Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (June 2020)
48 slides from Sol-gel Technologies's investor presentation, Jun 17, 2020
Slide 1: Sol-Gel Advanced Topical Therapy
@ a. “L ra Sol-Gel _, Advanced Topical Therapy NASDAQ: SLGL June, 2020
Slide 2: 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 statements by terms such as “may,
Slide 3: EPSOLAY & TWYNEO COVID-19
EPSOLAY® & TWYNEO® COVID-19 We completed the clinical programs required for the submission of our NDAs for EPSOLAY and TWYNEO 1 We also met with the FDA (physically and through telecoms) for pre-NDA meetings 2 Exhibit batches for EPSOLAY were produced at full commercial scale and the next production
Slide 4: Current modus operandi COVID-19
Business Continuity Plan (BCP) and Disaster Recovery Plan (DRP) were in place ahead of the COVID-19 crisis, and our Information Technology (IT) infrastructure allows recovery in case of a disaster including secured remote access to serversPurchase orders were placed to increase our current inventory
Slide 5: Our dermatology company overview
Proprietary silica-based microencapsulation technology Positive Phase III results in acne vulgaris NDA submission expected in 2H/20Potential to be first FDA-approved acne treatment that contains fixed-dose combination of BPO and tretinoin Pending patent applications for tapinarof and roflumilast in
Slide 6: 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 7: 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 8: 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 9: 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 10: EPSOLAY Sol-Gel solution
Encapsulation was designed to allow the BPO to slowly migrate from the microcapsules to help reduce irritationNDA submission expected in 2Q/20Potential to be the first single-active BPO approved by the FDA as a prescription drug product Encapsulated Benzoyl Peroxide Cream, 5% SOL-GEL SOLUTION*EPSOLA
Slide 11: EPSOLAY Phase III studies
Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD EPSOLAY® PHASE III STUDIES
Slide 12: 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” acne; ≥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 papules
Slide 13: Well-balanced clinical studies Phase III characteristics
WELL-BALANCED CLINICAL STUDIES PHASE III CHARACTERISTICS
Slide 14: Phase III results: success in primary endpoints
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 15: 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 16: 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 17: 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 18: 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 19: 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 20: 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 21: Treatment-emergent adverse events primarily mild-to-moderate
TREATMENT-EMERGENT ADVERSE EVENTS PRIMARILY MILD-TO-MODERATE
Slide 22: Local skin irritations fewer at week 12 than 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 23: 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 24: 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 25: TWYNEO Sol-Gel solution
Encapsulated Benzoyl Peroxide 3% &Encapsulated 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 t
Slide 26: TWYNEO Phase III studies
Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD TWYNEO® PHASE III STUDIES
Slide 27: TWYNEO Phase III study design and endpoints
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 28: Well-balanced clinical studies Phase III characteristics
WELL-BALANCED CLINICAL STUDIES PHASE III CHARACTERISTICS
Slide 29: Phase III results: success in IGA
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 30: Success in reducing lesions
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 31: 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 32: 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 33: Success in IGA, moderate subjects, side-by-side
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 34: Treatment-emergent adverse events primarily mild-to-moderate
TREATMENT-EMERGENT ADVERSE EVENTS PRIMARILY MILD-TO-MODERATE
Slide 35: Local skin reactions mild and improved over time (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 36: Local skin reactions mild and improved over time (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 37: Broad long-term intellectual property estate
EPSOLAY is protected until 2032 by granted patents and until 2040 by pending patentTWYNEO is protected until 2038 by granted patents and until 2040 by pending patent23 pending patent applications for erlotinib, tapinarof and roflumilast in various skin conditions (as of June 16, 2020) BROAD LONG-TER
Slide 38: Commercialization & Financials
COMMERCIALIZATION& FINANCIALS
Slide 39: 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 40: 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 41: 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 42: Lean commercialization approach
Efficiently Reaching 80% Dermatology TRx in Acne and Papulopustular Rosacea 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 LEAN COMMERCIALIZATION APPROACH
Slide 43: Lucrative generic pipeline
Seven collaborations with Perrigo with 50/50 gross profit sharingIn February 2019, Perrigo launched acyclovir cream, 5%, developed in collaboration with Sol-Gel. As of today this is the only generic product on the market other than an authorized generic. This product generated $22.8 million in net r
Slide 44: Strong 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 202022,972,335 Ordinary Shares as o
Slide 45: Looking Forward
LOOKING FORWARD
Slide 46: Palmoplantar keratoderma SGT-210: what's ahead
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 47: Recent milestones & next steps
2019 2020 2021 NDA submissionfor EPSOLAY Phase I results for SGT-210 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 NDA
Slide 48: Sol-Gel Advanced Topical Therapy
@ a. “L ra Sol-Gel _, Advanced Topical Therapy NASDAQ: SLGL
Sol-Gel Technologies — Investor Presentation (June 2020) on 6ix