Image source: Shutterstock

Highlights

  • Neuren’s royalty revenue surged 594% YoY to AUD 24.3 million in 1HFY24, and net profit fell to AUD 8.0 million from AUD 47.8 million.
  • The FDA has granted a Type C Meeting for NNZ-2591’s Phase 3 trial in Phelan-McDermid syndrome, scheduled for early April 2025.
  • The company expects FY24 total income to range between AUD 216 million and AUD 218 million, with continued expansion in neurodevelopmental treatments.

Neuren Pharmaceuticals Limited (ASX:NEU), an ASX-listed biopharmaceutical company focused on neurological disorder treatments, has reported significant financial and regulatory developments. Recently, the company has experienced substantial growth in royalty revenue, strengthened its partnership with Acadia Pharmaceuticals, and is advancing clinical trials for NNZ-2591.

Recent financial performance

For the half-year ended 30 June 2024 (1HFY24), Neuren recorded a remarkable surge in royalty revenue, reaching AUD 24.3 million, up from AUD 3.5 million in the same period last year, reflecting a 594% YoY increase. This growth stemmed from the licensing agreement with Acadia Pharmaceuticals for DAYBUE™ (trofinetide).

However, during the reported period, net profit fell to AUD 8.0 million from AUD 47.8 million in the previous year, primarily due to the absence of the AUD 59.4 million milestone revenue recognised in 2023 following DAYBUE’s first commercial sale. Interest income in 1HFY24  saw a significant increase, rising to AUD 5.8 million from AUD 0.7 million, marking a 729% YoY growth.

Recent developments

On the regulatory front, Neuren announced that the FDA has granted a Type C Meeting to discuss the primary efficacy endpoints for its planned Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome. This development follows a successful Type B End of Phase 2 Meeting, where key aspects of the trial were aligned. The Type C Meeting is set to take place in early April 2025.

Outlook

Neuren expects increased growth in royalty income and milestone payments from DAYBUE™, with FY24 total income projected between AUD 216 million and AUD 218 million. The company is advancing its clinical pipeline with ongoing developments for NNZ-2591 and DAYBUE™.

Share performance of NEU

NEU shares closed 1.95% lower at AUD 13.05 per share on 12 February 2025. Over the past one year, NEU’s share price has dropped by almost 43.26% and in the last three months, it has decreased by nearly 21.10%.

52-week high of NEU is AUD 24.00, recorded on 27 May 2024 and 52-week low is AUD 10.90, recorded on 15 January 2025.

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 12 February 2025. The reference data in this report has been partly sourced from REFINITIV.