- Q4 and full year 2022 total revenue of $49.9 million and $132.6
million, a YoY increase of 92% and 70%, respectively.
- Q4 and full year 2022 RHA® Collection revenue of $34.8 million
and $107.2 million, a YoY increase of 46% and 51%,
respectively.
- DAXXIFY® Q4 PrevU revenue of $11.0 million, with commercial
launch to begin late March 2023.
- PDUFA date for DAXXIFY® for the treatment of cervical dystonia
of August 19, 2023.
- Appointed Dr. Vlad Coric, M.D., Chairman and CEO of Biohaven,
to the company’s Board of Directors.
- Conference call and webcast today at 4:30 p.m. ET.
Revance Therapeutics, Inc. (RVNC), today reported financial
results for the fourth quarter and full year ended December 31,
2022 and provided a corporate update.
Financial Highlights
- Total revenue for the fourth quarter 2022 was $49.9
million compared to $26.0 million for the same period last year,
representing a 92% increase, primarily due to increased sales of
the RHA Collection® and sales of DAXXIFY® during the PrevU program.
Total revenue for the full year 2022 was $132.6 million compared to
$77.8 million for the full year 2021, representing a 70% increase,
primarily due to increased sales of the RHA® Collection of dermal
fillers. Total revenue for the fourth quarter included $34.8
million of RHA® Collection revenue, $11.0 million of DAXXIFY®
revenue during the PrevU program, $2.9 million of service revenue,
and $1.2 million of collaboration revenue.
- Selling, general and administrative (SG&A)
expenses for the fourth quarter and full year ended December
31, 2022 were $65.2 million and $223.9 million compared to $46.4
million and $198.8 million, respectively, for the same periods last
year, presented in accordance with U.S. generally accepted
accounting principles (“GAAP”). Excluding depreciation,
amortization and stock-based compensation, non-GAAP SG&A
expenses were $55.5 million and $183.1 million, respectively, for
the fourth quarter and full year ended December 31, 2022. The
increase on a quarterly and full year basis was primarily due to
higher sales and marketing expenses related to the RHA® Collection
and DAXXIFY®.
- Research and development (R&D) expenses for the
fourth quarter and full year ended December 31, 2022 were $19.5
million and $101.3 million compared to $29.5 million and $116.3
million, respectively, for the same periods in 2021. Excluding
depreciation, amortization and stock-based compensation, non-GAAP
R&D expenses were $17.3 million and $83.9 million,
respectively, for the fourth quarter and full year ended December
31, 2022. The decrease on a quarterly and full year basis was
primarily due to lower clinical trial and regulatory activity.
- Total operating expenses (OPEX) for the fourth quarter
and full year ended December 31, 2022 were $194.3 million and
$474.5 million compared to $87.6 million and $352.5 million,
respectively, for the same periods in 2021. GAAP OPEX were above
the company’s previously stated guidance range of $375 million to
$400 million primarily due to a $69.8 million goodwill impairment
charge in the company's service segment, recorded in the fourth
quarter of 2022. The non-cash impairment charge resulted from a
reduction in the internal segment forecast and growth rates, driven
by the performance of the service segment and the delay in the
development of certain platform features and functionalities. The
impairment analysis also reflected the decrease in the current
valuation of the broader payments sector. The company also
recognized a non-cash, accelerated amortization expense of $11.7
million in the fourth quarter of 2022 relating to the HintMD
developed technology asset. The expense was attributed to the
sunsetting of the platform following the migration of customers to
OPUL®. Excluding cost of revenue, depreciation, amortization,
stock-based compensation, and impairment charge, non-GAAP OPEX were
$72.8 million for the fourth quarter ended December 31, 2022. For
the full year, non-GAAP OPEX were $267.0 million, which was in-line
with the mid-point of the company’s previously announced guidance
range of $260 million to $280 million.
- Net loss for the fourth quarter and full year ended
December 31, 2022 was $146.0 million and $356.4 million,
respectively, compared to a net loss of $63.1 million and $281.3
million, respectively, for the same periods last year.
- Cash, cash equivalents and short-term investments as of
December 31, 2022 were $340.7 million.
