Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (June 2021)
46 slides from Sol-gel Technologies's investor presentation, Jun 22, 2021
Slide 1: Sol-Gel Advanced Topical Therapy
Sol-Gel _, Advanced Topical Therapy NASDAQ: SLGL June 2021
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: Our Dermatology Company Overview
PDUFA goal date was set for April 26, 2021. Awaiting FDA’s pre-approval inspectionPotential to be the first single-active BPO approved by the FDA as a prescription drug product EPSOLAY® Pending patent applications for tapinarof and roflumilast in various skin conditions EARLY STAGE Phase I proof-of-
Slide 4: The Science Behind Our Proprietary Technology
Aiming to provide effective and tolerable topical therapies to achieve local action THE SCIENCE BEHIND OUR PROPRIETARY TECHNOLOGY
Slide 5: Encapsulated Benzoyl Peroxide (E-BPO)
Silica-based shell wraps the BPO crystal and is intended to serve as a barrier between the BPO crystals and the skin CRYO-SEM PICTURE After application onto skin, BPO slowly migrates through the shell resulting in a continuous flow of BPO for up to 24 hours ENERGY-DISPERSIVE X-RAY SPECTROSCOPY MAPPI
Slide 6: Encapsulated Tretinoin (E-Tretinoin)
Complete encapsulation allows stabilization of tretinoin in the presence of BPO SEM PICTURE Silica-based shell allows for slow delivery of tretinoin to the skin over time SEM PICTURE ENCAPSULATED TRETINOIN (E-TRETINOIN) ENCAPSULATION IS DESIGNED TO ENHANCE STABILITY
Slide 7: Unmet Need in Papulopustular Rosacea
CHRONIC CONDITION WITH POOR ADHERENCE TO CURRENT TREATMENTS THE CHALLENGE Papulopustular RosaceaChronic, inflammatory condition that primarily affects the face and is often characterized by flushing, redness, inflamed bumps, and pustules How is it Treated?Topical antimicrobials (metronidazole, clind
Slide 8: EPSOLAY: Sol-Gel Solution
Encapsulation was designed to allow the BPO to slowly migrate from the microcapsules to help reduce irritationPDUFA goal date was set for April 26, 2021. Awaiting FDA’s pre-approval inspectionPotential to be the first single-active BPO approved by the FDA as a prescription drug product Benzoyl Perox
Slide 9: EPSOLAY Phase III Studies
Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD EPSOLAY® PHASE III STUDIES
Slide 10: Two Co-Primary Efficacy Endpoints at Week 12
Inclusion Criteria How is it Treated? Investigator Global Assessment (IGA) Definition ≥18 years old; “Moderate” or “Severe” rosacea; ≥15 to ≤70 inflammatory lesions; ≤2 nodules Weeks 2, 4, 8, 12 (end of study) “Clear”: Skin clear of inflammatory papules or pustules“Almost Clear”: Very few small papu
Slide 11: Well-Balanced Clinical Studies: Phase III Characteristics
WELL-BALANCED CLINICAL STUDIES PHASE III CHARACTERISTICS
Slide 12: Success in Primary Endpoints: Phase III Results
P<0.001 P<0.001 Change from Baseline in Inflammatory Lesion Count Success in IGA Week 12Success in IGA (ITT) Week 12Inflammatory Lesion Count Change from Baseline (ITT) Study 54-01 Study 54-02 SUCCESS IN PRIMARY ENDPOINTS PHASE III RESULTS P<0.001 P<0.001 Study 54-01 Study 54-02
Slide 13: Improvement as of Week 2: Success in IGA
Success in IGA Week 2Exploratory Endpoint (ITT) Week 8Secondary Endpoint (ITT) P<0.009 P<0.017 Study 54-01 Study 54-02 P<0.001 P<0.009 Study 54-01 Study 54-02 P<0.001 P<0.006 Study 54-01 Study 54-02 Week 4Secondary Endpoint (ITT) IMPROVEMENT AS OF WEEK 2 SUCCESS IN IGA
Slide 14: Improvement as of Week 2: Reduction of Lesions
Week 2Exploratory Endpoint (ITT) Week 4Secondary Endpoint (ITT) Week 8Secondary Endpoint (ITT) Change from Baseline in Inflammatory Lesion Count P<0.001 P<0.001 Study 54-01 Study 54-02 P<0.001 P<0.001 Study 54-01 Study 54-02 P<0.001 P<0.001 Study 54-01 Study 54-02 IMPROVEMENT AS OF WEEK 2 REDUCTION
Slide 15: Onset of Action as of Week 2
ONSET OF ACTION AS OF WEEK 2 Subject 116-009 || 41 years old | Female | White | Not Hispanic or Latino* * Individual results vary BASELINE “Severe”; 31 inflamed lesions WEEK 2 “Clear”; No inflamed lesions WEEK 4 “Clear”; No inflamed lesions WEEK 12 “Almost Clear”; 1 inflamed lesion WEEK 8 “Clear”; N
