- Q1 revenue for the RHA® Collection of dermal fillers of $11.6
million
- HintMD’s processing volume run-rate more than doubled to over
$400 million from the prior quarter
- Over 1,500 aesthetic accounts activated across products and
services at quarter-end
- Status of the U.S. Food and Drug Administration (FDA)
pre-approval inspection
- Conference call and webcast today at 4:30 p.m. ET
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
today reported financial results for the first quarter ended March
31, 2021 and provided a corporate update.
Financial Highlights
- Revenue for the first quarter 2021 totaled $13.3 million
compared to $0.1 million for the first quarter 2020. The increase
was primarily due to sales resulting from the commercial launch of
the RHA® Collection of dermal fillers and increased revenue related
to the biosimilar program. Revenue included $11.6 million of
product revenue from sales of the RHA® Collection of dermal
fillers, $1.5 million of collaboration revenue and $0.1 million of
service revenue from the HintMD platform.
- Selling, general and administrative (SG&A) expenses
for the first quarter 2021 were $49.0 million compared to $21.2
million for the first quarter 2020. The increase was primarily due
to sales and marketing expenses related for the RHA® Collection of
dermal fillers, pre-commercial activities for DaxibotulinumtoxinA
for Injection and other personnel-related expenses from integrating
HintMD. SG&A expenses include depreciation and amortization and
stock-based compensation. Excluding these expenses, non-GAAP
SG&A expenses were $40.8 million for the first quarter
2021.
- Research and development (R&D) expenses for the
first quarter 2021 were $27.3 million compared to $39.8 million for
the first quarter 2020. The decrease was primarily due to lower
clinical trial costs and regulatory costs as the company completed
multiple clinical trials in 2020, offset by costs related to
pre-commercial manufacturing and developmental efforts. R&D
expenses include depreciation and amortization and non-cash
stock-based compensation. Excluding these expenses, non-GAAP
R&D expenses were $23.5 million for the first quarter
2021.
- Total operating expenses for the first quarter 2021 were
$83.3 million compared to $61.0 million for first quarter 2020.
Excluding costs of revenue, depreciation and amortization,
stock-based compensation and in-process research and development,
non-GAAP operating expenses for the first quarter 2021 were $64.2
million.
- Net loss for the first quarter 2021 was $71.6
million.
- Cash, cash equivalents and short-term investments as of
March 31, 2021 were $386.8 million.
- Net proceeds from the issuance of approximately 0.8
million shares of common stock during the first quarter under the
company’s At-the-Market (ATM) program totaled $21.7 million. Since
the fourth quarter of 2020, a total of $90.1 million in net
proceeds have been raised on the ATM program, which has aggregate
offering price of up to $125 million.
“We are very pleased with our commercial execution in the first
quarter, particularly given the impact of COVID-19 and seasonality,
where the first quarter is traditionally a slower time of the year
for the aesthetics market. We are also encouraged by the progress
we are making in our therapeutics franchise as we begin laying the
groundwork for our first anticipated approval in the treatment of
muscle movement disorders,” said Mark Foley, President and Chief
Executive Officer. “Our FDA approval for DaxibotulinumtoxinA for
Injection for glabellar lines remains under review with a deferred
action due to COVID-related travel restrictions. We stand ready for
the pre-approval inspection of our manufacturing facility and are
actively engaging with the FDA to schedule an inspection date as
soon as possible. We continue to anticipate an approval this year
and, as we have noted before, the FDA did not indicate that there
were any other review issues beyond the pending inspection.”
Foley continued, “We remain focused on execution for the balance
of the year and believe we are well positioned for continued growth
based on our targeted launch strategy, differentiated products and
services and anticipated approval of our next-generation
neuromodulator. When combined with our efforts in therapeutics and
steady progress in our partnerships, we are encouraged by the
longer-term growth opportunities that will be available to us.”
First Quarter Highlights and Subsequent Updates
Aesthetics Franchise
- RHA® Collection revenue totaled $11.6 million for the first
quarter 2021 and $21.6 million in the first two full quarters of
commercial launch. Strong revenue growth was driven by
increased account penetration, supported by the ramp up of training
programs along with targeted influencer and digital media
campaigns. The number of aesthetic accounts across the RHA®
Collection and HintMD fintech platform totaled over 1,500 at the
end of the first quarter 2021.
- Record quarter for HintMD processing volume run-rate.
HintMD’s processing volume run-rate more than doubled to over $400
million from the prior quarter driven by increased account
penetration and a streamlined sales and customer acquisition
process.
- Biologics License Application (BLA) for DaxibotulinumtoxinA
for Injection in the treatment of glabellar lines remains under
U.S. Food and Drug Administration (FDA) review. As of the date
of this earnings press release, the FDA has not scheduled or
conducted a pre-approval inspection of the company's Northern
California manufacturing facility. The company previously announced
that the FDA did not indicate any further outstanding review issues
beyond the pending inspection. The company continues to work
closely with the FDA to schedule an inspection as soon as possible
and is building inventory of the drug product in preparation for
launch. The company will issue a press release when it receives
official communication from the FDA on the company’s inspection
timing.
