What changed in this filing

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Item 1. Business

2026-03-03 compared with 2025-03-04 · 92 added, 119 removed, 225 unchanged (48% of the section changed)

We are a global performance beauty company with a customer-centric approach to delivering breakthrough products.

We are a global performance beauty company delivering breakthrough products with a customer-centric approach.

Our primary market is the cash-pay aesthetic market, which consists of medical products that consumers pay for directly out of pocket.

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Our Products and Product Candidates

Our currently commercially available product and our product candidates represent two of the largest product categories within medical aesthetics, injectable neurotoxins and injectable hyaluronic acid gels, respectively.

Jeuveau ® is our commercially available proprietary 900 kilodalton, or kDa, purified botulinum toxin type A formulation indicated for the temporary improvement in the appearance of moderate to severe glabellar lines, also known as “frown lines,” in adults.

Our current commercially available products and our product candidates represent two of the largest product categories within medical aesthetics, injectable neurotoxins and injectable hyaluronic acid (“HA”) gels.

Jeuveau ® is a proprietary 900 kilodalton (“kDa”), purified botulinum toxin type A formulation indicated for the temporary improvement in the appearance of moderate to severe glabellar lines, also known as “frown lines,” in adults.

Jeuveau ® offers a 900 kDa botulinum toxin alternative to BOTOX (onabotulinumtoxinA).

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We believe the comprehensive TRANSPARENCY clinical data set, including a head-to-head Phase III study comparing Jeuveau ® and BOTOX, provides physicians with confidence in recommending Jeuveau ® to their patients.

Jeuveau ® is currently available in the United States, Canada and certain European markets and we plan to make the product available in Australia and additional European markets.

Evolysse TM is a collection of injectable hyaluronic acid gels which utilize first-generation cold technology.

The line includes a variety of products including mid face, nasolabial folds, lips and eyes in the United States and Europe.

In October 2024, regulatory approval was received in the European Union for four products in the Evolysse™ line:

Jeuveau ® is currently available in the United States, Canada, certain European markets and Australia, and we plan to make the product available in additional European markets.

Evolysse™ is a collection of injectable HA gels that utilizes first-generation cold technology.

The line includes a variety of products including mid face, nasolabial folds, lips and eyes.

In October 2024, regulatory approval in the European Union was received for four products in the Evolysse™ line:

Evolysse™ Form, Evolysse™ Smooth, Evolysse™ Sculpt and Evolysse™ Lips.

In February 2025, we received approval from the U.S.

Food and Drug Administration, or FDA, for Evolysse™ Form and Evolysse™ Smooth injectable hyaluronic acid gels for wrinkles and folds, such as nasolabial folds.

We anticipate launching Evolysse™ Form and Evolysse™ Smooth in the United States in the second quarter of 2025.

We also anticipate launching all four approved Evolysse™ products in Europe in the second half of 2025.

We are seeking premarket approval, or PMA, with the FDA for Evolysse™ Sculpt and Evolysse™ Lips and, if approved, we expect to launch those products in the United States in 2026 and 2027, respectively.

Food and Drug Administration (“FDA”) for Evolysse™ Form and Evolysse™ Smooth injectable HA gels for wrinkles and folds, such as nasolabial folds.

In April 2025, we launched Evolysse™ Form and Evolysse™ Smooth in the United States indicated for wrinkles and folds, such as nasolabial folds, in adults.

We expect to launch all four Evolysse™ products in Europe in the second quarter of 2026 and anticipate two additional Evolysse™ products, Evolysse™ Sculpt and Evolysse™ Lips, to be approved in the United States in 2026 and 2027, respectively.

In August 2025, we announced the submission of a Premarket Approval Application (“PMA”) to the FDA for Evolysse™ Sculpt.

We anticipate that the FDA’s review will follow the standard PMA process, with approval expected in the second half of 2026.

The following chart details certain important features of our primary product lines:

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United States* - $3.2 billion

Europe** - $1.0 billion

Launching in 2025

Portfolio of injectable hyaluronic acids

Improvement of moderate to severe nasolabial folds facial wrinkles, mid face volume, lip fullness and infraorbital hollow correction

Addressable countries** - $1.1 billion

Commercial (Evolysse™ Form and Smooth in the United States).

