- Q1 total revenue of $49.3 million, a YoY increase of 95.3%. -
Q1 RHA® Collection revenue of $30.3 million, a YOY increase of
45.3%. - Q1 DAXXIFY® revenue of $15.4 million, driven by PrevU and
March launch. - FDA approves Ajinomoto Biopharma Services,
Revance’s contract manufacturer for DAXXIFY®. - Fosun Pharma’s BLA
submission for DaxibotulinumtoxinA for Injection for glabellar
lines accepted for review by China’s National Medical Products
Administration (NMPA). - Conference call and webcast today at 4:30
p.m. ET.
Revance Therapeutics, Inc. (RVNC), today reported financial
results for the first quarter ended March 31, 2023 and provided a
corporate update.
Financial Highlights
- Total revenue for the first quarter ended March 31, 2023
was $49.3 million compared to $25.3 million for the same period
last year, representing an increase of 95.3% primarily due to the
growth of the RHA® Collection of dermal fillers and revenue from
DAXXIFY®. Revenue for the first quarter included $30.3 million of
RHA® Collection revenue, $15.4 million of DAXXIFY® revenue, $3.6
million of service revenue and $0.1 million of collaboration
revenue.
- Selling, general and administrative (SG&A) expenses
for the first quarter ended March 31, 2023 were $66.0 million
compared to $45.1 million for the same period in 2022, presented in
accordance with U.S. generally accepted accounting principles
(“GAAP”). The increase was primarily due to higher sales and
marketing expenses related to DAXXIFY® and the RHA® Collection.
Excluding depreciation, amortization and stock-based compensation,
non-GAAP SG&A expenses were $53.6 million for the first quarter
ended March 31, 2023, compared to $35.8 million for the same period
in 2022.
- Research and development (R&D) expenses for the
first quarter ended March 31, 2023 were $23.2 million compared to
$30.7 million for the same period in 2022. The decrease was
primarily due to lower clinical trial and regulatory activity.
Excluding depreciation, amortization and stock-based compensation,
non-GAAP R&D expenses were $17.9 million for the first quarter
ended March 31, 2023, compared to $24.1 million for the same period
in 2022.
- Total operating expenses for the first quarter ended
March 31, 2023 were $107.4 million compared to $87.5 million for
the same period in 2022. Excluding costs of revenue, depreciation,
amortization and stock-based compensation, non-GAAP operating
expenses for the first quarter ended March 31, 2023 were $71.5
million, compared to $59.9 million for the same period in
2022.
- Net loss for the first quarter ended March 31, 2023 was
$59.8 million compared to a net loss of $64.3 million for the same
period in 2022.
- Cash, cash equivalents and short-term investments as of
March 31, 2023 were $273.9 million.
“We are very pleased to see our momentum continue into 2023 with
outstanding Q1 results driven by DAXXIFY’s market introduction and
the continued growth of the RHA® Collection,” said Mark J. Foley,
Chief Executive Officer. “Importantly, DAXXIFY’s launch is off to a
great start, and we remain highly encouraged by the strong
enthusiasm for the product’s differentiated performance profile and
the positive feedback we’ve received from both injectors and
consumers. Further, with our contract manufacturer, Ajinonomoto
Biopharma Services, now approved by the FDA, we believe we are well
positioned to support the expected demand for DAXXIFY®, in both
aesthetics and therapeutics, as we continue to scale our
business.”
First Quarter Highlights and Subsequent Updates
- RHA® Collection revenue increased 45.3% year-over-year to
$30.3 million in the first quarter 2023.
- DAXXIFY® launch off to a great start, generating $15.4
million in revenue for the first quarter 2023. Following the
conclusion of the PrevU early experience program in March, Revance
initiated the market introduction of DAXXIFY® with an
initial focus on its existing practice partners.
- Aesthetics sales force expansion completed. At the end
of the first quarter, Revance hired ~50 additional sales
representatives, bringing its total sales force to over 150
representatives.
