BTMD 10-K & 10-Q changes, risk factors and insider trading

Our success depends on the acceptance of the hormone optimization methods we teach in our training. We cannot predict how quickly clinics, practitioners or their patients will accept the Biote Method (as further described in Part I, Item 1. “Business”) or, if accepted, how frequently it will be used. The methods that we currently recommend and any methods we recommend in the future may never gain broad market acceptance. Demonstrated HRT health risks or side effects, as well as negative publicity relating to the same, could negatively impact the perception of patient benefit and generate resistance and opposition from practitioners, which could limit adoption of the Biote Method and have a material adverse impact on our business. To date, a substantial majority of our revenue has been derived from a limited number of clinics and independent, third-party physicians and nurse practitioners who are certified under our training program (the “Biote-certified practitioners”).

For example, some Biote-certified practitioners may choose to utilize the Biote Method and our Biote-branded dietary supplements on only a subset of their total patient population or may not adopt our offerings at all. If we are not able to effectively demonstrate that the use of the Biote Method and our Biote-branded dietary supplements is beneficial in a broad range of their patients, adoption of our offerings will be limited and may not occur as rapidly as we anticipate or at all, which would have a material adverse effect on our business, financial condition and results of operations. We cannot assure you that the Biote Method or our Biote-branded dietary supplements will achieve broad market acceptance among clinics and practitioners. Additionally, even if the Biote Method and our Biote-branded dietary supplements achieve initial market acceptance, they may not maintain that market acceptance over time if competing methods, procedures or technologies are considered more cost-effective or otherwise superior. Any failure of our offerings to generate sufficient demand or to achieve meaningful market acceptance and penetration will harm our future prospects and have a material adverse effect on our business, financial condition and results of operations.

OutsourcingCurrently, outsourcing facilities manufacturecompound the productsbioidentical hormone pellets that we recommend as part of our training. The facilitiesfacilities, including Biote-owned Asteria Health, used to compound and distribute bioidentical hormone pellets, which may be prescribed by Biote-certified practitioners, are registered with the FDA as 503B outsourcing facilities. WeAs to the third-party outsourcing facilities, we do not control or direct the compounding or manufacturing processes used by these outsourcing facilities. WeSimilarly, we use contract manufacturers to produce the formulations of the dietary supplements we develop and sell under Biote’s private label, and we rely on those manufacturers for compliance with the applicable regulatory requirements. As such,Moreover, we have nodeveloped relationships with third party compounding pharmacies to expand our offering of therapeutic wellness products. Biote does not have control over the ability of third parties to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable international regulatory authority doestakes notsteps approveto restrict or prohibit the manufacture and/or distribution of products from these facilities for the manufacture of these products or if it withdraws any such approval in the future, we may need to identify alternative manufacturing facilities, which would significantly impact our ability to meet consumer demand. In addition, our inability to identify or enter into satisfactory arrangements with any such alternative manufacturing facilities may result in a material adverse effect on our business, financial condition and results of operations.

Any of these events could impact our ability to successfully commercialize any future products that we recommend as part of the Biote Method and our current or any future Biote-branded dietary supplements. Some of these events could be the basis for FDA action, including injunction, request for recall, seizure, or total or partial suspension of production. See also “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.” and “—Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we offer or may develop.”

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.

We entered into a Pharmacy Services Agreement with AnazaoHealth Corporation,Corporation or AnazaoHealth,(“AnazaoHealth”) on October 30, 2020 (the “AnazaoHealth Pharmacy Services Agreement”), and an Outsourcing Facility Services Agreement with Right Value Drug Stores, LLC d/b/a Carie Boyd’s Prescription Shop,Shop or (“Carie Boyd’s,Boyd’s”) on August 1, 2020, as amended by written agreement in September 2020, modified by verbal agreement in November 2020 and amended by written agreement in February 2025 (collectively, the “Outsourcing Facility Services Agreement”), and a Pharmacy Services Agreement withacquired Asteria Health on OctoberMarch 28,18, 2021, which was subsequently amended and restated in its entirety on October 19, 2023 (the “Asteria Health Pharmacy Services Agreement”),2024, to build relationships to support Biote-certified practitioners by offering an option for the compounded bioidentical hormones that the practitioners may order or prescribe. AnazaoHealth, Carie Boyd’s and Asteria Health are operators of FDA-registered 503B outsourcing facilities. While Biote-certified practitioners have the option to use a variety of different outsourcing facilities, AnazaoHealth, Carie Boyd’s and Asteria Health are the primary outsourcing facilities of the compounded bioidentical hormone pellets used by Biote-certified practitioners as part of the Biote Method. However, we do not control or direct the compounding or manufacturing processes of the AnazaoHealth and Carie Boyd 503B outsourcing facilities. WeHowever, we also do not control the time and resources AnazaoHealth,AnazaoHealth or Carie Boyd’s or Asteria Health devotes to compounding bioidentical hormone pellets. If AnazaoHealth, Carie Boyd’s or Asteria Health are unable to successfully fulfill a Biote-certified practitioner’s product orders, or if the state licenses held by AnazaoHealth, Carie Boyd’s or Asteria Health to ship medications for office use throughout the United States are revoked, expire or otherwise not maintained, it could adversely impact the practices of Biote-certified Practitionerspractitioners or Biote-partnered clinics, which could in turn have a material adverse effect on our business, financial condition and results of operations. The FDCA prohibits selling or transferring a drug compounded by an outsourcing facility by an entity other than the outsourcing facility that compounded the drug. In June 2023, the FDA released guidance, “Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act” clarifying its interpretation of this prohibition. If the FDA determines that we are selling or transferring a drug compounded by an outsourcing facility, we may be subject to penalties under the FDCA. Other changes in state and federal regulatory and 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.

