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Evolus Expands Global Footprint with Introduction of Nuceiva® (botulinum toxin type A) in Australia

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Evolus, Inc. (NASDAQ: EOLS) has launched Nuceiva® (prabotulinumtoxinA) in Australia, expanding its global footprint in the aesthetic market. This strategic move is part of the company's geographic expansion strategy, with Evolus Australia established to drive medical education, training, marketing, and sales to healthcare professionals in the medical aesthetics field.

Nuceiva® is approved by the Therapeutic Goods Administration (TGA) for temporarily improving the appearance of moderate to severe glabellar lines in adult patients. The product, known as Jeuveau® in the United States, has been the fastest-growing neurotoxin in the U.S. for three consecutive years. Evolus aims to offer this new treatment to patients by working closely with aesthetics healthcare professionals in Australia.

The company's expansion into Australia is led by Daniel Henry, with support from Dan Stewart, Vice President and General Manager of Evolus International. This launch is expected to fuel Evolus' global growth strategy and reinforce its position as a global leader in the aesthetics industry.

Evolus, Inc. (NASDAQ: EOLS) ha lanciato Nuceiva® (prabotulinumtoxinA) in Australia, ampliando la sua presenza globale nel mercato estetico. Questa mossa strategica fa parte della strategia di espansione geografica dell'azienda, con Evolus Australia istituita per promuovere l'educazione medica, la formazione, il marketing e le vendite ai professionisti sanitarî nel campo dell'estetica medica.

Nuceiva® è approvato dalla Therapeutic Goods Administration (TGA) per migliorare temporaneamente l'aspetto delle linee glabellari da moderate a severe nei pazienti adulti. Il prodotto, conosciuto come Jeuveau® negli Stati Uniti, è stato il neurotossina a più rapida crescita negli USA per tre anni consecutivi. Evolus punta a offrire questo nuovo trattamento ai pazienti collaborando strettamente con i professionisti della salute estetica in Australia.

L'espansione dell'azienda in Australia è guidata da Daniel Henry, con il supporto di Dan Stewart, Vice Presidente e Direttore Generale di Evolus International. Questo lancio è destinato a alimentare la strategia di crescita globale di Evolus e a rafforzare la sua posizione di leader globale nel settore estetico.

Evolus, Inc. (NASDAQ: EOLS) ha lanzado Nuceiva® (prabotulinumtoxinA) en Australia, expandiendo su huella global en el mercado estético. Este movimiento estratégico es parte de la estrategia de expansión geográfica de la compañía, con Evolus Australia establecida para impulsar la educación médica, la capacitación, el marketing y las ventas a profesionales de la salud en el campo de la estética médica.

Nuceiva® está aprobado por la Therapeutic Goods Administration (TGA) para mejorar temporalmente la apariencia de las líneas glabelares moderadas a severas en pacientes adultos. El producto, conocido como Jeuveau® en los Estados Unidos, ha sido el neurotóxico de más rápido crecimiento en EE. UU. durante tres años consecutivos. Evolus tiene como objetivo ofrecer este nuevo tratamiento a los pacientes trabajando en estrecha colaboración con los profesionales de la salud estética en Australia.

La expansión de la compañía en Australia está liderada por Daniel Henry, con el apoyo de Dan Stewart, Vicepresidente y Gerente General de Evolus International. Se espera que este lanzamiento impulse la estrategia de crecimiento global de Evolus y refuerce su posición como líder global en la industria estética.

Evolus, Inc. (NASDAQ: EOLS)는 호주에서 Nuceiva® (prabotulinumtoxinA)를 출시하여 미용 시장에서의 글로벌 입지를 확대했습니다. 이 전략적 이동은 회사의 지리적 확장 전략의 일환으로, Evolus Australia는 의료 교육, 훈련, 마케팅 및 의료 미용 분야의 전문가들에게 영업을 추진하기 위해 설립되었습니다.

Nuceiva®는 성인 환자의 중등도에서 중증의 미간 주름을 일시적으로 개선하는 데 대해 Therapeutic Goods Administration (TGA)로부터 승인받았습니다. 미국에서는 Jeuveau®로 알려진 이 제품은 미국에서 3년 연속으로 가장 빠르게 성장하는 신경독소입니다. Evolus는 호주에서 미용 의료 전문가들과 긴밀히 협력하여 이 새로운 치료제를 환자에게 제공할 계획입니다.

