Neuren’s Royalties Jump 24% to A$39.7M as NNZ-2591 Trial Kicks Off
Neuren Pharmaceuticals reported a robust half-year with an 88% increase in net profit, driven by rising royalties from DAYBUE™ sales and progress in its NNZ-2591 clinical program. The company also completed a $39.6 million share buy-back, underscoring confidence in its growth trajectory.
- Net profit after tax rose 88% to A$15.0 million
- Royalty revenue from Acadia’s DAYBUE™ increased 16% to A$28.3 million
- Initiation of Phase 3 trial for NNZ-2591 in Phelan-McDermid syndrome
- On-market share buy-back completed totaling A$39.6 million
- Strong cash position of A$299.5 million supports ongoing R&D
Financial Performance Highlights
Neuren Pharmaceuticals Limited has delivered a strong financial performance for the half-year ended 30 June 2025, reporting revenues of A$39.7 million, up 24% from the prior corresponding period. Net profit after tax surged 88% to A$15.0 million, reflecting higher royalty income and improved operational efficiencies. The company’s basic earnings per share nearly doubled to 11.88 cents, signaling enhanced shareholder value.
The primary driver behind this growth was royalty revenue from Acadia Pharmaceuticals’ sales of DAYBUE™, the first approved treatment for Rett syndrome in the United States. Royalty income increased to A$28.3 million, up from A$24.3 million in the previous half-year, supported by rising patient numbers and expanded commercial efforts by Acadia.
Progress on Key Drug Development Programs
Neuren is advancing its pipeline with the initiation of a pivotal Phase 3 clinical trial for NNZ-2591 targeting Phelan-McDermid syndrome (PMS), a rare neurodevelopmental disorder. The trial’s design, agreed upon with the US Food and Drug Administration, focuses on clinically meaningful endpoints related to communication improvements, a critical symptom area for PMS patients.
Beyond PMS, Neuren has expanded NNZ-2591’s development to include hypoxic-ischemic encephalopathy (HIE) and SYNGAP1-related disorder (SRD), both serious conditions with significant unmet medical needs. These additions underscore the company’s commitment to addressing a broader spectrum of neurodevelopmental disorders.
Strategic Capital Management and Market Position
During the half-year, Neuren completed an on-market share buy-back program, repurchasing 3.27 million shares at an average price of $12.09, totaling A$39.6 million. This move reflects the board’s confidence in the company’s long-term prospects and commitment to enhancing shareholder returns.
Neuren’s cash and short-term investments stood at a robust A$299.5 million as of 30 June 2025, providing ample runway to fund ongoing research and development activities without the need for additional capital raising. The company’s financial strength is further bolstered by steady royalty streams and milestone payments linked to DAYBUE™ sales.
Outlook and Regulatory Developments
Acadia Pharmaceuticals has provided guidance for full-year 2025 net sales of DAYBUE™ in the US between US$380 million and US$405 million, which translates to anticipated royalties for Neuren of A$62-67 million. Meanwhile, regulatory progress continues with a Marketing Authorisation Application submitted to the European Medicines Agency, aiming for approval in early 2026, and clinical trial preparations underway in Japan.
These developments position Neuren well for sustained growth, with expanding geographic reach and a diversified pipeline that could deliver multiple future revenue streams.
Bottom Line?
Neuren’s strong half-year results and pipeline momentum set the stage for a potentially transformative year ahead in neurodevelopmental therapeutics.
Questions in the middle?
- How will the Phase 3 trial outcomes for NNZ-2591 impact Neuren’s valuation and partnership opportunities?
- What is the timeline and likelihood of regulatory approval for DAYBUE™ in Europe and Japan?
- Could further share buy-backs or dividend declarations be on the horizon given the company’s cash position?
