Neuren (ASX:NEU) targets over 50% growth in FY24 commercial revenue from DAYBUE in North America

Highlights

• Neuren Pharmaceuticals, a biopharmaceutical company recorded 50% fall in group income in 1HFY24, while royalty income increased by nearly 600%
• Acadia, partner of NEU is advancing the development of trofinetide outside the United States, with regulatory approvals underway
• In FY24, the company anticipates 53.48% to 60.46% growth in its commercial revenue from DAYBUE^TM in North America

Neuren Pharmaceuticals Limited (ASX:NEU) is an Australia based biopharmaceutical company focused on development of new drug therapies for treating neurodevelopmental disorders.

In the first half of the financial year 2024 (1HFY24), group income dropped by 50.15% YoY to AUD 32.11 million, primarily due to the absence of any milestone payments. However, this decline was partially offset by a significant 594.29% YoY increase in royalty income, which reached AUD 24.30 million in 1HFY24. Additionally, R&D expenses surged by approximately 53% YoY to AUD 17.89 million, further impacting the company’s bottom line.

Profit before tax in 1HFY24 decreased by 76.13% YoY to AUD 11.84 million.  

Top 10 Shareholders of NEU

The top 10 shareholders of NEU hold around 22.47% stake in the company , while the top four hold nearly 12.76%. Milford Asset Management Ltd. has the highest stake in the firm with a shareholding of 4.74%, followed by Cameron Richard Pty. Ltd. with shareholdings of approximately 3.23%.

Recent Business Update

In its earnings release dated 27 August 2024, the company notified that NEU partner, Acadia is progressing the development of trofinetide outside the United States. In Canada, the New Drug Submission (NDS) has been accepted for Priority Review, with potential approval expected by the end of 2024. In Europe, the company has successfully filed a Pediatric Investigation Plan (PIP) with the European Medicines Agency (EMA), which has been accepted by EMA, paving the way for a potential Marketing Authorisation Application (MAA) submission in the first quarter of 2025. Additionally, Acadia had productive discussions with regulatory authorities in Japan.   

Outlook

In FY24, the company is targeting commercial revenue from DAYBUE^TM in North America in the range of AUD 132-138 million, representing a growth of 53.48% to 60.46% compared to FY23. This projection includes royalty revenue of AUD 55-61 million and a milestone payment of AUD 77 million in 2HFY24.

In FY24, U.S. net sales of DAYBUE^TM for Rett syndrome are projected to range from USD 340-370 million. Additionally, Acadia is engaged in expanding trofinetide beyond the U.S. market.

Share Performance of NEU

NEU shares closed 0.07% higher at AUD 13.96 apiece on 24 September 2024. In the past one year, NEU’s share price has increased by whopping 31.70%, while in the past three months, it has recorded a drop of nearly 30%.

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 24 September 2024. The reference data in this report has been partly sourced from REFINITIV.

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