What changed in this filing

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Item 1. Business

2024-03-07 compared with 2023-03-08 · 219 added, 117 removed, 182 unchanged (65% of the section changed)

We are a performance beauty company with a customer-centric approach to delivering breakthrough products in the self-pay aesthetic market.

Our first commercial product is Jeuveau ® , which is a 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 primary market is the self-pay aesthetic market, which includes medical products purchased by physicians and other customers that are then sold to consumers or used in procedures for aesthetic indications that are not reimbursed by any third-party payor, such as Medicaid, Medicare or commercial insurance.

We believe we offer customers and consumers a compelling value proposition with Jeuveau ® .

Currently, BOTOX (onabotulinumtoxinA) is the neurotoxin market leader, and prior to the approval of Jeuveau ® , was the only known 900 kDa botulinum toxin type A complex approved in the United States.

We believe aesthetic physicians generally prefer the performance characteristics of the complete 900 kDa neurotoxin complex and are accustomed to injecting this formulation.

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

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

Our customers are aesthetic practitioners who are properly licensed to deliver our products.

By avoiding the regulatory burdens that accompany reimbursed products and pursuing an aesthetic-only non-reimbursed product strategy, we believe that we create flexibility to deliver a unique value proposition to our customers.

We utilize this flexibility to drive customer adoption efforts through programs such as our consumer loyalty program, co-branded marketing programs, promotional events and pricing strategies.

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.

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

We believe aesthetic practitioners generally prefer the performance characteristics of the complete 900 kDa neurotoxin complex and are accustomed to injecting this formulation.

Jeuveau ® is bolstered by the results from our TRANSPARENCY global clinical program which included more than 2,100 patients and provides robust data to physicians evaluating the purchase of Jeuveau ® .

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

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.

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

Estimated Market Size in 2027

Injectable botulinum toxin type A

Temporary improvement in the appearance of frown lines in adults.

United States - 2019

In February 2019, we received the approval of our first product Jeuveau ® (prabotulinumtoxinA-xvfs) from the U.S.

Food and Drug Administration, or FDA.

In May 2019, we commercially launched Jeuveau ® in the United States.

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.

We completed our patient enrollment in the clinical study evaluating the “extra-strength” dose in the second quarter of 2022 and the trial is expected to be completed in the first half of 2023.

If this indication is approved by the FDA after our completion of all necessary clinical trials and regulatory submissions (including a Phase III clinical trial), we will have the opportunity to offer an extra-strength dosage option, which may make Jeuveau ® the first multi-strength neurotoxin and give customers and consumers increased treatment options.

International

In August 2018, we received approval from Health Canada for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients under 65 years of age.

We began marketing Jeuveau ® in Canada in October 2019 through our distribution partner, Clarion Medical Technologies, Inc., or Clarion.

In September 2019, we received approval from the European Commission, to market Jeuveau ® in all 27 European Union, or EU, member states plus the United Kingdom, Iceland, Norway and Liechtenstein.

In January 2021, we received a positive decision from the European Commission to add the 50 unit product to the existing approval obtained in September 2019.

We commercially launched Jeuveau ® in Great Britain in September 2022, in Germany and Austria in February 2023, and we are finalizing plans for entering additional countries in Europe as part of a phased rollout.

In January 2023, we received approval from the Australian Therapeutics Good Administration, or TGA, for regulatory approval of our neurotoxin in Australia.

Our primary market is self-pay aesthetic healthcare, which includes medical products purchased by physicians that are then sold to consumers or used in procedures for aesthetic indications that are not reimbursed by any third-party payor, such as Medicaid, Medicare or commercial insurance.

By focusing on the self-pay medical aesthetics market, we believe we are not exposed to reimbursement risk associated with a reliance on payments from such third-party payors, and we are subject to fewer regulations that place limits on the types of marketing and other interactions we have with physicians.

According to Medical Insight’s The Global Aesthetic Market Study, within the self-pay aesthetic market, the global aesthetic neurotoxin market is estimated to grow to approximately $6.4 billion in 2026 and the U.S.

aesthetic neurotoxin market is expected to grow to approximately $3.7 billion in 2026.

According to Clarivate Aesthetic Injectables Market Insights, the European aesthetic neurotoxin market is expected to grow to approximately $662 million in 2026.

