UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_____________

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): January 13, 2020


STRATA SKIN SCIENCES, INC.
(Exact Name of Registrant Specified in Charter)
 
 
 
Delaware
000-51481
13-3986004
(State or Other
(Commission File
(I.R.S. Employer
Jurisdiction of
Number)
Identification No.)
Incorporation)
 
 
 
  
5 Walnut Grove Drive, Suite 140, Horsham, Pennsylvania
   19044
 
 
(Address of Principal Executive Offices)
(Zip Code)
 
  
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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share
SSKN
The NASDAQ Stock Market LLC

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 January 13, 2020, Strata Skin Sciences (the “Company”) posted an investor presentation to its website at https://strataskinsciencesinc.gcs-web.com/. 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.

Safe Harbor
 
This Current Report on Form 8-K, and oral statements made regarding the subject matter hereof, contains "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, or the Reform Act, which may include, but are not limited to, statements regarding the Company’s revenue growth estimates, plans, objectives, expectations and intentions and other statements contained in this Current Report on Form 8-K that are not historical facts, including statements identified by words such as “believe,” “plan,” “seek,” “expect,” “intend,” “estimate,” “anticipate,” “will,” and similar expressions. All statements addressing the Company’s ability to generate the anticipated revenue stream, the Company’s ability to generate sufficient cash flow to fund the Company’s ongoing operations and research and development activities beginning at any time in the future, the Company’s ability to implement business strategies, regulatory and political factors or conditions affecting the Company and/or the medical device industry in general, the public’s reaction to the Company’s advertisements and marketing campaigns, the Company’s ability to build a leading franchise in dermatology and aesthetics, and the Company’s ability to grow revenues and sustain that growth as well as statements expressing optimism or pessimism about future operating results are forward-looking statements within the meaning of the Reform Act. The forward-looking statements are based on management’s current views and assumptions regarding future events and operating performance, and are inherently subject to significant business, economic, and competitive uncertainties and contingencies and changes in circumstances, many of which are beyond the Company’s control. The statements in this press release are made as of the date hereof, even if subsequently made available by the Company on its website or otherwise. The Company does not undertake any obligation to update or revise these statements to reflect events or circumstances occurring after the date of this press release.
 
 
Although the Company does not make forward-looking statements unless it believes it has a reasonable basis for doing so, the Company cannot guarantee their accuracy. The foregoing factors, among others, could cause actual results to differ materially from those described in these forward-looking statements. For a list of other factors which could affect the Company’s results, including revenue growth estimates, see the Company’s filings with the Securities and Exchange Commission, including “Cautionary Note Regarding Forward-Looking Statements,” “Item 1A. Risk Factors,” and “Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations” set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019. No undue reliance should be placed on any forward-looking statements.
 

- 2 -

 




Item 9.01 Financial Statements and Exhibits

(d) Exhibits

99.1 Strata Skin Sciences Investor Presentation dated January 13, 2020.

 
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.
 
 
STRATA SKIN SCIENCES, INC.
 
 
 
 
 
Date: January 13, 2020
By:
/s/ Matthew C. Hill        
 
 
 
Matthew C. Hill
 
 
  
Chief Financial Officer
 


 
- 3 -
 Investor Presentation  January 2020  Driving Value to Dermatology Partners  Matching Patients with Clinics  NASDAQ: SSKN 
 
 Safe Harbor Statement  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 revenue growth, product development, product extensions, product integration or product marketing; any statements regarding continued compliance with government regulations, changing legislation, insurance or regulatory environments; any statements of expectation or belief and any statements of assumptions underlying any of the foregoing; any 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 and undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.   2 
 
 STRATA Investment Highlights   A Win-Win-Win CompanyFor patients – safest, most effective treatment, no side effectsFor clinics – stable increased revenue baseFor Payers – the least expensive treatment availableExcimer Laser Technology for Dermatology IndicationsPsoriasis, Vitiligo, Atopic Dermatitis and LeukodermaLarge Market Opportunity 35 Million lives – $6 Billion annual revenueTreatment modality use growing > 25% per yearReimbursement - 3 unique CPT codes 25% target clinic penetrationUnique and Proven Business ModelBest in class XTRAC® and VTRAC ® Excimer Laser technologiesDomestic recurring revenue driven by DTC*OUS recurring revenue - Announced 7/2019 - 10 placed in 2H/2019Providing “business in a box” for dermatology practicesGrowing Install base – low hanging fruit  3  *DTC – Direct To Consumer awareness and advertising 
 
