Building a Global Neurotoxin Franchise

Transcription

1 JUNE 2, 2014 Building a Global Neurotoxin Franchise DAN BROWNE President & CEO

2 Forward-Looking Statements This presentation contains forward-looking statements, including statements related to the process and timing of anticipated future clinical development of our product candidates; statements about our business strategy and goals, plans and prospects; timing and outcome of our clinical trials; our ability to obtain regulatory approval; the potential therapeutic and economic benefits and value of our product candidates; potential benefits 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 ability to leverage our investment in our development and manufacturing platform; and intellectual property strategy. 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; 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 applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our product candidates; 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 other risks described in the Risk Factors section of our quarterly report on Form 10-Q as filed with SEC on May 14, These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements. Revance Therapeutics, TransMTS and the Revance logo are registered trademarks of Revance Therapeutics, Inc. All other trademarks or registered trademarks are the property of their respective owners. Revance Therapeutics, TransMTS 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

3 Topical Injectable Aesthetic Therapeutic Global BOTULINUM TOXIN Platform Multiple Specialties Worldwide Rights 3

4 Investment Highlights LARGE ADDRESSABLE MARKETS $2.5 Billion in 2012, Growing to over $4.3 Billion in 2018 PLATFORM TECHNOLOGY Enables Macromolecule Delivery; Enhances Penetration LATE STAGE PROGRAMS DERMATOLOGY FOCUS Phase 3 - Lead Topical Indication, Crow s Feet Lines Phase 2 - Second Topical Indication, Hyperhidrosis Phase 2 - Injectable, Glabellar Lines ROBUST COMMERCIAL OPPORTUNITY Three Launches Beginning in 2017 ESTABLISHED OPERATIONAL CAPABILITIES Commercial Scale Manufacturing EXPERIENCED TEAM Proven Expertise in Developing and Launching Products 4

5 Management Team NAME TITLE EXPERIENCE Dan Browne President & CEO PROGRAFT Jacob Waugh, MD Lauren Silvernail Chief Scientific Officer, Medical Director Chief Financial Officer, EVP, Corporate Development Sharon Hall VP, Regulatory Affairs Niquette Hunt SVP, Commercial Curtis Ruegg, PhD EVP, R&D 5

6 Botulinum Toxin Market - Large and Growing Global Neurotoxin Revenue Growth ACROSS INDICATIONS ACROSS GEOGRAPHIES $4.3B $4.3B CAGR 8% $2.5B Cosmetic CAGR 9% $2.5B ROW EU CAGR 9% CAGR 11% Therapeutic CAGR 11% US E E Source: Botulinum Toxin; A Global Strategic Business Report; Global Industry Analysts, March

7 Broad, Flexible Technology Platform Highly Charged TransMTS Peptide Binds Non-Covalently to Target TransMTS Peptide RT001 - TOPICAL Enable Macromolecule Delivery RT002 - INJECTABLE Deeper Targets OTHER ACTIVES Enhance Penetration 7

8 RT001 and RT002 Address Different Needs RT001 SUPERFICIAL MUSCLES RT002 DEEPER TARGETS Forehead Crow s Feet Eyebrow Glabellar Frown Lines Above the Lip Masseter (Face Shaping) Neck/ Décolletage Platysmal Bands 8

9 Rich Pipeline with Multiple Indications PIPELINE PRE- CLINICAL PHASE 1 PHASE 2 PHASE 3 RT001 TOPICAL PRODUCT CANDIDATE Crow s Feet Lines Hyperhidrosis (Excessive Sweating) Migraine Headache Other Therapeutic Indications RT002 INJECTABLE PRODUCT CANDIDATE Glabellar Lines Therapeutic Indications 9

10 RT001 Easy to Use, Not Technique Dependent 2-3 MINUTES 1 Prepare Applicator Proprietary Dispenser Minimizes Misuse Simple to Use 2 Apply Gel to Crow s Feet Viscous Gel: Stays at Target 30 MINUTES 3 Dwell Time/Removal 30 Minutes Fits into Current Practice Office Flow Gel Easily Removed with Proprietary Cleansing Step 10