We have developed relationships with third party compounding pharmacies to expand our offering of therapeutic wellness products. In the future, we may also seek to develop relationships with other 503B outsourcing facilities and/or 503A compounding pharmacies to support the manufacturingcompounding of medications such as bioidentical hormones for Biote-certified practitioners and Biote-partnered clinics in the United States and internationally. We already have a presence in Canada, Puerto Rico, Mexico and the Dominican Republic, where we hope to continue growing our business, and also hope to expand into Argentina, Brazil, Colombia, and Canada, as permitted by law, in the future.business. If we fail to develop new relationships with any other503B outsourcing facilities and/or 503A compounding pharmacies with which we seek to engage, including in new markets in the United States and/or internationally, fail to manage or incentivize these facilitiesoperations effectively, or if these facilitiesoperations are not successful in their sales and marketing efforts, our ability to support to Biote-certified practitioners and Biote-partnered clinics, and to generate revenue, cash flow and earnings growth could suffer, which could have a material adverse effect on our business, financial condition and results of operations. Moreover, these agreements may be non-exclusive, and some of these facilitiesoperations may also have cooperative relationships with certain of our competitors.

WeAdditionally, we may not be successful in expanding into new geographic areas within the United StatesStates. As, or internationally. In addition, asif we expand into new geographic areas, we may not be able to dedicate enough time or resources to maintain our market share in our core geographic areas, and our business may be negatively impacted.

Adoption of the Biote Method depends upon appropriate practitioner training,training and inadequate training may lead to negative patient outcomes and adversely affect our business.

We believe our long-term value as a company will be greater if we focus on longer-term growth rather than short-term results. As a result, our results of operations may be negatively impacted in the near term relative to a strategy focused on maximizing short-term profitability. Significant expenditures on marketing efforts, acquisitions and internationalexpansion expansionof our business into new markets may not ultimately grow our business or lead to expected long-term results.

We have experienced substantial growth in our operations, and we expect to experience continued growth in our business. This growth has placed, and will continue to place, significant demands on our management and our operational infrastructure. Any growth that we experience in the future could require us to expand our sales and marketing personnel and general and administrative infrastructure. In addition to the need to scale our organization, future growth will impose significant added responsibilities on management, including the need to identify, recruit, train and integrate additional employees. We cannot assure you that any increases in scale will be successfully implemented or that we will be able to hire additional personnel or that appropriate personnel will be available to facilitate the growth of our business. Rapid expansion in personnel could mean that less experienced people market and sell the Biote Method and our Biote-branded dietary supplements, which could result in inefficiencies and unanticipated costs, lowered quality standards and disruptions to our operations. Rapid and significant growth may strain our administrative and operational infrastructure and could require significant capital expenditures that may divert financial resources from other projects, such as research and development of potential future offerings. In addition, our ability to grow may be adversely impacted due to factors beyond our control, which could have a material adverse effect on our business, reputation, financial performance, financial condition and results of operations, and could expose us to liability. Our failure to manage growth effectively could have a material and adverse effect on our business, financial condition and results of operations. To manage the growth of our operations, we must establish appropriate and scalable operational and financial systems, procedures and controls and build and maintain a qualified finance, administrative and operations staff. If we are unable to manage our growth effectively, including by failing to implement necessary procedures, transition to new processes or hire necessary personnel, we may fail to execute our business strategy which would have a material adverse effect on our business, results of operations and financial condition.

We can provide no assurance that we will be successful in developing new training, methods,methods or Biote-branded dietary supplements or commercializing them in ways that achieve market acceptance. Moreover, any significant delays in the development or commercialization of new training, methods or Biote-branded dietary supplements may significantly impede our ability to enter or compete in a given market and may reduce the sales that we are able to generate, which could have a material adverse effect on our business, financial condition and results of operations.

Our successability to compete in a highly competitive industry depends on our ability to attract and retain our executive officers, key employeesleadership and other qualified personnel,managerial andpersonnel. Additionally, as a relatively small company with key talent residing in a limited number of employees, our operations and prospects may be severely disrupted if we lost any one or more of their services. AsFor instance, we buildare highly dependent on the services of our brand,current expandChief intoExecutive new domesticOfficer and internationalChief territoriesFinancial Officer, as well as several of our executive officers and becomeother moresenior welltechnical known,and theremanagement ispersonnel, increasedwho riskwould thatbe competitorsdifficult to replace. If these or other companieskey willpersonnel seekwere to depart, or we are unable to hire and retain other highly qualified personnel, we may not be able to conduct or grow our personnel.business. We do not maintain key person life insurance with respect to any member of management or other employee. While some of our employees are bound by non-competition agreements, these may prove to be unenforceable. The failure to attract, integrate, train, motivate and retain these personnel could seriously harm our business and prospects.

