- Announces collaboration and license agreement
with Mylan for proposed biosimilar to BOTOX® -
-Cash and investments of approximately $283
million as of December 31, 2017-
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing neuromodulators for use in treating aesthetic
and underserved therapeutic conditions, today announced results for
the fourth quarter and full year ended December 31, 2017.
Recent Company Highlights and Upcoming Milestones for
DaxibotulinumtoxinA for Injection (RT002)
- Today announced a collaboration and
license agreement with Mylan N.V. on a biosimilar to BOTOX® that
will provide an upfront payment of $25 million to Revance, with
contingent payments upon achievement of additional clinical,
regulatory and sales milestones, plus sales royalties worldwide
(except Japan).
- Reported positive Phase 3 results from
SAKURA 1 and SAKURA 2 pivotal trials of RT002 for the treatment of
glabellar (frown) lines, which met all primary and secondary
endpoints, and achieved 6-month duration in multiple secondary
measurements. Revance expects to complete the SAKURA 3 open-label
safety study in the second half of 2018.
- Received Orphan Drug Designation for
RT002 from the FDA for the treatment of cervical dystonia.
- Completed an End-of-Phase 2 meeting
with the FDA and received Scientific Advice from the Europe
Medicines Agency (EMA) on its clinical program for RT002 in the
treatment of moderate to severe isolated cervical dystonia. Revance
plans to commence a Phase 3 program for the U.S. in the second
quarter of 2018.
- Reported interim Phase 2a results for
RT002 in treating plantar fasciitis. Revance plans to initiate a
second Phase 2 trial in plantar fasciitis with a modified design in
the second half of 2018.
"As a company, our goal is to be innovative pioneers in
neuromodulators. In 2017, our clinical trials demonstrated RT002’s
ability to provide patients long-acting performance and duration of
effect, with potentially just two treatments a year in both
glabellar lines and cervical dystonia. We believe that RT002 has
the potential to meaningfully enhance the quality of life for
patients suffering from a wide array of diseases," said Dan Browne,
President and Chief Executive Officer at Revance. "As we announced
today, we are not only pursuing development and commercialization
of our premium, long-acting RT002 neuromodulator, we are also
leveraging our capabilities to produce a biosimilar to BOTOX in
collaboration with Mylan.
"Looking ahead, we are preparing for a 2019 Biologics Licensing
Application (BLA) filing for RT002 to treat glabellar lines, while
increasing our pre-commercial initiatives as part of the Revance
Product Launch Velocity Plan in facial aesthetics. In the clinic,
we plan to focus on accelerating development efforts of RT002 for
therapeutic indications. Down the road, we expect RT002 to drive
meaningful growth in the approximately $4 billion global
neuromodulator market."
Summary Financial Results
Cash and investments as of December 31,
2017 were $282.9 million.
Research and development expenses for the fourth
quarter and full year ended December 31,
2017 were $21.0 million and $80.4 million,
respectively, compared to $12.5 million and $50.4
million for the same periods in 2016, respectively. The change
in research and development expenses is primarily due to the
ongoing clinical trials for RT002 for the treatment of glabellar
lines, cervical dystonia, and plantar fasciitis and increased costs
to support manufacturing, quality efforts and research.
General and administrative expenses for the fourth
quarter and full year ended December 31, 2017
were $11.9 million and $37.4 million, respectively,
compared to $7.1 million and $29.1 million for
the same periods in 2016, respectively. The increase in general and
administrative expenses is primarily due to increased costs related
to personnel and consulting costs and pre-commercial activities to
support future product launches.
Total operating expenses for the fourth quarter and
full year ended December 31, 2017 were $35.8
million and $120.7 million, respectively, compared
to $26.7 million and $88.5 million for the same
periods in 2016, respectively. Stock-based compensation for the
fourth quarter and full year ended December 31,
2017 was $3.4 million and $13.2 million,
respectively. When excluding depreciation and stock-based
compensation, total operating expenses for the fourth quarter and
year ended December 31, 2017 were $32.0
million and $106.0 million, respectively.
Net loss for the fourth quarter and full year
ended December 31, 2017 was $35.9
million and $120.6 million, respectively, compared
to $26.8 million and $89.3 million for the same
periods in 2016, respectively.
2018 Financial Outlook
Revance reiterates its financial guidance provided in January
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 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.
