Neuren Pharmaceuticals (NEU: $22.46) has seen its share price surge on unexpected strong sales growth in DAYBUE, the therapy developed initially by Neuren and subsequently licensed to its partner Acadia Pharmaceuticals for the treatment of Rett syndrome.
DAYBUE sales jumped by 30% in the June quarter over the PCP to US$125 million, the highest quarterly sales recorded. For the quarter Neuren will receive royalties of US$12.9 million.
By comparison, sales in the June quarter 2025 increased by just 13% over the PCP. And sales in the March quarter this year fell by 8% to US$101 million, which appears to be a seasonal dynamic.
If sales in North America exceed US$500 million in a calendar year, then Neuren will receive an additional US$50 million milestone payment, and a US$100 million milestone payment if sales pass US$750 million in a calendar year.
A driver of the sales growth has been a new formulation of the product, called STIX, which is a powder formulation that can be added to any drink (other than dairy). The new formulation was released in just April and by the end of June 40% of patients were using the STIX formulation, which CEO Jon Pilcher said is an incredibly quick switch. The new formulation was developed by Acadia. Many patients who discontinued the original formulation are now also returning to try the new STIX formulation according to Pilcher.
Acadia has increased its guidance by US$20 million for 2026 sales to between US$480 - US$510 million. Whilst adoption within the Centres of Excellence for Rett syndrome has been high at 60%, in other areas, including regional clinics, the take up has only been 28% which leaves "huge scope for growth" believes Pilcher.
Other milestones ahead include launch of the product in Europe, pending approval, with sales expected to begin in Germany in the December quarter. This will trigger a US$35 million milestone payment plus royalties from mid teens to just over 20% that are higher than the US. The CHMP overturned its original decision in Europe in June, with considerable input from the Rett community following an earlier negative CHMP view.
A trial in Rett syndrome is underway in Japan, with results due this year and an new drug application expected to be filed next year. Upon first commercial sale in Japan Neuren will receive a US$15 million milestone payment from Acadia plus royalties similar to Europe.
Neuren finished March with $293 million in cash, having received $543 million from Acadia for DAYBUE, with the product launched only in 2023.
Bioshares recommendation: Hold
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