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): December 11, 2024

graphic

STRATA SKIN SCIENCES, INC.
(Exact Name of Registrant Specified in Charter)

Delaware
000-51481
13-3986004
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)

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))

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. ☐
 
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



Item 7.01.
Regulation FD Disclosure.

On December 11, 2024, 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 reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific 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
Investor Presentation dated December 11, 2024, issued by Strata Skin Sciences, Inc.
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: December 11, 2024
By:
/s/ John Gillings
 
   
John Gillings
 
   
Vice President Finance (Principal Financial Officer
and Principal Accounting Officer)
 




Exhibit 99.1

 Investor Presentation  December 2024  Driving Value in Dermatology   Matching Patients with Clinics for a Win-Win-Win Outcome  NASDAQ: SSKN 
 

 Safe Harbor Statement  2  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.  
 

 About Us  3  STRATA Skin Sciences is a medical technology company offering advanced medical devices for the in-office treatment of life-altering dermatological conditions.​  $38B Market Opportunity Across Psoriasis, Vitiligo, Eczema, and Acne markets  Experienced Management with 20+ Year History​ in Dermatology Market  Leading Global Provider of Dermatology In-Office Medical Procedures  Stock Symbol  NASDAQ: SSKN  Stock Price (as of 11/26/24)  $2.96  Shares Outstanding (as of 8/12/24)  4.2M   Market Cap   $12M  Cash & Equivalents*   $8.4M  Debt*  $15.2  Enterprise Value   $19M  Options*  Warrants*  501,726 @ $8.36 WAEP  80,000 @ $8.80 WAEP  Inside Ownership (%):  ~39%  Capitalization Table  * As of 9/30/24 
 

 Addressing $38B Dermatology Market Psoriasis - $20.1B1, Vitiligo - $1.2B2, Eczema - $11.8B3, Acne - $5.5B4  4  30M Patients in the U.S.  Psoriasis – 8M / Vitiligo - 5M / Eczema - 18M  Fortune Business Insights Market Report 2019; 2016-2018 historical, 2019 base year, 2020-2027 projected  Fortune Business Insights Market Report 2018; 2015-2017 historical, 2018 base year, 2019-2026 projected  Market Data Forecast Analysis Report 2020; 2020 base year, 2021-2026 projected  Strata Skin Sciences  50M+ Acne Patients in the U.S. 
 

 Affiliated Academic Institutions  STRATA has placed over 50 XTRAC® machines in residency programs across academic institutions  5  Affiliated Academic Institutions​  STRATA devices are available at over 50 academic institutes that offer dermatology residency programs  5 
 

 Management Team  Sales and Operational Dermatology Experience  Chief Executive Officer  Dr. Dolev Rafaeli  V.P. Finance  John Gillings  Chief Operating Officer Shmuel Gov  6 
 

 STRATA Investment Highlights   7  Unique and Proven Business Model  Best-in-class Excimer Laser technologies  Recurring revenue driven by DTC and growing installed base  Installed base of 873 XTRAC® domestic devices for Psoriasis, Vitiligo, and Eczema treatments  Installed base of 135 TheraClear®X domestic devices for Acne treatments  Installed base of ~1700 XTRAC® and VTRAC® devices internationally  Providing “business in a box” for dermatology practices without an upfront capital spend by practices  Over 300 peer-reviewed, published clinical studies  A Win-Win-Win Business Model  For patients – safest, most effective, minimal side effects  For clinics – stable increased revenue base   For Payers – the cheapest treatment available   Opportunity for Renewed Growth in U.S. in Recurring Revenue per Device  Re-emphasis on DTC marketing in U.S. with near-term opportunity of increasing recurring revenue/device by 40%  More rigorous sales and marketing strategy and process in place  Both initiatives could collectively grow revenue by double digit percent and help return the company to positive cash flow 
 

 3Q24 Financial Highlights  8  Revenue  Total revenue $8.8M (-1% YOY) vs. $8.9M 3Q23  Global net recurring revenue $5.4M (+2% YOY) vs. $5.3M 3Q23  Gross domestic XTRAC® recurring billings $4.8M (-2% YOY) vs. $4.9M 3Q23  Revenue per domestic XTRAC® system $5,332 (+2% YOY) on 873 systems vs. $5,233 on 929 systems in 3Q23  Gross Margin  60.3% (+430 bps YOY) vs. 56.0% in 3Q23  Operating Expenses  $5.2M (-7% YOY) (excluding one-time accrual expense) vs. $5.6M 3Q23  Operating Income  Non-GAAP operating profit (excluding accrual item) $128,000   First time generating positive operating profit since early 2018 
 

