products Launched in March 2019 • Initial uptake positive thus far (Q1/FY19 actual: 3.5 billion yen) • EVENITY has dual effects of increasing bone formation a
Slide 11: Enhancement of Initiatives in China
ENHANCEMENT OF INITIATIVES IN CHINA 11 Maximize the VALUE of existing growth products/new products and enhance commercial function (billion yen) Q1/FY18 Q1/FY19 YoY +7% Greater China 13.7 14.7 +14% (CER growth) Greater China: China, Hong Kong, Taiwan <Recent topics in China> • Expansion of clinical
Slide 12: Continued Progress on 6 Post-POC Projects Since Apr 2019
CONTINUED PROGRESS ON 6 POST-POC PROJECTS 12 SINCE APR 2019 Development advancing as intended in Strategic Plan 2018 Progress since April 2019 Completion/readout Indication P1 P2 P3 Filed* Approved enzalutamide M0 CRPC US, EU M1 HSPC US, EU M0 HSPC gilteritinib Relapsed or refractory AML US, JP EU N
Slide 13: 6 Post-POC Projects: Status Update
6 POST-POC PROJECTS: STATUS UPDATE 13 (Underline: Updates since FY2018 Announcement) enzalutamide gilteritinib enfortumab vedotin M1 HSPC FLT3 mut+ R/R AML mUC (3rd line, platinum and • sNDA submitted in US (Jun 2019) and • US: sNDA to include OS data approved PD-1/L1 inhibitor pretreated) MAA type
Slide 14: Enzalutamide: Results of ENZAMET in M1 HSPC
ENZALUTAMIDE: 14 RESULTS OF ENZAMET IN M1 HSPC Enzalutamide significantly improved OS compared to NSAA Supporting sNDA/MAA Type II variation for M1 HSPC together with ARCHES Primary endpoint: Overall survival • At 3 years, 36% NSAA vs 64% ENZA were still on their assigned study treatment. • Safety d
Slide 15: Enfortumab Vedotin
ENFORTUMAB VEDOTIN 15 BLA submitted to the FDA in July for patients pretreated with platinum and PD-1/L1 inhibitor • BLA submitted based on Cohort 1 results of EV-201 study for Accelerated Approval • Annually 56,000 patients are diagnosed with mUC in US, EU and Japan (US: 19K, EU5: 29K, Japan 8K)1 •
Slide 16: Enfortumab Vedotin: Results of Cohort 1 in Phase 2
ENFORTUMAB VEDOTIN: 16 RESULTS OF COHORT 1 IN PHASE 2 ORR was 44% in platinum and PD-1/L1 inhibitor pretreated patients Patients (N=125) ORR per RECIST v 1.1 assessed by BICR n (%) Confirmed objective response rate 55 (44) 95% confidence interval1 (35.1, 53.2) Best overall response per RECIST v. 1.1
Slide 17: Enfortumab Vedotin: Results of Cohort 1 in Phase 2
ENFORTUMAB VEDOTIN: 17 RESULTS OF COHORT 1 IN PHASE 2 DOR was 7.6 months in this heavily pre-treated patient population EV-201: Cohort 1 Safety data • The most common TEAEs occurring in more than 40% of patients • Fatigue, alopecia, rash, decreased appetite, taste distortion and peripheral neuropath
Slide 18: Fezolinetant: Phase 3 Study Design
FEZOLINETANT: PHASE 3 STUDY DESIGN 18 Initiated three MR-VMS (hot flashes, night sweats) Phase 3 studies in US and EU 2 Pivotal studies Long-term safety study (SKYLIGHT 1, SKYLIGHT 2) (SKYLIGHT 4) Women suffering from moderate to severe Women suffering from VMS VMS associated with menopause * associ
Slide 19: Expected Key Events in FY2019