 How XTRAC Works - Psoriasis  4  After 4 tx  After 2 tx  Baseline  Beam of UVB light applied to the affected area  UVB light induces apoptosis of the keratinocytes and T cells in the dermis  Promotes immunosuppression   Induces alterations in cytokine profile  150+ peer reviewed published clinical studies  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  Clinical Protocol – 6.2 treatments to PASI75  
 
 How XTRAC Works - Vitiligo  Long-term skin condition characterized by patches of skin losing its pigment Disease is believed to be due to genetic susceptibility where the autoimmune disease is then triggeredPotentially the immune system is attacking and destroying melanocytes of the skinLife-altering disease that leads to low self esteem UVB light reduces the immune system’s attack on the melanocytes and enhances the migration and proliferation of melanocytes resulting in re-pigmentation  5  STRATA HAS EXCLUSIVE LICENSE FOR TREATMENT OF VITILIGO USING EXCIMER LASER  After 29 tx  After 18 tx  Baseline 
 
 XTRAC a True Partnership: A complete business solution    Clinical Support  Reimbursement Support  Call Center Support  Field Service Support  Consumables and Parts  Laser Upgrades  Co-pay Support  DTC Marketing  6 
 
     Domestic XTRAC Revenue Funnel  7                                                    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  Patient leads turn into appointmentsAppointments drive XTRAC partner revenueOther revenue for the partner clinicRevenue for STRATA 
 
 XTRAC helps patients Live Clear, Live Free…    https://youtu.be/GdMBliZYy70  8 
 
 50,000 People See XTRAC Ads Daily      9 
 
 196% of Psoriasis and 76% of Vitiligo patients had XTRAC as a covered insurance benefit 2New Patients captured in STRATA reimbursement system  21%   21% new patient growth in 2019; 86% covered by insurance1  10 
 
 STRATA’s Domestic Recurring Revenue Model  11  + 74 devices   23% growth  2.3% Growth      13% Growth    1Reflects only partners that purchase treatment codes on an as needed basis. Other partners purchase codes on a fixed monthly billing 2Revenue is domestic recurring placements, net of discounts and co-pay support  As of December 31, 2018 and 2019  ~ 
 
   Growth of XTRAC Share in Groups *Combination of new XTRAC placements and Clinic acquisitions  Domestic Install Base Growth Drivers   12  1,673 clinics owned by 49 roll-up groups221 (13%) of which are XTRAC partnersStrata signed strategic expansion agreements with major groups  Expansion into group clinic roll ups  300-400 clinics own Excimer lasers Conversion to an XTRAC partner clinic leads to immediate revenue15 Comebacks in 2018 (4 in 2017)19 Comebacks in 2019  Comebacks  820  1,673  221*    As of December 31, 2019  As of December 31, 2018  746  1,200  86*      XTRAC Partners  Group Clinics 
 
 Domestic Market: Installed Base – sales and service engine  13  Territories color coded  Overview820 Partner XTRAC clinics155+ sold XTRAC5 Regions26 Sales Territories15 Field Service TechsIn-house call center to qualify leadsOnly one competitor in U.S. 
 
 Partner Academic Institutions    14 
 
 International Market: Installed Base   Strategic Growth TargetsMajor Markets – China, Japan, Saudi Arabia, South KoreaInsurance covered in most marketsUsage/device higher than domestic market – untapped potential in U.S.1,300 OUS devices sold and in servicePlacement recurring revenue model agreement executed for South Korea July 2019 – 10 devices placed 2H/2019  15                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
 
 Financial Metrics  16  Note: all quarterly numbers are unaudited Q4 2019 numbers are preliminary and unaudited * Total recurring revenue over total installed base    Q1 2018  Q2 2018  Q3 2018  Q4 2018  Q1 2019  Q2 2019  Q3 2019  Q4 2019  Dermatology recurring revenue   $4,770    $5,022    $5,393    $5,867    $5,312    $5,839   $5,991  ~$6,550  Dermatology equipment revenue   $1,968    $2,366    $2,336    $2,132    $2,171    $1,886   $1,489  ~$2,300  Total revenue    $6,738    $7,388    $7,729    $7,999    $7,483    $7,725   $7,480  ~$8,850  Domestic partner installed base  746    746   746    746   754   764   784  820  International installed base  -  -  -  -  -  -  2  10  Average recurring revenue/device*   $6,394    $6,732    $7,229    $7,865   $7,045    $7,643   $7,622  ~$7,891  Dermatology recurring revenue margin  58.3%  61.8%  66.7%  71.5%  66.2%  70.3%  67.2%  *  Total Company margin  50.4%  52.0%  59.9%  65.7%  61.6%  63.6%  61.8%  *                     (in thousands except for average recurring revenue/device and installed base)                 
 
