Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q2 FY2019 Earnings Presentation
48 slides from Astellas Pharma's earnings presentation, Oct 31, 2019
Slide 1: Q2/FY2019 Financial Results
Q2/FY2019 FINANCIAL RESULTS ENDED SEPTEMBER 30, 2019 Kenji Yasukawa, Ph.D. President and CEO Astellas Pharma Inc. October 31, 2019
Slide 2: Cautionary Statement Regarding Forward-Looking Information
CAUTIONARY STATEMENT REGARDING FORWARD- 2 LOOKING 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 st
Slide 3: Agenda
AGENDA 3 Q2/FY2019 Consolidated Financial Results I and FY2019 Revised Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 4: Q2/FY2019 Financial Results (Core Basis)
Q2/FY2019 FINANCIAL RESULTS (CORE BASIS) 4 FY19 (billion yen) Q2/FY18 Q2/FY19 Change Progress CER growth FCST * Revenue 647.1 650.5 +0.5% 1,224.0 53.1% +3.4% Cost of sales 143.5 138.9 -3.3% % of revenue 22.2% 21.3% SG&A expenses 231.5 226.1 -2.4% % of revenue 35.8% 34.8% R&D expenses 99.6 105.0 +5.4
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, etc. (billion yen) Q2/FY18 647.1 XTANDI XOSPATA mirabegron New products in Japan LOE impacts of Vesicare/Tarceva Other Termination of sale and dis
Slide 6: Core OP Analysis (Year on Year)
CORE OP ANALYSIS (YEAR ON YEAR) 6 In addition to major products/new products contributing to an increase in gross profit, SG&A expenses decreased due to one-off factor resulting in 9% core OP increase (billion yen) Q2/FY18 154.2 Gross profit XTANDI US co-promotion fee • Increase in new product launc
Slide 7: Q2/FY2019 Financial Results (Full Basis)
Q2/FY2019 FINANCIAL RESULTS (FULL BASIS) 7 FY19 (billion yen) Q2/FY18 Q2/FY19 Change Progress FCST * Core operating profit 154.2 168.0 +8.9% 240.0 70.0% Other income 4.7 7.2 +54.3% Other expense 32.0 13.0 -59.4% Operating profit 126.8 162.2 +27.9% 229.0 70.8% Profit before tax 128.3 161.6 +25.9% 230
Slide 8: Sales of Main Products: XTANDI, XOSPATA, mirabegron
SALES OF MAIN PRODUCTS: 8 XTANDI, XOSPATA, MIRABEGRON Q2/FY18 Q2/FY19 (billion yen) • Steady growth in all regions due to XTANDI 164.0 195.0 penetration in earlier stage of prostate cancer (+19%) • Increase of US M0 CRPC prescriptions • In 2019 NCCN guideline, XOSPATA has been added as Category 1 fo
Slide 9: XTANDI Upward Revision of Initial Forecasts
XTANDI 9 Upward revision of initial forecasts (Global sales: 364.2 383.9 billion yen) Global sales trend FY19 forecasts： Adjustment amount 383.9 (+15%) (billion yen) Revised FCST US +$174M 333.1 FX rate $=108 yen 294.3 €=120 yen Established Markets € 68M + Initial FCST 364.2 International +1.4 bil
Slide 10: New Products in Japan
NEW PRODUCTS IN JAPAN* 10 Q2 sales increased significantly with continued launches/additional indications Upward revision of initial forecasts for new products (Appox.45.0 60.0 billion yen) (billion yen) Q2/FY18 Q2/FY19 YoY Total Sales of 11.2 27.8 +147% New products Exceed 100.0 billion yen in ea
Slide 11: FY2019 Revised Forecasts: Summary
FY2019 REVISED FORECASTS：SUMMARY 11 Steady performance of XTANDI and new products in Japan such as EVENITY One-off factors that were not included into initial forecasts Revenue Transfer of three products in Asia region to Daiichi Sankyo Upward revision of US Prograf (Increase in demand due
Slide 12: Revised Forecasts for FY2019
REVISED FORECASTS FOR FY2019 12 FY19 FY19 (billion yen) Initial Revised Change FCST FCST Revenue 1,224.0 1,256.0 +32.0 R&D expenses 211.0 216.0 +5.0 % of revenue Core operating profit 240.0 264.0 +24.0 Core profit 194.0 214.0 +20.0 Core EPS (yen) 102.87 113.49 +10.62 Operating profit 229.0 263.0 +34
Slide 13: Agenda
