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): April 1, 2022


STRATA Skin Sciences, Inc.
(Exact Name of Registrant as Specified in Its Charter)


000-51481
(Commission File Number)

Delaware
13-3986004
(State or Other Jurisdiction of Incorporation)
(I.R.S. Employer Identification No.)

5 Walnut Grove Drive, Suite 140
Horsham, Pennsylvania 19044
(Address of principal executive offices, including zip code)

(215) 619-3200
(Registrant’s telephone number, including area code)

NOT APPLICABLE
(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 April 1, 2022, STRATA Skin Sciences, Inc. (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 set forth in this item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act or otherwise subject to the liabilities of such section, nor shall such information be deemed incorporated by refernce in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by sepcific reference in any such filing.


Item 9.01.          Financial Statements and Exhibits.

(d)          Exhibits.

The following presentation is furnished as an exhibit to this Current Report on Form 8-K and shall not be deemed to be “filed”:

Exhibit No.
Exhibit Description
99.1
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 
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: April 1, 2022
By:
/s/ Christopher Lesovitz        
       
 
 
Christopher Lesovitz
 
 
 
Chief Financial Officer
 


- 2 -

EXHIBIT 99.1


 Investor Presentation  December 2020  Investor Presentation  April 2022  Driving Value to Dermatology Partners  Matching Patients with Clinics 
 

 Safe Harbor Statement  This presentation includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, the Company’s ability to migrate customers from the Pharos system to XTRAC® and to execute new service agreements to at least portions of the Pharos user base, to generate the growth in its core business, including transitioning capital equipment purchasers into recurring revenue users, to integrate the Pharos service business into the Company’s field service offering, the Company’s ability to develop social media marketing campaigns, and the Company’s ability to build a leading franchise in dermatology, are based on the Company’s current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory, adverse market conditions or supply chain interruptions resulting from the coronavirus and political factors or conditions affecting the Company and the medical device industry in general, future responses to and effects of the COVID-19 pandemic and its variants including the distribution and effectiveness of the COVID-19 vaccines, as well as more specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all these forward-looking statements may prove to be incorrect or unreliable. The statements in this presentation are made as of the date of this presentation, 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 presentation. The Company urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.   2 
 

 3  Source: 1 Market Data Forecast Report 2021, Fortune Business Insights 2018, 2019  Addressing large markets for chronic skin diseases with differentiated laser-based treatments  Recurring revenue model drives repeat and sustainable revenues  Customer base of ~1K partner practices and growing  Sales driven by expanding device usage & new partner practices  Expanding international presence in key markets  Recent product acquisitions opening significant growth opportunity 
 

 Positioned for Growth Acceleration in the Treatment of Chronic Skin Conditions  4  CEO  CFO  VP Marketing  VP of Professional Relations  Director of Business Operations  3 new Board Members   New Leadership  Commercial Focus and Execution  Acquisitions  DTC marketing analytics  Direct to dermatologist marketing  Partnering with advocacy groups  Sales training and focus  International organic growth and expansion  Pharos excimer laser business from Ra Medical Systems, Aug ‘21  Theraclear® acne business from Theravant, Jan ‘22  Pipeline of new indications 
 

 Large Unmet Need in Common and Chronic Dermatologic Conditions  5  ATOPIC   DERMATITIS   PSORIASIS  VITILIGO  PSORIASIS: Autoimmune disease that causes the skin to regenerate faster than normal; characterized by red, itchy scaly patches (65% Mild; 25% Moderate; 10% Severe)  ~8 Million patients in the U.S.3   VITILIGO: Autoimmune condition due to a loss of melanocytes, characterized by patches of skin losing its pigment  ~5 Million patients in the U.S.4   ATOPIC DERMATITIS: Inflammatory condition characterized by red and itchy skin that flares-up periodically  ~18 Million patients in the U.S.5  
 

 XTRAC® Treatments by Indication – United States  6  5%  80%  15%  Opportunities exist for expanding use for other approved indications  Vitiligo   Eczema (Atopic Dermatitis)  #1use for XTRAC® lasers domestically  Psoriasis treatments remain  
 

    XTRAC®: Psoriasis  7  After 4 tx  After 2 tx  Baseline   Clinical Protocol – 6.2 treatments to PASI 75  Beam of UVB light applied to the   affected area  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  XTRAC®The treatment for Psoriasis  Promotes immunosuppression   UVB light induces apoptosis of the keratinocytes and   T cells in the dermis  Induces alterations in cytokine profile 
 

    XTRAC®: Vitiligo  8  Beam of UVB light applied to the   affected area  XTRAC®The solution for Vitiligo  Results in   re-pigmentation  UVB light reduces the immune system’s attack on the melanocytes  Simple, safe, effective + long-lasting  Excimer laser  Baseline   After 18 tx  After 29 tx 
 

 Multicenter Psoriasis Study7  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.  Scalp Study9   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 with a high rate of effectiveness.  Sample Studies from 150+ Clinical Studies  Vitiligo Study8  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 Study10  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).   9 
 

 Treatment Options Addressing Psoriasis Indication6  10  XTRAC  NB-UVB*  Topical Steroids  Non-biologic Systemics   Biologics   Approximate Costs ($)  Cost competitive  1K-3K  3K-9K  1K -7K  1K  32K-68K  Clinical Impact  Better clinical outcomes (PASI%75)   92%  71%  75%  48%  50-70%  Speed of Onset (in weeks)  Very fast rate of response  5  10  3  14  12  Days of Actual Care  Least days of actual care  18  80  294  52  12-65  Remission  Remission without maintenance  2.5 months  Continued with  maintenance  Continued with  maintenance  Continued with  maintenance  Continued with  maintenance  Adverse Events  Least significant side effects  Mild  Temp  MildTemp  Mild-ModTemp-Lasting  Mild-SevereTemp-Lasting  Mild-Severe  Temp-Lasting  *Narrow band UVB Light Therapy  Source: "Therapies for Psoriasis: Clinical and Economic Comparisons“   in the November 2020 issue of the Journal of Drugs in Dermatology. 
 

 Best-in-class Excimer TREATMENT  XTRAC® is the Leader in Targeted 308nm Excimer Laser Therapy   11  Safe & Effective Treatment  150+ Peer-Reviewed Clinical Studies  Economical for Patients and Payors  Win-Win for Providers and their Patients 
 

 Growing Installed Base Drives Recurring Revenue Model  12  01/01/19  Systems   12/31/19  1/01/20  12/31/20  Systems   12/31/21  01/01/21  Systems   Net Installed Base Growth 2019-2021  25% growth in installed base over the last 3 years  Actively redeploying under utilized devices  Group and international placements help drive growth  +160  -76  +106  -76  +169  -85  +84 net  +30 net  +84 net 
 

 A True Partnership – Delivering a Complete Business Solution  13  Clinical Support  Reimbursement Support  Call Center Support  Field Service Support  Consumables and Parts  Laser Upgrades  Co-pay Assistance  DTC Marketing 
 

 Key Priority: Driving Commercial Execution  14  Sustain investment in DTC marketing  Continue to focus and grow high-volume accounts  Drive increased utilization across all indications  Increase marketing to drive awareness among derms  Historical trends show positive correlation between DTC investment and revenue growth  High-volume accounts in Q4, 2021 accounted for 54% of recurring revenues  Expand usage for all approved indications beyond psoriasis to further drive revenue growth opportunities with existing partners   Direct to Derm marketing – Increasing clinical data to support all indications and reinforce safety, efficacy and cost benefit to patients and clinics 
 

 Domestic Market: – Sales and Service Engine  Overview  4 Regions  30 Sales Territories  2 National Account Managers  15 Field Service Techs  In-House Call Center to Qualify Leads  Predominant Provider of Excimer Laser Treatments  15  Territories color coded 
 

