biote (BTMD) risk factors, FY2025 10-K

biote's FY2025 10-K, filed Mar 13, 2026, lists 66 risk factors in 6 groups. Against the prior year's 64: 9 new, 7 dropped, 22 substantially reworded.

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Risk factors listed
666 groups
New this year
9vs 64 last year
Dropped
7since the prior 10-K
Substantially reworded
22of those kept
Section length
30k wordsItem 1A

What the changes say

  • Biote expanded disclosures on supply chain reliance, tariffs, inventory management, restructuring, and commercial agreements.
  • The company added new risks regarding trade policies affecting material sourcing like estradiol from China and trocars from Pakistan.
  • Disclosures now reflect the acquisition of Asteria Health and the termination notice from partner AnazaoHealth.

What changed since the prior 10-K

New

  • NewRisks Related to Our Industry and Business

    Failure by outsourcing facilities and dietary supplement contract manufacturers to meet applicable standards or, in the case of third-party facilities, to meet their obligations to us, could materially harm our reputation, business, financial condition and results of operations

    Outsourcing facilities and contract manufacturers may fail to meet standards, harming Biote's reputation and business.

  • NewRisks Related to Our Industry and Business

    under the FDCA. Other changes in state and federal regulatory enforcement with respect to compounded drugs may also affect AnazaoHealth, Carie Boyd’s and Asteria Health, and, in turn, have the potential to harm the practices of Biote-certified practitioners or Biote-partnered clinics or our business

    AnazaoHealth gave notice of contract termination, though an amendment extended the agreement through December 2027.

  • NewRisks Related to Our Industry and Business

    Our operating results could be adversely affected if we are unable to adequately manage our inventory

    Inaccurate demand forecasting by Biote or partner clinics could lead to excess inventory or product shortages.

  • NewRisks Related to Our Industry and Business

    If we cannot collect our receivables or if payment is delayed, our business may be adversely affected by our inability to generate cash flow, provide working capital or continue our business operations

    Delays or failures in collecting receivables from clinics, practitioners, or patients would impair cash flow and operations.

  • NewRisks Related to Our Industry and Business

    Our restructuring and reorganization activities may be disruptive to our operations or ineffective

    A commercial team restructuring reduced workforce by 16 employees, risking morale, key attrition, and disruption.

  • NewRisks Related to Our Industry and Business

    State fee-splitting prohibitions, which prohibit licensed healthcare professionals from sharing a portion of their professional fees collected from their professional services with unlicensed third parties

    State fee-splitting prohibitions and HIPAA obligations create regulatory risks and potential legal expenses.

  • NewRisks Related to Our Industry and Business

    Substantial new tariffs and other restrictive trade policies have created a dynamic and unpredictable trade landscape, which may adversely impact our business

    Tariffs on raw materials like estradiol from China and trocars from Pakistan may raise costs and disrupt supply chains.

  • NewRisks Related to Our Industry and Business

    Ongoing uncertainty regarding trade policies may also complicate our short- and long-term strategic planning, and that of our partners and customers, including decisions regarding hiring, product strategy, capital investment, supply chain design and geographic expansion

    Trade policy uncertainties and potential funding changes for the FDA and DEA could delay inspections or operations.

  • NewRisks Related to Ownership of Our Securities

    In addition, we have registered up to 30,661,965 shares of Class A common stock that we may issue under the Incentive Plan and the ESPP. Any of these shares can be freely sold in the public market upon issuance, subject to volume limitations applicable to Affiliates

    Registering up to 30,661,965 shares for the Incentive Plan and ESPP could dilute investors and depress the stock price.

Dropped

  • DroppedRisks Related to Our Industry and Business

    Outsourcing facilities that produce bioidentical hormone pellets that we offer training on in the Biote Method and failure by those parties to adequately perform their obligations could harm our business

  • DroppedRisks Related to Our Industry and Business

    We have limited history of providing the Biote Method to practitioners in the hormone optimization space, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability

    Reliance on outsourcing facilities for bioidentical hormone pellets.

