Exhibit 99.1
NASDAQ: SLGL
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,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “future,” “outlook,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this presentation relate to, among other things, statements regarding the commencement of our planned bioequivalence study for a generic product candidate, our expected date to report top-line data from our pivotal Phase III clinical program for TWIN, our anticipated NDA submission dates for Epsolay and TWIN, and estimated sales of our product candidates. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statement, including but not limited to the following: the fact that we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our ability to complete the development of our product candidates; our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; our ability to commercialize our product candidates; our ability to obtain and maintain adequate protection of our intellectual property; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing, and distribution channels; acceptance of our product candidates by healthcare professionals and patients; the possibility that we may face third-party claims of intellectual property infringement; the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing, and sales, distribution and personnel resources than we do; potential product liability claims; potential adverse federal, state, and local government regulation in the United States, Europe, or Israel; and loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 21, 2019, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this presentation. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation. This presentation contains trademarks, trade names, and service marks of other companies, which are the property of their respective owners. We do not intend our use or display of other parties' trademarks, trade names, or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.
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 data in acne vulgaris expected in Q4/2019 Successfully raised $86.3 million in IPO in February 2018 Non-dilutive revenues from generic pipeline as of 1H/2019 Seasoned management team with proven track record and broad dermatologic experience 1 2 3 4 5 6
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-Fluorouracil cream, 5%(RLD: Efudex®) TENTATIVE APPROVAL AS OF JANUARY 29, 2018 APPROVAL & SALES AS OF FEBRUARY 2019 BE STUDY RESULTS IN 2019 Research Filed Bioequivalence Company and Products Overview | July 2019
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 are emulsified together Silica monomers migrate to the oil/water interface in a well-controlled process A silica shell, microcapsule is formed SOL-GEL PROCESS 2 If approved, will be first core-shell encapsulation system for topical dermatology productsAPIs stabilized via microencapsulation, allowing for novel combinationsBarrier between entrapped API and skin may reduce irritation and improve complianceHurdle for generics to demonstrate similar release profile POTENTIAL BENEFITS 3 Foundation forbranded product pipeline
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
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 benzoyl peroxide crystals and skin, leading to less irritation Controlled release improves tolerability
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 a series of patent families, describing and claiming our proprietary processes, formulations, and methods of use IP, Expiry Product/Indication IP Protection for Our Branded Products (US) Granted/Allowed, 2038Pending, 2040 Granted/Allowed, 2032Pending, 2040 TWINacne vulgaris EPSOLAY®subtype II rosacea Intellectual property estate Company and Products Overview | July 2019
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, ivermectin)and systemic antibiotics (minocycline, doxycycline) Insufficient efficacy resulting in poor adherence; contributing to antibiotic resistance; systemic side effects; misdiagnosis is common1,3 What ispapulopustular rosacea? How is it treated? What are the current treatments shortfalls? Papulopustular rosacea—inflammatory condition with pooradherence to current treatments Erythematotelangiectatic Papulopustular Phymatous Ocular National Rosacea Society. www.rosacea.org.Berg, M. and Liden, S, Acta Derm Venereol. 1989;69: 419–423Prevalence of rosacea. http://www.rosacea.org/rr/index.php.Gether L et al. Br J Dermatol. 2018;179:282-289.Wilkin J et al. J Am Acad Dermatol. 2004;50:907-912 Multiple subtypes/phenotypes often seen in a single patient4,5
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
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 Two phase III, double-blind, randomized, vehicle-controlled studies epsolay® Study design PRIMARY ENDPOINTS:Proportion of patients with the primary measure of success "Clear" (0) or "Almost clear" (1) in the Investigator Global Assessment (IGA) relative to Baseline at Week 12Absolute mean change in inflammatory lesion counts from baseline to Week 12SECONDARY ENDPOINTS:Inflammatory lesion percentage change from baseline to Week 12Absolute mean change in inflammatory lesion counts from baseline at Week 8 and Week 4Proportion of patients with the primary measure of success "Clear" (0) or "Almost clear" (1) in the Investigator Global Assessment (IGA) relative to Baseline at Week 8 and Week 4 Randomization
Study population & discontinuation Study 54-02 Study 54-01 # of Patients Epsolay® Vehicle # of Patients
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 (91.8%)10 (8.2%) 29.8 (14.00)25.0 (15-70) 27.5 (13.04)22.5 (15-70)
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
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
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
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
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
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 † † † † † † † † †
