-SAKURA 1 & 2 Phase 3 pivotal trials on
track to report topline results before year-end 2017-
-SAKURA 3 open-label safety study for glabellar
lines has completed enrollment of more than 2,100 subjects-
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 third quarter ended September 30, 2017.
Recent Highlights and Upcoming Milestones for
DaxibotulinumtoxinA for Injection (RT002)
- Completed enrollment of more than 2,100
subjects at multiple sites in the United States and Canada for
SAKURA open-label safety Phase 3 study of RT002 injectable for the
treatment of glabellar (frown) lines; Revance expects to complete
the study in the second half of 2018.
- SAKURA 1 & 2 Phase 3 pivotal trials
remain on track to report topline results before the end of
2017.
- Completed enrollment of the Phase 2
trial of RT002 injectable in the management of plantar fasciitis in
October of 2017. Revance remains on track to report topline 8-week
safety and efficacy results at year-end.
- Scheduled meeting for the fourth
quarter of 2017 with the U.S. Food & Drug Administration to
review the data from the Phase 2 trial of RT002 for the treatment
of moderate to severe isolated cervical dystonia and to determine
next steps for the program.
- Announced the appointment of Mark
Foley, an industry veteran with more than 25 years of operational
and investment experience in the healthcare arena, to Revance’s
Board of Directors and Todd Zavodnick, a 20-year industry leader,
joining our executive team as Chief Commercial Officer and
President, Aesthetics & Therapeutics.
“We’ve made excellent progress in 2017 and now expect to report
topline results for both our SAKURA Phase 3 pivotal trials for
glabellar lines and Phase 2 trial for plantar fasciitis before
year-end,” said Dan Browne, President and Chief Executive Officer
at Revance. “We believe RT002 will set a new standard of
performance for neuromodulators and give patients and physicians a
profoundly different experience in both aesthetic and therapeutic
indications. There is growing interest in RT002 within the medical
communities, as the concept of a neuromodulator with improved
outcomes and durability has been resonating well with physicians at
conferences throughout the year. By year end, we will have
validated the potential advantages of RT002 injectable not just in
wrinkle reduction, but in two key therapeutic areas where better
patient outcomes are highly valued.”
Summary Financial Results
Cash and investments as of September 30, 2017 were
$153.4 million.
Research and development expenses for the three and nine
months ended September 30, 2017 were $21.6 million and $59.4
million compared to $10.3 million and $37.9 million for the same
periods in 2016, respectively. The change in research and
development expenses is primarily due to increased clinical trial
activity for RT002 injectable, including the SAKURA Phase 3
program, the plantar fasciitis Phase 2 trial, and the cervical
dystonia Phase 2 trial, along with increased pre-commercial
manufacturing activities.
General and administrative expenses for the three and
nine months ended September 30, 2017 were $9.1 million and $25.5
million compared to $7.5 million and $22.0 million for the same
periods in 2016, respectively. The increase in general and
administrative expenses is primarily due to increased personnel,
pre-commercial, and information technology expenses.
Total operating expenses for the three and nine months
ended September 30, 2017 were $30.8 million and $84.9 million
compared to $17.8 million and $61.8 million for the same periods in
2016, respectively. Stock-based compensation for the three and nine
months ended September 30, 2017 was $3.1 million and $9.8 million,
respectively. When excluding depreciation and stock-based
compensation, total operating expenses for the three and nine
months ended September 30, 2017 were $27.3 million and $74.0
million, respectively.
Net loss for the three and nine months ended September
30, 2017 was $30.7 million and $84.7 million compared to $18.0
million and $62.5 million for the same periods in 2016,
respectively.
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. 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, November 2, 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: 99298055; 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 November 3, 2017. To
access the replay, dial (855) 859-2056 or (404) 537-3406 and
reference conference ID: 99298055. 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 quarterly report on Form
10-Q filed August 4, 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)
September 30, December 31, 2017
2016 ASSETS CURRENT ASSETS Cash and cash equivalents
$ 56,323 $ 63,502 Short-term investments 97,117 122,026 Prepaid
expenses and other current assets 2,827 7,167 Total
current assets 156,267 192,695 Property and equipment, net 11,500
10,585 Restricted cash 580 580 Other non-current assets 836
500 TOTAL ASSETS $ 169,183 $ 204,360
LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES
Accounts payable $ 6,680 $ 3,754 Accruals and other current
liabilities 12,069 12,418 Financing obligations, current portion
2,727 3,475 Total current liabilities 21,476 19,647
Financing obligations, net of current portion — 1,872 Derivative
liability associated with Medicis settlement 2,233 2,022 Deferred
rent 3,418 3,648 Other non-current liabilities — 100
TOTAL LIABILITIES 27,127 27,289 Commitments and
Contingencies STOCKHOLDERS’ EQUITY
Common stock, par value $0.001 per share —
95,000,000 shares authorized as ofSeptember 30, 2017 and December
31, 2016; 30,935,094 and 28,648,954 sharesissued and outstanding as
of September 30, 2017 and December 31, 2016,respectively
31 29 Additional paid-in capital 648,329 598,630 Accumulated other
comprehensive loss (43 ) (45 ) Accumulated deficit (506,261 )
(421,543 ) TOTAL STOCKHOLDERS’ EQUITY 142,056 177,071
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 169,183 $
204,360
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per
share amounts)
(Unaudited)
Three Months EndedSeptember 30, Nine
Months EndedSeptember 30, 2017 2016
2017 2016 Revenue $ 75 $ 75 $ 225 $ 225
Operating expenses: Research and development 21,643 10,296 59,357
37,851 General and administrative 9,148 7,502 25,511 21,975 Loss on
impairment — — — 1,949 Total operating
expenses 30,791 17,798 84,868 61,775
Loss from operations (30,716 ) (17,723 ) (84,643 ) (61,550 )
Interest income 341 306 999 940 Interest expense (104 ) (256 ) (439
) (857 )
Change in fair value of derivative
liability associated with Medicissettlement
(44 ) (167 ) (211 ) (595 ) Other expense, net (128 ) (138 ) (386 )
(406 ) Net loss (30,651 ) (17,978 ) (84,680 ) (62,468 ) Unrealized
gain (loss) on available for sale securities 72 (132 ) 3
56 Comprehensive loss $ (30,579 ) $ (18,110 ) $
(84,677 ) $ (62,412 ) Net loss attributable to common stockholders:
Basic and Diluted $ (30,651 ) $ (17,978 ) $ (84,680 ) $ (62,468 )
Net loss per share attributable to common stockholders: Basic and
Diluted $ (1.01 ) $ (0.64 ) $ (2.86 ) $ (2.22 )
Weighted-average number of shares used in
computing net loss pershare attributable to common
stockholders:
Basic and Diluted 30,270,260 28,160,458 29,623,805
28,085,541
Revance Therapeutics, Inc.
2017 Financial Results
(Unaudited)
Reconciliation of GAAP Operating
Expense to Non-GAAP Operating Expense
(In thousands)
Three Months Ended Nine Months Ended
September 30, 2017 September 30, 2017 Operating
expense: GAAP operating expense $ 30,791 $ 84,868
Adjustments: Stock-based compensation (3,146 ) (9,820 )
Depreciation (375 ) (1,096 )
Non-GAAP operating expense $
27,270 $ 73,952
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
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171102006485/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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