Icure Pharmaceutical Incorporation filed an amendment on July 2 to its prior disclosure regarding the termination of the license agreement for Donepezil Patch Donecis Patch in Taiwan.
The amendment provides the specific reason for the Taiwan FDA rejection: the Phase 3 clinical trial results from 2017~2020 conducted in Korea and three other countries did not meet TFDA approval criteria.
The company retains the upfront payment of 1.386 billion KRW as non-refundable, but loses future milestones of EUR 8 million and estimated supply revenue of EUR 39.291 million.
This amendment supplements the original disclosure with no changes to financial figures; the impact of the termination remains as previously announced.
[AI Summary]This amendment is an administrative clarification of the TFDA rejection reason. With no additional revenue from the deal beyond the upfront, Icure faces a significant loss of growth opportunities, which is negative for shareholder value.
KOSDAQ Filing Information
[Correction of Description] Matters Related to Periodic Disclosure Obligations (Fair Disclosure) - Termination of License Transfer Agreement for Donepezil Patch (Product Name: Donesiv Patch)