 (As of January 9, 2020)  * On an as converted basis of the convertible preferred stock** Does not include 750K warrants with a weighted average exercise price of $4.12 as of September 30, 2019 of which 600K expire by June 2020** Does not include 4.0M options with a weighted average exercise price of $1.78 as of September 30, 2019  Common stock outstanding   32.9M   Series C preferred shares*    0.7M       Total**   33.6M  17  Financial Profile Shares and Share Equivalents – Market cap*- $73M 
 
 STRATA Investment Highlights   A Win-Win-Win CompanyFor patients – safest, most effective treatment, no side effectsFor clinics – stable increased revenue baseFor Payers – the least expensive treatment availableExcimer Laser Technology for Dermatology IndicationsPsoriasis, Vitiligo, Atopic Dermatitis and LeukodermaLarge Market Opportunity 35 Million lives – $6 Billion annual revenueTreatment modality use growing > 25% per yearReimbursement - 3 unique CPT codes 25% target clinic penetrationUnique and Proven Business ModelBest in class XTRAC® and VTRAC ® Excimer Laser technologiesDomestic recurring revenue driven by DTC*OUS recurring revenue - Announced 7/2019 - 10 placed 2H/2019Providing “business in a box” for dermatology practicesGrowing Install base – low hanging fruit  18  *DTC – Direct To Consumer awareness and advertising 
 
 Investor Presentation  January 2020  Driving Value to Dermatology Partners  Matching Patients with Clinics  NASDAQ: SSKN 
 
 Appendix  20 
 
 Additional Creative    21  https://youtu.be/LbmTKkN0Aq4 
 
 XTRAC® Excimer laser is FDA cleared for Psoriasis, Vitiligo, Atopic Dermatitis and Leukoderma. It uses a highly targeted beam of 308nm UVB to treat affected skin without damaging surrounding healthy tissue. Treatment has minimal side effects, avoids messy topicals and high cost of biologics.  #1 Prescribed Targeted Therapy for Psoriasis and Vitiligo by Dermatologists  22 
 
 Continuous technology investment and business growth  23  510 (K) FDA Approval            AL-7000                      Ultra  Velocity 400  Velocity 700  Velocity 7 Series   S3  2000  2005  2008  2010  2014  2018  CPT code Approval    DTC platform creation    510 (K) FDA Approval (MMD)*    Full Insurance Reimbursement    2012  *MMD tip is a diagnostic accessory for XTRAC used in optimal therapeutic dose (OTD) protocol that helps patients achieve Optimal Clinical Outcomes leading to increased Patient Retention  
 
 24  Historical phototherapy utilization. Trend in phototherapy utilization among Medicare beneficiaries by billing code across all providers, 2000 to 2015. HCPCS, Healthcare Common Procedure Coding System; PUVA, psoralen plus ultraviolet A; UVB, ultraviolet B.  30%  30% annual growth in excimer laser utilization in the US   
 
 Multicenter Psoriasis Study1    Scalp Study3     124 patients were enrolled and 80 completed the protocol. 72% achieved at least 75% clearing in an average of 6.2 treatments. 84% of patients reached improvement of 75% or better after 10 or fewer treatments. 50% of patients reached improvement of 90% or better after 10 or fewer treatments. Common side effects included erythema, blisters, hyperpigmentation, and erosions, but were well tolerated.  All patients improved. 17/35 (49%) of patients cleared>95% (mean: 21 treatments; range: 6-52) and 16/35 (45%) cleared 50-95%. Conclusion - The excimer laser is a successful approach to treatment of psoriasis of the scalp being a simple treatment that can be performed in a short period of time and which has a high rate of effectiveness.  Sample studies from 150+ clinical studies  Vitiligo Study2    Out of 221 vitiligo patches treated, 50.6% showed 75% pigmentation or more, 25.5% achieved 100% pigmentation of their patches, and 64.3% showed 50% pigmentation or more. Lesions on the face responded better than lesions elsewhere. Conclusion: The 308-nm xenon chloride excimer laser is an effective and safe modality for the treatment of vitiligo, with good results achieved in a relatively short duration of time.  Pediatric Study4    4 children with a mean age of 11.0 years and 12 adults with a mean age of 48.8 years completed the protocol. Both the children and the adult groups yielded a significant decrease in psoriatic severity scores of their respective target lesions. The children’s group had a greater reduction (91.3% reduction) as compared to the adult treatment group (61.6% reduction).   1Multicenter Psoriasis Study - Feldman SR, Mellen BG, Housman TS, Fitzpatrick RE, Geronemus RG, Friedman PM, Vasily DB, Morison WL. Efficacy of the 308-nm excimer laser for treatment of psoriasis: Results of a multicenter study. J Am Acad of Dermatol; vol. 46, no. 6, June 2002, pp. 900-906 2Vitiligo Study - Suhail Hadi, Patricia Tinio, Khalid Al-Ghaithi, Haitham Al-Qari, Mohammad Al-Helalat, Mark Lebwohl, and James Spencer. Photomedicine and Laser Surgery. Treatment of Vitiligo Using the 308-nm Excimer Laser. Jun 2006.ahead of printhttp://doi.org/10.1089/pho.2006.24.3543Scalp Study - Morison WL, Atkinson DF and Werthman L. Effective treatment of scalp psoriasis using the excimer (308nm) laser. Photodermatol Photoimmunol Photomed 2006; 22: 181-1834Pediatric Study - Pahlajani N, Katz BJ, Lonzano AM, Murphy F and Gottlieb A. Comparison of the Efficacy and Safety of the 308nm Excimer laser for the Treatment of Localized Psoriasis in Adults and in Children: A Pilot Study. Pediatric Dermatology Vol. 22 No. 2, March/April 2005, pp. 161-165Induration Protocol Study - Taneja A, Trehan M, Taylor C. 308-nm Excimer Laser for the Treatment of Psoriasis – Induration-Based Dosimetry. Arch Dermatol, Vol. 139, June 2003, pp. 759-764High Dose Protocol Study - Michael Abrouk,1 Ethan Levin,2 Merrick Brodsky,1 Jessica R Gandy,1 Mio Nakamura,2 Tian Hao Zhu,3 Benjamin Farahnik,4 John Koo,2 and Tina Bhutani, 2 Excimer laser for the treatment of psoriasis: safety, efficacy, and patient acceptability. Published online 2016 Dec 12. doi: 10.2147/PTT.S105047  25  25 
 
