– Q4 DAXXIFY® volume sold up 22% over Q3, reflecting positive
feedback on the product’s performance profile and the new pricing
strategy.
– Preliminary unaudited Q4 and full year 2023 product revenue
(DAXXIFY and RHA® Collection) of between $58 million and $59
million and $212 million and $213 million, representing
approximately 28% and 80% YoY growth, respectively.
– Provides 2024 product revenue guidance of at least $280
million, supporting blockbuster potential in U.S. aesthetics.
– 2024 GAAP and non-GAAP operating expense guidance expected to
be below 2023 levels; management expects to achieve positive
Adjusted EBITDA in 2025.
Revance Therapeutics, Inc. (NASDAQ:RVNC) today provided a
corporate update as well as preliminary unaudited fourth quarter
and full year 2023 financial results, 2024 guidance and financial
outlook. A supplemental presentation can also be found on the
company’s investor relations website.
"We are very pleased with the continued growth and adoption of
our innovative product portfolio which reaffirms our conviction in
our blockbuster opportunity in aesthetics,” said Mark J. Foley,
Chief Executive Officer of Revance. “Importantly, the new pricing
strategy for DAXXIFY continues to deliver encouraging results while
garnering strong engagement and support from injectors.
Specifically, DAXXIFY volume sold in Q4 increased 22% on a
quarter-over-quarter basis, with more than two-thirds of the
revenue coming from reordering accounts. We remain very encouraged
by the trends that we are seeing, which we believe reflect growing
injector confidence in the product’s duration, onset, and
appearance of improved skin quality. Our strong base of over 3,000
DAXXIFY accounts as of the end of Q4 provides us with significant
runway to increase adoption. Combined with the continued growth of
the RHA Collection, we believe we are well positioned to achieve at
least $280 million in DAXXIFY and RHA sales in 2024.”
Foley continued, “In 2024, we remain focused on partnering with
healthcare providers while executing on our aesthetics and
therapeutics priorities. Our disciplined capital allocation
supports these objectives through focused investments in our
aesthetics and therapeutics businesses and our ability to achieve
positive Adjusted EBITDA in 2025. I’d like to thank the entire
Revance team for their continued hard work and dedication and I
look forward to a promising year ahead.
“We also announced today that Dustin Sjuts will be stepping down
from his role as President, effective March 31, 2024. On behalf of
the Board and management, I would like to thank him for his
significant contributions to the company over the past six years
serving in various leadership capacities. He led Revance’s
transition from clinical stage to commercial, including supporting
key regulatory milestones for DAXXIFY in aesthetics and
therapeutics, establishing our sales infrastructure while
navigating the COVID-19 pandemic and leading the launch of our
aesthetics portfolio. We wish Dustin the best in his new
endeavors.”
Corporate Updates and Preliminary Q4 and FY 2023 Financial
Results:
- DAXXIFY (Aesthetics):
- Revance expects Q4 2023 preliminary unaudited DAXXIFY revenue
to be between $23.5 million and $24.5 million. Full year 2023
preliminary unaudited DAXXIFY revenue is expected to be between
$83.5 million and $84.5 million.
- Total preliminary unaudited revenue from the first five
quarters of launch for DAXXIFY is expected to be $95 million,
surpassing the combined sales of the first five quarters of launch
for the last three neuromodulators to enter the market.
- Q4 DAXXIFY volume sold increased 22% over Q3, with revenue
offset by a lower average selling price.
- Revenue from reordering accounts represented more than
two-thirds of total DAXXIFY revenue in the fourth quarter.
- The company ended the fourth quarter with over 3,000 accounts
that have ordered DAXXIFY.
- RHA Collection:
- Revance expects preliminary unaudited fourth quarter 2023 RHA
Collection revenue to be between $34 million and $35 million, and
full year preliminary unaudited 2023 RHA Collection revenue to be
between $128 million and $129 million.
- In October, the FDA approved Teoxane SA’s Pre-Marketing
Approval (PMA) application to expand the indication for RHA 3 to
include injection into the vermillion body, vermillion border and
oral commissure for lip augmentation and lip fullness in adults
aged 22 years and older. RHA 3 was previously approved for the
correction of moderate to severe dynamic wrinkles and folds, such
as nasolabial folds.
- Aesthetic Accounts:
- Total aesthetic accounts across DAXXIFY and RHA Collection
totaled over 7,000 as of the end of Q4 2024. Accounts that have
ordered DAXXIFY totaled over 3,000 as of the end of Q4 2024.
