biote Corp. (Biote) operates in practice-building business within the hormone optimization space.
Similar to a franchise model, the company provide the necessary components to enable Biote-certified practitioners to establish, build, and successfully implement a program designed to optimize hormone levels using personalized solutions for their patient populations.
The Biote Method is a comprehensive, end-to-end practice building platform that provides Biote-certified practitioners with the fol...
biote Corp. (Biote) operates in practice-building business within the hormone optimization space.
Similar to a franchise model, the company provide the necessary components to enable Biote-certified practitioners to establish, build, and successfully implement a program designed to optimize hormone levels using personalized solutions for their patient populations.
The Biote Method is a comprehensive, end-to-end practice building platform that provides Biote-certified practitioners with the following components specifically developed for practitioners in the hormone optimization space: Biote Method education, training and certification, practice management software, inventory management software, and information regarding available hormone replacement therapy (‘HRT’) products, as well as digital and point-of-care marketing support. The company also sells a complementary Biote-branded line of dietary supplements.
By incorporating the Biote Method in their practices, it enables practitioners to participate in the large and growing hormone optimization space. The company’s business opportunity in providing educational and practice management services is large and will similarly grow.
The company developed a highly differentiated practice-building platform to enable practitioners to treat the hormone imbalance symptoms experienced by their patients. The Biote Method has been designed specifically for practitioners who focus on treating perimenopause in women; post-menopause in women; and andropause/hypogonadism in men.
The company empowers Biote-certified practitioners by requiring rigorous in-person training, testing and certification for all Biote-certified practitioners and office staff wishing to use the Biote Method in their practice. The company’s practitioner instructors are among the nation’s most experienced clinical experts in hormonal therapy, including multiple modalities of HRT, such as creams, gels, patches, pills, injections and compounded bioidentical hormone pellets. The company offers training centrally and regionally to provide consistent and ongoing technical education. On an ongoing basis, the company provides access to clinical and technical support for Biote-certified practitioners.
The Biote Method’s enhanced proprietary clinical decision support software (‘CDSS’) assists physicians in establishing individualized dosing for patients. The company’s BioTracker software and business tools allow practitioners to efficiently manage the record management, product acquisition, inventory logistics and the business end of a robust hormone optimization practice. The company provides Biote-partnered clinics access to FDA-registered outsourcing facilities that can supply a wide array of hormone optimization products for Biote-certified practitioner patients. The company provides information to Biote-certified practitioners regarding how to integrate with its BioTracker software. The company’s BioTracker software allows Biote-certified practitioners to manage orders and maintain accurate inventory records to keep their regulatory and business systems up to date.
Beyond the breadth and depth of the company’s commercial and operational platform, the Biote name has achieved strong brand recognition among practitioners and patients in the communities it serves, as illustrated by QY Research’s market research publication entitled ‘South & North America Hormone Replacement Therapy Market Insights and Forecast to 2026.’ Leveraging the company’s brand strength, it offers marketing assistance, including office signage and patient education materials, to every Biote-certified practitioner within the company’s network.
Complementing the Biote Method is the company’s expanding line of private-labeled dietary supplements to address hormone, vitamin, and physiological deficiencies that regularly manifest in an aging population. This business segment appeals to practitioners’ patient demographic and enables patients the opportunity to receive practitioner-recommended Biote-branded dietary supplements to support healthy aging. By leveraging the company’s existing Biote-certified practitioner base to sell and distribute its Biote-branded dietary supplements.
The company also designed the Biote Method to permit beneficial practice economics for its Biote-partnered clinics. The company’s educational training and practice management platform helps enable Biote-partnered clinics to execute this all-cash model with minimal reimbursement risk.
Biote Business Model/Solution
The company has developed a comprehensive platform for Biote-certified practitioners to establish and operate a personalized hormone optimization program in their practices.
