Financial Data and Key Metrics - Revenue grew by 2.1% at constant exchange rate (CER) in Q1, driven by strong performance of Growth & Launch Products, which grew 17.8% at CER and now represent 46% of total revenue [3][4] - Core operating profit margin was 31.6% in Q1, benefiting from phasing of R&D investment, reduction in other OpEx, and temporarily lower-than-anticipated generic erosion of VYVANSE in the U.S. [4] - Reported operating profit declined by 1.3% to JPY 166.3 billion, impacted by restructuring expenses and impairment of soticlestat after Phase III study readouts [7] - Core EPS was JPY 176, while reported EPS was JPY 61 [8] - Operating cash flow was JPY 170.3 billion, and adjusted free cash flow was JPY 23.7 billion, reflecting significant business development activity [8] Business Line Performance - ENTYVIO growth accelerated to 7.6% at CER, supported by the launch of ENTYVIO Pen in the U.S., with 2 out of 3 patients having access as of July [10] - TAKHZYRO grew 19.8% at CER, capitalizing on its leading position in the expanding prophylaxis market for hereditary angioedema (HAE) [10] - Immunoglobulin portfolio grew 21.9%, while albumin declined 14.2% due to anticipated phasing of supply to China, with recovery expected later in the year [10] - FRUZAQLA and QDENGA showed strong initial uptake, with FRUZAQLA generating JPY 11.9 million in revenue and QDENGA now available in 21 countries [11] Market Performance - Growth & Launch Products grew 17.8% at CER, offsetting the loss of exclusivity impact from products like VYVANSE in the U.S. and AZILVA in Japan [9] - The depreciation of the yen versus major currencies provided an additional revenue tailwind of JPY 127.2 billion, resulting in 14.1% growth on an actual FX basis [9] - QDENGA saw strong demand in both endemic and non-endemic markets, with WHO pre-qualification and Gavi support expected to drive further awareness and access [11] Strategic Direction and Industry Competition - The company is focused on improving core operating profit margin through a multiyear efficiency program, targeting organizational agility, procurement savings, and leveraging data, digital, and technology [5] - Two option agreements were signed for mid- and late-stage programs: olverembatinib for chronic myeloid leukemia and ACI-24.060 for Alzheimer’s disease, complementing the existing pipeline [6] - The company is advancing its R&D pipeline, with significant opportunities in zasocitinib (TYK2 inhibitor) and TAK-861 (orexin 2 receptor agonist), both poised for near-term Phase III readouts [17] Management Commentary on Operating Environment and Future Outlook - Management expects VYVANSE generic erosion to align with projections in the coming quarters, while R&D investment will increase as multiple programs move into Phase III [4][12] - The company remains committed to transforming patients' lives while driving long-term business growth and profitability [6] - The full-year FY 2024 outlook remains unchanged, with continued monitoring of VYVANSE generic erosion, portfolio performance, and FX rates [13] Other Important Information - The company issued a new hybrid bond of JPY 460 billion in June and executed USD 3 billion of debt financing in July, both aimed at refinancing existing debt and smoothing out the debt maturity ladder [14] - The company introduced the term "adjusted free cash flow" in FY 2024, with the calculation remaining consistent with the previous year's free cash flow metric [8] Q&A Session Summary VYVANSE Generic Erosion and Plasma Business - VYVANSE demand declined by over 30% year-over-year, with further erosion expected as generic supply improves [27] - The plasma business saw strong growth, with donor fees remaining stable and margins improving due to optimized supply chain and manufacturing capacity utilization [28] Pipeline and Partnerships - The company ended its partnership with JCR for Hunter syndrome candidate JR-141 as part of pipeline prioritization [30] - The deal with AC Immune for Alzheimer’s disease reflects confidence in the amyloid beta target, with potential for earlier intervention and improved efficacy [31][32] ENTYVIO Growth and Market Share - ENTYVIO is expected to accelerate growth in the second half of the year, driven by improved access and the recent approval of the Crohn’s indication for ENTYVIO Pen [38][40] - The company maintains its leadership in first-line bio-naive IBD patients, with SKYRIZI impacting second-line and beyond [47] R&D Efficiency and Biosimilar Threats - The R&D organization is undergoing restructuring to improve productivity, with a focus on automation and leveraging data, digital, and technology [54][56] - The company expects ENTYVIO biosimilars to enter the market no earlier than 2030-2032, with no change to current assumptions [58] QDENGA and Immunoglobulin Performance - QDENGA is off to a strong start, with demand exceeding supply capacity, and the company is ramping up manufacturing to meet demand [61] - Immunoglobulin growth was strong in Q1, driven by the approval of CIDP indications and continued demand in primary immune deficiency markets [64][68] TYK2 Inhibitor and Competitive Landscape - The company believes TAK-279 has a differentiated profile and strong potential in IBD, with Phase III trials expected to read out in 2026 [43][44] - The slow uptake of BMS’s TYK2 inhibitor is not seen as indicative of TAK-279’s potential, given its differentiated profile and commercial strategy [67]

