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Thu Oct 22 · markets closed2 signals on Oct 21108 insider buys this week · $250.3MCIRO short report next: Oct 30The week ahead

EOLS

Evolus, Inc.
NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS
7.40
+0.03 +0.41%
USD · close Oct 21

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How EOLS rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
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New in FY2025

  • You should carefully consider the risks and uncertainties described below, together with all the other information in this Annual Report on Form 10-K, including Item 7“Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the consolidated financial statements and the notes thereto included in Item 8 “Financial Statements and Supplementary Data.” If any of the following risks actually occurs, our business, reputation, financial condition, results of operations, revenue, and future prospects could be seriously harmed.
  • These disclosures reflect the Company’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities in the future.
  • References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future.
  • Risks Related to Our Business and Strategy We have incurred significant losses since our inception, and we may continue to incur losses, which could adversely affect the market price of our common stock and our ability to raise additional capital.
  • We recorded net loss of $51.6 million and $50.4 million for the years ended December 31, 2025 and 2024, respectively.
  • We had an accumulated deficit of $661.0 million as of December 31, 2025.
  • Our ability to achieve profitability is dependent on our ability to successfully market and sell our commercial products and maintain cost controls.
  • While we strive to achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.
  • Our prior losses, combined with any future losses, may adversely affect the market price of our common stock and, if needed, our ability to raise capital to continue operations.
  • Within the dermal filler market we will also face large, experienced competitors such as AbbVie and Galderma S.A.
  • These competitors may also try to compete with our aesthetic products on price both directly, through rebates and promotional programs to high volume customers and coupons to consumers, and indirectly, through attractive product bundling with complimentary products, such as injectable HA gels that offer convenience and an effectively lower price compared to the total price of purchasing each product separately.
  • In addition, we are aware of other companies also developing and/or marketing products in one or more of our target markets.
  • The introduction of new products into our key markets will increase competition.
  • In addition, competitors may develop new technologies within the medical aesthetic market that may be superior in safety and efficacy to our products or offer alternatives to the use of toxins or injectable HA gels, including surgical and radio frequency techniques.
  • Our commercial opportunity could also be reduced or eliminated if our competitors develop and commercialize products that are safer, are more effective, have fewer or less severe side effects, are more convenient or are less expensive than our current product offerings or any other product that we may develop.
  • Our competitors also may obtain FDA or other regulatory approval for these products more rapidly than we may obtain approval for our products, which could result in our competitors establishing a strong market position before we are able to enter the market, which may create additional barriers to successfully commercializing our current product offerings and any future product candidates and attracting practitioner and consumer demand.
  • Jeuveau ® or the Evolysse™ collection of injectable HA gels may fail to gain sufficient market acceptance by aesthetic practitioners, consumers and others in the medical aesthetics community to continue to grow our net revenues.
  • The continued commercial success of Jeuveau ® , Evolysse™ and any future product candidates, including a proposed higher strength dose of Jeuveau ® and the Evolysse™ collection of injectable HA gels, will depend significantly on the broad adoption and use of the resulting product by aesthetic practitioners for approved indications, including, in the case of Jeuveau ® , the treatment of glabellar lines and other aesthetic indications that we may seek to pursue and in the case of Evolysse™ Form and Smooth, the treatment of wrinkles and folds, such as nasolabial folds.
  • The degree and rate of practitioner adoption of Jeuveau ® , Evolysse™, and any future product candidates depend on a number of factors, including the cost, profitability to our customers, consumer demand, characteristics and effectiveness of the product.