회사의 호주 확장은 Daniel Henry가 이끌고, Evolus International의 부사장 겸 총괄 관리자 Dan Stewart의 지원을 받습니다. 이번 출시는 Evolus의 글로벌 성장 전략을 촉진하고 미용 산업에서 글로벌 리더로서의 입지를 강화할 것으로 기대됩니다.

Evolus, Inc. (NASDAQ: EOLS) a lancé Nuceiva® (prabotulinumtoxinA) en Australie, élargissant ainsi son empreinte mondiale sur le marché esthétique. Ce mouvement stratégique fait partie de la stratégie d'expansion géographique de l'entreprise, avec l'établissement d'Evolus Australia pour promouvoir l'éducation médicale, la formation, le marketing et les ventes aux professionnels de santé dans le domaine de l'esthétique médicale.

Nuceiva® est approuvé par la Therapeutic Goods Administration (TGA) pour améliorer temporairement l'apparence des rides glabellaires modérées à sévères chez les patients adultes. Le produit, connu sous le nom de Jeuveau® aux États-Unis, a été le neurotoxine connaissant la plus forte croissance aux États-Unis pendant trois années consécutives. Evolus vise à offrir ce nouveau traitement aux patients en collaborant étroitement avec les professionnels de la santé esthétique en Australie.

L'expansion de l'entreprise en Australie est dirigée par Daniel Henry, avec le soutien de Dan Stewart, vice-président et directeur général d'Evolus International. Ce lancement devrait alimenter la stratégie de croissance mondiale d'Evolus et renforcer sa position en tant que leader mondial dans l'industrie esthétique.

Evolus, Inc. (NASDAQ: EOLS) hat Nuceiva® (prabotulinumtoxinA) in Australien eingeführt und damit seine globale Präsenz im ästhetischen Markt erweitert. Dieser strategische Schritt ist Teil der geografischen Expansionsstrategie des Unternehmens, wobei Evolus Australia gegründet wurde, um medizinische Ausbildung, Schulung, Marketing und Vertrieb an Gesundheitsfachleute im Bereich der medizinischen Ästhetik voranzutreiben.

Nuceiva® ist von der Therapeutic Goods Administration (TGA) genehmigt, um das Erscheinungsbild moderater bis ausgeprägter Glabellafalten bei erwachsenen Patienten vorübergehend zu verbessern. Das Produkt, das in den Vereinigten Staaten als Jeuveau® bekannt ist, war in den USA drei Jahre in Folge das am schnellsten wachsende Neurotoxin. Evolus hat das Ziel, diese neue Behandlung anzubieten, indem es eng mit Fachleuten im Bereich ästhetische Gesundheit in Australien zusammenarbeitet.

Die Expansion des Unternehmens nach Australien wird von Daniel Henry geleitet, unterstützt von Dan Stewart, Vizepräsident und Geschäftsführer von Evolus International. Dieser Launch wird voraussichtlich die globale Wachstumsstrategie von Evolus ankurbeln und seine Position als globalen Marktführer in der ästhetischen Industrie stärken.

Positive
  • Expansion into Australian market, a key growth region for aesthetics
  • Nuceiva® (Jeuveau® in US) has been the fastest-growing neurotoxin in the US for 3 consecutive years
  • Establishment of direct operating entity in Australia for local market penetration
  • TGA approval for Nuceiva® in treating glabellar lines in adult patients
Negative
  • None.

Insights

Evolus' expansion into Australia with Nuceiva® marks a significant strategic move in the global aesthetics market. This launch aligns with the company's geographic expansion strategy and positions them to capitalize on Australia's growing beauty market, which is estimated to reach $7.8 billion by 2025.

The company's approach of establishing a direct operating entity in Australia, led by Daniel Henry, demonstrates a commitment to localized operations. This strategy allows for tailored marketing, education and sales efforts, which are important in the highly personalized aesthetics industry.

Evolus' success with Jeuveau® in the U.S., being the fastest-growing neurotoxin for three consecutive years, provides a strong foundation for potential success in Australia. However, it's important to note that market dynamics and regulatory environments differ, which may impact adoption rates.

The company's focus on the millennial demographic is noteworthy, as this aligns with global trends of younger generations showing increased interest in non-surgical aesthetic treatments. This targeted approach could potentially give Evolus an edge in capturing market share from established competitors.

While the expansion presents growth opportunities, investors should consider potential challenges such as:

  • Competition from established brands like Botox®
  • Regulatory hurdles specific to the Australian market
  • The need for significant investment in marketing and education to build brand awareness

Overall, this expansion represents a calculated risk with potential for significant returns if executed effectively. The success of this venture could serve as a blueprint for further international expansion, potentially boosting Evolus' global market position in the long term.