We believe the growth in the medical aesthetics market is driven by a number of factors, including:

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

Canada - 2018

European Union/United Kingdom/European Economic Area - 2019

Australia - 2023

Switzerland - 2023

United States* - $3.9 billion

Europe** - $0.7 billion

Product Candidate in Regulatory Development

Portfolio of injectable hyaluronic-acid based dermal fillers.

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

United States* - $2.2 billion

Europe** - $1.6 billion

Medical Insight’s The Global Aesthetic Market Study

Clarivate Aesthetic Injectables Market Insights

The Medical Aesthetics Market Opportunity

According to Medical Insights, in 2023, total sales of professional medical aesthetic products were estimated to be $19.7 billion globally.

Through 2027, the total sales of professional medical aesthetic products is expected to expand by 7.5% per year to $26.8 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.

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 U.S.

Bureau of Economic Analysis reporting that real disposable income in the United States increased approximately 19% from December 2012 to December 2022;

• growing awareness, 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 physicians 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 U.S.

In 2019 there were estimated to be approximately 73 million millennials, defined as individuals born between 1981 and 1996.

We believe that approximately 1.7 million females between the age of 30 and 39, which includes many individuals we define as millennials, are considering neurotoxins in the next twelve months.

Our Competitive Strengths

We offer physicians and consumers a compelling value proposition because:

• Jeuveau ® offers the market the first known 900 kDa neurotoxin alternative to BOTOX.

The manufacture of both Jeuveau ® and BOTOX starts with a 900 kDa complex, includes adding the excipients human serum albumin, or HSA, and sodium chloride, and finishes by vacuum drying.

We believe Jeuveau ® is the only known neurotoxin product in the United States with a 900 kDa neurotoxin complex other than BOTOX.

We also believe an important component of competitiveness in the neurotoxin market relates to the characteristics associated with the 900 kDa complex and the potential of the accessory proteins to increase the effectiveness of the active toxin portion of the complex.

• Enhanced level of physician-customer interaction through a self-pay, aesthetic-only marketing strategy.

We have elected to specifically target the self-pay aesthetic market.

With a reduced regulatory burden compared to third-party payor reimbursed therapeutic products, there is a number of benefits that market participants in reimbursed markets are unable to achieve, such as an enhanced level of interaction with our physician-customers.

Jeuveau ® is the only U.S.

neurotoxin without a therapeutic indication.

We believe pursuing an aesthetic-only non-reimbursed product strategy creates meaningful strategic advantages in the United States, including pricing and marketing flexibility.

We utilize this flexibility to drive market adoption through programs such as promotional events, co-branded marketing programs and pricing strategies.

• We offer a unique technology platform.

We provide a simple, personal and connected experience for physicians utilizing our proprietary technology platform.

We have built and continue to improve our platform with the goal of limiting friction and enhancing the overall experience for physicians and ultimately consumers.

We are modernizing the customer engagement with our proprietary “Evolus Practice” app.

We not only leverage technology for operational efficiency, but more importantly, to enhance a customer’s experience.

We believe the combination of a highly specialized sales force and our technology platform is an effective and competitive model.

• Results from our TRANSPARENCY global clinical program in more than 2,100 patients provides robust data to physicians evaluating the purchase of Jeuveau ® .

• Our management team has significant experience and expertise in medical aesthetics .

Our management team has extensive experience in self-pay healthcare markets, in the development, market launch and commercialization of major medical products, execution and integration of business development transactions and understanding of the regulatory environment of the healthcare markets.

Key members of our leadership team have also served in relevant senior leadership positions with leading aesthetic companies.

We launched Jeuveau ® in the United States with our own specialty sales organization now consisting of over 100 positions between representatives, management and other sales employees and in Canada through our distribution partner, Clarion.

We launched in Great Britain in September 2022, in Germany and Austria in February 2023 and plan to launch in additional European countries and Australia.

We plan to expand our product offerings over time through in-licensing, partnerships and acquisitions and by launching our products internationally.

The key components of our strategy are:

• rising disposable income, with the United States Bureau of Economic Analysis reporting that real disposable income in the United States increased approximately 30% from December 2013 to December 2023;

• 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 receive aesthetic neurotoxin treatments, 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

The key components of our strategy are to:

• 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.

