- TEOXANE SA RHA® portfolio: first and only
range of FDA-approved dermal fillers for correction of dynamic
wrinkles -
- Revance gains access to the growing $1.1B
U.S. filler market with three differentiated products, and plans to
launch in second quarter 2020 -
- Fast-tracks Revance’s commercial
organization, and strengthens the anticipated launch of
DaxibotulinumtoxinA for Injection (DAXI), the company’s
next-generation neuromodulator -
- Conference call and webcast today at 8:30
a.m. ET -
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company pioneering new innovations in neuromodulators for aesthetic
and therapeutic indications, today announced the signing of a U.S.
distribution agreement with TEOXANE SA , making Revance the
exclusive commercialization partner of the Swiss company’s modern
and innovative Resilient Hyaluronic Acid® (RHA®) technology.
Revance will be holding a conference call and webcast at 8.30 a.m.
ET today to discuss the agreement, strategic rationale, and
commercialization plans.
TEOXANE’s RHA® and the Distribution Agreement
Under the distribution agreement announced today, Revance will
gain immediate and exclusive rights to commercialize TEOXANE’s RHA®
line of fillers in the U.S., starting with the U.S. Food and Drug
Administration (FDA)-approved RHA® 2, RHA® 3, and RHA® 4 products,
which include lidocaine. The RHA® line provides physicians with a
broad range of uniquely designed gels for individualized treatment
in the face. The RHA® line was designed using a patented
crosslinking method that preserves the hyaluronic acid network for
correction of moderate-to-severe dynamic facial wrinkles and folds.
The formulation optimizes strength, stretch and tissue integration.
Filler injections with RHA® gels have been shown to be safe and
well tolerated.2
Revance believes the RHA® dermal filler line, in combination
with the company’s next-generation neuromodulator,
DaxibotulinumtoxinA for Injection (DAXI), will position the company
to be the innovation leader in the $2 billion U.S. facial
injectable market.
The agreement also includes a fourth product, RHA® 1, currently
in clinical trials in the U.S. with FDA approval anticipated in
2021, and includes an ongoing collaboration with TEOXANE SA for a
robust pipeline of additional indications and next-generation
dermal filler technologies. Additionally, the agreement contains a
right of first negotiation to access TEOXANE’s novel cosmeceutical
line that incorporates its propriety RHA® technology.
In consideration for the U.S. distribution rights for all of the
above mentioned, Revance has agreed to issue 2.5 million shares of
Revance common stock to TEOXANE SA.
“This is a transformational deal for Revance, giving us access
to the fast-growing, billion-dollar U.S. dermal filler market, with
a line of highly differentiated fillers that are complementary to
our first and only, long-lasting neuromodulator,” said Mark Foley,
President and Chief Executive Officer of Revance. “Valérie Taupin
is a pioneer in the dermal filler market and her company, TEOXANE
SA, is dedicated to creating new innovations and providing
high-quality HA products to the aesthetic market. Importantly, both
these RHA® fillers and DAXI have the potential to deliver unique
customer experiences. This deal provides commercial synergies,
organizational leverage and fast-tracks the build-out of our sales
organization. It also creates a broad foundation from which to
launch DAXI upon anticipated approval later this year.”
“We are eager to introduce U.S. physicians and consumers to our
exciting, highly differentiated RHA® range of dermal fillers,” said
Valérie Taupin, Founder and Chief Executive Officer of TEOXANE SA.
“The combination of our RHA filler range with Revance’s
cutting-edge neuromodulator, DAXI, will create a premium facial
injectable portfolio that we believe will be unrivaled in the
industry. TEOXANE SA and Revance have a shared passion for
innovation, quality and excellence in aesthetic results.”
Revance has begun the build-out of a U.S. commercial
organization and is targeting the introduction of the TEOXANE RHA®
fillers in the second quarter of 2020, followed by the launch of
DAXI, upon regulatory approval, in the second half of 2020.
According to Dustin Sjuts, Chief Commercial Officer, Aesthetics and
Therapeutics, “We’re excited to partner with TEOXANE SA to launch
this innovative Swiss technology in the U.S. Their next-generation,
novel filler portfolio, sold in combination with DAXI, will
position Revance as the premium brand in the U.S. aesthetics facial
injectable market.”
