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STRATA Skin Sciences

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FY2020 Annual Report · STRATA Skin Sciences
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549
FORM 10-K

(Mark One)

[X]          ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2020

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

[  ]
For the transition period from ______________ to _____________
Commission file number: 0-11635

STRATA SKIN SCIENCES, INC.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction
of incorporation or organization)

13-3986004
(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
(Issuer’s telephone number, including area code)
Securities registered under Section 12(b) of the Exchange Act:

Title of each class
Common Stock, $0.001 par value per share

Trading
Symbol(s)
SSKN

Name of each exchange on which registered
The NASDAQ Stock Market LLC

Securities registered under Section 12(g) of the Exchange Act:
None
(Title of Class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. 

Yes [  ] No [X]

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange
Act.

Yes [  ] No [X]

 
 
 
 
 
 
 
Indicate by check mark whether the registrant:  (i) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such
reports), and (ii) has been subject to such filing requirements for the past 90 days.

Yes [_X _] No [__]

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period
that the registrant was required to submit such  les).

Yes [_X _] No [__]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller
reporting  company,  or  an  emerging  growth  company.  See  definitions  of  “large  accelerated  filer,”  “accelerated  filer,”  “smaller
reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer [__]

Accelerated filer [__]

Non-accelerated filer  [X]

Smaller reporting company [X]

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.   
[___]

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the
effectiveness of internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by
the registered public accounting firm that prepared or issued its audit report.  [__ ]

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).

Yes [  ] No [X]

The number of shares outstanding of our common stock as of June 30, 2020, was 33,754,909 shares. The aggregate market value
of the voting and non-voting common equity held by non-affiliates of the registrant was $23,624,112, computed by reference to
the closing market price $1.15 of the common stock as of June 30, 2020, and 20,542,706 shares held by non-affiliates.

As of March 17, 2021, the number of shares outstanding of our common stock was 33,801,045.

Documents Incorporated by Reference
None

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents

  Page

Part I

Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4

Part II

Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.

Part III

Item 10.
Item 11.
Item 12.
Item 13.
Item 14.

Part IV

Item 15.
Item 16. 

  Business
  Risk Factors
  Unresolved Staff Comments
  Properties
  Legal Proceedings
  Mine Safety Disclosures

  Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
  Selected Financial Data
  Management's Discussion and Analysis of Financial Condition and Results of Operations
  Quantitative and Qualitative Disclosures About Market Risk
  Financial Statements and Supplementary Data
  Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
  Controls and Procedures
  Other Information

  Directors, Executive Officers and Corporate Governance
  Executive Compensation
  Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
  Certain Relationships and Related Transactions and Director Independence
  Principal Accounting Fees and Services

  Exhibits, Financial Statement Schedules
  Form 10-K Summary
  Signatures

1
11
31
32
32
32

33
33
34
45
46
46
46
46

47
53
58
60
60

62
67
68

i

 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain  statements  in  this  Annual  Report  on  Form  10-K,  or  this  Report,  are  "forward-looking  statements."  These
forward-looking statements include, but are not limited to, statements about the plans, objectives, expectations and intentions
of STRATA Skin Sciences, Inc., a Delaware corporation, (referred to in this Report as “we,” “us,” “our”, “registrant” or “the
Company”)  and  other  statements  contained  in  this  Report  that  are  not  historical  facts.  The  Private  Securities  Litigation
Reform Act of 1995 (the “Reform Act”) provides a safe harbor for forward-looking statements made by or on behalf of the
Company. Forward-looking statements in this Report or hereafter included in other publicly available documents filed with
the  Securities  and  Exchange  Commission,  or  the  Commission,  reports  to  our  stockholders  and  other  publicly  available
statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our
actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial
or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon
management's  best  estimates  based  upon  current  conditions  and  the  most  recent  results  of  operations.  When  used  in  this
Report, the words "will, " "expect," "anticipate," "intend," "plan," "believe," "seek," "estimate" or the negative of such
terms and similar expressions identify statements that constitute “forward-looking statements” within the meaning of Section
27A  of  the  Securities  Act  of  1933  and  Section  21E  of  the  Securities  Exchange  Act  of  1934  and  that  are  intended  to  come
within  the  safe  harbor  protection  provided  by  those  sections.  Forward-looking  statements  involve  risks,  assumptions  and
uncertainties. There are important factors that could cause actual results to differ materially from those expressed or implied
by  these  forward-looking  statements,  including  our  plans,  objectives,  expectations  and  intentions  and  other  risks  set  forth
throughout this Annual Report, including under “Item 1, Business,” “Item 1A, Risk Factors,” and “Item 7, Management’s
Discussion and Analysis of Financial Condition and Results of Operations.” These forward-looking statements include, but
are not limited to, statements about:

•
•
•
•
•
•

•
•
•
•
•

forecasts of future business performance, consumer trends and macro-economic conditions;
descriptions of market, competitive conditions, and competitive product introductions;
descriptions of plans or objectives of management for future operations, products or services;
actions by the FDA or other regulatory agencies with respect to our products or product candidates;
changes to third-party reimbursement of laser treatments using our devices;
our  estimates  regarding  the  sufficiency  of  our  cash  resources,  expenses,  capital  requirements  and  needs  for  additional  financing  and  our
ability to obtain additional financing;
our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
anticipated results of existing or future litigation;
Our ability to grow an at-home phototherapy business
health emergencies, the spread of infectious disease or pandemics; and
descriptions or assumptions underlying or related to any of the above items.

