Aytu BioPharma receives FDA approval for Cotempla XR-ODT site transfer, expects margin boost in 2024

AYTU BIOPHARMA, INC

FDA approved Cotempla XR-ODT Prior Approval Supplement (PAS) for manufacturing transfer to contract manufacturer.
Adzenys XR-ODT received similar PAS approval in April 2023; both ADHD brands moving to contract production.
Company expects enhanced ADHD product margins starting calendar 2024 after exiting Grand Prairie facility.
Production ramp-up expected late 2023; Adzenys production already underway at contract manufacturer.
CEO cites multi-year effort: bioequivalence studies, strong contract partners, and regulatory navigation.

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