M A R C H The Next-Generation Neuromodulator is Here

Transcription

1 M A R C H The Next-Generation Neuromodulator is Here

2 Forward-Looking Statements / Safe Harbor / Market Data This presentation contains forward-looking statements, including statements related to: the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational product candidates; our business strategy, goals, plans and prospects; the initiation, enrollment, design, timing and outcome of our clinical trials, including the SAKURA 3 study, ASPEN Phase 3 study and other clinical programs, including for the treatment of 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 of our potential BLA submission for DAXI to treat glabellar (frown) lines and commercial potential of our client candidates, status of commercial collaborations and related potential receipt of milestones and royalties under our license agreement with Fosun Pharma and collaboration agreement with Mylan; our ability to obtain, and timing relating to, regulatory approval with respect to our drug candidates; the potential 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 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-K filed with the Securities and Exchange Commission on February 28, 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 data 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-K filed with the Securities and Exchange Commission on February 28, The Risk Factors section of our Form 10-K 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.

3 The Beauty of Neuromodulators Large and growing market Hundreds of potentials indications Currently approved products are not differentiated Relief for those suffering from muscle movement & pain disorders Simple, non-surgical aesthetic treatment High consumer awareness 30 years of safe use

4 $4.5 Billion* Global Opportunity Set to Reach $7.7 Billion by 2025 *Source: Decision Resources Group Aesthetics Injectables and Therapeutic Botulinum Toxin Reports December 2018

5 44% Aesthetics * 56% Therapeutics * Three Approved Indications in U.S. Currently Out of Pocket Pay Eight Approved Indications in U.S. Currently Reimbursed by Insurance *Global Industry Analysts, Inc. Botulinum Toxin A Global Strategic Business Report, Jan 2018

6 % of Sales of Neuromodulators by Indication 2018 WW* 16% Chronic Migraine 44% Facial Aesthetics 31% Muscle Movement 6% Overactive Bladder 700+ Other Potential Indications 2% Other 2% Axillary Hyperhidrosis *Based on 2018 estimates from Global Industry Analysts, Inc. Botulinum Toxin A Global Strategic Business Report, Jan 2018, UBS Specialty Pharmaceuticals Handbook April 2018 and Allergan 2018 Financials

7 DaxibotulinumtoxinA for Injection (DAXI) is uniquely suited to propel the market forward DAXI is the first and only long-lasting neuromodulator DAXI is the first and only new formulation of a neuromodulator with a proprietary peptide formulation DAXI is proven in clinical studies: the largest ever aesthetic program in glabellar lines DAXI is the only neuromodulator developed and manufactured in the U.S. DaxibotulinumtoxinA is an investigational agent that has not been approved by the FDA. Anticipated approval in 2020.

8 Remarkable Science First Major Innovation in 30 Years 150 kd Neurotoxin type A Stabilizing Peptide Excipient Buffers, Sugar and Polysorbate = DAXI Peptide associates with the 150kD neurotoxin (attraction) and has several important effects on stability and availability: Increases the binding of botulinum toxin to cell membranes in vitro Prevents botulinum toxin from sticking to surfaces (reduces adsorption) Increases stability of the toxin molecule (reduces aggregation) May increase overall amount of core neurotoxin available for binding & internalization at the neuromuscular junction

9 Valuable Foundation of Assets Develop, commercialize & distribute DAXI in China, Hong Kong and Macau Upfront: $30M, additional milestones, tiered lowdouble-digit to high-teens royalties Develop, manufacture & commercialize a biosimilar BOTOX worldwide* Upfront: $25M, additional potential milestones and royalties 419 issued patents - US, EU, Latin America, Asia 106 pending patents applications Core US composition and methods patents expire in 2027 and 2029, potentially extendable for up to 5 years US-based, state-of-the-art cgmp manufacturing facility Dedicated drug substance & drug product manufacturing Capability to manufacture drug substance from kda Scalable drug product capacity, plus CMO CMC/Analytics: US Select Agent License Extensive neuromodulator experience Small and large pharm backgrounds Entrepreneurial spirit Prior launch and commercialization experience 170 strong * Excluding Japan, BOTOX is a registered trademark of Allergan, Inc.

