- Conference call and webcast today at
Third Quarter 2020 and Subsequent Updates
Revance Aesthetics
-
Company’s
First Commercial Quarter – Successfully Launched Prestige Aesthetics Portfolio with the RHA® Collection of Dermal Fillers and HintMD Platform. In August, Revance announced that the company’s field force was established and would begin introducing its prestige Revance Aesthetics portfolio. In September, Revance began selling the RHA® Collection of dermal fillers and the HintMD financial technology (fintech) platform in select accounts in theU.S. , with initial launch activities generating$3.0 million in revenues in the third quarter.
-
Due to COVID-Related Travel Restrictions, Required Inspection of the Revance Manufacturing Site by the
U.S. Food and Drug Administration (FDA) has Not Been Scheduled. Today, Revance disclosed that, with 16 days left before its Prescription Drug User Fee Act (PDUFA) action date ofNovember 25, 2020 , the FDA has not scheduled a manufacturing site inspection related to the company’s Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar (frown) lines. The FDA has indicated that an inspection of theNewark, Calif. manufacturing site will be required prior to approval. Revance continues to work proactively with the FDA to secure an inspection at the earliest possible time.
-
Announced Two
Peer-Reviewed Publications Reporting Safety and Efficacy Results from the SAKURA 3 Open-Label Safety Study in Dermatologic Surgery. In August, Revance announced the publication of two separate peer-reviewed articles in Dermatologic Surgery, the official journal of theAmerican Society for Dermatologic Surgery (ASDS). The two peer-reviewed publications reported efficacy data as well as detailed safety results from the SAKURA 3 Phase 3 open-label, long-term safety study.
-
Presented Three New Abstracts Evaluating DaxibotulinumtoxinA for Injection and Two ePosters Evaluating the RHA® Collection During the
American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting. In October, Revance presented three new abstracts and two ePoster results at theAmerican Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting. Presented data showcased novel findings from the SAKURA Phase 3 program evaluating DaxibotulinumtoxinA for Injection for the treatment of moderate or severe glabellar (frown) lines, as well as a 4-week interim analysis from the Phase 2a open-label study for the treatment of moderate to severe lateral canthal lines (LCL), commonly known as crow’s feet lines. The ePosters focused on the unique properties of the RHA® Collection of hyaluronic acid-based dermal fillers.
-
Announced Positive Results from
ASPEN -1 Phase 3 Trial of DaxibotulinumtoxinA for Injection in Cervical Dystonia. In October, Revance announced positive topline results from itsASPEN -1 Phase 3 randomized, double-blind, placebo-controlled, parallel group clinical trial for its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia, a chronic and debilitating neurologic condition affecting the muscles of the neck. This pivotal study, which enrolled a total of 301 subjects at 60 sites in theU.S. ,Canada andEurope , met the primary and secondary endpoints for both 125- and 250-Unit doses with high statistical significance. The 125-Unit dose delivered a median duration of 24 weeks. The drug was generally safe and well-tolerated at both doses, with an encouraging safety profile.
- Reported Topline Results from Phase 2 Plantar Fasciitis Trial. Today, Revance reported results from its Phase 2 prospective, randomized, double-blind, multi-center, placebo-controlled trial evaluating the safety and efficacy for two doses of DaxibotulinumtoxinA for Injection for the treatment of plantar fasciitis. Although both doses demonstrated pain relief on the Numeric Pain Rating Scale that was numerically greater from the baseline than placebo, neither was statistically significant. As such, Revance will focus its efforts on indications for muscle movement and pain disorder indications where the use of neuromodulators is well-established.
“The third quarter of 2020 marked a significant milestone in the company’s history as Revance successfully transitioned to a fully integrated commercial enterprise. I am very pleased with the positive, early market feedback on our RHA® Collection of dermal fillers and HintMD fintech platform. We have assembled a portfolio of differentiated and unique assets for our aesthetics franchise and we believe we have the right commercial team and strategy for success,” said
“During the quarter, we also announced positive Phase 3 results from our
“Finally, today, we shared that the FDA has not yet scheduled a site inspection at our
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
Selling, 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:
-
PDUFA date of
November 25, 2020 , for potential FDA approval of DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar (frown) lines. However, this timing may be delayed as the FDA has not yet scheduled a site inspection at ourNewark, CA manufacturing facility as part of our BLA submission. -
Topline results from Phase 2 open-label, dose-escalation study of DaxibotulinumtoxinA for Injection in upper facial lines expected in
December 2020 .
Therapeutics:
- Topline results from JUNIPER Phase 2 placebo-controlled, dose-ranging study of DaxibotulinumtoxinA for Injection in upper limb spasticity expected first quarter 2021.