Over the past 12 months,Recently, we have experienced organizational changes, including the recent appointment of new executives, including a new Chief Executive Officer and a new Chief Marketing Officer, and the promotion, addition, or departure of members of our senior management team. These organizational changes have placed, and will continue to place, a significant strain on our management, administrative, operational and financial infrastructure. Our success will dependdepends in part upon the ability of our senior management team to manage these changes effectively. If we fail to manage these changes effectively, we may be unable to execute our business plan, maintain high levels of service or address competitive challenges adequately.

provisions of 18 U.S.C. § 1347 (the healthcare fraud provision of HIPAA) that prohibit knowingly and willfully executing a scheme or artifice to defraud a healthcare benefit program or falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services;

Statefederal fee-splittingand prohibitions,state laws related to confidentiality, privacy and security of personal information such as HIPAA, including protected health information (“PHI”), that limit the manner in which prohibitwe licensedmay healthcareuse professionalsand fromdisclose sharingthat information, impose obligations to safeguard that information and require that we notify our customers in the event of a portion of their professional fees collected from their professional services with unlicensed third parties; andbreach. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and their implementing regulations, also imposes obligations, including mandatory contractual terms, on covered entities, which are health plans, healthcare clearing houses, and certain healthcare providers, as those terms are defined by HIPAA, and their respective business associates and their subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.information;

Although Biote does not bill or receive any reimbursement from any third-party payor, to the extent that any Biote-certified practitionerspractitioner and Biote-partnered clinic with whom we partner accepts health insurance for their services, we could be subject to additionalsome of the aforementioned healthcare laws, including without limitation the federal Anti-Kickback Statute, False Claims Act and the healthcare fraud provisions of HIPAA.

In a regulatory climate that is uncertain, our operations may be subject to direct and indirect adoption, expansion or reinterpretation of various healthcare laws and regulations. Compliance with these and/or future healthcare laws and regulations may require us to change our practices at an undeterminable and possibly significant initial monetary and annual expense. These additional monetary expenditures may increase future overhead, which could have a material adverse effect on our results of operations. Additionally, theour introductiontraining of new training,offerings and Biote-branded dietary supplements may require us to comply with additional laws and regulations. Compliance may require obtaining appropriate licenses or certificates, increasing our security measures, and expending additional resources to monitor developments in applicable rules and ensure compliance. The failure to adequately comply with these and/or future healthcare laws and regulations may delay or possibly prevent any new training and products from being offered to Biote-certified practitioners, Biote-partnered clinics and their patients, which could have a material adverse effect on our business, financial condition, and results of operations.

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

Although we currently work with numerous clinics that are multi-national in scope, our current business is primarily focused on clinics and practitioners in the United States.States, Awe componenthave ofin ourthe growthpast strategyand involvesmay expandingin the future, seek to expand our operations to new markets outside the United States, including expansion into Argentina, Brazil, Colombia and Canada, as permitted by law. We may face difficulties as we expand our operations into new domestic and international marketsStates in which we have limited or no prior operating experience.

Our growth strategy for expanding our operations outside the United States willwould require significant resources and management attention and willwould subject us to regulatory, economic and political risks that are different from those in the United States, including:

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.

As we move to expand our business into Central and South America, our success will depend, in large part, on our ability to identify and work with international distributors. If our international distributors are unable to expand our business or are unable to provide an adequate training program, our business could be harmed. Our failure to manage any of these risks successfully, or to comply with these laws and regulations, could harm our operations, reduce our sales and harm our business, operating results and financial condition. For example, in certain countries, particularly those with developing economies, certain business practices that are prohibited by laws and regulations applicable to us, such as the Foreign Corrupt Practices Act, may be more commonplace. Although we have policies and procedures designed to ensure compliance with these laws and regulations, our employees, contractors and agents, as well as partners involved in our international sales, may take actions in violation of our policies. Any such violation could have an adverse effect on our business and reputation.

Biote-certified practitioners primarily focus their treatments on women experiencing symptoms due to hormonal imbalance before, during, and after menopause, and men experiencing symptoms of hypogonadism and male sex hormone deficiency. We believe our business opportunity in providing educational and practice management services is large and will similarly grow. Our estimates of our total addressable markets for our current offerings and those under development are based on a number of internal and third-party estimates, including, without limitation, the number of practitioners we can offer ourthe trainingBiote Method and Biote-branded dietary supplements to and the assumed prices at which we can sell offerings in markets that have not been established or that we have not yet entered. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these estimates. As a result, our estimates of the total addressable market for our current or future offerings may prove to be incorrect. If the actual number of a Biote-certified practitioner’s or Biote-partnered clinic’s patients who would benefit from the Biote Method or our Biote-branded dietary supplements, the price at which we can sell trainingthe Biote Method and Biote-branded dietary supplements, or the total addressable market for the Biote Method or our Biote-branded dietary supplements is smaller than we have estimated, it may impair our sales growth and have a material adverse impact on our business, financial condition and results of operations.

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

Biote does not manufacture or distribute any drug products. Nevertheless, ifIf the FDA determines that our practitioner training, including our paid consultants’ educational materials,training constitutes off-labelinappropriate drug promotion, it could subject us or our business partners to enforcement action, including warning letters, untitled letters, fines and penalties, including criminal fines and/or prosecution. If we are found to have inappropriately marketed or promoted anyFDA-regulated drugs,products, we may become subject to significant liability. The federal government has levied large civil and criminal fines and/or other penalties against companies for alleged improper promotion and has investigated, prosecuted and/or enjoined several companies fromunder engagingthe inFDCA off-labeland promotion.other federal statutes. If we become subject to civil or criminal fines or other penalties, or product liability suits, such fines, penalties or lawsuits could have a material adverse effect on our business, financial condition and results of operations.