  • DroppedRisks Related to Our Industry and Business

    damage to our reputation, and revenue losses. We also rely on vendors to process payment card data, who may be subject to PCI DSS, and our business may be negatively affected if our vendors are fined or suffer other consequences as a result of PCI DSS noncompliance

  • DroppedRisks Related to Intellectual Property

    affected. If we are not able to maintain freedom to operate for our products from third-party intellectual property rights, our ability to commercialize products may be limited unless we secure a license to such rights

  • DroppedRisks Related to Regulation

    We recently restated our financial statements for certain prior periods, which resulted in unanticipated costs

  • DroppedRisks Related to Regulation

    and September 30, 2022 to reflect a reduction in our basic and diluted income (loss) per common share, as a pro rata portion of gain (loss) from changes in fair value of the warrant and earnout liabilities attributed to noncontrolling interests of Holdings

  • DroppedRisks Related to Ownership of Our Securities

    We may be subject to periodic claims and litigation that could result in unexpected expenses and could ultimately be resolved against us

Reworded

  • 70% rewrittenRisks Related to Our Industry and Business

    The healthcare industry is highly regulated, and government authorities may determine that we have failed to comply with applicable laws, rules or regulations

    Added minor phrasing updates regarding federal healthcare regulations without altering core compliance obligations.

  • 64% rewrittenRisks Related to Regulation

    Compounded preparations and the compounding pharmacy industry are subject to regulatory scrutiny, which may impair our growth and sales

    Updated to explicitly include newly acquired Asteria Health alongside 503B outsourcing facilities and mention office stock distribution limits.

  • 64% rewrittenRisks Related to Our Industry and Business

    We may not be able to achieve or maintain satisfactory pricing and margins for the Biote Method or the Biote-branded dietary supplements we sell

    Maintained identical text warning of price competition and margin erosion for Biote-branded dietary supplements and the Biote Method.

    Was: We may not be able to achieve or maintain satisfactory pricing and margins for our training and the Biote Method or the Biote-branded dietary supplements we sell

  • 61% rewrittenRisks Related to Our Industry and Business

    Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities

    Maintained identical text regarding limited business interruption and product liability insurance coverage.

  • 56% rewrittenRisks Related to Our Industry and Business

    We and Biote-certified practitioners and Biote-partnered clinics are reliant on AnazaoHealth Corporation, Right Value Drug Stores, LLC, and Biote-owned Asteria Health to support the manufacturing of bioidentical hormones for prescribers

    Updated to reflect that Biote acquired Asteria Health on March 18, 2024, changing its status from a contracted provider.

    Was: We and Biote-certified practitioners and Biote-partnered clinics are reliant on AnazaoHealth Corporation, Right Value Drug Stores, LLC, and Asteria Health to support the manufacturing of bioidentical hormones for prescribers

  • 53% rewrittenRisks Related to Regulation

    Failure to comply with the FDCA and analogous state laws and regulations can result in administrative, civil, criminal penalties

    Shortened the FDA authority description by removing a clause about the practice of medicine.

  • 49% rewrittenRisks Related to Ownership of Our Securities

    Anti-takeover provisions contained in the Charter and Bylaws, as well as provisions of Delaware law, could impair a takeover attempt

    Fixed a typographical error from 'disputes with the us' to 'disputes with us'.

  • 45% rewrittenRisks Related to Regulation

    If we fail to comply with FDA regulations governing our medical device products, our business could suffer

    Refined wording regarding Medline Industries supplying convenience kits and component manufacturers for disposable trocars.

  • 42% rewrittenRisks Related to Our Industry and Business

    If we are unable to attract and retain executive officers, key employees and other qualified personnel, or are unable to attract and retain contracts with Biote-certified practitioners, our ability to compete could be harmed

  • 41% rewrittenRisks Related to Our Industry and Business

    As we engage in or consider strategic transactions, we may not realize expected business or financial benefits and the acquisitions could prove difficult to integrate, impact our liquidity, increase our expenses and present significant distractions to our management

  • 38% rewrittenRisks Related to Our Industry and Business

    Product promotion may result in civil and criminal fines and other penalties, as well as product liability suits, which could be costly to our business

    Was: Off-label promotion may result in civil and criminal fines and other penalties, as well as product liability suits, which could be costly to our business

