NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio, today announced it has entered into a definitive agreement with Symatese to be the exclusive distributor in the United Kingdom (U.K.) and Europe of four unique dermal fillers in late-stage development with anticipated regulatory clearances in second half of 2024 and commercialization under the brand name Estyme® (pronounced “esteem”) fillers in 2025.

加利福尼亚州纽波特海滩（BUSINESS WIRE）--Evolus，Inc.（纳斯达克股票代码：EOLS），一家专注于构建美学组合的性能美容公司，今天宣布，该公司已与Symatese签订最终协议，成为英国（英国）和欧洲四种独特真皮填充剂的独家经销商，处于后期开发阶段，预计2024年下半年获得监管许可，2025年将以Estyme®品牌（发音为“Estreme”）填充剂进行商业化。

It is the second agreement made with Symatese this year – with the first obtaining exclusive distribution rights to the same product line in the U.S., where it will be commercialized under the brand name EvolysseTM in 2025. As a result of the geographic expansion of the filler line, the company has doubled its total addressable international market (outside the U.S.) to $1.8 billion2..

这是今年与Symatese签订的第二份协议，也是第一份在美国获得同一产品线独家经销权的协议，该产品将于2025年以EvolysseTM品牌商业化。由于灌装线的地理扩张，该公司的国际市场（美国以外）总额翻了一番，达到18亿美元2。。

“Today’s announcement marks yet another crucial step in our global expansion to offer a multi-product portfolio to our customers and the patients they treat. The addition of the Estyme® facial fillers in the U.K. and Europe will complement the recent launch of Nuceiva®, our flagship neurotoxin, which has been met with very strong interest and growing demand from customers,” said David Moatazedi, President and Chief Executive Officer of Evolus.

David说：“今天的宣布标志着我们全球扩张的另一个关键步骤，即为我们的客户及其治疗的患者提供多产品组合。在英国和欧洲添加Estyme®面部填充物将补充我们最近推出的旗舰神经毒素Nuceiva®，该产品受到了客户的强烈兴趣和不断增长的需求。”Evolus总裁兼首席执行官Moatazedi。

“We are increasingly optimistic about the near-term potential that the next-generation technology in the EvolysseTM and Estyme® fillers lines will offer customers in the fast-growing facial HA market. We are confident that these innovative new products, along with our growing brand loyalty to our market-leading neurotoxin and the associated digital infrastructure and distribution platform will drive our topline growth for years to come.”.

“我们对EvolysseTM和Estyme®填充物系列中的下一代技术将为快速增长的面部HA市场的客户提供的近期潜力越来越乐观。我们相信，这些创新的新产品，以及我们对市场领先的神经毒素和相关数字基础设施和分销平台的品牌忠诚度将不断提高推动我们未来几年的收入增长。”。

Neurotoxins and dermal fillers are the two most requested medical aesthetic procedures in the U.S. and Europe3. The two distribution agreements for the EvolysseTM /Estyme® fillers portfolio will grant Evolus the ability to offer a complete range of filler solutions to cover mid-face, nasolabial folds and lip indications in Europe plus an eye product line in the U.S..

神经毒素和皮肤填充剂是美国和欧洲最需要的两种医学美容程序3。EvolysseTM/Estyme®填充物组合的两项分销协议将使Evolus能够提供全套填充物解决方案，以覆盖欧洲的中脸、鼻唇沟和唇部适应症，以及美国的眼部产品线。。

Regulatory approval has been received for the first nasolabial fold product in Europe and the remaining three products are anticipated to be approved in the back half of 2024. U.S. regulatory approval remains on track to begin in 2025. The company plans to commence commercialization of the approved product lines in 2025 with subsequent product launches in 2026 and 2027..

欧洲第一款鼻唇沟产品已获得监管部门的批准，其余三款产品预计将于2024年下半年获得批准。U、 美国监管部门的批准仍将于2025年开始。该公司计划在2025年开始批准产品线的商业化，随后在2026年和2027年推出产品。。

As part of the new agreement, Evolus will be licensing its neurotoxin, Nuceiva® (botulinum toxin type A), to Symatese for distribution in France, marking the fifth European market that Evolus has now entered. In addition, Evolus will sub-license its distribution rights for the Estyme® fillers line to a Symatese subsidiary for distribution in France..

作为新协议的一部分，Evolus将授权其神经毒素Nuceiva®（A型肉毒杆菌毒素）在法国销售，这是Evolus目前进入的第五个欧洲市场。此外，Evolus将把其Estyme®填料生产线的分销权再许可给Symatese子公司，以便在法国分销。。

“We are extremely excited to expand our partnership with Evolus beyond the U.S. to now include the U.K. and Europe. We firmly believe in the growth opportunity for our innovative filler lines in these markets and also in Evolus’ accelerating growth in the neurotoxin market. As such, we have agreed to receive payment for the license for the European markets in the form of Evolus’ common shares.

