8-K

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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): May 20, 2025

AEON Biopharma, Inc.

(Exact name of registrant as specified in its charter)

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Delaware	001-40021	85-3940478
(State or other jurisdiction<br><br>of incorporation)	(Commission<br><br>File Number)	(IRS Employer<br><br>Identification Number)

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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)
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☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:

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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

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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.      ☐ ​ ​

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Item 7.01. Regulation FD Disclosure.

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On May 20, 2025, AEON Biopharma, Inc. (the “Company” or “AEON”) made available in the investor relations section of its website a presentation (the “Corporate Presentation”), a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

The information from the Corporate Presentation may also be used by the management of the Company in future meetings regarding the Company. For important information about forward-looking statements in the Corporate Presentation, see the slide titled “Forward-Looking Statements” in Exhibit 99.1 attached hereto.

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The information furnished in this Item 7.01 of this Current 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.

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Item 9.01. Financial Statement and Exhibits.

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(d) Exhibits.

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Exhibit No.		Description
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99.1		Corporate Presentation, dated May 2025.
104	​	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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.

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​	AEON Biopharma, Inc.
Date: May 20, 2025	By:	/s/ Robert Bancroft
​	​	Robert Bancroft
​	​	Chief Executive Officer<br><br>​

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Exhibit 99

Corporate Presentation - Aegis Capital Healthcare Conference<br>May 2025<br>PrabotulinumtoxinA<br>Redefining access to therapeutic botulinum toxins
2<br>Forward-Looking Statements<br>This presentation includes forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements concerning possible or assumed future actions,<br>business strategies, events or results of operations, and any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are<br>forward-looking statements. These statements may involve known and unknown risks, uncertainties and other important factors that may cause the actual results, performance or achievements of AEON Biopharma,<br>Inc. (“AEON”) to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements may be preceded by, followed by or include<br>the words “believes”, “estimates”, “expects”, “projects”, “forecasts”, “may”, “will”, “should”, “seeks”, “plans”, “scheduled”, “anticipates” or “intends” or similar expressions. The forward-looking statements in this<br>presentation are only predictions. AEON has based these forward-looking statements largely on AEON’s current expectations and projections about future events and financial trends that AEON believes may affect its<br>business, financial condition and results of operations.<br>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<br>materially from current expectations include, but are not limited to: (i) the outcome of any meetings with any regulatory authorities, including the FDA’s review of the Company's biosimilar meetings and document<br>submissions, (ii) the outcome of any legal proceedings that may be instituted against AEON or others; (iii) AEON’s future capital requirements; (iv) AEON’s ability to raise financing in the future; (v) AEON’s ability to<br>continue to meet continued stock exchange listing standards; (vi) the ability of AEON to implement its strategic initiatives, including the continued development of ABP-450 and potential submission of a Biologics<br>License Application as a biosimilar for therapeutic uses of ABP-450; (vii) the ability of AEON to satisfy regulatory requirements; (viii) the ability of AEON to defend its intellectual property or avoid infringement of<br>existing intellectual property; (ix) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (x) other risks and uncertainties set forth in the section<br>entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in AEON’s Annual Report on Form 10-K for the year ended December 31, 2024 and any current or periodic reports filed with the<br>Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov.<br>Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond AEON’s control, you should not rely on these<br>forward-looking statements as predictions of future events. The events and circumstances reflected in AEON’s forward-looking statements may not be achieved or occur, and actual results could differ materially from<br>those projected in the forward-looking statements. Moreover, AEON operates in an evolving environment and a competitive industry. New risks and uncertainties may emerge from time to time, and it is not possible<br>for management to predict all risks and uncertainties, nor can AEON assess the impact of all factors on AEON’s business or the extent to which any factor, or combination of factors, may cause actual results to differ<br>materially from those contained in any forward-looking statements AEON may make in this presentation. As a result of these factors, although AEON believes that the expectations reflected in its forward-looking<br>statements are reasonable, AEON cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Except as required by applicable law, AEON does not plan to publicly update or<br>revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise. AEON qualifies all of its forward-looking statements by these<br>cautionary statements. You should view this presentation completely and with the understanding that the actual future results, levels of activity, performance, events and circumstances of AEON may be materially<br>different from what is expected.<br>This presentation concerns anticipated products that are under clinical and analytical investigation and which have not yet been approved for marketing by the FDA. These anticipated products are currently limited by<br>Federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.<br>Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and AEON’s own internal estimates and research. AEON has<br>not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this<br>presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, AEON’s own internal estimates and research have not been<br>verified by any independent source.<br>AEON Biopharma and the AEON Biopharma logo are trademarks of AEON Biopharma, Inc. All other trademarks used herein are the property of their respective owners.
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3<br>Redefining Access to Therapeutic Neurotoxins Through Biosimilarity<br>• Developing ABP-450, a 900kD<br>botulinum toxin, as a biosimilar to<br>Botox®<br>• Goal: match full range of Botox®<br>approved therapeutic indications<br>• Building on global biosimilar<br>approvals and FDA-approved<br>manufacturing*<br>BPD: Biosimilar (Biological) Product Development<br>*Approved for aesthetic indications. Facilities would require separate review and approval for therapeutic indications.<br>What We’re Building Why It Matters What’s Next<br>• Large and growing market<br>dominated by Botox®<br>• Persistent cost-related barriers:<br>o Patients: high out-of-pocket costs<br>o Physicians: product margin concerns<br>o Payers: inability to manage escalating<br>category costs<br>• Comparative Analytical<br>Assessment (CAA) underway<br>• FDA BPD Type 2a (BPD2a)<br>meeting targeted for 2H 2025<br>• Next-phase development and<br>capital strategy expected following<br>BPD2a meeting<br>Few biosimilar programs start with this level of readiness -<br>giving AEON a real opportunity to reshape access in a market that needs it
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4<br>A Rare Biosimilar Opportunity – with a Running Start<br>1. Structural similarity based on comparison of ABP-450 to Botox® published literature, not a head-to-head study. Comparative analytical testing of primary structure is expected to be<br>completed in the second half of 2025.<br>2. Developed and commercialized under brand name Jeuveau® (Evolus, Inc.). Facilities would require separate review and approval for therapeutic indications.<br>3. Average Selling Price<br>Regulatory Alignment Aligned with FDA on initial requirements of the biosimilar pathway at BIA meeting<br>Upcoming Catalyst Comparative analytical assessment (CAA) studies commenced in Q4 2024 and on<br>track to be completed in 2H 2025 → targeting FDA BPD2a meeting 2H 2025<br>Rock-Solid Science Evidence of functional and high structural “similarity” of 900kD ABP-450 to<br>Botox®1<br>Established Manufacturing Manufacturing approved by FDA, EMA & Health Canada for aesthetic product2<br>Favorable IP Landscape No neurotoxin composition-of-matter patents decreases litigation risk<br>Economic Pricing Advantage Therapeutic-only BLA → ASP3 would be unencumbered by the aesthetic price<br>compression that hampers competition’s reimbursement structure