“I'm very pleased with our outstanding performance in 2022,
highlighted by the FDA's approval of DAXXIFY® in September which
lays the foundation for our significant growth opportunity ahead.
To that end, we are encouraged by the positive early feedback we've
received on DAXXIFY® during our PrevU program and look forward to
initiating our commercial launch in late March with a focus on our
existing practice partners," said Mark J. Foley, Chief Executive
Officer. “During the course of 2022, we also took important steps
to fortify our balance sheet, allowing us to launch DAXXIFY® and
grow our aesthetics franchise from a position of strength. 2023
will be another exciting and important year for the company as we
introduce DAXXIFY® and prepare for our entry into the therapeutics
market."
Fourth Quarter Highlights and Subsequent Updates
- DAXXIFY® PrevU program continues into Q1, to be followed by
commercial launch in late March 2023. PrevU is an early
experience program that focuses on product education, practice
integration and real-world clinical insights for optimizing
aesthetic outcomes. The commercial launch of DAXXIFY® is expected
to begin in late March 2023, first with the company’s existing
prestige aesthetic accounts, which will leverage both in-person and
virtual training formats. Further, the company has begun its sales
force expansion, with the goal of adding approximately 50 people to
its ~100-person sales team by mid-year. Fourth quarter DAXXIFY®
revenue during the PrevU program was $11.0 million.
- RHA® Collection revenue increased 46% year-over-year to
$34.8 million in the fourth quarter. Strong RHA® Collection
revenue growth was driven by new account growth and increased
account productivity. Fourth quarter results also reflected the
impact of traditional seasonality. The number of aesthetic accounts
across the RHA® Collection and the company’s fintech platform
increased to over 5,000 as of year-end 2022.
- Gross payment volume (GPV) for fintech platforms totaled
$179 million for the fourth quarter. Revance defines GPV as the
total dollar amount of all transactions processed in the period
through OPUL® and HintMD, net of refunds. GPV for the company’s
fintech platforms was approximately $179 million for the fourth
quarter 2022 and approximately $665.0 million for the full year
ended December 31, representing a 31% and 17% increase from the
same periods last year, due to new account growth. Fourth quarter
OPUL® revenue was $2.9 million.
- Supplemental biologics license application (sBLA) for
DAXXIFY® for injection for the treatment of cervical dystonia
accepted by the FDA. In January 2023, the FDA accepted for
review the company’s sBLA for DAXXIFY® for the treatment of
cervical dystonia in adults. Revance was provided a Prescription
Drug User Fee Act (PDUFA) date of August 19, 2023.
- Prior-approval supplement (PAS) for Ajinomoto Biopharma
Services accepted by the FDA. In October, the FDA accepted the
company’s PAS submission for Ajinomoto Biopharma Services (Aji),
Revance’s fill-finish contract manufacturer for DAXXIFY®. The
company anticipates the potential approval of the PAS in 2023.
- Director and leadership appointments. Revance announced
today the appointment of Dr. Vlad Coric, MD, MBA, to its Board of
Directors, effective March 1, 2023. Dr. Coric, currently the
Chairman and CEO of Biohaven, brings more than 22 years of drug
discovery and executive leadership experience to Revance. Revance
also announced today the appointment of Amie Krause as its Chief
People Officer, succeeding Justin Ford, Senior Vice President,
Human Resources and Head of People, who will be retiring, effective
March 13, 2023. Krause brings over 25 years of human resource
experience and was formerly the Chief People Officer at Atara
Biotherapeutics and was the Human Resource Lead for various
departments at Amgen.
2023 Financial Outlook
Revance expects 2023 GAAP operating expenses to be $460 million
to $480 million and non-GAAP operating expenses, which exclude
costs of revenue, depreciation and amortization and stock-based
compensation to be $320 million to $340 million. Revance expects
2023 non-GAAP research and development expense to be $80 million to
$90 million. The company’s Non-GAAP operating expense guidance for
2023 primarily reflects increased investments in its aesthetics
commercial infrastructure, including sales team expansion, DAXXIFY®
and RHA® commercial investments, and biosimilar partnership
investments.
With current cash, cash equivalents and short-term investments
of $340.7 million, an additional $100 million of notes available
for issuance through Athyrium Capital, and anticipated revenues and
expenditures, management projects that the company’s U.S.
aesthetics portfolio (DAXXIFY®, RHA® Collection, OPUL®) will be
funded to cash flow breakeven.
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 February 28, 2023 to
discuss its financial results and provide a business and pipeline
update. Individuals interested in listening to the conference call
may do so by dialing (800) 715-9871 and reference conference ID:
1286316, 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 February 28,
2023, at 4.30 p.m. PT / 7.30 p.m. ET to March 28, 2023 at 4.30 p.m.
PT / 7.30 p.m. ET. To access the replay, dial (800) 770-2030 and
reference conference ID: 1286316. The webcast will be available in
the investor relations section on the company's website for 90 days
following the completion of the call.
About Revance
Revance is a biotechnology company setting the new standard in
healthcare with innovative aesthetic and therapeutic offerings that
elevate patient and physician experiences. Revance’s aesthetics
portfolio of expertly created products and services, including
DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection, the RHA®
Collection of dermal fillers, and OPUL®, the first-of-its-kind
Relational Commerce platform for aesthetic practices, deliver a
differentiated and exclusive offering for the company’s elite
practice partners and their consumers. Revance has also partnered
with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for
injection, which will compete in the existing short-acting
neuromodulator marketplace. Revance’s therapeutics pipeline is
currently focused on muscle movement disorders including evaluating
DAXXIFY® in two debilitating conditions, cervical dystonia and
upper limb spasticity.
Revance is headquartered in Nashville, Tennessee, with
additional office locations in Newark, Pleasanton and Irvine,
California. Learn more at www.Revance.com,
www.RevanceAesthetics.com, www.DAXXIFY.com, or connect with us on
LinkedIn.
“Revance” and the Revance logo, DAXXIFY®, and OPUL® are
registered trademarks of Revance Therapeutics, Inc.
Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE
SA.
Forward-Looking Statements
Any statements in this press release that are not statements of
historical fact, including statements related to our 2023 financial
outlook, milestone expectations, future expenses, future revenue,
expected cash runway, expected cash flow breakeven, the strength of
our balance sheet, and financial performance; our ability to
successfully commercialize DAXXIFY® and to continue to successfully
commercialize the RHA® Collection of dermal fillers; the timing of
the commercial launch of DAXXIFY®; the planned expansion of our
sales force; the PDUFA date and potential approval of our sBLA
submission for cervical dystonia and our entry into the
therapeutics market; the potential approval of our PAS submission
for Aji; the rate and degree of commercial acceptance, opportunity,
competition and growth potential of DAXXIFY®, the RHA® Collection
of dermal fillers and our business; our strategic priorities; the
safety, efficacy and duration of DAXXIFY® and the RHA® Collection
of dermal fillers; the potential to set a new standard of care; the
potential benefits of our products and services, including
DAXXIFY®, the RHA® Collection of dermal fillers and OPUL®; the
extent to which our products and services are considered innovative
and differentiated; development of a biosimilar to
onabotulinumtoxinA for injection with our partner, Viatris; and our
business strategy, timeline and other goals, plans and prospects,
including our commercialization plans; 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: our ability to obtain funding for our
operations; the timing of capital expenditures; the accuracy of our
estimates regarding expenses, future revenues, capital
requirements, our financial performance and the economics of
DAXXIFY®, the RHA® Collection of dermal fillers and OPUL®; the risk
of future goodwill impairment charges; our ability to comply with
our debt obligations and draw on our debt; the impact of the
COVID-19 pandemic and other macroeconomic factors on our
manufacturing operations, supply chain, end user demand for our
products and services, the aesthetics market, commercialization
efforts, business operations, regulatory meetings, inspections and
approvals, clinical trials and other aspects of our business and on
the market; our ability to maintain approval of our products; our
ability and the ability of our partners to manufacture supplies for
