Recent Company Highlights and Upcoming Milestones for DaxibotulinumtoxinA for Injection (RT002):
- Expects to report the SAKURA 3 open-label, long-term safety study of RT002 for the treatment of glabellar (frown) lines in the second half of 2018.
-
On track to file a Biologics Licensing Application (BLA) with the
U.S. Food and Drug Administration (FDA) for RT002 to treat glabellar (frown) lines in first half of 2019. -
Plans to commence enrollment in the
ASPEN Phase 3 program with RT002 for the treatment of moderate to severe isolated cervical dystonia for theU.S. in the second quarter of 2018. The program is expected to include a single pivotal trial, plus an open-label trial, totaling approximately 300 patients from theU.S. ,Canada andEurope . -
Announced a collaboration and license agreement in
February 2018 withMylan Ireland Limited , on a biosimilar to BOTOX® that provided for an upfront payment of$25 million to Revance, with contingent payments upon achievement of additional clinical, regulatory and sales milestones, plus sales royalties worldwide (exceptJapan ).
"With unparalleled 6-month duration demonstrated in the SAKURA 1 and
SAKURA 2 pivotal trials, the next major RT002 milestone is the reporting
of the SAKURA 3 open-label results later this year. SAKURA 3 represents
one of the largest data sets collected with a neuromodulator for an
aesthetic indication, with at least 2,500 patients evaluated over two
years. We believe the upcoming data from SAKURA 3 will further reinforce
RT002 as first and best positioned neuromodulator to address the most
sought after improvement to currently available products-the need for
longer duration," said
Summary Financial Results
Cash, cash equivalents and investments as of March 31, 2018 were $268.8 million.
Revenue for the first quarter ended
Research and development expenses for the first quarter
ended March 31, 2018 were $22.2 million compared to
General and administrative expenses for the first quarter
ended March 31, 2018 were
Total operating expenses for the first quarter ended March 31, 2018 were $35.9 million compared to $27.2 million for the same period in 2017. Stock-based compensation for the first quarter ended March 31, 2018 was $4.2 million. When excluding depreciation and stock-based compensation, total operating expenses for the first quarter ended March 31, 2018 were $31.3 million.
Net loss for the first quarter ended March 31, 2018 was $35.0 million compared to $27.2 million for the same period in 2017.
2018 Financial Outlook
Revance reiterates its financial guidance provided in
Conference Call
Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 4580549; or from the webcast link in the investor relations section of the company's website at: www.revance.com.
A replay of the call will be available beginning May 8, 2018 at 4:30pm
PT/7:30pm ET to May 9, 2018 at 4:30pm PT/
About
"Revance Therapeutics" and the Revance logo are registered trademarks of
BOTOX is a registered trademark of
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.
|
Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) |
|||||||
|
March 31, |
|
||||||
| 2018 | 2017 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS | |||||||
| Cash and cash equivalents | $ | 69,212 | $ | 282,896 | |||
| Short-term investments | 199,594 | — | |||||
| Prepaid expenses and other current assets | 4,612 | 2,315 | |||||
| Total current assets | 273,418 | 285,211 | |||||
| Property and equipment, net | 10,064 | 9,250 | |||||
| Restricted cash | 580 | 580 | |||||
| Other non-current assets | 718 | 658 | |||||
| TOTAL ASSETS | $ | 284,780 | $ | 295,699 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| CURRENT LIABILITIES | |||||||
| Accounts payable | $ | 5,361 | $ | 6,805 | |||
| Accruals and other current liabilities | 11,120 | 12,225 | |||||
| Deferred revenue, current portion | 5,532 | — | |||||
| Financing obligations | 983 | 1,872 | |||||
| Total current liabilities | 22,996 | 20,902 | |||||
| Derivative liability associated with Medicis settlement | 2,647 | 2,613 | |||||
| Deferred revenue, net of current portion | 19,275 | — | |||||
| Deferred rent | 3,221 | 3,339 | |||||
| TOTAL LIABILITIES | 48,139 | 26,854 | |||||
| Commitments and Contingencies | |||||||
| STOCKHOLDERS' EQUITY | |||||||
|
Common stock, par value |
37 | 37 | |||||
| Additional paid-in capital | 814,084 | 810,975 | |||||
| Accumulated other comprehensive loss | (276 | ) | — | ||||
| Accumulated deficit | (577,204 | ) | (542,167 | ) | |||
| TOTAL STOCKHOLDERS' EQUITY | 236,641 | 268,845 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 284,780 | $ | 295,699 | |||
|
Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) |
||||||||
|
Three Months Ended |
||||||||
| 2018 | 2017 | |||||||
| Revenue | $ | 193 | $ | 75 | ||||
| Operating expenses: | ||||||||
| Research and development | 22,239 | 19,409 | ||||||
| General and administrative | 13,616 | 7,754 | ||||||
| Total operating expenses | 35,855 | 27,163 | ||||||
| Loss from operations | (35,662 | ) | (27,088 | ) | ||||
| Interest income | 1,022 | 311 | ||||||
| Interest expense | (44 | ) | (193 | ) | ||||
| Change in fair value of derivative liability associated with Medicis settlement | (34 | ) | (60 | ) | ||||
| Other expense, net | (319 | ) | (126 | ) | ||||
| Net loss | (35,037 | ) | (27,156 | ) | ||||
| Unrealized loss on available for sale securities | (276 | ) | (52 | ) | ||||
| Comprehensive loss | $ | (35,313 | ) | $ | (27,208 | ) | ||
| Basic and Diluted net loss attributable to common stockholders | $ | (35,037 | ) | $ | (27,156 | ) | ||
| Basic and Diluted net loss per share attributable to common stockholders | $ | (0.97 | ) | $ | (0.94 | ) | ||
| Basic and Diluted weighted-average number of shares used in computing net loss per share attributable to common stockholders | 35,950,593 | 28,808,195 | ||||||
|
2018 Financial Results
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) |
|||||
|
Quarter Ended |
|||||
| Operating expense: | |||||
| GAAP operating expense | $ | 35,855 | |||
| Adjustments: | |||||
| Stock-based compensation | (4,158 | ) | |||
| Depreciation | (390 | ) | |||
| Non-GAAP operating expense | $ | 31,307 | |||
|
2018 Financial Guidance
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) |
|||||||||
| Fiscal Year | |||||||||
| 2018 | |||||||||
| Low | High | ||||||||
| Operating expense: | |||||||||
| GAAP operating expense | $ | 128,000 | $ | 154,000 | |||||
| Adjustments: | |||||||||
| Stock-based compensation | (17,000 | ) | (21,000 | ) | |||||
| Depreciation | (1,000 | ) | (3,000 | ) | |||||
| Non-GAAP operating expense | $ | 110,000 | $ | 130,000 | |||||
|
Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense (In thousands) |
|||||||||
| Fiscal Year | |||||||||
| 2018 | |||||||||
| Low | High | ||||||||
| R&D expense: | |||||||||
| GAAP R&D expense | $ | 84,000 | $ | 101,000 | |||||
| Adjustments: | |||||||||
| Stock-based compensation | (7,000 | ) | (9,000 | ) | |||||
| Depreciation | (1,000 | ) | (2,000 | ) | |||||
| Non-GAAP R&D expense | $ | 76,000 | $ | 90,000 | |||||
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