What changed in this filing

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Item 1. Business

2026-03-12 compared with 2025-03-12 · 203 added, 119 removed, 586 unchanged (35% of the section changed)

Company Overview

The Beauty Health Company (the “Company” or “we”) is a medtech meets beauty company that delivers skin health experiences that help consumers reinvent their relationship with their skin, bodies, and self-confidence.

The Company and its subsidiaries design, develop, manufacture, market, and sell esthetic technologies and products.

The Company’s brands are pioneers:

Hydrafacial in hydradermabrasion;

SkinStylus in nanoneedling and microneedling;

and Keravive in scalp health.

Together, with its powerful global community of estheticians, partners, and consumers, the Company is personalizing skin health for all ages, genders, skin tones, and skin types.

The Beauty Health Company (the “Company” or “we”) is a global medical aesthetics company delivering an integrated ecosystem of clinically proven solutions designed to help consumers achieve superior skin health and support the success of providers.

Anchored by Hydrafacial, a leading and widely requested professional skincare treatment, and supported by complementary offerings including SkinStylus microneedling and HydraScalp powered by Keravive, the Company combines advanced device technology, proprietary consumables, and clinical validation to deliver trusted treatment experiences through an omnichannel network of providers worldwide.

The following chart reflects our brand portfolio:

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Hydrafacial is a pioneer and created the category of hydradermabrasion with its patented delivery system (“Delivery System”) that cleanses, extracts, and hydrates the skin with proprietary solutions and serums.

SkinStylus is a pioneer in nanoneedling and microneedling where its products are designed to provide either a non-invasive (nanoneedling) or minimally-invasive (microneedling) skin treatment to individuals.

Keravive is a pioneer in scalp health with its products that are designed to support the hair’s natural growth by cleansing, exfoliating, and hydrating the scalp and hair follicles for a visibly improved appearance of healthier, thicker, fuller-looking hair.

The treatment extends to the scalp through the Company’s HydraScalp powered by Keravive treatment, which is designed to support the hair’s natural growth by cleansing, exfoliating, and hydrating the scalp and hair follicles for a visibly improved appearance of healthier, thicker, fuller-looking hair.

SkinStylus is a pioneer in nano-channeling and microneedling where its products are designed to provide either a non-invasive (nano-channeling) or minimally-invasive (microneedling) skin treatment to individuals.

Hydrafacial Products

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Serums Optional add-on to target specific skin concerns.

Offering includes proprietary booster serums that are co-developed via collaborations with various skincare brands.

Offering includes proprietary booster serums that are Hydrafacial branded as well as some that are co-developed via collaborations with various skincare brands.

Approximately 1-2 treatments per serum vial.

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We believe Hydrafacial treatments are accessible and appropriate for consumers across all genders, ages, skin types, and skin tones.

A Hydrafacial treatment results in instantly gratifying, glowy-looking skin and a “gunkie” container that collects dead skin cells and debris that were extracted from the skin during the Hydrafacial treatment.

A Hydrafacial treatment is clinically proven to improve skin quality, delivering results that are instantly gratifying and glowing.

The experience culminates in the reveal of a “gunkie” container that collects dead skin cells and debris that were extracted from the skin during the Hydrafacial treatment.

We believe the instant gratification provided by our Hydrafacial treatment generates high consumer and provider affinity for our brand.

A summary of the Hydrafacial treatment is set forth below.

In addition, consumers and providers can personalize their Hydrafacial treatments to target specific skin concerns or needs by adding customized chemical peels, various serums, LED light therapy, and/or lymphatic drainage.

In addition, consumers and providers can personalize their Hydrafacial treatments to target specific skin concerns or needs by choosing the abrasion of the tip, adding customized chemical peels, various serums, LED light therapy, and/or lymphatic drainage.

Furthermore, a Hydrafacial treatment can be applied to the neck/decolletage, back, hands, or other parts of the body.

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Hydrate Vortex Fusion Technology is paired with a specialized tip to deliver hyaluronic acid and antioxidants to the skin to help nourish, hydrate, and protect.

HydraScalp powered by Keravive Products

At the core of the HydraScalp product offering is the Keravive Peptide Solution that is designed to be delivered to an individual’s scalp using a Hydrafacial Delivery System and custom tips, and a take home spray that is intended to be used once daily at home for 30-days after an individual receives an in-office HydraScalp treatment to help support the appearance of healthier, thicker, fuller-looking hair.

We are evaluating the optimal re-launch strategy for HydraScalp and believe it will take time before sales of HydraScalp become a meaningful part of our business.

SkinStylus Products

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The SkinStylus SteriLock Microsystem, when used in connection with microneedling services, is considered to be a Class II medical device pursuant to the rules and regulations promulgated by the FDA.

SkinStylus SteriLock Microsystem (for nanoneedling)

The SkinStylus SteriLock Microsystem can also be used as a nanoneedling device where it and its related accessories are intended to help enhance the penetration and absorption of topical products, and improve exfoliation to promote smoother and more luminous-looking skin.The SkinStylus SteriLock Microsystem, when used in connection with nanoneedling services, is considered to be a cosmetic device.

Keravive Products

At the core of Keravive’s product offering is the Keravive Peptide Solution that is designed to be delivered to an individual’s scalp using a Delivery System, and a take home spray that is intended to be used once daily at home for 30-days after an individual receives an in-office Keravive treatment to help support the appearance of healthier, thicker, fuller-looking hair.

We are evaluating the optimal re-launch strategy for Keravive and believe it will take time before sales of Keravive become a meaningful part of our business.

SkinStylus SteriLock Microsystem (for nano-channeling)

The SkinStylus SteriLock Microsystem can also be used as a nano-channeling device where it and its related accessories are intended to help enhance the penetration and absorption of topical products and improve exfoliation to promote smoother and more luminous-looking skin.The SkinStylus SteriLock Microsystem, when used in connection with nano-channeling services, is considered to be a cosmetic device.

