Neuren Pharmaceuticals (NEU) H2 2024 earnings summary

Executive summary

• Achieved record comprehensive income of AUD 166 million and NPAT of AUD 142 million for 2024, driven by DAYBUE commercialization, milestone receipts, and a one-time priority review voucher sale.

• DAYBUE generated AUD 445 million in revenue over two years, with only 30% of diagnosed patients having tried the drug, indicating significant future growth potential.

• Positive Phase 2 results for NNZ-2591 in Phelan-McDermid, Pitt Hopkins, and Angelman syndromes, with all trials completed and phase three preparations underway.

• DAYBUE approved in Canada, EU marketing application submitted, and global expansion underway with first Canadian sales expected Q3 and EU approval targeted for Q1 next year.

• 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 U.S. net sales reached USD 348 million, up 97% year-over-year.

• Royalties from DAYBUE in 2024 were AUD 56 million, projected to rise to AUD 62–67 million based on Acadia's guidance.

• Pro forma cash position of AUD 359 million at year-end, factoring in milestone and PRV sale proceeds and tax payments.

• Operating expenses increased to AUD 44.9 million, mainly from higher R&D costs (AUD 33 million vs AUD 26.8 million prior year).

• Basic EPS was 111.17 cents, diluted EPS 108.61 cents, both lower than 2023.

Outlook and guidance

• 2025 DAYBUE U.S. net sales guidance is USD 380–405 million, implying AUD 62–67 million in royalties, with sequential growth expected after a seasonally lower Q1.

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

• Phase 3 trial for NNZ-2591 in PMS to commence mid-2025, with further registration trials for PTHS and AS planned.

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