In  light  of  these  assumptions,  risks  and  uncertainties,  the  results  and  events  discussed  in  the  forward-looking
statements  contained  in  this  Report  might  not  occur.  Investors  are  cautioned  not  to  place  undue  reliance  on  the  forward-
looking statements, which speak only as of the date of this Report, even if subsequently made available by us on our website or
otherwise. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking
statements, whether as a result of new information, future events or otherwise. You should not regard these statements as a
representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame,
or  at  all.  All  subsequent  forward-looking  statements  attributable  to  us  or  to  any  person  acting  on  our  behalf  are  expressly
qualified in their entirety by the cautionary statements contained or referred to in this section.

 
 
 
 
 
 
Item 1.

Business

Our Company

Overview

PART I

We are a medical technology company in Dermatology and Plastic Surgery dedicated to developing, commercializing and
marketing innovative products for the treatment of dermatologic conditions. Our primary products include the XTRAC® excimer
laser and VTRAC® lamp systems utilized in the treatment of psoriasis, vitiligo and various other skin conditions.

Corporate Information

We were incorporated in the State of New York in 1989 under the name Electro-Optical Sciences, Inc. and subsequently
reincorporated under the laws of the State of Delaware in 1997. In April 2010, we changed our name to MELA Sciences, Inc. On
January 5, 2016, we changed our name to STRATA Skin Sciences, Inc.

In June 2015, we completed the acquisition of the XTRAC® Excimer Laser and the VTRAC® excimer lamp businesses
from PhotoMedex, Inc. (the “Acquisition”). Prior to the Acquisition, the Company’s only product was the MelaFind® system, or
MelaFind,  a  device  for  aiding  dermatologists  in  the  evaluation  of  clinically  atypical  pigmented  skin  lesions.  We  have
discontinued the MelaFind business.

Impact of COVID-19 Pandemic

In late 2019, there was an outbreak of a new strain of coronavirus (“COVID-19”) which became a global pandemic. The
COVID-19  pandemic  has  negatively  impacted  the  global  economy,  disrupted  global  supply  chains,  constrained  work  force
participation  and  created  significant  volatility  and  disruption  of  financial  markets.  In  addition,  the  pandemic  has  led  to  the
suspension of elective procedures in the U.S. and to the temporary closure of many physician practices, which are our primary
customers. We do not know the full impact on our customers including their potential for permanent closure. While many offices
have  reopened,  the  on-going  impact  of  the  COVID-19  pandemic  on  the  Company’s  operational  and  financial  performance,
including  its  ability  to  execute  its  business  strategies  and  initiatives  in  the  expected  time  frames,  will  depend  on  future
developments, including the duration and spread of the COVID-19 outbreak, continued restrictions on business operations and
transport and the continued impact on worldwide economic and geopolitical conditions, all of which are uncertain and cannot be
predicted.

Domestically, as the procedures in which the Company’s devices are used are elective in nature and as social distancing,
travel  restrictions,  quarantines  and  other  restrictions  became  prevalent  in  the  United  States,  this  had  a  negative  impact  on  the
Company’s recurring revenue model and its financial position and cash flow. The virus has disrupted the supply chain from China
and other countries and the Company depends upon its supply chain to provide a steady source of components to manufacture
and repair our devices.

To  mitigate  the  impact  of  COVID-19  the  Company  has  taken  a  variety  of  measures  to  ensure  the  availability  and
functioning of its critical infrastructure by implementing business continuity plans, and to promote the safety and security of its
employees while complying with various government mandates, including work-from-home arrangements and social-distancing
initiatives  to  reduce  the  transmission  of  COVID-19,  such  as  providing  face  masks  for  employees  at  facilities  significantly
impacted  and  requiring  on-site  body  temperature  monitoring  before  entering  facilities.  In  addition,  the  Company  created  and
executed programs utilizing its direct to consumer advertising and call center to contact patients and partner clinics to restart the
Company’s partners’ businesses. To conserve its cash, in order to mitigate the on-going impact of the COVID-19 pandemic, in
the  second  quarter  the  Company  furloughed  employees,  who  returned  to  work  after  the  Company  received  proceeds  from  the
Paycheck Protection Program (“PPP Loan)”. The Company also reduced discretionary spending, reduced all inventory purchases
and  delayed  payments  to  vendors.  Delayed  payments  to  vendors  were  approximately  $678,000  as  of  December  31,  2020.  See
Note 2, included in the consolidated financial statements, Liquidity for discussion on Company liquidity.

