Kyowa Kirin (4151) Investor presentation summary

Strategic update and program transition

• Regains global control of rocatinlimab development and commercialization after termination of the Amgen partnership, following Amgen's portfolio reprioritization.

• Amgen will provide transitional long-term manufacturing and supply support during the handover period.

• Kyowa Kirin will lead all development, regulatory, and commercial activities globally, including in Japan, US, Europe, and Asia.

Clinical progress and efficacy

• All eight Phase 3 ROCKET studies met primary and key secondary endpoints, including significant improvement in the rIGA score at week 24.

• Safety profile in adolescent and adult trials remains consistent, with low discontinuation rates due to adverse events.

• Rocatinlimab targets OX40 receptor on pathogenic T cells, offering a novel mechanism for atopic dermatitis and potential expansion to other inflammatory diseases.

Market opportunity and unmet needs

• Moderate-to-severe atopic dermatitis remains a high-burden, under-treated condition with significant unmet medical needs.

• Only 10-15% of eligible patients currently receive biologic treatment, indicating substantial market growth potential.

• US biologic penetration is 15-20%, with projected sales growth over 15% and a 75% increase in advanced therapy-treated population by 2030.