- On August 11, 2024, Revance and Crown Laboratories, Inc.
entered into a merger agreement. As a result of discussions between
the Revance and Teoxane, Crown and Revance agreed to extend the
deadline upon which the tender offer must commence to November 12,
2024. The tender offer has not yet commenced.
- Revance entered into an amendment to the Exclusive
Distribution Agreement with Teoxane for the distribution of the
RHA® Collection of dermal fillers in the U.S. and an Exclusive
Distribution Agreement with Teoxane for DAXXIFY® in Australia and
New Zealand.
- Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.
announced China’s National Medical Products Association’s approval
of DAXXIFY in Mainland China for the temporary improvement of the
appearance of moderate to severe glabellar lines.
- Revance is withdrawing the Company’s 2024 financial guidance
and will not be holding a conference call to accompany its 3Q’24
financial results.
Revance Therapeutics, Inc. (NASDAQ: RVNC) (“Revance,” the
“Company” or “our”), today reported financial results for the third
quarter ended September 30, 2024 and provided a corporate
update.
Third Quarter Highlights and Subsequent Updates
- Crown Laboratories and Revance Announce Entry Into Merger
Agreement and Delay of Tender Offer Commencement. During the
quarter, Revance and Crown Laboratories, Inc (“Crown”) announced
that they had entered into a merger agreement pursuant to which the
companies would seek to merge the two complementary organizations.
Under the terms of the agreement, which was unanimously approved by
Revance's Board of Directors, Crown will commence a tender offer to
purchase all of Revance’s outstanding shares of common stock, at a
price of $6.66 per share, in cash. As a result of discussions
between the Company and Teoxane SA (“Teoxane”) regarding an alleged
breach of the Exclusive Distribution Agreement for the distribution
of the RHA® Collection of dermal fillers in the U.S. (the “U.S.
Distribution Agreement”), the parties extended the date by which
the tender offer must be commenced. Revance and Crown agreed to
extend the tender offer commencement date to November 12, 2024 or
another date mutually agreed to between the parties.
- Revance and Teoxane Enter into Agreements to Further their
Partnership. Following a notice from Teoxane to remedy alleged
material breaches of the U.S. Distribution Agreement and
discussions between the parties, on October 24, 2024, Revance and
Teoxane entered into a sixth amendment to the U.S. Distribution
Agreement and an exclusive distribution agreement (the “ANZ
Distribution Agreement”) pursuant to which Teoxane will act as
Revance’s and Revance Australia's exclusive distributor and
licensee in Australia and New Zealand of certain products
containing DaxibotulinumtoxinA-lanm, including DAXXIFY®, for the
treatment of (a) temporary improvements in the appearance of
glabellar lines and other indications related to altering cosmetic
appearance and (b) cervical dystonia. The ANZ Distribution
Agreement expires December 31, 2040.
- DAXXIFY Approved in Mainland China for Glabellar Lines.
On September 9, Shanghai Fosun Pharmaceutical Industrial
Development Co., Ltd. (“Fosun”) announced that the Biologics
License Application for DAXXIFY had been recently approved by
China’s National Medical Products Administration for the temporary
improvement in the appearance of moderate to severe glabellar
lines.
Financial Highlights
- Total net revenue for the third quarter ended September
30, 2024 was $59.9 million compared to $54.1 million for the same
period in 2023, representing an increase of 11%, due primarily to
an overall increase in the sales volume of DAXXIFY and the RHA®
Collection, partially offset by an overall reduction in the average
selling prices for both product lines. Net revenue for the third
quarter ended September 30, 2024 included $30.5 million of RHA®
Collection revenue, $28.3 million of DAXXIFY revenue, and $1.1
million of collaboration revenue. Total net revenue for the nine
months ended September 30, 2024 was $177.2 million compared to
$154.3 million for the same period in 2023.
- Selling, general and administrative (SG&A) expenses
for the three and nine months ended September 30, 2024 were $62.6
million and $197.3 million compared to $65.8 million and $202.5
million, respectively, for the same periods in 2023. The decrease
was primarily due to lower stock-based compensation charges and
sales and marketing expenses related to DAXXIFY and the RHA®
Collection, offset primarily by expenses related to the launch of
DAXXIFY for cervical dystonia and $7.3 million of transaction costs
related to the pending merger.
- Research and development (R&D) expenses for the
three and nine months ended September 30, 2024 were $11.4 million
and $41.7 million compared to $8.7 million and $43.8 million,
respectively, for the same periods in 2023. The decrease was
primarily due to the U.S. Food and Drug Administration’s approval
of our manufacturing partner’s, Ajinomoto Bio-Pharma Services, site
in late Q1 2023 which allowed the subsequent DAXXIFY manufacturing
expenses to be capitalized as inventory.
- Total operating expenses for the three and nine months
ended September 30, 2024 were $92.1 million and $290.8 million
compared to $91.7 million and $294.9 million, respectively, for the
same periods in 2023.