Conference Call
Individuals interested in listening to the conference call may
do so by dialing (855) 453-3827 for domestic callers, or (484)
756-4301 for international callers and reference conference ID:
5054928; or from the webcast link in the investor relations section
of the company's website at: www.revance.com.
A replay of the call will be available beginning February
28, 2018 at 4:30pm PT/7:30pm ET to March 1,
2018 at 4:30pm PT/7:30pm ET. To access the replay, dial
(855) 859-2056 or (404) 537-3406 and reference conference ID:
5054928. 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 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.BOTOX® is a registered
trademark of Allergan, Inc.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements related to Revance Therapeutics' 2018
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 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 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.
Consolidated Balance Sheets (In thousands, except
share and per share amounts) As of December 31,
2017 2016 ASSETS CURRENT ASSETS Cash
and cash equivalents $ 282,896 $ 63,502 Short-term investments —
122,026 Prepaid expenses and other current assets 2,315
7,167 Total current assets 285,211 192,695 Property and
equipment, net 9,250 10,585 Restricted cash 580 580 Other
non-current assets 658 500 TOTAL ASSETS $ 295,699
$ 204,360
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES Accounts payable $ 6,805 $ 3,754 Accruals and
other current liabilities 12,225 12,418 Financing obligations,
current portion 1,872 3,475 Total current liabilities
20,902 19,647 Financing obligations, net of current
portion — 1,872 Derivative liabilities associated with Medicis
settlement 2,613 2,022 Deferred rent 3,339 3,648 Other non-current
liabilities — 100 TOTAL LIABILITIES 26,854
27,289 Commitments and Contingencies STOCKHOLDERS’ EQUITY
Common stock, par value $0.001 per share — 95,000,000 shares
authorized both as of December 31, 2017 and 2016; 36,516,075 and
28,648,954 shares issued and outstanding as of December 31, 2017
and 2016, respectively 37 29 Additional paid-in capital 810,975
598,630 Accumulated other comprehensive loss — (45 ) Accumulated
deficit (542,167 ) (421,543 ) TOTAL STOCKHOLDERS’ EQUITY
268,845 177,071 TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY $ 295,699 $ 204,360
REVANCE THERAPEUTICS, INC.
Consolidated Statements of Operations
and Comprehensive Loss
(In thousands, except share and per
share amounts)
(Unaudited)
Quarter Ended December 31, Year
Ended December 31, 2017 2016 2017
2016 Revenue $ 37 $ 75 $ 262 $ 300 Operating
expenses: Research and development 21,004 12,530 80,361 50,381
General and administrative 11,887 7,100 37,398 29,075 Loss on
impairment 2,927 7,111 2,927 9,059
Total operating expenses 35,818 26,741 120,686
88,515 Loss from operations (35,781 ) (26,666 ) (120,424 )
(88,215 ) Interest income 411 230 1,410 1,170 Interest expense (18
) (225 ) (457 ) (1,082 ) Changes in fair value of derivative
liabilities associated with the Medicis settlement (380 ) (13 )
(591 ) (608 ) Other expense, net (138 ) (128 ) (525 ) (535 ) Net
loss (35,906 ) (26,802 ) (120,587 ) (89,270 ) Unrealized gain
(loss) and adjustment on securities included in net loss 42
(61 ) 45 (5 ) Comprehensive loss $ (35,864 ) $ (26,863 ) $
(120,542 ) $ (89,275 ) Basic and Diluted net loss attributable to
common stockholders $ (35,906 ) $ (26,802 ) $ (120,587 ) $ (89,270
) Basic and Diluted net loss per share attributable to common
stockholders $ (1.14 ) $ (0.95 ) $ (4.01 ) $ (3.18 ) Basic and
Diluted weighted-average number of shares used in computing net
loss per share attributable to common stockholders 31,580,146
28,201,880 30,101,125 28,114,784
Revance Therapeutics, Inc.
2017 Financial Results
Reconciliation of GAAP Operating
Expense to Non-GAAP Operating Expense
(In thousands)
Quarter EndedDecember 31,
2017
Year EndedDecember 31,
2017
Operating expense: GAAP operating expense $ 35,818 $ 120,686
Adjustments: Stock-based compensation (3,410 ) (13,230 )
Depreciation (372 ) (1,468 )
Non-GAAP operating expense $
32,036 $ 105,988
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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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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