Neuren Pharmaceuticals has affirmed the material impact of Acadia’s projection that DAYBUE global net sales could reach approximately US$700 million by 2028, underpinning its royalty revenue outlook.
- Neuren relies solely on royalties and milestones from Acadia’s DAYBUE sales
- Acadia projects DAYBUE net sales to hit ~US$700 million globally by 2028
- Neuren confirms compliance with ASX continuous disclosure rules
- Projection assumes European approval expected in Q1 2026
- Neuren’s royalty revenue for 2025 estimated between A$63m and A$66m
Background on the Partnership
Neuren Pharmaceuticals Limited (ASX – NEU) has provided a detailed response to an ASX Aware Letter following its recent announcement about the projected growth of DAYBUE, a drug licensed exclusively to Acadia Pharmaceuticals Inc (NASDAQ – ACAD). DAYBUE, approved and launched in the US in 2023, is currently Neuren’s sole source of product revenue through royalties and milestone payments tied directly to Acadia’s sales performance.
Material Impact of Sales Projections
Acadia’s projection that global net sales of DAYBUE could reach approximately US$700 million by 2028 represents a significant increase from its 2025 guidance of US$385 million to US$400 million. Neuren has confirmed that this forward-looking information is material and would reasonably be expected to influence the price or value of its securities, given the direct link between DAYBUE sales and Neuren’s royalty income.
Regulatory Compliance and Disclosure Process
Neuren’s response to the ASX letter outlines the timeline of awareness and disclosure, noting that the company became aware of Acadia’s updated projections on 14 January 2026 via international news alerts shortly after Acadia’s US announcement. Neuren promptly reviewed the information, cross-checked it against analyst reports and internal models, and secured board approval before releasing its own market announcement within hours, demonstrating adherence to ASX Listing Rules 3.1 and 3.1A.
Assumptions Underpinning the Projection
The projection to US$700 million in 2028 assumes several key factors – the rollout of DAYBUE STIX, a new formulation approved by the US FDA in December 2025 that may attract new patients; expansion of Acadia’s US customer-facing teams; and international growth contingent on European regulatory approval, with a decision expected in the first quarter of 2026. Neuren has stated it has reasonable grounds to rely on these assumptions, supported by Acadia’s disclosures and its own financial assessments.
Looking Ahead
Neuren anticipates that Acadia will provide updated sales guidance for DAYBUE when it reports its fourth-quarter 2025 financial results in February 2026. Investors will be watching closely to see if these projections hold and how they translate into royalty revenue for Neuren, which currently estimates royalties for 2025 between A$63 million and A$66 million.
Bottom Line?
Neuren’s fortunes remain tightly linked to Acadia’s execution and regulatory milestones, with 2026 set to be a pivotal year for validating these optimistic sales projections.
Questions in the middle?
- Will Acadia secure European approval for DAYBUE as anticipated in Q1 2026?
- How will the rollout of DAYBUE STIX impact patient uptake and sales growth?
- What updated sales guidance will Acadia provide in its Q4 2025 results?