Late-stage R&D Success — Three Positive Phase III Readouts
Takeda reported positive Phase III results for oveporexton, rusfertide and zasocitinib in 2025, each meeting or exceeding expectations. Oveporexton: ~85% of patients reached normative Epworth Sleepiness Scale (ESS) with statistically significant improvements across 14 primary/secondary endpoints; NDA submitted. Rusfertide: durable hematocrit control <45% through 52 weeks with improved patient-reported outcomes; NDA submitted. Zasocitinib: rapid efficacy (PASI75 within 4 weeks), >50% PASI90 at week 16 and ~30% PASI100; regulatory filing preparations underway with expected launch in H1 CY2027.
Growth & Launch Products Driving Revenue
Growth and launch products represent over 50% of total revenue and grew 6.7% at constant exchange rate (CER) year-to-date, an improvement versus the ~5% growth seen in Q1 and Q2.
ENTYVIO Momentum and Access Gains
ENTYVIO grew 7.4% at CER year-to-date. ENTYVIO Pen achieved formulary coverage with all three large PBMs and commercial coverage >80%, supporting management's position to be on track for its full-year 6% growth projection.
Strong Adjusted Free Cash Flow and Upgraded FCF Outlook
Adjusted free cash flow for the period was JPY 625.9 billion, generated even after a USD 1.2 billion upfront payment to Innovent Biologics in December; management upgraded the adjusted free cash flow forecast for the full year.
Maintained Core Profitability Targets Despite Headwinds
Management revised revenue guidance (to a low single-digit decline at CER) due to stronger-than-anticipated VYVANSE generic erosion, but maintained full-year guidance for core operating profit (core OP) and core EPS through disciplined OpEx management and cost efficiencies.
Updated Financial Guidance and Forecast Upside
Full-year revenue forecast set at JPY 4.53 trillion; core OP forecast JPY 1.15 trillion; core EPS forecast JPY 486. Management also noted a net increase to forecasts from FX and momentum (revenue +JPY 30 billion; core OP +JPY 20 billion).
Strong Vaccine and Selected Product Growth
QDENGA vaccine growth accelerated to 22.1%, driven primarily by Brazil. Subcutaneous IG products grew double digits, and overall IG was up 4.3% year-to-date. FRUZAQLA continues to expand with global rollout.
Strategic Pipeline Expansion with Innovent Partnership
Takeda added two innovative oncology assets (TAK-928 and TAK-921) via partnership with Innovent, with encouraging early clinical signals and plans for global development; shared investment and staged go/no-go decisions (TAK-928 60/40 split with Innovent).