Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q2 FY2020 Earnings Presentation
45 slides from Astellas Pharma's earnings presentation, Oct 30, 2020
Slide 1: Q2/FY2020 Financial Results Ended September 30, 2020
Q2/FY2020 FINANCIAL RESULTS ENDED SEPTEMBER 30, 2020 Kenji Yasukawa, Ph.D. President and CEO Astellas Pharma Inc. October 30, 2020
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/FY2020 Consolidated Financial Results I and FY2020 Revised Forecasts II Initiatives for Sustainable Growth
Slide 4: Q2/FY2020 Financial Results
Q2/FY2020 FINANCIAL RESULTS 4 Change (billion yen) Q2/FY19 Q2/FY20 Change CER growth (%) Revenue 650.5 615.5 -35.0 -5.4% -4.6% Cost of sales 138.9 119.5 -19.3 -13.9% % of revenue 21.3% 19.4% -1.9 ppt SG&A expenses 226.1 242.1 +16.1 +7.1% R&D expenses 105.0 111.7 +6.7 +6.4% Amortisation of intangible
Slide 5: Q2/FY2020 Financial Results: Revenue
Q2/FY2020 FINANCIAL RESULTS: REVENUE 5 Main products and new products continue to grow strongly Q2/FY2020 actual (billion yen) XTANDI 225.5 +30.5 XOSPATA 11.0 +5.2 Growth of main products PADCEV 6.0 +6.0 and new products mirabegron 80.0 +1.2 +50.1 billion yen New products in Japan 34.9 +7.1 Consolid
Slide 6: Q2/FY2020 Financial Results: Progress Against Forecast
Q2/FY2020 FINANCIAL RESULTS: 6 PROGRESS AGAINST FORECAST ⚫ Core basis Q2/FY2020 financial results are in line with full-year forecast revised in August 2020 Progress Q2/FY20 FY20 FCST against FCST Revenue 615.5 bil. yen 1,256.5 bil. yen 49.0% Core OP 130.3 bil. yen 251.0 bil. yen 51.9% ✓ Steady grow
Slide 7: FY2020 Revised Forecast
FY2020 REVISED FORECAST 7 ⚫ No changes have been made to Core basis FY2020 forecast Q2/FY20 Forecast (billion yen) Actual (Revised in Aug.) Revenue 615.5 1,256.5 R&D expenses 111.7 233.5 Forecast: Core operating profit 130.3 251.0 No changes Core profit 106.2 200.5 ⚫ Downward revision of Full basis
Slide 8: Agenda
AGENDA 8 Q2/FY2020 Consolidated Financial Results I and FY2020 Revised Forecasts II Initiatives for Sustainable Growth
Slide 9: Key Post-PoC Projects: Status Update
KEY POST-POC PROJECTS: STATUS UPDATE 9 (Underlined: Updates since Q1/FY2020 Financial Results Announcement in Aug 2020) enzalutamide gilteritinib enfortumab vedotin M0 CRPC R/R AML mUC • Approved in US in Oct 2020 • China: Filed in Mar 2020 • Previously treated: and filed in EU in Jun 2020 for Met t
Slide 10: Enfortumab Vedotin (1/5): Overall mUC Program
ENFORTUMAB VEDOTIN (EV) (1/5): 10 OVERALL mUC PROGRAM Early stage - Disease stage of urothelial cancer - Late stage NMIBC MIBC mUC Stages 0a-1 Stages 2 and 3 Stage 4 Ta: Noninvasive papillary T2: Tumor invades muscle T4b: Tumor invades pelvic wall, carcinoma T3: Tumor invades perivesical fat abdomin
Slide 11: Enfortumab Vedotin (2/5): mUC Program Updates
ENFORTUMAB VEDOTIN (EV) (2/5): 11 mUC PROGRAM UPDATES ⚫ Global development ✓ Phase 3 EV-301 study in mUC, platinum and PD-1/L1 inhibitor pretreated: Met the primary endpoint of OS (HR=0.70; p=0.001) and the secondary endpoint of PFS (HR=0.61; p<0.00001), compared to chemotherapy, based on the planne
Slide 12: Enfortumab Vedotin (3/5): MIBC Treatment Overview
ENFORTUMAB VEDOTIN (EV) (3/5): 12 MIBC TREATMENT OVERVIEW Early stage - Disease stage of urothelial cancer - Late stage NMIBC MIBC mUC Stages 0a-1 Stages 2 and 3 Stage 4 Ta: Noninvasive papillary T2: Tumor invades muscle T4b: Tumor invades pelvic wall, carcinoma T3: Tumor invades perivesical fat abd