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5<br>Backed by strong capital and financial leadership<br>Built for Biosimilarity: A Team with Deep Toxin Experience<br>Rob Bancroft Chad Oh, MD<br>Chief Executive Officer Chief Medical Officer<br>• 25+ years life sciences leadership<br>• Led Daxxify® therapeutic launch at Revance;<br>was engaged in biosimilar partnership with<br>Viatris<br>• Former Allergan: BOTOX® pipeline and<br>development strategy, US commercialization<br>across multiple therapeutic indications<br>• Orchestrated strategic turnaround at<br>Healthpoint Biotherapeutics - led to $782M<br>acquisition by Smith & Nephew<br>• 20+ years in clinical development and<br>regulatory strategy - responsible for multiple<br>IND, NDA, and BLA submissions<br>• Former VP, Clinical Development at Revance<br>(Daxxify®)<br>• Prior biosimilar experience and key architect<br>of AEON’s biosimilar regulatory and analytical<br>plan<br>• 20+ years in biotech and life sciences<br>capital markets<br>• Led equity and debt financings across<br>multiple clinical- and commercial-stage<br>companies<br>• Expertise in public company operations and<br>investor engagement<br>• Strategic partner on fundraising strategy<br>and investor readiness<br>EVP, Chief Legal Officer & Secretary<br>Alex Wilson Jennifer Sy<br>Chief Accounting Officer<br>• Proven leader in public company financial<br>operations and reporting<br>• Deep expertise in SEC compliance, SOX<br>controls, and corporate governance<br>• Strong track record in managing accounting<br>infrastructure for health care companies<br>• Drives AEON’s financial discipline and<br>operational accountability
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6<br>Consistent category growth despite concentrated brand share and payer cost fatigue<br>Botox® Commands 95% of >$2.8B U.S. Market – But Cost Limits Access<br>Source: AbbVie, Inc. quarterly earnings reports<br>• Organic growth: Continued penetration of existing indications driven by high clinical utility and patient<br>demographics<br>• New indications: Development in specialties without current neurotoxin treatment options<br>• Payer dynamics: Despite strong reimbursement frameworks, cost pressures are leading to tighter utilization<br>management<br>What’s<br>Driving<br>Market<br>Expansion?<br>Y/Y growth in high single<br>digits to low double<br>digits<br>US 2025 therapeutic<br>revenue annualizing >$2.8B<br>$429<br>$488<br>$534<br>$561<br>$500<br>$557<br>$584<br>$614<br>$587<br>$614 $626<br>$649<br>$611<br>$669<br>$708 $730 $723<br>17%<br>14%<br>9% 9%<br>17%<br>10%<br>7%<br>6%<br>4%<br>9%<br>13%<br>12%<br>18%<br>0<br>0.02<br>0.04<br>0.06<br>0.08<br>0.1<br>0.12<br>0.14<br>0.16<br>0.18<br>0.2<br>$300<br>$350<br>$400<br>$450<br>$500<br>$550<br>$600<br>$650<br>$700<br>$750<br>$800<br>Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Q3'24 Q4'24 Q1'25<br>Y/Y Growth<br>Revenue ($ mil)<br>Revenue Growth<br>2021: $2.0B 2022: $2.3B 2023: $2.5B 2024: $2.7B<br>Botox® U.S. Therapeutic Net Revenues
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7<br>ABP-450 Matches Botox® in Molecular Size – and Can Match Its Label<br>AbbVie Inc. Merz Pharma Ipsen Group Crown Laboratories<br>Molecular Size 900 kDa 900 kDa 150 kDa ~400 kDa 150 kDa<br>FDA Approved<br>Therapeutic<br>Indications<br>1. Chronic migraine<br>2. Overactive bladder<br>3. Detrusor overactivity<br>4. Pediatric detrusor overactivity<br>5. Adult upper limb spasticity<br>6. Adult lower limb spasticity<br>7. Pediatric upper limb spasticity<br>8. Pediatric lower limb spasticity<br>9. Cervical dystonia<br>10. Axillary hyperhidrosis<br>11. Blepharospasm<br>12. Strabismus<br>None (biosimilar<br>pathway aims to secure<br>all current and future<br>Botox® approved<br>therapeutic indications)<br>1. Blepharospasm<br>2. Cervical dystonia<br>3. Adult upper limb spasticity<br>4. Chronic sialorrhea<br>1. Cervical dystonia<br>2. Spasticity<br>1. Cervical dystonia<br>In Development<br>1. Essential Tremor Biosimilar Undisclosed 1. Neurogenic detrusor<br>overactivity<br>2. Migraine: episodic/chronic<br>1. Adult upper limb spasticity<br>US Share ~95% ~2% ~2% <1%<br>ASP linked to<br>aesthetics<br>Sources: Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2021<br>ASP = Average selling price; all competitors ASP influenced by aesthetic market pricing except AEON<br>Poised to challenge the category leader on label, economics, and access – in ways current competitors can’t
