# EDGAR Filing Document

**Accession Number:** 0001051514
**File Stem:** 0001051514-23-000007
**Filing Date:** 2023-1
**Character Count:** 14936
**Document Hash:** bd2209ba541f22d5eaeb2950900aa7e3
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001051514-23-000007.hdr.sgml**: 20230109

**ACCESSION NUMBER**: 0001051514-23-000007

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230109

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230109

**DATE AS OF CHANGE**: 20230109

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** STRATA Skin Sciences, Inc.
- **CENTRAL INDEX KEY:** 0001051514
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **IRS NUMBER:** 133986004
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-51481
- **FILM NUMBER:** 23518893

**BUSINESS ADDRESS:**
- **STREET 1:** 5 WALNUT GROVE DRIVE
- **STREET 2:** SUITE 140
- **CITY:** HORSHAM
- **STATE:** PA
- **ZIP:** 19044
- **BUSINESS PHONE:** 215-619-3200

**MAIL ADDRESS:**
- **STREET 1:** 5 WALNUT GROVE DRIVE
- **STREET 2:** SUITE 140
- **CITY:** HORSHAM
- **STATE:** PA
- **ZIP:** 19044

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** MELA SCIENCES, INC. /NY
- **DATE OF NAME CHANGE:** 20100504

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ELECTRO OPTICAL SCIENCES INC /NY
- **DATE OF NAME CHANGE:** 19971216

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

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### FORM 8-K

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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 9, 2023

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

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#### 000-51481
(Commission File Number)

---

| | |
|:---|:---|
| **Delaware**<br>| **13-3986004**<br>|
| (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**<br> **Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock, $0.001 par value per share | SSKN | NASDAQ |

---

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. ☐

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**Item 7.01.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **Regulation FD Disclosure.**

On January 9, 2023, 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.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **Financial Statements and Exhibits.**

**(d)**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **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":

---

| | |
|:---|:---|
| <u>Exhibit No.</u> | <u>Exhibit Description</u> |
| 99.1 | [Investor Presentation dated January 9, 2023, issued by Strata Skin Sciences, Inc.](ex_99-1.pdf) |
| 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.** | **STRATA SKIN SCIENCES, INC.** |
| Date: January 9, 2023 | By: | <u>/s/ Christopher Lesovitz&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u> <br>|
|  |  | Christopher Lesovitz |
|  |  | Chief Financial Officer |

---

------

## Exhibit 99.1

Please see attached PDF for document reference.<br>

### Attached PDF Documents

**Attachment 1:** `ex_99-1.pdf`

# STRATA
SKIN SCIENCES

Investor Presentation | January 2023

STRATA
SKIN SCIENCES

![img-0.jpeg](img-0.jpeg)

# Company Overview

A medical technology company dedicated to developing cutting-edge solutions for the in-office treatment of life-altering skin conditions.

STRATA

SKIN SCIENCES

![img-1.jpeg](img-1.jpeg)

Large Market Opportunity

Addressing $38B market

![img-2.jpeg](img-2.jpeg)

Treatment Focus

Psoriasis, Vitiligo, Eczema and Acne

![img-3.jpeg](img-3.jpeg)

2 Main Product Devices

XTRAC® & TheraClear®X

![img-4.jpeg](img-4.jpeg)

Global Leader

Dermatology excimer laser

![img-5.jpeg](img-5.jpeg)

Experienced Management

20+ year history

2

# Addressing a $38B Market

![img-6.jpeg](img-6.jpeg)

1Fortune Business Insights Market Report 2019; 2016-2018 historical, 2019 base year, 2020-2027 projected

2Market Data Forecast Analysis Report 2020; 2020 base year, 2021-2026 projected

3Fortune Business Insights Market Report 2018; 2015-2017 historical, 2018 base year, 2019-2026 projected

4Strata Skin Sciences

STRATA
SKIN SCIENCES

3

# Dermatology Device Market

$8.2 Billion Market$^{1}$

![img-7.jpeg](img-7.jpeg)

STRATA  
SKIN SCIENCES

$^{1}$Source: Dermatology Devices From 2016 to 2018

4

# Recent Acquisitions to Drive Top-line Growth

![img-8.jpeg](img-8.jpeg)

January 2022

![img-9.jpeg](img-9.jpeg)

August 2021

STRATA  
SKIN SCIENCES

5

# XTRAC®: Overview

![img-10.jpeg](img-10.jpeg)