AGENDA 13 Q2/FY2019 Consolidated Financial Results I and FY2019 Revised Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 14: Enhancement of Initiatives in China
ENHANCEMENT OF INITIATIVES IN CHINA 14 Enhancement of development and regulatory functions for the development of late-stage projects Aiming for 200.0 billion yen sales in the overall Chinese business in late 2020s Progress of clinical development in China Projects indication Current Status M1 CRPC
Slide 15: Continued Progress on Post-PoC Projects
CONTINUED PROGRESS ON 6 POST-POC PROJECTS 15 Development advancing as planned in Strategic Plan 2018 Progress since Q1/FY2019 announcement in July 2019 Indication P1 P2 P3 Filed Approved enzalutamide M1 hormone-sensitive prostate cancer US,EU,JP M0 hormone-sensitive prostate cancer gilteritinib Rela
Slide 16: Post-PoC Projects: Status Update
6 POST-POC PROJECTS: STATUS UPDATE 16 (Underlined: Updates since Q1/FY2019 announcement in July 2019) enzalutamide gilteritinib enfortumab vedotin M1 HSPC R/R FLT3 mut+ AML mUC (platinum and • Filed in US (June 2019; PDUFA Date set in Dec 2019 under Priority Review), • JP: Label updated in Aug 2019
Slide 17: Enfortumab Vedotin: mUC
ENFORTUMAB VEDOTIN: mUC 17 Platinum and PD-1/L1 inhibitor pretreated: Filed in US in July 2019, PDUFA Date set in March 2020 under Priority Review 1st line: Results from Phase 1 EV-103 study in combination with pembrolizumab presented at ESMO 2019, Phase 3 program currently under preparation mUC Tre
Slide 18: Enfortumab Vedotin: EV-103 Results (1/3)
ENFORTUMAB VEDOTIN: EV-103 RESULTS (1/3) 18 Objective Response Rate (ORR) High ORR (71%) in enfortumab vedotin + pembrolizumab cohorts in cisplatin-ineligible patients with locally advanced or metastatic UC ORR per RECIST v1.1 by investigator Patients (N=45) 18 Jun 2019 data cut-off n (%) Confirmed
Slide 19: Enfortumab Vedotin: EV-103 Results (2/3)
ENFORTUMAB VEDOTIN: EV-103 RESULTS (2/3) Maximum Percent Reduction from Baseline 19 in Sum of Diameters of Target Lesions per Investigator Activity regardless of PD-L1 expression PD-L1 Status 93% PD-L1 tested using the 22C3 PharmDx assay from Agilent/Dako C. J. Hoimes, ESMO 2019 CPS: Combined positi
Slide 20: Enfortumab Vedotin: EV-103 Results (3/3)
ENFORTUMAB VEDOTIN: EV-103 RESULTS (3/3) 20 Treatment-Related Adverse Events (TRAE) TRAEs by preferred term Patients (N=45) Any grade in≥ 20% of patients and n (%) ≥ Grade 3 in≥ 10% of patients Any Grade ≥ Grade 3 • 7 patients had treatment-related Overall 43 (96) 23 (51) serious adverse events (16%
Slide 21: Enfortumab Vedotin: 1st Line Metastatic UC Patients
ENFORTUMAB VEDOTIN: 21 Number of 1st Line Drug Treated Patients with Metastatic UC In addition to expanding the target patient number, expected to have longer duration of therapy in 1st line Potential sales size at peak including 1st line to be 100.0 - 200.0 billion yen Metastatic Drug Treated Drug
Slide 22: Roxadustat: Development in Japan
ROXADUSTAT: DEVELOPMENT IN JAPAN 22 Approved in Japan in Sep 2019 for renal anemia in patients on dialysis as a first-in-class orally administered HIF-PH inhibitor • Discovered by FibroGen and being Mechanism of action Roxadustat activates a natural pathway developed by Astellas in Japan to increase
Slide 23: Focus Area Approach: Immuno-Oncology Assets
FOCUS AREA APPROACH: 23 IMMUNO-ONCOLOGY ASSETS Details of the immuno-oncology assets to be introduced Immuno-oncology at Astellas R&D Meeting on Dec 10, 2019 Current Stage Compound Modality/Mechanism Origin/Partner Target Tumor Preclinical Clinical /Research Phase 1 ASP8374 Anti-TIGIT antibody * (To
