Recent Company Highlights and Upcoming Milestones for DaxibotulinumtoxinA for Injection (RT002)
- Revance expects to complete the SAKURA 3 open-label, long-term safety study of RT002 for the treatment of glabellar (frown) lines in the fourth quarter of 2018. The Company remains on track to file its Biologics Licensing Application (BLA) for RT002 to treat glabellar (frown) lines in first half of 2019.
-
Revance initiated the ASPEN Phase 3 program with RT002 for the
treatment of moderate to severe isolated cervical dystonia for the
U.S. in June of 2018. The program includes a single pivotal trial and
an open-label safety study, each to enroll approximately 300 patients
across sites in the U.S.,
Canada andEurope . -
Announced the appointments of
Susanne Fors , Vice President, Regulatory Affairs,Conor Gallagher , Ph.D., as Head of Medical Affairs, Aesthetics, andCaryn McDowell as Senior Vice President, General Counsel & Corporate Secretary in May of 2018.
"Our clinical body of work for RT002 injectable, including the SAKURA 1
& 2 pivotal trials for the treatment of glabellar lines, supports the
potential for this product to provide patients and physicians with
unequaled, enduring performance. We look forward to the SAKURA 3
open-label safety study readout in the fourth quarter of this year,
followed by the BLA filing in the first half of 2019," said
Summary Financial Results
Cash, cash equivalents and investments as of June 30, 2018 were $233.7 million.
Revenue for the three and six months ended
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
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: 3480629; 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 August 2, 2018
at 4:30pm PT/7:30pm ET to August 3, 2018 at 4:30pm PT/
About
“Revance Therapeutics” and the Revance logo are registered trademarks 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.
|
Revance Therapeutics, Inc. Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) |
||||||||
| June 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 39,282 | $ | 282,896 | ||||
| Short-term investments | 194,452 | — | ||||||
| Prepaid expenses and other current assets | 9,148 | 2,315 | ||||||
| Total current assets | 242,882 | 285,211 | ||||||
| Property and equipment, net | 12,196 | 9,250 | ||||||
| Restricted cash | 730 | 580 | ||||||
| Other non-current assets | 3,315 | 658 | ||||||
| TOTAL ASSETS | $ | 259,123 | $ | 295,699 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 5,435 | $ | 6,805 | ||||
| Accruals and other current liabilities | 13,569 | 12,225 | ||||||
| Deferred revenue, current portion | 9,320 | — | ||||||
| Financing obligations | — | 1,872 | ||||||
| Total current liabilities | 28,324 | 20,902 | ||||||
| Derivative liability associated with Medicis settlement | 2,717 | 2,613 | ||||||
| Deferred revenue, net of current portion | 14,800 | — | ||||||
| Deferred rent | 3,427 | 3,339 | ||||||
| TOTAL LIABILITIES | 49,268 | 26,854 | ||||||
| Commitments and Contingencies | ||||||||
| STOCKHOLDERS’ EQUITY | ||||||||
|
Common stock, par value $0.001 per share — 95,000,000 shares authorized as of June 30, 2018 and December 31, 2017; 36,917,723 and 36,516,075 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively |
37 | 37 | ||||||
| Additional paid-in capital | 821,326 | 810,975 | ||||||
| Accumulated other comprehensive loss | (224 | ) | — | |||||
| Accumulated deficit | (611,284 | ) | (542,167 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 209,855 | 268,845 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 259,123 | $ | 295,699 | ||||
|
Revance Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) |
||||||||||||||||
| Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue | $ | 686 | $ | 75 | $ | 880 | $ | 150 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 22,871 | 18,307 | 45,111 | 37,714 | ||||||||||||
| General and administrative | 12,734 | 8,609 | 26,350 | 16,363 | ||||||||||||
| Total operating expenses | 35,605 | 26,916 | 71,461 | 54,077 | ||||||||||||
| Loss from operations | (34,919 | ) | (26,841 | ) | (70,581 | ) | (53,927 | ) | ||||||||
| Interest income | 1,081 | 347 | 2,103 | 658 | ||||||||||||
| Interest expense | — | (141 | ) | (44 | ) | (335 | ) | |||||||||
| Change in fair value of derivative liability associated with Medicis settlement | (70 | ) | (107 | ) | (104 | ) | (167 | ) | ||||||||
| Other expense, net | (172 | ) | (132 | ) | (492 | ) | (258 | ) | ||||||||
| Net loss | (34,080 | ) | (26,874 | ) | (69,118 | ) | (54,029 | ) | ||||||||
| Unrealized gain (loss) on available for sale securities | 52 | (17 | ) | (224 | ) | (69 | ) | |||||||||
| Comprehensive loss | $ | (34,028 | ) | $ | (26,891 | ) | $ | (69,342 | ) | $ | (54,098 | ) | ||||
| Basic and Diluted net loss attributable to common stockholders | $ | (34,080 | ) | $ | (26,874 | ) | $ | (69,118 | ) | $ | (54,029 | ) | ||||
| Basic and Diluted net loss per share attributable to common stockholders | $ | (0.94 | ) | $ | (0.90 | ) | $ | (1.92 | ) | $ | (1.84 | ) | ||||
| Basic and Diluted weighted-average number of shares used in computing net loss per share attributable to common stockholders | 36,123,659 | 29,776,893 | 36,037,604 | 29,295,220 | ||||||||||||
|
Revance Therapeutics, Inc. 2018 Financial Results Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) |
||||||||
|
Three Months |
Six Months |
|||||||
| Operating expense: | ||||||||
| GAAP operating expense | $ | 35,605 | $ | 71,461 | ||||
| Adjustments: | ||||||||
| Stock-based compensation | (4,172 | ) | (8,330 | ) | ||||
| Depreciation | (417 | ) | (807 | ) | ||||
| Non-GAAP operating expense | $ | 31,016 | $ | 62,324 | ||||
|
Revance Therapeutics, Inc. 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 | ||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20180802005791/en/
Source:
INVESTORS
Revance Therapeutics, Inc.:
Jeanie Herbert,
714-325-3584
jherbert@revance.com
or
Burns
McClellan, Inc.:
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
or
MEDIA
General
Media:
TOGORUN:
Mariann Caprino, 917-242-1087
m.caprino@togorun.com
or
Trade
Media:
Nadine Tosk, 504-453-8344
nadinepr@gmail.com