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- ORZEYFULTM<\/sup> approved in the U.S., Japan and China for narcolepsy type 1 (NT1), MIMRYLOTM<\/sup> launched in the U.S. for erythrocytosis in polycythemia vera (PV)<\/i><\/b><\/li>\n
- Zasocitinib advances to U.S. Food & Drug Administration (FDA) Priority Review and European Medicines Agency (EMA) review<\/i><\/b><\/li>\n
- Late-stage pipeline continues to advance<\/i><\/b><\/li>\n
- FY2026 full-year outlook upgraded to reflect foreign exchange (FX) benefit<\/i><\/b><\/li>\n
- Takeda will host a Capital Markets Day on Dec. 11, 2026, in Tokyo, Japan<\/i><\/b><\/li>\n<\/ul>\n
OSAKA, Japan–(BUSINESS WIRE<\/a>)–
\nTakeda (TOKYO:4502\/NYSE:TAK<\/a><\/span>) 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\u2019s 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.<\/p>\nFY2026 First-Half Highlights<\/b><\/p>\n
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- \nRevenue 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).<\/p>\n<\/li>\n
- \nCore 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.<\/p>\n<\/li>\n
- \nReported Operating Profit increased by 60.4% on an AER basis reflecting the end of the amortization period for VYVANSE\u00ae intangible assets and lower impairment charges.<\/p>\n<\/li>\n
- \nCore 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.<\/p>\n<\/li>\n
- \nAdjusted Free Cash Flow was JPY 325.7 billion.<\/p>\n<\/li>\n
- \nORZEYFUL\u2019s approvals in the U.S., Japan and China, together with the U.S. launch of MIMRYLO, mark significant progress toward Takeda\u2019s near-term commercial priorities. ORZEYFUL is now available in Japan and China; its U.S. launch remains subject to Drug Enforcement Administration (DEA) scheduling.<\/p>\n<\/li>\n
- \nMIMRYLO launched in the U.S. in August 2026 and is now available to patients.<\/p>\n<\/li>\n
- \nThe 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.<\/p>\n<\/li>\n
- \nFY2026 full-year outlook upgraded to reflect FX benefit.<\/p>\n<\/li>\n<\/ul>\n
Takeda President and Chief Executive Officer, Julie Kim, commented:
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<\/b>\u201cThe 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.\u201d<\/p>\n\n\u201cOur 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\u2019s 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.\u201d<\/p>\n
Takeda Chief Financial Officer, Milano Furuta, commented:
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<\/b>\u201cWe 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.\u201d<\/p>\nFINANCIAL HIGHLIGHTS for First-Half Results ended September 30, 2026<\/b><\/p>\n
- Zasocitinib advances to U.S. Food & Drug Administration (FDA) Priority Review and European Medicines Agency (EMA) review<\/i><\/b><\/li>\n
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