Vyne Therapeutics Inc. · NASDAQ:VYNE
Vyne Therapeutics — Menlo Therapeutics — Merger or Acquisition (November 2019)
26 slides from Vyne Therapeutics's merger presentation, Nov 12, 2019
Slide 1: A Compelling Dermatology Combination
Investor Presentation | November 11, 2019 A Compelling Dermatology Combination
Slide 2: Forward-Looking Statements
Forward-Looking Statements 2 This presentation contains forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Words s
Slide 3: Transaction Highlights
Transaction Highlights Strategic combination expected to create a scaled player in the dermatological space with enhanced financial profile Merger creating a stronger dermatology focused companyEnhances the combined company’s late stage pipeline and commercial opportunityStrong balance sheet with ca
Slide 4: Strategic Rationale
Strategic Rationale Combination expected to create a scaled player in the dermatological space with enhanced financial profile Value creation through greater future earnings momentum (1+1=3+ earnings synergy)Potential of 3 product launches within next 24 months (each, anticipated $100mm+ revenue) HC
Slide 5: Combination Overview
Combination Overview Strategic combination expected to create a scaled player in the dermatological space with enhanced financial profile Terms Stock-for-Stock transactionEach holder of Foamix shares will receive Menlo shares based on the results of the two Phase III trials of Serlopitant in PN0.592
Slide 6: Diversified Dermatology-Focused Pipeline with Near Term Milestones
Diversified Dermatology-Focused Pipeline with Near Term Milestones 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. Preclinical Phase I Phase II Phase III Approved
Slide 7: Serlopitant and Prurigo Nodularis
Image courtesy of Prof. Sonja Stander, University Munster Serlopitant is a once-daily, highly selective oral small molecule NK1 Receptor Antagonist, being developed for the treatment of pruritus associated with PN Prurigo NodularisPrurigo Nodularis (PN) occurs along with chronic pruritus and present
Slide 8: Serlopitant PII Study Results (N=127)
Serlopitant PII Study Results (N=127) Met the primary endpoint and multiple secondary endpoints.Approximately 50% of subjects met the Phase 3 responder criterion (at least a 4-point improvement in WI-NRS) at Week 8. Four Point Responder Analysis (Week 8) Phase 2 Primary Endpoint: Change From Baselin
Slide 9: Ongoing NULARIS PIII Studies in PN
Ongoing NULARIS PIII Studies in PN Phase 3 Design Clinical Status and MilestonesPhase 3: Subject enrollment complete for both MTI-105 and MTI-106 with topline results expected March/April 2020. N=285 US study (1:1)N=295 EU study (1:1)Presence of PN ≥ 6 weeks.≥ 10 PN nodules on at least 2 anatomical
Slide 10: AMZEEQ (minocycline) topical foam, 4% indication
10 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 and older. Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of i
Slide 11: Molecule Stabilizing Technology (MST)
11 11 Stabilizes hydrophobic moleculesSurfactant & irritant free formulation maintains barrier function, improves tolerability and compliance1Low mechanical sheer enhances spreadabilityBeing investigated to deliver unstable drugs that have proven difficult to formulate topicallyOil-based excipients
Slide 12: AMZEEQ Phase 3 Efficacy Results in Moderate to Severe Acne
AMZEEQ Phase 3 Efficacy Results in Moderate to Severe Acne 12
Slide 13: AMZEEQ Phase 3 Efficacy Results in Moderate to Severe Acne
AMZEEQ Phase 3 Efficacy Results in Moderate to Severe Acne 13
Slide 14: FMX103 Phase 3 Study Results in Papulopustular Rosacea
ANCOVA, ITT population, multiple imputation FMX103 Phase 3 Study Results Studies in Papulopustular Rosacea Studies FX2016-11 and FX2016-12 14
