Revance Therapeutics, Inc. (RVNC) announced that the
company is hosting its Investor Day today, September 19, 2023, from
9:30 am ET to 12:00 pm ET.
The Investor Day will include management presentations on
Revance’s vision and strategy, Revance Aesthetics overview and
launch progress, DAXXIFY® KOL panel, Revance Therapeutics
commercial launch plans, future growth opportunities, and financial
review and outlook. The presentations will be followed by a Q&A
session.
Key Corporate Updates
- Real-world feedback reinforces DAXXIFY’s differentiated
performance profile and continued opportunity for long-term,
broad-based adoption.
- New pricing program for DAXXIFY®, which became effective
September 1, 2023, positions the product to be priced competitively
to Botox® Cosmetic for the provider, to further accelerate market
share expansion.
- Expects long-term supply chain strategy to support U.S.
DAXXIFY® adjusted gross margin of over 80%.
- Continued confidence in blockbuster potential in U.S.
aesthetics product portfolio.
- Provides update on DAXXIFY® cervical dystonia PrevU program and
commercial launch plans, early feedback from payers and market
access dynamics.
- Exiting OPUL® payments business by the end of Q1 2024 to
prioritize capital allocation and streamline operations. Expects to
free up approximately $20 million a year for reinvestment in
DAXXIFY® aesthetics and therapeutic commercial launches.
- The company provides additional updates to its 2023 financial
guidance:
- With current cash, cash equivalents, and short-term investments
of $319.7 million as of June 30, 2023, and the additional $50
million in notes funded through Athyrium Capital in August 2023,
the company is funded to breakeven and expects to be Adjusted
EBITDA positive in 2025.
- Expects to provide product revenue guidance in first half
2024.
- Q3 2023 product revenue has the potential to be around Q2 2023
levels based on the recent roll out of the new pricing program and
traditional seasonality in facial injectables.
- Revised 2023 GAAP and Non-GAAP operating expense guidance to
reflect the company’s exit of the OPUL® payments business:
- GAAP operating expenses updated from $460 million – $480
million to $545 million – $585 million.
- Non-GAAP operating expenses updated from $320 million – $340
million to $315 million – $335 million.
- Non-GAAP research and development expenses updated from $80
million – $90 million to $75 million – $85 million.
Interested parties can access the live webcast for this event
from the Events and Presentations section of the company’s
Investor Relations webpage.
A webcast replay will be available beginning September 19, 2023,
at 12:00 p.m. PT / 3:00 p.m. ET. To access the replay, please
register via the webcast link on the events page.
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” and the Revance logo, and DAXXIFY® are registered
trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid®
and RHA® are trademarks of TEOXANE SA. BOTOX® is a registered
trademark of Allergan, Inc.
Forward-Looking Statements
Any statements in this press release that are not statements of
historical fact, including statements related to our adjusted gross
margins; 2023 product revenue, operating expenses and research and
development expense guidance and our guidance plans; our funding to
cash flow breakeven; our capital requirements; the timing for
reaching positive adjusted EBITDA; projected loss from the services
segment; the plans for the OPUL® business and the anticipated cash
to be freed up from the exit of the OPUL® payments business; our
ability to successfully commercialize DAXXIFY®, drive adoption,
take market share and grow; our blockbuster potential; the
competitive pricing of DAXXIFY®; the potential benefits and
performance of our products; the efficacy, duration and safety of
DAXXIFY®; our ability to set a new standard of care; potential
benefits of our products to physicians and patients; development of
a biosimilar to onabotulinumtoxinA for injection with Viatris; and
our business and marketing strategy, timeline and other goals, and
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, 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, 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 payors for DAXXIFY®;the proper
training and administration of our products by physicians and
medical staff; our ability to gain acceptance from physicians in
the use of DAXXIFY® for therapeutic indications; 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 expectations
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 and June 30, 2023,
filed with the SEC on May 9, 2023 and 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
The Company has presented certain preliminary and unaudited
non-GAAP financial measures in this press release, including
non-GAAP R&D expense, non-GAAP operating expense, adjusted
gross margin and adjusted EBITDA. Non-GAAP R&D expense excludes
depreciation, amortization, non-cash stock-based compensation and
restructuring charges. Non-GAAP operating expense excludes costs of
revenue, depreciation, amortization, stock-based compensation, and
restructuring and impairment charges. Adjusted gross margin is
defined as gross margin, excluding stock-based compensation,
depreciation and amortization. Adjusted EBITDA is defined as
earnings before interest, taxes, depreciation and amortization,
stock-based compensation and extraordinary items such as
restructuring and impairment charges. Actual non-GAAP R&D
expense, non-GAAP operating expense and adjusted EBITDA may exclude
extraordinary items not indicative of our ongoing operating
performance such as 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.
Certain non-GAAP measures included in this press 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, stock-based compensation as well as extraordinary
items like restructuring and impairment charges. The unavailable
information could have a significant impact on the Company’s GAAP
financial results.
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version on businesswire.com: https://www.businesswire.com/news/home/20230919664980/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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