20-F: Takeda Reports Strong Revenue Growth Driven by Key Products, Navigates Generic Competition and Strategic Restructuring in Fiscal Year 2025

Sentiment:

Annual Report 25 June 2025 6:23 AM

📋All filings for Takeda Pharmaceutical CO LTD

Takeda Pharmaceutical Company Limited announced its fiscal year ended March 31, 2025 results, reporting a 7.5% increase in revenue to JPY 4,581.6 billion, primarily driven by growth in its Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology, and Vaccines segments, despite significant generic erosion impacting Neuroscience products.

Delay expectedThe U.S. biologics license application (BLA) for TAK-003 (dengue vaccine candidate) was voluntarily withdrawn in July 2023 following discussions with the FDA about data collection aspects that could not be addressed within that BLA review cycle.The construction of a new manufacturing facility for plasma-derived therapies at the Osaka plant has a revised expected commencement and completion schedule due to price surge in construction materials and labor shortage.The new R&D laboratory in Vienna's Donaustadt district is planned to be constructed in 2026, indicating a future project rather than an immediate completion.The new R&D and office facility in Kendall Square is planned to be occupied from 2026, indicating a future project rather than an immediate completion.

Capital raiseOn June 25, 2024, Takeda issued 60-year Unsecured Hybrid Bonds with an aggregate principal amount of JPY 460.0 billion.On July 5, 2024, Takeda issued USD 3,000 million in Unsecured U.S. Dollar-Denominated Senior Notes.On October 3, 2024, Takeda drew down a Syndicated Hybrid Loan with an aggregate principal amount of JPY 40.0 billion.On June 12, 2025, Takeda issued unsecured JPY denominated senior bonds (JPY 184,000 million aggregate principal amount) to redeem short-term commercial paper.

Worse than expectedNet profit for the year decreased by 25.0% (AER) and 33.1% (CER) in FY2025, primarily due to a large tax benefit in the prior year not recurring and increased tax expenses in the current year.Neuroscience segment revenue declined by 9.8% (AER) and 14.1% (CER), largely due to significant generic erosion of VYVANSE and ADDERALL XR in the U.S.Sales of AZILVA decreased substantially by 64.9% (AER/CER) due to generic entrants in Japan.Significant impairment losses of JPY 95.6 billion were recorded in FY2025 due to terminated development programs and study failures.The company incurred JPY 128.1 billion in restructuring expenses in FY2025, with more expected, negatively impacting short-term profitability.

Summary

Takeda's revenue for the fiscal year ended March 31, 2025, increased by JPY 317.8 billion (7.5% AER, 2.9% CER) to JPY 4,581.6 billion, primarily due to favorable foreign exchange rates and strong performance of key growth products.
Growth & Launch Products contributed JPY 2,201.9 billion (48% of consolidated revenue), showing a 20.6% AER (14.7% CER) increase, with ENTYVIO, Immunoglobulin products, Albumin products, and TAKHZYRO being significant drivers.
ENTYVIO revenue reached JPY 914.1 billion, up 14.1% AER (8.5% CER), driven by strong demand in the U.S. and Europe, including the subcutaneous formulation launch.
Plasma-Derived Therapies (PDT) revenue grew to JPY 1,032.7 billion, up 14.3% AER (8.6% CER), with immunoglobulin products showing double-digit growth due to strong global demand and supply.
Oncology revenue increased to JPY 560.4 billion, up 21.2% AER (17.2% CER), boosted by the launch momentum of FRUZAQLA and strong demand for ADCETRIS and ICLUSIG.
Vaccines revenue increased to JPY 55.4 billion, up 10.0% AER (7.5% CER), largely due to the expansion of QDENGA availability in approximately 30 countries.
Neuroscience revenue decreased to JPY 565.8 billion, down 9.8% AER (14.1% CER), primarily due to generic competition for VYVANSE in the U.S. (down 17.2% AER, 21.6% CER) and ADDERALL XR.
Operating profit significantly increased by JPY 128.5 billion (60.0% AER, 51.2% CER) to JPY 342.6 billion, benefiting from lower impairment charges compared to the prior year.
Net profit for the year decreased by JPY 36.1 billion (25.0% AER, 33.1% CER) to JPY 108.1 billion, mainly due to a tax expense reduction in the prior year and increased tax expenses in FY2025.
The company incurred JPY 128.1 billion in restructuring expenses in FY2025 as part of a multi-year, enterprise-wide efficiency program, with further expenses expected in FY2026 and FY2027.
Takeda completed the divestiture of its joint venture business with Teva Pharmaceutical Industries Ltd. in Japan, reclassifying Teva Takeda Pharma Ltd. shares to assets held for sale and recording an impairment loss of JPY 18.9 billion.
Capital expenditures for property, plant, and equipment and intangible assets were JPY 319.4 billion in FY2025, a decrease from JPY 496.7 billion in FY2024 and JPY 898.7 billion in FY2023.
Net cash from operating activities increased to JPY 1,057.2 billion, up JPY 340.8 billion from the prior year, driven by favorable changes in provisions and inventories.
Adjusted Free Cash Flow increased significantly to JPY 769.0 billion, up JPY 485.5 billion, due to higher operating cash flow and decreased acquisition of intangible assets.
Takeda's total bonds and loans decreased to JPY 4,515.3 billion as of March 31, 2025, from JPY 4,843.8 billion in the prior year, with an Adjusted Net Debt to Adjusted EBITDA ratio of 2.8x (down from 3.1x).
The company maintained its progressive dividend policy, with JPY 196 per share paid in FY2025, and intends to increase it to JPY 200 per share in FY2026.