![img-11.jpeg](img-11.jpeg)

Safe, effective treatment

![img-12.jpeg](img-12.jpeg)

150+ peer-reviewed clinical studies

![img-13.jpeg](img-13.jpeg)

Psoriasis treatment is the number 1 domestic use for XTRAC® lasers

![img-14.jpeg](img-14.jpeg)

Opportunities exist for expanding use for other approved indications like vitiligo and eczema

![img-15.jpeg](img-15.jpeg)

Clinical Support Team focused on:

- In-office training
- Best practices

STRATA
SKIN SCIENCES

6

# XTRAC®: Overview

## 30M Patient Opportunity

Indications: Psoriasis, Vitiligo + Eczema

- Psoriasis - 8M patients in U.S.
- Vitiligo - 5M patients in U.S.
- Eczema - 18M patients in U.S.

![img-16.jpeg](img-16.jpeg)

STRATA
SKIN SCIENCES

7

# XTRAC®: Psoriasis

## Clinical Protocol - 6.2 treatments to PASI* 75

![img-17.jpeg](img-17.jpeg)

Baseline

![img-18.jpeg](img-18.jpeg)

After 2 tx

![img-19.jpeg](img-19.jpeg)

After 4 tx

### How it Works:

- 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

Psoriasis: Autoimmune disease that causes the skin to regenerate faster than normal; characterized by red, itchy, scaly patches (65% Mild; 25% Moderate; 10% Severe)

STRATA

SKIN SCIENCES

*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

8

# XTRAC®: Psoriasis

Treatment Options Addressing Psoriasis Indication

|  | XTRAC LIVE CLEAR, USE FREE | NB-UVB | Topical Steroids | Non-biologic Systemics | Biologics |
| --- | --- | --- | --- | --- | --- |
| Approximate Costs ($) | ☑ 1K-3K | 3K-9K | 1K-7K | 1K | 32K-68K |
| Clinical Impact | ☑ 92% | 71% | 75% | 48% | 50-70% |
| Speed of Onset (in Weeks) | ☑ 5 | 10 | 3 | 14 | 12 |
| Days of Actual Care | ☑ 18 | 80 | 294 | 52 | 12-65 |
| Remission | ☑ 2.5 mos. | 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 |

STRATA

SKIN SCIENCES

9

# XTRAC®: Vitiligo

Vitiligo is an autoimmune condition due to a loss of melanocytes, characterized by patches of skin losing its pigment

![img-20.jpeg](img-20.jpeg)

Baseline

![img-21.jpeg](img-21.jpeg)

After 18 tx

![img-22.jpeg](img-22.jpeg)

After 29 tx

# How it Works:

- Beam of UVB light applied to the affected area
- UVB light reduces the immune system's attack on the melanocytes
- Results in re-pigmentation
- Simple, safe, effective + long-lasting

STRATA

SKIN SCIENCES

10

# TheraClear®X

![img-0.jpeg](img-0.jpeg)

STRATA

SKIN SCIENCES

# 50M+ Patient Opportunity

Indications: Acne vulgaris, comedonal acne and pustular acne

Dual mechanism of action (MOA) combining intense pulse light with vacuum (suction)

Mechanically evacuates sebum and acne causing bacteria

![img-1.jpeg](img-1.jpeg)

Addresses the estimated $5.5B acne care market

11

# TheraClear®X: Acne

TheraClear®X addresses multiple causes of acne in a single treatment

![img-2.jpeg](img-2.jpeg)

Baseline

![img-3.jpeg](img-3.jpeg)

After 5 tx

## How it Works:

- The system combines intense pulse light with vacuum (suction) for the treatment of mild to moderate inflammatory acne, comedonal acne and pustular acne

STRATA  
SKIN SCIENCES

12

# VTRAC®

![img-4.jpeg](img-4.jpeg)

GDO

STRATA

SKIN SCIENCES

# Large International Opportunity

Indications: Psoriasis, vitiligo and other various conditions

![img-5.jpeg](img-5.jpeg)

Excimer technology with the simplicity of design and reliability of a lamp

Lower-cost device

Marketed and sold internationally

Reliable device, requires low maintenance

13

# A True Partnership

Delivering a Complete Business Solution

DTC Marketing

Co-pay Assistance

Clinical Support

![img-6.jpeg](img-6.jpeg)

Field Service Support

Customer Support

Laser Upgrades*

Reimbursement Support*

Consumables and Parts

STRATA
SKIN SCIENCES

*Reimbursement Support and Laser Upgrades only applies to XTRAC®.