  • Moreover, our competitors may utilize negative selling efforts or offer more compelling marketing or discounting programs than we are able to offer, including by bundling multiple aesthetic products to provide a more comprehensive offering than our current approved product offerings allow.
  • Moreover, consumer demand has and may continue to fluctuate over time as a result of consumer sentiment about the benefits and risks of aesthetic procedures generally and our products in particular, changes in demographics and social trends, high inflation and general consumer confidence and consumer discretionary spending, which have been and may in the future be impacted by economic and political conditions.
  • If Jeuveau ® , Evolysse™, or any future product candidates fail to achieve the broad degree of aesthetic practitioner adoption necessary for commercial success or the requisite consumer demand, our operating results and financial condition will be adversely affected, which may delay, prevent or limit our ability to generate revenue and continue our business.
  • Our products rely on consumer discretionary spending and the purchasing decisions of our customers, both of which are sensitive to difficult to predict global economic conditions, including the imposition of tariffs, or changes in consumer or customer sentiment.
  • As a result, demand for our products from our customers is tied to the discretionary spending levels of our targeted consumer population.
  • We do not maintain long-term purchase commitments with most of our customers, instead, our sales depend on short-term purchasing decisions for our products made by our customers in response to consumer demand, aesthetics trends, our competitor’s sales tactics, inventory management, seasonality, and other factors affecting consumer and customer purchasing behavior.
  • Additionally, our customers’ businesses are susceptible to economic conditions that have and may continue to tighten their liquidity resulting in changes in their purchasing behavior or delays in payments for our products, each of which could have an adverse effect on our business.
  • As a result, it is difficult to forecast demand for our products and our revenues in a given period are subject to volatility based on any of these factors.
  • Recent macroeconomic events, including inflationary pressures and threatened and imposed tariffs have negatively impacted consumer sentiment, resulted in decreased procedural volume for cash-pay medical aesthetics treatments, especially in the United States, and have impacted our customer’s liquidity and purchasing behaviors.
  • If these or similar conditions persist or worsen, our business, financial condition, and results of operations could be materially harmed.
  • Our business is subject to trade policy risks, including tariffs and regulatory actions on imports which may have a material adverse impact on our results of operations and financial condition.
  • The current tariff environment is dynamic and uncertain, as the U.S. government has imposed, modified and paused tariffs multiple times since the beginning of 2025.
  • Changes to tariffs and other trade restrictions can be announced at any time with little or no notice.
  • Changes in trade policies, including increased or proposed tariffs in the United States or retaliatory tariffs in response to such have caused an increase in our cost of goods related to our products.
  • For example, we source our Evolysse™ products from France and our Jeuveau ® product from South Korea, and since 2025 they have been either subject to implemented or threatened tariffs.
  • In addition, while pharmaceutical products, like Jeuveau ® , are currently exempt from retaliatory tariffs, the U.S.
  • Department of Commerce has initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, to determine the effects of importing pharmaceuticals and pharmaceutical ingredients on national security.
  • This investigation may lead to the imposition of significant tariffs on pharmaceutical imports, such as Jeuveau ® .
  • All of these current and threatened tariffs are subject to implementation or change with little notice.
  • Although we have been proactively managing inventory flows into the United States to protect against such tariffs, there can be no assurance that we will be able to do so in the future.
  • If tariffs impact global supply chains, have a negative impact on consumer sentiment or cause a significant increase in our costs and we are unable to successfully make up for these increased costs, our revenues could be harmed, which would have an adverse effect on our business.

