Daring to Make a Difference - Company presentation December 2019 - Revance
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Daring to Make a Difference Company presentation December 2019
Forward-Looking Statements / Safe Harbor / Market Data
This presentation contains forward-looking statements, including forward-statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to: financial metrics, the
process and timing of, and ability to complete, current and anticipated future clinical development of our investigational product candidates, including anticipated near-term milestones; the initiation, enrollment,
design, timing and outcome of our clinical trials, including for the treatment of glabellar (frown) lines, forehead lines, lateral canthal lines (crow’s feet), cervical dystonia, plantar fasciitis, adult upper limb spasticity
and chronic migraine, relating to DaxibotulinumtoxinA for Injection (DAXI); and related results and reporting of such results and statements; timing and outcome of regulatory determinations regarding the potential
label for DAXI to treat glabellar (frown) lines and commercial potential of our drug candidates, status of commercial collaborations, including regulatory approval and related milestones and potential receipt of
royalties under our license agreement with Fosun Pharma and collaboration agreement with Mylan’s continuation decision and the timing thereof; our ability to obtain, and timing relating to, regulatory approval with
respect to our drug candidates; our ability to commercialize and launch, and related timelines relating to, our product candidates; the potential aesthetic, therapeutic and economic benefits and value of our product
candidates and our technologies; demand for our product candidates and drivers of demand; market size, adoption rate and potential revenue; growth opportunities and product pipeline; our business strategy,
timeline and other goals and market for our anticipated products, plans and prospects; our ability to leverage our investment in our development and manufacturing platform; our commercial and intellectual
property strategy; and our financial and operating projections, including cash and operating expense forecast.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome,
cost and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results, or
that positive results would assure regulatory approval or commercial success of our product candidates; that we may not obtain the anticipated financial and other benefits of the license agreement with Fosun
Pharma and the collaboration agreement with Mylan; our ability to obtain and maintain regulatory approval of our product candidates; our ability to obtain funding for our operations; our plans to research, develop
and commercialize our product candidates; our ability to achieve market acceptance of our product candidates; unanticipated costs or delays in research, development and commercialization efforts; the size and
growth potential of the markets for our product candidates; our ability to effectively and reliably manufacture clinical trial supplies of DAXI, biosimilar or any future product candidates and to develop, validate and
maintain a commercially viable manufacturing process; our ability to successfully commercialize our product candidates and the timing of commercialization activities; the rate and degree of market acceptance of
our product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue
obtaining and maintaining intellectual property protection for our product candidates; and our anticipated or planned financial and operational performance and requirements. These and other risks are described in
the “Risk Factors” section of our Form 10-Q filed with the Securities and Exchange Commission on November 4, 2019.
This presentation also includes information about the global neuromodulator market, including growth and trends that is based on various publicly available sources and on a number of assumptions and limitations.
The industry and third-party overview included in this presentation have been obtained from sources believed to be reliable, but we have not independently verified such information and assume no responsibility for
the accuracy of such information. In addition, projections, assumptions and estimates of the future performance of the global neuromodulator market are necessarily subject to a higher degree of uncertainty and risk
due to a variety of factors, including those described above and in the “Risk Factors” section of our Form 10-Q filed with the Securities and Exchange Commission on November 4, 2019.
The “Risk Factors” section of our Form 10-Q speaks only as of the date thereof. The forward-looking statements and market data in this presentation speak only as of the date hereof or the date specified. Revance
disclaims any obligation to update such forward-looking statements and also disclaims any obligation to update or correct such market data.
“Revance Therapeutics”, “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.
2
Value Creation Across The Business
DAXI AESTHETICS DAXI THERAPEUTICS
NEAR-TERM LAUNCH FUTURE REVENUE ENGINE
$2B global opportunity1 $2.5B global opportunity 1
• Positive P3 studies in Glabellar Lines • P3 in Cervical Dystonia fully enrolled
• High efficacy, 24-week duration* • P2 studies in Upper Limb Spasticity and
• P2 studies in Upper Face Plantar Fasciitis
• China partnership with Fosun • China partnership with Fosun
Pends U.S. approval/launch 2020 Key clinical results 2H 2020
BUSINESS ASSET
EXTENDS CASH RUNWAY
Biosimilar to BOTOX®
• Source of non-dilutive capital
• 351(k) pathway, potentially all
References:
BOTOX® indications
1. Based on 2018 estimates from Global Industry Analysts, Inc. Botulinum Toxin – A Global Strategic Business Report, January 2018, UBS Specialty Pharmaceuticals • Based on SAKURA 1 and SAKURA 2 studies. See slide 12.
