8-K
AEON Biopharma, Inc. (AEON)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 24, 2025
AEON Biopharma, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-40021 | 85-3940478 |
|---|---|---|
| (State or other jurisdiction<br><br>of incorporation) | (Commission<br><br>File Number) | (IRS Employer<br><br>Identification Number) |
5 Park Plaza
Suite 1750
Irvine , CA **** 92614
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: ( 949 ) 354-6499
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| | | | | |
|---|---|---|---|---|
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||
| Class A Common Stock, $0.0001 par value per share | | AEON | | NYSE American |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On March 24, 2025, AEON Biopharma, Inc. (the “Company” or “AEON”) announced financial results for the fiscal year ended December 31, 2024. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).
The information furnished in this Item 2.02 of this Report (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such a filing.
Item 9.01. Financial Statement and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
|---|---|---|
| | | |
| 99.1 | Press Release, dated March 24, 2025. | |
| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | | |
|---|---|---|
| | AEON Biopharma, Inc. | |
| Date: March 24, 2025 | By: | /s/ Marc Forth |
| | | Marc Forth |
| | | Chief Executive Officer |
Exhibit 99.1
PRESS RELEASE
AEON Biopharma Reports Fourth Quarter 2024 and Full Year Financial Results and Provides Corporate Update
– Initiated analytical studies in Q4 2024 to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 –
– Pursuing a 351(k) regulatory pathway for ABP-450, which offers potential access to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications –
IRVINE, Calif., March 24, 2025 – AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update.
“We are excited to move ahead with our biosimilar development program for ABP-450 under the 351(k) regulatory pathway utilizing BOTOX as the reference product. As part of this program, we initiated the primary analytical studies in the fourth quarter of 2024. The data from these studies will be used to complete the primary comparative analytical assessment, which the FDA will use to evaluate and determine the next steps for the program,” commented Marc Forth, AEON’s President and Chief Executive Officer.
“We are excited by the progress our team is making along this regulatory pathway, which we believe could allow us to bring ABP-450 to the U.S. market for all of BOTOX’s currently approved and future therapeutic indications under a single FDA approval. The financing we closed in January provided the critical funding that will allow us to work through our Biosimilar BPD Type 2a meeting with FDA. We look forward to announcing the results of that meeting and next steps in our development program, which we believe will offer a clear pathway for investors to see the opportunity AEON has to build significant shareholder value,” concluded Mr. Forth.
Recent Clinical and Corporate Highlights
●Pursuing the development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars – The Company is pursuing a 351(k) biosimilar regulatory pathway for ABP-450 (prabotulinumtoxinA) injection, using BOTOX® (onabotulinumtoxinA) as a proposed reference product for all of the therapeutic indications for which BOTOX is approved. The Company believes it is aligned with the FDA on the initial key requirements to proceed with the 351(k) regulatory pathway.
oIn the fourth quarter of 2024, the Company commenced the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA).
oExtensive preclinical toxicology and other data has been previously generated by the Company’s licensing partner.
oThe Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development.
●Strengthened the Company’s balance sheet – The Company closed an underwritten public offering on January 7, 2025, receiving gross proceeds of $20.0 million, before deducting underwriting fees and other estimated offering expenses. The Company expects the net proceeds from the offering,
Exhibit 99.1
PRESS RELEASE
together with its existing cash, to fund its operating plan and working capital through 2025. Investors in the offering received both Series A warrants and Series B warrants. Approximately 89% of the Series B warrants, which can be exercised on a cashless three-shares-per-warrant basis, have been exercised as of March 21, 2025.
About AEON Biopharma
AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com.
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of primary comparative analytical studies, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.
These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (vi) the outcomes from any meetings or discussions with regulatory authorities; and (vii) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov .
Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which
Exhibit 99.1
PRESS RELEASE
speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.
Contacts
Investor Contact: Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com
Source: AEON Biopharma
Exhibit 99.1
PRESS RELEASE
AEON BIOPHARMA, INC.
