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

Rhea-AI Summary

Evolus has launched its botulinum toxin type A product, Nuceiva, in Spain, one of Europe's largest markets for aesthetic injectables. This move is part of Evolus's geographic expansion strategy.

Nuceiva is approved for the temporary improvement of moderate to severe glabellar lines in adults under 65. The launch signifies Evolus's commitment to growth by establishing a direct presence in key regions. Led by Maria Cudeiro, Evolus aims to work closely with Spanish healthcare professionals to offer effective treatments.

Nuceiva has shown promising results in three Phase III trials and two long-term safety studies, with side effects similar to other neurotoxins. The product is known as Jeuveau in the US and has been the fastest-growing neurotoxin there for three consecutive years.

Positive

• Evolus's launch of Nuceiva in Spain targets one of Europe's largest aesthetic markets, indicating strategic geographic expansion.
• Nuceiva is approved by the European Commission for treating moderate to severe glabellar lines, adding credibility and potential market acceptance.
• The product has shown efficacy in three Phase III trials and two long-term safety studies.
• Nuceiva's brand Jeuveau is the fastest-growing neurotoxin in the US for three consecutive years, suggesting strong market acceptance.
• Evolus's commitment to direct operations in Spain will allow closer collaboration with healthcare professionals, enhancing service delivery.

Negative

• The launch requires significant investment in establishing a direct operating entity, which could impact short-term financials.
• The market for aesthetic neurotoxins is highly competitive, posing a challenge for Nuceiva to establish a strong foothold.
• Despite positive trial results, side effects similar to other neurotoxins may deter some potential users.
• The focus on geographic expansion might strain Evolus's resources, potentially affecting other operational areas.

Insights

Market Research Analyst

Evolus' launch of Nuceiva® in Spain is a strategic move that could significantly impact the company's market presence. Spain is one of the largest aesthetic toxin injectable markets in Europe, which presents a substantial opportunity for Evolus to expand its footprint.

From a market perspective, entering such a major market supports Evolus' ambition for geographic expansion. Given that Nuceiva® is already showing success in the U.S., this move could replicate that success in Europe. However, it's important to consider the competitive landscape—Botox® and other well-established brands dominate the European market. Evolus will need to leverage intensive marketing and educational strategies to capture market share.

For investors, this expansion could mean increased revenue streams and market diversification, potentially leading to more stable financials. Keep an eye on market penetration rates and growth metrics in the coming quarters to gauge the success of this launch.

Rating: 1

Financial Analyst

Analyzing the financial implications of this launch, the introduction of Nuceiva® into a major European market like Spain is promising for Evolus. With aesthetic treatments being a high-margin business, capturing even a small portion of the Spanish market could result in significant revenue boosts. Historically, the aesthetic neurotoxin market has seen robust growth and entering Spain aligns well with Evolus' strategy for above-market growth.

Investors should watch for quarterly financial reports to see how quickly revenue from Spain begins to materialize. Short-term, there will be costs associated with the launch, including marketing and distribution. However, long-term benefits could include recurrent revenue from repeat customers and strong brand positioning in Europe.

It's also worth noting the potential for cannibalization if existing markets don’t grow as expected. Additionally, evolving regulations in the EU could pose future risks.

Rating: 1

Medical Research Analyst

From a clinical perspective, Nuceiva® has undergone rigorous trials, including head-to-head comparisons with Botox®. This suggests a high level of confidence in its efficacy and safety, which is an important consideration for healthcare professionals and their patients. The clinical program's transparency and comprehensive data on safety profiles position Nuceiva® as a competitive option in the aesthetic treatment space.

For healthcare providers, the availability of another neurotoxin could enhance treatment options, potentially leading to better patient outcomes. For patients, the psychological benefits of improved appearance are well-documented, making effective aesthetic treatments like Nuceiva® highly desirable.

However, the product's acceptance will depend on real-world performance and patient satisfaction. Monitoring post-launch feedback will be critical to assessing the long-term success of Nuceiva® in Spain.

Rating: 1

• 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

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- 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 trials^3,4 including the largest head-to-head aesthetic pivotal study versus Botox® (onabotulinumtoxinA) to date, and two long-term safety studies^5,6. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240612853482/en/

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

Source: Evolus

FAQ

What is the new product launched by Evolus in Spain?

Evolus has launched Nuceiva, a botulinum toxin type A, in Spain.

What is Nuceiva approved to treat?

Nuceiva is approved for the temporary improvement of moderate to severe glabellar lines in adults under 65.

How has Nuceiva performed in clinical trials?

Nuceiva has shown promising results in three Phase III trials and two long-term safety studies.

What is the significance of Evolus launching Nuceiva in Spain?

The launch in Spain, one of Europe's largest aesthetic markets, is part of Evolus's strategy for geographic expansion.

Who is leading Evolus's operations in Spain?

Maria Cudeiro, General Manager for Spain, Portugal, and Switzerland, is leading Evolus's operations in Spain.

What is the US brand name for Nuceiva?

Nuceiva is known as Jeuveau in the United States.

How has Jeuveau performed in the US market?

Jeuveau has been the fastest-growing neurotoxin in the United States for three consecutive years.