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.

• Launch directly or partner outside of the United States to reach and serve physicians and consumers in those territories.

• Leverage our differentiated digital platform to efficiently open new accounts, personalize the purchasing process and efficiently deploy marketing programs at scale, including co-branded media.

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.

Jeuveau ® is currently the only U.S.

commercialized neurotoxin without a therapeutic indication.

• Launch directly or partner outside of the United States to reach and serve aesthetic practitioners and consumers in those territories.

• Leverage our differentiated digital platform to efficiently open new customer accounts, personalize the purchasing process and efficiently deploy marketing programs at scale, including co-branded media.

We have built and continue to improve our platform with the goal of limiting friction and enhancing the overall experience for aesthetic practitioners and ultimately consumers.

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

Jeuveau ® Overview

Jeuveau ® is an injectable formulation of a 900 kDa botulinum toxin type A complex designed to address the needs of the large and growing facial aesthetics market.

Jeuveau ® contains a 900 kDa botulinum toxin type A complex produced by the bacterium Clostridium botulinum.

The active part of the neurotoxin is the 150 kDa component, and the remaining 750 kDa of the complex is made up of accessory proteins that we believe help with the function of the active portion of the toxin.

Jeuveau ® has the same mechanism of action as other type A botulinum toxins.

When injected intramuscularly at therapeutic doses, botulinum toxin causes a chemical denervation of the muscle resulting in localized reduction of muscle activity.

Botulinum toxin type A specifically blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within the nerve endings leading to denervation and relaxation of the muscle.

TRANSPARENCY:

Clinical Evidence/Regulatory Development

Jeuveau ® - TRANSPARENCY:

Evolus Clinical Development for Glabellar Lines

TRANSPARENCY was a comprehensive five-study clinical development program for Jeuveau ® and was used to meet the regulatory requirements for a Biologics License Application, or BLA, in the United States, a Marketing Authorisation Application, or MAA, in the EU, and a New Drug Submission, or NDS, in Canada, for the treatment of moderate to severe glabellar lines.

The TRANSPARENCY program, which was developed in consultation with the FDA, Canadian, and European regulatory bodies, included three multicenter, randomized, double-blinded, controlled, single dose Phase III studies titled EV-001, EV-002 and EVB-003.

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.

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The two identical U.S.

Phase III studies, EV-001 and EV-002 (the “U.S.

Phase III Studies”), enrolled a combined 654 adults who had moderate to severe glabellar lines at maximum frown.

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.

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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 and Canadian Phase III Trial - Adverse Event Rate Summary

EU and Canadian Phase III Trial - Select Secondary Endpoints

EU Phase III Trial - Select Secondary Endpoints

*P-Value Placebo vs Jeuveau ® <0.001

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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%).

Phase II “Extra-Strength” Clinical Trial

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.

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

The trial is expected to be completed in the first half of 2023, and final results will be presented in the second half of 2023.

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.

Manufacturing

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We believe this facility will be sufficient to meet demand for Jeuveau ® for the foreseeable future.

The FDA conducted a current Good Manufacturing Practice, or cGMP, and pre-approval inspection of the facility in November 2017 in connection with our BLA for Jeuveau ® .

The UK Medicines

and Healthcare Products Regulatory Agency, or MHRA, also completed an inspection of the manufacturing facility in February 2018 in connection with our Marketing Authorisation Application, or MAA.

FDA approval of Jeuveau ® in February 2019 included approval to manufacture Jeuveau ® at Daewoong’s facility.

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 dermal fillers 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 .

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, certain members of the Commonwealth of Independent States, or CIS, and South Africa, as well as co-exclusive distribution rights with Daewoong in Japan.

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.

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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Under the Daewoong Agreement, Daewoong is responsible for all costs related to the manufacturing of Jeuveau ® , including costs related to the operation and upkeep of its manufacturing facility, and we are responsible for all costs related to obtaining regulatory approval, including clinical expenses, and commercialization of Jeuveau ® .

The initial term of the Daewoong Agreement expires September 30, 2023, and automatically renews for unlimited additional three-year terms if we meet certain performance requirements.

The initial term of the Daewoong Agreement expired September 30, 2023, and automatically renewed for an additional three-year term.