“我们非常高兴将与Evolus的合作伙伴关系扩展到美国以外的地区，现在包括英国和欧洲。我们坚信我们的创新填充线在这些市场上有增长机会，也相信Evolus在神经毒素市场上的加速增长。因此，我们同意以Evolus的通用shar的形式获得欧洲市场许可证的付款是的。

We have complete confidence in the Evolus team, and we look forward to pursuing this exceptional growth opportunity together,” said Jean-Paul Gérardin, CEO of Symatese..

我们对Evolus团队充满信心，我们期待着共同追求这一非凡的增长机会，”Symatese首席执行官Jean-Paul Gérardin表示。。

Symatese is a privately held French company that designs, engineers and manufactures regenerative medical solutions based on its innovative technology platforms. Symatese has a unique and combined expertise in the field of hyaluronic acid and injection systems and is well known for the development of the latest generation of Restylane® products in the U.S.

Symatese是一家私人控股的法国公司，根据其创新技术平台设计、设计和制造再生医疗解决方案。Symatese在透明质酸和注射系统领域拥有独特的综合专业知识，并以在美国开发最新一代Restylane®产品而闻名。

based on XpresHAn Technology™/OBT®. The products within the licensing agreement are a next-generation filler technology – the first to be developed using cold crosslinking manufacturing – which will be presented at IMCAS, 1st-3rd February 2024..

基于XpresHAn技术™/OBT®。许可协议中的产品是下一代填料技术，这是第一种使用冷交联制造技术开发的填料技术，将于2024年2月1日至3日在IMCAS上展出。。

Transaction Terms and Updated Outlook

交易条款和更新的Outlook

In exchange for the exclusive distribution rights in the United Kingdom and Europe, Evolus will issue 610,000 shares of the company’s common stock to Symatese. Two milestone payments will be made: (1) €1.2 million on the second anniversary of certain regulatory approvals currently expected to be achieved in 2026, and (2) €1.9 million on the earlier of the third anniversary of certain regulatory approvals or following a year in which Evolus achieves €25 million in revenue in Europe, currently expected to be achieved by 2027, both of which will be after the commercialization of the applicable products.

为了换取在英国和欧洲的独家经销权，Evolus将向Symatese发行610000股公司普通股。将支付两笔里程碑式的款项：（1）在目前预计2026年实现的某些监管批准两周年之际支付120万欧元，（2）在某些监管批准三周年之初支付190万欧元，或者在Evolus在欧洲实现2500万欧元收入（目前预计2027年实现）之后支付，这两者都将在适用产品商业化之后进行。

This agreement has no material impact on the company’s continued expectation to be fully funded to profitability1 by 2025..

本协议对公司在2025年之前获得全额盈利的持续预期没有实质性影响。。

Evolus will also pay Symatese a mid-single-digit royalty based on net sales and a transfer price for the product. Symatese will be responsible for the development of the products, including clinical studies, product testing and the conduct of regulatory activities required to obtain and maintain all necessary regulatory approvals.

Evolus还将根据净销售额和产品转让价格向Symatese支付中个位数的版税。Symatese将负责产品的开发，包括临床研究、产品测试以及开展获得和维持所有必要监管批准所需的监管活动。

The initial agreement is for a term of 15 years, with automatic five-year renewal provisions..

最初的协议期限为15年，自动续签5年。。

By leveraging the existing Evolus digital infrastructure, sales force, rewards program and co-branded media, the company expects the EvolysseTM line to achieve a high contribution margin at scale, which is expected to drive an expansion of our consolidated operating margin and income.

通过利用现有的Evolus数字基础设施、销售队伍、奖励计划和联合品牌媒体，公司预计EvolysseTM系列将实现规模上的高贡献率，这有望推动我们综合营业利润率和收入的扩大。

Additionally, Evolus will pre-announce preliminary, unaudited fourth quarter and full-year 2023 results and revenue guidance for 2024 in January.

此外，Evolus将于1月份预先宣布2023年第四季度和全年的初步未经审计业绩以及2024年的收入指导。

About Symatese

关于Symatese

Founded 25 years ago by Eric Perouse and Jean-Paul Gérardin, Symatese is a privately held French company specializing in Class I to III medical devices. The company maintains an international presence through six subsidiaries and four manufacturing facilities employing a team of 400 persons and 40 researchers.

Symatese由Eric Perouse和Jean-Paul Gérardin于25年前成立，是一家专门从事I至III类医疗器械的私人持有的法国公司。该公司通过六家子公司和四家制造工厂保持国际影响力，雇用了400人和40名研究人员。

At the heart of Symatese’s research is the science of tissue regeneration and anatomical reconstruction for the benefit of doctors and patients. Every year, more than 25 million patients worldwide are treated thanks to its innovative hyaluronic acid, collagen, thermoplastic and silicone technologies.

