CHAIR AND CEO MESSAGE PATRICK DAVIES & JON PILCHER In 2025 Neuren generated profit after tax of A$30 million, driven by DAYBUE® royalties growing by 15% to A$65 million. Cash reserves at the end of the year remained very strong at A$296 million. Neuren’s revenue from Acadia for DAYBUE since launch in 2023 has now exceeded A$500 million, which represents an outstanding success by any measure. This and our continuing disciplined investment in NNZ-2591 place Neuren in an enviable position to create further long-term value for shareholders. The most important part of that value creation is the Phase 3 development program for NNZ-2591 in Phelan-McDermid syndrome (PMS). The commencement of the Koala Phase 3 clinical trial was a pivotal milestone for Neuren. This was the culmination of many months of diligent preparation, including interactions with the US Food and Drug Administration (FDA). We are very encouraged by the support from the PMS community and look forward to building momentum this year as the remaining trial sites begin enrolment. We are proud to be the presenting sponsor of the PMS Foundation Family Conference in Colorado in July 2026, which will be a timely opportunity to engage further with the community. The alignment achieved at two meetings with the FDA means that we are confident a positive result in the Koala trial should enable us to prepare a New Drug Application. In parallel with executing the trial we are completing all the other studies and supply chain activities that are needed to support an application. We are prioritising pursuing indications for NNZ-2591 in which we have the potential to be first to market and maximise the impact for both patients and shareholders. In 2025 the treatment of the consequences of brain injury at birth (HIE) was added to PMS and Pitt Hopkins syndrome as the three highest value priorities. 2025 was a record year for DAYBUE, with sales of US$391 million and more than 1,000 patients treated during Q4. Even more exciting is Acadia’s guidance for 2026 sales of US$460-490 million, which would represent year-on-year growth of between 17% and 25%, assisted by the US launch of DAYBUE STIX, the powder formulation of trofinetide. STIX provides a potentially attractive new option for families who may have declined to try or discontinued the liquid formulation. Acadia has estimated that such families may number as many as 400. Patrick Davies Chair Jon Pilcher CEO As well as the continued growth in the US, we are very pleased that Rett syndrome patients in other parts of the world have been able to receive treatment under Acadia’s named patient programs, which are also providing a growing contribution to sales. Meanwhile, a small clinical study is underway in Japan, with results expected in Q4 2026 or Q1 2027 to support a potential marketing authorisation in that important market. Acadia has demonstrated its ongoing commitment to the Rett syndrome community in Europe through its request for a re-examination of the recent European Medicines Agency decision to deny marketing authorisation. Neuren believes that the community deserves a positive outcome. In the meantime, the fall in our share price following the decision far exceeded the valuation impact on Neuren, which means that if it were to be reversed this would now represent pure upside. Last month we initiated another share buyback program given what we believe is a material undervaluation of our assets in the current market, by reference to our own models and to those of the eight broker research analysts who formally cover Neuren. Our cash position, supported by growing cash flows from the DAYBUE franchise mean that Neuren’s NNZ-2591 development programs remain well funded alongside the buy-back. There is so much to look forward to in 2026 as our strategy advances, encompassing acceleration of enrolment in the Koala trial, initiation of the next stage for Pitt Hopkins and HIE, the anticipated impact of DAYBUE STIX in the US, completion of the small trial to support a marketing application in Japan and the result of the re-examination in Europe. We are grateful to our shareholders and the whole Neuren team for their ongoing dedication to what we all believe is such a meaningful mission. Delivering the impact on patients and their families that we are striving for should ultimately result in highly positive outcomes for all stakeholders. Neuren Pharmaceuticals Limited Annual Report 2025 2
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