Creating an Aesthetic Evolution - May 2019 Investor Presentation - Evolus | Investor Relations
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Creating an
Aesthetic Evolution
May 2019
Investor Presentation
1
Special Note Regarding Forward-Looking Statements Further Information
This presentation contains forward-looking statements. All statements other than statements of historical facts Certain of the industry, statistical and market data in this
contained in this presentation, including statements regarding our future results of operations and financial position; presentation was obtained from our own internal estimates and
business strategy; prospective product candidate; the timing of and our ability to obtain and maintain regulatory research as well as from industry and general publications and
approvals; ability to commercialize our product candidate; our ability to acquire rights to other product candidates; research, surveys and studies conducted by third parties. All of the
research and development costs; timing and likelihood of success, plans and objectives of management for future market data used in this presentation involves a number of
operations; products and product candidates; the potential market acceptance, demand market size, adoption rate assumptions and limitations. While we believe that the information
and and future results of our product candidate, are forward-looking statements. from these industry publications, surveys and studies is reliable, the
These forward-looking statements involve substantial known and unknown risks, uncertainties and other important industry in which we operate is subject to a high degree of
factors that may cause our actual results, levels of activity, performance or achievements to be materially different uncertainty and risk due to a variety of important factors, which could
from the information expressed or implied by the forward-looking statements. These risks and uncertainties include, cause results to differ materially from those expressed in the
but are not limited to: the ability to obtain and maintain on a timely basis, or at all, regulatory approval of our estimates made by third parties and by us.
product candidate; our reliance on our exclusive third-party manufacturer and supplier of our product candidate; EVOLUS™ & Jeuveau™ are two of our trademarks that are used in this
the sufficiency of our cash resources and needs for additional financing; our ability to commercialize our product presentation. This presentation also includes trademarks, trade
candidate; the size and growth of the potential markets for our product candidate and the ability to serve those names and service marks that are the property of other organizations.
markets; the rate and degree of market acceptance of our product candidate; our anticipated growth strategies; Solely for convenience, trademarks and trade names referred to in
the anticipated trends and challenges in our business and the market in which we operate; our ability to establish this presentation appear without the ® and ™ symbols, but those
and maintain development partnerships; our ability to attract or retain key personnel; our expectations regarding references are not intended to indicate that we will not assert, to the
federal, state and foreign regulatory requirements; and regulatory developments in the United States and foreign fullest extent under applicable law, our rights, or that the applicable
countries and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of owner will not assert its rights, to these trademarks and trade names.
Financial Condition and Results of Operations” sections of our Annual Report on Form 10-K for the year ended We do not intend our use or display of other companies’ trade names
December 31, 2018, which is on file with the Securities and Exchange Commission, or SEC. All of our filings are or trademarks (including Botox® and Botox® Cosmetic, which we
available on the SEC’s website at www.sec.gov. All written and verbal forward-looking statements attributable to our refer to as Botox®) to imply a relationship with, or endorsement or
Company or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements sponsorship of us by, any other companies.
contained or referred to herein. We may not actually achieve the plans, intentions or expectations disclosed in the
Hi-Pure ™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
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 Our financial results are prepared in accordance with Generally
anticipate that subsequent events and developments will cause our views to change. Forward-looking statements Accepted Accounting Principles (“GAAP”). This presentation includes
are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. non-GAAP financial measures. Our reconciliations of non-GAAP
financial measures to GAAP financial measures are located at the
Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements
end of this presentation. These non-GAAP financial measures should
contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise.
not be considered as an alternative to GAAP financial measures.
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.
2
Investor Presentation
First Company in Nearly a Decade to Enter the Fast-Growing
U.S. Aesthetic Neurotoxin Market
Jeuveau TM (prabotulinumtoxinA-xvfs) The Evolus Experience: A Frictionless
• FDA approved Feb. 1, 2019; Spring 2019 launch Alternative
• FDA approved for the temporary improvement in the appearance of • Highly experienced management team
moderate to severe glabellar lines associated with corrugator and/or
• Simple, personal and connected experience for
procerus muscle activity in adult patients
customers and consumers
• The first known 900 kilodalton (“kDa”) molecule in the U.S. since Botox
launched • Comprehensive digital platform
• Manufactured in a state-of-the-art facility using Hi-Pure™ technology
• EU / Canada Phase III head-to-head data versus market leader met
primary endpoint
Only Known Neurotoxin Dedicated to
Aesthetics
JeuveauTM expected to be the anchor product
• Pricing flexibility unconstrained by reimbursement
for building an aesthetic portfolio
• Greater focus on physicians and practice development
3
Investor Presentation
Deep industry Highly Experienced Management Team
knowledge and
commercialization
experience
David Moatazedi Lauren Silvernail Rui Avelar, MD Michael Jafar
President and CEO CFO and EVP, Chief Medical Officer Chief Marketing Officer
Corporate Development and Head of R&D
Amy Fox Jeff Plumer Kurt Knab Alex Sabad Crystal Muilenburg
Vice President, Vice President, Vice President, Vice President, Vice President, Corporate
Human Resources Legal Sales Operations Communications & PR
4
Investor Presentation
Medical Aesthetics:
O N E O F T H E F A S T E S T G R O W I N G M A R K E T S I N H E A LT H C A R E 1
The neurotoxin market represents the largest segment and remains highly underpenetrated1
Global Aesthetic Neurotoxin Sales ($mm)2
$3,924
$3,519
$3,132
$2,454 $2,765
$2,014 $2,216
$1,567 $1,798
$1,406
$1,189 $1,334 $1,505 $1,708
$1,048
2018E 2019E 2020E 2021E 2022E
U.S. Ex-U.S.
Evolus is Poised to Capture Share of a Robust & Growing Market
1. Self-Pay Healthcare Market Report, MarketsandMarkets
2. Medical Insights Global Facial Injectables Market Study, December 2018 5
Investor Presentation
Jeuveau™ is the First Known 900kDa Alternative to Botox
U.S. Aesthetics
Molecule Size Aesthetics Only?
Market Share1
Jeuveau™ 900 kDa N/A
Botox
(Allergan)
900 kDa2 75% X
Dysport
(Galderma / Ipsen)
Undisclosed 19% X
Xeomin
(Merz)
150 kDa3 6% X
1. Guidepoint Global Aesthetics Market Tracker, December 2018
6
Investor Presentation
Jeuveau™ FDA Approved Feb. 1, 2019
Indication: Temporary
improvement in the appearance
of moderate to severe glabellar
lines associated with corrugator
and/or procerus muscle activity
in adult patients
Total dose 20 units
Intramuscular injection into each
of five sites
State-of-the-Art Manufacturing Facility
with Patented Hi-PURE™ Technology
7
Investor Presentation
JeuveauTM (PrabotulinumtoxinA-xvfs)
>2,100 Patients Across Five Clinical Trials
Phase III Studies
Single Treatment, 5 Month Studies
US EV-001 and EV-002 Europe / Canada EVB-003
• Two identical Phase III studies • EVB-003
• N= 330 EV-001, N= 324 EV-002 • N=540
• Superiority to placebo • Non-Inferiority to Botox (OnabotulinumtoxinA)
• Vacuum dried formulation • Vacuum dried formulation
Phase II Studies
Repeat Treatment, 1 Year Studies
US EV-004 US EV-006
• N= 352 • N=570 formulation
• Freeze dried formulation • Vacuum dried formulation
Source: Data on file CSR’s EV-001, EV-002, EVB-003, EV-004 EV-006
8
Investor Presentation
U.S. Phase III:
JeuveauTM Primary Endpoint Secondary Endpoint
≥2 Grade Composite (investigator and ≥2 Point Composite GLS Improvement at
vs. Placebo subject agree) GLS Improvement at Maximum Frown at Day 120 & Day 150
Maximum Frown on Day 30 (investigator and subject agree)
Met FDA Mandated Primary
Endpoint Requirements and
Demonstrated Superiority to Day 120 Responder Rates
Placebo at Four & Five Months 80%
70.4% EV-001 EV-002
70% 67.5%
≥ 2 Composite Score ≥ 2 Composite Score
60% Treatment Placebo Treatment Placebo
8.3%* 1.3% 12.4%* 0%
50%
40%
Day 150 Responder Rates
30%
20% EV-001 EV-002
≥ 2 Composite Score ≥ 2 Composite Score
10%
1.2% 1.3% Treatment Placebo Treatment Placebo
0% 4.6%* 0% 4.6%* 0%
JeuveauTM Placebo JeuveauTM Placebo
*All p-values < 0.05.
