- Conference call and webcast today at 4:30
p.m. ET -
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
including its next-generation neuromodulator product,
DaxibotulinumtoxinA for Injection, today reported financial results
for the quarter ended March 31, 2020 and provided a corporate
update.
Key First Quarter 2020 and Subsequent Updates
- BLA for DaxibotulinumtoxinA for Injection in Glabellar Lines
Accepted by FDA, PDUFA Date Announced. In February, the company
received U.S. Food and Drug Administration (FDA) notification that
its Biologics License Application (BLA) for DaxibotulinumtoxinA for
Injection in the treatment of moderate to severe glabellar (frown)
lines was accepted for review. Revance has been given a target
action date under the Prescription Drug User Fee Act (PDUFA) of
November 25, 2020.
- Signed Exclusive U.S. Distribution Agreement for
FDA-Approved TEOXANE Dermal Fillers. In January, Revance
entered into a distribution agreement with Teoxane SA, making
Revance the exclusive commercialization partner of the Swiss
company’s modern and innovative Resilient Hyaluronic Acid® (RHA®)
line of dermal fillers in the U.S., the first and only range of
FDA-approved dermal fillers indicated for the correction of dynamic
facial wrinkles and folds.
- Provided Corporate Update in Response to COVID-19.
Consistent with its COVID-19 update on March 26, Revance’s BLA for
glabellar lines remains on track, as do topline data readouts from
the ASPEN-1 Phase 3 trial in cervical dystonia and Phase 2 trial in
plantar fasciitis, which will occur in the second half of 2020.
Additionally, the company is on schedule for second quarter 2020
readouts from its forehead lines and crow’s feet open-label Phase 2
studies. COVID-19 has, however, caused Revance to adjust the launch
of its RHA® dermal filler line, and the associated hiring of field
representatives, by one quarter, due to the temporary closure of
Teoxane’s Swiss manufacturing facility. Additionally, the company
announced a pause in enrollment of the Revance’s JUNIPER Phase 2
trial for adult upper limb spasticity. Despite these changes, the
company reiterated its 2020 financial guidance, with operating
expenses likely to come in at the lower end of guidance, as delayed
revenue is offset by the shift in sales force hires.
- Closed Public Offering of Common Stock and Private Offering
of Convertible Senior Notes - In January, Revance closed its
underwritten public offering of 7,475,000 shares of its common
stock at a price to the public of $17.00 per share. The gross
proceeds to the company from the offering, before deducting the
underwriters’ discounts, commissions and other offering expenses,
were approximately $127.1 million. In February, Revance closed its
offering of $287.5 million aggregate principal amount of
convertible senior notes due 2027 in a private placement to
qualified institutional buyers pursuant to Rule 144A under the
Securities Act of 1933, as amended.
“First of all, I would like to sincerely thank all of those who
are currently on the front lines of the COVID-19 pandemic. In
addition, I would also like to recognize my Revance colleagues for
their adaptability and resilience during these unprecedented
times,” said Mark Foley, President and Chief Executive Officer. “As
organizations adjust to the new world shaped by the COVID-19
pandemic, Revance does so from a position of financial, operational
and product portfolio strength. We remain excited about the
commercial potential for our RHA® dermal fillers in the U.S., which
we now plan to launch in the third quarter of 2020, followed by
DaxibotulinumtoxinA for Injection in glabellar lines, after an
anticipated FDA approval on November 25. We also look forward to
announcing the topline results from our Phase 3 trial in cervical
dystonia and Phase 2 trial in plantar fasciitis in the second half.
Despite the challenges that have resulted from the current
pandemic, Revance remains on track to deliver on our key 2020 value
drivers as we move into the back half of the year.”
Financial Highlights
Cash, cash equivalents and short-term investments as of
March 31, 2020 were $511.3 million.
Revenue for the quarter ended March 31, 2020 was $58
thousand compared to $278 thousand for the same period in 2019.
Research and development expenses for the quarter ended
March 31, 2020 were $39.8 million compared to $24.0 million for the
same period in 2019. The change in research and development
expenses is primarily due to a non-cash acquisition charge of $11.2
million allocated to in-process research and development from the
TEOXANE distribution agreement.
Selling, general and administrative expenses for the
first quarter 2020 were $21.2 million compared to $12.9 million for
the same period in 2019.
