Investor Presentaiton

Made public by

sourced by PitchSend

11 of 23

Creator

PitchSend logo
PitchSend

Category

Pending

Published

Unknown

Slides

Transcriptions

#1Takeda Better Health, Brighter Future Presentation by Takeda President & CEO Christophe Weber at the 41st Annual J.P. Morgan Healthcare Conference OSAKA, JAPAN, January 10, 2023 - Christophe Weber, president and chief executive officer of Takeda (TSE:4502/NYSE:TAK), presented at the 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9 at 4:30 PM PST / Tuesday, January 10 at 9:30 AM JST, on the company's progress driven by its Growth and Launch Products, pipeline updates and continued commitment to long-term growth and shareholder return. Slides from the J.P. Morgan Healthcare Conference presentation, and a link to the audio webcast, can be accessed on Takeda's website at: https://www.takeda.com/investors/ir-events/ ### Media Contact: Jun Saito Investor Contact: [email protected] +81 (0) 3-3278-2325 Christopher O'Reilly [email protected] +81 (0) 3-3278-2306#2Committed to Long-term Growth & Shareholder Returns 41st Annual J.P. Morgan Healthcare Conference Christophe Weber President & CEO January 9th, 2023 Takeda Better Health, Brighter Future#3| Important Notice Takeda 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 (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or a pproval in any jurisdiction. No shares or other securities are being offered to the public by means of this presentation. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This presentation is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this presentation, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are a Iso used where no useful purpose is served by identifying the particular company or companies. The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners. Forward-Looking Statements This presentation and any materials distributed in connection with this presentation may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could", "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); the extent to which our internal energy conservation measures and future advancements in renewable energy or low carbon energy technology will enable us to reduce our greenhouse gas emissions; and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this presentation or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this presentation may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Financial Information and Certain Non-IFRS Financial Measures Takeda's financial statements are prepared in accordance with International Financial Reporting Standards ("IFRS"). This presentation and materials distributed in connection with this presentation include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit, Core EPS, and Constant Exchange Rate ("CER") change. Takeda's management evaluates results and makes operating and investment decisions using both I FRS and non-IFRS measures included in this presentation. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. By including these non-IFRS measures, management intends to provide investors with additional information to further analyze Takeda's performance and core results, including when controlling for the effect of fluctuations in exchange rates. Takeda's non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as "reported" measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS financial measures to their most directly comparable IFRS measures, which are in the financial appendix appearing at the end of this presentation. Exchange Rates In this presentation, certain amounts presented in Japanese yen have been translated to US dollars solely for the convenience of the reader. The rate and methodologies used for these convenience translations differ from the currency exchange rates and translation methodologies under IFRS used for the preparation of Takeda's consolidated financial statements. These translations should not be construed as a representation that the relevant Japanese yen amounts could be converted into U.S. dollars at this or any other rate. Medical information This presentation contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. 