Neuren Pharmaceuticals (ASX: NEU) has reported a record total comprehensive income of A$166m for 2024, comprising a A$142m profit after tax and a A$24m foreign currency translation gain. The company saw a 110% increase in royalty income from its drug DAYBUE following strong US sales.
Neuren Pharmaceuticals is a Melbourne-based biopharmaceutical company developing treatments for neurological disorders. DAYBUE™ (trofinetide), its lead product, is the first approved treatment for Rett syndrome in the US and Canada. The company is also advancing NNZ-2591 for multiple neurodevelopmental disorders.
The company ended 2024 with A$222m in cash and short-term investments, with a pro-forma balance of A$359m after factoring in Q1 2025 receipts, including a US$50m sales milestone payment from its commercial partner Acadia Pharmaceuticals. This milestone was triggered by DAYBUE’s US$348.4m in net US sales, surpassing the US$250m threshold. Acadia has provided guidance for 2025 sales between US$380m and US$405m, which would further boost Neuren’s royalty income to A$62m–A$67m.
In addition to US market growth, DAYBUE has been approved in Canada, with first sales expected in Q3 2025. Acadia has also submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency, with potential approval in Q1 2026. In Japan, a small clinical study is planned for Q3 2025 to support a future marketing application.
Neuren’s pipeline includes NNZ-2591, a treatment targeting multiple neurodevelopmental disorders. The company achieved positive Phase 2 trial results for Phelan-McDermid, Pitt Hopkins, and Angelman syndromes, with a Phase 3 trial planned for mid-2025. The US FDA has granted Fast Track and Rare Pediatric Disease designations for NNZ-2591 in certain conditions, which may accelerate regulatory pathways.
Neuren’s CEO, Jon Pilcher, described 2024 as an “exceptional financial result,” citing the company’s strong cash position and ongoing expansion of DAYBUE into new markets.