 XTRAC® Installed Base – Multiple Growth Drivers   International   Current Markets: China, Japan, Saudi Arabia, S. Korea, Israel  Insurance covered in most markets  Usage per device higher than U.S. market  1,300 devices sold and in service  54 International partner XTRAC® clinics (up from 10 in 2019)  16     Expansion into group clinic roll ups  1,962 clinics owned by 49 roll-up groups  Opportunity to place multiple devices w/agreement  312 devices placed at 12/31/21, up from 251 at 12/31/20  Expansion into Group Clinic Roll Ups  300-400 clinics own excimer lasers   Conversion to XTRAC partnership leads to immediate revenue  48 Comebacks in 2021, up from 23 at 12/31/20  Comebacks  890  1,962  312*  XTRAC Partners  Group Clinics  12/31/21  12/31/20  * Combination of new XTRAC placements and clinic acquisitions  820  1,673  251*  746  1,200   86*  12/31/19  XTRAC Growth in Groups  
 

 Acquired the U.S. Dermatology Business of Ra Medical Systems  17  Provides STRATA with the opportunity to market its full business solution to Ra Medical’s existing customer base of 250+ active accounts  Positions STRATA as the predominant provider of excimer laser treatments in the U.S.  Thru 12/31/2021 successfully converted 30 of 73 Pharos users who have come off service agreements.  An additional 155 come off service agreements in 2022  Pharos business anticipated to be accretive in Q1 2022 
 

 Theraclear Acquisition  18  Substantially broadens STRATA’s opportunity with expansion potential into the estimated $5.5B acne care market  Creates robust pipeline of opportunities to target conditions beyond acne with a unique light treatment approach   Reinforces STRATA’s vision to be the premier provider of medical devices to dermatology community  Leverages STRATA’s innovative marketing platform, commercial team and worldwide distributor network  Addresses Multiple Causes of Acne in a Single Treatment 
 

 Executive Management Team: 100+ yrs. dermatology experience  Robert (Bob) J. Moccia, CEO  Encore Dermatology, Precision Dermatology, Medicis Pharmaceuticals, Graceway Pharmaceuticals, Bioglan Pharmaceuticals, Stiefel Laboratories, Dermik Laboratories (RPR)  Chris Lesovitz, CFO  Encore Dermatology, Iroko Pharmaceuticals  Shmuel Gov, VP of Operations, General Manager, Carlsbad  PhotoMedex, U.S.R. Electronic Systems  Ltd., Galor Ltd.: Negevtech Inc, Orbotech Inc. (a KLA company)  Brent Cowgill, VP Marketing  Encore Dermatology, Vantage Marketing Group, Graceway Pharmaceuticals, Bristol Myers Squibb  Keith Simeone, VP Sales  PhotoMedex Inc.: Sales Director, ForTec Medical  John Bagdasarian, VP Professional Services  Incyte, EPI Health, Alcaris Therapeutics, Valeant Pharmaceuticals, Graceway Pharmaceuticals, 3M Pharmaceuticals  Jay Sturm, General Counsel  Mela Sciences, Volcano Capital LLC, GC Vital Signs, Inc.  19 
 

 Financial Metrics  20  * Unaudited quarterly results     2018  2019  2020  Q1 '21*  Q2 '21*  Q3 '21*  Q4 '21*  2021  Dermatology recurring revenue  $21,053   $23,713   $17,409   $4,679   $5,452   $5,710   $6,687  $22,528  Dermatology equipment revenue   $8,802   $7,873   $5,681   $1,148   $1,930    $2,001   $2,370  $7,449  Total revenue   $29,855   $31,586   $23,090   $5,827   $7,382   $7,711  $9,057  $29,977  Domestic partner installed base  746   820   832   837   848   880   890  890  Dermatology recurring revenue margin  65%  70%  67%  68%  70%  74%  74%  72%  Total Company margin  57%  64%  61%  64%  65%  70%  66%  66% 
 

 Commercial Drivers in 2022  21  Continue DTC advertising campaign with social media   XTRAC® Awareness: Co-Op advertising to suitable patients (digital + print)   Develop patient advocacy partnerships   Broadened commercial strategy to expand use within partner practices  Added emphasis on professional relations and clinical communications  Sponsorship of select dermatology conferences and trade shows  Insurance coverage gap analysis and activity (vitiligo, atopic dermatitis)  Sales force training and execution  Grow installed base and redeploy under-utilized devices   Continue transition and integration of Ra Medical’s Pharos customers   Launch new acne device based on acquired technology from Theravant 
 

 STRATA Key Investment Takeaways  22  Differentiated Treatment providing a Win-Win-Win for Patients + Clinics + Payers  Addressing Large and Growing Markets +  Positioned for Inorganic Growth  Proven Business Model to Expand + Achieve Sustainable Results and Shareholder Returns 
 

 Investor Presentation  December 2020  Thank You 
 

 Investor Presentation  December 2020  Appendix 
 

 Board of Directors  William Humphries   Chairman of the Board and  Governance & Compensation Committee  CEO, Isosceles Pharmaceuticals, Inc. former President & Group Chairman Ortho Dermatologics, Merz Pharmaceuticals, Stiefel Pharmaceuticals, Allergan Pharmaceuticals  Dr. Uri Geiger  CEO Accelmed Inc. CEO Exalenz Bioscience, GalayOr Networks   Nachum Shamir  Governance & Compensation Committee Chairman and Audit Committee  Chairman & CEO Luminex Corporation, CEO Given Imaging   Samuel Rubinstein  Audit Committee and   Governance & Compensation Committee  Chairman of Board Trima Pharmaceuticals, former CEO & General Manager Taro Pharmaceuticals, Inc.   Douglas Strang  Audit Committee Chairman  Former partner PWC, Head of Global Pharmaceuticals & Life Science Advisory, US Pharmaceutical & Life Science Leader  Dr. Patricia Walker  Audit Committee  Private Practice Dermatologist, previously: President and Chief Scientific Officer of Brickell Biotech Inc, Chief Medical Officer at Kythera Biopharmaceuticals, prior to becoming the Chief Medical Officer at Allergan Medical–she was VP Dermatology Therapeutic Area, Inamed’s Executive Vice President and Chief Scientific Officer, Clinical faculty member at University of California Irvine’s Dept. of Dermatology   Robert J. Moccia  President & CEO  CEO STRATA Skin Sciences, CEO Encore Dermatology, Inc. CEO Precision Dermatology, Inc.   25 
 

 Partner Academic Institutions  26 
 

 Strata Dermatology Markets Addressed  Psoriasis  Eczema (Atopic Derm.)  Vitiligo  Acne  27  Psoriasis Treatment Market* Size (2019 to 2027)  2019 Global Market Value of $20.1B USD 1  Projected Market Value of $40.6B USD by 2027 1  CAGR of 9.2% 2020-2027 1  Eczema Treatment Market* Size (2020 to 2026)  2020 Global Market Value of $11.8B USD2  Projected Market Value of $21.8B USD by 20262  CAGR of 13.1% 2021-20262  1 Fortune Business Insights Market Report 2019; 2016-2018 historical, 2019 base year, 2020-2027 projected  2 Market Data Forecast Analysis Report 2020; 2020 base year, 2021-2026 projected   3 Fortune Business Insights Market Report 2018; 2015-2017 historical, 2018 base year, 2019-2026 projected  * Treatment market(s) include Rx drug therapies  Vitiligo Treatment Market* Size (2018 to 2026)  2018 Global Market Value of $1.2B USD3  Projected Market Value of $1.9B USD by 20263  CAGR of 5.8% 2019-20263  Acne Treatment Market* Size (2019 to 2027)  2019 Global Market Value of $7.7B USD3  Projected Market Value of $11.1B USD by 20273  CAGR of 4.6% 2020-20273 
 

 Growing Demand for Drug-Free Treatment Options  28  Source: Dermatology Devices Report, Grand View Research 2021 Base year 2020, historic information 2016 to 2019, and forecast 2021 to 2028   USD Millions  USD Millions  $7.1B  $34.1B  $5.1B  $993M  Projected CAGR +21.2%  2021-2028  Projected CAGR +19.9%  2021-2028