Slide 13: Enfortumab Vedotin (4/5): MIBC Development Program
ENFORTUMAB VEDOTIN (EV) (4/5): 13 MIBC DEVELOPMENT PROGRAM To expand the potential of EV and Pembro combo to MIBC, where high unmet medical needs still exist Rationales of EV + Pembro use for MIBC ⚫ EV + Pembro has shown promise as a platinum free option in the EV-103 study results for first line mU
Slide 14: Enfortumab Vedotin (5/5): Updated Potential Sales Size
ENFORTUMAB VEDOTIN (EV) (5/5): 14 UPDATED POTENTIAL SALES SIZE Significant upward revision Potential peak sales in mUC and MIBC to be 300.0 - 400.0 billion yen Potential sales size (at peak, billion yen) Update in Oct 2020 Upward revision due to the following factors: 300 - 400 ✓ Potential sales in
Slide 15: Focus Area Approach (1/3): ASP0367 for Primary Mitochondrial Myopathies
Mitochondria PROGRESS IN FOCUS AREA APPROACH (1/3): 15 ASP0367 FOR PRIMARY MITOCHONDRIAL MYOPATHIES FDA has granted Fast Track designation for the development of ASP0367 as a treatment for primary mitochondrial myopathies Primary mitochondrial myopathies (PMM) ASP0367/MA-0211 characteristics ⚫ A com
Slide 16: Focus Area Approach (2/3): ASP7317 for Dry AMD
PROGRESS IN FOCUS AREA APPROACH (2/3): Blindness & 16 Regeneration ASP7317 FOR DRY AMD A Phase 1b/2 study amendment aimed to optimize the overall development program has been submitted for FDA’s review ⚫ Significant enrollment delay has occurred, due to: ✓ More difficulty in enrollment of patients w
Slide 17: Focus Area Approach (3/3): Updated Primary Focus
PROGRESS IN FOCUS AREA APPROACH (3/3): ASIM 17 UPDATED PRIMARY FOCUS (PF) Completed Primary Focus “ASIM Biology” and shift to next-generation research Primary Focus ⚫ LAMP-vax, the key ASIM platform, has reached a stage of clinical validation, after completion of ✔ Blindness & Regeneration discovery
Slide 18: Key Events Expected in FY2020
KEY EVENTS EXPECTED IN FY2020 18 Regulatory enzalutamide M1 CSPC (EU) decision M0 CRPC (China) M0 CRPC, label update to include the OS data (EU) roxadustat Anemia associated with chronic kidney disease, non-dialysis (JP) Regulatory enfortumab mUC, platinum and PD-1/L1 inhibitor pretreated submission
Slide 19: Progress in Rx+ Program: Status Update
PROGRESS IN Rx+ PROGRAM: STATUS UPDATE 19 (Underlined: Updates since Q1/FY2020 Financial Results Announcement in Aug 2020) Steadily progress to establish a solid ground for business acceleration New style fitness service（Fit-eNce): ⚫ From Sep 1st, 2020, the service was offered through fitness clubs
Slide 20: Rx+ Program (1/2): Image-Guided Precision Surgery
PROGRESS IN Rx+ PROGRAM (1/2): 20 IMAGE-GUIDED PRECISION SURGERY FSFT of Phase 2 study achieved in October 2020 FDA granted Fast Track Designation based on nonclinical data for the development of a new imaging agent, ASP5354 Iatrogenic Ureteral Injury (IUI) ASP5354 ⚫ IUI is widely recognized as a de
Slide 21: Rx+ Program: Ultra-Small Implantable Medical Devices
PROGRESS IN Rx+ PROGRAM (1/2): 21 ULTRA-SMALL IMPLANTABLE MEDICAL DEVICES Entered into a Merger Agreement pursuant to acquire Iota Biosciences, Inc. ⚫ Acquire cutting-edge technologies applicable to multiple spheres, which Rx+ identified as focus business areas that embodies Rx+ World / Rx+ Values ⚫
Slide 22: Schedule
SCHEDULE 22 Dec 10th, 2020: R&D meeting - Progress of Focus Area approach - May 2021: New Corporate Strategic Plan
Slide 23: Appendix
APPENDIX
Slide 24: Q2/FY2020 Financial Results: Cost Items
