Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q1 FY2017 Earnings Presentation
43 slides from Astellas Pharma's earnings presentation, Jul 28, 2017
Slide 1: Q1/FY2017 Financial Results
Q1/FY2017 FINANCIAL RESULTS ENDED JUNE 30, 2017 July 28, 2017 Chikashi Takeda Chief Financial Officer Astellas Pharma Inc.
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. These statements
Slide 3: Agenda
AGENDA 3 I Q1/FY2017 Financial Results Initiatives to Build Resilience for II Sustainable Growth III Profit Distribution Policy
Slide 4: Q1/FY2017 Financial Results (Core Basis)
Q1/FY2017 FINANCIAL RESULTS (CORE BASIS) 4 On-track toward FY2017 FCST Excl impacts FY17 Achieve- from Fx and (billion yen) FY16/Q1 FY17/Q1 Change business FCST* ment transfer Net sales 337.8 322.6 -4.5% 1,279.0 25.2% -1% Cost of sales 71.5 79.3 +10.9% % of sales 21.2％ 24.6% +3.4ppt SG&A expenses 11
Slide 5: Sales Analysis (Year on Year)
SALES ANALYSIS (YEAR ON YEAR) 5 Slight decrease excluding impacts of Fx and business transfers (billion yen) Q1/FY16 337.8 (increase) XTANDI, Mainstay products Betanis/Myrbetriq/BETMIGA growth, etc (decrease) Vesicare GEs impacts in Japan Dermatology business Decrease in transfer * amortisation of d
Slide 6: Core OP Analysis (Year on Year)
CORE OP ANALYSIS (YEAR ON YEAR) 6 Development cost for late-stage projects increased (billion yen) Q1/FY16 94.0 Gross profit* Decrease in net sales SG&A expenses* Stay flat by efficient spending R&D expenses* Increase in late-stage development Increase due to acquisitions Others* Amortisation, Equit
Slide 7: Q1/FY2017 Financial Results (Full Basis)
Q1/FY2017 FINANCIAL RESULTS (FULL BASIS) 7 Other income/expenses for IMAB362 development plan review Achieve- （billion yen） Q1/FY16 Q1/FY17 Change FY17FCST* ment Core operating profit 94.0 65.1 -30.7% 254.0 25.6% Other income 0.2 9.7 - Other expenses 1.3 31.3 - Operating profit 92.9 43.5 -53.1% 254.
Slide 8: Sales in Three Key Areas
SALES IN THREE KEY AREAS 8 XTANDI increase on a global basis (billion yen) Q1/FY16 Q1/FY17 Change CER growth Oncology 79.1 81.8 +3.4% +2% XTANDI 64.2 67.9 +5.8% +4% OAB in Urology 54.0 51.8 -4.0% -6% Vesicare 30.4 24.6 -19.2% -20% Betanis/Myrbetriq/BETMIGA 23.6 27.2 +15.6% +14% Transplantation 49.4
Slide 9: Agenda
AGENDA 9 I Q1/FY2017 Financial Results Initiatives to Build Resilience for II Sustainable Growth III Profit Distribution Policy
Slide 10: Achieving Sustainable Growth
ACHIEVING SUSTAINABLE GROWTH 10 (same as Strategic Plan 2015-2017 slide) New products will drive mid-term growth; Sustainable growth will be reinforced by continuous selective investment in innovation and strengthening of the business foundation Maximizing the Creating Innovation Product Value Enhan
Slide 11: Maximize the Product Value
| MAXIMIZE THE PRODUCT VALUE Kastellas
Slide 12: XTANDI
XTANDI 12 Global sales on-track. All-time high quarterly sales in EMEA Sales by region Quarterly sales (local currency) (billion yen) US (M USD) 301 (+10%) 67.9(+6%) 64.2 1.2 0.7 20.0 24.4 Asia/Oceania 200 EMEA (M EUR) (+9%) EMEA Americas Japan 37.5 35.9 50 FY15 FY16 FY17 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
Slide 13: OAB Franchise in Urology
OAB FRANCHISE IN UROLOGY 13 Betanis/Myrbetriq/BETMIGA showed steady sales Sales by product Sales composition ratio by (billion yen) product (JPY basis) 54.0 51.8 (-4%) Betanis/Myrbetriq/ BETMIGA 23.6 53% 47% 27.2 Vesicare • Negative impacts of such as price 30.4 Betanis/Myrbetriq/ adjustments relate
Slide 14: Create Innovation: Pipeline
| CREATE INNOVATION PIPELINE Kastellas
Slide 15: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 15 Evaluating >30 new molecular/biological entities as potential drivers of future growth Phase 1 Phase 2 Phase 3 Filed ● ASG-15ME enzalutamide (HCC) enzalutamide enzalutamide (Tablet, EU/JP) ● AGS-16C3F (M0 CRPC, M0 BCR:US/EU/Asia, ● AGS67E (Renal cell carcinoma) M1 HSPC
Slide 16: Consistent Achievement on Filing/Approval