Slide 24: Progress in Focus Area Approach (1/2)
PROGRESS IN FOCUS AREA APPROACH (1/2) 24 Licensing agreement with RIKEN for artificial adjuvant vector cell (aAVC) Immuno-oncology technology as a novel and promising immuno-oncology platform aAVC characteristics Lead aAVC program - ASP7517 • Expects to show anti-tumor effects by • aAVC loading WT1,
Slide 25: Progress in Focus Area Approach (2/2)
PROGRESS IN FOCUS AREA APPROACH (2/2) 25 Fast Track designated by FDA for ASP1128/MA-0217 program Mitochondria for patients at risk of acute kidney injury (AKI) after cardiac surgery Mitochondria biology Unmet medical needs of AKI • Mitochondrial dysfunction contributes to various • AKI is rapid los
Slide 26: Key Events Expected in FY2019
KEY EVENTS EXPECTED IN FY2019 26 Regulatory enzalutamide M1 castration-resistant prostate cancer (China) decisions M1 hormone-sensitive prostate cancer (USa) enfortumab vedotin Metastatic urothelial cancer, platinum and PD-1/L1 inhibitor pretreated (USa,b) Regulatory roxadustat Anemia associated wit
Slide 27: Updates in Rx+ Program
UPDATES IN Rx+TM PROGRAM 27 - New digital healthcare solutions using gamification- • “Health Mock Lab.”, a virtual framework for industry-academia collaboration with Yokohama City University and Tokyo University of the Arts, has launched. • Aiming to create and commercialize new digital healthcare s
Slide 28: Updates in Rx+ Program
UPDATES IN Rx+TM PROGRAM 28 - Novel ultra-small implantable medical devices- • Joint research and development agreement with iota Biosciences, Inc. • Expecting to develop new bio sensing and treatment measures using ultra-small implantable medical devices. • Iota and Astellas will jointly design det
Slide 29: Agenda
AGENDA 29 Q2/FY2019 Consolidated Financial Results I and FY2019 Revised Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 30: Capital Allocation
CAPITAL ALLOCATION 30 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 License agreement Aiming for steady dividend increase d
Slide 31: R&D Meeting - Approaches to Immuno-Oncology
SCHEDULE 31 R&D meeting - Approaches to immuno-oncology - Date: December 10, 2019
Slide 32: Appendix
APPENDIX
Slide 33: Q2/FY2019: Revenue by Region
Q2/FY2019: REVENUE BY REGION 33 (billion yen) Q2/FY18 Q2/FY19 Change Japan 180.7 183.3 +1.5% United States 207.9 216.7 +4.2% Established Markets 149.6 146.7 -1.9% Greater China 29.3 29.4 +0.4% International 63.2 63.4 +0.3% Established Markets: Europe, Canada, Australia Greater China: China, Hong Kon
Slide 34: Q2/FY2019: Sales of Main Products
Q2/FY2019: SALES OF MAIN PRODUCTS 34 FY19 (billion yen) Q2/FY18 Q2/FY19 Change CER growth Progress FCST* XTANDI 164.0 195.0 +18.9% +22.8% 364.2 53.5% XOSPATA - 5.7 - - 15.1 37.7% OAB products 116.7 103.8 -11.0% -8.8% 202.4 51.3% mirabegron 68.6 78.8 +14.9% +17.5% 160.6 49.1% Vesicare 48.1 25.1 -47.9
Slide 35: FX Rate (Actual)
FX RATE (ACTUAL) 35 Average rate for the period Currency Q2/FY18 Q2/FY19 change USD 110 yen 109 yen -2 yen EUR 130 yen 121 yen -8 yen Change in closing rate from PY end Currency Q2/FY18 Q2/FY19 USD +7 yen -3 yen EUR +2 yen -7 yen Fx impact on elimination of unrealized gain: COGs ratio -1.4ppt
Slide 36: FY2019 Revised Forecast: FX Rate & FX Sensitivity
FY2019 REVISED FCST：FX RATE & FX SENSITIVITY 36 Exchange rate (yen) FY19 Initial FY19 Revised Average for the period FCST FCST FX impacts vs. initial forecasts (billion yen) USD 110 yen 108 yen • Revenue : -27.9 EUR 125 yen 120 yen • Core operating profit: -7.0 Forecast rates from Q3/FY2019 onwards:
Slide 37: Balance Sheet/Cash Flow Highlights