On May 26, 2022, certain direct and indirect subsidiaries of Biote entered into that certain Credit Agreement (the “Credit Agreement”) with BioTE Medical, LLC (the “BioTE Medical”) as borrower, and Truist Bank, as administrative agent, in connection with the Closing of the Business Combination. The Credit Agreement provides to borrower a $125.0 million five-year senior secured term loan A facility (the “Term Loan”) and a $50.0 million revolving line of credit. On April 26, 2024, we entered into a First Amendment to the Credit Agreement and Waiver (the “First Amendment to Credit Agreement and Waiver”) with the lender, that waived an event of default and also agreed that payments made to repurchase specified shares in settlement ofunder thethat certain settlement agreement with Gary S. Donovitz Litigation (as defined herein) will no longer continue as an event of default. On June 26, 2024, we entered into a Second Amendment to the Credit Agreement, in which the lender agreed that the payments made to repurchase specified shares in settlement ofunder thethat Junecertain 5,settlement 2024agreement Litigationwith (asMarci defined herein)Donovitz will not qualify as an event of default on the Term Loan. The proceeds of the Credit Agreement have beenwere used to repay existing debt, pay fees and expenses in connection with the Business Combination, and for general corporate purposes. The Credit Agreement contains affirmative, negative and financial covenants that could limit the manner in which we conduct our business, and we may be unable to expand or fully pursue itsour business strategies, engage in favorable business activities, or finance future operations or capital needs. Our ability to comply with the covenants under the Credit Agreement may be affected by events beyond our control, and we may not be able to comply with those covenants. A breach of any of the covenants contained in the Credit Agreement could result in a default under the Credit Agreement, which could cause all of the outstanding indebtedness under the facility to become immediately due and payable if not waived by the lender. We failed to notify the administrative agent of its commitment to repurchase certain shares currently beneficially owned by the Company’s founder pursuant to a settlement agreement reached in the Donovitz Litigation, resulting in an event of default as of March 31, 2024. On April 26, 2024, the lender waived the event of default. If we are unable to generate sufficient cash to repay our debt obligations under the Credit Agreement when they become due and payable, either as such obligations become due, when they mature, or in the event of a default, we may not be able to obtain additional debt or equity financing on favorable terms, if at all, which could have a material adverse effect on our business, financial condition and results of operations.

We face an inherent risk of product liability exposure. If we cannot successfully defend ourselves against claims that the products that we recommend as part of ourthe trainingBiote Method or our Biote-branded dietary supplements caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

Increase the number of Biote-certified practitioners. Our primary objective in marketing to healthcare providers is to inform them of the value in joining the Biote network. We accomplish this through provider referrals, a dedicated sales force, and through digital and traditional marketing channels. We target specific physicians based on their specialty, prescribing data, demographic information and location match withwithin our existing geographic footprint.

Increasing sales of Biote-branded dietary supplements. Our Biote-branded dietary supplement line currently includes 2426 dietary supplements that we offer to our Biote-certified practitioners through our eCommerce site, efficiently leveraging our core Biote provider platform. Practitioners then re-sell Biote-branded dietary supplements to their patients, enabling patients to receive physician-guided therapies to manage the related effects of aging. In August 2021, we launched aOur direct-to-patient eCommerce platform wherebyenables practitioners canto invite their patients to buy Biote-branded dietary supplements online via our online store. In addition to our direct-to-patient eCommerce platform, our Biote-branded dietary supplements are also offered through our eCommerce platform with Amazon.

A majorityportion of the bioidentical hormone pellets used by Biote-certified practitioners are manufactured by our 503B compoundingoutsourcing pharmacy:facility, however,Asteria Health; therefore, in order to meet demand we have agreements with AnazaoHealth (the “AnazaoHealth Pharmacy Services Agreement”) and Carie Boyd (the “Outsourcing Facility Services Agreement”) each of which are FDA registered 503B outsourcing facilities. Bioidentical hormone pellets are shipped directly to Biote-certified practitioners. Custody of the bioidentical hormone pellets is with Biote-certified practitioners. However, the bioidentical hormone pellets are recorded as inventory onin our consolidated balance sheets from the date of shipment until suchthe point in time as they are administereddispensed inby a patientBiote-certified treatment as monitored and recorded in our BioTracker system as an additional service for administrative convenience ofpractitioner. Biote-certified practitioners record the dispensation of bioidentical hormone pellets and Biote-partneredmonitor clinics.inventory levels in the inventory management system that is offered as part of the Biote Method.

TheseBioidentical productshormone pellets have a finite life ranging from six to twelve months. We assume the risk of loss due to expiration, damage or otherwise. Additionally, the products offered in our Biote-branded dietary supplement portfolio are produced by third-party manufacturers located in the United States. BioteWe contractscontract with a third-partythird party to provide warehousing, co-packing and logistics services for our Biote-branded dietary supplements.

To strengthen control over our supply chain, enhance operational efficiency and reduce production costs, we are focused on vertical integration through strategic transactions. For example, in March 2024, we acquired Asteria Health, a 503B manufactureroutsourcing offacility compoundedto compound bioidentical hormones. AsAlthough partAsteria ofHealth thehas integrationbeen processintegrated associatedinto withour this strategic transaction,processes, we arecontinue narrowingto utilize our current vendor network to better manage our supply chain.chain to meet the demands of our Biote-certified clinics. On November 1, 2024, AnazaoHealth provided notice that it was exercising its right to terminate the Pharmacy Services Agreement (the “AnazaoHealth Pharmacy Services Agreement”), which we previously entered into on October 30, 2020, with such termination to be effective as of May 1, 2025. WhileIn therethe issecond noquarter guaranteeof that2025, we willexecuted bea ablesecond amendment to negotiatethe AnazaoHealth Pharmacy Services Agreement effective July 19, 2025 (the “Second Amendment”), which extends the AnazaoHealth Pharmacy Services Agreement through December 31, 2027 and provides for a newone-year agreementextension withat AnazaoHealthour discretion. With the Second Amendment in place and continuethrough our partnershipexisting followingdirect suchmanufacturing notice of termination on terms that are acceptable to us, if at all,capabilities, we believe we canare well positioned to continue to meetmeeting the product demands of our Biote-practitionerscurrent throughBiote certified practitioners while focusing on expanding our existingBiote-certified directclinic manufacturing capabilities and vendor network while continuing to expand our vertical integration.network.

