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“Revance Therapeutics”, TransMTS, “Remarkable Science. Enduring Performance”, and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
All other trademarks or registered trademarks are the property of their respective owners.
3
Agenda
Revance Overview
Remarkable Science
– Clinical Update
– Regulatory Panel
Enduring Performance
• To Market We Go
– Market Analysis
– Market Realities – Expert Panel
– Revance Product Launch Velocity
Q&A
Summary and Close
APRIL 19, 2018
COMPANY OVERVIEW
DAN BROWNE
President & CEO
urinary urge/incontinence
wrinkles
marionette lines
sweaty
palms
lines Opportunity TMJ/teeth grinding
nasolabial foot
migraine
folds spasticity
pain
rosacea heart
$4B+
acne TODAY*
depression trouble
crows feet
… and 700+ Other Conditions
* Source: Global Industry Analysts, Inc. Botulinum Toxin – A Global Strategic Business Report, Jan 2018
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1 2 3
TEAM SCIENCE PERFORMANCE
OUR VALUES
Speed | Audacious | Grit | Empathy
8
AESTHETICS
GAIN APPROVAL in Glabellar Lines and
LAUNCH in Aesthetics
THERAPEUTICS
LEVERAGE Infrastructure and
EXPAND Therapeutic Pipeline
10
Facial Aesthetics
40%
Expanded New RT002
Neuroscience Pipeline Muscle
Movement
28%
Muscle Movement–
~$1.1BB Global
Opportunity*
Chronic Migraine –
Chronic
~$625MM Global Migraine
Opportunity* 16%
* Source: Calculated from estimates for 2017 – 2024 in the Global Industry Analysts, Inc. Botulinum Toxin – A Global Strategic Business Report, Jan 2018
RT002 is an investigational product
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REVANCE: MYLAN:
Manufacturing Ready Platform Biosimilar Expertise/Commercial Readiness
• US based dedicated cGMP commercial ready manufacturing facility • Critical mass in Dermatology franchise to address therapeutics and aesthetics
• Significant investment in manufacturing infrastructure • Robust portfolio of topical & systemic products spanning multiple therapeutic areas
and indications
• Established KOL relationships and partnerships with key dermatology stakeholders
BOTOX is a registered trademark of Allergan, Inc.
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RT002 AESTHETICS
Glabellar Lines
RT002 NEUROSCIENCE
Cervical Dystonia
Plantar Fasciitis
Chronic Migraine
Biosimilar to BOTOX®
Topical
REVIEW MECHANISM and CLINICAL DATA FOR LONG DURATION for daxi (RT002) across
both aesthetic and therapeutic indications
Examine the growing AESTHETIC MARKET from clinical & commercial perspectives
DAN BROWNE • >30 years pharmaceutical and medical technology experience Launch and Commercialization
Co-Founder, President & CEO • Various leadership roles in product development, sales and marketing
ABHAY JOSHI, PH.D., M.B.A. • >30 years global pharmaceutical and biotech experience in various leadership roles
COO • Extensive oversight of botulinum toxin development, strategy and ops
SUSANNE FORS, M.Sc. • >20 years of global regulatory leadership and strategy experience
VP, Regulatory Affairs • Extensive regulatory experience with FDA, EMA and other national authorities
REMARKABLE SCIENCE APRIL 19, 2018
• Technological Innovation
• Highly Differentiated Neuromodular/Peptide Technology
• Strong Operational Execution
• US-Based cGMP Manufacturing Facility
• On Track to File Glabellar Lines BLA in 1H2019
• Aesthetic and Therapeutic Pipeline
RT002 Composition:
Active 150 kD
Neurotoxin Type A 150 kD
from 900 kD Complex Complex
900 kD Complex
Accessory
Proteins
150 kD Complex
RT002
Composition:
Active 150 kD
Neurotoxin Type A
RT002 Composition:
Proprietary Stabilizing Peptide Excipient
RT002
CO is an
N investigational
F I D E N T product
IAL AND PROPRIETARY
22
Revance’s
Differentiated
Neuromodulator
Product
RT002
+ + =
APPROVED PRODUCTS
✓
PURITY
Free of Accessory Proteins ✕ ✕ ✓
• OnabotulinumtoxinA dose-ranging studies support 20U for women and 40U for men is ideal;
however, there is no dose response or increase in duration beyond these doses
• For RT002, Duration of 24 weeks in Glabellar Lines and > 24 weeks in CD have been
clinically demonstrated, and in the latter, duration is independent of Daxi dose
100%
90%
80%
70%
72%
% of Subjects
60% 64%
50% 55%
40%
Median Duration
30% 100-240U (n=20) 100-240U >24 weeks
20% 300-450U (n=16) 300-450U >24 weeks
10% All Subjects (n=36) All Subjects >24 weeks
0%
0 4 8 12 16 20 24
Weeks
Female Study (Carruthers 2005) Revance Phase 2 CD Study (Jankovic. et. al 2018)
C O isNanFinvestigational
RT002 I D E N T I Aproduct
L AND PROPRIETARY
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DaxibotulinumtoxinA OnabotulinumtoxinA
40U 20U
0.18 ng 150 kDa 0.17† ng 150 kDa
Neurotoxin Neurotoxin
*DaxibotulinumtoxinA 20U contains ~ 50% of the 150 kDa neurotoxin of OnabotulinumtoxinA 20U (0.092 ng vs. 0.17 ng, respectively)
†Nauman et al. (2013) Immunogenicity of botulinum toxins. J Neural Transm; 120: 275 – 290.
Differentiating Capabilities
RESEARCH &
CLINICAL MANUFACTURING REGULATORY
DEVELOPMENT
• Neuromodulator focused • Proven clinical • State-of-the-art commercial • Completed IND/EOP2
expertise from basic research to development expertise ready cGMP manufacturing submissions with FDA/EMA
product development • Strong global facility • Collaborated with global
• Peptide research platform KOL relationships • Dedicated drug health authorities for scientific
substance manufacturing advice meetings
• Modern analytical tools and cell • Completed Phase 3 SAKURA 1 &
2, Conducting SAKURA 3 OLS • Dedicated drug • First half 2019 US BLA
based assays product manufacturing
• Conducting Phase 2 submission planned for
• Fermentation/purification • No capacity constraints Glabellar Lines
Plantar Fasciitis (PF)
• Biosimilar development for drug substance
• 2019 EMA submission planned
• Conducting Phase 3 • Scalable drug product
Cervical Dystonia (CD) for Glabellar Lines
capacity augmented by CMO
• Leverage CRO when needed • Manufactured RT002
for all clinical trials
Attraction
Attraction
Peptide forms an electrostatic (noncovalent) charge interaction with Daxi – the active
pharmaceutical ingredient (API; 150 kDa BoNT/A molecule) -
RT002 is an investigational product
ATTRACTION: PROPRIETARY PEPTIDE AND DAXI INTERACTION 31
HSA 5.8
Peptide
13.1*
BoNT/A 6.1
BoNT/A 6.1
250
150
Response, RU
100
50 Daxi/HSA 60 µg/mL
-50
-20 0 20 40 60 80 100 120 140
Time, Sec
700
600
Binding level
300
200
1 3 5
Daxi only Peptide only
(100 µg/mL) (15 µg/mL)
Daxi : Peptide
Molar Ratio
Potency (U/vial)
0.20 50
0.15 40
30
0.10
20
0.05
10
0.00 0
Peptide + PS-20 PS-20 Only Peptide + PS-20 PS-20 Only
4000.000
Daxi alone
Z AVERAGE DIAMETER (NM)
1500.000
1000.000
500.000
0.000
30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70
TEMPERATURE (°C)
less stable more stable
• Attraction: Peptide
AESTHETICS
THERAPEUTICS
39
Daxi 40U Placebo Daxi 40U Placebo Daxi 40U Placebo Daxi 40U Placebo
Week (n=201) (n=102) (n=204) (n=102) Week (n=201) (n=102) (n=204) (n=102)
Note: Cochran-Mantel-Haenszel test stratified by study center was used for response rate comparison for Daxi vs Placebo at each time point on ITT population.
Missing data were imputed with worst post-baseline outcome for Daxi and best outcome for Placebo.
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98.0 97.5
100 95.6
94.6 SAKURA 1 Daxi 40U (n=201)
88 88.2
90 SAKURA 2 Daxi 40U (n=204)
90 91.5
80 83 Dysport USPI: GL-1
84.1 74.0
80 70 75
70 Dysport USPI: GL-3
74 71.1
BOTOX Cosmetic USPI
60 64 51 54.4
% of 48
50 53.2
Subjects
40 43
35.3
30 29
25 29.4
20 15.9
23
10 8
9 14.2 5
0 6.9 2.9
0 4 8 12 16 20 24 28 32 36
100 100
90 90
80 80
70 70
30 30
20 20
10 10
0 0
0 4 8 12 16 20 24 28 32 36 0 4 8 12 16 20 24 28 32 36
Weeks Since DaxibotulinumtoxinA 40U Weeks Since DaxibotulinumtoxinA 40U
SAKURA 1 SAKURA 2
(n=201) (n=204)
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1 2 3
Pre-Treatment Week 4 Week 24
SAKURA 1 SAKURA 2
*6 cases of mild severity, 3 cases of moderate severity. All cases resolved without sequelae. Median duration of 58 days.
**A placebo patient who received Daxi in error was included in the Daxi group for safety summary.
45
Cervical Dystonia
Largest Muscular Movement Disorder
0
100-240u (n=21)
-5 300-450U (n=16)
-30
0 4 8 12 16 20 24
Weeks
*Data approximated from Figure 2 of Poewe (2016): Efficacy and Safety of AbobotulinumtoxinA Liquid Formulation in
Cervical Dystonia: A Randomized-Controlled Trial
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Plantar Fasciitis
Highly Prevalent Foot/Heel Disorder
Plantar Fasciitis
Phase 2 results at Week 16 similar to Week 8 results
• Week 16 Results:
– Efficacy: Reduction from baseline in VAS-pain score of 58% observed with Daxi at Week 16; however strong
placebo response also observed with no difference between treatment arms (p=0.42). Similar outcome
observed across secondary endpoints
– Safety: Daxi appeared to be generally safe and well-tolerated over 16 weeks with no treatment-related
SAEs and no subjects discontinued from study secondary to treatment
Chronic Migraine
>15 Headache Days per Month, 8 or More Days Feature Migraines*
REGULATORY DISCUSSION
Expert Panel
Regulatory Panel
Susanne Fors
Regulatory Panel
Dr. Paul Lorenc
98.0 97.5
100 95.6 SAKURA 1 Daxi 40U (n=201)
94.6
88 88.2
90 SAKURA 2 Daxi 40U (n=204)
90 91.5
80 83 Dysport USPI: GL-1
84.1 74.0
80 70 75 Dysport USPI: GL-3
70 74 71.1
BOTOX Cosmetic USPI
60 64 51 54.4
% of
50 48
Subjects 53.2
40 43
35.3
30 29
25 29.4
20 15.9
23
10 8
9 14.2 5
0 6.9 2.9
0 4 8 12 16 20 24 28 32 36
100 100
90 90
80 80
70 70
30 30
20 20
10 10
0 0
0 4 8 12 16 20 24 28 32 36 0 4 8 12 16 20 24 28 32 36
Weeks Since DaxibotulinumtoxinA 40U Weeks Since DaxibotulinumtoxinA 40U
SAKURA 1 SAKURA 2
(n=201) (n=204)
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Regulatory Panel
Carmen Rodriguez
Regulatory Panel
Carmen Rodriguez
Regulatory Panel
Susanne Fors
98.0 97.5
100 95.6 SAKURA 1 Daxi 40U (n=201)
94.6
88 88.2
90 SAKURA 2 Daxi 40U (n=204)
90 91.5
80 83 Dysport USPI: GL-1
84.1 74.0
80 70 75 Dysport USPI: GL-3
70 74 71.1
BOTOX Cosmetic USPI
60 64 51 54.4
% of
50 48
Subjects 53.2
40 43
29 35.3
30
25 29.4
20 15.9
23
10 8
9 14.2 5
0 6.9 2.9
0 4 8 12 16 20 24 28 32 36
TO MARKET WE GO
Daryl Bogard
Partner, Niche HealthCare Strategic Advisors
$1.0
$0.5
$0.0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
International US
$1.0
$0.5
$0.0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Therapeutic Aesthetic
Sources: AGN, analysts’ reports, EvaluatePharma, Galderma, Hugel, Ipsen, L'Oréal, Medytox, Merz, Nestle, syndicated reports, estimates
A Total of Nine FDA Therapeutic Approvals for BOTOX Have Helped Drive the
Growth of the Therapeutic Neuromodulator Sales
$0.6
$0.4
$0.2
$0.0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
International US
S,B CM
HH UI OAB LLS
CD ULS
Sources: AGN, analysts’ reports, EvaluatePharma, Galderma, Hugel, Ipsen, L'Oréal, Medytox, Merz, Nestle, syndicated reports, estimates
$1.2
Xeomin
FDA approved BOTOX Cosmetic
$1.0 glabellar lines approved
crow’s feet
$0.8
Dysport
FDA approved
$0.6 glabellar lines
BOTOX Cosmetic
FDA approved
$0.4
glabellar lines
$0.2
$0.0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
International US
Sources: AGN, analysts’ reports, EvaluatePharma, Galderma, Hugel, Ipsen, L'Oréal, Medytox, Merz, Nestle, syndicated reports, estimates
Eylea’s Favorable Dosing Schedule Helped Drive Its US Branded Anti-VEGF US$
Share While Continuing to Expand the Market
$1.0
$0.0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
MARKET REALITIES
Expert Panel
Grant Stevens, MD, FACS, Marina Plastic Surgery and Orange Twist Institute
Joely Kaufman, MD, FAAD, Skin Associates of South Florida
Tom Seery, CEO/Founder, RealSelf
Jodi Kaback, Facial Injectable Consumer
MODERATOR: Todd Zavodnick CCO and President, Aesthetics & Therapeutics
73
Fillers, Fillers,
Neuromodulators, Neuromodulators,
Laser Hair Removal Laser Hair Removal
Neuro-
modulators
1 Neuro-
modulators
Quality
of Life
1 Quality
of Life
Year Year
Fillers, Fillers,
Neuromodulators, Neuromodulators,
Laser Hair Removal Laser Hair Removal
• Board-certified Dermatologist
• Private Practice in Coral Gables, Florida
• Voluntary Professor at University of Miami
• Director of Skin Research Institute
• Contributed to over 70 clinical trials in the dermatology space, with
over 1/3 focusing on neuromodulator and dermal filler trials
79
My Practice
Skin Research Institute
80
89% Female
11% Male
12-18% CAGR
85% onabotulinum toxin Over the last 3
1% incobotulinum toxin years
14% abobotulinum toxin
39% 41%
15%
1% 4%
<20 21-29 30-39 40-54 >55
My Practice
My perspective on common RT002 questions:
Tom Seery
CEO/Founder
Follow me on Instagram
@realself
@realself_tom
RealSelf is the leading digital marketplace in
aesthetics where millions of consumers and
thousands of HCP’s come together to share what’s
“worth it,” ask and deliver expert advice...
94 Million Millions
unique annual of cosmetic
visitors to reviews, procedure
photos, Q&A, posts
Neuromodulator brand
video hashtags
2,820,051 posts
60%
conduct plastic surgery research online
49%
say social media directly influenced
consideration
or decision to have cosmetic procedure
400,000
visits to neuromodulators
questions on RealSelf every
month
Sources: RealSelf Google Analytics, September 2016 through August 2017, American Academy of Facial Plastic and Reconstructive Surgery, RealSelf consumer survey, September 2014
These slides include content directly from a third party
It’s how consumers get answers
56%
2-year growth rate
RealSelf claimed
provider profiles
#plasticsurgery #dermatology
1,323,015 posts 559,044 posts # of new claimed provider profiles on realself
568 390,713
Sessions on RealSelf.com
1 Posts on RealSelf
Filler brand
on RealSelf
in Q1
13 382,850
Posts by RealSelf on
Impressions on RealSelf
social media
social media posts
vs vs vs
Jodi Kaback
Facial Injectable Consumer
TODD ZAVODNICK
Chief Commercial Officer, President Aesthetics and Therapeutics
BRANDING
and Market Launch
Preparations Underway
NURTURING MARKET
Relationships & To Drive
Fostering Advocacy ADOPTION
ASSEMBLING
Commercial Operation
Our Focus
SALES
Our
COMMERCIAL Focus
MARKETING
OPERATIONS
DIGITAL MARKETING
95
Our Focus
SALES SALES
• Revance Advocacy Program
Our • Commercial Policy Development
COMMERCIAL Focus – HCP
MARKETING
OPERATIONS
– Consumer
• Sales Force Sizing
DIGITAL MARKETING
96
Our Focus
Our Focus
DIGITAL MARKETING
SALES
• Authentic
– Actively involved and building relationships with social
communities and with the right partners
Our • Personalized
COMMERCIAL Focus – Leveraging precise targeting, segmentation and
MARKETING
OPERATIONS personalization at scale
• Opportunistic
– Real-time intelligence and rapid response to capitalize
on every opportunity
DIGITAL MARKETING
98
Digital Advantage
Our Focus
SALES
COMMERCIAL OPERATIONS
• Marketing Analytics
Our
Focus
• Supply Chain Management
COMMERCIAL
OPERATIONS
MARKETING
• Customer Relationship Management (CRM)
• Customer Service
DIGITAL MARKETING
100
PHYSICIANS PATIENTS
What are the most important unmet needs not addressed If you could create the ideal treatment for fine lines and
by currently available botulinum toxin products? (n=80) wrinkles, what would be the three most important things
for it to have? (n=80)
Eliminates Wrinkles
Topical 5% 21%
/Bumps/Spots
DUSTIN SJUTS
• >15 years global marketing, sales and operational experience within the medical aesthetics industry
VP, Strategy and Sales,
• Leadership roles in product launches, go to market strategies, and in market growth plans
Aesthetics & Therapeutics
MARC KORENBERG • >15 years in commercial operations, finance and analytics
Senior Director, Commercial • Build and lead domestic and international commercial operations, finance, analytics, strategic
Operations commercial partner leading market model design and implementation
JESSIE ROEDER • >12 years domestic and international healthcare sales and marketing experience
Associate Director, Marketing • Aesthetic and therapeutic launch excellence, market insights, and campaign development
DAN BROWNE
President & CEO
Closing Remarks
REVANCE PRODUCT LAUNCH VELOCITY
AESTHETICS
Ensuring preparation and targeted approach
* Source: Global Industry Analysts, Inc. Botulinum Toxin – A Global Strategic Business Report, Jan 2018
** Company estimate for FY 2015 based on Specialty Pharmaceuticals Monthly Handbook, UBS Global Research, January 2016
THANK YOU FOR JOINING US
DAN BROWNE
President & CEO