A. History and Development of the Company Takeda is a global R&D-driven biopharmaceutical company focused on discovering and delivering life-transforming treatments in our core therapeutic areas of gastrointestinal and inflammation, neuroscience and oncology, and through our plasma-derived therapies and vaccine business. Together with our partners, we strive to transform the patient experience and treatment paradigm for rare and more prevalent diseases through our robust pipeline. Integration of advanced technologies and AI across our value chain is making our business operations more effective and efficient, increasing innovation and allowing us to better serve our stakeholders. We have a presence in approximately 80 countries and regions, a network of manufacturing sites around the world, and major research centers in Japan and the United States. Commercially, we have a very significant presence in the United States, Japan and Europe, as well as a growing business in China. Our employees around the world are united by our purpose and grounded in the values that have defined us for more than two centuries. Our purpose is to contribute to better health for people and a brighter future for the world. We do this through the pursuit of our vision to discover and deliver life-transforming treatments, and our values ensure that the decisions we make consider all our stakeholders. We create long-term value for patients, shareholders and society while sustaining positive impact for our people, the communities we reach and the planet we share. Our 245-year history started in 1781, when Chobei Takeda began selling traditional Japanese and Chinese herbal medicines in Doshomachi, Osaka. After Japan’s Meiji Restoration opened the country to increased overseas trade in the late 1860s, we were one of the first companies to begin importing Western medicines into Japan. In 1895, we began our pharmaceutical manufacturing business, and our research division was formed in 1914, allowing us to begin to discover our own pharmaceutical products. In 1925, we were incorporated as Chobei Takeda & Co., Ltd. and our name was later changed to Takeda Pharmaceutical Company Limited. In 1949, our shares were listed on the Tokyo and Osaka stock exchanges. We began expanding into overseas markets in the 1960s; first in Asia and, subsequently, other markets around the world. We began enhancing our overseas business infrastructure in the late 1990s, with the formation of new subsidiaries in the U.S. and Europe. In 2008, we acquired a leading U.S. biopharmaceutical company in Millennium Pharmaceuticals, Inc. We leveraged the complementary strengths of Millennium and Takeda, with Millennium's innovative products, pipeline and expertise in oncology. Takeda also acquired Nycomed in 2011, with a strong presence in Europe and emerging markets. This allowed Takeda to expand to more than 70 markets and enhance our global sales structure in order to deliver pharmaceutical products to more patients around the world. These two large acquisitions within a short time span allowed Takeda to accelerate its globalization. In the period since 2014, our efforts have focused on enhancements to our R&D capabilities, prudent value-enhancing acquisition activities and post-acquisition integration. Specifically, Takeda implemented an R&D transformation process to diversify modalities in our research and actively engage with innovative ecosystems around the world in the form of partnerships. As examples of acquisition activities, in January 2019, we acquired Shire plc., bringing together Takeda and Shire’s complementary positions in gastroenterology and neuroscience, and establishing leading positions in rare diseases and PDT. In connection with our acquisition of Shire, our shares were listed on the New York Stock Exchange in the form of American Depositary Shares (ADSs), with each ADS representing a one-half interest in an ordinary share. Takeda continues to pursue prudent value-enhancing acquisitions and in February 2023, we acquired all shares of Nimbus Lakshmi, Inc., a subsidiary of Nimbus Therapeutics, LLC, which brought into our pipeline zasocitinib (TAK-279). Zasocitinib is a next-generation, highly selective oral TYK2 inhibitor with potential to demonstrate best-in-class efficacy, safety and convenience in the treatment of psoriasis as well as multiple other immune-mediated diseases, including inflammatory bowel disease and psoriatic arthritis. In December 2025, Takeda announced that zasocitinib met all primary and ranked secondary endpoints in two pivotal Phase 3 studies in patients with psoriasis, demonstrating rapid and durable skin clearance in a convenient once-daily pill with no fasting restrictions, and is currently on target to submit a New Drug Application with the FDA in calendar year 2026. With the continued progression of zasocitinib and other late-stage pipeline programs, Takeda has entered a new period focused on strategic pipeline investment, new product launches, efficiency improvements and shareholder returns. During the three fiscal years ended March 31, 2026, Takeda divested several businesses and assets in non-core areas. See “Item 5. Operating and Financial Review and Prospects—A. Operating Results” for further details on major businesses and assets acquired and divested. Our principal capital expenditures during the three fiscal years ended March 31, 2026, comprise our investment in, and acquisition of property, plant and equipment and intangible assets. In the fiscal years ended March 31, 2024, 2025 and 2026, we made capital expenditures (comprising the investment in, and acquisition of property, plant and equipment and intangible assets recorded on our consolidated statements of financial position) of JPY 496.7 billion, JPY 319.4 billion and JPY 426.9 billion, respectively, including the following highlights: •In the fiscal year ended March 31, 2024, we continued investing in our plasma collection center network, with the addition of 27 new centers to bring Takeda’s total global footprint to 260 centers. We also signed a worldwide license and collaboration agreement with Protagonist Therapeutics for the development and commercialization of rusfertide, an investigational injectable hepcidin mimetic peptide of the natural hormone hepcidin. In March 2025, the Phase 3 VERIFY trial evaluating rusfertide for the treatment of polycythemia vera (PV), met its primary endpoint and all key secondary endpoints. •In the fiscal year ended March 31, 2025, we continued investing in our plasma donation center network, with the addition of 15 new centers to bring Takeda’s total global footprint to 275 centers. We also signed an exclusive licensing agreement with Keros Therapeutics, Inc. to further develop, manufacture and commercialize elritercept, a late-stage investigational activin inhibitor designed to treat anemia associated with certain hematologic cancers, including myelodysplastic syndromes (MDS) and myelofibrosis (MF), worldwide outside of mainland China, Hong Kong and Macau. 22 Table of Contents •In the fiscal year ended March 31, 2026, plasma collection volume continued to grow, driven by the ramp-up of new plasma donation centers and optimization of our overall plasma donation network. This was further strengthened by our transformation initiatives, including the roll-out of our personalized nomogram program (Fresenius Kabi’s adaptive nomogram and Haemonetics Persona Nomogram), which drove efficiencies and improved productivity across our global network of more than 270 plasma donation centers in the U.S. and EU. We also entered into a license and collaboration agreement with Innovent Biologics, Inc. (“Innovent”) for the development, manufacturing and commercialization of two late-stage investigational medicines for solid tumors, IBI363 and IBI343, worldwide outside of China, Hong Kong, Macau and Taiwan. We currently have various capital expenditure projects in process, including the continued expansion of production capacity in our plasma manufacturing network and the projects described in Item 4.D. (Property, Plant and Equipment). We are primarily financing these projects with funds on hand. For additional information on our ongoing capital expenditure projects, see Note 10 and Note 12 to our audited consolidated financial statements. The address of our global head office is 1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan; telephone number: 81-3-3278-2111. Takeda’s agent in the U.S. in connection with this annual report, as well as its agent for service of process for its registration statements filed with the SEC, is Takeda Pharmaceuticals U.S.A., Inc., 500 Kendall Street, Cambridge, MA 02142 U.S.A., telephone number: 1-857-757-6000. The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. As a foreign private issuer, we are exempt from the rules under the Exchange Act prescribing the furnishing and content of proxy statements to shareholders. Our corporate website is www.takeda.com. B. Business Overview We are a global R&D-driven biopharmaceutical company focused on discovering and delivering life-transforming treatments in our core therapeutic areas of gastrointestinal and inflammation, neuroscience and oncology, as well as through our plasma-derived therapies and vaccines business. Our intent is to translate science into highly innovative life-transforming medicines. We have built an R&D engine focused on three core therapeutic areas, leveraging internal research and external partners in order to have access to different modalities like biologics or small molecules. We have a geographically diversified global business base and our prescription drugs are marketed worldwide. We have approximately 47,000 employees worldwide, and our culture is based on our values of Takeda-ism which incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. Our commercial efforts are focused on six key business areas of GI, Rare Diseases, PDT, Oncology, Vaccines and Neuroscience, which in the fiscal year ended March 31, 2026 accounted for 95.0% of our total revenue. We believe these business areas will drive our future revenue growth, and we will continue to make the necessary investments, as well as targeted acquisitions and divestitures, to further sharpen our focus and maximize the contributions of our portfolios in these areas. As of March 31, 2026, the following Growth & Launch Products have been our growth driver products in our key business areas: ENTYVIO, EOHILIA, TAKHZYRO, LIVTENCITY, ADZYNMA, Immunoglobulin products (including GAMMAGARD LIQUID/KIOVIG, HYQVIA and CUVITRU), Albumin products (including HUMAN ALBUMIN/FLEXBUMIN), FRUZAQLA, ALUNBRIG and QDENGA. Our R&D engine is focused on translating science into highly innovative, life-transforming medicines that make a critical difference to patients. Our R&D efforts focus on three core therapeutic areas: Gastrointestinal and Inflammation, Neuroscience, and Oncology. We also make targeted R&D investments in PDT. The R&D engine for our three core therapeutic areas are the largest component of our R&D investment and has produced exciting new molecular entities (“NMEs”) that represent potential best-in-class and/or first-in-class medicines in areas of high unmet medical need across our core therapeutic areas (Gastrointestinal and Inflammation, Neuroscience, and Oncology). Takeda is committed to developing therapies for both rare and more prevalent diseases, and many of the life-transforming medicines we are pursuing will treat rare diseases in our core therapeutic areas as well as in PDT. We are embracing data and digital technologies with the aim of improving the quality of innovation and accelerating execution. We seek to achieve a foundational shift that embeds AI into every stage of drug discovery, redesigning workflows to include automated, data-driven, predictive processes that accelerate innovation. We are also focused on our goals of optimizing our financial strength, delivering competitive margins and generating cash flows to invest in the business, to maintain a solid investment grade credit rating and to return cash to shareholders, while targeting increased productivity and efficiency across the whole enterprise through digitalization, automation and AI. In addition to these improvements, we also seek to improve operational efficiency across our organization through implementing transformational initiatives. On March 25, 2026, we announced that our Board of Directors had approved the next steps in our initiatives to enhance our long-term growth profile and accelerate launch execution, including through the streamlining of corporate functions and process simplifications through the use of advanced technologies. 23 Table of Contents The following is a summary of our principal products by business area. In GI, our principal products include: •ENTYVIO (vedolizumab), a treatment for moderate to severe ulcerative colitis (“UC”) and Crohn’s disease (“CD”). Sales of ENTYVIO have grown strongly since its launch in the U.S. and Europe in 2014, and it was our top selling product in the fiscal year ended March 31, 2026. ENTYVIO is now approved in more than 70 countries worldwide, with a subcutaneously administered formulation approved in the U.S., Europe and Japan. The subcutaneous formulation (ENTYVIO SC) continues to drive increased patient uptake due to its convenience and improved access. We also strive to maximize ENTYVIO’s potential by seeking approval in additional countries and further indications. In the fiscal year ended March 31, 2026, our revenue from ENTYVIO was JPY 958.0 billion. •GATTEX/REVESTIVE (teduglutide [rDNA origin]), a treatment for patients with short bowel syndrome (SBS) who are dependent on parenteral support. GATTEX/REVESTIVE has been launched in the U.S., Europe and Japan with adult and pediatric indications. In the fiscal year ended March 31, 2026, our revenue from GATTEX/REVESTIVE was JPY 145.7 billion. •TAKECAB/VOCINTI (vonoprazan fumarate), a treatment for acid-related diseases. TAKECAB was launched in Japan in 2015 and has achieved significant growth driven by its efficacy in reflux esophagitis and the prevention of recurrence of gastric and duodenal ulcers during low-dose aspirin administration. TAKECAB (Chinese brand name: VOCINTI) was approved for reflux esophagitis in 2019 in China. In the fiscal year ended March 31, 2026, our revenue from TAKECAB/VOCINTI was JPY 143.7 billion. •EOHILIA (budesonide oral suspension), a therapy for eosinophilic esophagitis (EoE). EOHILIA is a corticosteroid, and the first and only FDA-approved oral therapy indicated for 12 weeks of treatment in patients 11 years and older with EoE. EOHILIA was approved by the U.S. FDA in February of 2024 and subsequently launched. In the fiscal year ended March 31, 2026, our revenue from EOHILIA was JPY 8.8 billion. In Rare Diseases, our principal products are: •TAKHZYRO (lanadelumab-flyo), for the prevention of hereditary angioedema (HAE) attacks. TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein, an enzyme which is chronically uncontrolled in people with HAE. TAKHZYRO was approved for patients 12 years and older in both the U.S. and Europe in 2018, in China in 2020 and in Japan in 2022 and we are working to expand into further geographic areas. In 2023, TAKHZYRO was also approved by the FDA and the European Commission in patients aged 2 years and older, and in February 2025, an additional 2 mL pre-filled pen option for the product was approved by the EMA and Japan’s Ministry of Health, Labour and Welfare (“MHLW”) for subcutaneous administration in adolescents (aged 12 years and above) and adult patients with hereditary angioedema. In the fiscal year ended March 31, 2026, our revenue from TAKHZYRO was JPY 223.9 billion. •ADVATE (antihemophilic factor (recombinant)), a treatment for hemophilia A (congenital factor VIII deficiency) for control and prevention of bleeding episodes, for perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. In the fiscal year ended March 31, 2026, our revenue from ADVATE was JPY 105.5 billion. •ELAPRASE (idursulfase), an enzyme replacement therapy for the treatment of Hunter syndrome (also known as Mucopolysaccharidosis Type II or MPS II). In the fiscal year ended March 31, 2026, our revenue from ELAPRASE was JPY 100.5 billion. •REPLAGAL (agalsidase alfa), an enzyme replacement therapy for the treatment of Fabry disease, marketed outside of the U.S., and also approved in China in 2020. Additionally, Takeda has acquired the manufacturing and marketing approval and the marketing rights of REPLAGAL in Japan from Sumitomo Dainippon Pharma as of February 2022. Fabry disease is a rare, inherited genetic disorder resulting from a deficiency in the activity of the lysosomal enzyme alpha-galactosidase A, which is involved in the breakdown of fats. In the fiscal year ended March 31, 2026, our revenue from REPLAGAL was JPY 80.4 billion. •VPRIV (velaglucerase alfa), is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease. In the fiscal year ended March 31, 2026, our revenue from VPRIV was JPY 57.2 billion. •ADYNOVATE/ADYNOVI (antihemophilic factor (recombinant) [PEGylated]), an extended half-life recombinant factor VIII treatment for hemophilia A. ADYNOVATE/ADYNOVI uses the same manufacturing process as the standard half-life recombinant factor VIII therapy ADVATE, and adds a proven technology, PEGylation (a chemical process that prolongs the amount of time a compound remains in circulation, potentially allowing for fewer injections), which we exclusively licensed from Nektar Therapeutics. In the fiscal year ended March 31, 2026, our revenue from ADYNOVATE/ADYNOVI was JPY 56.7 billion. •LIVTENCITY (maribavir), a treatment for adults and pediatric patients (12 years and older and weighing at least 35 kg) for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, foscarnet or cidofovir. LIVTENCITY launched in the U.S. in December 2021, and was approved in Europe in November 2022, and China in December 2023. LIVTENCITY continues to show strong launch performance driven by fast uptake, rapid geographic expansion and positive market access trends indicating high unmet medical needs. In the fiscal year ended March 31, 2026, our revenue from LIVTENCITY was JPY 46.9 billion. •ADZYNMA (ADAMTS13, recombinant-krhn), a prophylactic and on-demand treatment of adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). ADZYNMA is the first and only FDA-approved recombinant ADAMTS13 (rADAMTS13) designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme. ADZYNMA (apadamtase alfa/cinaxadamtase alfa) has now also been approved in Japan for treatment of cTTP for individuals 12 years and older, and in Europe (EMA markets) for individual of all ages. In the fiscal year ended March 31, 2026, our revenue from 24 Table of Contents ADZYNMA was JPY 12.0 billion. In Plasma-Derived Therapies (PDT), our principal products are: •GAMMAGARD LIQUID/KIOVIG (Immune Globulin Intravenous (Human) 10%), a liquid formulation of the antibody replacement therapy immunoglobulin (IG), for the treatment of adult and pediatric patients two years or older with primary immunodeficiencies (PID) (administered either intravenously or subcutaneously), and adult patients with multifocal motor neuropathy (MMN) (administered intravenously). GAMMAGARD LIQUID was approved for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S. in January 2024. KIOVIG is the brand name used for GAMMAGARD LIQUID in many countries outside of the U.S.; KIOVIG is approved in Europe for multiple indications including CIDP. •HYQVIA (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase), a product consisting of human normal IG and recombinant human hyaluronidase (licensed from Halozyme). HYQVIA is the only subcutaneous IG treatment for PID patients with a dosing regimen