Neuren Pharmaceuticals (NEU) Q2 2024 earnings summary

Executive summary

• Q2 2024 net sales of DAYBUE™ (trofinetide) reached US$84.6 million, up from US$75.9 million in Q1 2024, earning A$13 million in royalties.

• Updated 2024 net sales guidance for DAYBUE™ is US$340–370 million, with expected royalties of A$55–61 million and a sales milestone of A$77 million.

• Real-world LOTUS™ study interim data showed 67.7%–82.2% of caregivers reported symptom improvements in Rett syndrome patients over six months.

• NNZ-2591 Phase 2 trial in Pitt Hopkins syndrome showed significant clinical improvements; Phase 3 preparations underway.

Financial highlights

• Cash and short-term investments at 30 June 2024 were A$213 million, down from A$243 million at 31 March 2024.

• Royalties of A$13 million earned in Q2 2024, with A$11.6 million received in Q2 for Q1 sales.

• First Australian income tax payment of A$34 million made in Q2 2024 for 2023.

• Interest income in Q2 2024 was A$3.1 million.

Outlook and guidance

• 2024 DAYBUE™ net sales guidance revised to US$340–370 million, down from previous US$370–420 million.

• Royalties for 2024 expected at A$55–61 million, plus A$77 million milestone if sales exceed US$250 million.

• Potential Canadian approval for DAYBUE™ by year-end 2024; European MAA filing planned for Q1 2025.

• End of Phase 2 FDA meeting for NNZ-2591 in Phelan-McDermid syndrome scheduled for September 2024.