Revance to Present Clinical Data on DaxibotulinumtoxinA for Injection and Hyaluronic Acid Filler Injection Technique at the 2021 American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting

Rhea-AI Summary

Revance Therapeutics (NASDAQ: RVNC) presented new data on DaxibotulinumtoxinA for Injection at the ASDS Virtual Annual Meeting from November 19-21, 2021. Highlights include findings from the SAKURA Phase 3 trials, which assessed immunogenicity and treatment for glabellar lines. An innovative injection technique for midface volumization using hyaluronic acid fillers was also discussed. The presentations underscore Revance's commitment to setting new standards in facial aesthetics and its robust growth pipeline.

Positive

• New data from SAKURA Phase 3 trials highlights the immunogenic potential of DaxibotulinumtoxinA for injection.
• Successful presentation of innovative injection techniques at a prominent dermatology conference.
• Strong growth potential of the product pipeline is emphasized.

Negative

• None.

- Two presentations highlighting data on DaxibotulinumtoxinA for Injection, including one oral presentation showcasing new data on clinical immunogenicity from the SAKURA Phase 3 program, and one abstract on injection technique for midface volumization with hyaluronic acid based fillers -

NASHVILLE--(BUSINESS WIRE)-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced two oral presentations and one ePoster at the American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting, November 19-21, 2021.

“We look forward to sharing a breadth of data at this year’s ASDS Virtual Annual Meeting, including new data on DaxibotulinumtoxinA for Injection in glabellar lines and a novel injection technique for midface volumization with hyaluronic acid fillers,” said Roman Rubio, Senior Vice President of Clinical Development at Revance. “These presentations further demonstrate our commitment to setting the new standard in facial aesthetic treatments, advancing innovation in the category, while supporting the strong growth potential of our pipeline.”

The first oral presentation will report on new data from the SAKURA Phase 3 trials evaluating the immunogenic potential of DaxibotulinumtoxinA for Injection in the treatment of glabellar lines, with repeated drug administration. A second oral presentation presents a new pooled responder analysis from the SAKURA 1 and 2 glabellar lines studies and introduces a novel method of visualizing the results.

An e-poster presents an optimized injection technique for midface volumization, appropriate for dynamic Hyaluronic Acid based fillers.

Oral Presentations:

• Title: Clinical Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines Including Subjects With Multiple Exposures: Pooled Data from the SAKURA Phase 3 Trials
  Authors and Affiliations: Shannon Humphrey, University of British Columbia and Humphrey Cosmetic Dermatology, Vancouver, British Columbia, Canada; Jeffrey S. Dover, SkinCare Physicians, Chestnut Hill, MA; Ronald R. Bowsher, Amanda Clancy, B2S Life Sciences, Franklin, IN; Yan Liu, Conor J. Gallagher, Revance Therapeutics, Inc., Nashville, TN

• Title: Visualizing the Elimination of Glabellar Lines Following Treatment With DaxibotulinumtoxinA for Injection
  Authors and Affiliations: Shannon Humphrey, University of British Columbia and Humphrey Cosmetic Dermatology, Vancouver, British Columbia, Canada; Sabrina Fabi, Cosmetic Laser Dermatology, San Diego, CA; Derek Jones, Skin Care and Laser Physicians of Beverly Hills, Beverly Hills, CA; Todd Gross, Yan Liu, Roman Rubio, Revance Therapeutics, Inc., Nashville, TN

e-Poster:

• Title: Midface volumization: A multilayering injection technique for soft tissue hyaluronic acid fillers designed for dynamic facial movement
  Authors and Affiliations: Hassan Galadari, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, UAE; Susan H. Weinkle, Private practice, Bradenton, FL and University of South Florida, Tampa, FL; Jay Mashburn, Revance Therapeutics, Inc., Nashville, TN

The above presentations will be live for the duration of the ASDS virtual conference and also available on-demand for 60 days post-meeting. Complete abstracts, details on presentation times and changes to dates can be found on the ASDS website. Please check www.asds.net for the latest information.

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 human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the OPUL™ Relational Commerce platform. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated 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 trademarks of TEOXANE SA.
BOTOX® is a registered trademark of Allergan, Inc.

Forward-Looking Statements

Any statements in this press release that are not statements of historical fact, including statements related to novel injection technique; our ability to set a new standard in facial aesthetic treatments; innovation in facial aesthetic treatments; our product pipeline growth; the potential benefits of DaxibotulinumtoxinA for Injection and the RHA® Collection of dermal fillers; differentiation of our products; development of a biosimilar to BOTOX®; and statements about our business strategy, timeline and other goals, plans and prospects, 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 upon 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 the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including our ability to obtain a Type A meeting with the FDA, remediate deficiencies identified by the FDA, obtain 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 the site inspection or other reasons; the timing of capital expenditures; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products and services, the aesthetics market, commercialization efforts, business operations, regulatory meetings and approvals, clinical trials and other aspects of our business and on the market; our ability and the ability of our partners to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, commercial acceptance, market, competition and/or size and growth potential of the RHA® Collection of dermal fillers, OPUL™ and our drug product candidates, if approved; our ability to continue to successfully commercialize the RHA® Collection of dermal fillers and OPUL™ and our ability to successfully commercialize DaxibotulinumtoxinA for Injection, if approved, and the timing and cost of commercialization activities; the proper training and administration of our products by physicians and medical staff; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with privacy and data protection laws; our ability to effectively manage our expanded operations in connection with the acquisition of Hint, Inc; the profitability of and our ability to scale OPUL™, our ability to transfer practices from HintMD to OPUL™, the features and functionalities and benefits to practices and patients of OPUL™; interruptions or performance problems associated with HintMD or OPUL™; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements, our financial performance and the economics of DaxibotulinumtoxinA for Injection, the RHA® Collection of dermal fillers and OPUL™; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; the volatility of our stock price; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks 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 September 30, 2021, expected to be filed with the SEC on November 9, 2021. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211119005265/en/

Media

Revance Therapeutics, Inc.:

Sara Fahy, 949-887-4476

sfahy@revance.com

Investors

Revance Therapeutics, Inc.:

Jessica Serra, 626-589-1007

Jessica.serra@revance.com

or

Gilmartin Group, LLC.:

Laurence Watts, 619-916-7620

laurence@gilmartinir.com

Source: Revance Therapeutics, Inc.

FAQ

What are the results of the SAKURA Phase 3 trials for RVNC?

The SAKURA Phase 3 trials demonstrate the immunogenic potential of DaxibotulinumtoxinA for Injection in treating glabellar lines.

What was presented at the ASDS Annual Meeting by Revance Therapeutics?

Revance presented new data on DaxibotulinumtoxinA and an innovative injection technique for hyaluronic acid fillers at the ASDS Annual Meeting.

How does DaxibotulinumtoxinA impact facial aesthetics?

DaxibotulinumtoxinA is positioned to set a new standard in facial aesthetic treatments, targeting glabellar lines specifically.

What is the significance of the ASDS Virtual Annual Meeting for RVNC?

The ASDS Virtual Annual Meeting provides Revance an opportunity to showcase their innovative developments and enhance visibility within the aesthetic community.