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Revance Releases First Quarter 2017 Results

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Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company
developing botulinum toxin products for use in treating aesthetic and
therapeutic conditions, today announced results for the first quarter
ended March 31, 2017.

Recent Highlights and Upcoming Milestones for DaxibotulinumtoxinA for
Injection (RT002)

  • Completed enrollment for the SAKURA 1 & 2 Phase 3 pivotal trials of
    RT002 injectable for the treatment of glabellar (frown) lines. The
    SAKURA program is comprised of the two pivotal trials, plus a
    long-term safety trial that continues to enroll subjects. Revance
    plans to report topline results from the SAKURA 1 & 2 pivotal trials
    in the fourth quarter of 2017.
  • Presented safety, efficacy and duration-of-effect results from Phase 2
    trials for RT002 injectable for the treatment of glabellar lines and
    cervical dystonia at TOXINS 2017, the International Neurotoxin
    Association Conference.
  • Presented BELMONT Phase 2 clinical data of RT002 injectable for the
    treatment of glabellar (frown) lines at the 2017 American Academy of
    Dermatology Annual Meeting.
  • Updated Phase 2 program for RT002 injectable in the management of
    plantar fasciitis by expanding to a multi-center study with protocol
    updates. The company plans to report topline results in the fourth
    quarter of 2017.
  • Expects to report 24-week results from all three cohorts of the Phase
    2 open-label, sequential, dose-escalating study of RT002 for the
    treatment of cervical dystonia in the second quarter of 2017.

"Studies conducted to date with RT002 injectable involving both large
and small muscles indicate not only a strong safety profile, but also
that this next-generation neuromodulator can potentially deliver high
response rates, long duration of effect and high patient satisfaction.
These clinical results are like no other in the neuromodulator space,"
said Dan Browne, President and Chief Executive Officer at Revance. "We
expect to report results for our Phase 3 pivotal trials for glabellar
lines, the 24-week Phase 2 results for cervical dystonia and topline
Phase 2 results for our new indication, plantar fasciitis, all within
the next seven months."

Summary Financial Results

Cash and investments as of March 31, 2017 were $188.6 million.

Research and development expenses for the three months ended
March 31, 2017 were $19.4 million compared to $12.4 million for the same
period in 2016. The increase in research and development expenses is
primarily due our SAKURA 1 and 2 Phase 3 pivotal trials of RT002
injectable.

General and administrative expenses for the three months ended
March 31, 2017 were $7.8 million compared to $7.5 million for the same
period in 2016. The increase in general and administrative expenses is
primarily due to increased costs related to personnel, offset by a
decrease in marketing expenses.

Total operating expenses for the three months ended March 31,
2017 were $27.2 million compared to $19.8 million for the same period in
2016. Stock-based compensation for the three months ended March 31, 2017
was $3.2 million. When excluding depreciation and stock-based
compensation, total operating expenses for the three months ended March
31, 2017 were $23.7 million.

Net loss for the three months ended March 31, 2017 was $27.2
million compared to $19.9 million for the same period in 2016.

2017 Financial Outlook

Revance reaffirmed its financial guidance provided in January 2017.
Revance expects cash burn for 2017 to be in the range of $102 to $112
million. Revance expects 2017 GAAP operating expense to be in the range
of $108 to $119 million, which when excluding depreciation of $1 to $2
million and estimated stock-based compensation of $13 to $15 million,
results in projected 2017 non-GAAP operating expense of $94 to $102
million. With three clinical programs underway, Revance anticipates 2017
GAAP research and development expense to be in the range of $75 to $83
million, which when excluding depreciation of $1 to $2 million and
estimated stock-based compensation of $5 to $6 million, results in
projected 2017 non-GAAP research and development expense of $69 to $75
million.

Conference Call

Individuals interested in listening to the conference call today, May 9,
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: 3251601; 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 4:30pm
PT/7:30pm ET through 4:30pm PT/7:30pm ET on May 10, 2017. To access the
replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference
ID: 3251601. 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, orthopedics and neurology. Revance's
science is based upon a proprietary 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, cervical dystonia and plantar fasciitis with the potential to be
the first long-acting neuromodulator. The company holds worldwide rights
to RT002 injectable and RT001 topical and the pharmaceutical uses of its
proprietary peptide technology platform. More information on Revance may
be found at www.revance.com.

