What the changes say
- The planned Eucalyptus acquisition adds major closing, funding, integration, regulatory, customer-retention, and expected-benefit risks.
- New laboratory operations face FDA scrutiny of LDTs, specimen-collection kits, prescription-device licensing, and international diagnostic regulation.
- Compounded-drug perceptions and government actions targeting compounded semaglutide and GLP-1 ingredients could damage reputation and operations.
- Provider classification, pharmacy regulation, and broader healthcare compliance remain significant operating risks.
What changed since the prior 10-K
New
- NewRisks Related to Our Business
Affiliated Medical Groups
Providers could be reclassified as employees, increasing wage, benefit, tax, penalty, relationship, and operating costs for the Affiliated Medical Groups.
- NewRisks Related to the Proposed Acquisition of Eucalyptus
The planned acquisition of Eucalyptus is subject to conditions, some or all of which may not be satisfied or completed on a timely basis, if at all
The Eucalyptus acquisition may be delayed or fail if regulatory approvals or other closing conditions are not satisfied.
- NewRisks Related to the Proposed Acquisition of Eucalyptus
Any of these risks could materially and adversely impact our financial condition and results of operations
Transaction and integration expenses for Eucalyptus may exceed expectations or outweigh benefits, even if the acquisition closes.
- NewRisks Related to the Proposed Acquisition of Eucalyptus
Our plans for funding the Proposed Acquisition may be adversely affected to the extent there are lower-than-expected operating results or significant financial market disruptions
Lower operating results or financial-market disruption could leave Hims & Hers unable to fund up to $1.15 billion of Eucalyptus consideration.
- NewRisks Related to the Proposed Acquisition of Eucalyptus
We may not realize the benefits, including growth opportunities, that are anticipated from the Proposed Acquisition
Hims & Hers may not achieve Eucalyptus’s anticipated growth, retain its customers, maintain commercial relationships, comply with foreign regulations, or integrate it successfully.
- NewRisks Related to Governmental Regulation
FDA has issued warning letters related to specimen-collection kits, and similar enforcement activity directed at our products or suppliers could materially and adversely affect our business
FDA enforcement against unauthorized at-home specimen-collection kits could affect workflows using blood and other sample-collection kits.
- NewRisks Related to Governmental Regulation
FDA regulation of laboratory developed tests (“LDTs”) and regulation by other countries of diagnostic offerings could materially and adversely affect our business
Evolving FDA regulation of laboratory-developed tests and foreign diagnostic rules could increase requirements and costs for the laboratory business.
- NewRisks Related to Governmental Regulation
If any of the sample collection kits we use are considered prescription medical devices, we may be required to obtain additional state licenses to distribute such devices, and failure to obtain or maintain these licenses could adversely affect our operations
Sample-collection kits classified as prescription medical devices could require additional state distribution licenses that Hims & Hers may fail to obtain or maintain.
- NewRisks Related to Governmental Regulation
Perceptions regarding the safety, efficacy, and quality of compounded drugs may significantly harm our business, financial condition, and results of operations
Negative perceptions of compounded drugs’ safety, efficacy, or quality could reduce trust in Hims & Hers products and harm results.
- NewRisks Related to Intellectual Property and Legal Proceedings
We have been, and in the future may be, subject to actions and public statements by U.S. federal and state government officials and agencies, which could materially and adversely affect our business, financial condition, results of operations and reputation
Government warnings, referrals, investigations, and enforcement concerning compounded semaglutide and GLP-1 ingredients could harm Hims & Hers’s business and reputation.
Dropped
- DroppedRisks Related to Governmental Regulation
Further, we recently announced two acquisitions
- DroppedRisks Related to Governmental Regulation
Although we believe our products meet the requirements for the statutory exemptions in 503A and 503B, changes to the regulatory requirements for compounding GLP-1 products may adversely impact our financial conditions and business operations, and we cannot predict such changes
- DroppedRisks Related to Intellectual Property and Legal Proceedings
From time to time, we are subject to legal proceedings in the ordinary course of business, which can include intellectual property disputes or claims related to our marketing or sale of products, any of which may be costly to defend and could materially harm our business and results of operations
Reworded
- 86% rewrittenRisks Related to Our Business
Our business could be adversely affected if Providers were classified as employees of the Affiliated Medical Groups instead of independent contractors
- 69% rewrittenRisks Related to Governmental Regulation
If we fail to comply with applicable healthcare and/or other laws and governmental regulations, we could face substantial penalties, our business, financial condition, and results of operations could be adversely affected, and we may be required to restructure our operations
The risk now expressly includes foreign healthcare laws and regulations, in addition to federal, state, and local requirements.
- 64% rewrittenRisks Related to Our Business
Our pharmacy business subjects us to additional healthcare laws and regulations beyond those we face with our core telehealth business, and increases the complexity and extent of our compliance and regulatory obligations
The discussion shifts from pharmacy ownership-transition licensing risks to broad U.S. and international regulation of pharmacies and prescription-drug operations.
- 59% rewrittenRisks Related to Intellectual Property and Legal Proceedings
We are, and may in the future be, subject to claims that we violated intellectual property rights of others, which are extremely costly to defend and could require us to pay significant damages and limit our ability to operate
The wording removes the specific reference to celebrity influencers and broadly covers intellectual-property rights involving influencers.
Was: We may in the future be subject to claims that we violated intellectual property rights of others, which are extremely costly to defend and could require us to pay significant damages and limit our ability to operate
- 46% rewrittenRisks Related to Governmental Regulation
Public scrutiny of internet privacy and security issues may result in increased regulation or enforcement and/or different industry standards, which could deter or prevent us from providing services to our customers, thereby harming our business
- 41% rewrittenRisks Related to Governmental Regulation
Changes in insurance and healthcare laws in the United States, as well as the potential for further healthcare reform legislation and regulation, have created uncertainty in the healthcare industry and could materially affect our business, financial condition, and results of operations
Was: Changes in insurance and healthcare laws, as well as the potential for further healthcare reform legislation and regulation, have created uncertainty in the healthcare industry and could materially affect our business, financial condition, and results of operations
- 36% rewrittenRisks Related to Our Results of Operations and Additional Capital Requirements
If our estimates or judgments relating to our significant accounting policies prove to be incorrect, our results of operations could be adversely affected
- 33% rewrittenRisks Related to Our Results of Operations and Additional Capital Requirements
We may not be able to maintain our profitability
Profitability figures now cover 2025: $128.4 million net income, $318.0 million Adjusted EBITDA, and a $113.8 million accumulated deficit.
- 32% rewrittenRisks Related to Our Business
Expansion into international markets is important for our growth, and as we expand internationally, we will face additional business, political, legal, regulatory, operational, financial, and economic risks, any of which could increase our costs and hinder such growth
Was: Expansion into international markets is important for our long-term growth, and as we expand internationally, we will face additional business, political, legal, regulatory, operational, financial, and economic risks, any of which could increase our costs and hinder such growth
- 32% rewrittenRisks Related to Our Business
Use of social media and influencers may materially and adversely affect our reputation or subject us to fines or other penalties
Was: Use of social media and celebrity influencers may materially and adversely affect our reputation or subject us to fines or other penalties
- 30% rewrittenRisks Related to Governmental Regulation
If our business practices are found to violate federal or state anti-kickback, physician self-referral, or false claims laws, we may incur significant penalties and reputational damage that could adversely affect our business
- 28% rewrittenRisks Related to Our Business
We have experienced rapid growth in recent fiscal years and expect to continue to invest in our growth for the foreseeable future. High levels of growth may not be achieved in future periods and may not generate a corresponding improvement in our results of operations
- 26% rewrittenRisks Related to Our Business
We depend on a number of third parties to perform functions critical to our ability to operate our platform, generate revenue from customers, and to perform many of the related functions
- 24% rewrittenRisks Related to Governmental Regulation
There could be laws and regulations applicable to our business that we have not identified or that, if changed, may be costly to us, and we cannot predict all the ways in which implementation of such laws and regulations may affect us
- 21% rewrittenRisks Related to Our Business
Our pricing decisions may adversely affect our ability to attract new customers, Providers, and other partners, or may otherwise impact our revenue and profitability
All 69 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business
- 01We have experienced rapid growth in recent fiscal years and expect to continue to invest in our growth for the foreseeable future. High levels of growth may not be achieved in future periods and may not generate a corresponding improvement in our results of operations28% rewritten
- 02If we are unable to successfully market to new customers and retain existing customers, or if evolving privacy, healthcare, or other laws or regulations prevent or limit our marketing activities, our business, financial condition, and results of operations could be harmed
- 03Use of social media and influencers may materially and adversely affect our reputation or subject us to fines or other penalties32% rewritten
- 04If we are unable to continue to expand our marketing infrastructure, we may fail to increase the usage of our platform to meet our forecasts
- 05Our brand is integral to our success. If we fail to effectively maintain, promote, and enhance our brand in a cost-effective manner, our business and competitive advantage may be harmed
- 06The failure of our offerings to achieve and maintain market acceptance could result in us achieving revenue below our expectations, which could cause our business, financial condition, and results of operations to be materially and adversely affected
- 07The market for our model and services is relatively new, rapidly evolving, and increasingly competitive, as the healthcare industry in the United States is undergoing significant structural change and consolidation, which makes it difficult to forecast demand for our offerings
- 08Competitive platforms or other technological breakthroughs for the monitoring, management, treatment, or prevention of medical conditions may adversely affect demand for our offerings
- 09We operate in highly competitive markets and face competition from large, well-established healthcare providers, traditional retailers, pharmaceutical providers, and technology companies with significant resources, and, as a result, we may not be able to compete effectively
- 10New competitors or alliances may emerge that have greater market share, a larger customer base, more widely adopted proprietary technologies, greater marketing expertise, and greater financial resources, which could put us at a competitive disadvantage
- 11We are dependent on our relationships with the Affiliated Medical Groups, which we do not own, to provide healthcare consultation services, and our business could be adversely affected if those relationships were disrupted
- 12The activities and quality of Providers treating our customers and Facilities performing fulfillment and distribution, including any potentially unethical or illegal practices, could damage our brand, subject us to liability, and harm our business and financial results
- 13Any failure to offer high-quality support may adversely affect our relationships with customers and Providers, and in turn our business, financial condition, and results of operations
- 14Our business could be adversely affected if Providers were classified as employees of the Affiliated Medical Groups instead of independent contractors86% rewritten
- 15Affiliated Medical GroupsNew
- 16Expansion into international markets is important for our growth, and as we expand internationally, we will face additional business, political, legal, regulatory, operational, financial, and economic risks, any of which could increase our costs and hinder such growth32% rewritten
- 17Economic uncertainty or downturns, particularly as it impacts particular industries, could adversely affect our business, financial condition, and results of operations
- 18If we are unable to deliver a rewarding experience on mobile devices, whether through our mobile website or our mobile applications, we may be unable to attract and retain customers
- 19Our business depends on continued and unimpeded access to the internet and mobile networks
- 20Any disruption of service at Amazon Web Services, Partner Pharmacies, or other third-party service providers could interrupt access to our platform or delay our customers’ ability to seek treatment
- 21We depend on a number of third parties to perform functions critical to our ability to operate our platform, generate revenue from customers, and to perform many of the related functions26% rewritten
- 22Disruption in our global supply chain, supply chain concentration, and changes to tax or trade policy could negatively impact our business
- 23Our pharmacy business subjects us to additional healthcare laws and regulations beyond those we face with our core telehealth business, and increases the complexity and extent of our compliance and regulatory obligations64% rewritten
- 24Our payments system depends on third-party service providers and is subject to evolving laws and regulations
- 25Our pricing decisions may adversely affect our ability to attract new customers, Providers, and other partners, or may otherwise impact our revenue and profitability21% rewritten
- 26Our success depends on the continuing and collaborative efforts of our management team, and our business may be severely disrupted if we lose their services
- 27We depend on our talent to grow and operate our business, and if we are unable to hire, integrate, develop, motivate, and retain our personnel, we may not be able to grow effectively
- 28A significant portion of our inventory is stored in our Facilities, and from time to time with third party logistics providers, and any damage or disruption at any Facility or with any third party logistics provider may harm our business
Risks Related to the Proposed Acquisition of Eucalyptus
- 29The planned acquisition of Eucalyptus is subject to conditions, some or all of which may not be satisfied or completed on a timely basis, if at allNew
- 30Any of these risks could materially and adversely impact our financial condition and results of operationsNew
- 31Our plans for funding the Proposed Acquisition may be adversely affected to the extent there are lower-than-expected operating results or significant financial market disruptionsNew
- 32We may not realize the benefits, including growth opportunities, that are anticipated from the Proposed AcquisitionNew
Risks Related to Governmental Regulation
- 33If we fail to comply with applicable healthcare and/or other laws and governmental regulations, we could face substantial penalties, our business, financial condition, and results of operations could be adversely affected, and we may be required to restructure our operations69% rewritten
- 34FDA has issued warning letters related to specimen-collection kits, and similar enforcement activity directed at our products or suppliers could materially and adversely affect our businessNew
- 35FDA regulation of laboratory developed tests (“LDTs”) and regulation by other countries of diagnostic offerings could materially and adversely affect our businessNew
- 36If any of the sample collection kits we use are considered prescription medical devices, we may be required to obtain additional state licenses to distribute such devices, and failure to obtain or maintain these licenses could adversely affect our operationsNew
- 37If our business practices are found to violate federal or state anti-kickback, physician self-referral, or false claims laws, we may incur significant penalties and reputational damage that could adversely affect our business30% rewritten
- 38Legislative and regulatory changes specific to the area of telehealth or pharmacy law may present the Affiliated Medical Groups and/or the Pharmacies with additional requirements and state compliance costs, which may create additional operational complexity and increase costs
- 39Evolving government regulations and enforcement activities may require increased costs or adversely affect our results of operations
- 40There could be laws and regulations applicable to our business that we have not identified or that, if changed, may be costly to us, and we cannot predict all the ways in which implementation of such laws and regulations may affect us24% rewritten
- 41Changes in public policy, including those that mandate or enhance healthcare coverage, could have a material adverse effect on our business, operations, and results of operations
- 42Changes in insurance and healthcare laws in the United States, as well as the potential for further healthcare reform legislation and regulation, have created uncertainty in the healthcare industry and could materially affect our business, financial condition, and results of operations41% rewritten
- 43Perceptions regarding the safety, efficacy, and quality of compounded drugs may significantly harm our business, financial condition, and results of operationsNew
- 44The information that we provide to Providers, customers, and our partners could be inaccurate or incomplete, which could harm our business, financial condition, and results of operations
- 45Public scrutiny of internet privacy and security issues may result in increased regulation or enforcement and/or different industry standards, which could deter or prevent us from providing services to our customers, thereby harming our business46% rewritten
- 46Security breaches, loss of data, and other disruptions could compromise sensitive information related to our business or customers, or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation
- 47Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws could subject us to penalties and other adverse consequences
Risks Related to Intellectual Property and Legal Proceedings
- 48Failure to protect or enforce our intellectual property rights could harm our business and results of operations
- 49We are, and may in the future be, subject to claims that we violated intellectual property rights of others, which are extremely costly to defend and could require us to pay significant damages and limit our ability to operate59% rewritten
- 50We have been, and in the future may be, subject to actions and public statements by U.S. federal and state government officials and agencies, which could materially and adversely affect our business, financial condition, results of operations and reputationNew
- 51We face the risk of product liability claims and may not be able to maintain or obtain insurance
- 52Our business could be disrupted by catastrophic events and man-made problems, such as power disruptions, data security breaches, and terrorism
Risks Related to Our Results of Operations and Additional Capital Requirements
- 53We may not be able to maintain our profitability33% rewritten
- 54Our results of operations, as well as the performance of our key metrics, may fluctuate on a quarterly and annual basis, which may result in us failing to meet the expectations of industry and securities analysts or our investors
- 55We rely significantly on revenue from customers purchasing subscription-based prescription products and services in the United States and may not be successful in expanding our offerings
- 56The requirements of being a public company have and may continue to strain our resources, divert management’s attention, and may result in litigation
- 57Further, in addition to being costly and time-consuming, any environmental, social and governance (“ESG”)-related disclosures we make may not meet investor expectations or attract additional investments in us, which could result in a decrease in the market price for our Class A common stock
- 58Changes in accounting rules, assumptions, or judgments could materially and adversely affect us
- 59We may require additional capital to support business growth, and this capital might not be available on acceptable terms, if at all
- 60If our estimates or judgments relating to our significant accounting policies prove to be incorrect, our results of operations could be adversely affected36% rewritten
- 61Adverse tax laws or regulations could be enacted or existing laws could be applied to us or our customers, which could subject us to additional tax liability and related interest and penalties, increase the costs of our offerings, and adversely impact our business
- 62Certain U.S. state tax authorities may assert that we have state nexus and seek to impose state and local income taxes which could harm our results of operations
Risks Related to Ownership of our Securities
- 63Our dual class common stock structure has the effect of concentrating voting power with our Chief Executive Officer and Co-Founder, Andrew Dudum, which limits an investor’s ability to influence the outcome of important transactions, including a change in control
- 64As a “controlled company” within the meaning of NYSE listing standards, we qualify for exemptions from certain corporate governance requirements. We have the opportunity to elect any of the exemptions afforded a controlled company
- 65Delaware law and our certificate of incorporation and bylaws contain certain provisions, including anti-takeover provisions, that limit the ability of stockholders to take certain actions and could delay or discourage takeover attempts that stockholders may consider favorable
- 66In addition, our certificate of incorporation includes a provision substantially similar to Section 203 of the DGCL, which may prohibit certain stockholders holding 15% or more of our outstanding capital stock from engaging in certain business combinations with us for a specified period of time
- 67The market price of our Class A common stock has been and may continue to be volatile
- 68The sale or the perception of future sales of a substantial number of shares of our Class A common stock could cause the market price of our Class A common stock to drop significantly, even if our business is doing well
- 69Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the market price and trading volume of our Class A common stock
Other Hims & Hers Health 10-Ks
- FY2024 10-K risk factors70 risks
GLP-1 demand, shortages, manufacturing limits, and regulatory restrictions create a prominent product-supply risk.
Filed Feb 24, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.