- Reports 2017 Unaudited Year-End Cash and
Investments Balance Exceeded $280 million -
- Expects to Complete RT002 SAKURA Phase 3
Program and Start RT002 Phase 3 Trial for Cervical Dystonia in 2018
-
- Plantar Fasciitis Phase 2a Interim Results by
Mid-January -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing neuromodulators for use in treating aesthetic
and underserved therapeutic conditions, today announced key 2018
clinical milestones for DaxibotulinumtoxinA for Injection (RT002)
and provided its financial outlook for 2018. The company also
announced its unaudited December 31, 2017 cash and investments
balance exceeded $280 million and now expects its cash and
investments to fund the company through 2019.
“We’re making rapid progress towards bringing a platform of
innovative treatments to patients who have conditions that lack
sustained treatment effect with current neuromodulators, as well as
treatments for new indications not approved by the FDA today,” said
Dan Browne, President and Chief Executive Officer of Revance. “In
2017, we announced positive clinical results for our clinical
programs for RT002 in treating glabellar lines and cervical
dystonia. These trials demonstrated that RT002 has unique
characteristics, delivering high patient response rates and
long-acting 6-month performance.”
Mr. Browne continued, “As we enter 2018, we are preparing for a
2019 BLA filing for RT002 to treat glabellar lines, while also
expanding our sales and marketing initiatives to execute our
Revance Product Launch Velocity Plan in facial aesthetics. From a
clinical development perspective, we will pivot to focus on
accelerating therapeutic uses for RT002, with plans to expand the
overall sales of neuromodulators with our uniquely differentiated
neuromodulator.”
RT002 INJECTABLE 2017 CLINICAL MILESTONES
SAKURA Phase 3 Program for Treatment of Glabellar (Frown)
Lines – Expects to Complete Open-Label, Long-Term Safety Study in
Second Half of 2018
In December 2017, Revance announced highly statistically
significant results for both the primary and secondary endpoints
for its two SAKURA Phase 3 pivotal trials of RT002 injectable for
the treatment of glabellar lines. Glabellar lines are the vertical
lines that develop between the eyebrows because of repeated
frowning, scowling, or merely focusing while listening or reading.
As a person ages, the skin becomes less elastic and glabellar lines
typically become more pronounced.
With the SAKURA 3 open-label, long-term safety study fully
enrolled, the company plans to complete the safety study in the
second half of 2018, and assuming successful completion of SAKURA
3, to file its biologics license application (BLA) with the U.S.
Food and Drug Administration (FDA) in the first half of 2019.
Phase 3 Trial for Treatment of Cervical Dystonia – Expects to
Initiate Trial in Second Quarter of 2018
In May of 2017, Revance reported positive results from its Phase
2 dose-escalating clinical trial of RT002 injectable for the
treatment of cervical dystonia. In November, Revance announced the
completion of its End-of-Phase 2 meeting with the FDA and
receipt of Scientific Advice from the Europe Medicines
Agency (EMA). Also in November, the FDA granted RT002 orphan
drug designation for this indication. Patients with cervical
dystonia suffer from painful, embarrassing twisting movements of
the neck, often impairing their ability to work, drive and perform
activities of daily living. The company expects to initiate a Phase
3 trial in patients with cervical dystonia in the second quarter of
2018 and anticipates the need for only one pivotal along with a
safety trial before seeking FDA approval.
Phase 2a Proof of Concept Trial for Treatment of Plantar
Fasciitis – Expects to Report Interim Results by Mid-January
2018
In mid-January of 2018, the company expects to report interim
8-week results from its Phase 2a clinical trial of RT002 injectable
for the management of plantar fasciitis. The plantar fascia is the
foot’s shock absorber. Repeated pressure on this tissue, whether
from sport activities, aging, or obesity, can result in plantar
fasciitis, characterized by inflammation accompanied by sharp,
constant pain in the heel that can become highly debilitating.