10 Develop, Manufacture and Commercialize a Biosimilar to BOTOX Potential 351(k) pathway viability established at BIAM in February FDA provided guidance on expectations for development program Directly addresses short-acting $3.6 billion BOTOX market Could result in approval for all 11 FDA-approved BOTOX indications Mylan/Revance to discuss potential development path & next steps BOTOX is a registered trademark of Allergan, Inc.

11 Revance is Advancing a Pipeline Neuromodulator

12 Expanding Pipeline in a Range of Indications, Doses, Anatomies and Formulations Submit BLA 1H 2019, Launch 2020 BOTOX is a registered trademark of Allergan, Inc.

13 Neuromodulators: #1 Minimally Invasive Cosmetic Procedure * ~$2B global facial aesthetics opportunity ** Only 7% WW of aesthetics considerers have used facial injectables *** Currently approved neuromodulator treatments for largest indication, glabellar lines, have 3-4 month duration of effect 7M+ neuromodulator procedures in US per year Typically treated by dermatologists and plastic surgeons *Source: In the US - American Society of Plastic Surgeons Report, March 2018 **Source: Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports, December 2018 ***Source: Allergan Business Analytics & Allergan 2016 Global Beauty Trends Report; User estimates based on calculation using AGN sales and market share data

14 Pursuing Largest Applications in Facial Aesthetics GLABELLAR (FROWN) LINES FOREHEAD LINES CROW S FEET Clinical programs for approval completed Positive SAKURA 1, 2 & 3 Phase 3 Results Nearly 2,700 patients, more than 3,800 treatments Combination forehead and glabellar line study initiated in Q1 Exploring dose and injection pattern Lateral canthal lines (crow s feet) study to be initiated in mid-2019 Exploring dose and injection pattern Plan to submit BLA 1H 2019, launch 1H 2020 Study results expected in 1H 2020 Study results expected in 1H 2020 * Source: Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports, December 2018

15 Pursuing Largest Markets and New Indications in Therapeutics CERVICAL DYSTONIA ADULT UPPER LIMB SPASTICITY PLANTAR FASCIITIS CHRONIC MIGRAINE Typically Treated by Neurologists Typically Treated by Neurologists Typically Treated by Podiatrists, Physiatrists & Orthopedic Surgeons Chronic Neurologic Disorder Primarily Treated by Neurologists Initiated Phase 3 study in Q Initiated Phase 2 study in Q Initiated Phase 2 study in Q Phase 2 to be initiated in 2019/2020 Current botulinum toxin treatments only provide relief for 8 12 weeks Significant unmet need for a longer lasting treatment Neuromodulator retreatment required every 8-12 weeks Significant unmet need for a longer lasting treatment No neuromodulator currently approved to treat plantar fasciitis Affects an estimated 20 million people in the U.S.* * Based on estimates from Global Industry Analysts, Decision Resources and Allergan 2018 financial results Estimated 3 4M chronic migraine sufferers in U.S. 1 Current treatment with BOTOX requires 31 injections, 4x year 2 1.Credit Suisse Global Pharmaceuticals, December BOTOX PI

16 Creating the New Standard in Neuromodulators

17 SAKURA Registration Trials SAKURA 1 PIVOTAL: 36 WEEKS N = 303 Treatment Centers: 15* SAKURA 2 PIVOTAL: 36 WEEKS N = 306 Treatment Centers: 15** SAKURA 3 OPEN-LABEL, LONG-TERM SAFETY: 84 WEEKS N = 2,691 Treatment Centers: 65** DAXI 201 Placebo 102 DAXI 204 Placebo 102 DAXI Treatment Cycle 1 (36 weeks) 2,380 DAXI Treatment Cycle 2 (36 weeks) 882 DAXI Treatment Cycle 3 (12 weeks) 568 * U.S. Only ** U.S. and Canada

