- Completed Enrollment in SAKURA 1 & 2
Phase 3 Pivotal Trials of RT002 for Glabellar Lines -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in treating
aesthetic and therapeutic conditions, today announced results for
the first quarter ended March 31, 2017.
Recent Highlights and Upcoming Milestones for
DaxibotulinumtoxinA for Injection (RT002)
- Completed enrollment for the SAKURA 1
& 2 Phase 3 pivotal trials of RT002 injectable for the
treatment of glabellar (frown) lines. The SAKURA program is
comprised of the two pivotal trials, plus a long-term safety trial
that continues to enroll subjects. Revance plans to report topline
results from the SAKURA 1 & 2 pivotal trials in the fourth
quarter of 2017.
- Presented safety, efficacy and
duration-of-effect results from Phase 2 trials for RT002 injectable
for the treatment of glabellar lines and cervical dystonia at
TOXINS 2017, the International Neurotoxin Association
Conference.
- Presented BELMONT Phase 2 clinical data
of RT002 injectable for the treatment of glabellar (frown) lines at
the 2017 American Academy of Dermatology Annual Meeting.
- Updated Phase 2 program for RT002
injectable in the management of plantar fasciitis by expanding to a
multi-center study with protocol updates. The company plans to
report topline results in the fourth quarter of 2017.
- Expects to report 24-week results from
all three cohorts of the Phase 2 open-label, sequential,
dose-escalating study of RT002 for the treatment of cervical
dystonia in the second quarter of 2017.
“Studies conducted to date with RT002 injectable involving both
large and small muscles indicate not only a strong safety profile,
but also that this next-generation neuromodulator can potentially
deliver high response rates, long duration of effect and high
patient satisfaction. These clinical results are like no other in
the neuromodulator space,” said Dan Browne, President and Chief
Executive Officer at Revance. “We expect to report results for our
Phase 3 pivotal trials for glabellar lines, the 24-week Phase 2
results for cervical dystonia and topline Phase 2 results for our
new indication, plantar fasciitis, all within the next seven
months.”
Summary Financial Results
Cash and investments as of March 31, 2017 were
$188.6 million.
Research and development expenses for the three months
ended March 31, 2017 were $19.4 million compared to $12.4 million
for the same period in 2016. The increase in research and
development expenses is primarily due our SAKURA 1 and 2 Phase 3
pivotal trials of RT002 injectable.
General and administrative expenses for the three months
ended March 31, 2017 were $7.8 million compared to $7.5 million for
the same period in 2016. The increase in general and administrative
expenses is primarily due to increased costs related to personnel,
offset by a decrease in marketing expenses.
Total operating expenses for the three months ended March
31, 2017 were $27.2 million compared to $19.8 million for the same
period in 2016. Stock-based compensation for the three months ended
March 31, 2017 was $3.2 million. When excluding depreciation and
stock-based compensation, total operating expenses for the three
months ended March 31, 2017 were $23.7 million.
Net loss for the three months ended March 31, 2017 was
$27.2 million compared to $19.9 million for the same period in
2016.
2017 Financial Outlook
Revance reaffirmed its financial guidance provided in January
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.
Conference Call
Individuals interested in listening to the conference call
today, May 9, at 1:30pm PT/4:30pm ET, may do so by dialing (855)
453-3827 for domestic callers, or (484) 756-4301 for international
callers and reference conference ID: 3251601; or from the webcast
link in the investor relations section of the Company's website at:
http://investors.revance.com/index.cfm.
A replay of the call will be available beginning today at 4:30pm
PT/7:30pm ET through 4:30pm PT/7:30pm ET on May 10, 2017. To access
the replay, dial (855) 859-2056 or (404) 537-3406 and reference
Conference ID: 3251601. The webcast will be available in the
investor relations section on the Company's website for 30 days
following the completion of the call.
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 to 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' 2017
Financial Outlook 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 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 annual report on Form 10-K
filed February 28, 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 to
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.
Condensed Consolidated Balance
Sheets
(In thousands, except share and per
share amounts)
(Unaudited)
March 31, December 31, 2017 2016
ASSETS CURRENT ASSETS Cash and cash equivalents $ 38,235 $
63,502 Short-term investments 150,404 122,026 Restricted cash,
current portion 502 — Prepaid expenses and other current assets
8,312 7,167 Total current assets 197,453 192,695
Property and equipment, net 11,205 10,585 Restricted cash, net of
current portion 580 580 Other non-current assets 216 500
TOTAL ASSETS $ 209,454 $ 204,360
LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES
Accounts payable $ 5,573 $ 3,754 Accruals and other current
liabilities 14,967 12,418 Financing obligations, current portion
3,502 3,475 Total current liabilities 24,042 19,647
Financing obligations, net of current portion 983 1,872 Derivative
liability associated with Medicis settlement 2,082 2,022 Deferred
rent 3,576 3,648 Other non-current liabilities 100 100
TOTAL LIABILITIES 30,783 27,289 Commitments
and Contingencies STOCKHOLDERS’ EQUITY Common stock, par value
$0.001 per share — 95,000,000 shares authorized both as of March
31, 2017 and December 31, 2016; 30,129,240 and 28,648,954 shares
issued and outstanding as of March 31, 2017 and December 31, 2016,
respectively 30 29 Additional paid-in capital 627,475 598,630
Accumulated other comprehensive loss (98 ) (45 ) Accumulated
deficit (448,736 ) (421,543 ) TOTAL STOCKHOLDERS’ EQUITY 178,671
177,071 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $
209,454 $ 204,360
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per
share amounts)
(Unaudited)
Three Months EndedMarch 31, 2017
2016 Revenue $ 75 $ 75 Operating expenses: Research
and development 19,409 12,364 General and administrative 7,754
7,455 Total operating expenses 27,163 19,819
Loss from operations (27,088 ) (19,744 ) Interest income 311
310 Interest expense (193 ) (315 ) Change in fair value of
derivative liability associated with Medicis settlement (60 ) (14 )
Other expense, net (126 ) (125 ) Net loss (27,156 ) (19,888 )
Unrealized gain (loss) on available for sale securities (52 ) 226
Comprehensive loss $ (27,208 ) $ (19,662 ) Net loss
attributable to common stockholders: Basic and Diluted $ (27,156 )
$ (19,888 ) Net loss per share attributable to common stockholders:
Basic and Diluted $ (0.94 ) $ (0.71 ) Weighted-average number of
shares used in computing net loss per share attributable to common
stockholders: Basic and Diluted 28,808,195 28,005,611
Revance Therapeutics, Inc.
2017 Financial Results
(Unaudited)
Reconciliation of GAAP Operating
Expense to Non-GAAP Operating Expense
(In thousands)
Three Months EndedMarch 31, 2017 Operating
expense: GAAP operating expense $ 27,163
Adjustments:
Stock-based compensation (3,155 ) Depreciation (357 )
Non-GAAP
operating expense $ 23,651
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/20170509006637/en/
Investors:Revance Therapeutics, Inc.:Jeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellan, Inc.:Ami
Bavishi, 212-213-0006abavishi@burnsmc.comorTrade Media, Inc.:Nadine
Tosk, 504-453-8344nadinepr@gmail.com
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