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 $5.0 billion in future growth opportunities1.
DAXXIFY$(R)$ (daxibotulinumtoxinA-lanm) injection IMPORTANT SAFETY INFORMATION INDICATIONS
DAXXIFY(R) (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(R) 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(R) is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines. ------------------------------------------------------------------------------
IMPORTANT SAFETY INFORMATION
Contraindications
DAXXIFY(R) 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(R) 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(R) 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(R) may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DAXXIFY(R) is unknown.
Use in Specific Populations
DAXXIFY(R) is not recommended for use in children or pregnant women.
Please see DAXXIFY(R) full Prescribing Information, including Boxed Warning and Medication Guide.
To report side effects associated with DAXXIFY(R), 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(R)
DAXXIFY(R) (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(R) is powered by Peptide Exchange Technology$(TM)$, 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(R) 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(R) 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(R) 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.
(MORE TO FOLLOW) Dow Jones Newswires
January 08, 2024 08:02 ET (13:02 GMT)
Comments