n=246 n=84 n=246 n=78
EV-001 EV-002
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Investor Presentation
U.S. Phase III: JeuveauTM vs. Placebo Exploratory Endpoints: EV-001 and EV-002
≥1 Point Improvement GLS at Maximum Frown (%)
R E S P O N D E R R AT E S T H RO U G H F I V E M O N T H S
Investigator Assessment Subject Assessment
100 95.4 95.8 100 94.6 95.0 100 95.0 94.6 100
91.2 92.9 92.5
91.2 90.8 89.9
90 90 90 90
77.4 79.0
80 80 80 80
73.5 73.4
70 64.6 70 70 70
59.0 59.2
60 60 56.0 57.5 60 60
49.6
50 46.2 50 50 50 46.5
41.8 42.6
40.5
40 40 40 40
33.8
30 30 30 30
22.7 22.1
18.1 18.8 18.4 17.1 17.3 17.1
20 20 17.1 17.1
14.5 20 14.5 14.6 16.3
13.6
20 15.3
13.3 13.3 12.5
9.6 10.7
8.4 8.8 7.5 7.5 7.4
10 6.1 10 6.5 10 10
0 0 0 0
Days Post Treatment Days Post Treatment Days Post Treatment Days Post Treatment
EV-001 EV-002 EV-001 EV-002
TM TM
Placebo Jeuveau TM Placebo Jeuveau
TM
Placebo Jeuveau Placebo Jeuveau
10
Investor PresentationJeuveau™ EU/CA Phase III Trial
Primary Endpoint: Non-Inferiority
Primary Endpoint
Responder Rate Day 30
GLS = 0 or 1 at Maximum Frown Investigator Assessment
100
90 87.2
82.8
80
70
60
50
40
30
20
10 4.2
0
Jeuveau™ Botox Placebo
n=235 n=244 n=48
Source: Data on file (CSR EVB-003, pg 5)
11
Investor PresentationJeuveau™ EU/CA Phase III Trial
Primary Endpoint: Non-Inferiority Met
Primary Endpoint
• Difference between groups: 4.4%
• Lower limit of one-sided 97.5% CI: -1.9%
• Non-inferiority margin: - 10%
Favors Botox Favors Jeuveau™
Lower Limit of two-sided Upper Limit of two-sided
Non- 95% CI: -1.9% 95% CI: 10.8%
inferiority
Margin= 4.4
-10%
-10 -5 0 5 10
Source: Data on file (CSR EVB-003, pg 5-6)
12
Investor PresentationJeuveau™ EU/CA Phase III Trial
Secondary Endpoints
≥1 Improvement GLS at Maximum Frown
Investigator Assessment
Placebo Botox Jeuveau™ Placebo Botox Jeuveau™
Day 2 12.20% 57.00% 54.2%* Day 150 8.30% 34.40% 37.7%*
Subject Satisfaction
≥1 Improvement Subject Satisfaction
Placebo Botox Jeuveau™
Day 30 6.30% 86.60% 91.3%*
*P-Value Placebo vs DWP-450GLS IMPROVEMENT GLOBAL AESTHETIC IMPROVEMENT SCALE
INVESTIGATOR ASSESSMENT INVESTIGATOR ASSESSMENT SUBJECT SATISFACTION
GLS IMPROVEMENT GLOBAL AESTHETIC IMPROVEMENT SCALE
SUBJECT ASSESSMENT SUBJECT ASSESSMENT
14
Investor PresentationJeuveauTM Safety Studies
> 2,100 Subjects Studied with No Drug Related Serious Adverse Events
U.S. Safety Profile: Adverse Events1
US PIII EV-001 US PIII EV-002
Placebo JeuveauTM Placebo JeuveauTM
Ptosis Rates
All 32.1% 38.2% 26.9% 28.5% JeuveauTM: 1.0% eyelid, 0.4%
eyebrow
Related 13.1% 15.4% 7.7% 9.8%
EU Safety Profile: Adverse Events2
EU PIII EVB-003
Placebo BOTOX JeuveauTM Ptosis Rates
All 32.7% 41.9% 37.6% JeuveauTM: 1.6% eyelid, 0.0% eyebrow
Botox: 0.0% eyelid, 0.4% eyebrow
Related 4.1% 14.6% 15.5%
1. Data on file (CSR EV-001, pg 100 & 107; CSR EV-002, pg 100 & 107)
2. Data on file (CSR EVB-003, pg 8)
15
Investor PresentationJeuveau™ EU/CA Phase III Trial
No Drug Related Serious Adverse Events
Jeuveau™ (N=245) Botox (N=246) Placebo (N=49)
Adverse Event Parameter
n (%) Events n (%) Events n (%) Events
Any AEs 92 (37.6) 152 103 (41.9) 165 16 (32.7) 27
Incidence diff., % (95% CI) 4.3 (-13.3, 4.4)
Any serious AE 3 (1.2) 6 1 (0.4) 2 1 (2.0) 3
Any study drug-related AE 38 (15.5) 46 36 (14.6) 45 2 (4.1) 2
Any study drug-related AE of
5 (2.0) 5 3 (1.2) 3 0 (0.0) 0
special interest
Any AE leading to study
0 (0.0) 0 1 (0.4) 1 0 (0.0) 0
discontinuation
Any AE leading to death 0 (0.0) 0 0 (0.0) 0 0 (0.0) 0
Any AE with frequency > 5% 52 (21.2) 59 48 (19.5) 54 9 (18.4) 12
Nervous system disorder,
34 (13.9) 38 25 (10.2) 26 7 (14.3) 10
headache
Incidence diff., % (95% CI) 3.7 (-5.2, 12.5)
Infections and infestations,
21 (8.6) 21 28 (11.4) 28 2 (4.1) 2
nasopharyngitis
Incidence diff., % (95% CI) -2.8 (-11.7, 6.0)
Source: Data on file (CSR EVB-003 p 112, 114, 116)
16
Investor PresentationDifferentiated
Marketing
Frictionless
Alternative
17
Investor Presentation
17Beauty Company by Design Not by Default
Others
Women’s
Health
Gastro-
enterology Medical
Aesthetics
Anti-
Eye
histamines Infectious performance
Care
Diseases beauty
Neuroscience Obesity
Oncology
Focused on multiple Exclusively for aesthetics
Therapeutic areas
18
Investor PresentationStrategically Focusing
on Today and Tomorrow
Targeting the Largest Population
73 72
MILLION MILLION
VS BABY
MILLENNIALS
BOOMERS 1
*2019 Estimate
Significant Opportunity Open to Trial
1
Botulinum Toxin use among
people ages 19 to 34 increased by
87% between 2011 and 20162
Neurotoxin treatments are the #1
cosmetic procedure considered by
millennials3
~1.7M considering neurotoxins in
the next year3
1. “Millennials projected to overtake Baby Boomers as America’s largest generation.” Pew Research Center, Washington, D.C. (March 1, 2018)
http://www.pewresearch.org/fact-tank/2018/03/01/millennials-overtake-baby-boomers/. Millennial defined as individuals born between 1981 and 1996.
2. American Society for Aesthetic Plastic Surgery
3. Survey of millennials conducted by Faith Popcorn for Evolus, July 2017 (n=40 millennials). Millennial defined as individuals aged 18-34.
19
Investor PresentationFor Our Provider For Our Consumer
LARGEST PHASE III
HEAD-TO-HEAD 3 TIMES*
Average patient
aesthetic study vs
treatments a year
BOTOX® Cosmetic
*Based on two open-label repeat dose safety studies, in which patients received on average 3 treatments in one year
20
Investor PresentationDesign Orientations
COMPANY BRAND PACKAGING
SCIENCE DATA TECHNOLOGY
21
Investor PresentationFrictionless Alternative
Creating a strongly desirable experience for customers and consumers
Extensive Industry Expertise Phase 3 Head-to-Head Data Simple, Personal and Connected Consumer Loyalty
Primary Endpoint: Non-Inferiority
GLS = 0 or 1 at Maximum Frown by Investigator
Assessment at Day 30
100% 87.2%
90% 82.8%
80%
70%
60%
50%
40%
30%
20%
10% 4.2%
0%
Jeuveau Botox Placebo
n=235 TM n=244 n=48
22
Investor PresentationFinancial Overview
Strong Cash Position
Q1 2019:
In USD, except shares
Operating Expenses: Non-GAAP1 $17.9M
Cash, cash equivalents and short-term investments $133.7M
Weighted-Average Shares Outstanding 27,330,174
1. See Appendix for Reconciliations of non-GAAP to GAAP financial measures. Includes $1.6M of milestone
payments paid under various arrangements upon receiving the FDA approval of Jeuveau™.
23
Investor PresentationKey 2019 Catalysts
Jeuveau™ FDA approved February 2019
Publications:
U.S Trials in Dermatologic Surgery Journal (February 2019)
EU / Canada head-to-head trials in Aesthetic Surgery Journal (April 2019)
Positive EU CHMP opinion received April 2019. Anticipate approval within 90 days of
opinion and we continue to evaluate commercial partnership opportunities in Europe.
U.S. commercial launch in May 2019
Expect Canada commercial launch in 2nd half 2019
24
Investor PresentationT H A N K Y O U
25
Investor PresentationAppendix $ Millions
Reconciliations of non-GAAP
to GAAP Financial Measures
Evolus has presented Non-GAAP Loss and
Non-GAAP operating expenses, which are
calculated as GAAP Net loss and GAAP total
operating expenses, respectively, excluding:
(i) the revaluation of contingent royalty
obligation payable and (ii) stock-based
compensation expense. Evolus has also
presented Non-GAAP Loss Earnings Per
Share by quarter and year-end, which is
calculated as Non-GAAP Loss divided by
quarterly and year-end weighted average
shares outstanding, respectively.
Management believes that non-GAAP
operating expenses and these other certain
non-GAAP financial measures are useful in
helping to identify recurring operation
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 expenses and these
other certain non-GAAP financial measures
will enable investors to assess in the same
way management assesses Evolus' current
and future operations. Non-GAAP operating
expenses and these other certain non-GAAP
financial measures should be considered in
addition to results prepared in accordance
with GAAP, but should not be considered a
substitute for or superior to GAAP results.
26
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