1

 
 
 
 
 
 
 
 
 
 
 
 
XTRAC Systems and VTRAC Systems

The  XTRAC  excimer  laser  technology  emits  highly  concentrated  UV  light  targeted  primarily  towards  autoimmune
dermatological skin disorders such as psoriasis, vitiligo, atopic dermatitis, and eczema, among others. It received U.S. Food and
Drug Administration (“FDA”) clearance in 2000 and has since become a widely recognized treatment for psoriasis, vitiligo and
other  skin  diseases.  Psoriasis  and  vitiligo  alone,  affect  up  to  13  million  people  in  the U.S. and 190 million people worldwide.
VTRAC is a UV light lamp system that works in much the same way as the XTRAC. It received FDA clearance in August 2005
and Conformité Européenne (“CE”) mark approval in January 2006 and has been marketed exclusively in international markets.

Present in natural sunlight, ultraviolet B (“UVB”) is an accepted psoriasis treatment that penetrates the skin to slow the
growth  of  damaged  skin  cells  thereby  placing  the  disease  into  remission  for  a  period  of  time.  Studies  have  shown  that  the
remission time can last 3 to 6 months or longer. In our XTRAC system, our targeted therapy approach delivers optimum amounts
of UVB light directly to skin lesions, sparing healthy tissue. Many peer reviewed studies have proven that the XTRAC excimer
laser can clear psoriasis faster and produce longer remissions than other UVB modalities, resulting in fewer treatments to produce
the desired result.

We currently market four XTRAC excimer models. In October 2018 we announced the launch of XTRAC S3®, which, as
compared to previous XTRAC generations, is smaller, faster and has a new user interface. In January 2020, we announced the
FDA  granted  clearance  for  our  XTRAC  Momentum  Excimer  Laser  System  platform.  This  clearance  is  the  first  full  platform
clearance since 2008. Momentum has an increased power range to improve patient safety and treatment efficiency; a new and
exclusive proprietary short-hair tip, providing ease of use in difficult-to-treat scalp psoriasis; and an enhanced user interface and
database.  We  continue  to  market  the  XTRAC  Velocity,  our  third-generation  laser  and  the  XTRAC  Ultra  Plus,  which  is  also  a
highly effective model marketed primarily in certain international markets. The Momentum, S3, Velocity and the Ultra Plus are
capable of treating mild, moderate and severe psoriasis, vitiligo, atopic dermatitis and leukoderma.

The XTRAC excimer laser is marketed in the U.S. mainly under a recurring revenue model in which we place the system
in the physician’s office for no upfront charge and generate our revenue on a per-use basis. We estimate that there are over 1,000
XTRAC lasers in use in the U.S., of which 832 systems were, as of December 31, 2020, included in our recurring revenue model.
The target U.S. audience for XTRAC lasers comprises approximately 3,500 dermatologists who perform disease management.
Until  2019,  in  markets  outside  the  U.S.  the  XTRAC  laser  had  been  marketed  primarily  as  a  capital  sale  through  a  master
international  distributor  to  distributors  in  over  twenty-five  countries.  The  VTRAC  is  marketed  exclusively  in  international
markets through the same master international distributor.

Since  2019,  we  have  been  transitioning  our  international  equipment  sales  through  our  master  distributor  to  a  direct
distribution model for equipment sales and recurring revenue on a country by country basis.  We have signed contracts in Korea
(in 2019), Japan (in 2020), and China (in January 2021). 

Studies have concluded that XTRAC treatment leads to significant improvement in psoriasis plaques and severity scores
in as few as 6 to 10 treatments. Treatment protocols recommend that patients receive two treatments per week with a minimum of
48 hours between treatments. Our data shows that treatment with XTRAC excimer lasers has an 89% efficacy rate and produces
only minimal side effects. In support of its clinical effect, the XTRAC excimer lasers have been cited in over 45 clinical studies
and research programs, with findings published in peer-reviewed medical journals around the world. The XTRAC excimer laser
has also been endorsed by the National Psoriasis Foundation, and its use for psoriasis is covered by nearly all major insurance
companies,  including  Medicare.  XTRAC  treatment  is  a  reimbursable  procedure  for  psoriasis  under  three  Current  Procedural
Terminology ("CPT") codes. There are three applicable CPT codes that differ based on the total skin surface area being treated.
Insurance  Reimbursement  to  physicians  varies  based  upon  insurance  company  and  location.  The  national  CPT  code
reimbursement established by the Center for Medicaid Services (“CMS”), which forms the basis for most insurance companies’
reimbursement  levels,  ranges  for  the  three  codes  between  $160  per  treatment  to  $250  per  treatment.  (See  “Third  Party
Reimbursement” below.)

2

 
 
 
 
 
 
 
 
 
Psoriasis, the disease

The  World  Health  Organization  describes  psoriasis  as  a  chronic,  noncommunicable,  painful,  disfiguring  and  disabling
disease for which there is no cure, which generates a great negative impact on patients’ quality of life. It manifests itself in many
forms  and  typically  causes  raised,  red,  scaly  patches  that  appear  on  the  skin  and  may  cause  itchiness,  burning  or  stinging.
Psoriasis is also associated with other serious health conditions such as diabetes, heart disease and depression.

Psoriasis Treatment Options

There are essentially three main types of psoriasis treatments, as listed below:

Topical therapies:

These can include corticosteroids, vitamin D3 derivatives, coal tar, anthralin and retinoids, among others, that are sold
as a cream, gel, liquid, spray, or ointment. The efficacy of topical agents varies from person to person, although these
products are commonly associated with a loss of potency over time as people develop resistance.