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 * # † * * * # #
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 head-to-head comparison trial or study
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 in IGA Difference from Vehicle FMX103 Minocycline foam, 1.5% 10-week study Epsolay® Oral administration 16-week study Primary endpoints historical comparisons(†) (†) 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 construedas conclusions to be drawn as if we conducted a head-to-head comparison trial or study 12- week study 12- week study 12- week study
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
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 (20.2%) 22 (18.2%) 1 (0.4%)2 2 (0.8%)3 4 (1.6%) 1 (0.8%)4 9 (3.6%) 1 Femur fracture2 Spinal compression fracture3 One subject with spinal compression fracture4 Urinary tract infection – Discontinuation defined as “other” reason
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 the mainstays of Rx systemic therapies Insufficient efficacy negatively affects self-esteem; contributes toantibiotic resistance; systemic side effects Encapsulation allows combining two highly effective APIs, BPO & ATRA,that have a complementary mechanism of actionEncapsulation may reduce the irritation of both BPO and ATRAPotential to be more effective than existing topical treatments What isacne vulgaris? How is it treated? What are the current treatments shortfalls? TWIN:E-ATRA/E-BPO cream Acne vulgaris—multifactorial disease requiringpowerful combination treatments
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 Change from Baseline at Week 12 Difference From Vehicle Phase II Phase II Phase II TWIN Active Treatment 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 comparison trial or study Acne trials efficacy results*: moderate patients
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 Success in IGA at Week 12 Inflammatory Lesions—Mean Percent Change from Baseline at Week 12 Active Treatment Arm Difference From Vehicle Winlevi™ FMX101 Minocycline foam, 4% Clascoterone cream, 1% Oral sarecycline Seysara™ Noninflammatory lesions not a co-primary endpoint Phase II Phase II Phase II Noninflammatory lesions not in label TWIN *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. Efficacy results of recent acne trials*
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: Proportion of patients in active treatment versus vehicle cream with an assessment of clear or almost clear with at least a 2-grade improvement in IGA at Week 12Absolute change from Baseline in inflammatory and non-inflammatory lesion count at Week 12 TOPLINE RESULTS EXPECTED IN Q4 2019 Twin phase III trial designs Male and female patients ≥ 9 years of ageIGA score of moderate or severeA diagnosis of facial acne ≥30 and ≤150 non-inflammatory lesions ≥20 and ≤100 inflammatory lesions including in the nose
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 retinoid,and no combination of benzoyl peroxide and tretinoinis available or currently possible Approximately 16 million people in the US suffer from rosacea(5-6 million type 2) (>30 years)Many patients are misdiagnosed or do not seek treatment at all, creating a large underserved patient population$478 million branded topical market (WAC)*Treated with topical products 76% of the time (rest oral)* Market potential for acne & rosacea *Sources: Symphony Health; Syneos Research & Insights ”Treatment Answers”; June 2019 MAT.
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
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
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 genericsQuantity limits POSSIBLE:Prior authorizationto label “If priced like Finacea, it would get parity access; 15%-20% rebate expected with WAC at parity to Finacea.” State AIS Health, 2019. http://www.aishealth.com/about.MMIT Network, 2019. http://www.mmitnetwork.comData on file. NPG Health primary market research, 2019.. PAYER UM POSITION BASED ON HIGHER NET-TO-PLAN PRICE COMPELLING TO DRIVE FORUMLARY CONSIDERATION COVERED OR BETTER:92% Commercial40% Part D74% Medicaid
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 strategies to reduce access hurdles and ensure pull-through. Leverage consumer activation in high patient-engagement categories Significant potential for sales force efficiency and addressing a challenging reimbursement environment
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, Perrigo received approval from the FDA and launched the sale of acyclovir cream,5%, developed in collaboration with Sol-Gel. As of today, there is no public disclosure of anotherfiler to the FDA. The sales of the RLD were ~$92 million in 2018. Bioequivalence (BE) study results for 5-fluorouracil cream, 5%, expected in 2H2019 A portfolio of generic product candidates with favorable commercial agreementsthat supplement our branded pipelineSeven collaborations with Perrigo and one with Douglas Pharmaceuticalswith 50/50 gross profit sharing FDA Approvals Recent Developments Multiple Collaborations Revenue-generating generics partnerships
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 expected to be sufficient to fund Phase III clinical programs for TWIN, regulatory activities for Epsolay®, a bioequivalence study, and our activities until the end of Q3/2020
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 report BE study results for 5-fluorouracil cream, 5% Recent milestones & next steps US pre-launch commercial preparations (Collaboration with Perrigo) ANDA for 5-fluorouracil cream, 5% filed in 1H/2020 Approval and launch of EPSOLAY® first in 2021 US commercial organization fully operational Receive notice of allowance extending TWIN market protection from 2032 2038 Start PoC for Palmoplantar Keratoderma Q4/2019 Approval and launch of TWIN product second in 2021 Recognized non-dilutive revenues early form launch of acyclovir cream (by Perrigo)
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.