Handbook April 2018, Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports market estimates for 2018, December 2018 , and Allergan 2018
Financials
BOTOX is a registered trademark of Allergan, Inc. 3
Broad and Balanced Pipeline
Preclinical Phase 1 Phase 2 Phase 3
DAXI - AESTHETICS
BLA Submitted Nov 2019,
Glabellar (Frown) Lines
Anticipate 2020 Launch
Forehead Lines
Lateral Canthal Lines (Crow’s Feet)
DAXI - THERAPEUTIC
Cervical Dystonia CD and PF Readouts in
2H 2020
Upper Limb Spasticity
Plantar Fasciitis
Migraine Evaluating path forward
and potential timing of
clinical studies
BIOSIMILAR AND OTHER
Mylan Decision
Biosimilar to BOTOX®
1H 2020
Topical
BOTOX is a registered trademark of Allergan, Inc.
4
Targeting a Large, Growing Neuromodulator Opportunity
16% 31%
Chronic Migraine Muscle Movement
$7.7 Billion
$4.5 Billion 1 by 2025 2
Global Revenues • Hundreds of potential indications
• High consumer awareness
6% • 30 years of established safety profile
Overactive • Currently products are not
Bladder differentiated
44% Facial 2%
Aesthetics Axillary
1% Hyperhidrosis
Other Reference:
1. Based on 2018 estimates from UBS Specialty Pharmaceuticals Handbook April 2018
2. Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2019, November 2018 and Decision Resources Group
Aesthetics Injectables Botulinum Toxin Reports, December 2018
1 1
44% Aesthetics 56% Therapeutics
5
DAXI – Our Lead Product Candidate
DaxibotulinumtoxinA for Injection (DAXI) is uniquely suited to
expand the market:
The first and only The first and only Exceptional Phase 3 U.S.-based
neuromodulator neuromodulator with clinical results: the manufacturing for
with high response a proprietary peptide largest aesthetic drug substance and
rates and long formulation program in glabellar drug product
duration of effect lines
DaxibotulinumtoxinA is an investigational agent that has not been approved by the FDA. Anticipated approval in 2020.
6
150 kD Neurotoxin type A
DAXI is a unique formulation with a
DAXI – novel proprietary stabilizing excipient
The First Major peptide
Neuromodulator • Peptide associates with the 150kD neurotoxin
(attraction) and has several important effects on
Innovation in 30 Stabilizing Peptide Excipient stability and availability:
— Prevents botulinum toxin from sticking to surfaces
Years (reduces adsorption)
— Increases stability of the toxin molecule (reduces
aggregation)
Buffers, Sugar, Polysorbate 20
No Human Serum Albumin
(HSA) or other animal-sourced
excipients
7
Large Consumer
Opportunity
#1
Neuromodulators are the
most-performed minimally
1
invasive cosmetic procedure
~$2B global facial aesthetics
neuromodulator opportunity
2
only
7%
WW of consumers considering
aesthetic procedures have used
3
facial injectables
7M+ U.S. neuromodulator procedures per
year
1
References:
1. In the US - American Society of Plastic Surgeons Report, March 2018
2. Based on 2018 estimates from Global Industry Analysts, Inc. Botulinum Toxin – A Global Strategic Business Report, January 2018, UBS Specialty Pharmaceuticals
Handbook April 2018, Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports market estimates for 2018, December 2018 , and Allergan 2018
Financials
3. Allergan Business Analytics & Allergan 2016 Global Beauty Trends Report; User estimates based on calculation using AGN sales and market share data 8
DAXI – Pursuing Largest Indications in Facial Aesthetics First
Upper Face Development Programs
GLABELLAR FOREHEAD LINES CROW’S FEET
(FROWN) LINES
• Clinical programs for • Combination forehead and • Lateral canthal lines (crow’s
approval completed glabellar line P2 study feet) P2 study underway
• Positive SAKURA 1, 2 & 3 underway • Exploring dose and injection
P3 Results • Exploring dose and injection pattern
• More than 4,400 DAXI pattern
treatments in P1, 2 & 3
glabellar line program