Phototherapy:

This is the area in which we operate. Our XTRAC Excimer Systems are FDA-cleared, reimbursed by insurance, and
exhibit none of the significant side-effects associated with some alternative therapies.

Systemic medications:

There  are  a  number  of  prescription  medications  available  for  psoriasis,  which  are  given  either  by  mouth  or  as  an
injection. The popularity and use of these medications are growing significantly, notwithstanding their cost and their
potentially severe side-effects.

XTRAC  excimer  lasers  are  particularly  significant  and  beneficial  for  mild  to  moderate  psoriasis  patients  who  prefer  a
noninvasive  treatment  approach  without  the  side  effects  of  invasive,  systemic  agents,  or  to  patients  who  have  developed  a
resistance  to  topical  agents.  In  many  cases,  patients  treated  with  topical  or  systemic  therapies  are  also  candidates  for
phototherapy.

Using the XTRAC Excimer Lasers to Treat Vitiligo and Other Skin Diseases

UV  light  therapy  is  considered  to  be  an  effective  and  safe  treatment  for  many  skin  disorders  beyond  psoriasis.  To  this
effect, the XTRAC technology is FDA cleared for the treatment of not only psoriasis but also vitiligo (a skin pigment deficiency),
atopic dermatitis (eczema) and leukoderma, which is a localized loss of skin pigmentation that occurs after an inflammatory skin
condition such as a burn, intralesional steroid injection, or post dermabrasion.

XTRAC technology for vitiligo patients typically requires more therapy sessions than for psoriasis but is dependent on the
severity  of  the  disease.  In  the  treatment  of  vitiligo,  we  believe  the  XTRAC  functions  to  reactivate  the  skin's  melanocytes  (the
cells that produce melanin), which causes pigment to return. To date, there is not sufficient data to confirm how long patients can
expect their vitiligo to be in remission after XTRAC therapy. Based on anecdotal reports, we believe that re-pigmentation may
last for several years. Historically, vitiligo treatments had been considered cosmetic procedures by insurance companies, and as
such were not reimbursed. However, over the past several years, there has been a significant increase in insurance coverage for
these  procedures  and  we  estimate  that  currently  approximately  76%  of  insurers  consider  XTRAC  treatments  to  be  medically
necessary for the treatment of vitiligo and therefore provide coverage.

We  believe  that  several  factors  have  limited  the  growth  of  the  use  of  XTRAC  treatments  from  those  who  suffer  from
psoriasis  and  vitiligo.  Specifically,  we  believe  that  awareness  of  the  positive  effects  of  XTRAC  treatments  has  not  been  high
enough among both sufferers and providers; and that the treatment regimen requiring sometimes up to 12 or more treatments has
limited  XTRAC  use  to  certain  patient  populations.  Addressing  the  lack  of  knowledge  issue,  we  have  a  direct  to  patient
advertising  campaign  aimed  at  motivating  psoriasis  and  vitiligo  patients  to  seek  out  XTRAC  treatments  from  our  physician
partners. Specific advertisements encourage prospective patients to contact our patient advocacy center via telephone or web site,
wherein we provide information on the treatment and insurance coverage, and ultimately we can schedule an appointment for the
prospective patient to be evaluated by a physician within our customer network, convenient to their location, to determine if they
would benefit from XTRAC treatments.

3

 
 
 
 
  
 
 
 
 
 
 
Home by XTRAC

In  January  2021,  we  announced  the  introduction  of  Home  by  XTRAC™  business,  leveraging  in-house  resources
including  DTC  advertising,  in-house  call  center  and  its  insurance  reimbursement  team  to  provide  an  at-home,  insurance-
reimbursed treatment option for patients with certain skin diseases that do not qualify for in-office treatments.

STRATAPEN

In  January  2017,  we  entered  into  an  OEM  agreement  with  Esthetic  Education,  LLC  to  private  label  the  STRATAPEN
device.  STRATAPEN®  MicroSystems  is  a  micropigmentation  device  that  provides  advanced  technology  offering  exceptional
results. This contract expired in January 2020, but we continue to sell this product on a purchase order basis.

Competition

Our  XTRAC  product  line  competes  with  pharmaceutical  compounds  and  methodologies  used  to  treat  an  array  of  skin
conditions. Such alternative treatments may be in the form of topical products, systemic medications, and phototherapies from
both  large  pharmaceutical  and  smaller  devices  companies.  Our  major  competitors  for  dermatological  solutions  include  The
Daavlin  Company,  National  Biologic  Corporation,  RA  Medical  and  pharmaceutical  companies  producing  topical  products  and
systemic  and  biologic  medications.  Currently,  our  XTRAC  system  is  believed  to  be  a  competitive  therapy  to  alternative
treatments on the basis of its recognized clinical effect, minimal side effect profile, cost-effectiveness and reimbursement.

