- Q2 revenue for the RHA® Collection of dermal fillers of
- Aesthetic accounts increased to over 2,000 from over 1,500 in the prior quarter
- Fintech payment processing volume run-rate increased to over
-
- Conference call and webcast today at
Financial Highlights
-
Revenue for the second quarter 2021 totaled
$18.8 million compared to$0.3 million for the second quarter 2020. Revenue for the six months endedJune 30, 2021 was$32.1 million compared to$0.4 million for the same period in 2020. The increase was due to sales resulting from the commercial expansion of the RHA® Collection of dermal fillers and revenue generated from the fintech platform. Revenue for the second quarter 2021 included$17.0 million of product revenue from sales of the RHA® Collection of dermal fillers,$1.4 million of collaboration revenue and$0.4 million of service revenue from the fintech platform.
-
Selling, general and administrative (SG&A) expenses for the three and six months ended
June 30, 2021 were$50.6 million and$99.6 million compared to$29.6 million and$50.8 million for the same periods in 2020, respectively, calculated in accordance withU.S. generally accepted accounting principles (“GAAP”). The increase was primarily due to sales and marketing expenses related for the RHA® Collection of dermal fillers, pre-commercial preparation activities for DaxibotulinumtoxinA for Injection and other fintech acquisition integration related expenses. SG&A expenses include depreciation and amortization and stock-based compensation. Excluding these expenses, non-GAAP SG&A expenses were$42.4 million and$83.2 million for the three and six months endedJune 30, 2021 , respectively.
-
Research and development (R&D) expenses for the three and six months ended
June 30, 2021 , were$29.4 million and$56.7 million compared to$27.1 million and$66.9 million for the same periods in 2020, respectively. Key drivers of the change were due to lower costs incurred by clinical trial and regulatory costs, offset by costs related to pre-commercial manufacturing and fintech platform development. R&D expenses include depreciation and amortization and non-cash stock-based compensation. Excluding these expenses, non-GAAP R&D expenses were$24.9 million and$48.4 million for the three and six months endedJune 30, 2021 , respectively.
-
Total operating expenses for the three and six months ended
June 30, 2021 were$89.1 million and$172.5 million compared to$57.4 million and$118.4 million for the same periods in 2020, respectively. Excluding costs of revenue, depreciation and amortization and stock-based compensation, non-GAAP operating expenses were$67.3 million and$131.6 million for the three and six months endedJune 30, 2021 , respectively.
-
Net loss for the three and six months ended
June 30, 2021 was$72.2 million and$143.8 million compared to$60.6 million and$122.5 million for the same periods in 2020, respectively.
-
Cash, cash equivalents and short-term investments as of
June 30, 2021 were$336.3 million .
“We are pleased to deliver our third consecutive quarter of growth, highlighted by the
Foley continued, “The FDA initiated their pre-approval inspection of our manufacturing facility in June, and we continue to anticipate approval of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines in 2021. We are actively preparing for the launch and once approved, expect DaxibotulinumtoxinA for Injection to underpin our aesthetics franchise and set the standard for neuromodulator performance in therapeutic indications. In the second half of this year, we look forward to the topline results from our
Second Quarter Highlights and Subsequent Updates
Aesthetics Franchise
-
RHA® Collection revenue totaled
$17.0 million for the second quarter 2021. Strong sales were driven by increased account penetration, supported by seasonality patterns and continued strength in the aesthetics market. The number of aesthetic accounts across the RHA® Collection and the fintech platform increased from over 1,500 in the first quarter to over 2,000 in the second quarter.
-
Fintech payment processing volume run-rate increased to over
$500 million in the second quarter 2021. The increase in processing volume run-rate was driven by account penetration and a more streamlined sales and customer acquisition process.
- Payment facilitator (PayFac) integration for the next-generation fintech platform. The company completed PayFac integration for its next-generation fintech platform and is currently in the process of beta testing the new platform which is expected to be launched in the fourth quarter 2021.
-
Status of the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection in the treatment of glabellar lines. Consistent with the company’s previous disclosure on the status of the pre-approval inspection, the FDA initiated the inspection of the company’s manufacturing facility in
June 2021 . Revance continues to anticipate receiving approval for DaxibotulinumtoxinA for Injection in 2021 and is actively building inventory and preparing for commercial launch.