Several publications have reported neuromodulators may reduce the
pain for patients suffering from a range of acute and chronic
plantar fasciitis conditions. The company plans to complete the
16-week trial and then expects to initiate a Phase 2b trial for
plantar fasciitis in the second half of 2018.
FINANCIAL OUTLOOK FOR 2018
Revance expects cash burn for 2018 to be in the range of $117 to
$137 million. Revance expects 2018 GAAP operating expense to be in
the range of $128 to $154 million, which when excluding
depreciation of $1 to $3 million and estimated stock-based
compensation of $17 to $21 million, results in projected 2018
non-GAAP operating expense of $110 to $130 million, driven by
increased research and development expenditure and launch
preparation activities. With three clinical programs and
preparations to file the Biologics License Application (BLA) all
underway, Revance anticipates 2018 GAAP research and development
expense to be in the range of $84 to $101 million, which when
excluding depreciation of $1 to $2 million and estimated
stock-based compensation of $7 to $9 million, results in projected
2018 non-GAAP research and development expense of $76 to $90
million. Revance’s unaudited shares outstanding as of December 31,
2017 were approximately 36.5 million.
About Revance Therapeutics, Inc.
Revance Therapeutics is a biotechnology company developing
neuromodulators for use in treating aesthetic and underserved
therapeutic conditions, including muscle movement disorders and
pain. 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.
Revance has developed a proprietary, stabilizing excipient
peptide technology designed to create novel, differentiated
therapies. The company has a comprehensive pipeline based upon its
peptide technology, including injectable and topical formulations
of daxibotulinumtoxinA. More information on Revance may be found at
www.revance.com.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements related to Revance Therapeutics' Financial
Outlook for 2018 and other financial performance, 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, number and
design of clinical studies for current and future indications,
related results, reporting and timing 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 risks that interim results are
not indicative of final results and 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 November 3, 2017. These forward-looking statements speak
only as of the date hereof. Revance disclaims any obligation to
update these forward-looking statements.
Use of Non-GAAP Financial Measures
Revance has presented certain non-GAAP financial measures in
this release. This release and the reconciliation tables included
herein include total non-GAAP operating expense and non-GAAP
R&D expense, both of which exclude depreciation and stock-based
compensation. Revance excludes depreciation costs and stock-based
compensation expense because management believes the exclusion of
these items is helpful for investors to evaluate Revance's
recurring operational performance. Revance management uses these
non-GAAP financial measures to monitor and evaluate its operating
results and trends on an on-going basis, and internally for
operating, budgeting and financial planning purposes. The non-GAAP
financial measures should be considered in addition to results
prepared in accordance with GAAP, but should not be considered a
substitute for or superior to GAAP results.
Revance Therapeutics, Inc.
2018 Financial Guidance
Reconciliation of GAAP Operating
Expense to Non-GAAP Operating Expense
(In thousands)
Fiscal Year 2018 Low High
Operating expense: GAAP operating expense $ 128,000 $
154,000
Adjustments: Stock-based compensation (17,000 )
(21,000 ) Depreciation (1,000 ) (3,000 )
Non-GAAP operating
expense $ 110,000 $ 130,000
Reconciliation of GAAP R&D Expense
to Non-GAAP R&D Expense
(In thousands)
Fiscal Year 2018 Low High
R&D expense: GAAP R&D expense $ 84,000 $ 101,000
Adjustments: Stock-based compensation (7,000 ) (9,000 )
Depreciation (1,000 ) (2,000 )
Non-GAAP R&D expense $
76,000 $ 90,000
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version on businesswire.com: http://www.businesswire.com/news/home/20180104005437/en/
INVESTORSRevance Therapeutics, Inc.:Jeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellan, Inc.:Ami
Bavishi, 212-213-0006abavishi@burnsmc.comorMEDIAGeneral
Media:TOGORUN:Mariann Caprino,
917-242-1087m.caprino@togorun.comorTrade Media:Nadine Tosk,
504-453-8344nadinepr@gmail.com
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