Vyne Therapeutics Inc. · NASDAQ:VYNE
Vyne Therapeutics — Investor Presentation (March 2021)
37 slides from Vyne Therapeutics's investor presentation, Mar 4, 2021
Slide 1: Investor Presentation March 2021
INVESTOR PRESENTATION March 2021 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements 2 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: Investment Highlights
Investment Highlights Improving the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond 1. FCD105 is being investigated for the treatment of moderate-to-severe acne vulgaris in patients 12 years of age and older; FMX114 is being investigated
Slide 4: Well Positioned To Deliver Significant Value
Well Positioned To Deliver Significant Value Focused approach for 2021 Commercial Execution • Continue to progress trial and utilization of AMZEEQ® and ZILXI® • Drive market share growth Maximize Operational Leverage • Scalable corporate and commercial capabilities and infrastructure • Prudent resou
Slide 5: Pipeline Overview
Pipeline Overview 1. AMZEEQ®, ZILXI® and FCD105 employ proprietary MSTTM technology 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. 5 Molecule Stabilizing Technol
Slide 6: Commercial Overview
COMMERCIAL OVERVIEW Cd “A THERAPEUTICS
Slide 7: Products Focused On Markets With Significant Opportunities
Products Focused On Markets With Significant Opportunities • >$5B in sales in 20191 • 22M TRx in 2019, growing 5% YOY1 • Consistently >2M active, diagnosed acne patients per year under HCP care2 • 40-50M acne sufferers3 (of which 10M are moderate-to severe) 1. Symphony Health Solutions METYS, data e
Slide 8: Commercial Strategy For AMZEEQ and ZILXI
Commercial Strategy For AMZEEQ® And ZILXI® 8 Comprehensive Access Consumer Activation Brand Positioning & Messaging Smart Deployment
Slide 9: Leverage Existing Infrastructure For Multiple Products And Scale
Leverage Existing Infrastructure For Multiple Products And Scale 9 FCD105 HCP Targets Sales force Commercial Support Supply Chain Trade and Distribution Human Resources
Slide 10: AMZEEQ Indication and Safety Information
AMZEEQ® 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 and older. 10 Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the develo
Slide 11: AMZEEQ Prescription Volume Performance
AMZEEQ® Prescription Volume Performance AMZEEQ® TRx volume has continued to increase after initial COVID-19 impact Symphony METYS – LTD ending Nov. ‘20 11 10 3,035 8,120 8,819 5,504 7,050 9,040 10,337 11,394 11,003 13,953 13,538 16,544 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 18,000 AMZ
Slide 12: AMZEEQ Unique Prescribers
AMZEEQ® Unique Prescribers AMZEEQ® continues to attract new unique prescribers each week, eclipsing 7,000 total since launch and averaging between 1,500-1,600 unique weekly prescribers. Source: Symphony Vantage Prescriber Insights, February 2021. 12 - 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000
Slide 13: AMZEEQ Target Penetration And Performance
AMZEEQ® Target Penetration And Performance Of those unique prescribers over half are from our target universe which is now 60% penetrated. The productivity of our targets continues to accelerate, averaging approximately 30 prescriptions per physician. Source: Prescriber data for AMZEEQ® and ZILXI® T
Slide 14: AMZEEQ New To Product And Switch Metrics
AMZEEQ® New To Product And Switch Metrics Roughly half of all new AMZEEQ® patients are new to prescription therapy, while the balance is either switched or added to existing therapy. Approximately 20% of all AMZEEQ® volume is due to refills. 14 CONTINUING 20.3% NEW TO MARKET 39.6% NEW TO PRODUCT (SW
Slide 15: ZILXI Indication and Safety Information
15 ZILXI® is indicated for the treatment of inflammatory lesions of rosacea in adults. See slide 36 for Important Safety Information. 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 wel
Slide 16: Rosacea Patient Dissatisfaction
Rosacea Patient Dissatisfaction Patients are likely to seek a better treatment solution and HCPs grant nearly 90% of patient requests for a specific product SOURCE: FMX103 Demand Study, Consumer Arm June 2019 Note: Rx users only n=156 Q.6 - How likely are you to seek a better solution for treating y
Slide 17: ZILXI Market Research Insights
ZILXI® Market Research Insights 1. Source: Attitude, Trial and Usage Study Wave 1 Sept 2020 2. Source: ZILXI® Qualitative Interviews Jan 2021 17 HCPs would prescribe ZILXI® to one-fifth of patients overall; Soolantra and Oracea would lose the most share1 Over 3 in 5 HCPs would make ZILXI® a regular
Slide 18: Launch Surrogates
Launch Surrogates Surrogates suggest strong adoption for launch products in rosacea, generating ~250k prescriptions in first full year. Source: Source: Symphony METYS, unweighted. Note: Oracea launch curve from Symphony PHAST, unweighted. 18 242,953 245,517 332,662 452,801 319,115 515,334 393,832 71
Slide 19: ZILXI Prescription Volume Performance
ZILXI® Prescription Volume Performance Source: Symphony METYS – 10/1/20 through 12/31/20 19 926 1,311 1,782 - 200 400 600 800 1,000 1,200 1,400 1,600 1,800 2,000 2020-10 2020-11 2020-12 ZILXI® NRx Volume 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% - 100 200 300 400 500 600 700 800 900 1,000 9/25/20 10/25
Slide 20: Commercial Summary