- Net loss from continuing operations for the three and
nine months ended September 30, 2024 were $38.1 million and $125.1
million, respectively, compared to $39.4 million and $146.1 million
for the same periods in 2023.
- Cash, cash equivalents and short-term investments as of
September 30, 2024 were $184.1 million.
Note: In connection with the exit of the Fintech Platform
business (HintMD and OPUL®), the results of the Fintech Platform
business are reflected as discontinued operations in our financial
statements as of September 30, 2024 and December 31, 2023 and for
the periods ended September 30, 2024 and 2023. Therefore, the
results discussed reflect our continuing operations and exclude
results of the Fintech Platform, which was presented in our
financial statements as the service segment.
2024 Financial Outlook
In light of the proposed merger with Crown and other recent
developments, Revance will not be providing any forward-looking
guidance and is withdrawing any previously provided guidance and
outlook. In addition, Revance will not hold a conference call to
discuss its third quarter 2024 earnings.
About Revance
Revance is a biotechnology company setting the new standard in
healthcare with innovative aesthetic and therapeutic offerings that
enhance patient outcomes and physician experiences. Revance’s
portfolio includes DAXXIFY (DaxibotulinumtoxinA-lanm) for injection
and the RHA® Collection of dermal fillers, which RHA® technology is
proprietary to and manufactured by Teoxane SA in Switzerland.
Revance has partnered with Teoxane, SA to supply HA fillers for
U.S. distribution. Revance has also partnered with Viatris Inc. to
develop a biosimilar to onabotulinumtoxinA for injection and
Shanghai Fosun Pharmaceutical to commercialize DAXXIFY in
China.
Revance’s global headquarters and experience center is located
in Nashville, Tennessee. Learn more at Revance.com,
RevanceAesthetics.com, DAXXIFY.com,
HCP.DAXXIFYCervicalDystonia.com, or connect with us on
LinkedIn.
“Revance”, the Revance logo, and DAXXIFY® 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 expectations with
respect to the tender offer and the merger, including the timing
thereof and the likelihood of the tender offer being commenced on
the same terms as previously announced, or at all; our and Crown's
ability to successfully complete the merger; the impact to the
Company if the merger is not completed; plans regarding 2024
guidance; the potential to set a new standard in healthcare;
patient outcomes and physician experiences; commercialization of
DAXXIFY in Australia and New Zealand with our partner, Teoxane;
development of an onobotulinumtoxinA biosimilar with our partner,
Viatris; and commercialization of DAXXIFY in China with our
partner, Shanghai Fosun Pharmaceutical; 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 and the timing of
events to differ materially from our expectations. These risks and
uncertainties relate to, but are not limited to: the risks and
uncertainties inherent in the tender offer and the merger,
including, among other things, regarding how many of the Company
stockholders will tender their shares in the offer, the possibility
that competing offers will be made, the ability to satisfy the
conditions to the closing of the tender offer and the merger, the
expected timing of the tender offer and the merger, the possibility
that the merger will not be completed, difficulties or
unanticipated expenses in connection with integrating the parties’
operations, products and employees and the possibility that
anticipated synergies and other anticipated benefits of the
transaction will not be realized in the amounts expected, within
the expected timeframe or at all, the effect of the announcement of
the tender offer and the merger on the Company’s and Crown’s
business relationships (including, without limitations, partners
and customers), the occurrence of any event, change or other
circumstances that could give rise to the termination of the Merger
Agreement, the expected tax treatment of the transaction, and the
impact of the transaction on the businesses of the Company and
Crown, and other circumstances beyond the Company’s and Crown’s
control; our ability to obtain funding for our operations; the
timing of capital expenditures; the accuracy of our estimates
regarding expenses, revenues, capital requirements, supply chain
and operational efficiencies; our financial performance and the
economics of DAXXIFY and the RHA® Collection of dermal fillers; our
ability to comply with our debt obligations; the impact of
macroeconomic factors on our manufacturing operations, supply
chain, end user demand for our products, 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, duration, 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; the timing and cost of commercialization
activities; securing or maintaining adequate coverage or
reimbursement by third-party payers for DAXXIFY; the proper
training and administration of our products by physicians and
medical staff; our ability to maintain and gain acceptance from
injectors and physicians in the use of DAXXIFY for aesthetic and
therapeutic indications; our ability to strengthen professional
partnerships; 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
continue obtaining and maintaining intellectual property protection
for our products; 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"
in our Form 10-K filed with the SEC on February 28, 2024, and
including, without limitation, our Form 10-Q for the quarter ended
September 30, 2024 expected to be filed with the SEC on November 7,
2024. 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.
REVANCE THERAPEUTICS,
INC.
