Takeda Pharmaceutical Company (4502) investor relations material

Strategic overview and leadership transition

• 2025 marked a highly successful year with three NMEs—rusfertide, oveporexton, and zasocitinib—achieving positive phase III results and moving toward launch.

• A new CEO, Julie Kim, will take over in June, signaling a major internal transition and continuity of momentum.

• The company is shifting focus from maturing launch and growth products to a new wave of launches, with a rebranding of product categories expected in Q4.

• Vyvanse expiry impacts are expected to stabilize by 2026, with new products set to drive future growth.

Oveporexton and orexin franchise

• Oveporexton targets type 1 narcolepsy, showing normalization across multiple efficacy endpoints in phase III; PDUFA date is set for August, with efforts to accelerate approval.

• The label is expected to be broad, reflecting significant efficacy across 14 endpoints, with more data to be disclosed throughout the year.

• Additional phase III trial for oveporexton will support EU registration and explore higher dosing for a minority of patients.

• TAK-360 and TAC-495 are advancing in phase II and early clinical stages for other rare sleep-wake disorders, with a strategy to expand indications based on orexin 2 receptor agonism.

• Safety profile for oveporexton is favorable, with transient insomnia and urinary symptoms as main side effects; no significant visual disturbances observed.

Zasocitinib and immunology pipeline

• Zasocitinib, a potent TYK2 inhibitor, demonstrated strong phase III efficacy in psoriasis, with over 30% of patients achieving complete clearance and rapid onset of action.

• Once-daily dosing differentiates it from competitors; safety and tolerability are consistent with earlier trials.

• Phase II trials in IBD (ulcerative colitis and Crohn's) are ongoing, with higher TYK2 inhibition expected to address previous failures in the class.

• Zasocitinib is positioned for both monotherapy and combination therapy, with Entyvio cited as a logical partner.