-
Expanded leadership in aesthetic fintech services segment. Subsequent to the quarter-end and as part of the company’s commitment to continue developing and innovating its aesthetics services offering, the company appointed
Käthe Anchel as the General Manager of Financial Services.Ms. Anchel brings over 20 years of experience in designing and building successful consumer products in payments, eCommerce, and financial services at leading companies includingUmpqua Bank , Citigroup and PayPal.
Corporate Highlights
-
Advancement in international partnership with
Shanghai Fosun Pharmaceutical Industrial Development Co. (Fosun Pharma Industrial ). In April, the company announced thatFosun Pharma Industrial enrolled their first patients in two separate Phase 3 trials of DaxibotulinumtoxinA for Injection inChina for the potential treatment of glabellar lines and cervical dystonia.
-
Expanded leadership in therapeutics franchise. As a result of the company’s progress in its clinical trial programs, including the successful completion of the
ASPEN -1 Phase 3 trial of DaxibotulinumtoxinA for Injection in cervical dystonia, the company continued to strengthen the commercial foundation of its therapeutics franchise in preparation for launch, following approval. Subsequent to the quarter-end, the company appointedRob Bancroft as General Manager of Therapeutics.Mr. Bancroft brings more than 25 years of experience in the healthcare and life sciences industries including a strong background in the toxin space. At Allergan,Mr. Bancroft led a global pipeline development strategy for BOTOX®, laying the groundwork for expansion investments such as spasticity, migraine and neurogenic/overactive bladder. He was most recently the Chief Executive Officer of QMENTA and was also the Executive Vice President of Healthpoint Biotherapeutics.
Near-Term Milestone Expectations
Aesthetics Franchise:
- FDA approval of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines anticipated in 2021.
- The commercial launch of the company’s next-generation fintech platform in the fourth quarter 2021.
-
Our partner,
Teoxane SA , has submitted the pre-market approval application for RHA® 1 for perioral (lip) lines and anticipates FDA approval in the second half 2021.
Therapeutics Franchise:
-
Topline results from the
ASPEN -OLS Phase 3 open-label, long-term safety study of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia expected in the second half 2021.
- End-of-Phase 2 meeting with the FDA anticipated in the second half 2021 for DaxibotulinumtoxinA for Injection for the treatment of adults with upper limb spasticity.
2021 Financial Outlook
Revance reiterates its financial guidance provided in
Conference Call
Revance will host a corresponding conference call and a live webcast at
A replay of the call will be available beginning
About Revance
Revance is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing
“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
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 and meetings with respect to our drug product candidates, including with respect to DaxibotulinumtoxinA for Injection in glabellar lines and in therapeutic indications; the outcome of the FDA’s inspection of the