Slide 15: FMX103 Phase 3 Study Results in Papulopustular Rosacea
ANCOVA, ITT population, multiple imputation FMX103 Phase 3 Study Results Studies in Papulopustular Rosacea Studies FX2016-11 and FX2016-12 15
Slide 16: ries
ries Menlo Therapeutics ‘ ial Pharmaceuticals
Slide 17: Attractive Commercial Opportunity in PN
Attractive Commercial Opportunity in PN IQvia.estimate for 2017.Menlo internal estimate.Estimates based on company payer research and symptom relief analogs ~200k PN patients treatedeach year(1) ~500k – 1m patients in US(1) On therapy two to six months per year(2) $900–$2,400per month(3) 75% of PN p
Slide 18: Acne Market Size
Acne Market Size1 Source: (1) Symphony Health Solutions PHAST, data ending DEC’18- weighted 18M Brand vs. Generic AcneTRx Volume 2018 Generic 12.9M 71% Brand 5.2M 29% Brand vs. Generic Acne$ Volume 2018 Generic $1.7B 33% Brand $3.4B 67% $5.2B 18
Slide 19: Rosacea Market Size
Rosacea Market Size1 Source: (1) Symphony Health Solutions PHAST, data ending DEC’18- weighted 5M Brand vs. Generic RosaceaTRx Volume 2018 Generic 3.4M 72% Brand 1.3M 28% Brand vs. Generic Rosacea$ Volume 2018 Generic $454.8M 37% Brand $759.2M 63% $1.2B 19
Slide 20: AMZEEQ Targeting Approach
Source: Symphony Integrated Dataverse (IDV) Patient Claims Database, Time Period: 24 months ending Feb ‘19 97% >170k 3% 67% Acne Sufferers 73% Acne TRx ~6k HCP Target List AMZEEQ™ Targeting Approach Patient Claims based targeting strategy enables Foamix to narrow the acne diagnosing HCP field from >
Slide 21: Territory Mapping using Patient Concentrations
Territory Mapping using Patient ConcentrationsSales territories aligned to capture majority of acne patients, resulting in 51 territories and 6 regions. Mapping of Targeted Patients Concentrations across US States 21
Slide 22: Opportunity to Leverage Commercial Infrastructure
~80% of PN and rosacea patients overlap with Foamix Sales Force alignmentInternal infrastructure, data resources, and expertise leverageable to launch successfullyGiven small patient size and significant unmet need, expect orphan-like pricing flexibility for serlopitant Opportunity to Leverage Comme
Slide 23: Opportunity to Leverage Commercial Infrastructure
Opportunity to Leverage Commercial Infrastructure Launch in January 202050 million people of US (1)Prevalence age 12-24Moderate-to-severe acne affects ~10 million people in the US>14 million physician visits per year for treatment of acne (2) PDUFA in June 2020Rosacea is a chronic inflammatory disor
Slide 24: Multiple Potential Value-Creating Catalysts in Next Months
Multiple Potential Value-Creating Catalysts in Next 12 Months Q1’2020 Q2’2020 Q3’2020 Q4’2020 AMZEEQ Commercial Launch (January 2020) FMX103 PDUFA(June 2020) FCD105 Top-Line Data (Mid-2020) Serlopitant CPUOPhase II Data(Jan / Feb 2020) Serlopitant PNPhase III Data(March / April 2020) Serlopitant Pru
Slide 25: A Compelling Dermatology Combination
A Compelling Dermatology Combination Source: Cash balance as of September,30, 2019, respectively. Combined Approved / Marketed Commercial Products AMZEEQ™ (formerly FMX101) Near-Term Commercial Products FMX103 Serlopitant (PN) Clinical Pipeline FCD105 Other Indications Platform Technology
Slide 26: Additional Information and Where to Find It
Additional Information and Where to Find ItMenlo plans to file a Registration Statement on Form S-4 containing a joint proxy statement/prospectus of Menlo and Foamix and other documents concerning the proposed merger with the Securities and Exchange Commission (the “SEC”). BEFORE MAKING ANY VOTING D
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