Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Day (July 2019)
63 slides from Sol-gel Technologies's investor day presentation, Jul 25, 2019
Slide 1: Investor & Analyst Day July 25, 2019
INVESTOR & ANALYST DAYJuly 25, 2019
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: Agenda
Agenda TOPIC SPEAKER Introduction and Company Overview Alon Seri-LevyCEO, Sol-Gel Current Challenges in Acne and Rosacea Treatment Dr. Linda Stein GoldDirector of Dermatology Clinical Research,Henry Ford Health Systems, Michigan EPSOLAY® Phase III Clinical Studies Dr. Jeff SugarmanMedical Director,
Slide 4: Three-fold strategy
THREE-FOLD STRATEGY Leverage on 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 i
Slide 5: 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 GENERIC PRODUCTS/CANDIDATES Ivermectin cream, 1%(RLD: Soolantra®) Acyclovir cream, 5%(RLD: Zovirax®) 5-
Slide 6: Current challenges in Acne Vulgaris
Current challengesin Acne Vulgaris Dr. Linda Stein GoldDirector of Dermatology Clinical Research, Henry Ford Health Systems
Slide 7: Acne: prevalence & presentation
Collier CN, et al. J Am Acad Dermatol. 2008;58:56-59.Zaenglein AL. N Engl J Med. 2018;379:1343-1352.AAD 2016 Burden of Disease Report, https://www.aad.org/media/stats/conditions. Percent Age Group PRESENTATION2 Moderate Mild Severe aCNE: PREVALENCE & PRESENTATION PREVALENCE1,3Acne is the most common
Slide 8: The impact of acne
The impact of acne In addition to physical effects such as permanent scarring and disfigurement,acne has long-lasting psychosocial effects that affect the patient's quality of lifeDepression, social isolation and suicidal ideation are frequent comorbidities of acnethat should not be neglected in the
Slide 9: Acne treatment
Treatment Mild Acne Moderate Acne Severe Acne First-line Treatment Benzoyl peroxide, topical retinoid, or topical combination therapy Topical combination therapy; oral antibiotic, topical retinoid, and benzoyl peroxide; oral antibiotic plus topical retinoid; or benzoyl peroxide plus topical antibiot
Slide 10: Unmet need
Unmet need There is a strong trend toward and professional recommendation to avoid or be more discerning with antibiotics use in dermatology whenever possible1Combination products or use of multiple products/modalities is common2,3 Benzoyl peroxide and tretinoin have both been shown to be effective2
Slide 11: Benzoyl peroxide in acne
Benzoyl peroxide in acne Benzoyl radicals kill bacteria and inflammatory cellsBenzoic acid promotes the opening of clogged poresBenzoyl peroxide combines with other treatments for synergistic effects Benzoyl peroxide White blood cells Bacteria Benzoic acid Benzoyl radicals Seth V, et al. Int J Adv M
Slide 12: Tretinoin in acne
Elevated sebum production C. acnes colonization Tretinoin Inflammation Seth V, et al. Int J Adv Med. 2015;2:1-5. Tretinoin in acne Hyperkeratosis (keratin plug)
Slide 13: Tretinoin and benzoyl peroxide in acne
Elevated sebum production C. acnes colonization Tretinoin Hyperkeratosis (keratin plug) Inflammation TRETINOIN AND BENZOYL PEROXIDE IN ACNE Benzoyl Peroxide Seth V, et al. Int J Adv Med. 2015;2:1-5.
Slide 14: Treatment to date
Treatment to date… Preference for dual action, but preferred products unable to be combined until now…Encapsulation permits storage and delivery of benzoyl peroxide with tretinoin in strengths repeated shownto be efficacious in patients of acne vulgaris SEM Encapsulated Tretinoin SEM Encapsulated Be
Slide 15: TWIN Phase II summary
TWIN low and TWIN high demonstratedsignificant improvements in moderate to severe acne vulgaris after 12 weeks of treatment:Statistically significant (P <0.006) improvements were observed in both the IGA and lesion counts (inflammatory and noninflammatory) over vehicle aloneTWIN low and TWIN high ha
Slide 16: Current challenges in Rosacea
Current challengesin Rosacea
Slide 17: Rosacea is a chronic inflammatory skin disease
Blount BW, Pelletier AL. Am Fam Physician. 2002;66:435-440. National Rosacea Society. http://www.rosacea.org/rr/2010/winter/article_1.php. Moustafa F. J Am Acad Dermatol. 2014;71:973-980.Gether L, et al. Br J Dermatol. 2018;179:282-289Wilkin J, et al. J Am Acad Dermatol. 2004;50:907-912 Erythematous
Slide 18: Rosacea pathophysiology is complex
Rosacea pathophysiology is complex Pathogenesis of rosacea is thought to be an immune detection dysfunction *TLR-2 – Toll-like receptor-2Yamasaki K et al. Nature Medicine. 2007;13:975-980.Yamasaki K et al J Dermatol Sci. 2009;55:77-81.Fleischer AB. J Drugs Dermatol. 2011;10:614-620.Yamasaki K et al.
