AEON Biopharma (AEON) risk factors, FY2025 10-K

AEON Biopharma's FY2025 10-K, filed Mar 30, 2026, lists 53 risk factors in 6 groups. Against the prior year's 62: 8 new, 17 dropped, 11 substantially reworded.

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Risk factors listed
536 groups
New this year
8vs 62 last year
Dropped
17since the prior 10-K
Substantially reworded
11of those kept
Section length
37k wordsItem 1A

What the changes say

  • AEON Biopharma relies entirely on obtaining FDA approval for ABP-450 as a biosimilar to Botox.
  • Development requires navigating complex 351(k) pathways, litigation risks, and strict compliance standards.

What changed since the prior 10-K

New

  • NewRisks Related to Our Business Operations and Financial Position

    Our future success depends entirely on obtaining U.S. regulatory approval and successfully commercializing ABP-450 as a proposed biosimilar to Botox®, and the biosimilar licensure pathway for a botulinum toxin product is uncertain

    Our success depends entirely on gaining FDA approval for ABP-450 as a biosimilar to Botox under an uncertain pathway.

  • NewRisks Related to Our Business Operations and Financial Position

    Clinical development for a proposed biosimilar product involves a lengthy, expensive and uncertain process, including extensive comparative analytical work and potentially clinical investigations; we may incur greater costs than we anticipate or encounter substantial delays or difficulties in our studies

    Pursuing a BLA for ABP-450 via the 351(k) pathway is an expensive, lengthy, and uncertain process.

  • NewRisks Related to Our Business Operations and Financial Position

    To obtain licensure under section 351(k), we must demonstrate that ABP-450 is biosimilar to a single FDA-licensed reference product. Clinical development is generally required to demonstrate biosimilarity

    We must demonstrate that ABP-450 is biosimilar to Botox through sophisticated analytical testing and clinical investigations.

  • NewRisks Related to our Reliance on Third Parties

    Medytox’s trade secrets to manufacture, offer to sell, or sell therapeutic BTX products, including ABP-450, and (v) attorneys’ fees and costs

    Ongoing litigation involving Medytox, Allergan, and Evolus concerns trade secrets for manufacturing therapeutic BTX products like ABP-450.

  • NewRisks Related to our Reliance on Third Parties

    Actual or threatened public health outbreaks, epidemics or pandemics may in the future adversely affect, among other things, our research and development efforts, clinical trial operations, manufacturing and supply chain operations, administrative personnel, third-party service providers, and business partners

    Public health outbreaks or pandemics could disrupt our clinical trials, supply chain, and access to capital markets.

  • NewRisks Related to Government Regulation

    whether the good or service was reimbursed by a government program, so called all- payor laws. These all-payor laws could apply to our sales and marketing activities even if the Anti-Kickback Statute and FCA laws are inapplicable

    All-payor laws and HIPAA regulations apply broadly to our sales and marketing activities regarding healthcare benefit programs.

  • NewRisks Related to Government Regulation

    responsible for alleged violations. If we become the target of such an investigation or prosecution based on our contractual relationships with providers or institutions or our marketing and promotional practices, we could face similar sanctions, which would materially harm our business

    Violations of the FCPA or anti-bribery laws by our employees or partners could result in severe fines and reputational harm.

  • NewRisks Related to Being a Public Company and Ownership of Our Securities

    Our outstanding warrants may never be in the money and they may expire worthless

    Our outstanding warrants may expire worthless if our common stock price of $1.16 remains below the $2.00 to $828.00 exercise range.

Dropped

  • DroppedRisks Related to Our Business Operations and Financial Position

    drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized

  • DroppedRisks Related to Our Business Operations and Financial Position

    If ABP-450 fails to demonstrate the requisite safety, purity, potency or biosimilarity in our planned clinical studies or does not gain approval, our business and results of operations will be materially and adversely harmed

    Only a small percentage of drugs in development successfully complete regulatory approval.

  • DroppedRisks Related to Our Business Operations and Financial Position

    We may not commercialize, market, promote or sell any product candidate, including ABP-450, without obtaining regulatory approval from the FDA or other regulatory agencies, and we may never receive such approvals

    AEON has completed one clinical study evaluating ABP-450 for cervical dystonia.

  • DroppedRisks Related to Our Business Operations and Financial Position

    Our product development costs will also increase if we experience delays in testing or obtaining regulatory approvals. We do not know whether any of our preclinical studies or clinical studies will begin as planned, need to be restructured or be completed on schedule, if at all

    Clinical testing is expensive, takes years, and carries uncertain outcomes without guarantee.

