0001837607false00018376072024-08-122024-08-12

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): August 12, 2024

AEON Biopharma, Inc.

(Exact name of registrant as specified in its charter)

Delaware

    

001-40021

    

85-3940478

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

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 August 12, 2024, AEON Biopharma, Inc. (the “Company” or “AEON”) announced financial results for the fiscal quarter ended June 30, 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 August 12, 2024.

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: August 12, 2024

By:

/s/ Marc Forth

Marc Forth

Chief Executive Officer

Graphic

Exhibit 99.1

PRESS RELEASE

AEON Biopharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update

– Progressing plans to develop ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product

– Scheduled to hold a biosimilar initial advisory meeting with FDA in 3Q 2024

– 351(k) regulatory pathway offers potential to bring ABP-450 to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications

IRVINE, Calif., August 12, 2024 – 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 second quarter ended June 30, 2024, and provided a business update.

“We are excited by the significant opportunity to advance our development of ABP-450 under the planned biosimilar strategy. Once we host and receive the minutes from our FDA meeting, which is being held later this quarter, we expect to have a clear path forward to initiate a single pivotal study directly comparing ABP-450 to BOTOX in the treatment of CD,” commented Marc Forth, AEON’s President and Chief Executive Officer. “The biosimilar approach may offer a potential regulatory pathway for us to bring ABP-450 differentiated economic model to the U.S. market for all of BOTOX’s currently approved and future therapeutic indications under a single approval.”

Recent Clinical and Corporate Highlights

Development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars - announced plans to initiate, subject to securing funding, a single pivotal clinical development study in cervical dystonia (“CD”) for the Company’s lead candidate, ABP-450 (prabotulinumtoxinA), utilizing the 351(k) regulatory pathway for biosimilars with the market leader, BOTOX® (onabotulinumtoxinA), as the reference product.
oSubmitted a briefing package to the FDA that provided extensive data from analytical, pharmacological, and animal studies that could contribute to a Biologics License Application (“BLA”) filing.
oScheduled to hold a biosimilar initial advisory meeting with FDA in 3Q 2024.
oExpect to initiate a planned Phase 3 CD study in approximately 400 patients to compare ABP-450 to BOTOX with a goal to demonstrate non-inferiority to BOTOX.
oA successful Phase 3 comparative study in CD could potentially provide the necessary clinical data to support a determination that ABP-450 is highly similar to Botox for all currently approved and future therapeutic indications.


Graphic

Exhibit 99.1

PRESS RELEASE

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 a potential Phase 3 comparative study in CD, the translation of clinical trial results into support for a BLA filing, 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, including with respect to potential obligations pursuant to the forward purchase agreements; (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; and (vi) 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 speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.


Graphic

Exhibit 99.1

PRESS RELEASE

Contacts

Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Source: AEON Biopharma


Graphic

Exhibit 99.1

PRESS RELEASE

AEON BIOPHARMA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data and par value amounts)

Successor

Successor

June 30, 

December 31, 

    

2024

    

2023

(Unaudited)

ASSETS

 

  

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

3,442

$

5,158

Prepaid expenses and other current assets

 

577

 

1,064

Total current assets

 

4,019

 

6,222

Property and equipment, net

 

282

 

332

Operating lease right-of-use asset

 

1,404

 

262

Other assets

 

29

 

29

Total assets

$

5,734

$

6,845

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

3,030

$

3,388

Accrued clinical trials expenses

 

2,333

 

5,128

Accrued compensation

 

1,248

 

943

Other accrued expenses

 

3,818

 

3,590

Total current liabilities

 

10,429

 

13,049

Convertible notes at fair value, including related party amount of $13,292 and $0, at June 30, 2024 and December 31, 2023, respectively

 

13,292

 

Operating lease liability

 

1,262

 

Warrant liability

1,467

1,447

Contingent consideration liability

6,886

104,350

Embedded forward purchase agreements and derivative liabilities

345

41,043

Total liabilities

 

33,681

 

159,889

Commitments and contingencies

 

  

 

  

Stockholders’ Deficit:

 

  

 

Class A common stock, $0.0001 par value; 500,000,000 shares authorized at June 30, 2024 and December 31, 2023, and 39,122,238 and 37,159,600 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively

 

4

 

4

Additional paid-in capital

 

399,557

 

381,264

Subscription receivables

(60,710)

Accumulated deficit

 

(427,508)

 

(473,602)

Total stockholders' deficit

 

(27,947)

 

(153,044)

Total liabilities and stockholders' deficit

$

5,734

$

6,845


Graphic

Exhibit 99.1

PRESS RELEASE

AEON BIOPHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(in thousands, except share and per share data)

    

Three Months Ended

Six Months Ended

June 30, 

June 30, 

2024

    

    

2023

2024

    

    

2023

Successor

Predecessor

        

Successor

Predecessor

Operating expenses:

 

 

 

  

 

  

Selling, general and administrative

$

3,321

$

4,946

$

7,970

$

8,787

Research and development

 

4,439

 

9,025

 

10,172

 

18,230

Change in fair value of contingent consideration

 

(161,233)

 

 

(97,464)

 

Total operating costs and expenses

 

(153,473)

 

13,971

 

(79,322)

 

27,017

Income (loss) from operations

 

153,473

 

(13,971)

 

79,322

 

(27,017)

Other income (loss):

 

  

 

  

 

  

 

  

Change in fair value of convertible notes

 

1,795

 

(1,453)

 

1,708

 

(6,110)

Change in fair value of warrants

 

5,905

 

 

(14,999)

 

Loss on embedded forward purchase agreements and derivative liabilities, net

2,905

(20,012)

 

Other income, net

 

34

 

45

 

75

 

109

Total other income (loss), net

 

10,639

 

(1,408)

 

(33,228)

 

(6,001)

Income (loss) before taxes

 

164,112

 

(15,379)

 

46,094

 

(33,018)

Income taxes

 

 

 

 

Net income (loss) and comprehensive income (loss)

$

164,112

$

(15,379)

$

46,094

$

(33,018)

Basic and diluted net income (loss) per share

$

4.22

$

(0.11)

$

1.21

$

(0.24)

Weighted average shares of common stock outstanding used to compute basic and diluted net income (loss) per share

38,843,627

138,825,356

38,055,850

138,825,356

The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The condensed 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 closing of the Merger. The accompanying financial statements include 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. 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.

# # #


v3.24.2.u1
Document and Entity Information
Aug. 12, 2024
Document and Entity Information [Abstract]  
Document Type 8-K
Document Period End Date Aug. 12, 2024
Entity File Number 001-40021
Entity Registrant Name AEON Biopharma, Inc.
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 85-3940478
Entity Address State Or Province CA
Entity Address, Address Line One 5 Park Plaza
Entity Address, Adress Line Two Suite 1750
Entity Address, City or Town Irvine
Entity Address, Postal Zip Code 92614
City Area Code 949
Local Phone Number 354-6499
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Class A Common Stock, $0.0001 par value per share
Trading Symbol AEON
Security Exchange Name NYSEAMER
Entity Emerging Growth Company true
Entity Ex Transition Period false
Entity Central Index Key 0001837607
Amendment Flag false

AEON Biopharma (AMEX:AEON)
Historical Stock Chart
From Sep 2024 to Oct 2024 Click Here for more AEON Biopharma Charts.
AEON Biopharma (AMEX:AEON)
Historical Stock Chart
From Oct 2023 to Oct 2024 Click Here for more AEON Biopharma Charts.