– Conference call and webcast today at
Third Quarter 2019 and Subsequent Updates
-
Board Appointed Mark J. Foley as President and Chief Executive Officer (CEO). In October, Revance announced that
Mark Foley had assumed the role of President and CEO, having served on theRevance Board for the prior two years. He brings more than 25 years of operational and investment experience in the healthcare arena. Previously, Mr. Foley served as Chairman, President and CEO of ZELTIQ Aesthetics from 2012 to 2017, where he led the company through a period of significant transformation and growth, culminating in its acquisition byAllergan .
-
BLA On Track for Submission in
November 2019 . Revance plans to submit its Biologics License Application (BLA) to theU.S. Food and Drug Administration (FDA ) for DaxibotulinumtoxinA for Injection (DAXI) for the treatment of glabellar lines inNovember 2019 .
- Enrollment Now Complete in Phase 2 Trials for DAXI in Both Forehead Lines and Lateral Canthal Lines. In July, Revance completed enrollment in its Phase 2 clinical trial of DAXI for forehead lines. In August, the company also completed enrollment in its Phase 2 trial of DAXI in lateral canthal lines (crow’s feet). Topline results for both trials are expected in the first half of 2020.
-
Completed Enrollment in
ASPEN -1 Phase 3 Trial of DAXI in Cervical Dystonia. Today, Revance announced completion of enrollment in the company’sASPEN -1 Phase 3 clinical trial for DAXI for the treatment of cervical dystonia (CD). In total, 301 adult patients were enrolled at 60 sites across the U.S.,Canada andEurope . Topline data from this Phase 3 trial is expected in the second half of 2020.
“Revance is entering a pivotal period, given the large number of value-inflection points we have created for the company, beginning in just a few weeks with the anticipated submission of our first BLA for DAXI with the FDA,” said
Financial Highlights
Cash, cash equivalents and short-term investments as of
Revenue for the quarter ended
Research and development expenses for the three and nine months ended
General and administrative expenses for the three and nine months ended
Total operating expenses for the three and nine months ended
Net loss for the three and nine months ended
Near-Term Milestone Expectations
Aesthetics:
-
Submission of a Biologics License Application (BLA) to the
FDA for DAXI for the treatment of glabellar (frown) lines inNovember 2019 . - Topline results from Phase 2 study of DAXI in forehead lines expected in 1H 2020.
- Topline results from Phase 2 study of DAXI in lateral canthal lines (crow’s feet) expected in 1H 2020.
Therapeutics:
- Completion of patient enrollment in Phase 2 plantar fasciitis study expected in 4Q 2019.
- Completion of patient enrollment in Phase 2 upper limb spasticity study expected in 1H 2020.
- Topline results from Phase 3 study of DAXI in cervical dystonia expected in 2H 2020.
- Topline results from Phase 2 study of DAXI in plantar fasciitis expected in 2H 2020.
2019 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: 3774965; 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
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. Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) |
||||||||||||
|
|
September 30, |
|
|
December 31, |
|||||||
|
|
|
2019 |
|
|
2018 |
||||||
ASSETS |
||||||||||||
CURRENT ASSETS |
|
|
|
|||||||||
Cash and cash equivalents |
$ |
58,922 |
|
|
$ |
73,256 |
|
|||||
Short-term investments |
150,110 |
|
|
102,556 |
|
|||||||
Accounts receivable |
5,000 |
|
|
27,000 |
|
|||||||
Prepaid expenses and other current assets |
6,536 |
|
|
5,110 |
|
|||||||
Total current assets |
220,568 |
|
|
207,922 |
|
|||||||
Property and equipment, net |
14,917 |
|
|
14,449 |
|
|||||||
Operating lease right of use assets |
27,078 |
|
|
— |
|
|||||||
Restricted cash |
730 |
|
|
730 |
|
|||||||
Other non-current assets |
2,519 |
|
|
3,247 |
|
|||||||
TOTAL ASSETS |
$ |
265,812 |
|
|
$ |
226,348 |
|
|||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||||||
CURRENT LIABILITIES |
|
|
|
|||||||||
Accounts payable |
$ |
6,902 |
|
|
$ |
8,434 |
|
|||||
Accruals and other current liabilities |
18,694 |
|
|
14,948 |
|
|||||||
Deferred revenue, current portion |
5,241 |
|
|
8,588 |
|
|||||||
Operating lease liabilities, current portion |
