- Conference call and webcast today at
Key First Quarter 2020 and Subsequent Updates
-
BLA for DaxibotulinumtoxinA for Injection 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 DaxibotulinumtoxinA for Injection 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.
-
Provided Corporate Update in Response to COVID-19. Consistent with its COVID-19 update on
March 26 , Revance’s BLA for glabellar lines remains on track, as do topline data readouts from theASPEN -1 Phase 3 trial in cervical dystonia and Phase 2 trial in plantar fasciitis, which will occur in the second half of 2020. Additionally, the company is on schedule for second quarter 2020 readouts from its forehead lines and crow’s feet open-label Phase 2 studies. COVID-19 has, however, caused Revance to adjust the launch of its RHA® dermal filler line, and the associated hiring of field representatives, by one quarter, due to the temporary closure of Teoxane’s Swiss manufacturing facility. Additionally, the company announced a pause in enrollment of the Revance’s JUNIPER Phase 2 trial for adult upper limb spasticity. Despite these changes, the company reiterated its 2020 financial guidance, with operating expenses likely to come in at the lower end of guidance, as delayed revenue is offset by the shift in sales force hires.
-
Closed Public Offering of Common Stock and Private Offering of Convertible Senior Notes - 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. The gross proceeds to the company from the offering, before deducting the underwriters’ discounts, commissions and other offering expenses, were approximately$127.1 million . 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.
“First of all, I would like to sincerely thank all of those who are currently on the front lines of the COVID-19 pandemic. In addition, I would also like to recognize my Revance colleagues for their adaptability and resilience during these unprecedented times,” said
Financial Highlights
Cash, cash equivalents and short-term investments as of
Revenue for the quarter ended
Research and development expenses for the quarter ended
Selling, general and administrative expenses for the first quarter 2020 were
Total operating expenses for the quarter ended
Net loss for the first quarter was
Near-Term Milestone Expectations
Aesthetics:
- Commercial launch of RHA® range of dermal fillers expected in 3Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study of DaxibotulinumtoxinA for Injection in forehead lines expected in 2Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study of DaxibotulinumtoxinA for Injection in lateral canthal lines (crow’s feet) expected in 2Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study of DaxibotulinumtoxinA for Injection in upper facial lines expected in 4Q 2020.
-
PDUFA date of
November 25, 2020 , for potential FDA approval of DaxibotulinumtoxinA for Injection in glabellar lines.
Therapeutics:
-
Topline results from
ASPEN -1 Phase 3 placebo-controlled, parallel-group study of DaxibotulinumtoxinA for Injection in cervical dystonia expected in 2H 2020. - Topline results from Phase 2 placebo-controlled study of DaxibotulinumtoxinA for Injection in plantar fasciitis expected in 2H 2020.
- Patient enrollment in JUNIPER Phase 2 placebo-controlled, dose-ranging study of DaxibotulinumtoxinA for Injection in upper limb spasticity has been paused. Company will provide a new date for expected full enrollment after trial is reopened and an enrollment trajectory is established.
Biosimilar:
-
Revance expects a decision regarding whether or not Mylan plans to move forward with the biosimilar to BOTOX® program by the end of
May 2020 .
2020 Financial Outlook
Based on the impact of the COVID-19 situation on the company’s plans and operations, Revance expects 2020 U.S. generally accepted accounting principles (“GAAP”) operating expense to be at the lower end of 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: 4799936; 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
The live webcast can be accessed here and will be available in the investor relations section on the company's website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Revance requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone.
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 DaxibotulinumtoxinA for Injection; 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 and amortization, stock-based compensation, and non-cash in-process research and development costs. Revance excludes depreciation and amortization, stock-based compensation, and non-cash in-process research and development 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.