European launch is expected in Q2 2026.

Portfolio of injectable HA gels

Improvement of moderate to severe wrinkles and folds, such as nasolabial folds facial wrinkles, mid face volume, lip fullness and infraorbital hollow correction

European Union - 2024 (4 products)

United States - 2025 (2 products)

United States* - $1.8 billion

Europe** - $1.0 billion

Medical Insight’s The Global Aesthetic Market Study

Clarivate Aesthetic Injectables Market Insights

United States - 2025 (2 products) United States* - $1.3 billion

Addressable countries** - $0.9 billion

Medical Insight’s The Global Aesthetic Market Study, Guidepoint Point of Sale Data

Clarivate Aesthetic Injectables Market Insights, BIP Consulting Market Analysis

The Medical Aesthetics Market Opportunity

According to Medical Insights, in 2024, total sales of professional medical aesthetic products were estimated to be $17.1 billion globally.

Through 2028, the total sales of professional medical aesthetic products is expected to expand by 7.0% per year to $21.9 billion.

Within this market, the facial injectables market, consisting of neurotoxins and hyaluronic acid gels, is estimated to be $10.9 billion in 2024 and is expected to grow to $14.5 billion in 2028.

We believe that the medical aesthetics market and the facial injectables market are poised for consistent growth driven by a number of factors, including:

• increased use by millennials and younger demographics who are increasingly seeking medical aesthetic treatments and utilizing neurotoxins as an entry point for aesthetic procedures due to their minimally invasive nature;

• an aging population together with an increasing life expectancy, which is resulting in more consumers with a desire for improved appearance and well-being over a longer period of time;

• rising disposable income, with the United States Bureau of Economic Analysis reporting that real disposable income in the United States increased approximately 29% from December 2014 to December 2024;

• growing awareness, including through social media, utilization and acceptance of elective or minimally invasive aesthetic procedures;

• continued innovation and improved accessibility to these treatments due to an increase in the number of aesthetic practitioners who perform these procedures.

Within the multiple age groups that utilize our products, we strategically focus our marketing efforts on the millennial segment which is the largest cohort in the United States population.

Millennials are defined as individuals born between 1981 and 1996.

We believe millennials view aesthetic treatments as integral to personal health and self-care, heavily influenced by social media and the internet.

Our Strategic Differentiation

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• Focus on the largest segments of the medical aesthetic market.

Aesthetic neurotoxins and hyaluronic acid gels are the largest and two of the fastest growing segments in the rapidly expanding global aesthetics market.

Aesthetic neurotoxins and injectable HA gels are the largest and two of the fastest growing segments in the rapidly expanding global aesthetics market.

With their high regulatory barriers to entry, these economically resilient product segments are poised for continued growth and adoption.

• Pursue an aesthetic-only strategy to enhance marketing and pricing flexibility along with improving transparency for our customers.

With a reduced regulatory burden compared to third-party payor reimbursed therapeutic products, there are a number of benefits that market participants in reimbursed markets are unable to achieve.

There are a number of benefits that market participants in reimbursed markets are unable to achieve, including reduced regulatory burden compared to third-party payor reimbursed therapeutic products.

Jeuveau ® is currently the only U.S.

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Regulatory Development

Hyaluronic Acid Gels Pipeline

The graphic below provides a summary of the current status of development of the Evolysse TM collection of hyaluronic acid gels in the United States and European Union and anticipated key milestones.

Injectable HA Gels Pipeline

The graphic below provides a summary of the current status of development of the Evolysse™ collection of injectable HA gels in the United States and European Union and anticipated key milestones.

In the United States, we obtained FDA approval of Evolysse™ Form and Evolysse™ Smooth in February 2025, and we are seeking a PMA approval for Evolysse™ Sculpt and Evolysse™ Lips.

In the European Union we obtained a CE mark for the Evolysse TM collection of hyaluronic acid gels in December 2024.

In the European Union, we obtained a CE mark for the Evolysse™ collection of injectable HA gels in December 2024.

Manufacturing

Daewoong Pharmaceuticals Co.