Sentiment

Score: 5

Explanation: The company shows strong revenue growth in key strategic areas and improved operating profit, indicating underlying business health. However, the significant decline in net profit, ongoing generic erosion in major products, and substantial restructuring costs temper the overall positive sentiment. The pipeline setbacks and ongoing litigations also add a layer of caution, resulting in a neutral-to-slightly-negative overall sentiment.

Positives

Strong revenue growth of 7.5% (AER) and 2.9% (CER) in FY2025, indicating robust business momentum.
Significant contribution from Growth & Launch Products, accounting for 48% of consolidated revenue and showing strong double-digit growth (14.7% CER).
Exceptional performance in Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology, and Vaccines segments, with many products achieving double-digit sales growth.
Successful launch momentum for FRUZAQLA in the U.S. and other countries, addressing unmet needs in metastatic colorectal cancer.
Expansion of QDENGA availability to approximately 30 countries, driving substantial vaccine revenue growth.
Operating profit increased by 60.0% (AER) and 51.2% (CER), reflecting improved operational efficiency and lower impairment charges.
Net cash from operating activities increased significantly by JPY 340.8 billion, demonstrating strong cash generation.
Adjusted Free Cash Flow saw a substantial increase of JPY 485.5 billion, indicating improved liquidity and financial flexibility.
Reduction in total bonds and loans and an improved Adjusted Net Debt to Adjusted EBITDA ratio (2.8x), signaling progress in deleveraging.
Commitment to a progressive dividend policy, with an intended increase to JPY 200 per share for FY2026, indicating confidence in future performance and commitment to shareholder returns.
Successful Phase 3 VERIFY trial for rusfertide in polycythemia vera, meeting primary and key secondary endpoints, indicating a promising pipeline asset.
Approval of EOHILIA by the U.S. FDA in February 2024, leading to a reversal of impairment loss of JPY 35.7 billion in FY2024.

Negatives

Net profit for the year decreased by 25.0% (AER) and 33.1% (CER) in FY2025, primarily due to a large tax benefit in the prior year not recurring and increased tax expenses in the current year.
Neuroscience segment experienced a revenue decline of 9.8% (AER) and 14.1% (CER), largely due to generic erosion of VYVANSE and ADDERALL XR in the U.S.
Sales of VELCADE continued to decline significantly (down 80.0% AER, 81.3% CER in FY2024) due to generic competition, with further declines in FY2025.
Sales of AZILVA decreased substantially (down 64.9% AER/CER in FY2025) due to generic entrants in Japan.
Significant restructuring expenses of JPY 128.1 billion were recorded in FY2025, with further expenses expected in FY2026 and FY2027, negatively impacting short-term profitability.
Impairment losses of JPY 95.6 billion were recorded in FY2025, primarily due to the termination of acquired oncology product development (TAK-186 and TAK-280) and neuroscience product study failures (soticlestat).
The voluntary withdrawal of marketing authorization for Alofisel in Europe due to ADMIRE-CD II study results not meeting primary endpoints.
Voluntary withdrawal of U.S. biologics license application (BLA) for TAK-003 (dengue vaccine candidate) following discussions with the FDA regarding data collection aspects.
Termination of development for several pipeline projects (TAK-141/JR-141, TAK-935 (soticlestat) for LGS, TAK-925 for postanesthesia recovery, Cx601 pediatric indication, MLN0002 for GvHD prophylaxis, cabozantinib for mCRPC, TAK-500, TAK-186, TAK-280, TAK-062, TAK-676), leading to impairment charges and lost potential.
Ongoing litigation, including the AbbVie supply agreement litigation which resulted in a final damages award of USD 505 million including interest against Takeda in December 2023.
Increased inventory write-downs to JPY 40.2 billion in FY2025 from JPY 26.3 billion in FY2024.

Risks

Research and development of pharmaceutical products are expensive and subject to significant uncertainties, with no guarantee of commercial success or recouping development costs.
Failure to comply with government regulations over product development, regulatory approvals, and reimbursement requirements could adversely affect the business.
Government policies and other pressures to reduce medical costs (e.g., IRA in the U.S., NHI price revisions in Japan, HTA in Europe) could adversely affect product sales and profitability.
Expiration or loss of patent or regulatory exclusivity, or patent infringement by generic/biosimilar manufacturers, could lead to significant competition and sales declines.
Difficulty maintaining product competitiveness due to new competing products, superior medical technologies, or increased regulatory approvals of competitor therapies.
Inability to adequately expand the product portfolio through third-party alliance arrangements, including identifying suitable opportunities, managing upfront/milestone payments, and ensuring partner performance.
Risks associated with dependence on third parties for key business functions (manufacturing, commercialization, IT systems), including cybersecurity risks, non-compliance with regulations, and supply chain disruptions.
Technical complexity and high regulation of product manufacturing, leading to potential supply interruptions, product recalls, or production problems.
Heightened or additional risks in the development and manufacture of biologics and cell therapies, including raw material inconsistencies, quality control, and sourcing challenges.
Illegal distribution and sale of counterfeit products or stolen inventory could harm reputation and business.
Substantial debt may limit the ability to execute business strategy, refinance, or incur new debt, and a credit rating downgrade could increase borrowing costs.
Acquisition risks, including difficulties in integration, failure to retain key personnel, inability to achieve expected synergies, and assumption of unexpected liabilities.
Restructuring initiatives may not provide expected benefits on time and incur significant costs, negatively affecting short-term profitability.
Risks associated with global operations, particularly in emerging markets, including difficulties in coordination, regulatory changes, trade restrictions, geopolitical instability, and currency fluctuations.
Difficulty implementing and resourcing corporate sustainability-related measures or complying with emerging requirements, potentially increasing costs and reputational risk.
Digital transformation initiatives may be unsuccessful, hurting profitability or disrupting business, and increasing exposure to cybersecurity risks.
Increased dependence on information technology systems and infrastructure, facing risks of misuse, theft, exposure, tampering, or other intrusions.
Inability to attract and retain key management and other personnel in competitive markets.
Involvement in ongoing litigation (product liability, intellectual property, antitrust, sales & marketing) could result in financial losses or harm the business.
Unanticipated adverse effects or possible adverse effects of products, leading to restricted use, product liability claims, or recalls.
Intellectual property infringement claims directed at Takeda by third parties, potentially leading to recalls, termination of sales, significant damages, or royalties.
Exposure to evolving and complex tax laws and regulations, including intercompany transfer pricing and global minimum tax frameworks (Pillar Two), which may result in additional tax assessments.
Changes in data privacy and protection laws and regulations or failure to comply, leading to legal and reputational risks.
Claims relating to the use, manufacture, handling, storage, or disposal of hazardous materials, potentially resulting in substantial costs and liabilities.
Adverse effects on business from climate change, extreme weather events, earthquakes, civil/political unrest, terrorism, or other catastrophic events.
Concentration of sales to a small number of wholesalers, exposing the company to credit risks and pricing pressures.
Potential for additional charges on statements of profit or loss due to impairment of goodwill, other intangible assets, and equity method investments.

