Evolus Receives Acceptance of Submission in Australia, a Pivotal Step in Approval Process for Nuceiva®

Rhea-AI Summary

Evolus, Inc. (NASDAQ: EOLS) has announced that its submission for regulatory approval of Nuceiva® (prabotulinumtoxinA) has been accepted by the Australian Therapeutics Good Administration (TGA). This is a significant milestone for the company's international growth strategy, as Australia represents one of the largest global markets for aesthetics. Nuceiva® is already approved in the U.S. as Jeuveau®, and in Europe and Canada. Evolus aims to complete the TGA approval process in 2023 and plans to launch Nuceiva® in select European countries later this year.

Positive

• Acceptance of Nuceiva® submission by the TGA signals progress in international expansion.
• Potential to capture a significant share of the Australian aesthetic market.
• Plans for concurrent launch in select European countries enhance revenue opportunities.

Negative

• None.

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company, today announced the acceptance of its submission to the Australian Therapeutics Good Administration (TGA) for regulatory approval of Nuceiva^® (prabotulinumtoxinA), the first and only neurotoxin dedicated exclusively to aesthetics.

“The acceptance of our submission to the TGA represents a pivotal step in offering Nuceiva^® to Australian aesthetic customers and an important milestone toward our international growth strategy,” said David Moatazedi, President and Chief Executive Officer. “We look forward to completing the necessary regulatory process to obtain commercial approval in Australia, one of the largest global markets, while we concurrently work toward the launch of Nuceiva^® in select European countries later this year.”

Evolus expects to receive full TGA regulatory approval of Nuceiva^® in 2023. The product received U.S. Food and Drug Administration approval in February 2019 under the brand name Jeuveau^®. Nuceiva^® received marketing approval in Europe and the United Kingdom in October 2019 and was approved by Health Canada in August 2018.

Nuceiva^® and Jeuveau^® are used for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) in adults below 65 years of age. The safety and efficacy of Nuceiva^® and Jeuveau^® were evaluated as part of Evolus’ global TRANSPARENCY clinical development program, which enrolled more than 2,100 patients in the United States, Europe and Canada and included the largest head-to-head pivotal study versus BOTOX^® to date.

About Evolus, Inc.

Evolus (Nasdaq: EOLS) is a performance beauty company with a customer-centric approach to delivering breakthrough products. Approved in 2019 by the U.S. Food and Drug Administration, Jeuveau^® (prabotulinumtoxinA-xvfs) is the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Jeuveau^® is powered by Evolus’ unique technology platform and is designed to transform the aesthetic market by eliminating the friction points existing for customers today. 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, regulatory approvals and international commercial product launches.

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 Jeuveau^®, the efficiency and operability of our digital platform, competition and market dynamics, and our ability to maintain regulatory approval of Jeuveau^® and other risks described in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 that was filed with the Securities and Exchange Commission on November 2, 2021. 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, 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.

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

Botox^® is a registered trademark of Allergan, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220208005491/en/

David K. Erickson, Evolus, Inc.

Vice President, Investor Relations

Tel: 949-966-1798

Email: david.erickson@evolus.com

Source: Evolus

FAQ

What was announced by Evolus regarding Nuceiva®?

Evolus announced that its submission for Nuceiva® regulatory approval has been accepted by the Australian TGA.

When does Evolus expect to receive TGA approval for Nuceiva®?

Evolus expects to receive full TGA regulatory approval for Nuceiva® in 2023.

What markets is Evolus targeting for Nuceiva®?

Evolus is targeting the Australian market as well as select European countries for Nuceiva®.

How does Nuceiva® compare to Jeuveau®?

Nuceiva® is the same product as Jeuveau®, which is approved in the U.S. and is also used for aesthetic purposes.

What is the significance of the TGA acceptance for Evolus?

The acceptance represents a critical step in Evolus' strategy to expand its international presence and customer base.