2#43 Better Health for People, Brighter Future for the World Takeda Our vision is to discover and deliver life-transforming treatments, guided by our commitment to: PATIENT • PEOPLE PLANET Responsibly translate • Accelerate access to improve lives worldwide • Create an exceptional people experience • Protect our planet science into highly medicines and vaccines innovative, life-changing ... AND BY UNLEASHING THE POWER OF DATA AND DIGITAL . • We strive to transform Takeda into the most trusted, science-driven, digital biopharmaceutical company We are guided by our values of Takeda-ism which incorporate Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient- Trust-Reputation-Business, in that order.#5| Growth & Launch Products Driving Topline & Profit Growth Strong FY2022 H1 Performance Takeda On Track to Full-year FY2022 Guidance st 4 Core Revenue +5.5% at CER1,2 Revenue Core EPS Core EPS +15.8% JPY 3,930B 525 yen at CER1,2 (USD $29.7B)³ (USD $3.97)³ Growth & Launch Products +19% at CER1,2 represent 38% of total revenue Core Operating Profit Margin 31.7% FY2022 MANAGEMENT GUIDANCE CORE REVENUE CORE OPERATING PROFIT CORE EPS GROWTH AT CER² Low-single-digit growth High-single-digit growth High-single-digit growth 1. Please refer to appendix slide 15 for definition of core financial measures and slides 16-19 for reconciliation. 2. Constant Exchange Rate. Please refer to appendix slide 15 for definition. 3. Forecast in USD given for reference using full-year FX rate assumption of 132.4 JPY/USD. This reflects H1 at actual FX and applies the Apr-Oct 2022 average rate to H2 projections.#65 Growth & Launch Products Revenue Grew +19% at CER in FY22 H1 (M) GI MM RARE DISEASES 0 PLASMA-DERIVED THERAPIES (PDT) IMMUNOLOGY ONCOLOGY NEUROSCIENCE Takeda OTHER Entyvio vedolizumab TAKHZYRO (lanadelumab-flyo) injection +31% +17% GROWTH & LAUNCH PRODUCTS ALOFISEL +33% HyQvia GAMMAGARDLIQUID [Immune Globulin Intravenous (Human)] 10% Human Normal Immunoglobulin (0%) Recombinant Human Hyaluronidase Cuvitru Immure Globulin Subcutaneous Human 20% IMMUNOGLOBULIN +17% LIVTENCITY™ tablets (maribavir) 200 New Launch Flexbumin (Human Albumin) HUMANALBUMIN ALBUMIN +8% ALUNBRIG BRIGATINIB 30 mg TABLETS +41% EXKIVITY mobocertinib 40 mg capsules New Launch ウイルスワクチン COVID-19 Vaccine spikevax Suspension for Intramuscular Injection (JP) ヌバキソビッド筋注 NuvaxovidⓇ (JP) Total FY2022 H1 Revenue 759.8B (USD 5.3B)¹ (+19% growth at CER) Ninlaro IclusigⓇ Adcetris (ex-N. America) Leuprorelin Advate/AdynoviⓇ OTHER KEY PRODUCTS Takecab/VocintiⓇ Gattex/RevestiveⓇ VonvendiⓇ Elaprase® VprivⓇ ReplagalⓇ(EU,JP) GlassiaⓇ AralastⓇ VyvanseⓇ Trintellix (US,JP) AzilvaⓇ (JP) Zejula (UP) CabometyxⓇ (JP) All growth rates indicate FY2022 H1 revenue growth at CER 1. Convenience translation at an exchange rate of 1USD = 144.71 JPY, the Noon Buying Rate certified by the Federal Reserve Bank of New York on September 30, 2022.#7• • • • 6 1234 1. Source: US: SHA Medical and Pharmacy Claims data, June 2022 2. 3. Sands BE, Peyrin-Biroulet L, Loftus EV, et al. Vedolizumab versus adalimumab for moderate to severe ulcerative colitis. N Engl J Med. 2019;381(13):1215–1226. Forecast in USD given for reference using full-year FY2022 FX rate assumption of 132.4 JPY/USD 4. Source: US: SHA Medical and Pharmacy Claims data, June 2022; EUCAN: Internal estimate; Japan: Japan Medical Data Center, June 2022 BN JPY 800 700 600 500 400 300 200 ENTYVIO REVENUE JPY 721.0B USD $5.4B 35% 30% 25% 20% 15% 10% 5% 0% 100 0 FY14 FY15 FY16 FY17 FY18 FY19 FY20 FY21 FY22 (Forecast³) Strong uptake of SC formulation in Europe & Canada Outstanding Growth Momentum Gut-selective alpha4beta7 integrin antagonist #1 prescribed biologic in IBD bio-naïve patients in the U.S." Head-to-head superiority versus adalimumab in UC² 1 >9 yrs of patient experience supports favorable safety profile • Jun-14 Sep-14 Dec-14 US Overall