- Exclusive Distributor Agreement with Symatese
Broadens Evolus’ Dermal Filler Footprint Beyond the U.S. to Include
the United Kingdom and Europe
- European Regulatory Approvals Anticipated in
Second Half of 2024
- Company Continues to Expect to be Fully Funded
to Profitability1
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a
focus on building an aesthetic portfolio, today announced it has
entered into a definitive agreement with Symatese to be the
exclusive distributor in the United Kingdom (U.K.) and Europe of
four unique dermal fillers in late-stage development with
anticipated regulatory clearances in second half of 2024 and
commercialization under the brand name Estyme® (pronounced
“esteem”) fillers in 2025. It is the second agreement made with
Symatese this year – with the first obtaining exclusive
distribution rights to the same product line in the U.S., where it
will be commercialized under the brand name EvolysseTM in 2025. As
a result of the geographic expansion of the filler line, the
company has doubled its total addressable international market
(outside the U.S.) to $1.8 billion2.
“Today’s announcement marks yet another crucial step in our
global expansion to offer a multi-product portfolio to our
customers and the patients they treat. The addition of the Estyme®
facial fillers in the U.K. and Europe will complement the recent
launch of Nuceiva®, our flagship neurotoxin, which has been met
with very strong interest and growing demand from customers,” said
David Moatazedi, President and Chief Executive Officer of Evolus.
“We are increasingly optimistic about the near-term potential that
the next-generation technology in the EvolysseTM and Estyme®
fillers lines will offer customers in the fast-growing facial HA
market. We are confident that these innovative new products, along
with our growing brand loyalty to our market-leading neurotoxin and
the associated digital infrastructure and distribution platform
will drive our topline growth for years to come.”
Neurotoxins and dermal fillers are the two most requested
medical aesthetic procedures in the U.S. and Europe3. The two
distribution agreements for the EvolysseTM /Estyme® fillers
portfolio will grant Evolus the ability to offer a complete range
of filler solutions to cover mid-face, nasolabial folds and lip
indications in Europe plus an eye product line in the U.S.
Regulatory approval has been received for the first nasolabial
fold product in Europe and the remaining three products are
anticipated to be approved in the back half of 2024. U.S.
regulatory approval remains on track to begin in 2025. The company
plans to commence commercialization of the approved product lines
in 2025 with subsequent product launches in 2026 and 2027.
As part of the new agreement, Evolus will be licensing its
neurotoxin, Nuceiva® (botulinum toxin type A), to Symatese for
distribution in France, marking the fifth European market that
Evolus has now entered. In addition, Evolus will sub-license its
distribution rights for the Estyme® fillers line to a Symatese
subsidiary for distribution in France.
“We are extremely excited to expand our partnership with Evolus
beyond the U.S. to now include the U.K. and Europe. We firmly
believe in the growth opportunity for our innovative filler lines
in these markets and also in Evolus’ accelerating growth in the
neurotoxin market. As such, we have agreed to receive payment for
the license for the European markets in the form of Evolus’ common
shares. We have complete confidence in the Evolus team, and we look
forward to pursuing this exceptional growth opportunity together,”
said Jean-Paul Gérardin, CEO of Symatese.
Symatese is a privately held French company that designs,
engineers and manufactures regenerative medical solutions based on
its innovative technology platforms. Symatese has a unique and
combined expertise in the field of hyaluronic acid and injection
systems and is well known for the development of the latest
generation of Restylane® products in the U.S. based on XpresHAn
Technology™/OBT®. The products within the licensing agreement are a
next-generation filler technology – the first to be developed using
cold crosslinking manufacturing – which will be presented at IMCAS,
1st-3rd February 2024.
Transaction Terms and Updated Outlook
In exchange for the exclusive distribution rights in the United
Kingdom and Europe, Evolus will issue 610,000 shares of the
company’s common stock to Symatese. Two milestone payments will be
made: (1) €1.2 million on the second anniversary of certain
regulatory approvals currently expected to be achieved in 2026, and
(2) €1.9 million on the earlier of the third anniversary of certain
regulatory approvals or following a year in which Evolus achieves
€25 million in revenue in Europe, currently expected to be achieved
by 2027, both of which will be after the commercialization of the
applicable products. This agreement has no material impact on the
company’s continued expectation to be fully funded to
profitability1 by 2025.
Evolus will also pay Symatese a mid-single-digit royalty based
on net sales and a transfer price for the product. Symatese will be
responsible for the development of the products, including clinical
studies, product testing and the conduct of regulatory activities
required to obtain and maintain all necessary regulatory approvals.
The initial agreement is for a term of 15 years, with automatic
five-year renewal provisions.
By leveraging the existing Evolus digital infrastructure, sales
force, rewards program and co-branded media, the company expects
the EvolysseTM line to achieve a high contribution margin at scale,
which is expected to drive an expansion of our consolidated
operating margin and income.
Additionally, Evolus will pre-announce preliminary, unaudited
fourth quarter and full-year 2023 results and revenue guidance for
2024 in January.
About Symatese
Founded 25 years ago by Eric Perouse and Jean-Paul Gérardin,
Symatese is a privately held French company specializing in Class I
to III medical devices. The company maintains an international
presence through six subsidiaries and four manufacturing facilities
employing a team of 400 persons and 40 researchers. At the heart of
Symatese’s research is the science of tissue regeneration and
anatomical reconstruction for the benefit of doctors and patients.
Every year, more than 25 million patients worldwide are treated
thanks to its innovative hyaluronic acid, collagen, thermoplastic
and silicone technologies. Symatese is able to address the most
delicate and complex health issues based on its expertise in 15
therapeutic specialties, aesthetic medicine and its associated
administration systems, while also relying on its own product and
technology brands. Research & development partnerships with
major global companies and from now on with Evolus, demonstrate
this strong scientific and technological excellence. For more
information, visit us at www.symatese.com, and follow us on
LinkedIn.
About Evolus, Inc.
Evolus (Nasdaq: EOLS) is a performance beauty company evolving
the aesthetic neurotoxin market for the next generation of beauty
consumers through its unique, customer-centric business model and
innovative digital platform. Our mission is to become a global,
multi-product aesthetics company based on our flagship product,
Jeuveau® (prabotulinumtoxinA-xvfs), the first and only neurotoxin
dedicated exclusively to aesthetics and manufactured in a
state-of-the-art facility using Hi-Pure™ technology. Evolus is
expanding its product portfolio having entered into a definitive
agreement to be the exclusive U.S. distributor of Evolysse™, and
the exclusive distributor in Europe of Estyme®, a line of unique
dermal fillers currently in late-stage development. Visit us at
www.evolus.com, and follow us on LinkedIn, X, Instagram or
Facebook.
Forward-Looking Statements
This press release contains forward-looking statements as
defined under the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties, including statements about
future events, our business, financial condition, results of
operations and prospects, our industry and the regulatory
environment in which we operate. Any statements contained herein
that are not statements of historical or current facts are
forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as “anticipate,”
“believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “will,” “would” or the
negative of those terms, or other comparable terms intended to
identify statements about the future. The company’s forward-looking
statements include, but are not limited to, statements related to
financial and other benefits expected from the exclusive European
distribution rights for the Estyme® dermal filler product line; the
company’s long-term revenue outlook; expectations regarding
regulatory approvals and product launches for the Estyme® dermal
filler product lines; and the company’s cash position and
expectations for reaching profitability.
The forward-looking statements included herein are based on our
current expectations, assumptions, estimates and projections, which
we believe to be reasonable, and are subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by the forward-looking statements.
These risks and uncertainties, all of which are difficult or
impossible to predict accurately and many of which are beyond our
control, include, but are not limited to uncertainties associated
with our ability to comply with the terms and conditions in the
Medytox Settlement Agreements, our ability to fund our future
operations or obtain financing to fund our operations, unfavorable
global economic conditions and the impact on consumer discretionary
spending, uncertainties related to customer and consumer adoption
of Jeuveau® and EvolysseTM/Estyme®, the efficiency and operability
of our digital platform, competition and market dynamics, our
ability to successfully launch and commercialize our products in
new markets, including the EvolysseTM dermal filler product line in
the U.S. or the Estyme® dermal filler product line in Europe, our
ability to maintain regulatory approvals of Jeuveau® or obtain
regulatory approvals for new product candidates or indications, our
reliance on Symatese to achieve regulatory approval for the
EvolysseTM dermal filler product line in the U.S. or the Estyme®
dermal filler product line in Europe, and other risks described in
our filings with the Securities and Exchange Commission, including
in the section entitled “Risk Factors” in our Annual Report on Form
10-K and our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023 expected to be filed with the Securities and
Exchange Commission on or about November 7, 2023. These filings can
be accessed online at www.sec.gov. Readers are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Except as required by law, we
undertake no obligation to update or revise any forward-looking
statements to reflect new information, changed circumstances or
unanticipated events. If we do update or revise one or more of
these statements, investors and others should not conclude that we
will make additional updates or corrections.
Jeuveau®, Nuceiva®, and Evolysse™ are trademarks of Evolus, Inc.
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd. Estyme®
is a trademark of Symatese Aesthetics S.A.S. Restylane®, XpresHAn
Technology™ and OBT® are trademarks of Galderma S.A.
1 Within this press release, “profitability” is defined as
achieving positive non-GAAP operating income. “Non-GAAP operating
income” excludes the revaluation of contingent royalty obligations,
stock-based compensation expense, and depreciation and
amortization. Management believes that non-GAAP operating income is
useful in helping to identify the company’s core operating
performance and enables management to consistently analyze the
period-to-period financial performance of the core business
operations. Management also believes that non-GAAP operating income
will enable investors to assess the company in the same way that
management has historically assessed the company’s operating income
against comparable companies with conventional accounting
methodologies. The company’s definition of non-GAAP operating
income has limitations as an analytical tool and may differ from
other companies reporting similarly named measures. Non-GAAP
measures should not be considered superior to and are not intended
to be considered in isolation or as a substitute for GAAP financial
measures. Due to the forward-looking nature of the non-GAAP
operating income outlook disclosed in this press release, no
reconciliation of such non-GAAP measure to the comparable GAAP
financial measure is available without unreasonable efforts. This
is due to the inherent difficulty of forecasting the timing or
amount of various reconciling items that would impact the
forward-looking non-GAAP operating income, that have not yet
occurred and/or cannot be reasonably predicted. Such unavailable
information could have a significant impact on the company’s GAAP
financial results.
2 Source: Medical Insights Dermal Filler Market Study, March
2023 (www.miinews.com) and Aesthetic Injectables | Market Insights
| Europe 2024 © 2023 Clarivate
3 Source: International Society of Aesthetic Plastic Surgery
International Survey, BCG Aesthetic Research presented at IMCAS
2023 and company estimates.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231219269963/en/
Evolus Contacts: Investors:
Ned Mitchell Investor Relations Tel: 949-284-4536 Email:
ir@evolus.com
Media: U.S. or Global Media
Inquiries: media@evolus.com
European Media Inquiries: Janet Kettels Communications
Consultant, Evolus International Tel: +447738506476 Email:
janet.kettels@evolus.com
Symatese Contact: Laurent Brones Corporate Communication
Director Tel: +33 6 14 31 13 57 Email: l.brones@symatese.com
Evolus (NASDAQ:EOLS)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Evolus (NASDAQ:EOLS)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024