Slide 16: Long-Term Safety Study
Phase III Studies Followed by 40 Weeks Long-Term Safety Study Extension Percentage of Subjects IMPROVEMENT IN IGA* LONG-TERM SAFETY STUDY * This study was not designed for efficacy; however, efficacy was evaluated. Interpret results with caution
Slide 17: Improvement Over Time Side-by-Side with Historical Results
Success in IGA * 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 head-to-head comparison trial or study IMPROVEMENT OVER TIME SIDE-BY-SIDE WITH
Slide 18: Primary Endpoints Side-by-Side with Historical Results
Success in IGA Inflammatory Lesion Percent Change from Baseline 10-week study EPSOLAY® 16-week studyPer os 12-week study 12-week study 12-week study * 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 co
Slide 19: Treatment-Emergent Adverse Events Primarily Mild-to-Moderate
TREATMENT-EMERGENT ADVERSE EVENTS PRIMARILY MILD-TO-MODERATE
Slide 20: Local Skin Irritations Fewer at Week 12 than at Baseline
% of Subjects Week 12 % of Subjects DRYNESS SCALING ITCHING BURNING/STINGING None Mild Moderate Severe Baseline Study 54-01 LOCAL SKIN IRRITATIONS FEWER AT WEEK 12 THAN AT BASELINE
Slide 21: Local Skin Irritations Comparable to Vehicle
DRYNESS SCALING ITCHING BURNING/STINGING Study 54-02 % of Subjects Week 12 % of Subjects Baseline LOCAL SKIN IRRITATIONS COMPARABLE TO VEHICLE None Mild Moderate Severe
Slide 22: Unmet Need in Acne Vulgaris
MULTIFACTORIAL DISEASE REQUIRING POWERFUL COMBINATION TREATMENTS THE CHALLENGE Acne VulgarisA multifactorial disease of the pilosebaceous unit, involving abnormalities in sebum production, follicular epithelial desquamation, bacterial proliferation, and inflammation How is it Treated?Topical BPO, re
Slide 23: TWYNEO: Sol-Gel Solution
Benzoyl Peroxide 3% & Tretinoin 0.1%, Cream SOL-GEL SOLUTION*TWYNEO® * TWYNEO is investigational. Safety and efficacy have not been established Encapsulation was designed to stabilize tretinoin and to enable both tretinoin and BPO to slowly migrate from their microcapsules to help reduce irritationP
Slide 24: TWYNEO Phase III Studies
Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD TWYNEO® PHASE III STUDIES
Slide 25: Inclusion Criteria and IGA Definition
Inclusion Criteria Visits Investigator Global Assessment (IGA) Definition ≥9 tears old; “Moderate” or “Severe” acne; ≥20 to ≤100 inflammatory lesions; ≥30 to ≤150 non-inflammatory lesions; ≤2 cysts/nodules Weeks 2, 4, 8, 12 (end of study) “Clear”: Normal, clear skin with no evidence of acne vulgaris
Slide 26: Well-Balanced Clinical Studies: Phase III Characteristics
WELL-BALANCED CLINICAL STUDIES PHASE III CHARACTERISTICS
Slide 27: Success in IGA: Phase III Results
Success in IGA Week 12Success in IGA (ITT) P<0.001 Study 65-04 P<0.017 Study 65-05 SUCCESS IN IGA PHASE III RESULTS
Slide 28: Success in Reducing Lesions: Phase III Results
Week 12Inflammatory Lesion Count Change From Baseline Change from Baseline in Inflammatory Lesion Count P<0.001 Study 65-04 P=0.018 Study 65-05 P<0.001 Study 65-04 P<0.001 Study 65-05 Week 12Non-Inflammatory Lesion Count Change From Baseline SUCCESS IN REDUCING LESIONS PHASE III RESULTS
Slide 29: Improvement in Severe Patient
IMPROVEMENT IN SEVERE PATIENT Subject 507-003 || 18 years old | Female | White | Not Hispanic or Latino* * Individual results vary BASELINE “Severe”; 29 inflamed lesions31 non-inflamed lesions; 1 nodule WEEK 12 “Moderate”; 9 inflamed lesions5 non-inflamed lesions; No nodules
Slide 30: Success in IGA Side-by-Side with Historical Results
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 drawn as if we conducted a head-to-head
Slide 31: Success in IGA, Moderate Subjects Only