EXPECTED KEY EVENTS IN FY2019 19 Continued progress on important milestones for 6 post-POC projects Regulatory enzalutamide M1 CRPC (China) decisions M1 HSPC (US/EU) gilteritinib Relapsed/refractory AML (EU) ✓ Label update to include OS data (US) Label update to include OS data (JP) roxadustat Anemi
Slide 20: Progress in Focus Area Approach
PROGRESS IN FOCUS AREA APPROACH 20 License agreement1 for clinical Start of Phase 2 part of ASP3772 Regeneration ASIM stage program, FX-322 in Phase 1/2 study Regenerative therapeutic candidate Vaccine targeting pneumococcus targeting sensorineural hearing loss utilizing Affinivax’ Multiple Antigen
Slide 21: Oncology Assets in Early Stages
ONCOLOGY ASSETS IN EARLY STAGES 21 Multiple assets in clinical stage including novel immuno-oncology programs Modality/MoA Origin/Partner * Target cancer P1 P2 Anti-Claudin 18.2 Pancreatic zolbetuximab monoclonal antibody adenocarcinoma Anti-Claudin 6 ASP1650 monoclonal antibody Testicular cancer AG
Slide 22: Updates in Rx+ Program: Image-Guided Precision Surgery: ASP5354
UPDATES IN Rx+TM PROGRAM: 22 IMAGE-GUIDED PRECISION SURGERY: ASP5354 Potential to improve surgery outcome by providing rapid time to ureteral visualization with alternative to conventional methods Business concept and characteristics • Use established Astellas proprietary pharmaceutical drug Kidney
Slide 23: Agenda
AGENDA 23 I Q1/FY2019 Consolidated Financial Results II Initiatives for Sustainable Growth III Capital Allocation
Slide 24: Capital Allocation
CAPITAL ALLOCATION 24 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 License agreement d
Slide 25: Appendix
APPENDIX
Slide 26: Q1/FY2019: Revenue by Region
Q1/FY2019: REVENUE BY REGION 26 (billion yen) Q1/FY18 Q1/FY19 Change Japan 94.1 98.5 +4.6% United States 102.7 105.3 +2.5% Established Markets 76.9 75.8 -1.4% Greater China 13.7 14.7 +7.4% International 32.1 34.2 +6.6% Established Markets: Europe, Canada, Australia Greater China: China, Hong Kong, T
Slide 27: Q1/FY2019: Sales of Main Products
Q1/FY2019: SALES OF MAIN PRODUCTS 27 FY19 (billion yen) Q1/FY18 Q1/FY19 Change CER growth Progress FCST* XTANDI 81.2 96.0 +18.2% +20.1% 364.2 26.4% XOSPATA - 2.5 - - 15.1 16.3% OAB products 59.3 53.5 -9.8% -8.7% 202.4 26.4% mirabegron 34.4 39.9 +16.1% +16.8% 160.6 24.9% Vesicare 24.9 13.6 -45.6% -44
Slide 28: FY2019 FCST: XTANDI Sales by Region
FY2019 FCST: XTANDI SALES BY REGION 28 Sales by region Japan United states Established Markets (yen) +10% (USD) +10% (euro) +11% +24% +14% +8% FY17 FY18 FY19 FY17 FY18 FY19 FY17 FY18 FY19 FCST FCST FCST International Greater China 5x% 4x% +24% +42% (yen) (yen) +30% +42% FY17 FY18 FY19 FY17 FY18 FY19
Slide 29: FY2019 FCST: Mirabegron Sales by Region
FY2019 FCST: MIRABEGRON SALES BY REGION 29 Sales by region Japan United states Established Markets (yen) (USD) +10% +11% +4% +17% (euro) +20% +11% FY17 FY18 FY19 FY17 FY18 FY19 FY17 FY18 FY19 FCST FCST FCST International Greater China 5x% 4x% +23% +93% (yen) (yen) +36% +62% FY17 FY18 FY19 FY17 FY18
Slide 30: FX Rate (Actual)
FX RATE (ACTUAL) 30 Average rate for the period Currency Q1/FY18 Q1/FY19 change USD 109 yen 110 yen +1 yen EUR 130 yen 123 yen -7 yen Change in closing rate from PY end Currency Q1/FY18 Q1/FY19 USD +4 yen -3 yen EUR -3 yen -2 yen Fx impact on elimination of unrealized gain: COGs ratio -1.1ppt
