-Successful 2018: Positive SAKURA 3 topline data,
-On track to complete BLA submission with U.S.
-Raised approximately
Recent Highlights for DaxibotulinumtoxinA for Injection (DAXI) and Upcoming Company Milestones
- DAXI demonstrated unprecedented efficacy and duration in alleviating moderate-to-severe glabellar (frown) lines in the SAKURA 3 Phase 3 open-label, long-term safety study. DAXI consistently produced long duration and high response rates and was well tolerated in over 3,800 treatments.
-
Completed a pre-BLA meeting with the
U.S. Food and Drug Administration (FDA ) in December of 2018, and is on-track to submit a Biologics Licensing Application (BLA) in the first half of 2019 for DAXI for the treatment of glabellar (frown) lines. - Initiated two separate Phase 2 trials of DAXI for the management of plantar fasciitis, and for the treatment of adult upper limb spasticity. Expects to complete enrollment for both Phase 2 trials and its Phase 3 trial for cervical dystonia during the second half of 2019.
-
Announced license agreement with
Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. to commercialize DAXI in mainlandChina ,Hong Kong andMacau . Received upfront payment of$30 million , and is eligible to receive additional development and sales milestone payments, as well as tiered double-digit royalty payments on future net sales. -
Revance and Mylan recently had a Biosimilar Initial Advisory Meeting
with the
FDA on a proposed biosimilar to BOTOX®. In this meeting, theFDA provided guidance on their expectations for a development program to establish biosimilarity to BOTOX®. Based on the agency’s feedback, the companies believe that a 351(k) pathway for the development of a biosimilar to onabotulinumtoxinA is viable and provides the opportunity to develop and commercialize a biosimilar product for all 11 currently approved indications of BOTOX® and BOTOX® Cosmetic.
“The unprecedented results from our SAKURA Phase 3 trials for DAXI
supplied us a with comprehensive data package for our BLA submission and
provides a powerful springboard for our anticipated product launch to
treat frown lines in 2020. Based on our unique peptide technology, only
Revance is able to deliver the first true innovation in a neuromodulator
by addressing the number one unmet need desired by physicians and
patients alike -- longer duration,” said
Summary Financial Results
Cash, cash equivalents and short-term investments as
of
Revenue for the fourth quarter and full year ended
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
2019 Financial Outlook
Revance expects 2019 GAAP operating expense to be in the range of
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: 2298778; 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
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 "SEC"), including factors
described in the section entitled "Risk Factors" of our quarterly report
on Form 10-Q filed
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, stock-based compensation, and non-recurring milestone costs. Revance excludes depreciation, stock-based compensation, and non-recurring milestone costs 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. Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) |
||||||||||
| As of December 31, | ||||||||||
| 2018 | 2017 | |||||||||
| ASSETS | ||||||||||
| CURRENT ASSETS | ||||||||||
| Cash and cash equivalents | $ | 73,256 | $ | 282,896 | ||||||
| Short-term investments | 102,556 | — | ||||||||
| Accounts and other receivables | 27,000 | 48 | ||||||||
| Prepaid expenses and other current assets | 5,110 | 2,267 | ||||||||
| Total current assets | 207,922 | 285,211 | ||||||||
| Property and equipment, net | 14,449 | 9,250 | ||||||||
| Restricted cash | 730 | 580 | ||||||||
| Other non-current assets | 3,247 | 658 | ||||||||
| TOTAL ASSETS | $ | 226,348 | $ | 295,699 | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||
| CURRENT LIABILITIES | ||||||||||
