UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): June 20, 2018
STRATA SKIN SCIENCES, INC.
(Exact Name of Registrant Specified in Charter)
Delaware
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000-51481
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13-3986004
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(State or Other
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(Commission File
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(I.R.S. Employer
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Jurisdiction of
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Number)
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Identification No.)
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Incorporation)
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100 Lakeside Drive, Suite 100, Horsham, Pennsylvania
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19044
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(Address of Principal Executive Offices)
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(Zip Code)
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Registrant's telephone number, including area code: 215-619-3200
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure
On June 20, 2018, Strata Skin Sciences (the "Company") posted an investor presentation to its website at http://investors.strataskinsciences.com/investors/home. A copy of the investor presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall it be deemed subject to the requirements of amended Item 10 of Regulation S-K, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
Item 9.01 Financial Statements and Exhibits
(d)
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Exhibits
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99.1
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Strata Skin Sciences Investor Presentation dated June 20, 2018
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Exhibit No.
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Exhibit Description
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99.1
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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STRATA SKIN SCIENCES, INC.
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Date: June 20, 2018
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By:
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/s/ Matthew C. Hill
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Matthew C. Hill
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Chief Financial Officer
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EXHIBIT 99.1
June 2018 Investor Presentation Driving Value to Dermatology Partners Matching Patients and Clinics
This presentation includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including any statements of the plans, strategies and objectives of management for future operations; any statements regarding product development, product extensions, product integration or product marketing; any statements regarding continued compliance with government regulations, changing legislation or regulatory environments; any statements of expectation or belief and any statements of assumptions underlying any of the foregoing. In addition, there are risks and uncertainties related to successfully integrating the products and employees of the Company, as well as the ability to ensure continued regulatory compliance, performance and/or market growth. These risks, uncertainties and other factors, and the general risks associated with the businesses of the Company described in the reports and other documents filed with the SEC, could cause actual results to differ materially from those referred to, implied or expressed in the forward-looking statements. The Company cautions readers not to rely on these forward-looking statements. All forward-looking statements are based on information currently available to the Company and are qualified in their entirety by this cautionary statement. The Company anticipates that subsequent events and developments will cause its views to change. The information contained in this presentation speaks as of the date hereof and the Company has or undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Safe Harbor Statement 2
STRATA Investment Highlights Seasoned Management Team – Experienced in the BusinessDr. Dolev Rafaeli, CEO returns with the Accelmed transaction Excimer Laser Technology for DermatologyPsoriasis, Vitiligo, Eczema, Atopic Dermatitis and Leukoderma Large Market Opportunity Over 35 Million patients in the United States alone Proven StrategyBest in class XTRAC and VTRAC Excimer Laser technologies DTC awareness and lead generation driving revenue growth at dermatology practices 3
XTRAC Revenue Growth Strategy 8n6 Protocol Treatment *RDX – Reimbursement Database XTRAC (proprietary system) REOCCURRENCE DTC ADVERTISING ASSIGNING A DOCTOR PARTNER PATIENTAPPOINTMENT TREATMENT WIN WIN WIN DOCTOR PATIENT STRATA (AND PAYER) INTEREST CREATION IN-HOUSE CALL CENTER INSURANCE ADVOCACY VERIFY APPOINTMENTPrescription of treatment VERIFY XTRACTREATMENT Clinic Appointments DTC Appointments RDX Fee Per Use 4
Lead Generation is a Business Driver Patient leads in one quarterLeads turn into appointmentsAppointments lead to XTRAC partner revenueOther revenue for the partner clinicRevenue for STRATA 6
DTC Initial Results – Reduced Acquisition Costs Total Likes Total Reach 7
The Market Opportunity XTRAC cleared in four indications PsoriasisVitiligoEczema and Atopic DermatitisLeukodermaOver 35 million domestic patients3 CPT codes ($150 - $250 based on BSA)$170 average reimbursement rate per treatmentClinical Protocol – 6.2 treatments to PASI 75 Average of 23 treatments per patientPatient Life Time Value ~ $4,000 PASI - A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis.BSA = Body Surface Area affected 8