  • DroppedRisks Related to Our Business Operations and Financial Position

    Results of other parties’ clinical studies involving the same or a nearly identical botulinum toxin complex as ABP-450, or results in any preclinical studies we conduct, may not be predictive of future results of our clinical studies

    Development costs increase if testing or regulatory approvals experience delays.

  • DroppedRisks Related to Our Business Operations and Financial Position

    Interim, topline or preliminary data from our clinical studies that we may announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data

  • DroppedRisks Related to Our Business Operations and Financial Position

    components, and that it has no clinically meaningful differences as compared to the reference product in terms of the safety, purity and potency of the product

    Daewoong and Evolus clinical results for identical botulinum toxin do not ensure AEON success.

  • DroppedRisks Related to Our Business Operations and Financial Position

    adult upper limb spasticity, and which has also entered into a collaboration and license agreement with Viatris Inc. to develop and commercialize a biosimilar to Botox

    Topline or preliminary clinical data may change following comprehensive analysis and audits.

  • DroppedRisks Related to our Reliance on Third Parties

    or inability to effectively operate, the facility and produce products of consistent quality, may harm our ability to compete in our market

  • DroppedRisks Related to our Reliance on Third Parties

    Public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic) may materially and adversely affect our business and operations

    The biosimilar pathway for a neurotoxin using Botox as a reference product is untested.

  • DroppedRisks Related to Intellectual Property

    scientists and management, even if the eventual outcome is favorable to us. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects

  • DroppedRisks Related to Intellectual Property

    strategies, and patent applications currently being prosecuted may be abandoned by the patent owner without our knowledge or consent

  • DroppedRisks Related to Government Regulation

    not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country

  • DroppedRisks Related to Being a Public Company and Ownership of Our Securities

    Certain existing stockholders of AEON acquired securities at a price below the current trading price of such securities, and may experience a positive rate of return based on the current trading price or at lower trading prices. Future investors in AEON may not experience a similar rate of return

  • DroppedRisks Related to Being a Public Company and Ownership of Our Securities

    Requirement by August 3, 2026, or if the Company does not make progress consistent with the Plan, then the NYSE American will initiate delisting proceedings as appropriate

  • DroppedRisks Related to Being a Public Company and Ownership of Our Securities

    The Warrants may never be in the money, and they may expire worthless and the terms of such Warrants may be amended in a manner adverse to a holder if holders of at least a majority of the then-outstanding Warrants approve of such amendment

  • DroppedGeneral Risks

    as a result we manage a number of third-party vendors and other contractors and consultants who have access to our confidential information

Reworded

  • 95% rewrittenRisks Related to Government Regulation

    Even if we obtain FDA approval for ABP-450 in the United States, we may never obtain approval for or commercialize such candidates in any other jurisdiction, which would limit our ability to realize their full market potential

    Added specific language stating that foreign clinical trials may not be accepted and approval processes vary significantly by country.

  • 90% rewrittenRisks Related to Our Business Operations and Financial Position

    We announced a strategic pivot to pursue regulatory approval for ABP-450 utilizing a 351(k) biosimilar pathway. Obtaining regulatory approvals under this novel approach may prove difficult, or even impossible, for a variety of reasons

    Updated the 351(k) strategic pivot description to emphasize the statutory requirement of proving no clinically meaningful differences from Botox.

    Was: We recently announced a strategic pivot to pursue regulatory approval for ABP-450 utilizing a 351(k) biosimilar pathway. Obtaining regulatory approvals under this novel approach may prove difficult, or even impossible, for a variety of reasons

  • 88% rewrittenRisks Related to our Reliance on Third Parties

    A material breach by us of the terms of our license and settlement agreement with Medytox, Inc. could have a material adverse effect on our business

    Added specific remedies sought by Medytox in the litigation, including actual damages, royalties, disgorgement of profits, and injunctions.

  • 79% rewrittenRisks Related to Being a Public Company and Ownership of Our Securities

    Sales of a substantial number of our securities in the public market by our existing securityholders could cause the price of our common stock to fall

    Removed specific references to Private Placement Warrants and updated stock sale dilution warnings for existing holders.

    Was: Sales of a substantial number of our securities in the public market by our existing securityholders could cause the price of our common stock and Private Placement Warrants to fall

  • 78% rewrittenRisks Related to Our Business Operations and Financial Position

    Changes in tax laws may impact our future financial position and results of operations

    Removed a sentence noting that Priveterra and AEON identified material weaknesses in internal control over financial reporting.

