Further information about DAYBUE, including prescribing information can be accessed at www.DAYBUE.com Neuren’s attractive economics from the Acadia partnership A redacted version of the licence agreement between Neuren and Acadia was filed with the US Securities and Exchange Commission as a material contract exhibit to Acadia’s 2018 10-K Annual Report, which is available to view via the SEC Filings section of Acadia’s website. Under the terms of the agreement, the development and commercialisation of trofinetide in North America is fully funded by Acadia. In October 2022, Neuren received from Acadia a milestone payment of US$10 million following the acceptance of the New Drug Application (NDA) for review by the FDA. The next milestone payment to Neuren is US$40 million, payable following the first commercial sale of trofinetide in the United States, which is anticipated at the end of April 2023. Neuren is eligible to received ongoing royalties on net sales of trofinetide in North America, plus milestone payments of up to US$350m on achievement of a series of four thresholds of total annual net sales, plus one third of the market value of the Rare Pediatric Disease Priority Review Voucher that was awarded to Acadia by the FDA upon approval of the NDA, with one third share estimated by Neuren as US$33 million. No royalties or similar costs are payable by Neuren to third parties, which means Neuren’s revenue from Acadia will flow through to pre-tax profit. The royalty rates and sales milestone payments are related to the total amount of annual net sales in trofinetide in all indications, as set out in the following tables: Tiered royalty rates (% of net sales)1 Sales Milestone payments1 Annual Net Sales Rates Net Sales in one calendar year US$m ≤US$250m 10% ≥US$250m 50 >US$250m, ≤US$500m 12% ≥US$500m 50 >US$500m, ≤US$750m 14% ≥US$750m 100 >US$750m 15% ≥US$1bn 150 1 Royalty rates payable on the portion of annual net sales that fall within the applicable range. Each sales milestone payment is payable once only. Consistent safety and tolerability findings 23 LAVENDER (12 weeks) Placebo-controlled LILAC (40 weeks) Open-label extension Adverse Events (AEs) >10% observed in Trofinetide group Diarrhea 80.7% (97% Mild and Moderate) Vomiting 27.0% (96% Mild and Moderate) Source: Acadia presentation (Acadia Corporate Presentation (4Q22 Earnings), Lavender Study Results (acadia.com)) Adverse Events (AEs) >10% observed in Lilac Diarrhea 74.7% (96% Mild and Moderate) Vomiting 28.6% (100% Mild and Moderate) COVID-19 11% Discontinuations due to AE of diarrhea: 21% No new safety or tolerability findings in Lilac OPERAT I NG REV I EW CON T I NU E D Consistent safety and tolerability findings Source: Acadia presentation (Acadia Corporate Presentation (4Q22 Earnings), Lavender Study Results (acadia.com)) Neuren Pharmaceuticals Limited Annual Repor t 2022 6
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