The Daewoong Agreement automatically renews for unlimited additional three-year terms if we meet certain performance requirements.

We expect to meet these performance requirements.

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However, if we do not renew the Daewoong Agreement or upon termination of the Daewoong Agreement due to a breach by us, we are obligated to transfer our rights to Daewoong.

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:

(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.

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.

The agreements can be terminated based upon a material breach that remains uncured or failure to meet the minimum purchase requirements.

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.

Impact of Settlement Agreements

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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 of $35.0 million in multiple payments 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.

Going forward, our remaining obligation will be 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.

Our primary competitors are companies offering injectable dose forms of botulinum toxin.

There are only five approved injectable botulinum toxin type A neurotoxins in the United States, including Jeuveau ® .

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.

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.

Aesthetic Neurotoxins

There are only six approved injectable botulinum toxin type A neurotoxins in the United States for aesthetic indications, including Jeuveau ® .

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 and Daxxify:

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

Allergan (now AbbVie) was the first company to market neurotoxins for aesthetic purposes.

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.

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

Additionally, Hugel Inc., has submitted a BLA to the FDA for an injectable botulinum toxin type A neurotoxin.

If the Hugel BLA is approved, we expect the competition in the U.S.

• 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 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.

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.

In addition to the companies commercializing and developing neurotoxins, there are other products and treatments that may indirectly compete with Jeuveau ® , such as dermal fillers, laser treatments, brow lifts, chemical peels, fat injections and removal and cold therapy.

Dermal Fillers

There are a number of dermal fillers currently offered 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, which are 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 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.

Other Medical Aesthetics Products

In addition to the companies commercializing and developing neurotoxins and dermal fillers, there are other products and treatments that may indirectly compete with our products and product candidates, including but not limited to laser treatments, brow lifts, chemical peels, medical grade and mass-market skin care products, fat injections and removal and cold therapy.

We compete with various companies that have products in these medical aesthetic categories.

Among these companies are Allergan (now AbbVie), Sanofi, Revance, Sun Pharma, Valeant Pharmaceuticals International, Inc., or Valeant, Mentor Worldwide LLC, a division of Johnson & Johnson, Merz, Galderma, and Skinceuticals, a division of L’Oreal SA.

In addition, we are aware of other companies also developing and/or marketing products in one or more of our target markets, including competing injectable botulinum toxin type A formulations that are in various phases of development in North America for the treatment of glabellar lines.

Historically, given the limited history of the commercialization of Jeuveau ® , the impact of the COVID-19 outbreak and the impact of the ITC remedial orders, we have not observed significant seasonality in our net revenues up to the second half of 2022.

However, we are aware that historically the aesthetic neurotoxin market generally experiences higher revenue in the second and fourth calendar quarters as compared to the first and third calendar quarters.

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 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 and medical devices are subject to regulation under the FFDCA and PHS Act.

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

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.

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.

Failure to comply with applicable U.S.

requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending license or marketing applications, warning letters and other enforcement actions, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.

FDA Marketing Approval

requirements may subject a company to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending license or marketing applications, warning letters and other enforcement actions, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.

FDA Marketing Approval of Biologics

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

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• FDA review and approval of the BLA .

Post-Approval Requirements

Post-Approval Requirements for Biologics in the United States

Once a BLA is approved, a product is subject to certain post-approval requirements.

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Biologics may be marketed only for the approved indications and in accordance with the provisions of the approved labeling.

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

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.

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Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.

Medical Device Regulation

The FDA regulates the sale and distribution in interstate commerce of medical devices under FFDCA.

Devices must undergo premarket review by the FDA prior to commercialization unless the device is of a type exempted from such review by statute, regulation, or pursuant to the FDA’s exercise of enforcement discretion.

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.

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.

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.

Premarket notifications are subject to user fees, unless a specific exemption applies.

To obtain 510(k) clearance, a manufacturer must submit a premarket notification demonstrating that the proposed device is “substantially equivalent” to a predicate device, which is a previously cleared 510(k) device or a pre-amendment device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for the submission of a PMA application.

In determining substantial equivalence, the FDA assesses whether the proposed device has the same intended use as the predicate device, and the same technological characteristics as the predicate device or different technological characteristics but the information submitted in the premarket notification demonstrates the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness than the predicate device.

