Market Overview

Positive BELMONT Phase 2 Trial Results Published in Dermatologic Surgery


Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company
developing botulinum toxin products for use in treating aesthetic and
therapeutic conditions, today announced the electronic publication
(ePub) of its completed BELMONT Phase 2 trial results in the
peer-reviewed journal, Dermatologic Surgery. Positive 24-week
results for BELMONT, a Phase 2 active comparator, double-blinded,
placebo-controlled, multi-center trial of DaxibotulinumtoxinA for
Injection (RT002) for the treatment of glabellar (frown) lines, were
first announced in October 2015.


  • SAFETY: All dose levels of RT002 appeared to be generally safe
    and well-tolerated.
  • EFFICACY: When compared to placebo, all dose levels of RT002
    achieved highly statistically significant efficacy at Week 4 (p <
    0.001) based on investigator and patient reporting. When compared to
    20U of onabotulinumtoxinA (BOTOX* Cosmetic/VISTABEL*), the 40U dose of
    RT002 showed statistical and clinical superiority over
    onabotulinumtoxinA for a range of efficacy outcomes, as rated by
    investigators, for none or mild and 1- and 2-point improvement in
    glabellar wrinkle severity.
    • Response Rate: The proportion of subjects with glabellar
      line severity rated by investigators as none or mild with 40U of
      daxibotulinumtoxinA was more than double – and significantly
      greater than that with 20U of onabotulinumtoxinA at weeks 16 and
      24 (67% vs 32% at Week 16 {p=0.002} and 31% vs. 12% at Week 24
      {p=0.041}, respectively), according to the Investigator Global
      Assessment- Facial Wrinkle Severity (IGA-FWS) score at maximum
      frown. Similarly, the proportion of subjects rated by
      investigators as improved per the Global Aesthetic Improvement
      Scale (GAIS) at 16 and 24 weeks was greater for 40U of
      daxibotulinumtoxinA than 20U of onabotulinumtoxinA (97% vs 81% at
      Week 16 {p<0.05} and 44% vs. 19% at Week 24 {p<0.05},
    • Duration: The median duration of response (at least a
      1-point improvement for baseline in IGA-FWS score at maximum
      frown) was longer with daxibotulinumtoxinA (20.0, 23.6 and 20.9
      weeks for 20U, 40U and 60U, respectively) than for
      onabotulinumtoxinA (18.8 weeks) or placebo (0.0 weeks) (p< .001
      for all botulinum toxins vs placebo and p=.030 for
      daxibotulinumtoxinA 40U vs onabotulinumtoxinA).

The publication's key conclusion stated that of the three dose ranges,
the 40U dose of RT002 had the best risk/benefit profile, exhibiting an
absence of ptosis as an adverse event, a significantly greater response
rate, and a significantly longer duration of response (median of 24 vs
19 weeks; p=.030) compared to onabotulinumtoxinA. The abstract and
access to the article in Dermatologic Surgery can be retrieved
via this link: BELMONT

"The BELMONT trial results are exciting, in that they show RT002
injectable could be the first new generation botulinum toxin treatment
offering patients higher response rates and a longer duration of
response without compromising safety or tolerability," said trial
investigator Jean D. Carruthers, MD, Clinical Professor, at University
of British Columbia, Medical Director at Jean Carruthers Cosmetic
Surgery Inc., and one of the world's foremost leaders in aesthetic
botulinum toxin use. "Treatment of glabellar lines represents the
largest use of botulinum toxin in aesthetics practice today. I believe
my patients would be thrilled to benefit from enduring wrinkle reduction
over a six-month period. To my knowledge, RT002 is the only
neuromodulator that has shown the potential to be meaningfully longer
acting than the market leader."

Added Dan Browne, President and Chief Executive Officer at Revance, "The
emergence of a differentiated, new neuromodulator is significant to
physicians and patients alike. RT002 has the potential to provide a
better aesthetic experience. Acceptance in a peer-reviewed publication,
such as Dermatologic Surgery, validates the significance of our
BELMONT results and underscores the confidence we have in our SAKURA
Phase 3 program using RT002 injectable for the treatment of frown lines.
The two pivotal trials are fully enrolled, and we look forward to
reporting topline results in the fourth quarter of 2017."

BELMONT Phase 2 Study Design

BELMONT was a Phase 2, randomized, double-blind, dose-ranging, active
comparator and placebo-controlled, multi-center study conducted at key
sites in Canada. The study evaluated the safety, efficacy and duration
of three doses of RT002 (RTT150 (Botulinum Toxin Type A) for Injection,
20U, 40U or 60U), compared to the labeled dose of the current market
leader BOTOX Cosmetic 20U (or VISTABEL as trademarked in Canada) and a
placebo control in treating glabellar lines. The BELMONT study enrolled
268 subjects with moderate to severe glabellar lines during maximum
frown. The primary efficacy measurements for the study were the
investigator's assessment of glabellar line severity at maximum frown
(IGA-FWS) and median duration of effect from the date of treatment to
when a subject reverts to baseline severity. Subjects in the BELMONT
study were randomized equally across five study groups receiving one of
three doses of RT002, the active comparator or placebo. The trial
followed subjects for up to 36 weeks or until they returned to baseline.

