Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (July 2019)
37 slides from Sol-gel Technologies's investor presentation, Jul 23, 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: Novel Delivery System for Best-in-Class Topical Drugs
NOVEL DELIVERY SYSTEMFOR BEST-IN-CLASS TOPICAL DRUGS Proprietary silica-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 TWIN Phase III da
Slide 4: Pipelines & Upcoming Milestones
Pipelines & upcoming milestones BRANDED CANDIDATES EPSOLAY®Papulopustular rosacea TWINAcne vulgaris Research Preclinical Phase II Phase III NDA submission 1H/2020 2H/2020 Top-lineresultsin Q4/2019 GENERIS PRODUCTS/CANDIDATES Ivermectin cream, 1%(RLD: Soolantra®) Acyclovir cream, 5%(RLD: Zovirax®) 5-
Slide 5: Why Silica?
WHY SILICA? FDA approved for topical useSmooth, no-grit feel for userPhysical properties of silica shell tuned to modify release of active ingredientStrong IP protection to 2032 (Epsolay®) and 2038 (TWIN)Proprietary process produces high encapsulation efficiency 1 Silica monomers and drug substance
Slide 6: Encapsulated Tretinoin (E-ATRA)
SEM PICTURE SEM PICTURE Encapsulated Tretinoin (E-ATRA) High encapsulation efficiency protects tretinoin Encapsulated tretinoin is stable in the presence of benzoyl peroxide High encapsulation efficiency enhances stability
Slide 7: Encapsulated Benzoyl Peroxide (E-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 4 14 29 16 4 in US, IL, CA, EP EPSOLAY® 5 in US, CA, EP, IL TWIN US Patents Granted/Allowed Pending Foreign Patents Granted/Allowed Pending Trademarks Registered/Allowed Registered/Allowed Our intellectual property is protected through
Slide 9: Papulopustular rosacea: inflammatory condition with poor adherence to current treatments
Chronic, inflammatory condition that primarily affects the face, and is often characterized by flushing, redness, inflamed bumps, and pustulesAffects approximately 16 million in the United States1 — ~5 million have papulopustular2 Topical antimicrobials or anti-mites (metronidazole, clindamycin, ive
Slide 10: Epsolay Microencapsulated BPO cream, 5%
Epsolay®Microencapsulated BPO cream, 5% Encapsulation may reduce the irritation of BPOPotential to be more effective than existing treatmentsPotential to be the first FDA-approved single-active BPO Rx drug product
Slide 11: Epsolay Phase III study design
Male and female ≥18 years of age Clinical diagnosis of moderate to severe rosacea≥15 ≤ 70 inflammatory lesions≤2 nodules 2:1 EPSOLAY® cream, 5% (once daily) Vehicle cream (once daily) 54 Total Sites - Study 54-01: 361Study 54-02: 372 12 weeks of treatment Baseline 2 4 8 12 Weeks Inclusion criteria T
Slide 12: Study population & discontinuation
Study population & discontinuation Study 54-02 Study 54-01 # of Patients Epsolay® Vehicle # of Patients
Slide 13: 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 14: Primary endpoints (ITT)
Primary endpoints (itt) Study 54-02 Study 54-01 P-value < 0.001 P-value < 0.001 Success in IGA @ Week 12 Inflammatory Lesion Count Change from Baseline @ Week 12 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01
Slide 15: Secondary endpoint (ITT)
Secondary endpoint (itt) Inflammatory Lesion Percent Change from Baseline to Week 12 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01
Slide 16: Exploratory endpoints (ITT)
Exploratory endpoints (itt) Study 54-02 Study 54-01 Success in IGA @ Week 2 Inflammatory Lesion Count Change from Baseline @ Week 2 P-value = 0.009 P-value = 0.017 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01
Slide 17: Secondary endpoints (ITT)
Secondary endpoints (itt) Success in IGA @ Week 4 Inflammatory Lesion Count Change from Baseline @ Week 4 P-value < 0.001 P-value = 0.009 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01 Study 54-02 Study 54-01
Slide 18: Secondary endpoints (ITT)
Secondary endpoints (itt) Success in IGA @ Week 8 Inflammatory Lesion Count Change from Baseline @ Week 8 P-value < 0.001 P-value = 0.006 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01 Study 54-02 Study 54-01
Slide 19: Absolute change in inflammatory lesion count over time
absolute change IN Inflammatory lesion count from baseline over time (itt) Demonstrated statistical significant improvement in reducing inflammatory lesions as of Week 2 P<0.001 vs corresponding vehicle † † † † † † † † †
