Takeda Pharmaceutical Company (4502) investor relations material

Leadership transition and strategic outlook

• Retirement of the long-serving R&D head announced, with transition planned over the next 8–9 months and new CEO Julie Kim leading future strategy.

• Capital Markets Day scheduled for December 11 in Tokyo to unveil new strategic direction under Julie Kim, focusing on pipeline investment and growth phases (Horizon one and two).

• Horizon one emphasizes deep pipeline investment and launches with low overall growth, while Horizon two targets accelerated growth.

• The company is at a significant inflection point, with increased pipeline visibility and upcoming leadership changes.

Pipeline and product launches

• Recent FDA approval of ORZEYFUL for narcolepsy, with DEA scheduling expected by November and anticipated Schedule IV classification.

• Competitive pricing strategy for ORZEYFUL aimed at broad patient access, with focus on rapid market penetration and physician education.

• Fast uptake expected for ORZEYFUL due to unmet needs and high residual symptoms in current treatments; strategy centers on patient switching and increasing diagnosis rates.

• TAK-360 phase II data for NT2 and IH expected later this year, with additional orexin molecules advancing in the clinic.

• Zasocitinib (oral TYK2) PDUFA date set for March 13, 2027, with launch planned within the fiscal year and competitive pricing to ensure access.

Clinical development and data timelines

• TAK-360 phase II data may be disclosed at Capital Markets Day or a scientific congress, depending on results and competitive landscape.

• Ongoing studies for TAK-360 in NT1 as a precaution, with ORZEYFUL positioned as best-in-class for NT1.

• Zasocitinib safety profile remains clean with no JAK-related effects; one-year safety data submitted to FDA.

• IBD (UC and CD) studies for zasocitinib ongoing, with data readouts expected at the end of the fiscal year; higher doses being tested for IBD indications.

• Peak sales guidance for psoriasis and psoriatic arthritis remains $3–6 billion; IBD peak sales guidance pending data.