Vyne Therapeutics Inc. · NASDAQ:VYNE
Vyne Therapeutics — Menlo Therapeutics — Investor Presentation (June 2020)
30 slides from Vyne Therapeutics's investor presentation, Jun 2, 2020
Slide 1: Investor Presentation June 2020
Investor Presentation June 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 Menlo’s products and product candidates and othe
Slide 3: Menlo Investment Highlights
Menlo Investment Highlights x Commercial stage company focused on large and growing markets in dermatology x Two commercial products: AMZEEQ ® and ZILXI™ employ proprietary differentiated MST TM technology x Strong intellectual property with latest patent into 2037 and barriers to genericization inh
Slide 4: Menlo's Vision and Mission
Menlo’s Vision and Mission Improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond. We are dedicated to advancing dermatology medicine and redefining standard of care for millions of patients. 4
Slide 5: Timeline
Timeline Our execution has led to two major dermatology approvals in two consecutive years IPO 2014 Phase 2 FMX103 trial completed 2016 Initial phase 3 FMX101 trials completed 2017 Third phase 3 FMX101 trial completed FMX101 NDA submitted Two phase 3 FMX103 trials completed 2018 Amzeeq (FMX101) appr
Slide 6: Corporate Strategy
Corporate Strategy Create a Scaled Leader in Dermatology Grow existing franchises and create durability through focused development and acquisition Mid - term Expand product portfolio into synergistic technologies/ markets Long - term Leverage commercial infrastructure and product synergies of Amzee
Slide 7: Proprietary Technology
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 8: Pipeline
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 available. FCD
Slide 9: Commercial Stage Company
Commercial Stage Company Commercial launch team experience in 14 therapeutic areas including 11 dermatology product launches Commercialization Pipeline Regulatory People Clinical Manufacturing 9
Slide 10: AMZEEQ indication and product overview
Please see Important Safety Information on slide 28 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 mod
Slide 11: AMZEEQ Opportunity
AMZEEQ ® Opportunity Large, Growing Acne Market 1. Symphony Health Solutions METYS, data ending DEC’19 - weighted 2. Symphony Health Solutions, MAT ending October ’18 3. AAD. Acne Stats and Facts. https://www.aad.org/media/stats - numbers . Accessed June 1, 2020 4. Symphony Health Solutions IDV Vant
Slide 12: AMZEEQ Market Research Feedback
AMZEEQ ® Market Research Feedback 1. Source: Data on File, Foamix Pharmaceuticals, 2019. 12 In market research, physicians and health care providers have consistently expected Amzeeq to disrupt the acne market and displace a broad range of products. “It’s quite unique in that it’s a minocycline topi
Slide 13: AMZEEQ Strategy
AMZEEQ ® Strategy • Opportunity for ownable, unique product positioning rooted in novel delivery (MST TM ), minocycline potency, and level of systemic absorption Brand Positioning and Messaging • Opportunity to target consumers digitally • Generation Z Focus: Spend 7+ hours consuming media 1 Consume
Slide 14: AMZEEQ Prescription Volume Performance
0 500 1,000 1,500 2,000 2,500 3,000 AMZEEQ Prescription Trend NRx Count TRx Count AMZEEQ ® Prescription Volume Performance • Rx performance was strong through 1Q until COVID - 19 impacted the acne market and direct sales capability • Implemented virtual sales and speaker efforts during state and loc
Slide 15: AMZEEQ Weekly Unique Prescribers
AMZEEQ ® Weekly Unique Prescribers Continued week - over - week growth of unique prescribers despite absence of face - to - face selling during COVID - 19 Source: Symphony Vantage Prescriber Insights 15 10 261 606 956 1,287 1,627 1,953 2,234 2,490 2,723 2,886 2,991 3,078 3,170 3,242 3,305 3,383 3,45
Slide 16: AMZEEQ Market Access
AMZEEQ ® Market Access ~60% of Covered Lives in the first 5 months * Includes Express Scripts, EnvisionRx , OptumRx Source: 2020 Managed Markets Insight & Technology, LLC • Approximately 60% of commercial lives with covered or better status* • Ongoing discussions with payors are productive and in pr
Slide 17: ZILXI Indication
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 as well as to maintain the effectiveness of other anti
Slide 18: ZILXI (FMX103) Clinical Results: Highlights
ZILXI™ (FMX103) Clinical Results: Highlights 1.Co - primary endpoint: Investigator's Global Assessment (IGA) Treatment Success at Week 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 (clea
Slide 19: ZILXI Opportunity
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 Large, Unsatisfied Rosacea Market
Slide 20: ZILXI Launch Strategy
ZILXI™ Launch Strategy • Opportunity for strong, unique and ownable product positioning • Product position rooted in novel delivery and efficacy • First topical minocycline Product Positioning • Competition not investing in consumers which represents an opportunity • Millennials and generation X (ag
Slide 21: Portfolio Synergies
Portfolio Synergies Complimentary Patient Types and Call Points 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 - 50: inflammatory lesions 21
Slide 22: FCD105 minocycline/adapalene combination foam
3% minocycline, 0.3% adapalene combination foam formulation being investigated for the treatment of moderate - to - severe acne vulgaris in patients 12 years of age and older. 22 FCD105 Combines the bacteriostatic and anti - inflammatory properties of minocycline with the comedolytic, antiproliferat
Slide 23: FCD105 Commercial Opportunity
FCD105 Commercial Opportunity Source: Symphony Health Solutions METYS, data ending 5/15/20, acne weighted market 23 - 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 ada
Slide 24: FCD105 Study Design
FCD105 Study Design (Study FX2016 - 40*) 24 IGA: Investigator’s Global Assessment • Subjects aged 12 years or older. • 20 - 50 inflammatory lesions. • 25 - 100 non - inflammatory lesions. • Score of 3 “Moderate” or 4 “Severe” on 5 point IGA scale. • No more than 2 active nodules on the face. Key Inc
Slide 25: FCD105 Co-Primary Efficacy Endpoints at Week 12
- 19.4 0 - 15.58 - 18.67 - 15.78 -25 -20 -15 -10 -5 0 FCD105 Foam Vehicle Foam 3% Minocycline Foam 0.3% Adapalene Foam Absolute Change from Baseline in Inflammatory Lesions at Week 12 P =0.0020 P =0.4053 P =0.0012 Absolute Change in Inflammatory Lesions at Week 12 2 35.9 15.7 30 .0 21.4 0 5 10 15 20
Slide 26: Safety: Local Skin Tolerance Assessments
75 80 85 90 95 100 Burning/Stinging Itching Dryness Scaling Erythema Hyperpigmentation % of Subjects with “None” or “Mild” LSTA Scores Local Skin Tolerance Assessment FCD105 Foam % Vehicle Foam % 3% Minocycline Foam % 0.3% Adapalene Foam % Safety: Local Skin Tolerance Assessments (LSTA, Safety Popul
Slide 27: 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 28: AMZEEQ Indication and Important Safety Information
AMZEEQ ® (minocycline) topical foam, 4% Indication and Important Safety Information 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 a
Slide 29: ZILXI Indication and Important Safety Information
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 not been evaluated in the treatment of infections. To reduce the development of drug -
Slide 30: 30 Investor Presentation June 2020
30 Investor Presentation June 2020
Menlo Therapeutics — Investor Presentation (June 2020) on 6ix