Evolus' introduction of Nuceiva® in Australia is backed by a robust clinical program, which enhances its credibility in the medical community. The TRANSPARENCY clinical program, comprising three Phase III trials and two long-term safety studies, provides a solid foundation for the product's efficacy and safety profile.

Particularly noteworthy is the head-to-head study against Botox®, which is the largest of its kind in the aesthetic pivotal study arena. This direct comparison to the market leader demonstrates Evolus' confidence in Nuceiva®'s performance and could be a strong selling point for healthcare professionals considering adopting the product.

The safety profile of Nuceiva®, reported as similar to other products in its class, is important for regulatory approval and physician adoption. However, it's important to note that long-term real-world data will be essential to fully establish the product's safety and efficacy profile in diverse patient populations.

From a research perspective, Evolus' entry into the Australian market presents opportunities for:

  • Gathering real-world evidence on Nuceiva®'s performance in a new population
  • Conducting comparative effectiveness studies against local competitors
  • Investigating potential new indications or applications specific to the Australian market

The company's commitment to medical education and training for healthcare professionals is a positive sign, as it can lead to better patient outcomes and potentially faster market penetration. However, the success of these initiatives will depend on their quality and relevance to local practices.

While the clinical data supports Nuceiva®'s launch, ongoing post-market surveillance and additional studies tailored to the Australian population will be important for long-term success and potential label expansions in this new market.

  • Launching into this growth market1 as part of the company’s geographic expansion strategy
  • Evolus Australia established to drive medical education, training, marketing and sales to medical aesthetics healthcare professionals

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company focused on building an aesthetic portfolio, has commenced operations in Australia with the launch of Nuceiva® (prabotulinumtoxinA).

Nuceiva® is approved by the Therapeutic Goods Administration (TGA) for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients2.

"Launching Evolus in Australia underscores our commitment to strategic geographic expansion and our dedicated focus on customers in this growth market," said David Moatazedi, President and Chief Executive Officer. "This milestone fuels our global growth strategy by establishing a strong presence in a key region. Successfully entering new markets like Australia positions us for sustained above-market growth, reinforcing Evolus' position as a global leader in its industry."

Evolus has established a direct operating entity in Australia, under the leadership of Daniel Henry. 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 has been the fastest-growing neurotoxin in the United States for three consecutive years*.

"As the beauty and healthcare landscape continues to evolve, we understand the importance of working closely with our customers and partners to navigate these changes successfully," said Dan Stewart, Vice President and General Manager of Evolus International. "I have full confidence in Daniel Henry, who brings a wealth of experience and vision to our team. We are dedicated to supporting Australian healthcare professionals by providing exceptional customer service, innovative educational initiatives, and a user-friendly online service platform to help evolve their practices and continually deliver outstanding patient satisfaction."

"Beauty in Australia is evolving as younger generations get curious about non-surgical enhancement and rejuvenation options,” said Dr. Steven Liew, renowned Plastic Surgeon and Medical Director at Shape Clinic in Sydney. “With their unapologetically millennial focus, I’m excited to be working with Evolus as they expand to Australia. By offering aesthetics healthcare professionals more choice, practitioners like me will be able to deliver optimal outcomes tailored to each patient's evolving beauty preferences and needs."

The safety and efficacy of Nuceiva® has been 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® Prescribing Information.

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.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-PI-01255-1&d=20240723172310101 (Accessed 23/07/24)
  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.

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, Inc.

FAQ

What is Evolus' new product launched in Australia?

Evolus has launched Nuceiva® (prabotulinumtoxinA), a botulinum toxin type A treatment, in Australia for temporary improvement in the appearance of moderate to severe glabellar lines in adult patients.

How has Evolus (EOLS) expanded its operations in Australia?

Evolus has established a direct operating entity in Australia, led by Daniel Henry, to drive medical education, training, marketing, and sales to medical aesthetics healthcare professionals in the country.

What is the performance of Nuceiva® (Jeuveau®) in the United States?

Nuceiva®, known as Jeuveau® in the United States, has been the fastest-growing neurotoxin in the U.S. market for three consecutive years.

What clinical trials support the safety and efficacy of Nuceiva®?

The safety and efficacy of Nuceiva® have been evaluated through the TRANSPARENCY clinical program, which includes three Phase III trials and two long-term safety studies, including the largest head-to-head aesthetic pivotal study versus Botox® to date.

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