Slide 1: Q3/FY2018 Financial Results
Q3/FY2018 FINANCIAL RESULTS ENDED DECEMBER 31, 2018 Chikashi Takeda Chief Financial Officer Astellas Pharma Inc. January 31, 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 Q3/FY2018 Consolidated Financial Results II Pipeline III Initiatives for Sustainable Growth
Slide 4: Q3/FY2018 Financial Results (Core Basis)
Q3/FY2018 FINANCIAL RESULTS (CORE BASIS) 4 FY18 (billion yen) Q3/FY17 Q3FY18 Change Progress CER growth FCST* Net sales 999.4 1,005.0 +0.6% 1,300.0 77.3% +0.6% Cost of sales 238.9 227.7 -4.7% % of sales 23.9% 22.7% SG&A expenses 350.0 355.8 +1.6% % of sales 35.0％ 35.4% R&D expenses 161.6 150.0 216.0
Slide 5: Sales Analysis (Year on Year)
SALES ANALYSIS (YEAR ON YEAR) 5 Growth of XTANDI and mirabegron contributed to increase in net sales (billion yen) Q3/FY17 999.4 XTANDI OAB products -Decrease in long-listed drugs Others (incl. Micardis) and Tarceva Fx impacts -0.3 Q3/FY18 1,005.0 OAB：Overactive bladder OAB products：Vesicare＋mirabeg
Slide 6: Core OP Analysis (Year on Year)
CORE OP ANALYSIS (YEAR ON YEAR) 6 Increased core OP by 11% through combination of increased sales of main products and optimal resource allocation (billion yen) Q3/FY17 220.5 Gross profit* -Increase in XTANDI US co-promotion fee SG&A expenses* -Efficient spending and optimal resource allocation -Inc
Slide 7: Q3/FY2018 Financial Results (Full Basis)
Q3/FY2018 FINANCIAL RESULTS (FULL BASIS) 7 FY18 (billion yen) Q3/FY17 Q3/FY18 Change Progress FCST* Core operating profit 220.5 244.0 +10.7% 270.0 90.4% Other income 10.4 13.1 +25.8% Other expense 51.2 47.8 -6.6% Operating profit 179.8 209.4 +16.5% 234.0 89.5% Profit before tax 184.6 212.8 +15.3% 23
Slide 8: Sales of Main Products
SALES OF MAIN PRODUCTS 8 Main growth products contributing to increased net sales FY18 (billion yen) Q3/FY17 Q3/FY18 Change CER growth Progress FCST* XTANDI 219.9 253.4 +15.2% +15.3% 325.9 77.7% OAB products in 171.6 184.3 +7.4% +7.5% 245.7 75.0% Urology Vesicare 78.5 74.4 -5.2% -5.2% 96.1 77.4% Mir
Slide 9: XTANDI
XTANDI 9 XTANDI sales increased in all regions due to penetration in earlier stage of prostate cancer 1,227 (+17.4%) Sales by region 25.1 (+25.3%) 1,045 20.0 Japan ex-US Americas (billion yen) (million USD) 1,135 US 968 672 (+9.3%) 4.8 (+18.4%) 615 1,168 Asia/ 4.0 +21.2% EMEA 1,056 (million euro) Oc
Slide 10: OAB Franchise in Urology
OAB FRANCHISE IN UROLOGY 10 Mirabegron growth driving OAB franchise sales. Educating on novel mechanism of action with balance of efficacy and safety Quarterly sales (Global) (bil. yen) 800 80.0 Vesicare Mirabegron OAB products total 700 70.0 600 60.0 500 50.0 400 40.0 61% 300 30.0 39% 200 20.0 100
Slide 11: Agenda
AGENDA 11 I Q3/FY2018 Consolidated Financial Results II Pipeline III Initiatives for Sustainable Growth
Slide 12: Four Approvals Obtained Since Last Earnings
FOUR APPROVALS OBTAINED SINCE LAST EARNINGS 12 Continue to deliver VALUE for patients New molecular entity New molecular entity gilteritinib ipragliflozin romosozumab degarelix Nov 2018 (US) Dec 2018 (JP) Jan 2019 (JP) Jan 2019 (JP) Relapsed or refractory Type I diabetes Osteoporosis in patients Pro
Slide 13: Gilteritinib: Approved as First FLT3 Inhibitor for R/R AML
GILTERITINIB: APPROVED AS FIRST FLT3 INHIBITOR 13 FOR R/R AML Achieved important milestone in accordance with Strategic Plan 2018 • Approved in US in Nov 2018, launched in Japan and US in Dec 2018, for FLT3 mut+ R/R AML • First FLT3 inhibitor for this patient segment • Utilized regulatory expedited
