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- **VYVANSE Impact Waning**: FY25 H1 LOE peak, FY26 growth acceleration with 3 new launches.
- **ENTYVIO Growth Revised**: FY25 growth 6% (vs. 9%) due to competition, but Pen QoQ +20% in U.S.
- **FX Headwinds**: Euro volatility reduces FY25 core OP by ~JPY 10 billion.
- **Innovent Deal Potential**: 3 assets targeting $40+ billion lung/CRC market; Phase III data expected Q4 FY25.
- **R&D Efficiency**: 90%+ R&D programs enabled by AI by FY26; JPY 27.4 billion H1 restructuring savings.

**【CEO Summary Section】**
- FY25 H1 revenue: JPY 2.2 trillion (-6.9% YoY, -3.9% at CER) due to VYVANSE LOE impact (JPY 100 billion loss). Core OP: JPY 639.2 billion (-11.2% YoY, -8.8% at CER). ENTYVIO launch products grew 5.3% at CER, with ENTYVIO Pen QoQ +20% in U.S. FY26 outlook: VYVANSE LOE impact waning, 3 new launches (rusfertide, oveporexton, zasocitinib), and Innovent Biologics partnership to drive growth.

**【CFO Financial Commentary】**
- FY25 H1: Core EPS JPY 279 (-40% YoY), reported EPS JPY 72 (impacted by JPY 58.2 billion cell therapy impairment). FX headwinds: Euro strength vs. BRL (QDENGA) and JPY appreciation. FY25 guidance: Core OP and EPS now expected to decline low single digits (vs. prior flat guidance). FY25 AFG: JPY 525.4 billion free cash flow, JPY 200 dividend per share.

**【R&D & Pipeline Updates】**
- **Oveporexton**: Phase III data shows statistically significant improvement across 14 endpoints for NT1. U.S. filing planned for FY25. Next-gen orexin agonist (TAK-360) in Phase II for NT2/idiopathic hypersomnia.
- **Mezagitamab**: 96-week IgA nephropathy data shows stable renal function 18 months post-treatment. Phase III VERIFY study enrolling well.
- **Innovent Biologics Deal**: 3 assets acquired:
  - IBI363 (PD-1/IL-2 alpha bias bispecific) for NSCLC/CRC
  - IBI343 (Claudin 18.2 ADC) for gastric/pancreatic cancer
  - Option for IBI3001 (EGFR/B7H3 ADC)
- **Nabla Bio Partnership**: AI-driven drug discovery to accelerate pipeline (e.g., 90%+ of R&D programs enabled by in silico tech by FY26).

**【Q&A Highlights】**
- **Innovent Deal Costs**: 60-40 cost split for IBI363, with Takeda leading global dev/commercialization. R&D spending offset by efficiency programs (e.g., JPY 27.4 billion H1 restructuring savings).
- **FX Mitigation**: Long-term manufacturing footprint rebalancing; FY25 euro volatility impact estimated at JPY 10 billion.
- **ENTYVIO Pen Penetration**: U.S. Pen share 9%, targeting acceleration via PBM contract expansion (2/3 PBMs signed). FY25 ENTYVIO growth revised to 6% (vs. prior 9%) due to competition and Medicare Part D redesign.
- **Innovent Data Reliability**: Global Phase II IBI363 data (U.S./Australia) expected Q4 FY25; China data correlation validated via Takeda radiologist review.
- **Dividend Sustainability**: Progressive policy based on core EPS, free cash flow, and debt reduction. FY26 dividend proposal to be announced in May FY26.


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