– Conference call and webcast today at 4:30 p.m. ET –
NEWARK, Calif.–(BUSINESS WIRE)–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 (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 (In thousands) (Unaudited) |
||||
|
Three Months Ended |
||||
| 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 |
||||
| R&D expense | ||||
| GAAP R&D expense | $ | 23,995 | ||
| Adjustments: | ||||
| Stock-based compensation | (2,079 | ) | ||
| Depreciation | (461 | ) | ||
| Non-GAAP R&D expense | $ | 21,455 | ||
Contacts
INVESTORS
Revance Therapeutics, Inc.:
Jeanie Herbert,
714-325-3584
jherbert@revance.com
or
Gilmartin
Group, LLC.:
Laurence Watts, 619-916-7620
laurence@gilmartinir.com
MEDIA
General Media:
Y&R:
Jenifer Slaw
347-971-0906
jenifer.slaw@YR.com
or
Trade
Media:
Nadine Tosk, 504-453-8344
nadinepr@gmail.com