Neuren’s DAYBUE Sales Climb 11% as European Launch Nears
Neuren Pharmaceuticals reports a robust 11% rise in DAYBUE™ US net sales for Q1 2025, alongside a 17% jump in royalty income, setting the stage for an anticipated European market entry in early 2026.
- Q1 2025 DAYBUE US net sales up 11% to US$84.6 million
- Neuren’s Q1 2025 royalty income rises 17% to A$13.5 million
- Record 954 unique patients treated, with improved persistency rates
- Full-year 2025 US sales guidance maintained at US$380–405 million
- European marketing approval expected in Q1 2026; first shipment under Managed Access Program
Strong US Sales Momentum
Neuren Pharmaceuticals has delivered a solid start to 2025, buoyed by its partner Acadia Pharmaceuticals’ DAYBUE™ (trofinetide) sales performance in the United States. The first quarter saw net sales rise 11% year-on-year to US$84.6 million, reflecting steady patient uptake and improved treatment persistence. This growth is particularly notable given the typical seasonal dip following a strong Q4 2024, attributed to refills being brought forward into December.
Patient Growth and Treatment Persistence
The number of unique patients receiving DAYBUE shipments hit a record 954 in Q1 2025, a 4% increase from the previous quarter. Discontinuation rates have dropped sharply, down 35% from Q4 2024 and 66% from Q1 2024, signaling enhanced patient adherence. Impressively, 65% of active patients have remained on therapy for 12 months or longer, underscoring the drug’s sustained value in managing Rett syndrome.
Royalty Income and Financial Position
Neuren’s royalty income for the quarter rose 17% to A$13.5 million, benefiting from the stronger US sales and a favourable exchange rate assumption. The company’s cash and short-term investments stood at a robust A$341 million as of March 31, 2025, bolstered by milestone payments and proceeds from a Priority Review Voucher sale. This financial strength provides a solid runway for ongoing development and expansion efforts.
Looking Ahead: Europe and Asia-Pacific Expansion
Acadia has reaffirmed its full-year 2025 US net sales guidance of US$380–405 million, implying Neuren royalties between A$62 million and A$67 million. Beyond the US, the company is preparing for a pivotal European launch, with marketing approval anticipated in Q1 2026. The first shipment to a German patient under a Managed Access Program in April signals early market entry. Additionally, trofinetide has secured Orphan Drug designation in Japan, with clinical trials slated to begin in Q3 2025. Distribution agreements are also in place to facilitate named patient supply across Latin America, the Middle East, and Asia Pacific, broadening the drug’s global footprint.
Strategic Outlook
With two-thirds of the estimated 5,500 to 5,800 diagnosed Rett syndrome patients in the US yet to try DAYBUE, significant growth potential remains. Acadia’s recent 30% expansion of its field force aims to accelerate patient outreach and uptake. Meanwhile, Neuren’s pipeline continues to advance, with NNZ-2591 progressing through Phase 2 trials targeting multiple neurodevelopmental disorders, promising further long-term value.
Bottom Line?
Neuren’s steady royalty growth and expanding global reach position it well for sustained momentum, but upcoming regulatory milestones will be key to watch.
Questions in the middle?
- How will European regulatory approval and launch execution impact Neuren’s revenue trajectory?
- What are the prospects and timelines for trofinetide’s clinical trials and approval in Japan?
- Can patient uptake in emerging markets like Latin America and Asia Pacific match US growth rates?
