Revance Releases Fourth Quarter and Full Year 2016 Results
February 27, 2017
- Cash and investments of
Recent Highlights and Upcoming Milestones
-
Presented clinical data for RT002 injectable at TOXINS 2017, the third
International Neurotoxin Association Conference inMadrid, Spain . The podium presentations and poster abstracts highlighted the safety, efficacy and duration-of-effect results for RT002 injectable in the treatment of glabellar lines and cervical dystonia. -
Presented safety, efficacy, and duration of effect data from the
BELMONT Phase 2 study of RT002 injectable at the 19th annual IMCAS (InternationalMaster Course on Aging Skin)World Congress . -
Clinical Development for DaxibotulinumtoxinA for Injection (RT002)
- Announced subject dosing in the Phase 3 program of RT002 for the treatment of glabellar (frown) lines, comprised of two pivotal trials and a long-term safety trial. Revance plans to report topline results from both pivotal trials in the fourth quarter of 2017.
- Reported positive interim results from the Phase 2 open-label, sequential, dose-escalating study of RT002 for the treatment of cervical dystonia. RT002 injectable appeared to be generally safe and well-tolerated, displayed clinically significant impact on cervical dystonia signs and symptoms, and subjects in the first completed cohort (n=12) achieved median duration of effect of at least 24 weeks. Revance expects to report 24-week Phase 2 results in the second quarter of 2017.
- Initiated Phase 2 trial to evaluate the safety and efficacy of RT002 in reducing the signs and symptoms of plantar fasciitis. The trial is actively enrolling and Revance expects to report results in the second half of 2017.
"The fourth quarter was highly productive for Revance. We announced
compelling subject response rates and duration of effect interim data
reported from our Phase 2 study for RT002 in cervical dystonia, plus the
initiation of patient enrollment for two additional clinical programs
evaluating RT002 injectable," 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
2017 Financial Outlook
Revance reiterates its financial guidance provided in
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, 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 for all indications of 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
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.
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Consolidated Balance Sheets (In thousands, except share and per share amounts) |
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As of |
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| 2016 | 2015 | |||||||||
| ASSETS | ||||||||||
| CURRENT ASSETS | ||||||||||
| Cash and cash equivalents | $ | 63,502 | $ | 201,615 | ||||||
| Short-term investments | 122,026 | 50,688 | ||||||||
| Restricted cash, current portion | — | 35 | ||||||||
| Prepaid expenses and other current assets | 7,167 | 1,625 | ||||||||
| Total current assets | 192,695 | 253,963 | ||||||||
| Property and equipment, net | 10,585 | 19,708 | ||||||||
| Long-term investments | — | 1,751 | ||||||||
| Restricted cash, net of current portion | 580 | 400 | ||||||||
| Other non-current assets | 500 | — | ||||||||
| TOTAL ASSETS | $ | 204,360 | $ | 275,822 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| CURRENT LIABILITIES | ||||||||||
| Accounts payable | $ | 3,754 | $ | 2,657 | ||||||
| Accruals and other current liabilities | 12,418 | 6,245 | ||||||||
| Financing obligations, current portion | 3,475 | 3,135 | ||||||||
| Total current liabilities | 19,647 | 12,037 | ||||||||
| Financing obligations, net of current portion | 1,872 | 5,346 | ||||||||
| Derivative liabilities associated with Medicis settlement | 2,022 | 1,414 | ||||||||
| Deferred rent | 3,648 | 3,773 | ||||||||
| Other non-current liabilities | 100 | — | ||||||||
| TOTAL LIABILITIES | 27,289 | 22,570 | ||||||||
| Commitments and Contingencies | ||||||||||
| STOCKHOLDERS' EQUITY | ||||||||||
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Common stock, par value |
29 | 28 | ||||||||
| Additional paid-in capital | 598,630 | 585,537 | ||||||||
| Accumulated other comprehensive loss | (45 | ) | (40 | ) | ||||||
| Accumulated deficit | (421,543 | ) | (332,273 | ) | ||||||
| TOTAL STOCKHOLDERS' EQUITY | 177,071 | 253,252 | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 204,360 | $ | 275,822 | ||||||
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Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) |
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Quarter Ended
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Year Ended
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| 2016 | 2015 | 2016 | 2015 | |||||||||||||||||
| Revenue | $ | 75 | $ | 75 | $ | 300 | $ | 300 | ||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | 12,530 | 14,956 | 50,381 | 47,529 | ||||||||||||||||
| General and administrative | 7,100 | 6,905 | 29,075 | 25,088 | ||||||||||||||||
| Loss on impairment | 7,111 | — | 9,059 | — | ||||||||||||||||
| Total operating expenses | 26,741 | 21,861 | 88,515 | 72,617 | ||||||||||||||||
| Loss from operations | (26,666 | ) | (21,786 | ) | (88,215 | ) | (72,317 | ) | ||||||||||||
| Interest income | 230 | 87 | 1,170 | 231 | ||||||||||||||||
| Interest expense | (225 | ) | (356 | ) | (1,082 | ) | (1,190 | ) | ||||||||||||
| Changes in fair value of derivative liabilities associated with the Medicis settlement | (13 | ) | 67 | (608 | ) | 127 | ||||||||||||||
| Other expense, net | (128 | ) | (106 | ) | (535 | ) | (327 | ) | ||||||||||||
| Net loss | (26,802 | ) | (22,094 | ) | (89,270 | ) | (73,476 | ) | ||||||||||||
| Unrealized loss on available for sale securities | (61 | ) | (50 | ) | (5 | ) | (40 | ) | ||||||||||||
| Comprehensive loss | $ | (26,863 | ) | $ | (22,144 | ) | $ | (89,275 | ) | $ | (73,516 | ) | ||||||||
| Net loss attributable to common stockholders: | ||||||||||||||||||||
| Basic and Diluted | $ | (26,802 | ) | $ | (22,094 | ) | $ | (89,270 | ) | $ | (73,476 | ) | ||||||||
| Net loss per share attributable to common stockholders: | ||||||||||||||||||||
| Basic and Diluted | $ | (0.95 | ) | $ | (0.83 | ) | $ | (3.18 | ) | $ | (3.02 | ) | ||||||||
| Weighted-average number of shares used in computing net loss per share attributable to common stockholders: | ||||||||||||||||||||
| Basic and Diluted | 28,201,880 | 26,460,955 | 28,114,784 | 24,340,466 | ||||||||||||||||
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2016 Financial Results |
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Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) |
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| Quarter Ended | Year Ended | |||||||||
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| Operating expense: | ||||||||||
| GAAP operating expense | $ | 26,741 | $ | 88,515 | ||||||
| Adjustments: | ||||||||||
| Stock-based compensation | (2,969 | ) | (11,953 | ) | ||||||
| Depreciation | (377 | ) | (1,445 | ) | ||||||
| Non-GAAP operating expense | $ | 23,395 | $ | 75,117 | ||||||
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2017 Financial Guidance |
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Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) |
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| 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 | ||||||
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Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense (In thousands) |
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| 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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or
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