Evolus Launches Nuceiva® (botulinum toxin type A) in Italy

Rhea-AI Summary

Evolus, Inc. has launched Nuceiva® (botulinum toxin type A) in Italy, one of the largest aesthetic toxin markets in Europe. The product is now available for direct order and delivery to customers. Evolus aims to expand its presence in the dynamic European market and partner with GP Dermal Solution, a leading company in the Italian cosmetic and wellness sector.

Positive

• Evolus has commenced the commercial launch of Nuceiva® in Italy, a significant market for aesthetic toxins in Europe.
• Nuceiva® is approved by the European Commission for the temporary improvement of glabellar lines, and it targets adults below 65 years of age.
• Nuceiva® is currently available in Canada, Germany, Austria, and Great Britain, and it is licensed in the United States under the brand name Jeuveau®.

Negative

• None.

• Launching in the fourth largest aesthetic toxin injectables market in Europe¹ is part of the company’s geographic expansion strategy
• GP Dermal Solution will serve as distribution partner in Italy

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company focused on building an aesthetic portfolio, has commenced the commercial launch of Nuceiva® (botulinum toxin type A) in Italy. The product is now available for direct order and delivery to customers.

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.

“We are excited to introduce Nuceiva® to medical aesthetics customers in Italy, one of the largest aesthetic toxin markets in Europe¹ and a crucial step in growing our global footprint,” said David Moatazedi, President and CEO of Evolus Inc. “Expanding within the dynamic European market continues to be a strategic ambition and will help fuel Evolus’ market growth, globally.”

Evolus is partnering with GP Dermal Solution, a pioneering company in the Italian cosmetic and wellness sector. Working closely with their suppliers, GP Dermal Solution delivers specialist products to aesthetics practitioners across Italy. In addition to Italy, Nuceiva® is currently commercially available in Canada, Germany, Austria and Great Britain. The product is licensed in the United States under the brand name Jeuveau® and in 2022, was the fastest growing neurotoxin in the U.S. market.³

“I’m pleased to start offering Nuceiva® to my patients. They are looking for targeted and natural-looking results to improve the appearance of facial lines.” said Dr. Erminio Mastroluca, a plastic and aesthetic surgeon from Rome. “As I’m gaining real world experience, I have the opportunity to deliver more of what my patients want - precision-driven results using innovative products supported by robust clinical data.”

“We understand the needs of our customers and patients are evolving. That’s why we are thrilled to bring a new neurotoxin to Italy,” said Dan Stewart, Vice President and General Manager, Evolus International. “By working with our partner, GP Dermal Solution, we will bring a range of educational programs and an easy-to-use online service platform to help customers grow their practice and deliver patient satisfaction with Nuceiva®.”

The safety and efficacy of Nuceiva® was evaluated through the company’s TRANSPARENCY clinical program - three Phase III trials^4,5 including the largest head-to-head aesthetic pivotal study versus Botox® (onabotulinumtoxinA) to date, and two long-term safety studies^6,7.

About 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), globally licensed under the brand name Nuceiva^®. The product is 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™, a line of five unique dermal fillers currently in late-stage development. Visit us at www.evolus.com, and follow us on LinkedIn, Twitter, 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, 2023 filed with the Securities and Exchange Commission on May 9, 2023. 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, 2021. Data on file
2. https://www.ema.europa.eu/en/documents/product-information/nuceiva-epar-product-information_en.pdf (Accessed 23/02/23)
3. Medical Insights US Facial Injectables Tracker, March 2023 www.miinews.com (Accessed 23/06/2023)
4. Berthold-Josef Rzany, MD, ScM et al. Aesthetic Surgery Journal, 2019, 1–16
5. Kenneth R. Beer et al. Dermatol Surgery 2019; 45 (11); 1381 – 1393
6. Joely Kaufman-Janette, MD et al. Aesthetic Surgery Journal 2021, 1–14
7. Z. Paul Lorenc, MD, FACS et al. Aesthetic Surgery Journal 2021, 1–16

View source version on businesswire.com: https://www.businesswire.com/news/home/20230628243406/en/

Investor Contact:

David K. Erickson

Vice President, Investor Relations

Tel: +1-949-966-1798

Email: david.erickson@evolus.com

Media Contacts:

Email: Media@Evolus.com

Janet Kettels

Communications Consultant, Evolus International

Tel: +447738506476

Email: janet.kettels@evolus.com

Source: Evolus

FAQ

What is Nuceiva® and where is it available?

Nuceiva® is a botulinum toxin type A product launched by Evolus, Inc. It is currently available in Italy, Canada, Germany, Austria, Great Britain, and the United States under the brand name Jeuveau®.

What is the target market for Nuceiva® in Italy?

Nuceiva® targets the aesthetic toxin market in Italy, which is one of the largest in Europe.

Who is Evolus partnering with in Italy?

Evolus is partnering with GP Dermal Solution, a leading company in the Italian cosmetic and wellness sector, for the distribution of Nuceiva® in Italy.