Share UC ... US Overall Share CD Mar-15 Jun-15 Sep-15 Dec-15 Mar-16 Jun-16 Sep-16 Dec-16 Mar-17 Jun-17 Sep-17 Dec-17 EUCAN Overall Share UC EUCAN Overall Share CD Mar-18 Jun-18 Sep-18 Dec-18 Mar-19 % OF PATIENTS RECEIVING ENTYVIO4 Jun-19 Sep-19 Dec-19 Mar-20 Jun-20 Japan Overall Share CD Japan Overall Share UC Sep-20 SC formulation regulatory filing in U.S. expected in FY2023 Continuing to invest in further evidence generation • Biologics market continues to expand globally • ENTYVIO total patient share still increasing Entyvio Peak Sales Estimate Raised to USD $7.5-9.0B Raised Peak Sales Reflect Growth Opportunity • Revised assumption on biosimilar entry timing High unmet patient need remains in IBD Dec-20 Mar-21 Jun-21 Sep-21 Dec-21 Mar-22 Jun-22 21.5% 19.6% 16.2% 28.8% 36.3% 3.7% Takeda#8PDT Portfolio Revenue Growth of +10-20% at CER Expected in FY22 Driven by Strong Demand and Stable Supply • CAPACITY EXPANSION Takeda Fastest and strongest post-pandemic recovery of donation volumes in the industry On track to increase plasma supply and manufacturing capacity >65% by end FY2023¹ • Dedicated R&D organization focused on maximizing potential of PDT R&D INVESTMENT • Positive Phase 3 data for HyQvia in CIDP . Improving efficiencies across the entire value chain to improve profitability MARGIN IMPROVEMENT • Reduced donor compensation by >15% in H1 FY2022 versus same period in prior year Enhancement of PDT operations is driving double-digit annual revenue growth for key PDT products PDT IMMUNOLOGY REVENUE GROWTH IMMUNOGLOBULIN REVENUE GROWTH (@CER) ALBUMIN REVENUE GROWTH (@CER) (@CER) +10-20% CAGR +11% CAGR +11% +10-20% CAGR +14% +10-20% FY2018 FY2021 FY2022 (projection) FY2018 FY2021 FY2022 (projection) FY2018 FY2021 FY2022 (projection) 7 1. Versus calendar year 2018 baseline#9| Strong Pipeline Progression Since FY22 Q2 Takeda Fm MM ASSET VACCINES QDENGA TAK-003 ONCOLOGY ICLUSIG ponatinib RARE GENETICS & HEMATOLOGY TAK-755 LIVTENCITY maribavir MILESTONE Approved in EU and Indonesia, and positive CHMP opinion for dengue-endemic countries that participated in EMA EU-M4all procedure 1L Ph+ ALL positive phase 3 PhALLCON trial Phase 3 trial interim analysis in cTTP: Favorable efficacy and safety profile versus standard of care 1L CMV infection in HSCT² phase 3 AURORA trial confirmed favorable safety and showed evidence of durable anti-viral efficacy NEXT STEPS Launch in Indonesia, Europe Seek additional approvals: US and endemic countries Data from this trial will be discussed with regulatory agencies and shared with the scientific community U.S. filing expected in FY22 CTTP: 2 case reports published in NEJM¹ Engaging regulatory agencies about filing strategy 12wk./16wk./20wk. data favorable for LIVTENCITY • • Favorable safety profile with lower incidence of neutropenia Did not achieve non-inferiority at 8 wk. 1' endpoint Phase 3 start expected in FY22 GASTRO- ENTEROLOGY fazirsiran TAK-999 AATD-LD positive phase 2b SEQUOIA trial ✓ NEURO- SCIENCE TAK-861 Met prespecified criteria to advance to Phase 2 1. 2. 8 N Engl J Med 2022; 387:2356-2361, N Engl J Med 2022; 387:2391-2392 HSCT: hematopoietic stem cell transplantation; Press release: www.takeda.com/newsroom/newsreleases For full glossary of abbreviations please refer to appendix. Phase 2b on-track to start in January 2023#109 • TM Qdenga™ Approved in Indonesia & EU for Prevention of Dengue Disease Dengue letravalent vaccine Against All Serotypes, Regardless of Prior Dengue Exposure (Live, Attenuated) Significant prevention of hospitalizations, an important factor for dengue fever management¹ Pivotal study in >20,000 children and adolescents in Latin America & Asia • 80.2% reduction in symptomatic dengue @ 12 months (primary endpoint); 90.4% reduction in hospitalizations @18 months (key secondary endpoint) • Continued protection through 4.5 years (exploratory analyses): • 61% reduction in symptomatic dengue and 84% reduction in hospitalizations No important safety risks identified² • • • Takeda Two approvals in 2022 and continuing regulatory