Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in aesthetic
and therapeutic indications, today announced results for the third
quarter ended September 30, 2016.
Recent Highlights and Upcoming Milestones for
DaxibotulinumtoxinA for Injection (RT002)
- Initiated the Phase 3 program for RT002
to treat glabellar (frown) lines and expects to dose the first
patient this quarter. Revance plans to report topline results in
the fourth quarter of 2017.
- Announced that the Data Safety
Monitoring Board has reviewed data from the second cohort of the
Phase 2 open-label study in cervical dystonia. Commenced enrollment
in the third and final cohort of the study. Revance expects to
report interim safety, efficacy and duration results for cohorts 1
and 2 later this quarter.
- Initiated Phase 2 trial of RT002 to
treat plantar fasciitis. The placebo-controlled study will evaluate
the safety and efficacy of a single administration of RT002 in
reducing the signs and symptoms of plantar fasciitis, a common
cause of heel pain. Led by L. Andrew Koman, MD, Professor and Chair
of the Department of Orthopaedic Surgery and Executive Director
Musculoskeletal Service Line, Wake Forest School of Medicine, this
trial advances a whole new treatment area for botulinum toxin to
address pain and muscle tightness. Revance expects to report
results in 2017.
“With three active programs for RT002 injectable underway to
demonstrate the power of our differentiated neurotoxin, we expect
to deliver the first uniquely new neuromodulator in nearly 30
years,” said Dan Browne, President and Chief Executive Officer at
Revance. “Following the filing and opening of our IND application
submission to treat frown lines, we initiated investigator training
and are on track to start patient dosing for the Phase 3 program
this quarter. In addition, we are making significant progress in
the Phase 2 cervical dystonia trial. The third cohort is nearly
fully enrolled and we expect to report interim data for the first
two cohorts later this quarter. Finally, as we announced this
morning, we are excited to pursue plantar fasciitis as a new
indication, where Revance has the opportunity to deliver the first
neurotoxin therapy approved to treat this painful condition. In the
United States alone, more than two million patients undergo
treatment annually and we believe the market could grow
significantly larger if patients had a compelling neurotoxin
treatment option.”
Summary Financial Results
Research and development expenses for the three months
ended September 30, 2016 were $10.3 million compared to $13
million for the same period in 2015. The decrease in research and
development expenses is primarily attributable to a reduction in
clinical trial activities for RT001 topical, offset by an increase
in clinical trial activities for RT002 injectable and manufacturing
activities. Research and development expenses for the nine months
ended September 30, 2016 were $37.9 million compared to $32.6
million for the same period in 2015. The increase in research and
development expenses is primarily attributable to personnel costs,
manufacturing activities, and the acquisition of botulinum
toxin-related patents and patent applications from Botulinum Toxin
Research Associates, Inc.
General and administrative expenses for the three and
nine months ended September 30, 2016 were $7.5 million and $22
million compared to $5.8 million and $18.2 million for the same
periods in 2015, respectively. The increase in general and
administrative expenses is primarily attributable to personnel
costs, legal matters, and marketing activities.
Total operating expenses for the three and nine months
ended September 30, 2016 were $17.8 million and $61.8 million
compared to $18.8 million and $50.8 million for the same periods in
2015, respectively. Stock-based compensation for the three and nine
months ended September 30, 2016 was $2.8 million and $9
million, respectively. When excluding depreciation and stock-based
compensation, total operating expenses for the three and nine
months ended September 30, 2016 were $14.7 million and $51.7
million.
Net loss for the three and nine months ended
September 30, 2016 was $18 million and $62.5 million compared
to $19.2 million and $51.4 million for the same periods in 2015,
respectively.
Cash and investments as of September 30, 2016 were
$201.3 million.
2016 Financial Outlook
Revance updated its 2016 full-year guidance last provided
on August 4, 2016. The company now expects its cash burn for
2016 to be in the range of $80 to $90 million. Revance
expects its 2016 GAAP operating expense to now be in the range
of $84 to $96 million, which when excluding
depreciation of $2 to $3 million and estimated
stock-based compensation of $12 to $13 million,
results in projected 2016 non-GAAP operating expense
of $70 to $80 million. Revance also now anticipates
2016 GAAP research and development expense to be in the range
of $55 to $63 million, which when excluding
depreciation of $2 to $3 million and estimated
stock-based compensation of $6 to $7 million,
results in projected 2016 non-GAAP research and development expense
of $47 to $53 million.
Conference Call
Individuals interested in listening to the conference call
today, November 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: 96279951; 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 5:00pm PT/8:00pm ET on November 4, 2016. To
access the replay, dial (855) 859-2056 or (404) 537-3406 and
reference Conference ID: 96279951. 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 and
neurology. Revance's science is based upon a proprietary TransMTS®
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 and has 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 the TransMTS technology platform. More
information on Revance may be found at www.revance.com.