CONSOLIDATED BALANCE SHEET****S
(in thousands, except share data and par value amounts)
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | | December 31, | | | December 31, | ||
| | | 2024 | **** | **** | 2023 | ||
| | | | | | | ||
| ASSETS | | | | ||||
| Current assets: | | | | ||||
| Cash and cash equivalents | | $ | 13 | | | $ | 5,158 |
| Prepaid expenses and other current assets | | 1,577 | | | 1,064 | ||
| Total current assets | | 1,590 | | | 6,222 | ||
| Property and equipment, net | | 235 | | | 332 | ||
| Operating lease right-of-use asset | | 1,288 | | | 262 | ||
| Other assets | | 29 | | | 29 | ||
| Total assets | | $ | 3,142 | | | $ | 6,845 |
| LIABILITIES AND STOCKHOLDERS' DEFICIT | | | | ||||
| Current liabilities: | | | | ||||
| Accounts payable | | $ | 5,910 | | | $ | 3,388 |
| Accrued clinical trials expenses | | 3,571 | | | 5,128 | ||
| Accrued compensation | | 1,068 | | | 943 | ||
| Other accrued expenses | | 3,600 | | | 3,590 | ||
| Total current liabilities | | 14,149 | | | 13,049 | ||
| Convertible notes at fair value, including related party amount of $11,689 and $0, at December 31, 2024 and December 31, 2023, respectively | | 11,689 | | | — | ||
| Operating lease liability | | 1,145 | | | — | ||
| Warrant liability | | | 1,187 | | | | 1,447 |
| Contingent consideration liability | | | 3,541 | | | | 104,350 |
| Embedded forward purchase agreements and derivative liabilities | | | — | | | | 41,043 |
| Total liabilities | | 31,711 | | | 159,889 | ||
| Commitments and contingencies | | | | ||||
| Stockholders’ Deficit: | | | | ||||
| Class A common stock, $0.0001 par value; 500,000,000 shares authorized at December 31, 2024 and December 31, 2023, and 555,511 and 516,404 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively | | 4 | | | 4 | ||
| Additional paid-in capital | | 403,024 | | | 381,264 | ||
| Subscription receivables | | | — | | | | (60,710) |
| Accumulated deficit | | (431,597) | | | (473,602) | ||
| Total stockholders' deficit | | (28,569) | | | (153,044) | ||
| Total liabilities and stockholders' deficit | | $ | 3,142 | | | $ | 6,845 |
Exhibit 99.1
PRESS RELEASE
AEON BIOPHARMA, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME
(in thousands, except share and per share data)
| | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | **** | Three Months Ended | | Year Ended | ||||||||||||
| | | December 31, | | December 31, | ||||||||||||
| | | 2024 | 2023 | | 2024 | 2023 | | | 2023 | |||||||
| | | | Successor | | | Successor | **** | | Successor | | | Successor July 22 to December 31 | **** | | | Predecessor **** January 1 to July 21 |
| Operating expenses: | | | | | | | | | | | | | | |||
| Selling, general and administrative | | $ | 2,629 | | $ | 4,683 | | $ | 13,643 | | $ | 9,949 | | | $ | 9,841 |
| Research and development | | 3,036 | | 6,854 | | 14,181 | | 13,243 | | | 19,803 | |||||
| Acquired in-process research and development | | | — | | | — | | | — | | | 348,000 | | | | — |
| Change in fair value of contingent consideration | | (3,344) | | 23,189 | | (100,809) | | (52,750) | | | — | |||||
| Total operating costs and expenses | | 2,321 | | 34,726 | | (72,985) | | 318,442 | | | 29,644 | |||||
| Income (loss) from operations | | (2,321) | | (34,726) | | 72,985 | | (318,442) | | | (29,644) | |||||
| Other income (loss): | | | | | | | | |||||||||
| Change in fair value of convertible notes | | 3,481 | | — | | 3,311 | | — | | | (19,359) | |||||
| Change in fair value of warrants | | 657 | | 725 | | (14,719) | | 2,318 | | | — | |||||
| Loss on embedded forward purchase agreements and derivative liabilities, net | | | 264 | | | 7,410 | | | (19,667) | | (8,366) | | | (11,789) | ||