14

# Domestic Commercial Operations

Sales team targeting 7,500 dermatologists

Sales team covering 30 territories

Opportunity to sell TheraClear®X through existing salesforce

# Other Statistics

- 4 sales regions
- 2 national account managers
- 15 field service technicians

STRATA

SKIN SCIENCES

15

# Affiliated Academic Institutions

STRATA has placed over 50 XTRAC® machines in residency programs across academic institutions

![img-7.jpeg](img-7.jpeg)

STRATA
SKIN SCIENCES

16

# International Sales Operations

![img-8.jpeg](img-8.jpeg)

- New experienced in-house Head of International Sales
- 39 international partner XTRAC® clinics
- Capital equipment sales preferred model
- Usage per device higher than in U.S. market
- TheraClear®X equipment sales opportunity
- Latin America & European markets untapped

STRATA
SKIN SCIENCES

17

# Enhancing STRATA's Business Model

![img-9.jpeg](img-9.jpeg)

Improved sales team

- Transitioned sales team
- Strengthen dermatology experience & relationships
- Sales force training/CRP

![img-10.jpeg](img-10.jpeg)

Improved client education + marketing

- KOL engagement
- Direct to dermatologist marketing

![img-11.jpeg](img-11.jpeg)

Focused on operational performance

- Improved data collection and analytics
- Messaging targeted therapy: 3 indications
- Management of international distributors in-house

STRATA
SKIN SCIENCES

18

# Financials

**$33M - $35M**

Est. 2022 annualized  
revenue, representing  
strong double-digit  
growth

Total Revenue

![img-12.jpeg](img-12.jpeg)

STRATA  
SKIN SCIENCES

19

# New Management...New Focus

## 100+ Years of Sales and Operational Dermatology Experience

New leadership: CEO, CFO, VP of Marketing, VP of Professional Relations, Head of International Sales, Director of Business Operations, and 3 new board members

![img-13.jpeg](img-13.jpeg)

Chief Executive Officer
Robert (Bob) Moccia

![img-14.jpeg](img-14.jpeg)

Chief Financial Officer
Chris Lesovitz

![img-15.jpeg](img-15.jpeg)

VP of Operations
Shmuel Gov

![img-16.jpeg](img-16.jpeg)

VP of Professional Relations
John Bagdasarian

![img-17.jpeg](img-17.jpeg)

VP of Sales
Keith Simeone

![img-18.jpeg](img-18.jpeg)

VP of Marketing
Brent Cowgill

![img-19.jpeg](img-19.jpeg)

Senior Director of International Sales
Michael Goodman

STRATA
SKIN SCIENCES

20

# Strategic Initiatives

![img-0.jpeg](img-0.jpeg)

- Expansion Opportunities
  - Continued and growing usage of XTRAC® machines
  - International business growth - selling TheraClear®X outside of the U.S.
  - Expand the use of TheraClear®X
  - M&A opportunities - focused on the medical device side of business, strong presence

![img-1.jpeg](img-1.jpeg)

- Upcoming Catalysts/Milestones
  - Launch new acne device based on acquired technology from Theravant
  - New product registrations in Asia and Latin America
  - New drug approvals in vitiligo will grow market domestically

![img-2.jpeg](img-2.jpeg)

- Cost Savings:
  - Net installed base growth - redeploying underutilized devices
  - Leverage commercial team for new products
  - Distribution network active internationally; reduces need for additional infrastructure

STRATA
SKIN SCIENCES

21

# Company Overview

A medical technology company dedicated to developing cutting-edge solutions for the in-office treatment of life-altering skin conditions.

STRATA

SKIN SCIENCES

![img-3.jpeg](img-3.jpeg)

Large Market Opportunity

Addressing $38B market

![img-4.jpeg](img-4.jpeg)

Treatment Focus

Psoriasis, Vitiligo, Eczema and Acne

![img-5.jpeg](img-5.jpeg)

2 Main Product Devices

XTRAC® & TheraClear®X

![img-6.jpeg](img-6.jpeg)

Global Leader

Dermatology excimer laser

![img-7.jpeg](img-7.jpeg)

Experienced Management

20+ year history

22