Global economic conditions have been challenging, with disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide resulting from the effects of public health crises, uncertainties associated with the changes to and by the U.S. federal government and otherwise. If these conditions persist and deepen, we could experience an inability to access additional capital or our liquidity could otherwise be impacted. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs and/or other efforts. A recession or additional market corrections resulting from the impact of the effects of global health crises,crises suchor asgeopolitical the COVID-19 pandemic,turmoil, could materially affect our business and the value of our securities. The impact of global health crises and the related disruptions caused to the global economy did not have a material impact on our business during the years ended December 31, 20242025 and 2023.2024. Additionally, we continue to monitor ongoing changes to global trade policies, including the imposition of tariffs. Although the impact of these policies did not have a material impact on our business in 2025, the broader economic impact is uncertain, and while we may experience additional operational expenses related to the costs of obtaining materials, we do not expect to be materially impacted in future periods.

On February 1, 2025, we appointed Bret Christensen as Chief Executive Officer. In connection with his appointment, we entered into an employment agreement with Mr. Christensen, dated as of January 29, 2025 which provides for Mr. Christensen’s at-will employment as the Chief Executive Officer for a term commencing on February 1, 2025 and continuing until terminated by either us or Mr. Christensen. Teresa S. Weber, our prior Chief Executive Officer, transitioned out of her role, effective February 1, 2025. On January 30, 2025, Ms. Weber entered into a consulting agreement with us, which provides that Ms. Weber will serveserves as a strategic advisor to us and our Board of Directors for up to one year, to assist with the transition and to work on special projects.

We generate revenue by charging the Biote-partnered clinics fees associated with the Biote Method and from the sale of Biote-branded dietary supplements. Revenue generated from individual Biote-partnered clinics varies significantly due to many factors.factors, including but not limited to, the tenure of practitioners as Biote-certified practitioners; the number of certified practitioners in an individual clinic; the number of patients served by a clinic; the clinic’s patient demographics; and the clinic’s geographic location and population density. The MSAs we enter into with Biote-partnered clinics contain tiered pricing provisions for the management fees. These provisions provide for decreasing management fees owed to us based on the number of new patients treated. This can result in declines in revenue we realize from management fees from existing Biote-partnered clinics unless these are offset by revenue generated from newly acquirednew Biote-partnered clinics which begin at higher fee levels under the MSA.

the effects of competition on market share and pricing;

Product revenue includes both bioidentical hormone pellets, in connection with the service described above, and the related inventory and practice management services provided to clinics. Product revenue is recognized atwhen the point in time when theBiote-partnered clinic obtains ownership of the pellet,bioidentical hormone pellets, which we determined to be whenthe point in time in which the bioidentical hormone pellets are dispensed by a Biote-certified practitioner performs the procedure to implant the pellet into their patient.practitioner. The consideration allocated to this performance obligation is a procedure-based service fee which we refer to as procedure revenue. Our product revenue also includes revenue earned from sales of pellet insertion kits and Biote-branded dietary supplements. Revenue from the sale of pellet insertion kits and Biote-branded dietary supplements is recognized when the clinic or clinic’s patient (supplements only) obtains control of the productproduct, and iswhich generally occurs at the time of shipment from our third-party distribution facility.facility or supplier. Any shipping or handling fees paid by clinics are also recorded within product revenue.

Service revenue is revenue earned from fees paid by Biote-partnered clinics for Biote Method education, training and certification services and other contract termcontract-term services provided pursuant to our MSAs. While the option to receive and right to use the reusable trocars through the term of the contract represents an embedded lease, we have adopted the practical expedient within ASC 842 to combine the lease and non-lease components and account for the combined component under ASC 606.

The training completion and time-elapsed bases represent the most reliable measure of transfer of control to the clinic for trainingstraining and contract-term services, respectively. Revenue is deferred for amounts billed or received prior to delivery of the services.

Cost of service revenue consists primarily of costs incurred to deliver training to Biote-partnered clinics. Cost of product revenues include the pass-through cost of bioidentical hormone pellets purchased from outsourcing facilities, the cost of pellet insertion kits and Biote-branded dietary supplements purchased from manufacturing facilities, and the shipping and handling costs incurred to deliver these products to Biote-partnered clinics. Cost of service revenue consists primarily of costs incurred to provide Biote Method education, training and certification services and other contract-term services to Biote-certified practitioners.

Selling, general and administrative expense consists primarily of software licensing and maintenance andmaintenance, the cost of our sales force and the employees who engage in corporate functions, such as executive management, finance and accounting, human resources, information technology, human resources, legal,legal and executive management.marketing. Also included are rent occupancy costs, office expenses, recruiting expenses, marketing and advertising expenses,costs, entertainment allocations, depreciation and amortization, share-based compensation, transaction relatedtransaction-related expenses, other general overhead costs, insurance premiums, professional service fees, research and development anddevelopment, costs related to regulatory and legal matters.matters and other general overhead costs.

Interest expense, net consists primarily of cash and non-cash interest under our Term Loan, commitment fees for ourthe unused portion of our Revolving Loans, accreted non-cash interest related to our share repurchase liabilities,liability, net of interest income earned on our money market account and our now matured short-term investment.account.

