Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (March 2021)
28 slides from Sol-gel Technologies's investor presentation, Mar 1, 2021
Slide 1: Sol-Gel Advanced Topical Therapy
Sol-Gel _, Advanced Topical Therapy NASDAQ: SLGL March 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
Pending patent applications for tapinarof and roflumilast in various skin conditions EARLY STAGE Ongoing Phase I proof-of-concept study for erlotinib gel in palmoplantar keratoderma SGT-210 Twelve 50/50 gross profit-sharing collaborations with Perrigo$8.7 million in net revenues last year GENERICS P
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 by the FDA for April 26, 2021Potential to be the first single-active BPO approved by the FDA as a prescription drug product Benzoyl Peroxide Cream, 5% SOL-GEL SOLUTIO
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: 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 11: 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 12: 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 13: 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 14: 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 15: 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 16: 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 17: TWYNEO Phase III Studies
Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD TWYNEO® PHASE III STUDIES
Slide 18: 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 19: 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 20: 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 21: 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 provisional patent applications for erlotinib, tapinarof and roflumilast in various skin conditions (as of February 2
Slide 22: EPSOLAY & TWYNEO Are 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 23: Prudent Commercialization Approach
We are in discussions with potential partners regarding the commercialization of EPSOLAY and TWYNEO in the US* 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 COMME
Slide 24: Lucrative Generic Pipeline
12 collaborations with Perrigo with 50/50 gross profit sharing In March 2017, Perrigo filed a Paragraph IV Certification for Soolantra®In February 2019, Perrigo launched acyclovir cream, 5%, developed in collaboration with Sol-Gel. This product generated $22.8 million in net revenues in 2019 and $8.
Slide 25: 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 202023,000,782 Ordinary Shares as o
Slide 26: What's Ahead: SGT-210 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 feetPhase I proof-of-concept study for erlotinib gel in PPK is ongoing
Slide 27: Recent Milestones & Next Steps
2019 2020 2021 Potential FDA approvaland launch of EPSOLAY Potential FDA approvaland launch of 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
Slide 28: Sol-Gel Advanced Topical Therapy
—_ SL - Sol-Gel _, Advanced Topical Therapy NASDAQ: SLGL
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