Total operating expenses for the quarter ended March 31,
2020 were $61.0 million compared to $36.9 million for the same
period in 2019. Stock-based compensation for the first quarter was
$6.5 million. When excluding depreciation and amortization,
stock-based compensation, and non-cash in-process research and
development, total operating expenses for the quarter ended March
31, 2020 were $42.6 million.
Net loss for the first quarter was $61.9 million compared
to $35.3 million for the same period in 2019.
Near-Term Milestone Expectations
Aesthetics:
- Commercial launch of RHA® range of dermal fillers expected in
3Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study
of DaxibotulinumtoxinA for Injection in forehead lines expected in
2Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study
of DaxibotulinumtoxinA for Injection in lateral canthal lines
(crow’s feet) expected in 2Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study
of DaxibotulinumtoxinA for Injection in upper facial lines expected
in 4Q 2020.
- PDUFA date of November 25, 2020, for potential FDA approval of
DaxibotulinumtoxinA for Injection in glabellar lines.
Therapeutics:
- Topline results from ASPEN-1 Phase 3 placebo-controlled,
parallel-group study of DaxibotulinumtoxinA for Injection in
cervical dystonia expected in 2H 2020.
- Topline results from Phase 2 placebo-controlled study of
DaxibotulinumtoxinA for Injection in plantar fasciitis expected in
2H 2020.
- Patient enrollment in JUNIPER Phase 2 placebo-controlled,
dose-ranging study of DaxibotulinumtoxinA for Injection in upper
limb spasticity has been paused. Company will provide a new date
for expected full enrollment after trial is reopened and an
enrollment trajectory is established.
Biosimilar:
- Revance expects a decision regarding whether or not Mylan plans
to move forward with the biosimilar to BOTOX® program by the end of
May 2020.
2020 Financial Outlook
Based on the impact of the COVID-19 situation on the company’s
plans and operations, Revance expects 2020 U.S. generally accepted
accounting principles (“GAAP”) operating expense to be at the lower
end of the range of $270 to $280 million and non-GAAP operating
expense, which excludes depreciation and amortization, stock-based
compensation, and non-cash in-process research and development
costs, to be at the lower end of the range of $220 to $230 million
driven by RHA® and DaxibotulinumtoxinA for Injection launch
activities. With multiple clinical programs underway, along with
regulatory and pre-commercial manufacturing activities, Revance
anticipates 2020 non-GAAP research and development expense to be
$95 to $100 million. With current cash and equivalents, management
projects that the company is funded into 2023.
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:
4799936; 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 7, 2020 at 4:30 p.m. PT/7:30 p.m.
ET to May 8, 2020 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: 4799936.
The live webcast can be accessed here and will be available in
the investor relations section on the company's website for 30 days
following the completion of the call. In light of reduced call
center resources during this time of required social-distancing,
Revance requests that listeners who do not plan on participating in
the question and answer session listen to the live webcast rather
than dialing in by phone.
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. is a biotechnology company focused on
innovative aesthetic and therapeutic offerings, including its
next-generation neuromodulator product, DaxibotulinumtoxinA for
Injection. DaxibotulinumtoxinA for Injection combines a proprietary
stabilizing peptide excipient with a highly purified botulinum
toxin that does not contain human or animal-based components.
Revance has successfully completed a Phase 3 program for
DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is
pursuing U.S. regulatory approval in 2020. Revance is also
evaluating DaxibotulinumtoxinA for Injection in the full upper
face, including glabellar lines, forehead lines and crow’s feet, as
well as in three therapeutic indications - cervical dystonia, adult
upper limb spasticity and plantar fasciitis. Beyond
DaxibotulinumtoxinA for Injection, Revance gained exclusive rights
to commercialize TEOXANE SA’s Resilient Hyaluronic Acid® (RHA®)
line of fillers in the U.S., the first and only range of
FDA-approved dermal fillers for correction of dynamic facial
wrinkles and folds. Revance has also begun development of a
biosimilar to BOTOX®, which would compete in the existing
short-acting neuromodulator marketplace. Revance is dedicated to
making a difference by transforming patient experiences. For more
information or to join our team visit us at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid®
and RHA® are trademarks of TEOXANE SA. BOTOX® is a registered
trademark of Allergan, Inc.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements related to Revance Therapeutics' 2020
financial outlook, milestone expectations, 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, enrollment, submission, timing and results of our clinical
studies, including the near-term milestone expectations described
above; 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;
statements about our ability to obtain, and the timing relating to,
regulatory approval with respect to our drug product candidates and
to launch products, including with respect to the anticipated
approval of DaxibotulinumtoxinA for Injection and expected PDUFA
date; potential benefits of our drug product candidates and our
technologies, including with respect to the RHA line of dermal
fillers.