Future Outlook

Takeda anticipates filing for FDA approval of rusfertide in the fiscal year ending March 31, 2026, and expects Phase 3 clinical trial readouts for oveporexton and zasocitinib, which, if successful, could lead to commercial launches in 2026 or 2027. The company intends to increase its annual dividend to JPY 200 per share for the fiscal year ending March 31, 2026. Takeda expects continued, albeit decreased, restructuring expenses in FY2026 and FY2027 as part of its multi-year efficiency program. The company also expects the Inflation Reduction Act (IRA) to negatively impact future profits due to changes in the Part D program and future price negotiation of Takeda products, and the U.S. administration's executive order on Most Favored Nation (MFN) pricing could further reduce product prices in the U.S. The EU's revised pharmaceutical legislation and Health Technology Assessment regulation are expected to increase clinical evidentiary requirements and potentially impact pricing and reimbursement in EU markets.

Management Comments

Takeda's management evaluates its results of operations and financial condition and makes operating and investment decisions using both IFRS measures and non-IFRS measures.
The company's purpose is to contribute to better health for people and a brighter future for the world, achieved through discovering and delivering life-transforming treatments, guided by Patient, People, and Planet imperatives, and powered by data and technology.
Takeda is committed to both rare and more prevalent diseases, pursuing life-transforming medicines in core therapeutic areas and PDT.
The company is embracing data and digital technologies with the aim of improving the quality of innovation and accelerating execution.
Takeda's pipeline is positioned to support both near-term and long-term sustained growth.
Management monitors Growth & Launch Products as key drivers of future growth and believes information on these products is useful to investors.
Takeda continues to closely monitor its funding situation and does not currently anticipate experiencing funding or liquidity shortfalls in the short term.
Management believes that the unimpaired amounts of trade receivables that are past due are still collectible in full, based on historical payment behavior and extensive analysis of customer credit risk.
Takeda's fundamental principles of capital risk management are to build and maintain a steady financial base for soundness and efficiency of operations and achieving sustainable growth.
Takeda's policy is that financial derivatives be used only for hedging foreign currency and interest rate exposure and not for speculative purposes.

Industry Context

The pharmaceutical industry is highly competitive, characterized by intense R&D, significant regulatory hurdles, and increasing pressure to control healthcare costs globally. Takeda's focus on specialized therapeutic areas (GI, Rare Diseases, PDT, Oncology, Vaccines, Neuroscience) aligns with a broader industry trend towards high-unmet-need areas and biologics. The company is actively engaging in external partnerships and digital transformation, reflecting industry-wide efforts to accelerate innovation and improve efficiency. However, the industry faces significant headwinds from patent expirations, generic/biosimilar competition, and government-mandated price controls (e.g., IRA in the U.S., NHI price revisions in Japan, HTA in Europe), which are driving down prices and impacting profitability. Geopolitical tensions and supply chain disruptions also pose ongoing challenges for global pharmaceutical operations.

Comparison to Industry Standards

Takeda's R&D efforts focus on three core therapeutic areas (Gastrointestinal and Inflammation, Neuroscience, Oncology) and targeted investments in PDT, a common strategy among large biopharmaceutical companies to concentrate resources on high-potential areas.
The company's reliance on external partnerships for R&D and commercialization (e.g., with HUTCHMED for FRUZAQLA, Protagonist for rusfertide, Keros Therapeutics for elritercept, Pfizer for ADCETRIS) is a prevalent industry model to diversify risk and access innovation.
Takeda's experience with generic erosion for products like VYVANSE and VELCADE is typical for pharmaceutical companies facing patent expiry, highlighting the industry's constant need for new product innovation to offset revenue declines.
The company's engagement with government organizations (WHO, PAHO, Gavi) for vaccine development (QDENGA) reflects a common approach in the vaccine sector to address global health challenges and expand market access.
Takeda's multi-year efficiency program, including investments in digital, data, and technology, aligns with broader industry trends of leveraging technology to improve productivity and reduce costs amidst increasing competitive and pricing pressures.
The company's credit ratings (BBB+ Stable by S&P, Baa1 Stable by Moody's) are generally in line with other large, diversified pharmaceutical companies, reflecting its financial strength despite substantial debt from acquisitions like Shire.
The impact of the Inflation Reduction Act (IRA) in the U.S. and ongoing NHI price revisions in Japan are industry-wide challenges, with Takeda's expected negative impact on profits being a shared concern among pharmaceutical manufacturers operating in these markets.
The company's commitment to reducing Scope 1, 2, and 3 GHG emissions aligns with increasing environmental sustainability expectations and reporting requirements (e.g., CSRD, EU Taxonomy, SEC climate rules) faced by global corporations across all sectors.