18 Efficacy Established in SAKURA 1 and 2 Primary Endpoint at Week 4 Proportion of Subjects Who Achieve 2-Point Composite Response at Max Frown* % of Subjects 73.6% % of Subjects 74.0% Two-Point Composite Response of 74% Achieved in Both Pivotal Phase 3 Studies Daxi 40U (n=201) Placebo (n=102) *p < (vs Placebo) 0% Daxi 40U (n=201) Placebo (n=102) *p < (vs Placebo) 1% *Achieving a score of 0 or 1 (none or mild) and an improvement of 2 points from baseline on both the investigator and patient scales concurrently at Week 4. DAXI is an investigational product

19 Strong Safety Data SAKURA Phase 3 OLS Results with DAXI Treatment-Related Adverse Event Rate was Low and Decreased with Successive Treatments in SAKURA 3 OLS SAKURA 1 & 2 pivotal trials and SAKURA 3 open-label safety study (OLS) Most Common Treatment-Related AEs SAKURA 1 & 2 Pooled (N=406) n (%) SAKURA 3 (N=2691) n (%) 26 (6.4%) 124 (4.6%) 15 (3.7%) 98 (3.6%) 5 (1.2%) 81 (3.0%) 6 (1.5%) 76 (2.8%) 9 (2.2%) 34 (1.3%) SAKURA 3 open-label safety study (OLS) Common AE of Most Concern Cycle One (n=2380) DAXI 40U Treatments Cycle Two (n=882) Cycle Three (n=568) Total (n=3830) 23 (1%) 7 (0.8%) 4 (0.7%) 34 (0.9%) Treatment-Related Adverse Events ( 1%) SAKURA 3 OLS Compared with SAKURA 1 and 2 * Median resolution time is 44 days.

20 % of subjects SAKURA 1, 2 and SAKURA 3 Results BOTOX Cosmetic USPI 1, Dysport USPI 1, Jeuveau 2 Data None or Mild Response Rates on 4-Point Investigator Assessment over Time SAKURA 3 Cycle 1 (n=2380 treatments) SAKURA 3 Cycle 2 (n=882 treatments) SAKURA 3 Cycle 3 (n=568 treatments) SAKURA 1 Daxi 40U (n=201) 64 SAKURA 2 Daxi 40U (n=204) Dysport USPI: GL-1 48 Dysport USPI: GL BOTOX Cosmetic USPI Jeuveau: EV Days United 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 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

21 % of Subjects SAKURA 1, 2, & 3 Median Duration of at Least 24 Weeks Observed on Multiple Secondary Endpoints Median Duration of 24 Weeks Time to Loss of None or Mild Wrinkle Severity in Both SAKURA 1&2 Pivotal Studies and SAKURA 3 OLS Median Duration of 28 Weeks Time to Return to Baseline Wrinkle Severity in Both SAKURA 1&2 Pivotal Studies and SAKURA 3 OLS Median (95% CI) 24.0 (23.9, 24.0) weeks 24.1 (24.0, 24.7) weeks 24.0 (23.4, 24.1) weeks 23.9 (20.3, 24.0) weeks Median (95% CI) 28.0 (28.0, 28.1) weeks 28.1 (28.0, 28.4) weeks 27.7 (24.7, 28.0) weeks 26.0 (24.1, 28.0) weeks OLS Treatment 1 (n=2380) OLS Treatment 2 (n=882) SAKURA 1 (n=201) SAKURA 2 (n=204) OLS Treatment 1 (n=2380) OLS Treatment 2 (n=882) SAKURA 1 (n=201) SAKURA 2 (n=204) Weeks Since DAXI 40U

22 SAKURA 3 Example 2-Point Improvement by IGA-FWS & PFWS* at Week 4 Two-Point Sustained Duration of Effect through Week 16 and 1-Point Improvement Sustained Through Week 24 in 23-year-old Female Baseline Week 4 Week 16 Week 24 IGA-FWS: 2 PFWS: 2 IGA-FWS: 0 PFWS: 0 IGA-FWS: 0 PFWS: 0 IGA-FWS: 1 PFWS: 1 *Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) & Patient Facial Wrinkle Severity (PFWS) scales