Core Insights - Takeda Pharmaceutical Company is showing signs of improvement despite previous revenue declines in key areas, with a focus on its "return to growth program" aimed at operational optimization and financial stability [2][4][17] - The company has seen revenue increases in the gastrointestinal and inflammation sectors, with significant contributions from products like Entyvio [9][10] - Takeda's long-term forecast appears brighter, but projections for FY2024 remain unfavorable, leading to a "Hold" rating for the stock [2][24] Business Overview - Takeda is one of Japan's largest pharmaceutical companies, with a diverse portfolio that includes oncology, gastrointestinal and inflammation, rare diseases, plasma-derived therapies, vaccines, and neurosciences [3] - The company has a large list of commercial products and a robust pipeline of candidates, with recent advancements in clinical trials and product approvals [2][3] Financial Performance - FY2023 was disappointing for Takeda, with a 54.51% decline in net profits despite a 5.86% increase in total revenues year-over-year [17][18] - The company reported a 10.9% increase in net debt, primarily due to refinancing efforts related to the acquisition of Shire [18] - For FY2024, Takeda expects flat or slightly declining total revenues, with a projected 10% decline in operating profits and mid-teens percentage decline in EPS [18][20] Product Performance - The gastrointestinal and inflammation sector is the largest revenue driver, with FY2023 revenues of JPY 1,216.2 billion, an 11.1% increase year-over-year [9] - The rare diseases sector generated JPY 770 billion in FY2023, with Takhzyro and Advate being significant contributors [11] - The oncology sector reported revenues of JPY 462.4 billion, with mixed performance across products, including a notable decline in Velcade [15] Strategic Initiatives - The "returning to growth program" aims to improve operating margins by 100-250 basis points annually from FY2025 onwards, leveraging AI to optimize operations [5][6] - The program is expected to carry a cost of JPY 140 billion in 2024, approximately $894 million, with anticipated improvements in product launches and clinical trial efficiencies [6][20] Market Outlook - Takeda's management anticipates that new product launches will account for 50% of revenues in FY2024, offsetting losses from declining sales of Vyvanse [20] - The company is focusing on expanding its vaccine portfolio, particularly with Qdenga, which is expected to see significant revenue growth [16] - Despite positive developments, the overall performance in FY2024 is not sufficient to justify a rating upgrade, maintaining a "Hold" rating for the stock [24][27]

115 The following table shows the number of shares as of March 31, 2024 owned by directors of the Company as of the date of this annual report. Table of Contents F. Disclosure of a Registrant's Action to Recover Erroneously Awarded Compensation Not applicable. A. Major Shareholders B. Related Party Transactions C. Interests of Experts and Counsel Our audited consolidated financial statements are included under "Item 18—Financial Statements." Takeda's policy in the allocation of capital is as follows: • Inve ...

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 TAKEDA PHARMACEUTICAL COMPANY LIMITED (Translation of registrant's name into English) Form 20-F ☒ Form 40-F ☐ Exhibit Number Norimasa Takeda Chief Accounting Officer and Corporate Controller News Release U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Commission File Number: 001-38757 Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or ...

1 Preface 2 Scope and Methodology 2.1 Objectives of the Study 2.2 Stakeholders 2.3 Data Sources 2.3.1 Primary Sources 2.3.2 Secondary Sources 2.4 Market Estimation 2.4.1 Bottom-Up Approach 2.4.2 Top-Down Approach 2.5 Forecasting Methodology 3 Executive Summary 4 Celiac Disease - Introduction 4.1 Overview 4.2 Regulatory Process This report also provides a detailed analysis of the current celiac disease marketed drugs and late-stage pipeline drugs. Drug Overview Mechanism of Action Regulatory Status Clinical ...

Takeda Pharmaceutical Company Limited (NYSE:TAK) Fiscal Year 2023 Earnings Conference Call May 9, 2024 6:00 AM ET Company Participants Christopher O’Reilly – Head-Investor Relations Christophe Weber – President and Chief Executive Officer Andy Plump – President of R&D Milano Furuta – Chief Financial Officer Ramona Sequeira – President of Global Portfolio Division Julie Kim – President of U.S. Business Unit Giles Platford – President, PDT Business Unit Conference Call Participants Steve Barker – Jefferies Hi ...

The most closely comparable measure presented in accordance with IFRS is net profit for the period. Please refer to Net Profit to Adjusted EBITDA Bridge for a reconciliation to the respective most closely comparable measures presented in accordance with IFRS. The most directly comparable measures under IFRS for Net Debt is bonds and loans. Please refer to Net Debt to Adjusted EBITDA for a reconciliation to this measure. A-3 When comparing results to the same period of the previous fiscal year, the amount of ...

Table of Contents FORM 6-K U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________________ Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 Commission File Number: 001-38757 For the month of February 2024 ________________________________________ TAKEDA PHARMACEUTICAL COMPANY LIMITED (Translation of registrant's name into English) ________________________________________ 1-1, Nihonbashi-Honcho 2-Chome Chuo-ku, To ...

On oncology, if we can bring new assets like [Indiscernible] fruquintinib that we just in-licensed, that would be terrific. So we are looking at this type of deals to complement our portfolio. We have a very attractive pipeline, but it's more mid-stage. So many of these products in our pipeline will be launched towards the end of the decade. So if we can bring more assets to enrich our portfolio, we'll do. Unidentified Company Representative Company Participants Conference Call Participants Christopher O'Re ...

 Our results at constant exchange rate are tracking well against our full year management guidance for fiscal year 2023 and there is no change to our guidance at this time. Looking ahead, we are continuing to work closely with the WHO and look forward to the release of the recommendation from SAGE, the WHO advisory group, which is anticipated later this year. I should also note the important notices are attached to the presentation material. We are proud of all this progress, which represents the potential ...