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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Contacts:
Revance Therapeutics, Inc.:
Jeanie Herbert, 714-325-3584
jherbert@revance.com
or
Gilmartin Group, LLC.:
Laurence Watts, 619-916-7620
laurence@gilmartinir.com