and 58 more.

Gone since FY2024

  • Item 1A Risk Factors in this Annual Report.
  • You should carefully consider these risks, as well as the additional risks described in other documents we file with the U.S.
  • Securities and Exchange Commission, or SEC, in the future, including subsequent Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, which may from time to time amend, supplement or supersede the risks and uncertainties we disclose.
  • We also operate in a very competitive and rapidly changing environment.
  • New risks emerge from time to time and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.
  • In light of the significant risks and uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that such results will be achieved, and readers are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof.
  • Except as required by law, we undertake no obligation to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
  • You should read this Annual Report on Form 10-K and the other documents we file with the SEC with the understanding that our actual future results, levels of activity, performance and achievements may be materially different from what we expect.
  • We qualify all of our forward-looking statements by the cautionary statements referenced above.
  • Summary of Risk Factors An investment in our securities involves various risks and you are urged to carefully consider the risks discussed under Item 1A “Risk Factors,” in this Annual Report on Form 10-K prior to making an investment in our securities.
  • If any of the risks below or in Item 1A “Risk Factors” occurs, our business could be materially and adversely affected.
  • As more fully described in Item 1A “Risk Factors”, the principal risks and uncertainties that may affect our business, financial condition and results of operations include, but are not limited to, the following: • We have incurred significant losses since our inception. • Jeuveau ® faces, and any of our future product candidates will face, significant competition and our failure to effectively compete may prevent us from maintaining our market share and expansion. • Our products may fail to achieve the broad degree of aesthetic practitioner adoption and use or consumer demand necessary for continued commercial success. • We are dependent on Symatese Aesthetics, S.A.S., or Symatese, to achieve regulatory approval for the Evolysse™ hyaluronic acid gels product line in the United States and Europe.
  • Failure to obtain approval or obtain approval on our estimated time frame for the Evolysse™ product line would negatively affect our ability to sell these products. • We may require additional financing to fund our future operations or execute corporate development activities, and a failure to obtain additional capital when so needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our operations. • If we or our counterparties do not comply with the terms of our settlement agreements with Medytox, Inc., or Medytox, we may face litigation or lose our ability to market and sell Jeuveau ® , which would materially and adversely affect our ability to carry out our business and our financial condition and ability to continue as a going concern. • The terms of the Medytox Settlement Agreements will continue to reduce our profitability. • We rely on our licensing agreements with Daewoong Pharmaceutical Co.
  • Ltd, or Daewoong, and Symatese and any termination or loss of significant rights, including exclusivity, under these agreements would materially and adversely affect our business. • Our failure to successfully in-license, acquire, develop and market additional product candidates or approved products would impair our ability to grow our business. • Our ability to market our products is limited to their approved indications, and if we want to expand the indications for which we market our products, we will need to obtain additional regulatory approvals, which will be expensive and may not be granted. • Third party claims of intellectual property infringement may prevent or delay our commercialization efforts and interrupt our supply of products. • If we or any of our current or future licensors, including Daewoong and Symatese, are unable to maintain, obtain or protect intellectual property rights related to our products or any of our future product candidates, we may not be able to compete effectively in our market. • We may need to increase the size of our organization, including our sales and marketing capabilities in order to further market and sell Jeuveau ® and we may experience difficulties in managing this growth. • We rely on our digital technology and applications and our business and operations would suffer in the event of information system failures or a cybersecurity incident. • We are subject to extensive government regulation, and we may face delays in or not obtain regulatory approval of our product candidates and our compliance with ongoing regulatory requirements may result in significant additional expense, limit or delay regulatory approval or subject us to penalties if we fail to comply.
  • Unless the context indicates otherwise, as used in this Annual Report on Form 10-K, the terms “Evolus,” “company,” “we,” “us” and “our” refer to Evolus, Inc., a Delaware corporation, and our subsidiaries taken as a whole, unless otherwise noted.
  • EVOLUS ™ , Jeuveau ® , Evolux ® and Evolysse™ are trademarks of ours that are used in this Annual Report on Form 10-K.
  • Jeuveau ® is the trade name in the United States for our approved product with non-proprietary name, prabotulinumtoxinA-xvfs.
  • This product has different trade names outside of the United States, including Nuceiva ® in Canada, Europe and Australia, but is referred to throughout this Annual Report on Form 10-K as Jeuveau ® .
  • Our hyaluronic acid gel products have different trade names outside of the United States, including Estyme ® in Europe, but are referred to throughout this Annual Report on Form 10-K as Evolysse™.
  • This Annual Report on Form 10-K also includes trademarks, trade names and service marks that are the property of other organizations, such as BOTOX ® and BOTOX ® Cosmetic, which we refer to throughout this Annual Report on Form 10-K as BOTOX.
  • Solely for convenience, trademarks and trade names referred to in this Annual Report on Form 10-K may appear without the ® and ™ symbols, but those references are not intended to indicate that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and trade names.
  • We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
  • Website References In this Annual Report on Form 10-K, we make references to our website at www.evolus.com.
  • References to our website through this Form 10-K are provided for convenience only and the content on our website does not constitute a part of, and shall not be deemed incorporated by reference into, this Annual Report on Form 10-K.
  • Overview 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 hyaluronic acid gels, respectively.
  • Jeuveau ® is our commercially available proprietary 900 kilodalton, or kDa, purified botulinum toxin type A formulation indicated for the temporary improvement in the appearance of moderate to severe glabellar lines, also known as “frown lines,” in adults.
  • 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 collection of injectable hyaluronic acid gels which utilize first-generation cold technology.
  • The line includes a variety of products including mid face, nasolabial folds, lips and eyes in the United States and Europe.
  • In October 2024, regulatory approval was received in the European Union for four products in the Evolysse™ line: Evolysse™ Form, Evolysse™ Smooth, Evolysse™ Sculpt and Evolysse™ Lips.
  • In February 2025, we received approval from the U.S.

and 314 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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