Condensed Consolidated Balance
Sheets
(In thousands, except share
and per share amounts)
(Unaudited)
September 30,
December 31,
2024
2023
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
58,585
$
137,329
Restricted cash, current
465
550
Short-term investments
125,491
116,586
Accounts receivable, net
48,263
27,660
Inventories
85,213
45,579
Prepaid expenses and other current
assets
9,935
9,308
Current assets of discontinued
operations
1,735
1,853
Total current assets
329,687
338,865
Property and equipment, net
15,897
17,225
Intangible assets, net
7,634
9,270
Operating lease right-of-use assets
47,996
53,167
Finance lease right-of-use asset
13,100
19,815
Restricted cash, non-current
5,564
5,995
Finance lease prepaid expense
41,514
32,383
Other non-current assets
172
321
Non-current assets of discontinued
operations
—
1,413
TOTAL ASSETS
$
461,564
$
478,454
LIABILITIES AND STOCKHOLDERS’
DEFICIT
CURRENT LIABILITIES
Accounts payable
$
12,335
$
13,554
Accruals and other current liabilities
34,022
52,863
Deferred revenue, current
6,329
10,737
Operating lease liabilities, current
6,372
5,703
Finance lease liability, current
10,841
2,651
Debt, current
10,150
2,500
Current liabilities of discontinued
operations
—
1,216
Total current liabilities
80,049
89,224
Debt, non-current
421,041
426,595
Deferred revenue, non-current
85,550
70,419
Operating lease liabilities,
non-current
35,043
40,985
Other non-current liabilities
2,911
2,835
TOTAL LIABILITIES
624,594
630,058
STOCKHOLDERS’ DEFICIT
Preferred stock, par value $0.001 per
share — 5,000,000 shares authorized, and no shares issued and
outstanding as of September 30, 2024 and December 31, 2023
—
—
Common stock, par value $0.001 per share —
190,000,000 shares authorized as of September 30, 2024 and December
31, 2023; 104,895,611 and 87,962,765 shares issued and outstanding
as of September 30, 2024 and December 31, 2023, respectively
105
88
Additional paid-in capital
2,043,893
1,926,654
Accumulated other comprehensive gain
72
14
Accumulated deficit
(2,207,100
)
(2,078,360
)
TOTAL STOCKHOLDERS’ DEFICIT
(163,030
)
(151,604
)
TOTAL LIABILITIES AND STOCKHOLDERS’
DEFICIT
$
461,564
$
478,454
REVANCE THERAPEUTICS,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except share
and per share amounts)
(Unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
Revenue:
Product revenue, net
$
58,827
$
54,109
$
175,874
$
154,160
Collaboration revenue
1,052
3
1,330
139
Total revenue, net
59,879
54,112
177,204
154,299
Operating expenses:
Cost of product revenue (exclusive of
amortization)
17,633
16,821
50,179
46,915
Selling, general and administrative
62,578
65,791
197,314
202,523
Research and development
11,379
8,688
41,674
43,844
Amortization
545
374
1,636
1,636
Total operating expenses
92,135
91,674
290,803
294,918
Loss from continuing operations
(32,256
)
(37,562
)
(113,599
)
(140,619
)
Interest income
2,631
3,733
8,806
9,851
Interest expense
(6,732
)
(5,093
)
(17,667
)
(13,958
)
Other expense, net
(258
)
(223
)
(1,149
)
(1,056
)
Loss from continuing operations before
income taxes
(36,615
)
(39,145
)
(37,469
)
(58,166
)
Income tax provision
(1,500
)
(300
)
(1,500
)
(300
)
Net loss from continuing operations
(38,115
)
(39,445
)
(125,109
)
(146,082
)
Net loss from discontinued operations
—
(101,731
)
(3,631
)
(122,205
)
Total net loss
(38,115
)
(141,176
)
(128,740
)
(268,287
)
Unrealized gain
98
48
58
361
Comprehensive loss
$
(38,017
)
$
(141,128
)
$
(128,682
)
$
(267,926
)
Basic and diluted net loss per share:
Continuing operations
$
(0.37
)
$
(0.46
)
$
(1.25
)
$
(1.74
)
Discontinued operations
—
(1.17
)
(0.04
)
(1.46
)
Total net loss per basic and diluted
share
$
(0.37
)
$
(1.63
)
$
(1.29
)
$
(3.20
)
Basic and diluted weighted-average number
of shares used in computing net loss per share
104,212,891
86,613,425
100,016,088
83,816,577
REVANCE THERAPEUTICS,
INC.
Product Revenue Breakdown
(Unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
(in thousands)
2024
2023
2024
2023
Product:
RHA® Collection of dermal fillers
$
30,503
$
32,133
$
96,704
$
94,180
DAXXIFY®
28,324
21,976
79,170
59,980
Total product revenue, net
$
58,827
$
54,109
$
175,874
$
154,160
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241107685733/en/
Investors Laurence Watts, New Street Investor Relations
laurence@newstreetir.com
Media Revance@evolvemkd.com
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