- DAXXIFY (Therapeutics):
- The DAXXIFY cervical dystonia (CD) PrevU program continues to
advance. Since the program's initiation on September 1st, 2023,
approximately 250 patients have been treated with DAXXIFY across 30
practices, allowing Revance to collect valuable real-world clinical
insights to inform commercial launch. Coverage for DAXXIFY for
cervical dystonia has been secured for approximately 100 million
commercial lives, which includes 8 out of the top 10 payers in the
country, underscoring the product’s differentiated clinical profile
and potential in the therapeutics market. The company expects to
receive a permanent J-Code for DAXXIFY in early 2024, prior to
commercial launch in mid-2024.
2024 Strategic Priorities:
- Aesthetics: Grow DAXXIFY share by highlighting the value
proposition of the product’s peptide formulation, long-duration,
fast-onset, and the appearance of improved skin quality; strengthen
professional partnerships through robust engagement initiatives and
thought leadership efforts; grow share of RHA Collection with
continued training and education, indication expansion and
realization of portfolio synergies.
- Therapeutics: Successfully complete the DAXXIFY CD PrevU
program; leverage learnings and real-world clinical insights to
support commercial success; secure ~50% commercial coverage by
commercial launch; launch DAXXIFY for cervical dystonia mid-year
2024.
- Focused and disciplined capital allocation:
- Revance expects U.S. generally accepted accounting principles
(GAAP) and non-GAAP operating expenses in 2023 to be within its
previously announced GAAP and non-GAAP operating expense guidance
ranges of between $545 million to $585 million and $315 million to
$335 million, respectively.
- Revance is on track to fully exit its OPUL® payments business
by the end of Q1 2024, enabling greater focus on the company’s
strategic priorities in aesthetics and therapeutics while
generating up to approximately $20 million in annual savings. As a
result of the exit of OPUL and prioritization of capital
allocation, the company expects its 2024 GAAP and non-GAAP
operating expense guidance to be below 2023 levels.
- With preliminary, unaudited cash, cash equivalents, and
short-term investments of approximately $250 million as of December
31, 2023, and anticipated revenues and expenditures, management
projects that the company will be funded to cash flow break-even
and expects to reach positive Adjusted EBITDA in 2025.
- Enhanced and streamlined organizational structure:
- With the appointment of Erica Jordan as Chief Commercial
Officer, Aesthetics in the fourth quarter of 2023, the commercial
organization was restructured to integrate and streamline
marketing, sales, commercial operations, professional partnerships,
strategy, data analytics and professional engagement functions. The
new structure is designed to support the company’s strategic
priorities by enhancing execution and performance while improving
efficiencies.
- As part of the company’s efforts to streamline the
organization, Revance announced today that Dustin Sjuts, President,
will be stepping down from his role, effective March 31, 2024.
2024 Guidance and Financial Outlook:
- Product Revenue Guidance. Revance expects 2024 total
product revenue, which includes sales of DAXXIFY and the RHA
Collection, to be at least $280 million. Product revenue guidance
for 2024 reflects the following assumptions:
- DAXXIFY volume growth through deeper and broader account
penetration, incorporating new pricing strategy.
- Continued market share growth of the RHA Collection.
- Modest revenue contribution from a measured DAXXIFY cervical
dystonia launch, which is expected to occur mid-year 2024.
- Operating Expense Guidance. The company expects its GAAP
and non-GAAP operating expenses for 2024 to be in the range of $460
million to $490 million, and $290 million to $310 million,
respectively, the mid-points of which represent a ~16% and ~8%
reduction from the midpoints of the company's 2023 operating
expense guidance ranges. The reduction primarily reflects the exit
of the company's OPUL payments business and prioritization of
capital to support growth in aesthetics and the launch of DAXXIFY
in cervical dystonia.
- Financial Outlook. Revance expects to achieve positive
Adjusted EBITDA in 2025 by driving top-line growth through focused
investments in aesthetics and therapeutics while exercising
disciplined expense management and capital allocation. Longer-term,
the company reaffirms its blockbuster potential in U.S. aesthetics
supported by its innovative product portfolio, including DAXXIFY,
the first and only long-lasting peptide formulated neuromodulator
and the RHA Collection, the least modified collection of hyaluronic
acid dermal fillers on the market, delivering natural looking
results. The company expects to increase revenue growth through
deeper and broader account penetration of DAXXIFY and RHA and the
introduction of new RHA indications and products. Further, the
company believes meaningful upside can be achieved with the
expansion of DAXXIFY into therapeutics and internationally, as well
as the company’s strategic partnerships with Fosun and Viatris –
representing at least $5.0 billion in future growth
opportunities1.
