Morning Trading January 31, page-237

NEU hmm good timing, Q4 Ann just outQ4 2023 Activity Report
Highlights:
• Continued momentum of successful launch in the United States of DAYBUE™ (trofinetide) for Rett
syndrome by partner Acadia:
• Net sales of US$66.9 million in Q3 2023 and Acadia guidance for net sales of US$80-87.5
million in Q4 2023
• Royalty to Neuren is currently 10% of net sales: A$10.4 million earned for Q3 2023 and
approx. A$12.1-13.2 million anticipated for Q4 20231
• Acadia advancing trofinetide outside the United States:
• Canada: NDS filing in Q1 2024 and potential approval around year-end 2024
• Europe: engaging with EMA in Q1 2024, MAA filing in H1 2025
• Japan: engaging regulatory agency (PMDA) in 2024
• Highly encouraging top-line results in Phase 2 clinical trial of NNZ-2591 for Phelan-McDermid
syndrome:
• Significant improvement was assessed by both clinicians and caregivers across multiple
efficacy measures
• Improvements were consistently seen across clinically important aspects of PhelanMcDermid syndrome
• Clinician and caregiver global efficacy measures showed a level of improvement typically
considered clinically meaningful
• NNZ-2591 was safe and well tolerated, with no clinically significant changes in laboratory
values or other safety parameters during treatment
• Enrolment completed in Phase 2 trials of NNZ-2591 in Pitt Hopkins syndrome and Angelman
syndrome - on track for top-line results for Pitt Hopkins in Q2 2024 and Angelman in Q3 2024
• Cash generated from operations: Q4 2023 A$4.8 million, full-year A$185 million
• Cash at 31 December 2023: A$229 million