Product Development Pipeline

A key differentiating factor of the Hydrafacial treatment is how we partner with leading skincare brands to co-develop optional add-on serums that tailor a Hydrafacial treatment based on a consumer’s skincare concerns (each, a “Booster”, and collectively, “Boosters”).

A key differentiating factor of the Hydrafacial treatment is our optional add-on serums that are delivered via a Hydrafacial Delivery System and clinically proven to increase absorption of topical products as compared to manual application to the skin.

Hydrafacial develops its own boosters, as well as partners with leading skincare brands to co-develop these serums that tailor a Hydrafacial treatment based on a consumer’s skincare concerns (each, a “Booster”, and collectively, “Boosters”).

By leveraging the unique technologies of our partners, we believe our Booster strategy allows us to innovate rapidly and cost effectively, staying current with dynamic skincare trends and gaining exposure to new consumers through our partner brands.

We currently offer a portfolio of approximately 20 Boosters and intend to continue strategically partnering with new brands internationally and locally to offer innovative and tailored Booster products to our consumers.

We currently offer a portfolio of approximately 15+ Boosters and intend to continue strategically developing Hydrafacial branded and partnership boosters internationally and locally to offer innovative and tailored Booster products to our consumers.

MyBeautyHealth Mobile Application

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Growth Strategy in General

We intend to fulfill our vision of expanding our platform and connecting our global community of estheticians, partners, and consumers by employing the following strategy, which we believe will generate a flywheel effect to increase our platform’s momentum:

Expand our footprint by selling innovative products and connected experiences to providers and consumers;

Invest in our providers, especially estheticians, to help turn them into brand evangelists and advocates providing first-class experiences to our customers;

Nurture direct relationships with our consumers, building brand awareness and driving them toward our trusted community of providers;

Leverage our global infrastructure and our connected technology platform to fuel growth and community engagement;

Supercharge our platform with targeted acquisitions to complement our portfolio.

Our strategy begins with developing a network of providers, brand partners, and retail partners to build a distribution platform for our innovative products and experiences.

We intend to utilize our sales force to sell our products by inviting providers and partners to become a part of our community.

We believe that each placement of our product will grow the platform and increase consumers’ awareness of our Company, ultimately building a recognizable and aspirational brand that draws in consumers.

In this process, we will particularly focus on the esthetician.

Historically, companies in the medical aesthetics industry focused on physicians, nurses, front-office staff, and business owners.

Notably absent from that focus was the esthetician, a highly influential provider who serves as a source of skincare information and recommendations for clients and patients.

We recognized the opportunity to empower estheticians and created programs to elevate their skills, knowledge, and confidence so that they feel supported through a continued relationship.

As a result, we have open dialogue with our esthetician providers and receive valuable information on consumer preferences and behaviors they see in their practices.

These estheticians have since become our most influential ambassadors, driving awareness, recommending our products, and becoming a point of education for our consumers.

While these estheticians are not our employees or contractors, we believe they provide us with an important competitive advantage because a well-trained esthetician can provide consumers with consistent, memorable, first-class experiences, no matter where a consumer accesses our products.

We believe that this relationship with the esthetician in turn builds loyalty from the consumer to the Company.

Estheticians are one part of our community that we recognize as powerful.

We continue to focus on other providers as well, including physicians, nurses, and other partners, to build consumer awareness for our brands.

By investing in our providers, we believe we are creating a thriving community because they recommend our products and experiences as part of skincare and wellness routines.

In our view, investing our efforts in our community drives utilization amongst consumers, resulting in a potentially potent formula for growth.

Another focus area of our growth strategy is nurturing our relationship with the consumer.

As the ultimate end user, the consumer is at the core of our efforts.

We have an experienced team that meticulously curates the consumer journey, from lead generation that invites consumers to our community to the user experience of our offerings.

We employ a multi-pronged approach to consumer acquisition and engagement including, but not limited to, agile marketing activation events, storytelling, gamification, and loyalty.

We believe driving increased consumer traffic to our network of providers, retailers, and brand partners will increase the utilization of our products and experiences, further cementing the value proposition we offer to our partners and thereby driving increased purchases from them.

We believe our products and experiences are universal in their appeal across cultures, genders, skin tones, and skin types, making a compelling case for our international expansion.

We believe there is significant opportunity in exporting our products and experiences to global markets and applying our strategy abroad to further increase the reach and influence of our platform.

Our offering is available globally through a combination of having a direct commercial presence in certain countries, or utilizing a distributor model or hybrid model in other countries.

Lastly, if we are presented with the right opportunity, we may supercharge our platform via targeted acquisitions, expanding the breadth of our platform with additional innovative products and experiences.

We believe the introduction of additional offerings will generate increased engagement among our community, while further expanding it via the introduction of the acquired company’s established base of consumers.

We will take a disciplined approach to acquisitions, searching for opportunities that satisfy the following criteria:

Include a differentiated product or service, which can generally be demonstrated with a high Net Promoter Score, which is a customer loyalty and satisfaction measurement;

Complement our existing platform and community, leveraging the esthetician;

Provide a financially attractive profile via compelling revenue growth, recurring revenue characteristics, or profitability.

These criteria are not intended to be exhaustive.

Any evaluation relating to the merits of a particular acquisition may be based, to the extent relevant, on these general guidelines as well as other considerations, factors and criteria that our management may deem relevant.

Our strategic objective is to establish BeautyHealth as a leader in medical aesthetics by delivering an integrated ecosystem of solutions that combine devices, consumables, clinical credibility, and brand strength to achieve superior skin health outcomes for consumers and positive economic outcomes for providers.

We believe our platform benefits from several foundational advantages, including a globally recognized brand, a large installed base of Hydrafacial systems across provider practices worldwide, and a consumables-driven economic model that should generate meaningful operating leverage when utilization increases.

Our strategy is focused on unlocking the full economic potential of these assets by strengthening commercial execution, increasing utilization across our installed base, and continuing to invest in clinically meaningful innovation.

Our commercial model is designed to create a reinforcing cycle of growth.

Our brand and marketing initiatives help generate consumer demand, which drives client traffic into provider practices.