DAXXIFY® (daxibotulinumtoxinA-lanm) injection
IMPORTANT SAFETY INFORMATION INDICATIONS
DAXXIFY® (daxibotulinumtoxinA-lanm) injection is an
acetylcholine release inhibitor and neuromuscular blocking agent
indicated for the temporary improvement in the appearance of
moderate to severe glabellar lines associated with corrugator
and/or procerus muscle activity in adult patients and for the
treatment of cervical dystonia in adults.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DAXXIFY® and all
botulinum toxin products may spread from the area of injection to
produce symptoms consistent with botulinum toxin effects. These
symptoms have been reported hours to weeks after injection.
Swallowing and breathing difficulties can be life threatening and
there have been reports of death. DAXXIFY® is not approved for the
treatment of spasticity or any conditions other than cervical
dystonia and glabellar lines.
IMPORTANT SAFETY INFORMATION
Contraindications DAXXIFY® contraindications include
hypersensitivity to any botulinum toxin preparation or any of the
components in the formulation and infection at the injection
site(s).
Warnings and Precautions Please refer to Boxed Warning
for Distant Spread of Toxin Effect.
The potency units of DAXXIFY® are not interchangeable with
preparations of other botulinum toxin products. Recommended dose
and frequency of administration should not be exceeded. Patients
should seek immediate medical attention if respiratory, speech or
swallowing difficulties occur. Use caution when administering to
patients with pre-existing cardiovascular disease. Concomitant
neuromuscular disorders may exacerbate clinical effects of
treatment.
Adverse Reactions The most commonly observed adverse
reactions are:
Glabellar lines (≥1%): headache (6%), eyelid ptosis (2%) and
facial paresis (1%). Cervical dystonia (≥5%): headache (9%),
injection site pain (8%), injection site erythema (5%), muscular
weakness (5%), and upper respiratory tract infection (5%).
Drug Interactions Co-administration of DAXXIFY® and
aminoglycoside antibiotics, anticholinergic agents or any other
agents interfering with neuromuscular transmission or muscle
relaxants should only be performed with caution as the effect of
DAXXIFY® may be potentiated. The effect of administering different
botulinum neurotoxins during course of treatment with DAXXIFY® is
unknown.
Use in Specific Populations DAXXIFY® is not recommended
for use in children or pregnant women.
Please see DAXXIFY® full Prescribing
Information, including Boxed Warning and Medication
Guide.
To report side effects associated with DAXXIFY®, please visit
safety.revance.com, or call 1-877-373-8669. You may also report
side effects to the FDA at 1-800-FDA-1088 or visit
www.fda.gov/medwatch.
About DAXXIFY®
DAXXIFY® (daxibotulinumtoxinA-lanm) for injection is the first
and only FDA approved long-lasting, peptide formulated
neuromodulator product with approved indications in the U.S. for
the temporary improvement of glabellar lines (frown lines) and for
the treatment of cervical dystonia in adults. DAXXIFY® is powered
by Peptide Exchange Technology™, Revance's proprietary, synthetic,
35-amino-acid stabilizing excipient, and is developed free of human
serum albumin or animal-based components.2-6 Manufactured in the
U.S., DAXXIFY® is the first true innovation in neuromodulator
product formulation in over 30 years.