progress around the world First approval in Indonesia in Aug 2022 for individuals 6-45 years of age Approved in EU in Dec 2022 for individuals 4 years of age and older, and positive CHMP opinion recommending use in dengue-endemic countries that participated in the EMA EU-M4all procedure Regulatory reviews progressing in dengue-endemic countries in Latin America & Asia Cumulative Incidence of Participants With Hospitalised Virologically Confirmed Dengue, % 2.51 2.0- 1.5- 1.0- 0.5- 84% reduction of hospitalized cases 0 0 3 69 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 Placebo, seropositive Time Since First Vaccination, Months Placebo, seronegative TAK-003, seropositive TAK-003, seronegative • Granted priority review by U.S. FDA in November 2022 1.Tricou, V. Efficacy and Safety of Takeda's Tetravalent Dengue Vaccine Candidate (TAK-003) After 4.5 Years of Follow-Up. Presented at the 8th Northern European Conference of Travel Medicine; June 2022. 2. Most common adverse events were injection-site pruritus, bruising, and pyrexia EMA: European Medicines Agency#1110 Takeda to Acquire Late-Stage, Potential Best-in-Class, Oral Allosteric TYK2 Inhibitor NDI-034858 from Nimbus Therapeutics¹ • High Selectivity Allows for Greater Inhibition of TYK2 NDI-034858 is a novel, investigational, oral, allosteric inhibitor of tyrosine kinase 2 (TYK2) with high specificity for TYK2 over JAK1, JAK2, JAK3 kinases NDI-034858 Deucravacitinib TYK-2-JH2 binding KD 0.0034 nM 0.0045 nM JAK1-JH2 binding KD 5000 nM 0.49 nM Biochemical Selectivity 1.5 x 106 109 (Fold) Fold Selectivity (vs. 1.3 x 104 deucravacitinib) Source: Nimbus proprietary structure based computational modeling; side-by-side evaluation of biochemical potency of NDI-034858 and deucravacitinib (synthesized by Nimbus for nonclinical research purposes only). Potential for enhanced efficacy without introducing JAK-related toxicities Takeda • • Potential for Best-in-Class Profile Potential to demonstrate best-in-class efficacy, safety and convenience in multiple immune-mediated diseases, including psoriasis, Inflammatory Bowel Disease, psoriatic arthritis and lupus Phase 3 psoriasis study expected to start in 2023; potential for regulatory filing in FY25-27 IL-12 IL-23 IFNa/ẞ JAK2 TYK2 TYK2 JAK1 JAK2 TYK2 STAT 1-5 Source: Gangolli, et al. 2022. Characterization of pharmacokinetics, pharmacodynamics, tolerability and clinical activity in Phase 1 studies of the novel allosteric tyrosine kinase 2 (TYK2) inhibitor NDI-034858. 1. Transaction is expected to close before the end of FY2022, contingent on completion of review under antitrust laws#12| Committed to Long-term Growth & Shareholder Returns Takeda 11 Near-term (FY2022-2023) • Growth & Launch Products expected to mitigate near- term Loss of Exclusivities (e.g. VELCADE & VYVANSE) Medium-term (FY2024 - early 2030s) • Continued expansion of Growth & Launch Products • Late-stage pipeline launches • Limited LOE exposure until Entyvio biosimilars launch Long-term (FY2030s and beyond) • Additional contribution from clinical pipeline of ~40 NMES Robust research engine Continued Pipeline Enhancement Supported by a Solid Financial Foundation#13Q&A Takeda CHRISTOPHE WEBER Representative Director; President & CEO ANDY PLUMP Director; President, Research & Development COSTA SAROUKOS Director; Chief Financial Officer JULIE KIM President, US Business Unit TERESA BITETTI President, Global Oncology Business Unit#14APPENDIX Takeda#1514 Entyvio Any biosimilar that seeks to launch prior to 2032 would need to address vedolizumab potential infringement and/or the validity of all relevant patents Takeda Takeda has granted patents that cover various aspects of Entyvio, including formulation, dosing regimens and process for manufacturing. These patents are expected to expire in 2032 in the U.S. Potential scenario in the U.S. should patents be challenged in biosimilar litigation 2023 2024 2025 2026 2027 Clinical development timeline Regulatory Biosimilar clinical trials expected to take 3-4+ years review (~1 year) Legal