The FDA may request additional information, including clinical data.

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

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.

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.

Some pre-amendment Class III devices for which the FDA has not yet required a PMA require the FDA’s clearance of a premarket notification in order to be marketed.

However, most Class III devices are required to undergo the PMA process in which the manufacturer must demonstrate reasonable assurance of the safety and effectiveness of the device to the FDA’s satisfaction.

A PMA application must provide valid scientific evidence, typically extensive preclinical and clinical trial data and information about the device and its components regarding, among other things, device design, manufacturing and labeling.

PMA applications (and supplemental PMA applications) are subject to significantly higher user fees than are 510(k) premarket notifications.

Some PMA applications are exempt from a user fee, for example a small business’s first PMA.

After a PMA application is submitted and found to be sufficiently complete, the FDA begins an in-depth review of the submitted information.

During this review period, the FDA may request additional information or clarification of information already provided.

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.

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

If the FDA’s evaluations of both the PMA application and the manufacturing facilities are favorable, the FDA will either issue an approval letter authorizing commercial marketing or an approvable letter that usually contains a number of conditions that must be met in order to secure final approval.

If the FDA’s evaluations are not favorable, the FDA will deny approval of the PMA or issue a not approvable letter.

The agency may determine that additional clinical trials are necessary, in which case the PMA approval may be delayed while the trials are conducted and the data acquired are submitted in an amendment to the PMA.

Even with additional trials, the FDA may not approve the PMA application.

The PMA process, including the gathering of clinical and nonclinical data and the submission to and review by the FDA, can take several years, and the process can be expensive and uncertain.

Even if the FDA approves a PMA, the agency can impose post approval conditions that it believes necessary to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution.

After approval of a PMA, a new PMA or PMA supplement may be required for a modification to the device, its labeling or its manufacturing process.

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.

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.

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

Even if regulatory approval or clearance of a device is granted, the FDA may impose limitations on the uses and indications for which the device may be labeled and promoted, and the device remains subject to significant regulatory requirements.

Medical devices may be marketed only for the uses and indications for which they are cleared or approved.

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.

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.

Some manufacturers also may be subject to post-market surveillance regulations.

Facility records and manufacturing processes are subject to periodic unscheduled inspections by the FDA.

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.

In the event that a supplier fails to maintain compliance with a device manufacturer’s quality requirements, the manufacturer may have to qualify a new supplier and could experience manufacturing delays as a result.

Other Regulation of the Healthcare Industry

While we do not currently have plans for our neurotoxin product 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 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.

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

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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 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;

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Government Regulation in Europe

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.

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Under the above described procedures, before granting the MA, the EMA or the competent authorities of the Member States of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.

EU Regulation of Medical Devices

In the European Union, medical devices must be CE marked in order to be marketed.

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.

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.

UK Regulation of Biologics and Medical Devices

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 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.

At present, Great Britain has implemented EU legislation on the marketing, promotion and sale of medicinal products through the Human Medicines Regulations 2012 (as amended) (under the Northern Ireland Protocol, the EU regulatory framework will continue to apply in Northern Ireland).

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.

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.

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.

Regulation Outside of the United States and Europe

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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.

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.

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.

HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.

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Human Capital Resources

As of December 31, 2022, we had 215 employees, all of whom were full-time in the United States and United Kingdom, and 70% of our full-time employees were women.

As of December 31, 2023, we had 273 employees, all of whom were full-time in the United States, Canada and Europe, and 63% 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.

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We also ensure that pay is internally equitable by differentiating rewards based on employee performance and impact to the company.

This empowers employees to take ownership over their career

and development trajectory.

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.

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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 by maintaining many of the changes implemented in response to COVID-19 including our hybrid work schedule, access to tests and sanitary supplies.

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

Inclusion and Belonging

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We offer paid volunteer time off to our employees and encourage our team of employees to become involved in their communities, lending their voluntary support to programs that positively impact the quality of life within these communities.

We value the impact of ongoing volunteer opportunities with community partners Orangewood Foundation, Samueli Academy and the Jesse Rees Foundation.

Corporate Information

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

We are an emerging growth company under the Jumpstart Our Business Startups Act of 2012 and also a smaller reporting company, and therefore we are subject to reduced public company reporting requirements.

Available Information

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