Slide 31: FY2019 FCST: FX Rate & FX Sensitivity
FY2019 FCST：FX RATE & FX SENSITIVITY 31 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 FY2019 forecasts by 1 ye
Slide 32: Balance Sheet/Cash Flow Highlights
BALANCE SHEET/CASH FLOW HIGHLIGHTS 32 (billion yen) FY18 end Jun. 2019 Total assets 1,897.6 1,927.0 Cash and cash equivalents 311.1 259.4 Total equity attributable to 1,258.4 1,249.7 owners of the parent 66.3% 64.9% Equity ratio (%) (billion yen) Q1/FY18 Q1/FY19 FY18 Cash flows from operating activi
Slide 33: Details of Shareholder Returns
Details of shareholder returns 33 (yen) (billion yen) 40 Dividends per 250 2,500 Profit** (right axis) Share* (left 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 dividends 39.3
Slide 34: Filing Opportunities Announced in Strategic Plan
FILING OPPORTUNITIES 34 ANNOUNCED IN STRATEGIC PLAN enzalutamide ✓✓✓: Approved M0 HSPC ✓✓: Filed enzalutamide zolbetuximab ✓: Data obtained, M1 HSPC (US/EU) ✓✓ Gastric and gastroesophageal filing under preparation junction adenocarcinoma enfortumab gilteritinib vedotin AML (Post-HSCT maintenance) Me
Slide 35: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 35 Phase 1 Phase 2 Phase 3 Filed ASP1235/AGS62P1 zolbetuximab enzalutamide enzalutamide (Pancreatic adenocarcinoma) (M1 HSPC: JP, M0 HSPC) (M1 CRPC, China) AGS-16C3F (Renal cell carcinoma) ASP8374/PTZ-201 gilteritinib enzalutamide ASP1650 (Testicular cancer) (R/R AML: Chi
Slide 36: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 36 Phase 1 entry to approval, since FY2018 financial results announcement in April 2019 Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP7517 ASP3772 fezolinetant enzalutamide evolocumab Cancer Prevention of Menopause-related Metastatic hormone-sensitive Fami
Slide 37: Enzalutamide
ENZALUTAMIDE 37 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 ENZAMET
Slide 38: Gilteritinib
GILTERITINIB 38 HOVON PrECOG Chemo Maintenance High- consolidation Salvage therapy GOSSAMER intensity 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 2019
Slide 39: Enfortumab Vedotin
ENFORTUMAB VEDOTIN 39 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 Gem-Cis EV-301 eligible • CPI • Gem-Carbo • Single agent chemo • Single agent chemo • Clinic
Slide 40: Enfortumab Vedotin: Results of Cohort 1 in Phase 2
ENFORTUMAB VEDOTIN: 40 RESULTS OF COHORT 1 IN PHASE 2 N = 125; 54 Events N = 125; 81 Events Median OS: 11.7 months Median PFS: 5.8 months (95% CI: 9.1-not reached) (95% CI: 4.9-7.5) Petrylak DP, et al., ASCO2019
Slide 41: Zolbetuximab
ZOLBETUXIMAB 41 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 42: Abbreviations
ABBREVIATIONS 42 ADC Antibody-drug conjugate AML Acute myeloid leukemia ASCO American Society of Clinical Oncology BLA Biologics licensing application CKD Chronic kidney disease ESMO European Society for Medical Oncology FDA Food and Drug Administration FLT3 Fms-like tyrosine kinase 3 FLT3 mut+ FLT3
Slide 43: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE