Neuren Pharmaceuticals’ (ASX:NEU) DAYBUETM gets Health Canada approval for Rett Syndrome

Highlights

• NEUs’ partner, Acadia Pharmaceuticals, received approval from Health Canada for DAYBUE^TM, making it the first drug approved in Canada for Rett Syndrome.
• The company saw a 50% drop in total income to AUD 32.11 million in 1HFY24 due to no milestone payments.
• Neuren expects North American commercial revenue from DAYBUE^TM to rise by 53.48% - 60.46%.

Neuren Pharmaceuticals Limited (ASX:NEU) develops new drug therapies for treatment of neurological disorders. The company’s product DAYBUE^TM is developed to treat Rett syndrome. The company is focused on expanding the access to DAYBUE^TM.

On 17 October 2024, the company informed that Acadia Pharmaceutical, partner of NEU, has obtained Health Canada approval for DAYBUE^TM, targeting Rett Syndrome. With this approval, DAYBUE^TM becomes the first and only drug approved in CANADA for treating Rett Syndrome.

Key financial metrics for 1HFY24

In the first half of the financial year 2024 (1HFY24), the company recorded a significant drop of nearly 50% in its total income to AUD 32.11 million due to zero sales milestone payments in 1HFY24, compared to AUD 59.4 million in previous corresponding period. The period saw around 53% YoY rise in R&D expenses, weighing on the bottom line, which stood at AUD 8.02 million, compared to AUD 47.81 million in 1HFY23.

NEU’s royalty income increased by nearly 600% YoY to AUD 24.30 million in 1HFY24

Outlook

With the approval of DAYBUE^TM in Canada, the future sales in Canada will be part of US sales for calculation of royalties and sales milestone payments for NEU.

In FY24, the company expects commercial revenue from DAYBUE^TM in North America to be in the range of AUD 132-138 million, reflecting a 53.48% - 60.46% rise over FY23. The projected figures include milestone payment of AUD 77 million in 2HFY24 and royalties of AUD 55-61 million.

In FY24, US net sales of DAYBUE^TM are expected to range between USD 340-370 million, compared to USD 177 million in FY23.     

Share performance of NEU

NEU shares closed 2.79% lower at AUD 12.55 apiece on 22 October 2024. In the past one year, NEU’s share price has increased by over 11.06%, while in the past three months, the share price has declined by nearly 39.87%.

52-week high of NEU is AUD 25.95, recorded on 28 December 2023, and 52-week low is AUD 10.02, recorded on 30 October 2023.

NEU Daily Technical Chart, Source: REFINITIV

Note 1: Past performance is neither an Indicator nor a guarantee of future performance.

Note 2: The reference date for all price data, and currency, is 22 October 2024. The reference data in this report has been partly sourced from REFINITIV.

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