Gain (Loss) from Change in Fair Value of Earnout Liabilities

LossGain (loss) from change in fair value of earnout liabilities consists of the change in fair value during the period of the earnoutMember liabilityand relatedSponsor to the Business Combination Agreementearnouts and the earnout liability related to the acquisition of Simpatra. during the period.

Other Income /(Expense), Expensenet

Other income and(expense), othernet expense consistconsists of the foreign currency exchange gains and losses for sales denominated in foreign currencies and other income or paymentsexpenses not appropriately classified as operating expenses.

Income TaxesTax Expense

Gain (Loss) from Change in Fair Value of Earnout Liabilities

Other Income (Expense), net

Income Tax Expense (Benefit)

Income tax expense for the year ended December 31, 20242025 decreasedincreased $1.7$5.0 million compared to the year ended December 31, 2023.2024. ThisThe increase relates to the deferred tax expense, primarily driven by a decrease reflectsin incomethe attributableCompany’s outside basis in Holdings in 2025, compared to Biotethe deferred tax benefit recognized in 2024 comparedfrom toan certainincrease one-timein decreases made to theits outside basis difference of Holdings in 2023.basis.

The following table presents a reconciliation of net income (loss) to Adjusted EBITDA:

Represents cash and non-cash interest on our debt obligations, commitment fees for our unused Revolving Loans, net of interest income earned on our money market account and short-term investment. For the yearyears ended December 31, 2025 and 2024, interest expense, net included $3.2 million and $2.6 millionmillion, respectively, of accreted interest related to the share repurchase liabilities (2) Represents depreciation expense on property and equipment, amortization expense on capitalized software and amortization expense on purchased intangible assets. Depreciation expense of $0.03 million was included in cost of products for the year ended December 31, 2024.liabilities.

Increasing sales of Biote-branded dietary supplements. Our Biote-branded dietary supplement line currently includes 26 dietary supplements that we offer to our Biote-certified practitioners through our eCommerce site, efficiently leveraging our core Biote provider platform. Practitioners then re-sell Biote-branded dietary supplements to their patients, enabling patients to receive physician-guided therapies to manage the related effects of aging. Our direct-to-patient eCommerce platform enables practitioners to invite their patients to buy Biote-branded dietary supplements online via our online store. In addition to our direct-to-patient eCommerce platform, our Biote-branded dietary supplements are also offered through our eCommerce platform with Amazon.platform.

To strengthen control over our supply chain, enhance operational efficiency and reduce production costs, we are focused on vertical integration through strategic transactions. For example, in March 2024, we acquired Asteria Health, a 503B outsourcing facility to compound bioidentical hormones. Although Asteria Health has been integrated into our processes, we continue to utilize our current vendor network to manage our supply chain to meet the demands of our Biote-certified clinics. On November 1, 2024, AnazaoHealth provided notice that it was exercising its right to terminate the AnazaoHealth Pharmacy Services Agreement with such termination to be effective as of May 1, 2025. In the second quarter of 2025, we executed a second amendment to the AnazaoHealth Pharmacy Services Agreement effective July 19, 2025 (the “Second Amendment”), which extendsextended the AnazaoHealth Pharmacy Services Agreement through December 31, 2027 and providesprovided for a one-year extension at our discretion. On April 9, 2026, we extended the Second Amendment for a term of one year, with the option to extend our commitment until December 31, 2028 (the “2027 Commitment”). With the Second Amendment and 2027 Commitment in place and through our existing direct manufacturing capabilities, we believe we are well positioned to continue meeting the product demands of our current Biote certified practitioners while focusing on expanding our Biote-certified clinic network.

*Please refer to “Non-GAAP Measures” below for reconciliations of Adjusted EBITDA to the most directly comparable U.S. GAAP measure, net income,income (loss), and for additional information about Adjusted EBITDA.

Global economic conditions have been challenging, with disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide resulting from the effects of public health crises, uncertainties associated with the changes to and by the U.S. federal government and otherwise. If these conditions persist and deepen, we could experience an inability to access additional capital or our liquidity could otherwise be impacted. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs and/or other efforts. A recession or additional market corrections resulting from the impact of the effects of global health crises or geopolitical turmoil, could materially affect our business and the value of our securities. Additionally, we continue to monitor ongoing changes to global trade policies, including the imposition of tariffs. Although the impact of these policies did not have a material impact on our business during the three and six months ended MarchJune 31,30, 2026 and 2025, the broader economic impact is uncertain, and while we may experience additional operational expenses related to the costs of obtaining materials, we do not expect to be materially impacted in future periods.

On January 26, 2026, Asteria Health initiated a voluntary recall of specific lots of hormone pellets shipped by Asteria Health between May 20, 2025 and January 20, 2026 due to the potential presence of metal particulate matter (the “January 2026 Voluntary Recall”). Since the initiation of the January 2026 Voluntary Recall, all reasonable efforts have been made to remove such lots from the market in accordance with the recall strategy and the recall is being conducted with the knowledge of the FDA. In the fourth quarter of 2025, we recorded an inventory impairment charge of $1.3 million related to the January 2026 Voluntary Recall. Biote withdrew specific lots of hormone pellets from the market during the three and six months ended MarchJune 31,30, 2026. We have been working with our supply network to increase inventory levels and to ensure continuity of care throughout our clinic network. Additionally, we continue to improve our hormone pellet inventory at Asteria Health and have executed on our plan to add a second manufacturing shift in order to relieve the supply constraints in the second quarter of 2026. As a result of the January 2026 Voluntary Recall, we estimate our revenue growth from pellet procedures for the three and six months ended MarchJune 31,30, 2026 was negatively impacted by approximately $1.7$3.3 million.million and $5.0 million, respectively. Additionally, during the three and six months ended June 30, 2026 we incurred approximately $1.5$0.8 million and $2.2 million, respectively, in recall-related costs and we expect to incur additional costs in future periods associated with this recall. See Part I, Item 1A, “Risk Factors—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” in our 2025 Form 10-K for more information.