that requires only one infusion up to once per month and one injection site per infusion to deliver a full therapeutic dose of IG. HYQVIA is approved in the U.S. for adults with PID, in Europe for patients with PID syndromes and myeloma or CLL with severe secondary hypogammaglobulinemia and recurrent infections and in Japan for patients with PID or secondary immunodeficiency (SID) with agammaglobulinemia or hypogammaglobulinemia. In January 2024, HYQVIA was approved for maintenance treatment in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S. and CIDP patients of all ages in Europe. •CUVITRU (Immune Globulin Subcutaneous (Human), 20% Solution), indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years and older. CUVITRU is also indicated in Europe for the treatment of certain secondary immunodeficiencies. CUVITRU is the only 20% subcutaneous IG treatment option without proline and with the ability to infuse up to 60 mL (12 grams) per site and 60 mL per hour, per site as tolerated, resulting in fewer infusion sites and shorter infusion durations compared to other conventional subcutaneous IG treatments. In the fiscal year ended March 31, 2026, the total revenue from our PDT immunology portfolio, including GAMMAGARD LIQUID/KIOVIG, HYQVIA and CUVITRU, was JPY 790.6 billion. •FLEXBUMIN (Human Albumin in a bag) and Human Albumin (glass), available as 5%, 20% and 25% solutions, indicated for hypovolemia, hypoalbuminemia due to general causes and burns, and for use during cardiopulmonary bypass surgery as a component of the pump prime. FLEXBUMIN 25% is also indicated for hypoalbuminemia associated with adult respiratory distress syndrome (ARDS) and nephrosis, and hemolytic disease of the newborn (HDN). In the fiscal year ended March 31, 2026, the total revenue from our albumin portfolio, including FLEXBUMIN and Human Albumin (glass) was JPY 140.3 billion. In Oncology, our principal products include: •ADCETRIS (brentuximab vedotin), an anti-cancer agent used to treat Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), has received marketing authorization in more than 70 countries worldwide and was approved in China in May 2020. Takeda jointly developed ADCETRIS with Seagen, Inc., now a wholly owned subsidiary of Pfizer Inc. (“Pfizer”), and has commercialization rights in countries outside the U.S. and Canada. In the fiscal year ended March 31, 2026, our revenue from ADCETRIS was JPY 140.2 billion. •LEUPLIN/ENANTONE (leuprorelin) is a treatment for hormone-responsive cancers such as prostate cancer or breast cancer in women, as well as children with central precocious puberty, women with endometriosis and infertility, and to improve anemia in women with uterine leiomyomata (fibroids). While leuprorelin is no longer protected by patent, there is limited generic competition due to manufacturing considerations. In the fiscal year ended March 31, 2026, our revenue from LEUPLIN/ENANTONE was JPY 120.8 billion. •NINLARO (ixazomib), the first oral proteasome inhibitor for the treatment of multiple myeloma (MM), was approved in the U.S. in 2015 for relapsed/refractory MM and was approved in Europe in 2016, in Japan in 2017 and in China in 2018. In Japan, NINLARO is also approved as a maintenance treatment for MM. In the fiscal year ended March 31, 2026, revenue from NINLARO was JPY 82.1 billion. •ICLUSIG (ponatinib),a tyrosine kinase inhibitor targeting BCR::ABL1 with indications across chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), received full approval in the U.S. in 2016 and subsequent U.S. approvals in expanded indications in 2020 and 2024. We have commercialization rights in the U.S. and Australia. Outside of the U.S. and Australia, ICLUSIG is marketed in over 60 markets by five authorized partners from whom Takeda receives varying levels of supply, royalty and milestone payments. In the fiscal year ended March 31, 2026, our revenue from ICLUSIG was JPY 75.0 billion. •FRUZAQLA (fruquintinib) is a treatment for adults with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. FRUZAQLA is approved in the U.S., EU, Japan and a number of other countries around the world as a selective oral inhibitor of all three VEGF receptors. Takeda has the exclusive worldwide license to further develop, commercialize and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. Fruquintinib is developed and marketed in China by HUTCHMED. In the fiscal year ended March 31, 2026, our revenue from FRUZAQLA was JPY 55.1 billion. •ALUNBRIG (brigatinib), an orally administered small molecule anaplastic lymphoma kinase (“ALK”) inhibitor used to treat ALK-positive non-small cell lung cancer (NSCLC), was granted accelerated approval for patients who have progressed on or are 25 Table of Contents intolerant to crizotinib in the U.S. in 2017, and marketing authorization for patients previously treated with crizotinib in the EU in 2018. The indication of ALUNBRIG was expanded to include newly diagnosed ALK-positive NSCLC patients in both the U.S. and the EU in 2020. ALUNBRIG was approved as a first and second-line therapy in Japan in January 2021. ALUNBRIG was also approved in China in March 2022. In the fiscal year ended March 31, 2026, our revenue from ALUNBRIG was JPY 36.9 billion. In Neuroscience, our principal products are: •VYVANSE/ELVANSE (lisdexamfetamine dimesylate), a stimulant medication indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients six years and older and for the treatment of moderate to severe binge eating disorder in adults. Sales declined in the U.S. since 2023, following the entry of generic competition. In the fiscal year ended March 31, 2026, our revenue from VYVANSE/ELVANSE was JPY 203.2 billion. •TRINTELLIX (vortioxetine), an antidepressant indicated for the treatment of major depressive disorder (MDD) in adults. TRINTELLIX was co-developed with H. Lundbeck A/S, and Takeda has commercialization rights in the U.S., where it was launched in 2014 and in Japan, where it was launched in 2019. In the fiscal year ended March 31, 2026, our revenue from TRINTELLIX was JPY 121.8 billion. In Vaccines, our principal product is: •QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]), a dengue vaccine that is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four dengue virus serotypes and is designed to protect against any of these serotypes. QDENGA is approved in over 40 countries, including endemic countries and travel markets. In the fiscal year ended March 31, 2026, our revenue from QDENGA was JPY 40.8 billion. For a breakdown of revenues by geographic region, see Note 4 to our audited consolidated financial statements. Research and Development Research and development expenses for the fiscal year ended March 31, 2026 were JPY 675.9 billion. Takeda does not report disaggregated R&D expenses, including by therapeutic area or clinical trial stage, as our R&D budget is determined on a company-wide basis and specific expenditures may be subject to re-allocation depending on development results and priorities. The research and development (R&D) of biopharmaceutical products is a lengthy and expensive process that can span more than 10 years. The process includes multiple studies to evaluate a product’s efficacy and safety, followed by submission to regulatory authorities who review the data and decide whether to grant marketing approval. Only a small number of therapeutic candidates pass such rigorous investigation and become available for use in clinical treatment. Once approved, there is ongoing R&D support for marketed products, including life-cycle management, medical affairs, and other investments. Clinical trials, which must comply with regional and international regulatory guidelines, generally take five to seven years or longer, and require substantial expenditures. In general, clinical trials are performed in accordance with the guidelines set by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The relevant regional regulatory authorities are the Food and Drug Administration (FDA) for the United States, the European Medicines Agency (EMA) for the EU, the Ministry of Health, Labour and Welfare (MHLW) for Japan and National Medical Products Administration (NMPA) for China. The three phases of human clinical trials, which may overlap with each other, are as follows: Phase 1 clinical trials Conducted using a small group of healthy adult volunteers in order to evaluate safety and absorption, distribution, metabolism and excretion of the drug. Phase 2 clinical trials Conducted using a small group of patient volunteers in order to evaluate safety, efficacy, dosage and administration methods. Phase 2 clinical trials may be divided into two sub-categories, Phase 2a and Phase 2b. Phase 2a are usually pilot studies designed to demonstrate clinical efficacy or biological activity. Phase 2b studies look to find the optimum dose at which the drug shows biological activity with minimal side-effects. Phase 3 clinical trials Conducted using a large number of patient volunteers in order to evaluate safety and efficacy in comparison to other medications already available or placebo. Of these three phases, Phase 3 requires the largest expenditures and thus the decision to proceed with Phase 3 testing is a critical business decision in the drug development process. For those drug candidates that pass Phase 3 clinical trials, a New Drug Application (“NDA”), Biologics License Application (“BLA”) or a Marketing Authorization Application (“MAA”) is submitted to the relevant governmental authorities for approval, which if granted permits the subsequent commercial launch of the drug. The preparation of an NDA, BLA or MAA submission involves considerable data collection, verification, analysis and expense. Even after the launch of the product, health authorities require post-marketing surveillance of adverse events, and they may request a post-marketing study to provide additional information regarding the risks and benefits of the product. Takeda’s R&D engine is focused on translating science into highly innovative, life-transforming medicines that make a critical difference to patients. Our R&D efforts focus on three core therapeutic areas: Gastrointestinal and Inflammation, Neuroscience, and Oncology. We also make targeted R&D investments in PDT. The R&D engine for our three core therapeutic areas are the largest component of our R&D investment and has 26 Table of Contents produced exciting new molecular entities (“NMEs”) that represent potential best-in-class and/or first-in-class medicines in areas of high unmet medical need across our core therapeutic areas (Gastrointestinal and Inflammation, Neuroscience, and Oncology). Takeda is committed to developing therapies for both rare and more prevalent diseases, and many of the life-transforming medicines we are pursuing will treat rare diseases in our core therapeutic areas as well as in PDT. We are embracing data and digital technologies with the aim of improving the quality of innovation and accelerating execution. We seek to achieve a foundational shift that embeds AI into every stage of drug discovery, redesigning workflows to include automated, data-driven, predictive processes that accelerate innovation. Takeda’s pipeline is positioned to support both the near-term and long-term sustained growth of the company. Once first approval of a product is achieved, Takeda R&D is equipped to support geographic expansions of such approval and approvals in additional indications, as well as post-marketing commitment and potential additional formulation work. Takeda’s R&D team works closely with the commercial functions to maximize the value of marketed products and reflect commercial insights in its R&D strategies and portfolio. In addition to our concentrated efforts to increase our in-house R&D capabilities, external partnerships with third-party partners are a key component of our strategy for enhancing our R&D pipeline. Our strategy to expand and diversify our external partnerships allows us to take part in research of a wide variety of new products and increases the chances that we will be able to take part in a major research-related breakthrough. Our key R&D facilities include: •Greater Boston Area Research and Development Site: Our R&D sites are located in Cambridge and Lexington, Massachusetts in the United States. They are the R&D center for global Gastrointestinal and Inflammation, Oncology, and our global R&D Headquarters. They also support R&D in other areas including plasma-derived therapies. Furthermore, Takeda signed a 15-year lease for an approximately 600,000 square foot state-of-the-art R&D and office facility under construction in Kendall Square, which Takeda plans to occupy from 2026. •Takeda Research Center in Shonan Health Innovation Park: Located in Fujisawa and Kamakura in Kanagawa Prefecture in Japan, the site houses a Takeda Research laboratory where the company’s neuroscience research is conducted. The Shonan Health Innovation Park (“Shonan iPark”) was opened in 2018 when Takeda transformed its Shonan Research Center into the first pharma-led science park in Japan by opening its doors to external parties. To attract more diverse partners and to further the success of the Shonan iPark, Takeda transferred ownership rights of Shonan iPark to a trustee in 2020 and transferred operation of Shonan iPark to a company established by Takeda in 2023. Takeda, as a flagship tenant, is committed to invigorating life science research in Japan. •Vienna, Austria Research and Development Sites: Our R&D sites, located in Vienna, Austria, support programs in R&D and in PDT. The research centers focus on biologics programs in R&D and contain manufacturing sites for plasma derived products. Major progress on R&D events since April 2025 are listed as follows: Gastrointestinal and Inflammation In Gastrointestinal and Inflammation, Takeda focuses on delivering innovative, life-changing therapeutics for patients with gastrointestinal diseases (including those of the liver) as well as immune-mediated inflammatory diseases. Takeda is maximizing the potential of our inflammatory bowel disease (IBD) franchise around ENTYVIO, including the introduction of a subcutaneous formulation and running real-world evidence generation studies that demonstrate ENTYVIO’s place as a backbone therapy in the IBD treatment paradigm and further our understanding of how to improve outcomes for patients. Zasocitinib (TAK-279) is a next generation oral tyrosine kinase 2 (TYK2) inhibitor with potential to treat multiple immune-mediated inflammatory diseases. Fazirsiran (TAK-999) is a potential first-in-class RNAi treatment for alpha-1 antitrypsin-deficiency associated liver disease in late-stage development. Mezagitamab (TAK-079) is a potential best-in-class anti-CD38 antibody with disease modifying potential for multiple immune-mediated diseases like immune thrombocytopenia (ITP) and IgA nephropathy (IgAN). Furthermore, Takeda is making progress on its pipeline built through in-house discovery, partnerships and business development, which explores opportunities in inflammatory diseases (specifically in gastric, dermatological and rheumatic disorders), along with select rare hematological and renal disorders (ADZYNMA, mezagitamab (TAK-079)), liver diseases, and neurogastric disorders. ADZYNMA / Generic name: recombinant ADAMTS13 –In December 2025, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved ADZYNMA, expanding its indication to pediatric congenital thrombotic thrombocytopenic purpura (cTTP) under the age of 12. The approval is primarily based on safety and efficacy data of the global Phase 3 281102 trial in cTTP patients ages 0-70, which included five Japanese individuals, and the Phase 3b continuation trial TAK-755-3002. ENTYVIO / Generic name: vedolizumab –In February 2026, Takeda announced positive data from the pivotal Phase 3 KEPLER trial which evaluated vedolizumab intravenous (IV) in pediatric ulcerative colitis (UC) patients ages 2 to 17 who had an inadequate response to either conventional treatment options or tumor necrosis factor (TNF) antagonists. The study demonstrated that nearly half (47.3%) of patients achieved primary endpoint of clinical remission at 54 weeks. Vedolizumab’s safety profile was generally consistent with its known safety profile in adults. These results were presented at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO). –In June 2026, Takeda announced that the U.S. Food and Drug Administration (FDA) accepted for review its supplemental Biologics License Application (sBLA) for intravenous (IV) ENTYVIO for the treatment of moderately to severely active UC and Crohn’s disease in pediatric patients ages 2 years and older. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the first quarter of calendar year 2027. Takeda also submitted a marketing authorization application (MAA) to the European Medicines Agency for ENTYVIO IV for the treatment of 27 Table of Contents moderately to severely active UC and Crohn’s disease in pediatric patients ages 2 years and older. The sBLA and MAA are supported by data from two Phase 3 pediatric trials, the KEPLER study in UC and the ongoing WEBB study in Crohn’s disease. Development code: TAK-079 / Generic name: mezagitamab –In June 2025, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted Orphan Drug Designation for mezagitamab, for the potential indication of chronic immune thrombocytopenia (ITP). –In November 2025, Takeda announced new interim data from the Phase 1b, open-label, proof-of-concept study of subcutaneous mezagitamab in primary IgA nephropathy (IgAN). The results, presented at the American Society of Nephrology (ASN) Kidney Week 2025, showed stable kidney function (eGFR) in patients treated with investigational mezagitamab through week 96 (18 months after last dose), as well as a rapid reductions in proteinuria and serum Gd-IgA1 levels that were sustained through week 96, In this study, mezagitamab was generally well tolerated with no new safety concerns identified. –In November 2025, Takeda announced that the MHLW granted Orphan Drug Designation for mezagitamab for the potential indication of IgAN. Development code: TAK-279 / Generic name: zasocitinib –In December 2025, Takeda announced positive topline results for two pivotal Phase 3 studies of zasocitinib in adults with moderate-to-severe plaque psoriasis (PsO). The studies demonstrated superiority of zasocitinib compared to placebo for the co-primary endpoints, static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75, at week 16. The studies also met all 44 ranked secondary endpoints, showing the potential of a convenient once-daily pill to deliver complete skin clearance for patients with PsO. More than half of study participants treated with zasocitinib achieved PASI 90, and on average about 30 percent achieved PASI 100 by week 16. Zasocitinib was generally well-tolerated with no new safety signals identified. –In March 2026, Takeda announced new data from the two pivotal Phase 3 studies of zasocitinib in adults with moderate-to-severe PsO. About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16, and a significantly greater PASI 75 response rate versus placebo was observed as early as week 4. Zasocitinib also demonstrated statistically significant improvements in complete skin clearance, against placebo and apremilast, an increasingly important treatment goal for patients with PsO. Responses for co-primary and key secondary endpoints continued to increase through week 24 in both studies. Zasocitinib was generally well-tolerated, and safety profile was consistent with Phase 2b studies with no new safety signals identified. The results were presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting. –In June 2026, Takeda announced positive topline results for the Phase 3 study comparing zasocitinib (TAK-279) to deucravacitinib in adults with moderate-to-severe PsO. In the LATITUDE Atlas (TAK-279-PsO-3004) head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib for the primary endpoint, PASI 100 response rate at week 16, with more than 35% of zasocitinib-treated patients achieving PASI 100. The study also demonstrated statistical superiority over deucravacitinib for all key secondary endpoints, including PASI 90 response and sPGA 0 at week 16. Zasocitinib was generally well tolerated with a consistent safety and tolerability profile and no new safety signals identified. Neuroscience In Neuroscience, Takeda is focusing its R&D investments on potentially transformative treatments for neurological and neuromuscular diseases of high unmet need building its innovative pipeline by leveraging internal expertise and external collaborations. Takeda Neuroscience’s core focus is orexin biology, rare neurology and neurodegeneration diseases. We are advancing a portfolio of tailored therapies designed to unlock the full power of orexin (i.e., oveporexton (TAK-861), TAK-360, TAK-495) to redefine the standard of care for people living with rare sleep-wake disorders and other conditions where orexin biology is implicated. Across our portfolio, we are harnessing advances in disease biology understanding, translational tools, innovative modalities and digital innovation to accelerate development and patient access. VYVANSE / Generic name: lisdexamfetamine –In June 2026, Takeda announced that it received notification from the Japanese Ministry of Health, Labour and Welfare (MHLW) regarding the partial lifting of certain approval conditions applied to VYVANSE. The partial lifting of the approval conditions is based on the MHLW’s assessment that the necessary measures associated with the relevant approval condition have been appropriately implemented, based on data submitted by Takeda, including results from post-marketing surveillance studies and initiatives to ensure appropriate use. Lifted approval condition: “Measures ensuring that VYVANSE would be used only in cases where other attention-deficit/hyperactivity disorder (ADHD) treatments are insufficient, until evaluation of abuse and dependence under actual use conditions has been completed.” Development Code: TAK-861 / Generic name: oveporexton –In September 2025, Takeda presented orexin data from the landmark oveporexton Phase 3 program in NT1, during multiple oral presentations at the World Sleep 2025 Congress. Both the FirstLight and the RadiantLight studies met all primary and secondary endpoints demonstrating statistically significant (p<0.001) and clinically meaningful improvements in a broad range of NT1 symptoms compared to placebo across all doses (twice-daily 1mg/twice-daily 2mg) at week 12. The oral presentations at World Sleep included data from objective and patient-reported measures of wakefulness, cataplexy, symptom severity and quality of life. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies to date. –In February 2026, Takeda announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton for the treatment of NT1. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of calendar year 2026. The NDA filing is supported by a comprehensive data package including the FirstLight and RadiantLight global 28 Table of Contents Phase 3 studies. Oveporexton previously received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in NT1 from the U.S. FDA and the Center for Drug Evaluation of China’s National Medical Products Administration. –In March 2026, Takeda announced that it submitted the NDA to the Japanese Ministry of Health, Labour and Welfare (MHLW) for oveporexton for the expected indication of NT1. Oveporexton has received SAKIGAKE and Orphan Drug Designation from the MHLW. The NDA filing is supported by a comprehensive data package including the FirstLight and RadiantLight global Phase 3 studies. –In June 2026, Takeda presented additional results from two pivotal studies at SLEEP 2026 showing oveporexton improved daily functioning as well as cognitive and sleep-related symptoms associated with NT1. The presentations highlighted results from secondary and exploratory endpoints from the FirstLight and the RadiantLight including functioning, cognition, and nighttime sleep. At all doses, oveporexton significantly improved daily functioning at week 12 compared to placebo (p<0.001) across the six domains of the Functional Impacts of Narcolepsy Instrument (FINI). Oveporexton improved cognitive symptoms associated with NT1 compared to placebo, as measured using objective neuropsychological tests of attention, executive function and memory along with patient-reported measures. Exploratory endpoints demonstrated that oveporexton improved quality of sleep across both studies. Oncology In Oncology, we are advancing a pipeline of potential therapies across thoracic, gastrointestinal, and hematologic malignancies. In thoracic and gastrointestinal cancers, TAK‑928 (IBI363) and TAK‑921 (IBI343) are being evaluated across multiple indications. In hematologic cancers, we are growing a portfolio focused on myeloid malignancies, including rusfertide (TAK‑121) and elritercept (TAK‑226). Our deep internal expertise, global footprint and strong network of strategic collaborators underpin our ability to drive innovation and long‑term value creation. We aspire to cure cancer, with inspiration from patients and innovation from everywhere. ADCETRIS / Generic name: brentuximab vedotin –In June 2025, Takeda announced that the European Commission (EC) approved ADCETRIS in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (BrECADD) in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. The approval for this ADCETRIS-based combination regimen, known as BrECADD, in frontline Hodgkin lymphoma is based on the results of the randomized Phase 3 HD21 trial. VECTIBIX / Generic name: panitumumab –In September 2025, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved a partial change to the manufacturing and marketing authorization for VECTIBIX to include a new indication, dosage and administration in combination with LUMAKRAS (sotorasib), a KRAS G12C inhibitor, for the treatment of unresectable, advanced or recurrent KRAS G12C mutation-positive colorectal cancer progressed after chemotherapy. The approval is based on the results of the CodeBreaK 300 trial, a Phase 3, international, multicenter, randomized, open-label, active-controlled trial evaluating the efficacy and safety of combination therapy with VECTIBIX and LUMAKRAS in previously treated patients with KRAS G12C mutation-positive metastatic colorectal cancer. Development code: TAK-121 / Generic name: rusfertide –In June 2025, Takeda and Protagonist Therapeutics announced that detailed results from the Phase 3 VERIFY study were presented at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session. The study met its primary endpoint, which was the proportion of patients achieving a clinical response, defined as the absence of phlebotomy eligibility during study weeks 20-32. Rusfertide plus current standard of care more than doubled clinical response rates across high- and low-risk polycythemia vera (PV) groups, significantly reducing phlebotomy eligibility compared to placebo plus current standard of care, which was the primary endpoint. Rusfertide was generally well tolerated. The majority of adverse events were low grade and non-serious, and no serious adverse events considered related to rusfertide were reported. There was no evidence of increased risk of cancer in rusfertide arm compared to placebo arm at the time of the primary analysis. –In December 2025 at the 67th American Society of Hematology (ASH) Annual Meeting, Takeda and Protagonist Therapeutics presented new 52-week results from the pivotal Phase 3 VERIFY study evaluating rusfertide in patients with PV. The new data demonstrated sustained hematocrit control and response, defined by absence of phlebotomy eligibility, with no new safety signals. –In March 2026, Takeda and Protagonist Therapeutics announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide for the treatment of adults with PV. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. In addition to Priority Review, rusfertide has received Breakthrough Therapy designation, Orphan Drug designation and Fast Track designation from the U.S. FDA. The NDA for rusfertide was primarily based on the positive 32-week primary analysis and 52-week results from the Phase 3 VERIFY study, as well as four-year efficacy and safety data from the Phase 2 REVIVE study and long-term extension THRIVE study. Development code: TAK-853 / Generic name: mirvetuximab soravtansine –In January 2026, Takeda announced it submitted the New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) for mirvetuximab soravtansine for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant recurrent ovarian cancer (PROC) in Japan. The NDA submission is based on the results of the MIRASOL and SORAYA trials, which are global Phase 3 studies in patients with FRα-positive PROC, as well as the TAK-853-1501 trial, a Phase 1/2 study conducted in Japan. Across these trials, mirvetuximab soravtansine demonstrated consistent efficacy and a favorable safety profile in the treatment of patients with FRα-positive PROC. Mirvetuximab soravtansine has been designated as an orphan drug by the MHLW for the anticipated indication of FRα-positive recurrent ovarian cancer, and this application is subject to priority review. 29 Table of Contents Other Rare Diseases programs Takeda’s R&D engine is focused on areas of high unmet medical need, both in rare and more prevalent conditions, across three core therapeutic areas (Gastrointestinal and Inflammation, Neuroscience, and Oncology). In other Rare Diseases programs, Takeda focuses on several areas of high unmet medical need, on top of marketed products such as TAKHZYRO in hereditary angioedema. In rare hematology, Takeda focuses on addressing today’s needs in the treatment of bleeding disorders, including through ADVATE and ADYNOVATE/ADYNOVI. In addition, Takeda aims to redefine the management of post-transplant cytomegalovirus (CMV) infection/disease with LIVTENCITY. Takeda commits to fulfilling our vision to deliver life-transforming medicines to patients with rare diseases. Takeda will continue to explore late-stage business development that may leverage our rare diseases capabilities as well as bolster our commitment and leadership in rare diseases. VONVENDI / Generic name: von Willebrand factor (Recombinant) –In September 2025, Takeda announced that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for VONVENDI, expanding the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of bleeding in pediatric patients with VWD. The approval is based on data from three clinical trials – a Phase 3 trial in adults with VWD, a Phase 3 study in children with VWD, and a Phase 3b continuation trial in adults and children with VWD, as well as supportive real-world data. –In February 2026, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved a partial change to the manufacturing and marketing authorization for VONVENDI for an additional dosage and administration for patients under the age of 18 for the treatment of VWD. The application is primarily based on the safety and efficacy data related to bleeding episodes and perioperative management in VWD patients under 18 years old from Phase 3 open-label study (071102 trial) and Phase 3b extension study (SHP677-304 trial), both of which were conducted outside of Japan. TAKHZYRO / Generic name: lanadelumab –In September 2025, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved TAKHZYRO Pen 300mg for subcutaneous administration as an additional formulation to TAKHZYRO Syringe. Plasma-Derived Therapies (PDT) Takeda has created a dedicated PDT business unit with a focus on managing the business end-to-end, from plasma donation to manufacturing, R&D, and commercialization. In PDT, we aspire to develop life-saving plasma-derived therapies, which are essential for patients with a variety of rare and complex chronic diseases. The dedicated R&D organization within PDT is charged with maximizing the value of existing therapies, identifying new targeted therapies, and optimizing efficiencies across the PDT value chain, from plasma donation to product manufacturing. Near-term, our priority is focused on delivering value from our broad immunoglobulin portfolio (HYQVIA, CUVITRU, GAMMAGARD LIQUID and GAMMAGARD LIQUID ERC) through the pursuit of new indications, geographic expansions, and enhanced patient experience through integrated healthcare technologies. Additionally, we are developing next generation immunoglobulin product with 20% facilitated SCIG (TAK-881) and are pursuing other early-stage opportunities (e.g. TAK-411: hypersialylated Immunoglobulin (hsIgG)) that would add to our diversified commercial portfolio of more than 20 therapeutic products distributed worldwide. HYQVIA / Generic name: Immunoglobulin (IG) Infusion 10% (Human) w/ Recombinant Human Hyaluronidase for subcutaneous administration –In June 2025, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved a partial change to the manufacturing and marketing approval items of HYQVIA for additional indications of slowing of progression of motor weakness in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) (if improvement of muscle weakness is observed). The approval is based on a Phase 3 study in Japanese patients with CIDP and MMN (TAK-771-3002) as well as two Phase 3 studies in patients with CIDP conducted outside of Japan (161403, 161505). –In July 2025, Takeda announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for HYHUB and HYHUB DUO, devices for patients 17 years of age and older that allow HYQVIA to be transferred from vials without using a needle in a home environment or clinical setting. HYHUB and HYHUB DUO reduce the number of steps required to prepare the infusion of HYQVIA. GAMMAGARD LIQUID ERC / Generic name: Immunoglobulin (IG) Infusion 10% (Human) (Low IgA) –In June 2025, Takeda announced that the U.S. Food and Drug Administration (FDA) approved GAMMAGARD LIQUID ERC with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). As a ready-to-use liquid, GAMMAGARD LIQUID ERC may help ease the administration burden for patients and their health care providers by eliminating the need for reconstitution and can be administered intravenously or subcutaneously. KENKETU GLOVENIN-I / Generic name: Immunoglobulin (IG) Infusion (Human) for intravenous administration –In February 2026, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved KENKETU GLOVENIN-I 10% Intravenous Injection. The approval covers the indications approved for KENKETU GLOVENIN-I Intravenous Injection (5% formulation) which are approved in Japan. KENKETU GLOVENIN-I 10% is derived from Japanese plasma and is an improved formulation of Takeda’s existing approved KENKETU GLOVENIN-I; the formulation was improved from a freeze-dried formulation to a liquid formulation, and the active 30 Table of Contents ingredient concentration is raised from 5 % to 10%. A higher concentration of the active ingredient is expected to reduce the volume of infusion, shorten the infusion time, and enable high-dose therapy with less fluid loading. Development code: TAK-881 / Generic name: Immunoglobulin (IG) Infusion 20% (Human) w/ Recombinant Human Hyaluronidase for subcutaneous administration –In May 2026, Takeda announced that TAK-881-3001, a pivotal Phase 2/3 clinical trial in patients with Primary Immunodeficiency Disease (PID), met its primary endpoint, which demonstrated pharmacokinetic (PK) comparability between the investigational TAK-881 and HYQVIA. Additionally, secondary endpoints showed that TAK-881, a SCIG 20% facilitated with hyaluronidase, demonstrated safety, efficacy and tolerability profiles comparable to HYQVIA, an established SCIG 10% facilitated with hyaluronidase. These findings support the potential of TAK-881 to deliver the required immunoglobulin (IG) dose for PID patients in half the volume of HYQVIA, reducing infusion duration while maintaining flexible, up to once-monthly dosing for patients (every three or four weeks for PID). Vaccines In Vaccines, Takeda is applying innovation to tackle infectious diseases such as dengue (QDENGA), and COVID-19 (NUVAXOVID). To support the expansion of our pipeline and the development of our programs, we have entered into partnerships with government organizations in Japan, and leading global institutions including WHO (World Health Organization), PAHO (Pan American Health Organization) and Gavi (Global Alliance for Vaccines and Immunization), among others. These partnerships have been essential in building the critical capabilities that will be necessary to deliver on our programs and realize their full potential. NUVAXOVID Intramuscular Injection / Generic name: Recombinant coronavirus (SARS-CoV-2) vaccine –In August 2025, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved a partial change to the manufacturing and marketing authorization for NUVAXOVID formulated to target Omicron LP8.1 lineage for which the application was submitted in June 2025. The approval is based on data related to the change of the antigen strain, as well as non-clinical data in which NUVAXOVID was shown to induce neutralizing antibodies against recent SARS-CoV-2 variants (LP.8.1, LP.8.1.1, JN.1, KP.3.1.1, XEC, XEC.4, NP.1, LF.7 and LF.7.2.1). QDENGA / Generic name: Dengue tetravalent vaccine [live, attenuated] –In November 2025, Takeda announced the completion of the 7-year pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial evaluating QDENGA. These data, including an exploratory analysis of a booster dose, confirm the favorable benefit and risk profile of QDENGA and that the two-dose regimen provides sustained protection against dengue. After initial two doses of QDENGA, a booster dose administered at 4.5 years only marginally increased efficacy after 2 years. Overall efficacy was seen across all four dengue virus serotypes through seven years. No new safety signals were observed following the administration of a booster dose. These data were presented at the World Society for Pediatric Infectious Diseases (WSPID) 14th Annual Congress. Takeda also presented results from additional non-endemic booster studies at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Congress. The following summarizes our primary R&D activities within each of our therapeutic and business areas. The therapeutic candidates in our pipeline disclosed within the key therapeutic and business areas below are in various stages of development, and the contents of the pipeline may change as candidates currently under development are removed and new candidates are introduced. Whether the candidates listed below are ever successfully released as products depends on various factors, including the results of pre-clinical and clinical trials, market conditions for various drugs and regulatory approvals. This table primarily shows the indications for which we are actively pursuing regulatory approval and those regulatory approvals granted in fiscal year 2025. We are also conducting additional studies of certain assets to examine their potential for use in further indications and in additional formulations. The listings in the tables below are limited to the U.S., EU, Japan, and China, but we are also conducting development activities in other regions. “Global” refers to at least three regions or key countries. “Modality” of our pipeline assets in the following table is classified into either of the following categories: ‘small molecule’, ‘peptide/oligonucleotide’ or ‘biologic and other’. Our Gastrointestinal and Inflammation pipeline in clinical development as of May 13, 2026 (the date of our annual earnings release), along with notes for major subsequent developments thereafter, is as follows: Development code<generic name>Brand name(country/region) Type of Drug(administration route) Modality Indications / additional formulations Country/Region Stage TAK-755*1 <rADAMTS13> ADZYNMA (U.S., EU, Japan) Recombinant ADAMTS13 therapy (injection) Biologic and other Congenital Thrombotic Thrombocytopenic Purpura China Filed (Mar 2025) MLN0002 <vedolizumab> ENTYVIO(Global) Humanized monoclonal antibody against α4β7 integrin (injection) Biologic and other Pediatric Study (intravenous formulation for ulcerative colitis, Crohn’s disease) Global P-III*2 Pediatric Study (subcutaneous formulation for ulcerative colitis, Crohn’s disease) Global P-III 31 Table of Contents Development code<generic name>Brand name(country/region) Type of Drug(administration route) Modality Indications / additional formulations Country/Region Stage TAK-999*3 <fazirsiran> GalNAc based RNA interference (RNAi) (injection) Peptide/oligonucleotide Alpha-1 antitrypsin-deficiency associated liver disease U.S. EU P-III P-III TAK-279 <zasocitinib> TYK2 inhibitor (oral) Small molecule Psoriasis Global P-III Pediatric psoriasis Global P-III Psoriatic arthritis Global P-III Crohn’s disease - P-II (b) Ulcerative colitis - P-II (b) Vitiligo - P-II (b) Hidradenitis suppurativa - P-II (a) TAK-079 <mezagitamab> Anti-CD38 monoclonal antibody (injection) Biologic and other Immune thrombocytopenia Global P-III Immunoglobulin A nephropathy Global P-III TAK-227/ZED1227*4 Transglutaminase 2 inhibitor (oral) Small molecule Celiac disease - P-II (b) TAK-101*5 Tolerizing Immune Modifying nanoParticle (TIMP) (injection) Biologic and other Celiac disease - P-II TAK-781 GalNAc siRNA targeting CYP7A1 (injection) Peptide/oligo-nucleotide Primary sclerosing cholangitis - P-I *1Partnership with KM Biologics. *2In June 2025, Takeda announced that the U.S. Food and Drug Administration (FDA) accepted for review its supplemental Biologics License Application (sBLA) for intravenous ENTYVIO for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in pediatric patients ages 2 years and older. *3Partnership with Arrowhead Pharmaceuticals *4Partnership with Zedira and Dr. Falk Pharma. Dr. Falk Pharma leads development. *5Partnership with COUR Pharmaceuticals. 