BALANCE SHEET/CASH FLOW HIGHLIGHTS 37 (billion yen) FY18 end Sep. 2019 Total assets 1,897.6 1,979.8 Cash and cash equivalents 311.1 311.4 Total equity attributable to 1,258.4 1,296.1 owners of the parent 66.3% 65.5% Equity ratio (%) (billion yen) Q2/FY18 Q2/FY19 FY18 Cash flows from operating activi
Slide 38: Details of Shareholder Returns
DETAILS OF SHAREHOLDER RETURNS 38 (yen) (billion yen) 40 Dividends per Share* (left axis) Profit** (right axis) 250 2,500 2,000 200 30 150 1,500 20 38 40 100 1,000 10 50 500 0 00 (billion yen) FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 (Forecast) Total dividends 39.3
Slide 39: Filing Opportunities Announced in Strategic Plan
FILING OPPORTUNITIES 39 ANNOUNCED IN STRATEGIC PLAN enzalutamide ✓✓✓: Approved M0 HSPC ✓✓: Filed zolbetuximab ✓: Data obtained, enzalutamide Gastric and gastroesophageal filing under preparation M1 HSPC (US,EU,JP) ✓✓ junction adenocarcinoma gilteritinib enfortumab vedotin AML (Post-HSCT maintenance)
Slide 40: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 40 Phase 1 Phase 2 Phase 3 Filed ASP1235/AGS62P1 zolbetuximab enzalutamide enzalutamide (Pancreatic adenocarcinoma) (M0 HSPC, M1 HSPC: China) (M1 CRPC: China) ASP8374/PTZ-201 gilteritinib enzalutamide ASP1650 (Testicular cancer) (R/R AML: China, Other AML) (M1 HSPC: US,EU
Slide 41: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 41 Phase 1 entry to approval, since 1Q/2019 financial results announcement in July 2019 Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP1617 enzalutamide roxadustat Systemic lupus Metastatic Renal anemia in erythematosus hormone-sensitive patients on dialysi
Slide 42: Enzalutamide: Androgen Receptor Inhibitor
ENZALUTAMIDE: ANDROGEN RECEPTOR INHIBITOR 42 US/EU/JP Definitive Therapy Hormone or Castration Castration-Resistant Sensitive ARCHES M1 HSPC Initial newly-diagnosed PREVAIL AFFIRM Diagnosis Surgery M1 CRPC M1 CRPC M1 HSPC (1st line) (lines 2+) Salvage recurrent Filed Launched Launched Active Surveil
Slide 43: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 43 PASHA (HOVON) PrECOG Chemo Maintenance ADMIRAL High- consolidation GOSSAMER intensity induction Maintenance FLT3 mut+ Transplant Salvage therapy chemo MORPHO AML patients Launched (US, JP) Low-intensity Approved (EU) chemo LACEWING Monotherapy vs salvage chemo JP: Lab
Slide 44: Enfortumab Vedotin: Nectin-4 Targeted ADC
ENFORTUMAB VEDOTIN: NECTION-4 TARGETED ADC 44 mUC Treatment Landscape Overall treatment flow similar among regions, although standard of care and approved drugs can vary PD-1/L1 inhibitor Platinum and PD-1/L1 1st line pretreated inhibitor pretreated EV-201 cisplatin Filed in US (Cohort 1) eligible G
Slide 45: Enfortumab Vedotin: EV-103 Study Design
ENFORTUMAB VEDOTIN: EV-103 STUDY DESIGN 45 Dose Escalation Cohort Dose Expansion Cohorts Patient Cohort D Recommended EV dose Population EV + cisplatin Dose Escalation Cohort A Cohort G Locally 1L Advanced EV + pembro EV + pembro EV + cis/carbo or + pembro Metastatic cis-ineligible cis-ineligible Co
Slide 46: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: 46 ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY Target: Claudin 18.2 Gastric and gastroesophageal junction • Claudin is a major structural component of tight (GEJ) adenocarcinoma junctions and seals intercellular space in • Target patient population: locally advanced and epithelial sheets met
Slide 47: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 47 US/EU Phase 3 studies: FSFT of all the 3 studies in Aug 2019 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 * associated with menopa
Slide 48: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE