Notice of Conclusion of Outsourcing Agreement for Obtaining PMDA Approval of Botulinum Toxin Formulation

Overview of Outsourcing Agreement

CONVANO Inc.'s consolidated subsidiary, Syncs Healthcare Inc., aims to obtain PMDA approval for botulinum toxin formulation domestically in Japan and plans to conclude an outsourcing agreement with CM Plus Inc., a company specialized in pharmaceutical regulatory application support. CM Plus will provide comprehensive support including regulatory strategy assessment, quality (CMC) evaluation, clinical package assessment, GMP, supply, and legal risk evaluations to enhance the accuracy and expedite the preparation of the approval application.

Future Outlook and Impact on Business Performance

The contract is scheduled for conclusion in April 2026, and the impact on FY2026 results is expected to be minimal. The FY2027 business plan does not include sales from this formulation, but certain costs are already factored in. From FY2028 onward, progress in approval acquisition and market launch plans could significantly impact performance, but the amount of impact is currently unknown and under review. If approval is granted, expanded sales through existing sales channels targeting aesthetic medical clinics and continuous revenue generation are expected.