Manufacturing

We  manufacture  our  XTRAC  products  at  our  17,000  sq.  ft.  facility  in  Carlsbad,  California.  Our  California  facility  is
certified  as  ISO  13485  compliant.  ISO  13485  is  an  International  standardization  written  by  the  International  Organization  for
Standardization, which publishes requirements for a comprehensive quality management system for the design and manufacture
of medical devices. Certification to the standard is awarded by accredited third parties. We believe that our present manufacturing
capacity at these facilities is sufficient to meet foreseeable demand for our products.

Research and Development Efforts

Our research and development team, including engineers, consists of approximately four employees. We conduct research
and  development  activities  at  our  facility  located  in  Carlsbad,  California.  Currently,  our  research  and  development  efforts  are
focused on the application of our XTRAC system for the treatment of inflammatory skin disorders.

 Intellectual Property

Our policy is to protect our intellectual property by obtaining U.S. and foreign patents to protect technology, inventions
and improvements important to the development of our business. As of December 31, 2020, 26 issued U.S. patents are in force,
and many of these patents have foreign counterparts issued and pending. Of those issued, 10 U.S. patents and one German patent
relate to the XTRAC and VTRAC product lines and eighteen U.S. patents. Additionally, the Company maintains 16 patents from
Mela Sciences, Inc. related to the MelaFind product.

We also rely on trade secrets and technical know-how in the manufacture and marketing of our products. We require our

employees, consultants and contractors to execute confidentiality agreements with respect to our proprietary information. 

In February 2021, the license for the exclusive rights for patents related to the delivery of treatment to vitiligo with the

Icahan School of Medicine at Mount Sinai expired. We do not believe that this will have a material impact on our business.

4

 
 
 
 
  
 
 
 
 
  
 
  
 
 
 
 
 
We  believe  that  our  patented  methods  and  apparatus,  together  with  proprietary  trade-secret  technology  and  registered
trademarks,  give  us  a  competitive  advantage;  however,  whether  a  patent  is  infringed  or  is  valid,  or  whether  or  not  a  patent
application should be granted, are all complex matters of science and law, and therefore, we cannot be certain that, if challenged,
our  patented  methods  and  apparatus  and/or  trade-secret  technology  would be upheld. If  one  or  more  of  our  patented  methods,
patented  apparatus  or  trade-secret  technology  rights,  or  our  trademark  rights,  are  invalidated,  rejected  or  found  unenforceable,
that could reduce or eliminate any competitive advantage we might otherwise have had.

Government Regulation

Regulations Relating to Products and Manufacturing

Our products and research and development activities are regulated by numerous governmental authorities, principally the
FDA and corresponding state and foreign regulatory agencies. Any medical device or cosmetic we manufacture and/or distribute
will be subject to pervasive and continuing regulation by the FDA. The U.S. Food, Drug and Cosmetics Act, or FD&C Act, and
other federal and state  laws  and  regulations  govern  the  pre-clinical and clinical testing, design, manufacture, use, labeling and
promotion  of  medical  devices,  including  our  XTRAC,  VTRAC,  STRATAPEN  and  Home  by  XTRAC  devices.  Product
development  and  approval  for  medical  devices  within  this  regulatory  framework  takes  a  number  of  years  and  involves  the
expenditure of substantial resources.

In the U.S., medical devices are classified into three different classes, Class I, II and III, on the basis of controls deemed
necessary to provide a reasonable assurance of the safety and effectiveness of the device. Class I devices are subject to general
controls,  such  as  facility  registration,  medical  device  listing,  labeling  requirements,  premarket  notification  (unless  the  medical
device  has  been  specifically  exempted  from  this  requirement),  adherence  to  the  FDA’s  Quality  System  Regulation,  and
requirements  concerning  the  submission  of  device-related  adverse  event  reports  to  the  FDA.  Class  II  devices  are  subject  to
general and special controls, such as performance standards, premarket notification (510(k) clearance), post-market surveillance,
and FDA Quality System Regulations. Generally, Class III devices are those that must receive premarket approval by the FDA to
provide a reasonable assurance of their safety and effectiveness, such as life-sustaining, life-supporting and implantable devices,
or new devices that have been found not to be substantially equivalent to existing legally marketed devices.

With  limited  exceptions,  before  a  new  medical  device  can  be  distributed  in  the  U.S.,  marketing  authorization  typically
must be obtained from the FDA through a premarket notification under Section 510(k) of the FD&C Act, or through a premarket
approval application under Section 515 of the FD&C Act. The FDA will typically grant a 510(k) clearance if it can be established
that  the  device  is  substantially  equivalent  to  a  predicate  device  that  is  a  legally  marketed  Class  I  or  II  device  (or  to  pre-
amendments  Class  III  devices  for  which  the  FDA  has  yet  to  call  for  premarket  approvals).  We  have  received  FDA  510(k)
clearance to market our XTRAC and VTRAC systems for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.
The  FDA  granted  these  clearances  under  Section  510(k)  on  the  basis  of  substantial  equivalence  to  other  technologies  that  had
received prior clearances.

For any devices that are cleared through the 510(k) process, modifications or enhancements that could significantly affect
the safety or effectiveness of the device, or that constitute a major change in the intended use of the device, will require a new
510(k) submission. In August 2003 the FDA granted 510(k) clearance for a significantly modified version of our XTRAC laser,
which  we  have  marketed  as  the  XTRAC  XL  Plus  Excimer  Laser  System.  In  October 2004 the FDA granted clearance for the
XTRAC Ultra (AL 8000) Excimer Laser System and, in March 2008 we received 510(k) clearance for the XTRAC Velocity (AL
10000) Excimer Laser System. These approvals were originally granted to PhotoMedex, Inc. and acquired by us in the June 2015
Acquisition described above. In January 2020, we announced the FDA granted clearance of our XTRAC Momentum Excimer
Laser platform

We  are  subject  to  routine  inspection  by  the  FDA  and,  as  noted  above,  must  comply  with  a  number  of  regulatory
requirements applicable to firms that manufacture medical devices and other FDA-regulated products for distribution within the
U.S., including requirements related to device labeling (including prohibitions against promoting products for unapproved or off-
label uses), facility registration, medical device listing, adherence to the FDA’s Quality System Regulation, good manufacturing
processes and requirements for the submission of reports regarding certain device-related adverse events to the FDA.

5

 
 
 
 
 
 
 
 
 
 
 
We  are  also  subject  to  the  radiological  health  provisions  of  the  FD&C  Act  and  the  general  and  laser-specific  radiation
safety  regulations  administered  by  the  Center  for  Devices  and  Radiological  Health,  or  CDRH,  of  the  FDA.  These  regulations
require  laser  manufacturers  to  file  initial,  new  product,  supplemental  and  annual  reports,  to  maintain  quality  control,  product
testing and sales records, to incorporate certain design and operating features (depending on the class of product) in lasers sold to
end users pursuant to a performance standard and to certify and appropriately label each laser sold as belonging to one of four
classes, based on the level of radiation from the laser that is accessible to users. Moreover, we are obligated to repair, replace, or
refund the cost of certain electronic products that are found to fail to comply with applicable federal standards or otherwise are
found to be defective. The CDRH is empowered to seek fines and other remedies for violations of the regulatory requirements.
To date, we have filed the documentation with the CDRH for our laser products requiring such filing and have not experienced
any difficulties or incurred significant costs in complying with such regulations.

We  are  approved  by  the  European  Union  to  affix  the  CE  mark  to  our  XTRAC  laser  and  VTRAC  lamp  systems.  This
certification  is  a  mandatory  conformity  mark  for  products  placed  on  the  market  in  the  European  Economic  Area,  which  is
evidence that they meet all European Community, or EC, quality assurance standards and compliance with applicable European
medical device directives for the production of medical devices. This will enable us to market our approved products in all of the
member countries that accept the CE mark. We also are required to comply with additional individual national requirements that
are in addition to those required by these nations. Our products have also met the requirements for marketing in various other
countries.

We purchase our Home by XTRAC and STRATAPEN devices from third parties, who are subject to the same regulations.

We rely on these third parties to ensure compliance with the regulations.

Failure  to  comply  with  applicable  regulatory  requirements  can  result  in  fines,  injunctions,  civil  penalties,  recalls  or
seizures of products, total or partial suspensions of production, refusals by the U.S. and foreign governments to permit product
sales and criminal prosecution.

We are, or may become, subject to various other federal, state, local and foreign laws, regulations and policies relating to,
among  other  things,  safe  working  conditions,  good  laboratory  practices  and  the  use  and  disposal  of  hazardous  or  potentially
hazardous substances used in connection with research and development.

Fraud and Abuse Laws

Because of the significant federal funding involved in Medicare and Medicaid, Congress and the states have enacted, and
actively enforce, a number of laws whose purpose is to eliminate fraud and abuse in federal health care programs. Our business is
subject to compliance with these laws.

Anti-Kickback Laws

In  the  U.S.,  there  are  federal  and  state  anti-kickback  laws  that  generally  prohibit  the  payment  or  receipt  of  kickbacks,
bribes or other remuneration in exchange for the referral of patients or other health-related business. The U.S. federal healthcare
programs’ Anti-Kickback Statute makes it unlawful for individuals or entities knowingly and willfully to solicit, offer, receive or
pay any kickback, bribe or other remuneration, directly or indirectly, in exchange for or to induce the purchase, lease or order, or
arranging for or recommending purchasing, leasing, or ordering, any good, facility, service, or item for which payment may be
made in whole or in part under a federal healthcare program such as Medicare or Medicaid. The Anti-Kickback Statute covers
“any  remuneration,”  which  has  been  broadly  interpreted  to  include  anything  of  value,  including  for  example  gifts,  certain
discounts, the furnishing of free supplies, equipment or services, credit arrangements, payments of cash and waivers of payments.
Several  courts  have  interpreted  the  statute’s  intent  requirement  to  mean  that  if  any  one  purpose  of  an  arrangement  involving
remuneration is to induce referrals of federal healthcare covered business, the arrangement can be found to violate the statute.
Penalties for violations include criminal penalties and civil sanctions such as fines, imprisonment and possible exclusion from
Medicare,  Medicaid  and  other  federal  healthcare  programs.  In  addition,  several  courts  have  permitted  kickback  cases  brought
under the Federal False Claims Act to proceed, as discussed in more detail below.