Q2/FY2020 FINANCIAL RESULTS: COST ITEMS 24 Core basis: Year-on-Year comparison Cost of sales ✓ Decrease mainly due to changes in product mix % of revenue (FX impact on elimination of unrealized gain: Increase in COGs ratio (+1.0 ppt)) 1.9 ppt decrease SG&A expenses ✓ XTANDI US co-promotion fee incre
Slide 25: Q2/FY2020: Revenue by Region
Q2/FY2020: REVENUE BY REGION 25 (billion yen) Q2/FY19 Q2/FY20 Change (%) Japan 183.3 144.2 -21.3% United States 216.7 236.7 +9.2% Established Markets 146.7 138.9 -5.4% Greater China 29.4 29.6 +0.5% International 63.4 56.7 -10.5% Established Markets: Europe, Canada, Australia Greater China: China, Ho
Slide 26: Q2/FY2020: Sales of Main Products
Q2/FY2020: SALES OF MAIN PRODUCTS 26 FY20 (billion yen) Q2/FY19 Q2/FY20 Change CER growth FCST * XTANDI 195.0 225.5 +15.6% +16.8% 464.6 XOSPATA 5.7 11.0 +91.9% +94.0% 23.1 PADCEV - 6.0 - - 13.0 OAB products 103.8 96.1 -7.4% -6.5% 197.9 mirabegron 78.8 80.0 +1.5% +2.6% 167.9 Vesicare 25.1 16.2 -35.4%
Slide 27: FY2020 Revised Forecast
FY2020 REVISED FORECAST 27 FY20 Forecast FY20 (billion yen) Change (Revised in August) Revised forecast Revenue 1,256.5 R&D expenses 233.5 No changes Core operating profit 251.0 Core profit 200.5 <Full basis> Operating profit 246.5 210.5 -36.0 Profit 197.5 169.5 -28.0
Slide 28: Q2/FY2020 Actual: FX Rate
Q2/FY2020 ACTUAL: FX RATE 28 Average rate for the period Currency Q2/FY19 Q2/FY20 Change USD 109 yen 107 yen -2 yen EUR 121 yen 121 yen -0 yen Change in closing rate from previous fiscal year end Currency Q2/FY19 Q2/FY20 USD -3 yen -3 yen EUR -7 yen +5 yen <Impact of exchange rate on financial resul
Slide 29: FY2020 Forecast: FX Rate & FX Sensitivity
FY2020 FCST： FX RATE & FX SENSITIVITY 29 Exchange rate (yen) FY20 FCST Average for the period USD 109 yen EUR 120 yen Forecast rates from Q2/FY2020 onwards: 110 USD/yen, 120 EUR/yen Estimated FX sensitivity (Q2 and onward) of FY2020 revised forecasts by 1 yen appreciation * Year-end rate Average rat
Slide 30: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 30 (billion yen) FY19 end Sep 30, 2020 Total assets 2,315.2 2,237.0 Cash and cash equivalents 318.4 286.7 Total equity attributable to owners of the parent 1,289.2 1,329.6 Equity ratio (%) 55.7% 59.4% (billion yen) Q2/FY19 Q2/FY20 FY19 Cash flows from operating a
Slide 31: Capital Allocation
CAPITAL ALLOCATION 31 ⚫ Top priority is investment for strategic business growth FY15 FY16 FY17 FY18 FY19 FY20 Pursue business development opportunities in line with our strategy (yen) ⚫ Dividends to be increased 40 Dividends per Share continuously based on 30 20 38 40 42 mid-and long-term growth 10
Slide 32: Details of Shareholder Returns
DETAILS OF SHAREHOLDER RETURNS 32 (yen) (billion yen) Dividends per Share* (left axis) Profit** (right axis) 250 2,500 40 2,000 200 30 150 1,500 42 20 40 38 100 1,000 10 50 500 0 00 (billion yen) FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20 (FCST) Total dividends 3
Slide 33: Filing Opportunities Announced in Strategic Plan 2018
FILING OPPORTUNITIES 33 ANNOUNCED IN STRATEGIC PLAN 2018 As of Oct 2020 enzalutamide M0 CSPC ✓✓✓: Approved ✓✓: Filed zolbetuximab Gastric and gastroesophageal ✓: Data obtained, enzalutamide junction adenocarcinoma filing under preparation M1 CSPC ✓✓✓ gilteritinib (US, JP) AML (Post-HSCT maintenance)
