Takeda Pharmaceutical Company (4502) investor relations material

Leadership transition and strategic outlook

• Head of R&D is retiring after over 15 years, with a transition period of 8–9 months and confidence in the new leadership under Julie Kim.

• Capital Markets Day on December 11 in Tokyo will unveil the new strategy, focusing on two horizons: deep pipeline investment and future growth.

• Horizon one emphasizes pipeline launches and execution with low growth, while horizon two targets significant growth acceleration.

Pipeline developments and product launches

• Recent FDA approval for ORZEYFUL (orexin agonist for narcolepsy) with DEA scheduling expected by November, likely as Schedule IV.

• Competitive pricing and broad access are priorities for ORZEYFUL, aiming for rapid market penetration and early patient switches.

• Additional orexin molecules (TAK-360, TAK-495) are in clinical development, with phase II data for TAK-360 expected later this year.

• Zasocitinib (oral TYK2 inhibitor) has a PDUFA date of March 13, 2027, with launch planned within the current fiscal year.

Market strategy and competitive positioning

• ORZEYFUL is positioned for fast uptake due to unmet needs and positive feedback from patients and healthcare professionals.

• Twice-daily dosing of ORZEYFUL is highlighted as offering flexibility and efficacy, with future molecules in the pipeline.

• For NT2, TAK-360 phase II data is anticipated, with dosing flexibility considered important for mimicking natural physiology.

• Pricing for future indications (e.g., NT2) will depend on market and data, with differentiation from competitors emphasized.