CONSISTENT ACHIEVEMENT ON FILING/APPROVAL 16 Commitment to steady progress and achievement for filing and approval Filing Approval solifenacin/mirabegron quetiapine fumarate (extended release tablet)* • Combination use for OAB (US) • Indication: Improvement of depressive symptoms • Filed in June 201
Slide 17: Steady Progress in Development
STEADY PROGRESS IN DEVELOPMENT 17 SUMMARY OF PROGRAM PHASE TRANSITION FROM APR 2017 TO JULY 2017 Steady progression of pipeline P1 Entry P2 Entry P3 Entry ASP6981 ASP5094 Cognitive impairment Rheumatoid arthritis associated with schizophrenia MA-0211 Duchenne muscular dystrophy enzalutamide: Breast
Slide 18: Enzalutamide: Maximize the Value for Prostate Cancer Patients
ENZALUTAMIDE: MAXIMIZE THE VALUE FOR PROSTATE 18 CANCER PATIENTS Data readout of PROSPER study is planned in 2017. Localized Castration Anti-Androgens Chemotherapy Therapy* M0 BCR M0 CRPC EMBARK >>> >>> PROSPER -T PSA/ Chemo-naive Tumor Post-chemo M1 HSPC volume >>> >>> ARCHES** (PREVAIL) (AFFIRM) C
Slide 19: Gilteritinib: Treatment Landscape in AML
GILTERITINIB: TREATMENT LANDSCAPE IN AML 19 FDA granted orphan drug designation to gilteritinib for AML Phase 1 study Ongoing Chemo Maintenance High- consolidation GOSSAMER study intensity induction Transplant Maintenance chemo FLT3 + AML MORPHO study Salvage patients therapy Low-intensity chemo LAC
Slide 20: Gilteritinib: Publication in The Lancet Oncology
GILTERITINIB: PUBLICATION IN THE LANCET ONCOLOGY 20 The Lancet Oncology publishes anti-leukemic activity and safety data from Phase 1/2 CHRYSALIS study Overall survival of patients receiving Key findings: gilteritinib ≤ 40mg/day vs ≥ 80mg/day • Gilteritinib monotherapy was well tolerated, generated
Slide 21: Enfortumab Vedotin: Updated Phase 1 Data in Metastatic Urothelial Cancer
ENFORTUMAB VEDOTIN: ROBUST UPDATED DATA OF PHASE 1 21 STUDY IN METASTATIC UROTHELIAL CANCER Registrational Phase 2 study initiation planned in 2017 in mUC patients with prior checkpoint inhibitor supported by the robust data of Phase 1 study in mUC patients ASCO2017: Updated analysis in mUC patients
Slide 22: Roxadustat: Robust Phase 3 Program
ROXADUSTAT: ROBUST PHASE 3 PROGRAM TO SUPPORT 22 FILING AND REIMBURSEMENT IN EUROPE AND JAPAN Planned data readouts from 3 studies (1 global, 2 Japanese studies) in FY2017. Dialysis Non-dialysis HIMALAYAS: DOLOMITES, vs darbepoetin Incident dialysis, vs epoetin alfa ALPS, vs placebo SIERRAS: Enrollm
Slide 23: Roxadustat: Treatment Landscape of CKD with Anemia
ROXADUSTAT: TREATMENT LANDSCAPE OF CKD WITH ANEMIA 23 Potential to become a new treatment option for CKD patients with anemia Patient numbers* Characteristics 1,000,000 • Orally administrated CKD with anemia • Small molecule agent CKD without anemia 800,000 • New mechanism of action that is differen
Slide 24: Fezolinetant: High Unmet Medical Needs in VMS
FEZOLINETANT: HIGH UNMET MEDICAL NEEDS IN VMS 24 A safe non-hormonal drug has been awaited by patients with VMS Disease Background Unmet Medical Needs US Annual Branded TRx Trends for MR-VMS*2 • MR-VMS patients are women generally in mid-40’s to mid-60’s. 80,000 Data release by WHI in 2001 • VMS fou
Slide 25: Fezolinetant: POC Study in MR-VMS
FEZOLINETANT: POC STUDY IN MR-VMS 25 Robust data in terms of improvement in the frequency and extent of hot flashes Average Daily Hot Flash Frequency* Score of average severity of Hot Flash* At Week 4: 14/40 patients have ZERO 1 - Mild: sensation of heat without sweating hot flash in fezolinetant gr
Slide 26: Fezolinetant: Phase 2b Study Initiation in MR-VMS
FEZOLINETANT: PHASE 2B STUDY INITIATION IN MR-VMS 26 First Patient is expected soon Target patient Co-primary endpoints • Post menopausal women suffering from moderate to severe vasomotor symptoms at • Change from baseline in the mean number least 50 per week (n=352) of hot flashes (mild, moderate a
Slide 27: Phase 2 Programs: Highlights
PHASE 2 PROGRAMS: HIGHLIGHTS 27 Steady progress and near-term plans of Phase 2 programs IMAB362 CK-2127107 • Regulatory meetings in US/EU/JP • Top Line Result of Phase 2 study in SMA planned in 2017 to consult the overall patients is planned in 1Q/2018. development plan for Phase 3 study • FDA grant
