drugset / Press release

Record DAYBUE net sales of US$101.1 million in Q3 2025

2025-11-05 · Neuren Pharmaceuticals Limited · original neurenpharma.com ↗

1 of 3 Neuren (NEU) – ASX Announcement 6 November 2025 Record DAYBUE™ net sales of US$101.1 million in Q3 2025, up 11% from Q3 2024 Q3 Highlights: • Q3 2025 DAYBUE™ (trofinetide) net sales of US$101.1 million, up 11% from Q3 2024 and up 5% from Q2 2025 • For the first time more than 1,000 patients received shipments • Largest quarter-over-quarter increase in referrals since launch driven by expanded team • 74% of prescriptions to new patients were written by physicians in the community setting outside centers of excellence • Named patient supply programs active across multiple regions outside North America • Neuren earned Q3 2025 royalty income of A$16.4 million, up 24% from Q3 2024 and up 12% from Q2 2025 • Acadia narrowed full year 2025 DAYBUE US net sales guidance to US$385 – 400 million (previously US$380 - 405 million), implying full year 2025 US royalty income for Neuren of A$63 – 66 million (previously A$62 - 67 million) Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) today reported highlights from the Q3 2025 financial results announcement and conference call of its partner Acadia Pharmaceuticals (Nasdaq: ACAD). Acadia announced Q3 2025 net sales of DAYBUE™ (trofinetide) of US$101.1 million, up 11% on Q3 2024 and up 5% on Q2 2025. Acadia narrowed its full year 2025 guidance for DAYBUE US net sales to US$385 – 400 million (previously US$380 - 405 million). Anticipated royalties to Neuren are: • A$16.4 million for Q3 2025, up 24% on Q3 2024 and up 12% on Q2 2025 • Between A$63 million and A$66 million for the full year 2025 (assuming Acadia guidance is met and exchange rate of 0.65) In Q3 2025, the number of unique patients receiving a DAYBUE shipment exceeded 1,000 for the first time, growing to 1,006 from 987 in Q2 2025 and 954 in Q1 2025. Approximately 74% of the prescriptions to new patients in Q3 2025 were written by physicians in the community setting outside the Rett syndrome centers of excellence. Q3 2025 also saw the highest quarter-on-quarter increase in patient referrals since launch driven by Acadia’s expanded field force. The long-term persistency rate remained steady above 50% after 12 months of treatment. There is substantial potential for future growth in the US, as overall US penetration reached approximately 40% while community penetration reached approximately 27%. 2 of 3 In the European Union, a CHMP opinion on Acadia’s marketing application is expected in Q1 2026. Acadia has commenced a Phase 3 trial in Japan. Named patient supply programs are active across multiple regions including Europe, Israel, Middle East and Latin America. * Assuming Acadia DAYBUE US net sales guidance of US$385 – 400m is met and AUDUSD of 0.65 Acadia’s Q3 earnings conference call and presentation can be accessed in the Investors section of the Acadia website www.acadia.com. 103 76 85 91 97 85 96 101 118 Q1 2024 Q2 2024 Q3 2024 Q4 2024 Q1 2025 Q2 2025 Q3 2025 Q4 2025E DAYBUE Net Sales (US$m) Actual Estimate range (based on Acadia CY25 guidance) 3 of 3 About Neuren Neuren is developing new drug therapies to treat multiple serious neurological disorders that emerge in early childhood and have no or limited approved treatment options. DAYBUE™ (trofinetide) is approved by the US Food and Drug Administration (FDA) and Health Canada for the treatment of Rett syndrome. Neuren has granted an exclusive worldwide licence to Acadia Pharmaceuticals Inc. for the development and commercialisation of trofinetide. Neuren’s second drug candidate, NNZ-2591, is in development for multiple neurodevelopmental disorders, with positive results achieved in Phase 2 clinical trials in Phelan-McDermid syndrome, Pitt Hopkins syndrome and Angelman syndrome. Recognising the urgent unmet need, each program has been granted “orphan drug” designation in the United States and the European Union. Orphan drug designation provides incentives to encourage development of therapies for rare and serious diseases. Contact: [email protected] Jon Pilcher, CEO: +61 438 422 271 ASX Listing Rules information This announcement was authorized to be given to the ASX by the CEO & Managing Director of Neuren Pharmaceuticals Limited, Suite 201, 697 Burke Road, Camberwell, VIC 3124 Forward-looking Statements This announcement contains forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements of Neuren to be materially different from the statements in this announcement.

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