- Conference call and webcast today at 4:30
p.m. ET -
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company developing next-generation neuromodulators for use in
treating aesthetic and therapeutic conditions, today reported
financial results for the quarter ended March 31, 2019 and provided
a corporate update.
First Quarter 2019 and Subsequent Highlights/Updates
- Continued progress and update on
Biologics Licensing Application (BLA) submission for
DaxibotulinumtoxinA for Injection (DAXI) for the treatment of
glabellar (frown) lines. Revance is in the process of compiling
the largest clinical data package for an aesthetic indication. The
company has been working in parallel to develop a 100-unit vial, in
addition to an initial 50-unit vial. This has added additional work
streams for process validation and stability. Revance now expects
to submit the BLA in the fall of 2019 and is on track for a 2020
approval and launch for DAXI for the treatment of glabellar
lines.
- Announced the initiation of Phase 2
clinical trials for DAXI in two therapeutic indications. In
January, Revance announced it initiated a Phase 2 trial for the
treatment of upper limb spasticity. Upper limb spasticity is a form
of movement disorder that presents as increased tone or stiffness
of the muscles, affecting a patient’s ability to produce or control
voluntary movement in the arms and hands. Also in January, the
company announced it initiated a Phase 2 study for the management
of plantar fasciitis. Plantar fasciitis, characterized by
inflammation accompanied by sharp, constant pain in the heel that
can become highly debilitating, is a condition that currently has
no FDA-approved drug treatments. Revance expects to complete
enrollment for both Phase 2 trials, along with its Phase 3 trial
for cervical dystonia, in the second half of 2019.
- Initiated two Phase 2 clinical
trials of DAXI in facial aesthetic indications. In January,
Revance initiated a study in forehead lines, followed in March with
one in lateral canthal lines (crow’s feet). These studies are being
conducted to understand the potential dosing and injection patterns
of DAXI in other areas of the upper face, in addition to the lead
indication in glabellar lines. Revance expects to complete
enrollment in both trials in the summer of 2019.
- Presented clinical and non-clinical
data to physicians at key medical meetings. In January, DAXI
was featured in 11 podium and poster presentations at the TOXINS
2019 conference, in Denmark. In April, the company supported podium
and poster presentations of its SAKURA 3 Phase 3 open-label,
long-term safety study of DAXI for the treatment of glabellar
(frown) lines at the 17th Aesthetics & Anti-Aging Medical World
Congress, held in Monte Carlo.
- Completed a successful public
offering. In January, Revance closed an underwritten public
offering. The gross proceeds to the company from the offering,
before deducting the underwriters’ discounts, commissions, and
other offering costs, were approximately $115.0 million.
- Continued discussions with Mylan on
proposed biosimilar to BOTOX®. Following the February meeting
with the FDA, the companies believe a potential 351(k) biosimilar
pathway is viable.
- Appointed Taryn Conway as Vice
President of Marketing, and Atul R. Mahableshwarkar, MD, as
Vice President of Clinical Development. In April, Revance
announced the appointment of Taryn Conway, a former Allergan
marketing veteran. Ms. Conway will be an integral architect of
product launch strategies and implementation, further enhancing our
commercial readiness. In March, Revance appointed Atul R.
Mahableshwarkar, MD, to oversee clinical science for its
therapeutic programs, including cervical dystonia, upper limb
spasticity, plantar fasciitis and migraine. Prior to Revance, Dr.
Mahableshwarkar held key clinical development and medical director
roles at BlackThorn Therapeutics and Takeda Pharmaceutical Company
Ltd.
Dan Browne, President and Chief Executive Officer at Revance,
comments: “During the first quarter of 2019, we made continued
progress on the BLA for DAXI in glabellar lines, advanced our
pipeline in both aesthetics and therapeutics, and further
strengthened our balance sheet. Following the strong results of our
Phase 3 program for DAXI in glabellar lines, Revance has
constructed a thoughtful roadmap for the approval and dynamic
launch of our first product in facial aesthetics. We plan to create
a new standard in neuromodulators, marketing DAXI as a premium
product that provides patients with lasting frown line correction
with just two treatments a year.
“Concurrent with two additional studies for the upper face
initiated in the first quarter, we continue to target the leading
indications for neuromodulators in therapeutics, where we believe
DAXI’s long-acting profile will set it apart from existing
products. We are pleased to have clinical trials of DAXI underway
in cervical dystonia, adult upper limb spasticity and plantar
fasciitis, and anticipate completing enrollment in all three trials
in the second half of 2019.”
Financial Highlights
Cash, cash equivalents and short-term investments as
of March 31, 2019 were $271.0 million, compared to
compared to $175.8 million as of December 31, 2018.
Revenue for the quarter ended March 31, 2019 was $0.3
million compared to $0.2 million for the same period in 2018. The
revenue recognized represents the portion of revenue earned from
the $25 million upfront payment from Mylan under the biosimilar
collaboration and license agreement.
Research and development expenses for the quarter ended
March 31, 2019 were $24.0 million compared to $22.2 million for the
same period in 2018. The change in research and development
expenses is primarily due to the initiation and continuation of
clinical trials and studies for multiple therapeutic and aesthetic
indications and pre-BLA filing activities for DAXI for the
treatment of glabellar lines.
General and administrative expenses for the first quarter
2019 were $12.9 million compared to $13.6 million for the same
period in 2018. The decrease in general and administrative expenses
is primarily due timing of planned pre-commercial projects to
support future product launches, offset by increased costs related
to personnel, and infrastructure build-out.
Total operating expenses for the quarter ended March 31,
2019 were $36.9 million compared to $35.9 million for the same
period in 2019. Stock-based compensation for the first quarter was
$4.2 million. When excluding depreciation and stock-based
compensation, total operating expenses for the quarter ended March
31, 2019 were $32.1 million.
Net loss for the first quarter was $35.3 million compared
to $35.0 million for the same period in 2018.
Near-Term Milestone Expectations
Aesthetics:
- Submission of a Biologics Licensing
Application (BLA) to the FDA for DAXI for the treatment of
glabellar (frown) lines in the fall of 2019.
- Topline results from Phase 2 study of
DAXI in forehead lines expected in 1H 2020.
- Topline results from Phase 2 study of
DAXI in lateral canthal lines (crow’s feet) expected in 1H
2020
Therapeutics:
- Completion of patient enrollment in
Phase 2 upper limb spasticity study expected in 2H 2019.
- Completion of patient enrollment in
Phase 2 plantar fasciitis study expected in 2H 2019.
- Completion of patient enrollment in
Phase 3 cervical dystonia study in 2H 2019.
Biosimilar:
- Revance plans to share more details on
this program in the coming months.
2019 Financial Outlook
Revance reiterates its financial guidance provided in February
2019. Revance expects 2019 GAAP operating expense to be in the
range of $173 to $185 million and non-GAAP operating expense, which
excludes depreciation and stock-based compensation costs, in the
range of $148 to $158 million as driven by increased research and
development expenditure and launch preparation activities. With
five clinical programs and preparations to file the BLA underway,
Revance anticipates 2019 non-GAAP research and development
(R&D) expense to be $93 to $100 million. With the successful
capital infusion through partnering agreements in 2018 and an
equity raise in January, management feels the company has adequate
cash reserves to fund its operations through 2020.
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:
5753548; 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 May 8, 2019 at
4:30 p.m. PT/7:30 p.m. ET to May 9, 2019 at 4:30 p.m. PT/7:30 p.m.
ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and
reference conference ID: 5753548. 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 focused on
developing transformative neuromodulators to address a broad
spectrum of aesthetic and therapeutic conditions. Revance’s lead
product candidate, DaxibotulinumtoxinA for Injection (DAXI),
utilizes a unique proprietary peptide excipient technology combined
with highly purified botulinum toxin type A to produce a novel,
long-acting neuromodulator set to enter a $4.5 billion global
market. In aesthetics, Revance successfully completed its Phase 3
program for DAXI in glabellar (frown) lines and is currently
pursuing U.S. regulatory approval in 2020, while also running two
separate Phase 2 studies in forehead lines and lateral canthal
lines (crow’s feet). In therapeutics, DAXI is being studied in
three indications, including a Phase 3 trial in cervical dystonia,
a Phase 2 trial in adult upper limb spasticity, and a Phase 2 trial
in plantar fasciitis, with plans to also study migraine. Beyond
DAXI, Revance also has begun development of a biosimilar to BOTOX®,
which would compete in the existing short-acting neuromodulator
marketplace. 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' 2019
financial outlook, expected cash runway 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, the initiation, design,
timing and results of our clinical studies, including the SAKURA 3
study of DAXI, Phase 3 program for treatment of cervical dystonia,