The company provides partnered clinics with up-to-date scientific education delivered by highly experienced practitioner instructors. The company’s training content is based on a scientifically rigorous approach and is continually updated. The company provides Biote-certified practitioners with the clinical mentorship, practice support resources, inventory management tools and marketing capability necessary to operate an efficient hormone optimization practice. Biote-certified practitioners can access FDA-registered outsourcing facilities that can supply hormone optimization therapies should practitioners determine such treatment is appropriate for their patients. Further, the company’s practice management software allows Biote-certified practitioners to efficiently order, track and manage hormone optimization product inventory, and meet other administrative requirements. The company’s BioTracker software is integrated with the outsourcing facilities’ own software to facilitate ordering and inventory control.
A majority of the bioidentical compounded hormone pellets used by Biote-certified practitioners as part of the Biote Method are manufactured by the company’s 503B compounding pharmacy, Asteria Health, and it also contracts with certain third-party operators of FDA-registered 503B outsourcing facilities, namely AnazaoHealth Corporation (‘AnazaoHealth’), and Right Value Drug Stores, LLC d/b/a Carie Boyd’s Prescription Shop (‘Carie Boyd’s’). It is Biote’s understanding that these 503B outsourcing facilities make these compounded drugs from bulk substances that comport with FDA’s final guidance on its interim policy on bulk substances. However, the company does not control or direct the compounding or manufacturing processes of the AnazaoHealth or Carie Boyd 503B outsourcing facilities. While Biote generates revenue by charging the Biote-partnered clinics procedure-based fees associated with the Biote-provided end-to-end platform for running an efficient practice that includes tracking compounded products ordered from 503B outsourcing facilities, as well as other services, Biote does not receive compensation for the sale of bioidentical pellets from these 503B outsourcing facilities to Biote-certified practitioners.
The company’s Biote-branded dietary supplements are a natural extension of its practice-building business. The company’s Biote-branded dietary supplements provide Biote-certified practitioners with an opportunity to further balance other important aspects of a patient’s profile and simultaneously increase practice revenue. Biote-partnered clinics directly purchase Biote-branded dietary supplements from the company, and its third-party logistics (‘3PL’) suppliers fill and ship directly to the ordering practice. The Biote-partnered clinic then sets their own pricing in compliance with the company’s applicable policies and sells Biote-branded dietary supplements directly to patients. The company has leveraged its existing commercial infrastructure and relationships with Biote-certified practitioners to build the company’s Biote-branded dietary supplement business. As a result, as of December 31, 2024, approximately 76% of Biote-branded dietary supplements were sold through Biote-certified practitioners.
Hormone Therapy
The Biote Method is purpose built to enable Biote-certified practitioners to treat hormone imbalance using bioidentical estrogen and testosterone products as necessary. The Biote Method is focused on promoting the use of bioidentical hormones to provide optimized clinical results using bioidentical estrogen, progesterone and testosterone rather than synthetic, chemically modified versions of the hormone. The Biote Method encourages practitioners to begin each patient treatment with comprehensive lab testing, which includes checking testosterone, thyroid and vitamin levels.
The Biote Difference
Biote training and certification program
To become a Biote-certified practitioner, the company vet healthcare providers ensure the necessary commitment, patient population and office staff needed to build a successful hormone optimization practice. The company also understands the importance of staff interaction in any patient experience and require each prospective Biote-partnered clinic’s office staff to attend training regarding the best practices for maintaining a hormone therapy practice.
Biote training facilities & faculty
The company operates one national and four regional training facilities for Biote-certified practitioners, healthcare providers and medical staff.
Biote BioTracker system
The company requires Biote-partnered clinics to keep patient and inventory records, which was accomplished historically with manually completed paper copies. The company’s BioTracker software is integrated with the outsourcing facilities’ software to facilitate ordering and inventory control. The company also leverages this data to electronically transmit to it the number of hormone optimization pellet insertion procedures performed, affording the company’s the most direct way to seamlessly assess a fair, transparent and consistent fee for it Biote Method, including the education, training, re-training and comprehensive services and support.
Biote Clinical Decision Support software
The CDSS is part of the company’s offerings available to Biote-certified practitioners. The CDSS programs assist practitioners in identifying potential patient-specific treatment options and provide these practitioners with access to publications and guidelines that serve as independently verifiable bases for treatment recommendations. The practitioner enters a patient’s clinical markers into the program, and an algorithm based on the published literature with clinical data and clinical guidelines suggests potential individualized treatment option for the practitioner’s evaluation and consideration.
Biote-branded Dietary Supplements
The company’s expanding Biote-branded dietary supplements business sells dietary supplements. The company introduced its line of Biote-branded dietary supplements in 2013 with two specific dietary supplement products, DIM SGS+ and ADK 5. The company offers wholesale sales directly to over 3,500 Biote-certified practitioners through its own eCommerce site, efficiently leveraging the core Biote provider platform. As of December 31, 2024, 76% of Biote-partnered clinics also offer the company’s Biote-branded dietary supplement products.
Practitioner Growth, Sales,and Marketing
Clinic and Practitioner Growth
As of December 31, 2024, the company contracts with over 8,600 Biote-certified practitioners. The company’s commercial footprint has expanded to 10 core states including Alabama, Arkansas, Colorado, Florida, Georgia, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas.
The company derives the majority of its revenue through service fees that encompass the comprehensive platform and wraparound support the company provides its Biote-partnered clinics. These service fees are realized when Biote-certified practitioners perform HRT procedures utilizing pellets dispensed in office.
Sales
As of December 31, 2024, the company sales force, structured to attract new Biote-certified practitioners while simultaneously supporting the productivity within existing partnered clinics. As of December 31, 2024, the company’s regional sales team consisted of area vice presidents, regional managers, district managers, liaisons and practice development managers (‘PDMs’). Liaisons are charged with identifying non-Biote-certified practitioners and educating them on value in attending the comprehensive two-day training program to become a Biote-certified practitioner. The role of the PDM is to act as a resource and facilitate the practice management of the Biote Method in both new and existing partnered clinics.
Marketing
Clinic / Practitioner Marketing
The company accomplishes this through referrals from existing Biote-certified practitioners to their healthcare provider relationships, a dedicated sales force, and through digital and traditional marketing channels. The company targets specific healthcare providers based on their specialty, prescribing data, demographic information and location match with its existing geographic footprint and targeted new geographic markets. The company have invested significantly in building its digital marketing capabilities, the company is utilizing this extensive capability to generate practitioner leads and have established media capabilities across all digital channels.
Consumer Marketing
Consumer outreach is a growing portion of the company’s marketing. The Biote brand is highly differentiated and leverageable across key consumer channels.
Strategic Acquisitions
On March 18, 2024, the company acquired Asteria Health, a privately held 503B manufacturer of compounded bioidentical hormones.
Intellectual Property
Patents
As of December 31, 2024, the company owned three issued U.S. design patents related to trocars. The first filed of these three patents, D773,664, is subject to a 14-year term and will expire on December 6, 2030. The remaining two patents, D791,322 and D800,307, are subject to a 15-year term and will expire on July 4, 2032, and October 17, 2032, respectively.
Trademarks
As of December 31, 2024, the company’s trademark portfolio consists of 25 trademark registrations or active trademark applications worldwide. Such portfolio includes nine U.S. trademark registrations, two pending U.S. applications, and 14 non-U.S. trademark registrations.
Competition
The company’s primary competitors in the education and bioidentical hormone pellet therapy space are Evexias Health Solutions, SottoPelle, Pellecome LLC, Purepell and Pro-pell Therapy Program.
Government Regulation
The company is registered with the U.S. Food and Drug Administration (FDA) for its facility as a repackager/relabeler and a specification developer and the company’s Class I disposable and reusable trocars which are included in convenience kits for sale to its customers are listed on FDA’s device database.
History
biote Corp. was founded in 2012.
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