- Conference call and webcast today at 4:30
p.m. ET -
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company pioneering new innovations in neuromodulators for aesthetic
and therapeutic indications, today reported financial results for
the quarter ended June 30, 2019 and provided a corporate
update.
Second Quarter 2019 and Subsequent Highlights/Updates
- BLA On Track for Fall Submission. Revance remains
confident in a Fall submission for its Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA)
for DaxibotulinumtoxinA for Injection (DAXI) for the treatment of
glabellar lines.
- Enrollment Progressing for Phase 2 Trials in “Upper Face”
Expansion Indications. In July, Revance completed enrollment in
its Phase 2 clinical trial of DAXI for forehead lines. Enrollment
for the company’s Phase 2 trial of DAXI in lateral canthal lines
(crow’s feet) is expected to be completed shortly. Topline results
for both are expected in the first half of 2020.
- Appointed Jill Beraud to Board of Directors. In June,
Revance announced that Ms. Beraud joined Revance’s board of
directors. Ms. Beraud brings more than 25 years’ experience
building luxury, fashion, beauty, and consumer brands. She will
also chair a new Revance Brand Strategy Committee.
- Added Chris Nolet to Board of Directors. In July, the
company announced that Chris Nolet joined Revance’s board of
directors. Mr. Nolet brings deep experience as a long-time audit
partner and business advisor to the life sciences industry. He will
also assume the role of Chair of Revance’s Audit Committee.
Dan Browne, President and Chief Executive Officer at Revance
comments: “We made excellent progress in the second quarter,
advancing our regulatory submission for DAXI, and we remain on
track to complete a compelling BLA submission for the treatment of
glabellar lines in the Fall of 2019. To raise physician awareness
of DAXI, pre-launch, I’m excited to announce that Revance’s SAKURA
trial results have been accepted for publication in the upcoming
issues of both the Journal of the American Academy of Dermatology
and Plastic and Reconstructive Surgery, elevating the significance
of our DAXI clinical outcomes. We continue to make headway with our
clinical development pipeline for DAXI in both aesthetic and
therapeutic expansion indications. We believe we have positioned
Revance for a number of significant value-creating milestones
through year end and in 2020.”
Financial Highlights
Cash, cash equivalents and short-term investments as of
June 30, 2019 were $241.9 million.
Revenue – There was no revenue recognized for the three
months ended June 30, 2019 compared to $0.7 million for the same
period in 2018. Revenue for the six months ended June 30, 2019 was
$0.3 million compared to $0.9 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 three and six
months ended June 30, 2019 were $25.5 million and $49.5 million
compared to $22.9 million and $45.1 million for the same periods in
2018, respectively. 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 three and six
months ended June 30, 2019 were $13.6 million and $26.5 million
compared to $12.7 million and $26.4 million for the same periods in
2018, respectively. The increase in general and administrative
expenses is primarily due to increased costs related to personnel
and infrastructure build-out.
Total operating expenses for the three and six months
ended June 30, 2019 were $39.1 million and $76.0 million compared
to $35.6 million and $71.5 million for the same periods in 2018,
respectively. Stock-based compensation for the three and six months
ended June 30, 2019 was $4.4 million and $8.6 million,
respectively. When excluding depreciation and stock-based
compensation, total operating expenses for the three and six months
ended June 30, 2019 were $33.9 million and $66.0 million,
respectively.
Net loss for the three and six months ended June 30, 2019
was $37.4 million and $72.7 million compared to $34.1 million and
$69.1 million for the same periods in 2018, respectively.
Near-Term Milestone Expectations
Aesthetics:
- Submission of a Biologics License 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 plantar fasciitis
study expected in 4Q 2019.
- Completion of patient enrollment in Phase 3 cervical dystonia
study in 4Q 2019.
- Completion of patient enrollment in Phase 2 upper limb
spasticity study expected in 1H 2020.
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, to be in
the range of $148 to $158 million as driven by increased research
and development expenditures 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 current 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:
9260859; 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 August 5, 2019 at 4:30 p.m. PT/7:30
p.m. ET to August 6, 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: 9260859. 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 Silicon Valley-based biotechnology
company, pioneering new innovations in neuromodulators for
aesthetic and therapeutic indications. Revance’s lead product
candidate, DaxibotulinumtoxinA for Injection (DAXI), 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 DAXI in glabellar (frown) lines, delivering unprecedented
efficacy and long-lasting duration of effect, and is pursuing U.S.
regulatory approval in 2020. Revance is also evaluating DAXI in
forehead lines and lateral canthal lines (crow’s feet), as well as
in three therapeutic indications - cervical dystonia, adult upper
limb spasticity and plantar fasciitis, with plans to study
migraine. Beyond DAXI, Revance has 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. 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,
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 and timing of
our anticipated BLA submission 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; 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 quarterly report on Form 10-Q filed May 9, 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)
June 30,
December 31,
2019
2018
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
90,034
$
73,256
Short-term investments
151,858
102,556
Accounts receivable
—
27,000
Prepaid expenses and other current
assets
8,013
5,110
Total current assets
249,905
207,922
Property and equipment, net
15,263
14,449
Operating lease right of use assets
27,602
—
Restricted cash
730
730
Other non-current assets
2,392
3,247
TOTAL ASSETS
$
295,892
$
226,348
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable
$
7,966
$
8,434
Accruals and other current liabilities
14,737
14,948
Deferred revenue, current portion
18,825
8,588
Operating lease liabilities, current
portion
3,168
—
Total current liabilities
44,696
31,970
Derivative liability associated with the
Medicis settlement
2,824
2,753
Deferred revenue, net of current
portion
32,169
42,684
Operating lease liabilities, net of
current portion
27,661
—
Deferred rent
—
3,319
TOTAL LIABILITIES
107,350
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 June 30, 2019 and December 31,
2018
—
—
Common stock, par value $0.001 per share —
95,000,000 shares authorized as of June 30, 2019 and December 31,
2018; 44,105,474 and 36,975,203 shares issued and outstanding as of
June 30, 2019 and December 31, 2018, respectively
44
37
Additional paid-in capital
945,851
830,368
Accumulated other comprehensive income
(loss)
116
(8
)
Accumulated deficit
(757,469
)
(684,775
)
TOTAL STOCKHOLDERS’ EQUITY
188,542
145,622
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
295,892
$
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 June
30,
Six Months Ended June
30,
2019
2018
2019
2018
Revenue
$
—
$
686
$
278
$
880
Operating expenses:
Research and development
25,526
22,871
49,521
45,111
General and administrative
13,596
12,734
26,506
26,350
Total operating expenses
39,122
35,605
76,027
71,461
Loss from operations
(39,122
)
(34,919
)
(75,749
)
(70,581
)
Interest income
1,596
1,081
3,166
2,103
Interest expense
—
—
—
(44
)
Change in fair value of derivative
liability associated with the Medicis settlement
21
(70
)
(71
)
(104
)
Other income (expense), net
115
(172
)
(40
)
(492
)
Net loss
(37,390
)
(34,080
)
(72,694
)
(69,118
)
Unrealized gain (loss) and adjustment on
securities included in net loss
46
52
124
(224
)
Comprehensive loss
$
(37,344
)
$
(34,028
)
$
(72,570
)
$
(69,342
)
Basic and diluted net loss
$
(37,390
)
$
(34,080
)
$
(72,694
)
$
(69,118
)
Basic and diluted net loss per share
$
(0.86
)
$
(0.94
)
$
(1.71
)
$
(1.92
)
Basic and diluted weighted-average number
of shares used in computing net loss per share
43,260,317
36,123,659
42,434,137
36,037,604
REVANCE THERAPEUTICS,
INC.
Reconciliation of GAAP
Operating Expense to Non-GAAP Operating Expense
(In thousands)
(Unaudited)
Three Months Ended June 30,
2019
Six Months Ended June 30,
2019
Operating expense:
GAAP operating expense
$
39,122
$
76,027
Adjustments:
Stock-based compensation
(4,420
)
(8,579
)
Depreciation
(790
)
(1,418
)
Non-GAAP operating expense
$
33,912
$
66,030
REVANCE THERAPEUTICS,
INC.
Reconciliation of GAAP R&D
Expense to Non-GAAP R&D Expense
(In thousands)
(Unaudited)
Three Months Ended June 30,
2019
Six Months Ended June 30,
2019
R&D expense
GAAP R&D expense
$
25,526
$
49,521
Adjustments:
Stock-based compensation
(2,253
)
(4,332
)
Depreciation
(572
)
(1,033
)
Non-GAAP R&D expense
$
22,701
$
44,156
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version on businesswire.com: https://www.businesswire.com/news/home/20190805005527/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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