Revance Reports Fourth Quarter and Full Year 2019 Financial Results, Provides Corporate Update
- Conference call and webcast today at
Key Fourth Quarter 2019 Events and Subsequent Updates
Commercial:
-
BLA for DAXI in Glabellar Lines Accepted by FDA, PDUFA Date Announced. In February, the company received
U.S. Food and Drug Administration (FDA) notification that its Biologics License Application (BLA) for DAXI in the treatment of moderate to severe glabellar (frown) lines was accepted for review. Revance has been given a target action date under the Prescription Drug User Fee Act (PDUFA) ofNovember 25, 2020 .
-
Signed Exclusive
U.S. Distribution Agreement for FDA-Approved TEOXANE Dermal Fillers. In January, Revance entered into a distribution agreement withTEOXANE SA , making Revance the exclusive commercialization partner of the Swiss company’s modern and innovative Resilient Hyaluronic Acid® (RHA®) line of dermal fillers in theU.S. , the first and only range of FDA-approved dermal fillers indicated for the correction of dynamic facial wrinkles and folds.
Clinical:
-
Completed Enrollment in Phase 3 Cervical Dystonia Trial and Phase 2 Plantar Fasciitis Trial. In November, Revance announced the completion of enrollment of more than 300 patients in the company’s
ASPEN -1 Phase 3 clinical trial for DAXI for the treatment of cervical dystonia. Topline data from this Phase 3 trial is expected in the second half of 2020. In December, Revance enrolled the last of 155 subjects in its Phase 2 placebo-controlled clinical trial of DAXI for the management of plantar fasciitis. The company expects to report topline results from this Phase 2 trial in the second half of 2020.
- Initiated New Phase 2 Trial for Treatment of the Upper Facial Lines. In December, Revance initiated a new open-label Phase 2 trial of DAXI for treatment of upper facial lines– glabellar (frown), lateral canthal (crow’s feet), and forehead lines combined. This trial is being conducted to assess the safety and efficacy, including potential dosing and injection patterns of DAXI, covering the upper face. The company expects completion of enrollment in the first quarter, with topline results in fourth quarter of 2020.
-
Announced Publication and Presentations of SAKURA Program Results. In December, Revance announced publication in the
Journal of the American Academy of Dermatology (JAAD) of the pooled data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (SAKURA 1 and SAKURA 2) evaluating DAXI for the treatment of moderate to severe glabellar lines. In October, Revance published results from the Phase 3 studies, SAKURA 1 and SAKURA 2, in Plastic and Reconstructive Surgery (PRS), the peer reviewedJournal of the American Society of Plastic Surgeons . Also, in October, the company made three oral presentations on DAXI for glabellar lines at theAmerican Society for Dermatologic Surgery (ASDS) 2019 Annual Meeting, inChicago .
Financial:
-
Closed Public Offering of Common Stock– In January, Revance closed its underwritten public offering of 7,475,000 shares of its common stock at a price to the public of
$17.00 per share, which includes the exercise in full by the underwriters of their option to purchase 975,000 shares. The gross proceeds to the company from the offering, before deducting the underwriters’ discounts, commissions and other estimated offering expense payable by Revance, were approximately$127.1 million .
-
Closed Private Offering of Convertible Senior Notes – In February, Revance closed its offering of
$287.5 million aggregate principal amount of convertible senior notes due 2027 in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Following this financing and the close of the stock offering in January, as ofFebruary 14 , Revance had$533.3 million in cash, cash equivalents and short-term investments on a preliminary basis.
Corporate:
-
Enhanced Leadership Team. During and subsequent to the end of the fourth quarter, Revance strengthened its executive team through a number of key hires and promotions. These include: the appointment of
Mark Foley as President and Chief Executive Officer; the promotion ofDustin Sjuts to Chief Commercial Officer, Aesthetics & Therapeutics; the promotion ofAbhay Joshi to Chief Operating Officer and President of R&D and Product Operations; the promotion ofAzita Nejad to Senior Vice President, Technical Operations; and the hiring ofDwight Moxie as Senior Vice President, General Counsel & Corporate Secretary.