Conference Call
Individuals interested in listening to the conference call may
do so by dialing (855) 453-3827 for domestic callers, or (484)
756-4301 for international callers and reference conference ID:
7659336; 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 January 10, 2020 at 8:30 a.m. PT/11:30
a.m. ET to January 11, 2020 at 8:30 a.m. PT/11:30 a.m. ET. To
access the replay, dial (855) 859-2056 or (404) 537-3406 and
reference conference ID: 7659336. The webcast will be available in
the investor relations section on the company's website for 30 days
following the completion of the call.
About Dermal Fillers in the United States
Dermal fillers are injected into the superficial and deep layers
of the skin to restore volume, smooth lines, provide facial lift
and contour, plump the lips or improve the appearance of facial
scars commonly caused by acne. Hyaluronic acid (HA) dermal fillers
represent 88% of the total U.S. dermal filler market and are the
second most frequently preformed non-surgical aesthetic treatment
after neuromodulator injections. The American Society of Aesthetic
Plastic Surgery (ASAPS) reported HA dermal filler procedures have
increased by more than 58% since 2014, with an estimated 810,240 HA
dermal filler procedures performed in 2018.**
Hyaluronic acid is naturally found in the body, primarily in the
skin, joints and connective tissue. With age, human skin loses its
ability to produce HA, resulting in loss of volume, firmness and
elasticity. HA dermal fillers are manufactured from synthesized
hyaluronic acid crosslinked to significantly enhance durability in
the skin. These products can restore lost volume for six to 12
months or longer before the body gradually and naturally absorbs
the HA. *** Most HA dermal fillers also contain lidocaine to help
minimize discomfort during and after treatment.
The US dermal filler market is estimated to be $1.1 billion in
2019 and is expected to double to $2.2 billion by 2026.****
About TEOXANE SA
TEOXANE Laboratories, a private company, was established in
Geneva in 2003, by Madame Valérie Taupin and specializes in the
design and manufacturing of hyaluronic acid-based dermal fillers
and cosmeceuticals. As a result of our uncompromising commitment to
innovation, quality and patient satisfaction, TEOXANE Laboratories
is now among the top hyaluronic acid-based dermal filler
manufacturers in the world, with products across more than 90
countries.
Moreover, with its scientific expertise, TEOXANE is one of the
first Swiss laboratories offering a range of innovative
cosmeceutical care formulated with cross-linked hyaluronic acid
from its patented process, RHA resilient hyaluronic acid®. The
cosmeceutical range, TEOXANE, is designed for patients who have
undergone aesthetic medical procedures and continue their skin care
with a targeted cosmetic routine designed specifically for them.
For more information go to www.TEOXANE.com.
About Revance Therapeutics, Inc.
Revance Therapeutics is a Silicon Valley-based biotechnology
company, pioneering new innovations in neuromodulators for
aesthetic and therapeutic indications. Revance’s lead product
candidate, DaxibotulinumtoxinA for Injection (DAXI), combines a
proprietary stabilizing peptide excipient with a highly purified
botulinum toxin that does not contain human or animal-based
components. Revance has successfully completed a Phase 3 program
for DAXI in glabellar (frown) lines and is pursuing U.S. regulatory
approval in 2020. Revance is also evaluating DAXI in the full upper
face, including glabellar lines, forehead lines and crow’s feet, as
well as in three therapeutic indications - cervical dystonia, adult
upper limb spasticity and plantar fasciitis, with plans to study
migraine. Beyond DAXI, Revance has begun development of a
biosimilar to BOTOX®, which would compete in the existing
short-acting neuromodulator marketplace. Revance is dedicated to
making a difference by transforming patient experiences. For more
information or to join our team visit us at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc. 1 RHA® is a trademark of
TEOXANE SA. RHA® 2, RHA® 3, RHA® 4 are products of TEOXANE SA. They
are class III medical devices and have received FDA approval but
are not yet commercialized in the United States. The United States
Federal law restricts these devices to sale by or on the order of a
physician or license practitioner. RHA® 2, RHA® 3 and RHA® 4 are
indicated for the correction of moderate to severe dynamic facial
wrinkles and folds, such as nasolabial folds (NLF), in adults aged
22 years or older. RHA® 2, RHA® 3, and RHA® 4 are sterile gels
containing crosslinked hyaluronic acid in physiological buffer and
0.3% lidocaine hydrochloride to reduce pain on injection. RHA® 2,