-
Topline results from the companion
ASPEN -OLS Phase 3 open-label, long-term safety trial, expected in 2021.
2020 Financial Outlook
Revance expects GAAP (
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: 4467177; 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
To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for
Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered trademarks of
RHA resilient hyaluronic acid® and RHA® are trademarks of
BOTOX® is a registered trademark of
Forward-Looking Statements
Any statements in this press release that are not statements of historical fact, including statements related to Revance’s financial outlook, milestone expectations, expected cash runway and financial performance; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and the expected PDUFA date; the rate and degree of commercial acceptance, opportunity and growth potential of Teoxane’s RHA® Collection of dermal fillers and the HintMD payments platform, and our product candidates, if approved; the process and timing of, and ability to complete, the current and anticipated future clinical development of our product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; and potential benefits of our drug product candidates and our technologies, including the RHA® Collection of dermal fillers and HintMD fintech platform, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including the potential delay in the anticipated PDUFA target action date for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines due to COVID-19-related policies and travel restrictions currently in place at the FDA; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, clinical trials and other aspects of our business; our ability to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process, including the risk that the top-line results from 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 costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs. Revance excludes costs of revenue, 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.
Certain non-GAAP measures included in this report were not reconciled to the comparable GAAP financial measures because the GAAP measures are not accessible on a forward-looking basis. The company is unable to reconcile these forward-looking non-GAAP financial measures to the most directly comparable GAAP measures without unreasonable efforts because the company is currently unable to predict with a reasonable degree of certainty the type and extent of certain items that would be expected to impact GAAP measures for these periods but would not impact the non-GAAP measures. Such items include costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs. The unavailable information could have a significant impact on the company’s GAAP financial results.
|
|||||||||
Condensed Consolidated Balance Sheets |
|||||||||
(In thousands, except share and per share amounts) |
|||||||||
(Unaudited) |
|||||||||
|
|
|
|
||||||
|
2020 |
|
|
2019 |
|
||||
ASSETS |
|||||||||
CURRENT ASSETS |
|
|
|
||||||
Cash and cash equivalents |
$ |
339,439 |
|
|
|
$ |
171,160 |
|
|
Short-term investments |
96,392 |
|
|
|
118,955 |
|
|
||
Accounts and other receivable |
2,585 |
|
|
|
— |
|
|
||
Inventories |
3,976 |
|
|
|
— |
|
|
||
Prepaid expenses and other current assets |
7,713 |
|
|
|
6,487 |
|
|
||
Total current assets |
450,105 |
|
|
|
296,602 |
|
|
||
Property and equipment, net |
14,843 |
|
|
|
14,755 |
|
|
||
|
144,505 |
|
|
|
— |
|
|
||
Intangible assets, net |
74,849 |
|
|
|
— |
|
|
||
Operating lease right of use assets |
25,446 |
|
|
|
26,531 |
|
|
||
Restricted cash |
1,245 |
|
|
|
730 |
|
|
||
Other non-current assets |
1,154 |
|
|
|
1,669 |
|
|
||
TOTAL ASSETS |
$ |
712,147 |
|
|
|
$ |
340,287 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|||||||||
CURRENT LIABILITIES |
|
|
|
||||||
Accounts payable |
$ |
7,860 |
|
|
|
$ |
8,010 |
|
|
Accruals and other current liabilities |
37,659 |
|
|
|
18,636 |
|
|
||
Deferred revenue, current portion |
10,931 |
|
|
|
7,911 |
|
|
||
Operating lease liabilities, current portion |
4,040 |
|
|
|
3,470 |
|
|
||
Derivative liability |
3,163 |
|
|
|
2,952 |
|
|
||