- Accounts across Revance’s aesthetics portfolio totaled over
5,500 at the end of first quarter 2023.
- In March, the FDA approved the prior-approval supplement
(PAS) for Ajinomoto Biopharma Services (Aji), Revance’s fill-finish
contract manufacturer. With approval, Aji will support the
commercial growth of DAXXIFY® and all inventory produced at Aji,
prior to approval, has been released for commercial use.
- Gross payment volume (GPV) for the OPUL® Relational Commerce
platform totaled $180.4 million for the first quarter 2023 and $690
million for the trailing-twelve months ended March 31,
2023.
- In April, Fosun Pharma’s biologics license application (BLA)
submission for DaxibotulinumtoxinA for Injection for glabellar
lines was accepted for review by China’s NMPA. Revance entered
into a license agreement with Shanghai Fosun Pharmaceutical
Industrial Development Co., Ltd. (Fosun Pharma Industrial), a
wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group)
Co., Ltd., in 2018, whereby Revance granted Fosun Pharma Industrial
the exclusive rights to develop and commercialize (excluding
manufacturing) DaxibotulinumtoxinA for Injection in mainland China,
Hong Kong and Macau.
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® Collection commercial investments, and biosimilar
partnership investments.
With current cash, cash equivalents and short-term investments,
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 May 9, 2023 to discuss
its financial results and provide a corporate update. Individuals
interested in listening to the conference call may do so by dialing
(800) 715-9871 and reference conference ID: 7745325, 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 9, 2023, at
4.30 p.m. PT / 7.30 p.m. ET to June 9, 2023 at 4.30 p.m. PT / 7.30
p.m. ET. To access the replay, dial (800) 770-2030 for domestic
callers or (609) 800-9909 for international callers and reference
conference ID: 7745325. 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; our ability to draw on our debt and expected
cash flow breakeven; our ability to successfully commercialize
DAXXIFY® and to continue to successfully commercialize the RHA®
Collection of dermal fillers; the timing and planned onboarding of
our sales force; our entry into the therapeutics market; the growth
potential of our products, services and our business; the potential
to set a new standard of care; consumer preferences and behavior;
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; our ability to support expected demand; the
commercialization of DAXXIFY® through our Fosun partnership;
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
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 filed with the SEC on February 28, 2023, and
including, without limitation, our Form 10-Q for the quarter ended
March 31, 2023, expected to be filed with the SEC on May 9, 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.
Condensed Consolidated Balance
Sheets
(In thousands, except share
and per share amounts)
(Unaudited)
March 31,
December 31,
2023
2022
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
136,678
$
108,965
Restricted cash, current
275
—
Short-term investments
137,271
231,742
Accounts receivable, net
15,373
11,339
Inventories
27,775
18,325
Prepaid expenses and other current
assets
5,652
4,356
Total current assets
323,024
374,727
Property and equipment, net
13,953
13,799
Goodwill
77,175
77,175
Intangible assets, net
31,223
35,344
Finance lease right-of-use asset
27,810
6,393
Operating lease right-of-use assets
37,899
39,223
Restricted cash, non-current
7,145
6,052
Finance lease prepaid expense
27,500
27,500
Other non-current assets
2,072
1,687
TOTAL ASSETS
$
547,801
$
581,900
LIABILITIES AND STOCKHOLDERS’
EQUITY (DEFICIT)
CURRENT LIABILITIES
Accounts payable
$
12,996
$
4,546
Accruals and other current liabilities
35,865
59,357
Deferred revenue, current
6,036
6,867
Finance lease liability, current
18,611
669
Operating lease liabilities, current
4,477
4,243
Total current liabilities
77,985
75,682
Debt, non-current
379,859
379,374
Deferred revenue, non-current
81,024
78,577
Operating lease liabilities,
non-current
32,771
34,182
Other non-current liabilities
2,835
1,485
TOTAL LIABILITIES
574,474
569,300
STOCKHOLDERS’ EQUITY (DEFICIT)
Preferred stock, par value $0.001 per
share — 5,000,000 shares authorized, and no shares issued and
outstanding as of March 31, 2023 and December 31, 2022
—
—
Common stock, par value $0.001 per share —
190,000,000 shares authorized as of March 31, 2023 and December 31,
2022, respectively; 84,017,208 and 82,385,810 shares issued and
outstanding as of March 31, 2023 and December 31, 2022,
respectively
84
82
Additional paid-in capital
1,787,535
1,767,266
Accumulated other comprehensive loss
(125
)
(374
)
Accumulated deficit
(1,814,167
)
(1,754,374
)
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)
(26,673
)
12,600
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT)
$
547,801
$
581,900
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,
2023
2022
Revenue:
Product revenue
$
45,658
$
20,837
Service revenue
3,557
856
Collaboration revenue
116
3,568
Total revenue
49,331
25,261
Operating expenses:
Cost of product revenue (exclusive of
depreciation and amortization)
12,487
7,328
Cost of service revenue (exclusive of
amortization)
3,684
565
Selling, general and administrative
66,011
45,075
Research and development
23,177
30,729
Depreciation and amortization
2,004
3,785
Total operating expenses
107,363
87,482
Loss from operations
(58,032
)
(62,221
)
Interest income
2,970
76
Interest expense
(4,497
)
(1,931
)
Other expense, net
(234
)
(266
)
Net loss
(59,793
)
(64,342
)
Unrealized gain (loss)
249
(41
)
Comprehensive loss
$
(59,544
)
$
(64,383
)
Basic and diluted net loss
$
(59,793
)
$
(64,342
)
Basic and diluted net loss per share
$
(0.74
)
$
(0.94
)
Basic and diluted weighted-average number
of shares used in computing net loss per share
81,134,111
68,333,117
REVANCE THERAPEUTICS,
INC.
Product Revenue Breakdown
(Unaudited)
Three Months Ended
(in thousands)
March 31, 2023
March 31, 2022
Product:
RHA® Collection of dermal fillers
$
30,280
$
20,837
DAXXIFY®
15,378
—
Total product revenue
$
45,658
$
20,837
Reconciliation of GAAP
SG&A Expense to Non-GAAP SG&A Expense (Unaudited)
Three Months Ended
(in thousands)
March 31, 2023
March 31, 2022
SG&A expense:
GAAP SG&A expense
$
66,011
$
45,075
Adjustments:
Stock-based compensation
(10,265
)
(8,164
)
Depreciation and amortization
(2,142
)
(1,134
)
Non-GAAP SG&A expense
$
53,604
$
35,777
Reconciliation of GAAP R&D
Expense to Non-GAAP R&D Expense (Unaudited)
Three Months Ended
(in thousands)
March 31, 2023
March 31, 2022
R&D expense:
GAAP R&D expense
$
23,177
$
30,729
Adjustments:
Stock-based compensation
(2,817
)
(6,199
)
Depreciation and amortization
(2,473
)
(457
)
Non-GAAP R&D expense
$
17,887
$
24,073
Reconciliation of GAAP
Operating Expenses to Non-GAAP Operating Expenses
(Unaudited)
Three Months Ended
(in thousands)
March 31, 2023
March 31, 2022
Operating expenses:
GAAP operating expenses
$
107,363
$
87,482
Adjustments:
Costs of revenue (exclusive of
depreciation and amortization)
(16,171
)
(7,893
)
Stock-based compensation
(13,082
)
(14,363
)
Depreciation and amortization
(6,619
)
(5,376
)
Non-GAAP operating expenses
$
71,491
$
59,850
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230509005998/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
Revance Therapeutics (NASDAQ:RVNC)
Historical Stock Chart
From Jun 2024 to Jul 2024
Revance Therapeutics (NASDAQ:RVNC)
Historical Stock Chart
From Jul 2023 to Jul 2024