Management Changes

Role	Previous Person	New Person	Effective Date	Reason
Chief Financial Officer (CFO)	Costa Saroukos (retired June 26, 2024)	Milano Furuta	April 2024	Appointment of new CFO, with previous CFO's retirement.
Director	N/A	Milano Furuta	June 2024	Appointment to the Board of Directors.
External Director	N/A	Miki Tsusaka	June 2023	Appointment to the Board of Directors.
External Director	N/A	John Maraganore, PhD	June 2022	Appointment to the Board of Directors.
External Director and Chair of the Board of Directors	N/A	Masami Iijima	June 2022	Appointment to the Board of Directors and Chair role.
External Director (Audit and Supervisory Committee Member)	N/A	Kimberly A. Reed	June 2022	Appointment to the Board of Directors and Audit and Supervisory Committee.
External Director (Audit and Supervisory Committee Member)	N/A	Yoshiaki Fujimori	June 2022	Appointment to the Board of Directors and Audit and Supervisory Committee.
Global General Counsel	Yoshihiro Nakagawa	Natalie Furney	July 1, 2025	Retirement of previous Global General Counsel.
President, Global Portfolio Division	Ramona Sequeira	Julie Kim (interim)	August 1, 2025	Retirement of previous President, Global Portfolio Division.
President, Chief Executive Officer (CEO) and Representative Director	Christophe Weber	Julie Kim	June 2026 (expected)	Succession planning upon Mr. Weber's expected retirement.
Director	Olivier Bohuon	N/A	May 5, 2024	Passed away.
External Director (Audit and Supervisory Committee Member)	Emiko Higashi	Jean-Luc Butel	June 2024	Re-appointment to Audit and Supervisory Committee.
External Director (not Audit and Supervisory Committee Member)	Jean-Luc Butel	Emiko Higashi	June 2024	Change in committee assignment.

Corporate Governance

Change Type	Description	Effective Date	Impact Assessment
Corporate Governance Structure	Adopted the audit and supervisory committee system in June 2016 to increase transparency and independence of the board, enhance corporate governance, and separate business execution and supervision.	June 2016	Increased agility in decision-making by delegating certain authority to individual directors, allowing the board to focus more on strategic matters. Enhanced audit and supervision by the Audit and Supervisory Committee with a higher proportion of External Directors.
Board of Directors Composition	Board consists of directors who are Audit and Supervisory Committee members and directors who are not. No more than 12 non-Audit and Supervisory Committee members and no more than four Audit and Supervisory Committee members. All directors elected by shareholders.	N/A (ongoing structure)	Ensures a structured board composition with distinct roles for oversight and management. The separation of election processes for Audit and Supervisory Committee members aims to enhance their independence.
Director Term Limits	Term of office for non-Audit and Supervisory Committee directors is one year; for Audit and Supervisory Committee directors, it is two years. All directors may serve any number of consecutive terms.	N/A (ongoing policy)	Annual re-election for most directors provides regular accountability, while a two-year term for Audit and Supervisory Committee members offers continuity in oversight. Unlimited consecutive terms allow for retention of experienced leadership.
Indemnity Agreements for Directors	Entered into indemnity agreements with each director for liability arising from their status or alleged wrongful acts, to the extent permitted by law.	N/A (ongoing policy)	Provides protection for directors against certain liabilities, potentially encouraging qualified individuals to serve on the board, while adhering to legal limitations.
Audit and Supervisory Committee Role	Statutory duty to audit affairs, examine financial statements and business reports, prepare audit reports, determine proposals for independent auditors, and provide opinions on director elections/compensation. Serves as audit committee for Exchange Act purposes.	N/A (ongoing structure)	Ensures robust internal and external audit functions, promoting financial integrity and compliance with regulatory requirements, including SEC Rule 10A-3.
Executive Sessions of Independent External Directors	Independent external directors hold regularly scheduled executive sessions without management, despite not being required by Japanese law or Tokyo Stock Exchange rules.	N/A (ongoing practice)	Enhances independent oversight and allows for candid discussions among non-management directors, promoting stronger corporate governance.
Voluntary Nomination and Compensation Committees	Established Nomination and Compensation Committees as advisory bodies to the board, with all members being External Directors and chaired by an external director. Authority to determine individual compensation for Internal Directors delegated to the Compensation Committee.	N/A (ongoing structure)	Ensures transparency and objectivity in director appointments, reappointments, succession planning, and compensation decisions, aligning with best practices for corporate governance.
Clawback Policy	Adopted and amended a clawback policy in 2020 and 2023. The amended policy provides for mandatory recovery of erroneously paid incentive compensation in case of financial restatement (in accordance with SEC and NYSE rules) and allows independent External Directors to recoup additional incentive/contingent compensation in cases of restatement and/or significant misconduct.	October 2, 2023 (amended policy)	Strengthens accountability for executive officers and aligns compensation with financial integrity and ethical conduct, in line with evolving regulatory expectations.
Shareholder Meeting Venue Flexibility	Amended Articles of Incorporation to allow general meetings of shareholders to be held without specifying a venue when the Board decides it's not appropriate to hold with a specific venue (e.g., due to infectious disease spread or natural disaster).	August 5, 2021	Provides flexibility to ensure shareholder meetings can proceed safely and effectively during unforeseen circumstances, while securing shareholder interests.
Global Code of Conduct	Adopted the Takeda Global Code of Conduct, applicable to all employees, including principal executive, financial, and accounting officers. No waivers granted in FY2025.	N/A (ongoing policy)	Establishes clear ethical guidelines for all personnel, promoting integrity and compliance across the organization.
Insider Trading Policy	Adopted a Global Insider Trading Policy designed to promote compliance with applicable insider trading laws, rules, and regulations.	N/A (ongoing policy)	Reinforces commitment to ethical conduct and regulatory compliance regarding securities trading by insiders.
Cybersecurity Governance	Board of Directors is ultimately responsible for overseeing cybersecurity risk management. CISO reports to CDTO and provides annual updates to the Board. Risk, Ethics & Compliance Committee (RECC) oversees risk management, including cybersecurity.	N/A (ongoing structure)	Establishes clear lines of responsibility and oversight for cybersecurity risks, integrating it into enterprise-wide risk management and ensuring regular reporting to senior management and the Board.