Excimer Laser Technology - XTRAC®/VTRAC® TechnologyXTRAC excimer laser uses highly targeted (308nm) beam of UVB light to treat affected skin area without damaging surrounding tissueVTRAC is a lamp based 308nm laserTreatment avoids side effects and cost of biologics, and messy topicalsTreatments are safe and efficaciousMultiple FDA 510(k) and other international clearancesOver 500,0000 patients treated Over 2,000 devices installed base WWCompelling partner clinic economicsXTRAC DTC provides a significant revenue sourceHalo effect of XTRAC DTC marketing platform Center of Excellence partner clinic revenue approx. $500,000/year Charge revenue on a per-use basis 9
How XTRAC Works After 4 tx After 2 tx Baseline Beam of UVB light applied to the affected area UV light induces apoptosis of the keratinocytes and T cells in the dermis Promotes immunosuppression Induces alterations in cytokine profile 140+ peer reviewed published clinical studies 10
Domestic Market: Installed Base Overview 750 Partner XTRAC 138 sold XTRAC 4 Regions 22 Territories 15 Field Service In-house call center 11
International Market: Installed Base OUS sales are through distribution with no current recurring revenue model appliedMajor Markets – China, Japan, Saudi Arabia, South KoreaInsurance covered in most marketsUsage/device higher that domestic market1,186 OUS devices sold and in service Strategic Growth Target 12
Turnaround Strategy DOMESTIC MARKET OUS MARKETS Enhance technology offeringExpand geographical reach in certain markets Rebuild XTRAC value proposition for partner physician accountsDTC is a revenue driver: Online and offline advertisement, in-house call centerPatient Communication: For both referrals and enrollment patientsPractice Development Programs: increase prescriptions for XTRACOptimize Clinical Outcomes: Deploy Education for High Dose/OTD and 8N6 as driversCurrent Excimer owners – Revisit “Comeback Program” (>250 dermatologists “came back” to recurring revenue model between 2012-2014)Expanding installed base (location within 10 miles of every patient)Improving XTRAC market share across all disease indications Revenue = # of lasers x # of treatments/pt x # patients x cost/tx x recurrence factor 13
May 2018: Transformative Transaction 2013 2014 2015 2016 2017 2012 Based on STRATA 10-k Annual Report; Dec 31, 2017* STRATA bought XTRAC business from PhotoMedex in 2015 Average Treatment Revenue Per Laser By Quarter 14
Media Spend to XTRAC Treatment Revenue: The Opportunity Based on STRATA and PhotoMedex Investor Presentations* STRATA bought XTRAC business from PhotoMedex in 2015 15
Optimal Therapeutic Dose (“OTD”) – 510(k) Submitted for MMDThe Path to Optimal Clinical Outcomes and Patient Retention MECHANISMTip applies 4 simultaneous doses of energy to the patient’s plaque PURPOSETo minimize number of treatments to clearance USEDose allows provider to determine blister threshold unique to each patient and each plaque. 510(k) submission Filed Baseline After 2 tx Clinical Studies 16
Current Clinical Protocol For Optimal Patient Outcomes: 8N6 Protocol 01 Twice a week: Minimum 8 visits in 6 weeks 02 Starting dose of at least 300 mj 03 Increase Dose over Time 04 Patient Returns: At least 8 visits per patient 05 …and management of the database to track results 17
Maximizing Partner Clinical Revenue Data collected directly from the lasers demonstrates the importance of following treatment guidelines Revenue = # of lasers x # of treatments/pt x # patients x cost/tx x recurrence factor 18
Opportunity: Improving Clinical Delivery to Increase Revenue by Over 50% Clinical Outcomes* Currently 40% of all patients treated have a regimen that provides NO clinical resultAdding all patients to 8N6 will increase Company revenue by $5.4M annually ($7k/account) Retention Rates*Current Patient Retention Rate (more than 1 course of treatment): 13%Adding only 1 additional regimen, in just 50% of the accounts will increase revenue by $8M annually ($10k/account) Assumptions: Number of Accts: 750, Number of visits 11, *Number Regimens 2 *If every 2nd patient has 2 regimens instead of 1 = 32% greater revenue per account Revenue = # of lasers x # of treatments/pt x # patients x cost/tx x recurrence factor Avg. No. Patient Regimens 1 *2+ Per Acct Revenue Install Base Revenue Breakdown of Patient Population 87% 13% $31,510 $23,632,537.50 75% 25% $34,856 $26,142,187.50 50% 50% $41,828 $31,370,625.00 25% 75% $48,799 $36,599,062.50 0% 100% $55,770 $41,827,500.00 *Extrapolated from a sample of 48 accounts. 19
During 2.5 years (owned by PhotoMedex), XTRAC recurring businessRevenue grew by 317% from $8.4 to $26.5 millionGross Margin grew from 39% to 68%Consigned Installed base grew by 382 (from 268 to 650)Average Treatment Revenue/device/qtr grew from $5K to $11KPatient acquisition cost ranged $450-500/appointmentAdvertising cost 15-18% of recurring revenue Current XTRAC domestic recurring revenue businessConsigned installed base is 746Gross Margin (1Q/2018) – 56.7%Average Treatment Revenue/device/qtr (1Q/2018) – $6KPatient Acquisition Cost – sub $200/appointment 20 Opportunity: Turnaround to growth
STRATA 10-k Annual Report; Dec 31, 2017 Financial Profile Shares and Share Equivalents – Market cap*- $75M (As of June 8, 2018) * On an as converted basis of the convertible preferred stock** Does not include warrants as of December 31, 2017 of 2,406,625 with a weighted average strike price of $5.52 Common stock outstanding 28.5M Series C preferred shares* 5.0M Options outstanding 4.4M Total** 37.9M 21
STRATA Investment Highlights Seasoned Management Team – Experienced in the BusinessDr. Dolev Rafaeli, CEO returns with the Accelmed transaction Excimer Laser Technology for DermatologyPsoriasis, Vitiligo, Eczema, Atopic Dermatitis and Leukoderma Large Market Opportunity Over 35 Million patients in the United States alone Proven Strategy Best in class XTRAC and VTRAC Excimer Laser technologies DTC awareness and lead generation driving revenue growth at dermatology practices 22
June 2018 Investor Presentation Driving Value to Dermatology Partners Matching Patients and Clinics