| Accounts payable | $ | 8,434 | $ | 6,805 | ||||||
| Accruals and other current liabilities | 14,948 | 12,225 | ||||||||
| Deferred revenue, current portion | 8,588 | — | ||||||||
| Financing obligations | — | 1,872 | ||||||||
| Total current liabilities | 31,970 | 20,902 | ||||||||
| Derivative liability associated with the Medicis settlement | 2,753 | 2,613 | ||||||||
| Deferred revenue, net of current portion | 42,684 | — | ||||||||
| Deferred rent | 3,319 | 3,339 | ||||||||
| TOTAL LIABILITIES | 80,726 | 26,854 | ||||||||
| STOCKHOLDERS’ EQUITY | ||||||||||
| Common stock, par value $0.001 per share — 95,000,000 shares authorized both as of December 31, 2018 and 2017; 36,975,203 and 36,516,075 shares issued and outstanding as of December 31, 2018 and 2017, respectively | 37 | 37 | ||||||||
| Additional paid-in capital | 830,368 | 810,975 | ||||||||
| Accumulated other comprehensive loss | (8 | ) | — | |||||||
| Accumulated deficit | (684,775 | ) | (542,167 | ) | ||||||
| TOTAL STOCKHOLDERS’ EQUITY | 145,622 | 268,845 | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 226,348 | $ | 295,699 | ||||||
|
REVANCE THERAPEUTICS, INC. Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) |
||||||||||||||||||||
| Quarter Ended December 31, | Year Ended December 31, | |||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||||||
| Revenue | $ | 487 | $ | 37 | $ | 3,729 | $ | 262 | ||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | 25,532 | 21,004 | 92,500 | 80,361 | ||||||||||||||||
| General and administrative | 13,358 | 11,887 | 53,863 | 37,398 | ||||||||||||||||
| Loss on impairment | — | 2,927 | — | 2,927 | ||||||||||||||||
| Total operating expenses | 38,890 | 35,818 | 146,363 | 120,686 | ||||||||||||||||
| Loss from operations | (38,403 | ) | (35,781 | ) | (142,634 | ) | (120,424 | ) | ||||||||||||
| Interest income | 924 | 411 | 4,023 | 1,410 | ||||||||||||||||
| Interest expense | — | (18 | ) | (44 | ) | (457 | ) | |||||||||||||
| Changes in fair value of derivative liability associated with the Medicis settlement | 10 | (380 | ) | (140 | ) | (591 | ) | |||||||||||||
| Other expense, net | (147 | ) | (138 | ) | (773 | ) | (525 | ) | ||||||||||||
| Loss before income taxes | (37,616 | ) | (35,906 | ) | (139,568 | ) | (120,587 | ) | ||||||||||||
| Income tax provision | (3,000 | ) | — | (3,000 | ) | — | ||||||||||||||
| Net loss | (40,616 | ) | (35,906 | ) | (142,568 | ) | (120,587 | ) | ||||||||||||
| Unrealized gain (loss) and adjustment on securities included in net loss | 125 | 42 | (8 | ) | 45 | |||||||||||||||
| Comprehensive loss | $ | (40,491 | ) | $ | (35,864 | ) | $ | (142,576 | ) | $ | (120,542 | ) | ||||||||
| Basic and Diluted net loss attributable to common stockholders | $ | (40,616 | ) | $ | (35,906 | ) | $ | (142,568 | ) | $ | (120,587 | ) | ||||||||
| Basic and Diluted net loss per share attributable to common stockholders | $ | (1.12 | ) | $ | (1.14 | ) | $ | (3.94 | ) | $ | (4.01 | ) | ||||||||
| Basic and Diluted weighted-average number of shares used in computing net loss per share attributable to common stockholders | 36,334,364 | 31,580,146 | 36,171,582 | 30,101,125 | ||||||||||||||||
|
Revance Therapeutics, Inc. 2018 Financial Results Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) (Unaudited) |
|||||||||
|
Quarter Ended |
Year Ended |
||||||||
| Operating expense: | |||||||||
| GAAP operating expense | $ | 38,890 | $ | 146,363 | |||||
| Adjustments: | |||||||||
| Stock-based compensation | (3,851 | ) | (16,273 | ) | |||||
| Depreciation | (475 | ) | (1,726 | ) | |||||
| Non-recurring milestone | — | (1,000 | ) | ||||||
| Non-GAAP operating expense | $ | 34,564 | $ | 127,364 | |||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190226006075/en/
Source:
INVESTORS
Revance Therapeutics, Inc.:
Jeanie Herbert,
714-325-3584
jherbert@revance.com
or
Burns
McClellan, Inc.:
John Grimaldi, 212-213-0006
jgrimaldi@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