- Completes Enrollment in REALISE 1 Phase 3 Trial
for RT001 Topical for Crow’s Feet Lines –- Moves Phase 2
Dose-Escalating Trial for RT002 Injectable for Cervical Dystonia
into Second Cohort -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company
developing botulinum toxin products for use in aesthetic and
therapeutic indications, today announced results for the first
quarter ended March 31, 2016.
Recent Highlights and Upcoming Milestones
- DaxibotulinumtoxinA Topical Gel (RT001)
- Completed enrollment of 450 patients in REALISE 1, a Phase 3
trial for patients with moderate to severe lateral canthal lines
(crow’s feet). Revance plans to release 28-day top-line safety and
efficacy results from this Phase 3 trial by the end of the second
quarter of 2016.
- DaxibotulinumtoxinA for Injection (RT002)
- Positive 6-month Phase 2 clinical results from the BELMONT
Phase 2 Active Comparator Trial of RT002 were presented in a podium
presentation at the American Academy of Dermatology (AAD) annual
meeting in March 2016.
- Scheduled the End-of-Phase 2 meeting with the U.S. Food and
Drug Administration regarding RT002 injectable for the treatment of
glabellar (frown) lines. Following the End-of-Phase 2 meeting,
Revance expects to initiate a global Phase 3 clinical program in
this indication during the second half of 2016.
- Completed interim planned safety analysis of the first cohort
of 12 patients in a dose-escalating Phase 2 clinical trial of RT002
injectable for the treatment of cervical dystonia. RT002 appeared
to be safe and well-tolerated in the first cohort of 12
subjects. Upon review of the 6 Week safety data by an
independent Data Monitoring Committee, the committee unanimously
approved initiation of the second of three cohorts in this
dose-escalating study, with enrollment of the first patient Cohort
2 taking place in April. Revance expects to report additional
safety, efficacy and duration results in the second half of
2016.
- Appointed Roman G. Rubio, MD, a seasoned executive with
extensive drug development experience, as Senior Vice President,
Clinical Development.
“We are pleased with the continued progress of our
investigational neurotoxin drug product candidates, RT001 topical
and RT002 injectable, which have the potential to be the first
differentiated neurotoxins to be approved by the FDA in nearly 30
years,” said Dan Browne, President and Chief Executive Officer of
Revance. “Both RT001 topical and RT002 injectable have significant
milestones approaching before the end of this quarter. For RT002,
it’s the End-of-Phase 2 meeting with the FDA that would allow us to
finalize plans to begin our global Phase 3 program to treat frown
lines. For RT001, it’s the topline results from our Phase 3 trial
for the treatment of crow’s feet, potentially putting us one step
closer to launching the first commercially available topically
delivered botulinum toxin. Our path to growth is clear, as we
continue in our endeavors to offer physicians, patients and payers
a fundamentally distinctive neurotoxin experience.”
Summary Financial Results
Research and development expenses for the first
quarter ended March 31, 2016 were $12.4 million compared to
$9.3 million for the same period in 2015. The increase in
research and development expenses is primarily attributable to
personnel costs and expenditures related to ongoing clinical
trials.
General and administrative expenses for the
first quarter ended March 31, 2016 were $7.5 million compared
to $6.0 million for the same period in 2015. The increase in
general and administrative expenses is primarily attributable to
personnel costs, legal matters, and administrative activities.
Total operating expenses for the first quarter
ended March 31, 2016 were $19.8 million compared to $15.3
million for the same period in 2015. Stock-based compensation for
the first quarter ended March 31, 2016 was $3.0 million. When
excluding depreciation and stock-based compensation, total
operating expenses for the first quarter ended March 31, 2016
were $16.5 million.
Net loss for the first quarter ended
March 31, 2016 was $19.9 million compared to $15.4 million for
the same period in 2015.
Cash and investments as of March 31, 2016
were $236.6 million.
2016 Financial Outlook Revance
reaffirms its 2016 full year guidance. The company expects its 2016
non-GAAP operating expense to be in the range of $95 to $105
million, excluding depreciation of $2 to $3 million and estimated
stock-based compensation of $15 to $17 million. The company expects
its cash burn for 2016 to be in the range of $105 to $115 million.
Revance anticipates 2016 non-GAAP research and development expenses
to be in the range of $72 to $78 million, excluding depreciation of
$2 to $3 million and estimated stock-based compensation of $8 to $9
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: 87895155; 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 midnight on May 10, 2016. To access the
replay, dial (855) 859-2056 or (404) 537-3406 and reference
Conference ID: 87895155. 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 trajectory to
commercial success begins with the company’s novel and proprietary
TransMTS® carrier-peptide delivery system, which is uniquely
designed to target and transport macromolecules to their desired
location.
Revance’s journey to market starts with the neurotoxin
daxibotulinumtoxinA, the company’s highly purified botulinum toxin
type A. The TransMTS technology is used in the delivery of
botulinum toxin through two novel drug product candidates:
DaxibotulinumtoxinA Topical Gel (RT001) which permits needle-free
application, and DaxibotulinumtoxinA for Injection (RT002), which
is designed to enable targeted administration and long-lasting
effect.
Revance is developing RT001 and RT002 for a broad spectrum of
aesthetic and therapeutic indications, including facial wrinkles,
excessive sweating and muscle movement disorders. The company holds
worldwide rights for all indications of RT001, RT002 and the
TransMTS technology platform. Beyond botulinum toxin, Revance
believes the TransMTS technology can be applied to transdermal,
mid-dermal or deep tissue delivery of a variety of other
macromolecules. More information on Revance can 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 annual report on Form 10-K
filed March 4, 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) |
|
|
March 31, |
|
December 31, |
|
2016 |
|
2015 |
ASSETS |
CURRENT ASSETS |
|
|
|
Cash and cash equivalents |
$ |
40,793 |
|
|
$ |
201,615 |
|
Short-term investments |
195,815 |
|
|
50,688 |
|
Restricted cash, current
portion |
— |
|
|
35 |
|
Prepaid expenses and other current
assets |
1,882 |
|
|
1,625 |
|
Total current assets |
238,490 |
|
|
253,963 |
|
Property and equipment,
net |
19,714 |
|
|
19,708 |
|
Long-term investments |
— |
|
|
1,751 |
|
Restricted cash, net of
current portion |
580 |
|
|
400 |
|
Other non-current
assets |
216 |
|
|
— |
|
TOTAL ASSETS |
$ |
259,000 |
|
|
$ |
275,822 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
CURRENT LIABILITIES |
|
|
|
Accounts payable |
$ |
3,307 |
|
|
$ |
2,657 |
|
Accruals and other current
liabilities |
5,925 |
|
|
6,245 |
|
Financing obligations,
current portion |
3,256 |
|
|
3,135 |
|
Total current liabilities |
12,488 |
|
|
12,037 |
|
Financing obligations, net
of current portion |
4,486 |
|
|
5,346 |
|
Derivative liability
associated with Medicis settlement |
1,428 |
|
|
1,414 |
|
Deferred rent |
3,746 |
|
|
3,773 |
|
TOTAL LIABILITIES |
22,148 |
|
|
22,570 |
|
Commitments and
Contingencies |
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Preferred stock, par value $0.001
per share — 5,000,000 shares authorized both as of |
|
— |
|
|
|
— |
|
March 31, 2016 and
December 31, 2015; no shares issued and outstanding both as
of |
|
|
|
March 31, 2016 and
December 31, 2015. |
|
|
|
Common stock, par value $0.001 per
share — 95,000,000 shares authorized both as of |