Therapeutics Franchise
- Positive topline Phase 2 data from the JUNIPER study on
DaxibotulinumtoxinA for Injection for the treatment of adults with
upper limb spasticity. In February, the company announced that
the JUNIPER study delivered efficacy, safety and dosing data that
warranted advancement of the program to Phase 3.
- Strengthened commercial foundation of the therapeutics
franchise. Given 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 has begun building the commercial foundation for the
therapeutics franchise in preparation for launch, following
approval. During and subsequent to the quarter-end, the company
strengthened its therapeutics team with key hires and promotions,
including the appointment of Angela Willis as Vice President of
Market Access. Ms. Willis has more than 20 years of experience in
biopharma market access and pricing strategy across multiple
therapeutics areas including neurology, having served as the Vice
President of Market Access at Alder Pharmaceuticals (now Lundbeck
Seattle BioPharmaceuticals).
Corporate Highlights
- Advancement in international partnership with Shanghai Fosun
Pharmaceutical Industrial Development Co. (Fosun Pharma
Industrial). In April, the company announced that Fosun Pharma
Industrial enrolled their first patients in two separate Phase 3
trials of DaxibotulinumtoxinA for Injection in China, for the
potential treatment of glabellar lines and cervical dystonia.
Near-Term Milestone Expectations
Aesthetics Franchise:
- BLA approval for DaxibotulinumtoxinA for Injection in the
treatment of glabellar lines anticipated in 2021.
- The release of the next-generation HintMD fintech platform,
including the vertical integration of payment facilitation
(PayFac), planned for mid-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. RHA® 1 will be added to Revance’s
RHA® Collection offering, once approved.
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 of 2021 for DaxibotulinumtoxinA for Injection for the
treatment of adults with upper limb spasticity.
2021 Financial Outlook
Revance reiterates its financial guidance provided in February
2021. The company expects 2021 GAAP operating expenses to be $375
million to $390 million and non-GAAP operating expenses, which
exclude costs of revenue, depreciation and amortization and
stock-based compensation to be $270 million to $285 million.
Revance expects 2021 non-GAAP research and development expense to
be $95 million to $105 million. With the current cash, cash
equivalents and short-term investments, management projects that
the company is funded into 2024.
Conference Call
Revance will host a corresponding conference call and a live
webcast at 1:30 p.m. PT / 4:30 p.m. ET on May 10, 2021 to discuss
the results and provide a business and pipeline update. 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: 5082423; 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 May 10, 2021 at
4:30 p.m. PT / 7:30 p.m. ET to May 11, 2021 at 4:30 p.m. PT / 7:30
p.m. ET. To access the replay, dial (855) 859-2056 or (404)
537-3406 and reference conference ID: 5082423. The webcast will be
available in the investor relations section on the company's
website for 30 days following the completion of the call.
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. 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 U.S. regulatory approval. Revance is also evaluating
DaxibotulinumtoxinA for Injection in the full upper face, including
glabellar lines, forehead lines and crow's feet, as well as in two
therapeutic indications - cervical dystonia and adult upper limb
spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance
owns a unique portfolio of premium products and services for U.S.
aesthetics practices, including the exclusive U.S. distribution
rights to the RHA® Collection of dermal fillers, the first and only
range of FDA-approved fillers for correction of dynamic facial
wrinkles and folds, and the HintMD fintech platform, which includes
integrated smart payment, subscription and loyalty digital
services. Revance has also partnered with Viatris (formerly 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 Revance Therapeutics, Inc. Resilient Hyaluronic Acid®
and RHA® are trademarks of TEOXANE SA. BOTOX® is a registered
trademark of Allergan, Inc.
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 timing and outcome of the FDA’s
inspection of the Northern California manufacturing facility; the
rate and degree of commercial acceptance, opportunity and growth
potential of Teoxane’s RHA® Collection of dermal fillers and the
HintMD fintech platform, and our product candidates, if approved;
the growth opportunities available to the company; the ability and
timing for our partner, Teoxane SA, to obtain FDA approval for RHA®
1 for perioral (lip) lines; 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;
the timing of the release of the next-generation HintMD fintech
platform; development of a biosimilar to BOTOX® with our partner,
Viatris; the progress of our international partnerships; statements
about our business strategy, timeline and other goals, 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 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 delays in the site inspection
conducted of our manufacturing facility due to COVID-19-related
policies and travel restrictions currently in place at the FDA,
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 Securities and Exchange
Commission (SEC), including factors described in the section
entitled "Risks Factors" on our Form 10-K filed with the SEC on
February 25, 2021 and including, without limitation, our Form 10-Q
for the quarter ended March 31, 2021, expected to be filed with the
SEC on May 10, 2021. The forward-looking statements in this press
release speak only as of the date hereof. We disclaim any
obligation to update these forward-looking statements.
