AFT Pharmaceuticals Limited (AFT) Trading Update summary

North American expansion and product launches

• Launched Maxigesic IV (Combogesic IV) in Canada, marking entry into the North American market.

• Extended US Maxigesic licensing agreement with Hikma Pharmaceuticals to maximize commercial reach.

• Canadian business hub established, led by local executive, with further OTC and in-licensed product launches planned.

• Similar operational models set up in Singapore, Hong Kong, South Africa, US, Europe, and UK.

• Combogesic IV offers a non-opioid alternative for pain management amid Canada's opioid crisis.

Commercial and partnership developments

• Hikma to take over all channels for Combogesic Rapid in the US, except for certain categories licensed to Alexso.

• Profit share arrangement with Hikma restructured to regular quarterly payments, with increased involvement in sales and marketing.

• New agreement expected to deliver greater commercial benefits than previous arrangements.

• US opioid abuse costs estimated at $11 billion annually, highlighting market need for alternatives.

• Combogesic IV and Rapid positioned to reduce chronic opioid use in postoperative care.

Research and development progress

• Pre-IND for antibiotic eyedrop filed with FDA; IND filing targeted before year-end.

• Preparing pre-IND for Strawberry Birth Marks topical treatment and IND for novel iron injection.

• Maxigesic IV paediatric study planned to support regulatory approvals and dosing for children.

• R&D pipeline includes 14 projects, with five candidates nearing or in commercialization.

• Added improved formulation project targeting a $180M global niche market.