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 in the U.S. 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 is headquartered in Nashville, Tenn., with additional
office locations in Newark and Irvine, Calif. Learn more at
www.Revance.com, www.RevanceAesthetics.com,
www.DAXXIFY.com, www.hcp.DAXXIFYTherapy.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 our guidance,
including 2024 revenue and operating expense guidance, anticipated
product revenue and volume growth, 2023 product revenue and
operating expense guidance, and related guidance assumptions; our
blockbuster potential; our expected cash flow breakeven; our
ability and timing related to achieving positive Adjusted EBITDA;
our ability to execute our strategic priorities; our potential to
strengthen relationships with healthcare providers; the impact of
our pricing strategy on our results, customer support and DAXXIFY
adoption; our ability to grow market share; the timing and plans
related to the launch of DAXXIFY for the treatment of cervical
dystonia; including expectations regarding receipt of a J-Code; our
potential to obtain approval for DAXXIFY in additional therapeutics
indications; the commercial success of DAXXIFY; the exit of the
OPUL payments business and anticipated cost savings generated by
the exit; international expansion; RHA® Collection of dermal
fillers pipeline expansion; the growth potential of our products
and our business; our runway to increase product adoption; the
potential to set a new standard of care; the potential benefits of
our products; the extent to which our products are considered
innovative and differentiated; our strategic partnerships; the
anticipated approvals of DAXXIFY and 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, and timeline, 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 and the timing of
events 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, cost savings related to the
divestiture of the OPUL payments business and supply chain and
operational efficiencies; our financial performance and the
economics of DAXXIFY and the RHA Collection of dermal fillers; the
extent of future impairment charges; 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; our ability to effectively manage the
exit of the OPUL payments business; 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, 2023, and including, without limitation, our Form
10-Qs for the quarters ended March 31, 2023, June 30, 2023 and
September 30, 2023, filed with the SEC on May 9, 2023, August 8,
2023 and November 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 preliminary and unaudited non-GAAP
financial measures and forward-looking non-GAAP financial measures
in this release, including Adjusted EBITDA and non-GAAP operating
expense. Adjusted EBITDA is defined as earnings before interest,
taxes, depreciation and amortization, stock-based compensation and
extraordinary items such as restructuring and impairment charges.
Non-GAAP operating expense excludes costs of revenue, depreciation,
amortization, stock-based compensation, and restructuring and
impairment charges. The Company excludes costs of revenue,
depreciation, amortization, stock-based compensation and
extraordinary items like restructuring and impairment charges
because management believes the exclusion of these items is helpful
to investors to evaluate the Company’s recurring operational
performance. Company 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.
Revance is unable to reconcile preliminary unaudited and
forward-looking non-GAAP operating expense or forward-looking
Adjusted EBITDA to the most directly comparable GAAP measure
because the items that are being excluded from the non-GAAP
financial measure are difficult to predict and a reconciliation or
a range of results could lead to disclosure that would be imprecise
or potentially misleading. Material changes to any one of the
exclusions could have a significant effect on our preliminary
estimates, forward-looking estimates and GAAP results. Such items
include costs of revenue, depreciation, amortization and
stock-based compensation, as well as extraordinary items like
restructuring and impairment charges.
Sources
- Includes U.S. therapeutic market of $2.2 billion based on
Decision Resources Group Market Analysis 2024; International toxin
market (aesthetic and therapeutic) of $2.2 billion, based on
Decision Resources Group Therapeutic Botulinum Toxin Market
Analysis Global 2024 and Decision Resources Group Aesthetics
Injectables Botulinum Toxin Reports 2024; Fosun partnership
opportunity of up to $223 million in milestone payments and low to
high-teens royalties; and Viatris partnership opportunity of up to
$225 million in milestone payments and low to mid-teens royalties
for key markets.
- Comella C, Jankovic J, Hauser R, et al. Efficacy and Safety of
DaxibotulinumtoxinA for Injection (DAXI) in Cervical Dystonia:
ASPEN-1 Phase 3 Randomized Controlled Trial. In review.
- Data on file. ASPEN CSR. Revance. Newark, CA: Revance
Therapeutics, Inc., 2018.
- DAXXIFY. Prescribing Information. Revance Therapeutics, Inc,
2022.
- Fabi SG, Cohen JL, Green LJ, et al. DaxibotulinumtoxinA for
Injection for the treatment of glabellar lines: efficacy results
from SAKURA 3, a large, open label, phase 3 safety study. Dermatol
Surg. 2020;47(1):48-54.
- Waugh JM, Lee J, Dake MD, Browne D. Nonclinical and clinical
experiences with CPP-based self-assembling peptide systems in
topical drug development. Methods Mol Biol. 2011;683:553-572.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240108972078/en/
Investors Jessica Serra, 510-279-6886
jessica.serra@revance.com or Laurence Watts, 619-916-7620
laurence@gilmartinir.com
Media Sara J. Fahy, 949-887-4476 sfahy@revance.com
Revance Therapeutics (NASDAQ:RVNC)
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Revance Therapeutics (NASDAQ:RVNC)
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