9M 2023 Financial Overview

9M 2023: R&D update Highly productive R&D in the first nine months of 2023 Key R&D milestones Rexulti AADAD approval & PTSD phase III HLR • AADAD: JAMA Neurology published complete results of positive phase III trial of Rexulti for AADAD AADAD: Regulatory process ongoing in Canada, Singapore, Australia and Switzerland PTSD: Flexible dose trial met primary endpoint (p<0.05), whereas Fixed dose trial missed primary endpoint (p>0.05) Aripiprazole 2-month RTU advancement 9 • European MAA progresses. Approval expected Q1 2024 Research JAMA Neurology | Original Investigation Brexpiprazole for the Treatment of Agitation in Alzheimer Dementia A Randomized Clinical Trial Daniel Lee, MD; Mary Slomkowski, PharmD; Nanco Hefting, MSc; Dalei Chen, PhD; Klaus Groes Larsen, PhD; Eva Kohegyi, MD; Mary Hobart, PhD; Jeffrey L. Cummings, MD, SCD(HC); George T. Grossberg, MD Submitted in Australia and Korea Anti-PACAP PoC data presented at IHC 2023 • Progressing to phase llb trial in migraine prevention to establish full dose range and subcutaneous efficacy IMPORTANCE Agitation is a prevalent, distressing, and burdensome manifestation of Alzheimer dementia in need of an efficacious, safe, and well-tolerated treatment. OBJECTIVE To confirm the efficacy, safety, and tolerability of brexpiprazole in patients with agitation in Alzheimer dementia. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial was a 12-week, double-blind, placebo-controlled, fixed-dose, parallel-arm trial that ran from May 2018 to June 2022 at 123 clinical trial sites in Europe and the United States. Participants included patients with agitation in Alzheimer dementia in a care facility or community-based setting. Stable Alzheimer disease medications were permitted. INTERVENTIONS In this 2-arm trial, patients were randomized to receive oral brexpiprazole or placebo (2:1 ratio) for 12 weeks. Within the brexpiprazole arm, patients were further randomized to receive fixed doses of 2 mg/d or 3 mg/d in a 1:2 ratio MAIN OUTCOMES AND MEASURES The Agitation Inva AADAD: agitation associated with dementia due to Alzheimer's disease, PTSD: post-traumatic stress disorder, HLR: headline result, RTU: ready-to-use, MAA: Marketing Authorization Application. PACAP: pituitary adenylate cyclase activating peptide, PoC: proof of concept, IHC: International Headache Congress Lundbeck

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