23 Confidence is Based on Six Objective and Data-Driven Points 1. Clinical meaningfulness and relevance of the clinical data 2. Strength of the data and pre-specified endpoints 3. FDA guidance both prescriptive and descriptive 4. Sponsor and FDA interactions 5. Class label approach 6. Precedent labels for similar approved neuromodulators

24 Validating DAXI s Differentiation in Therapeutic Indications

25 Mean Change from Baseline Score Phase 2 Dose-Ranging Trial in Cervical Dystonia 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 in Phase 3 Study % u (n=21) U (n=16) % 34% 35% 37% 38% 39% 48% 50% 51% 47% 43% 45% 42% 35% 47% 38% 39% 38% 39% 38% 39% 30% 38% All Subjects (n=37) Placebo (ABO) (n=54)* ABO 500U (n=159)* Weeks *Data approximated from Figure 2 of Poewe (2016): Efficacy and Safety of AbobotulinumtoxinA Liquid Formulation in Cervical Dystonia: A Randomized-Controlled Trial DAXI Phase 2 was an open-label, dose-escalating trial. Abo Phase 3 was a double-blind, placebo-controlled study.

26 Creating the DAXI Premium Brand

27 DAXI is Highly Differentiated From all U.S. Approved Neuromodulators DAXI *1 Not Disclosed DAXI and onabotulinumtoxina have nearly identical amounts of core active ingredient, with DAXI demonstrating a long duration of effect 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. *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.

28 Physicians and Patients Want Innovation In Aesthetics, Longer Duration Highly Desired Current Neuromodulators Lacking CONSUMERS CONSUMERS When considering a neuromodulator, 88% of users consider long-lasting results either very important or absolutely essential PHYSICIANS I wish there was a neuromodulator that offered longer-lasting results than what is available today PHYSICIANS Strongly agree Somewhat agree The Harris Poll, Landmark Survey Results, Survey base: qualified women users, qualified physicians

29 Innovation moves markets

30 DAXI Delivers Innovation 2or less 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

31 DAXI is Premium TRUE TECHNOLOGICAL INNOVATION DAXI is proven in clinical studies: the largest ever aesthetic program in GL MEETS DESIRES OF PHYSICIANS AND CONSUMERS Addresses #1 PHYSICIAN AND #1 CONSUMER unmet need PROVIDES THE LUXURY OF CONVENIENCE Desired look and performance that lasts longer and delivers an experience like no other

32 Preparing for Dynamic DAXI Launch in 2020 Establish the long-acting neuromodulator category Redefine the value of long-lasting results Upgrade the treatment paradigm Resonate with today s consumer

33 Anticipated Near-Term Milestones & Events Ph3 Cervical Dystonia Top-line Ph2 Plantar Fasciitis Top-line Forehead Lines Study Initiation Lateral Canthal Lines Study Initiation Ph2 Plantar Fasciitis Enrollment Complete Glabellar Lines BLA submission Potential Biosimilar Clinical Trial Initiation Glabellar Lines EU Submission Forehead Lines & Crow s Feet Studies Complete Ph2 Upper Limb Spasticity & Phase 3 Cervical Dystonia Enrollments Complete Planned Glabellar Lines Launch Ph2 Upper Limb Spasticity Top-line Potential Mylan Biosimilar Opt-in Denotes DAXI Denotes Biosimilar to BOTOX

34 2019 Financial Overview and Guidance $295.5 M 44 M 4.4 M $ M $ M $ M 1 As of Jan 31, 2019, unaudited 2 Shares as of Feb 22, 2019, unaudited 3 Guidance provided as of Feb 26, 2019

35 Executing Plan to Be Premier, Neuromodulator Provider >$4.5 Billion 2018 Under-Penetrated Global Opportunity DAXI Unprecedented Results, Premium Neuromodulator Launch in Aesthetics, Expand Neuroscience Pipeline Biosimilar and Geographic Partnering *Sources: Decision Resources Group Aesthetics Injectables and Therapeutic Botulinum Toxin Reports December 2018 and Global Industry Analysts, Inc. Botulinum Toxin A Global Strategic Business Report, Jan 2018

36 Thank You