Legal Proceedings

ACTOS Economic Loss Cases: Takeda is named in lawsuits by plaintiffs claiming economic loss from ACTOS prescriptions due to alleged inadequate warnings about bladder cancer risks. Takeda is unable to make a reliable estimate of the expected financial effect.
Proton Pump Inhibitor (PPI) Product Liability Claims: Over 6,100 lawsuits in U.S. federal and state courts allege kidney injuries or gastric cancer from PREVACID and/or DEXILANT due to alleged failure to adequately warn. Takeda reached an agreement in principle in April 2024 and executed a final written settlement agreement in November 2024 for a non-material, confidential amount, with no material impact on profit or loss.
TRINTELLIX Patent Infringement: Takeda filed lawsuits against sixteen generic companies for ANDA submissions. A trial in 2021 found US Patent 7,144,884 (vortioxetine active ingredient) valid. An appeal affirmed method of use patents as valid but not infringed, and a process patent infringed by Lupin. Attorney fee motions by generic companies were denied in February 2025, and the case is officially closed with no material impact on profit or loss.
ACTOS Antitrust Litigation: Two class action lawsuits allege Takeda improperly characterized patents, delaying generic market entry for ACTOS. Takeda is unable to make a reliable estimate of the expected financial effect.
INTUNIV Antitrust Litigation: An antitrust class action alleges Shire's 2013 patent litigation settlement with Actavis Elizabeth LLC related to INTUNIV was anticompetitive. Takeda reached an agreement-in-principle in June 2024 for an immaterial amount, which received final court approval in November 2024, with no material impact on profit or loss.
AMITIZA Antitrust Litigation: Antitrust class actions allege Takeda's 2014 settlement with Par Pharmaceutical, Inc. related to AMITIZA's generic formulation was anticompetitive. Additional complaints were filed in January and February 2025. Takeda is unable to make a reliable estimate of the expected financial effect.
COLCRYS Antitrust Litigation: Antitrust class actions allege Takeda's 2015 and 2016 settlements with generic manufacturers related to COLCRYS were anticompetitive. Takeda reached an agreement in principle in September 2023 for an immaterial amount, fully executed in December 2023, with no material impact on profit or loss.
DEXILANT Antitrust Litigation: Civil actions filed in March 2025 allege Takeda's 2015 settlement agreement with Twi Pharmaceuticals, Inc. related to DEXILANT violated U.S. antitrust laws. Takeda is unable to make a reliable estimate of the expected financial effect.
Department of Justice Civil Investigative Demands (CIDs): Takeda received CIDs in February 2020 for investigations into possible off-label promotion and Anti-Kickback Statute violations related to TRINTELLIX, and possible kickbacks related to subcutaneous IG products (CUVITRU, HYQVIA, GAMMAGARD). Takeda is cooperating with both investigations and is unable to make a reliable estimate of the expected financial effect.
Brazilian Investigation Related to ELAPRASE and REPLAGAL: Brazilian federal authorities executed a search warrant in November 2021 seeking records related to information from AVISA and donations to charitable organizations funding patient reimbursement claims. Takeda is cooperating with the investigation and is unable to make a reliable estimate of the expected financial effect.

Related Party Transactions

Takeda enters into agreements and engages in transactions with related parties in the ordinary course of business, including R&D-related services agreements, charitable donations, and equity investments.
The terms and conditions of related party transactions are consistent with third-party transactions and reflect market prices.
Takeda does not consider the amounts involved in these transactions to be material to its business.

Stakeholder Impact

**Shareholders:** Impacted by the progressive dividend policy (JPY 196/share in FY2025, JPY 200/share planned for FY2026) and share buybacks, indicating capital return. Net profit decline and restructuring costs may affect short-term earnings per share, while strategic growth drivers and deleveraging efforts aim for long-term value creation. Litigation outcomes and patent expirations pose financial risks.
**Patients:** Benefit from the continued development and commercialization of innovative medicines in high unmet medical needs (e.g., ENTYVIO, TAKHZYRO, LIVTENCITY, FRUZAQLA, QDENGA). However, product withdrawals (Alofisel, Exkivity) and development terminations (soticlestat, TAK-186, TAK-280) mean certain treatment options will not reach patients. Supply chain stability and product quality are critical for patient access and safety.
**Employees:** Affected by the multi-year, enterprise-wide efficiency program, which includes organizational changes and potential reallocations of human resources, leading to restructuring expenses (e.g., severance payments). The company aims to provide an exceptional people experience and attract/retain talent through competitive compensation and career development.
**Customers (Wholesalers, Healthcare Providers, Payers):** Face pricing pressures due to government policies (IRA, NHI price revisions) and market consolidation among managed care groups. Takeda's sales concentration with a few large wholesalers (McKesson, Cencora) exposes it to credit risks and increased purchasing leverage from these customers.
**Suppliers:** Subject to Takeda's environmental sustainability initiatives, including commitments to science-based emissions reduction targets, which may require cooperation and potentially impact their operations and costs. Geopolitical tensions and trade policies could affect supply chain stability and costs.
**Creditors:** Monitored through Takeda's financial leverage ratios (Adjusted Net Debt to Adjusted EBITDA) and compliance with financial covenants. The company's debt refinancing activities and investment-grade credit ratings are important for maintaining creditor confidence.