6

 
 
 
  
  
  
 
 
 
 
 
 
 
 
The reach of the Anti-Kickback Statute was broadened by the Patient Protection and Affordable Care Act of 2010 (the
“ACA”),  which,  among  other  things,  amends  the  intent  requirement  of  the  federal  Anti-Kickback  Statute.  Pursuant  to  the
statutory amendment, a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in
order to have committed a violation. In addition, the ACA provides that the government may assert that a claim including items
or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of
the civil False Claims Act (discussed below) or the civil monetary penalties statute, which imposes penalties against any person
who  is  determined  to  have  presented  or  caused  to  be  presented  a  claim  to  a  federal  health  program  that  the  person  knows  or
should know is for an item or service that was not provided as claimed or is false or fraudulent.

Because  the  Anti-Kickback  Statute  is  broadly  written  and  encompasses  many  harmless  or  efficient  arrangements,
Congress authorized the Office of Inspector General of the U.S. Department of Health and Human Services, or OIG, to issue a
series  of  regulations,  known  as  “safe  harbors.”  For  example,  there  are  regulatory  safe  harbors  for  payments  to  bona  fide
employees, properly reported discounts and rebates, and for certain investment interests. Although an arrangement that fits into
one  or  more  of  these  exceptions  or  safe  harbors  is  immune  from  prosecution,  arrangements  that  do  not  fit  squarely  within  an
exception or safe harbor do not necessarily violate the statute. The failure of a transaction or arrangement to fit precisely within
one  or  more  of  the  exceptions  or  safe  harbors  does  not  necessarily  mean  that  it  is  illegal  or  that  prosecution  will  be  pursued.
However, conduct and business arrangements that arguably implicate the Anti-Kickback Statute but do not fully satisfy all the
elements of an exception or safe harbor may be subject to increased scrutiny by government enforcement authorities such as the
OIG.

Many states have laws that implicate anti-kickback restrictions similar to the Anti-Kickback Statute. Some of these state
prohibitions apply, regardless of whether federal health care program business is involved, to arrangements such as for self-pay or
private-pay patients.

Government  officials  have  focused  their  enforcement  efforts  on  marketing  of  healthcare  services  and  products,  among
other  activities,  and  recently  have  brought  cases  against  companies,  and  certain  sales,  marketing  and  executive  personnel,  for
allegedly offering unlawful inducements to potential or existing customers in an attempt to procure their business.

Federal Civil False Claims Act and State False Claims Laws

The  federal  civil  False  Claims  Act  imposes  liability  on  any  person  or  entity  who,  among  other  things,  knowingly  and
willfully presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program, including
Medicare and Medicaid. The “qui tam,” or “whistleblower” provisions of the False Claims Act allow a private individual to bring
actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government, and
to share in any monetary recovery. In recent years, the number of suits brought against healthcare providers by private individuals
has increased dramatically. Medical device companies, like us,  can  be  held  liable  under  false  claims  laws,  even  if  they  do  not
submit  claims  to  the  government,  when  they  are  deemed  to  have  caused  submission  of  false  claims  by,  among  other  things,
providing  incorrect  coding  or  billing  advice  about  their  products  to  customers  that  file  claims,  or  by  engaging  in  kickback
arrangements with customers that file claims.

The False Claims Act also has been used to assert liability on the basis of misrepresentations with respect to the services
rendered and in connection with alleged off-label promotion of products. Our future activities relating to the manner in which we
sell  our  products  and  document  our  prices,  such  as  the  reporting  of  discount  and  rebate  information  and  other  information
affecting federal, state and third-party reimbursement of our products, and the sale and marketing of our products, may be subject
to scrutiny under these laws.

7

 
 
 
  
 
 
 
 
 
 
When an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual
damages sustained by the government, plus civil penalties of $5,500 to $11,000 for each separate false claim. There are many
potential basis for liability under the False Claims Act. A number of states have enacted false claim laws analogous to the federal
civil False Claims Act and many of these state laws apply where a claim is submitted to any state or private third-party payer. In
this  environment,  our  engagement  of  physician  consultants  in  product  development  and  product  training  and  education  could
subject us to similar scrutiny. We are unable to predict whether we would be subject to actions under the False Claims Act or a
similar state law, or the impact of such actions. However, the costs of defending such claims, as well as any sanctions imposed,
could significantly affect our financial performance.

HIPAA Fraud and Other Regulations

The Health Insurance Portability and Accountability Act of 1996, or HIPAA, created a class of federal crimes known as
the  “federal  health  care  offenses,”  including  healthcare  fraud  and  false  statements  relating  to  healthcare  matters.  The  HIPAA
health care fraud statute prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme or
artifice to defraud any healthcare benefit program, or to obtain by means of false or fraudulent pretenses, any money under the
control of any health care benefit program, including private payers. A violation of this statute is a felony and may result in fines,
imprisonment  and/or  exclusion  from  government-sponsored  programs.  The  HIPAA  false  statements  statute  prohibits,  among
other  things,  knowingly  and  willfully  falsifying,  concealing  or  covering  up  a  material  fact  or  making  any  materially  false,
fictitious or fraudulent statement or representation in connection with the delivery of or payment for healthcare benefits, items or
services. A violation of this statute is a felony and may result in fines and/or imprisonment. Entities that are found to have aided
or abetted in a violation of the HIPAA federal health care offenses are deemed by statute to have committed the offense and are
punishable as a principal.