32 Table of Contents Our Neuroscience pipeline in clinical development as of May 13, 2026 (the date of our annual earnings release), along with notes for major subsequent developments thereafter, is as follows: Development code<generic name>Brand name(country/region) Type of Drug(administration route) Modality Indications / additional formulations Country/Region Stage TAK-861 <oveporexton> Orexin 2R agonist (oral) Small molecule Narcolepsy type 1 Japan U.S. China EU Filed (Mar 2026) Filed (Feb 2026) Filed (Jan 2026) P-III TAK-755*1 <rADAMTS13> Recombinant ADAMTS13 therapy (injection) Biologic and other Acute ischemic stroke - P-II TAK-360 Orexin 2R agonist (oral) Small molecule Idiopathic hypersomnia - P-II Narcolepsy type 2 - P-II TAK-495 Orexin 2R agonist (oral) Small molecule - - P-I *1Partnership with KM Biologics. Our Oncology pipeline in clinical development as of May 13, 2026 (the date of our annual earnings release), along with notes for major subsequent developments thereafter, is as follows: Development code<generic name>Brand name(country/region) Type of Drug(administration route) Modality Indications / additional formulations Country/Region Stage SGN-35*1<brentuximab vedotin> ADCETRIS (EU, Japan, China) CD30 monoclonal antibody-drug conjugate (injection) Biologic and other Front line Hodgkin’s lymphoma – BrECADD regimen (brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone) *2 EU Approved (June 2025) TAK-121*3<rusfertide> Hepcidin mimetic peptide (injection) Peptide/oligonucleotide Polycythemia vera U.S. Filed (Feb 2026) TAK-853*4<mirvetuximab soravtansine-gynx> Antibody-drug conjugate targeting folate receptor α (FRα) (injection) Biologic and other Platinum-resistant ovarian cancer Japan Filed (Jan 2026) Platinum-sensitive ovarian cancer Japan P-III TAK-226*5<elritercept> Activin A/B ligand trap (injection) Biologic and other 2L anemia-associated Myelodysplastic Syndrome Global P-III Anemia-associated Myelofibrosis - P-II TAK-928 / IBI363*6 PD-1/α-biased IL-2 bispecific antibody fusion protein (injection) Biologic and other 2L squamous Non-Small Cell Lung Cancer Global P-III Solid Tumors - P-II TAK-921 / IBI343*6 Antibody-drug conjugate targeting Claudin 18.2 (injection) Biologic and other 3L Gastric Cancer Japan China P-III Solid Tumors - P-I 33 Table of Contents Development code<generic name>Brand name(country/region) Type of Drug(administration route) Modality Indications / additional formulations Country/Region Stage TAK-168 / KQB168*7 Immune modulator (oral) Small molecule Solid Tumors - P-I TAK-188 Antibody-drug conjugate targeting CCR8 (injection) Biologic and other Solid Tumors - P-I *1Partnership with Pfizer Inc. *2Submission based on data from German Hodgkin Study Group HD21 trial. *3Partnership with Protagonist Therapeutics. *4Partnership with AbbVie. Global P-III trial in platinum-sensitive ovarian cancer is led by AbbVie. *5Partnership with Keros Therapeutics, Inc. *6Partnership with Innovent Biologics. *7Partnership with Kumquat Biosciences Inc. Kumquat leads P-I development. Our Other Rare Diseases pipeline in clinical development as of May 13, 2026 (the date of our annual earnings release), along with notes for major subsequent developments thereafter, is as follows: Development code<generic name>Brand name(country/region) Type of Drug(administration route) Modality Indications / additional formulations Country/Region Stage TAK-577 VONVENDI (U.S., Japan, China) VEYVONDI (EU) von Willebrand factor [recombinant] (injection) Biologic and other Pediatric on-demand and surgery treatment of von Willebrand disease Japan EU U.S. EU Approved (Feb 2026) Approved (on-demand) Dec 2025 Approved (Sept 2025) P-III (surgery) Pediatric prophylactic treatment of von Willebrand disease Global P-III TAK-660 ADYNOVATE (U.S., Japan) ADYNOVI (EU) Antihemophilic factor [recombinant], PEGylated (injection) Biologic and other Hemophilia A China Filed (July 2025) Pediatric Hemophilia A EU P-III TAK-620*1 <maribavir> LIVTENCITY (Global) Benzimidazole riboside inhibitor (oral) Small molecule Treatment of children and teenage transplant recipients with CMV infection Global P-III *1Partnership with GSK. 34 Table of Contents Our PDT pipeline in clinical development as of May 13, 2026 (the date of our annual earnings release), along with notes for major subsequent developments thereafter, is as follows: Development code<generic name>Brand name(country/region) Type of Drug(administration route) Modality Indications / additional formulations Country/Region Stage TAK-961 <IVIG> KENKETU GLOVENIN-I (Japan) Immunoglobulin (10%) [human] (injection) Biologic and other Multiple Indications Japan Approved (Feb 2026) Autoimmune Encephalitis (AE) Japan Filed (Oct 2025) TAK-339 <IVIG> GLOVENIN-I (Japan) GAMMAGARD LIQUID (U.S.) Immunoglobulin (10%) [human] (injection) Biologic and other Multiple Indications Japan Approved (July 2025) Autoimmune Encephalitis (AE) Japan Filed (Oct 2025) Secondary Immunodeficiencies U.S. P-III TAK-771*1 <SCIG Infusion 10% (Human) w/ Recombinant Human Hyaluronidase> HYQVIA (U.S., EU, Japan) Immunoglobulin (IgG) + recombinant hyaluronidase replacement therapy (injection) Biologic and other Chronic inflammatory demyelinating polyradiculoneuropathy and multifocal motor neuropathy Japan Approved (June 2025) TAK-880 <10% IVIG (Low IgA)> GAMMAGARD LIQUID ERC (U.S.) DEQSIGA (EU) Immunoglobulin (10%) [human] (injection) (Low IgA) Biologic and other Primary Immunodeficiencies U.S. EU Approved (June 2025) Approved (May 2025) TAK-330 PROTHROMPLEX TOTAL (EU) Four-factor prothrombin complex concentrate [human] (injection) Biologic and other Coagulation Disorder, Direct Oral Anticoagulants (DOAC) reversal in surgical situations U.S. P-III TAK-881 <Facilitated 20% SCIG> Immunoglobulin (20%) [human] + recombinant hyaluronidase replacement therapy (injection) Biologic and other Primary Immunodeficiencies U.S. EU Japan P-III P-III P-III Chronic inflammatory demyelinating polyradiculoneuropathy U.S. EU Japan P-III P-III P-III TAK-411 Hypersialylated Immunoglobulin [human] (injection) Biologic and other Chronic inflammatory demyelinating polyradiculoneuropathy - P-II *1Partnership with Halozyme. 35 Table of Contents Select Options: Other Selected Assets That Takeda Holds Contractual Rights to Potentially Clinically Develop and/or Commercialize in the Future Other selected assets that Takeda holds contractual rights to potentially clinically develop and/or commercialize in the future as of May 13, 2026 (the date of our annual earnings release), along with notes for major subsequent developments thereafter, are as follows: Development code<generic name>Brand name(country/region) Type of Drug(administration route) Modality Indications / additional formulations Country/Region Stage HQP1351*1 <olverembatinib> BCR-ABL tyrosine kinase inhibitor (TKI) (oral) Small molecule Chronic phase-chronic myeloid leukemia U.S. EU Japan P-III ACI-24.060*2 Abeta active immunotherapy Biologic and other Alzheimer’s disease - P-II IBI3001*3 Antibody-drug conjugate targeting EGFR and B7H3 Biologic and other Solid tumors - P-I *1Olverembatinib/HQP1351 is included for reference only. Ascentage Pharma retains ownership of this asset and is solely responsible for its clinical development prior to Takeda’s potential exercise of its option to exclusively license certain rights, which is subject to customary conditions including regulatory approval. *2ACI-24.060 is included for reference only. AC Immune retains ownership of this asset and is solely responsible for its clinical development prior to Takeda’s potential exercise of its option to exclusively license certain rights, which is subject to customary conditions including regulatory approval. *3IBI3001 is included for reference only. Innovent Biologics retains ownership of this asset and is solely responsible for its clinical development prior to Takeda’s potential exercise of its option to exclusively license certain rights, which is subject to customary conditions including regulatory approval. 36 Table of Contents Projects removed from pipeline Our projects removed from pipeline since April 1, 2025 are as follows: Development code<generic name> Indications (Region/Country, Stage) Reason TAK-961 <5% IVIG> Autoimmune Encephalitis (AE) (P-III) Removed due to portfolio/filing strategy: AE filing is being pursued solely via the 10% liquid formulations, leveraging Phase 3 AE data generated with the 5% product. TAK-003 Prevention of dengue fever (booster extension) (P-III) Findings reinforced QDENGA’s long-term seven-year safety profile and two-dose vaccination schedule TAK-755 <rADAMTS13> Immune Thrombotic Thrombocytopenic Purpura (P-II(b)) TAK-755 development in iTTP was discontinued due to strategic reasons TAK-594 / DNL593 Frontotemporal dementia (P-II) TAK-594 co-development with Denali was discontinued due to strategic considerations TAK-004 Nausea and vomiting (P-I) Development of TAK-004 was discontinued due to strategic consideration TAK-341/MEDI1341 Multiple System Atrophy (MSA) (P-II) TAK-341 Phase 2 trial results did not meet primary and secondary endpoints, which does not support further development in MSA. TAK-925 <danavorexton> Narcolepsy (P-I) Danavorexton (TAK-925) development in narcolepsy discontinued due to strategic considerations. TAK-012 Relapsed/refractory Acute Myeloid Leukemia (P-1) TAK-012 has been discontinued due to strategic reasons. 37 Table of Contents Availability of Raw Materials In the ordinary course of business, we purchase raw materials and supplies essential to our operations from suppliers around the world. While we develop and manufacture the active ingredients used in some of our products at our own facilities, we are dependent on third-party suppliers for a portion of the raw materials and compounds used in certain other products we produce. We believe that, in the event we are unable to source any products or ingredients from any of our major suppliers, we could replace those products or substitute ingredients from other suppliers, although we may not be able to do so without significant difficulty or significant increases in our cost of sales. While efforts are made to diversify our sources of components and materials, in certain instances we acquire components and materials from a sole supplier. In the case of plasma-derived-therapies, we are dependent on healthy individuals to donate human plasma to develop and manufacture our products. We own and operate plasma donation facilities, principally in the U.S., Austria, Hungary and Czechia, and we also maintain relationships with other plasma suppliers for external sourcing to meet our planned supply commitments to patients. We closely monitor, continuously review and revise the supply sourcing strategy for our products to identify in a timely manner any risks in our supply chain, including risks arising from our dependency on outsourced manufacturing relationships with third-party suppliers or risks arising from geopolitical decision-making including but not limited to trade policies such as policies that impose tariffs. Where necessary, inventory levels of either key materials or finished products are managed strategically to address potential risks relating to operational and quality issues, production capacity and single sourcing among others. For critical and strategic products, we have decided to make significant long-term capital investments to build internal manufacturing capacity and secure dual sources to reduce the dependency on outsourced manufacturing relationships with third-party suppliers. Manufacturing The manufacturing of our products is highly regulated by governmental health authorities around the world, including the U.S. FDA, EMA, Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) and NMPA. Furthermore, many of our products involve technically complex manufacturing processes or may require a supply of highly specialized raw materials. We manufacture a certain number of our products in our own facilities within our global manufacturing network. In addition, we source certain other products from third-party contract manufacturers. We have a network of more than 100 contract manufacturers which provide varying services such as the manufacture of active pharmaceutical ingredients, bulk drug product, aseptic fill finish and final packaging. In cases where we utilize contract manufacturers, we are often dual sourced with an internal manufacturing site. In cases where we are not dual sourced, we manage the risks associated with the reliance on a single source of production by carrying additional inventories. Sales and Marketing Our primary sales and marketing activities are organized around regional business units—the U.S. Business Unit (“USBU”) and the International Business Unit (“IBU”) together with the Japan Pharma Business Unit (“JPBU”)—and complemented by select therapeutic area business units, the Oncology Business Unit (“OBU”) and Plasma-Derived Therapies Business Unit (“PDT BU”). These business units make focused investments that support the growth potential of their respective markets. The U.S. is the largest pharmaceutical market in the world and is also Takeda’s largest region by revenue. USBU is focused on the successful launch of a subcutaneous administration of ENTYVIO (ENTYVIO Pen), approved for ulcerative colitis in September 2023 and Crohn’s disease in April 2024, and the expanded indications for HYQVIA and GAMMAGARD LIQUID. In addition, USBU is preparing for future anticipated launches, pending regulatory approval, of oveporexton and zasocitinib, and ensuring appropriate investment on mature products. Across IBU, Takeda’s portfolio focus is centered on key global brands, such as ENTYVIO (gastrointestinal and inflammatory diseases), VYVANSE/ELVANSE (neuroscience), TAKHZYRO (rare diseases), plasma‑derived therapies, innovative oncology medicines, and QDENGA (vaccines). JPBU continues to lead our commercial business in Japan; execution and financial planning for JPBU are managed through IBU to support alignment with our commercial strategy and standardized processes. With respect to JPBU, although we continue to promote our strong primary care portfolio, with the Japanese government driving stricter control of drug prices and promoting the penetration of generics, our strategy is to shift focus more toward the uptake of our highly innovative and differentiated specialty medicines such as ENTYVIO, GATTEX/REVESTIVE, TAKECAB, TRINTELLIX, INTUNIV, TAKHZYRO and our PDT products. Furthermore, four new products—ADZYNMA, OBIZUR, LIVTENCITY and CEPROTIN—were launched in FY2024, along with the introduction of a new 2-dose vial of NUVAXOVID for Omicron JN.1, to further drive revenue growth. In China, we are focused on unleashing the growth potential in the world’s second largest pharmaceutical market, and continue to maximize the value of brands such as ENTYVIO, ADCETRIS, TAKHZYRO, REPLAGAL, ALUNBRIG, LIVTENCITY, HUMAN ALBUMIN/FLEXBUMIN and LEUPRORELIN while also aiming to bring more new medicines and treatment options to China in the future from the therapeutic areas of Gastrointestinal and Inflammation (“GI”), Neuroscience, Oncology, and Rare Genetics and Hematology. We consider Japan, China, Germany, Brazil, the U.K./Ireland and Canada as “core markets” of the IBU, as they are strategically significant due to their scale, patient reach and importance for portfolio growth and launch execution. Core markets play a central role in shaping IBU priorities, setting execution standards and supporting consistent delivery of Takeda’s portfolio across international markets. In the other international markets, we are focused on delivering highly innovative medicines to patients living with complex and rare diseases in our key business areas of GI, Rare Diseases, PDT, Oncology, Vaccines (including QDENGA) and Neuroscience. 