  • 33% rewrittenRisks Related to Our Industry and Business

    logistics carrier disruptions or increased costs that are beyond our control

  • 31% rewrittenRisks Related to Our Industry and Business

    In addition, due to potential costs from any international expansion efforts and potentially higher supplier costs outside of the United States, our international operations may operate with a lower margin profile. As a result, our margins may fluctuate if and as we expand our operations internationally

    Was: In addition, due to potential costs from any international expansion efforts and potentially higher supplier costs outside of the United States, our international operations may operate with a lower margin profile. As a result, our margins may fluctuate as we expand our operations internationally

  • 28% rewrittenRisks Related to Regulation

    If we are unable to maintain our listing on Nasdaq, it could become more difficult to sell our Class A common stock in the public market

  • 27% rewrittenRisks Related to Our Industry and Business

    Extreme weather conditions, natural disasters, and other catastrophic events, including those caused by climate change, could negatively impact our results of operations and financial condition

  • 26% rewrittenRisks Related to Regulation

    We have and will continue to incur significant increased expenses and administrative burdens as a public company, which could negatively impact our business, financial condition and results of operations

    Was: We will continue to incur, significant increased expenses and administrative burdens as a public company, which could negatively impact our business, financial condition and results of operations

  • 25% rewrittenRisks Related to Regulation

    If a compounded drug formulation provided through an outsourcing facility or a compounding pharmacy leads to patient injury or death or results in a product recall, we may be exposed to significant liabilities and reputational harm

    Was: If a compounded drug formulation provided through a compounding pharmacy or an outsourcing facility leads to patient injury or death or results in a product recall, we may be exposed to significant liabilities and reputational harm

  • 25% rewrittenRisks Related to Our Industry and Business

    In the future, we may seek to expand our operations to new markets outside the United States, creating a variety of operational challenges

    Was: We plan to expand our operations to new markets outside the United States, creating a variety of operational challenges

  • 24% rewrittenRisks Related to Our Industry and Business

    Biote-certified practitioners and Biote-partnered clinics are concentrated in certain geographic regions, which makes us sensitive to regulatory, economic, environmental and competitive conditions in those regions

  • 24% rewrittenRisks Related to Taxes

    Increases in our income tax rates, changes in tax laws or disagreements with tax authorities may adversely affect our business, financial condition or results of operations

  • 23% rewrittenRisks Related to Our Industry and Business

    Market and economic conditions may negatively impact our business, financial condition and stock price

  • 22% rewrittenRisks Related to Our Industry and Business

    Certain direct and indirect subsidiaries of Biote entered into that certain credit agreement which contains affirmative, negative and financial covenants that may limit its flexibility in operating its businesses

All 66 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Industry and Business

