• ORZEYFULTM approved in the U.S., Japan and China for narcolepsy type 1 (NT1), MIMRYLOTM launched in the U.S. for erythrocytosis in polycythemia vera (PV)
• Zasocitinib advances to U.S. Food & Drug Administration (FDA) Priority Review and European Medicines Agency (EMA) review
• Late-stage pipeline continues to advance
• FY2026 full-year outlook upgraded to reflect foreign exchange (FX) benefit
• Takeda will host a Capital Markets Day on Dec. 11, 2026, in Tokyo, Japan

OSAKA, Japan--(BUSINESS WIRE)--Takeda (TOKYO:4502/NYSE:TAK) announced financial results for the first half of fiscal year 2026 (April 1, 2026, to Sept. 30, 2026). The period included the approval of ORZEYFUL (oveporexton) in the U.S., Japan and China, the U.S. launch of MIMRYLO (rusfertide), progress in the regulatory review of zasocitinib, and additional clinical evidence across the late-stage pipeline. Takeda’s focus remains on execution against the first horizon of its growth strategy: successfully launching three new medicines, advancing its late-stage pipeline, ensuring resilience of core in-line brands and executing its transformation program.

FY2026 First-Half Highlights

• Revenue increased by 8.4% versus the prior period on an actual exchange rates (AER) basis and decreased by 1.0% at constant exchange rates (CER).
• Core Operating Profit increased by 11.2% on an AER basis, and increased by 0.7% on a CER basis, supported by enterprise-wide transformation, which is helping fund growth investments.
• Reported Operating Profit increased by 60.4% on an AER basis reflecting the end of the amortization period for VYVANSE® intangible assets and lower impairment charges.
• Core EPS was 308 JPY, an increase of 10.5% at AER and decrease of 1.2% at CER. Reported EPS was 193 JPY, an increase of 169.0% at AER.
• Adjusted Free Cash Flow was JPY 325.7 billion.
• ORZEYFUL’s approvals in the U.S., Japan and China, together with the U.S. launch of MIMRYLO, mark significant progress toward Takeda’s near-term commercial priorities. ORZEYFUL is now available in Japan and China; its U.S. launch remains subject to Drug Enforcement Administration (DEA) scheduling.
• MIMRYLO launched in the U.S. in August 2026 and is now available to patients.
• The FDA accepted the New Drug Application (NDA) under Priority Review for zasocitinib; the EMA is also reviewing the application. Phase 3 head-to-head data in plaque psoriasis further strengthened the clinical evidence for zasocitinib.
• FY2026 full-year outlook upgraded to reflect FX benefit.

Takeda President and Chief Executive Officer, Julie Kim, commented:
“The launches of ORZEYFUL and MIMRYLO, combined with the acceptance of zasocitinib under Priority Review and its positive head-to-head Phase 3 data, represent a significant moment for Takeda and reflect strong execution against our two-horizon growth strategy.”

“Our focus now is to translate these milestones into strong commercial execution, while continuing to advance our late-stage pipeline, ensuring resilience of our core in-line brands and unlocking capabilities through transformation. Progress against our priorities in Horizon One of our strategy is building the foundation for Takeda’s next phase of growth. We look forward to sharing more details on our growth strategy and how we will build sustainable leadership in our core therapeutic areas at our Capital Markets Day in December.”

Takeda Chief Financial Officer, Milano Furuta, commented:
“We are reinvesting transformation savings to support new product launches and advance our pipeline. Our first-half results demonstrate that we are on track in advancing our Horizon One priorities and we will continue our disciplined execution to deliver on our revised full-year forecast and management guidance.”

FINANCIAL HIGHLIGHTS for First-Half Results ended September 30, 2026

New Medicines and Late-Stage Pipeline Progress
New medicine approvals and late-stage pipeline progress during the first half of FY2026 reinforce progress against Takeda’s strategic priorities. The following updates highlight key milestones.

ORZEYFUL

• An orexin receptor agonist with a first-in-class mechanism of action, designed to address the orexin deficiency that causes narcolepsy type 1 (NT1).
• Launched in Japan and China for adults with NT1 on October 15; U.S. commercial launch remains subject to DEA scheduling, expected in early November 2026.
• Phase 3 results were published in the New England Journal of Medicine, demonstrating significant improvements across key symptoms and quality-of-life measures.

MIMRYLO

• First-in-class hepcidin mimetic approved in the U.S. for the treatment of erythrocytosis in adults with polycythemia vera (PV); launched in August.
• MIMRYLO has been shown to maintain hematocrit control, the primary treatment goal in PV, as well as reduce phlebotomy burden and alleviate symptoms including fatigue.
• Approval supported by Phase 3 VERIFY results showing 76.9% of patients achieved clinical response during weeks 20-32.
• MIMRYLO is the only treatment to be recommended as a Category 1 option across low- and high-risk PV in the National Comprehensive Cancer Network® (NCCN®) clinical practice guidelines in oncology for myeloproliferative neoplasms.

Zasocitinib

• The FDA accepted the NDA under Priority Review for adults with moderate-to-severe plaque psoriasis; the EMA also accepted the Marketing Authorization Application for review.
• Phase 3 demonstrated superiority to deucravacitinib on the primary and all key secondary efficacy endpoints; more than 2.5 times as many patients achieved complete skin clearance.
• Zasocitinib remains investigational, with commercial launch planning underway, subject to regulatory approval.

Broader Oncology Pipeline

• At the European Society for Medical Oncology (ESMO), Takeda presented positive Phase 3 results showing that arcotatug tavatecan (TAK-921) delivered statistically significant and clinically meaningful improvements in overall survival and progression-free survival in patients with advanced gastric cancer.
• The findings support a regulatory filing in Japan in FY2027 and continued global development of arcotatug tavatecan in CLDN18.2-positive cancers.
• Development of TAK-928 continues, including through a global Phase 3 study in patients with immunotherapy-resistant squamous NSCLC. Takeda also recently announced that it will expand this study to include a new sub-trial for patients with non-squamous NSCLC.
• ELAHERE® (mirvetuximab soravtansine) was approved in Japan for folate receptor alpha-positive, platinum-resistant recurrent ovarian cancer.

Transformation, Capital Allocation and Shareholder Returns
Takeda continues to make solid progress on its enterprise transformation, a key FY2026 priority alongside the launch of new medicines and the advancement of its R&D pipeline. These efforts are designed to enhance operational efficiency, strengthen capabilities and optimize resource allocation, and support near-term execution under Horizon One of Takeda’s two-horizon growth strategy, while laying the foundation for sustainable growth under Horizon Two. Takeda maintains a disciplined capital allocation framework that prioritizes investment in new product launches and innovation, while maintaining its commitment to shareholder returns through its progressive dividend policy.

Additional Information Regarding FY2026 First Half Results
Takeda will host a conference call for investors and analysts on Thursday, Oct. 29, 2026, at 19:00 Japan Time / 6:00 U.S. Eastern Time to discuss its FY2026 first half results.

A live webcast of the conference call and the presentation materials will be available in the Investor Relations section of Takeda’s website (www.takeda.com/investors). The presentation materials include details on Takeda’s FY2026 first half results, business progress and pipeline updates, as well as definitions of non-IFRS measures.

About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit https://www.takeda.com.

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Financial information and Non-IFRS Measures

Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”).

This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our FY2026 H1 investor presentation (available at www.takeda.com/investors).

Medical Information

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Contacts

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Media Relations
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