28 |
|
|
28 |
|
March 31, 2016 and
December 31, 2015; 28,471,412 and 28,288,464 shares
issued |
|
|
|
|
|
and outstanding as of March 31,
2016 and December 31, 2015, respectively |
|
|
|
|
|
Additional paid-in capital |
588,799 |
|
|
585,537 |
|
Accumulated other comprehensive
income (loss) |
186 |
|
|
(40 |
) |
Accumulated deficit |
(352,161 |
) |
|
(332,273 |
) |
TOTAL STOCKHOLDERS’
EQUITY |
236,852 |
|
|
253,252 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
259,000 |
|
|
$ |
275,822 |
|
REVANCE THERAPEUTICS, INC. |
|
Condensed Consolidated Statements of Operations
and Comprehensive Loss |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
Quarter
EndedMarch 31, |
|
2016 |
|
2015 |
Revenue |
$ |
75 |
|
|
$ |
75 |
|
Operating expenses: |
|
|
|
Research and development |
12,364 |
|
|
9,254 |
|
General and administrative |
7,455 |
|
|
5,996 |
|
Total operating expenses |
19,819 |
|
|
15,250 |
|
Loss from operations |
(19,744 |
) |
|
(15,175 |
) |
Interest income |
310 |
|
|
27 |
|
Interest expense |
(315 |
) |
|
(165 |
) |
Changes in fair value of
derivative liability associated with Medicis settlement |
(14 |
) |
|
(42 |
) |
Other expense, net |
(125 |
) |
|
(47 |
) |
Net loss |
|
(19,888 |
) |
|
|
(15,402 |
) |
Unrealized gain on
available for sale securities |
226 |
|
|
— |
|
Comprehensive loss |
$ |
(19,662 |
) |
|
$ |
(15,402 |
) |
Net loss attributable to
common stockholders: |
|
|
|
Basic |
$ |
(19,888 |
) |
|
$ |
(15,402 |
) |
Diluted |
$ |
(19,888 |
) |
|
$ |
(15,402 |
) |
Net loss per share
attributable to common stockholders: |
|
|
|
Basic |
$ |
(0.71 |
) |
|
$ |
(0.65 |
) |
Diluted |
$ |
(0.71 |
) |
|
$ |
(0.65 |
) |
Weighted-average number of
shares used in computing net loss per share attributable to |
|
|
|
common stockholders: |
|
|
|
Basic |
28,005,611 |
|
|
23,535,080 |
|
Diluted |
28,005,611 |
|
|
23,535,080 |
|
Revance Therapeutics, Inc. |
2016 Financial Results |
(Unaudited) |
Reconciliation of GAAP Operating Expense to
Non-GAAP Expense |
(In thousands) |
|
|
|
Quarter EndedMarch 31, 2016 |
Operating
expense: |
|
|
GAAP operating
expense |
|
$ |
19,819 |
|
Adjustments: |
|
|
Stock-based compensation |
|
(2,977 |
) |
Depreciation |
|
(344 |
) |
Non-GAAP
operating expense |
|
$ |
16,498 |
|
Revance Therapeutics, Inc. |
2016 Financial Guidance |
|
Reconciliation of GAAP Operating Expense to
Non-GAAP Expense |
(In thousands) |
|
|
|
Fiscal Year |
|
2016 |
|
Low |
|
High |
Operating
expense: |
|
|
|
GAAP operating
expense |
$ |
112,000 |
|
|
$ |
125,000 |
|
Adjustments: |
|
|
|
Stock-based compensation |
(15,000 |
) |
|
(17,000 |
) |
Depreciation |
(2,000 |
) |
|
(3,000 |
) |
Non-GAAP
operating expense |
$ |
95,000 |
|
|
$ |
105,000 |
|
Reconciliation of GAAP R&D Expense to
Non-GAAP R&D Expense |
(In thousands) |
|
|
|
Fiscal Year |
|
2016 |
|
Low |
|
High |
Operating
expense: |
|
|
|
GAAP operating
expense |
$ |
82,000 |
|
|
$ |
90,000 |
|
Adjustments: |
|
|
|
Stock-based compensation |
(8,000 |
) |
|
(9,000 |
) |
Depreciation |
(2,000 |
) |
|
(3,000 |
) |
Non-GAAP
operating expense |
$ |
72,000 |
|
|
$ |
78,000 |
|
Contacts
Investors:
Revance Therapeutics
Jeanie Herbert
(714) 325-3584
jherbert@revance.com
Burns McClellan
Ami Bavishi
212-213-0006
abavishi@burnsmc.com
Trade Media:
Nadine Tosk
504.453.8344
nadinepr@gmail.com
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