Takeda Pharmaceutical Co. Ltd. · TSE:4502
Takeda Pharmaceutical — Q1 2024 Earnings Presentation
52 slides from Takeda Pharmaceutical's earnings presentation, Jul 31, 2024
Slide 1: Committed to Growth & Shareholder Returns
TSE: 4502 Committed to Growth & Shareholder Returns FY2024 Q1 Earnings Announcement July 31st, 2024
Slide 2: Important Notice
Important Notice For the purposes of this notice, “presentation” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this presentation. This presentation (i
Slide 3: Agenda
Opening Remarks Christophe Weber, President & CEO Business & Financial Highlights Milano Furuta, Chief Financial Officer AGENDA Pipeline Update Andy Plump, President, R&D Q&A Question & Answer Session
Slide 4: Positive Start to FY2024 with Momentum in Portfolio & Pipeline
Positive Start to FY2024 with Momentum in Portfolio & Pipeline Strong Momentum of Driving Efficiencies to Progress in Late-Stage Growth & Launch Products Improve Margins Innovative Pipeline • Total Q1 Revenue +2.1% at CER1 • Core Operating Profit margin 31.6%2 • Soticlestat totality of Dravet Syndro
Slide 5: Agenda
Opening Remarks Christophe Weber, President & CEO Business & Financial Highlights Milano Furuta, Chief Financial Officer AGENDA Pipeline Update Andy Plump, President, R&D Question & Answer Session
Slide 6: FY2024 Q1 Results Driven by Growth & Launch Products
FY2024 Q1 Results Driven by Growth & Launch Products and Upside from Milder than Anticipated VYVANSE Generic Erosion FY2024 Q1 (APR-JUN) FINANCIAL RESULTS (SUMMARY) (BN YEN, except EPS) REPORTED CORE1 ACTUAL % ACTUAL % CER2 % CHANGE FY2024 Q1 FY2023 Q1 CHANGE FY2024 Q1 FY2023 Q1 CHANGE REVENUE 1,208
Slide 7: FY2024 Q1 Revenue: Growth & Launch Products More Than Offset LOE Impact
FY2024 Q1 Revenue: Growth & Launch Products More Than Offset LOE Impact FY2024 Q1 REVENUE VS PRIOR YEAR (BN JPY) +14.1% 1,208.0 +2.1% at CER 127.2 1,058.6 Includes VYVANSE, Growth of AZILVA & ADDERALL XR +17.8% at CER FY2023 Q1 Growth & Launch LOE impacted Other products FX FY2024 Q1 Revenue Product
Slide 8: Growth & Launch Products +17.8% at CER Driven by IG, ENTYVIO & TAKHZYRO
Growth & Launch Products +17.8% at CER Driven by IG, ENTYVIO & TAKHZYRO, with Strong Uptake of New Launches QDENGA and FRUZAQLA Balanced Portfolio Across 6 Key Business Areas PLASMA-DERIVED GI RARE DISEASES THERAPIES (PDT) ONCOLOGY VACCINES NEUROSCIENCE % of Sales: 29% % of Sales: 17% % of Sales: 22
Slide 9: FY2024 Q1 Core Operating Profit
FY2024 Q1 Core Operating Profit: Benefit from Phasing of R&D Investment and Reduction of Other OPEX FY2024 Q1 CORE OPERATING PROFIT VS PRIOR YEAR (BN JPY) +17.1% +4.5% at CER 382.3 41.2 326.3 Gross Profit Impact FY2023 Q1 Growth & Launch LOE impacted products R&D and DD&T Other Opex FX FY2024 Q1 Cor
Slide 10: FY2024 Q1 Reported Operating Profit
FY2024 Q1 Reported Operating Profit: Restructuring Costs Associated with Enterprise-wide Efficiency Program In-Line with Expectations FY2024 Q1 REPORTED OPERATING PROFIT VS PRIOR YEAR (BN JPY) -1.3% 168.6 166.3 Includes JPY 21.5B 18.0 impairment of intangible assets related to soticlestat booked in
Slide 11: No Change to Full-Year FY2024 Outlook Announced in May
No Change to Full-Year FY2024 Outlook Announced in May (BN YEN, except EPS) REPORTED CORE CORE CHANGE AT CER FY2024 FORECAST VS. PRIOR YEAR FY2024 FORECAST VS. PRIOR YEAR FY2024 MANAGEMENT GUIDANCE REVENUE 4,350.0 +2.0% 4,350.0 +2.0% Flat to slightly declining OPERATING PROFIT 225.0 +5.1% 1,000.0 -5
