Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q1 2022 Earnings Presentation
43 slides from Astellas Pharma's earnings presentation, Aug 1, 2022
Slide 1: Q1/FY2022 Financial Results
Q1/FY2022 FINANCIAL RESULTS ENDED JUNE 30, 2022 Minoru Kikuoka Chief Financial Officer (CFO) Astellas Pharma Inc. August 1, 2022
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/FY2022 Consolidated Financial Results II Initiatives for Sustainable Growth
Slide 4: Q1/FY2022 Financial Results: FX Impact and One-Time Factors
Q1/FY2022 FINANCIAL RESULTS: 4 FX IMPACT AND ONE-TIME FACTORS （FULL BASIS） Affected the significant FX impact incl. elimination of unrealized profit due to the sharp depreciation of yen in Q1 Financial results were on track when excluding FX impact and one-time factors Q1/FY22 Q1/FY22 (billion yen)
Slide 5: Q1/FY2022 Financial Results: Overview
Q1/FY2022 FINANCIAL RESULTS: OVERVIEW 5 Revenue increased 17% YoY and was on track when excluding FX impact ⚫ Sales of XTANDI and Strategic products increased 26% YoY ⚫ Cost of sales ratio increased YoY due to significant FX impact ⚫ SG&A expenses were on track and decreased YoY when excluding FX im
Slide 6: Q1/FY2022 Financial Results
Q1/FY2022 FINANCIAL RESULTS 6 Change FY22 (billion yen) Q1/FY21 Q1/FY22 Change Progress FX impact (%) Initial FCST Revenue 326.1 381.8 +55.6 +17.1% 1,443.0 26.5% +35.5 bil. yen Cost of sales 62.2 88.9 +26.6 +18.5 bil. yen* +42.8% % of revenue 19.1% 23.3% +4.2 ppt SG&A expenses 137.1 153.4 +16.3 +11.
Slide 7: Q1/FY2022 Financial Results: XTANDI and Strategic Products
Q1/FY2022 FINANCIAL RESULTS: 7 XTANDI AND STRATEGIC PRODUCTS Sales of XTANDI and Strategic products increased 26% YoY FY2022 (billion yen) Q1/FY2022 Act YoY Progress Initial FCST +29.5 ✓ Global sales are in line with expectations 162.4 （+22%） 642.5 25% ✓ Signs of sales recovery in US from Q4 slowdow
Slide 8: Business Update for XTANDI and PADCEV
Q1/FY2022 FINANCIAL RESULTS: 8 BUSINESS UPDATE FOR XTANDI AND PADCEV Revenue by Region (billion yen) Global sales grew as expected, mainly from M1 CSPC contribution 162.4 143.9 <US> Performed below expectations, but showed signs of sales recovery 132.9 134.7 122.7 • Impact from generic competitor pr
Slide 9: Q1/FY2022 Financial Results: Cost Items
Q1/FY2022 FINANCIAL RESULTS: COST ITEMS 9 Cost of sales ratio increased YoY due to significant FX impact SG&A expenses were on track and decreased YoY when excluding FX impact R&D expenses were on track Core basis: Main items for YoY and progress against FCST Cost of sales ✓ FX impact on elimination
Slide 10: Agenda
AGENDA 10 I Q1/FY2022 Consolidated Financial Results II Initiatives for Sustainable Growth
Slide 11: XTANDI & Strategic Products: Key Events Expected in FY2022
XTANDI & STRATEGIC PRODUCTS: KEY EVENTS EXPECTED IN FY2022 11 Q1 Q2 Q3 Q4 EMBARK TLR 1 enzalutamide / Filing (M0 CSPC; US) XTANDI China ARCHES TLR 1 EV-103 Cohort K TLR enfortumab Jul Filing (1L mUC; US) vedotin / PADCEV EV-203 TLR (pre-treated mUC; China) 1 EV-202 Initial TLR Jun Jul SPOTLIGHT TLR
Slide 12: Enfortumab Vedotin (1/2): Topline Results for EV-103 Study Cohort K
ENFORTUMAB VEDOTIN (EV) (1/2): 12 TOPLINE RESULTS FOR EV-103 STUDY COHORT K Positive topline results obtained, showing consistent efficacy and safety with previous data 1 ⚫ First-line treatment for advanced urothelial cancer (cis-ineligible, combination with pembrolizumab) ⚫ Plan to discuss results