DAXXIFY® and our drug product candidates; our ability to acquire
supplies of the RHA® Collection of dermal fillers; the uncertain
clinical development process; our ability to obtain, and the timing
relating to, regulatory submissions and approvals with respect to
our drug product candidates and third-party manufacturers; the risk
that clinical trials may not have an effective design or generate
positive results or that positive results would assure regulatory
approval or commercial success; the applicability of clinical study
results to actual outcomes; the rate and degree of economic
benefit, safety, efficacy, commercial acceptance, market,
competition and/or size and growth potential of DAXXIFY®, the RHA®
Collection of dermal fillers, and our drug product candidates, if
approved; our ability to successfully commercialize DAXXIFY® and to
continue to successfully commercialize the RHA® Collection of
dermal fillers and OPUL®; the timing and cost of commercialization
activities; the proper training and administration of our products
by physicians and medical staff; our ability to expand sales and
marketing capabilities; the status of commercial collaborations;
changes in and failures to comply with laws and regulations; our
ability to effectively manage our expanded operations in connection
with the acquisition of Hint, Inc; the rate and degree of
commercial acceptance, market, competition and growth potential of
OPUL®; the profitability of and our ability to scale OPUL®, the
features and functionalities and benefits to practices and patients
of OPUL®; interruptions or performance problems associated with
OPUL®; our ability to continue obtaining and maintaining
intellectual property protection for our drug product candidates;
the cost and our ability to defend ourselves in product liability,
intellectual property, class action or other lawsuits; the
volatility of our stock price; 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 our periodic
filings with the Securities and Exchange Commission (SEC),
including factors described in the section entitled "Risks Factors"
on our Form 10-K expected to be filed with the SEC on February 28,
2023. 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, amortization and stock-based
compensation; non-GAAP R&D expense, which excludes
depreciation, amortization and non-cash stock-based compensation;
and total non-GAAP operating expense, which excludes costs of
revenue, depreciation, amortization and stock-based compensation.
Revance excludes costs of revenue, depreciation, amortization and
stock-based compensation 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 release 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,
amortization, and stock-based compensation. The unavailable
information could have a significant impact on the company’s GAAP
financial results.
REVANCE THERAPEUTICS,
INC.
Consolidated Balance
Sheets
(In thousands, except share
and per share amounts)
(Unaudited)
December 31,
2022
2021
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
108,965
$
110,623
Short-term investments
231,742
114,448
Accounts receivable, net
11,339
3,348
Inventories
18,325
10,154
Prepaid expenses and other current
assets
4,356
7,544
Total current assets
374,727
246,117
Property and equipment, net
22,139
24,661
Goodwill
77,175
146,964
Intangible assets, net
27,004
55,334
Operating lease right-of-use assets
39,223
44,340
Finance lease right-of-use asset
6,393
—
Restricted cash
6,052
5,046
Finance lease prepaid expense
27,500
7,700
Other non-current assets
1,687
1,001
TOTAL ASSETS
$
581,900
$
531,163
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable
$
4,546
$
10,603
Accruals and other current liabilities
59,357
39,558
Deferred revenue, current
6,867
9,362
Finance lease liability, current
669
—
Operating lease liabilities, current
4,243
4,746
Derivative liability
—
3,020
Total current liabilities
75,682
67,289
Debt, non-current
379,374
280,635
Deferred revenue, non-current
78,577
74,152
Operating lease liabilities,
non-current
34,182
39,131
Other non-current liabilities
1,485
1,485
TOTAL LIABILITIES
569,300
462,692
STOCKHOLDERS’ EQUITY
Preferred stock, par value $0.001 per
share — 5,000,000 shares authorized, and no shares issued and
outstanding as of December 31, 2022 and 2021
—
—
Common stock, par value $0.001 per share —
190,000,000 shares authorized as of December 31, 2022 and 2021,
respectively; 82,385,810 and 71,584,057 shares issued and
outstanding as of December 31, 2022 and 2021, respectively
82
72
Additional paid-in capital
1,767,266
1,466,369
Accumulated other comprehensive loss
(374
)
(18
)
Accumulated deficit
(1,754,374
)
(1,397,952
)
TOTAL STOCKHOLDERS’ EQUITY
12,600
68,471
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
581,900
$
531,163
REVANCE THERAPEUTICS,
INC.
Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share
and per share amounts)
(Unaudited)
Quarter Ended December
31,
Year Ended December
31,
2022
2021
2022
2021
Revenue:
Product revenue
$
45,730
$
23,838
$
118,131
$
70,820
Collaboration revenue
1,247
1,621
7,444
5,655
Service revenue
2,944
491
6,990
1,323
Total revenue
49,921
25,950
132,565
77,798
Operating expenses:
Cost of product revenue (exclusive of
depreciation and amortization)
20,284
7,672
44,414
23,125
Cost of service revenue (exclusive of
amortization)
3,231
209
7,253
285
Selling, general and administrative
65,237
46,436
223,934
198,821
Research and development
19,541
29,468
101,286
116,255
Impairment loss
69,789
—
69,789
—
Depreciation and amortization
16,250
3,769
27,847
13,988
Total operating expenses
194,332
87,554
474,523
352,474
Loss from operations
(144,411
)
(61,604
)
(341,958
)
(274,676
)
Interest income
3,031
71
4,891
337
Interest expense
(3,752
)
(1,573
)
(16,474
)
(6,273
)
Other income (expense), net
(820
)
8
(2,181
)
(698
)
Loss before income taxes
(145,952
)
(63,098
)
(355,722
)
(281,310
)
Income tax provision
—
—
(700
)
—
Net loss
(145,952
)
(63,098
)
(356,422
)
(281,310
)
Unrealized gain (loss)
86
(15
)
(356
)
(18
)
Comprehensive loss
$
(145,866
)
$
(63,113
)
$
(356,778
)
$
(281,328
)
Basic and diluted net loss
$
(145,952
)
$
(63,098
)
$
(356,422
)
$
(281,310
)
Basic and diluted net loss per share
$
(1.82
)
$
(0.93
)
$
(4.90
)
$
(4.17
)
Basic and diluted weighted-average number
of shares used in computing net loss per share
80,126,454
68,034,811
72,713,340
67,507,818
REVANCE THERAPEUTICS,
INC.
Product Revenue Breakdown
(Unaudited)
Quarter Ended December
31,
Year Ended December
31,
(in thousands)
2022
2021
2022
2021
Product:
RHA® Collection of dermal fillers
$
34,755
$
23,838
$
107,156
$
70,820
DAXXIFY®
10,975
—
10,975
—
Total product revenue
$
45,730
$
23,838
$
118,131
$
70,820
Reconciliation of GAAP
SG&A Expense to Non-GAAP SG&A Expense (Unaudited)
Quarter Ended
Year Ended
(in thousands)
December 31, 2022
December 31, 2022
SG&A expense:
GAAP SG&A expense
$
65,237
$
223,934
Adjustments:
Stock-based compensation
(8,658
)
(36,595
)
Depreciation and amortization
(1,048
)
(4,238
)
Non-GAAP SG&A expense
$
55,531
$
183,101
Reconciliation of GAAP R&D
Expense to Non-GAAP R&D Expense (Unaudited)
Quarter Ended
Year Ended
(in thousands)
December 31, 2022
December 31, 2022
R&D expense:
GAAP R&D expense
$
19,541
$
101,286
Adjustments:
Stock-based compensation
(2,069
)
(15,745
)
Depreciation and amortization
(168
)
(1,647
)
Non-GAAP R&D expense
$
17,304
$
83,894
Reconciliation of GAAP
Operating Expense to Non-GAAP Operating Expense (Unaudited)
Quarter Ended
Year Ended
(in thousands)
December 31, 2022
December 31, 2022
Operating expense:
GAAP operating expenses
$
194,332
$
474,523
Adjustments:
Impairment loss
(69,789
)
(69,789
)
Costs of revenue (exclusive of
depreciation and amortization)
(23,515
)
(51,667
)
Stock-based compensation
(10,727
)
(52,340
)
Depreciation and amortization
(17,466
)
(33,732
)
Non-GAAP operating expense
$
72,835
$
266,995
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230228005598/en/
Investors Revance Therapeutics, Inc.: Jessica Serra,
510-279-6886 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
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