Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (December 2019)
32 slides from Sol-gel Technologies's investor presentation, Dec 26, 2019
Slide 1: NASDAQ: SLGL
NASDAQ: SLGL
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statem
Slide 3: Three-Fold Strategy
THREE-FOLD STRATEGY Leverage our capabilities to generate significant non-dilutive funding Identify targeted opportunities in other areas of high unmet need where we can bring innovation and exceed current standard-of-care treatments Successfully commercialize best-in-class dermatology brands in acn
Slide 4: Novel Delivery System for Best-in-Class Topical Drugs
NOVEL DELIVERY SYSTEMFOR BEST-IN-CLASS TOPICAL DRUGS Proprietarysilica-based microencapsulation topical delivery platform for dermatology indications Positive phase III results from EPSOLAY® clinical trial in papulopustular rosacea in July 2019NDA submission anticipated in 1H/2020 TWYNEO® phase III
Slide 5: Pipelines & Upcoming Milestones
Pipelines & upcoming milestones BRANDED CANDIDATES EPSOLAY®Papulopustular rosacea TWYNEO®Acne vulgaris Research/Preclinical Proof of Concept Phase I Phase II Phase III 1H/2020 2H/2020 Top-lineresultsin Q4/2019 GENERIC PRODUCTS/CANDIDATES Ivermectin cream, 1%(RLD: Soolantra®) Acyclovir cream, 5%(RLD:
Slide 6: Why Silica?
WHY SILICA? FDA approved for topical useProprietary process produces high encapsulation efficiencyPhysical properties of silica shell tuned to modify release of active ingredientSmooth, no-grit feel for userStrong IP protection to 2032 (EPSOLAY®) and 2038 (TWYNEO®) 1 Silica monomers and drug substan
Slide 7: Cryo-SEM Picture and Energy-Dispersive X-Ray Spectroscopy Mapping
CRYO-SEM PICTURE ENERGY-DISPERSIVE X-RAY SPECTROSCOPY MAPPING Encapsulated Benzoyl Peroxide (E-BPO) Skin lipids migrate through the silica shell to promote solubilization of BPO. Dissolved BPO then migrates to skin’s sebaceous follicles Silica shell wraps BPO crystals and serves as a barrier between
Slide 8: Patents and Trademarks
Patents and Trademarks # of Patents Related to Company Products 5 11 34 15 4 in US, IL, CA, EP EPSOLAY® 5 in US, CA, EP, IL TWYNEO® US Patents Granted/Allowed Pending Foreign Patents Granted/Allowed Pending Trademarks Registered/Allowed Registered/Allowed Our intellectual property is protected throu
Slide 9: Papulopustular Rosacea: Our Solution EPSOLAY
Encapsulation aims to reduce irritation of BPOPotential to be more effective than existing treatmentsPotential to be first FDA-approved single-agent BPO Rx drug product Chronic, inflammatory condition that primarily affects the face and is often characterized by flushing, redness, inflamed bumps, an
Slide 10: EPSOLAY Phase III Study Design
Male and female ≥18 years of age Clinical diagnosis of moderate to severe rosacea≥15 to ≤70 inflammatory lesions≤2 nodules 2:1 EPSOLAY® cream, 5% (once daily) Vehicle cream (once daily) 54 Total SitesStudy 54-01: 361Study 54-02: 372 12 weeks of treatment Baseline 2 4 8 12 Weeks Inclusion criteria Tw
Slide 11: Study Populations & Discontinuation
STUDY POPULATIONS & DISCONTINUATION Study 54-02 Study 54-01 Percent of patients EPSOLAY® Vehicle Randomized (n=243), Safety (n=239),Per Protocol (n=190) Randomized (n=118), Safety (n=113),Per Protocol (n=93) Randomized (n=250), Safety (n=249),Per Protocol (n=235) Percent of patients Randomized (n=12
Slide 12: Patient Severity at Baseline
Patient severity at baseline Study 54-01 Characteristic EPSOLAY® Vehicle IGA “Moderate”IGA “Severe” 210 (86.4%)33 (13.6%) 104 (88.1%)14 (11.9%) Mean lesion count (SD)Median lesion count (range) 25.7 (11.07)22.0 (15-69) 26.3 (12.45)21.0 (15-70) Study 54-02 EPSOLAY® Vehicle 227 (90.8%)23 (9.2%) 112 (9
Slide 13: Primary Endpoints (ITT)
Primary endpoints (itt) Study 54-02 Study 54-01 P<0.001 P<0.001 Success in IGA at Week 12 Inflammatory Lesion Count Change From Baseline at Week 12 P<0.001 P<0.001 Study 54-02 Study 54-01 ITT, intent-to-treat.
