Revance to Highlight Aesthetic Clinical Data on DaxibotulinumtoxinA for Injection and Hyaluronic Acid Filler Study Results at Maui Derm for Dermatologists 2021

Rhea-AI Summary

Revance Therapeutics, Inc. (Nasdaq: RVNC) announced the presentation of three ePosters at the Maui Derm for Dermatologists 2021 meeting, showcasing findings from the Phase 2 study of DaxibotulinumtoxinA for Injection for treating upper facial lines. The data highlight progressive improvement in static glabellar lines with repeated treatments, along with in vitro results on the RHA® Collection fillers. Revance aims to establish DaxibotulinumtoxinA as a new standard in facial aesthetics, with U.S. regulatory approval for glabellar lines pending.

Positive

• Presentation of promising Phase 2 study results for DaxibotulinumtoxinA for Injection.
• Demonstrated progressive improvement in static glabellar lines with repeated treatments.
• Potential to set new standards in facial aesthetics with DaxibotulinumtoxinA.

Negative

• None.

Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that three ePosters will be presented at the Maui Derm for Dermatologists 2021 meeting being held in-person at the Grand Wailea in Maui, Hawaii from January 25-29, 2021 and broadcasted via live-stream for those unable to join in person. The presentations will showcase findings from the open-label Phase 2 study evaluating DaxibotulinumtoxinA for Injection for the simultaneous treatment of moderate to severe upper facial lines (glabellar lines, forehead lines and lateral canthal lines), as well as data demonstrating the progressive effects of DaxibotulinumtoxinA for Injection on static/resting, glabellar lines with repeated treatment as a secondary analysis of data from the SAKURA Phase 3 program. Additionally, results of an in vitro study evaluating the ability of recombinant hyaluronidase to degrade the RHA® Collection of hyaluronic acid based dermal fillers, alongside a number of other commercially available HA fillers will be shared.

“We continue to build on our existing body of evidence, underscoring the potential of DaxibotulinumtoxinA for Injection to set a new standard in facial aesthetics treatments,” said Roman Rubio, Senior Vice President of Clinical Development at Revance. “At Maui Derm 2021, we are excited to present positive results from our Phase 2 upper facial lines study and data from the SAKURA Phase 3 program on static glabellar lines, in addition to the first in vitro data describing the sensitivity of the RHA® Collection to hyaluronidase degradation.”

The following ePosters are currently available to attendees and the abstracts are available online via the Maui Derm website at MauiDerm.com.

ePosters:

• Title: Treatment of Upper Facial Lines with DaxibotulinumtoxinA for Injection: Results from an Open-label Phase 2 Study
  Authors and Affiliations: Jeffrey S. Dover, Skincare Physicians, Chestnut Hill Massachusetts; Shannon Humphrey, University of British Columbia, Vancouver, British Columbia; Z. Paul Lorenc, Department of Plastic Surgery, Lenox Hill Hospital, New York New York; Ava Shamban, AVA MD, Santa Monica, California; Todd Gross, Yan Liu, Roman Rubio, Domenico Vitarella, Revance Therapeutics, Inc. Newark, California

• Title: DaxibotulinumtoxinA for Injection–treated Subjects Show Progressive Improvement in Static Glabellar Lines with Repeated Treatment
  Authors and Affiliations: Richard Glogau, Department of Dermatology, University of California at San Francisco, San Francisco, California; Theda Kontis, Department of Otolaryngology-Head and Neck Surgery, Division of Facial Plastic and Reconstructive Surgery, Johns Hopkins Medical Institutions, Baltimore, Maryland; Yan Liu, Conor J. Gallagher, Revance Therapeutics, Inc. Newark, California

• Title: An in vitro Kinetic Study of Hyaluronic Acid Filler Enzymatic Degradation to Human Recombinant Hyaluronidase
  Authors and Affiliations: Jimmy Faivre, Teoxane, Mélanie Gallet, Teoxane, Conor Gallagher, Revance Therapeutics, François Bourdon, Teoxane

About Revance Therapeutics, Inc.

Revance Therapeutics, Inc. 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 HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. 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 development of a biosimilar to BOTOX®; statements about our business strategy, the market for our anticipated products and plans and prospects, and potential benefits of our drug product candidates 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 delays in the approval of our BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to successfully compete with treatments and therapies; our ability to achieve, and the rate and degree of commercial acceptance and the market, size and growth potential of our drug product candidates, if approved; our ability to successfully commercialize our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to obtain and maintain regulatory approval of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; 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-Q filed with the SEC on November 9, 2020. 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.

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FAQ

What are the findings presented by Revance Therapeutics at the Maui Derm 2021?

Revance presented findings from the Phase 2 study showing that DaxibotulinumtoxinA for Injection significantly improves upper facial lines and demonstrates progressive efficacy with repeated treatments.

What is DaxibotulinumtoxinA for Injection used for?

DaxibotulinumtoxinA for Injection is used to treat moderate to severe upper facial lines, including glabellar lines, forehead lines, and crow's feet.

What does the in vitro study about RHA® Collection reveal?

The in vitro study evaluates how recombinant hyaluronidase affects the RHA® Collection of hyaluronic acid fillers, providing insights into their stability and degradation.

How does Revance plan to commercialize DaxibotulinumtoxinA?

Revance aims to achieve regulatory approval for DaxibotulinumtoxinA and is also exploring its application in various therapeutic indications, including cervical dystonia and upper limb spasticity.

What is the significance of the Maui Derm for Dermatologists meeting for Revance?

The Maui Derm meeting is significant as it provides a platform for Revance to showcase groundbreaking clinical data, potentially influencing market perception and acceptance of its products.