NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that the Australian Therapeutic Goods Administration (TGA) has provided regulatory approval for Nuceiva® (prabotulinumtoxinA)▼, a neurotoxin dedicated exclusively to aesthetics. Nuceiva® was approved for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients. Glabellar lines are the vertical lines between the eyebrows seen at maximum frown.
“We are thrilled to gain regulatory approval for Nuceiva® in Australia, one of the largest market opportunities for aesthetic neurotoxins outside of the United States, where we are rapidly gaining market share, and Great Britain, where we recently launched commercial operations,” said David Moatazedi, President and Chief Executive Officer, Evolus. “This approval is the latest example of our commitment to broaden our international presence, which is a key component to reaching our aspiration of $500 million in total revenue by 2028.”
Evolus plans to launch Nuceiva® in Australia during the second half of 2023 after commencing additional launches in Europe – beginning with Germany and Austria – in the first half of 2023. In addition to Great Britain, Nuceiva® is also commercially available in Canada.
The safety and efficacy of Nuceiva® was evaluated through the company’s global TRANSPARENCY clinical program, which included two Phase III U.S. trials, the largest head-to-head aesthetic pivotal study versus BOTOX® (onabotulinumtoxinA) to date, and two long-term safety studies. The product is approved for sale in the U.S. under the brand name Jeuveau®.
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), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Visit us at www.evolus.com, and follow us on LinkedIn, Twitter, Instagram or Facebook.
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 based on our current expectations, assumptions, estimates and projections about future events, our business, financial condition, results of operations and prospects, our industry and the regulatory environment in which we operate. Any statements contained herein that are not statements of historical facts may be deemed to be 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. The company’s forward-looking statements include, but are not limited to, statements related to the company’s financial outlook in 2023 and beyond, expectations regarding share growth and international product launches.
The forward-looking statements included herein are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. 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 Allergan/Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, the continued impact of COVID-19 or other outbreaks of contagious diseases on our business, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Nuceiva® / Jeuveau®, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, our ability to successfully broaden our product portfolio, our ability to maintain regulatory approvals of Nuceiva® / Jeuveau® or obtain regulatory approvals for new product candidates or indications and other risks described in our filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 filed with the Securities and Exchange Commission on November 8, 2022. These filings can be accessed online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, we undertake no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. If we do update or revise one or more of these statements, investors and others should not conclude that we will make additional updates or corrections.
▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at Report a problem or side effect.
1Sources: Medical Insights, Inc., DRG/Clarivate and company estimates
Jeuveau® and Nuceiva® are registered trademarks of Evolus, Inc.
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
BOTOX® is a registered trademark of Allergan, Inc.