- Reports 2016 Unaudited Year-end Cash and
Investments Balance –
- Three Clinical Trials Expected to Report
Results in 2017 -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in aesthetic
and therapeutic indications, today defined key 2017 clinical
milestones for DaxibotulinumtoxinA for Injection (RT002) and
provided its financial outlook for 2017. The company also announced
its unaudited December 31, 2016 cash and investments balance was
$185 million and now expects its cash and investments to fund the
company into the third quarter of 2018.
“As we enter 2017, we remain focused on leveraging our
neurotoxin platform and rapidly advancing our RT002 programs with
three active clinical trials that will yield key results before
year end,” said Dan Browne, President and Chief Executive Officer
of Revance. “We are applying our proprietary peptide technology to
a highly purified botulinum toxin to help patients suffering from
serious muscle movement disorders such as cervical dystonia, and
painful musculoskeletal conditions such as plantar fasciitis. And,
our RT002 aesthetics program in glabellar (frown) lines, which is
furthest along in development, is on track to report results from
both Phase 3 pivotal trials in the fourth quarter of this year. Our
strategy is to position long-lasting, sustained duration of effect
-- demonstrated in both cosmetic and muscle movement clinical
studies -- as the key differentiation of RT002 when compared to the
first-generation neurotoxin products available today.”
RT002 INJECTABLE 2017 CLINICAL MILESTONES
Phase 3 Program for Treatment of Glabellar (Frown) Lines –
Report Pivotal Results 4Q 2017
Glabellar lines are the vertical lines that develop between the
eyebrows as a result of repeated frowning, scowling, or merely
focusing while listening or reading. As a person ages, the skin
becomes less elastic and glabellar lines become more pronounced. In
the fourth quarter of 2016, Revance initiated its Phase 3 program
of RT002 injectable for the treatment of glabellar lines, comprised
of two Phase 3 pivotal trials evaluating the efficacy, safety and
duration of RT002, and a long-term safety trial. Revance plans to
report results from both pivotal trials in the fourth quarter of
2017.
Phase 2 Trial for Treatment of Cervical Dystonia – Share
Topline Results 1H 2017
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. In
December 2016, Revance reported positive interim results from its
Phase 2 dose-escalating clinical trial of RT002 injectable for the
treatment of cervical dystonia. The company expects to complete
this trial and share topline results for all three dose cohorts,
followed for at least 6 months, in the first half of 2017.
Phase 2 Trial for Treatment of Plantar Fasciitis – Report
Phase 2 Results 2H 2017
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. Revance initiated a Phase 2
clinical trial of RT002 injectable for the treatment of plantar
fasciitis in the fourth quarter of 2016 and continues to enroll
patients. Topline results are expected in the second half of
2017.
FINANCIAL OUTLOOK FOR 2017
Revance expects cash burn for 2017 to be in the range of $102 to
$112 million. Revance expects 2017 GAAP operating expense to be in
the range of $108 to $119 million, which when excluding
depreciation of $1 to $2 million and estimated stock-based
compensation of $13 to $15 million, results in projected 2017
non-GAAP operating expense of $94 to $102 million. With three
clinical programs underway, Revance anticipates 2017 GAAP research
and development expense to be in the range of $75 to $83 million,
which when excluding depreciation of $1 to $2 million and estimated
stock-based compensation of $5 to $6 million, results in projected
2017 non-GAAP research and development expense of $69 to $75
million.
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 neurotoxin. 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 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 2017 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 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 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 4, 2016. 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.2017
Financial Guidance
Reconciliation of GAAP Operating
Expense to Non-GAAP Operating Expense(In thousands)
Fiscal Year 2017
Low High Operating expense: GAAP
operating expense $ 108,000 $ 119,000
Adjustments:
Stock-based compensation (13,000 ) (15,000 ) Depreciation (1,000 )
(2,000 )
Non-GAAP operating expense $ 94,000 $
102,000
Reconciliation of GAAP R&D Expense
to Non-GAAP R&D Expense(In thousands)
Fiscal Year 2017 Low High
R&D expense: GAAP R&D expense $ 75,000 $ 83,000
Adjustments: Stock-based compensation (5,000 ) (6,000 )
Depreciation (1,000 ) (2,000 )
Non-GAAP R&D expense $
69,000 $ 75,000
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version on businesswire.com: http://www.businesswire.com/news/home/20170105006357/en/
Investors:Revance TherapeuticsJeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellanAmi Bavishi,
212-213-0006abavishi@burnsmc.comorTrade Media:Nadine Tosk,
504-453-8344nadinepr@gmail.com
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