AEON Biopharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update

Core Insights - AEON Biopharma is advancing the development of ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA) with plans to hold an initial advisory meeting with the FDA in the third quarter of 2024 [1][2][3] - The 351(k) regulatory pathway may allow AEON to bring ABP-450 to the U.S. market under a single approval for all current and future therapeutic indications of BOTOX [1][2] Company Overview - AEON Biopharma is a clinical-stage biopharmaceutical company focused on developing ABP-450 for various therapeutic indications, initially targeting the neurosciences market [4] - ABP-450 is the same botulinum toxin complex currently marketed for cosmetic uses under the name Jeuveau by Evolus [4] - The product is already approved as a biosimilar in Mexico and India, and AEON holds exclusive rights for therapeutic indications in the U.S., Canada, EU, UK, and other territories [4] Financial Highlights - For the second quarter ended June 30, 2024, AEON reported a significant loss from operations amounting to $153.5 million, compared to a loss of $14 million in the same period of the previous year [11][12] - Operating expenses included $3.3 million for selling, general, and administrative costs, and $4.4 million for research and development [11] - The net income for the second quarter of 2024 was reported at $164.1 million, a substantial increase from a net loss of $15.4 million in the same quarter of 2023 [12] Development Plans - AEON plans to initiate a pivotal clinical study comparing ABP-450 to BOTOX in treating cervical dystonia (CD), pending funding [3] - The company has submitted a briefing package to the FDA containing extensive data from various studies to support a Biologics License Application (BLA) filing [3] - A successful Phase 3 study could provide the necessary data to demonstrate that ABP-450 is highly similar to BOTOX for all approved and future indications [3]