Slide 12: Hybrid Bonds Financing and USD 3.0B Leverage Neutral Debt Financing
JPY 460.0B Hybrid Bonds Financing Executed in June, USD 3.0B Leverage Neutral Debt Financing Executed in July MATURITY LADDER AS OF 30 JUNE 2024 (AS ADJUSTED) 1 800 CALLED AND REFINANCED 600 USD 3B LEVERAGE NEUTRAL DEBT FINANCING BILLION JPY 400 HYBRID HYBRID2 200 - ‖ ‖ ‖ ‖ ‖ ‖ ‖ ‖ ‖ FY 24 FY 25 FY
Slide 13: Agenda
Opening Remarks Christophe Weber, President & CEO Business & Financial Highlights Milano Furuta, Chief Financial Officer AGENDA Pipeline Update Andy Plump, President, R&D Question & Answer Session
Slide 14: Major Updates to Our Pipeline Since Q4 FY23
Major Updates to Our Pipeline Since Q4 FY23 • Soticlestat: Failed to demonstrate clinical benefit in LGS. Totality of Dravet syndrome data suggests clinically meaningful benefit despite missing Phase 3 primary endpoint Data & • TAK-861: Phase 3 narcolepsy type 1 trials enrolling; positive Phase 2b n
Slide 15: Late-Stage Programs have the Potential to Generate Significant Value
Developing Life Transforming Medicines for Rare and More Prevalent Diseases: Late-Stage Programs have the Potential to Generate Significant Value FY24 FY25 FY26-27 Psoriasis Psoriasis Head-to-Head vs. deucravacitinib Start Target Filling zasocitinib Psoriatic Arthritis Psoriatic Arthritis (TAK-279)
Slide 16: TAK-861 Potential to Address Patient Needs Across NT1
TAK-861 has the Potential to Address Patient Needs Across Multiple Symptoms and the Overall Disease Burden of NT1 TAK-861 Phase 2b: Optimized profile TAK-861 potential to be the first transformative therapy balances efficacy and safety to treat underlying NT1 pathophysiology Improvement in wakefulne
Slide 17: Mezagitamab Rapid and Sustained Improvement in ITP
Mezagitamab Showed Rapid and Sustained Improvement in Multiple Efficacy Measures of Durable Platelet Response through Week 16 in Patients with Immune Thrombocytopenia Mezagitamab Phase 2b data Immune Thrombocytopenia (ITP) Platelet response (PR) Complete PR 100 PC ≥50,000/µL and ≥20,000/µL 90.9 PC ≥
Slide 18: R&D Day: Focus on Late-Stage Pipeline and Market Opportunity
R&D Day: Focus on Late-Stage Pipeline and Market Opportunity R&D DAY: DECEMBER 12TH, 2024 THURSDAY (Evening ET) FOCUS ON LATE-STAGE PIPELINE DECEMBER 13TH, 2024 FRIDAY (Morning JST) AND MARKET OPPORTUNITY 18
Slide 19: Q&A Session
Q&A SESSION CHRISTOPHE WEBER Representative Director; MILANO FURUTA Director; ANDY PLUMP Director; President, J ULIE KIM President, US Business Unit President & CEO Chief Financial Officer Research & Development
Slide 20: Appendix
APPENDIX
Slide 21: ENTYVIO Growth Driven by Increasing Momentum of the Pen
G AST R OENT ER OL OG Y ( G I) ENTYVIO Growth Driven by Increasing Momentum of the Pen GI PORTFOLIO FY2024 Q1 Revenue JPY 234.4B (+7.6% growth) FY 2024 Q 1 R E V E NUE (BN JPY) • ENTYVIO growth continues to outperform the overall IBD market • In the U.S., ENTYVIO maintains the lead as #1 brand in bo
Slide 22: Sustained TAKHZYRO Momentum; LIVTENCITY Market Penetration
R AR E D ISEASES Sustained TAKHZYRO Momentum with Double-Digit Growth LIVTENCITY Strong Market Penetration in U.S. & Rapid Geographical Expansion RARE DISEASES PORTFOLIO FY2024 Q1 Revenue JPY 56.0B (+19.8% growth) FY 2024 Q 1 R E V E NUE • TAKHZYRO continues to be the #1 prescribed modern long-term
Slide 23: PDT Portfolio Continues to Deliver Outstanding Growth