proceedings Pre-litigation process 2028 2029 2030 2031 2032 Entyvio is only approved in IBD indications, for which clinical trials are typically longer and more challenging to complete than other auto-immune diseases which we have recently observed biosimilar manufacturers target In general, biosimilar litigation proceedings in the U.S. may take 3-5 years In the U.S., the biosimilar litigation process is triggered by FDA acceptance of a relevant aBLA Competitive Intelligence suggests Ph1 activity starting with biosimilar companies in China and Iran. However, no vedolizumab biosimilar Phase 1 clinical trial starts targeting the U.S., EU, or Japan markets has been publicly disclosed so far.#1615 Definition of Core Financial Measures and Constant Exchange Rate change Takeda Core Revenue represents revenue adjusted to exclude significant items unrelated to Takeda's core operations. Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda's core operations, such as non-recurring items, purchase accounting effects and transaction related costs. Core EPS represents net profit adjusted to exclude the impact of items excluded in the calculation of Core Operating Profit, and other non-operating items (e.g. amongst other items, fair value adjustments and the imputed financial charge related to contingent consideration) that are unusual, non-recurring in nature or unrelated to Takeda's ongoing operations and the tax effect of each of the adjustments, divided by the average outstanding shares (excluding treasury shares) of the reporting periods presented. CER (Constant Exchange Rate) change eliminates the effect of foreign exchange rates from year-over-year comparisons by translating Reported or Core results for the current period using corresponding exchange rates in the same period of the previous fiscal year.#1716 FY2022 H1 Reported Results with Actual and CER % Change vs. PY (Billion JPY) Revenue Cost of sales Gross profit Margin SG&A expenses R&D expenses FY2021 H1 FY2022 H1 1,794.4 1,974.8 180.3 ACTUAL % CHANGE 10.1% CER % CHANGE*¹ (2.3)% (517.1) (598.3) (81.3) (15.7)% (3.9)% 1,277.4 1,376.4 99.1 7.8% (4.8)% 71.2 % 69.7 % (1.5) pp (1.8) pp (431.9) (480.2) (48.4) (11.2)% 1.4% (254.1) (297.8) (43.7) (17.2)% (1.4)% Amortization of intangible assets associated with products (204.1) (240.8) (36.7) (18.0)% (1.1)% Impairment losses on intangible assets associated with products (1.5) (32.8) (31.4) (2,137.8)% (1,695.6)% Other operating income 19.5 13.5 (6.1) (31.0)% (36.9)% Other operating expenses (59.4) (83.4) (23.9) (40.2)% (22.0)% Operating profit 346.0 255.0 (91.0) (26.3)% (30.7)% Margin 19.3 % 12.9 % (6.4) pp (5.6) pp Finance income 46.9 Finance expenses (104.9) 75.7 (109.3) 28.8 61.4% 55.6% (4.3) (4.1)% (5.4)% Share of profit (loss) of investments accounted for using the equity method (3.5) (1.4) 2.2 61.3% 76.7% Profit before tax 284.4 220.0 (64.4) (22.6)% (29.2)% Income tax expenses Net profit for the period Non-controlling interests (100.7) 183.7 (53.3) 47.4 47.1% 44.1% 166.8 (17.0) (9.2)% (21.1)% (0.1) 0.0 0.1 Net profit attributable to owners of the Company Basic EPS (yen) 183.6 166.8 (16.9) (9.2)% (21.0)% 117.08 107.62 (9.46) (8.1)% (20.1)% *1 Please refer to page 15 definition of Core Financial Measures and Constant Exchange Rate change for the definition. Note: % change versus prior year is presented as positive when favorable to profits, and negative when unfavorable to profits. Takeda#18FY2022 H1 Core Results with Actual and CER % Change Takeda vs. PY (Billion JPY) FY2021 H1 FY2022 H1 Revenue Cost of sales Gross profit Margin SG&A expenses R&D expenses Operating profit Margin 1,661.4 (494.1) 1,974.8 313.4 ACTUAL % CHANGE 18.9% CER % CHANGE*1 5.5% (571.6) (77.4) (15.7)% (4.0)% 1,167.2 1,403.2 236.0 20.2% 6.2% 70.3 % 71.1 % 0.8 pp 0.4 pp (428.7) (480.5) (51.8) (12.1)% 0.6% (252.8) (297.5) (44.7) (17.7)% (1.8)% 485.7 625.2 139.4 28.7% 14.5% 29.2 % 31.7 % 2.4 pp 2.5 pp Finance income 31.7 32.6 0.9 2.9% 2.5% Finance expenses (90.1) (100.8) (10.7) (11.9)% (14.6)% Share of profit (loss) of investments accounted for using the equity method 2.8 2.7 (0.2) (6.1)% (5.6)% Profit before tax 430.1 559.6 129.5 30.1% 13.4% Income tax expenses (94.2) (112.9) (18.7) (19.9)% (10.0)% Net profit for the period 335.9 446.7 110.7 33.0% 14.4% Non-controlling interests Net profit attributable to owners the Company (0.1) 335.9 0.0 0.1 Basic EPS (yen) 214 446.7 288 110.8 33.0% 14.4% 74 34.6% 15.8% 17 17 *1 Please refer to page 15 definition of Core Financial Measures and Constant Exchange Rate change for the definition. Note: % change versus prior year is presented as positive when favorable to profits, and negative when unfavorable to profits.#1918 FY2022 H1 Reconciliation from Reported to Core (Billion JPY) REPORTED TO CORE ADJUSTMENTS REPORTED Amortization of intangible assets Other Impairment of operating intangible income/ assets expenses CORE Others Revenue Cost of sales Gross profit 1,974.8 (598.3) 1,376.4 SG&A expenses (480.2) R&D expenses (297.8) 1,974.8 26.8 (571.6) 26.8 1,403.2 (0.3) (480.5) 0.3 (297.5) Amortization of intangible assets associated with products (240.8) 240.8 Impairment losses on intangible assets associated with products (32.8) 32.8 Other operating income 13.5 (13.5) - Other operating expenses (83.4) 83.4 Operating profit 255.0 240.8 32.8 69.9 26.7 625.2 Margin 12.9% 31.7% Finance income and (expenses), net (33.6) (34.7) (68.3) Share of profit (loss) of investments accounted for using the equity method (1.4) 4.0 2.7 Profit before tax 220.0 240.8 32.8 69.9 (4.0) 559.6 Tax expenses (53.3) (51.5) (7.0) (13.1) 12.0 (112.9) Non-controlling interests 0.0 0.0 Net profit attributable to owners of the Company 166.8 189.3 25.8 56.8 8.0 446.7 EPS (yen) 108 288 Number of shares (millions) 1,549 1,549 Takeda#2019 FY2021 H1 Reconciliation from Reported to Core REPORTED TO CORE ADJUSTMENTS (Billion JPY) REPORTED Amortization Impairment of of intangible intangible assets assets Other operating income/ expenses Sale of Japan diabetes portfolio Irish Tax Assessment 1 CORE Others Revenue Cost of sales Gross profit 1,794.4 (133.0) 1,661.4 (517.1) 0.6 22.3 (494.1) 1,277.4 (132.4) 22.3 1,167.2 SG&A expenses (431.9) 1.0 2.1 (428.7) R&D expenses (254.1) 1.3 (252.8) Amortization of intangible assets associated with products (204.1) 204.1 Impairment losses on intangible assets associated with products (1.5) 1.5 Other operating income 19.5 (18.8) (0.7) Other operating expenses (59.4) 59.4 Operating profit 346.0 204.1 1.5 40.6 (131.4) 25.0 485.7 Margin 19.3% 29.2% Finance income and (expenses), net Share of profit (loss) of investments accounted for using the equity method (58.0) (0.4) (58.5) (3.5) 6.4 2.8 Profit before tax 284.4 Tax expenses (100.7) 204.1 (45.5) 1.5 40.6 (0.5) (11.5) (131.4) 40.2 31.0 430.1 63.7 (39.9) (94.2) Non-controlling interests (0.1) (0.1) Net profit attributable to owners of the Company EPS (yen) 183.6 158.6 0.9 29.2 (91.2) 63.7 (9.0) 335.9 117 214 Number of shares (millions) 1,568 1,568 *1 Tax charges of 63.7 billion JPY arising from the tax assessment involving Irish taxation ofthe breakfee Shire received from AbbVie in connection with the terminated offer to acquire Shire made by AbbVie in 2014, net of 0.5 billion JPY of associated tax benefit. Takeda#21GLOSSARY OF ABBREVIATIONS Takeda Regional Abbreviations: DS CN: China; EU: Europe; JP: Japan; US: United States of America DU AATD-LD a1-antitrypsin deficiency associated liver disease Dx Dravet syndrome duodenal ulcer Diagnosis LCM lifecycle management PK LGS Lennox-Gastaut syndrome PMDA pharmacokinetics Japan's Pharmaceuticals and Medical Devices Agency mAb monoclonal antibody POC proof of concept ADC antibody drug conjugate EE H erosive esophagitis healing MAOB monoamine oxidase B POGD ADHD attention deficit hyperactivity disorder EE M erosive esophagitis maintenance MDD major depressive disorder PONV AHA acquired hemophilia A EGFR epidermal growth factor receptor MG myasthenia gravis PRIME ALK anaplastic lymphoma kinase post-operative gastrointestinal dysfunction postoperative nausea and vomiting