Next Steps

File for FDA approval of rusfertide in the fiscal year ending March 31, 2026.
Anticipate Phase 3 clinical trial readouts for oveporexton and zasocitinib, with potential commercial launches in 2026 or 2027.
Increase annual dividend to JPY 200 per share for the fiscal year ending March 31, 2026.
Continue to incur restructuring expenses in the fiscal years ending March 31, 2026 and 2027 as part of the enterprise-wide efficiency program.
Julie Kim will assume responsibility for overseeing the Global Portfolio Division on an interim basis effective August 1, 2025.
Julie Kim is expected to transition responsibility for overseeing the U.S. Business Unit later in FY2026.
Julie Kim will be proposed as a candidate for election to the board of directors at the annual general meeting of shareholders in June 2026.
Christophe Weber is expected to retire from Takeda in June 2026.
Natalie Furney will become Global General Counsel effective July 1, 2025.
Continue to invest in plasma collection center network, with 15 new centers added in FY2025, bringing total global footprint to 275 centers.
Continue expansion of production capacity in the plasma manufacturing network.
Construction of a new R&D laboratory in Vienna's Donaustadt district is planned for 2026.
Occupy the new R&D and office facility in Kendall Square from 2026.
Monitor the implementation of the EU Regulation on Health Technology Assessment starting in 2025.
Monitor the impact of the U.S. Inflation Reduction Act (IRA) and potential Most Favored Nation (MFN) pricing policies on drug prices and profitability.
Continue efforts to meet Science Based Targets initiative (SBTi) validated goals for GHG emission reductions (65% for Scope 1 and 2 by FY2030, 25% for Scope 3 by FY2030, net-zero for Scope 1 and 2 by FY2035, Scope 3 by FY2040).

Key Dates

Date	Description
2013-12-31	First antitrust class action lawsuit filed against Takeda related to ACTOS in the U.S. District Court for the Southern District of New York.
2014-03-31	End of fiscal year 2014, after which Takeda implemented an R&D transformation process.
2015-04-01	Christophe Weber appointed Chief Executive Officer.
2017-01-01	Antitrust class action filed against Shire related to INTUNIV in the U.S. District Court for the District of Massachusetts.
2018-01-01	Shonan Health Innovation Park (Shonan iPark) opened in Japan.
2018-01-01	TAKHZYRO approved for patients 12 years and older in both the U.S. and Europe.
2018-01-01	ADYNOVATE/ADYNOVI licensed from Nektar Therapeutics.
2018-01-01	ALUNBRIG marketing authorization for patients previously treated with crizotinib in the EU.
2018-01-01	ADSs listed on the New York Stock Exchange.
2018-02-01	Takeda entered into an agreement with Wave Life Sciences, Inc. to discover, develop and commercialize nucleic acid therapies for CNS disorders.
2019-01-08	Acquisition of Shire plc completed.
2019-01-01	TAKECAB approved for reflux esophagitis in China.
2019-01-01	TRINTELLIX launched in Japan.
2019-01-01	Takeda issued JPY 500.0 billion in Hybrid Bonds.
2020-01-01	TAKHZYRO approved in China.
2020-01-01	ALUNBRIG indication expanded to include newly diagnosed ALK-positive NSCLC patients in both the U.S. and the EU.
2020-02-19	Received Civil Investigative Demand (CID) from the DOJ regarding possible off-label promotion and Anti-Kickback Statute violations for TRINTELLIX.
2020-02-28	Received Civil Investigative Demand (CID) from the DOJ regarding possible kickbacks for subcutaneous IG products.
2020-05-01	ADCETRIS approved in China.
2020-06-24	Board approved Long-Term Incentive Plan for Company Group Employees residing outside of Japan (LTIP).
2020-07-01	First awards granted under LTIP.
2020-11-06	AbbVie filed a lawsuit against Takeda for alleged breach of supply agreement related to Leuprorelin.
2021-01-15	Trial for TRINTELLIX patent infringement lawsuit began.
2021-01-28	Trial for TRINTELLIX patent infringement lawsuit concluded.
2021-01-01	ALUNBRIG approved as a first and second-line therapy in Japan.
2021-06-16	Act for Partially Amending the Industrial Competitiveness Act of Japan partially came into effect, allowing general meetings of shareholders without a specified venue.
2021-06-29	Annual general meeting of shareholders approved amendment to Articles of Incorporation regarding venue-less meetings.
2021-08-05	Partial amendment of Articles of Incorporation regarding venue-less meetings became effective.
2021-08-01	Antitrust class action filed against Takeda Pharmaceuticals U.S.A., Inc. regarding AMITIZA.
2021-09-01	Antitrust class action filed against Takeda Pharmaceuticals U.S.A., Inc. regarding COLCRYS.
2021-11-30	Brazilian federal authorities executed a search warrant at Takeda offices in Brazil related to ELAPRASE and REPLAGAL.
2021-12-01	LIVTENCITY launched in the U.S.
2022-02-01	Acquisition of manufacturing and marketing approval and marketing rights of REPLAGAL in Japan from Sumitomo Dainippon Pharma.
2022-03-01	ALUNBRIG approved in China.
2022-03-31	End of fiscal year 2022, used as baseline for certain GHG emission reduction goals.
2022-06-01	TAKHZYRO approved in Japan.
2022-06-01	John Maraganore and Kimberly A. Reed appointed External Directors.
2022-06-01	Masami Iijima appointed External Director and Chair of the Board of Directors.
2022-06-01	Yoshiaki Fujimori appointed External Director who is a member of the Audit and Supervisory Committee.
2022-11-01	LIVTENCITY approved in Europe.
2022-12-13	Entered into a share purchase agreement with Nimbus Therapeutics, LLC to acquire Nimbus Lakshmi, Inc.
2023-01-01	Entered into an exclusive licensing agreement with HUTCHMED for fruquintinib.
2023-02-08	Acquisition of Nimbus Lakshmi, Inc. (TAK-279) closed.
2023-03-01	HUTCHMED licensing agreement closed.
2023-03-28	Japanese Diet passed a tax reform bill to implement OECD BEPS Pillar Two initiative.
2023-04-01	Effective date for Japanese Pillar Two tax provisions.
2023-04-01	Buy-back of full rights for INTUNIV in Japan became effective.
2023-06-01	Miki Tsusaka appointed External Director.
2023-06-01	Generic version of AZILVA approved by PMDA in Japan.
2023-07-01	Voluntarily withdrew U.S. BLA for TAK-003 (dengue vaccine candidate).
2023-08-01	Patent protection covering VYVANSE and associated pediatric exclusivity expired in the U.S.
2023-09-08	Oral argument at the Federal Circuit Court for TRINTELLIX patent infringement appeal.
2023-09-01	Reached agreement in principle to resolve COLCRYS antitrust matter.
2023-09-01	ENTYVIO Pen approved for ulcerative colitis in the U.S.
2023-11-01	FRUZAQLA launched in the U.S.
2023-11-01	Neurocrine announced TAK-041/NBI-1065846 Phase 2 trial results did not meet primary and secondary endpoints.
2023-11-01	Subsequent antitrust class action challenging COLCRYS settlements filed in the U.S. District Court for the Southern District of New York.
2023-12-01	AbbVie supply agreement litigation: Delaware state court ruled in favor of AbbVie on alleged breach.
2023-12-01	LIVTENCITY approved in China.
2023-12-01	Federal Circuit Court affirmed district court decision on TRINTELLIX patent infringement.
2023-12-01	COLCRYS antitrust settlement fully executed.
2024-01-01	Entered into worldwide license and collaboration agreement with Protagonist Therapeutics for rusfertide.
2024-01-01	GAMMAGARD LIQUID approved for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S.
2024-01-01	HYQVIA 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.
2024-01-01	Retail pharmacies plaintiffs filed a complaint regarding AMITIZA antitrust litigation.
2024-02-01	EOHILIA approved by the U.S. FDA.
2024-02-01	TAKHZYRO approved by the FDA and the European Commission in patients aged 2 years and older.
2024-02-01	Macleods, Sandoz, and Alembic filed motions seeking recovery of attorney fees for TRINTELLIX.
2024-03-01	Takeda notified regulators and BioLife plasma donors of potential unauthorized access of certain online donor accounts.
2024-03-01	Japanese government extended volume-based target of 80% generic drug penetration until end of FY2030.
2024-03-01	ICLUSIG U.S. label expanded for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
2024-03-15	Takeda filed opposition briefs to attorney fee motions for TRINTELLIX.
2024-03-31	Termination of distribution contract of SPIKEVAX, a COVID-19 vaccine in Japan.
2024-04-01	ENTYVIO Pen approved for Crohn's disease in the U.S.
2024-04-01	Milano Furuta appointed Chief Financial Officer.
2024-04-01	Takeda reached an agreement in principle to resolve U.S. PPI product liability cases.