3,317 |
|
|
— |
|
|||||||
Total current liabilities |
34,154 |
|
|
31,970 |
|
|||||||
Derivative liability associated with the Medicis settlement |
2,892 |
|
|
2,753 |
|
|||||||
Deferred revenue, net of current portion |
50,707 |
|
|
42,684 |
|
|||||||
Operating lease liabilities, net of current portion |
26,778 |
|
|
— |
|
|||||||
Deferred rent |
— |
|
|
3,319 |
|
|||||||
TOTAL LIABILITIES |
114,531 |
|
|
80,726 |
|
|||||||
STOCKHOLDERS’ EQUITY |
|
|
|
|||||||||
Convertible preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of September 30, 2019 and December 31, 2018 |
— |
|
|
— |
|
|||||||
Common stock, par value $0.001 per share — 95,000,000 shares authorized as of September 30, 2019 and December 31, 2018; 44,108,407 and 36,975,203 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively |
44 |
|
|
37 |
|
|||||||
Additional paid-in capital |
950,073 |
|
|
830,368 |
|
|||||||
Accumulated other comprehensive income (loss) |
42 |
|
|
(8 |
) |
|||||||
Accumulated deficit |
(798,878 |
) |
|
(684,775 |
) |
|||||||
TOTAL STOCKHOLDERS’ EQUITY |
151,281 |
|
|
145,622 |
|
|||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
265,812 |
|
|
$ |
226,348 |
|
|||||
REVANCE THERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) |
||||||||||||||||
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|||||||||||||
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Revenue |
$ |
46 |
|
|
$ |
2,362 |
|
|
$ |
324 |
|
|
$ |
3,242 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|||||||||
Research and development |
25,847 |
|
|
21,848 |
|
|
75,368 |
|
|
66,968 |
|
|||||
General and administrative |
16,739 |
|
|
14,155 |
|
|
43,245 |
|
|
40,505 |
|
|||||
Total operating expenses |
42,586 |
|
|
36,003 |
|
|
118,613 |
|
|
107,473 |
|
|||||
Loss from operations |
(42,540 |
) |
|
(33,641 |
) |
|
(118,289 |
) |
|
(104,231 |
) |
|||||
Interest income |
1,329 |
|
|
996 |
|
|
4,495 |
|
|
3,099 |
|
|||||
Interest expense |
— |
|
|
— |
|
|
— |
|
|
(44 |
) |
|||||
Change in fair value of derivative liability associated with the Medicis settlement |
(68 |
) |
|
(45 |
) |
|
(139 |
) |
|
(150 |
) |
|||||
Other expense, net |
(130 |
) |
|
(144 |
) |
|
(170 |
) |
|
(626 |
) |
|||||
Net loss |
(41,409 |
) |
|
(32,834 |
) |
|
(114,103 |
) |
|
(101,952 |
) |
|||||
Unrealized gain (loss) and adjustment on securities included in net loss |
(74 |
) |
|
90 |
|
|
50 |
|
|
(133 |
) |
|||||
Comprehensive loss |
$ |
(41,483 |
) |
|
$ |
(32,744 |
) |
|
$ |
(114,053 |
) |
|
$ |
(102,085 |
) |
|
Basic and diluted net loss |
$ |
(41,409 |
) |
|
$ |
(32,834 |
) |
|
$ |
(114,103 |
) |
|
$ |
(101,952 |
) |
|
Basic and diluted net loss per share |
$ |
(0.96 |
) |
|
$ |
(0.91 |
) |
|
$ |
(2.67 |
) |
|
$ |
(2.82 |
) |
|
Basic and diluted weighted-average number of shares used in computing net loss per share |
43,314,831 |
|
|
36,272,445 |
|
|
42,730,983 |
|
|
36,116,745 |
|
|||||
REVANCE THERAPEUTICS, INC. Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) (Unaudited) |
||||||||
|
Three Months Ended September 30, 2019 |
|
Nine Months Ended September 30, 2019 |
|||||
Operating expense: |
|
|
|
|||||
GAAP operating expense |
$ |
42,586 |
|
|
$ |
118,613 |
|
|
Adjustments: |
|
|
|
|||||
Stock-based compensation |
(4,303 |
) |
|
(12,882 |
) |
|||
Depreciation |
(734 |
) |
|
(2,152 |
) |
|||
Non-GAAP operating expense |
$ |
37,549 |
|
|
$ |
103,579 |
|
|
REVANCE THERAPEUTICS, INC. Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense (In thousands) (Unaudited) |
||||||||
|
Three Months Ended September 30, 2019 |
|
Nine Months Ended September 30, 2019 |
|||||
R&D expense |
|
|
|
|||||
GAAP R&D expense |
$ |
25,847 |
|
|
$ |
75,368 |
|
|
Adjustments: |
|
|
|
|||||
Stock-based compensation |
(2,106 |
) |
|
(6,438 |
) |
|||
Depreciation |
(492 |
) |
|
(1,525 |
) |
|||
Non-GAAP R&D expense |
$ |
23,249 |
|
|
$ |
67,405 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20191104005237/en/
Source:
INVESTORS
Revance Therapeutics, Inc.:
Jeanie Herbert, 714-325-3584
jherbert@revance.com
or
Gilmartin Group, LLC.:
Laurence Watts, 619-916-7620
laurence@gilmartinir.com
MEDIA
Revance Therapeutics, Inc.:
Sara Fahy, 949-887-4476
sfahy@revance.com
or
General Media:
Y&R:
Jenifer Slaw, 347-971-0906
jenifer.slaw@YR.com
or
Trade Media:
Nadine Tosk, 504-453-8344
nadinepr@gmail.com