38 Table of Contents OBU is focused on the development and marketing of oncology medicines in the U.S., Japan, Europe and Canada. Our promoted oncology portfolio consists of three global brands (ALUNBRIG, NINLARO and FRUZAQLA) as well as products that we market on a regional basis including ICLUSIG in the U.S., ADCETRIS in markets outside of the U.S. and Canada and VECTIBIX, ZEJULA, and CABOMETYX in Japan. PDT BU is focused on transforming the lives of patients from the collection of plasma to the production and delivery of life-saving medicines worldwide. We offer a broad portfolio of greater than twenty therapies, four of which represent Global Brands for Takeda, HYQVIA and CUVITRU, subcutaneous immunoglobulin, KIOVIG/GAMMAGARD LIQUID, intravenous immunoglobulin and FLEXBUMIN, our differentiated bag Albumin product. In-market commercialization of PDT products is carried out through our geographic business units, including USBU, JPBU and IBU, enabling local decision-making and optimization across markets. Intellectual Property An important part of our business strategy is to protect our products and technologies using patents and trademarks, to the extent available. We rely on trade secrets, proprietary know-how, technological innovations and contractual arrangements with third parties to maintain and enhance our competitive position. Our commercial success depends, in part, upon our ability to obtain and enforce strong patents, to maintain trade secret protection, to operate without infringing the proprietary rights of others and to comply with the terms of licenses granted to us. Due to the lengthy development periods for new drugs, the high costs of R&D and the small percentage of researched therapeutic candidates that reach the market, the protection of intellectual property plays an important role in the return on investments into R&D for a new drug. We seek patent protection for proprietary technology whenever possible in the U.S., Japan and major European countries. Where practicable, we seek patent protection in other countries on a selective basis. In all cases, we endeavor to either obtain patent protection itself or support patent applications through licensors. Patents are our primary means of protecting the technologies we use. Patents provide the holder with the right to exclude others from making, using, selling, or offering for sale an invention related to a pharmaceutical product during the term of the patent. We use various types of patents to protect our biopharmaceutical products, including substance patents, which cover active ingredients, as well as patents covering usage, manufacturing processes and formulation of drugs. Also, our trademark registrations play a key role in protecting Takeda’s brands and preserving their long-term value, in particular, against other parties that pursue confusingly similar names or branding. Our products, especially small molecules, are mainly protected by substance patents. While the expiration of a substance patent can result in a loss of market exclusivity for the protected pharmaceutical products, commercial benefits may continue to be protected by non-substance patents such as patents relating to the method of use of such substance, patents relating the manufacturing method of such substance and patents relating to the new composition or formulation of such substance. The products can be also protected by regulatory data or market protection under relevant laws in each country even if the substance patent expires. In the U.S., patents generally expire 20 years after the earliest non-provisional filing date of the application, subject to potential patent term adjustments for delays in patent issuance based upon certain delays in prosecution by the U.S. Patent and Trademark Office. A U.S. pharmaceutical patent that claims a product, method of treatment using a product or method of manufacturing a product may also be eligible for a patent term extension based on the time the FDA took to approve the product. This type of extension may only extend the patent term for a maximum of 5 years and may not extend the patent term beyond 14 years from regulatory approval. Only one patent may be extended for any product based on FDA delay. In addition to patent exclusivities, the FDA may provide data or market exclusivity for a new chemical entity or an orphan drug, each of which run in parallel to any patent protection. Regulatory data protection or exclusivity prevents a potential generic competitor from relying on clinical trial data that were generated by the sponsor when establishing the safety and efficacy of its competing product for a period of 5 years for a new chemical entity, 7 years for an orphan drug or 12 years for a biological drug. Market exclusivity prohibits any marketing of the same drug for the same indication. In Japan, a patent can be issued for active pharmaceutical ingredients by the Japan Patent Office (“JPO”). Although claims directed to methods of treating/diagnosing human diseases are not patentable in Japan, claims directed to pharmaceutical compositions for use to treat a specific conditions or indications are patentable, as well as processes to make a pharmaceutical composition are patentable. Patents in Japan generally expire 20 years after the filing date of the patent application. Patents for pharmaceuticals may be extended for up to 5 years, depending on the amount of time spent for the drug approval process. Unlike the U.S., more than one patent per product can be extended in Japan. Japan also has a re-examination system which confirms the safety and efficacy of drugs and offers a re-examination period of 8 years for pharmaceuticals that contain new active pharmaceutical ingredients and 4 years to 6 years for new combination products and 10 years for orphan drugs. In the EU, patent applications may be filed in the European Patent Office (“EPO”) or in the national patent office of a country in Europe. The EPO system permits a single application to be granted for the EU, plus certain other non-EU countries, such as United Kingdom, Switzerland and Turkey. When the EPO grants a patent, it is then validated in the countries that the patent owner designates. At the patent owner's request, unitary effect is given for the territory of the EU Member States participating in the Unitary Patent (“UP”) system, that have ratified the Agreement on a Unified Patent Court (“UPC”). The term of a patent granted by the EPO or a European country office is generally 20 years from the filing date of the patent application. Pharmaceutical patents covering an approved medicinal product can be granted a further period of exclusivity under the Supplementary Protection Certificate (“SPC”) system. SPCs are designed to compensate the owner of the patent for the time it took to receive marketing authorization by the European Medicines Agency or the National Health Authorities. An SPC may only extend the patent term for a maximum of 5 years and not extend the patent term beyond 15 years from the date of the first European marketing authorization. The SPC duration can additionally be extended by a further Pediatric Extension of 6 months if the SPC relates to a non-orphan medicinal product for which data has been submitted according to a Pediatric Investigation Plan (“PIP”). The post-grant phase of patents, including the SPC system, is currently administered on a country-by-country basis under national laws. Therefore, although regulations concerning patents and SPCs have been created at the EPO and EU level, respectively, due to different national implementation they may not always lead to the same result, for example, if challenged in National Courts in the various EU countries. The EU also provides a system of regulatory data protection (RDP) for authorized human 39 Table of Contents medicines, which runs in parallel to any patent protection. The system for drugs being approved today is usually referred to as 8+2+1 rule because it provides an initial period of 8 years of data exclusivity, during which a competitor cannot rely on the relevant data, a further period of 2 years of market exclusivity, during which the data can be used to support applications for marketing authorization but the competitive product cannot be launched and a possible 1-year extension of the market exclusivity period if, during the initial 8-year data exclusivity period, the sponsor registered a new therapeutic indication for the concerned drug. However, the additional 1-year extension is only available if either no therapy exists for the new indication or if the concerned product provides for the new indication a “significant clinical benefit over existing therapies”. This system applies both to national and centralized authorizations. The EU also has an orphan drug exclusivity system for medicines similar to the U.S. system. If a medicine is designated as an orphan drug, it benefits from 10 years of market exclusivity, during which time a similar medicine for the same indication will not receive marketing authorization. Under certain circumstances, this exclusivity can be extended with a 2-year Pediatric Extension for completion of a PIP. The Pharma Legislation in Europe, including systems such as regulatory data protection is currently under revision and may result in different exclusivity periods in the future. In the revision process, a political agreement was reached between the European Council and the European Parliament in December 2025 agreeing on a 8+1+1+1 scheme for RDP and revised incentives for orphan medicines. The agreed texts of the new legislation have not yet been published, leaving the timeline uncertain. Worldwide, we experience challenges in the area of intellectual property from factors such as the penetration of generic versions of our products following the expiry of the relevant patents and the launch by competitors of over-the-counter versions of our products. Our Global General Counsel is responsible for the oversight of our Intellectual Property operations, as well as our legal operations. Our Intellectual Property Department supports our overall corporate strategy by focusing efforts on three main themes: •maximization of the value of our products and research pipeline and protection of related rights aligned to the strategies of our therapeutic area and business units; •facilitation of more dynamic harnessing of external innovation through partner alliance support; and •securing and protection of intellectual property rights around the world, including in emerging markets, except that, in least developed countries (LDCs) and low-income countries (LICs), we committed not to file or enforce patents as part of our commitment to widen access to our medicine. As infringement of our intellectual property rights poses a risk of loss of expected earnings derived from those rights, we have internal processes in place to manage patents and other intellectual property. This process includes both remaining vigilant against patent infringement by others as well as exercising caution, starting at the R&D stage, to ensure that our products and activities do not violate intellectual property rights held by others. In the regular course of business, our patents may be challenged by third parties. We are party to litigation or other proceedings relating to intellectual property rights. Details of material ongoing litigation are provided in Note 31 to our audited consolidated financial statements included in this annual report. The following table describes our outstanding substance patents and the regulatory protection (“RP”) (U.S. and EU) or re-examination period (“RP”) (Japan) for the indicated product by territory and expiry date. Patent term extensions (“PTE”), SPC and pediatric exclusivity periods (“PEP”) are reflected in the expiry dates to the extent they have been granted by the issuing authority. For PTE’s, SPC’s and PEP’s in which the application is in process but not yet granted, the extended expiry is separately provided. Our biologic products may face or already face competition from companies who produce similar products for the same indications, and/or biosimilars, regardless of expiry dates below. Certain European patents may be the subject of supplemental protection certificates that provide additional protection for the product in certain countries beyond the dates listed in the table. Our product Japan expiry dates*1, *2 U.S. expiry dates*1 EU expiry dates*1 Gastroenterology (GI): ENTYVIO Patent: - RP: July 2028*2 Patent: -*6 Patent: -*6 GATTEX/REVESTIVE Patent: - RP: June 2031*2 Patent: -*5 Patent: - TAKECAB*3 Patent: August 2031 Patent: -*3 Patent: -*3 PANTOLOC /CONTROLOC (PANTOPRAZOLE) Not commercialized Patent: - Patent: - DEXILANT Not commercialized Patent: - Patent: - LIALDA/MEZAVANT*3 Patent: - *3 Patent: - Patent: - RESOLOR/MOTEGRITY Not commercialized Patent: - Patent: - EOHILIA Not commercialized Patent: - RP: February 2031 Not commercialized 40 Table of Contents Our product Japan expiry dates*1, *2 U.S. expiry dates*1 EU expiry dates*1 Rare Diseases: TAKHZYRO Patent: January 2036 RP: March 2032*2 Patent: August 2032 RP: August 2030 Patent: November 2033 RP: November 2030 ADVATE Patent: - Patent: - Patent: - ADYNOVATE/ADYNOVI Patent: - Patent: - RP: November 2027 Patent: Extended expiry of February 2029*10 RP: January 2028 ELAPRASE *3 Patent: - *3 Patent: - Patent: - REPLAGAL Patent: - Not commercialized Patent: - VPRIV Patent: - Patent: - Patent: - FIRAZYR Patent: - RP: September 2028*2 Patent: - Patent: - LIVTENCITY Patent: - RP: June 2034*2 Patent: - RP: November 2028 Patent: - RP: November 2032 VONVENDI Patent: - RP: March 2030*2 Patent: December 2030 RP: December 2027*9 Patent: - RP: August 2028 ADZYNMA Patent: - RP: March 2034*2 Patent: - RP: November 2035 Patent: - RP: August 2034 PDT: GAMMAGARD LIQUID Patent: - Patent: - Patent: - HYQVIA Patent: - RP: September 2031*2 Patent: - RP: September 2026 Patent: - CUVITRU Patent: - RP: September 2031 Patent: - RP: September 2028 Patent: - RP: July 2026 FLEXBUMIN Not commercialized Patent: - Patent: - HUMANALBUMIN Not commercialized Patent: - Not commercialized FEIBA Patent: - Patent: - Patent: - HEMOFIL Not commercialized Patent: - Not commercialized IMMUNATE Not commercialized Not commercialized Patent: - IMMUNINE Not commercialized Not commercialized Patent: - CINRYZE Not commercialized Patent: - Patent: - GLASSIA Not commercialized Patent: - Not commercialized ARALAST Not commercialized Patent: - Not commercialized Oncology: ADCETRIS*4 Patent: July 2028*7 RP: May 2028*2*8 Patent: -*4 Patent: October 2027 LEUPLIN/ENANTONE Patent: - Patent: - Patent: - NINLARO Patent: July 2031 RP: March 2027*2 Patent: November 2029 Patent: November 2031 RP: November 2026 ICLUSIG*3 Patent: -*3 Patent: January 2027 Patent: -*3 ALUNBRIG Patent: November 2032 RP: January 2029*2 Patent: April 2031 Patent: November 2033 RP: November 2028 VECTIBIX*4 Patent: - Patent: -*4 Patent: -*4 ZEJULA*4 Patent: January 2033 RP: September 2028*2 Patent: -*4 Patent: -*4 41 Table of Contents Our product Japan expiry dates*1, *2 U.S. expiry dates*1 EU expiry dates*1 FRUZAQLA Patent: May 2034 RP: September 2032*2 Patent: March 2032 RP: November 2028 Patent: May 2029 RP: June 2034 CABOMETYX*4 Patent: September 2029 RP: March 2028*2 Patent: -*4 Patent: -*4 Vaccines: QDENGA Not commercialized Not commercialized Patent: - RP: December 2032 Neuroscience: VYVANSE/ELVANSE Patent: June 2029 RP: March 2027*2 Patent: - Patent: Extended expiry of February 2028, July 2028 or September 2029 in certain countries TRINTELLIX *4 Patent: October 2027 RP: September 2029*2 Patent: December 2026 Patent: -*4 ADDERALL XR Not commercialized Patent: - Not commercialized INTUNIV Patent: - Patent: - Patent: - Other: AZILVA Patent: - Not commercialized Not commercialized FOSRENOL*3 Patent: -*3 Patent: - Patent: - *1A “-” within the table indicates the substance patent is expired or not applicable. *2In Japan, an application for a generic product is filed after the re-examination period ends, and the product is listed in the approval and drug price listing after a regulatory review. Therefore, the generic product would enter the market after a certain period of time from the expiry of the re-examination period. *3This product is not sold by Takeda in all regions because of out-licensing agreements to third parties. *4This product is not sold by Takeda in all regions because of in-licensing agreements from third parties exclusive to certain regions. See “—Licensing and Collaboration” for further information on the licensing agreements. *5No generic has been launched in the U.S. as of March 2026. The exact timing of the market entry of the generic version of GATTEX/REVESTIVE is uncertain. *6Takeda has been granted patents that cover various aspects of ENTYVIO, including formulation, dosing regimens and process for manufacturing, some of which are expected to expire in 2032. Biosimilars seeking to launch prior to 2032 must address potential infringement and/or the validity of all relevant patents and therefore the exact timing of biosimilar entry is uncertain. *7Patent term extensions (PTE) for (a) frontline Hodgkin’s lymphoma, (b) relapsed/refractory PTCL excluding ALCL and (c) pediatric use for relapsed/refractory Hodgkin’s lymphoma, relapsed/refractory PTCL and frontline Hodgkin’s lymphoma (PTE for each of relapsed/refractory Hodgkin’s lymphoma and relapsed/refractory ALCL expires in April 2026). *8RP for pediatric frontline Hodgkin’s lymphoma only (RP for each of relapsed/refractory Hodgkin’s lymphoma, relapsed/refractory ALCL, frontline Hodgkin’s lymphoma, PTCL and pediatric relapsed/refractory Hodgkin’s lymphoma and pediatric relapsed/refractory PTCL expired in January 2024, RP for relapsed/refractory CTCL is September 2029). *9RP for routine prophylaxis of adults with severe type 3 VWD expires in January 2029. RP for on-demand treatment and perioperative management of bleeding in pediatric patients with VWD, and for routine prophylaxis in adults with VWD (other than severe type 3 VWD), expires in September 2032. *10It applies only in Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland and the United Kingdom. 42 Table of Contents Licensing and Collaboration In the ordinary course of business, we enter into arrangements for licensing and collaboration for the development and commercialization of products with third parties. Our business does not materially depend on any one of these arrangements. Instead they form a portion of our strategy and give us the ability to leverage a mix of internal and external resources to develop and commercialize new products. A sample of the agreements which have led to successful commercialization to date are summarized below: •ADCETRIS: We entered into a Collaboration Agreement with Pfizer Inc. (“Pfizer”) (as successor in interest to Seagen, Inc., which was acquired by Pfizer in December 2023) in 2009 for the global co-development of ADCETRIS and its commercialization around the world (other than the U.S. and Canada, where ADCETRIS is commercialized by Pfizer). We were required to pay milestone payments related to regulatory and commercial progress by us under the collaboration. We also pay tiered royalties with percentages ranging from the low-teens to the mid-twenties based on net sales of ADCETRIS within our licensed territories. We and Pfizer equally co-fund the cost of selected development activities conducted under the collaboration but as of March 31, 2026, there are no further incremental potential commercial milestone payments remaining under the ADCETRIS collaboration. Either party may terminate the collaboration for cause, or by mutual consent. We may terminate the collaboration at will, and Pfizer may terminate the collaboration in certain circumstances. If neither party terminates the collaboration agreement, then the agreement automatically terminates on the expiration of all payment obligations. •FRUZAQLA: We entered into a License Agreement with HUTCHMED Limited (“HUTCHMED”) in 2023 for the global development, commercialization and manufacture of fruquintinib outside of mainland China, Hong Kong and Macau. FRUZAQLA is now approved in the U.S., EU, Japan and a number of other countries in our licensed territory. Under the License Agreement, we are required to pay milestone payments related to development, regulatory and commercial progress by us, as well as royalties on net sales. Subject to earlier termination, the License Agreement will continue until the expiration of the last royalty term for the last licensed product in our licensed territory. We may terminate the License Agreement for convenience by providing a written notice in advance. Additionally, either party may terminate the License Agreement for cause. •TRINTELLIX: We entered into a License, Development, Supply and Commercialization Agreement with H. Lundbeck A/S in 2007 for the exclusive co-development and co-commercialization in the U.S. and Japan of several compounds in Lundbeck’s pipeline for the treatment of mood and anxiety disorders. In July 2024, Lundbeck announced our agreement to amend the Collaboration to provide for royalty payments by Takeda to Lundbeck based on net sales of TRINTELLIX in the U.S. in lieu of Lundbeck’s co-promotion and co-funding responsibilities, which have concluded. The term of the agreement is indefinite, but the agreement may be terminated by mutual decision of the parties or for cause. The following tables describe other research & development collaborations/partnering and externalization projects entered into by Takeda, but do not represent a comprehensive list of all Takeda R&D collaborations. All of the “subject” descriptions listed below are as of the date of execution of the relevant agreement unless otherwise noted: Gastrointestinal and Inflammation Partner Countryof incorporation Subject Arrowhead Pharmaceuticals U.S. Collaboration and licensing agreement to develop fazirsiran (TAK-999; ARO-AAT), an investigational RNA interference (RNAi) therapy in development to treat alpha-1 antitrypsin-associated liver disease (AATLD). ARO-AAT is a potential first-in-class therapy designed to reduce the production of mutant alpha-1 antitrypsin protein, the cause of AATLD progression. COUR Pharmaceuticals U.S. Takeda has acquired an exclusive global license to develop and commercialize the investigational medicine TIMP-GLIA (TAK-101), an immune modifying nanoparticle containing gliadin proteins. Engitix U.K. Collaboration and licensing agreement to utilize Engitix’s unique extracellular matrix discovery platform to identify and develop novel therapeutics for liver fibrosis and fibrostenotic inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. Halozyme U.S. Collaboration and license agreement granting Takeda exclusive access to Halozyme’s proprietary ENHANZE® drug delivery technology for use with vedolizumab. Mirum Pharmaceuticals U.S. Exclusive licensing agreement for the development and commercialization of LIVMARLI (maralixibat, TAK-625) in Japan for Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia (BA). 