AEON Biopharma Announces Strategic Exchange Agreement with Daewoong
IRVINE, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) - AEON Biopharma, Inc. (NYSE American: AEON), a leading biopharmaceutical company focused on securing full-label U.S. market entry for its BOTOX (onabotulinumtoxinA) biosimilar, has announced a definitive agreement with Daewoong Pharmaceutical. This strategic partnership involves the exchange of $15 million in notes plus accrued interest for new equity, alongside $1.5 million in new notes due in 2030 and a cash-exercise warrant for 8 million shares of common stock. The agreement is pending shareholder approval.
Details of the Exchange Agreement
Under the terms of this agreement, AEON will convert $15 million of convertible notes into new equity and issue new notes valued at $1.5 million, which are due in 2030. Furthermore, the agreement includes a cash-exercise warrant for 8 million shares of common stock. If fully exercised, these warrants could generate over $8 million in additional cash for AEON.
Rob Bancroft, President and CEO of AEON, stated, “We are pleased to report the signing of definitive documentation for our exchange of Daewoong’s existing AEON-issued debt. While the transaction remains subject to a shareholder vote, this is an important step forward in deleveraging the company and sets the stage for continued progress in our ABP-450 biosimilar strategy for 2026.”
Significance of the Exchange
The exchange agreement aims to eliminate more than 90% of AEON's outstanding debt, thereby enhancing Daewoong’s long-term strategic alignment with the company and its stakeholders. This transformation of AEON's capital structure is expected to position the company favorably for future growth initiatives.
This deal follows a previously established binding term sheet between AEON and Daewoong, leading to the current definitive documentation that confirms the agreed-upon terms.
About AEON Biopharma
AEON is dedicated to accelerating full-label access to the U.S. therapeutic neurotoxin market through the development of its biosimilar to BOTOX. The therapeutic neurotoxin market in the U.S. exceeds $3.0 billion annually, highlighting a significant opportunity for biosimilar entries with AEON's lead asset, ABP-450, designed for debilitating medical conditions.
ABP-450, which is identical to the botulinum toxin complex marketed by Evolus, Inc. under the name Jeuveau®, is manufactured according to current Good Manufacturing Practice (cGMP) standards in facilities certified by the U.S. Food and Drug Administration, Health Canada, and the European Medicines Agency. Its approval as a biosimilar is already established in markets including India, Mexico, and the Philippines.
The U.S. Biosimilar Pathway
The development of biosimilars in the U.S. is governed by the FDA’s 351(k) pathway under the Public Health Service Act. This regulatory framework requires developers to demonstrate that their product is highly similar to an approved reference biologic, ensuring no clinically significant differences in safety, purity, or potency.
The achievement of analytical similarity is essential in the development process, followed by FDA interactions that assess any remaining uncertainties and whether limited clinical evaluation is necessary.
Forward-Looking Statements
This announcement contains forward-looking statements about AEON's expectations for future events or performance. These statements involve inherent risks and uncertainties that could cause actual results to differ significantly. Investors are advised to consider these risks carefully and refer to AEON's SEC filings for a comprehensive overview of potential risks.
Additional Information
As part of the process to obtain shareholder approval for the Exchange, AEON intends to file a proxy statement and other relevant materials with the SEC. Stakeholders are encouraged to read these documents thoroughly when available, as they will provide essential information regarding the company and the transactions involved.
For more details on AEON Biopharma, visit www.aeonbiopharma.com.