Slide 20: Success in IGA over time
Success in iga over time (itt) Statistical significant improvement in getting patients to the stage of “clear” or “almost clear” †P < 0.05, #P < 0.01, *P < 0.001 vs corresponding vehicle * # † * * * # #
Slide 21: Comparison of onset of action to historical Soolantra results
Comparison of Onset of action tohistorical soolantra® results(†) Rapid Efficacy 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 construed as conclusions to be drawn as if we conducted a
Slide 22: Primary endpoints historical comparisons
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 23: Skin tolerability
Skin tolerability Study 54-01 Study 54-02 Itching Burning/Stinging Dryness Scaling Percent of Patients Epsolay® Vehicle Percent of Patients Itching Burning/Stinging Dryness Scaling
Slide 24: Treatment emergent adverse events
Treatment emergent adverse events (†)Safety population No. (%) of Subjects Study 54-01 Epsolay® Vehicle Subjects reporting any TEAE 49 (20.5%) 17 (15.0%) Serious TEAE 1 (0.4%)1 Severe TEAE 2 (0.8%) Discontinuation 5 (2.1%) 1 (0.9%) Treatment-related 14 (5.9%) 3 (2.7%) Study 54-02 Epsolay® Vehicle 50
Slide 25: Acne vulgaris: multifactorial disease requiring powerful combination treatments
A multifactorial disease of the pilosebaceous unit, involving abnormalitiesin sebum production, follicular epithelial desquamation, bacterial proliferation,and inflammation BPO, retinoids, antibiotics and their combinations are the mainstays of Rx topical therapies. Isotretinoin and antibiotics are
Slide 26: 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 Noninflamed 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 C
Slide 27: 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 Noninflamed 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 Succe
Slide 28: TWIN Phase III trial designs
Week 12 Week 6 0 2-1 Randomization Screening Encapsulated BPO 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: Propo
Slide 29: Market potential for acne & rosacea
ROSACEA ACNE 50 million people suffer from acne in the US(ages 12-24 years)$1.8 billion branded topical market (WAC)* Treated with topicals 56% of the time (rest oral)*Dermatologists account for ~60% of acne treatment(higher for branded products)Tretinoin is prescribed at 5x the rate of any other re
Slide 30: 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 31: Approach to building a commercial organization
DENSITY& PRODUCTIVITY METRICS MARKET FACTORS APPROACH TO building a commercial organization - Efficient and effective - PRESCRIBER VALUE ~15,000 Dermatologists ~6500 Decile3-10 ~6000 NP/PAs FlexibleScalableHighly efficient SALES FORCE 3280 Target offices~45-62 sales representatives
Slide 32: Competitive pricing and payer response for Epsolay
COMPETITIVE PRICING Addressing access & UM for epsolay®1,2,3 Positive payer response to EPSOLAY® - Competitive pricing likely equals parity access in rosacea ~70% Most would cover at preferred or non-preferred level dependingon cost PAYER RESPONSE TO CLINICAL PROFILE LIKELY:Step-through genericsQuan
Slide 33: Commercial approach
Symphony Health IDV Vantage, 10/18 Commercial approach Efficient reach to 80% dermatology market for acne and rosacea Targeted high-value and focus use of resources and effort Build a highly effective organizational model that is flexible and scalable Exploit Innovative channel and payment strategie
Slide 34: Generic portfolio and Perrigo 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. Sales of RLD reached $175 million in 2018.In February 2019, Perri
Slide 35: Financial profile
Financial profile Gross proceeds of $86.3 million raised in IPO of 7,187,500 ordinary shares on February 5, 201818,949,968 shares outstanding as ofJune 30, 2019$49.8 million of cash and investmentsas of June 30, 2019Approximately $7.0 million in revenue from acyclovir cream in Q2/2019Cash runway exp
Slide 36: Recent milestones & next steps
2021 File NDA for EPSOLAY® in 1H/2020 File NDA for TWIN in 2H/2020 2019 2020 Obtained ANDA approvalfor acyclovir cream (sponsored by Perrigo) Reported positive Phase III results for EPSOLAY® in papulopustular rosacea Plans to report Phase III results for TWIN in acne vulgaris End of 2019 Plans to re
Slide 37: 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.
Sol-Gel Technologies — Investor Presentation (July 2019) on 6ix