Neuren Pharmaceuticals (NEU) H2 2024 earnings summary

Executive summary

• Achieved record comprehensive income of AUD 166 million (including AUD 24 million FX gain) and profit after tax of AUD 142 million for 2024, driven by DAYBUE royalties, milestone payments, and PRV sale proceeds.

• DAYBUE generated AUD 445 million in revenue over 2023 and 2024, with only 30% of diagnosed Rett patients having accessed the drug, indicating significant future growth potential.

• NNZ-2591 advanced with positive Phase 2 results in Phelan-McDermid, Pitt Hopkins, and Angelman syndromes, and regulatory designations to expedite development.

• DAYBUE approved in Canada, with first sales expected Q3 2025; European and Japanese market expansion underway.

• All revenue derived from U.S. partner Acadia Pharmaceuticals, with significant milestone and royalty payments recognized.

Financial highlights

• DAYBUE revenue for 2023 and 2024 totaled AUD 445 million; 2024 US net sales reached USD 348.4 million, up 97% year-over-year.

• US royalty income from DAYBUE was AUD 56 million in 2024, projected to rise to AUD 62–67 million based on Acadia's 2025 guidance.

• Pro forma cash position of AUD 359 million after milestone and PRV sale receipts and tax payments; year-end cash and short-term investments were AUD 222 million.

• R&D investment in NNZ-2591 was AUD 33 million in 2024, reflecting increased clinical activity.

• Comprehensive income margin of 73% after tax, reflecting minimal costs attached to DAYBUE revenue.

Outlook and guidance

• 2025 DAYBUE US net sales guidance is USD 380–405 million, with expected royalties of AUD 62–67 million.

• First DAYBUE sales in Canada expected Q3 2025; EU approval targeted for Q1 2026; Japanese trial to start Q3 2025.

• Phase 3 trial for NNZ-2591 in Phelan-McDermid syndrome to commence mid-2025, with further registration trials for Pitt Hopkins and Angelman syndromes planned.

• Ongoing preparations for NNZ-2591 phase three, with a key FDA type C meeting in April 2025 to finalize endpoints.