 Maximizing Dermatologist Partner Clinical Revenue  26  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 
 
 Source: National Psoriasis Foundation  XTRAC a preferred treatment for 90% of psoriasis patients (<10% BSA)    27 
 
 Opportunity map for XTRAC  Indications  Prevalence   Source  Atopic dermatitis  18 Million  National Eczema Association  Vitiligo  2-5 Million  Vitiligo Support  Psoriasis  7.5 Million  NPF      Topicals/ Targeted Phototherapy  Systemics/Biologics/UVB Booth  Recommended  Actual  XTRAC  Biologics  28 
 
 Source: Findings From the National Psoriasis Foundation Surveys, 2003-2011 (n=5604)  Source: Real-world health outcomes study sponsored by Eli Lilly (n=2200)        Phototherapy has highest patient perceived treatment effectiveness  29 
 
 Leads, Appointments, RDX Charts    2015  2016  2017  2018  2019  Leads  36,473  21,296  7,269  22,213  47,911  Appointments  10,032  6,524  2,563  3,856  5,924  RDX Charts   26,237  23,481  18,747  18,107  21,989  30 
 
 Total Calls in call center  31 
 
 XTRAC adds (delegated) recurring revenue driver for its partners  Treatment  Patient Type  Reimbursement Details  Annual Revenue per Patient  Can be delegated**  XTRAC  Mild / moderate / severe  CPT Code 96920-96922 ($168-$251) average $186; 16 tx/course (2/yr) and Office Visit -$70 (2/Yr)  $6,092    Phototherapy*  Moderate / severe  Office visit - $70 (2/yr)  $140  X  Biologics  Moderate / severe  Office visit - $70 (6/yr)  $420  X  Systemics  Moderate / severe  Office visit - $70 (3/yr)  $210  X  Topicals  Mild / moderate  Office visit - $70 (3/yr)  $210  X  CPT CODE  Description  2018 National AverageMedicare Payment Rate  96920  Laser treatment for inflammatory skin diseases, (psoriasis); total area less than 250 sq cm  $168.12   96921  Laser treatment for inflammatory skin diseases, (psoriasis); total area between 250 – 500 sq cm  $184.32   96922  Laser treatment for inflammatory skin diseases, (psoriasis); total area greater than 500 sq cm  $250.92   Number of Treatments / Weeks  20  30  # of Weeks / Year  48  48  Total # of Treatments / Year  960  1,440  Average Revenue Per Treatment   $186    $186   Physician Gross Revenue (Annual)  $178,485   $267,728   *Phototherapy Center Revenue – CPT Code 96910 $40 per tx; 30 tx/course (2/yr) - $2,400**Subject to state legislation  32      32 
 
 How XTRAC works for offices: $250 revenue in less than 7 minutes  Established CPT Codes 2019 National Medicare Average Rate 96920 - $167.2296921 - $183.4496922 - $249.03  33