P L ASM A - D ER IVED T H ER AP IES PDT Portfolio Continues to Deliver Outstanding Growth Fueled By Sales of Immunoglobulin Products Immunoglobulin Albumin PDT PORTFOLIO FY 2024 Q 1 R E V E NUE FY24 Q1 Revenue JPY 201.5B (+21.9% growth) FY24 Q1 Revenue JPY 29.4B (-14.2% change) (BN JPY) • Strong dem
Slide 24: Growth Across Key Brands in Oncology Marketed Portfolio
ONC OL OG Y Growth Across Key Brands in Oncology Marketed Portfolio ONCOLOGY PORTFOLIO FY 2024 Q 1 R E V E NUE FY2024 Q1 Revenue JPY 11.9B (Newly Launched) (BN JPY) • Continued strong uptake following U.S. FDA approval in November 2023 for metastatic colorectal cancer (mCRC) patients previously trea
Slide 25: QDENGA Demand Exceeding Expectations
VAC C INES QDENGA Demand Exceeding Expectations; Driving Awareness and Access VACCIN ES P O RTFO LIO FY2024 Q1 Revenue JPY 9.5B (+1,099% growth) FY 2024 Q 1 R E V E NUE (BN JPY) • Strong global demand: now available in 21 countries, including 17 European countries with travel recommendations to supp
Slide 26: VYVANSE U.S. Loss of Exclusivity Impact from August 2023
NEU R OSC IENC E VYVANSE U.S. Loss of Exclusivity Impact from August 2023 N EURO SCIENCE P O RTFOL IO FY2024 Q1 Revenue JPY 114.6B (-17.9% change) FY 2024 Q 1 R E V E NUE • U.S. revenue declined -32.0% at 12 Vyvanse Weekly Volume (million units)1 百万 (BN JPY) CER in Q1, impacted by Loss of Exclusivit
Slide 27: Pipeline Milestones for Early to Mid-Stage Programs
Impactful Pipeline Milestones for Early to Mid-Stage Programs Advance Science and Address Unmet Patient Needs FY24 FY25 Celiac Disease TAK-227 Phase 2b GASTROINTESTINAL AND INFLAMMATION Lupus Nephritis TAK-007 Proof-of-Mechanism in (CAR-NK Platform) Autoimmune Disease danavorexton Postanesthesia Rec
Slide 28: Important Near-Term LCM Expansions
Important Near-Term LCM Expansions Represent Significant Growth Opportunities FY24 FY25 GASTROINTESTINAL maralixibat ENTYVIO AND INFLAMMATION Filed ALGS, PFIC (Japan) Target Filing Crohn’s/UC Peds (US, EU) ADCETRIS Filed FL HL BrECADD (EU)1 ONCOLOGY CABOMETYX Target Filing CRPC (Japan) HYQVIA Target
Slide 29: Potential NME Approvals and Indication Expansions in FY24
Potential NME Approvals and Indication Expansions in FY24 ENTYVIO SC Crohn’s disease U.S. approval QDENGA Dengue vaccine Additional endemic countries1 ADZYNMA cTTP EU approval KEY POTENTIAL EU approval FRUZAQLA mCRC REGULATORY JP approval APPROVALS LIVTENCITY Refractory post-transplant CMV infection
Slide 30: Consolidated Development Pipeline by Phase
Consolidated Development Pipeline by Phase PHASE 3 (6 NMEs + 15 LCMs) FILED (2 NME + 7 LCMs) zasocitinib ADZYNMA® ADZYNMA® TAK-279 rusfertide cTTP (CN) fazirsiran cTTP (EU) Polycythemia Vera AATD Liver Disease Psoriasis GASTROINTESTINAL AND INFLAMMATION ALOFISEL® ENTYVIO® ENTYVIO® ENTYVIO® Pediatric
Slide 31: Consolidated Development Pipeline by Phase
Consolidated Development Pipeline by Phase PHASE 1 (5 NMEs + 1 LCM) PHASE 2 (12 NMEs) mezagitamab zasocitinib zasocitinib TAK-101 ADZYNMA® IgAN TAK-279 TAK-279 Celiac Disease iTTP Psoriatic Arthritis Crohn’s Disease GASTROINTESTINAL AND INFLAMMATION zasocitinib TAK-227 zamaglutenase mezagitamab TAK-
Slide 32: Advancing Zasocitinib (TAK-279) In Parallel Across Multiple Indications
Advancing Zasocitinib (TAK-279) In Parallel Across Multiple Indications Phase 2 Start Phase 2b Readout Phase 3 Target Filing Ph2b March 2023 Ph3 Start FY23 FY26-27 Psoriasis Head-to-Head Start FY24/25 Psoriatic Arthritis Ph2b September 2023 Ph3 Start FY24 Crohn’s Disease Ph2b March 2024 Zasocitinib
Slide 33: Continuing Evidence Generation and Indication Expansion
Continuing Evidence Generation and Indication Expansion PHASE 3 PHASE 3b / 4 PUBLISHED APPROVED ENTYVIO® IV ENTYVIO® IV (VERDICT) ENTYVIO® IV (VARSITY) ENTYVIO® IV Pediatric (Global) (Global)3,4 ENT vs. ada1 (Global) Ulcerative colitis ENTYVIO® IV (EXIGEM) ENTYVIO® SC ENT + tof (US/Can)3 (US, EU, JP
Slide 34: Glossary of Abbreviations
Glossary of Abbreviations Regional Abbreviations: EGFR epidermal growth factor receptor LGS Lennox-Gastaut syndrome PNS Peripheral Nerve Society CN: China; EU: Europe; JP: Japan; UK: United Kingdom; U.S.: EMA European Medicines Agency LS least square POC proof of concept United States of America ESS
Slide 35: Financial Appendix
FINANCIAL APPENDIX Definition of Non-IFRS Measures Definition and Explanation of Non-IFRS Measures and U.S. Dollar Convenience Translations A-1 Reconciliations and Other Financial Information FY2024 Q1 Reported Results with CER % Change A-4 FY2024 Q1 Core Results with CER % Change A-5 FY2024 Q1 Reco
Slide 36: Definition and Explanation of Non-IFRS Measures
Definition and Explanation of Non-IFRS Measures and U.S. Dollar Convenience Translations Core Financial Measures Takeda’s Core Financial Measures, particularly Core Revenue, Core Operating Profit, Core Net Profit for the Year attributable to owners of the Company and Core EPS, exclude revenue from d
Slide 37: Free Cash Flow and Adjusted Free Cash Flow
Free Cash Flow and Adjusted Free Cash Flow Takeda defines Free Cash Flow as cash flows from operating activities less acquisition of property, plant and equipment (“PP&E”). Takeda defines Adjusted Free Cash Flow as cash flows from operating activities, subtracting payments for acquisition of PP&E, i
Slide 38: Net Debt and Adjusted Net Debt
Net Debt and Adjusted Net Debt Takeda defines Net Debt as the book value of bonds and loans on consolidated statements of financial position adjusted only for cash and cash equivalents, and Adjusted Net Debt first by calculating the sum of the current and non-current portions of bonds and loans as s
Slide 39: FY2024 Q1 Reported Results with CER % Change
FY2024 Q1 Reported Results with CER % Change vs. PY (Million USD, except EPS) FY2023 FY2024 AER CER (Billion JPY, except EPS) FY2024 Q1 Q1 Q1 Convenience Amount of Change % CHANGE % CHANGE USD Translation Revenue 1,058.6 1,208.0 149.4 14.1% 2.1% 7,509 Cost of sales (321.1) (387.0) (65.8) (20.5)% (8.
Slide 40: FY2024 Q1 Core Results with CER % Change
FY2024 Q1 Core Results with CER % Change vs. PY (Million USD, except EPS) FY2023 FY2024 AER CER (Billion JPY, except EPS) FY2024 Q1 Q1 Q1 Convenience Amount of Change % CHANGE % CHANGE USD Translation Revenue 1,058.6 1,208.0 149.4 14.1% 2.1% 7,509 Cost of sales (321.2) (387.1) (65.8) (20.5)% (8.1)%
Slide 41: FY2024 Q1 Reconciliation from Reported to Core
FY2024 Q1 Reconciliation from Reported to Core REPORTED TO CORE ADJUSTMENTS (Billion JPY, except EPS and number of shares) REPORTED Amortization of Impairment of Other CORE intangible intangible operating income/ Others assets assets expenses Revenue 1,208.0 1,208.0 Cost of sales (387.0) (0.1) (387.
Slide 42: FY2023 Q1 Reconciliation from Reported to Core
FY2023 Q1 Reconciliation from Reported to Core REPORTED TO CORE ADJUSTMENTS (Billion JPY, except EPS and number of shares) REPORTED Amortization of Impairment of Other CORE intangible intangible operating income/ Others assets assets expenses Revenue 1,058.6 1,058.6 Cost of sales (321.1) (0.1) (321.