Priority medicines scheme by EMA EMA European Medicines Agency MLD metachromatic leukodystrophy PTCL ALCL anaplastic large-cell lymphoma peripheral T-cell lymphoma FDA the U.S. Food & Drug Administration MM multiple myeloma ALL acute lymphocytic leukemia FL front line PTH parathyroid hormone MMN multifocal motor neuropathy AML acute myeloid leukemia FSI first subject in R/R relapsed/refractory NBE New Biological Entity ASCT autologous stem cell transplant FY fiscal year RCC renal cell cancer NCE New Chemical Entity ARD acid-related diseases GERD gastroesophageal reflux disease RTK receptor tyrosine kinase ND newly diagnosed AVA Advanced Vial Access GI BBB blood brain barrier GU 29 gastrointestinal RTU ready to use NDA new drug application gastric ulcer SALCL Neg Negative BLA biologics license application GvHD graft versus host disease SBS systemic anaplastic large cell lymphoma short bowel syndrome NERD non-erosive reflux disease BMA bradykinin mediated angioedema HAE hereditary angioedema SC subcutaneous formulation NHL BTD breakthrough therapy designation non-Hodgkin lymphoma H2H head-to-head SCD sickle cell disease CAR-T chimeric antigen receptor-T NK natural killer HemA hemophilia A SCT CD Crohn's disease NME new molecular entity stem cell transplant HL Hodgkin lymphoma SID CHMP Committee for Medicinal Products for Human Use NMPA National Medical Products Administration secondary immunodeficiency HSCT hematopoietic stem cell transplant chronic inflammatory demyelinating NSCLC CIDP IBD poly radiculoneuropathy inflammatory bowel disease non-small cell lung cancer SLE systemic lupus erythematosus NSCT sq CLL chronic lymphocytic leukemia IgAN immunoglobulin A nephropathy non stem cell transplant squamous STING CML chronic myeloid leukemia H IH idiopathic hypersomnia NT1 or 2 CMV cytomegalovirus INCAT Inflammatory Neuropathy Cause and Treatment disability score ORR narcolepsy Type 1 or 2 overall response rate stimulator of interferon genes SUMO small ubiquitin-related modifier CNS central nervous system OSA obstructive sleep apnea TCE T-cell engager IND investigational new drug CPF complex perianal fistulas PARP poly (ADP-ribose) polymerase TESD treatment emergent sexual dysfunction iNHL indolent non-Hodgkin's lymphoma CRL complete response letter PAS prior approval supplement TKI ITP Immune thrombocytopenic purpura CRPC Castrate-resistant prostate cancer PCAB potassium competitive acid blocker TREM2 iTTP immune thrombotic thrombocytopenic purpura CTCL cutaneous T-cell lymphoma PCD protein C deficiency UC IV intravenous CTTP congenital thrombotic thrombocytopenic purpura PEX plasma exchange VCD tyrosine kinase inhibitor triggering receptor expressed on myeloid cells 2 ulcerative colitis virologically confirmed dengue iPSC induced pluripotent stem cells DEE developmental and epileptic encephalopathies Philadelphia chromosome-positive acute L-ASA low dose aspirin Ph+ ALL vWD von Willebrand disease DLBCL diffuse large B-cell lymphoma lymphoblastic leukemia VWF von Willebrand factor LSD lysosomal storage disorder PID primary immunodeficiency DOAC direct oral anti-coagulation 20 20#22Takeda Better Health, Brighter Future © 2023 Takeda Pharmaceutical Company Limited. All rights reserved.

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Q4 & FY22 - Investor Presentation image

Q4 & FY22 - Investor Presentation

Financial Services

FY23 Results - Investor Presentation image

FY23 Results - Investor Presentation

Financial Services

Ferocious - Plant Growth Optimizer image

Ferocious - Plant Growth Optimizer

Agriculture

Market Outlook and Operational Insights image

Market Outlook and Operational Insights

Metals and Mining

2023 Investor Presentation image

2023 Investor Presentation

Financial

Leveraging EdTech Across 3 Verticals image

Leveraging EdTech Across 3 Verticals

Technology

Axis 2.0 Digital Banking image

Axis 2.0 Digital Banking

Sustainability & Digital Solutions

Capital One’s acquisition of Discover image

Capital One’s acquisition of Discover

Mergers and Acquisitions