AEON Biopharma, Inc. SEC 10-Q Report

AEON Biopharma, Inc., a biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450, as a biosimilar to BOTOX® for debilitating medical conditions, has released its Form 10-Q report for the third quarter of 2025. The report provides a comprehensive overview of the company's financial performance and strategic business initiatives.

Financial Highlights

Net (loss) income: AEON Biopharma reported a net loss of $(4.5) million for the three months ended September 30, 2025, reflecting an improvement from a net loss of $(6.2) million for the same period in 2024. For the nine months ended September 30, 2025, the net loss was $(2.1) million, a significant decrease from a net income of $39.9 million for the same period in 2024.

Basic net (loss) income per share: The basic net loss per share was $(0.39) for the three months ended September 30, 2025, compared to $(11.24) for the same period in 2024. For the nine months ended September 30, 2025, the basic net loss per share was $(0.23), compared to a net income per share of $74.53 for the same period in 2024.

Diluted net (loss) income per share: The diluted net loss per share was $(0.39) for the three months ended September 30, 2025, compared to $(11.24) for the same period in 2024. For the nine months ended September 30, 2025, the diluted net loss per share was $(0.23), compared to a net income per share of $69.53 for the same period in 2024.

Business Highlights

Segment Operating Expenses: The company reported total operating costs and expenses of $2,493 thousand for the three months ended September 30, 2025, compared to $4,016 thousand for the same period in 2024. This decrease is primarily attributed to reduced selling, general, and administrative expenses, as well as a significant reduction in research and development costs.

Research and Development Focus: AEON Biopharma is focused on developing its proprietary botulinum toxin complex, ABP-450, as a biosimilar to BOTOX® for debilitating medical conditions. The company has shifted its strategic focus to pursue a Section 351(k) biosimilar regulatory pathway for ABP-450, using AbbVie Inc.’s product Botox as a proposed reference product.

Clinical Trials and Regulatory Pathway: The company announced the discontinuation of its Phase 2 clinical trials for episodic and chronic migraine in May 2024 to implement cash preservation measures. Instead, AEON is pursuing a biosimilar regulatory pathway and has commenced analytical studies to prepare for a Biosimilar Biological Product Development Type 2a meeting with the FDA.

Strategic Reprioritization: In July 2024, AEON announced a strategic reprioritization to focus on developing a Botox biosimilar. This decision was made following the discontinuation of its migraine clinical trials and is aimed at aligning with the FDA on next steps for biosimilar development.

Future Outlook: The company expects to incur losses and use cash in its operations for the foreseeable future. AEON is actively attempting to secure additional capital to fund its operations, which is crucial for the continuation of its research and development programs and the pursuit of regulatory approval for its product candidates.

Operational Challenges: AEON faces significant operational challenges, including dependency on the clinical and commercial success of its product candidates, the need for substantial additional financing, and the ability to manage organizational growth and protect its technology.

Supplier Dependency: The company relies on Daewoong Pharmaceutical Co., Ltd. as an exclusive and sole supplier to manufacture the source material for its product candidates. Any termination or loss of significant rights under the Daewoong Agreement would materially and adversely affect AEON's commercialization efforts.

SEC Filing: AEON Biopharma, Inc. [ AEON ] - 10-Q - Nov. 14, 2025