Slide 13: Enfortumab Vedotin (2/2): Overview
ENFORTUMAB VEDOTIN (2/2): OVERVIEW 13 The most significant growth driver is 1L mUC indication, which is expected to account for more than half of total sales in the future Mono/ Target filing Number of Peak Patient segment Pivotal study OS PFS ORR DoR Combo 1 timing eligible patients 2 300 - 400 bil
Slide 14: Fezolinetant: Latest Status
FEZOLINETANT: LATEST STATUS 14 <Regulatory submission> NDA submitted to US FDA on June 22 SKYLIGHT 2 study 52-w data (VMS frequency) <Data presentation> Latest data presented at ACOG and ENDO 14 Placebo ⚫ SKYLIGHT 1 study 12-w data: Consistent results with those of SKYLIGHT 2 study 12 Fezolinetant 3
Slide 15: Progress in Focus Area Approach (1/4): Current Status of Projects in Clinical Trial
PROGRESS IN FOCUS AREA APPROACH (1/4): 15 CURRENT STATUS OF PROJECTS IN CLINICAL TRIAL (Red: Updates since the last financial results announcement) No. of projects Primary Focus Biology/Modality/Technology 1 Project Current status aiming PoC by end FY25 2 AT132 ASPIRO study put on clinical hold by F
Slide 16: Progress in Focus Area Approach (2/4): AT845
PROGRESS IN FOCUS AREA APPROACH (2/4): AT845 16 ⚫ FORTIS study placed on clinical hold by FDA, following the reporting of an SAE of peripheral sensory neuropathy ⚫ Remain committed to the safe and effective development of AT845 for Pompe disease, and to gene therapy Comments were SAE reported by Fol
Slide 17: Progress in Focus Area Approach (3/4): ASP7317
PROGRESS IN FOCUS AREA APPROACH (3/4): ASP7317 17 Clinical study of ASP7317, the lead program of cell therapy, anticipated to restart ⚫ ASP7317 ✓ Human embryonic stem cell-derived retinal pigment epithelial cells ✓ Target disease: Geographic atrophy secondary to age-related macular degeneration, Sta
Slide 18: Progress in Focus Area Approach (4/4): ASP3082
PROGRESS IN FOCUS AREA APPROACH (4/4): ASP3082 18 Potential first-in-class program from Focus Area approach entered clinical phase Degradation of target protein with technology enabling access to “Undruggable target” Protein degrader: degrades target protein through intrinsic mechanism Conventional
Slide 19: Progress in Rx+ Program
PROGRESS IN Rx+ PROGRAM 19 Key events expected in FY2022 (announced in Apr 2022） Category Program Event Result Digital health EG Holter/AI Software Initiation of sales pilot Achieved (Jun 2022) Other services Digital therapeutics BlueStar Initiation of clinical study (Japan) Drug-device pudexacianin
Slide 20: Progress Toward Achieving CSP2021
PROGRESS TOWARD ACHIEVING CSP2021 20 Revenue, Pipeline Value Core OP XTANDI and Strategic products: 1 5 Flat SG&A in absolute terms ✓ SG&A expenses decreased YoY ¥1.2T in FY2025 when excluding FX impact Sufficient R&D investments ✓ Sales growth on track 6 Core OP margin of 30% in FY2025 ✓ PADCEV
Slide 21: Upcoming IR Event
UPCOMING IR EVENT 21 (SECURITIES ANALYSTS AND INSTITUTIONAL INVESTORS) fezolinetant meeting ➢ Oct 17th 2022, 9:30-10:45 (JST) Enfortumab Vedotin meeting (EV-103 Cohort K) ➢ To be announced
Slide 22: Appendix
APPENDIX
Slide 23: FX Impacts on Elimination of Unrealized Profit
