- Completes Enrollment of Second Cohort of
Patients in RT002 Phase 2 Study for Cervical Dystonia -
- Updates 2016 Financial Outlook -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in aesthetic
and therapeutic indications, today announced results for the second
quarter ended June 30, 2016.
Recent Highlights
- DaxibotulinumtoxinA for Injection
(RT002)
- Completed enrollment of the second
cohort of patients in a Phase 2 dose-escalating study of RT002
injectable to treat cervical dystonia, a neurological muscle
movement disorder.
- Announced the completion of pre-Phase 3
meeting with the U.S. Food and Drug Administration (FDA) regarding
RT002 injectable for the treatment of glabellar (frown) lines.
Based upon the discussion with the FDA and the minutes received
following the meeting, Revance plans to move forward with an
Investigational New Drug (IND) submission for the Phase 3 clinical
program for RT002 in glabellar lines and other supportive studies
required for the Biologics License Application (BLA) filing.
- DaxibotulinumtoxinA Topical Gel (RT001)
- Released 28-day top-line safety and
efficacy results of REALISE 1 study, a Phase 3 trial for patients
with moderate to severe lateral canthal lines (crow’s feet) in June
2016. Based on the REALISE 1 results, the company reported that it
would discontinue its RT001 topical clinical development programs
in crow’s feet and axillary hyperhidrosis.
- Acquired intellectual property
portfolio consisting of more than 70 botulinum toxin-related
patents and patent applications from Botulinum Toxin Research
Associates, Inc. (BTRX).
- Appointed Julian Gangolli, President,
North America at GW Pharmaceuticals plc, to Revance’s Board of
Directors.
“We have successfully pivoted our focus to RT002 injectable and
believe we remain on track to deliver the first differentiated
neuromodulator in nearly 30 years,” said Dan Browne, President and
Chief Executive Officer at Revance. “For our aesthetics program in
glabellar lines, we had productive discussions with the FDA during
our recent pre-Phase 3 meeting, and anticipate the initiation of
Phase 3 clinical trials of RT002 injectable in 2016. In cervical
dystonia, with enrollment of patients in the second cohort of our
RT002 injectable Phase 2 study completed, we expect to report
interim results from the first two cohorts later this year.”
Summary Financial Results
Research and development expenses for the three and six
months ended June 30, 2016 were $15.2 million and $27.6
million compared to $10.3 million and $19.6 million for the same
periods in 2015, respectively. The increase in research and
development expenses is primarily attributable to personnel costs,
ongoing clinical trials, and the acquisition of botulinum
toxin-related patents and patent applications from BTRX.
General and administrative expenses for the three and six
months ended June 30, 2016 were $7.0 million and $14.5 million
compared to $6.4 million and $12.4 million for the same periods in
2015, respectively. The change in general and administrative
expenses is primarily attributable to increases in personnel,
consulting, legal and administrative costs.
Total operating expenses for the three and six months
ended June 30, 2016 were $24.2 million and $44.0 million
compared to $16.7 million and $31.9 million for the same periods in
2015, respectively. Stock-based compensation for the three and six
months ended June 30, 2016 was $3.3 million and $6.2 million,
respectively. When excluding depreciation and stock-based
compensation, total operating expenses for the three and six months
ended June 30, 2016 were $20.6 million and $37.1 million.
Net loss for the three and six months ended June 30,
2016 was $24.6 million and $44.5 million compared to $16.8 million
and $32.2 million for the same periods in 2015, respectively.
Cash and investments as of June 30, 2016 were $216.9
million.
2016 Financial Outlook
Revance updated its 2016 full-year guidance last provided on May
9, 2016. The company now expects its cash burn for 2016 to be in
the range of $90 to $100 million. Revance expects its 2016 GAAP
operating expense to be in the range of $95 to $108 million, which
when excluding depreciation of $2 to $3 million and estimated
stock-based compensation of $13 to $15 million, results in
projected 2016 non-GAAP operating expense of $80 to $90 million.
Revance also anticipates 2016 GAAP research and development expense
to be in the range of $66 to $74 million, which when excluding
depreciation of $2 to $3 million and estimated stock-based
compensation of $7 to $8 million, results in projected 2016
non-GAAP research and development expense of $57 to $63
million.