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8<br>FDA uses a stepwise, totality-of-evidence approach – basing additional requirements on the level of<br>residual uncertainty<br>ABP-450 is Advancing Through the FDA Biosimilar Pathway<br>1. Manufacturing facilities for therapeutics use would require separate regulatory inspection<br>https://www.fda.gov/drugs/biosimilars/review-and-approval<br>https://www.fda.gov/media/82647/download<br>1. Analytical characterization<br>• Physiochemical and functional assays supportive of “high similarity”<br>• Comparative analytical studies to confirm structural and functional similarity<br>2. Animal studies<br>• Toxicology and pharmacology information<br>3. Clinical studies<br>• Phase 2 in cervical dystonia<br>• Potential comparative Phase 3 program with clinical efficacy endpoint<br>4. Establish manufacturing<br>• PrabotulinumtoxinA manufactured by Daewoong1<br>; approved in 2019 for aesthetic<br>indications by US and international regulators<br>1. BIA meeting with FDA completed in 2024. Now executing initial structure analytical work aligned with the agency’s guidance.<br>2. BPD Type 2a meeting is targeted for 2H 2025 to review results and determine next steps.<br>Animal<br>Studies<br>Safety and<br>Efficacy Studies Human Studies<br>Analytical<br>Physiochemical and Functional Assays<br>Comparative Analytical Assessment<br>Nonclinical Comparative Clinical<br>Studies<br>Clinical<br>Pharmacology<br>》
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9<br>FDA precedent supports broad label access – unlocking full Botox® market potential for ABP-450<br>Extrapolation: Potential Full Indication Capture Without Redundant Trials<br>1. https://www.fda.gov/drugs/biosimilars/review-and-approval<br>Chronic migraine<br>Cervical dystonia<br>Adult upper limb spasticity<br>Adult lower limb spasticity<br>Pediatric upper limb spasticity<br>Pediatric lower limb spasticity<br>Blepharospasm<br>Strabismus<br>Overactive bladder<br>Neurogenic detrusor overactivity<br>Pediatric neurogenic detrusor overactivity<br>Axillary hyperhidrosis<br>• A biosimilar can meet the<br>requirements for approval<br>based on data from a clinical<br>study that demonstrates safety<br>and effectiveness in an<br>appropriate condition1<br>• FDA may approve a biosimilar<br>for indications without direct<br>clinical studies in those<br>indications if the manufacturer<br>provides adequate scientific<br>justification1<br>✓<br>✓<br>✓<br>✓<br>✓<br>✓<br>✓<br>✓<br>✓<br>✓<br>✓<br>✓
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10<br>Decoupled ASP → attractive & stable provider cost recovery → amplifies impact of payer contracting levers<br>AEON’s Therapeutics-Only BLA Avoids ASP* Compression from Aesthetics<br>*Average selling price<br>Value to Payer<br>Ability to implement<br>utilization controls and<br>drive preferred product<br>adoption<br>Value to Physician<br>Predictable ASP enables<br>margin clarity & provider<br>certainty in buy-and-bill<br>Physician adoption drives payer confidence<br>Payer contracting accelerates physician conversion<br>Untethered ASP creates rare alignment<br>between payers and providers - giving AEON<br>leverage to decisively contract for share
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11<br>Recent biosimilars hit 70% share within 3 years of launch<br>Modern Biosimilars Are Achieving Rapid Market Penetration<br>Reproduced with permission; IQVIA “Biosimilars in the United States 2023-2027”<br>IQVIA MIDAS, IQVIA DDD, Oct 2022; IQVIA Institute, Dec 2022
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12<br>Physician-administered settings have reached nearly 60% biosimilar share in 2 years<br>Buy-and-Bill Dynamics Accelerate Physician-Driven Biosimilar Adoption<br>Reproduced with permission; IQVIA “Biosimilars in the United States 2023-2027”<br>IQVIA LAAD Medical Procedures Claims, Sep 2022; US Market Access Strategy Consulting, Dec 2022.
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13<br>Top-performing biosimilars gained share at 18–50% discounts — not a race to the bottom<br>Significant Share Gains Have Not Required Deep Price Cuts<br>Reproduced with permission; IQVIA “Biosimilars in the United States 2023-2027”<br>IQVIA National Sales Perspective, US Market Access Strategy Consulting, Dec 2022.
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14<br>14<br>AEON Biopharma: A High-Conviction Play in Biosimilar Innovation<br>Accelerated Biosimilar<br>Pathway<br>Only Toxin Positioned<br>to Match Botox® Label<br>Untethered ASP<br>Advantage<br>Catalysts<br>Ahead<br>900kD structure +<br>completed assays, FDA-approved manufacturing*,<br>and positive Phase 2<br>cervical dystonia data<br>support scientific and<br>regulatory confidence<br>Biosimilar strategy enables<br>potential full label<br>extrapolation – potentially<br>positioning ABP-450 as<br>the first true competitor to<br>Botox® across all<br>therapeutic indications<br>Therapeutics-only BLA<br>avoids aesthetic price<br>compression - enabling<br>consistent reimbursement<br>and aligned payer-provider<br>incentives<br>Initial CAA results and<br>BPD Type 2a (BPD2a)<br>meeting with FDA targeted<br>for 2H 2025 will determine<br>next steps required to<br>advance towards biosimilar<br>BLA approval<br>Disciplined Capital<br>Formation Strategy<br>Funded through fourth<br>quarter 2025 and targeted<br>BPD2a meeting; next raise<br>expected to align with<br>development progress and<br>value inflection milestones<br>*Approved for aesthetic indications. Facilities would require separate review and approval for therapeutic indications.
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