SAKURA Phase 3 Clinical Program

The company's Phase 3 clinical program includes two randomized,
double-blind, placebo-controlled pivotal trials to evaluate the safety
and efficacy of a single administration of RT002 for the treatment of
moderate to severe glabellar lines in adults. The pivotal trials have
enrolled a total of approximately 600 subjects at multiple sites in the
United States and Canada. In both trials, subjects have been randomized
in a 2:1 ratio to either the RT002 or placebo treatment groups,
respectively. Post-treatment, subjects will be followed for at least 24
weeks and up to 36 weeks.

The primary efficacy endpoint of the pivotal trials will be a composite
of the proportion of subjects who achieve a score of 0 or 1 (none or
mild) and a two-point improvement from baseline in glabellar line
severity on the Investigator Global Assessment-Facial Wrinkle Severity
(IGA-FWS) and Patient Facial Wrinkle Severity (PFWS) scales, at maximum
contraction (frown), at Week 4. Duration of the reduction of severity of
the glabellar lines will be assessed as a secondary efficacy endpoint in
the Phase 3 pivotal trials.

In addition to the two pivotal trials, the Phase 3 program includes a
long-term, open-label safety trial, which is designed to evaluate the
long-term safety of RT002 for the treatment of moderate to severe
glabellar lines in adults following both single and repeat treatment
administration. The long-term safety trial is expected to enroll
approximately 1,500 subjects at multiple sites in the US and Canada.
Depending on the number of treatments and duration of follow-up, a
subject may be on trial for a maximum of 84 weeks. Additional
information about the SAKURA Phase 3 program, including subject
eligibility criteria, is available at

About Revance Therapeutics, Inc.

Revance, a Silicon Valley-based biotechnology company, is committed to
the advancement of remarkable science. The company is developing a
portfolio of products for aesthetic medicine and underserved therapeutic
specialties, including dermatology, orthopedics and neurology. Revance's
science is based upon a proprietary peptide technology, which when
combined with active drug molecules, may help address current unmet
needs. Revance's initial focus is on developing daxibotulinumtoxinA, the
company's highly purified botulinum toxin, for a broad spectrum of
aesthetic and therapeutic indications, including facial wrinkles and
muscle movement disorders.

The company's lead drug candidate, DaxibotulinumtoxinA for Injection
(RT002), is currently in development for the treatment of glabellar
lines, cervical dystonia and plantar fasciitis with the potential to be
the first long-acting neuromodulator. The company holds worldwide rights
for all indications of RT002 injectable and RT001 topical and the
pharmaceutical uses of its proprietary peptide technology platform. More
information on Revance may be found at

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

*BOTOX® and VISTABEL® are registered trademarks of Allergan, Inc.

Forward-Looking Statements

This press release contains forward-looking statements, including
statements related to the process and timing of, and ability to
complete, current and anticipated future clinical development of our
investigational drug product candidates, including but not limited to
initiation and design of clinical studies for current and future
indications, related results and reporting of such results; statements
about our business strategy, timeline and other goals and market for our
anticipated products, plans and prospects; and statements about our
ability to obtain regulatory approval; and potential benefits of our
drug product candidates and our technologies.

Forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from our
expectations. These risks and uncertainties include, but are not limited
to: the outcome, cost, and timing of our product development activities
and clinical trials; the uncertain clinical development process,
including the risk that clinical trials may not have an effective design
or generate positive results; our ability to obtain and maintain
regulatory approval of our drug product candidates; our ability to
obtain funding for our operations; our plans to research, develop, and
commercialize our drug product candidates; our ability to achieve market
acceptance of our drug product candidates; unanticipated costs or delays
in research, development, and commercialization efforts; the
applicability of clinical study results to actual outcomes; the size and
growth potential of the markets for our drug product candidates; our
ability to successfully commercialize our drug product candidates and
the timing of commercialization activities; the rate and degree of
market acceptance of our drug product candidates; our ability to develop
sales and marketing capabilities; the accuracy of our estimates
regarding expenses, future revenues, capital requirements and needs for
financing; our ability to continue obtaining and maintaining
intellectual property protection for our drug product candidates; 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 Revance's
periodic filings with the Securities and Exchange Commission (the
"SEC"), including factors described in the section entitled "Risk
Factors" of our quarterly report on Form 10-Q filed May 9, 2017. These
forward-looking statements speak only as of the date hereof. Revance
disclaims any obligation to update these forward-looking statements.

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