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, stock-based
compensation and 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.
REVANCE THERAPEUTICS,
INC.
Condensed Consolidated Balance
Sheets
(In thousands, except share
and per share amounts)
(Unaudited)
March 31,
December 31,
2021
2020
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
249,427
$
333,558
Short-term investments
137,386
102,947
Accounts and other receivables, net
5,186
1,829
Inventories
5,629
5,876
Prepaid expenses and other current
assets
8,799
5,793
Total current assets
406,427
450,003
Property and equipment, net
20,766
17,499
Goodwill
146,964
146,964
Intangible assets, net
67,837
71,343
Operating lease right of use assets
28,779
29,632
Restricted cash
3,445
3,445
Other non-current assets
1,729
1,334
TOTAL ASSETS
$
675,947
$
720,220
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable
$
7,079
$
12,657
Accruals and other current liabilities
27,101
32,938
Deferred revenue, current portion
9,046
7,851
Operating lease liabilities, current
portion
4,472
4,437
Derivative liability
3,140
3,081
Total current liabilities
50,838
60,964
Convertible senior notes
279,694
180,526
Deferred revenue, net of current
portion
74,967
77,294
Operating lease liabilities, net of
current portion
26,201
27,146
TOTAL LIABILITIES
431,700
345,930
STOCKHOLDERS’ EQUITY
Convertible preferred stock, par value
$0.001 per share — 5,000,000 shares authorized, and no shares
issued and outstanding as of March 31, 2021 and December 31,
2020
—
—
Common stock, par value $0.001 per share —
95,000,000 shares authorized both as of March 31, 2021 and December
31, 2020; 71,411,389 and 69,178,666 shares issued and outstanding
as of March 31, 2021 and December 31, 2020, respectively
71
69
Additional paid-in capital
1,432,457
1,500,514
Accumulated deficit
(1,188,281
)
(1,126,293
)
TOTAL STOCKHOLDERS’ EQUITY
244,247
374,290
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
675,947
$
720,220
REVANCE THERAPEUTICS,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except share
and per share amounts)
(Unaudited)
Three Months Ended March
31,
2021
2020
Revenue:
Product revenue
$
11,647
$
—
Collaboration revenue
1,511
58
Service revenue
141
—
Total Revenue
13,299
58
Operating expenses:
Cost of product revenue (exclusive of
amortization)
4,217
—
Cost of service revenue (exclusive of
amortization)
—
—
Selling, general and administrative
49,005
21,224
Research and development
27,251
39,794
Amortization
2,838
—
Total operating expenses
83,311
61,018
Loss from operations
(70,012
)
(60,960
)
Interest income
97
1,491
Interest expense
(1,560
)
(2,148
)
Changes in fair value of derivative
liability
(59
)
(90
)
Other expense, net
(105
)
(126
)
Loss before income taxes
(71,639
)
(61,833
)
Income tax provision
—
(100
)
Net loss
(71,639
)
(61,933
)
Unrealized gain and adjustment on
securities included in net loss
—
521
Comprehensive loss
$
(71,639
)
$
(61,412
)
Basic and diluted net loss
$
(71,639
)
$
(61,933
)
Basic and diluted net loss per share
$
(1.08
)
$
(1.15
)
Basic and diluted weighted-average number
of shares used in computing net loss per share
66,636,830
53,868,036
REVANCE THERAPEUTICS,
INC.
Reconciliation of GAAP
SG&A Expense to Non-GAAP SG&A Expense
(In thousands)
(Unaudited)
Three Months Ended
March 31, 2021
SG&A expense:
GAAP SG&A expense
$
49,005
Adjustments:
Stock-based compensation
(7,281
)
Depreciation and amortization
(932
)
Non-GAAP SG&A expense
$
40,792
REVANCE THERAPEUTICS,
INC.
Reconciliation of GAAP R&D
Expense to Non-GAAP R&D Expense
(In thousands)
(Unaudited)
Three Months Ended
March 31, 2021
R&D expense:
GAAP R&D expense
$
27,251
Adjustments:
Stock-based compensation
(3,326)
Depreciation and amortization
(471)
Non-GAAP R&D expense
$
23,454
REVANCE THERAPEUTICS,
INC.
Reconciliation of GAAP
Operating Expense to Non-GAAP Operating Expense
(In thousands)
(Unaudited)
Three Months Ended
March 31, 2021
Operating expense:
GAAP operating expense
$
83,311
Adjustments:
Stock-based compensation
(10,607)
Depreciation and amortization
(4,241)
Costs of revenue (exclusive of
amortization)
(4,217)
Non-GAAP operating expense
$
64,246
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210510005766/en/
Investors Revance Therapeutics, Inc.: Jessica Serra,
626-589-1007 Jessica.serra@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: Goodfuse: Jenifer Slaw,
347-971-0906 jenifer.slaw@Goodfuse.com or Trade Media: Nadine Tosk,
504-453-8344 nadinepr@gmail.com
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