First Major Technological Breakthrough in
Hyaluronic Acid Dermal Fillers in a Decade; U.S. Launch Planned in
Q2 2025
Launch Establishes Evolus as a Multi-Product
Performance Beauty Company and Expands Addressable Market by
78%
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a
focus on building an aesthetic portfolio, today announced that the
U.S. Food and Drug Administration (FDA) has approved Evolysse™ Form
and Evolysse™ Smooth injectable hyaluronic acid (HA) gels, the
first two products in the Evolysse™ collection. These approvals
mark Evolus’ entry into the U.S. HA dermal filler market and
solidifies the company’s position as a multi-product innovator in
aesthetics, expanding Evolus’ total addressable market by 78% to
approximately $6 billion1.
“This milestone represents an exciting new chapter in our
long-term strategy to expand our portfolio and transition from a
single-product company to a multi-product innovator, strengthening
our leadership in performance beauty,” said David Moatazedi,
President and Chief Executive Officer of Evolus. “Evolysse™ Form
and Evolysse™ Smooth represent the first major technological
breakthrough in HA dermal fillers in a decade, offering our
customers and consumers a new standard in performance and
innovation. The launch of these products is a catalyst in our
growth as we are focused on achieving at least $700 million in net
revenue and non-GAAP operating income margin2 of at least 20% by
2028.”
Evolus plans to launch Evolysse™ Form and Evolysse™ Smooth in
the U.S. market in Q2 2025. This launch will leverage Evolus’
scalable cash-pay business model and existing digital
infrastructure, creating tremendous synergy with the company’s
fast-growing neurotoxin business and driving significant value for
both customers and consumers.
Evolysse™ Form and Evolysse™ Smooth are part of a collection of
injectable HA gels designed by Symatese, which utilizes innovative
Cold-X™ technology that is designed to better preserve the natural
structure of the HA molecule for long-lasting, natural-looking
results. The commercial launch of these first two injectable HA
gels in 2025 will be followed by Evolysse™ Sculpt in 2026, and
Evolysse™ Lips in 2027.
“We are proud to partner with Evolus in bringing the Evolysse™
collection of injectable HA gels to the U.S. market. With decades
of experience in biomaterial science and aesthetics, Symatese has a
strong legacy of developing innovative aesthetic products that meet
the evolving needs of practitioners and their patients. With one of
the largest clinical trial programs undertaken for an injectable HA
technology, Evolysse™ products are being evaluated for safety and
effectiveness in over 2,000 patients globally,” said Jean-Paul
Gérardin, Chief Executive Officer of Symatese.
Dr. Rui Avelar, Evolus Chief Medical Officer and Head of
R&D, added, “The FDA approval of Evolysse™ Form and Evolysse™
Smooth reflects our commitment to bringing high-quality, innovative
aesthetic products to market. These additions to our portfolio
reinforce Evolus’ dedication to the highest standards of patient
safety and efficacy. With the introduction of Cold-X™ technology,
Evolysse™ offers a differentiated approach to the dermal filler
category, providing healthcare practitioners with new options to
address the unique needs of their patients with precision and
confidence.”
Dr. Michael Kaminer, MD, lead investigator for the U.S. NLF
pivotal study and an internationally recognized expert in cosmetic
surgery, commented, “The Evolysse™ Form and Evolysse™ Smooth
injectable HA gels demonstrated impressive safety, efficacy, and
versatility, with the unique property of being injectable at
various depths in the skin. These products allow practitioners to
achieve precise, natural-looking results, while delivering high
patient satisfaction with their effectiveness and longevity.” The
U.S. Nasolabial Fold (NLF) pivotal study for Evolysse™ Form and
Evolysse™ Smooth included 140 patients in a double-blind,
prospective, randomized, active-control split-face trial. Seventy
patients were treated with each product, with investigators
performing the procedures, evaluating outcomes, and following a
rigorous clinical protocol.
Evolysse™ Form and Evolysse™ Smooth were evaluated in a
head-to-head study with Restylane®-L. Both products met the primary
endpoint of non-inferiority3, and both the confidence intervals as
well as the corresponding p-values (<0.001) demonstrated
statistical superiority3.
As assessed by the live, blinded investigators, Evolysse™ Form
showed statistically significant differences4 compared to
Restylane-L at all measured timepoints for the entire 12-month
study period. Evolysse™ Smooth showed statistically significant
differences4 compared to Restylane-L at 6 and 9 months – even
though 20% more Restylane-L was used5.
In the head-to-head clinical study versus Restylane-L, the
safety profile of Evolysse™ Form and Evolysse™ Smooth was similar
to the control, with most adverse events being mild to moderate.
There were no treatment-related serious adverse events, and no
delayed-onset nodules were observed.
Evolus previously announced that EU Medical Device Regulation
(MDR) approval was received for four unique injectable hyaluronic
acid (HA) gels under the brand name Estyme® (pronounced “esteem”),
reflecting the product’s compliance with the highest regulatory
standards. Evolus is also introducing Estyme® through a limited
experience program with select physician partners in Europe, to
continue to expand global experience with the product’s
performance. A broader European launch remains on track for the
second half of 2025, further expanding Evolus’ footprint into the
global dermal filler market and reinforcing its position as a
leader in performance beauty.
About Evolus, Inc.
Evolus (NASDAQ: EOLS) is a global performance beauty company
redefining the aesthetic injectable 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 leader in aesthetics anchored by our flagship products:
Jeuveau® (prabotulinumtoxinA-xvfs), the first and only neurotoxin
dedicated exclusively to aesthetics, and Evolysse™, a collection of
unique injectable hyaluronic acid (HA) gels. Visit us at
www.evolus.com, and follow us on LinkedIn, X, Instagram or
Facebook.
1Sources: Medical Insight, Inc.: The Global Aesthetic Market
Study—January 2024 (US), Clarivate | DRG: Aesthetic Injectables
Market Insights North America 2024—October 2023 (Canada), Clarivate
| DRG: Aesthetic Injectables Market Insights Europe 2024—June 2023
(Europe), Clarivate | DRG: Aesthetic Injectables Market Insights
Asia Pacific 2024—December 2023 (Australia), and company
estimates.
2 “Non-GAAP operating income margin” is not a measure presented
in accordance with accounting principles generally accepted in the
United States of America (“GAAP”). Non-GAAP operating income margin
excludes (i) the revaluation of contingent royalty obligations,
(ii) stock-based compensation expense, and (iii) depreciation and
amortization. Management believes that disclosure of non-GAAP
operating income margin enables investors to assess the company in
the same way that management assesses the company’s operating
performance against comparable companies with conventional
accounting methodologies, however this measure 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 margin,
a reconciliation to the closest comparable GAAP financial measures
is not available without unreasonable efforts due to the
unpredictability of future adjustments impacting these measures,
which could significantly affect the GAAP results.
3Based on the primary endpoint analysis for Evolysse™ Form (95%
CI [-0.500, -0.032]) and Evolysse™ Smooth (95% CI [-0.416,
-0.019])
4Based on WSRS Live Investigator Assessments (p < 0.05)
5In the clinical study, the mean injection volume for optimal
correction was 1.0 mL for Evolysse™ Smooth versus 1.2 mL for
Restylane-L
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 or anticipated 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
anticipated product launches; market conditions, market growth and
consumer demand; timing of regulatory submissions and approvals;
the company’s revenue and non-GAAP operating margin outlook and its
financial outlook for 2025 and beyond; and the company’s
operational efficiency and leverage.
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™ Hyaluronic Acid (HA) gels 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™ HA gel 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 Quarterly Report on Form
10-Q for the quarter ended September 30, 2024 filed with the
Securities and Exchange Commission on November 6, 2024. 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 Nuceiva®, are registered trademarks and Evolysse™
is a trademark of Evolus, Inc. Hi-Pure™ is a trademark of Daewoong
Pharmaceutical Co, Ltd. Cold-X™ and Estyme® are trademarks of
Symatese Group and Symatese Aesthetics S.A.S. Restylane® is a
trademark of Galderma S.A.
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version on businesswire.com: https://www.businesswire.com/news/home/20250213924915/en/
Evolus Contacts: Investors:
Nareg Sagherian Vice President, Head of Global Investor Relations
and Corporate Communications Tel: 248-202-9267 Email:
ir@evolus.com
Media: Email: media@evolus.com
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