Phase 2 and other clinical programs for the management of plantar
fasciitis and for the treatment of adult upper limb spasticity, and
related results and reporting of such results; development of a
biosimilar to BOTOX®; results of our non-clinical programs;
statements about our business strategy, timeline and other goals
and market for our anticipated products, plans and prospects;
including our pre-commercialization plans and timing of our
potential submission of a BLA filing for DAXI to treat glabellar
(frown) lines and potential regulatory approach and product launch;
statements about our ability to obtain, and the timing relating to,
regulatory approval with respect to our drug product candidates;
statements regarding additional milestone payments through our
partnerships, and potential benefits of our drug product candidates
and our excipient peptide and other 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 of our annual report on Form
10-K filed February 28, 2019. 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, stock-based
compensation, and non-recurring milestone costs. Revance excludes
depreciation, stock-based compensation, and non-recurring milestone
costs 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, 2019
2018 ASSETS CURRENT ASSETS Cash and cash equivalents
$ 65,269 $ 73,256 Short-term investments 205,719 102,556 Accounts
receivable — 27,000 Prepaid expenses and other current assets 6,128
5,110 Total current assets 277,116 207,922 Property
and equipment, net 15,378 14,449 Operating lease right of use
assets 28,105 — Restricted cash 730 730 Other non-current assets
3,146 3,247 TOTAL ASSETS 324,475 $ 226,348
LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT
LIABILITIES Accounts payable $ 4,486 $ 8,434 Accruals and other
current liabilities 13,521 14,948 Deferred revenue, current portion
13,054 8,588 Operating lease liabilities, current portion 3,009
— Total current liabilities 34,070 31,970
Derivative liability associated with the Medicis settlement
2,845 2,753 Deferred revenue, net of current portion 37,940 42,684
Operating lease liabilities, net of current portion 28,517 —
Deferred rent — 3,319 TOTAL LIABILITIES 103,372
80,726 STOCKHOLDERS’ EQUITY Convertible preferred
stock, par value $0.001 per share — 5,000,000 shares authorized,
and no shares issued and outstanding as of March 31, 2019 and
December 31, 2018 — — Common stock, par value $0.001 per share —
95,000,000 shares authorized as of March 31, 2019 and December 31,
2018; 44,004,658 and 36,975,203 shares issued and outstanding as of
March 31, 2019 and December 31, 2018, respectively 44 37 Additional
paid-in capital 941,068 830,368 Accumulated other comprehensive
income (loss) 70 (8 ) Accumulated deficit (720,079 ) (684,775 )
TOTAL STOCKHOLDERS’ EQUITY 221,103 145,622 TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY $ 324,475 $ 226,348
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per
share amounts)
(Unaudited)
Three Months Ended March 31, 2019
2018 Revenue $ 278 $ 193 Operating expenses: Research and
development 23,995 22,239 General and administrative 12,910
13,616 Total operating expenses 36,905 35,855
Loss from operations (36,627 ) (35,662 ) Interest income 1,570
1,022 Interest expense — (44 ) Change in fair value of derivative
liability associated with the Medicis settlement (92 ) (34 ) Other
expense, net (155 ) (319 ) Net loss (35,304 ) (35,037 ) Unrealized
gain (loss) and adjustment on securities included in net loss 78
(276 ) Comprehensive loss $ (35,226 ) $ (35,313 ) Basic and
diluted net loss attributable to common stockholders $ (35,304 ) $
(35,037 ) Basic and diluted net loss per share attributable to
common stockholders $ (0.85 ) $ (0.97 ) Basic and diluted
weighted-average number of shares used in computing net loss per
share attributable to common stockholders 41,598,919
35,950,593
REVANCE THERAPEUTICS, INC.
Reconciliation of GAAP Operating
Expense to Non-GAAP Operating Expense
(In thousands)
(Unaudited)
Three Months Ended March 31,
2019
Operating expense: GAAP operating expense $ 36,905
Adjustments: Stock-based compensation (4,159 ) Depreciation
(628 )
Non-GAAP operating expense $ 32,118
REVANCE THERAPEUTICS, INC.
Reconciliation of GAAP R&D Expense
to Non-GAAP R&D Expense
(In thousands)
(Unaudited)
Three Months Ended March 31,
2019
R&D expense GAAP R&D expense $ 23,995
Adjustments: Stock-based compensation (2,079 ) Depreciation
(461 )
Non-GAAP R&D expense $ 21,455
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version on businesswire.com: https://www.businesswire.com/news/home/20190508005698/en/
INVESTORSRevance Therapeutics, Inc.:Jeanie Herbert,
714-325-3584jherbert@revance.comorGilmartin Group, LLC.:Laurence
Watts, 619-916-7620laurence@gilmartinir.com
MEDIAGeneral Media:Y&R:Jenifer
Slaw347-971-0906jenifer.slaw@YR.comorTrade Media:Nadine Tosk,
504-453-8344nadinepr@gmail.com
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