11 RT001 is Safe and Well Tolerated 1,031 SUBJECTS NO Related SAE s NO Subject Discontinued Due to an AE NO Significant Observations or Evidence of Regional Spread of Toxin NO Systemic Safety Concerns or Evidence of Any Systemic Exposure Based On Clinical Laboratory Results and Electrocardiograms (ECGs) 11

12 Validated Phase 3 Scales and Endpoints ENDPOINTS (Rest / Smile) AT REST Demonstrate Consistency of Treatment Effect Across Distinct Scales and Endpoints SCALE (Points Improvement) Consumer Compelling 1 POINT IMPROVEMENT AT SMILE Baseline (Pre-treatment) Regulatory Endpoint 2 POINT IMPROVEMENT 4 Weeks Post Treatment (Single Treatment) Baseline (Pre-treatment) 4 Weeks Post Treatment (Single Treatment) 12

13 Phase 3 Primary Endpoint Achieved in Two Phase 2b Trials Statistically Significant at p< POINT IMPROVEMENT COMPOSITE PHYSICIAN (IGA) AND PATIENT (PSA) CL024 Study (n=90) 44.4% 40.7% CL017 Study (n=180) 0.0% 0% 0% 3.3% 1.1% RT001 Control RT001 Peptide Toxin Placebo Combined Controls Statistically Significant at p< POINT IMPROVEMENT 1 POINT IMPROVEMENT CL024 Study CL024 Study 89% 58% 64% 44% 28% 14% 14% 2% RT001 Control RT001 Control Patient Assessment (PSA) Physician Assessment (IGA) RT001 Control RT001 Control Patient Assessment (PSA) Physician Assessment (IGA) 13

14 RT001 Crow s Feet Lines - Lead Indication Phase 3 Plan US & Europe US Pivotal Trial #1 (n=170) Single Dose, Placebo Controlled Efficacy Data 2H 2014 BLA Filing 2,000+ Patients Treated US Approval & Launch Open Label, Safety Trial for ICH Database (n=1800) Interim Data 2015 Pivotal Trial #2 (n=170) Single Dose, Placebo Controlled Data 2015 EUROPE EU Pivotal Trial (n=200) Single Dose, Placebo Controlled Data 2015 MAA Filing EU Approval & Launch 14

15 Significant Market Expansion Opportunity MAJORITY OF US WOMEN REMAIN ON THE SIDELINES US Market in M Women 30+ (HHI>$50K) 27M Considering Treatments 6.6M Considering BoNTA Injections 1.8M Female Users Only 7% of Women Actively Considering Treatments Have Had BoNTA Injections Source: Primary Quantitative Research Conducted by GfK Healthcare, 2012 Sample size of 630 female consumers 15

16 RT001 Expands the Patient Pool in Two Dimensions DEEPER MORE USAGE BROADER MORE USERS US Injectable BoNTA Users 1.8M US Women 27M Considering Aesthetic Treatment 16.7M Have Had Aesthetic Treatment 1.4M Interested in RT ,000 ADD RT001 To Their Regimen 450,000 REPLACE Injectable BoNTA 80% Will Try RT M Considering Injectables 4.2M Will Try RT001 Sources: Primary Quantitative Research Conducted by GfK Healthcare 2009 Study Total sample size of 258 female consumers; subset of 105 Injectable BoNTA users 2012 Study Sample size of

17 Core Physicians Capitalizing on Existing Patients To Increase Practice Profitability WELL-DEFINED PHYSICIANS 20% of Current Patients get Injectables ~18K Core Four Specialists Well-Served by Specialty Sales Force Geographically Concentrated 82% are Extremely/Very Interested in Purchasing RT001 Source: Primary Quantitative Research Conducted by GfK Healthcare, 2009; Sample size of 204 physicians Recommend RT001 to 43% of Patients Double Cosmetic Revenue Without Increasing Patient Base 17

18 RT002 Next Generation Injectable Phase 1/2 Study COHORT 1 (Lowest Dose) GLABELLAR LINE SEVERITY SCALE AT MAXIMUM FROWN AT WEEK 4 (% Responders) Baseline Week 4 94% 94% 98% 98% Objective Safety and efficacy of RT002 in moderate and severe glabellar lines 67% 67% Study Design Open-label, dose escalating; 4 cohorts Efficacy Measures Consistent with Approved Injectables RT002 appears to be safe and well tolerated Patients with None/Mild None/Mild 1-Point Improvement 2-Point Improvement 1-Point 2-Point N=48 18