Slide 28: Expected Key Pipeline Events in FY2017
EXPECTED KEY PIPELINE EVENTS IN FY2017 28 Important milestones from POC through registration *Subject to internal assessment, decision and regulatory consultation, as appropriate Data Readouts Filing* Regulatory Decisions Phase 2 (POC) study Phase 3 study solifenacin/mirabegron enzalutamide Concomit
Slide 29: Potential Growth Drivers
POTENTIAL GROWTH DRIVERS 29 Future growth driven by compounds that already have achieved POC gilteritinib enzalutamide solifenacin/ (label expansion) mirabegron enfortumab (Combination therapy) vedotin evolocumab IMAB362 (Cardiovascular outcome study) roxadustat linaclotide ASP0113 (Chronic constipa
Slide 30: Create Innovation: New Initiatives
CREATE INNOVATION NEW INITIATIVES
Slide 31: Initiatives to Create Innovation
INITIATIVES TO CREATE INNOVATION 31 Alliance Station in Kyoto University with aim of realizing advanced medical treatment • New open innovation scheme evolving 10-year collaborative research since 2007 • Establish Alliance Laboratory for Advanced Medical Research in Graduate School of Medicine Kyoto
Slide 32: Pursue Operational Excellence
PURSUE OPERATIONAL EXCELLENCE
Slide 33: Optimal Resource Allocation: Wind-down Agensys Research Operations
OPTIMAL RESOURCE ALLOCATION: 33 WIND-DOWN AGENSYS RESEARCH OPERATIONS Optimize resource allocation to further refine oncology strategy • Continuous evaluation of oncology strategy: Reduce focus on Antibody-Drug Conjugate (ADC) research Expand investment in the research in new technologies and modali
Slide 34: Create Social Value
CREATE SOCIAL VALUE 34 Resolve social issues and enhance our enterprise value over the long-term Expand scope of collaborative research for rice-based oral vaccine MucoRice technology • To viral gastroenteritis diarrhea in addition to original scope; cholera and enterotoxigenic Escherichia coli Glob
Slide 35: Agenda
AGENDA 35 I Q1/FY2017 Financial Results Initiatives to Build Resilience for II Sustainable Growth III Profit Distribution Policy
Slide 36: Profit Distribution Policy
Profit Distribution Policy 36 Top priority on investment for growth business Dividends to be increased continuously based on mid-and long-term growth Share buybacks to be implemented in a flexible manner （billion yen） 40 250 （yen） Profit for the Dividends per year** (right axis) Share* (Left axis) 2
Slide 37: Realize Sustainable Growth
REALIZE SUSTAINABLE GROWTH 37 Turn innovative science into value for patients on the forefront of healthcare change New technologies/ modalities * Pre-POC projects Post-POC projects Strategic resource allocation -Transfer of dermatology business -Transfer of US manufacturing subsidiary -Transfer of
Slide 38: Appendix
APPENDIX
Slide 39: Q1/FY2017: Sales by Region
Q1/FY2017: SALES BY REGION 39 Q1/FY16 Q1/FY17 Change Japan (billion yen) 124.2 114.2 -8.1% of sales in Japanese market 114.8 106.1 -7.5% Americas (million USD) 995 914 -8.1% EMEA (million EUR) 699 683 -2.4% Asia/Oceania (billion yen) 20.7 23.4 +13.2%
Slide 40: FY2017 FCST: FX Sensitivity
FY2017 FCST：FX SENSITIVITY 40 Estimated Fx sensitivity of FY2017 forecasts by 1 yen appreciation Year-end rate Average rate 1 yen higher than Currency 1 yen higher than expected assumption expected assumption Net sales Core OP Core OP USD Approx. -4.9 bil yen Approx. -1.2 bil yen Approx. +0.5 bil ye
Slide 41: Balance Sheet/Cash Flow Highlights
BALANCE SHEET/CASH FLOW HIGHLIGHTS 41 (billion yen) FY16 end Jun. 2017 Total assets 1,820.9 1,901.2 Cash and cash equivalents 340.9 314.4 Total net assets 1,271.8 1,319.7 Equity ratio (%) 69.8% 69.4% (billion yen) Q1/FY16 Q1/FY17 FY16 Cash flows from operating business 18.2 59.5 235.6 Cash flows fro
Slide 42: Profit Distribution
PROFIT DISTRIBUTION 42 FY2017 FY2015 FY2016 (forecast) Core EPS 92.12 101.15 94.43 Divided per share 32 34 36 (forecast) ROE 15.0% 17.3% - DOE 5.4% 5.6% - 68 million shares 60 million shares Share buyback - 119.3 billion yen 91.4 billion yen Treasury stock 38 million shares 68 million shares 85 mill
Slide 43: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE