What changed in this filing

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Item 1. Business

2025-02-24 compared with 2024-02-26 · 157 added, 102 removed, 177 unchanged (59% of the section changed)

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(and together with its subsidiaries, “Hims & Hers”, the “Company”, “we”, “us” or “our”) has built a consumer-first platform transforming the way customers fulfill their health and wellness needs.

We believe that the Company has the technical platform, distributed provider network, and access to clinical capabilities to lead the migration of routine office visits to a digital format.

The Hims & Hers platform includes access to a highly-qualified and technologically-capable provider network, a clinically-focused electronic medical record system, digital prescriptions, and cloud pharmacy fulfillment.

Our digital platform enables access to treatments for a broad range of conditions, including those related to sexual health, hair loss, dermatology, mental health, and weight loss.

Hims & Hers connects patients to licensed healthcare professionals who can prescribe medications when appropriate.

Prescriptions are fulfilled online through licensed pharmacies on a subscription basis.

We believe that the Company has the technical platform, distributed provider network, and access to clinical capabilities to lead the migration of routine office visits to a personalized, digital, accessible format.

The Hims & Hers platform includes access to a highly-qualified and technologically-innovative provider network, a clinically-focused electronic medical record system, digital prescriptions, cloud pharmacy fulfillment, and personalization capabilities.

Our digital platform enables access to treatments for a broad range of chronic conditions, including those related to sexual health, hair loss, dermatology, mental health, and weight loss.

Hims & Hers connects patients to licensed healthcare professionals who can prescribe medications when appropriate and prescriptions are fulfilled online through licensed pharmacies on a subscription basis.

In addition, we also offer access to a range of health and wellness products designed to meet individual needs, which can include curated prescription and non-prescription products.

Through the Hims & Hers mobile apps, consumers can access a range of educational programs, wellness content, community support, and other services that promote lifelong health and wellness.

Since our founding, we have facilitated nearly twenty million telehealth consultations, enabling greater access to high-quality, convenient, and affordable care for people in all 50 states and the United Kingdom.

Hims & Hers products can also be found in tens of thousands of top retail locations in the United States.

Through the Hims & Hers mobile applications, consumers can access a range of educational programs, wellness content, community support, and other services that promote lifelong health and wellness.

Since our founding, we have facilitated over thirty million telehealth consultations, enabling greater access to high-quality, convenient, affordable, personalized care for people in all 50 states and the United Kingdom.

The mission of Hims & Hers is to help the world feel great through the power of better health.

To fulfill this mission, our business strategy and market differentiation are centered around our trusted brand, leading technology, innovative products and services and clinical excellence.

To fulfill this mission, our business strategy and market differentiation are centered around our trusted brand, innovative products and services, leading technology, and clinical excellence.

• We work to build a brand that is trusted by our customers, easy to use, and normalizes the practice of seeking and receiving treatment by empowering our customers with personalized care and an omnichannel experience.

• The Hims & Hers platform offers a streamlined patient and clinician experience facilitated by proprietary algorithms and a customizable and integrated technology stack, allowing us to give customers a seamless experience and to follow up programmatically and with precision.

• The Hims & Hers platform offers a streamlined, personalized patient and clinician experience facilitated by proprietary algorithms and a customizable and integrated technology stack, allowing us to give customers a seamless experience and to follow up programmatically and with precision.

• We can leverage these insights and feedback to offer access to personalized prescription and non-prescription treatments that are designed to meet individual needs.

• At the foundation of our broader platform is the consumer trust we establish through our clinical excellence.

Care accessed through the Hims & Hers platform is subject to evidence-based clinical guidelines and delivered by highly-trained healthcare providers to ensure consistency and quality.

Care accessed through the Hims & Hers platform is subject to evidence-based clinical guidelines and delivered by highly-trained licensed healthcare providers to ensure consistency and quality.

Our medical advisory board helps ensure the utmost quality of care on our platform.

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Business Strategy

We are a consumer-first health and wellness platform focused on providing modern personalized health and wellness solutions to consumers.

We are a consumer-first health and wellness platform focused on providing access to modern personalized health and wellness solutions to consumers.

We offer access to a range of health and wellness products and services available for customers to purchase through our websites and mobile applications.

The offerings generally focus on conditions where treatment typically involves use of prescription medication on a recurring basis and ongoing care from healthcare providers.

We offer access to certain prescription generic, brand-name and compounded medications, including certain sterile compounded medications.

The majority of prescriptions for these medications are fulfilled through our affiliated pharmacies.

We also offer over-the-counter drug and device products and cosmetics and supplement products, which are primarily focused on general wellness, skincare, sexual health and wellness, and hair care.

These curated non-prescription products include melatonin, and biotin in the wellness specialty, moisturizer, creams, sunscreen, serum, face oil, and face wash in the skincare specialty, condoms, climax delay spray and wipes, vibrators, and lubricants in the sexual health and wellness specialty, and shampoos, conditioners, scalp scrubs, and topical treatments such as minoxidil in the hair care specialty.

We also offer many of these over-the-counter products through retail partnerships, in stores and online.

We offer many of these over-the-counter products through retail partnerships, in stores and online.

The over-the-counter drug and device products and some of the cosmetics and supplement products we sell are “white-labeled” products, where we sell the manufacturer-developed product under the Hims & Hers brand name or co-branded along with the manufacturer’s brand.

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For these products, the manufacturer develops the formulation with input from the internal Hims & Hers Product Research & Development team.

In all cases, the manufacturer is responsible for obtaining and maintaining authorization from the U.S.

Food and Drug Administration (“FDA”), if required, and complying with current Good Manufacturing Processes (cGMP) as adopted and enforced by the FDA.

In addition, the internal

Hims & Hers Quality team is responsible for maintaining policies and procedures to ensure non-prescription products comply with quality standards, which include independent laboratory testing of products, supplier and quality and compliance assessments.

Most of the offerings on our websites and mobile applications are sold to customers on a subscription basis.

Subscription plans provide an easy and convenient way for customers to get the ongoing treatment they need while simultaneously providing the Company with predictability through a recurring revenue stream.

For subscription plans, customers select a desired cadence to receive products, which can range from every 30 days to every 60 to 360 days, depending on the product.

For subscription plans, in addition to a 30-day cadence or treatment term, we offer customers the ability to select a desired cadence to receive products or treatments, which can range from every 60 to 360 days, depending on the product.

The customer is billed on a recurring basis based on the selected cadence and a specified quantity of product is shipped at each billing.

Customers can cancel subscriptions in accordance with our Terms and Conditions agreed to by customers to stop receiving additional products and can reactivate subscriptions to continue receiving additional products.

Customers can cancel or snooze subscriptions in accordance with our Terms and Conditions agreed to by customers to stop receiving additional products and can reactivate subscriptions to continue receiving additional products.

Our integrated technology platform allows us to serve our customers efficiently from start to finish:

initially from customer discovery and purchase of offerings on our websites and mobile application, to connecting customers with medical providers for telehealth consultations, to the fulfillment and delivery of customer orders, and finally through ongoing clinical management by medical providers.

Management believes this technology-driven efficiency provides cost advantages that allow us to offer customers affordable prices and to generate robust gross margins.

We believe this technology-driven efficiency provides cost advantages that allow us to offer customers affordable prices and to generate robust gross margins.

We acquire new customers and drive brand awareness through various marketing channels, including social media, online search, television, radio, other media channels, presence in brick-and-mortar retail stores, and physical brand advertising campaigns.

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The Hims & Hers platform is purpose-built to scale efficiently and to accommodate the seamless addition of new products and services.

We plan to launch new subscription-based offerings which we expect will have a similar margin profile and unit economics to current offerings.

As we implement our product roadmap, we expect to grow revenue through additional subscription-based recurring revenue offerings.

The recent launches of new prescription products in weight loss, sexual health, and dermatology, and launches of hair care and supplement retail products, demonstrate the scalability of the platform.

The recent launches of new prescription products in weight loss, sexual health, dermatology, and mental health and launches of hair care and supplement retail products, demonstrate the scalability of the platform.

Growth Opportunities

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In addition, our brand positioning has afforded significant partnerships with leading talent whose promotional efforts drive meaningful awareness of the products and services we make available.

As our portfolio of products and services grows across specialties, we believe that our market presence and brand recognition will expand, driving more consumers to seek out Hims & Hers for future healthcare needs.

Based on externally reported data, we believe our market share, both in terms of number of customers and total sales, in each of our sexual health, dermatology, and mental health specialties has increased in recent years.

As our portfolio of products and services grows across specialties, we believe that our market presence and brand recognition will continue to expand, driving more consumers to seek out Hims & Hers for future healthcare needs.

Grow within existing customer base

Our expanded offerings that include more personalized products and clinical experiences across a broader range of conditions provide a large opportunity for us to grow our revenue within our existing customer base.

Through more robust customer engagement, we have the ability to deliver longer term subscription adoption and drive more cross sell opportunities.

We believe our expanded offerings that include more personalized products and clinical experiences across a broader range of conditions provide a large opportunity for us to grow our revenue within our existing customer base.

Through ongoing robust customer engagement, we have the ability to deliver longer-term subscription adoption and drive more cross-sell opportunities.

Specialty expansion into new conditions

We are pursuing a roadmap of rapid specialty expansion into new conditions that can be treated safely and effectively via telehealth, require ongoing and recurring customer relationships, and for which generic medication has been established as an effective means of treatment.

Future care opportunities that show high prevalence within our existing customer base and offer traits similar to our existing specialties in terms of business model characteristics include testosterone treatment, menopause, sleep disorders, post-traumatic stress disorder, fertility, diabetes, cholesterol, and hypertension, which we believe represent

significant opportunities.

We are pursuing a roadmap of rapid specialty expansion into new conditions that can be treated safely and effectively via telehealth, require ongoing and recurring customer relationships, and generally for which generic medication has been established as an effective means of treatment.

For example, at the end of 2023 we launched access to certain weight loss offerings, which we continued to expand over the course of 2024.

Given the prevalence of these conditions, we see a large market opportunity for our current and future offerings.

Leverage existing capabilities to penetrate new sales channels and further improve operations

Leverage existing capabilities and continue to expand capabilities to penetrate new sales channels and further improve operations

Our pharmacy, affiliated pharmacies, and compounding outsourcing facility enable seamless drug delivery, and drive increased operating leverage across the platform by allowing us to further personalize and consolidate shipping of orders as well as expand capabilities quickly for adjacent and other new conditions.

These facilities allow us to lower our cost structure by reducing some of the costs typically associated with contractual third-party pharmacy relationships.

In 2020, we opened an approximately 300,000 square foot facility in New Albany, Ohio.

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(“Apostrophe”), allowing us to expand personalized dermatological offerings to our customers.

Apostrophe Pharmacy LLC (“Apostrophe Pharmacy,” and together with XeCare, the “Affiliated Pharmacies”), is an additional dedicated licensed mail order pharmacy located in Arizona that provides prescription fulfillment services solely to Hims & Hers customers as part of our acquisition of Apostrophe in 2021.

Apostrophe Pharmacy LLC (“Apostrophe Pharmacy,” and together with XeCare, the “Pharmacies”), is an additional dedicated licensed mail order pharmacy located in Arizona that provides prescription fulfillment services solely to Hims & Hers customers as part of our acquisition of Apostrophe in 2021.

In 2022, we expanded the Apostrophe Pharmacy facility and opened an approximately 25,000 square foot facility in Gilbert, Arizona.

The Affiliated Pharmacies together enable seamless drug delivery, and drive increased operating leverage across the platform by allowing us to further personalize and consolidate shipping of orders as well as expand capabilities quickly for adjacent and other new conditions.

The Affiliated Pharmacies allow us to lower our cost structure by reducing some of the costs typically associated with contractual third-party pharmacy relationships.

We have entered into services agreements with each of the Pharmacies.

In 2024, we acquired Seaview Enterprises, LLC (d/b/a MedisourceRx) (“MedisourceRx”), a licensed 503B compounding outsourcing facility, which compounds products primarily for Hims & Hers customers (our “Outsourcing Facility”).

Additionally, in February 2025, we acquired a peptide manufacturing facility and certain related assets from C S Bio, Co., which will allow us to expand our supply chain capabilities in the future (our “Peptide Facility”).

Also in February 2025, we acquired Sigmund NJ, LLC, marketed as Trybe Labs, a lab testing services business, which will allow us to add lab testing capabilities to our platform in the future (our “Lab Facility”).

The facilities and operations of our Pharmacies, Outsourcing Facility, Peptide Facility, and Lab Facility are sometimes referred to collectively herein as our “Facilities”.

Expand into new geographies

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We believe the consumer-focused services our model provides are applicable to a range of geographies across the world.

Affiliated Medical Groups, Providers, Health System Partnerships and Partner and Affiliated Pharmacies

Affiliated Medical Groups, Providers, Health System Partnerships, and Partner Pharmacies

Affiliated Medical Groups and Providers

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“Affiliated Medical Groups” are separate professional corporations or other professional entities owned solely by licensed physicians and that engage licensed healthcare professionals to provide telehealth consultations and related services, including applicable physician supervision of nurse practitioners and physician assistants.

We are prohibited from owning a professional entity such as any of the Affiliated Medical Groups under the rules prohibiting the corporate practice of medicine.

However, the Affiliated Medical Groups were incorporated and established with our assistance for the specific purpose of providing clinical services to patients through the Hims & Hers platform and have no other operations or activities outside of the provision of services through the Hims & Hers platform.

While we are prohibited from owning a professional entity such as any of the Affiliated Medical Groups, the Affiliated Medical Groups were incorporated and established with our assistance for the specific purpose of providing clinical services to patients through the Hims & Hers platform and have no other operations or activities outside of the provision of services through the Hims & Hers platform.

The Affiliated Medical Groups contract with or employ physicians, nurse practitioners, physician assistants, and behavioral health providers (each, a “Provider”) to provide telehealth consultations and related services on the Hims & Hers platform.

We enter into certain contractual agreements with the Affiliated Medical Groups and their physician owners, including administrative services agreements and continuity agreements, under which we serve as an administrative services manager for the Affiliated Medical Groups for the non-clinical aspects of their operations and receive a fixed administrative fee from each Affiliated Medical Group for these services.

The administrative services and support we provide include IT products and support, including the Hims & Hers platform and electronic medical record system, billing and collection services, non-clinical personnel, customer service support, administrative support for provider credentialing and quality assurance, and other non-clinical items and services, including access to a line of credit we make available to the Affiliated Medical Groups as necessary to support their operations.

personnel, customer service support, administrative support for provider credentialing and quality assurance, and other non-clinical items and services, including access to a line of credit we make available to the Affiliated Medical Groups as necessary to support their operations.

The Affiliated Medical Groups retain sole control of clinical decision-making and the practice of medicine.

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The strength of the Hims & Hers brand affords us numerous opportunities to partner with and offer new solutions to help transform existing healthcare stakeholders.

We have relationships with leading health systems including Ochsner Health, Mount Sinai Health System, Carbon Health, ChristianaCare Health System, and Hartford Healthcare to provide a clinically focused, telehealth-enabled patient care collaboration.

We have relationships with leading health systems including, as of December 31, 2024, Ochsner Health, Mount Sinai Health System, Carbon Health, ChristianaCare Health System, and Hartford Healthcare to provide a clinically focused, telehealth-enabled patient care collaboration.

These relationships offer our customers access to applicable in-person care within these systems to enhance their overall healthcare experience.

These collaborations, which are intended to help Hims & Hers customers obtain in-person care not accessible through the Hims & Hers platform, do not involve any monetary exchange, compensation, or other financial incentives between the parties.

Partner and Affiliated Pharmacies

We maintain contractual arrangements with three licensed pharmacies (sometimes referred to herein as “Partner Pharmacies”), EHT Pharmacy LLC (d/b/a Curexa Pharmacy), ITC Inc.

Partner Pharmacies

In addition to fulfilling orders through the Pharmacies, we maintain contractual arrangements with three licensed pharmacies (sometimes referred to herein as “Partner Pharmacies”), EHT Pharmacy LLC (d/b/a Curexa Pharmacy), ITC Inc.

(d/b/a ITC Compounding Pharmacy), and The London Specialist Pharmacy Limited for fulfillment and distribution of certain prescription and non-prescription products available through the Hims & Hers platform.

We are not bound by any exclusivity or minimum order requirements with respect to our use of each pharmacy, and have the ability to utilize other pharmacies at our discretion.

The contractual arrangements with the pharmacies are typically for one-year terms with automatic renewals, subject to standard termination rights of the parties.

The pharmacies’ rates are fixed in the contractual arrangements and changes require the mutual agreement of the parties.

We have also entered into service agreements with each of our Affiliated Pharmacies.

We are not bound by any exclusivity or minimum order requirements with respect to our use of any Partner Pharmacy, and have the ability to utilize other pharmacies, including the Pharmacies, at our discretion.

The contractual arrangements with the Partner Pharmacies are typically for one-year terms with automatic renewals, subject to standard termination rights of the parties.

The Partner Pharmacies’ rates are fixed in the contractual arrangements and changes require the mutual agreement of the parties.

Regulatory Environment

As a consumer-focused health and wellness company delivering comprehensive telehealth technologies and services and health and wellness products (prescription and over-the-counter), in addition to the typical legal and regulatory considerations faced by a technology-based company, we are required to comply with complex healthcare laws and regulations, and consumer protection laws and regulations, all at both the state and federal level.

As a consumer-focused health and wellness company delivering comprehensive telehealth technologies and services and health and wellness products such as prescription drugs, compounded drugs, over-the-counter drugs and devices, cosmetics, and dietary supplements, in addition to the typical legal and regulatory considerations faced by a technology-based company, we are required to comply with complex healthcare laws and regulations, and consumer protection laws and regulations, all at both the state and federal level.

Our business and operations are subject to extensive regulation, including with respect to the practice of medicine, the use of telehealth, relationships with healthcare providers, privacy and security of personal health information, product safety and pharmacy operations.

Regulatory and/or legal enforcement actions by the FDA, Department of Health and Human Services, or other federal, state, or foreign enforcement authorities could have material adverse consequences on our business or its operations.

Government regulation of healthcare generally

Generally speaking, the healthcare industry is one of the most highly regulated industries in the United States.

We and other healthcare companies are subject to significant regulation in the United States.

Healthcare-related businesses are subject to a broad array of governmental regulation at the federal, state, and local levels.

While portions of our business are subject to significant regulations, some of the more well-known healthcare regulations do not apply to the Company because of the way our current operations are structured.

We currently accept payments only from our customers—not any third-party payors, such as government healthcare programs or health insurers.

While portions of our business are subject to significant regulations, such as those related to compounding practices, certain regulations do not apply to our business because of the way our current operations are structured.

For example, we currently accept payments only from our customers—not any third-party payors, such as government healthcare programs or health insurers.

Because of this approach, we are not subject to many of the laws and regulations that impact other participants in the healthcare industry.

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Irrespective of our business model, the healthcare industry is subject to changing political, economic and regulatory influences that may affect health and wellness companies like Hims & Hers.

During the past several years, the healthcare industry has been subject to an increase in governmental regulation and subject to potential disruption due to legislative initiatives and government regulation, as well as judicial interpretations thereof.

Congress has enacted the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), which created new compliance requirements for manufacturers of cosmetic products in the U.S.

and also significantly expanded the FDA’s authority to oversee and regulate cosmetics, though the FDA has yet to complete its development of implementing regulations for MoCRA.

While these regulations may not directly impact us or our offerings in any given case, they will affect the healthcare industry as a whole and may impact customer use of the Company’s solutions.

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Because the practice of telehealth is relatively new and rapidly developing, regulation of telehealth is evolving and the application, interpretation and enforcement of these laws, regulations and standards can be uncertain or uneven.

Similarly, the ability of the Affiliated Pharmacies to fulfill prescriptions and distribute pharmaceutical products, including compounded pharmaceutical products, is dependent upon the laws that govern licensed pharmacies and the fulfillment and distribution of prescription medication and other pharmaceutical products, which include in some cases requirements relating to telehealth.

As a result, we must continually monitor legislative, regulatory, and judicial developments regarding the practice of medicine, telehealth and pharmaceutical laws in order to support the Affiliated Medical Groups and the Affiliated Pharmacies.

Similarly, the ability of the Pharmacies to fulfill prescriptions and distribute pharmaceutical products, including compounded pharmaceutical products, is dependent upon the laws that govern licensed pharmacies and the fulfillment and distribution of prescription medication and other pharmaceutical products, which include in some cases requirements relating to telehealth.

Physicians, mid-level providers (e.g., physician assistants, nurse practitioners), and behavioral health providers who provide professional clinical services via telehealth must, in most instances, hold a valid license to provide the applicable professional services in the state in which the patient is located.

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Some states have similar doctrines with respect to other professional licensure categories, including behavioral health services and providers.

Other practices, such as professionals splitting their professional fees with non-professional persons or entities, is also prohibited in some jurisdictions.

Other practices, such as professionals splitting their professional fees with non-professional persons or entities, are also prohibited in some jurisdictions.

Many states also limit the extent to which nurse practitioners and physician assistants can practice independently and require that they practice under the supervision of or in collaboration with a supervising physician.

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Instead, the Affiliated Medical Groups provide services on the platform and we contract with but do not own the Affiliated Medical Groups.

The Affiliated Medical Groups and their providers maintain exclusive authority regarding the provision of healthcare services (including consults that may lead to the writing of prescriptions) and remain responsible for retaining and compensating their providers, credentialing decisions regarding their providers, maintaining professional standards, maintaining clinical documentation within medical records, establishing their own fee schedule, and submitting accurate information to us so that we can bill customers.

Despite our care in structuring arrangements with the Affiliated Medical Groups, it is possible that a regulatory authority or another party, including providers affiliated with Affiliated Medical Groups, could assert that we (or other organizations with similar business models) are engaged in the corporate practice of medicine or that the contractual arrangements with Affiliated

Medical Groups violate a state’s fee-splitting prohibition.

The Affiliated Medical Groups and their providers maintain exclusive authority regarding the provision of healthcare services (including

consults that may lead to the writing of prescriptions) and remain responsible for retaining and compensating their providers, credentialing decisions regarding their providers, maintaining professional standards, maintaining clinical documentation within medical records, establishing their own fee schedule, and submitting accurate information to us so that we can bill customers.

Failure to comply with these state laws could lead to materially adverse consequences for the Company.

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Additionally, should we begin accepting reimbursement payments from insurance providers or other third-party payors, the Company will be subject to significantly increased compliance obligations and costs.

FDA regulation

Certain of the products available through our platform, and the third-party suppliers and manufacturers of these products, including pharmaceuticals, over-the-counter drugs, over-the-counter devices, cosmetics, and dietary supplements, are subject to extensive regulation by the FDA and international, federal, state, and local authorities.

These authorities can enforce regulations related to methods and documentation of the testing, production, compounding, control, safety, quality assurance, labeling, packaging, sterilization, storage, and shipping of products.

Government regulations specific to pharmaceuticals are wide ranging and govern, among other things:

the ability to bring a pharmaceutical to market, the conditions under which it can be sold, the conditions under which it must be manufactured, and permissible claims that may be made for such product.

Certain of the products available through the Hims & Hers platform require approval by the FDA and are subject to the limitations placed by the FDA on the approved uses in the product prescribing information.

Some of these products are prescribed by Providers on the platform for “off-label” uses (i.e., for a use other than that specifically authorized by the FDA for the medication in question).

Regulation of medical and wellness products

Certain of the products available through our platform, including prescription pharmaceuticals, over-the-counter drugs, over-the-counter devices, cosmetics, and dietary supplements, and the third-party suppliers and manufacturers of these products (“Manufacturing Suppliers,”) which manufacture and/or supply certain of our products or product ingredients, including compounded glucagon-like peptide-1 receptor agonists (“GLP-1s”), to the Pharmacies, are subject to extensive regulation by the FDA and international, federal, state, and local authorities.

These authorities enforce regulations related to methods and documentation of the testing, production, compounding, control, safety, quality assurance, labeling, packaging, sterilization, storage, and shipping of products and the components of those products.

The Federal Food, Drug and Cosmetic Act (“FDCA”), and FDA’s implementing regulations, set forth, among other things, requirements for the testing, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record-keeping, reporting, distribution, import, export, advertising, and promotion of many of the products offered on our platform.

FDA enforces regulations to ensure that the methods used in, and the facilities and controls used for, the manufacture, processing, packaging and holding of drugs conform to current good manufacturing practice (“cGMP”).

The cGMP regulations are comprehensive and cover all aspects of manufacturing operations, from receipt of raw materials to finished product distribution, and are designed to ensure that the finished products meet all the required identity, strength, quality and purity characteristics.

Compliance with cGMP includes adhering to requirements relating to organization and training of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, quality control and quality assurance, packaging and labeling controls, holding and distribution, laboratory controls, and records and reports.

If, after receiving approval, a company makes a material change in manufacturing equipment, location, or process (all of which are, to some degree, incorporated in the NDA), additional regulatory review and approval may be required.

The FDA also conducts regular, periodic visits to re-inspect equipment, facilities, and processes following the initial approval of a product.

Failure to comply with applicable cGMP requirements and conditions of product approval may lead the FDA to take enforcement actions or seek sanctions, including fines, issuance of warning letters, civil penalties, injunctions, suspension of manufacturing operations, operating restrictions, withdrawal of FDA approval, seizure or recall of products, and criminal prosecution.

Although we periodically monitor the FDA compliance of our third-party manufacturers, we cannot be

certain that our present or future third-party manufacturers will consistently comply with cGMP and other applicable FDA regulatory requirements.

Several cosmetics and supplement products have been developed by us in partnership with the applicable manufacturers.

For these products, the manufacturer is responsible for complying with the FDA’s laws and regulations applicable to developing and manufacturing.

There are also adverse event reporting requirements, labeling requirements, and product quality requirements applicable to dietary supplements and cosmetics, although the product quality requirements are generally less stringent than those for drug products.

However, in recent years, the FDA has issued warning letters to several cosmetic companies alleging improper claims regarding their cosmetic products.

In addition, the FDA does not currently require pre-market approval for cosmetic products.

The statutory and regulatory requirements applicable to drugs are extensive and require significant resources and time to ensure compliance.

While we periodically monitor the FDA compliance of our third-party manufacturers, we cannot be certain that our present or future third-party manufacturers will consistently comply with applicable FDA regulatory requirements.

Furthermore, certain of the products available through the Hims & Hers platform require approval by the FDA and are subject to the limitations placed by the FDA on the approved uses in the product labeling or are otherwise marketed under a “monograph,” which establishes conditions such as the active ingredient, uses, doses, routes of administration, labeling, and testing, for over-the-counter drugs.

Healthcare providers, including Providers prescribing on our platform, are permitted to prescribe drugs offered on the platform for “off-label” uses (i.e., uses not approved by the FDA and not described in the product’s labeling) because the FDA generally does not regulate the practice of medicine.

While Providers are legally permitted to prescribe medications for off-label uses, and although we believe our product promotion is conducted in material compliance with FDA and other regulations, if the FDA determines that our product promotion constitutes promotion of an unapproved use of an approved product or of an unapproved product, the FDA could request that we modify our product promotion or subject us to regulatory and/or legal enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine, and criminal penalties.

It is also possible that other federal, state, or foreign enforcement authorities might take action if they consider the product promotion to constitute promotion of an unapproved use of an approved product or of an unapproved product, which could result in significant fines or penalties under other statutes, such as laws prohibiting false claims for reimbursement.

Certain of the products available through our platform are compounded drug products under Section 503A of the Federal Food, Drug & Cosmetic Act (“FDCA”).

While we believe the compounded drug products available through our platform meet the requirements for exemption under Section 503A of the FDCA, if the FDA were to determine that such products do not meet the requirements for exemption, the FDA could subject us, our Affiliated Pharmacies, Partner Pharmacies, Affiliated Medical Groups or Providers to regulatory and/or legal enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine, and criminal penalties.

Other federal, state, or foreign enforcement authorities might also take action against us or the Affiliated Pharmacies, Partner Pharmacies, Affiliated Medical Groups or Providers if they determine that compounded drug products available through our platform do not meet applicable legal or regulatory requirements.

Regulatory and/or legal enforcement actions by the FDA or other federal, state, or foreign enforcement authorities could have material adverse consequences on the Company and/or its operations.

FDA regulations relating to the advertising and promotion of prescription and over-the-counter drugs, including prescription compounded drugs, also require that promotional materials for prescription drugs not be false or misleading.

Failure to comply with FDA requirements can result in a prescription drug being deemed misbranded under the FDCA.

Misbranding a drug in interstate commerce is a prohibited act and can result in regulatory and/or legal enforcement actions, including the issuance of an untitled letter or warning letter, injunctions, or in extreme instances, criminal prosecution.

In addition, FDA findings of misleading promotional statements and practices can lead to private litigation under federal and state consumer protection and unfair trade practices laws.

Regulation of compounded drugs

Certain of the products available through our platform are compounded drug products under Section 503A or Section 503B of the FDCA, which provide exemptions from the requirements for preapproval to market a new drug and labeling with adequate directions for use.

To market our products under these exemptions, we must comply with the applicable requirements.

Section 503A permits compounding of a drug that is not “essentially a copy” of a commercially available (or FDA-approved) drug product by a licensed pharmacist or a licensed physician based on receipt of a valid prescription for an individual patient or limited quantities before receipt of a valid prescription if certain conditions are met.

503A pharmacies are not subject to current cGMP requirements, and these facilities are not inspected by FDA.

Compounding under 503A is primarily regulated by state pharmacy laws and regulations governing pharmacy operations.

These laws and regulations often include specific requirements for compounding operations, including requirements for licensing of pharmacists, pharmacy technicians and pharmacies, supervision and training, inspections, sterility assurance, and recordkeeping, among other requirements.

Regulations are updated periodically, generally under the jurisdiction of individual state boards of pharmacy.

Failure to comply with the state pharmacy regulations of a particular state could result in a pharmacy being prohibited from operating in that state, financial penalties and/or becoming subject to additional oversight from that state’s board of pharmacy.

In addition, many states are considering imposing, or have already begun to impose, more stringent requirements on compounding operations.

We also offer access to drugs compounded by facilities referred to as 503B outsourcing facilities, including MedisourceRx.

Under Section 503B, outsourcing facilities may compound drugs without an individual patient prescription.

Outsourcing facilities must be registered with FDA and are subject to cGMP requirements and regular FDA inspections.

Section 503B also includes requirements regarding adverse event reporting, use of bulk drug substances, and prohibitions on wholesaling and compounding “essentially a copy” of an FDA approved drug, unless the drug is on FDA’s Drug Shortage List at the time of compounding, distribution, and dispensing.

Sections 503A and 503B also prohibit compounding of drug products that present “demonstrable difficulties for compounding.” However, FDA must publish a list of such drugs, through notice and comment rulemaking, before implementing this rule, and FDA has never finalized the list for any drug products.

In May 2024, we began offering access to GLP-1s, first in the form of compounded injectable semaglutide and in August 2024, in the form of branded (or FDA-approved) injectable semaglutide, as part of our weight loss specialty.

Certain aspects of our GLP-1 compounding business are permitted by FDA based on current shortages of branded GLP-1s, and we cannot predict when such shortages will be resolved.

Additionally, all doses of semaglutide marketed under the trade names Ozempic and Wegovy became listed as available on the FDA’s Drug Shortage List as of October 30, 2024.

On February 21, 2025, the FDA resolved the semaglutide shortage, which could constrain our ability to continue providing access to compounded semaglutide on our platform once our current inventory has been sold.

While we believe the compounded drug products available through our platform meet the requirements for exemption under Section 503A or Section 503B of the FDCA, as applicable, if the FDA were to determine that such products do not meet the requirements for exemption, the FDA could subject us, the Pharmacies, Partner Pharmacies, Affiliated Medical Groups, Providers, Facilities, or Manufacturing Suppliers to regulatory and/or legal enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine, and criminal penalties.

Other federal, state, or foreign enforcement authorities might also take action against us or the Pharmacies, Partner Pharmacies, Affiliated Medical Groups, Providers, Facilities, or Manufacturing Suppliers if they determine that compounded drug products available through our platform do not meet applicable legal or regulatory requirements.

New regulatory requirements

We recently announced two acquisitions of (i) a peptide manufacturing facility (and related assets) and (ii) a laboratory business.

These are both new operational areas where we have not operated previously as an organization.

These operations present regulatory requirements to which we have not previously been subject for us to comply with once we have integrated the acquisitions and have commenced operations.

For example, with respect to the peptide manufacturing business, we will now be subject to provisions governing FDA-registered manufacturers of active pharmaceutical ingredients (“API”), as well as federal regulations regarding cGMP applicable to API manufacturers.

We will also be subject to CDPH Food & Drug Branch oversight as a CDPH-registered drug manufacturer and will be required to comply with certain rules and regulations from the departments of health, boards of pharmacy, or other regulatory authorities of other states to which we ship or otherwise introduce API.

Additionally, with respect to our expansion into laboratory testing services, we will now be subject to new licensure and certification requirements and federal, state, and local laws and regulations applicable to laboratory testing including the FDCA the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), and similar state laws.

This will also result in additional oversight by various regulatory agencies, including the Centers for Medicare & Medicaid Services (“CMS”) and the FDA within the United States Department of Health and Human Services (“HHS”) on the federal side, as well as state and local departments of health responsible for regulating clinical laboratory testing within the jurisdictions where we will conduct laboratory testing.

We may also be subject to additional state licensure requirements applicable to entities engaging in the distribution of prescription medical devices and products depending on how we integrate the laboratory services into our current customer offerings.

Furthermore, we may also become subject to certain FDA premarket review requirements relating to the diagnostic testing products that are used in the newly acquired laboratory-developed tests (“LDTs”), including but not limited to 510(k) clearance, de novo classification, premarket approval, and others.

There remains some uncertainty over whether the FDA has the authority under the FDCA to regulate LDTs.

The FDA asserts that it does have authority and has issued a final rule regarding the regulation of LDTs.

The final rule is currently being challenged by the American Clinical Laboratory Association (“ACLA”) in a lawsuit pending in the United States District Court for the Eastern District of Texas.

Further, the FDA revises its regulations and guidance in light of new legislation in ways that may affect our business or products.

It is impossible to predict whether other changes to legislation, regulation, or guidance will be enacted, or what the impact of such changes, if any, may be.

Health information privacy and security laws

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As our business operations continue to develop, including through the launch of new product offerings or the development of new services, we may collect additional sensitive health and personal information from our customers that could create additional compliance obligations and may increase our exposure to compliance and regulatory risks regarding the protection and dissemination of such information.

In addition to HIPAA, numerous other federal, state, and foreign laws and regulations protect the confidentiality, privacy, availability, integrity and security of health information and other types of PII, including the California Confidentiality of Medical Information Act, and these laws and regulations are rapidly evolving.

These laws and regulations in many cases are more restrictive than, and may not be preempted by, HIPAA and its implementing rules, particularly with respect to highly sensitive PII involving behavioral health or sexually transmitted diseases.

These laws and regulations are often uncertain, contradictory, and subject to changing or differing interpretations, and we expect new laws, rules and regulations regarding privacy, data protection, and information security to be proposed and enacted in the future.

This complex, dynamic legal landscape regarding privacy, data protection, information security, and artificial intelligence creates significant compliance issues for us, the Affiliated Medical Groups, the Affiliated Pharmacies, and the Providers, and potentially exposes us to additional expense, adverse publicity, and liability.

Additionally, these laws may be similar to or even more protective than, and may not be preempted by, HIPAA and other federal privacy laws, particularly with respect to highly sensitive PII involving behavioral health or sexually transmitted diseases.

This complex, dynamic legal landscape regarding privacy, data protection, information security, and artificial intelligence creates significant compliance issues for us, the Affiliated Medical Groups, the Pharmacies, Facilities, and the Providers, and potentially exposes us to additional expense, adverse publicity, and liability.

Various government and consumer agencies have also called for new regulation and changes in industry practices.

Practices regarding the registration, collection, processing, storage, sharing, disclosure, use, and security of personal and other information by companies offering an online service like our platform have recently come under increased public scrutiny, and federal and state governmental authorities have increased their enforcement activity and demonstrated varying interpretations of existing laws.

The privacy and data protection laws in many states in which we operate are more restrictive than HIPAA and/or may apply more broadly than HIPAA.

For example, the California Consumer Privacy Act (“CCPA”) and the California Privacy Rights Act (“CPRA”) require, among other things, covered companies to provide new disclosures to California consumers and afford such consumers new abilities to opt-out of certain sales of personal information.

For example, the California Consumer Privacy Act (“CCPA”) and the California Privacy Rights Act (“CPRA”) require, among other things, covered companies to provide specific disclosures to California consumers and afford such consumers new abilities to opt-out of certain sales of personal information.

Similar legislation has been proposed or adopted in other states.

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Under the GDPR, data protection authorities in the EU have the power to impose significant administrative fines for violations, which may also lead to damages claims by data controllers and data subjects.

The UK GDPR sits alongside the UK Data Protection Act 2018 which implements certain derogations in the GDPR into UK law.

The UK GDPR sits alongside the UK Data Protection Act 2018 which implements

certain derogations in the GDPR into UK law.

Under the UK GDPR, companies not established in the UK but who process personal data in relation to the offering of goods or services to individuals in the UK, or to monitor their behavior, are subject to the UK GDPR - the requirements of which are (at this time) largely aligned with those under the GDPR and may lead to significant compliance and operational costs.

Additionally, in July 2023, the European Commission adopted an adequacy decision concluding that the United States ensures an adequate level of protection for personal data transferred from the EEA to the United States under the EU-U.S.

Data Privacy Framework (followed in October 2023 with the adoption of an adequacy

decision in the UK for the UK-United States Data Bridge).

Data Privacy Framework (followed in October 2023 with the adoption of an adequacy decision in the UK for the UK-United States Data Bridge).

However, the adequacy decision does not foreclose, and is likely to face, future legal challenges.

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We view our marketing capabilities as a core strength of the Company and a key differentiator in the market.

We expect our weight loss specialty will drive new seasonality considerations for our business.

Specifically, we expect individuals’ health and wellness-based New Year's resolutions to result in additional traffic to our platform and thus increase the number of Subscribers utilizing one of our weight loss offerings.

This may result in higher Subscriber and Monthly Online Revenue per Average Subscriber growth in the first quarter compared to the remainder of the year.

See Part II, Item 7:

“Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Annual Report on Form 10-K for definitions of Subscribers and Monthly Online Revenue per Average Subscriber.

Human Capital Management

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At Hims & Hers, we are focused on providing an exceptional experience to our employees, while focusing on serving our customers.

Our team is central to our mission to transform the health and wellness industry and to help the world feel great through the power of better health.

We believe that celebrating multiple approaches and perspectives allows us to better meet the challenge of providing access to people-centered, more personalized health and wellness solutions.

Our team is central to our mission to help the world feel great through the power of better health.

We believe that celebrating multiple approaches and perspectives allows us to better meet the challenge of providing access to affordable, accessible, personalized health and wellness solutions.

We continue to look for intentional ways to expand our programs and initiatives to not only attract, develop, and retain top talent, but also to center the well-being of our people.

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As of December 31, 2024, our team was comprised of 1,637 employees across various functions.

We took prompt action to protect our employees’ health in response to the COVID-19 pandemic, including closing our offices in March 2020 and shifting to an official remote-first policy in June 2020.

We have had an official remote-first policy for all corporate functions since June 2020.

We have heavily invested in the software, tools, and culture that allow our company to be a leading force in the new remote-work environment.

Not only has this allowed us to maintain and enhance our commitment to quality, our management team believes it has also provided a real competitive advantage by attracting diverse talent and garnering new geographic exposure.

Because we prioritize hiring team members with a variety of lived experiences, we believe we get the benefit of more multi-faceted and nuanced insight into the customers we serve.