  • 70% rewrittenRisks Related to Being a Public Company and Ownership of Our Securities

    Any failure to meet the continued listing requirements of NYSE American could result in a delisting of our common stock

    Updated NYSE American delisting risk to note that the compliance plan was successfully submitted and approved by the exchange.

  • 44% rewrittenRisks Related to Our Business Operations and Financial Position

    Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our products and may affect the prices we may set

    Retained core healthcare legislative risks regarding the Affordable Care Act without material strategic changes.

  • 43% rewrittenRisks Related to Our Business Operations and Financial Position

    ABP-450, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving significant market penetration and expansion

    Retained pharmaceutical industry competition disclosures without substantive textual modifications.

  • 38% rewrittenRisks Related to Our Business Operations and Financial Position

    Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited

  • 26% rewrittenRisks Related to Our Business Operations and Financial Position

    We have a limited operating history and have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. If we ever achieve profitability, we may not be able to sustain it

  • 22% rewrittenRisks Related to Our Business Operations and Financial Position

    Obtaining coverage and adequate reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to the payor

All 53 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business Operations and Financial Position

  1. 01We have a limited operating history and have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. If we ever achieve profitability, we may not be able to sustain it26% rewritten
  2. 02Our future success depends entirely on obtaining U.S. regulatory approval and successfully commercializing ABP-450 as a proposed biosimilar to Botox®, and the biosimilar licensure pathway for a botulinum toxin product is uncertainNew
  3. 03Clinical development for a proposed biosimilar product involves a lengthy, expensive and uncertain process, including extensive comparative analytical work and potentially clinical investigations; we may incur greater costs than we anticipate or encounter substantial delays or difficulties in our studiesNew
  4. 04To obtain licensure under section 351(k), we must demonstrate that ABP-450 is biosimilar to a single FDA-licensed reference product. Clinical development is generally required to demonstrate biosimilarityNew
  5. 05ABP-450 may cause undesirable side effects or have other properties that could delay or prevent its regulatory approval, limit its commercial potential or result in significant negative consequences following any potential regulatory approval
  6. 06We announced a strategic pivot to pursue regulatory approval for ABP-450 utilizing a 351(k) biosimilar pathway. Obtaining regulatory approvals under this novel approach may prove difficult, or even impossible, for a variety of reasons90% rewritten
  7. 07Even if ABP-450 receives regulatory approval as a biosimilar or otherwise, it may fail to achieve the broad degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
  8. 08Our efforts to educate physicians, patients, third party payors and others in the medical community on the benefits of our product candidates, if approved, may require significant resources and may never be successful
  9. 09Due to our limited resources and access to capital, we must prioritize the regulatory approval for ABP-450 utilizing a 351(k) biosimilar pathway and evaluate the development of certain therapeutic uses of ABP-450; these decisions may prove to be wrong and may adversely affect our business
  10. 10Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. We may focus our efforts and resources on potential therapeutic uses of ABP-450 that ultimately prove to be unsuccessful
  11. 11Obtaining coverage and adequate reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to the payor22% rewritten
  12. 12Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our products and may affect the prices we may set44% rewritten
  13. 13ABP-450, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving significant market penetration and expansion43% rewritten
  14. 14If we are unable to establish sales and marketing capabilities on our own or through third parties, we will be unable to successfully commercialize ABP-450, if approved, or generate product revenue
  15. 15We will need to grow the size of our organization, and we may experience difficulties in managing this growth
  16. 16Our employees, independent contractors, consultants, commercial collaborators, principal investigators, vendors and other agents may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
  17. 17Our potential international operations will expose us to risks, and failure to manage these risks may adversely affect our operating results and financial condition
  18. 18If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of ABP-450
  19. 19If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop ABP-450, conduct our clinical studies and commercialize ABP-450
  20. 20Our business involves the use of hazardous materials, and we and our third-party manufacturer and supplier must comply with environmental laws and regulations, which can be expensive and restrict how we do business
  21. 21Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited38% rewritten
  22. 22Changes in tax laws may impact our future financial position and results of operations78% rewritten