Slide 14: Secondary Endpoint (ITT)
Secondary endpoint (itt) Inflammatory Lesion Percent Change From Baseline to Week 12 P<0.001 P<0.001 Study 54-02 Study 54-01
Slide 15: Success in IGA (ITT)
Success in iga (itt) Week 2Exploratory Endpoint P=0.009 P=0.017 Study 54-02 Study 54-01 Week 4Secondary Endpoint P<0.001 P=0.009 Study 54-02 Study 54-01 Week 8Secondary Endpoint P<0.001 P=0.006 Study 54-02 Study 54-01
Slide 16: Inflammatory Lesion Count Change from Baseline (ITT)
Inflammatory lesion Count Change from Baseline (itt) Study 54-02 Study 54-01 P<0.001 P<0.001 Week 2Exploratory Endpoint Week 4Secondary Endpoint Week 8Secondary Endpoint Study 54-02 Study 54-01 P<0.001 P<0.001 Study 54-02 Study 54-01 P<0.001 P<0.001
Slide 17: Rapid Onset of EPSOLAY
Comparison of Onset of action tohistorical soolantra® results* Rapid Onset of EPSOLAY® *Sol-Gel did not conduct a head-to-head comparison trial or study. The results described above are for illustrative purposes only and should not be construedas conclusions to be drawn as if we conducted a head-to-
Slide 18: Side-by-side with Other Historical Trial Results
Baseline Characteristics of Active Arm IGA Severe 33 23 82 113 26 65 0 51 71 52 48 Moderate 210 227 369 346 172 418 557 444 443 67 77 Mild 0 0 0 0 0 0 0 0 0 8 17 Inflammatory Lesions 25.7 29.8 31.0 33.3 21.6 21.7 18.3 28.5 30.0 19.5 20.5 Inflammatory Lesions–Mean Percent Change From Baseline Success
Slide 19: Skin Tolerability
SKIN TOLERABILITY Safety population. Dryness Scaling Burning/Stinging Itching Percent Reporting Any (%) Study 54-01 Percent Reporting Any (%) Study 54-02 Dryness Scaling Burning/Stinging Itching
Slide 20: Treatment-Emergent Adverse Events Summary
Study 54-01 Study 54-02 TEAEs, n (%) EPSOLAY®(n=239) Vehicle(n=113) EPSOLAY®(n=249) Vehicle (n=120) Any TEAE 49 (20.5%) 17 (15.0%) 50 (20.2%) 22 (18.2%) Serious TEAE 0 1 (0.4%)* 1 (0.4%)† 0 Severe TEAE 2 (0.8%) 0 2 (0.8%)‡ 0 Discontinuation 5 (2.1%) 1 (0.9%) 4 (1.6%) 1 (0.8%)§ Treatment-related 14 (
Slide 21: Acne Vulgaris: Our Solution TWYNEO
A multifactorial disease of the pilosebaceous unit, involving abnormalities in sebum production, follicular epithelial desquamation, bacterial proliferation, and inflammation Topical BPO, retinoids, antibiotics, and their combinations; isotretinoin and antibiotics are mainstays of systemic therapy I
Slide 22: Acne Trials Efficacy Results: Moderate Patients
Number of Patients Severe 0 0 1 0 Moderate 102 111 1,043 1,118 Mild 0 0 0 0 Average Baseline # of Lesions Inflamed 25.9 ~29.7 28.8 29.6 Non-inflamed 42.1 ~53.7 46.9 46.7 Non-Inflammatory Lesions—Mean Percent Change From Baseline at Week 12 Success in IGA at Week 12 Inflammatory Lesions—Mean Percent
Slide 23: Efficacy Results of Recent Acne Trials
Number of Patients Severe 14 61 64 37 118 70 79 Moderate 102 292 305 296 620 413 440 Mild 0 0 0 0 0 0 0 Average Baseline # of Lesions Inflamed 26.7 42.4 42.9 31.6 30.7 29.7 30.3 Non-inflamed 42.9 59.1 62.8 50.5 49.7 42.4 42.3 Non-Inflammatory Lesions—Mean Percent Change From Baseline at Week 12 Succ