43 Table of Contents Partner Countryof incorporation Subject UCSD/Fortis Advisors U.S. Technology license for the development of EOHILIA (oral budesonide formulation, TAK-721) for treatment of eosinophilic esophagitis. Zedira/Dr. Falk Pharma Germany Collaboration and license agreement to develop and commercialize a potential first-in-class therapy TAK-227/ZED1227, a tissue transglutaminase 2 (TG2) inhibitor, designed to prevent the immune response to gluten in celiac disease. Takeda has exclusive rights in the U.S. and other territories outside of Europe, Canada, Australia and China. Neuroscience Partner Countryof incorporation Subject AC Immune Switzerland Exclusive, worldwide option and license agreement for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24.060 for the treatment of Alzheimer’s disease. AcuraStem U.S. Exclusive worldwide license agreement to develop and commercialize AcuraStem’s PIKFYVE targeted therapeutics for the treatment of Amyotrophic Lateral Sclerosis (ALS). Anima Biotech U.S. Strategic collaboration to discover and develop mRNA translation modulators for genetically-defined neurological diseases. BioMarin U.S. Agreement for the in-license of enabling technology for the exogenous replacement of Arylsulfatase A enzyme with intrathecal (IT) administration directly into the central nervous system for the long-term treatment of patients with metachromatic leukodystrophy (MLD), a rapidly-progressive and ultimately fatal neuro-degenerative rare disease (TAK-611). Denali Therapeutics U.S. Strategic option and collaboration agreement to develop and commercialize up to three specified therapeutic product candidates for neurodegenerative diseases, incorporating Denali’s transport vehicle (TV) platform for increased exposure of biotherapeutic products in the brain; options exercised on DNL593/TAK-594 and DNL919/TAK-920 in Q3 FY2021. DNL919/TAK-920 molecule was discontinued in Q2 FY2023, and the ATV:TREM2 collaboration program was terminated in February 2025 by mutual agreement between Takeda and Denali. In April 2026, Takeda informed Denali that it was terminating co-development of DNL593/TAK-594 and the collaboration in its entirety. Luxna Biotech Japan Exclusive worldwide license agreement for the use of Luxna’s breakthrough xeno nucleic acid technology for multiple undisclosed target genes in the area of neurological diseases. 44 Table of Contents Partner Countryof incorporation Subject Neurocrine Biosciences U.S. Collaboration to develop and commercialize 7 compounds in Takeda’s early-to-mid stage neuroscience pipeline, including TAK-041/NBI-1065846, TAK-653/NBI-1065845 and TAK-831/NBI-1065844 (luvadaxistat). Takeda will be entitled to certain development milestones, commercial milestones and royalties on net sales and will, at certain development events, be able to opt in or out of a 50:50 profit share on all clinical programs on an asset-by-asset basis. Takeda received notices from Neurocrine announcing the termination of TAK-041 and TAK-831 development which took effect in March 2025. In January 2025, the Takeda/Neurocrine agreement was amended for TAK-653. Takeda re-acquired exclusive rights in Japan and is eligible to receive milestone payments and royalties from commercialization in other regions. Takeda will be responsible for the development costs in Japan; Neurocrine will be responsible for the development costs worldwide ex-Japan and is eligible to receive royalties for sales in Japan. PeptiDream Japan Collaborative research and exclusive license agreement to create peptide-drug conjugates (PDCs) for neuromuscular and neurodegenerative diseases. Oncology Partner Countryof incorporation Subject AbbVie U.S. Exclusive licensing agreement to develop and commercialize mirvetuximab soravtansine-gynx in Japan for folate receptor-alpha (FRa) positive ovarian cancer. Adimab U.S. Agreement for the discovery, development and commercialization of three mAbs and three CD3 Bi-Specific antibodies for oncology indications. Ascentage Pharma China Option agreement to enter into an exclusive license agreement for olverembatinib/HQP1351, a BCR-ABL tyrosine kinase inhibitor (TKI), currently in development for chronic myeloid leukemia (CML) and other hematological cancers. If exercised, the option would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia. Crescendo Biologics U.K. Collaboration and licensing agreement for the discovery, development and commercialization of Humabody®-based therapeutics for cancer indications. Exelixis U.S. Exclusive licensing agreement to commercialize and develop CABOMETYX (cabozantinib) and its all potential future indications in Japan, including advanced renal cell carcinoma and hepatocellular carcinoma. F-star U.K. Worldwide exclusive royalty-bearing license to Takeda to research, develop, and commercialize a bispecific antibody directed towards an undisclosed immuno-oncology target using F-star’s proprietary Fcab™ and mAb2 ™ platforms. Takeda will be responsible for all research, development and commercialization activities under the agreement. GSK U.K. Exclusive licensing agreement to develop and commercialize ZEJULA (niraparib) for the treatment of all tumor types in Japan, and all tumor types excluding prostate cancer in South Korea and Taiwan. Heidelberg Pharma Germany Antibody-Drug-Conjugate (ADC) research collaboration on 2 targets and licensing agreement (α-amanitin payload and proprietary linker). 45 Table of Contents Partner Countryof incorporation Subject Innovent Biologics China Exclusive license, option and collaboration agreement with Innovent Biologics to advance next-generation immuno-oncology and antibody-drug conjugate (ADC) cancer therapies including: a collaboration on TAK-928 (IBI363), a first-in-class PD-1/α-biased IL-2 bispecific antibody fusion protein, including global co-development, U.S. co-commercialize, and exclusive commercialization rights outside the U.S. and Greater China; an exclusive license to further develop and commercialize TAK-921 (IBI343), an ADC targeting Claudin 18.2, outside of Greater China; and an exclusive option to license global development, manufacturing, and commercialization rights for IBI3001 (EGFR/B7H3 ADC) outside of Greater China. Keros Therapeutics U.S. Exclusive licensing agreement with Keros Therapeutics, Inc. to further develop, manufacture and commercialize elritercept (TAK-226) worldwide outside of mainland China, Hong Kong and Macau. Kumquat Biosciences U.S. Strategic and exclusive collaboration to develop and commercialize a novel immuno-oncology small molecule inhibitor as a mono- and/or combination-therapy. Protagonist Therapeutics U.S. Worldwide license and collaboration agreement for the development and commercialization of rusfertide (TAK-121), an investigational injectable hepcidin mimetic peptide of the natural hormone hepcidin for treatment of polycythemia vera. Plasma-Derived Therapies Partner Countryof incorporation Subject Halozyme U.S. Agreement for the in-license of Halozyme’s proprietary ENHANZE® platform technology to increase dispersion and absorption of HYQVIA. Kamada Israel In-license agreement to develop and commercialize IV Alpha-1 proteinase inhibitor (GLASSIA); Exclusive supply and distribution of GLASSIA in the U.S., Canada, Australia and New Zealand; work on post market commitments ongoing. Johnson & Johnson/Momenta Pharmaceuticals U.S. In-licensing agreement with Momenta Pharmaceuticals, Inc. which was acquired by Johnson & Johnson for an investigational hypersialylated immunoglobulin (hsIgG) candidate. PreviPharma Germany Research collaboration and option agreement to develop new targeted proteins. 46 Table of Contents Vaccines Partner Countryof incorporation Subject Novavax U.S. Partnership for the development, manufacturing and commercialization of NUVAXOVID® Intramuscular Injection, Novavax’s COVID-19 vaccine in Japan, which is being funded by the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) and Agency for Medical Research and Development (AMED). In September 2024, Takeda announced that the MHLW granted manufacturing and marketing approval for the 2 dose NUVAXOVID Intramuscular Injection 1 mL for the prevention of infectious disease caused by the SARS-CoV-2 Omicron JN.1 variant. Other / Multiple Therapeutic Area Partner Countryof incorporation Subject BridGene Biosciences U.S. Research collaboration to discover small molecule drugs for “undruggable” targets using BridGene’s chemoproteomics platform. Charles River Laboratories U.S. Collaboration on multiple integrated programs across Takeda’s core therapeutic areas using Charles River Laboratories’ end-to-end drug discovery and safety assessment platform to progress these programs towards candidate status. GSK U.K. In-license agreement between GSK and University of Michigan for LIVTENCITY (maribavir, TAK-620) in the treatment of human cytomegalovirus. Iambic Therapeutics U.S. Cross-therapeutic area discovery research alliance to leverage Iambic’s computational-driven discovery engine to accelerate delivery of high-quality small molecule candidate for first-in-class and best-in-class programs. Ipsen France Purchase agreement for the development of OBIZUR for the treatment of Acquired Hemophilia A including for patients with Congenital Hemophilia A with inhibitors indication in elective or emergency surgery. KM Biologics Japan Collaboration and license agreement for the development of therapeutic uses of ADZYNMA (rADAMTS13, TAK-755), including but not limited to TTP. Massachusetts Institute of Technology U.S. MIT-Takeda Program to fuel the development and application of artificial intelligence (AI) capabilities to benefit human health and drug development. Centered within the Abdul Latif Jameel Clinic for Machine Learning in Health (J-Clinic), the new program will leverage the combined expertise of both organizations, and is supported by Takeda’s investment. Nabla Bio U.S. Research collaboration to discover novel protein sequences with Nabla’s AI and experimental technologies for drug design. 47 Table of Contents Competition Competition in each market where we conduct business is based on, among other things, product safety, efficacy, convenience of dosing, reliability, availability and pricing. Our competitors include large international companies whose capabilities cover the entire product creation process from R&D to manufacturing and marketing, as well as biopharmaceutical companies with a focus on specific therapeutic areas. We also face competition from generic drugs and biosimilars that enter the market when our patent protection or regulatory exclusivity expires. See “—Intellectual Property” for additional description of our patents. Additionally, we may face competition from the introduction of our own new products that treat similar diseases as our older products. The competition we face often differs by product and geographic market, and competitors may emerge and fall away over time due to advances in innovation, merger activity and other business and market changes. The following table shows the principal sources of competition for our main products: Our product Principal competing product Primary manufacturer or distributor GI: DEXILANT, PANTOPRAZOLE (Protonix) Generic lansoprazole Various PANTOLOC/CONTROLOC Generic dexlansoprazole Various Pantroprazole Pfizer Nexium AstraZeneca Prilosec Procter and Gamble Prevacid Takeda Generic omeprazole Various Generic esomeprazole Various Generic rabeprazole Various ENTYVIO Remicade Janssen Biotech Humira Abbvie Stelara Janssen Biotech Xeljanz / Xeljanz XR Pfizer Velsipity Pfizer Omvoh Eli Lilly and Company Infliximab biosimilars Amgen, Pfizer, Organon Adalimumab biosimilars Various Rinvoq AbbVie Skyrizi AbbVie Zeposia BMS Jyseleca Alfasigma / Galapagos Carogra EA Pharma Zymfentra / Remsima SC Celltrion Simponi Janssen Biotech Cimzia UCB Tysabri Biogen Tremfya Johnson & Johnson Ustekinumab biosimilars Various EOHILIA Dupixent Regeneron / Sanofi 48 Table of Contents Our product Principal competing product Primary manufacturer or distributor Jorveza Dr. Falk Pharma TAKECAB Nexium AstraZeneca Generic lansoprazole, omeprazole, esomeprazole — Rare Diseases: ADVATE and ADYNOVATE Xyntha/Refacto AF Pfizer and Sobi Kovaltry Bayer Eloctate/Elocta Sanofi and Sobi Novoeight Novo Nordisk Nuwiq Octapharma Afstyla CSL Jivi Bayer Esperoct Novo Nordisk Hemlibra Roche Altuviiio Sanofi and Sobi Hympavzi Pfizer Alphanate Grifols Qfitlia Sanofi Alhemo Novo Nordisk ADZYNMA Octaplas Octapharma Koate-DVI Kedrion Dried Factor VIII Fraction Type 8Y Bio Products Laboratory ELAPRASE Hunterase Korean Green Cross IZCARGO JCR Pharmaceuticals AVLAYAH Denali FEIBA Hemlibra Roche Novo 7 Novo Nordisk Alhemo Novo Nordisk Qfitlia Sanofi LIVTENCITY Ganciclovir Various Valganciclovir Various Valaciclovir Various Aciclovir Various Foscarnet Various Cidofovir Various Letermovir Merck / MSD REPLAGAL Fabrazyme Sanofi Genzyme Galafold Amicus Fabagal Isu Abxis Elfabrio Chiesi TAKHZYRO Ruconest Pharming Haegarda CSL Berinert CSL Orladeyo BioCryst Androgens Various Andembry CSL Dawnzera Ionis 49 Table of Contents Our product Principal competing product Primary manufacturer or distributor VPRIV Cerezyme Sanofi Genzyme Elelyso/uplyso Pfizer/Protalix Zavesca Actelion [Janssen] Cerdelga Sanofi Genzyme Abcertin Isu Abxis PDT Immunology FLEXBUMIN and HUMAN ALBUMIN Alburex/AlbuRx CSL Albuminar, Albumex CSL Plasbumin Grifols Albutein/Albutein Flexbag Grifols Albunorm Octapharma Albumin Octapharma Kedbumin, Albuked Kedrion Albuminex BPL GAMMAGARD LIQUID, HYQVIA, CUVITRU Hizentra CSL Xembify Grifols Gamunex-C Grifols Cutaquig/Gammanorm Octapharma Vvygart Hytrulo Argenx Privigen CSL Flebogamma Grifols Asceniv ADMA Bivigam ADMA Gammaked Kedrion Qivigy Kedrion Yimmugo Kedrion Alyglo GC Biopharma Corp Gammaplex BPL Octagam Octapharma Panzyga Octapharma Oncology: ADCETRIS Keytruda Merck/MSD Opdivo Bristol-Myers Squibb ALUNBRIG Xalkori Pfizer Zykadia Novartis Alecensa Roche Lorbrena Pfizer Ensacove Xcovery FRUZAQLA Lonsurf Taiho Pharmaceutical Co. Stivarga Bayer ICLUSIG Gleevec Novartis Tasigna Novartis Scemblix Novartis Sprycel Bristol-Myers Squibb Bosulif Pfizer LEUPRORELIN (LEUPLIN) Zoladex AstraZeneca Eligard Recordati Gonax Ferring Orgovyx Sumitomo, Accord Healthcare Camcevi Accord BioPharma Generic leuprorelin Various NINLARO Revlimid Bristol-Myers Squibb Pomalyst/Imnovid Bristol-Myers Squibb Kyprolis Amgen 50 Table of Contents Our product Principal competing product Primary manufacturer or distributor Darzalex Janssen Biotech Empliciti Bristol-Myers Squibb Xpovio Karyopharm Sarclisa Sanofi Abecma Bristol-Myers Squibb Blenrep GSK Talvey/ Tecvayli Janssen Carvykti Janssen Elrexfio Pfizer Neuroscience: INTUNIV Generic atomoxetine Various Generic Guanfacine Various Qelbree Supernus Generic clonidine ER Various TRINTELLIX Viibryd AbbVie Auvelity Axsome Generics: bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, maprotiline, mirtazapine, nefazodone, nomifensine, paroxetine, sertraline, trazodone, venlafaxine, vilazodone Various VYVANSE/ELVANSE Generic mixed salts of a single-entity amphetamine product: –Adderall IR Various Generic mixed salts of a single-entity amphetamine product, extended release: –Adderall XR Various –Dyanavel XR Tris Pharma –Azstarys Corium Generic methylphenidate, extended release: –Concerta Janssen Pharmaceuticals –Jornay PM Ironshore Pharmaceuticals –Adhansia XR Purdue Pharma –Quillivant XR Tris Pharma –Ritalin LA Sandoz Dexmethylphenidate, extended release: –Focalin, XR Novartis –Generic dexmethylphenidate Various Non-stimulants: –Strattera (atomoxetine) Eli Lilly and Company –Intuniv (guanfacine) Takeda –Kapvay (clonidine) Shionogi –Qelbree (viloxazine) Supernus –Onyda XR (clonidine) Tris Pharma Vaccines: QDENGA Dengvaxia Sanofi Pasteur Butantan-DV Butantan 51 Table of Contents Regulation The pharmaceutical industry is subject to extensive global regulation by regional, national, state and local agencies. The regulatory agencies govern the testing, approval, production, labeling, distribution, post-market surveillance, advertising, dissemination of information and promotion of our products. The following is a description of the major regulations affecting our products in the U.S., Japan and the EU, our largest markets. The introduction of new pharmaceutical products generally entails a lengthy approval process. Products must be authorized or registered prior to marketing, and such authorization or registration must subsequently be maintained. In recent years, the registration process has required increased testing and documentation for the approval of new drugs, with a corresponding increase in the expense of introducing a new product to market. To register a pharmaceutical product, a registration dossier containing evidence establishing the safety, efficacy and quality of the product must be submitted to regulatory authorities. Generally, a therapeutic product must be registered in each country in which it will be sold. It is possible that a drug can be registered and marketed in one country while the registration authority in another country may, prior to registration, request additional information from the pharmaceutical company or even reject the product. It is also possible that a drug may be approved for different indications in different countries. The registration process generally takes between many months to several years, depending on the country, the quality of the data submitted, the efficiency of the registration authority’s procedures and the nature of the product. Many countries provide for accelerated processing of registration applications for innovative products of therapeutic interest. In recent years, efforts have been made among the U.S., Japan and the EU to harmonize registration requirements to achieve shorter development and registration times for medical products. United States In the U.S., applications for drug registration are submitted to and reviewed by the FDA, which regulates the testing, manufacturing, labeling, approval for marketing, and promotion and advertising of pharmaceutical products intended for