Commercial Summary AMZEEQ® and ZILXI® have significant market opportunities Despite COVID-19, continued momentum as we execute against our strategy Complimentary commercial strategies, with leverageable and scalable infrastructure • Favorable prescriber and TRx trends • Ensuring broad coverage throu
Slide 21: Pipeline Opportunities
PIPELINE OPPORTUNITIES » “\) THERAPEUTICS
Slide 22: FCD105 Expands Potential Acne Vulgaris Product Offering
FCD105 Expands Potential Acne Vulgaris Product Offering Phase 3 ready, potential best-in-class treatment of moderate-to-severe acne formulated in VYNE’s proprietary MSTTM 22 1. Symphony Health Solutions METYS, data ending 5/15/20, acne weighted market Multiple Modes of Action to Address the Multifac
Slide 23: FCD105 Clinical Highlights - Efficacy (IGA Treatment Success)
FCD105 Phase 2 Clinical Highlights - Efficacy Co-primary endpoint: IGA Treatment Success at Week 12 [Score Clear (0) or Almost Clear (1)]1 FCD105 treatment group was statistically superior to Vehicle and 0.3% Adapalene treatment groups and numerically superior to the 3% minocycline treatment group a
Slide 24: FCD105 Clinical Highlights - Inflammatory Lesion Count
FCD105 Phase 2 Clinical Highlights - Efficacy Co-primary endpoint: Absolute Reduction in Inflammatory Lesion Count at Week 121 FCD105 treatment group was statistically superior to Vehicle and 0.3% Adapalene treatment groups and numerically superior to the 3% minocycline treatment group at Week 12 fo
Slide 25: FCD105 Efficacy vs. Leading Treatments for Acne
FCD105 Efficacy vs. Leading Treatments for Moderate-to-Severe Acne Comparison of independent studies measuring IGA treatment success and reduction in inflammatory lesions* FCD105 Phase 2 data suggests improved rates of IGA treatment success compared to leading treatments for moderate-to-severe acne
Slide 26: FCD105 Clinical Highlights - Safety
FCD105 Phase 2 Clinical Highlights - Safety Summary of TEAEs in > 2 subjects (any treatment group) in descending order of frequency • Overall, TEAEs were few in type and frequency. All resolved prior to study completion. • There were no reported TESAEs during the conduct of the study. • ≥ 93% of sub
Slide 27: FCD105 Cutaneous Tolerability vs. Leading Treatments
FCD105 Cutaneous Tolerability vs. Leading Treatments for Moderate-to-Severe Acne Based on independent studies, FCD105 cutaneous tolerability profile improved when compared to leading treatments* 1At least moderate severity Data from non-VYNE products has been taken from corresponding product prescri
Slide 28: FMX114 Atopic Dermatitis Market Opportunity
FMX114 Atopic Dermatitis Market Opportunity Source: Data on file 28 • Topical glucocorticosteroids account for 8 of the 10 highest prescribed topical products for atopic dermatitis. • In 2019, ~2M prescriptions were formulations of triamcinolone acetonide. Of 22M Treated Mild 10.5M Moderate 8.5M Sev
Slide 29: FMX114 Addresses Source and Cause of Inflammation in AD
29 FMX114 Attempts to address both the source and cause of inflammation in AD Image Sources: Leung DY, Guttman-Yassky E. J Allergy Clin Immunol. 2014;134(4):769-779 and Hodge JA, Kawabata TT, Krishnaswami S et al. Clin & Exper Rheum. 2016; 34(2): 318-328 Fingolimod (Sphingosine 1-phosphate receptor
Slide 30: FMX114 Nonclinical Efficacy and Tolerance: mADI
FMX114 Nonclinical Efficacy and Tolerance From a DNCB Induction Murine AD model: Modified Atopic Dermatitis Index (mADI*) Dorsal depilated BALB-C mice were dosed for 39 days with 100µl topical DNCB solution (Day 1-32 induction phase, Day 32-38 treatment phase). N=8 animals were assigned to 7 treatme
Slide 31: FMX114 Nonclinical Efficacy and Tolerance: Body Weight
31 80 85 90 95 100 105 110 115 120 0 1 2 3 4 5 6 7 M e a n p e rc e n t ch a n g e i n b o d y w e ig h t Post-induction treatment day Vehicle control DNCB control Tofacitinib 0.3%, Fingolimod 0.02% gel Tofacitinib 0.6%, Fingolimod 0.01% gel Triamcinolone 0.1% cream 21% FMX114 Nonclinical Efficacy a
Slide 32: FMX114 Nonclinical Efficacy: End-of-Treatment Clinical Images
FMX114 Nonclinical Efficacy and Tolerance From a DNCB Induction Murine AD Model: End-of-Treatment Clinical Images (Day 7) DNCB - 2,4-Dinitrochlorobenzene 32 FMX114 Tofacitinib 0.6%, Fingolimod 0.01% Gel DNCB Control Triamcinolone 0.1% Cream
Slide 33: FMX114 Phase 2a Proof of Concept Study
FMX114 Phase 2a Proof of Concept Study Randomized, double-blinded, vehicle-controlled Phase 2a clinical trial with separate open-label active treatment phase evaluating the safety and efficacy of FMX114 gel compared with vehicle gel in the treatment of mild-to-moderate atopic dermatitis 33 Baseline
Slide 34: Well Positioned To Deliver Significant Value
Well Positioned To Deliver Significant Value Focused approach for 2021 Commercial Execution Maximize Operational Leverage Build a Diversified Portfolio and Pipeline 34 Long-term Value
Slide 35: AMZEEQ Indication and Important Safety Information
AMZEEQ® (minocycline) topical foam, 4% Indication and Important Safety Information 35 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 an
Slide 36: ZILXI Indication and Important Safety Information
ZILXI® (minocycline) topical foam, 1.5% Indication and Important Safety Information 36 INDICATION ZILXI® (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
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