Symatese研究的核心是组织再生和解剖重建科学，以造福医生和患者。由于其创新的透明质酸、胶原蛋白、热塑性塑料和硅胶技术，每年全世界有2500多万患者接受治疗。

Symatese is able to address the most delicate and complex health issues based on its expertise in 15 therapeutic specialties, aesthetic medicine and its associated administration systems, while also relying on its own product and technology brands. Research & development partnerships with major global companies and from now on with Evolus, demonstrate this strong scientific and technological excellence.

Symatese凭借其在15个治疗专业、美容医学及其相关管理系统方面的专业知识，能够解决最微妙和复杂的健康问题，同时也依靠自己的产品和技术品牌。与全球主要公司以及从现在起与Evolus的研发合作伙伴关系证明了这一强大的科学和技术优势。

For more information, visit us at www.symatese.com, and follow us on LinkedIn..

有关更多信息，请访问www.symatese.com，并在LinkedIn上关注我们。。

About Evolus, Inc.

关于Evolus，Inc。

Evolus (Nasdaq: EOLS) is a performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau® (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology.

Evolus（纳斯达克股票代码：EOLS）是一家性能美容公司，通过其独特的、以客户为中心的商业模式和创新的数字平台，为下一代美容消费者发展美学神经毒素市场。我们的使命是在我们的旗舰产品Jeuveau®（prabotulinumtoxinA-xvfs）的基础上，成为一家全球性的多产品美学公司，Jeuveau®是第一种也是唯一一种专门用于美学的神经毒素，在使用Hi Pure的最先进设施中生产™技术。

Evolus is expanding its product portfolio having entered into a definitive agreement to be the exclusive U.S. distributor of Evolysse™, and the exclusive distributor in Europe of Estyme®, a line of unique dermal fillers currently in late-stage development. Visit us at www.evolus.com, and follow us on LinkedIn, X, Instagram or Facebook..

Evolus已签订最终协议，成为Evolysse的美国独家经销商，因此正在扩大其产品组合™,以及Estyme®在欧洲的独家经销商，Estyme®是目前处于后期开发阶段的一系列独特真皮填充剂。请访问www.evolus.com，并在LinkedIn、X、Instagram或Facebook上关注我们。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including statements about future events, our business, financial condition, results of operations and prospects, our industry and the regulatory environment in which we operate.

本新闻稿包含1995年《私人证券诉讼改革法案》定义的前瞻性声明，涉及风险和不确定性，包括关于未来事件、我们的业务、财务状况、经营成果和前景、我们的行业和我们经营的监管环境的声明。

Any statements contained herein that are not statements of historical or current facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, or other comparable terms intended to identify statements about the future.

本文中包含的任何不是历史或当前事实陈述的陈述都是前瞻性陈述。在某些情况下，您可以通过诸如“预期”、“相信”、“可能”、“估计”、“预期”、“打算”、“可能”、“计划”、“潜力”、“预测”、“项目”、“应该”、“将会”、“将会”或这些术语的否定词，或其他旨在识别未来陈述的类似术语来识别前瞻性陈述。

The company’s forward-looking statements include, but are not limited to, statements related to financial and other benefits expected from the exclusive European distribution rights for the Estyme® dermal filler product line; the company’s long-term revenue outlook; expectations regarding regulatory approvals and product launches for the Estyme® dermal filler product lines; and the company’s cash position and expectations for reaching profitability..

公司的前瞻性声明包括但不限于与Estyme®真皮填充产品线的欧洲独家经销权所预期的财务和其他利益相关的声明；公司的长期收入前景；对Estyme®真皮填充产品线的监管批准和产品发布的期望；以及公司的现金状况和达到盈利能力的预期。。

The forward-looking statements included herein are based on our current expectations, assumptions, estimates and projections, which we believe to be reasonable, and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements.

本文中包含的前瞻性陈述基于我们目前的预期、假设、估计和预测，我们认为这些是合理的，并且存在可能导致实际结果与前瞻性陈述中明示或暗示的结果产生重大差异的风险和不确定性。

These risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control, include, but are not limited to uncertainties associated with our ability to comply with the terms and conditions in the Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Jeuveau® and EvolysseTM/Estyme®, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, including the EvolysseTM dermal filler product line in the U.S.

这些风险和不确定性都难以或不可能准确预测，其中许多风险和不确定性超出了我们的控制范围，包括但不限于与我们遵守美迪托克斯和解协议条款和条件的能力、我们为未来运营提供资金或获得运营资金的能力相关的不确定性，不利的全球经济条件和对消费者可自由支配支出的影响，与客户和消费者采用Jeuveau®和EvolysseTM/Estyme®相关的不确定性，我们数字平台的效率和可操作性，竞争和市场动态，我们在新市场成功推出和商业化产品的能力，包括美国的EvolysseTM真皮填充产品线。

or the Estyme® dermal filler product line in Europe, our ability to maintain regulatory approvals of Jeuveau® or obtain regulatory approvals for new product candidates or indications, our reliance on Symatese to achieve regulatory approval for the EvolysseTM dermal filler product line in the U.S. or the Estyme® dermal filler product line in Europe, and other risks described in our filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our Annual Report on Form 10-K and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 expected to be filed with the Securities and Exchange Commission on or about November .

或欧洲的Estyme®真皮填充产品线，我们保持Jeuveau®监管批准或获得新产品候选产品或适应症监管批准的能力，我们依靠Symatese获得美国EvolysseTM真皮填充产品线或欧洲的Estyme®真皮填充产品线的监管批准，以及我们向美国证券交易委员会提交的文件中描述的其他风险，包括表10-K年度报告中题为“风险因素”的部分以及表10-Q中截至2023年9月30日的季度报告，预计将于11月或左右提交给美国证券交易委员会。

Jeuveau®, Nuceiva®, and Evolysse™ are trademarks of Evolus, Inc.

Jeuveau®、Nuceiva®和Evolysse™是Evolus，Inc.的商标。

Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd.

嗨，Pure™是大宇制药有限公司的商标。

Estyme® is a trademark of Symatese Aesthetics S.A.S.

Estyme®是Symatese美学公司的商标。

Restylane®, XpresHAn Technology™ and OBT® are trademarks of Galderma S.A.

Restylane®，XpresHAn Technology公司™和OBT®是Galderma S.A.的商标。

1 Within this press release, “profitability” is defined as achieving positive non-GAAP operating income. “Non-GAAP operating income” excludes the revaluation of contingent royalty obligations, stock-based compensation expense, and depreciation and amortization. Management believes that non-GAAP operating income is useful in helping to identify the company’s core operating performance and enables management to consistently analyze the period-to-period financial performance of the core business operations.

1在本新闻稿中，“盈利能力”被定义为实现积极的非GAAP营业收入。“非GAAP营业收入”不包括或有特许权使用费义务的重估、基于股票的补偿费用以及折旧和摊销。管理层认为，非公认会计准则营业收入有助于确定公司的核心经营业绩，并使管理层能够始终如一地分析核心业务运营的期间财务业绩。

Management also believes that non-GAAP operating income will enable investors to assess the company in the same way that management has historically assessed the company’s operating income against comparable companies with conventional accounting methodologies. The company’s definition of non-GAAP operating income has limitations as an analytical tool and may differ from other companies reporting similarly named measures.

管理层还认为，非公认会计准则的营业收入将使投资者能够以管理层以往使用传统会计方法对可比公司的营业收入进行评估的方式对公司进行评估。该公司对非公认会计准则营业收入的定义作为分析工具存在局限性，可能与其他报告类似指标的公司有所不同。

Non-GAAP measures should not be considered superior to and are not intended to be considered in isolation or as a substitute for GAAP financial measures. Due to the forward-looking nature of the non-GAAP operating income outlook disclosed in this press release, no reconciliation of such non-GAAP measure to the comparable GAAP financial measure is available without unreasonable efforts.

不应认为非公认会计原则措施优于公认会计原则财务措施，也不应单独考虑或替代公认会计原则财务措施。由于本新闻稿中披露的非公认会计准则营业收入前景具有前瞻性，因此，如果没有不合理的努力，就无法将此类非公认会计准则指标与可比的公认会计准则财务指标进行对账。

This is due to the inherent difficulty of forecasting the timing or amount of various reconciling items that would impact the forward-looking non-GAAP operating income, that have not yet occurred and/or cannot be reasonably predicted. Such unavailable information could have a significant impact on the company’s GAAP financial results..

这是由于预测尚未发生和/或无法合理预测的影响前瞻性非公认会计准则营业收入的各种对账项目的时间或金额存在固有的困难。此类不可用信息可能会对公司的GAAP财务业绩产生重大影响。。

2 Source: Medical Insights Dermal Filler Market Study, March 2023 (www.miinews.com) and Aesthetic Injectables | Market Insights | Europe 2024 © 2023 Clarivate

2来源：Medical Insights Dermal Filter Market Study，2023年3月（www.miinews.com）和美学注射剂| Market Insights | Europe 2024©2023 Clarivate

3 Source: International Society of Aesthetic Plastic Surgery International Survey, BCG Aesthetic Research presented at IMCAS 2023 and company estimates.

3来源：国际美容整形外科学会国际调查，BCG美学研究在IMCAS 2023和公司估计。