19 RT002 Demonstrates Duration of 7.3 Months Both investigator and subject assessments, duration of effect back to baseline was 29.4 weeks At the 6 month time-point 80% of subjects maintained at least 1-point improvement 70% demonstrated None/Mild wrinkles 19

20 RT002 Treatment Example Cohort 4 Baseline and Week 24 SUBJECT RT SINGLE TREATMENT COHORT 4 Baseline Week 24 20

21 RT001 for Hyperhidrosis Improving Tolerability of Treatment RT001 IMPACT ON HYPERHIDROSIS Dose Response Observed Increased Response as Dose Increased No Dose Related Increase in AE s Strong Safety Profile All AE s Were Mild or Moderate and Transient 8M Sufferers in the US More than 50% of Sufferers Are Not Diagnosed or Treated 1.3M Rate Sweating as Intolerable RT001 STARCH IODINE RESULTS Baseline Week 4 Opportunity Consumers Who Believe They Sweat Too Much More than 1/3 of US adults 60% Are Embarrassed by Sweating Sources: Strutton, et. al., US Prevalence of Hyperhidrosis and Impact on Individuals with Axillary Hyperhidrosis: Results from a National Survey. JAAD,, August 2004, Volume 51, Number 2 and International Hyperhidrosis Society Harris Interactive Survey, June

22 Potential Future Applications SUPERFICIAL TARGETS (RT001) Headache DEEPER TARGETS (RT002) TMJ/Teeth Grinding Post Herpetic Neuralgia (Shingles) Stretch Marks Anal Fissures Osteoarthritis Vocal Cord Dystonia Back Pain Overactive Bladder Benign Prostatic Hyperplasia 22

23 RT001 for Migraine Consistent Efficacy Across Indications RT001 IMPACT ON MIGRAINE Migraine Affects Roughly 12% of the US Population A Total of About 36 Million Migraine Sufferers in the US 14M Suffer from chronic migraine Lost Productivity of $13B/Yr 113M Lost Work Days Proof of Concept Study, Double-Blind Achieved Primary Endpoint Well Tolerated Initial Data Confirms Topical RT001 Has the Expected Impact on Migraine Consistent with Clinical Literature PHASE 1/2 TRIAL RESULTS Composite HIT-6, # Attacks & Intensity at Week % * 10.5% Percent of Subjects with 50% Improvement RT001 Placebo n = 16 n = 19 * Denotes p=

24 Intellectual Property Botulinum Toxin Type A Topical (RT001) Injectable (RT002) TransMTS Composition Indications Methods of Manufacture Applicator Safe Disposal Composition of Matter GRANTED/PENDING PATENTS 86 Issued Patents - US, EU, Latin America, Asia Approximately 150 Pending Core US composition and methods patents expire in 2027 and 2029 Potentially extendable for up to 5 years 24

25 Future Catalysts First Half RT002 GL Reported Phase 1/2 Data Second Half RT001 CFL Report Data From 1 st US Phase 3 RT001 CFL Report Data From 2nd US Phase 3 Report EU Phase 3 Data RT001 HH Report Phase 2 Data RT001 CFL Report US Long Term Safety Data File US BLA File EU MAA RT001 CFL Launch in US RT001 HH Report Phase 3 Data RT002 GL Report Phase 2 Data CFL = Crow s Feet Lines GL = Glabellar Lines HH = Hyperhidrosis 25

26 Investment Highlights LARGE ADDRESSABLE MARKETS $2.5 Billion in 2012, Growing to over $4.3 Billion in 2018 PLATFORM TECHNOLOGY Enables Macromolecule Delivery; Enhances Penetration LATE STAGE PROGRAMS DERMATOLOGY FOCUS Phase 3 - Lead Topical Indication, Crow s Feet Lines Phase 2 - Second Topical Indication, Hyperhidrosis Phase 2 - Injectable, Glabellar Lines ROBUST COMMERCIAL OPPORTUNITY Three Launches Beginning in 2017 ESTABLISHED OPERATIONAL CAPABILITIES Commercial Scale Manufacturing EXPERIENCED TEAM Proven Expertise in Developing and Launching Products 26