Slide 14: Romosozumab: Japan Approval First in the World
ROMOSOZUMAB: JAPAN APPROVAL FIRST IN THE 14 WORLD Aiming at paradigm shift in osteoporosis treatment • Approved in Japan in Jan. 2019 for osteoporosis in patients at high risk of fracture • Prior fracture is one of the major risk factors for further fractures in osteoporosis patients. Especially the
Slide 15: Updates in Post-POC Projects
UPDATES IN 6 POST-POC PROJECTS 15 Since Q2/FY2018 financial results announcement in Oct 2018 Steady progress and successful achievements of late-stage projects enzalutamide gilteritinib enfortumab vedotin M1 HSPC FLT3 mut+ R/R AML mUC with prior CPI treatment • ADMIRAL study: Met primary • TLR of Ph
Slide 16: Enzalutamide
ENZALUTAMIDE 16 ARCHES study in M1 HSPC met its primary endpoint. Filing for M1 HSPC in US/EU/Japan planned by mid-2019 M1 HSPC ARCHES study Disease background M1 HSPC patients (n=1,150) including • Approximately 38,000 men in the US -Low- and high-volume diseases develop M1 HSPC every year.1,2 -Rec
Slide 17: Fezolinetant
FEZOLINETANT 17 Phase 2b study met all four co-primary endpoints in most cohorts. Full results to be presented at ENDO2019 in March 2019 Study Design Top Line Results Post menopausal woman suffering from at Efficacy least 50 moderate to severe VMS per week • All four co-primary endpoints demonstrate
Slide 18: Roxadustat
ROXADUSTAT 18 Potential first-in-class oral treatment for anemia associated with CKD NORMAL OXYGEN Target profile HIF-PH Enzymes HIF-α Degrades Rapidly Novel mechanism of action Degradation HIF-α Potential new treatment option that is HIF-α orally administered LOW OXYGEN Potential new treatmen
Slide 19: Roxadustat
ROXADUSTAT 19 TLRs of all 6 Phase 3 studies supporting EU filing were obtained. MAA submission in EU planned in mid-2019 Phase 3 program supporting EU filing TLRs of all 6 Phase 3 studies obtained and reimbursement Dialysis • All studies met their primary endpoints. • Roxadustat was well tolerated.
Slide 20: Maximize Value of Key Late Stage Projects
MAXIMIZE VALUE OF KEY LATE STAGE PROJECTS 20 Initiated development of additional indication for zolbetuximab to expand the value for patients Target disease: Phase 2a study pancreatic adenocarcinoma • Pancreatic cancer is the 7th most common • Patient segment: metastatic pancreatic cause of cancer d
Slide 21: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 21 P1 entry to filing, since Q2/FY2018 financial results announcement in Oct 2018 Steady progression of pipeline P1 Entry P2 Entry P3 Entry Filing ASP3772 zolbetuximab Pancreatic adenocarcinoma Prevention of pneumococcal disease ASP1128/MA-0217 Acute kidney injury *Pleas
Slide 22: Expected Key Events Within a Year
EXPECTED KEY EVENTS WITHIN A YEAR 22 Important milestones from POC study through registration Data readouts Phase 2 (POC) study reldesemtiv (CK-2127107) ALS Phase 2 study enfortumab vedotin mUC, Cohort 1 (CPI-pretreated/platinum-pretreated) Filings* roxadustat Anemia associated with CKD, dialysis/no
Slide 23: Agenda
AGENDA 23 I Q3/FY2018 Consolidated Financial Results II Pipeline III Initiatives for Sustainable Growth
Slide 24: Focus Area Approach: Acquisition of Potenza
FOCUS AREA APPROACH: 24 ACQUISITION OF POTENZA Expand our oncology portfolio Strategy Mechanism of Immunomodulation • Introduced novel immuno- oncology programs in NK cell clinical stage 3 programs entered into Phase1 Targeting patient population who are non-responsive to existing immuno-oncolog
