March 02, 2016
- Announces 2016 Outlook -
- On Track to Achieve Multiple Clinical Development Milestones in 2016 -
Recent Highlights and Upcoming Milestones
"With positive clinical trial results reported for both RT001 topical and RT002 injectable in 2015, we were able to demonstrate the viability of our two neurotoxin drug candidates, while simultaneously establishing a foundation of financial and operational stability as we move closer to commercialization," said
Summary Financial Results
Research and development expenses for the fourth quarter and full year ended
General and administrative expenses for the fourth quarter and full year ended
Total operating expenses for the fourth quarter and full year ended
Net loss for the fourth quarter and full year ended
Cash and investments as of
2016 Financial Outlook
Revance expects its 2016 non-GAAP operating expense to be in the range of
For modeling purposes and assuming no material issuances of equity, we expect 2016 weighted average number of shares outstanding will be approximately 28 to 29 million.
Conference Call
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A replay of the call will be available beginning today at
About
Revance, a
Revance's journey to market starts with the neurotoxin daxibotulinumtoxinA, the company's highly purified botulinum toxin type A. The TransMTS technology is used in the delivery of botulinum toxin through two novel drug product candidates: DaxibotulinumtoxinA Topical Gel (RT001) that permits needle-free application, and DaxibotulinumtoxinA for Injection (RT002), which is designed to enable targeted administration and long-lasting effect. Revance is developing RT001 and RT002 for a broad spectrum of aesthetic and therapeutic indications, including facial wrinkles, excessive sweating and muscle movement disorders. The company holds worldwide rights for all indications of RT001, RT002 and the TransMTS technology platform. Beyond botulinum toxin, Revance expects the TransMTS technology can be applied to transdermal, mid-dermal or deep tissue delivery of a variety of other macromolecules. More information on Revance can be found at www.revance.com.
"Revance Therapeutics", TransMTS®, "Remarkable Science Changes Everything", and the Revance logo are registered trademarks of
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to Revance Therapeutics' financial outlook and other financial performance, and about our investigational drug product candidates, including but not limited to statements about our business strategy, clinical development, timeline and other goals and market for our anticipated products, plans and prospects and statements about 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 November 10, 2015. 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.
Consolidated Balance Sheets | |||||||
(In thousands, except share and per share amounts) | |||||||
As of | |||||||
2015 | 2014 | ||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 201,615 | $ | 171,032 | |||
Short-term investments | 50,688 | — | |||||
Restricted cash, current portion | 35 | 75 | |||||
Prepaid expenses and other current assets | 1,625 | 1,624 | |||||
Total current assets | 253,963 | 172,731 | |||||
Property and equipment, net | 19,708 | 19,274 | |||||
Long-term investments | 1,751 | — | |||||
Restricted cash, net of current portion | 400 | 435 | |||||
Other non-current assets | — | 29 | |||||
TOTAL ASSETS | $ | 275,822 | $ | 192,469 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES | |||||||
Accounts payable | $ | 2,657 | $ | 3,149 | |||
Accruals and other current liabilities | 6,245 | 4,145 | |||||
Financing obligations, current portion | 3,135 | 307 | |||||
Notes payable, current portion and net of discount | — | 2,635 | |||||
Total current liabilities | 12,037 | 10,236 | |||||
Financing obligations, net of current portion | 5,346 | 598 | |||||
Derivative liabilities associated with Medicis settlement | 1,414 | 1,541 | |||||
Deferred rent | 3,773 | 3,725 | |||||
TOTAL LIABILITIES | 22,570 | 16,100 | |||||
Commitments and Contingencies | |||||||
Convertible preferred stock, par value | — | — | |||||