 Core Domestic Business Model 
 

 A True Partnership – A Complete Business Solution  10  No upfront capital expense; instead, it’s a fee-per-use business model  Complete business solution includes a suite of value-added support services to maximize practice’s success  Clinical Support  Reimbursement Support  Call Center Support  Field Service Support  Consumables and Parts  Device Upgrades  Co-pay Support  DTC Marketing  PartnershipProgram 
 

 ~900 Partner Dermatology Clinics​ with 3,000+ Dermatology Providers Across the U.S.  11  Overview  873 Partner XTRAC® clinics + >150 sold XTRAC® devices  135 TheraClear®X clinics  3 Regions / 23 Sales Territories / 1 National Accounts Manager  15 Field Service Techs  In-house call center and insurance benefits team  4 Clinical specialists  
 

 Practice Development Program  In-Office Patient Education Materials for psoriasis, vitiligo & atopic dermatitis:  Patient Brochures  Counter Cards  In Office Branding  “Patient-Directed” marketing initiative:  Patient Education Mailings  Outreach Programs  Eblasts  12  12 
 

 Marketing Support Drives Additional Patient Awareness  13  Patient Eblasts  Direct Mailers   In-office Branding  Social Media  Trade Shows  Clinical Webinars  
 

 DTC Advertising Generates Direct and Indirect Appointments in Partner Clinics   14  See XTRAC® ad on Facebook, Google and Instagram  Click on the ad to go to an XTRAC® page  Leave their contact information  In-house call center team confirms appointment and insurance benefits  Show in the office  Convert to XTRAC®  Stay on XTRAC®  Patient Journey 
 

 Leads  Appointments  RDX Charts (New Patient Charts)  1  2  1  3  DTC Model Driver  15  Core Business Refocused to DRIVE Recurring Revenue Model  $21.1M  Net U.S. Recurring Revenue   Significant opportunity to increase ARR back to 2019 levels using proven DTC strategies that should yield appreciable incremental revenue and at higher incremental margins, allowing the Company to become cash flow positive again  $23.6M  $16.8M  $21.2M  $21.6M  $20.2M  Change in US Recurring Revenue  +12%  -29%  +26%  +2%  -6%  Recurring Revenue model in practice.  Pandemic reduces in-person appointments, company pivots to device sales over recurring model.  Device sales model stays in tact as   pandemic eases.  15 
 

 International Sales Operations  India  Israel  S. Korea Japan  China  Bahrain, Iraq, Jordan, Kuwait, Qatar, Oman, Saudi Arabia, UAE  Mexico  In-house Head of International Sales  39 international partner XTRAC® clinics (S. Korea, Japan) at 9/30/24  Capital equipment sales preferred model  Usage per device higher than in U.S. market  TheraClear®X equipment sales opportunity  Latin America & European markets untapped  Total International Install Base > 1,700 devices  Markets added in 2023  STRATA’s international markets  16  ($000s) 
 

 XTRAC®: Overview  Safe, effective treatment  150+ peer-reviewed clinical studies  Psoriasis treatment is the number 1 domestic use for XTRAC® lasers – 80% of treatments  Opportunities exist for expanding use for other approved indications like vitiligo and eczema  Clinical support team focused on:  In-office training  Best practices  17 
 

 Indicated for Chronic Dermatological Diseases  Visible skin disorders can limit healthy psychosocial development and have profoundly negative consequences on quality of life3-5  VITILIGO  ~7.5 million  adults in the US1,a  PSORIASIS  ATOPIC DERMATITIS  ~2–3 million  adults in the US2  ~16.5 million  adults in the US3  1. Armstrong AW et al. JAMA Dermatol. 2021;157(8):940-946.aIncludes people 20 years of age and older.   2. Gandhi K et al. JAMA Dermatol. 2022;158(1):43-50.   3. Fuxench ZCC et al. J Invest Dermatol. 2019;139(3):583-590.4. Elbuluk N, Ezzedine K. Dermatol Clin. 2017;35:117-128. 5. Armstrong AW, Read C. JAMA. 2020;323(19):1945-1960.  18 
 

