Shares in Neuren Pharmaceuticals Ltd (ASX: NEU) are slightly lower on Friday after the company released its full-year results for 2025.
In early afternoon trade, the Neuren share price is down 0.37% to $13.39.
Let's take a closer look at what Neuren reported for the financial year.
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Underlying royalties rise but total income declines
For the 12 months to 31 December 2025, Neuren generated royalty income of $65 million from DAYBUE, up 15% from $56 million in 2024.
Interest income also increased to $12 million from $11 million.
However, total income fell to $85 million from $228 million in 2024. The prior year included significant one-off revenue, including a milestone payment and proceeds from the sale of a rare paediatric disease priority review voucher.
Research and development expenditure increased to $36 million, up from $33 million, reflecting investment in the Phase 3 Koala trial of NNZ-2591 in Phelan-McDermid syndrome.
Neuren reported profit before tax of $39 million and net profit after tax (NPAT) of $30 million. This compares with $142 million in net profit in 2024, which again included the benefit of one-off items.
Cash position strengthens as buybacks continue
Neuren finished the year with $296 million in cash and short-term investments as at 31 December 2025, up from $222 million a year earlier.
Net cash generated from operating activities totalled $125 million during the year.
The company completed a $50 million on-market share buyback during 2025 and has announced a further buyback to commence in early March 2026.
Management said that growing cash flows from DAYBUE continue to fund development programs across Phelan-McDermid syndrome, Pitt Hopkins syndrome, and hypoxic-ischaemic encephalopathy.
US sales growth drives higher royalty outlook
DAYBUE, marketed by partner Acadia Pharmaceuticals in the United States, delivered net sales of US$391 million in 2025, up 12% from 2024.
Neuren's royalty income from DAYBUE reflects tiered royalty rates on those sales.
Patient numbers continued to trend higher during the year, with more than 1,000 patients receiving treatment in the fourth quarter. Persistence rates at 12 months were reported at approximately 55%.
In December 2025, the US Food and Drug Administration (FDA) approved a new powder formulation, DAYBUE STIX. The company said that a broader commercial launch is being targeted for sometime early this year.
Acadia has guided to 2026 net sales of US$460 million to US$490 million. Based on current exchange rates, Neuren expects royalty income of $70 million to $77 million in 2026.
Phase 3 trial underway
Neuren's second drug candidate, NNZ-2591, made progress during the year.
The Phase 3 Koala study in Phelan-McDermid syndrome began dosing patients in early 2026. This followed agreement with the US FDA on the trial design and the key measures of success.
The program has also received Orphan Drug and Fast Track status in the United States.
Neuren is continuing development of NNZ-2591 in Pitt Hopkins syndrome and hypoxic-ischaemic encephalopathy, with discussions ongoing with regulators.