“With the FDA’s recent acceptance of our BLA submission for DAXI in glabellar lines, and the announcement of our distribution agreement for TEOXANE’s RHA® technology, Revance has constructed an exceptional start to what we believe will be a transformational year for the company. These milestones represent the first two of twelve potential value inflection points for our company in 2020,” said
“In addition to supporting our DAXI approval efforts, we are focused on preparing for a successful launch of the RHA® line of dermal fillers in the
Fourth Quarter and Full Year 2019 Financial Highlights
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
Near-Term Milestone Expectations
Aesthetics:
- Commercial launch of RHA®range of dermal fillers expected in 2Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study of DAXI in forehead lines expected in 2Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study of DAXI in lateral canthal lines (crow’s feet) expected in 2Q 2020.
- Completion of patient enrollment in Phase 2 open-label, dose-escalation study of DAXI in upper facial lines expected in 1Q 2020, with topline results in 4Q 2020.
-
PDUFA date of
November 25, 2020 , for potential BLA approval of DAXI in glabellar lines.
Therapeutics:
- Completion of patient enrollment in JUNIPER Phase 2 placebo-controlled, dose-ranging study of DAXI in upper limb spasticity expected in mid-year 2020.
-
Topline results from
ASPEN -1 Phase 3 placebo-controlled, parallel-group study of DAXI in cervical dystonia expected in 2H 2020.
- Topline results from Phase 2 placebo-controlled study of DAXI in plantar fasciitis expected in 2H 2020.
Biosimilar:
-
Decision by Mylan on continuation of biosimilar to BOTOX® program expected by
April 30, 2020 .
2020 Financial Outlook
Revance expects 2020 U.S. generally accepted accounting principles (“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: 2087638; 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
Resilient Hyaluronic Acid® and RHA® are 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, including our ability to receive timely approval of DAXI; 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.
|
Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) |
|
||||||
|
|
As of |
||||||
|
|
2019 |
|
2018 |
||||
|
ASSETS |
|||||||
|
CURRENT ASSETS |
|
|
|
||||
|
Cash and cash equivalents |
$ |
171,160 |
|
|
$ |
73,256 |
|
|
Short-term investments |
118,955 |
|
|
102,556 |
|
||
|
Accounts and other receivables |
— |
|
|
27,000 |
|
||
|
Prepaid expenses and other current assets |
6,487 |
|
|
5,110 |
|
||
|
Total current assets |
296,602 |
|
|
207,922 |
|
||
|
Property and equipment, net |
14,755 |
|
|
14,449 |
|
||
|
Operating lease right of use assets |
26,531 |
|
|
— |
|
||
|
Restricted cash |
730 |
|
|
730 |
|
||
|
Other non-current assets |
1,669 |
|
|
3,247 |
|
||
|
TOTAL ASSETS |
$ |
340,287 |
|
|
$ |
226,348 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|||||||
|
CURRENT LIABILITIES |
|
|
|
||||
|
Accounts payable |
$ |
8,010 |
|
|
$ |
8,434 |
|
|
Accruals and other current liabilities |
18,636 |
|
|
14,948 |
|
||
|
Deferred revenue, current portion |
7,911 |
|
|
8,588 |
|
||
|
Operating lease liabilities, current portion |
3,470 |
|
|
— |
|
||
|
Derivative liability, current |
2,952 |
|
|
— |
|
||
|
Total current liabilities |
40,979 |
|
|
31,970 |
|
||
|
Deferred revenue, net of current portion |
47,948 |
|
|
42,684 |
|
||
|
Operating lease liabilities, net of current portion |
25,870 |
|
|
— |
|
||
|