 Induces Apoptosis of T cells and Keratinocytes in Psoriatic Plaques  19  Baseline  After 2 tx  After 4 tx  XTRAC® Psoriasis Clinical Protocol - 6.2 treatments to PASI* 75  Induces apoptosis in T cells and keratinocytes1  T cell  Keratinocytes  Psoriasis: Autoimmune disease that causes the skin to regenerate faster than normal; characterized by red, itchy scaly patches   *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 Tx- treatments  1. Abrouk M et al. Psoriasis Targets Ther. 2016;6:165-173. 2. Esmat S et al. Dermatol Clin. 2017;35:171-192. 3. Oh CT et al. Lasers Surg Med. 2016;48(6):629-637,  XTRAC® Targeted 308nm UVB 
 

 Induces Melanocyte Proliferation and T cell Apoptosis in Vitiligo Patches  20  Baseline  After 18 tx  After 21 tx  XTRAC® Vitiligo Clinical Protocol - >75% repigmentation in less than 20 treatments1  Vitiligo: An autoimmune condition due to a loss of melanocytes, characterized by white patches of skin losing its pigment  Long lasting results  No pigment loss during 2-year follow-up2  80% facial repigmentation retention at 3-year follow-up3  XTRAC® Targeted 308nm UVB  Stimulates melanocyte proliferation and induces T cell apoptosis2  Melanocyte  T cell  Shi Q et al. Photodermatol Photoimmunol Photomed. 2013;29(1):27-33. 2. Esposito M et al. Clin Exp Dermatol. 2004;29:133-137. 3. Hong SB et al. J Korean Med Sci. 2005;20:273-278  Hadi S et al. Photomed Laser Surg. 2006; 24(3):354-357   Sethi S, Silverberg NB. J Drugs Dermatol.2022;21(7):773-775.  
 

 Source: National Psoriasis Foundation  XTRAC® is a Preferred Treatment for 90% of Psoriasis Patients (<10% BSA)  21 
 

 Has Clinical and Economic Competitive Advantage  22  XTRAC®  NB-UVB  Topical Steroids  Non-Biologic Systemics  Biologics  Approximate Costs ($)  1K-3K  3K-9K  1K-7K  1K  32K-68K  Clinical Outcomes  92%  71%  75%  48%  50-70%  Speed of Onset  5  10  3  14  12  Days of Actual Care  18  80  294  52  12-65  Remission   2.5 Months  Continued with maintenance  Continued with maintenance  Continued with maintenance  Continued with maintenance  Adverse Events   Mild Temp  Mild Temp  Mild-Mod  Temp –Lasting  Mild-Severe  Temp – Lasting  Mild-Severe  Temp – Lasting  Marchetti A, Bhutani T, Lockshin B, Siegel DM, Behringer F. Therapies for Psoriasis: Clinical and Economic Comparisons. J Drugs Dermatol. 2020 Nov 1;19(11):1101-1108. doi: 10.36849/JDD.2020.5510. PMID: 33196750 
 

 XTRAC® Adds (Delegated)* Reimbursed Recurring Revenue for Dermatology Partners  23  CPT Code  Description  2024 National Average Medicare Payment Rate  96920  Excimer Laser Treatment for Psoriasis (<250 sq cm)  $152.92  96921  Excimer Laser Treatment for Psoriasis (250 - 500 sq cm)  $167.65  96922  Excimer Laser Treatment for Psoriasis (>500 sq cm)  $228.23  Number of Treatment/ Week  20  30  # of Weeks / Year  48  48  Total # of Treatments / Year  960  1440  Average Revenue Per Treatment  $190  $190  Physician Gross Revenue (Annual)  $182,067  $273,100  * Subject to state legislation  ** Patients who are eligible to receive CPT code 10040 services are those with acne lesions such as milia, comedones, cysts, or pustules that require surgical intervention. This may include patients with severe or persistent acne that has not responded to other treatments, or those with large or painful cysts that need to be drained or removed. Determination of the appropriate usage of the CPT code is made by the treating physician. 
 