|
Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) |
|||||||
|
|
|
|
|
||||
|
|
2020 |
|
2019 |
||||
|
ASSETS |
|||||||
|
CURRENT ASSETS |
|
|
|
||||
|
Cash and cash equivalents |
$ |
286,649 |
|
|
$ |
171,160 |
|
|
Short-term investments |
224,621 |
|
|
118,955 |
|
||
|
Prepaid expenses and other current assets |
7,171 |
|
|
6,487 |
|
||
|
Total current assets |
518,441 |
|
|
296,602 |
|
||
|
Property and equipment, net |
13,967 |
|
|
14,755 |
|
||
|
Intangible assets |
32,334 |
|
|
— |
|
||
|
Operating lease right of use assets |
25,961 |
|
|
26,531 |
|
||
|
Restricted cash |
730 |
|
|
730 |
|
||
|
Other non-current assets |
1,494 |
|
|
1,669 |
|
||
|
TOTAL ASSETS |
$ |
592,927 |
|
|
$ |
340,287 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|||||||
|
CURRENT LIABILITIES |
|
|
|
||||
|
Accounts payable |
$ |
8,709 |
|
|
$ |
8,010 |
|
|
Accruals and other current liabilities |
16,178 |
|
|
18,636 |
|
||
|
Deferred revenue, current portion |
10,079 |
|
|
7,911 |
|
||
|
Operating lease liabilities, current portion |
3,627 |
|
|
3,470 |
|
||
|
Derivative liability |
3,042 |
|
|
2,952 |
|
||
|
Total current liabilities |
41,635 |
|
|
40,979 |
|
||
|
Convertible senior notes |
171,305 |
|
|
— |
|
||
|
Deferred revenue, net of current portion |
46,722 |
|
|
47,948 |
|
||
|
Operating lease liabilities, net of current portion |
24,890 |
|
|
25,870 |
|
||
|
TOTAL LIABILITIES |
284,552 |
|
|
114,797 |
|
||
|
STOCKHOLDERS’ EQUITY |
|
|
|
||||
|
Convertible preferred stock, par value |
— |
|
|
— |
|
||
|
Common stock, par value |
57 |
|
|
52 |
|
||
|
Additional paid-in capital |
1,213,931 |
|
|
1,069,639 |
|
||
|
Accumulated other comprehensive income |
524 |
|
|
3 |
|
||
|
Accumulated deficit |
(906,137 |
) |
|
(844,204 |
) |
||
|
TOTAL STOCKHOLDERS’ EQUITY |
308,375 |
|
|
225,490 |
|
||
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
592,927 |
|
|
$ |
340,287 |
|
|
Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) |
|||||||
|
|
Three Months Ended |
||||||
|
|
2020 |
|
2019 |
||||
|
Revenue |
$ |
58 |
|
|
$ |
278 |
|
|
Operating expenses: |
|
|
|
||||
|
Research and development |
39,794 |
|
|
23,995 |
|
||
|
Selling, general and administrative |
21,224 |
|
|
12,910 |
|
||
|
Total operating expenses |
61,018 |
|
|
36,905 |
|
||
|
Loss from operations |
(60,960 |
) |
|
(36,627 |
) |
||
|
Interest income |
1,491 |
|
|
1,570 |
|
||
|
Interest expense |
(2,148 |
) |
|
— |
|
||
|
Changes in fair value of derivative liability |
(90 |
) |
|
(92 |
) |
||
|
Other expense, net |
(126 |
) |
|
(155 |
) |
||
|
Loss before income taxes |
(61,833 |
) |
|
(35,304 |
) |
||
|
Income tax provision |
(100 |
) |
|
— |
|
||
|
Net loss |
(61,933 |
) |
|
(35,304 |
) |
||
|
Unrealized gain and adjustment on securities included in net loss |
521 |
|
|
78 |
|
||
|
Comprehensive loss |
$ |
(61,412 |
) |
|
$ |
(35,226 |
) |
|
Basic and diluted net loss |
$ |
(61,933 |
) |
|
$ |
(35,304 |
) |
|
Basic and diluted net loss per share |
$ |
(1.15 |
) |
|
$ |
(0.85 |
) |
|
Basic and diluted weighted-average number of shares used in computing net loss per share |
53,868,036 |
|
|
41,598,919 |
|
||
|
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) (Unaudited) |
|||
|
|
Three Months Ended |
||
|
|
|
||
|
Operating expense: |
|
||
|
GAAP operating expense |
$ |
61,018 |
|
|
Adjustments: |
|
||
|
In-process research and development |
(11,184 |
) |
|
|
Stock-based compensation |
(6,544 |
) |
|
|
Depreciation and amortization |
(739 |
) |
|
|
Non-GAAP operating expense |
$ |
42,551 |
|
|
Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense (In thousands) (Unaudited) |
|||
|
|
Three Months Ended |
||
|
|
|
||
|
R&D expense: |
|
||
|
GAAP R&D expense |
$ |
39,794 |
|
|
Adjustments: |
|
||
|
In-process research and development |
(11,184 |
) |
|
|
Stock-based compensation |
(2,442 |
) |
|
|
Depreciation and amortization |
(497 |
) |
|
|
Non-GAAP R&D expense |
$ |
25,671 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200507005947/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:
