- Q2 total revenue of $58.1 million, a YoY increase of 104.9%. -
Q2 RHA® Collection revenue of $31.8 million, a YoY increase of
24.7%. - Q2 DAXXIFY® revenue of $22.6 million, a QoQ increase of
47.1%. - Bolstered financial position with $100 million net
proceeds from ATM program and $50 million in notes available to be
issued through Athyrium Capital on or before August 31, 2023. -
PDUFA date of August 19, 2023 for DAXXIFY® for the treatment of
cervical dystonia. - Conference call and webcast today at 4:30 p.m.
ET.
Revance Therapeutics, Inc. (RVNC), today reported financial
results for the second quarter ended June 30, 2023 and provided a
corporate update.
Financial Highlights
- Total revenue for the second quarter ended June 30, 2023
was $58.1 million compared to $28.4 million for the same period
last year, representing an increase of 104.9% primarily due to the
sales growth of the RHA® Collection of dermal fillers and the
commercialization of DAXXIFY®. Revenue for the second quarter
included $31.8 million of RHA® Collection revenue, $22.6 million of
DAXXIFY® revenue and $3.7 million of service revenue. Revenue for
the six months ended June 30, 2023 was $107.5 million compared to
$53.6 million for the same period in 2022.
- Selling, general and administrative (SG&A) expenses
for the three and six months ended June 30, 2023 were $77.4 million
and $143.4 million compared to $47.8 million and $92.9 million,
respectively, for the same periods in 2022, presented in accordance
with U.S. generally accepted accounting principles (“GAAP”). The
quarterly 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 $64.2 million and $117.8 million,
respectively, for the three and six months ended June 30,
2023.
- Research and development (R&D) expenses for the
three and six months ended June 30, 2023 were $22.8 million and
$46.0 million compared to $24.9 million and $55.6 million,
respectively, for the same periods in 2022. The quarterly decrease
was primarily due to the effects of capitalizing certain
manufacturing-related expenses for DAXXIFY®. Excluding
depreciation, amortization and stock-based compensation, non-GAAP
R&D expenses were $19.0 million and $36.9 million,
respectively, for the three and six months ended June 30,
2023.
- Total operating expenses for the three and six months
ended June 30, 2023 were $123.6 million and $231.0 million compared
to $86.2 million and $173.7 million, respectively, for the same
periods in 2022. Excluding costs of revenue, depreciation,
amortization and stock-based compensation, non-GAAP operating
expenses were $83.2 million and $154.7 million, respectively, for
the three and six months ended June 30, 2023.
- Net loss for the three and six months ended June 30,
2023 was $67.3 million and $127.1 million, respectively, compared
to a net loss of $61.4 million and $125.8 million for the same
periods in 2022.
- Cash, cash equivalents and short-term investments as of
June 30, 2023 were $319.7 million.
- At-the-market (ATM) program. During the second quarter,
the company issued 3.2 million shares of common stock pursuant to
the company’s ATM offering, which provided net proceeds of $100
million.
- Note purchase agreement with Athyrium Capital. On August
8th, Revance and Athyrium Capital amended the company’s existing
Note Purchase Agreement entered into on March 18, 2022. Pursuant to
the amendment, the committed 8.5% Second Tranche note was reduced
from $100 million to $50 million, and the uncommitted Third Tranche
note was increased from $100 million to $150 million. The company
expects to issue its Second Tranche note of $50 million on or
before August 31, 2023, provided certain conditions are met.
“We are very pleased with our strong Q2 performance highlighted
by DAXXIFY’s first full quarter of launch and the continued growth
of the RHA® Collection. With regards to DAXXIFY®, we remain very
encouraged by the product’s performance, uptake, and ongoing
demand. Coupled with the strong execution of our commercial team,
we continue to believe we have the right people, products and
strategy in place to realize our blockbuster potential in
aesthetics,” said Chief Executive Officer, Mark J. Foley. “Given
our growth, we have taken prudent steps to significantly bolster
our financial position to ensure that we have the necessary
resources to support our aesthetics business while also preparing
for our entry into the therapeutics market. We believe we are well
positioned for our opportunities ahead and look forward to sharing
more on our business and outlook at our upcoming Investor Day in
September.”
Second Quarter Highlights and Subsequent Updates
- Total DAXXIFY® sales generated through Q2 of 2023 was $49.0
million, which surpassed the total sales generated by any
competitor to Botox® in their first launch year.
- The onboarding of 50 additional aesthetic salespeople was
completed in the second quarter 2023, bringing the company’s total
aesthetic sales force to more than 150 people.
- Accounts across Revance’s aesthetic portfolio totaled over
6,000 at the end of the second quarter 2023.
- Revance launched its first unbranded, “Break Up with Botox®”,
direct-to-consumer campaign, driving strong consumer awareness
across key channels and platforms. Since its initiation in June,
the targeted campaign garnered 57 million impressions and over 9
million views.
- In July, the U.S. Food and Drug Administration (FDA) approved
the expansion of RHA® 4’s label to include cannula use. RHA® 4 is
indicated for the correction of moderate to severe dynamic facial
wrinkles and folds, such as nasolabial folds.
- Gross payment volume (GPV) for the OPUL® Relational Commerce
platform totaled $173 million for the second quarter 2023 and $697
million for the trailing-twelve months ended June 30, 2023.
- Fosun Pharma’s biologics license application (BLA) for DAXXIFY®
for cervical dystonia was accepted for review by China’s National
Medical Products Administration (NMPA). This is Fosun Pharma’s
second BLA acceptance for DAXXIFY® by China’s NMPA.
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 expenses 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 investment, and biosimilar
partnership investment.
With current cash, cash equivalents and short-term investments,
$50 million in notes the company plans to issue through Athyrium
Capital, provided certain conditions are met, and anticipated
revenues and expenditures, management projects that the company
will be funded to cash flow break-even.
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 August 8, 2023 to discuss
its financial results and provide a corporate update. Individuals
interested in listening to the conference call may do so by dialing
(888) 330-3637 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 August 8, 2023,
at 4.30 p.m. PT/7.30 p.m. ET until November 9, 2023 at 4.30 p.m. PT
/ 7.30 p.m. ET. To access the replay, please register through the
webcast link found in the investor relations section of the
company’s website. 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, delivers 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 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, and financial
position; the availability of the Second Tranche; our expected cash
flow breakeven; our ability to successfully commercialize DAXXIFY®;
our blockbuster potential; the PDUFA date and potential approval of
our sBLA submission for cervical dystonia and our entry into the
therapeutics market; the growth potential of our products, services
and our business; our investor day plans; 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; the commercialization of DAXXIFY® through our
Fosun partnership; development of a biosimilar to
onabotulinumtoxinA for injection with our partner, Viatris; and our
business and marketing 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 to, 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, 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; our ability
to limit or mitigate cybersecurity incidents; 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 "Risk Factors" on our Form 10-K filed with the SEC
on February 28, 2023, and including, without limitation, our Form
10-Qs for the quarters ended March 31, 2023 and June 30, 2023,
filed on May 9, 2023 and expected to be filed with the SEC on
August 8, 2023, respectively. 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 ongoing 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 effort 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)
June 30,
December 31,
2023
2022
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
141,235
$
108,965
Restricted cash, current
275
—
Short-term investments
178,488
231,742
Accounts receivable, net
17,043
11,339
Inventories
34,448
18,325
Prepaid expenses and other current
assets
7,458
4,356
Total current assets
378,947
374,727
Property and equipment, net
12,690
13,799
Goodwill
77,175
77,175
Intangible assets, net
28,461
35,344
Operating lease right-of-use assets
34,438
39,223
Finance lease right-of-use asset
26,460
6,393
Restricted cash, non-current
7,145
6,052
Finance lease prepaid expense
27,500
27,500
Other non-current assets
4,719
1,687
TOTAL ASSETS
$
597,535
$
581,900
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable
$
8,345
$
4,546
Accruals and other current liabilities
39,535
59,357
Deferred revenue, current
5,433
6,867
Finance lease liability, current
15,505
669
Operating lease liabilities, current
5,261
4,243
Total current liabilities
74,079
75,682
Debt, non-current
380,348
379,374
Deferred revenue, non-current
82,213
78,577
Operating lease liabilities,
non-current
31,274
34,182
Other non-current liabilities
2,835
1,485
TOTAL LIABILITIES
570,749
569,300
STOCKHOLDERS’ EQUITY
Preferred stock, par value $0.001 per
share — 5,000,000 shares authorized, and no shares issued and
outstanding as of June 30, 2023 and December 31, 2022
—
—
Common stock, par value $0.001 per share —
190,000,000 shares authorized as of June 30, 2023 and December 31,
2022; 87,949,987 and 82,385,810 shares issued and outstanding as of
June 30, 2023 and December 31, 2022, respectively
88
82
Additional paid-in capital
1,908,244
1,767,266
Accumulated other comprehensive loss
(61
)
(374
)
Accumulated deficit
(1,881,485
)
(1,754,374
)
TOTAL STOCKHOLDERS’ EQUITY
26,786
12,600
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
597,535
$
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 June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Revenue:
Product revenue
$
54,393
$
25,483
$
100,051
$
46,320
Service revenue
3,721
1,226
7,278
2,082
Collaboration revenue
20
1,659
136
5,227
Total revenue
58,134
28,368
107,465
53,629
Operating expenses:
Cost of product revenue (exclusive of
depreciation and amortization)
17,607
8,121
30,094
15,449
Cost of service revenue (exclusive of
amortization)
3,700
1,402
7,384
1,967
Selling, general and administrative
77,384
47,847
143,395
92,922
Research and development
22,807
24,913
45,984
55,642
Depreciation and amortization
2,135
3,927
4,139
7,712
Total operating expenses
123,633
86,210
230,996
173,692
Loss from operations
(65,499
)
(57,842
)
(123,531
)
(120,063
)
Interest income
3,148
619
6,118
695
Interest expense
(4,368
)
(3,874
)
(8,865
)
(5,805
)
Other expense, net
(599
)
(338
)
(833
)
(604
)
Net loss
(67,318
)
(61,435
)
(127,111
)
(125,777
)
Unrealized gain (loss)
64
(327
)
313
(368
)
Comprehensive loss
$
(67,254
)
$
(61,762
)
$
(126,798
)
$
(126,145
)
Basic and diluted net loss
$
(67,318
)
$
(61,435
)
$
(127,111
)
$
(125,777
)
Basic and diluted net loss per share
$
(0.80
)
$
(0.88
)
$
(1.54
)
$
(1.82
)
Basic and diluted weighted-average number
of shares used in computing net loss per share
83,685,919
70,061,457
82,417,064
69,202,062
REVANCE THERAPEUTICS,
INC.
Product Revenue Breakdown
(Unaudited)
Three Months Ended
Six Months Ended
(in thousands)
June 30, 2023
June 30, 2022
June 30, 2023
June 30, 2022
Product:
RHA® Collection of dermal fillers
$
31,767
$
25,483
$
62,047
$
46,320
DAXXIFY®
22,626
—
38,004
—
Total product revenue
$
54,393
$
25,483
$
100,051
$
46,320
Reconciliation of GAAP
SG&A Expense to Non-GAAP SG&A Expense (Unaudited)
Three Months Ended
Six Months Ended
(in thousands)
June 30, 2023
June 30, 2022
June 30, 2023
June 30, 2022
SG&A expense:
GAAP SG&A expense
$
77,384
$
47,847
$
143,395
$
92,922
Adjustments:
Stock-based compensation
(12,178
)
(6,528
)
(22,443
)
(14,692
)
Depreciation and amortization
(1,040
)
(1,018
)
(3,182
)
(2,152
)
Non-GAAP SG&A expense
$
64,166
$
40,301
$
117,770
$
76,078
Reconciliation of GAAP R&D
Expense to Non-GAAP R&D Expense (Unaudited)
Three Months Ended
Six Months Ended
(in thousands)
June 30, 2023
June 30, 2022
June 30, 2023
June 30, 2022
R&D expense:
GAAP R&D expense
$
22,807
$
24,913
$
45,984
$
55,642
Adjustments:
Stock-based compensation
(3,421
)
(2,735
)
(6,238
)
(8,934
)
Depreciation and amortization
(355
)
(506
)
(2,828
)
(963
)
Non-GAAP R&D expense
$
19,031
$
21,672
$
36,918
$
45,745
Reconciliation of GAAP
Operating Expenses to Non-GAAP Operating Expenses
(Unaudited)
Three Months Ended
Six Months Ended
(in thousands)
June 30, 2023
June 30, 2022
June 30, 2023
June 30, 2022
Operating expenses:
GAAP operating expenses
$
123,633
$
86,210
$
230,996
$
173,692
Adjustments:
Costs of revenue (exclusive of
depreciation, amortization, and stock-based compensation)
(20,359
)
(9,523
)
(36,530
)
(17,416
)
Stock-based compensation
(16,547
)
(9,263
)
(29,629
)
(23,626
)
Depreciation and amortization
(3,530
)
(5,451
)
(10,149
)
(10,827
)
Non-GAAP operating expenses
$
83,197
$
61,973
$
154,688
$
121,823
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230808658601/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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