STOCKHOLDERS' EQUITY | |||||||
Common stock, par value | 28 | 24 | |||||
Additional paid-in capital | 585,537 | 435,142 | |||||
Accumulated other comprehensive loss | (40 | ) | — | ||||
Accumulated deficit | (332,273 | ) | (258,797 | ) | |||
TOTAL STOCKHOLDERS' EQUITY | 253,252 | 176,369 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 275,822 | $ | 192,469 |
Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
(In thousands, except share and per share amounts) | |||||||||||||||
Quarter Ended | Year Ended | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Revenue | $ | 75 | $ | 75 | $ | 300 | $ | 383 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 14,956 | 9,129 | 47,529 | 33,390 | |||||||||||
General and administrative | 6,905 | 4,792 | 25,088 | 19,043 | |||||||||||
Total operating expenses | 21,861 | 13,921 | 72,617 | 52,433 | |||||||||||
Loss from operations | (21,786 | ) | (13,846 | ) | (72,317 | ) | (52,050 | ) | |||||||
Interest income | 87 | 26 | 231 | 44 | |||||||||||
Interest expense | (356 | ) | (336 | ) | (1,190 | ) | (10,672 | ) | |||||||
Change in fair value of derivative liabilities associated with the convertible notes | — | — | — | 4,032 | |||||||||||
Changes in fair value of derivative liabilities associated with Medicis settlement | 67 | 106 | 127 | (320 | ) | ||||||||||
Change in fair value of common stock warrant liability | — | — | — | (2,151 | ) | ||||||||||
Change in fair value of convertible preferred stock warrant liability | — | — | — | (210 | ) | ||||||||||
Loss on settlement of preferred stock warrant | — | — | — | (1,356 | ) | ||||||||||
Other expense, net | (106 | ) | (162 | ) | (327 | ) | (234 | ) | |||||||
Net loss | $ | (22,094 | ) | $ | (14,212 | ) | $ | (73,476 | ) | $ | (62,917 | ) | |||
Unrealized loss on available for sale securities | (50 | ) | — | (40 | ) | — | |||||||||
Comprehensive loss | (22,144 | ) | (14,212 | ) | (73,516 | ) | (62,917 | ) | |||||||
Net loss attributable to common stockholders: | |||||||||||||||
Basic | $ | (22,094 | ) | $ | (14,212 | ) | $ | (73,476 | ) | $ | (62,917 | ) | |||
Diluted | $ | (22,094 | ) | $ | (14,212 | ) | $ | (73,476 | ) | $ | (62,917 | ) | |||
Net loss per share attributable to common stockholders: | |||||||||||||||
Basic | $ | (0.83 | ) | $ | (0.60 | ) | $ | (3.02 | ) | $ | (3.24 | ) | |||
Diluted | $ | (0.83 | ) | $ | (0.60 | ) | $ | (3.02 | ) | $ | (3.24 | ) | |||
Weighted-average number of shares used in computing net loss per share attributable to common stockholders: | |||||||||||||||
Basic | 26,460,955 | 23,492,415 | 24,340,466 | 19,391,523 | |||||||||||
Diluted | 26,460,955 | 23,492,415 | 24,340,466 | 19,391,523 |
2015 Financial Results | |||||||
Reconciliation of GAAP Operating Expense to Non-GAAP Expense | |||||||
(In thousands) | |||||||
Quarter Ended | Year Ended | ||||||
Operating expense: | |||||||
GAAP operating expense | $ | 21,862 | $ | 72,617 | |||
Adjustments: | |||||||
Stock-based compensation | (5,074 | ) | (12,388 | ) | |||
Depreciation | (409 | ) | (1,995 | ) | |||
Non-GAAP operating expense | $ | 16,379 | $ | 58,234 |
2016 Financial Guidance | |||||||
Reconciliation of GAAP Operating Expense to Non-GAAP Expense | |||||||
(In thousands) | |||||||
Fiscal Year | |||||||
2016 | |||||||
Low | High | ||||||
Operating expense: | |||||||
GAAP operating expense | $ | 112,000 | $ | 125,000 | |||
Adjustments: | |||||||
Stock-based compensation | (15,000 | ) | (17,000 | ) | |||
Depreciation | (2,000 | ) | (3,000 | ) | |||
Non-GAAP operating expense | $ | 95,000 | $ | 105,000 |
Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense | |||||||
(In thousands) | |||||||
Fiscal Year | |||||||
2016 | |||||||
Low | High | ||||||
Operating expense: | |||||||
GAAP R&D expense | $ | 82,000 | $ | 90,000 | |||
Adjustments: | |||||||
Stock-based compensation | (8,000 | ) | (9,000 | ) | |||
Depreciation | (2,000 | ) | (3,000 | ) | |||
Non-GAAP R&D expense | $ | 72,000 | $ | 78,000 |
Contacts Investors:Source:Revance Therapeutics, Inc. Jeanie Herbert (714) 325-3584 jherbert@revance.com Trade Media: Nadine Tosk (847) 920-9858 nadinepr@gmail.com
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