- Portfolio of 5 Fillers in Late-Stage Development; First
Approval Expected in 1H 2025
- Raises 2028 Revenue Outlook from $500 Million to $700 Million
Representing a 29% CAGR
- Highly Capital Efficient Deal Structure Funded Through $50
Million Pharmakon Tranche; Company Expects to Remain Fully Funded
to Profitability
- Symatese, with 25 Years of Experience, Developed the XpresHAn
Technology™/OBT® for the Latest Generation Restylane® HA
Products
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a
customer-centric approach focused on delivering breakthrough
products, today announced it has entered into a definitive
agreement to be the exclusive U.S. distributor of a line of five
unique dermal fillers currently in late-stage development. The
addition of a filler line expands the company’s total addressable
U.S. market by 70%1 by adding a $1.6 billion U.S. filler market
opportunity to the existing $2.3 billion aesthetic neurotoxin
market, with both markets expected to nearly double by 20281. As a
result of this product expansion, the company has raised its 2028
revenue outlook by $200 million to $700 million.
“Today’s announcement represents a material step in achieving
our goal of transforming Evolus into a multi-product aesthetics
company,” said David Moatazedi, Evolus’ President and Chief
Executive Officer. “We are excited to expand our portfolio with
Evolysse™, a highly competitive filler line that complements our
fast-growing aesthetic neurotoxin, Jeuveau®. Injectables are the
cornerstone of aesthetics with neurotoxins and dermal fillers as
the top two aesthetic procedures in the U.S. Our customer-centric
approach, existing digital infrastructure and distribution platform
will power the launch of this innovative filler technology into the
hands of our customers and their patients.”
Moatazedi continued, “We are honored to partner with Symatese to
introduce the Evolysse™ line to our U.S. customers beginning with
the expected launch of the first two indications in the first half
of 2025, followed by a third in 2026 and two more in 2027. Once
fully launched, the Evolysse™ portfolio will offer a complete range
of filler solutions to cover the spectrum of indications including
mid-face, nasolabial folds, lips and eyes.
“From a financial standpoint, this long-term partnership is
highly capital efficient and expected to be gross margin and
operating income accretive at scale. Using the available $50
million tranche of our credit facility with Pharmakon Advisors we
are funding our agreement obligations and expecting to carry Evolus
to profitability in 20252. This transaction expands our product
portfolio with a differentiated filler product line and we gain
access to a large and growing market estimated to nearly double in
size by 20281.”
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 United States based on
XpresHAn Technology™/OBT®.
“For the last 25 years, Symatese has had a rich history in
developing numerous products for aesthetic and therapeutic
purposes,” said Jean-Paul Gérardin, CEO of Symatese. “We are
particularly excited to partner with Evolus in bringing our
next-generation HA filler product line to the U.S. This innovative
technology, which is supported by a robust global clinical
development program, is based on a pioneering, gentler crosslinking
technology that better preserves hyaluronic acid chains and aims to
improve product performance and safety for the benefit of
practitioners and their patients.”
Transaction Terms and Updated Outlook
In consideration for the exclusive U.S. distribution rights,
Evolus will pay Symatese a total of €16.2 million (approximately
$17.8 million based on current foreign exchange rates) including an
upfront payment of €4.1 million and €12.1 million of additional
payments beginning in June 2025. Evolus will also pay Symatese a
mid-single-digit royalty based on net sales and a transfer price
for the product. The two companies will share responsibility for
expenses related to the registration process for the two planned
product launches in 2027. 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 Evolysse™ line to achieve a high contribution margin at scale,
which is expected to drive an expansion of our consolidated
operating margin and income. The company will finance the
transaction, including certain upfront transaction costs and
related development and launch expenses, through a
capital-efficient structure by drawing from its existing $50
million credit agreement with Pharmakon Advisors. It is the
company’s expectation that this funding will be sufficient to
support its operations through to profitability as described more
fully below.
The company’s 2028 revenue expectation for the organic growth of
Jeuveau® to $500 million remains unchanged. Assuming the Evolysse™
product line launches as described above, the company expects to
achieve $200 million in incremental annual sales by 2028. As such,
the company is raising its 2028 revenue outlook to $700
million.
On a combined basis, taking into consideration the transaction
fees, upfront costs, financing costs and initial operating losses
introducing the filler line, the company now expects it will
achieve non-GAAP operating income on a consolidated basis in
2025.
Conference Call Information
Management will host a conference call and live webcast to
discuss this announcement and its financial results for the quarter
ended March 31, 2023 today at 4:30 p.m. ET. To participate in the
conference call, dial (877) 407-6184 (U.S.) or (201) 389-0877
(international) or connect to the live webcast via the link on the
Investor Relations page of our website at www.evolus.com.
Following the completion of the call, an audio replay can be
accessed for 48 hours by dialing (877) 660-6853 (U.S.) or (201)
612-7415 (international) and using conference number 13737457. An
archived webcast, which will remain available for 30 days, can also
be accessed on the Investor Relations page of our website at
www.evolus.com.
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, most notably in China and Brazil, employing a team of
380 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. Visit us at
www.evolus.com, and follow us on LinkedIn, Twitter, 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 U.S.
distribution rights for the Evolysse™ HA dermal filler product
line; the company’s long-term revenue outlook and its financial
outlook for 2023, expectations regarding regulatory approvals and
product launches for the Evolysse™ HA 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 Evolysse™, 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 Evolysse™ dermal filler product line in the U.S., 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
Evolysse™ dermal filler product line in the U.S., 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 March 31, 2023 expected to be filed with the
Securities and Exchange Commission on or about May 9, 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® and Evolysse™ are trademarks of Evolus, Inc. Hi-Pure™
is a trademark of Daewoong Pharmaceutical Co, Ltd. Restylane®,
XpresHAn Technology™ and OBT® are trademarks of Galderma S.A.
1 Source: Medical Insights Dermal Filler Market Study, March
2023 (www.miinews.com), BCG Aesthetic Research presented at IMCAS
2023 and company estimates.
2 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230509006122/en/
Evolus Contacts:
Investors: David K. Erickson Vice
President, Investor Relations Tel: 949-966-1798 Email:
david.erickson@evolus.com
Media: Email: media@evolus.com
Symatese Contact:
Laurent Brones Corporate Communication Director Tel: +33 6 14 31
13 57 Email: l.brones@symatese.com
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