Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (February 2020)
42 slides from Sol-gel Technologies's investor presentation, Feb 5, 2020
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 Positive phase III
Slide 5: Pipelines & upcoming milestones
Pipelines & upcoming milestones BRANDED CANDIDATES EPSOLAY®Papulopustular rosacea TWYNEO®Acne vulgaris Research/Preclinical Phase I Phase II Phase III NDA Submission 1H/2020 NDA Submission 2H/2020 GENERIC PRODUCTS/CANDIDATES Ivermectin cream, 1%(RLD: Soolantra®) Acyclovir cream, 5%(RLD: Zovirax®) 5-
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 X-ray spectroscopy mapping of encapsulated BPO
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: Acne vulgaris and Twyneo solution
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 10: Twyneo study design
Co-Primary EndpointsProportion of subjects with an assessment of clear or almost clear and with at least a 2-grade improvement in IGA from baseline at Week 12Absolute change in inflammatory lesion counts from baseline at Week 12Absolute change in non-inflammatory lesion counts from baseline at Week
Slide 11: Twyneo baseline characteristics
Study 65-04 Study 65-05 Number of sites 32 31 Twyneo®(n=281) Vehicle (n=143) Twyneo®(n=290) Vehicle (n=144) Age, yearsMean (SD)Median (range) 20.9 (8.48)18.0 (11-67) 21.4 (8.62)18.0 (10-57) 20.1 (6.96)18.0 (10-51) 20.3 (6.67)18.5 (9-42) Sex, n (%)MaleFemale 106 (37.7%)175 (62.3%) 60 (42.0%)83 (58.0%
Slide 12: Low discontinuation rate across studies
Low discontinuation rate across studies Study 65-04 Study 65-05 Twyneo®(n=281) Vehicle (n=143) Twyneo®(n=290) Vehicle (n=144) Randomized Subjects Discontinued 32 12 48 12 Adverse events 4 (1.4%) 0 12 (4.1%) 0 Lost to follow-up 10 (3.6%) 7 (4.9%) 15 (5.2%) 7 (4.9%) Lack of efficacy 0 0 0
Slide 13: Co-primary endpoint: IGA treatment success at Week 12
Co-primary endpoint (itt) IGA Treatment Success at Week 12 Percent of subjects achieving IGA success at Week 12 P<0.001 Study 65-04 Vehicle(n=143) Vehicle P=0.017 Study 65-05 (n=290) (n=144) (n=281)
Slide 14: Co-primary endpoint: inflammatory lesions change
Co-primary endpoint (itt) Absolute Mean Change From Baseline in Inflammatory Lesions at Week 12 P<0.001 P=0.018 Study 65-04 Study 65-05 Mean reduction in inflammatory lesion count from baseline at Week 12 Vehicle(n=143) (n=281) (n=290) Vehicle(n=144)
Slide 15: Co-primary endpoint: non-inflammatory lesions change
Co-primary endpoint (itt) Absolute Mean Change From Baseline in Non-Inflammatory Lesions at Week 12 Mean reduction in non-inflammatory lesion count from baseline at Week 12 Study 65-04 Study 65-05 P<0.001 P<0.001 Vehicle(n=143) Vehicle(n=144) Twyneo®(n=281) Twyneo®(n=290)
Slide 16: Success in IGA in recent acne trials
SUCCESS IN IGA IN RECENT ACNE TRIALS* Trials With Highest Difference in IGA Between the Active Arm and the Vehicle Arm *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 construed as conclusions to be dr
Slide 17: Success in IGA in moderate subjects
SUCCESS IN IGA IN MODERATE Subjects* Trials With Highest Difference in IGA Between the Active Arm and the Vehicle ArmModerate Subjects at Baseline Only Percent of subjects achieving IGA success at Week 12 normalized to vehicle Twyneo® *Sol-Gel did not conduct a head-to-head comparison trial or study
Slide 18: Supportive efficacy: IGA treatment success over time
Twyneo®(n=281) Supportive efficacy analysis*(itt) IGA Treatment Success Over Time Percent of subjects achieving IGA success Week Week Study 65-04 Study 65-05 *Percent of subjects with an assessment of clear or almost clear and with at least a 2-grade improvement in IGA from baseline, at Weeks 2, 4
Slide 19: Supportive efficacy: lesion count reduction over time
Supportive efficacy analysis* (itt) Mean Reduction in Non-Inflammatory Lesion Count Over Time Mean change from baseline in non-inflammatory lesion count Study 65-04 Study 65-05 Week Week Mean change from baseline in inflammatory lesion count Study 65-04 Study 65-05 Week Week Mean Reduction in Inflam
Slide 20: Safety & tolerability
Safety & tolerability Nearly all AEs were mild or moderate in severityTotal of 18 subjects discontinued from Studies 65-04 and 65-05 due to a TEAE: 18 (2%) in Twyneo® and 0 in vehicle No treatment-related SAEs were identified in either study2 subjects reported SAEs in Study 65-05; (1) Twyneo® subjec
Slide 21: Local skin tolerability assessment
Local Skin Tolerability assessment* at week 12 *Safety population Study 65-04 Study 65-05
Slide 22: Local skin tolerability assessments over time
Local skin tolerability assessments over time Safety population for Study 65-04 (n=274). Safety population for Study 65-04 (n=281). BL=baseline; 12W=12 weeks Erythema Scaling Pigmentation Dryness Itching Burning Stinging Percent of subjects BL 12W BL 12W BL 12W BL 12W BL 12W BL 12W BL 12W BL 12W BL
Slide 23: Papulopustular rosacea and Epsolay solution
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 24: Epsolay 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 25: 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 26: 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 27: Primary endpoints
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 28: Secondary endpoint: inflammatory lesion percent change
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 29: Success in IGA over time
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 30: Inflammatory lesion count change from baseline
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 31: Rapid onset of Epsolay vs historical Soolantra results
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 32: 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 33: 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 34: 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 35: 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 36: 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 37: 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 38: Competitive pricing and payer access for Epsolay
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 39: Generic collaborations with Perrigo and Douglas
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 40: 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 41: 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 Reported positive phase III results for TWYNEO® in acne vulgaris at end o
Slide 42: 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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