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Revance Aesthetics

Revance is ushering in a new era of neuromodulator science, redefining the expectations of how a neuromodulator treatment may perform, endure,
and deliver.

Aesthetics: Facts, Figures, & Trends

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30

Number of years since the first neuromodulator was approved for use by the FDA.1

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7.4 million

In 2018, 7,437,378 botulinum toxin type A procedures were performed in the U.S. alone.2

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12-16 Weeks

The approximate duration of botulinum toxin type A injection treatments that are currently available.3,4

DAXI - Potentially the First Neuromodulator Innovation in 30 years

Investigational product, anticipated approval 2020

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150kD Botulinum Toxin Type A

Stabilizing Peptide Excipient

Buffers, Sugar and Polysorbate 20

DaxibotulinumtoxinA for Injection

DAXI is the first and only neuromodulator formulated with a proprietary peptide excipient.

Revance’s investigational product DAXI combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Anticipated approval in 2020.

Explore Clinical Information
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DAXI is the only neuromodulator developed and manufactured in the U.S.

Revance employs in-house, state-of-the-art manufacturing and analytics capabilities, and holds 419 issued patents in the US, EU, Latin America and Asia, as of February 2019.

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DAXI has the potential to be the first and only long-lasting neuromodulator.

Based on clinical studies (BELMONT and SAKURA 1, 2, & 3), DAXI holds the potential to deliver unprecedented response rates and duration of effect.5

DAXI has been studied in the largest aesthetic neuromodulator clinical trials ever conducted in glabellar lines. Results showed that DAXI effect lasted a median of 24 weeks, which may allow for only 2 treatments per year.

Revance completed the SAKURA Phase 3 pivotal and safety trials of DAXI for the treatment of glabellar (frown) lines and anticipates FDA approval in 2020.

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24 weeks

The median duration of results achieved in clinical trials with DAXI for the treatment of moderate to severe glabellar lines*5

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28 Weeks

The median time to return to baseline wrinkle severity in clinical trials with DAXI*5

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95%

Response rate for DAXI across the largest aesthetic neuromodulator clinical trial ever conducted dataset. 4,5
*this data point represents a 1-point change at 4 weeks5

Revance Clinical Program Update

  • PRECLINICAL
  • PHASE 1
  • PHASE 2
  • PHASE 3

DAXI — Aesthetics

a Glabellar (Frown) Lines Submit BLA Fall 2019, anticipate launch 2020
PHASE 3 COMPLETE
b Forehead Lines
IN PHASE 2
c Lateral Canthal Lines (Crow’s Feet)
IN PHASE 2
Anticipated BLA submission Fall 2019
a b c

Glabellar (Frown) Lines – A

In the largest aesthetic neuromodulator clinical trial ever conducted for the treatment of glabellar frown lines, our lead compound DaxibotulinumtoxinA for Injection (DAXI) delivered unprecedented duration and efficacy of effect.

DAXI has the potential to deliver the first long-lasting injectable formulation of botulinum toxin type A, representing the first major innovation to hit the $4.5 billion neuromodulator market in 30 years.

DAXI has been evaluated in a Phase 2 head-to-head, active comparator study (BELMONT), and in three Phase 3 trials (SAKURA 1, 2, 3) for the treatment of glabellar lines. We plan to file for regulatory approval in 2019 and potentially launch DAXI in 2020.

Forehead Lines and Lateral Canthal Lines (Crow’s Feet) – B&C

DAXI is also being studied for the treatment of forehead lines and lateral canthal lines, commonly known as crow’s feet. Phase 2 trials are expected to be fully enrolled in the Summer of 2019 and have results in the first half of 2020. For the latest information regarding our clinical development programs, please see our public filings with the Securities and Exchange Commission or visit clinicaltrials.gov.

Publications & Videos

DAXI is an investigational product. It is currently undergoing clinical studies for both therapeutic and aesthetic indications.

Clinical Information
  • Announcing Sakura 3 Results
  • SAKURA 3 Results, Jean Carruthers, M.D. and Shannon Humphrey, M.D.
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Careers with Revance

Do you have what it takes to join our team? Check out our Careers page and find out.

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References

  1. FDA Approved Drug Products Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103000 Accessed August 2019
  2. The American Society of Plastic Surgeons. 2018 Plastic Surgery Statistic Report Available at: https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf Accessed July 2019
  3. Full details included in Botox product insert. Available at https://www.allergan.com/assets/pdf/botox_cosmetic_pi.pdf. Accessed August 2019.
  4. Full details included in Dysport product insert. Available at: https://www.galderma.com/us/sites/g/files/jcdfhc341/files/2019-04/Dysport-PI.pdf?_ga=2.84005469.555576802.1566939002-1781280672.1566939002 Accessed August 2019
  5. Revance Data on File

Disclaimers

* DAXI is an investigational agent that is not approved by the FDA, nor has the FDA determined it to be safe or efficacious in humans. Anticipated approval in 2020.

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