Moderate Subjects at Baseline Only Success in IGA Normalized to Vehicle SUCCESS IN IGA SIDE-BY-SIDE WITH HISTORICAL RESULTS* Trials with Highest Difference in IGA Between the Active Arm and the Vehicle Arm TWYNEO® * Sol-Gel did not conduct a head-to-head comparison trial or study. The results descri
Slide 32: Treatment-Emergent Adverse Events Primarily Mild-to-Moderate
TREATMENT-EMERGENT ADVERSE EVENTS PRIMARILY MILD-TO-MODERATE
Slide 33: Local Skin Reactions Mild and Improved Over Time (Study 65-04)
DRYNESS SCALING ITCHING BURNING None Mild Moderate Severe ERYTHEMA PIGMENTATION STINGING % of Subjects % of Subjects % of Subjects Study 65-04 Week 12 Baseline Week 2 LOCAL SKIN REACTIONS MILD AND IMPROVED OVER TIME
Slide 34: Local Skin Reactions Mild and Improved Over Time (Study 65-05)
DRYNESS SCALING ITCHING BURNING ERYTHEMA PIGMENTATION STINGING % of Subjects % of Subjects % of Subjects Study 65-05 Week 12 Baseline Week 2 LOCAL SKIN REACTIONS MILD AND IMPROVED OVER TIME None Mild Moderate Severe
Slide 35: Broad Long-Term Intellectual Property Estate
EPSOLAY is protected until 2032 by granted patents, and until 2040 by allowed patentsTWYNEO is protected until 2038 by granted patents and until 2041 by pending patent applications25 patent applications for erlotinib, tapinarof and roflumilast in various skin conditions (as of February 26, 2021) BRO
Slide 36: Commercialization & Financials
COMMERCIALIZATION& FINANCIALS
Slide 37: Papulopustular Rosacea US Market
Source: IQVIA; Year 2019 PAPULOPUSTULAR ROSACEA US MARKET 2019 (IN $US) Oral vsTopical Topical Generic vsTopical Branded Branded Topicals are Important Segment
Slide 38: Acne Vulgaris US Market
Branded Topical Combinations are Important SegmentTretinoin is the Most Prescribed Topical Retinoid ACNE VULGARIS US MARKET 2019 (IN $US) Adapalene vsTretinoin Oral vsTopical Topical Generic vsTopical Branded Combinations vs Single Active Source: IQVIA; Year 2019
Slide 39: EPSOLAY & TWYNEO Compelling Enough to Drive Payor Coverage
Sources: NaviSync LLC (Morristown, NJ), Sol-Gel Managed Market Access for Acne and Rosacea, July 2019 NaviSync LLC (Morristown, NJ), Twyneo Payer Market Research Topline Summary, February 2020 TWYNEO® EPSOLAY® “All respondents recognized the product as a unique molecule for rosacea”“Near unanimous r
Slide 40: Prudent Commercialization Approach
We are in advanced negotiations with a potential partner regarding the commercialization of EPSOLAY® and TWYNEO® 45-62Sales Reps 3,300Dermatology Offices 6,500Dermatologists 80%Potential Market Value 6,000NPs/PAs Source: Syneos Health (Morrisville, NC), Sol-Gel Market Analysis, June 2019 PRUDENT COM
Slide 41: Lucrative Generic Pipeline
12 collaborations with Perrigo – with 50/50 gross profit sharing In June 2021, Perrigo launched ivermectin cream, 1%In February 2019, Perrigo launched acyclovir cream, 5%In June 2020, Perrigo was first-to-file a Paragraph IV Certification for Duobrii®In January 2020, Perrigo filed a Paragraph IV Cer
Slide 42: Financial Profile
Gross proceeds of $86.3 million raised in IPO on February 5, 2018Gross proceeds of $11.5 and $23 million raised in public follow-on offerings on August 12, 2019, and February 13, 2020, respectivelyAdditional $5 million investment by controlling shareholder in April 202023,028,264 Ordinary Shares as
Slide 43: Looking Forward
LOOKING FORWARD
Slide 44: What's Ahead: SGT-210 for Palmoplantar Keratoderma
PALMOPLANTAR KERATODERMA SGT-210 WHAT’S AHEAD Palmoplantar keratoderma (PPK) is a group of skin conditions characterized by thickening of the skin on the palms of the hands and soles of the feet
Slide 45: Recent Milestones & Next Steps
2019 2020 2021 Potential FDA approvalof EPSOLAY Potential FDA approvalof TWYNEO Revenues from generics DONE Phase III results for EPSOLAY DONE Granted patent forTWYNEO until 2038 DONE Phase I studyfor SGT-210 IN PROGRESS Phase III results for TWYNEO DONE RECENT MILESTONES& NEXT STEPS NDA for EPSOLAY
Slide 46: Sol-Gel Advanced Topical Therapy
—_ SL - Sol-Gel _, Advanced Topical Therapy NASDAQ: SLGL
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