 TheraClear®X: Overview  Safe, effective treatment  Peer-reviewed clinical studies  Opportunities exist for expanding use for expanding the installed base to clinics using reimbursed acne surgery procedures  Clinical support team focused on:  In-office training  Best practices  24 
 

 Acne is the Most Common Skin Condition in Dermatology  Up to 50 Million Americans affected annually2  ~85% of all adolescents experience some degree of acne from the ages of 12 to 24 years3  >50% of US women experience acne in their 20s4  Acne occurring in adults is increasing5   #1  skin disease in the US1   Bickers DR et al. J Am Acad Dermatol. 2006;55:490-500.  Tan JKL, Bhate K. Br J Dermatol. 2015;172 (Suppl 10:3-12.  White GM. J Am Acad Dermatol. 1998;39:S34-S37.  Collier CN et al. J Am Acad Dermatol. 2008;58:56-59.  Holzmann R, Shakery K. Skin Pharmacol Physiol. 2014;27 (Suppl 1):3-8.  25 
 

 Photopneumatic Technology Combines VACUUM with PULSED BROADBAND LIGHT   26  Clears bacteria and follicular contents from pilosebaceous unit, C acnes are removed both mechanically and thermally from the active acne lesion. Reduces sebum production  cleans pores by extracting sebaceous and follicular material  light activates porphyrins to directly reduce C acnes and sebum production   skin normalizes upon completion  Place  Extract  Treat  Complete  contact with treatment area  Baseline  After 4 tx  Photos courtesy of Suneel Chilukuri, MD. 
 

 Addresses Limitations of Existing Acne Therapies  27  Visible improvement of acne lesions as early as after second treatment  Visible improvement of skin texture, pore size, and perilesional erythema after the first few treatments  Time to improvement  Initiation 4 to 6 treatments, scheduled 1-2 weeks apart  Maintenance1 to 2 months apart as needed  Treatment regimen  Procedure  ~15 minutes per treatment  No pre-treatment with topical analgesics  Comfortable with no down time  Can be delegated (depending on state laws)  Systemic and topical acne treatments  Are often associated with poor adherence due to forgetfulness, inconvenience, and adverse effects1,2  Typically require 3 to 6 weeks to achieve visible improvement3  Can be associated with skin dryness, irritation, burning, and bleaching effects2   TheraClear®X  Comfortable in-office treatment with no down-time  Visible improvement of acne lesions as early as after second treatment  Visible improvement of skin texture, pore size, and perilesional erythema after the first few treatments  Snyder S et al. Am J Clin Dermatol. 2014;15(2):87-94. 2. Tuchayi SM et al. Patient Pref Adherence. 2016;10:2091-2096 3. Fox L et al. Molecules. 2016;21:1063. doi:10.3390/molecules21081063. 4. Data on file. STRATA Skin Sciences. 
 

 TheraClear®X Adds (Delegated)* Reimbursed Recurring Revenue for Dermatology Partners  28  CPT Code  Description  2024 National Average Medicare Payment Rate  10040  Acne Surgery, which Involves the opening or removal of multiple milia, comedones, cysts and pustules.  $114.61  Number of Treatment/ Week  20  30  # of Weeks / Year  48  48  Total # of Treatments / Year  960  1,440  Average Revenue Per Treatment  $114.61  $114.61  Physician Gross Revenue (Annual)  $110,025.60  $165,038.40  * Subject to state legislation  ** Patients who are eligible to receive CPT code 10040 services are those with acne lesions such as milia, comedones, cysts, or pustules that require surgical intervention. This may include patients with severe or persistent acne that has not responded to other treatments, or those with large or painful cysts that need to be drained or removed. Determination of the appropriate usage of the CPT code is made by the treating physician. 
 