Increased client traffic drives treatment utilization per device, and higher utilization increases demand for consumables, which would serve as a key driver of our revenue and margin profile.

As providers experience increased client demand and revenue, we believe this would help incentivize them to expand their use of our technologies, upgrade systems, and deepen their relationship with our platform.

To accelerate this flywheel, we are focused on the following strategic priorities:

Salesforce excellence, including strengthening commercial discipline and adopting a value-based selling approach to help activate our installed base and expand provider relationships;

Marketing discipline, focused on generating consumer demand that supports provider success and reinforces the clinical credibility of our platform;

Focused innovation, prioritizing clinically supported technologies and products that expand the capabilities of our platform and improve provider economics

Salesforce Excellence

We are evolving our commercial organization toward a more structured, data-driven model consistent with leading medical technology companies.

Historically, much of our commercial success was relationship-driven;

however, we believe the next phase of growth requires greater discipline, segmentation, and performance management.

We are transitioning to a value-based selling approach designed to clearly demonstrate the economic and clinical benefits of our platform to providers.

This includes strengthening our clinical and economic differentiation, improving how we segment and prioritize accounts, and implementing structured sales planning processes.

Our commercial focus includes both expanding the number of provider practices on our platform and increasing utilization across our existing installed base, including taking measures to work toward reactivating lower-utilization accounts.

We are also investing in improved commercial analytics and tools that allow us to monitor activation, utilization, and retention across the installed base, enabling more precise management of commercial performance.

Marketing Discipline

Our marketing strategy is focused on generating demand that directly supports provider growth and strengthens the value proposition of our platform.

We are working to refine the positioning of Hydrafacial as a clinically credible skin health platform supported by science, outcomes, and provider education.

We also intend to expand consumer demand generation programs designed to increase consumer awareness and direct traffic to our provider network.

These initiatives are intended to increase treatment utilization within provider practices while reinforcing the role of providers as trusted experts in skin health.

In addition, we are working to expand the commercial contribution of technologies within our portfolio, including SkinStylus, which participates in the growing microneedling and nano-channeling category and represents an opportunity to broaden treatment offerings within provider practices, as well as HydraScalp powered by Keravive.

Focused Innovation

Innovation remains a central component of our long-term growth strategy.

Our approach prioritizes clinically supported technologies and products that strengthen our platform and improve provider economics.

Our innovation pipeline includes the development of next-generation Hydrafacial systems designed to drive upgrades across our installed base which we believe should meaningfully expand our market share.

We are also investing in a focused portfolio of clinically supported boosters and consumables designed to increase booster attachment rates, enhance treatment protocols, and improve provider profitability.

While Hydrafacial has historically been viewed primarily as a single treatment, we believe it represents the foundation of a broader skin health platform.

Our vision is to integrate devices, boosters, protocols, and complementary technologies into a comprehensive ecosystem for providers and consumers.

We are also exploring selective commercial and technology partnerships that may expand our product ecosystem and enhance the value we deliver to providers.

Business Model

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Industry Overview

We are a pioneer and key player in the emerging category of beauty health, which represents the intersection of over-the-counter consumer beauty / wellness products with medical esthetic / health products and procedures.

Historically, these categories were viewed separately, but they are part of a spectrum aimed at helping consumers look and feel their best.

The beauty / wellness industry sells widely accessible topicals, supplements, and digital tools.

However, the market is a crowded and confusing space – the sheer volume of products can leave consumers overwhelmed by choice.

On the other end of the spectrum, medical esthetics offers more corrective and invasive products and procedures such as injectables and energy-based treatments.

The high price tag and clinical setting of these treatments may serve as barriers to generating wider consumer demand.

We seek to position ourselves not as a substitute for or competitor to either of these categories, but rather as the complementary bridge linking the two categories.

We believe that the consumer who follows a beauty and wellness regimen with topicals or supplements may someday graduate to medical procedures, while the medical esthetics patient is highly likely to be a loyal consumer of beauty topical products.

We don’t believe we have to be an “either/or” company (beauty or health/non-invasive or minimally invasive).

Rather, we believe we are an “and” company.

We intend to gather insights to inform our strategy as the consumer travels through the worlds of beauty and health, whether it be at home or in a provider’s office, allowing us to tailor increasingly engaging experiences that ultimately generate revenue.

Many of our providers offer Hydrafacial treatments as a bundle with other procedures, such as injectables, microneedling/nanoneedling, or energy-based treatments.

We operate within the global medical aesthetics industry, a market focused on improving skin health and appearance through clinically supported, non-invasive and minimally invasive treatments delivered by licensed providers.

We believe the category is experiencing sustained long-term growth driven by evolving consumer behavior, increasing provider adoption of advanced technologies, and a broader shift toward preventative and routine skin health.

Several industry trends continue to support growth in the category.

Consumers are increasingly prioritizing skin health as part of their overall wellness routines and continue to invest in treatments even during periods of broader consumer spending pressure.

At the same time, consumer preferences are shifting toward outcomes that look healthy, natural, and authentic, driving demand for non-invasive and minimally invasive treatments that can be incorporated into regular skin health regimens.

Consumers are also more informed than ever before and increasingly seek treatments supported by clinical outcomes.

The provider landscape is also evolving.

Practices are increasingly focused on technologies that generate client demand and deliver attractive economic returns, while treatment protocols are increasingly combining multiple modalities—such as lasers, microneedling, injectables, and skin health treatments—to improve clinical outcomes and client satisfaction.

Within this evolving landscape, we believe Hydrafacial occupies a differentiated position.

Our treatments are non-invasive, clinically credible, and repeatable, enabling providers to incorporate them into routine skin health protocols.

Hydrafacial treatments also serve as an accessible entry point for consumers into the aesthetics category, helping providers attract new clients while creating opportunities for additional procedures within their practices.

Hydrafacial is also highly versatile, with treatments suitable across genders, age groups, skin tones, and skin types.

Because the treatment is repeatable and easily integrated into provider workflows, it fits naturally into preventative skin health routines and combination treatment protocols.

We believe these industry dynamics—including growing demand for non-invasive treatments, clinically supported outcomes, and combination therapy approaches—favor companies with strong provider relationships, scalable platforms, and recurring revenue models.

Manufacturing;

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n=1100), we are focused on maximizing our organic presence and introducing our brand to highly targeted consumer growth markets around the world.

With over 60% U.S.

With approximately 60% U.S.

market share in the microdermabrasion category, we continue to innovate and drive growth via novel treatment protocols by launching new Boosters, combination treatment regimens, and new indications backed by clinical data and real-world evidence.

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Part of our marketing spend is based on a targeted “push and pull” marketing model that engages with both providers and consumers.

On the “push” side, we foster relationships with our providers by investing in proprietary training programs, educational content-branding initiatives, digital marketing materials, and a loyalty program that offers tiered pricing on Consumables based on the provider’s and consumer’s spend.

To support the “pull” side of our products, we are investing in tactics to drive consumer demand such as gift-with-purchase promotions, in-office events, targeted paid campaigns, and regional experiences such as the GLOWvolution tour, a traveling experiential program to promote Hydrafacial.

To support the “pull” side of our products, we are investing in tactics to drive consumer demand such as gift-with-purchase promotions, in-office events, targeted paid campaigns, and regional experiences such as influencer spa days conducted in partnership with key accounts and local influencers to promote both the Hydrafacial brand and product offerings.

We believe enhancing our sales force effectiveness with “pull” side marketing initiatives will be key to driving year-over-year account growth.

Digital Marketing

We are also continuously innovating with digital marketing strategies to drive incremental revenue, brand equity, and customer/consumer engagement by elevating our digital presence, social media presence, and influencer marketing efforts.

We are in the process and intend to revamp our digital infrastructure over the next 1-2 years to help improve user experience, maximize organic engagement, and drive online sales through artificial intelligence (“AI”) assisted targeting/check-out functions.

We are also continuously innovating with digital marketing strategies to drive incremental revenue, brand equity, and customer/consumer engagement by elevating our digital presence, e-commerce capabilities, social media presence, and influencer marketing efforts.

We are currently in the process of enhancing our digital infrastructure over the next 1-2 years to help improve user experience, maximize organic engagement, and drive online sales through artificial intelligence (“AI”) assisted targeting/check-out functions.

The majority of our customers are providers within the professional medical industry (dermatologists, plastic surgeons, and medical spas), esthetician, and beauty retail industry (spas, hotels, and other retailers).

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Trademarks, Patents and Domain Names

As of December 31, 2024, we had 179 patents with 87 pending patent applications worldwide to protect Hydrafacial’s current and contemplated technology platform.

As of December 31, 2025, we had a total of 226 patents with 84 pending patent applications worldwide to protect Hydrafacial’s current and contemplated technology platform.

We also have 3 patents to protect certain aspects of the cartridge and needling system for the SkinStylus SteriLock Microsystem.

Our patent portfolio covers key aspects of certain products, systems, and designs, including several issued U.S.

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As of the date of this report, the portfolio includes 10 issued U.S.

patents directed to the manifold and console of the Hydrafacial MD® system and skin treatment tips used in the system that will expire in 2026.

patents directed to the manifold and console of the Hydrafacial MD® system and skin treatment tips used in the system that will expire in March 2026.

Following the expiration of these patents, third parties may be able to manufacture or commercialize products that incorporate features previously covered by such patents, which could result in increased competition or the introduction of competing products that incorporate similar features.

Although these patents are scheduled to expire in March 2026, we do not believe that the expiration of these patents will have a material impact on our revenue.

We continue to maintain patent protection in the U.S.

and worldwide related to current and contemplated products and technologies, including handpieces, tips, improvements to the console and the like.

We also own and have applied to register numerous trademarks and service marks in the United States and in other countries throughout the world.

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FDA Premarket Clearance and Approval Requirements

Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a premarket notification submitted under Section 510(k) of the FDCA, follow a regulatory process that the FDA uses to classify low-to moderate-risk devices (the “De Novo pathway”), or approval of a premarket approval application (“PMA”).

Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a premarket notification submitted under Section 510(k) of the FDCA, to follow a regulatory process that the FDA uses to classify low-to moderate-risk devices for which there is no predicate device already on the market (the “De Novo pathway”), or approval of a premarket approval application (“PMA”).

Under the FDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure the device’s safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation (“QSR”);

Class I includes devices

with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation (“QSR”);

facility registration and product listing;

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and truthful and non-misleading labeling, advertising, and promotional materials.

Class II devices are subject to the FDA’s General Controls, and Special Controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.

Class II and Class III devices are subject to the FDA’s General Controls, and Special Controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.

These Special Controls can include performance standards, post-market surveillance, patient registries, and any additional recommendations set forth in FDA guidance documents.

While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification application under Section 510(k) of the FDCA before engaging in commercial distribution for the device.

While most Class I devices are exempt from the premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification application under Section 510(k) of the FDCA before engaging in commercial distribution for the device.

The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.

Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting, some implantable devices, or devices that have a new intended use or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA.

Alternatively, low to moderate risk novel medical devices for which there is no existing predicate may submit a De Novo classification request through which the FDA may establish a new classification for the device, Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting, some implantable devices, or devices that have a new intended use or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA.

Some pre-amendment devices, which are devices legally marketed prior to May 28, 1976, are unclassified but are subject to FDA’s premarket notification and clearance process in order to be commercially distributed.

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Also, in these circumstances, the manufacturer may be subject to significant regulatory fines, penalties, or other regulatory actions from the FDA.

Over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products by limiting the number of devices available for use to demonstrate equivalence as a predicate device.

For example, in November 2018, FDA officials announced steps that the FDA intended to take to modernize the 510(k) pathway.

Among other things, the FDA announced that it planned to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates.

Over the last several years, the FDA has proposed and implemented several changes to modernize and strengthen the 510(k) clearance process.

Future proposals or the finalization of any unimplemented proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products by limiting the number of devices available for use to demonstrate equivalence as a predicate device.

One such proposal was announced in November 2018, where the FDA indicated that it planned to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates.

These proposals included plans to potentially sunset certain older devices that were used as predicates under the 510(k) clearance pathway, and to potentially publish a list of devices that have been cleared on the basis of demonstrated substantial equivalence to predicate devices that are more than 10 years old.

These proposals have not yet been finalized or adopted, although the FDA may work with Congress to implement such proposals through legislation.

In September 2019, the FDA issued revised final guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process.

Further, in September 2019, the FDA issued revised final guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process.

The FDA has developed and maintains a list of device types appropriate for the “safety and performance based” pathway and continues to develop product-specific guidance documents that identify the performance criteria for each such device type, as well as the testing methods recommended in the guidance documents, where feasible.

Most recently, in September 2023, the FDA released three draft guidance documents proposing recommendations on best practices for selecting a predicate device, situations in which clinical data may be necessary in a 510(k) submission, and evidentiary expectations for 510(k) submissions for implanted devices.

More recently, in September 2023, the FDA released three draft guidance documents proposing recommendations on best practices for selecting a predicate device, situations in which clinical data may be necessary in a 510(k) submission, and evidentiary expectations for 510(k) submissions for implanted devices.

The FDA recommended the use of best practices such as choosing a predicate device that meets or exceeds expected safety and performance, or that does not have unmitigated use-related or design-related safety issues.

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Furthermore, as devices continue to become more interconnected, cybersecurity risks continue to develop and grow exponentially.

As a result, the FDA released guidance in September 2023 on the evolving landscape of cybersecurity threats in relation to premarket review and quality systems.

As a result, the FDA released guidance on the evolving landscape of cybersecurity threats in relation to premarket review and quality systems.

The FDA intends to promote consistency, facilitate efficient premarket review, and ensure that devices are sufficiently resilient to cybersecurity threats by establishing recommended design, labeling, and documentation of testing to be included in premarket submissions of relevant devices.

While the FDA has not substantially altered the 510(k) process within the past year, the FDA can always release new guidance or make changes to the program in the future, which could significantly impact the clearance and/or approval process for applicable medical devices.

De Novo Classification Pathway

Novel medical devices, for which general controls alone or special controls provide reasonable assurance of safety and effectiveness for intended use, may seek approval through the De Novo pathway.

A device that is classified into Class I or Class II via a De Novo classification request may be marketed and may also be used as a predicate device for future 510(k) submissions.

The De Novo classification request standard user fee for fiscal year 2026 is $173,782 and the small business fee is $43,446.

Class III devices require PMA approval before they can be marketed, although some pre-amendment Class III devices for which FDA has not yet required a PMA are cleared through the 510(k) process.

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The FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements to conduct additional clinical studies post-approval.

The FDA may condition PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use.

The FDA may condition PMA approval on some form of post-market surveillance when deemed necessary to protect public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use.

In such cases, the manufacturer might be required to follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those patients.

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Clinical Trials

Clinical trials are almost always required to support a PMA and are sometimes required to support a 510(k) submission.

Clinical trials are almost always required to support a PMA and are sometimes required to support a 510(k) submission or De Novo classification request.

All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption (“IDE”) regulations that govern investigational device labeling and prohibit promotion of the investigational device while specifying an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

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• post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.

Manufacturing processes for medical devices are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use.

The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files.

As a manufacturer, we are subject to periodic scheduled and unscheduled inspections by the FDA.

Failure to maintain compliance with the QSR requirements could result in an adverse inspection or audit reports such as Form 483 Notices of Inspectional Observations;

The FDA finalized the Quality Management System Regulation (“QMSR”) on February 2, 2024, which replaces the prior QSR and incorporates the international standard ISO 13485:2016 by reference.

The QMSR becomes effective February 2, 2026.

Manufacturing processes for medical devices are required to comply with the applicable portions of the QSR/QMSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use.

The QSR/QMSR also requires, among other things, maintenance of a device master file, device history file, and complaint files.

As a manufacturer, we are subject to periodically scheduled and unscheduled inspections by the FDA.

Failure to maintain compliance with the QSR/QMSR requirements could result in an adverse inspection or audit reports such as Form 483 Notices of Inspectional Observations;

the shut-down of, or restrictions on, manufacturing operations;

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• criminal prosecution.

State Regulation of Medical Devices

In addition to federal regulation of medical devices, individual states regulate various activities related to the medical device industry at large.

State regulations can vary widely and include things such as permit or licensure requirements for manufacturing of devices at a facility located within certain states, manufacturing of devices which are sold in certain states, and the distribution of medical devices into or out of various states.

Regulation of Cosmetics

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In addition to FDA requirements, the FTC as well as state consumer protection laws and regulations can subject a cosmetics company to a range of requirements and theories of liability, including similar standards regarding false and misleading product claims, under which FTC or state enforcement or class-action lawsuits may be brought.

In the United States, the FDA has not promulgated finalized regulations establishing GMPs (as defined below) for cosmetics.

In the United States, the FDA has not yet promulgated finalized regulations establishing GMPs (as defined below) for cosmetics.

However, Congress enacted MoCRA on December 29, 2022, which directed the FDA to implement a set of new regulatory requirements that previously were not applicable to cosmetic products.

Pursuant to MoCRA, the FDA now subjects manufacturers and cosmetic products to requirements such as facility registration and product listing requirements, compliance with certain GMP requirements, adverse event reporting requirements, and other labeling requirements.

In addition, the FDA is required to promulgate final regulations implementing GMPs for cosmetics by December 29, 2025.

Pursuant to MoCRA, the FDA now subjects manufacturers and cosmetic products to requirements such as facility registration and product listing requirements, adverse event reporting requirements, and other labeling requirements.

The ongoing implementation timeline of MoCRA is uncertain as the FDA was required to promulgate final regulations implementing GMPs for cosmetics by December 29, 2025, a deadline which has now passed.

The FDA has not indicated when the agency plans to promulgate final regulations implementing GMPs for cosmetics as required by MoCRA and this could occur at any time.

Subsequently, compliance with such GMP requirements will become mandatory for manufacturers of cosmetic products.

Until then, the FDA’s existing draft guidance on cosmetic GMPs, most recently updated in June 2013, and other guidance such as the FDA’s Good Manufacturing Practice (“GMP”) Guidelines/Inspection Checklist from February 2022, will continue to provide guidance and recommendations related to process documentation, recordkeeping, building and facility design, and equipment maintenance and personnel.

Until then, the FDA’s existing draft guidance on cosmetic GMPs, most recently updated in June 2013, and other guidance such as the FDA’s Good Manufacturing Practice (“GMP”) Guidelines/Inspection Checklist current as of November 2025, will continue to provide guidance and recommendations related to process documentation, recordkeeping, building and facility design, and equipment maintenance and personnel.

Compliance with these recommendations can reduce the risk that products will be adulterated or misbranded in violation of the FDCA and its regulations.

In addition to GMP requirements, MoCRA brought on additional changes and updates to FDA’s cosmetics regulations.

For example, cosmetic manufacturing and processing facilities are now required to be registered with FDA, and any products that are marketed after MoCRA’s effective date need to be listed with FDA.

Adulterated or misbranded cosmetic products will be subject to recalls that are mandated by FDA, similar to medical devices.

In addition, a responsible person, as defined under FDA regulations, will be required to report any serious adverse events that result from the use of a cosmetic product manufactured, packaged, or distributed by the person, and the records relating to each adverse event report will be required to be kept for six years.

Additionally, cosmetic labels now need to identify the responsible person for the purpose of serious adverse event reporting, and cosmetic labels need to identify fragrance allergens.

The FDA also recommends that manufacturers maintain product complaint and recall files and voluntarily report adverse events to the agency.

For example, cosmetic manufacturing and processing facilities are required to be registered with FDA, and products must be listed with FDA.

Adulterated or misbranded cosmetic products are subject to recalls that are mandated by FDA, similar to medical devices.

In addition, a responsible person, as defined under FDA regulations, is required to report any serious adverse events that result from the use of a cosmetic product manufactured, packaged, or distributed by the person, and the records relating to each adverse event report must be kept for six years.

Additionally, cosmetic labels need to identify the responsible person for the purpose of serious adverse event reporting, and cosmetic labels need to identify fragrance allergens.

The FDA also requires that manufacturers maintain product complaint and recall files and voluntarily report adverse events to the agency.

The FDA monitors compliance of cosmetic products through market surveillance and inspection of cosmetic manufacturers and distributors to ensure that the products are not manufactured under unsanitary conditions or labeled in a false or misleading manner.

Inspections also may arise from consumer or competitor complaints filed with the FDA.

In the event the FDA identifies unsanitary conditions, false or misleading labeling, or any other violation of FDA regulation, FDA may request or a manufacturer may independently decide to conduct a recall or market withdrawal of a product or to make changes to its manufacturing processes or product formulations or labels.

State Regulation of Medical Devices

In addition to federal regulation of medical devices, individual states regulate various activities related to the medical device industry at large.

In the event the FDA identifies unsanitary conditions, false or misleading labeling, or any other violation of FDA regulation, FDA may require, request, or a manufacturer may independently decide to conduct a recall or market withdrawal of a product or to make changes to its manufacturing processes or product formulations or labels.

State Regulation of Cosmetics

In addition to federal regulation of cosmetics, some states regulate cosmetics to a limited degree, generally focusing on substances used in cosmetic products.

For example, California implemented the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020, which requires companies selling cosmetic products in the state to report the presence of any fragrance or flavor ingredient listed on designated hazard lists.

Similarly, Washington’s Toxic-Free Cosmetics Act restricts sale of cosmetic products that contain certain specified compounds.

Regulation of Drugs

Even if a product is intended for use as a cosmetic, certain marketing claims, functional characteristics, or other factors can result in the product being considered a drug product by the FDA.

Drug products are regulated differently from cosmetics and generally require FDA approval through a New Drug Application (“NDA”), Abbreviated New Drug Application (“ANDA”), or FDA monograph process before they can be marketed.

The Company does not currently market any drug products;

however, it may in the future market certain products that could be considered over the counter (“OTC”) drugs and subject to FDA regulations.

Regulation of OTC Drugs

In the United States, OTC drugs are regulated by the FDA under the FDCA.

There are two primary regulatory pathways for bringing an OTC drug to market in compliance with FDA requirements:

the drug application process, and the OTC drug monograph process.

Under the drug application process, a sponsor must submit an NDA or ANDA to FDA for approval before marketing the product.

A sponsor may also seek approval to market a new drug directly as a non-prescription drug.

To support such applications, sponsors typically conduct consumer behavior studies to demonstrate that consumers can use the OTC drug safely and effectively without the supervision of a healthcare provider.

These studies include label comprehension studies to assess whether consumers understand the Drug Facts labeling in hypothetical situations, self-selections studies to evaluate whether consumers can determine if the drug is appropriate for their respective health condition, actual use studies to examine real-world use to confirm safe and effective self-treatment, and human factors studies to assess product design to minimize use-related hazards.

The FDA also encourages sponsors to engage early with the Office of Nonprescription Drugs (for NDA products) or the Office of Generic Drugs for (ANDA products) and to review FDA guidance on these processes.

Once the FDA approves the application, the product may be marketed, provided it complies with all labeling and manufacturing requirements.

Under the OTC drug monograph process, certain OTC drugs may be marketed without an approved NDA or ANDA if they comply with an applicable OTC monograph and other requirements under the FDCA.

An OTC monograph establishes conditions under which an OTC drug is generally recognized as safe and effective for its intended use, including specifications for active ingredients, uses, dosage, routes of administration, labeling, and testing.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) added Section 505G to the FDCA, modernizing the OTC monograph framework.

A key change introduced by the CARES Act was introducing an administrative order system, which allows the FDA to add, remove, or modify OTC monograph conditions more efficiently and keep pace with scientific and technological advancements.

The administrative order process can be initiated by either industry (any person or group of persons marketing, manufacturing, processing, or developing a drug) or FDA.

For industry-initiated orders, an entity submits an OTC Monograph Order Request to the FDA, which, if accepted for filing, is reviewed by the FDA.

The FDA then issues a proposed order, followed by a public comment period of at least 45 days, and subsequently a final order.

The FDA may also initiate an order on its own, following the same process.

In both scenarios, all final orders are subject to dispute resolution, administrative hearings, and judicial review.

Manufacturers are also expected to monitor FDA announcements and guidance closely and to engage with the agency to ensure compliance with these requirements.

Like all other drug products regulated by the FDA, the agency requires that OTC drug labeling and claims be truthful and not misleading.

OTC drugs may not be marketed or labeled for uses other than the terms or phrases established in the applicable OTC drug monograph or NDA/ANDA.

Any claims beyond the scope of the monograph or approved NDA/ANDA may render the product misbranded.

FDA monitors compliance through inspections and market surveillance and may take enforcement actions, including recalls, if products are found to be adulterated, misbranded, or otherwise in violation of the FDCA.

State of Regulation of OTC Drugs

In addition to federal regulations of OTC drugs, individual states may regulate various activities related to the OTC drug industry at large.

While in some cases federal law preempts states from imposing requirements that differ from or modify FDA rules governing OTC drugs, states may have authority to implement certain measures that protect public interests without creating conflict with federal law or regulations.

State regulations can vary widely and include things such as age restrictions for the purchase of specific OTC products, limitations on quantity of product that can be purchased or sold, licensure requirements for various activities related to OTC drugs, such as manufacturing and wholesaling, and requirements governing professionals such as pharmacists.

State Regulation of Professionals

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Political Changes and Associated Legal Considerations

With the start of a new congressional session and a new presidential administration in the United States, it is expected there will be broad changes to the FDA and the commodities that it regulates.

There have been significant political and legal developments that could impact regulatory agencies, including the FDA.

These include broad restructuring within the federal government, major legal changes affecting the authority of administrative agencies, and shifts in enforcement priorities.

Various court decisions have influenced how agencies operate and govern, while changes in personnel and organizational restructuring at agencies, such as the FDA, have altered oversight and compliance approaches.

Additionally, evolving political priorities have led to changes in policy direction, which could affect how regulations are interpreted and enforced.

While it is impossible to predict exactly what will occur, changes to the laws described in this filing are expected and could be significant.

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Foreign Government Regulation

In addition to United States regulations, we are subject to a variety of foreign government regulations applicable to medical devices and cosmetic products.

In addition to United States regulations, we are subject to a variety of foreign government regulations applicable to medical devices, cosmetic products, and drugs.

Regulation of Medical Devices in the European Union

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Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.

Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can self-assess the conformity of its products with the essential

requirements (except for any parts which relate to sterility or metrology), a conformity assessment procedure requires the intervention of a notified body.

Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can self-assess the conformity of its products with the essential requirements (except for any parts which relate to sterility or metrology), a conformity assessment procedure requires the intervention of a notified body.

Notified bodies are independent organizations designated by EU member states to assess the conformity of devices before being placed on the market.

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The new Regulation among other things:

• strengthens the rules on placing devices on the market (e.g.

reclassification of certain devices and wider scope than the EU Medical Devices Directive) and reinforces surveillance once they are available;

• strengthens the rules on placing devices on the market (e.g., reclassification of certain devices and wider scope than the EU Medical Devices Directive) and reinforces surveillance once they are available;

• establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;

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Moreover, the “sell-off” deadline in the EU Medical Devices Regulation is deleted which aims to prevent unnecessary disposal of safe devices.

The transition period of devices is extended through to December 31, 2027 or December 31, 2028 depending on the device risk classification and certain other conditions being satisfied.

The transition period of devices is extended through December 31, 2027 or December 31, 2028 depending on the device risk classification and certain other conditions being satisfied.

On December 16, 2025, the European Commission proposed to amend the EU Medical Devices Regulation in order to simplify requirements, reduce administrative burden, and enhance the predictability and cost‑efficiency of notified body certification.

The proposal will now proceed through the ordinary legislative procedure, with the European Parliament and Council each discussing the European Commission’s proposal and potentially proposing revisions.

Formal adoption of the proposal is not expected before the second quarter of 2027.

The EU Medical Devices Regulation requires that before placing a device, other than a custom-made device, on the market, manufacturers (as well as other economic operators such as authorized representatives and importers) must register by submitting identification information to Eudamed, unless they have already registered.

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The new Regulation also requires that before placing a device, other than a custom-made device, on the market, manufacturers must assign a unique identifier to the device and provide it along with other core data to the unique device identifier (“UDI”) database.

These new requirements aim at ensuring better identification and traceability of

These new requirements aim at ensuring better identification and traceability of the devices.

Manufacturers are also notably responsible for entering the necessary data on Eudamed, which includes the UDI database, and for keeping it up to date.

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Until a certain module is functional and thus mandatory under Eudamed, the corresponding provisions of the EU Medical Devices Directive continue to apply for the purpose of meeting the obligations laid down in the provisions regarding exchange of information, including, and in particular, information regarding registration of devices and economic operators.

Commission Decision (EU) 2025/2371 declared the full functionality of the first four modules of Eudamed.

The modules include:

actor registration, UDI/device registration, notified bodies and certificates and market surveillance systems.

Under the transitional provisions set out in Regulation 2024/1860, this decision triggers a six-month transition period, after which the four modules will become mandatory from May 28, 2026.

All manufacturers placing medical devices on the market in the EU must comply with the EU medical device vigilance system which has been reinforced by the EU Medical Devices Regulation.

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The consultation indicated that the MHRA will publish guidance in relation to the changes to the regulatory framework and may rely more heavily on guidance to add flexibility to the regime.

A subsequent consultation on the new pre-market regime was opened on November 14, 2024.

A subsequent consultation on the new pre-market regime was opened on November 14, 2024 which closed on January 5, 2025.

The first part of the government response to the consultation was published on February 26, 2025 and the second part on July 22, 2025.

The responses will inform the regulatory reforms, which will introduce additional measures that must be taken before a device can be put on the market.

This new pre-market legislation will be implemented by way of amending the Medical Devices Regulations 2002 and is expected to come into effect in 2026.

By way of Statutory Instruments 2024 No.

1368, the UK introduced amendments to the UK Medical Device Regulations 2002 regarding post-market surveillance.

These amendments will come into effect on June 16, 2025.

1368, the UK already introduced amendments to the UK Medical Device Regulations 2002 regarding post-market surveillance.

These amendments came into effect on June 16, 2025.

In addition, the Trade and Cooperation Agreement between the UK and the EU that went into effect in 2021 generally provides for cooperation and exchange of information between the parties in the areas of product safety and compliance, including market surveillance, enforcement activities and measures, standardization-related activities, exchanges of officials, and coordinated product recalls.

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The aforementioned EU rules are generally applicable in the EEA.

On July 8, 2025, the European Commission published a proposal for the simplification of the current EU Cosmetics Regulation 1223/2009.

This includes planned simplifications in processes and documentation requirements, intended to facilitate the work of cosmetic product manufacturers.

The European Commission’s proposal is currently under review by the EU co-legislators (European Parliament and Council).

UK Regulation of Cosmetic Products following Brexit

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The main difference currently is that the UK Government has established a cosmetic product notification service to replace the EU’s CPNP in Great Britain, and that serious undesirable effects (“SUEs”) now should be notified on the new UK SUE form.

Regulation of Medicinal Products in the EU

Similar to the United States, products which are intended for use as a cosmetic could be reclassified as a medicinal product in view of certain claims, composition, functional characteristics, presentation, or other factors.

Medicinal products are regulated differently from cosmetics and require a marketing authorization before they can be placed on the EU market.

Authorization may be obtained through one of the EU authorization procedures and must be supported by appropriate quality, safety, and efficacy data.

The Company does not currently market any medicinal products in the EU;

however, it may in the future market certain products that would be considered prescription or non-prescription (OTC) medicines and would therefore be subject to EU and Member State medicinal product requirements.

In the European Economic Area (which is comprised of 27 Member States of the EU plus Norway, Iceland and Liechtenstein), medicinal products can only be commercialized after a related marketing authorization has been granted.

Marketing authorization for medicinal products can be obtained through several different procedures.

These are through a centralized, mutual recognition procedure, decentralized procedure, or national procedure (if marketing authorization is sought for a single EU Member State).

The holder of an EU marketing authorization for a medicinal product must also comply with the EU’s pharmacovigilance legislation.

This includes requirements to conduct pharmacovigilance, or the assessment and monitoring of the safety of medicinal products.

Various requirements apply to the manufacturing and placing on the EU market of medicinal products.

Manufacture of medicinal products in the EU requires a manufacturing authorization, and import of medicinal products into the EU requires a manufacturing authorization allowing for import.

The manufacturing authorization holder must comply with various requirements set out in the applicable EU laws, regulations and guidance.

These requirements include compliance with EU cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients (“APIs”), including the manufacture of APIs outside of the EU with the intention to import the APIs into the EU.

Similarly, the distribution of medicinal products within the EU is subject to compliance with the applicable EU laws, regulations and guidelines, including the requirement to hold appropriate authorizations for distribution granted by the competent authorities of the EU Member States.

Marketing authorization holders, manufacturing authorization holders, and/or distribution authorization holders may be subject to civil, criminal or administrative sanctions, including suspension of manufacturing authorization, in case of non-compliance with the EU or EU Member States’ requirements applicable to the manufacturing of medicinal products.

In the EU, the advertising and promotion of medicinal products are subject to EU Member States’ laws governing promotion of medicinal products, interactions with physicians and other healthcare professionals, misleading and comparative advertising and unfair commercial practices.

For example, applicable laws require that promotional materials and advertising in relation to medicinal products comply with the product’s Summary of Product Characteristics (the “SmPC”), as approved by the competent authorities in connection with a marketing authorization approval.

The SmPC is the document that provides information to physicians concerning the safe and effective use of the product.

Promotional activity that does not comply with the SmPC is considered off-label and is prohibited in the EU.

Breaches of the rules governing the promotion of medicinal products in the EU could be penalized by civil, criminal or administrative sanctions, which may include fines and imprisonment.

These laws may further limit or restrict the advertising and promotion of medicinal products to healthcare professionals.

Advertising of medicinal products that contain psychotropic and narcotic substances is in any case prohibited.

Environmental Regulations

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None of our employees are represented by a labor organization or are a party to any collective bargaining arrangement.

We believe we have good relations with our employees based on the results of an internal survey we conducted during the fourth quarter of 2024.

We believe we continue to maintain strong employee relations, which is consistent with employee feedback we received in prior years and reinforced through ongoing employee interactions and communication channels.

Talent Attraction and Development

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Our investments include providing programs to ensure our employees are equipped with the right skillsets and knowledge, as well as providing opportunities to transfer to other functions or regions through short-term and long-term assignments.

For instance, we provide our employees with a 3-5 day training program that informs and educates our employees about our business model, marketing strategies, and other related topics about our business operations.

For instance, we provide eligible employees with a 3-5 day training program that informs and educates our employees about our business model, marketing strategies, and other related topics about our business operations.

We believe these programs and opportunities create a pipeline of talent and leadership among our employees, while fostering a sense of shared ownership necessary to drive and deliver on our long-term strategy.

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We have enhanced our strategy in many areas including hiring, employee engagement, development, and talent management to further support diversity and inclusion across our organization.

For instance, we have identified several priorities designed to guide our efforts in this matter such as increasing diverse representation throughout our organization, creating an environment where every employee feels included and valued for who they are, and promoting equal opportunity in recruitment, hiring, training, development, and advancement across our organization.

For instance, we have identified several priorities designed to guide our efforts in this matter such as creating an environment where every employee feels included and valued for who they are, and promoting equal opportunity in recruitment, hiring, training, development, and advancement across our organization.

As of December 31, 2025, a breakdown of our workforce is as follows:

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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