DAYBUE (trofinetide) 2024 net sales US$348 million
2025-02-26 · Neuren Pharmaceuticals Limited · original neurenpharma.com ↗
1 of 2 Neuren (NEU) – ASX Announcement 27 February 2025 DAYBUE™ (trofinetide) 2024 net sales US$348 million Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) today reported highlights from the Q4 and full year 2024 earnings announcement and conference call of its partner Acadia Pharmaceuticals (Nasdaq: ACAD). Acadia announced 2024 net sales of DAYBUE™ (trofinetide) in the United States of US$348.4 million, up 97% from 2023, and towards the top of its previous guidance range of US$340-350 million. Q4 net sales of US$96.7 million was a record quarter of sales since launch in April 2023. With 70% of the 5,500 to 5,800 diagnosed Rett patients yet to try DAYBUE, there is substantial potential for growth in the US. As announced in January 2025, Acadia is implementing initiatives to accelerate adoption, in particular among patients treated outside the Rett syndrome Centers of Excellence. Acadia is expanding its field force by ~30%, optimizing patient support, launching branded Direct-to-Consumer campaigns to showcase DAYBUE benefits and utilizing a range of communication channels to bring DAYBUE clinical data to life. Acadia provided guidance for full-year US only net sales in 2025 of between US$380 million and US$405 million. Outside the US, first sales in Canada are anticipated in Q3 2025, pending price negotiations. Acadia is also expecting initial revenues from managed access programs in certain EU countries this year, while continuing to build EU leadership and launch teams anticipating approval of the marketing application in Q1 2026. Anticipated royalties to Neuren are: • A$56.2 million for the full year 2024, up 110% from 2023; A$18.7 million for Q4 2024, up 46% from 2023 • Between A$62 million and A$67 million for the full year 2025 (assuming Acadia guidance is met and exchange rate of 0.65) Acadia’s Q4 and full year earnings conference call and presentation can be accessed in the Investors section of the Acadia website www.acadia.com. * Assuming Acadia DAYBUE US net sales guidance of US$380 – 405m is met and AUDUSD of 0.65 380 177 348 405 CY2023 (Apr -Dec) CY2024 CY2025 Acadia Guidance DAYBUE US Net Sales (US$m) + 97% + 9-16% 62 27 56 67 CY2023 CY2024 CY2025E* US Royalty to Neuren (A$m) + 110% + 11-19% 2 of 2 About Neuren Neuren is developing new drug therapies to treat multiple serious neurological disorders that emerge in early childhood and have no or limited approved treatment options. Recognising the urgent unmet need, all programs have been granted “orphan drug” designation in the United States. Orphan drug designation provides incentives to encourage development of therapies for rare and serious diseases. DAYBUE™ (trofinetide) is approved by the US Food and Drug Administration (FDA) and Health Canada for the treatment of Rett syndrome. Neuren has granted an exclusive worldwide licence to Acadia Pharmaceuticals Inc. for the development and commercialisation of trofinetide. Neuren’s second drug candidate, NNZ-2591, is in development for multiple neurodevelopmental disorders, with positive results achieved in Phase 2 clinical trials in Phelan-McDermid syndrome, Pitt Hopkins syndrome and Angelman syndrome. Contact: [email protected] Jon Pilcher, CEO: +61 438 422 271 ASX Listing Rules information This announcement was authorized to be given to the ASX by the CEO & Managing Director of Neuren Pharmaceuticals Limited, Suite 201, 697 Burke Road, Camberwell, VIC 3124 Forward-looking Statements This announcement contains forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements of Neuren to be materially different from the statements in this announcement. 23 67 87 76 85 91 97 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Q4 2024 DAYBUE US Net Sales (US$m)
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