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): August 29, 2022
(Exact Name of Registrant as Specified in Its Charter)
(Commission File Number)
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(State or Other Jurisdiction of Incorporation)
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(I.R.S. Employer Identification No.)
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
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Name of each exchange on which registered
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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 August 29, 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”:
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Exhibit No.
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Exhibit Description
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99.1
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Investor Presentation dated August 29, 2022, issued by Strata Skin Sciences, Inc.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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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: August 29, 2022
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By:
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/s/ Christopher Lesovitz
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Christopher Lesovitz
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Chief Financial Officer
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- 2 -
Investor Presentation December 2020 Investor Presentation August 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 Company Overview A medical technology company dedicated to developing cutting-edge solutions for the
in-office treatment of life-altering skin conditions. PhotoMedex Mela Skin Sciences Global leader in dermatology excimer laser Expanding domestic and international presence in key markets 1000+ XTRAC units Psoriasis, Vitiligo, Other
accumulating >5 millionXTRAC treatments performed Executive management 100+ years Dermatology experience Addressing chronic skin diseases via devices offering market leading phototherapy technology 20+ year history
Positioned for Growth Acceleration in the Treatment of Chronic Skin Conditions 4 CEO CFO VP
Marketing VP of Professional Relations Head of International Sales 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
Chronic Dermatologic Conditions Treated with XTRAC Excimer Laser 5 ECZEMA
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 ECZEMA (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 Systems FY 19 Systems FY 20 Systems FY 21
Net Installed Base Growth 2019 – 1H 2022 28% growth in installed base over the last 3+ years Actively redeploying under utilized devices Group placements and Ra Medical conversions drive growth +160 -76 +84 net +106 -76 +30
net +169 -85 +84 net Systems 1H 22 +42 -33 +9 net 953
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
Q2, 2022 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 55 International partner XTRAC® clinics (up from 10 in 2019) 16 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 57 since signing agreement in August 2021 12 conversions in Q2, 2022 Another 54 Pharos
users coming off service agreements in 2022 Ra Medical Pharos Conversions 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 06/31/2022 successfully converted 57 Pharos users who
have come off service agreements An additional 54 come off service agreements in 2022 and an additional 43 in 2023 and 2024
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
TheraClear®X Acne System The TheraClearX Acne System is FDA cleared for the treatment of multiple acne
forms ● Acne Vulgaris ● Pustular Acne ● Comedonal Acne Dual mechanism of action (MOA) combining negative pressure vacuum with pulsed broadband light delivered through a liquid cooled, handheld delivery system Mechanically evacuates sebum and
acne causing bacteria Standard Treatment Regimen: 4-6 treatments, performed two weeks apart Maintenance Therapy: As needed Launching in 2022 under the STRATA Partnership Program 19
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 Michael Goodman, Head of International Sales Pulse Biosciences, Obagi Medical Products, Syneron-Candela, Sound Surgical/Solta Medical/Valeant
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. 20
Financial Metrics 21 * Unaudited quarterly results 2018 2019 2020 Q1 '21* Q2 '21* Q3 '21* Q4
'21* 2021 Q1’22* Q2’22* Recurring revenue $21,053 $23,713 $17,409 $4,679 $5,452 $5,710 $6,687 $22,528 $5,067 $5,582 Equipment revenue $8,802 $7,873 $5,681 $1,148 $1,930 $2,001
$2,370 $7,449 $1,974 $3,523 Total revenue $29,855 $31,586 $23,090 $5,827 $7,382 $7,711 $9,057 $29,977 $7,041 $9,105 Domestic installed base 746 820 832 837 848 880 890 890 903 915 Recurring revenue
margin 65% 70% 67% 68% 70% 74% 74% 72% 60%** 59%** Total Company margin 57% 64% 61% 64% 65% 70% 66% 66% 59%** 55%** ** Lower gross margin primarily due to the increase in intangible amortization expenses associated with
the most recent asset acquisitions.
Commercial Drivers in 2022 22 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 23 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 Former 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. 26
Partner Academic Institutions 27
Footnotes Company estimates 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 National Eczema Association The Vitiligo
Foundation National Psoriasis Foundation "Therapies for Psoriasis: Clinical and Economic Comparisons" in the November 2020 issue of the Journal of Drugs in Dermatology Multicenter 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 Vitiligo 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.2006.24.354 Scalp Study - Morison WL, Atkinson DF and Werthman L. Effective treatment of scalp psoriasis using the excimer (308nm) laser. Photodermatol Photoimmunol Photomed 2006; 22: 181-183 Pediatric 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. 161-165 28