commercialization. The FDA continues to monitor the safety of pharmaceutical products after they have been approved for sale in the U.S. market. When a pharmaceutical company has gathered data to demonstrate a drug’s safety, efficacy and quality, it may file for the drug an NDA or Biologics License Application (“BLA”), along with information regarding the clinical experiences of patients tested in the drug’s clinical trials. A supplemental New Drug Application (“sNDA”) or supplemental Biologics License Application (“sBLA”) must be filed for changes including, but not limited to new indications for a previously approved drug. The FDA offers several distinct expedited programs – e.g., Fast Track designation, Breakthrough Therapy designation, Priority Review designation, and the Accelerated Approval pathway – each with different criteria, timing, and regulatory implications, but do not change the statutory standards for approval. Once an application is submitted, the FDA assigns reviewers from its staff, including experts in biopharmaceutics, chemistry, clinical microbiology, pharmacology/toxicology, and statistics. After a complete review, these content experts then provide written evaluations of the NDA or BLA. These evaluations are consolidated and are used by senior FDA staff in its final evaluation of the NDA or BLA. Based on that final evaluation, the FDA then provides to the NDA or BLA’s sponsor an approval, or a “complete response” letter if the NDA or BLA application is not approved. If not approved, the letter will state the specific deficiencies in the NDA or BLA which need to be addressed. The sponsor must then submit an adequate response to the deficiencies to restart the review procedure. Once the FDA has approved an NDA, BLA, sNDA or sBLA amendment, the company can make the new drug available for physicians to prescribe. The drug owner must submit periodic reports to the FDA, including any cases of adverse reactions. For some medications, the FDA requires additional post-approval studies (Phase IV) to evaluate long-term effects or to gather information on the use of the product under specified conditions. Certain products may be subject to Risk Evaluation and Mitigation Strategies (REMS), which can impose additional post-marketing obligations such as restricted distribution, prescriber training, and patient monitoring. Throughout the life cycle of a product, the FDA requires compliance with standards relating to good laboratory, clinical and manufacturing practices. The FDA also requires compliance with rules pertaining to the manner in which we may promote our products. The Drug Price Competition and Patent Restoration Term Act of 1984, known as the Hatch-Waxman Act, established the application procedures for obtaining FDA approval for generic forms of brand-name drugs. Under these procedures, instead of conducting full-scale pre-clinical and clinical trials, the FDA can accept data establishing that the drug formulation, which is the subject of an abbreviated application, is bio-equivalent and has the same therapeutic effect as the previously approved drug, among other requirements. This act also provides market exclusivity provisions for brand-name drugs that can delay the submission and/or the approval of Abbreviated New Drug Applications (“ANDAs”), which are the applications for generic drug registrations. The Orphan Drug Act of 1983 grants seven years of exclusive marketing rights to a specific drug for a specific orphan indication. The term “orphan drug” refers, generally, to a drug that treats a rare disease affecting fewer than 200,000 persons in the U.S. and the applicable market exclusivity provisions are distinct from patent protections and apply equally to patented and non-patented drug products. While the Hatch-Waxman Act addresses the development and approval of generic drugs, the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”), enacted in the Affordable Care Act (the “ACA”) amended the Public Health Service Act (the “PHS Act”) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to, or “interchangeable”, with an FDA-licensed reference product. BPCIA allows for approval of a biosimilar if it is “highly similar” and has no clinically meaningful differences from its approved and existing biological product. Furthermore, as codified in the 2016 Physician Fee Schedule Final Rule, effective January 1, 2016, the physician reimbursement amount for a biosimilar is based on the average sales price (the “ASP”) of all National Drug Codes (the “NDCs”) assigned to the biosimilars included within the same billing and payment code. In general, this meant that CMS grouped biosimilar products that were licensed with a common reference product with the same payment limit and HCPCS code. However, effective January 1, 2018 under the 2018 Physician Fee Schedule Final Rule, newly approved biosimilar and reference products are assigned distinct HCPCS billing codes under current CMS policy, following the 2018 update to Medicare Part B biosimilar reimbursement. 52 Table of Contents The Food and Drug Omnibus Reform Act (“FDORA”) of 2022 requires the FDA to develop several different kinds of informational documents as it pertains to pharmaceuticals and it amends statutory authorities to reform aspects of the FDA’s regulatory framework. FDORA introduces several changes to the FDA’s authority, particularly for accelerated approvals. Recent statutory changes generally require that confirmatory trials be underway at the time of accelerated approval and provide the FDA with enhanced authorities to ensure timely completion or to withdraw approval if studies fail to verify clinical benefit. Japan Manufacturers and sellers of drugs, quasi-drugs, cosmetics, medical devices and regenerative medical products (collectively the “Designated Products”) in Japan are subject to the supervision of the MHLW primarily under the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics of Japan (“Pharmaceutical and Medical Device Act” or the “PMD Act”). Under the PMD Act, the relevant licenses must be obtained from the MHLW in order to conduct the business of manufacturing, marketing or selling Designated Products. Applications for the approval of new products are made through the PMDA. The clinical trial data and other pertinent data must be attached to the application for approval. If the drugs, medical devices or regenerative medical products under application are of types designated by ministerial ordinance of the MHLW, the attached data mentioned above must be obtained in compliance with the standards established by the Minister, such as the Good Laboratory Practice (the “GLP”) and the Good Clinical Practice (the “GCP”). Once an application for approval is submitted, a review team is formed, which consists of specialized officials of the PMDA, including experts on chemistry/manufacturing, non-clinical, clinical, and biostatistics. Team evaluation results are passed to the PMDA’s external experts, who then report back to the PMDA. After a further team evaluation, a report is provided to the Minister; the Minister makes a final determination for approval and refers this to the Council on Drugs and Foods Sanitation, which then advises the MHLW on final approvability. Marketing and distribution approvals require a review to determine whether or not the product in the application is suitable as a drug to be manufactured and distributed with which a manufacturing and distribution business license for the type of drug concerned has been obtained, and to confirm that the product has been manufactured in a plant compliant with the GMP. Once the MHLW has approved the application, the company can make the new drug available for physicians to prescribe. After that, the MHLW lists its NHI price within 60 days (or 90 days at the latest) from the approval, and physicians can obtain reimbursement. For some medications, the MHLW requires additional post‑marketing studies (Phase IV) to further evaluate safety and/or to gather information concerning the quality, efficacy, and safety of the product under specified conditions, in addition to post-marketing surveillance including Early Post-marketing Phase Vigilance (“EPPV”) based on the risk management plan (“RMP”) for all new medications. The MHLW also requires the drug’s sponsor to submit periodic safety update reports. Within three months from the specified re‑examination period, which is designated at the time of the approval of the application for the new product, the company must submit a re‑examination application to enable the drug’s quality, efficacy, and safety to be reassessed against approved labeling by the PMDA. The PMD Act also provides for special regulations applicable to drugs, quasi-drugs, cosmetics and medical devices made of biological raw materials. These regulations impose various obligations on manufacturers and other persons in relation to manufacturing facilities, explanation to patients, labeling on products, record-keeping and reporting to the Minister. Under the PMD Act, the Minister may take various measures to supervise manufacturing and marketing license holders of Designated Products. The Minister has the authority to order manufacturing and marketing license holders to temporarily suspend the marketing, leasing or providing of the Designated Products to prevent risks or increases in risks to the public health. Also, the Minister may revoke a license or approval granted to a manufacturing and marketing license holder or order a temporary business suspension under certain limited circumstances such as violation of laws relating to drugs. European Union In the EU, there are two main routes for an application for authorization to market pharmaceutical products in the EU Member States: the Centralized route and a national route. The national route includes the Mutual Recognition Procedure (the “MRP”) and the Decentralized Procedure (the “DCP”). It is also possible to obtain a pure national authorization for products intended for commercialization in a single EU Member State only. Under the Centralized Procedure, applications are made to the EMA for an authorization which is valid throughout the EU, as well as in Iceland, Liechtenstein and Norway. The Centralized Procedure is mandatory for human medicines containing a new active substance to treat cancer, neurodegenerative disorders, diabetes, AIDS, autoimmune diseases or other immune dysfunctions, viral diseases, medicines derived from biotechnology processes, advanced therapy medicines, and orphan medicines. It is optional for other medicines containing new active substances for indications other than those stated above or if there is a significant therapeutic, scientific or technical innovation or if in the interest of public health. When a pharmaceutical company has gathered data which it believes sufficiently demonstrates a drug’s safety, efficacy, and quality, then the company may submit an application to the EMA. The EMA then receives and validates the application, and the Committee for Medicinal Products for Human Use (the “CHMP”) appoints a Rapporteur and Co-Rapporteur to lead review of the dossier. The entire review cycle must be completed within 210 days, although there is a “clock stop” at day 120, which allows the company to respond to questions set forth in the Rapporteur and Co-Rapporteur’s Assessment Report. After the company’s complete response is submitted to the EMA, the clock restarts on day 121. If there are further aspects of the dossier requiring clarification, the EMA will then request an Oral Explanation on day 180, in which case the sponsor must appear before the CHMP to provide the requested additional information. On day 210, the CHMP will then take a vote to recommend the approval or non-approval of the application. The final decision under this Centralized Procedure is a European Community decision which is binding in its entirety on all EU Member States. This decision occurs on average 60 days after a positive CHMP recommendation. In the case of a negative opinion, a written request for re-examination of the opinion can be made by the applicant within a time limit of 15 days from the date of 53 Table of Contents the opinion. The detailed grounds for re-examination must be submitted to the EMA within 60 days from the date of the opinion. In the EU, biosimilars may be approved under the centralized procedure. Similar to the pathway in the U.S., applicants seek and obtain regulatory approval for a biosimilar once the data exclusivity period for the original reference product has expired relying in part on the data submitted for the original reference product together with data evidencing that the biosimilar is “highly similar” in terms of quality, safety and efficacy to the original reference product authorized in the European Economic Area. Under both the MRP and DCP, the assessment is led by a single EU Member State, called the Reference Member State, which then liaises with other EU Member States, known as the concerned member states. In the MRP, the company first obtains a marketing authorization in the Reference Member State, which is then recognized by the concerned member states in 90 days. In the DCP, the application is done simultaneously in the Reference Member State and all concerned member states. During the DCP, the Reference Member State drafts an assessment report within 120 days. Within an additional 90 days, the concerned member states review the application and can issue objections or requests for additional information. On day 90, each concerned member state must be assured that the product is safe and effective, and that it will cause no risks to the public health. Once an agreement has been reached, each member state grants national marketing authorizations for the product. After the Marketing Authorizations have been granted, the company must submit Periodic Safety Update Reports (PSURs) exclusively through the PSUR Repository, which serves as a single EU platform used by marketing authorization holders, the EMA, and national competent authorities. Since June 13, 2016, use of the repository has been mandatory for all PSUR submissions, except for products authorized under Article 58. The repository supports both PSUR Single Assessment (PSUSA) procedures and national PSUR procedures for products outside the EURD list. In addition, several pharmacovigilance measures must be implemented and monitored including Adverse Event collection, evaluation and expedited reporting and implementation, as well as update Risk Management Plans. For some medications, post-approval studies (Phase IV) may be required to complement available data with additional data to evaluate long-term effects (called a Post-Approval Safety Study) or to gather additional efficacy data (called a Post-Approval Efficacy Study). European Marketing Authorizations have an initial duration of five years. After this first five-year period, the holder of the marketing authorization must apply for its renewal, which may be granted based on the competent authority’s full benefit-risk review of the product. Conditional MAs granted under Article 14-a of Regulation (EC) No 726/2004 do not fall under the above provisions. They are valid for one year and should therefore be renewed annually until data obligations are fulfilled. Once renewed, the marketing authorization is generally valid for an unlimited period. Any Marketing Authorization which is not followed within three years of its granting by the actual placing on the market in any EU member state of the corresponding medicinal product ceases to be valid. In December 2025, the Council of the European Union and the European Parliament reached a provisional agreement on the long-awaited “Pharma Package.” The Pharma Package is a comprehensive and major overhaul of the EU legislative framework for pharmaceuticals, although the reform must be formally approved by both institutions and published in the EU’s Official Journal prior to taking force and most of the provisions are expected to apply following an applicable transition period. This reform is expected to significantly affect regulations over product development, supply, access and other matters. Proposed changes include revisions to the EU General Pharmaceutical Legislation that would modify regulatory data protection and market exclusivity rules, reducing the minimum exclusivity period by one year while providing for the possibility of up to two years of extensions, streamline and shorten the regulatory approval process, allow member states to require that products be launched in their country, and introduce new restrictions on comparative advertising. These changes are expected to take effect between 2028 and 2029. Third-Party Reimbursement and Pricing We consider global competitive conditions, such as the price of competing products, in setting and revising the price of our pharmaceutical products. Government regulation also has a significant effect in determining the price of pharmaceutical products in many of the countries in which we operate due to the fact that government policy in many countries has emphasized and purchasers continue to seek large discounts on pharmaceutical products. United States In the U.S. our sales are subject to various voluntary and mandatory rebates and ceiling prices, which vary depending on the type of coverage and can have a significant impact on our results. The most significant of these are rebates associated with commercial managed care, Medicaid, Medicare and other government programs. In general, the details of these rebates are not disclosed publicly. Commercial Managed Care Payers negotiate rebates to reduce the pricing of products, and use formularies to encourage members to utilize preferred products to manage their costs. Exclusion from a formulary, or a disfavored formulary position, can directly reduce product usage. Consolidation of payers, pharmacy benefit managers and specialty pharmacies has resulted, and may continue to result, in increasing rebates and other discounts due to the purchasing power of the consolidated entities. Copay assistance to help patients afford their prescribed drugs may also affect product usage. In recent years, some states such as California and Massachusetts, have passed legislation that limits the use of manufacturer sponsored copay assistance programs, and some payers have limited manufacturer copay assistance benefits to patients. Medicaid Medicaid is a state administered program adhering to federal requirements that provides healthcare coverage to eligible low-income adults, children, pregnant women, elderly adults and people with disabilities. Takeda must pay rebates on purchases of our products under the Medicaid Drug Rebate Program. This includes a mandatory minimum rebate, additional rebates if commercial discounts are greater than the mandatory minimum rebate and an inflation penalty if our prices have 54 Table of Contents increased above inflation. These rebates guarantee that any patient in the Medicaid program can have access to Takeda’s products, although there could be significant utilization management imposed by the state. In addition to the mandatory rebates, Takeda may also choose to offer supplemental rebates to a state or Medicaid managed care organization to ensure Takeda’s drugs are on the preferred drug list (which is similar to a formulary for Medicaid programs). Takeda must also calculate and report to government agencies the amount of the rebate. The required calculations are complex, and a misrepresentation in the reported information may expose Takeda to penalties. We are required to report any revisions to prior calculations, which could affect the rebate liability for prior quarters. Medicare Medicare is a federally run program that provides