Revance Continues to Anticipate FDA Approval of DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Wrinkles in 2021

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NASHVILLE, Tennessee – (COMMERCIAL THREAD) – Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, responds to public disclosure of its Form 483 pursuant to a Freedom of Information Act (FOIA) request that has been sent to the FDA. The Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection remains under FDA review and the company continues to anticipate FDA approval of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines in 2021.

Revance notes that issuing a Form 483 following the conclusion of an on-site inspection is not uncommon. A Form 483 lists observations made by FDA officials during the inspection of a facility. A Form 483 is not a final agency decision.

Revance provided its response to Form 483 in July 2021 following a pre-approval inspection and is currently awaiting the FDA’s decision on its BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines. The company remains confident in the quality of its BLA submission and continues to anticipate FDA approval in 2021.

About Revance

Revance is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain components of human or animal origin. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for injection in glabellar lines (frowning) and is seeking regulatory approval in the United States. Revance is also evaluating DaxibotulinumtoxinA for injection in the upper part of the face, including glabellar lines, forehead lines and crow’s feet, as well as in two therapeutic indications – cervical dystonia and upper limb spasticity in adults. . To accompany DaxibotulinumtoxinA for Injection, Revance has a unique portfolio of premium products and services for American aesthetic practices, including exclusive distribution rights in the United States of the RHA® collection of dermal fillers, the first and the only line of filler products approved by the FDA for the correction of dynamic facial wrinkles and folds and the OPUL â„¢ relationship commerce platform. Revance has also partnered with Viatris (formerly Mylan NV) to develop a biosimilar to BOTOX®, which would compete in the current market for short-acting neuromodulators. Revance is committed to making a difference by transforming patient experiences. For more information or to join our team, visit us at www.revance.com.

“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

Resilient Hyaluronic Acid® and RHA® are registered trademarks of TEOXANE SA.

BOTOX® is a registered trademark of Allergan, Inc.

Forward-looking statements

All statements in this press release that are not statements of historical fact, including statements relating to our ability to obtain and the timing of the FDA approval of our BLA for DaxibotulinumtoxinA for Injection for treatment glabellar wrinkles; our confidence in the quality of our BLA submission; the status of our BLA submission; the outcome of the FDA inspection of the company’s manufacturing facility in Northern California and the development of a biosimilar to BOTOX® with our partner, Viatris; constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, section 27A of the Securities Act of 1933, as amended, and section 21E of the Securities Exchange Act of 1934, as amended . You should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or will occur.

Forward-looking statements are subject to risks and uncertainties which could cause actual results to differ materially from our expectations. These risks and uncertainties relate to, but are not limited to: the results, timing, costs and completion of our research and development activities and regulatory approvals, including the continued delay in FDA approval of the BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of observations made by the FDA during site inspection or for other reasons; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end-user demand for our products, marketing efforts, business operations, clinical trials and other aspects of our company and in the market; our ability to manufacture supplies for our product candidates and to acquire supplies from the RHA® collection of dermal fillers; uncertain clinical development process; the risk that clinical trials may not be designed effectively or generate positive results or that positive results will ensure regulatory approval or commercial success; the applicability of clinical study results to actual results; the rate and degree of economic advantage, safety, efficacy, commercial and market acceptance, competition, size and growth potential of OPUL â„¢, the RHA® collection of fillers skin and our hollowed-out product candidates, if approved; our ability to continue to successfully market the RHA® collection of dermal fillers and OPUL â„¢ and our ability to successfully market DaxibotulinumtoxinA for Injection, if approved, as well as the timing and cost of marketing activities; our ability to expand our sales and marketing capabilities; the status of commercial collaborations; our ability to obtain financing for our operations; the cost and our ability to defend against product liability, intellectual property and other lawsuits; our ability to continue to obtain and maintain intellectual property protection for our drug candidates; our financial performance, including future income, expenses and capital requirements; and other risks. Detailed information regarding factors that could cause actual results to differ materially from the results expressed or implied by the statements contained in this press release can be found in our periodic filings with the Securities and Exchange Commission (SEC ), including the factors described in the section titled “Risk Factors” on our Form 10-K filed with the SEC on February 25, 2021 and including, without limitation, our Form 10-Q for the quarter ended February 30, 2021. June 2021, filed with the SEC on August 5, 2021. The forward-looking statements contained in this press release speak only as of the date hereof. We disclaim any obligation to update any forward-looking statements.


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