Total current liabilities |
63,653 |
|
|
|
40,979 |
|
|
||
Convertible senior notes |
177,377 |
|
|
|
— |
|
|
||
Deferred revenue, net of current portion |
74,811 |
|
|
|
47,948 |
|
|
||
Operating lease liabilities, net of current portion |
23,453 |
|
|
|
25,870 |
|
|
||
TOTAL LIABILITIES |
339,294 |
|
|
|
114,797 |
|
|
||
STOCKHOLDERS’ EQUITY |
|
|
|
||||||
Convertible preferred stock, par value |
— |
|
|
|
— |
|
|
||
Common stock, par value |
67 |
|
|
|
52 |
|
|
||
Additional paid-in capital |
1,420,770 |
|
|
|
1,069,639 |
|
|
||
Accumulated other comprehensive income |
— |
|
|
|
3 |
|
|
||
Accumulated deficit |
(1,047,984 |
) |
|
|
(844,204 |
) |
|
||
TOTAL STOCKHOLDERS’ EQUITY |
372,853 |
|
|
|
225,490 |
|
|
||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
712,147 |
|
|
|
$ |
340,287 |
|
|
|
|
|||||||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss |
|||||||||||||||||||
(In thousands, except share and per share amounts) |
|||||||||||||||||||
(Unaudited) |
|||||||||||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||||||
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
||||||||
Revenue: |
|
|
|
|
|
|
|
||||||||||||
Product revenue |
$ |
2,819 |
|
|
|
$ |
— |
|
|
|
$ |
2,868 |
|
|
|
$ |
— |
|
|
Collaboration revenue |
808 |
|
|
|
46 |
|
|
|
1,116 |
|
|
|
324 |
|
|
||||
Service revenue |
208 |
|
|
|
— |
|
|
|
208 |
|
|
|
— |
|
|
||||
Total revenue |
3,835 |
|
|
|
46 |
|
|
|
4,192 |
|
|
|
324 |
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
||||||||||||
Cost of product revenue (exclusive of amortization) |
1,081 |
|
|
|
— |
|
|
|
1,102 |
|
|
|
— |
|
|
||||
Cost of service revenue (exclusive of amortization) |
4 |
|
|
|
— |
|
|
|
4 |
|
|
|
— |
|
|
||||
Research and development |
29,130 |
|
|
|
25,847 |
|
|
|
96,027 |
|
|
|
75,368 |
|
|
||||
Selling, general and administrative |
48,183 |
|
|
|
16,739 |
|
|
|
99,013 |
|
|
|
43,245 |
|
|
||||
Amortization |
2,565 |
|
|
|
— |
|
|
|
3,239 |
|
|
|
— |
|
|
||||
Total operating expenses |
80,963 |
|
|
|
42,586 |
|
|
|
199,385 |
|
|
|
118,613 |
|
|
||||
Loss from operations |
(77,128 |
) |
|
|
(42,540 |
) |
|
|
(195,193 |
) |
|
|
(118,289 |
) |
|
||||
Interest income |
413 |
|
|
|
1,329 |
|
|
|
2,868 |
|
|
|
4,495 |
|
|
||||
Interest expense |
(4,334 |
) |
|
|
— |
|
|
|
(10,738 |
) |
|
|
— |
|
|
||||
Changes in fair value of derivative liability |
(62 |
) |
|
|
(68 |
) |
|
|
(211 |
) |
|
|
(139 |
) |
|
||||
Other expense, net |
(146 |
) |
|
|
(130 |
) |
|
|
(406 |
) |
|
|
(170 |
) |
|
||||
Loss before income taxes |
(81,257 |
) |
|
|
(41,409 |
) |
|
|
(203,680 |
) |
|
|
(114,103 |
) |
|
||||
Income tax provision |
— |
|
|
|
— |
|
|
|
(100 |
) |
|
|
— |
|
|
||||
Net loss |
(81,257 |
) |
|
|
(41,409 |
) |
|
|
(203,780 |
) |
|
|
(114,103 |
) |
|
||||
Unrealized gain (loss) and adjustment on securities included in net loss |
(117 |
) |
|
|
(74 |
) |
|
|
(3 |
) |
|
|
50 |
|
|
||||
Comprehensive loss |
$ |
(81,374 |
) |
|
|
$ |
(41,483 |
) |
|
|
$ |
(203,783 |
) |
|
|
$ |
(114,053 |
) |
|
Basic and diluted net loss |
$ |
(81,257 |
) |
|
|
$ |
(41,409 |
) |
|
|
$ |
(203,780 |
) |
|
|
$ |
(114,103 |
) |
|
Basic and diluted net loss per share |
$ |
(1.34 |
) |
|
|
$ |
(0.96 |
) |
|
|
$ |
(3.62 |
) |
|
|
$ |
(2.67 |
) |
|
Basic and diluted weighted-average number of shares used in computing net loss per share |
60,526,740 |
43,314,831 |
56,233,093 |
42,730,983 |
|
||||||||||||||
|
|||||||||
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense |
|||||||||
(In thousands) |
|||||||||
(Unaudited) |
|||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||
|
|
|
|
||||||
Operating expense: |
|
|
|
||||||
GAAP operating expense |
$ |
80,963 |
|
|
|
$ |
199,385 |
|
|
Adjustments: |
|
|
|
||||||
In-process research and development |
— |
|
|
|
(11,184 |
) |
|
||
Stock-based compensation |
(10,677 |
) |
|
|
(24,574 |
) |
|
||
Depreciation and amortization |
(3,779 |
) |
|
|
(5,931 |
) |
|
||
Costs of revenue (exclusive of amortization) |
(1,085 |
) |
|
|
(1,106 |
) |
|
||
Non-GAAP operating expense |
$ |
65,422 |
|
|
|
$ |
156,590 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20201109005959/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: