drugset / Press release

Q1 2026 DAYBUE net sales US$101m, up 20% from Q1 2025

2026-05-06 · Neuren Pharmaceuticals Limited · original neurenpharma.com ↗

1 of 3 Neuren (NEU) – ASX Announcement 7 May 2026 Q1 2026 DAYBUE® net sales US$101m, up 20% from Q1 2025 Q1 Highlights: • Q1 2026 DAYBUE® (trofinetide) net sales of US$101 million, up 20% from Q1 2025 • Positive early reception for DAYBUE STIX after limited launch in Q1 with >250 prescriptions and >80% caregiver satisfaction • Delphi expert consensus panel recently recommended DAYBUE as part of the standard of care for eligible patients with Rett syndrome1 • Japan trofinetide trial accelerated with topline results expected in Sep to Nov 2026 timeframe • Neuren earned Q1 2026 royalty income of US$10.4 million, up 23% from Q1 2025 • Acadia reaffirmed full year 2026 DAYBUE net sales guidance of US$460 – 490 million, implying full year 2026 royalty income for Neuren of US$50 – 54 million (A$70 – 77 million assuming exchange rate of 0.70 – 0.72) Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) today reported highlights from the Q1 2026 financial results announcement and conference call of its partner, Acadia Pharmaceuticals (Nasdaq: ACAD), both of which can be accessed in the Investors section of the Acadia website www.acadia.com. Acadia announced Q1 2026 net sales of DAYBUE® (trofinetide) of US$101 million, up 20% on Q1 2025 — the highest year-on-year growth since Q3 2024. Acadia reaffirmed its full-year 2026 guidance for DAYBUE net sales of US$460–490 million. A Delphi expert consensus panel recently recommended DAYBUE as part of the standard of care for eligible patients with Rett syndrome1. DAYBUE STIX, the new powder formulation of trofinetide, was launched on a limited basis in the US during Q1 2026, focusing on Rett syndrome Centers of Excellence (COEs), and became broadly available in early April. In Q1 2026, more than 250 STIX prescriptions were written, with approximately 30% of these for treatment-naïve (new) patients or patients who had previously discontinued treatment. STIX received a positive early reception, with caregiver satisfaction exceeding 80% and strong healthcare professional (HCP) endorsement. Neuren CEO Jon Pilcher commented: “This was a strong start to the year for DAYBUE. I am very encouraged by the initial uptake and enthusiasm for DAYBUE STIX following the limited launch in Centers of Excellence (COEs) and I look forward to seeing the impact of the recent broader US launch. I see significant potential upside remaining in the US, with penetration rates currently ~60% in the COEs and ~28% in the broader community.” Outside the US, contributions from Named Patient Supply programs continued to grow. In Japan, enrolment in the ongoing trofinetide clinical trial accelerated, with topline results now anticipated in the 1 Prange EO, Beisang A, Pehlivan D, et al. Expert Consensus on Real-World Use of Trofinetide for Rett Syndrome Using a Modified Delphi Method. Ann Child Neurol. 2026; 4:38-51. 2 of 3 September to November 2026 timeframe (previously Q4 2026 / Q1 2027). In Europe, the re- examination process for trofinetide is expected to conclude in June 2026. In Q1 2026 Neuren earned royalties of US$10.4 million, up 23% on Q1 2025. Anticipated royalties for the full year 2026 are unchanged at between US$50 million and US$54 million (A$70 to 77 million assuming AUD/USD exchange rate of 0.70 – 0.72). * Full year estimates based on Acadia full year 2026 DAYBUE Net Sales Guidance of US$460-490m, conservatively assuming North America royalty rates only (10% of DAYBUE net sales up to US$250m and 12% of DAYBUE net sales between US$250m and US$500m) 76 85 91 97 85 96 101 110 101 Q1 2024 Q2 2024 Q3 2024 Q4 2024 Q1 2025 Q2 2025 Q3 2025 Q4 2025 Q1 2026 DAYBUE Net Sales (US$m) +20% 10 50 18 37 42 54 CY2023 CY2024 CY2025 CY2026E* Royalty to Neuren (US$m) 101 460 177 348 391 490 CY2023 (Apr -Dec) CY2024 CY2025 CY2026 Acadia Guidance DAYBUE Net Sales (US$m) 3 of 3 About Neuren Neuren Pharmaceuticals is developing new drug therapies to treat multiple serious neurological disorders caused by genetic abnormalities or brain injury, that have no or limited approved treatment options. Neuren’s therapies target the critical role of Insulin-like growth factor 1 (IGF-1) in the brain, using orally administered analogs of naturally occurring peptides. DAYBUE® (trofinetide) oral solution is approved by the US Food and Drug Administration (FDA), Health Canada and the Ministry of Health in Israel and DAYBUE STIX (trofinetide) powder is approved by the FDA for the treatment of Rett syndrome. Neuren has granted an exclusive worldwide license to Acadia Pharmaceuticals Inc. for the development and commercialization of trofinetide. Neuren’s second drug candidate, NNZ-2591, is in clinical development as an oral solution treatment for multiple neurodevelopmental disorders, with positive results achieved in Phase 2 clinical trials in Phelan- McDermid syndrome, Pitt Hopkins syndrome and Angelman syndrome. Each of these programs has been granted “orphan drug” designation in the United States and the European Union as well as Fast Track and Rare Pediatric Disease designations from the FDA. Neuren is also developing NNZ-2591 for the treatment of hypoxic ischemic encephalopathy (HIE), a serious condition caused by brain injury before or shortly after birth. Currently, Neuren is conducting a Phase 3, randomized, double-blind, placebo-controlled clinical trial (“Koala”) evaluating the safety and efficacy of NNZ-2591 in children aged 3 to 12 years with Phelan- McDermid syndrome and a 52-week open-label extension study. 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 Board of Neuren Pharmaceuticals Limited, Suite 1.01, 117 Camberwell Road, Hawthorn East, VIC 3123 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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