Slide 24: TWYNEO Phase III Trial Designs
Week 12 Week 6 0 2:1 Randomization Screening E-BPO + E-ATRA vs Topical Vehicle Placebo-Controlled Two 12-week, randomized, double-blind, vehicle-controlled studies in patients with acne vulgarisEnrollment of ~420 subjects per study at a ratio of 2:1, yielding 99% powering PRIMARY ENDPOINTS: Proporti
Slide 25: Market Potential for Acne & Rosacea
ROSACEA ACNE Approximately 16 million people in the US suffer from rosacea; 5-6 million have type 2 (age >30 years)~$800 million branded topical market (WAC)1Treated with topical products 76% of the time1Dermatologists account for 80% of treatmentsMany patients are misdiagnosed or do not seek treatm
Slide 26: EPSOLAY
EPSOLAY® Advanced technology platform Trusted API Topical creamNon-systemicAntibiotic-freeComplimentary mechanism Potential to advance rosacea treatment Demonstrated strong efficacy Demonstrated fast onset of action Observed favorable tolerability profile
Slide 27: Approach to Building a Commercial Organization
DENSITY &PRODUCTIVITY METRICS MARKET FACTORS APPROACH TO building a commercialorganization—Efficient and effectivE PRESCRIBER VALUE ~12,000 Dermatologists ~6,500 Decile3-10 ~6,000 NP/PAs FlexibleScalableHighly efficient SALES FORCE 3,280 target offices~45-62 sales representatives
Slide 28: Competitive Pricing and Payer Response
COMPETITIVE PRICING Addressing access & UM for epsolay®1-3 ~70% Most would cover at preferred or non-preferred level dependingon cost PAYER RESPONSE TO CLINICAL PROFILE LIKELY:Step-through genericsQuantity limits POSSIBLE:Prior authorizationto label “If priced like Finacea, it would get parity acces
Slide 29: Generic Product Portfolio and Collaborations
In January 2018, Perrigo received tentative approval from the FDA for ivermectin cream,1%, developed in collaboration with Sol-Gel. Perrigo was second to file and, as of today,there is no public disclosure of a third filer to the FDA. In February 2019, Perrigo received approval from the FDA and laun
Slide 30: Financial Profile
Financial profile Gross proceeds of $86.3 million raised in IPO of 7,187,500 ordinary shares on February 5, 2018Gross proceeds of $11.5 million raised in a public follow-on offering on August 12, 201920,387,468 shares outstanding as ofSeptember 30, 2019$57.7 million of cash and investmentsas of Sept
Slide 31: Recent Milestones & Next Steps
2021 File NDA for EPSOLAY® in 1H/2020 File NDA for TWYENO® in 2H/2020 2019 2020 Obtained ANDA approval for acyclovir cream (collaboration with Perrigo) Reported positive phase III results for EPSOLAY® in papulopustular rosacea Plans to report phase III results for TWYNEO® in acne vulgaris at end of
Slide 32: NASDAQ: SLGL
NASDAQ: SLGLwww.sol-gel.com ©2019 Sol-Gel Technologies Ltd. All Rights Reserved. EPSOLAY® is a registered trademark of Sol-Gel Technologies Ltd. All other trademarks are the property of their respective owners.
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