 SUMMARY 
 

 Financial Metrics  Unaudited quarterly results  30  2019  2020  2021  2022  Q1 2023  Q2 2023   Q3 2023  Q4 2023  FY 2023  Q1 2024  Q2 2024  Q3 2024  U.S. Gross Recurring Revenue  $24,590  $16,901  $22,071  $22,271  $4,735  $5,057  $4,883  $4,947  $19,622  $4,578  $4,735  $4,799  U.S. Installed Base (XTRAC® Devices)   820  832  890  909  916  930  929  923  923  907  882  873  Average Gross Recurring Revenue/device/Qtr  $7,497  $5,078  $6,200  $6,125  $5,169  $5,438  $5,256  $5,360  $5,315  $5,047  $5,369  $5,497                                Revenues, net  $31,586  $23,090  $29,977  $36,161  $7,567  $8,250  $8,852  $8,689  $33,358  $6,754  $8,435  $8,797  Cost of revenues  11,316   8,956   10,127   14,393   3,179   3,932   3,898   3,888   14,897   3,674  3,498  3,490  Gross profit  20,270   14,134   19,850   21,768   4,388   4,318   4,954   4,801   18,461   3,080  4,937  5,307                                Operating expenses:                             Engineering and product development  1,002   1,274   1,434   1,029   315   374   248   380   1,317   241  199  243  Selling and marketing  12,003   9,038   13,106   15,301   3,742   3,416   3,038   2,760   12,956   3,018  3,014  3,048  General and administrative  10,275   7,898   9,712   10,087   2,917   2,490   2,283   2,818   10,508   2,710  2,210  1,888  Impairment of goodwill  -   -   -  -  -  -  -  2,284   2,284   5,969  -  -   Total Expenses  $23,280  $18,210  $24,252  $26,417  $6,974  $6,280  $5,569  $8,242  $27,065  $11,938  $5,423  $5,179  Loss from operations  ($3,010)  ($4,076)  ($4,402)  ($4,649)  ($2,586)  ($1,962)  ($615)  ($3,441)  ($8,604)  ($2,889)  ($486)  $128  Non-GAAP adjusted EBITDA  $3,036   $1,492   $1,467   $2,557   ($759)  ($95)  $1,291   $520   $957   ($1,279)  $1,012  $1,493  Net cash provided (used) by operating activities  $2,229   $2,096   $1,508   ($924)  ($1,203)  $175  $(997)   $1,506   ($519)  ($804)  $591  ($515)   (All numbers below in $'000s except for U.S. Installed Base) 
 

 STRATA Investment Summary   Unique and Proven Business Model  Best-in-class Excimer Laser technologies  Recurring revenue driven by DTC and growing installed base  Installed base of 873 XTRAC® domestic devices for Psoriasis, Vitiligo, and Eczema treatments  Installed base of 135 TheraClear®X domestic devices for Acne treatments  Installed base of ~1700 XTRAC® and VTRAC® devices internationally  Providing “business in a box” for dermatology practices without an upfront capital spend by practices  Over 300 peer-reviewed, published clinical studies  A Win-Win-Win Business Model  For patients – safest, most effective, minimal side effects  For clinics – stable increased revenue base   For Payers – the cheapest treatment available   Opportunity for Renewed Growth in U.S. in Recurring Revenue per Device  Re-emphasis on DTC marketing in U.S. with near-term opportunity of increasing recurring revenue/device by 40%  More rigorous sales and marketing strategy and process in place  Both initiatives could collectively grow revenue by double digit percent and help return the company to positive cash flow  31 
 

 THANK YOU!  Investor Contact:  CORE IR  516-222-2560  IR@strataskin.com  www.strataskinsciences.com 
 

 APPENDIX 
 

 Acquisitions to Drive Top-line Growth  January 2022  August 2021  $3.7M Acquisition  Minimal acquisition cost compared to exclusivity in external laser market  $1M Acquisition  Adds attractive business segment to address $5.5B acne market  34 
 

   Domestic XTRAC® Installed Base Growth Drivers  873  2286  370  As of 9/30/2024  Signed strategic expansion into group clinic rollups  Within the 48 groups:  61 TheraClear®X devices  Penetration grew from 86 in 2018 to 386 in 2023  Group partnership accounts represent 37% of XTRAC® domestic recurring revenue  XTRAC®Partners  GroupClinics  35  Representative PE Backed Groups:  Over 250 comeback opportunities of existing excimer laser owners  Increased penetration into facility locations (e.g. Kaiser, VA, and Mt. Sinai) 
 

 Example – NYC Metro Area XTRAC® Placements and DTC Leads (1Q24)   36  Metro NYC XTRAC® installed base   Metro NYC 1Q24 DTC Patient Leads 
 

 Psoriasis Case Study: Patient I.B., Lewisburg, PA  37  Treatment Room  After  Before