healthcare to persons aged 65 and over, and certain persons under the age of 65 who have a long-term disability and meet certain eligibility requirements. Drugs are primarily covered under two different benefits for Medicare beneficiaries, Medicare Part B and Medicare Part D. Medicare Part B covers outpatient health and medical services, which includes some drugs under the medical benefit. These drugs tend to be the most biologically complex and are generally administered in a doctor’s office or hospital outpatient setting. Medicare Part D is a voluntary drug offering available to Medicare beneficiaries through private health insurance plans that contract with the government to deliver this benefit. Part B covers drugs that are administered by infusion or injection in a doctor’s office or hospital outpatient setting, as well as certain drugs furnished in the home. Medicare pays physicians and outpatient hospitals for most separately payable Part B-covered drugs they furnish to beneficiaries at a rate of 106 percent of the manufacturer-reported ASP before sequestration. A product’s ASP reflects the average price realized by the manufacturer for sales to all commercial purchasers net of rebates, discounts, and price concessions with certain exceptions. Takeda must also calculate and report specific prices to government agencies, including the ASP used by the Medicare Part B program. The required calculations are complex, and a misrepresentation in the reported pricing may expose Takeda to penalties. Part D covers most of the other outpatient prescription drugs. Except as set forth below with respect to drugs covered by the negotiation provisions of the Inflation Reduction Act (“IRA”), rather than Medicare setting prices administratively, Medicare pays Part D plan sponsors (health plans offering the benefit) that, through their pharmacy benefit managers, contract with pharmacies over payment rates for each prescription filled by an enrollee and negotiate with drug manufacturers for prices and post-sale rebates. Takeda may offer a rebate that goes to plan sponsors to ensure that our products are on formulary. In 2022, Congress passed the IRA, which imposes penalties on manufacturers that raise Part D and Part B drug prices, AMP and ASP respectively, faster than the rate of inflation starting in 2022 for Part D drugs and 2023 for Part B drugs; shifts greater liability to the manufacturer in the Part D program resulting in a 10% discount on brand drugs in the initial coverage phase and 20% in the catastrophic phase, as well as implementing a USD 2,000 out-of-pocket cap for patients on drug expenses starting in 2025; and mandates the negotiation of a new Medicare “maximum fair price” for certain drugs in the Medicare Part D program and the Part B program effective in 2026 and 2028 respectively. In January 2026, the U.S. Centers for Medicare & Medicaid Services selected ENTYVIO, which was our highest-selling product in the fiscal year ended March 31, 2026, for Medicare price negotiations pursuant to the IRA effective January 2028. 340B and Federal Agency Discounted Pricing Takeda must offer discounted pricing for purchases by certain designated health care entities and federal agencies under certain federal programs, including the Public Health Service (the “PHS”) pharmaceutical pricing program (“340B”) and the Federal Supply Schedule (the “FSS”). The 340B program was designed to assist safety net hospitals that serve a disproportionate share of indigent patients by requiring manufacturers, as a stipulation of participation in the Medicaid Drug Rebate Program, to provide deep discounts on covered outpatient drugs. The discounts adhere to a statutory formula, per product, that requires manufacturers to charge no more than a certain price. Entities that may apply to participate in the 340B program include qualifying hospitals, federal grantees, the Centers for Disease Control and Prevention, and the Indian Health Service. The FSS is a list of contracts and prices for frequently used supplies and services available for purchase by federal agencies and other entities such as the U.S. territories and tribal governments. Although there are no statutory ceilings on prices, the government often uses a favored price as a starting point in negotiations to obtain below-market prices. Health Care System Reform For the past few years, there has been an increased focus and downward pressure on pricing which we expect to continue for a variety of circumstantial reasons. There are a number of legislative and regulatory proposals under consideration that would impact how drugs are reimbursed in the U.S., could restrict patient access, and have financial implications for manufacturers. Recent and potential Executive Orders and other policy proposals by the U.S. administration addressing pharmaceutical pricing and reimbursement could result in additional pricing pressures or changes on manufacturers. See also “Item 3. Key Information—D. Risk Factors—Government policies and other pressures to reduce medical costs could have an adverse effect on sales of our pharmaceutical products.” Japan In Japan, manufacturers of pharmaceutical products must have new products listed on the National Health Insurance (the “NHI”), a price list published by the MHLW. The NHI price list provides rates for calculating the price of pharmaceutical products used in medical services provided under various public medical care insurance systems. Prices on the NHI price list have been previously subject to revisions based on the actual prices and amounts by which the pharmaceutical products are purchased by medical institutions in Japan, and the average price of previously listed products generally decreases as a result of these price revisions. The Japanese government is currently undertaking healthcare reform initiatives with the goal of sustaining the universal coverage of the NHI program and balancing competing national expenditures. As part of these initiatives, the annual NHI price list revision, implemented since April 2021, has led to more frequent downward price revisions. The government is also addressing the efficient use of generic drugs, with a primary target of 80% penetration in each prefecture by volume and a secondary target of 65% in value by March 2030 with respect to products for which market exclusivity has expired. In addition, products on the NHI price list nominated 55 Table of Contents based on pre-defined criteria, such as innovativeness and the financial impact, are subject to a cost-effectiveness evaluation under MHLW rules, and subject to price adjustments depending on the outcome of this evaluation. Furthermore, effective June 1, 2026, for certain drugs under the MHLW’s selected medical care framework, a surcharge equal to one-half of the difference in drug prices, will apply as a special charge if patients request a long-listed originator drug for which generic drugs are available (unless medically necessary or where generics cannot be provided), which may lead to reduced utilization of originator products and as a result, may limit our ability to maintain pricing levels in Japan. Europe In the EU, our operations are subject to significant price and marketing regulations. Many governments in the EU continuously introduce revisions to healthcare reforms to curb increasing healthcare costs. The governments in the EU influence the price of pharmaceutical products through their control of national healthcare systems that fund a large part of the cost of such products to patients. The general downward pressure on healthcare costs, particularly regarding prescription drugs, has been increasing. In addition, prices for marketed products are referenced within and amongst the EU Member States and internationally, which further affects pricing in each EU Member State. As an additional control for healthcare budgets, some EU Member States have passed legislation to impose further mandatory rebates for pharmaceutical products and financial claw-backs on the pharmaceutical industry. In this regard, many countries have health technology assessment organizations that use formal clinical and economic metrics such as cost-effectiveness to inform prices, coverage and reimbursement decisions of new therapies, and these organizations are expanding in established and emerging markets. We expect that countries will continue to take aggressive actions to seek to ensure the sustainability of expenditures related to drugs and biologics. Similarly, fiscal constraints may also affect the extent to which countries are willing to approve new and innovative therapies and/or allow access to new treatments. Starting in 2025, the EU Regulation on Health Technology Assessment took effect, initially to new oncology and advanced therapeutic medicinal products, expanding in 2028 to orphan drugs and from 2030 to all centrally registered products, adding an additional layer of scrutiny to subsequent national-level pricing and reimbursement processes. While the exact impact of this regulation is not yet known, it is expected to increase clinical evidentiary requirements on manufacturers by pooling specific data requirements from all EU member states. If we are unable to meet these heightened requirements, our products could face potential adverse impacts on pricing and reimbursement in EU markets. In addition, the recent Critical Medicine Act proposal expands the existing possibilities for collaborative procurement involving Member States and the Commission. It sets out the options for joint procurement by Member States (facilitated by the Commission), centralized procurement by the Commission on behalf of or in the name of Member States and joint procurement by Member States and the Commission (Articles 21 to 24 CMA Proposal). If implemented, this could exert downward pressure on prices of such jointly procured products. The EU is currently undergoing an analysis of the rewards extended for intellectual property of pharmaceutical products as well as the overall regulatory framework for the approval and commercialization of all medicinal products. This may lead to significant changes in the way drugs are approved and commercialized as well as the duration of exclusivity, in particular for drugs of biological origin. These changes are likely to affect the market within a 3-5-year timeframe. Furthermore, certain European countries also utilize aggressive competitive tendering practices to secure undifferentiated prescription drugs at lower price levels, fueled by competitive forces. Takeda often participates in tendering in these regions, which usually results in a significant price discount. Other Many other countries around the world are also taking steps to control prescription drug prices. For example, China's National Health Security Administration (NHSA) conducts annual price negotiations and assessments to determine which new drugs can be added to the national reimbursement list. This has accelerated the inclusion of innovative drugs, with significant price discounts. Additionally, Volume-based Procurement (VBP) allows off-patent drugs to compete with their generics in a tendering process, where they must compete on price to win large volume contracts. Canada has proposed amendments to its Patented Medicines Regulations that could reduce prices for specialty medicines, such as biologics and medicines for rare diseases. Disclosures Under the Iran Threat Reduction and Syria Human Rights Act of 2012 Takeda is a global R&D-driven biopharmaceutical company with a presence in approximately 80 countries and regions. A non-U.S. Takeda legal entity that is not owned or controlled by a U.S. affiliate currently sells a limited number of pharmaceutical products in Iran through a third-party, private distributor, which involves further sales by the distributor to the Ministry of Health for distribution to local hospitals and other patient care providers. The products involved are standard of care therapeutics prescribed for chronic and acute medical needs, and Takeda does not maintain any physical operations, assets, or personnel in Iran. Takeda’s gross revenues and net profits from these sales were approximately JPY 3.2 billion and JPY 1.4 billion, respectively, in FY2025. Such sales are not financially material to Takeda, accounting for less than 1% of Takeda’s consolidated global sales. Takeda’s U.S. subsidiaries, as well as its non-U.S. subsidiaries that are owned or controlled by Takeda’s U.S. entities, either do not engage in Iran-related activities or act under a general license issued by the U.S. Department of Treasury’s Office of Foreign Assets Control (OFAC). As of the date of the annual report containing this disclosure, we do not anticipate any change to our activities with respect to Iran. C. Organizational Structure We are a holding company and administer our business through a number of subsidiaries worldwide. Information about Takeda’s organizational structure, including a list of our subsidiaries, their country of incorporation and residence and our proportion of ownership interest, is included in Note 28 to our audited consolidated financial statements included in this annual report. 56 Table of Contents D. Property, Plant and Equipment Our registered head office is located in Osaka, Japan and our global head office is located in Tokyo, Japan. We generally own our facilities or have entered into long-term lease arrangements for them. As of March 31, 2026, the net book values of the buildings and structures, machinery and vehicles, tools, furniture and fixtures and land we owned were JPY 1,169.5 billion, JPY 416.1 billion, JPY 53.4 billion and JPY 108.3 billion, respectively. We own the majority of our facilities, none of which are subject to any material encumbrances. We believe our facilities are generally suitable for future needs. Please refer to “Item 3.D Risk Factors” for more information about risks related to our manufacturing. The following table describes our major facilities, including production facilities for biopharmaceutical products, plasma-derived therapies and vaccines, as of March 31, 2026: Group company Location*1 Use of facility Land Area (in square meter) Takeda Pharmaceutical Company Limited Chuo-ku, Tokyo, Japan and others Global Headquarters*2(Administrative and sales) 16,052 Takeda Pharmaceutical Company Limited Chuo-ku, Osaka, Japan and others Head Office*2(Administrative and sales) 362,305 Takeda Pharmaceutical Company Limited Yodogawa-ku, Osaka, Japan Production, research and development 163,694 Takeda Pharmaceutical Company Limited Hikari-shi, Yamaguchi, Japan Production, research and development 1,011,061 Takeda Pharmaceutical Company Limited Narita-shi, Chiba, Japan Production, research and development 27,644 Takeda Pharmaceutical Company Limited Fujisawa-shi, Kanagawa, Japan Research and development 21,009 Baxalta US Inc. Covington, GA, U.S. Production and others 823,227 BioLife Plasma Services LP Bannockburn, IL, U.S. Production and others 453,691 Shire Human Genetic Therapies, Inc. Lexington, MA, U.S. Production and others 393,799 Takeda Ireland Limited Kilruddery, Ireland Production and others 202,679 Baxalta Belgium Manufacturing S.A. Lessines, Belgium Production and others 150,599 Takeda Manufacturing U.S.A., Inc. Round Lake, IL, U.S.A. Production and others 144,649 Takeda Manufacturing Austria AG Vienna, Austria Production and others 140,559 Takeda Manufacturing Italia S.p.A. Rome, Italy Production and others 111,150 Baxalta Manufacturing S.à r.l. Neuchatel, Switzerland Production and others 87,040 Takeda Development Center Americas, Inc. Cambridge, MA, U.S. Research, development and others 73,382 Takeda Austria GmbH Linz, Austria Production and others 24,850 Takeda Singen Real Estate GmbH & Co. KG Singen, Germany Production and others 141 Takeda Pharmaceuticals U.S.A., Inc. Cambridge, MA, U.S. Administrative, sales and others — Takeda GmbH Konstanz, Germany Production and others — Takeda Manufacturing Singapore Pte. Ltd. Singapore Production and others — *1For subsidiaries, location specified is the main location of the subsidiary. Certain production facilities may be in other locations in the country specified. *2Global Headquarters and Head Office consist of buildings, accompanying facilities and lands, including dormitories, company housing and other lands and facilities managed by Global Headquarters and Head Office. 57 Table of Contents The following table sets forth our material new facility construction, facility removal projects and/or facilities sales projects: Classification Company Name [Main Location] Operating Segment Details Budget Financing Schedule Total JPY (millions) Paid JPY (millions) Commencement Completion Construction Takeda Pharmaceutical Company Limited [Yodogawa-ku, Osaka, Japan] Pharmaceuticals Manufacturing *1 -*2 9,756 Funds on hand - *2 - *2 Construction Baxalta US Inc. [Los Angeles, CA, U.S.A.] Pharmaceuticals Manufacturing *3 38,966 29,767 Funds on hand January 2024 February 2028 Construction Takeda Pharmaceuticals U.S.A., Inc. [Cambridge, MA, U.S.A.] Pharmaceuticals Research and office 310,667 *4 14,143 Funds on hand/Lease January 2023 December 2028 Construction Takeda Pharmaceuticals U.S.A., Inc. [Cambridge, MA, U.S.A.] Pharmaceuticals Office 31,143 17,657 Funds on hand October 2022 October 2026 Construction Baxalta Belgium Manufacturing S.A. [Lessines, Belgium] Pharmaceuticals Manufacturing and warehouse *5 46,813 46,777 Funds on hand February 2022 June 2027 Construction Baxalta Manufacturing, S.à r.l. [Neuchatel, Switzerland] Pharmaceuticals Manufacturing 32,209 30,494 Funds on hand June 2021 July 2027 *1The facility is for the manufacturing of plasma-derived therapies. *2Takeda had planned a long-term investment to construct a new manufacturing facility for plasma-derived therapies at the Osaka plant with a total budget of JPY 95,000 million. In the fiscal year ended March 31, 2025, Takeda decided to increase the total planned investment amount to JPY 153,000 million and revised the expected commencement and completion schedule, reflecting a price surge in construction materials, partly attributable to the depreciation of the Japanese yen, as well as a labor shortage among construction companies. In the fiscal year ended March 31, 2026, following a comprehensive review of construction costs with its partners, Takeda observed additional upward pressure on project costs and proceeded to reevaluate the scope of the construction plan, as well as the timeline for the commencement and completion of the construction. *3The facility is for a plasma fractionation capacity expansion. *4The budget includes a lease term payment obligation expected to start in 2026 based on a lease agreement we entered into. *5The facility is for the manufacturing of plasma-derived therapies. Environmental Matters We are subject to laws and regulations concerning the environment, safety matters, regulation of chemicals and product safety in the countries where we manufacture and sell our products or otherwise operate our business. These requirements include regulation of the handling, manufacture, transportation, use and disposal of materials, including the discharge of pollutants into the environment. In the normal course of our business, we are exposed to risks relating to possible releases of hazardous substances into the environment, which could cause environmental or property damage or personal injuries, and which could require remediation of contaminated soil and groundwater, in some cases over many years, regardless of whether the contamination was caused by us, or by previous occupants of the property. See “Item 3. Key Information—D. Risk Factors—We may incur claims relating to our use, manufacture, handling, storage or disposal of hazardous materials.”