Slide 43: FY2024 Q1 Adjusted Free Cash Flow
FY2024 Q1 Adjusted Free Cash Flow (Million USD) FY2023 FY2024 FY2024 Q1 (Billion JPY) vs. PY Q1 Q1 Convenience USD Translation Net profit 89.4 95.3 5.9 6.6 % 592 Depreciation, amortization and impairment loss 179.3 218.2 38.9 1,356 Decrease (increase) in trade working capital (153.6) (95.3) 58.3 (59
Slide 44: FY2024 Q1 Adjusted Net Debt to Adjusted EBITDA
FY2024 Q1 Adjusted Net Debt to Adjusted EBITDA NET DEBT/ADJUSTED EBITDA RATIO NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS FY2024 FY2023 FY2024 (Billion JPY) Q1 (Billion JPY) vs. PY Q1 Q1 Book value of bonds and loans on consolidated statements of Net cash from operating activities (Operatin
Slide 45: FY2023 Adjusted Net Debt to Adjusted EBITDA
FY2023 Adjusted Net Debt to Adjusted EBITDA NET DEBT/ADJUSTED EBITDA RATIO NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (Billion JPY) FY2023 (Billion JPY) FY2022 FY2023 vs. PY Book value of bonds and loans on consolidated statements of Net cash from operating activities (Operating Cash Flow)
Slide 46: FY2024 Q1 Net Profit to Adjusted EBITDA Bridge
FY2024 Q1 Net Profit to Adjusted EBITDA Bridge FY2023 FY2024 (Billion JPY) vs. PY Q1 Q1 Net profit 89.4 95.3 5.9 6.6 % Income tax (expenses) benefit 45.6 41.3 Depreciation and amortization 171.5 192.2 Interest expense, net 26.6 26.6 EBITDA 333.2 355.4 22.2 6.7 % Impairment losses 7.8 26.0 Other oper
Slide 47: FY2024 Q1 Net Profit to Adjusted EBITDA LTM Bridge
FY2024 Q1 Net Profit to Adjusted EBITDA LTM Bridge FY2023 FY2023 FY2024 FY2024 (Billion JPY) Full Year Q1 Q1 Q1 LTM*1 (Apr - Mar) (Apr - Jun) (Apr - Jun) (Jul - Jun) Net profit 144.2 89.4 95.3 150.1 Income tax (expenses) benefit (91.4) 45.6 41.3 (95.7) Depreciation and amortization 728.0 171.5 192.2
Slide 48: FY2024 Q1 CAPEX, Depreciation and Amortization and Impairment Losses
FY2024 Q1 CAPEX, Depreciation and Amortization and Impairment Losses FY2023 FY2024 (Billion JPY) vs. PY FY2024 Forecast Q1 Q1 Capital expenditures*1 269.2 137.8 (131.4) (48.8)% 380.0 - 420.0 Tangible assets 46.0 57.4 11.5 25.0 % Intangible assets 223.3 80.4 (142.9) (64.0)% Depreciation and amortizat
Slide 49: FY2024 Full Year Detailed Forecast
FY2024 Full Year Detailed Forecast FY2023 FY2024 (BN JPY) Forecast vs. PY Variances Actual (May 9, 2024) Momentum of Growth & Launch products and FX benefit largely offset by LOE impact Revenue 4,263.8 4,350.0 86.2 2.0 % (mainly VYVANSE) Cost of sales (1,426.7) (1,500.0) (73.3) (5.1)% Gross Profit 2
Slide 50: FY2024 Full Year Reconciliation from Reported to Core Operating Profit Forecast
FY2024 Full Year Reconciliation from Reported Operating Profit to Core Operating Profit Forecast REPORTED TO CORE ADJUSTMENTS Other operating (Billion JPY) REPORTED Amortization of Impairment of CORE income (expenses) intangible intangible and other assets assets adjustments Revenue 4,350.0 4,350.0
Slide 51: FY2024 FX Rates Assumptions and Currency Sensitivity
FY2024 Full Year FX Rates Assumptions and Currency Sensitivity vs. Forecast Average Exchange Rates vs. JPY Impact of depreciation of yen from April 2024 to March 2025 (100 million JPY) Core FY2023 FY2024 FY2024 Operating Revenue Net Profit Operating Actual Actual Assumption Profit (IFRS) (IFRS) Prof
Slide 52: Takeda Investor Relations
Takeda Investor Relations: takeda.ir.contact@takeda.com © 2024 Takeda Pharmaceutical Company Limited. All rights reserved.
Takeda Pharmaceutical Company — Q1 2024 Earnings Presentation on 6ix