Risks Related to our Reliance on Third Parties

  1. 23We rely on the Daewoong Agreement to provide us exclusive rights to commercialize and distribute ABP-450 in certain territories. Any termination or loss of significant rights, including exclusivity, under the Daewoong Agreement would materially and adversely affect our development or commercialization of ABP-450
  2. 24A material breach by us of the terms of our license and settlement agreement with Medytox, Inc. could have a material adverse effect on our business88% rewritten
  3. 25Medytox’s trade secrets to manufacture, offer to sell, or sell therapeutic BTX products, including ABP-450, and (v) attorneys’ fees and costsNew
  4. 26We rely, and will continue to rely, on third parties, CROs and consultants to conduct all of our preclinical studies and clinical studies. If these third parties or consultants do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for ABP-450
  5. 27Actual or threatened public health outbreaks, epidemics or pandemics may in the future adversely affect, among other things, our research and development efforts, clinical trial operations, manufacturing and supply chain operations, administrative personnel, third-party service providers, and business partnersNew
  6. 28We may use third-party collaborators to help us develop, validate or commercialize any new products, and our ability to commercialize such products could be impaired or delayed if these collaborations are unsuccessful

Risks Related to Intellectual Property

  1. 29We may become involved in lawsuits to protect or enforce our intellectual property or the patents and other intellectual property of our licensors, which could be expensive and time-consuming
  2. 30We may not be able to protect our intellectual property rights throughout the world
  3. 31In addition to seeking patent protection for our product candidates, including ABP-450, we and our licensors also rely on trade secrets protection to protect our and their unpatented know-how, technology and other proprietary information, in order to maintain our and their competitive positions
  4. 32We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or asserting ownership of what we regard as our own intellectual property
  5. 33If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
  6. 34Intellectual property rights do not necessarily address all potential threats

Risks Related to Government Regulation

  1. 35Our business and products are subject to extensive government regulation
  2. 36If we experience delays in obtaining approval or if we fail to obtain approval of ABP-450, the commercial prospects for ABP-450 may be harmed and our ability to generate revenue will be materially impaired
  3. 37Even if we obtain FDA approval for ABP-450 in the United States, we may never obtain approval for or commercialize such candidates in any other jurisdiction, which would limit our ability to realize their full market potential95% rewritten
  4. 38whether the good or service was reimbursed by a government program, so called all- payor laws. These all-payor laws could apply to our sales and marketing activities even if the Anti-Kickback Statute and FCA laws are inapplicableNew
  5. 39responsible for alleged violations. If we become the target of such an investigation or prosecution based on our contractual relationships with providers or institutions or our marketing and promotional practices, we could face similar sanctions, which would materially harm our businessNew
  6. 40We are subject to stringent and often unsettled privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies and contractual obligations could adversely affect our business

Risks Related to Being a Public Company and Ownership of Our Securities

  1. 41The price of our common stock may be volatile
  2. 42Sales of a substantial number of our securities in the public market by our existing securityholders could cause the price of our common stock to fall79% rewritten
  3. 43Fluctuations in our stock price may yield material changes in the valuation of the underlying derivatives securities associated with our capital structure
  4. 44We will require additional capital, which additional financing may result in restrictions on our operations or substantial dilution to our stockholders, to support the growth of our business, and this capital might not be available on acceptable terms, if at all
  5. 45We may incur significant costs from class action litigation due to the expected stock volatility
  6. 46Any failure to meet the continued listing requirements of NYSE American could result in a delisting of our common stock70% rewritten
  7. 47We are an “emerging growth company” and it cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors, which may make it more difficult to compare our performance with other public companies
  8. 48Future sales and issuances of our common stock or rights to purchase our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our common stock price to fall
  9. 49Our outstanding warrants may never be in the money and they may expire worthlessNew
  10. 50Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
  11. 51The obligations associated with being a public company involve significant expenses and require significant resources and management attention, which may divert from AEON’s business operations

General Risks

  1. 52We rely on third parties to provide services and technology necessary for the operation of our business. Any failure of one or more of our vendors, suppliers or licensors to provide these services or technology could have a material adverse effect on our business
  2. 53If securities or industry analysts do not publish research or publish unfavorable research about our business, our stock price and trading volume could decline

Other AEON Biopharma 10-Ks

  • FY2024 10-K risk factors
    62 risks

    Clinical-stage biopharmaceutical company dependent entirely on the regulatory approval and commercialization of ABP-450 as a biosimilar to Botox. Relies heavily on exclusive licensing and supply agreements with Daewoong for ABP-450 manufacturing and distribution. Faces significant financial risk with limited operating history, only five employees, and substantial accumulated losses.

    Filed Mar 24, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.