2024-04-25	Repaid JPY 50.0 billion in Bilateral Loans and entered into new Bilateral Loans of JPY 50.0 billion maturing on April 25, 2031.
2024-05-01	Entered into an exclusive, worldwide option and license agreement with AC Immune for ACI-24.060.
2024-05-05	Olivier Bohuon passed away and his term as director terminated.
2024-05-09	Announced a multi-year, enterprise-wide efficiency program.
2024-06-01	Milano Furuta appointed as a Director.
2024-06-01	Reached an agreement-in-principle to resolve INTUNIV antitrust matter.
2024-06-01	Signed an option agreement with Ascentage Pharma to enter into an exclusive license agreement for olverembatinib.
2024-06-01	ADCETRIS received approval from the European Commission (EC) for frontline Hodgkin's lymphoma.
2024-06-12	Issued unsecured JPY denominated senior bonds with an aggregate principal amount of JPY 184,000 million.
2024-06-25	Issued 60-year Unsecured Hybrid Bonds with an aggregate principal amount of JPY 460.0 billion.
2024-07-05	Issued USD 3,000 million in Unsecured U.S. Dollar-Denominated Senior Notes.
2024-07-12	Tender offer to redeem USD 1,500 million in Unsecured Senior Notes completed.
2024-07-01	Lundbeck announced agreement to amend Collaboration for TRINTELLIX, providing for royalty payments by Takeda.
2024-08-01	ADZYNMA approved in Japan for treatment of cTTP for individuals 12 years and older.
2024-08-01	VONVENDI approved in China for adult on-demand and surgery treatment of von Willebrand disease.
2024-09-01	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.
2024-09-01	Neurocrine announced TAK-831/NBI-1065846 Phase 2 results did not meet primary endpoint in patients with CIAS.
2024-10-02	Amended clawback policy became effective.
2024-10-03	Drew down a Syndicated Hybrid Loan with an aggregate principal amount of JPY 40.0 billion.
2024-10-06	Redemption of JPY 500.0 billion in Hybrid Bonds issued in June 2019.
2024-10-01	Takeda decided not to exercise the multi-program option to co-develop and co-commercialize WVE-003 with Wave Life Sciences, Inc.
2024-11-01	Final written settlement agreement executed for U.S. PPI product liability cases.
2024-11-01	INTUNIV antitrust settlement received final approval from the court.
2024-12-01	Entered into an exclusive licensing agreement with Keros Therapeutics to further develop, manufacture and commercialize elritercept.
2024-12-01	U.S. Department of Justice rule implementing Executive Order 14117 issued, restricting certain data transactions.
2025-01-01	Takeda/Neurocrine agreement amended for TAK-653.
2025-01-30	Board of directors resolved to approve the repurchase of shares of common stock up to JPY 100.0 billion.
2025-01-30	Board of directors resolved to appoint Julie Kim as successor to Christophe Weber, effective June 2026.
2025-02-01	Keros Therapeutics upfront payment of USD 200 million made.
2025-02-01	EMA approved an additional 2 mL pre-filled pen option for TAKHZYRO.
2025-02-08	Court ruled to deny attorney fee motions for TRINTELLIX.
2025-03-01	Entered into a development funding agreement with Blackstone Life Sciences (BXLS) for mezagitamab (TAK-079).
2025-03-01	Rusfertide Phase 3 VERIFY trial met its primary endpoint and all key secondary endpoints.
2025-03-01	Four individual retail pharmacies filed a civil action against Takeda and Twi Pharmaceuticals, Inc. regarding DEXILANT antitrust.
2025-03-31	End of fiscal year 2025.
2025-03-31	Prepaid JPY 313.5 billion and USD 1,500 million in Syndicated Loans.
2025-03-31	All interest rate swap and cross currency interest rate swaps entered in 2017 and 2024 were terminated due to early repayment of USD Syndicated Loans.
2025-05-01	Transfer of manufacturing operation of TACHOSIL in Austria completed.
2025-05-01	Transfer of business operations related to MEPACT completed.
2025-06-01	Transfer of business operations related to non-core products in the Middle East and North Africa regions completed.
2025-06-25	Date of filing of this annual report on Form 20-F.
2025-06-30	Yoshihiro Nakagawa will retire as Global General Counsel.
2025-07-01	Natalie Furney will become Global General Counsel.
2025-07-31	Ramona Sequeira will retire from Takeda.
2025-08-01	Julie Kim will assume responsibility for overseeing the Global Portfolio Division on an interim basis.
2026-01-01	Expected start of Medicare drug price negotiation under the IRA.
2026-03-31	Expected continued incurrence of restructuring expenses (albeit at a decreased level).
2026-09-01	Maturity of JPY 700.0 billion undrawn bank commitment line.
2026-01-01	Takeda plans to occupy its new R&D and office facility in Kendall Square.
2026-01-01	New R&D laboratory planned to be constructed in Vienna's Donaustadt district.
2026-06-01	Expected retirement of Christophe Weber as President, CEO, and Representative Director.
2026-06-01	Julie Kim to be proposed as a candidate for election to the board of directors.
2027-01-01	IFRS 18 Presentation and Disclosure in Financial Statements becomes effective.
2027-03-31	Expected continued incurrence of restructuring expenses.
2028-01-01	EU Regulation on Health Technology Assessment expands to orphan drugs.
2029-06-25	First call date for 2024 Hybrid Subordinated Bonds, with Takeda expecting early repayment of principal.
2029-10-03	First prepayment date for 2024 Syndicated Hybrid Subordinated Loan, with Takeda expecting early repayment.
2030-03-31	Japanese government target for 80% generic drug penetration in each prefecture by volume and 65% in value.
2030-03-31	SBTi validated goal for 65% reduction in Scope 1 and 2 GHG emissions from FY2016 baseline.
2030-03-31	SBTi validated goal for 25% reduction in Scope 3 GHG emissions from FY2022 baseline.
2030-01-01	EU Regulation on Health Technology Assessment expands to all centrally registered products.
2032-01-01	Certain patents covering various aspects of ENTYVIO are expected to expire.
2035-03-31	SBTi validated goal for achieving net-zero for Scope 1 and 2 GHG emissions.
2037-12-31	End of period for special reconstruction surtax on Japanese withholding tax.
2040-03-31	SBTi validated goal for achieving net-zero for Scope 3 GHG emissions.

Recommendation

hold

Keywords

Pharmaceuticals, Biopharma, SEC Filing, Annual Report, Financial Results, Revenue, Operating Profit, R&D, Pipeline, Generic Competition, Patent Expiry, Drug Development, Regulatory Approval, Global Commercialization, Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology, Vaccines, Neuroscience, ENTYVIO, VYVANSE, QDENGA, FRUZAQLA, LIVTENCITY, TAKHZYRO, ADZYNMA, Immunoglobulin, Albumin, Restructuring, Debt Management, Acquisitions, Divestitures, Litigation, Intellectual Property, Supply Chain, Cybersecurity, Corporate Governance, Shareholder Returns

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