August 04, 2016
- Completes Enrollment of Second Cohort of Patients in RT002 Phase 2 Study for Cervical Dystonia -
- Updates 2016 Financial Outlook -
Recent Highlights
"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
Summary Financial Results
Research and development expenses for the three and six months
ended
General and administrative expenses for the three and six months
ended
Total operating expenses for the three and six months ended
Net loss for the three and six months ended
Cash and investments as of
2016 Financial Outlook
Revance updated its 2016 full-year guidance last provided on
Conference Call
Individuals interested in listening to the conference call today,
A replay of the call will be available beginning today at
About
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.
"
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
"
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.
|
||||||||
Condensed Consolidated Balance Sheets | ||||||||
(In thousands, except share and per share amounts) | ||||||||
(Unaudited) | ||||||||
|
|
|||||||
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 |
— | — | ||||||
Common stock, par value |
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 | ||||
|
||||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
(In thousands, except share and per share amounts) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||||||
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 with |
(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 net |
||||||||||||||||
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 | ||||||||||||
|
||||||||
2016 Financial Results | ||||||||
(Unaudited) | ||||||||
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense | ||||||||
(In thousands) | ||||||||
Three Months Ended |
Six Months Ended |
|||||||
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 | ||||
|
||||||||
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:
jherbert@revance.com
or
abavishi@burnsmc.com
or
Trade
Media:
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