Submitted BLA Nov 2019, Phase 2 Fully Enrolled, Phase 2 Fully Enrolled,
approval expected in 2H 2020 topline results expected topline results expected
in 1H 2020 in 1H 2020
Source: Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports, December 2018
9
DAXI: Glabellar Lines - SAKURA 1, 2 & 3 Phase 3 Results
Largest-Ever Aesthetic Neuromodulator Clinical Program Completed
1
SAKURA 3 Example 2-Point Improvement by IGA-FWS & PFWS at Week 4
Baseline Week 04 Week 16 Week 24
Program Efficacy Safety Median Duration of
Summary Effect
SAKURA 1 & 2 pivotal trials Proportion of subjects who achieve Most common treatment- At least 24 weeks observed on
1
and SAKURA 3 long-term ≥ 2-point composite response at related AEs were headache, multiple secondary endpoints
safety study max frown at 4 weeks injection site pain and
injection site erythema
>3,300 patients at 65 total SAKURA 1- 73.6% vs. placebo at 0%
sites in US and Canada SAKURA 2 - 74.0% vs placebo at 1% Ptosis rates - 2.2% for
pooled SAKURA 1&2,
References:
1.3% for SAKURA 3
1. Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) & Patient Facial Wrinkle Severity (PFWS) scales
10DAXI – Glabellar Lines: High Efficacy and Long Duration of Effect
None or Mild Response Rates on 4-Point Investigator Assessment over Time
98 SAKURA 3 Cycle 1 (n=2380 treatments)
100 96
95 SAKURA 3 Cycle 2 (n=882 treatments)
88 88
90 90 SAKURA 3 Cycle 3 (n=568 treatments)
86 86
80 8379 SAKURA 1 Daxi 40U (n=201)
74
80 70 75 SAKURA 2 Daxi 40U (n=204)
70 74
Dysport USPI: GL-1
60 64 Dysport USPI: GL-3
51 58 54
50 48 BOTOX Cosmetic USPI
Jeuveau: EV-001
40 43 38
30 29
25 29
20 21
% of subjects
23
16
10 9 14
6
0 7 3
0 4 8 12 16 20 24 28 32 36
Days 30 60 90 120 150 180
1United States Prescribing Information Phase 3 Studies in GL for each neuromodulator with data available through at least Day 120 conducted separately and presented for reference only.
USPI: US Package Insert. 2 Jeuveau data from results published in Dermatologic Surgery March 2019. Note: In SAKURA 1 and 2 (ITT), missing data were imputed with the worst post-baseline outcome (or best outcome for
Placebo arm) on visits up to Week 24. Non-responder imputation was used for visits post Week 24.
BOTOX, Dysport and Jeuveau are registered trademarks of their respective companies
11DAXI – Glabellar Lines: Median Duration of at Least 24 Weeks Observed
on Multiple Secondary Endpoints
Median Duration of 24 Weeks Median Duration of 28 Weeks
Time to Loss of None or Mild Wrinkle Severity in Both Time to Return to Baseline Wrinkle Severity in Both
SAKURA 1&2 Pivotal Studies and SAKURA 3 OLS SAKURA 1&2 Pivotal Studies and SAKURA 3 OLS
Median (95% CI)
100 Median (95% CI) 100
28.0 (28.0, 28.1) weeks
90 24.0 (23.9, 24.0) weeks 90
28.1 (28.0, 28.4) weeks
24.1 (24.0, 24.7) weeks
80 80 27.7 (24.7, 28.0) weeks
24.0 (23.4, 24.1) weeks
70 70 26.0 (24.1, 28.0) weeks
23.9 (20.3, 24.0) weeks
60 60
OLS Treatment 1 (n=2380)
OLS Treatment 1 (n=2380)
50 50
OLS Treatment 2 (n=882)
OLS Treatment 2 (n=882)
40 40
SAKURA 1 (n=201)
SAKURA 1 (n=201)
30 30
SAKURA 2 (n=204)
% of Subjects
SAKURA 2 (n=204)
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 DAXI 40U
12DAXI – SAKURA Program Supports 6-Month Label
We believe the SAKURA clinical results support 6-month duration on
label for glabellar lines based on five objective and data-driven points:
Clinical Strength of data FDA guidance - Class label Precedent labels
meaningfulness and pre-specified both prescriptive approach for similar
and clinical data endpoints and descriptive approved
relevance neuromodulators
13DAXI – Highly Differentiated, Not a Dose Effect
0.12 ng7
DAXI and BOTOX have
nearly identical amounts
of core active ingredient,
botulinum toxin type A,
in respective glabellar
line dosage, with DAXI
demonstrating sustained
duration of effect1 ***
References:
1. Revance Data on file (SAKURA 1 and 2 Phase 3 Trials with DAXI40 Units).
2. Full details included in Botox product insert.
3. Full details included in Dysport product insert, FDA Dysport Summary Basis of Approval (CMC section).
4. Full details included in Xeomin product insert.
5. Full details included in Jeuveau product insert.
6. Field, et al. AbobotulinumtoxinA (Dysport®), OnabotulinumtoxinA (Botox®), and IncobotulinumtoxinA (Xeomin®) Neurotoxin Content and Potential Implications for Duration of Response in Patients, Toxins 2018, 10(12), 535.
7. Full details included in Canadian Nucevia Product Monograph
*DAXI is an investigational product. **Mass of 150kDa core neurotoxin contained within the glabellar line dose for each product.
***Time to loss of none or mild wrinkle severity on both IGA-FWS and PFWS. All other trademarks referenced herein are the property of their respective owners.
14Potentially
treatments
per year
“ My study patients were thrilled with their
appearance and the longevity [DAXI] delivered,
and they can’t wait for this treatment option.”
Jean D. Carruthers, M.D.
SAKURA Investigator
15DAXI – Glabellar Lines: Preparing Today to Disrupt Tomorrow
Commercial Launch
Establish the Redefine the Upgrade the Resonate with
long-acting “value” of long- treatment today’s
category lasting results paradigm consumer
1611 Approved Therapeutic Indications
in Neuromodulator Category
Chronic Migraine
Strabismus
Large Therapeutics Blepharospasm
Market Opportunity
700+
Cervical Dystonia
Axillary Hyperhidrosis
Adult Spasticity (Upper and Lower) Potential
Therapeutic Indications2
Pediatric Spasticity (Upper and Lower)
Overactive Bladder
$2.5B
1
Detrusor Overactivity
Global Market Opportunity
References:
1. Based on 2018 estimates from Global Industry Analysts, Inc. Botulinum Toxin – A Global Strategic Business Report, January 2018, UBS Specialty Pharmaceuticals Handbook April 2018,
Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports market estimates for 2018, December 2018 , and Allergan 2018 Financials
2. Time Magazine, January 16, 2017, How BOTOX Became the Drug That’s Treating EverythingDAXI Therapeutics Expansion Indications Program
Pursuing Largest Markets and New Indications in Therapeutics
CERVICAL ADULT PLANTAR MIGRAINE
DYSTONIA UPPER LIMB FASCIITIS
SPASTICITY
~$200M Global Cervical ~$300M Global ~$250M US Plantar ~$625M Global Sales
Dystonia Opportunity Spasticity Opportunity Fasciitis Treatment for BOTOX® in 2018
1 1 1
Market Typically treated by
1
Typically treated by Typically treated by
neurologists neurologists Typically treated by neurologists
podiatrists, physiatrists &
orthopedic surgeons
ASPEN-1 Phase 3 Fully Enrolling JUNIPER Enrolling Phase 2, Evaluating path forward
Enrolled, topline results Phase 2, topline results topline results expected & potential timing of
expected in 2H 2020 expected in 1H 2021 in 2H 2020 clinical studies
References:
1. Based on 2018 estimates from Global Industry Analysts, Inc. Botulinum Toxin – A Global Strategic Business Report, January 2018; DRG Therapeutic Botulinum Toxin Market Analysis Global 2019; UBS Specialty Pharmaceuticals Handbook April 2018;
Allergan 2018 Financials, and https://heelthatpain.com/15-plantar-fasciitis-facts/
BOTOX is a registered trademark of Allergan, Inc. 18DAXI – Cervical Dystonia: Phase 2 Dose-Ranging Trial Suggests Potential
for Long Duration in High-Dose Muscle Movement Indications
Reduction from Baseline in TWSTRS Total Score with DAXI in CL005
Phase 2 Study and AbobotulinumtoxinA (Dysport®) in US Pivotal Trials (500U)
0
DAXI 100-240U (n=21)
DAXI 300-450U (n=16)
-5
DAXI All Subjects (n=37)
-10 24% Placebo (ABO) (n=61)1
30% ABO 500U (n=55)1
34% 35% 35%
-15 38% 38% 38% Placebo (ABO) (n=43)2
34% 37% 38%
43% 42% 39% ABO 500U (n=37)2
38% 39% 39%
-20 39% 48%
47% Note: Results drawn from
45%
50% 47% multiple studies. Caution
51% should be used when
-25
interpreting cross-study
comparisons.