  1. 01Our success depends upon whether the Biote Method and our Biote-branded dietary supplements attain significant market acceptance among clinics, practitioners and their patients
  2. 02Failure by outsourcing facilities and dietary supplement contract manufacturers to meet applicable standards or, in the case of third-party facilities, to meet their obligations to us, could materially harm our reputation, business, financial condition and results of operationsNew
  3. 03logistics carrier disruptions or increased costs that are beyond our control33% rewritten
  4. 04We and Biote-certified practitioners and Biote-partnered clinics are reliant on AnazaoHealth Corporation, Right Value Drug Stores, LLC, and Biote-owned Asteria Health to support the manufacturing of bioidentical hormones for prescribers56% rewritten
  5. 05under the FDCA. Other changes in state and federal regulatory enforcement with respect to compounded drugs may also affect AnazaoHealth, Carie Boyd’s and Asteria Health, and, in turn, have the potential to harm the practices of Biote-certified practitioners or Biote-partnered clinics or our businessNew
  6. 06Biote-certified practitioners and Biote-partnered clinics are concentrated in certain geographic regions, which makes us sensitive to regulatory, economic, environmental and competitive conditions in those regions24% rewritten
  7. 07The frequency of use by practitioners and clinics of the Biote Method may not increase at the rate that we anticipate or at all
  8. 08Adoption of the Biote Method depends upon appropriate practitioner training and inadequate training may lead to negative patient outcomes and adversely affect our business
  9. 09The continuing development of the Biote Method depends upon our maintaining strong working relationships with Biote-certified practitioners and other medical personnel
  10. 10We believe our long-term value as a company will be greater if we focus on growth, which may negatively impact our results of operations in the near term
  11. 11We face significant competition, and if we are unable to compete effectively, we may not be able to achieve or maintain expected levels of market penetration and market share, which could have a material adverse effect on our business, financial condition and results of operations
  12. 12greater financial and human resources for development, sales and marketing and patent prosecution of our offerings
  13. 13obtain, maintain, enforce and defend our intellectual property rights and operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others
  14. 14We may not be able to achieve or maintain satisfactory pricing and margins for the Biote Method or the Biote-branded dietary supplements we sell64% rewritten
  15. 15Our operating results could be adversely affected if we are unable to adequately manage our inventoryNew
  16. 16If we cannot collect our receivables or if payment is delayed, our business may be adversely affected by our inability to generate cash flow, provide working capital or continue our business operationsNew
  17. 17Our quarterly results may fluctuate significantly and may not fully reflect the underlying performance of our business
  18. 18the timing of expenses related to the development or acquisition of technologies or businesses and potential future charges for impairment of goodwill or intangibles from acquired companies
  19. 19If we are unable to attract and retain executive officers, key employees and other qualified personnel, or are unable to attract and retain contracts with Biote-certified practitioners, our ability to compete could be harmed42% rewritten
  20. 20Our restructuring and reorganization activities may be disruptive to our operations or ineffectiveNew
  21. 21The healthcare industry is highly regulated, and government authorities may determine that we have failed to comply with applicable laws, rules or regulations70% rewritten
  22. 22State fee-splitting prohibitions, which prohibit licensed healthcare professionals from sharing a portion of their professional fees collected from their professional services with unlicensed third partiesNew
  23. 23In the future, we may seek to expand our operations to new markets outside the United States, creating a variety of operational challenges25% rewritten
  24. 24In addition, due to potential costs from any international expansion efforts and potentially higher supplier costs outside of the United States, our international operations may operate with a lower margin profile. As a result, our margins may fluctuate if and as we expand our operations internationally31% rewritten
  25. 25Substantial new tariffs and other restrictive trade policies have created a dynamic and unpredictable trade landscape, which may adversely impact our businessNew
  26. 26Ongoing uncertainty regarding trade policies may also complicate our short- and long-term strategic planning, and that of our partners and customers, including decisions regarding hiring, product strategy, capital investment, supply chain design and geographic expansionNew
  27. 27The size of the markets for our current and future offerings has not been established with precision and may be smaller than we estimate
  28. 28Our forecasted operating and financial results rely upon assumptions and analyses developed by us. If these assumptions and analyses prove to be incorrect, our actual operating and financial results may be significantly below our forecasts
  29. 29regulatory, legislative and political changes
  30. 30If our estimates or judgments relating to our critical accounting policies prove to be incorrect, our results of operations could be adversely affected
  31. 31Product promotion may result in civil and criminal fines and other penalties, as well as product liability suits, which could be costly to our business38% rewritten
  32. 32Certain direct and indirect subsidiaries of Biote entered into that certain credit agreement which contains affirmative, negative and financial covenants that may limit its flexibility in operating its businesses22% rewritten
  33. 33Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we offer or may develop
  34. 34the inability to commercialize any methods, training, or products that we may develop
  35. 35Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities61% rewritten
  36. 36As we engage in or consider strategic transactions, we may not realize expected business or financial benefits and the acquisitions could prove difficult to integrate, impact our liquidity, increase our expenses and present significant distractions to our management41% rewritten
  37. 37Extreme weather conditions, natural disasters, and other catastrophic events, including those caused by climate change, could negatively impact our results of operations and financial condition27% rewritten
  38. 38Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions could adversely affect our results of operations and financial condition
  39. 39Market and economic conditions may negatively impact our business, financial condition and stock price23% rewritten

