Vyne Therapeutics Inc. · NASDAQ:VYNE
Vyne Therapeutics — Investor Presentation (September 2020)
28 slides from Vyne Therapeutics's investor presentation, Sep 14, 2020
Slide 1: Investor Presentation September 2020
Investor Presentation September 2020
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 , including, but not limited to statements regarding the development and commercialization of VYNE’s products and product candidates and other
Slide 3: VYNE Investment Highlights
VYNE Investment Highlights x Commercial stage company focused on large and growing markets in dermatology x Two commercial products: AMZEEQ ® and ZILXI TM employ proprietary differentiated MST TM technology x Strong intellectual property with latest patent into 2037 and barriers to genericization in
Slide 4: Proprietary Technology: Molecule Stabilizing Technology (MST)
Proprietary Technology Innovative and Proprietary Molecule Stabilizing Technology (MST™) 1. Hazot Y, et al. J Anal Pharm Res. 2017;4(5):00117. 2. Amzeeq (minocycline) topical foam, 4% [package insert]. Bridgewater, NJ; Foamix Pharmaceuticals Inc. • Stabilizes hydrophobic molecules • Surfactant & irr
Slide 5: Products/Pipeline: Advancing a leading dermatology portfolio
Products/Pipeline Advancing a leading dermatology portfolio Dermatology assets positioned for growth and value creation Safety and efficacy of these investigational products have not been established. There is no guarantee that pipeline products will receive FDA approval or become commercially avail
Slide 6: Commercial Strategy for AMZEEQ and ZILXI
Commercial Strategy for AMZEEQ ® and ZILXI™ 6 • Opportunity for ownable, unique product positioning rooted in novel delivery (MST TM ) and first - to - market topical minocycline Brand Positioning and Messaging • Untapped opportunity in consumer space • Target gen Z (age 9 - 24) consumers digitally
Slide 7: AMZEEQ: The minocycline you know and trust
The minocycline you know and trust. The tolerability of a gentle foam. The innovation you’ve been waiting for. INDICATIONS AND USAGE AMZEEQ ® (minocycline) topical foam, 4% is indicated for the treatment of inflammatory lesions of non - nodular moderate to severe acne vulgaris in adults and pediatri
Slide 8: AMZEEQ Opportunity: Large, Growing Acne Market
AMZEEQ ® Opportunity Large, Growing Acne Market 1. Symphony Health Solutions METYS, data ending DEC’19 - weighted 2. Symphony Health Solutions, MAT ending April ’19 3. AAD. Acne Stats and Facts. https://www.aad.org/media/stats - numbers . Accessed June 1, 2020 4. Symphony Health Solutions IDV Vantag
Slide 9: AMZEEQ Market Research Feedback
AMZEEQ ® Market Research Feedback In market research, physicians and health care providers have consistently expected Amzeeq to disrupt the acne market and displace a broad range of products. 1. Source: Data on File, Foamix Pharmaceuticals, 2019. 9 “It’s quite unique in that it’s a minocycline topic
Slide 10: AMZEEQ Prescription Volume Performance
AMZEEQ ® Prescription Volume Performance • Rapid uptake of Amzeeq reflected in strong Rx performance in Q1 pre COVID - 19 • Implemented virtual sales and speaker efforts during state and local stay - at - home orders to stabilize business • As statewide and county restrictions have lifted , direct s
Slide 11: AMZEEQ Target Penetration and Productivity
AMZEEQ ® Target Penetration and Productivity Launch - to - date (LTD), 62% of platinum targets have prescribed at least 1 Rx and on average prescribed 25 Rx’s 11 45% 62% 49% 0% 10% 20% 30% 40% 50% 60% 70% Gold Platinum Total Target Penetration LTD* 14 25 17 0 5 10 15 20 25 30 Gold Platinum Total Pre
Slide 12: AMZEEQ Weekly Total Prescribers
AMZEEQ ® Weekly Total Prescribers Continued WoW growth of total prescribers despite limitations in face - to - face selling during COVID - 19 Source: Symphony Vantage Prescriber Insights 12 10 262 607 959 1,291 1,632 1,959 2,242 2,500 2,734 2,898 3,003 3,090 3,183 3,259 3,323 3,401 3,477 3,563 3,650
Slide 13: AMZEEQ Market Access
AMZEEQ ® Market Access ~63% of Covered Lives with Additional Contract Talks Ongoing * Includes Express Scripts, EnvisionRx, OptumRx Source: 2020 Managed Markets Insight & Technology, LLC. 13 • Approximately 63% of commercial lives with covered or better status* • Ongoing discussions with payors are
Slide 14: ZILXI Indication
14 Please see Important Safety Information on slide 27 ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults. Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug - resistant bacteria
Slide 15: ZILXI (FMX103) Clinical Results: Highlights
