- AEON and Daewoong Pharmaceutical have executed definitive documentation to exchange $15 million of notes plus accrued interest into new equity, $1.5 million of new notes due 2030, and a cash-exercise warrant for 8 million shares of common stock – - Exchange remains subject to shareholder approval - IRVINE, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company seeking accelerated and full-label U.S. market entry by devel ...

Core Points - AEON Biopharma, Inc. has completed the first closing of its PIPE, generating approximately $1.79 million in proceeds [1][2] - The FDA has rescheduled AEON's BPD Type 2a meeting to January 21, 2026, to review the analytical development plan and initial data supporting biosimilarity [3] Financial Summary - The first closing of the PIPE occurred on November 18, 2025, resulting in $1.79 million in proceeds [2] - The anticipated proceeds from the second closing will support AEON's analytical program and may accelerate the development of ABP-450 by up to six months [2] Regulatory Update - The FDA's rescheduling of the BPD Type 2a meeting to January 21, 2026, indicates continued engagement with AEON's biosimilar program [3] - The meeting will focus on AEON's analytical development plan without citing any scientific or program-related issues [3] Company Overview - AEON Biopharma is focused on gaining accelerated and full-label access to the U.S. therapeutic neurotoxin market, which exceeds $3.0 billion annually [5] - The company's lead asset, ABP-450, is a biosimilar to BOTOX and is manufactured in compliance with cGMP standards [5] - ABP-450 is already approved as a biosimilar in India, Mexico, and the Philippines, with exclusive development rights in the U.S., Canada, EU, UK, and other territories [5]

Core Insights - AEON Biopharma has announced two transactions that could provide up to approximately $22 million in potential proceeds, significantly improving its balance sheet and reducing outstanding debt by over 90% [1][7] Financing Details - AEON has entered a $6 million PIPE financing agreement, with the potential to raise over $7 million in additional capital through cash-exercise warrants [1][3] - The PIPE involves the sale of 6,581,829 shares at a price of $0.9116 per share, along with five-year warrants to purchase the same number of shares at an exercise price of $1.094 [3][4] - The first closing of the PIPE is expected in November 2025, with an initial gross proceeds of $1.79 million [4] Debt Exchange - AEON and Daewoong Pharmaceutical have agreed to exchange $15 million of existing convertible notes for approximately 23,103,694 shares of AEON common stock, a new $1.5 million note due in 2030, and 8 million cash-exercise warrants [6][7] - This exchange is anticipated to eliminate more than 90% of AEON's outstanding debt, thereby strengthening its capital structure [7] Program Advancement - The proceeds from these transactions are expected to support the uninterrupted advancement of AEON's ABP-450 biosimilar program, following positive analytical data submitted to the FDA [1][5] - The financing is projected to accelerate the biosimilar development timeline by up to six months [5] Market Context - AEON is focused on entering the U.S. therapeutic neurotoxin market, which exceeds $3 billion annually, through the development of ABP-450 as a biosimilar to BOTOX [10] - The company has exclusive rights for therapeutic indications of ABP-450 in the U.S., Canada, and the EU, among other regions [10]

Market Position and Growth - Evolus is gaining market share in the U S neurotoxin market, with Jeuveau's share increasing from 4% in 2019 to 14% in 2025[18] - The global addressable market for neurotoxins and fillers is expected to grow to $7 billion in 2028, with neurotoxins reaching $3.7 billion and fillers reaching $3.7 billion[20] - Evolus International is expected to achieve $100 million in revenue in 2028[23] Financial Performance and Projections - The company anticipates total net revenues for 2025 to be between $295 million and $305 million, representing an 11% to 15% increase over 2024[119] - Evolysse injectable HA gels are projected to contribute 10% to 12% of total revenue for the full year 2025[119] - Evolus projects $700 million in total net revenue and a non-GAAP operating income margin of 20% by 2028[120] Product Launches and Expansion - Evolysse Form and Evolysse Smooth HA gels launched in the U S in Q2 2025[45] - Estyme products are expected to launch internationally in the first half of 2026[119] - Evolysse Sculpt is scheduled to launch in the U S in the second half of 2026[45] Customer Engagement and Loyalty - The Evolus Rewards program has grown to over 13 million total enrollments by Q3 2025[63] - 70% of toxin consumers also use a dermal filler[74] - 37% of consumers receive both toxin and filler treatments during the same appointment[76]

Core Insights - AEON Biopharma is progressing towards significant biosimilar development milestones for ABP-450, aiming for a Type 2a meeting with the FDA in 4Q'25 [2][5] - The U.S. therapeutic neurotoxin market exceeds $3.0 billion, presenting a substantial opportunity for AEON's entry with ABP-450 as a cost-effective alternative to BOTOX [4][5] Financial Overview - As of June 30, 2025, AEON reported cash and cash equivalents of $8.4 million, expected to fund operations through the planned FDA meeting in 4Q'25 [5] - The company incurred a net loss of $6.6 million for the three months ended June 30, 2025, compared to a net income of $164.1 million for the same period in 2024 [12][13] - Total current assets amounted to $10.3 million, while total liabilities were reported at $27.5 million, resulting in a stockholders' deficit of $15.9 million [11] Upcoming Milestones - Completion of primary structure analysis and select functional analyses for ABP-450 is expected in 3Q'25 [5] - The anticipated Type 2a meeting with the FDA in 4Q'25 will discuss the results of these studies and outline the next steps for ABP-450's development [5][6] Product Development - ABP-450 is being developed as a biosimilar to BOTOX, utilizing the 351(k) regulatory pathway to potentially cover all therapeutic indications of BOTOX [2][5] - The product is already approved as a biosimilar in India, Mexico, and the Philippines, with exclusive development rights in the U.S., Canada, EU, and UK [6]

Market Position and Growth - Evolus is gaining market share in the fast-growing neurotoxin market[16] - Jeuveau's share of the toxin market has increased from 4% in 2019 to 14% in 2025[19] - The global addressable market for neurotoxins and fillers is expected to grow to $7 billion in 2028[20] - Evolus International is expected to achieve $100 million in 2028[23] Financial Performance - The company has exhibited double-digit revenue growth for the fifth consecutive year[28] - Net revenue is projected to be between $295 million and $305 million in 2025, representing 11% to 15% growth over 2024[29, 118] - Evolysse contributed 10%-12% of total revenue for the full year 2025[108, 118] - The company is projecting $700 million total net revenue by 2028[119] Product and Strategy - The company's total addressable market expands by 78% with the addition of the injectable HA gel portfolio[16] - Evolysse was the strongest first quarter filler launch in over a decade[106] - Evolus Rewards program has over 1.2 million total enrollments in Q2 2025[62, 113] - 70% of toxin consumers also use a filler[74]