Ltd., or Daewoong, manufactures and supplies Jeuveau ® to us.

(“Daewoong”) manufactures and supplies Jeuveau ® to us.

Daewoong has over 70 years of experience manufacturing pharmaceutical products and is one of the largest pharmaceutical companies in South Korea.

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The Daewoong facility has been cleared by regulators in each jurisdiction in which Jeuveau ® is approved and is subject to continuous inspections from these regulators.

Symatese Aesthetics S.A.S., or Symatese, manufactures and supplies Evolysse TM for us.

Symatese has 25 years of experience in manufacturing biomaterials and over a decade of experience manufacturing hyaluronic-acid based gels which have been approved in the United States, Europe and elsewhere.

Symatese maintains a manufacturing facility outside Lyon, France for the production of Evolysse TM .

We believe this facility will be sufficient to meet the foreseeable demand for Evolysse TM .

Symatese Aesthetics S.A.S.

(“Symatese”) manufactures and supplies Evolysse™ to us.

Symatese has 25 years of experience in manufacturing biomaterials and over a decade of experience manufacturing HA based gels, which have been approved in the United States, Europe and elsewhere.

Symatese maintains a manufacturing facility outside Lyon, France for the production of Evolysse™.

We believe this facility will be sufficient to meet the foreseeable demand for Evolysse™.

In connection with regulatory approvals for the United States and Europe, the Symatese facility will be inspected by regulators in those countries.

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Symatese License, Supply and Distribution Agreements

On May 9, 2023, we entered into a License, Supply and Distribution Agreement, or the Symatese U.S.

Agreement, with Symatese, pursuant to which Symatese granted us an exclusive right to commercialize and distribute its five Evolysse™ hyaluronic acid gels product candidates, including the products referred to as:

On May 9, 2023, we entered into a License, Supply and Distribution Agreement (the “Symatese U.S.

Agreement”) with Symatese, pursuant to which Symatese granted us an exclusive right to commercialize and distribute its five Evolysse™ injectable HA gels product candidates, including the products referred to as:

(iii) Sculpt;

and (v) Eye in the United States for use in the aesthetics and dermatological field of use.

On December 20, 2023, we entered into a License, Supply and Distribution Agreement, or the Symatese Europe Agreement, pursuant to which Symatese granted to us an exclusive right to commercialize and distribute four hyaluronic acid gel product candidates, which are referred to as:

On December 20, 2023, we entered into a License, Supply and Distribution Agreement (the “Symatese Europe Agreement”), pursuant to which Symatese granted to us an exclusive right to commercialize and distribute four HA gel product candidates, which are referred to as:

(iii) Sculpt and (iv) Lips in 50 countries in Europe for use in the aesthetics and dermatological fields.

Under both agreements, which we refer to collectively as the Symatese agreements, we also have the right of first negotiation to obtain a license from Symatese to commercialize and distribute any new products developed using the same technology as the Evolysse™ collection of hyaluronic acid gels.

Both Symatese agreements require us to make certain minimum purchases in order to maintain the exclusivity of our licenses.

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Under the agreements, Symatese is responsible for all costs related to the manufacturing of Evolysse™ including costs related to the operation and upkeep of its manufacturing facility, and we are responsible for certain costs related to the registration of the Lips and Eye Products with the FDA and all costs related to commercialization of Evolysse™.

Under both agreements, Symatese will be responsible for and the sole owner of any marketing authorization and clinical trial results for the hyaluronic acid gel products.

Under both agreements, Symatese will be responsible for and the sole owner of any marketing authorization and clinical trial results for the injectable HA gel products.

Impact of Settlement Agreements

In February 2021, we settled certain litigation claims related to a complaint against us filed by Allergan, Inc.

and Allergan Limited, collectively Allergan, and Medytox, Inc.

International Trade Commission related to Jeuveau ® and certain related matters by entering into a Settlement and License Agreement with Medytox and Allergan, which we refer to as the U.S.

Settlement Agreement, and another Settlement and License Agreement with Medytox, which we refer to as the ROW Settlement Agreement.

We refer to the U.S.

Settlement Agreement and the ROW Settlement Agreement collectively as the Medytox Settlement Agreements.

In the first quarter of 2022, we made our second cash payment of $15.0 million, and in the first quarter of 2023, we completed our final cash payment of $5.0 million .

Our remaining obligation is to pay Medytox a mid-single digit royalty percentage on net sales of Jeuveau ® in the United States and all territories we have licensed outside the United States through September 16, 2032.

In February 2021, we settled certain litigation claims and entered into settlement and licensing agreements with Medytox, Inc.

(“Medytox”) related to Jeuveau ® .

We refer to these agreements as the Medytox Settlement Agreements.

Under the Medytox Settlement Agreements, we pay a mid-single digit percentage royalty on net sales of Jeuveau ® in the United States and all territories that we have licensed outside the United States through September 16, 2032.

Aesthetic Neurotoxins

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There are also other injectable botulinum toxin type A products being developed for the U.S.

We believe the primary competing products in this market include BOTOX, Dysport, Xeomin, Daxxify and Letybo:

• BOTOX, marketed by AbbVie, received FDA approval in 2002 for glabellar lines.

• Dysport, marketed by Galderma S.A., or Galderma, received FDA approval in 2009 for glabellar lines.

• Xeomin, marketed by Merz Pharma GmbH & Co., or Merz, received FDA approval in 2011 for glabellar lines.

• Daxxify, marketed by Revance Therapeutics, Inc., or Revance, received FDA approval in late 2022 for glabellar lines.

• Letybo, marketed by Hugel, Inc., or Hugel, received FDA approval in February 2024 for glabellar lines.

Additionally, Medytox, Inc.

and Galderma S.A.

have each submitted a Biologics License Application, or BLA, to the FDA for injectable botulinum toxin type A neurotoxins.

Within the U.S.

market we compete with botulinum toxin based products commercialized by Abbvie, Galderma S.A., Merz Pharma GmbH & CO, Revance Therapeutics, Inc., and Hugel, Inc.

Additionally, Medytox, Abbvie and Galderma have each submitted a Biologics License Application (“BLA”) to the FDA for injectable botulinum toxin products.

If any one of these BLAs is approved, we expect the competition in the U.S.

injectable botulinum toxin market to further increase.

Most of our primary competitors are also approved to sell injectable botulinum toxin type A neurotoxins in Europe and other markets that we may enter.

injectable botulinum toxin market to increase further.

Most of our primary competitors are also approved to sell injectable botulinum toxin in Europe and other markets that we may enter.

Dermal Filler Market

Our Evolysse™ collection of injectable hyaluronic acid gels competes in the Dermal Filler market in the United States.

The major competitive products in the United States are:

Hyaluronic Acid Based Dermal Fillers

• Juvéderm line of fillers, marketed by AbbVie.

• Restylane line of fillers, marketed by Galderma.

• Belotero line of fillers, marketed by Merz.

• RHA line of fillers, manufactured by Teoxane S.A.

and marketed by Revance.

• Revanesse line of fillers, marketed by Prollenium Medical Technologies, Inc.

Non-Hyaluronic Acid Dermal Fillers

• Sculptra Aesthetic, marketed by Galderma.

• RADIESSE line of fillers, marketed by Merz.

A number of companies are currently developing hyaluronic acid gels for the United States market.

Outside of the United States there are an even greater number of competitors with hyaluronic acid gel products available.

Our Evolysse™ collection of injectable HA gels competes in the dermal filler market in the United States.

Within the U.S.

market we compete with HA based dermal filler products commercialized by Abbvie, Galderma, Merz, Revance, Prollenium Medical Technologies and Obagi.

We also compete with non-HA based dermal fillers from Galderma and Merz.

A number of companies are currently developing HA gels for the United States market.

Outside of the United States there are an even greater number of competitors with injectable HA gel products available.

Other Medical Aesthetics Products

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Among these companies are AbbVie, Sanofi, Revance, Sun Pharma, Bausch Health Companies, Mentor Worldwide LLC, a division of Johnson & Johnson, Merz, Galderma, and Skinceuticals, a division of L’Oreal SA.

We have not observed significant seasonality in our net revenues in recent years.