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, including our ability to receive timely
approval of DaxibotulinumtoxinA for Injection; 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" on annual report Form 10K filed
February 26, 2020. 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
amortization, stock-based compensation, and non-cash in-process
research and development costs. Revance excludes depreciation and
amortization, stock-based compensation, and non-cash in-process
research and development 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,
2020
2019
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
286,649
$
171,160
Short-term investments
224,621
118,955
Prepaid expenses and other current
assets
7,171
6,487
Total current assets
518,441
296,602
Property and equipment, net
13,967
14,755
Intangible assets
32,334
—
Operating lease right of use assets
25,961
26,531
Restricted cash
730
730
Other non-current assets
1,494
1,669
TOTAL ASSETS
$
592,927
$
340,287
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable
$
8,709
$
8,010
Accruals and other current liabilities
16,178
18,636
Deferred revenue, current portion
10,079
7,911
Operating lease liabilities, current
portion
3,627
3,470
Derivative liability
3,042
2,952
Total current liabilities
41,635
40,979
Convertible senior notes
171,305
—
Deferred revenue, net of current
portion
46,722
47,948
Operating lease liabilities, net of
current portion
24,890
25,870
TOTAL LIABILITIES
284,552
114,797
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, 2020 and December 31,
2019
—
—
Common stock, par value $0.001 per share —
95,000,000 shares authorized both as of March 31, 2020 and December
31, 2019; 57,026,154 and 52,374,735 shares issued and outstanding
as of March 31, 2020 and December 31, 2019, respectively
57
52
Additional paid-in capital
1,213,931
1,069,639
Accumulated other comprehensive income
524
3
Accumulated deficit
(906,137
)
(844,204
)
TOTAL STOCKHOLDERS’ EQUITY
308,375
225,490
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
592,927
$
340,287
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,
2020
2019
Revenue
$
58
$
278
Operating expenses:
Research and development
39,794
23,995
Selling, general and administrative
21,224
12,910
Total operating expenses
61,018
36,905
Loss from operations
(60,960
)
(36,627
)
Interest income
1,491
1,570
Interest expense
(2,148
)
—
Changes in fair value of derivative
liability
(90
)
(92
)
Other expense, net
(126
)
(155
)
Loss before income taxes
(61,833
)
(35,304
)
Income tax provision
(100
)
—
Net loss
(61,933
)
(35,304
)
Unrealized gain and adjustment on
securities included in net loss
521
78
Comprehensive loss
$
(61,412
)
$
(35,226
)
Basic and diluted net loss
$
(61,933
)
$
(35,304
)
Basic and diluted net loss per share
$
(1.15
)
$
(0.85
)
Basic and diluted weighted-average number
of shares used in computing net loss per share
53,868,036
41,598,919
REVANCE THERAPEUTICS,
INC.
Reconciliation of GAAP
Operating Expense to Non-GAAP Operating Expense
(In thousands)
(Unaudited)
Three Months Ended
March 31, 2020
Operating expense:
GAAP operating expense
$
61,018
Adjustments:
In-process research and development
(11,184
)
Stock-based compensation
(6,544
)
Depreciation and amortization
(739
)
Non-GAAP operating expense
$
42,551
REVANCE THERAPEUTICS,
INC.
Reconciliation of GAAP R&D
Expense to Non-GAAP R&D Expense
(In thousands)
(Unaudited)
Three Months Ended
March 31, 2020
R&D expense:
GAAP R&D expense
$
39,794
Adjustments:
In-process research and development
(11,184
)
Stock-based compensation
(2,442
)
Depreciation and amortization
(497
)
Non-GAAP R&D expense
$
25,671
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version on businesswire.com: https://www.businesswire.com/news/home/20200507005947/en/
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 Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476
sfahy@revance.com or General Media: Y&R: Jenifer Slaw,
347-971-0906 jenifer.slaw@YR.com or Trade Media: Nadine Tosk,
504-453-8344 nadinepr@gmail.com
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