Slide 25: Pursuing Operational Excellence
PURSUING OPERATIONAL EXCELLENCE 25 Management priorities for resource allocation in FY2018 IN OUT Capex in new modality / technology Review of organization / structure -New centers in Japan (Toyama and Tsukuba) -Optimization of organization / structure in EMEA -Enhancement of AIRM production fac
Slide 26: Capital Allocation
CAPITAL ALLOCATION 26 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 Acquisition during
Slide 27: Appendix
APPENDIX
Slide 28: Q3/FY2018: Sales by Region
Q3/FY2018: SALES BY REGION 28 (billion yen) Q3/FY17 Q3/FY18 Change Japan 337.3 312.7 -7.3% Americas 326.8 352.0 +7.7% EMEA 260.0 261.8 +0.7% Asia/Oceania 75.3 78.5 +4.3%
Slide 29: FX Rate (Actual)
FX RATE (ACTUAL) 29 Average rate for the period Currency Q3/FY17 Q3/FY18 Change USD 112 yen 111 yen -1 yen EUR 129 yen 129 yen +1 yen Change in closing rate from PY end Currency Q3/FY17 Q3/FY18 USD +1 yen +5 yen EUR +15 yen -4 yen Fx impact on elimination of unrealized gain: COGs ratio -0.6 ppt
Slide 30: FY2018 Forecast: FX Rate & FX Sensitivity
FY2018 FCST：FX RATE & FX SENSITIVITY 30 Forecast rates from October 2018 onwards: 110 USD/yen, 130 EUR/yen Estimated Fx sensitivity (October 2018 and onward) of FY2018 forecasts by 1 yen appreciation* Year-end rate Average rate 1 yen higher than 1 yen higher than assumption Currency assumption Net s
Slide 31: Balance Sheet/Cash Flow Highlights
BALANCE SHEET/CASH FLOW HIGHLIGHTS 31 (billion yen) FY17 end Dec. 2018 Total assets 1,858.2 1,928.3 Cash and cash equivalents 331.7 331.3 Total net assets 1,268.3 1,292.2 Equity ratio (%) 68.3% 67.0% (billion yen) Q3/FY17 Q3/FY18 FY17 Cash flows from operating activities 215.3 203.7 312.6 Cash flows
Slide 32: Details of Shareholder Returns
DETAILS OF SHAREHOLDER RETURNS 32 (yen) (billion yen) Dividends per Profit for the 40 Share* (left axis) year** (right axis) 250 200 30 150 20 38 36 100 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 33: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 33 Phase 1 Phase 2 Phase 3 Filed zolbetuximab (IMAB362) enzalutamide peficitinib (ASP015K) ASP1235/AGS62P1 (Pancreatic adenocarcinoma) (M0 HSPC:US/EU/Asia, (Rheumatoid arthritis, JP) M1 HSPC:US/EU/JP/Asia,) AGS-16C3F (Renal cell carcinoma) solifenacin* (Pediatric NDO, US)
Slide 34: Filing Timeline for Key Post-POC Projects
FILING TIMELINE FOR 6 KEY POST-POC PROJECTS 34 Filed/Expected filing FY2018 FY2019-FY2020 FY2021 - gilteritinib enzalutamide enzalutamide (M1 HSPC) (M0 HSPC) (Relapsed or Refractory AML: EU) roxadustat enfortumab vedotin gilteritinib (Anemia associated with CKD (Metastatic urothelial cancer) (Other
Slide 35: Enzalutamide
ENZALUTAMIDE 35 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 TLR obta
Slide 36: Gilteritinib
GILTERITINIB 36 Phase 1 study Chemo Maintenance Salvage therapy High- intensity consolidation GOSSAMER induction Maintenance FLT3 + chemo Transplant ADMIRAL MORPHO AML patients Launched (US, JP) Low-intensity Filing planned in chemo 1Q/2019 (EU) LACEWING Full OS data obtained Label update to include
Slide 37: Enfortumab Vedotin
ENFORTUMAB VEDOTIN 37 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 eligible Gem-Cis EV-301 • CPI • Gem-Carbo • Single agent chemo • Single agent chemo • Clinical
Slide 38: Zolbetuximab
ZOLBETUXIMAB 38 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 39: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE