Neuren Pharmaceuticals to receive significant royalties on back of DAYBUE sales surge
Neuren Pharmaceuticals (ASX: NEU) is expecting to receive increasing royalty payments from its US partner Acadia Pharmaceuticals, with sales of the recently launched DAYBUE treatment continuing to surge.
The Australian pharmaceutical company developed a unique Rett syndrome treatment and granted an exclusive worldwide licence to Acadia for the development and commercialisation of its trofinetide breakthrough, which is being marketed in the US as DAYBUE.
DAYBUE was launched by Acadia in the US in mid-April 2023 as the first treatment ever approved for Rett syndrome by the US Food and Drug Administration (FDA).
In North America, Neuren receives quarterly royalties on net sales, plus milestone payments of up to $545 million subject to achievement of annual net sales thresholds, plus one third of the market value of a rare paediatric disease priority review voucher when sold or used by Acadia.
Strong quarterly performance
Neuren has welcomed news from Acadia that it has obtained third quarter DAYBUE net sales in the United States of $104 million, up from $36 million in the second quarter.
Acadia also provided positive guidance for net sales in Q4 2023 of between $125 million and $136 million.
Neuren now expects its royalty returns for DAYBUE will reach $10.4 million for Q3 2023, before climbing to between $12.5 and $13.7 million for Q4 2023 and between $26 million to $28 million for full year 2023.
Acadia also reported that there has been uptake by 800 patients of DAYBUE as of 30 September 2023, which exceeds pre-launch expectations.
“The launch of DAYBUE has been exceptional, with all metrics exceeding expectations and we are delighted to see the positive impact in the Rett community,” said Neuren’s chief executive officer Jon Pilcher.
“The first full quarter of sales has achieved an annual run-rate of more than $380 million. For Neuren, in addition to very significant royalty revenues, this brings into focus the potential sales milestone payments.”
In late July Neuren received an upfront payment of around $155 million following the expansion of its partnership with Acadia.
Under that expanded agreement, the existing future payments to Neuren relating to trofinetide in North America remained unchanged, with up to $545 million milestone payments on achievement of escalating thresholds of annual net sales.
For trofinetide outside North America, in addition to the $155 million upfront payment, Neuren is eligible to receive potential first commercial sale milestone payments of up to $100 million, plus up to $564 million milestone payments on achievement of escalating thresholds of annual net sales, plus tiered royalties ranging from mid-teens to early 20s% of net sales.
Other treatments progressing
Victoria-headquartered Neuren is developing a range of new drug therapies to treat multiple serious neurological disorders that emerge in early childhood and have no or limited approved treatment options.
The company is currently conducting Phase 2 trials of a second drug candidate, NNZ-2591, for Phelan-McDermid syndrome, Angelman syndrome, Pitt Hopkins syndrome and Prader-Willi syndrome.