AEON Biopharma(AEON) - 2024 Q2 - Quarterly Results

Financial Performance - AEON Biopharma reported a net income of $164.1 million for Q2 2024, compared to a net loss of $15.4 million in Q2 2023, reflecting a significant turnaround in financial performance[10]. - Total operating expenses for Q2 2024 were $153.5 million, a substantial increase from $14.0 million in Q2 2023, primarily due to a change in the fair value of contingent consideration[10]. - The total liabilities of AEON Biopharma as of June 30, 2024, were $33.7 million, a decrease from $159.9 million at the end of 2023[8]. - AEON's additional paid-in capital increased to $399.6 million as of June 30, 2024, from $381.3 million at the end of 2023[8]. - The financial results of AEON Biopharma Sub, Inc. prior to the Merger are not directly comparable to the results following the Merger[11]. - Historical financial statements of AEON Biopharma Sub, Inc. became the historical financial statements of the combined Company after the Merger[11]. - The financial statements reflect both Predecessor periods for the three and six months ended June 30, 2023, and Successor periods for the three and six months ended June 30, 2024[11]. - A black line in the financial statements highlights the lack of comparability between Predecessor and Successor periods[11]. Cash Position - The company has $3.4 million in cash and cash equivalents as of June 30, 2024, down from $5.2 million at the end of 2023[8]. Clinical Development - AEON plans to initiate a Phase 3 clinical study in approximately 400 patients to compare ABP-450 to BOTOX, aiming to demonstrate non-inferiority[3]. - The company submitted a briefing package to the FDA, providing extensive data that could support a Biologics License Application (BLA) filing for ABP-450[3]. - AEON is scheduled to hold an initial advisory meeting with the FDA in Q3 2024 regarding the biosimilar development of ABP-450[3]. - The company aims to leverage the 351(k) regulatory pathway to bring ABP-450 to the U.S. market under a single approval for all of BOTOX's therapeutic indications[2]. Development Rights - The company has exclusive development and distribution rights for ABP-450 in the U.S., Canada, EU, UK, and other territories[4].