"Revance Therapeutics," TransMTS®, "Remarkable Science Changes
Everything," 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' 2016
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 5, 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 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, 2016
2015 ASSETS CURRENT ASSETS Cash and cash equivalents
$ 130,481 $ 201,615 Short-term investments 70,770 50,688 Restricted
cash, current portion — 35 Prepaid expenses and other current
assets 7,428 1,625 Total current assets 208,679
253,963 Property and equipment, net 17,385 19,708 Long-term
investments — 1,751 Restricted cash, net of current portion 580 400
Other non-current assets 213 — TOTAL ASSETS $ 226,857
$ 275,822
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES Accounts payable $ 2,871 $ 2,657 Accruals and
other current liabilities 11,306 6,245 Financing obligations,
current portion 3,339 3,135 Total current liabilities
17,516 12,037 Financing obligations, net of current portion 2,836
5,346 Derivative liability associated with Medicis settlement 2,009
1,414 Deferred rent 3,681 3,773 Other non-current liabilities 100
— TOTAL LIABILITIES 26,142 22,570
Commitments and Contingencies STOCKHOLDERS’ EQUITY Preferred stock,
par value $0.001 per share — 5,000,000 shares authorized both as of
September 30, 2016 and December 31, 2015; no shares issued and
outstanding both as of September 30, 2016 and December 31, 2015. —
— Common stock, par value $0.001 per share — 95,000,000 shares
authorized both as of September 30, 2016 and December 31, 2015;
28,515,161 and 28,288,464 shares issued and outstanding as of
September 30, 2016 and December 31, 2015, respectively 29 28
Additional paid-in capital 595,411 585,537 Accumulated other
comprehensive income (loss) 16 (40 ) Accumulated deficit (394,741 )
(332,273 ) TOTAL STOCKHOLDERS’ EQUITY 200,715 253,252
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 226,857 $
275,822
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per
share amounts)
(Unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2016 2015 2016 2015
Revenue $ 75 $ 75 $ 225 $ 225 Operating expenses: Research and
development 10,296 13,016 37,851 32,573 General and administrative
7,502 5,827 21,975 18,183 Loss on impairment — —
1,949 — Total operating expenses 17,798 18,843
61,775 50,756 Loss from operations (17,723 )
(18,768 ) (61,550 ) (50,531 ) Interest income 306 68 940 144
Interest expense (256 ) (390 ) (857 ) (834 ) Change in fair value
of derivative liability associated with Medicis settlement (167 )
13 (595 ) 60 Other expense, net (138 ) (98 ) (406 ) (221 ) Net loss
(17,978 ) (19,175 ) (62,468 ) (51,382 ) Unrealized gain/(loss) on
available for sale securities (132 ) 22 56 10
Comprehensive loss $ (18,110 ) $ (19,153 ) $ (62,412 ) $ (51,372 )
Net loss attributable to common stockholders: Basic $ (17,978 ) $
(19,175 ) $ (62,468 ) $ (51,382 ) Diluted $ (17,978 ) $ (19,175 ) $
(62,468 ) $ (51,382 ) Net loss per share attributable to common
stockholders: Basic $ (0.64 ) $ (0.81 ) $ (2.22 ) $ (2.17 ) Diluted
$ (0.64 ) $ (0.81 ) $ (2.22 ) $ (2.17 ) Weighted-average number of
shares used in computing net loss per share attributable to common
stockholders: Basic 28,160,458 23,755,199 28,085,541
23,625,869 Diluted 28,160,458 23,755,199
28,085,541 23,625,869
Revance Therapeutics, Inc.
2016 Financial Results
(Unaudited)
Reconciliation of GAAP Operating
Expense to Non-GAAP Operating Expense
(In thousands)
Three Months Ended
Nine Months Ended
September 30,
September 30,
Operating expense: GAAP operating expense $ 17,798 $ 61,775
Adjustments: Stock-based compensation (2,755 ) (8,984 )
Depreciation (369 ) (1,068 )
Non-GAAP operating expense $
14,674 $ 51,723
Revance Therapeutics, Inc.
2016 Financial Guidance
Reconciliation of GAAP Operating
Expense to Non-GAAP Operating Expense
(In thousands)
Fiscal Year 2016 Low High
Operating expense: GAAP operating expense $ 84,000 $ 96,000
Adjustments: Stock-based compensation (12,000 ) (13,000 )
Depreciation (2,000 ) (3,000 )
Non-GAAP operating expense $
70,000 $ 80,000
Reconciliation of GAAP R&D Expense
to Non-GAAP R&D Expense
(In thousands)
Fiscal Year 2016 Low High
R&D expense: GAAP R&D expense $ 55,000 $ 63,000
Adjustments: Stock-based compensation (6,000 ) (7,000 )
Depreciation (2,000 ) (3,000 )
Non-GAAP R&D expense $
47,000 $ 53,000
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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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