Slide 19: Psychological consequences of rosacea
National Rosacea Society. http://www.rosacea.org/press/new-rosacea-survey-shows-emotional-toll-facial-redness-equals-impact-bumps-pimples. Accessed November 7, 2016. Moustafa F, et al. J Am Acad Dermatol. 2014;71(5):973-980. Patients with rosacea suffer psychologicalconsequences that impact their ev
Slide 20: Clearer skin reduces impact on rosacea patient QOL
DLQI=Dermatology Life Quality Index; QOL=quality of life. Tan J, et al. Rosacea. Beyond the visible. 2018. Available at https://hosted.bmj.com/rosaceabeyondthevisible. Accessed October 15, 2018. Clearer skin reduces impact onrosacea patient qol Data from an online global survey of 710 rosacea patien
Slide 21: Same woman, different impressions
Same woman, different impressions
Slide 22: Rosacea is a largely untapped market
ROSACEA IS A LARGELY UNTAPPED MARKET Of the approximate 16 million rosacea sufferers in the US: Only 10% seek treatment1 Misdiagnosis is common1,2 There is a clearly understood medical need for effective treatment options Our goal is to address the underdiagnosis and to offer a safe and effective op
Slide 23: Why not benzoyl peroxide for rosacea?
WHY NOT BENZOYL PEROXIDE FOR ROSACEA? The skin of patients with rosacea is extremely sensitive and hyper-reactive to dietary, environmental, and topical factors1The use of topical retinoids and benzoyl peroxide has shown to be beneficial in treating rosaceain smaller case series2Data suggest that to
Slide 24: EPSOLAY Phase III clinical study results
EPSOLAY® phase III clinical study results Dr. Jeff SugarmanMedical Director, Northern California Medical AssociatesAssociate Clinical Professor, University of California, San Francisco
Slide 25: Study design
Male and female ≥18 years of age Clinical diagnosis of moderate to severe rosacea≥15 inflammatory lesions≤2 nodules 2:1 EPSOLAY® cream, 5% (once daily) Vehicle cream (once daily) 54 Total Sites— RandomizationStudy 54-01: 361Study 54-02: 372 12 weeks of treatment Baseline 2 4 8 12 Weeks Inclusion cri
Slide 26: 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 Rand
Slide 27: Baseline characteristics
Study 54-01 Study 54-02 CHARACTERISTIC EPSOLAY ®(n = 243) Vehicle(n = 118) EPSOLAY ®(n = 250) Vehicle(n = 122) Age, yearsMean (SD)Median (range) 52.8 (13.21)54.0 (19-81) 52.4 (13.26)52.5 (24-85) 49.5 (14.04)50.0 (18 to 79) 51.5 (12.55)50 (22 to 84) Sex, n (%)MaleFemale 60 (24.7)183 (75.3) 35 (29.7)8
Slide 28: Primary endpoint (IGA)
P<0.001 P<0.001 Success in IGA at Week 12 Study 54-02 Study 54-01 Primary endpoint (igA) Success in IGA at Week 12 Intent-to-treat population
Slide 29: Primary endpoint (change in lesion count)
Study 54-02 Study 54-01 P<0.001 P<0.001 Primary endpoint (change in lesion count) Inflammatory lesion count change from baseline at Week 12 Inflammatory lesion count change frombaseline at Week 12 Intent-to-treat population
Slide 30: Secondary endpoint (% change in lesions)
SECONDARY ENDPOINT (% CHANGE IN LESIONS) Study 54-02 Study 54-01 Inflammatory lesion percent change from baseline at Week 12 P<0.001 P<0.001 Inflammatory lesion percent change frombaseline at Week 12 Intent-to-treat population
Slide 31: Exploratory endpoint (efficacy at 2 weeks)
Study 54-02 Study 54-01 Success in IGA at Week 2 Inflammatory lesion count change from baseline at Week 2 P = 0.009 P = 0.017 P < 0.001 P < 0.001 Study 54-02 Study 54-01 * Intent-to-treat population Exploratory endpoint (efficacy at 2 weekS) Intent-to-treat population Intent-to-treat population
Slide 32: Success in IGA over time
SUCCESS in IGA OVER TIME Percent Achieving Clear or Almost Clear * # † * * * ₳ # Intent-to-treat population †P = 0.017, #P = 0.009, ₳ P =0.006, *P <0.001 vs corresponding vehicle
Slide 33: Absolute change in inflammatory lesion count over time
ABSOLUTE change in inflammatory lesioncount from baseline over time Week Inflammatory lesion count change from baseline † † † † † † † † †P < 0.001 vs corresponding vehicle Intent-to-treat population
Slide 34: Improvement over time
IMPROVEMENT OVER TIME 4 0 0 0 1 3 2 1 0 0 IGA IGA
Slide 35: Improvement over time
3 0 0 0 0 4 3 3 3 2 IMPROVEMENT OVER TIME IGA IGA
Slide 36: 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 37: TEAE summary
No. (%) of Subjects 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 1 (0.4%)2 0 Severe TEAE 2 (0.8%) 0 2 (0.8%)3 0 Discontinuation 5 (2.1%) 1 (0.9%) 4 (1.6%) 1
Slide 38: 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 39: Commercial Overview
Commercial Overview John Vieira, US Head of Commercialization
Slide 40: Three-fold strategy
THREE-FOLD STRATEGY Leverage on our capabilities to generate significant non-dilutive revenues 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
Slide 41: 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, remaining is oral*Dermatologists account for ~60% of acne treatment(higher for branded products)Combining treatments is the bestway to combat a
Slide 42: Launch aligned performance of select brands
24 month Launch aligned performance Select ACNE brands Select ROSACEA brands Fixed dose combination—21% of topical acne market Tretinoin is ~25% of all retinoids used in acne~ 20% of all acne treatments involve benzoyl peroxide TRx /month (000’s) TRx /month (000’s) Rosacea market has grown ~4% (MAT
Slide 43: 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 44: Capture significant opportunity in rosacea
Capture significant opportunity in rosacea Rosacea subtype II treatments by phase & severity Note: *Branded products may have generic equivalentSource: L.E.K. interviews and analysis; company websites OTC Generic Branded* Laser treatment Intense pulsed light Mild Moderate Severe OTC products typical
Slide 45: Approach to building a commercial organization
DENSITY &PRODUCTIVITY METRICS MARKET FACTORS APPROACH TO building a commercialorganization—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 46: Scalable marketing investment
Scalable marketing investment An integrated approach built from the ground up GEO-TARGETING& NONPERSONAL HIGH TOUCHPOINTS NONPERSONAL Access services Digital CRM Social media Patient activation SalesReps
Slide 47: Competitive pricing
COMPETITIVE PRICING Addressing access & UM for epsolay®1,2,3 Positive payer response to EPSOLAY®—Competitive pricing likelyequals parity access in rosacea ~70% Most would cover at preferred or non-preferred level dependingon cost PAYER RESPONSE TO CLINICAL PROFILE LIKELY:Step-through genericsQuantit
Slide 48: 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 49: Technology overview
Technology overview Ofer Toledano, VP Research and Development
Slide 50: 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 51: 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 52: 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 53: Intellectual property estate
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 54: Pipeline lifecycle & active research areas
Pipeline Lifecycle & active research areas Mori Arkin, Chairman Investor and Analyst Day, July 2019
Slide 55: Lifecycle
Lifecycle PROJECT DESCRIPTION SGT-129 EPSOLAY® + alpha agonist for the treatmentof rosacea type I and II SGT-138 TWIN + immune modulator for the treatment of severe acne —Hydradenitis Suppurativa Investor and Analyst Day, July 2019
Slide 56: Pipeline and early research
Pipeline and Early research PROJECT DESCRIPTION SGT-210 Topical treatment of hyper-keratinization disorders—Palmoplantar Keratoderma Non-melanoma skin cancer NMSC (BCC/SCC) Investor and Analyst Day, July 2019
Slide 57: Palmoplantar keratoderma (PPK)
A group of skin conditions characterized by thickening of the skin on the hands and soles of the feet1Can be a manifestation of various syndromes2Inherited:Due to mutations that result in keratin abnormalitiesCan be autosomal recessive or autosomal dominantAcquired due to1,2:Drugs, malnutrition, che
Slide 58: Financial overview
Financial overview Gilad Mamlok, CFO
Slide 59: Generic product candidates and 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 2018In February 2019, Perrig
Slide 60: 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 61: Summary
Summary Alon Seri-Levy, CEO
Slide 62: Advancements to topical therapies
Advancements to Topical Therapies Effective and efficient commercial organization on trackHighly positive Phase III results imply EPSOLAY®as best-in-classNew patent allowance extends value for TWINfrom 2032 to 2038Phase III topline results for TWIN on track in 4Q/19NDA submissions for EPSOLAY® and T
Slide 63: Q&A
Q&A