We prioritize hiring team members with a diversity of lived experiences, and we believe we get the benefit of more multi-faceted and nuanced insight into the customers we serve.

This also ensures that our internal community reflects our vision for an equity-centered, inclusive workforce.

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We are a company with a growth mindset.

To that end, we gauge our employees’ level of engagement and satisfaction through annual engagement surveys.

To that end, we gauge our employees’ level of engagement and satisfaction through ongoing engagement surveys.

We leverage these surveys to gather information to ensure we hear directly from our employees on their personal work experiences and how we can continue working to manifest our value set.

We evaluate the data obtained through employee feedback to architect learning pathways and experiences that are truly valuable to our employees.

For example, in 2022 we launched people manager training and labs as well as effective communication training across the organization.

We are continually working to improve our process and policies to align with our growing and evolving workforce.

We have regular people manager training and labs as well as effective communication training across the organization.

We are continually working to improve our processes and policies to align with our growing and evolving workforce.

Further, we have committed to, and formalized, employee development programs that are focused on feedback, coaching and employee development.

Programming includes a formalized performance review process that includes a self-evaluation process and a manager self-evaluation process, together with training and resources on how to approach these evaluations.

Programming includes a formalized performance review process that includes a self-evaluation process, peer-evaluation process and a manager self-evaluation process, together with training and resources on how to approach these evaluations.

We also offer our employees a holistic total rewards package with premier benefit and well-being programs intended to fit the needs of our employees and their family members.

In addition to standard medical coverage, we offer employees dental and vision coverage, health savings and flexible spending accounts, employee assistance programs, short-term and long-term disability coverage, and life insurance.

We also offer a 401(k) Savings Plan and the ability to participate in our Employee Stock Purchase Plan to all U.S.

In addition, the majority of our employees are eligible for equity awards, depending on function, to align incentives and provide the opportunity to share in the Company’s financial success.

Additionally, our paid time off programs enable and encourage our workforce to enjoy personal time away from their job responsibilities.

We also offer generous parental leave benefits for eligible employees.

We offer a 401(k) Savings Plan and the ability to participate in our Employee Stock Purchase Plan to all U.S.

The majority of our employees are eligible for equity awards, depending on function, to align incentives and provide the opportunity to share in the Company’s financial success.

Our paid time off programs enable and encourage our workforce to enjoy personal time away from their job responsibilities.

We also offer generous parental leave benefits for eligible employees as well as a variety of perks including backup childcare, family forming resources, fitness and coworking space reimbursements, providing support for our employees’ needs.

Commitment to highest standards of provider quality

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provided services on the Hims & Hers platform through the Affiliated Medical Groups.

These medical professionals adhere to a rigorous set of assessments and all credentials, licenses, and qualifications are cross-checked against federal, state, and other agencies.

The Affiliated Medical Groups implement comprehensive processes, including written testing, to ensure adequate clinical skill and quality.

Testing results are reviewed by an advisory board of physicians, with only the most qualified applicants approved by the Affiliated Medical Groups to provide consultations on the Hims & Hers platform.

All credentials, licenses, and qualifications of these medical professionals are cross-checked against federal, state, and other agencies.

The Affiliated Medical Groups implement comprehensive processes, to ensure adequate clinical skill and quality.

Only the most qualified applicants are approved by the Affiliated Medical Groups to provide consultations on the Hims & Hers platform.

This rigor in provider selection ensures a strong culture of high standards focused around improving health and wellness outcomes for our customers.

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through an antiquated model focused around brick-and-mortar healthcare providers and cost coverage through commercial and government payor programs.

At the same time, many consumers are not aware of the relative affordability, convenience, and accessibility of care through the use of telehealth.

At the same time, many consumers are not aware of the relative affordability, convenience, and accessibility of care through telehealth.

Much of our marketing efforts since our founding have thus focused on consumer education around these capabilities and the underlying conditions that providers on our platform can help treat.

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Our ability to obtain and maintain intellectual property protection for our proprietary technology platform, preserve the confidentiality of our trade secrets, and operate without violating the intellectual property rights of others is important to our success.

We have a number of measures to protect our intellectual property and brand, including trademarks, confidentiality procedures, non-disclosure agreements, and employee non-disclosure and invention assignment agreements, to establish and

protect our proprietary rights.

Despite these efforts, there can be no assurance that we will adequately protect our intellectual property.

As of December 31, 2023, we held 26 registered trademarks in the U.S.

and 188 in non-U.S.

jurisdictions, and 33 pending trademarks in the U.S.

and 82 in non-U.S.

jurisdictions, including pending trademarks for our brand, Hims & Hers.

We obtained our first registered trademark in December 2018 with the majority of our trademark registrations obtained between 2019 and 2023.

Each trademark registration is due for renewal within ten years from the date of its respective registration date and may be renewed in ten year intervals thereafter.

In addition, we have registered domain names for websites that we use in our business, such as www.hims.com, www.forhers.com, www.forhims.co.uk, and www.apostrophe.com.

We have one pending patent and hold no registered patents at this time.

Hims & Hers owns or is licensed to use valuable intellectual property, including trademarks, service marks, patents, copyrights, trade secrets, and other proprietary information.

We consider the trademarks “HIMS,” “HERS,” “H,” and “HIMS & HERS” to be of material importance to our business.

Depending on the jurisdiction, trademarks, and service marks generally are valid as long as they are used and/or registered.

Patents, copyrights, and licenses are of varying durations.

In addition, we have registered and maintain numerous Internet domain names, including “www.hims.com” and “www.forhers.com.”

Additional Information

Our website addresses are www.hims.com, www.forhers.com, www.forhims.co.uk and www.apostrophe.com.

Our products and services are available through the following websites:

www.hims.com, www.forhers.com, www.forhims.co.uk and www.apostrophe.com.

We make available free of charge at the Investor Relations section of the hims.com website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we file or furnish such materials with the Securities and Exchange Commission (the “SEC”).

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business