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 second quarter ended June 30, 2017.
Recent Highlights and Upcoming Milestones for
DaxibotulinumtoxinA for Injection (RT002)
- Reported positive topline 24-week
duration of effect results in all three cohorts of RT002 injectable
for the treatment of moderate to severe isolated cervical dystonia.
Study investigators presented two posters highlighting this and
additional data at the 21st International Congress of Parkinson’s
Disease and Movement Disorders in June.
- Published results from its successfully
completed BELMONT Phase 2 trial in glabellar (frown) lines in the
peer-reviewed journal, Dermatologic Surgery.
- Announced expansion of its leadership
team with the addition of industry veteran Todd Zavodnick, who will
join Revance in September as its Chief Commercial Officer and
President, Aesthetics & Therapeutics to lead the company’s
commercial operations along with the launch of RT002
injectable.
- SAKURA 1 & 2 Phase 3 pivotal trials
of RT002 injectable for the treatment of glabellar (frown) lines
remain on track to report topline results in the fourth quarter of
2017.
- Phase 2 trial of RT002 injectable in
the management of plantar fasciitis continues to enroll subjects,
and Revance plans to report topline results in the fourth quarter
of 2017.
“The recent clinical results from our Phase 2 cervical dystonia
program, along with the peer-reviewed publication of results from
the BELMONT Phase 2 clinical trial for glabellar lines, reinforce
the potential advantages we believe RT002 injectable has over
commercially available toxins in terms of safety, response rates
and duration of effect,” said Dan Browne, President and Chief
Executive Office at Revance. “The totality of the evidence is
building and we look forward to reporting topline results for our
SAKURA Phase 3 pivotal trials for glabellar lines and Phase 2 trial
for plantar fasciitis in the fourth quarter of this year. We
believe these trial results will validate our differentiation and
put us on track to file for our first regulatory approval. Long
term, we believe we can build a meaningful aesthetics business
around RT002 that will allow us to fund and support a fast-growing
therapeutics portfolio.”
Summary Financial Results
Cash and investments as of June 30, 2017 were $165.5
million.
Research and development expenses for the three and six
months ended June 30, 2017 were $18.3 million and $37.7 million
compared to $15.2 million and $27.6 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, the Phase 2 cervical dystonia trial, along
with increased pre-commercial manufacturing activities.
General and administrative expenses for the three and six
months ended June 30, 2017 were $8.6 million and $16.4 million
compared to $7.0 million and $14.5 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 six months
ended June 30, 2017 were $26.9 million and $54.1 million compared
to $24.2 million and $44.0 million for the same periods in 2016,
respectively. Stock-based compensation for the three and six months
ended June 30, 2017 was $3.5 million and $6.7 million,
respectively. When excluding depreciation and stock-based
compensation, total operating expenses for the three and six months
ended June 30, 2017 were $23.0 million and $46.7 million,
respectively.
Net loss for the three and six months ended June 30, 2017
was $26.9 million and $54.0 million compared to $24.6 million and
$44.5 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. 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, August 3, 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: 51659239; 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 August 4, 2017. To
access the replay, dial (855) 859-2056 or (404) 537-3406 and
reference conference ID: 51659239. 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 May 9, 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)
June 30, December 31,
2017 2016 ASSETS CURRENT ASSETS Cash and cash
equivalents $ 53,693 $ 63,502 Short-term investments 111,852
122,026 Restricted cash, current portion 502 — Prepaid expenses and
other current assets 8,306 7,167 Total current assets
174,353 192,695 Property and equipment, net 11,255 10,585
Restricted cash, net of current portion 580 580 Other non-current
assets 888 500 TOTAL ASSETS $ 187,076 $
204,360
LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT
LIABILITIES Accounts payable $ 4,079 $ 3,754 Accruals and other
current liabilities 14,347 12,418 Financing obligations, current
portion 3,550 3,475 Total current liabilities 21,976
19,647 Financing obligations, net of current portion — 1,872
Derivative liability associated with Medicis settlement 2,189 2,022
Deferred rent 3,497 3,648 Other non-current liabilities —
100 TOTAL LIABILITIES 27,662 27,289
Commitments and Contingencies STOCKHOLDERS’ EQUITY Common stock,
par value $0.001 per share — 95,000,000 shares authorized both as
of June 30, 2017 and December 31, 2016; 30,416,028 and 28,648,954
shares issued and outstanding as of June 30, 2017 and December 31,
2016, respectively 30 29 Additional paid-in capital 635,108 598,630
Accumulated other comprehensive loss (114 ) (45 ) Accumulated
deficit (475,610 ) (421,543 ) TOTAL STOCKHOLDERS’ EQUITY 159,414
177,071 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $
187,076 $ 204,360
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per
share amounts)
(Unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2017 2016 2017 2016
Revenue $ 75 $ 75 $ 150 $ 150 Operating expenses: Research and
development 18,307 15,192 37,714 27,556 General and administrative
8,609 7,018 16,363 14,473 Loss on impairment — 1,949
— 1,949 Total operating expenses 26,916 24,159
54,077 43,978 Loss from operations (26,841 )
(24,084 ) (53,927 ) (43,828 ) Interest income 347 324 658 635
Interest expense (141 ) (286 ) (335 ) (601 ) Change in fair value
of derivative liability associated with Medicis settlement (107 )
(413 ) (167 ) (428 ) Other expense, net (132 ) (143 ) (258 ) (268 )
Net loss (26,874 ) (24,602 ) (54,029 ) (44,490 ) Unrealized gain
(loss) on available for sale securities (17 ) (38 ) (69 ) 188
Comprehensive loss $ (26,891 ) $ (24,640 ) $ (54,098 ) $
(44,302 ) Net loss attributable to common stockholders: Basic and
Diluted $ (26,874 ) $ (24,602 ) $ (54,029 ) $ (44,490 ) Net loss
per share attributable to common stockholders: Basic and Diluted $
(0.90 ) $ (0.88 ) $ (1.84 ) $ (1.59 ) Weighted-average number of
shares used in computing net loss per share attributable to common
stockholders: Basic and Diluted 29,776,893 28,089,731
29,295,220 28,047,671
Revance Therapeutics, Inc.
2017 Financial Results
(Unaudited)
Reconciliation of GAAP Operating
Expense to Non-GAAP Operating Expense
(In thousands)
Three Months Ended
Six Months Ended
June 30, 2017
June 30, 2017
Operating expense: GAAP operating expense $ 26,916 $ 54,077
Adjustments: Stock-based compensation (3,519 ) (6,674 )
Depreciation (364 ) (722 )
Non-GAAP operating expense $
23,033 $ 46,681
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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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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