SCIENTIFIC
INVESTOR PRESENTATION
May 2024
DISCLOSURES
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This presentation contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position; business strategy; the market growth for our product; our ability to meet our goals related to the market position of our product and product candidates; the potential market acceptance, demand market size, adoption rate, revenue expectations, future results of our product, product candidates and related loyalty programs, and timing and results of the company's clinical programs, regulatory programs and product approvals, the potential performance profile of any product candidate, are forward-looking statements. Forward-looking statements are based on current estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Other factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include uncertainties associated with the success of the launch of Jeuveau®, customer and consumer adoption of the product, competition and market dynamics, the effects of economic conditions on consumer discretionary spend, the efficiency and operability of our digital platform, the ability to successfully complete clinical programs, make regulatory filings and achieve FDA approval for Evolysse and "extra strength" Jeuveau® and ultimate commercial acceptability and pricing for Evolysse or an "extra strength" Jeuveau® dose, our ability to comply with our settlement agreement with Medytox, and our ability to maintain regulatory approval of Jeuveau® 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 for the year ended December 31, 2023 that was filed with the Securities and Exchange Commission and any subsequent filings, each of which is available online at www.sec.gov.
All written and verbal forward-looking statements attributable to our Company or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. We may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements, and you should not place undue reliance on the forward-looking statements. The forward-looking statements in this presentation represent our views as of the date of this presentation. We anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation.
Certain of the industry, statistical and market data in this presentation was obtained from our own internal estimates and research as well as from industry and general publications and research, surveys and studies conducted by third parties. All of the market data used in this presentation involves a number of assumptions and limitations. While we believe that the information from these industry publications, surveys and studies is reliable, the industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of important factors, which could cause results to differ materially from those expressed in the estimates made by third parties and by us. Evolus®, Jeuveau®, Nuceiva®, Evolux® and Evolysse are five of our trademarks that are used in this presentation. All other trademarks and tradenames are the property of their respective owners.
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EVOLYSSE AN INNOVATIVE TECHNOLOGY THAT COMPLEMENTS THE JEUVEAU® BRAND
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HIGHLIGHTS
A HIGHLY COMPETITIVE FILLER LINE
- Evolysse -afirst-generation cold technology Hyaluronic Acid line
- 5 fillers in late-stage clinical development
- Indications including mid face, nasolabial folds, lips and eyes
- In partnership with Symatese, developer of the latest generation of Restylane® products in the U.S.
RAISING 2028 REVENUE OUTLOOK FROM $500M TO AT LEAST $700M
- Increasing guidance by $200M in 2028 based on product launches in 2025, 2026 and 2027
A HIGHLY CAPITAL EFFICIENT AGREEMENT
- Minimal short-term dilution delivering material long-term value accretion
- Leverage existing sales force, digital infrastructure, Evolus Rewards and co-branded media
SYMATESE SCIENCE GENESIS
25+ YEARS IN R&D AND MANUFACTURING OF AESTHETICS & MEDICAL BIOMATERIALS
LAUNCHED FIRST
2 PRODUCTS: HEMOTESE® &
COLLAPAT®II
1997 | 2003 |
SYMATESE
FOUNDED BY
INDUSTRY EXPERTS
2004
ENTERED PARTNERSHIP WITH L'ORÉAL
PEROUSE PLASTIE BREAST IMPLANTS SOLD TO MENTOR
2007
LAUNCH OF
NEVELIA®, DERMAL
REGENERATION
MATRIX
2011 | 2013 |
SOLD RIGHTS OF XpresHAn
TECHNOLOGY /OBT® AND
RELATED DERMAL FILLERS
TO GALDERMA
2021
R&D PARTNERSHIP STRENGTHENED WITH L'ORÉAL ON BIOMATERIALS
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EVOLYSSE MANUFACTURING
FIRST-GENERATION COLD TECHNOLOGY HA BY SYMATESE
CROSS-LINKING HA
Typical cross-linking:Heat
Symatese cross-linking:Cold
BENEFIT
- Cross-linkingtechnology that better preserves the hyaluronic acid chain designed for dynamic performance and efficacy
- Potentially improves safety and efficacy for the benefit of both practitioner and patient
- Less BDDE is required to get the same gel dynamics
FRAGMENTS
BDDE
HA
HEAT | COLD | 6 |
EVOLYSSE PRODUCT LINE
2026 | LAUNCH
2025 | LAUNCH | 2027 | LAUNCH | ||
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Novel HA Dermal Filler: US NLF Pivotal Study
Study Devices
- Investigational HA Filler
New "cold" manufacturing process to preserve the HA molecule
- EvolysseTM Smooth (20mg/ml)
- EvolysseTM Lift (22mg/ml)
- Evolus, Newport Beach CA
- Control
- Restylane-L20mg/cc
- Galderma, Dallas TX
Study Design
DBL blind, prospective, randomized, active control
- Split face
- Investigational vs Control
- N=140
- 70 E-Smooth vs Control
- 70 E-Lift vs Control
- Primary Endpoint
- At 6 months
- Change from baseline on a validated 5 grade scale WSRS
- Non-inferiority
• Duration: 12m+ 3m repeat Rx | 8 |
Novel HA Dermal Filler: US NLF Pivotal Study
Demographics
Evolysse Lift | Restylane-L | |||||||||||
Age | ||||||||||||
Mean | 58.8 | |||||||||||
Range | 25 - 83 | |||||||||||
Sex | ||||||||||||
Female | 66 | (94.3%) | ||||||||||
Male | 4 | (5.7%) | ||||||||||
Race | ||||||||||||
White | 51 | (72.9%) | ||||||||||
Black /African American | 14 | (20.0%) | ||||||||||
Other | 2 | (2.9%) | ||||||||||
Asian | 2 (2.9%) | |||||||||||
Multiple | 1 | (1.4%) | ||||||||||
Skin Type (Fitzpatrick) | ||||||||||||
Type I | 1 | (2.9%) | ||||||||||
Type II | 19 | (27.1%) | ||||||||||
Type III | 22 | (31.4%) | ||||||||||
Type IV | 16 | (22.9%) | ||||||||||
Type V | 9 (12.9%) | |||||||||||
Type VI | 2 | (2.9%) |
Evolysse Smooth | Restylane-L | |||||||||||||||||
Age | ||||||||||||||||||
Mean | 57.3 | |||||||||||||||||
Range | 31 - 84 | |||||||||||||||||
Sex | ||||||||||||||||||
Female | 65 | (92.9%) | ||||||||||||||||
5 | (7.1%) | |||||||||||||||||
Male | ||||||||||||||||||
Race | ||||||||||||||||||
White | 50 | (71.4%) | ||||||||||||||||
Black /African American | 19 | (27.1%) | ||||||||||||||||
Other | 0 | |||||||||||||||||
Asian | 0 | |||||||||||||||||
1 | (1.4%) | |||||||||||||||||
Multiple | ||||||||||||||||||
Skin Type (Fitzpatrick) | ||||||||||||||||||
Type I | 1 | (1.4%) | ||||||||||||||||
Type II | 16 | (22.9%) | ||||||||||||||||
22 | (31.4%) | |||||||||||||||||
Type III | ||||||||||||||||||
14 (20%) | ||||||||||||||||||
Type IV | ||||||||||||||||||
11 | (15.7%) | |||||||||||||||||
Type V | ||||||||||||||||||
6 | (8.6%) | |||||||||||||||||
Type VI |
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US NLF PIVOTAL STUDY: Results Evolysse Lift vs Restylane-L
PRIMARY ENDPOINT: Non-Inferiority at 6 Months
MEAN GRADE CHANGE IN NASOLABIAL SEVERITY SCORE
Independent Photographic Review Panel
INJECTED VOLUMES | EVOLYSSE LIFT | RESTYLANE-L |
Vol | Mean: 1.2mL | Mean: 1.3mL |
Min, Max | 0.2mL; 3.0mL | 0.5mL; 3.2mL |
12%
MEAN GRADE CHANGE IN NASOLABIAL SEVERITY SCORE
Blinded Live Investigator
FAVORS EVOLYSSE LIFT
LOWER CI | UPPER CI |
95%: -0.500 | 95%: -0.032 |
-0.3
FAVORS RESTYLANE-L
NI
MARGIN =0.5
1.6 | 1.5*p=0.018 | 88%1.5*p=0.037 | Evolysse Lift | ||||
1.3 *p=0.04 | Restylane-L | ||||||
1.4 | 1.2*p=0.013 | ||||||
1.2 | 1.3 | 1.3 | 1.1*p<0.001 | ||||
1.0 | |||||||
1.0 | |||||||
0.8 | |||||||
0.9 | |||||||
0.6 | |||||||
0.7 | |||||||
0.4 | |||||||
0.2 | |||||||
-0.5 | -0.4 | -0.3 | -0.2 | -0.1 | 0 | 0.1 | 0.2 | 0.3 | 0.4 | 0.5 |
Corresponding P-value 0.03
0.0 | ||||
1.5 | 3.0 | 6.0 | 9.0 | 12.0 |
* Statistically significant
MONTHS
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Evolus Inc. published this content on 20 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 May 2024 16:07:07 UTC.