| Other income, net | | 2 | | 350 | | 95 | | 536 | | | 114 | |||||
| Total other loss, net | | 4,404 | | 8,485 | | (30,980) | | (5,512) | | | (31,034) | |||||
| Income (loss) before taxes | | 2,083 | | (26,241) | | 42,005 | | (323,954) | | | (60,678) | |||||
| Income taxes | | — | | — | | — | | — | | | — | |||||
| Net income (loss) | | $ | 2,083 | | $ | (26,241) | | $ | 42,005 | | $ | (323,954) | | | $ | (60,678) |
| Basic net income (loss) per share | | $ | 3.76 | | $ | (50.81) | | $ | 77.74 | | $ | (627.33) | | | $ | (0.44) |
| Diluted net income (loss) per share | | $ | 3.75 | | $ | (50.81) | | $ | 72.93 | | $ | (627.33) | | | $ | (0.44) |
| Weighted average shares of common stock outstanding used to compute basic net income (loss) per share | | | 554,260 | | | 516,404 | | | 540,360 | | | 516,404 | | | | 138,848,177 |
| Weighted average shares of common stock outstanding used to compute diluted net income (loss) per share | | 555,344 | | 516,404 | | 575,945 | | 516,404 | | | 138,848,177 |
The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company and its controlled subsidiaries.
On July 21, 2023, AEON completed the Merger with AEON Biopharma Sub, Inc. (“Old AEON”), with Old AEON surviving the merger as a wholly-owned subsidiary of the Company, the accounting acquirer. The transaction has been accounted for as a forward merger asset acquisition.
Unless the context otherwise requires, the “Company,” for periods prior to the close of the Merger, refers to Old AEON, currently AEON Biopharma Sub, Inc. (“Predecessor”), and for the periods after the close of the Merger, refers to AEON Biopharma, Inc., including AEON Biopharma Sub, Inc. (“Successor”). As a result of the Merger, the results of operations, financial position and cash flows of the Predecessor and Successor are not directly comparable. AEON Biopharma Sub, Inc. was deemed to be the Predecessor entity. Accordingly, the historical financial statements of AEON Biopharma Sub, Inc. became the historical financial statements of the combined Company, upon the consummation of the Merger. As a result, the financial statements included in this release reflect (i) the historical operating results of AEON Biopharma Sub, Inc. prior to the Merger and (ii) the combined results of the Company, including AEON Biopharma Sub, Inc., following the
Exhibit 99.1
PRESS RELEASE
closing of the Merger. The accompanying financial statements include Successor periods for the three months ended December 31, 2024 and December 31, 2023, the year ended December 31, 2024 and the periods from July 22, 2023 to December 31, 2023, and the Predecessor period from January 1, 2023 to July 21, 2023. A black line between the Successor and Predecessor periods has been placed in the condensed consolidated financial statements and in the tables to the notes to the condensed consolidated financial statements to highlight the lack of comparability between these periods.
On February 24, 2025, AEON effectuated a reverse stock split at a ratio of 1-for-72 (the “Reverse Stock Split”) whereby each 72 pre-split shares of Common Stock outstanding automatically combined into one new share of Common Stock without any action on the part of the holders. The capital stock accounts, all share data and earnings (loss) per share, restricted stock units and stock options and corresponding exercise price give effect to the reverse stock split, applied retrospectively, to all periods presented for Successor and on-the-line periods. However, share amounts and per share data for the Predecessor have not been adjusted to reflect the 1-for-72 reverse stock split because the capital structure of Predecessor is not comparable to the Successor.
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