ZILXI™ (FMX103) Clinical Results: Highlights 1. Co - primary endpoint: Investigator's Global Assessment (IGA) Treatment Success at W eek 12 [Score Clear (0) or Almost Clear (1) ]; Significantly greater number of subjects receiving FMX103 achieved IGA treatment success defined as an IGA score of 0 (c
Slide 16: ZILXI Opportunity: Large, Unsatisfied Rosacea Market
ZILXI Opportunity 1. Symphony Health Solutions METYS, data ending DEC’19 - weighted 2. Kantar Media, Jan. 2015 thru Dec. 2018 3. FMX103 Demand Study, Consumer Arm June 2019 4. Symphony Health unprojected patient claims data Period of Analysis – Jan 2015 – Dec 2018 16 Large, Unsatisfied Rosacea Marke
Slide 17: ZILXI Market Research: Intent to Prescribe
ZILXI Market Research: Intent to Prescribe • 76% of physicians are likely to prescribe ZILXI based on blinded product profile and 8.5 out of 10 are likely to use after hearing the complete ZILXI promotional story. Source: Ipsos HCP ATU September 2020 Topline Report Q630. How likely would you be to p
Slide 18: Portfolio Synergies
Portfolio Synergies Complimentary Patient Types and Call Points 18 COMMON STRATEGIES Similar HCP Targets Focused Positioning Predictive Analytics Consumer Outreach Broad Market Access ACNE PATIENTS, AGE 13 - 24: bacteria and in f la mm a t i o n ROSACEA PATIENTS, AGE 30 - 60: inflammatory lesions
Slide 19: Layering ZILXI Targeting with AMZEEQ Sales Efforts
Layering ZILXI™ Targeting with AMZEEQ ® Sales Efforts 19 Zilxi™ targets are already being called on 87% Amzeeq Only 40% Zilxi Only 6% Both 54% ~6700 Unique Targets of diagnosed patient volume captured within target universe 75% High volume prescribers captured without field footprint alternative ~85
Slide 20: FCD105
FCD105 Combines the bacteriostatic and anti - inflammatory properties of minocycline with the comedolytic, antiproliferative and anti - inflammatory properties of adapalene 3% minocycline, 0.3% adapalene combination foam formulation being investigated for the treatment of moderate - to - severe acne
Slide 21: FCD105 Commercial Opportunity
FCD105 Commercial Opportunity - Adapalene is one of the most widely prescribed retinoids available for acne therapy. - Adapalene and its combination products represent a 1.7M annual Rx opportunity, with branded adapalene products representing ~15% of total acne branded market. Source: Symphony Healt
Slide 22: FCD105 Study Design (Study FX2016-40)
FCD105 Study Design (Study FX2016 - 40*) *A Prospective, Multicenter, Randomized, Double - Blind, Vehicle - Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of Minocycline and Adapalene Topical Foam Formulation for the Treatment of Acne Vulgaris (Study FX2016 - 40) 22 •
Slide 23: Co-Primary Efficacy Endpoints at Week 12
Co - Primary Efficacy Endpoints at Week 12: Absolute Change in Inflammatory & Non - inflammatory Lesion Counts; IGA0/1 Treatment Success (ITT population) 1: Cochran - Mantel - Haenszel test stratified by analysis center. P - value is for the null hypothesis that the Risk Ratio equals 1. 2: P - value
Slide 24: Safety: Local Skin Tolerance Assessments
Safety: Local Skin Tolerance Assessments (LSTA, Safety Population) Summary of LSTA at Week 12 (Severity Score of 0 “None” or 1 “Mild”) 1 1: Observed cases. 24 • 93% of subjects or greater who received FCD105 treatment had either “None” or “Mild” local skin tolerance scores at Week 12. • In general,
Slide 25: Summary
Summary • Continued momentum demonstrated as company executes against business plan o AMZEEQ script trends have recovered and are growing on a week/week basis o Prescriber trends are robust and recent formulary addition strengthens coverage o FDA approval of ZILXI in rosacea complements our existing
Slide 26: AMZEEQ Indication and Important Safety Information
AMZEEQ ® (minocycline) topical foam, 4% Indication and Important Safety Information 26 INDICATIONS AND USAGE AMZEEQ™ (minocycline) topical foam, 4% is indicated for the treatment of inflammatory lesions of non - nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age
Slide 27: ZILXI Indication and Important Safety Information
ZILXI™ (minocycline) topical foam, 1.5% Indication and Important Safety Information 27 INDICATION ZILXI TM (minocycline) topical foam, 1.5% is a tetracycline - class drug indicated for the treatment of inflammatory lesions of rosacea in adults. Limitations of Use: This formulation of minocycline has
Slide 28: Investor Presentation September 2020
Investor Presentation September 2020
VYNE Therapeutics — Investor Presentation (September 2020) on 6ix