Conference Call
Individuals interested in listening to the conference call
today, August 4, 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: 46636498; 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 5:00pm
PT/8:00pm ET through 5:00pm PT/8:00pm ET on August 5, 2016. To
access the replay, dial (855) 859-2056 or (404) 537-3406 and
reference conference ID: 46636498. 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 science is based upon a proprietary TransMTS®
peptide technology, which when combined with active drug molecules,
may help address current unmet needs. Revance’s initial focus is on
developing daxibotulinumtoxinA, the company's highly purified
botulinum toxin, for a broad spectrum of aesthetic and therapeutic
indications, including facial wrinkles and muscle movement
disorders. The company’s lead drug candidate, DaxibotulinumtoxinA
for Injection (RT002), is currently in development for the
treatment of glabellar lines and cervical dystonia and has the
potential to be the first long-acting neurotoxin. The company holds
worldwide rights for all indications of RT002 injectable and RT001
topical and the pharmaceutical uses of the TransMTS technology
platform. More information on Revance may 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 quarterly report on Form
10-Q filed May 10, 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) June
30, December 31, 2016 2015
ASSETS CURRENT ASSETS Cash and cash equivalents $ 52,651 $
201,615 Short-term investments 164,293 50,688 Restricted cash,
current portion — 35 Prepaid expenses and other current assets
1,613 1,625 Total current assets 218,557 253,963
Property and equipment, net 17,658 19,708 Long-term investments —
1,751 Restricted cash, net of current portion 580 400 Other
non-current assets 214 — TOTAL ASSETS $ 237,009
$ 275,822
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES Accounts payable $ 2,982 $ 2,657 Accruals and
other current liabilities 5,622 6,245 Financing obligations,
current portion 3,314 3,135
Total current liabilities
11,918 12,037 Financing obligations, net of current portion 3,659
5,346 Derivative liability associated with Medicis settlement 1,842
1,414 Deferred rent 3,714 3,773 Other non-current liabilities 100
— TOTAL LIABILITIES 21,233 22,570
Commitments and Contingencies STOCKHOLDERS’ EQUITY
Preferred stock, par value $0.001 per
share — 5,000,000 shares authorized both as ofJune 30, 2016 and
December 31, 2015; no shares issued and outstanding both as ofJune
30, 2016 and December 31, 2015.
— —
Common stock, par value $0.001 per share —
95,000,000 shares authorized both as ofJune 30, 2016 and December
31, 2015; 28,481,172 and 28,288,464 shares issuedand outstanding as
of June 30, 2016 and December 31, 2015, respectively
28 28 Additional paid-in capital 592,362 585,537 Accumulated other
comprehensive income (loss) 148 (40 ) Accumulated deficit (376,762
) (332,273 ) TOTAL STOCKHOLDERS’ EQUITY 215,776 253,252
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 237,009
$ 275,822
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and
Comprehensive Loss (In thousands, except share and per share
amounts) (Unaudited)
Three Months EndedJune
30,
Six Months EndedJune 30,
2016 2015 2016 2015
Revenue $ 75 $ 75 $ 150 $ 150 Operating expenses: Research and
development 15,192 10,303 27,556 19,557 General and administrative
7,018 6,360 14,473 12,356 Loss on impairment 1,949 —
1,949 — Total operating expenses 24,159 16,663
43,978 31,913 Loss from operations (24,084 )
(16,588 ) (43,828 ) (31,763 ) Interest income 324 49 635 76
Interest expense (286 ) (279 ) (601 ) (444 )
Change in fair value of derivative
liability associated withMedicis settlement
(413 ) 89 (428 ) 47 Other expense, net (143 ) (76 ) (268 ) (123 )
Net loss (24,602 ) (16,805 ) (44,490 ) (32,207 ) Unrealized
gain/(loss) on available for sale securities (38 ) (12 ) 188
(12 ) Comprehensive loss $ (24,640 ) $ (16,817 ) $ (44,302 ) $
(32,219 ) Net loss attributable to common stockholders: Basic $
(24,602 ) $ (16,805 ) $ (44,490 ) $ (32,207 ) Diluted $ (24,602 ) $
(16,805 ) $ (44,490 ) $ (32,207 ) Net loss per share attributable
to common stockholders: Basic $ (0.88 ) $ (0.71 ) $ (1.59 ) $ (1.37
) Diluted $ (0.88 ) $ (0.71 ) $ (1.59 ) $ (1.37 )
Weighted-average number of shares used in
computing netloss per share attributable to common
stockholders:
Basic 28,089,731 23,584,910 28,047,671
23,560,133 Diluted 28,089,731 23,584,910
28,047,671 23,560,133
Revance
Therapeutics, Inc. 2016 Financial Results
(Unaudited) Reconciliation of GAAP Operating
Expense to Non-GAAP Operating Expense (In thousands)
Three Months EndedJune
30,
Six Months EndedJune 30,
Operating expense: GAAP operating expense $ 24,159 $ 43,978
Adjustments: Stock-based compensation (3,252 ) (6,229 )
Depreciation (355 ) (699 )
Non-GAAP operating expense $
20,552 $ 37,050
Revance
Therapeutics, Inc. 2016 Financial Guidance
Reconciliation of GAAP Operating Expense to Non-GAAP Operating
Expense (In thousands) Fiscal Year
2016 Low High Operating expense:
GAAP operating expense $ 95,000 $ 108,000
Adjustments:
Stock-based compensation (13,000 ) (15,000 ) Depreciation (2,000 )
(3,000 )
Non-GAAP operating expense $ 80,000 $ 90,000
Reconciliation of GAAP R&D Expense
to Non-GAAP R&D Expense
(In thousands) Fiscal Year 2016
Low High R&D expense: GAAP R&D
expense $ 66,000 $ 74,000
Adjustments: Stock-based
compensation (7,000 ) (8,000 ) Depreciation (2,000 ) (3,000 )
Non-GAAP R&D expense $ 57,000 $ 63,000
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Investors:Revance TherapeuticsJeanie Herbert, (714)
325-3584jherbert@revance.comorBurns McClellanAmi Bavishi, (212)
213-0006abavishi@burnsmc.comorTrade Media:Nadine Tosk, (504)
453-8344nadinepr@gmail.com
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