Record Q2 DAYBUE net sales of US$125m, CY26 royalty upgraded
2026-08-04 · Neuren Pharmaceuticals Limited · original neurenpharma.com ↗
1 of 3 Neuren (NEU) – ASX Announcement 5 August 2026 Record Q2 DAYBUE® net sales of US$125m; CY26 royalty upgraded Q2 Highlights: • Q2 2026 DAYBUE® (trofinetide) net sales of US$125 million, up 30% from Q2 2025 and 24% from Q1 2026 • Sales growth almost entirely volume-driven, as strong DAYBUE STIX adoption exceeding expectations • Launch in Germany anticipated in early Q4 2026 pending European Commission approval decision • Japan trial readout on track for Sep to Nov 2026, with regulatory submission anticipated in 2027 • Neuren earned Q2 2026 royalty income of US$12.9 million, up 34% from Q2 2025 and 24% from Q1 2026 • Acadia increased full year 2026 DAYBUE net sales guidance to US$480 – 510 million (from US$460 – 490 million), implying full year 2026 royalty income for Neuren of US$53 – 56 million (previously US$50 – 54 million) • Acadia reaffirmed target DAYBUE net sales in 2028 of US$700 million Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) today reported highlights from the Q2 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 Q2 2026 net sales of DAYBUE® (trofinetide) of US$125 million, up 30% on Q2 2025 and 24% on Q1 2026, which is the highest quarterly sales since launch. Acadia increased its full-year 2026 guidance for DAYBUE net sales to US$480 – 510 million, from the previous range of US$460 – 490 million. Neuren CEO Jon Pilcher commented: “We are pleased to see an exceptional quarter for DAYBUE, with very strong sales volume growth reflecting the early success of STIX in the US, as well as achievement of the positive CHMP opinion – both important steps toward bringing trofinetide to more patients with Rett syndrome globally. Subject to approval being confirmed, we now look forward to Acadia’s anticipated European launch later this year.” DAYBUE STIX, the new powder formulation of trofinetide, became broadly available in the US from early April. Following a limited launch focusing on Rett syndrome Centers of Excellence (COEs) in Q1 2026, Q2 2026 saw continued patient demand and robust uptake of STIX, with 40% of all US DAYBUE patients receiving STIX by quarter end. In Q2, approximately 45% of STIX demand came from new or returning patients. In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion at the end of June 2026, following a re-examination procedure, recommending the granting by the European Commission (EC) of a marketing authorisation 2 of 3 for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If DAYBU® is approved, the marketing authorisation would apply to all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Commercial launch in Germany is anticipated in early Q4 2026. Under the licence agreement, for Europe, Neuren is entitled to receive US$35 million following first commercial sale, sales milestone payments of up to US$170 million on achievement of escalating annual net sales thresholds, and tiered royalties from mid-teens to low-20s % of net sales. In Japan, topline results of the ongoing trofinetide clinical trial remain on track for the September to November 2026 timeframe, with a regulatory submission in Japan anticipated in 2027. In Q2 2026 Neuren earned royalties of US$12.9 million, up 34% on Q2 2025 and 24% on Q1 2026. Anticipated royalties for the full year 2026 increased to a range of US$53 million to US$56 million, from the previous range of US$50 million to US$54 million. * Full year estimates b ased on Acadia full year 2026 DAYBUE Net Sales Guidance of US$4 80-510 m Click here to view this announcement on our Investor Hub. 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 commercialisation of trofinetide. Neuren’s investigative drug candidate, NNZ-2591 (ercanetide), is in clinical development as an oral solution treatment for multiple neurodevelopmental disorders, including 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. Investor contact: Jon Pilcher, CEO & Managing Director +61 438 422 271 [email protected] Media Contact: Monsoon Communications Rudi Michelson [email protected] 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. Investor Hub
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