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 continuing delay in the FDA’s approval of the BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of observations made by the FDA during the site inspection or other reasons; 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; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, the safety, commercial acceptance and the market, competition, size and growth potential of the RHA® Collection of dermal fillers, the HintMD fintech platform and our drug product candidates, if approved; our ability to successfully commercialize the RHA® Collection of dermal fillers, the HintMD fintech platform and our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and our financial performance, including future revenue, expenses and capital requirements. 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 our 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 non-GAAP selling, general and administrative expenses, which excludes depreciation and amortization and stock-based compensation; non-GAAP R&D expense, which excludes depreciation and amortization and non-cash stock-based compensation; and total non-GAAP operating expense, which excludes costs of revenue, depreciation and amortization and stock-based compensation. 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) |
||||||||
|
|
|
|
|
|||||
|
|
2021 |
|
2020 |
|||||
|
ASSETS |
||||||||
|
CURRENT ASSETS |
|
|
|
|||||
|
Cash and cash equivalents |
$ |
167,634 |
|
|
$ |
333,558 |
|
|
|
Short-term investments |
168,662 |
|
|
102,947 |
|
|||
|
Accounts receivable, net |
641 |
|
|
1,829 |
|
|||
|
Inventories |
5,065 |
|
|
5,876 |
|
|||
|
Prepaid expenses and other current assets |
12,602 |
|
|
5,793 |
|
|||
|
Total current assets |
354,604 |
|
|
450,003 |
|
|||
|
Property and equipment, net |
21,092 |
|
|
17,499 |
|
|||
|
|
146,964 |
|
|
146,964 |
|
|||
|
Intangible assets, net |
63,655 |
|
|
71,343 |
|
|||
|
Operating lease right of use assets |
46,334 |
|
|
29,632 |
|
|||
|
Restricted cash |
3,452 |
|
|
3,445 |
|
|||
|
Other non-current assets |
4,774 |
|
|
1,334 |
|
|||
|
TOTAL ASSETS |
$ |
640,875 |
|
|
$ |
720,220 |
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
|
CURRENT LIABILITIES |
|
|
|
|||||
|
Accounts payable |
$ |
8,176 |
|
|
$ |
12,657 |
|
|
|
Accruals and other current liabilities |
31,405 |
|
|
32,938 |
|
|||
|
Deferred revenue, current |
9,862 |
|
|
7,851 |
|
|||
|
Operating lease liabilities, current |
5,646 |
|
|
4,437 |
|
|||
|
Derivative liability |
3,159 |
|
|
3,081 |
|
|||
|
Total current liabilities |
58,248 |
|
|
60,964 |
|
|||
|
Convertible senior notes |
280,003 |
|
|
180,526 |
|
|||
|
Deferred revenue, non-current |
75,113 |
|
|
77,294 |
|
|||
|
Operating lease liabilities, non-current |
41,276 |
|
|
27,146 |
|
|||
|
TOTAL LIABILITIES |
454,640 |
|
|
345,930 |
|
|||
|
STOCKHOLDERS’ EQUITY |
|
|
|
|||||
|
Convertible preferred stock, par value |
— |
|
|
— |
|
|||
|
Common stock, par value |
72 |
|
|
69 |
|
|||
|
Additional paid-in capital |
1,446,643 |
|
|
1,500,514 |
|
|||
|
Accumulated other comprehensive loss |
(2 |
) |
|
— |
|
|||
|
Accumulated deficit |
(1,260,478 |
) |
|
(1,126,293 |
) |
|||
|
TOTAL STOCKHOLDERS’ EQUITY |
186,235 |
|
|
374,290 |
|
|||
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
640,875 |
|
|
$ |
720,220 |
|
|
|
Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) |
||||||||||||||||
|
|
|
|
|
|
||||||||||||
|
|
|
Three Months Ended |
|
Six Months Ended |
||||||||||||
|
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||
|
Revenue |
|
|
|
|
|
|
|
|||||||||
|
Product revenue |
$ |
17,039 |
|
|
$ |
49 |
|
|
$ |
28,686 |
|
|
$ |
49 |
|
|
|
Collaboration revenue |
1,394 |
|
|
250 |
|
|
2,905 |
|
|
308 |
|
|||||
|
Service revenue |
371 |
|
|
— |
|
|
512 |
|
|
— |
|
|||||
|
Total revenue |
18,804 |
|
|
299 |
|
|
32,103 |
|
|
357 |
|
|||||
|
Operating expenses: |
|
|
|
|
|
|
|
|||||||||
|