Gain (Loss) from Change in Fair Value of Earnout Liabilities

Gain (loss) from change in fair value of earnout liabilities consists of the change in fair value during the period of the Member and Sponsor earnouts and the earnout related to the acquisition of Simpatra.

The table and discussion below present our results for the three months ended MarchJune 31,30, 2026 and 2025:

Revenue for the three months ended MarchJune 31,30, 2026 decreased $4.1$4.6 million to $44.9$44.2 million, or 8.3%,9.5%, compared to the three months ended MarchJune 31,30, 2025. Revenue from pellet procedures decreased $4.7$4.9 million during the three months ended MarchJune 31,30, 2026, as a result of lower procedure volumes at established Biote-certified clinics and lower productivity of newer Biote-certified clinics, each of which were impacted by a temporary contraction of bioidentical hormone pellet inventory availability and a brief shift in focus of our commercial sales organization to support practitioners during the January 2026 Voluntary Recall, compared to the three months ended MarchJune 31,30, 2025. Further, we estimated that the January 2026 Voluntary Recall negatively impacted revenue growth from pellet procedures by approximately $1.7$3.3 million during the three months ended MarchJune 31,30, 2026. Service revenue for the three months ended MarchJune 31,30, 2026 decreased $0.9$0.4 million compared to the three months ended MarchJune 31,30, 2025, primarily due to a decline in technologytraining fees earned from physician orders placed through our BioteRx platform.revenue. These decreases in revenue for the three months ended MarchJune 31,30, 2026 were partially offset by a $1.8$0.6 million improvement in revenue from Biote-branded dietary supplements compared to the three months ended MarchJune 31,30, 2025 due to increased demand from customers purchasing these products through our e-commerce platforms for the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025.

Cost of revenue for the three months ended MarchJune 31,30, 2026 increased $1.4 million, to $14.0$15.3 million, or 10.9%,10.4%, compared to the three months ended MarchJune 31,30, 2025. Cost of pellet procedures increased 7.7%8.0% while revenue from pellet procedures decreased 13.2%.13.9%. The increase in the cost of pellet procedures reflects a shift in the sourcing of bioidentical hormone pellets from Asteria Health to other third-party outsourcing facilities due to inventory constraints caused by the January 2026 Voluntary Recall, compared to the three months ended MarchJune 31,30, 2025. Cost of Biote branded dietary supplements increased $0.2 million for the three months ended MarchJune 31,30, 2026 primarily as a result of the increase in Biote-branded dietary supplement revenue,revenue generated through our e-commerce platforms, compared to the three months ended MarchJune 31,30, 2025. Additionally, costCost of services increaseddecreased $0.3$0.05 million primarily due to anthe increasedecrease in continuingtraining education programs offered under the Biote Method to existing Biote-certified practitionersrevenue during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025.

Selling, general and administrative expense for the three months ended MarchJune 31,30, 2026 increased $1.1$8.2 million to $27.8$32.4 million, or 4.1%,33.9%, compared to the three months ended MarchJune 31,30, 2025. The increase for the three months ended MarchJune 31,30, 2026 was primarily due to a $3.3$5.1 million increase in legal-relatedexpenses incurred to settle various legal matters and a $2.5 million increase in legal expenses related to claims asserted in normal course of business and expenses incurred to settle various legal matters compared to the three months ended MarchJune 31,30, 2025. This increase in expense was partially offset by a $1.2$0.5 million decrease in our bad debt expense, which was driven by lower revenue and the timing of collections on accounts receivable at the end of the quarter.

Interest expense, net for the three months ended MarchJune 31,30, 2026 decreased $0.9$0.7 million to $2.0$2.2 million compared to the three months ended MarchJune 31,30, 2025, primarily due to a $1.1$0.9 million decline in accreted interest related to our share repurchase liability that was incurred during the three months ended MarchJune 31,30, 2025 that did not reoccur during the three months ended MarchJune 31,30, 2026. Additionally, interest income earned on our money market account declined as a result of lower cash balances during the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025. These decreases were partially offset by an increase in interest expense on our Revolving Loans, which historically have a higher interest rate on borrowings. As of March 31, 2026, we had $5.0 million outstanding under our Revolving Loans, compared to March 31, 2025 when we had no amounts outstanding under the Revolving Loans.

The change in fair value of the earnout liabilities was primarily due to a 48.1%27.3% decrease in the closing price of our Class A common stock during the threesix months ended MarchJune 31,30, 2026. In addition to the changes in the closing price of our Class A common stock, other assumptions used to calculate the fair value of the earnout liability, such as stock price volatility, revenue volatility, estimated timing of satisfying the Triggering Events and the risk-free rate varied from period to period, each of which impacted the fair value of the earnout liability and the associated gain or loss recorded for the periods presented.

The change in other expense for the threesix months ended MarchJune 31,30, 2026, compared with the threesix months ended MarchJune 31,30, 2025, primarily resulted from foreign currency fluctuations during the period.

Income tax expense for the threesix months ended MarchJune 31,30, 2026 decreased $1.0$2.8 million, compared to the threesix months ended MarchJune 31,30, 2025. This decrease in expense was primarily driven by a lower year to date and forecasted profit before tax, excluding certain non-includable items.

Adjusted EBITDA is a non-GAAP performance measure that provides supplemental information that we believe is useful to analysts and investors to evaluate our ongoing results of operations when considered alongside net income,income (loss), the most directly comparable U.S. GAAP measure).measure.

We use Adjusted EBITDA as alternative measures to evaluate our operational performance. We calculate Adjusted EBITDA by excluding from net income (loss): interest expense; depreciation and amortization expenses; and income taxes. Additionally, we exclude certain expenses we believe are not indicative of our ongoing operations or operational performance. We present Adjusted EBITDA because it is a key measure used by our management to evaluate our operating performance, generate future operating plans and determine payments under compensation programs. Accordingly, we believe that Adjusted EBITDA provides useful information to investors and others in understanding and evaluating our operating results in the same manner as our management. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. Some of these limitations are as follows:

The following table presents a reconciliation of net income (loss) to Adjusted EBITDA for the three and six months ended MarchJune 31,30, 2026 and 2025:

Represents cash and non-cash interest on our debt obligations, commitment fees on the unused portion of our Revolving Loans, net of interest income earned on our money market account. For the three and six months ended MarchJune 31,30, 2025, interest expense, net included $1.1$0.9 million and $2.0 million of accreted interest related to the share repurchase liability. There was no accreted interest for the three and six months ended MarchJune 31,30, 2026.

Represents depreciation expense on property and equipment, amortization expense on capitalized software and amortization expense on purchased intangible assets. Depreciation expense of $0.2 million and $0.01$0.06 million for the three months ended June 30, 2026 and 2025, respectively, and $0.4 million and $0.07 million for the six months ended June 30, 2026 and 2025, respectively, was included in cost of products for the three months ended March 31, 2026 and 2025, respectively.products.

Represents legal fees totaling $0.04 million and $0.1 million incurred during the three and six months ended MarchJune 31,30, 2026 related to strategic opportunities to expand the business. RepresentsFor the six months ended June 30, 2025 this amount represents legal fees and professional fees totaling $0.1 million incurred during the three months ended March 31, 2025 to finalize the purchase price allocation of Asteria Health and for other strategic opportunities to expand the business.

Our liquidity is derived primarily from available cash and cash equivalents, cash generated from operations, capacity under our Revolving Loans and, when necessary, debt and equity financing activities. We believe that for at least the next 12 months, our current cash position, coupled with anticipated cash generated from operations and the capacity under our revolving loans, is sufficient to fund our operations and our debt service obligations. As of MarchJune 31,30, 2026 and December 31, 2025, we had cash and cash equivalents of $5.3$11.2 million and $24.1 million, respectively. Additionally, as of eachJune March30, 31, 2026 and December 31, 2025, respectively,2026, we had $45.0$50.0 million of Revolving Loans available under our TruistAmended Credit Agreement.Agreement and as of December 31, 2025, we had $45.0 million available under our then-existing $50.0 million senior secured revolving credit facility.

Net cash used in investing activities decreasedof $0.7 million to $1.2$3.8 million for the threesix months ended MarchJune 31,30, 2026,2026 was relatively unchanged, compared to $1.8 million for the threesix months ended MarchJune 31,30, 2025. ThisDuring decreasethe wassix principallymonths drivenended byJune a30, $0.92026 millionour investmentnet investments in leasehold improvements and other fixed assets for our 503B compounding facility duringdecreased compared to the threesix months ended MarchJune 31,30, 2025,2025 thatand didprovided not$0.5 reoccurmillion duringin cash over the threeprior monthsyear ended March 31, 2026.period. The decrease in cash used by investingleasehold activitiesimprovements and fixed assets was partially offset by an increase in investments in our internally developed software during the threesix months ended MarchJune 31,30, 2026, compared to the threesix months ended MarchJune 31,30, 2025.

Net cash used in financing activities increaseddecreased $19.3$17.6 million to $21.5$11.9 million for the threesix months ended MarchJune 31,30, 2026, compared to $2.3$29.5 million for the threesix months ended MarchJune 31,30, 2025. The increasedecrease in our cash flow used in financing activities was primary driven by the timingrefinancing of our Term Loan, which provided $125.0 million of proceeds and $12.5 million of borrowings under the final $18.5$50.0 million senior secured revolving credit facility. The proceeds from the refinancing were used to repay and retire the Term Loan and repay the then outstanding amount on the senior secured revolving credit facility and fund debt issuance costs of $3.4 million. Cash flow used in financing activities also decreased $6.6 million due to a decrease in the cash payment required under our repurchase liabilities compared to the threesix months ended MarchJune 31,30, 2025. As of MarchJune 31,30, 2026, we had fully repaid all obligations associated with the share repurchase liabilities. Additionally,These duringdecreases thewere threepartially monthsoffset endedby March 31, 2026, we used $1.1$5.9 million of cash used to repurchase 726,3883,162,565 shares of our Class A common stock at an average price of $1.461.95 per share.share during the six months ended June 30, 2026.

See Note 2, Significant Accounting Policies, to the audited consolidated financial statements included in our 2025 Form 10-K for more information about our significant accounting policies, including our critical accounting policies. The critical accounting estimates that reflect our most significant judgments and estimates used in the preparation of our consolidated financial statements are described in Part II, Item 7 “Management's Discussion and Analysis of Financial Condition and Results of Operations,” included in our 2025 Form 10-K. During the three and six months ended MarchJune 31,30, 2026, there were no material changes to our critical accounting policies and estimates from those discussed in our 2025 Form 10-K.