Slide 34: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 34 Phase 1 Phase 2 Phase 3 Filed ASP1948/PTZ-329 zolbetuximab enzalutamide enzalutamide (Pancreatic adenocarcinoma) (M0 CSPC, M1 CSPC: China) (M1 CSPC: EU) ASP1951/PTZ-522 enfortumab vedotin gilteritinib enzalutamide (Other solid tumors) (Earlier-stage AML, Pediatric use)
Slide 35: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 35 Phase 1 Entry to Approval since Q1/FY2020 Financial Results Announcement in Aug 2020 Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP0367 enfortumab mirabegron enzalutamide Primary vedotin Neurogenic Tablet mitochondrial Muscle-invasive detrusor in (new f
Slide 36: Enzalutamide: Androgen Receptor Inhibitor (1/2)
ENZALUTAMIDE: 36 ANDROGEN RECEPTOR INHIBITOR (1/2) US/EU/JP Definitive Therapy Castration-Sensitive Castration-Resistant ARCHES M1 CSPC newly-diagnosed Initial M1 CSPC PREVAIL AFFIRM Diagnosis Surgery recurrent M1 CRPC M1 CRPC Launched (1st line) (2nd line+) Salvage in US & JP Launched Launched Acti
Slide 37: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): 37 PHASE 3 STUDY DATA BY DISEASE STAGE Continued potential in earlier lines with consistent survival benefit and longer duration of treatment Early stage Late stage Disease Castration-sensitive (CSPC) Castration-resistant (CRPC) stage M1 M1 M0 M1 M0 (pre-chemo) (post-chemo) Phase
Slide 38: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 38 PASHA (HOVON) PrE0905 (PrECOG) Chemo Maintenance ADMIRAL High- consolidation GOSSAMER intensity induction Maintenance chemo Transplant MORPHO Salvage therapy FLT3 mut+ AML Launched Low-intensity chemo LACEWING Launched in US, JP, and EU Monotherapy vs salvage Relapsed
Slide 39: Enfortumab Vedotin: Nectin-4 Targeted ADC (1/3)
ENFORTUMAB VEDOTIN (EV) : NECTIN-4 TARGETED ADC (1/3) 39 For urothelial cancer mUC, Platinum and PD-1/L1 inhibitor pretreated; Met the primary endpoint (OS) in Sep 2020, P3: EV-301 n=608 EV monotherapy vs. Chemotherapy based on the planned interim analysis FSFT: Apr 2020 n=760 Removed Arm C “EV+Pemb
Slide 40: Enfortumab Vedotin (2/3): Phase 1b/2 EV-103 Study Design
ENFORTUMAB VEDOTIN (EV) (2/3): 40 PHASE 1b/2 EV-103 STUDY DESIGN Dose Escalation Cohort Dose Expansion Cohorts Recommended Cohort A Cohort D Cohort G EV dose EV + Pembro EV + Pembro EV + Cis, 1L EV + Cis/Carbo Locally Cis-ineligible Cis-ineligible + Pembro advanced 1L or 2L 1L Cohort E 1L or metasta
Slide 41: Enfortumab Vedotin (3/3): Number of UC Patients
ENFORTUMAB VEDOTIN (3/3): 41 NUMBER OF UC PATIENTS MIBC mUC Urothelial Total All stages cancer Post- (Incident Drug treated Drug treated (Incidence) (Annual) cystectomy + Newly (1L) (2L+*) recurrent) US 79,000 20,000 19,000 15,000 8,000 EU5 118,000 32,000 29,000 27,000 12,000 JP 39,000 10,000 8,000
Slide 42: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: 42 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 43: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 43 VMS has a significant negative impact on Women’s Health Initiative (WHI) Study 2 quality of life ⚫ Physical symptoms include hot flashes and ⚫ Initial data analyses showed an association sweating/night sweats, which can impact sleep. between chronic HRT use a
Slide 44: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): Genetic Regulation 44 rAAV8-Des-hMTM1 Characteristics of AT132 X-linked myotubular myopathy (XLMTM) ⚫ Lead program in the gene therapy pipeline of ⚫ Rare neuromuscular disease with X-linked, Audentes Therapeutics, acquired by Astellas loss of function mutations in M
Slide 45: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE