What changed in this filing

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Item 1. Business

2025-03-04 compared with 2024-03-07 · 56 added, 113 removed, 288 unchanged (37% of the section changed)

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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 dermal fillers, 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.

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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 line of hyaluronic acid dermal fillers which utilizes first-generation cold technology currently in regulatory development.

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.

Regulatory approval has been received for the Evolysse TM nasolabial fold product in Europe and the remaining three products are anticipated to be approved in late 2024.

We anticipate a Premarket Approval, or PMA, applications for the first two Evolysse™ dermal filler products will be submitted to the U.S.

Food and Drug Administration by mid-year 2024.

The United States regulatory approval and commercial launch is expected in 2025 for the first two products with subsequent regulatory approval and product launches for the three remaining products in 2026 and 2027.

In October 2024, regulatory approval was received in the European Union 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.

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

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Europe** - $1.0 billion

Product Candidate in Regulatory Development

Portfolio of injectable hyaluronic-acid based dermal fillers.

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

Europe - Anticipated Late 2024

United States - Anticipated 2025

European Union - 2024 (4 products)

United States - 2025 (2 products)

United States* - $1.8 billion

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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 dermal fillers, is estimated to be $9.5 billion in 2023 and is expected to grow to $13.3 billion in 2027.

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:

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• 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 receive aesthetic neurotoxin treatments, we strategically focus our marketing efforts on the millennial segment which is the largest cohort in the United States population.

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.

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

Aesthetic neurotoxins and dermal fillers are the largest and two of the fastest growing segments in the rapidly expanding global aesthetics market.

Aesthetic neurotoxins and hyaluronic acid 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.

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• Establish a leading medical aesthetics company with a diversified product offering by in-licensing technology, developing partnerships and potentially acquiring products.

Clinical Evidence/Regulatory Development

Jeuveau ® - TRANSPARENCY:

Evolus Clinical Development for Glabellar Lines

Our TRANSPARENCY clinical program was a comprehensive five-study clinical development program for Jeuveau ® and was used to meet international regulatory requirements.

The TRANSPARENCY program included three Phase III studies titled EV-001, EV-002 and EVB-003.

Treatment of the Glabellar lines was based on a 4-point photonumeric Glabellar Line Scale, or GLS, where 0=no lines, 1=mild lines, 2=moderate lines and 3=severe lines.

Phase III Clinical Trials – Composite End Point Versus Placebo

The two identical U.S.

Phase III studies, EV-001 and EV-002, enrolled a combined 654 adults who had moderate to severe glabellar lines at maximum frown.

Subjects were randomly assigned in a 3:1 ratio to receive a single treatment of either Jeuveau ® or placebo.

The primary efficacy endpoint was defined as the proportion of subjects classified as responders on Day 30.

A subject was considered a responder only if both the investigator and the subject independently agreed that there was a 2 point improvement or greater on the GLS from Day 0 to Day 30 at maximum frown.

This type of endpoint where both the investigator and subject must agree is known as a composite endpoint.

Both of the U.S.

Phase III studies met the primary endpoint of superiority over placebo.

The percentages of responders in the intent to treat population were:

1.2% placebo, 67.5% Jeuveau ® , with an absolute difference between the groups of 66.3%, 95% CI (59.0, 72.4)

1.3% placebo, 70.4% Jeuveau ® , with an absolute difference between the groups of 69.1%, 95% CI (61.5, 75.1)

EU Phase III Clinical Trials – Head-to-Head Comparison of Jeuveau ® , Botox and Placebo

The EVB-003 study was the third Phase III safety and efficacy study in the TRANSPARENCY Program and compared the efficacy of Jeuveau ® , Botox and Placebo.

The study was conducted in Europe and Canada and enrolled 540 adults who (i) the investigator assessed to have moderate to severe glabellar lines and (ii) who felt their glabellar lines had an important psychological impact, such as on their mood, anxiety or depressive symptoms.

Subjects were randomly assigned in a 5:5:1 ratio to receive a single treatment of 20 units of Jeuveau ® , 20 units of BOTOX or placebo.

The primary efficacy endpoint was defined as the proportion of subjects classified as responders on Day 30.

A responder was a subject with a GLS score of 0 or 1, as assessed by the investigator at maximum frown.

The primary analysis of the primary efficacy endpoint in the EVB-003 study showed the superiority of Jeuveau ® over placebo, and established non-inferiority of Jeuveau ® to BOTOX.

The percentages of responders for the primary efficacy endpoint were:

• 4.2% in the placebo group, 95% CI (0.0, 9.8);

• 82.8% in the BOTOX group, 95% CI (78.1, 87.5);

• 87.2% in the Jeuveau ® group, 95% CI (83.0, 91.5).

A confidence interval, or CI, is a range of values in which, statistically, there is a specified level of confidence where the result lies.

As an example, in the results above for this Phase III study, the results indicate that there is a 95% level of confidence that the responder rate for placebo was between 0.0% and 9.8%, which we express as:

95% CI (0.0, 9.8).

The absolute differences between the treatment groups were:

• 83.1% between Jeuveau ® and placebo groups, 95% CI (70.3, 89.4), (p<0.001), indicating Jeuveau ® was superior to placebo;

• 4.4% between Jeuveau ® and BOTOX groups, 95% CI (-1.9, 10.8), with non‑inferiority of Jeuveau ® versus BOTOX concluded based on the lower bound of the 95% CI for the absolute difference exceeding -10.0%.

EU Phase III Primary Endpoint - Responder Rates at Maximum Frown on Day 30 (GLS = 0 or 1) by Investigator Assessment EU Phase III Primary Endpoint - Non-Inferiority, at Maximum Frown on Day 30 by Investigator Assessment

EU Phase III Trial - Select Secondary Endpoints

*P-Value Placebo vs Jeuveau ® <0.001

TRANSPARENCY Safety Evaluations

Safety was studied across all five studies that made up the TRANSPARENCY Clinical Program.

Jeuveau ® was relatively well tolerated with no drug related serious adverse events, or SAEs.

Most adverse events were mild and the labeling information for Jeuveau ® lists the most common adverse reactions as headache (9.3%), eyelid ptosis (2.0%), upper respiratory tract infections (3%) and increase white blood cell count (1%).

Dermal Filler Pipeline

The graphic below provides a summary of the current status of development of the Evolysse TM line of dermal fillers in the United States and European Union and anticipated key milestones.

In the United States we are seeking a PMA with the FDA.

In the European Union we are seeking a CE mark for the Evolysse TM line of dermal fillers.

Other Clinical Evaluations

Phase II “Extra-Strength” Jeuveau ® Clinical Trial

In November 2021, we announced the initiation of a Phase II clinical trial designed to investigate a higher strength dose of Jeuveau ® in the glabellar lines.

This planned glabellar line study is a controlled, randomized, prospective, double blind, three-arm trial following patients out to a maximum of 12 months.

Three-arms will be enrolled:

the currently approved 20 units of BOTOX and 20 units of Jeuveau ® compared to 40 units of “extra-strength” Jeuveau ® .

In January 2023, we announced positive interim results from the Phase II clinical trial.

The interim data analysis of the “extra-strength” formulation of Jeuveau ® demonstrated a median duration of at least 26 weeks based on the time for patients to return to their original glabellar line scale score (baseline) and the duration of at least one point improvement on the same scale.

The safety results included 33 adverse events, 88% of which rated as mild and 12% of which rated at moderate.

There were no severe or serious adverse events observed in the safety results.

In June 2023, we announced the successful completion of the Phase II clinical trial and in November 2023, we presented the final results of the “extra-strength” clinical trial.

The clinical trial data showed that the “extra-strength” formulation of Jeuveau ® had a similar safety profile to the controls and demonstrated a median duration of at least 26 weeks based on the time for patients to return to baseline after treatment.

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.

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.

Manufacturing

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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 dermal fillers which have been approved in the United States, Europe and elsewhere.

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 .

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

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

Daewoong License and Supply Agreement

In 2013, we entered into the Daewoong Agreement, which has been amended from time to time, pursuant to which Daewoong agreed to manufacture and supply Jeuveau ® and grant us an exclusive license to import, distribute, promote, market, develop, offer for sale and otherwise commercialize and exploit Jeuveau ® for aesthetic indications in the United States, EU, United Kingdom, members of the European Economic Area, Switzerland, Canada, Australia, New Zealand, and South Africa, as well as co-exclusive distribution rights with Daewoong in Japan.

In 2013, we entered into a License and Supply Agreement with Daewoong, the Daewoong Agreement, which has been amended from time to time, pursuant to which Daewoong agreed to manufacture and supply Jeuveau ® and grant us an exclusive license to import, distribute, promote, market, develop, offer for sale and otherwise commercialize and exploit Jeuveau ® for aesthetic indications in the United States, EU, United Kingdom, members of the European Economic Area, Switzerland, Canada, Australia, New Zealand, and South Africa, as well as co-exclusive distribution rights with Daewoong in Japan.

Under the Daewoong Agreement, we are required to make certain minimum annual purchases in order to maintain the exclusivity of the license.

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Symatese License, Supply and Distribution Agreements

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™ dermal filler product candidates, including the products referred to as:

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:

(iii) Sculpt;

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

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™ line of dermal fillers.

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 dermal filler product candidates, which are referred to as:

(iii) Sculpt and (iv) Lips (collectively, the “European Filler Products”) in 50 countries in Europe for use in the aesthetics and dermatological fields.

We also have the right of first negotiation to obtain a license from Symatese to commercialize and distribute certain other new products developed using the same technology as the European Filler Products.

Regulatory approval has been received for the Evolysse™ nasolabial fold product in Europe and the remaining three products are anticipated to be approved in late 2024.

United States regulatory approval remains on track to begin in 2025.

We plan to commence commercialization of the approved product lines in 2025 with subsequent product launches in 2026 and 2027.

Under both Symatese Agreements we are required to make certain minimum purchases in order to maintain the exclusivity of our licenses.

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:

(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.

Both agreements have a 15-year term from the first product that is approved under the agreement and contain unlimited automatic renewal terms of 5-years thereafter.

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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 dermal filler products.

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.

Impact of Settlement Agreements

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

and Allergan Limited (together, “Allergan”) and Medytox, Inc.

(“Medytox”) in the U.S.

International Trade Commission related to Jeuveau ® (the “ITC Action”) 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 Medytox Settlement Agreement.

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 Medytox Settlement Agreement collectively as the Medytox/Allergan Settlement Agreements.

We have completed all obligations to Allergan and the majority of our obligations to Medytox under the Medytox/Allergan Settlement Agreements.

These completed obligations consisted of (i) cash payments totaling $35.0 million to Allergan and Medytox, of which we paid $15.0 million in the third quarter of 2021, $15.0 million in the first quarter of 2022, and $5.0 million in the first quarter of 2023, (ii) royalty payments to Allergan and Medytox on the sale of Jeuveau ® , based on a certain dollar amount per vial sold of Licensed Products by or on our behalf in the United States, from December 16, 2020 through September 16, 2022, (iii) royalty payments to Medytox, from December 16, 2020 to September 16, 2022, of a low-double digit percentage of net sales of Jeuveau ® sold by us or on our behalf in territories we have licensed outside the United States, and (iv) the issuance of 6,762,652 shares of our common stock to Medytox.

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.

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and Galderma S.A.

have each submitted a BLA to the FDA for injectable botulinum toxin type A neurotoxins.

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

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

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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.

Dermal Fillers

There are a number of dermal fillers currently offered in the United States.

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:

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• Juvéderm line of fillers, marketed by AbbVie.

• Restylane line of fillers, which are marketed by Galderma.

• Restylane line of fillers, marketed by Galderma.

• Belotero line of fillers, marketed by Merz.

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• RADIESSE line of fillers, marketed by Merz.

A number of companies are currently developing dermal fillers for the United States market.

Outside of the United States there are an even greater number of competitors with dermal filler products available.

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.

Other Medical Aesthetics Products

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

However, we are aware that sales of aesthetic neurotoxins 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.

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.

Government Regulation in the United States

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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, such as our dermal filler product candidates, are subject to regulation under the FFDCA and PHS Act.

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.

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

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Under the FFDCA, a manufacturer submits a premarket notification 90 days before introducing a device into interstate commerce, but the FDA’s review of the premarket notification can take significantly longer.

If the FDA determines that the device is substantially equivalent to the predicate device(s), the subject device may be

If the FDA determines that the device is substantially equivalent to the predicate device(s), the subject device may be marketed.

However, if the FDA makes a not substantially equivalent determination, then the device would be regulated as a Class III device, discussed below.

If a manufacturer obtains a 510(k) clearance for its device and then makes a modification could significantly affect the device’s safety or effectiveness, a new premarket notification must be submitted to the FDA.

If a manufacturer obtains a 510(k) clearance for its device and then makes a modification that could significantly affect the device’s safety or effectiveness, a new premarket notification must be submitted to the FDA.

Class III devices are deemed by the FDA to pose the greatest risk, such as those for which reasonable assurance of the device’s safety and effectiveness cannot be assured solely by the general controls and special controls described above and that are life-sustaining or life-supporting.

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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 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 neurotoxin product or our dermal filler product candidate 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.

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:

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• 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 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 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;

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

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

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

The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, and medicinal products indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and viral diseases.

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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.

By July 1, 2023, in Great Britain, all medical devices will require a UKCA (UK Conformity Assessed) mark but CE marks issued by EU notified bodies will remain valid until December 2024.

Manufacturers may choose to use the UKCA mark on a voluntary basis until June 30, 2023.

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.

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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.

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

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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We make available, free of charge, on our website at www.evolus.com our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments to such reports, as soon as reasonably practicable after such reports are electronically filed with, or furnished to, the SEC.

All such reports are also available free of charge via EDGAR

through the SEC website at www.sec.gov.

All such reports are also available free of charge via EDGAR through the SEC website at www.sec.gov.

We do not incorporate the information on or accessible through these websites into this Annual Report on Form 10-K, and you should not consider any information on, or that can be accessed through, these websites a part of this Annual Report on Form 10-K or any other filing we make with the SEC.

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