Sawai Group Holdings Co (4887) Investor Day 2025 summary

Incident and quality remediation

• Teprenone Capsules 50 mg stability testing used an unapproved method that refilled the drug into a different capsule; an OOS result in Apr. 2023 led to discovery and reporting of misconduct.

• Improper testing traced to out-of-specification dissolution results around 2010 and 2013; the practice became routine around 2017, before discovery in 2023.

• Investigation cited normalized misconduct, weak supervision and test-record controls, excessive QC workload, and staff tendencies to underrate stability monitoring or follow instructions without question.

• Four improvement pillars: corporate culture reform; reassessment of Teprenone and other products; stronger head-office reliability assurance; and manufacturing initiatives at Kyushu and across manufacturing.

• Administrative sanctions on Dec. 22, 2023, included improvement orders covering quality-information management, manufacturing oversight, legal compliance and recurrence prevention.

Governance and operational upgrades

• Quality and production/sales responsibilities are separated; monthly President-level reporting covers major quality issues, deviation remediation and judgments on notifying authorities.

• GMP cases are reviewed with an external lawyer; an external lawyer monitors the Group Compliance Committee, and quality leaders report to both pharmaceutical and holdings boards.

• Recurrence controls include a President-led culture reform project, stronger whistleblowing and compliance education; town halls were held 13 times in FY2023 and 14 times in FY2024.

• Audits at all 8 manufacturing facilities increased from once to twice a year; third parties joined FY2024 audits, and on-site QA was established.

• Head-office QA/RA staffing rose from 56 in Apr. 2024 to 61 in Oct. 2024, with 80 planned by 2026; factory QA/QC moved from 465 to 521, with 570 planned. LIMS completion is targeted for July 2026; MES rollout starts Apr. 2026.

Board oversight and workforce

• Board monitoring includes manufacturing and quality KPIs such as deviation severity and remediation time; short-term deviations rose slightly as sensitivity increased, with longer-term handling and trends under review.

• Directors flagged production-volume pressure and pressure to eliminate all quality issues as cultural risks; KPIs are cascaded to managers, while frontline consultation and head-office response are monitored.

• Annualized resignation rates through December were 3.94% overall and 4.21% in manufacturing, versus 4.86% overall in FY2023; health-related resignations, workplace stress, line changes and data-entry burden remain concerns.