Risks Related to Intellectual Property

  1. 40Our success depends in part on our ability to obtain and maintain patent and other intellectual property protection in the United States and other countries with respect to our Biote-branded dietary supplements
  2. 41We may become a party to intellectual property litigation or administrative proceedings that could be costly and could interfere with our ability to sell and market the Biote Method and our Biote-branded dietary supplements
  3. 42If we are unable to protect the confidentiality of our other proprietary information, our business and competitive position may be harmed
  4. 43We may be subject to claims challenging our intellectual property
  5. 44If our trademarks and trade names are not adequately protected, then we may not be able to build brand recognition in our markets and our business may be adversely affected

Risks Related to Regulation

  1. 45Compounded preparations and the compounding pharmacy industry are subject to regulatory scrutiny, which may impair our growth and sales64% rewritten
  2. 46If a compounded drug formulation provided through an outsourcing facility or a compounding pharmacy leads to patient injury or death or results in a product recall, we may be exposed to significant liabilities and reputational harm25% rewritten
  3. 47Failure to comply with the FDCA and analogous state laws and regulations can result in administrative, civil, criminal penalties53% rewritten
  4. 48If we fail to comply with FDA or state regulations governing our Biote-branded dietary supplements, our business could suffer
  5. 49If we fail to comply with FDA regulations governing our medical device products, our business could suffer45% rewritten
  6. 50As products recommended as part of the Biote Method are not typically covered by third-party and government payors we could see decreased demand for our training and support services
  7. 51We have and will continue to incur significant increased expenses and administrative burdens as a public company, which could negatively impact our business, financial condition and results of operations26% rewritten
  8. 52Management, including our Chief Executive Officer and our Chief Financial Officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2025, and concluded that we did not maintain effective internal control over financial reporting
  9. 53The market price of our common stock is volatile and may fluctuate substantially, and you could lose all or part of your investment
  10. 54general economic and political conditions such as recessions, interest rates, fuel prices, international currency fluctuations and acts of war or terrorism
  11. 55If we are unable to maintain our listing on Nasdaq, it could become more difficult to sell our Class A common stock in the public market28% rewritten

Risks Related to Ownership of Our Securities

  1. 56Because there are no current plans to pay cash dividends on our Class A common stock for the foreseeable future, you may not receive any return on investment unless you sell our Class A common stock for a price greater than that which you paid for it
  2. 57We may require additional capital to support business growth, and if capital is not available to us or is available only by diluting existing stockholders, our business, operating results and financial condition may suffer
  3. 58Anti-takeover provisions contained in the Charter and Bylaws, as well as provisions of Delaware law, could impair a takeover attempt49% rewritten
  4. 59In addition, we have registered up to 30,661,965 shares of Class A common stock that we may issue under the Incentive Plan and the ESPP. Any of these shares can be freely sold in the public market upon issuance, subject to volume limitations applicable to AffiliatesNew

Risks Related to our Organizational Structure

  1. 60Our only material asset is our ownership interest in Holdings, and accordingly we depend on distributions from Holdings to pay distributions, dividends on our Class A common stock, taxes and other expenses, and make any payments required to be made by us under the Tax Receivable Agreement (the “TRA”)
  2. 61In certain cases, payments under the TRA may exceed the actual tax benefits we realize
  3. 62In certain cases, payments under the TRA may be accelerated or significantly exceed the actual benefits we realize in respect of the tax attributes subject to the TRA
  4. 63We may not be able to realize all or a portion of the tax benefits that are expected to result from the acquisition of Retained Holdings Units from Biote Members

Risks Related to Taxes

  1. 64Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our financial condition and results of operations
  2. 65lower than anticipated future earnings in jurisdictions where we have lower statutory tax rates and higher than anticipated future earnings in jurisdictions where we have higher statutory tax rates
  3. 66Increases in our income tax rates, changes in tax laws or disagreements with tax authorities may adversely affect our business, financial condition or results of operations24% rewritten

Other biote 10-Ks

  • FY2024 10-K risk factors
    64 risks

    Revenue heavily concentrates in ten southern states, making operations vulnerable to regional disruptions. Reliance on specific third-party compounding pharmacies creates supply chain vulnerability. International expansion into Latin America introduces lower margin profiles and distribution risks.

    Filed Mar 14, 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.