CHAIR AND CEO MESSAGE PATRICK DAVIES & JON PILCHER 2023 was a transformational year for Neuren. In all three areas of the business, we achieved the key planned milestones that generated very significant value for all stakeholders. The approval of DAYBUE™ by the US Food and Drug Administration (FDA) in March 2023 as the first ever treatment for Rett syndrome was a proud moment for the Neuren team. Our partner Acadia launched DAYBUE a month later. In our message to you last year, we stated that we were confident Acadia was very well placed for successful commercialisation. The launch was indeed highly successful and 2023 net sales of US$177 million in less than 9 months, with Acadia’s guidance for net sales to more than double in 2024, is an outstanding outcome. We are very encouraged by testimonials from families about the impact of treatment. In July 2023 we expanded our partnership with Acadia for DAYBUE from North America to worldwide, following a competitive partnering process. Acadia is in a unique position of being able to leverage knowledge of all aspects of the development, marketing and distribution of DAYBUE. The expanded agreement delivered to Neuren US$100 million up-front and very attractive future economics linked to launches and sales in key territories. In December 2023 we announced highly encouraging results from our Phase 2 clinical trial of NNZ-2591 in Phelan-McDermid syndrome. These results exceeded our expectations, both in the consistency of the findings and the magnitude of improvements seen across clinically important aspects of Phelan-McDermid syndrome, including communication, behaviour, cognition/learning and socialisation. Neuren is currently leading the way in striving to achieve the first approved treatment for PhelanMcDermid syndrome and the team is very excited by that prospect. We have noted before that Neuren has no cost attached to the royalty and milestone revenue we receive from Acadia, which therefore flows straight into pre-tax profit. The impact of this was evident in our financial results for 2023, the highlight of which was profit after tax of $157 million. This reflected revenue from Acadia of A$232 million, comprising royalty of A$27 million, a milestone payment of A$59 million and A$146 million from the expanded worldwide agreement. Neuren was promoted into the S&P/ASX 200 index in September 2023 and was the best performing ASX 200 stock in 2023, with a share price increase of 214%. We now have many more institutional shareholders and a high level of interest and engagement from the financial markets community. We continue to seek higher interest and investment, both in Australia and overseas, assisted by a wide range of intermediaries. In October 2023, Neuren was presented with the 2023 Australian Growth Company of the Year Award for Health and Life Sciences. Jon Pilcher CEO Patrick Davies Chair 2 Neuren Pharmaceuticals Limited Annual Report 2023
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