-30
0 4 8 12 16 20 24
Weeks
References:
1. Truong et al, Parkinsonism Relat Disord. 2010 Jun; 16(5):316-23 DAXI Phase 2 was an open-label, dose-escalation trial. Abo Phase 3 studies were double-blind,
placebo-controlled studies. Dysport is a registered trademark of its respective company.
2. Truong et al. Mov Disord. 2005 Jul;20(7):783-91 19Biosimilar to BOTOX® Program – Monetizing a Business Asset
Partnership aims to develop, chosen for biosimilar expertise from a
$3.6Billion
Directly addresses short-acting
manufacture & commercialize a range of potential program suitors BOTOX® global market1
biosimilar to BOTOX® worldwide
351(k)
provided guidance on
expectations for development
program. Approval could
pathway viability established result in all 14 FDA-approved
at BIAM in February 2019 BOTOX® indications
$30Million
Plus additional potential Mylan’s target action date:
milestones and royalties By April 30, 2020
1. Based on 2018 Allergan YE 2018 financial report
BOTOX is a registered trademark of Allergan, Inc.
20Intellectual Property Intellectual Property and Manufacturing Capability
400+ 100+
Core US composition and
methods patents expire in
2030 and 2032, potentially
with a potential 5-year
issued patents* pending patents extension
applications*
U.S.-based
Capability to manufacture CMC/Analytics: U.S. Select
drug substance from 150 to Agent License
Manufacturing
900 kDa
Scalable drug product
state-of-the-art cGMP Dedicated drug substance capacity with CMO
manufacturing facility & drug product
manufacturing
*As of January 19, 2019 21Anticipated Near-Term Milestones
DAXI AESTHETICS DAXI THERAPEUTICS BIOSIMILAR
Glabellar Lines ✓ Complete Enrollment Mylan Continuation 1H 2020
P2 Plantar Fasciitis 2H 2019 Decision
BLA Submission
Topline Results 1H 2020 Complete Enrollment
P2 Forehead Lines P3 Cervical Dystonia ✓
Topline Results 1H 2020 Complete Enrollment P2
P2 Crow’s Feet Upper Limb Spasticity 1H 2020
1H 2020
Glabellar Lines Topline Results
EU Submissions P3 Cervical Dystonia 2H 2020
Glabellar Lines BLA 2H 2020 Topline Results
Approval and Launch P2 Plantar Fasciitis 2H 2020
22Financial Overview
$209M* 45.8M*
Cash, cash equivalents and short- Shares outstanding2
term investments 1 . No debt
1 As of Sept 30, 2019, unaudited 2 Shares as of Dec 1st, 2019, unaudited *Prior to Dec 3rd offering 23Value Creation Across The Business
DAXI AESTHETICS DAXI THERAPEUTICS
NEAR-TERM LAUNCH FUTURE REVENUE ENGINE
$2B global opportunity1 $2.5B global opportunity 1
• Positive P3 studies in Glabellar Lines • P3 in Cervical Dystonia fully enrolled
• High efficacy, 24-week duration* • P2 studies in Upper Limb Spasticity and
• P2 studies in Upper Face Plantar Fasciitis
• China partnership with Fosun • China partnership with Fosun
Pends U.S. approval/launch 2020 Key clinical results 2H 2020
BUSINESS ASSET
EXTENDS CASH RUNWAY
Biosimilar to BOTOX®
• Source of non-dilutive capital
• 351(k) pathway, potentially all
BOTOX® indications
References:
1. Based on 2018 estimates from Global Industry Analysts, Inc. Botulinum Toxin – A Global Strategic Business Report, January 2018, UBS Specialty Pharmaceuticals • Based on SAKURA 1 and SAKURA 2 studies. See slide 12.
Handbook April 2018, Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports market estimates for 2018, December 2018 , and Allergan 2018 Financials BOTOX is a registered trademark of Allergan, Inc. 24Thank you
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