RHA® 3 and RHA® 4 are contraindicated in patients with previous
hypersensitivity to local anesthetics of the amide type, such as
lidocaine. Please refer to the Instructions for Use
(https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170002C.pdf). It
is the practitioner’s full responsibility to read and inform the
patient about contraindications, warnings, precautions, risks and
benefits. 2 RHA® 2 and RHA® 3 clinical study G140028: Study 1302: A
Controlled, Randomized, Double- Blinded, Within-Subject,
Multicenter, Prospective Clinical Study of TEOSYAL® RHA 2 and
TEOSYAL® RHA 3 versus Juvéderm® Ultra XC in the Treatment of
Moderate to Severe Nasolabial Folds. RHA® 4 clinical study G140106:
Study 1402: A Controlled, Randomized, Double- Blinded, Within
Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA 4
versus Perlane-L® in the Treatment of Moderate to Severe Nasolabial
Folds. *Sources: Medical Insight, Inc. | Global Facial Injectables
Market Study | December 2018; DRG Report Aesthetic Injectables |
Market Insights | Europe | 2020 France, Germany, Italy, Spain, UK,
Author: Diksha Garg Published: November 2019 – Table 21 **Source:
https://www.surgery.org/sites/default/files/ASAPS-Stats2018_0.pdf
ASAPS-Stats2018-Proof5e - surgery.org ***Source:
https://www.fda.gov/medical-devices/cosmetic-devices/dermal-fillers-approved-center-devices-and-radiological-health
****Source: DRG – Medtech 360 "Aesthetic Injectables | Market
Analysis | US | 2019", Medical Insights – "The Global Aesthetics
Market Study – XVII", ASPS – "Plastic Surgery Statistics" (2019
report) “Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc. BOTOX® is a registered
trademark of Allergan, Inc. TEOXANE® is a registered trademark of
TEOXANE SA.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements related to the anticipated strategic and
financial benefits of our exclusive distribution agreement with
TEOXANE SA; commercial acceptance and therapeutic potential of
TEOXANE’s dermal fillers, including market size and anticipated
adoption rates; statements about our business strategy, timeline
and other goals and market for our anticipated products, plans and
prospects, including our pre-commercialization plans; statements
about the timing and our ability to obtain regulatory approval and
launch products, including with respect to DaxibotulinumtoxinA for
Injection to treat glabellar (frown) lines; and potential benefits
of our drug product candidates and our technologies.
Forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from our
expectations. These risks and uncertainties include, but are not
limited to: anticipated financial and other benefits of the
distribution agreement with TEOXANE SA, including our ability to
realize anticipated synergies and successfully commercialize
TEOXANE’s dermal fillers; the outcome, cost, and timing of our
product development activities and clinical trials; our ability to
obtain and maintain regulatory approval of our drug product
candidates, including with respect to DAXI for Injection to treat
glabellar (frown) lines; our ability to obtain funding for our
operations and achieve our goals; our plans to research, develop,
and commercialize our drug product candidates; our ability to
successfully compete with treatments and therapies, our ability to
achieve, and the rate and degree of market acceptance and adoption
of our drug product candidates; unanticipated costs or delays in
research, development, and commercialization efforts; the size and
growth potential of the markets for our drug product candidates;
our ability to successfully manufacture and commercialize our drug
product candidates and the timing of commercialization activities;
our ability to develop sales and marketing capabilities; the
accuracy of our estimates regarding expenses, future revenues and
capital requirements; our ability to continue obtaining and
maintaining intellectual property protection for our drug product
candidates; 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 Revance’s periodic filings with the Securities and
Exchange Commission (the "SEC"), including factors described in the
section entitled "Risk Factors" of our quarterly report on Form
10-Q filed November 4, 2019. These forward-looking statements speak
only as of the date hereof. Revance disclaims any obligation to
update these forward-looking statements.
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INVESTORS Revance Therapeutics, Inc.: Jeanie Herbert,
714-325-3584 jherbert@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 or General Media: Y&R: Jenifer Slaw,
347-971-0906 jenifer.slaw@YR.com or Trade Media: Nadine Tosk,
504-453-8344 nadinepr@gmail.com
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