Cost of product revenue (exclusive of amortization) |
5,409 |
|
|
21 |
|
|
9,626 |
|
|
21 |
|
|||||
|
Cost of service revenue (exclusive of amortization) |
17 |
|
|
— |
|
|
17 |
|
|
— |
|
|||||
|
Selling, general and administrative |
50,598 |
|
|
29,606 |
|
|
99,603 |
|
|
50,830 |
|
|||||
|
Research and development |
29,441 |
|
|
27,103 |
|
|
56,692 |
|
|
66,897 |
|
|||||
|
Amortization |
3,676 |
|
|
674 |
|
|
6,514 |
|
|
674 |
|
|||||
|
Total operating expenses |
89,141 |
|
|
57,404 |
|
|
172,452 |
|
|
118,422 |
|
|||||
|
Loss from operations |
(70,337 |
) |
|
(57,105 |
) |
|
(140,349 |
) |
|
(118,065 |
) |
|||||
|
Interest income |
85 |
|
|
964 |
|
|
182 |
|
|
2,455 |
|
|||||
|
Interest expense |
(1,569 |
) |
|
(4,256 |
) |
|
(3,129 |
) |
|
(6,404 |
) |
|||||
|
Changes in fair value of derivative liability |
(19 |
) |
|
(59 |
) |
|
(78 |
) |
|
(149 |
) |
|||||
|
Other expense, net |
(357 |
) |
|
(134 |
) |
|
(462 |
) |
|
(260 |
) |
|||||
|
Loss before income taxes |
(72,197 |
) |
|
(60,590 |
) |
|
(143,836 |
) |
|
(122,423 |
) |
|||||
|
Income tax provision |
— |
|
|
— |
|
|
— |
|
|
(100 |
) |
|||||
|
Net loss |
(72,197 |
) |
|
(60,590 |
) |
|
(143,836 |
) |
|
(122,523 |
) |
|||||
|
Unrealized gain (loss) and adjustment on securities included in net loss |
(2 |
) |
|
(407 |
) |
|
(2 |
) |
|
114 |
|
|||||
|
Comprehensive loss |
$ |
(72,199 |
) |
|
$ |
(60,997 |
) |
|
$ |
(143,838 |
) |
|
$ |
(122,409 |
) |
|
|
Basic and diluted net loss |
$ |
(72,197 |
) |
|
$ |
(60,590 |
) |
|
$ |
(143,836 |
) |
|
$ |
(122,523 |
) |
|
|
Basic and diluted net loss per share |
$ |
(1.07 |
) |
|
$ |
(1.12 |
) |
|
$ |
(2.15 |
) |
|
$ |
(2.27 |
) |
|
|
Basic and diluted weighted-average number of shares used in computing net loss per share |
67,462,413 |
|
|
54,257,320 |
|
|
67,051,902 |
|
|
54,062,678 |
|
|||||
|
Reconciliation of GAAP SG&A Expense to Non-GAAP SG&A Expense (In thousands) (Unaudited) |
||||||||
|
|
Three Months Ended |
|
Six Months Ended |
|||||
|
|
|
|
|
|||||
|
SG&A expense: |
|
|
|
|||||
|
GAAP SG&A expense |
$ |
50,598 |
|
|
$ |
99,603 |
|
|
|
Adjustments: |
|
|
|
|||||
|
Stock-based compensation |
(7,288 |
) |
|
(14,569 |
) |
|||
|
Depreciation and amortization |
(919 |
) |
|
(1,851 |
) |
|||
|
Non-GAAP SG&A expense |
$ |
42,391 |
|
|
$ |
83,183 |
|
|
|
Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense (In thousands) (Unaudited) |
||||||||
|
|
Three Months Ended |
|
Six Months Ended |
|||||
|
|
|
|
|
|||||
|
R&D expense: |
|
|
|
|||||
|
GAAP R&D expense |
$ |
29,441 |
|
|
$ |
56,692 |
|
|
|
Adjustments: |
|
|
|
|||||
|
Stock-based compensation |
(4,080 |
) |
|
(7,406 |
) |
|||
|
Depreciation and amortization |
(448 |
) |
|
(919 |
) |
|||
|
Non-GAAP R&D expense |
$ |
24,913 |
|
|
$ |
48,367 |
|
|
|
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) (Unaudited) |
||||||||
|
|
Three Months Ended |
|
Six Months Ended |
|||||
|
|
|
|
|
|||||
|
Operating expense: |
|
|
|
|||||
|
GAAP operating expense |
$ |
89,141 |
|
|
$ |
172,452 |
|
|
|
Adjustments: |
|
|
|
|||||
|
Stock-based compensation |
(11,368 |
) |
|
(21,975 |
) |
|||
|
Depreciation and amortization |
(5,043 |
) |
|
(9,284 |
) |
|||
|
Costs of revenue (exclusive of amortization) |
(5,426 |
) |
|
(9,643 |
) |
|||
|
Non-GAAP operating expense |
$ |
67,304 |
|
|
$ |
131,550 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210805005976/en/
Investors
Jessica.serra@revance.com
or
laurence@gilmartinir.com
Media
sfahy@revance.com
or
General Media:
Goodfuse:
Jenifer Slaw, 347-971-0906
jenifer.slaw@Goodfuse.com
or
Trade Media:
Nadine Tosk, 504-453-8344
nadinepr@gmail.com
Source:
