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Evolus Broadens International Presence with Launch of Nuceiva® (botulinum toxin type A) in Spain

  • Launching in one of the five largest aesthetic toxin injectable markets in Europe1 as part of the company’s geographic expansion strategy
  • Evolus to provide Nuceiva® for direct order and delivery to Spanish medical aesthetics healthcare professionals

Evolus, Inc. (NASDAQ: EOLS), a performance beauty company focused on building an aesthetic portfolio, has commercially launched Nuceiva® (botulinum toxin type A) in Spain. The product is now available for direct order and delivery to Spanish medical aesthetics healthcare professionals.

Nuceiva® is approved by the European Commission for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age2.

"Launching our direct operations in Spain, one of Europe's largest aesthetic markets, underscores our commitment to strategic geographic expansion," said David Moatazedi, President and CEO of Evolus. "This milestone supports our goal of fueling market growth worldwide by establishing a strong presence in key regions. Our continued success in entering new markets positions us for sustained above-market growth in the aesthetic neurotoxin sector."

Evolus is establishing a direct operating entity in Spain, under the leadership of Maria Cudeiro, General Manager, Spain, Portugal and Switzerland. Working closely with aesthetics healthcare professionals will enable Evolus to offer this new treatment to patients. Nuceiva® is licensed in the United States under the brand name Jeuveau® and is the fastest-growing neurotoxin in the United States for three consecutive years*.

“We know that beauty is evolving and recognize the importance of supporting our healthcare professional customers as they adapt to changing trends. I am confident that Maria Cudeiro will successfully establish Evolus in Spain, introducing a new neurotoxin to Spanish customers," said Dan Stewart, Vice President and General Manager of Evolus International. "By delivering great customer services, innovative educational programs and user-friendly online platforms we aim to enhance the practice of Spanish healthcare professionals as they deliver exceptional patient experiences.”

“Offering treatments that deliver pleasing and long-lasting results to my patients is a priority for me,” said Dr. Jaime Tufet, Medical Director at Clinica Tufet, one of Spain’s premier aesthetic clinics. “We are very pleased to be able to offer Nuceiva® to our patients.”

The safety and efficacy of Nuceiva® was evaluated through the company’s TRANSPARENCY clinical program – three Phase III trials3,4 including the largest head-to-head aesthetic pivotal study versus Botox® (onabotulinumtoxinA) to date, and two long-term safety studies5,6. Side effects were similar to others in this class of medicine. For the full list of adverse events, warnings and contraindications consult the Nuceiva® SmPC.

About Evolus, Inc.

Evolus (Nasdaq: EOLS) is a global 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 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.

Forward Looking Statements

This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements that relate to the status of regulatory processes, future plans, events, prospects or performance and statements containing the words “plans,” “expects,” “believes,” “strategy,” “opportunity,” “anticipates,” “outlook,” “designed,” or other forms of these words or similar expressions, although not all forward-looking statements contain these identifying words. The company’s forward-looking statements include, but are not limited to, statements related to the company’s prospects, geographical expansion, milestones and programs.

Forward-looking statements involve risks and uncertainties that could cause actual results or experiences to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include uncertainties associated with our ability to address all of our losses, costs, expenses, liabilities and damages resulting from the settlement agreement with Daewoong and our ability to comply with the terms and conditions in the Allergan/Medytox Settlement Agreements, the continued impact of COVID-19 on our business and the economy generally, uncertainties related to customer and consumer adoption of Nuceiva® / Jeuveau®, the efficiency and operability of our digital platform or commercialization strategies, competition and market dynamics, and our ability to maintain regulatory approval of Nuceiva® / Jeuveau® and other risks described in Evolus’ filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our in our Annual Report on Form 10-K and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed with the Securities and Exchange Commission on May 7, 2024. These filings can be accessed online at www.sec.gov. Except as required by law, Evolus undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. If the company does update or revise one or more of these statements, investors and others should not conclude that the company will make additional updates or corrections.

Jeuveau® and Nuceiva® are registered trademarks of Evolus, Inc.

Evolysse™ is a trademark of Evolus, Inc.

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

Botox® (Botulinum toxin type A) is a registered trademark of Allergan, Inc.

References:

  1. Decision Research Group (DRG) Aesthetic Injectables Market Insights, Europe, July 2023. Data on file
  2. https://www.ema.europa.eu/en/documents/product-information/nuceiva-epar-product-information_en.pdf (Accessed 23/02/24)
  3. Berthold-Josef Rzany, MD, ScM et al. Aesthetic Surgery Journal, 2019, 1–16
  4. Kenneth R. Beer et al. Dermatol Surgery 2019; 45 (11); 1381 – 1393
  5. Joely Kaufman-Janette, MD et al. Aesthetic Surgery Journal 2021, 1–14
  6. Z. Paul Lorenc, MD, FACS et al. Aesthetic Surgery Journal 2021, 1–16

* Measured by comparing year-over-year revenue growth of each aesthetic neurotoxin on the market for the entirety of each comparable year.

Contacts

Investor Contact:

Nareg Sagherian

Vice President, Head of Global Investor Relations and Corporate Communications

Tel: +1-(248) 202-9267

Email: ir@evolus.com

Media Contacts:

Email: Media@Evolus.com

Janet Kettels

Communications Consultant, Evolus International

Tel: +447738506476

Email: janet.kettels@evolus.com

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