Deferred rent |
— |
|
|
3,319 |
|
||
|
Derivative liability, non-current |
— |
|
|
2,753 |
|
||
|
TOTAL LIABILITIES |
114,797 |
|
|
80,726 |
|
||
|
STOCKHOLDERS’ EQUITY |
|
|
|
||||
|
Convertible preferred stock, par value |
— |
|
|
— |
|
||
|
Common stock, par value |
52 |
|
|
37 |
|
||
|
Additional paid-in capital |
1,069,639 |
|
|
830,368 |
|
||
|
Accumulated other comprehensive income (loss) |
3 |
|
|
(8 |
) |
||
|
Accumulated deficit |
(844,204 |
) |
|
(684,775 |
) |
||
|
TOTAL STOCKHOLDERS’ EQUITY |
225,490 |
|
|
145,622 |
|
||
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
340,287 |
|
|
$ |
226,348 |
|
|
Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) |
|||||||||||||||
|
|
|
|
|
||||||||||||
|
|
Quarter Ended |
|
Year Ended |
||||||||||||
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
|
Revenue |
$ |
89 |
|
|
$ |
487 |
|
|
$ |
413 |
|
|
$ |
3,729 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
|
Research and development |
27,493 |
|
|
25,532 |
|
|
102,861 |
|
|
92,500 |
|
||||
|
General and administrative |
18,766 |
|
|
13,358 |
|
|
62,011 |
|
|
53,863 |
|
||||
|
Total operating expenses |
46,259 |
|
|
38,890 |
|
|
164,872 |
|
|
146,363 |
|
||||
|
Loss from operations |
(46,170 |
) |
|
(38,403 |
) |
|
(164,459 |
) |
|
(142,634 |
) |
||||
|
Interest income |
1,037 |
|
|
924 |
|
|
5,532 |
|
|
4,023 |
|
||||
|
Interest expense |
— |
|
|
— |
|
|
— |
|
|
(44 |
) |
||||
|
Changes in fair value of derivative liability |
(60 |
) |
|
10 |
|
|
(199 |
) |
|
(140 |
) |
||||
|
Other expense, net |
(133 |
) |
|
(147 |
) |
|
(303 |
) |
|
(773 |
) |
||||
|
Loss before income taxes |
(45,326 |
) |
|
(37,616 |
) |
|
(159,429 |
) |
|
(139,568 |
) |
||||
|
Income tax provision |
— |
|
|
(3,000 |
) |
|
— |
|
|
(3,000 |
) |
||||
|
Net loss |
(45,326 |
) |
|
(40,616 |
) |
|
(159,429 |
) |
|
(142,568 |
) |
||||
|
Unrealized gain (loss) and adjustment on securities included in net loss |
(39 |
) |
|
125 |
|
|
11 |
|
|
(8 |
) |
||||
|
Comprehensive loss |
$ |
(45,365 |
) |
|
$ |
(40,491 |
) |
|
$ |
(159,418 |
) |
|
$ |
(142,576 |
) |
|
Basic and diluted net loss |
$ |
(45,326 |
) |
|
$ |
(40,616 |
) |
|
$ |
(159,429 |
) |
|
$ |
(142,568 |
) |
|
Basic and diluted net loss per share |
$ |
(0.99 |
) |
|
$ |
(1.12 |
) |
|
$ |
(3.67 |
) |
|
$ |
(3.94 |
) |
|
Basic and diluted weighted-average number of shares used in computing net loss per share |
45,626,470 |
|
|
36,334,364 |
|
|
43,460,804 |
|
|
36,171,582 |
|
||||
|
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) (Unaudited) |
|||||||
|
|
Quarter Ended
|
|
Year Ended
|
||||
|
Operating expense: |
|
|
|
||||
|
GAAP operating expense |
$ |
46,259 |
|
|
$ |
164,872 |
|
|
Adjustments: |
|
|
|
||||
|
Stock-based compensation |
(5,040 |
) |
|
(17,922 |
) |
||
|
Depreciation |
(757 |
) |
|
(2,909 |
) |
||
|
Non-GAAP operating expense |
$ |
40,462 |
|
|
$ |
144,041 |
|
|
Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense (In thousands) (Unaudited) |
|||||||
|
|
Quarter Ended
|
|
Year Ended
|
||||
|
R&D expense: |
|
|
|
||||
|
GAAP R&D expense |
$ |
27,493 |
|
|
$ |
102,861 |
|
|
Adjustments: |
|
|
|
||||
|
Stock-based compensation |
(2,074 |
) |
|
(8,512 |
) |
||
|
Depreciation |
(514 |
) |
|
(2,039 |
) |
||
|
Non-GAAP R&D expense |
$ |
24,905 |
|
|
$ |
92,310 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200224005742/en/
INVESTORS
jherbert@revance.com
or
laurence@gilmartinir.com
MEDIA
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
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