DAYBUE Q2 2025 net sales US$96.1 million up 14% from Q2 2024
2025-08-06 · Neuren Pharmaceuticals Limited · original neurenpharma.com ↗
1 of 3 Neuren (NEU) – ASX Announcement 7 August 2025 DAYBUE™ Q2 2025 net sales US$96.1 million up 14% from Q2 2024 Q2 Highlights: • Q2 2025 DAYBUE™ (trofinetide) net sales of US$96.1 million, up 14% from Q2 2024 and 14% from Q1 2025 • Record number of patients in the US received shipments, growing for third consecutive quarter • Acadia completed planned expansion of DAYBUE sales force to accelerate future growth • Neuren earned Q2 2025 royalty income of A$14.7 million, up 16% from Q2 2024 and 9% from Q1 2025 • Acadia reiterated full year 2025 DAYBUE US net sales guidance of US$380 - 405 million, implying full year 2025 US royalty income for Neuren of A$62 - 67 million • Acadia initiated named patient supply programs in Europe through Clinigen and Rest of the World through Farmamondo Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) today reported highlights from the Q2 2025 financial results announcement and conference call of its partner Acadia Pharmaceuticals (Nasdaq: ACAD). Acadia announced Q2 2025 net sales of DAYBUE™ (trofinetide) of US$96.1 million, up 14% on Q2 2024 and 14% on Q1 2025, primarily due to the growth in unit sales shipped to more unique patients. Acadia reiterated its full year 2025 guidance for DAYBUE US net sales of US$380 - 405 million. In Q2 2025, all key metrics continued to strengthen. The number of unique patients receiving a DAYBUE shipment continued to grow and reached a record high of 987, up from 954 in Q1 2025 and 920 in Q4 2024. The persistency rate remains steady above 50% after 12 months of treatment. 70% of active patients have now been on therapy for 12 months or longer, up from 65%. During the quarter, Acadia completed the planned expansion of its DAYBUE field force by ~30% to accelerate future growth through penetration in the community outside the Rett syndrome centres of excellence. Approximately three-quarters of new patient referrals in Q2 came from the community. Acadia has also strengthened the DAYBUE leadership team with the addition of Allyson McMillian- Youngblood as SVP, Rare Disease Franchise. There is substantial potential for future growth in the US with two-thirds of the 5,500 to 5,800 diagnosed Rett patients yet to try DAYBUE. Outside the US, Acadia continues to build its European commercial team in anticipation of approval of the marketing application for Europe in Q1 2026. Named patient supply programs are now active in Europe through Clinigen, Israel through Rafa and Rest of the World through Farmamondo. 2 of 3 Anticipated royalties to Neuren are: • A$14.7 million for Q2 2025, up 16% on Q2 2024 or 9% on Q1 2025 • Between A$62 million and A$67 million in the US for the full year 2025 (assuming Acadia guidance is met and exchange rate of 0.65) * Assuming Acadia DAYBUE US net sales guidance of US$380 – 405m is met and AUDUSD of 0.65 Acadia’s Q2 earnings conference call and presentation can be accessed in the Investors section of the Acadia website www.acadia.com. 380 177 348 405 CY2023 (Apr -Dec) CY2024 CY2025 Acadia Guidance DAYBUE US Net Sales (US$m) + 97% + 9-16% 62 27 56 67 CY2023 CY2024 CY2025E* US Royalty to Neuren (A$m) + 110% + 11-19% 23 67 87 76 85 91 97 85 96 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Q4 2024 Q1 2025 Q2 2025 DAYBUE Net Sales (US$m) 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. 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.
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