"Revance Therapeutics" 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' 2017 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 annual report on Form 10-K filed February 28, 2017.
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)

 
March 31, December 31,
2017 2016
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 38,235 $ 63,502
Short-term investments 150,404 122,026
Restricted cash, current portion 502
Prepaid expenses and other current assets 8,312   7,167  
Total current assets 197,453 192,695
Property and equipment, net 11,205 10,585
Restricted cash, net of current portion 580 580
Other non-current assets 216   500  
TOTAL ASSETS $ 209,454   $ 204,360  
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable $ 5,573 $ 3,754
Accruals and other current liabilities 14,967 12,418
Financing obligations, current portion 3,502   3,475  
Total current liabilities 24,042 19,647
Financing obligations, net of current portion 983 1,872
Derivative liability associated with Medicis settlement 2,082 2,022
Deferred rent 3,576 3,648
Other non-current liabilities 100   100  
TOTAL LIABILITIES 30,783   27,289  
Commitments and Contingencies
STOCKHOLDERS' EQUITY
Common stock, par value $0.001 per share — 95,000,000 shares
authorized both as of March 31, 2017 and December 31, 2016;
30,129,240 and 28,648,954 shares issued and outstanding as of March
31, 2017 and December 31, 2016, respectively
30 29
Additional paid-in capital 627,475 598,630
Accumulated other comprehensive loss (98 ) (45 )
Accumulated deficit (448,736 ) (421,543 )
TOTAL STOCKHOLDERS' EQUITY 178,671   177,071  
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 209,454   $ 204,360  
 
   

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,
2017     2016
Revenue $ 75 $ 75
Operating expenses:
Research and development 19,409 12,364
General and administrative 7,754   7,455  
Total operating expenses 27,163   19,819  
Loss from operations (27,088 ) (19,744 )
Interest income 311 310
Interest expense (193 ) (315 )
Change in fair value of derivative liability associated with Medicis
settlement
(60 ) (14 )
Other expense, net (126 ) (125 )
Net loss (27,156 ) (19,888 )
Unrealized gain (loss) on available for sale securities (52 ) 226  
Comprehensive loss $ (27,208 ) $ (19,662 )
Net loss attributable to common stockholders:
Basic and Diluted $ (27,156 ) $ (19,888 )
Net loss per share attributable to common stockholders:
Basic and Diluted $ (0.94 ) $ (0.71 )
Weighted-average number of shares used in computing net loss per
share attributable to common stockholders:
Basic and Diluted 28,808,195   28,005,611  
 
   

Revance Therapeutics, Inc.

2017 Financial Results

(Unaudited)

 

Reconciliation of GAAP Operating Expense to Non-GAAP Operating
Expense

(In thousands)

 
Three Months Ended
March 31, 2017
Operating expense:
GAAP operating expense $ 27,163
Adjustments:
Stock-based compensation (3,155 )
Depreciation (357 )
Non-GAAP operating expense $ 23,651  
 
   

Revance Therapeutics, Inc.

2017 Financial Guidance

 

Reconciliation of GAAP Operating Expense to Non-GAAP Operating
Expense

(In thousands)

 
Fiscal Year
2017
Low     High
Operating expense:
GAAP operating expense $ 108,000 $ 119,000
Adjustments:
Stock-based compensation (13,000 ) (15,000 )
Depreciation (1,000 ) (2,000 )
Non-GAAP operating expense $ 94,000   $ 102,000  
 
   

Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense

(In thousands)

 
Fiscal Year
2017
Low     High
R&D expense:
GAAP R&D expense $ 75,000 $ 83,000
Adjustments:
Stock-based compensation (5,000 ) (6,000 )
Depreciation (1,000 ) (2,000 )
Non-GAAP R&D expense $ 69,000   $ 75,000  
 

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