However, we are aware that sales of aesthetic neurotoxins and dermal fillers are historically subject to the impact of traditional seasonality in the medical aesthetic market, which generally experiences higher revenue in the second and fourth calendar quarters as compared to the first and third calendar quarters.

The sales of aesthetic neurotoxins and injectable HA gels are historically subject to the impact of traditional seasonality in the medical aesthetic market, which generally experiences higher revenue in the second and fourth calendar quarters as compared to the first and third calendar quarters.

Government Regulation in the United States

We operate in a highly regulated industry that is subject to significant federal, state, local and foreign regulation.

Our business has been, and will continue to be, subject to a variety of laws including the Federal Food Drug and Cosmetic Act, or FFDCA, and the Public Health Service Act, or the PHS Act, among others.

Biologics, such as our neurotoxin product, and medical devices, including our hyaluronic acid gel product candidates, are subject to regulation under the FFDCA and PHS Act.

Our business has been, and will continue to be, subject to a variety of laws including the Federal Food Drug and Cosmetic Act (“FFDCA”), and the Public Health Service Act (the “PHS Act”), among others.

Biologics, such as our neurotoxin product, and medical devices, including our injectable HA gel products and product candidates, are subject to regulation under the FFDCA and PHS Act.

In the United States, biopharmaceutical products and medical devices are subject to extensive regulation by the FDA.

The FFDCA, PHS Act, and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, regulatory approval, license or clearance, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of these products.

The FFDCA, PHS Act, and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacturing, storage, recordkeeping, regulatory approval, license or clearance, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of these products.

Failure to comply with applicable U.S.

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The process required by the FDA before a biological product may be marketed in the United States generally involves the following:

• completion of nonclinical laboratory tests and animal studies according to good laboratory practices, or GLPs, and applicable requirements for the humane use of laboratory animals or other applicable regulations;

• submission to the FDA of an investigative new drug application, or IND, which must become effective before human clinical trials may begin;

• performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed biological product for its intended use, according to the FDA’s regulations, commonly referred to as good clinical practices, or GCPs, and any additional requirements including those for the protection of human research subjects and their health and other personal information;

• completion of nonclinical laboratory tests and animal studies according to good laboratory practices (“GLPs”) and applicable requirements for the humane use of laboratory animals or other applicable regulations;

• submission to the FDA of an investigative new drug application (“IND”), which must become effective before human clinical trials may begin;

• performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed biological product for its intended use, according to the FDA’s regulations, commonly referred to as good clinical practices, and any additional requirements including those for the protection of human research subjects and their health and other personal information;

• submission to the FDA of a BLA for marketing approval that includes substantive evidence of safety;

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Adverse event reporting and submission of periodic reports is required following the FDA approval of a BLA.

The FDA also may require post-marketing testing, known as Phase IV testing, Risk Evaluation and Mitigation Strategies, or REMS, and surveillance to monitor the effects of an approved product or place conditions on an approval that could restrict the distribution or use of the product.

The FDA also may require post-marketing testing, known as Phase IV testing, Risk Evaluation and Mitigation Strategies (“REMS”), and surveillance to monitor the effects of an approved product or place conditions on an approval that could restrict the distribution or use of the product.

In addition, quality control as well as product manufacturing, packaging and labeling procedures must continue to conform to cGMP after approval.

Manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA during which the agency inspects manufacturing facilities to assess compliance with applicable regulations such as cGMP and the Quality System Regulation.

Accordingly, manufacturers must continue to expend time, money and effort in the areas of production and quality control to maintain compliance with cGMP.

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Pursuant to the FFDCA, medical devices are subject to varying degrees of regulatory control and are classified in one of three classes depending on the controls the FDA determines necessary to reasonably ensure their safety and effectiveness.

Class I devices are those for which reasonable assurance of safety and effectiveness can be provided by adherence to the FDA’s general controls for medical devices, which include applicable portions of the FDA’s Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse medical events and appropriate, truthful and non-misleading labeling, advertising and promotional materials.

Class I devices are those for which reasonable assurance of safety and effectiveness can be provided by adherence to the FDA’s general controls for medical devices, which include applicable portions of the FDA’s Quality Management System Regulation (“QMSR”), facility registration and product listing, reporting of adverse medical events and appropriate, truthful and non-misleading labeling, advertising and promotional materials.

Many Class I devices are exempt from premarket regulation;

however, some Class I devices require premarket clearance by the FDA through the 510(k) premarket notification process described below.

Class II devices are subject to the FDA’s general controls, and any other special controls, such as performance standards, post-market surveillance, and the FDA guidelines, deemed necessary by the FDA to provide reasonable assurance of the devices’ safety and effectiveness.

devices’ safety and effectiveness.

Premarket review and clearance by the FDA for Class II devices are accomplished through the 510(k) premarket notification procedure, although some Class II devices are exempt from the 510(k) requirements.

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The FDA also may convene an advisory panel of outside experts to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.

In addition, the FDA generally will conduct a pre-approval inspection of the manufacturing facility to ensure compliance with the QSR.

In addition, the FDA generally will conduct a pre-approval inspection of the manufacturing facility to ensure compliance with the QMSR.

The FDA can delay, limit or deny approval of a PMA application for many reasons.

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A clinical trial may be required in support of a 510(k) submission and generally is required for a PMA application.

These trials generally require an Investigational Device Exemption, or IDE, approved by the FDA for a specified number of patients, unless the product is exempt from IDE requirements or deemed a non-significant risk device eligible for more abbreviated IDE requirements.

These trials generally require an Investigational Device Exemption (“IDE”), approved by the FDA for a specified number of patients, unless the product is exempt from IDE requirements or deemed a non-significant risk device eligible for more abbreviated IDE requirements.

The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.

Clinical trials may begin 30 days after the submission of the IDE application unless the FDA disapproves the IDE or places the trial on clinical hold.

Additionally, clinical trials may not begin until their protocol and informed consent receive approval from the appropriate institutional review boards, or IRBs, at the clinical trial sites.

Additionally, clinical trials may not begin until their protocol and informed consent receive approval from

the appropriate institutional review boards (“IRBs”), at the clinical trial sites.

All clinical trials must be conducted in accordance with the FDA’s IDE regulations.

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Device manufacturers must register their facilities and list their devices with the FDA.

A device manufacturer’s manufacturing processes and those of some of its suppliers are required to comply with the applicable portions of the QSR, which covers quality management, design, production and process controls, quality assurance, labeling, packaging, shipping, and complaint handling.

A device manufacturer’s manufacturing processes and those of some of its suppliers are required to comply with the applicable portions of the QMSR, which covers quality management, design, production and process controls, quality assurance, labeling, packaging, shipping, and complaint handling.

Device manufacturers must submit to the FDA medical device reports for deaths, serious injuries, and certain malfunctions and report certain field corrections and product recalls or removals.

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Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

public warning letters, fines, injunctions, civil or criminal penalties, recall or seizure of products, operating restrictions, partial suspension or total shutdown of production, delays in or denial of 510(k) clearance or PMA applications for new products, challenges to existing 510(k) clearances or PMA applications, and a recommendation by

the FDA to disallow a device manufacturer from entering into government contracts.

The FDA also has the authority to request repair, replacement or refund of the cost of any device manufactured or distributed.

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Other Regulation of the Healthcare Industry

While we do not currently have plans for our products to be covered by insurance or government reimbursement programs, if we were to offer reimbursable products, we could be subject to federal laws and regulations covering reimbursable products, such as the Anti-Kickback Statute, Stark Law and Physician Payment Sunshine Act.

These laws that may affect our ability to operate include, but are not limited to:

The laws that may affect our ability to operate include, but are not limited to:

• The Anti-Kickback Statute, which prohibit persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual, or furnishing or arranging for a good or service, for which payment may be made under a federal healthcare program;

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• The Foreign Corrupt Practices Act (“FCPA”), which prohibits certain payments made to foreign government officials;

• The Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services relating to healthcare matters;

• The Federal Physician Payments Sunshine Act, and its implementing regulations, which require that certain manufacturers of drugs, medical devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report to the Centers for Medicare & Medicaid Services, or CMS, information related to certain payments or other transfers of value made or distributed to physicians, which is defined broadly to include other healthcare providers, teaching hospitals, and ownership and investment interests held by physicians and their immediate family members;

• The Federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services relating to healthcare matters;

• The Federal Physician Payments Sunshine Act, and its implementing regulations, which require that certain manufacturers of drugs, medical devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report to the Centers for Medicare & Medicaid Services (“CMS”), information related to certain payments or other transfers of value made or distributed to physicians, which is defined broadly to include other healthcare providers, teaching hospitals, and ownership and investment interests held by physicians and their immediate family members;

• State and foreign law equivalents of the foregoing and state laws regarding pharmaceutical company marketing compliance, reporting and disclosure obligations.

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EU Regulation of Biologics

In the European Economic Area, or EEA (which is composed of the 27 Member States of the EU plus Norway, Iceland and Liechtenstein), medicinal products can only be commercialized after obtaining a Marketing Authorization, or MA.

In the European Economic Area (“EEA”) (which is composed of the 27 Member States of the EU plus Norway, Iceland and Liechtenstein), medicinal products can only be commercialized after obtaining a Marketing Authorization (“MA”).

There are two types of MAs:

• The Community MA, which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or

• The Community MA, which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use (“CHMP”), of the European Medicines Agency (“EMA”).

and which is valid throughout the entire territory of the EEA.

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CE marking a device involves working with a Notified Body (or in some cases, for the lowest risk class devices, the manufacturer can self-certify) to demonstrate that the device meets all applicable requirements of the EU medical devices legislation and that the Quality Management System is compliant.

The EU’s Medical Device Directive, or MDD, has been replaced by the EU Medical Device Regulation, or EU MDR, enacted in 2017, and which became effective on May 26, 2021.

The EU’s Medical Device Directive (“MDD”), has been replaced by the EU Medical Device Regulation (“EU MDR”), enacted in 2017, and which became effective on May 26, 2021.

EU MDR requirements will phase in on a product-by-product basis as certifications issued under the MDD lapse and will require all products to undergo review and approval under these new regulations.

The timing for this transition has been extended from no later than May 26, 2024 to December 2027 or December 2028, depending on device classification, provided certain conditions are met with regard to the new regulation, one of which being that all submissions are filed by May 26, 2024.

The EU MDR will generally require increased levels of clinical data as compared to MDD requirements, and all product technical data must comply to the latest standards regardless of when the product was initially developed.

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The UK formally left the EU on January 31, 2020.

The EU and the UK have concluded a trade and cooperation agreement, or TCA, which was provisionally applicable since January 1, 2021 and has been formally applicable since May 1, 2021.

The EU and the UK have concluded a trade and cooperation agreement (“TCA”), which was provisionally applicable since January 1, 2021 and has been formally applicable since May 1, 2021.

The TCA includes specific provisions concerning pharmaceuticals, which include the mutual recognition of GMP, inspections of manufacturing facilities for medicinal products and GMP documents issued, but does not foresee wholesale mutual recognition of UK and EU pharmaceutical regulations.

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The regulatory regime in Great Britain therefore currently aligns with EU regulations in many ways, however it is possible that these regimes will diverge more significantly in the future now that Great Britain’s regulatory system is independent from the EU.

In respect of medical devices, since the end of the Brexit transitional period on January 1, 2021, new regulations require medical devices to be registered with the Medicines and Healthcare products Regulatory Agency, or MHRA (the UK medicines and medical devices regulator) before being placed on the Great Britain market.

The MHRA will only register devices where the manufacturer or their United Kingdom Responsible Person has a registered place of business in the United Kingdom.

As of July 1, 2023, in Great Britain, all medical devices will require a UKCA (UK Conformity Assessed) mark.

UCKA marking will, however, not be recognized in the EU.

The rules for placing medical devices on the market in Northern Ireland, which is part of the United Kingdom, differ from those in the rest of the United Kingdom.

In respect of medical devices, devices placed on the market in Great Britain (England, Scotland and Wales) must be registered with the Medicines and Healthcare products Regulatory Agency (“MHRA”).

Manufacturers based outside the United Kingdom must appoint a United Kingdom Responsible Person with a registered place of business in the United Kingdom to register the device with the MHRA.

The United Kingdom has introduced the UK Conformity Assessed (“UKCA”) marking regime for medical devices;

however, under current transitional arrangements, CE-marked devices that comply with applicable EU legislation may continue to be placed on the Great Britain market for a limited period, subject to specified conditions and evolving regulatory requirements.

UKCA marking is not recognized in the European Union.

The regulatory framework applicable in Northern Ireland differs from that in Great Britain and, pursuant to the Windsor Framework, continues to align in significant respects with EU medical device legislation.

Regulation Outside of the United States and Europe

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The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval or MA approval.

requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

Data Privacy and Security Laws and Regulations

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jurisdictions in which we conduct our business.

For example, HIPAA, as amended by the Health Information Technology and Clinical Health Act, or HITECH, and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information.

For example, HIPAA, as amended by the Health Information Technology and Clinical Health Act (“HITECH”), and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information.

Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates,” those independent contractors or agents of covered entities that create, receive, maintain, transmit or obtain protected health information in connection with providing a service on behalf of a covered entity.

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For example, the Federal Trade Commission uses its consumer protection authority to initiate enforcement actions in response to alleged privacy and data security violations.

Further, certain states have proposed or enacted legislation that will create new data privacy and security obligations for certain entities, such as the California Consumer Privacy Act, or CCPA, which came into effect January 1, 2020 and was recently amended and expanded by the California Privacy Rights Act, or the CRPA, passed on November 3, 2020.

The CCPA and CPRA, among other things, create new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information.

Further, certain states have proposed or enacted legislation that will create new data privacy and security obligations for certain entities, such as the California Consumer Privacy Act (“CCPA”), which came into effect January 1, 2020 and was amended and expanded by the California Privacy Rights Act (the “CRPA”), passed on November 3, 2020.

The CCPA and CPRA, among other things, create data privacy obligations for covered companies and provides privacy rights to California residents, including the right to opt out of certain disclosures of their information.

The CCPA also created a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach.

It remains unclear what, if any, additional modifications will be made to the CPRA by the California legislature or how it will be interpreted.

Therefore, the effects of the CCPA and CPRA are significant and will likely require us to modify our data processing practices and may cause us to incur substantial costs and expenses to comply, particularly given our base of operations in California.

Environmental Regulation

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Human Capital Resources

As of December 31, 2024, we had 332 employees, all of whom were full-time in the United States, Canada and Europe, and 57% of our full-time employees were women.

None of our employees are represented by labor unions or covered by collective bargaining agreements, and we have never experienced any work stoppage.

As of December 31, 2025, we had 334 employees, all of whom were full-time in the United States, Canada, Europe, and Australia, and 67% of our full-time employees were women.

We believe we have good relations with our employees.

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We are committed to a Total Rewards strategy that complements our mission, culture, and business objectives.

Our goal is to provide competitive compensation and benefit programs that drive a high level of employee satisfaction and allow us to attract and retain the best and brightest talent.

Our goal is to provide competitive compensation and benefit programs that drive a high level of employee satisfaction, allowing us to attract and retain the best and brightest talent.

We want employees to feel at their best and be at their best so they can make a profound impact on our culture, community and business results.

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This empowers employees to take ownership over their career and development trajectory.

Long-term incentives in the form of equity (Stock Options and RSUs) provide a sense of ownership in the company’s long-term success and help retain talent that can make a difference.

Long-term incentives in the form of equity (Stock Options and restricted stock units) provide a sense of ownership in our company’s long-term success and help retain talent that can make a difference.

We also provide a robust and highly competitive benefits package to ensure employees’ personal and family needs are met whether it’s health (medical/dental/vision), wealth and retirement (401(k) with competitive employer match), or well-being (flexible PTO, paid leave, wellness coaching).

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We provide our employees with access to a variety of health and wellness programs, including programs that support physical and mental health and well-being by providing tools, resources, and coaching to help them improve or maintain a healthy lifestyle.

We maintain a healthy workplace by encouraging employees to work remotely if feeling ill and offering a hybrid work schedule.

We also offer a hybrid work schedule.

Inclusion and Belonging

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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