FX IMPACTS ON ELIMINATION OF UNREALIZED PROFIT 23 ⚫ In elimination of unrealized intercompany profit included in inventories as a part of the consolidation accounting process, FX fluctuation could cause impacts on cost of sales Overview of cost of sales FX impacts related to inventories held by fore
Slide 24: Q1/FY2022: Revenue by Region
Q1/FY2022: REVENUE BY REGION 24 (billion yen) Q1/FY21 Q1/FY22 Change (%) Japan 67.5 66.8 -1.0% United States 133.6 160.9 +20.4% Established Markets 78.0 88.7 +13.7% Greater China 16.4 23.2 +41.0% International Markets 27.8 31.8 +14.5% Established Markets: Europe, Canada, Australia Greater China: Chi
Slide 25: Q1/FY2022: Sales of Main Products
Q1/FY2022: SALES OF MAIN PRODUCTS 25 FY22 (billion yen) Q1/FY21 Q1/FY22 Change CER growth Initial FCST XTANDI 132.9 162.4 +22.2% +9.3% 642.5 PADCEV 4.2 10.6 +151.6% +122.9% 36.5 XOSPATA 8.3 10.5 +26.3% +12.1% 46.2 EVRENZO 0.6 0.7 +19.3% +18.8% 9.9 mirabegron 44.0 47.9 +9.0% -2.2% 178.7 Prograf 45.2
Slide 26: Q1/FY2022 Actual: FX Rate
Q1/FY2022 ACTUAL: FX RATE 26 Average rate for the period Currency Q1/FY21 Q1/FY22 Change USD 109 yen 130 yen -20 yen EUR 132 yen 138 yen -6 yen Change in closing rate from previous fiscal year end Currency Q1/FY21 Q1/FY22 USD +0 yen -14 yen EUR -2 yen -8 yen <Impact of exchange rate on financial res
Slide 27: FY2022 Forecast: FX Rate & FX Sensitivity
FY2022 FCST： FX RATE & FX SENSITIVITY 27 Average rate for the period Currency FY2021 FY2022 FCST change USD 112 yen 120 yen +8 yen EUR 131 yen 135 yen +4 yen Change in closing rate from the previous FY end Currency FY2021 FY2022 FCST USD +11 yen -2 yen EUR +5 yen +0 yen Estimated FX sensitivity of F
Slide 28: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 28 (billion yen) FY21 end Jun 30, 2022 Total assets 2,332.4 2,481.8 Cash and cash equivalents 316.0 313.0 Total equity attributable to owners of the parent 1,460.3 1,539.1 Equity ratio (%) 62.6% 62.0% (billion yen) Q1/FY21 Q1/FY22 FY21 Cash flows from operating a
Slide 29: Capital Allocation
CAPITAL ALLOCATION 29 1 Top priority is investment 2 Raise dividend level aligned 3 Flexibly execute share for business growth with profit / cashflow plan and buyback by excess cash actual performance throughout CSP2021 period Aiming for higher level of dividends increase during CSP2021 aligned with
Slide 30: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 30 Phase 1 Phase 2 Phase 3 Submitted enfortumab vedotin enfortumab vedotin enzalutamide fezolinetant (NMIBC) (Other solid tumors) (M0 CSPC, M1 CSPC: China) (VMS associated with menopause: US) gilteritinib zolbetuximab enfortumab vedotin (Newly diagnosed AML, HIC-ineligibl
Slide 31: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 31 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval fezolinetant Vasomotor symptoms associated with menopause: US Discontinuation ASP8062: Opioid use disorder (Phase 2) Note: Phase 1 entry i
Slide 32: XTANDI & Strategic Products: Status Update
XTANDI & STRATEGIC PRODUCTS: STATUS UPDATE 32 (Red: Updates since the last financial results announcement) Project / Product Indication Current status enzalutamide / M1 CSPC • US: Filed label update to include the OS data in Dec 2021 XTANDI • EU: CHMP positive opinion received for label update to in
Slide 33: Enzalutamide (1/2): Androgen Receptor Inhibitor
ENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR 33 US/Europe/JP Definitive Therapy Castration-Sensitive Castration-Resistant ARCHES M1 CSPC Initial newly-diagnosed PREVAIL AFFIRM Diagnosis Surgery M1 CRPC M1 CRPC M1 CSPC recurrent (1st line) (2nd line+) Salvage Launched Launched Launched Active Surv
Slide 34: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE 34 Continued potential in earlier lines with consistent survival benefit and longer duration of treatment Early stage Late stage Castration-sensitive (CSPC) Castration-resistant (CRPC) Disease stage M1 M1 M0 M1 M0 (pre-chemo) (post-chemo) Phase
Slide 35: Enfortumab Vedotin (1/3): Nectin-4 Targeted ADC Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/3): NECTIN-4 TARGETED ADC 35 OVERALL UC PROGRAM Early stage - Disease stage of urothelial cancer - Late stage NMIBC MIBC mUC Stages 0a-1 Stages 2 and 3 Stage 4 Previously Platinum and Patient BCG- PD-1/L1 inhibitor RC-eligible untreated PD-1/L1 inhibitor treatment unrespon
Slide 36: Enfortumab Vedotin (2/3): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/3): 36 CLINICAL STUDIES (Red: Updates since the last financial results announcement) For urothelial cancer mUC, Platinum and PD-1/L1 inhibitor pretreated; sBLA (to convert regular approval) approved in US in Jul 2021. P3: EV-301 n=608 EV mono vs. Chemo Approved in JP in Se
Slide 37: Enfortumab Vedotin (3/3): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/3): 37 STUDY DATA BY DISEASE STAGE OF UC (Red: Updates since the last financial results announcement) Early stage Late stage MIBC mUC Disease Surgery eligible Previously untreated (first line) PD-1/L1 inhibitor pretreated stage Cis- Cis- Platinum Platinum naïve Cis-ineligi
Slide 38: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 38 (Red: Updates since the last financial results announcement) PASHA (HOVON) PrE0905 (PrECOG) Chemo Maintenance ADMIRAL High- consolidation intensity GOSSAMER induction Maintenance chemo Transplant Salvage therapy FLT3 mut+ MORPHO AML Launched Low-intensity chemo P1 (tr
Slide 39: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY 39 Target: Claudin 18.2 Gastric and (GEJ) adenocarcinoma ⚫ Claudin is a major structural component of tight junctions ⚫ Target patient population: and seals intercellular space in epithelial sheets HER2-, Claudin 18.2+ locally advanced and ⚫ Broadl
Slide 40: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 40 (Red: Updates since the last financial results announcement) VMS has a significant negative impact on QoL Women’s Health Initiative (WHI) Study 2 ⚫ Physical symptoms include hot flashes and night sweats, which can ⚫ Initial data analyses showed an association
Slide 41: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): rAAV8-Des-hMTM1 41 Characteristics of AT132 X-linked myotubular myopathy (XLMTM) ⚫ Lead program in the gene therapy pipeline of Audentes ⚫ Rare neuromuscular disease with X-linked, Therapeutics, acquired by Astellas loss of function mutations in MTM1 gene in Jan 202
Slide 42: Focus Area Approach: Clinical Proof and Expansion of Key Platforms
FOCUS AREA APPROACH: 42 CLINICAL PROOF AND EXPANSION OF KEY PLATFORMS Expecting PoC judgement in 2 projects, Phase 1 entry in 5 projects (lead and follow-on projects) No. of projects Modality Primary Focus Biology/Modality/Technology 1 Lead project FY22 FY23 FY24-25 aiming PoC Small molecule by end
Slide 43: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE