Financial Performance - Total operating costs and expenses for the three months ended September 30, 2025, were $2,493 million, compared to $4,016 million for the same period in 2024, representing a decrease of 38.0%[26] - Net loss for the three months ended September 30, 2025, was $4,538 million, compared to a net loss of $6,171 million for the same period in 2024, indicating an improvement of 26.4%[26] - Basic net loss per share for the three months ended September 30, 2025, was $0.39, compared to a loss of $11.24 per share for the same period in 2024, reflecting a significant reduction in losses[26] - Research and development expenses for the nine months ended September 30, 2025, totaled $2,485 million, down from $11,144 million in the same period of 2024, a decrease of 77.7%[26] - Total other loss income for the three months ended September 30, 2025, was $(2,045) million, compared to $(2,155) million for the same period in 2024, showing a slight improvement[26] - Loss on issuance of warrants for the nine months ended September 30, 2025, was $(75,644) million, indicating significant financial impact[26] - Change in fair value of convertible notes for the three months ended September 30, 2025, resulted in a loss of $(1,877) million, consistent with the previous year's loss of $(1,878) million[26] - The company reported a total loss before taxes of $(4,538) million for the three months ended September 30, 2025, compared to $(6,171) million for the same period in 2024, reflecting a reduction of 26.4%[26] - The change in fair value of warrants resulted in a loss of $(236) million for the three months ended September 30, 2025, compared to a gain of $85,950 million in the same period of 2024, indicating volatility in financial instruments[26] Financing and Cash Position - The company announced two financing transactions totaling $6 million, expected to reduce outstanding debt by over 90% and extend cash runway into Q2 2026[5][6] - As of September 30, 2025, AEON had cash and cash equivalents of $5.9 million, which will be sufficient to fund operations through Q2 2026[6] - Total assets increased to $8.734 million as of September 30, 2025, compared to $3.142 million at the end of 2024[23] - Total liabilities decreased to $28.606 million as of September 30, 2025, down from $31.711 million at the end of 2024[23] - AEON's accumulated deficit stood at $433.682 million as of September 30, 2025, compared to $431.597 million at the end of 2024[23] Product Development and Regulatory Updates - AEON reported positive biosimilarity data for ABP-450, confirming a 100% amino-acid sequence match to BOTOX® with 93-99% sequence coverage across all five proteins[3][4] - The FDA Type 2a meeting is scheduled for November 19, 2025, to discuss the analytical development plan and initial data for ABP-450[1][7] - AEON has exclusive development and distribution rights for ABP-450 in the U.S., Canada, EU, UK, and other territories, targeting a market exceeding $3.0 billion annually[9] - The company aims to accelerate the ABP-450 biosimilar program by up to six months following the recent financing[2][5] - The company has a globally approved manufacturing platform for ABP-450, with approvals in 69 countries, validating its biosimilar strategy[2]
AEON Biopharma(AEON) - 2025 Q3 - Quarterly Results