We  are  also  subject  to  the  U.S.  Foreign  Corrupt  Practices  Act  and  similar  anti-bribery  laws  applicable  in  non-U.S.
jurisdictions that generally prohibit companies and their intermediaries from making improper payments to non-U.S. government
officials  for  the  purpose  of  obtaining  or  retaining  business.  Because  of  the  predominance  of  government-sponsored  healthcare
systems around the world, most of our customer relationships outside of the U.S. will be with governmental entities and therefore
subject to such anti-bribery laws.

Effective January 1, 2020, The California Consumer Privacy Act (CCPA) became effective. The CCPA provides certain
privacy  protections  for  California  residents  not  generally  available  to  citizens  of  any  other  state.  The  law  provides  California
residents with the right to know that their personal data is being collected; know whether that data is being sold or disclosed; to
prevent  the  sale  of  their  personal  information;  to  access  their  personal  data;  to  request  that  a  business  delete  their  personal
information; and to not be discriminated against for exercising these rights.

HIPAA and Other Privacy Regulations

The  regulations  that  implement  HIPAA  also  establish  uniform  standards  governing  the  conduct  of  certain  electronic
healthcare  transactions  and  protecting  the  security  and  privacy  of  individually  identifiable  health  information  maintained  or
transmitted  by  healthcare  providers,  health  plans  and  healthcare  clearinghouses,  which  are  referred  to  as  “covered  entities.”
Several  regulations  have  been  promulgated  under  HIPAA’s  regulations  including:  the  Standards  for  Privacy  of  Individually
Identifiable  Health  Information,  or  the  Privacy  Rule,  which  restricts  the  use  and  disclosure  of  certain  individually  identifiable
health information; the Standards for Electronic Transactions, or the Transactions Rule, which establishes standards for common
healthcare transactions, such as claims information, plan eligibility, payment information and the use of electronic signatures; and
the  Security  Standards  for  the  Protection  of  Electronic  Protected  Health  Information,  or  the  Security  Rule,  which  requires
covered entities to implement and maintain certain security measures to safeguard certain electronic health information. Although
we do not believe we are a covered entity and therefore are not currently directly subject to these standards, we expect that our
customers generally will be covered entities and may ask us to contractually comply with certain aspects of these standards by
entering  into  requisite  business  associate  agreements.  While  the  government  intended  this  legislation  to  reduce  administrative
expenses  and  burdens  for  the  healthcare  industry,  our  compliance  with  certain  provisions  of  these  standards  entails  significant
costs for us.

8

 
 
 
 
  
 
 
 
 
The Health Information Technology for Economic and Clinical Health Act, or the HITECH Act, which was enacted in
February  2009  strengthens  and  expands  the  HIPAA  Privacy  and  Security  Rules  and  the  restrictions  on  use  and  disclosure  of
patient  identifiable  health  information.  HITECH  also  fundamentally  changed  a  business  associate’s  obligations  by  imposing  a
number  of  Privacy  Rule  requirements  and  a  majority  of  Security  Rule  provisions  directly  on  business  associates  that  were
previously only directly applicable to covered entities. HITECH includes, but is not limited to, prohibitions on exchanging patient
identifiable  health  information  for  remuneration,  restrictions  on  marketing  to  individuals,  and  obligations  to  agree  to  provide
individuals an accounting of virtually all disclosures of their health information. Moreover, HITECH requires covered entities to
report  any  unauthorized  use  or  disclosure  of  patient  identifiable  health  information,  known  as  a  breach,  to  the  affected
individuals,  the  United  States  Department  of  Health  and  Human  Services,  or  HHS,  and,  depending  on  the  size  of  any  such
breach, the media for the affected market. Business associates are similarly required to notify covered entities of a breach. Most
of the HITECH provisions became effective in February 2010. HHS had already issued regulations governing breach notification
which were effective in September 2009.

HITECH has increased civil penalty amounts for violations of HIPAA by either covered entities or business associates up
to an annual maximum of $1.5 million for uncorrected violations based on willful neglect. Imposition of these penalties is more
likely  now  because  HITECH  significantly  strengthens  enforcement.  It  requires  HHS  to  conduct  periodic  audits  to  confirm
compliance and to investigate any violation that involves willful neglect which carries mandatory  penalties.  Additionally,  state
attorneys general are authorized to bring civil actions seeking either injunctions or damages in response to violations of HIPAA
Privacy and Security Rules that threaten the privacy of state residents.

In  addition  to  federal  regulations  issued  under  HIPAA,  some  states  have  enacted  privacy  and  security  statutes  or
regulations that, in some cases, are more stringent than those issued under HIPAA. In those cases, it may be necessary to modify
our planned operations and procedures to comply with the more stringent state laws. If we fail to comply with applicable state
laws and regulations, we could be subject to additional sanctions.

Federal  and  state  consumer  protection  laws  are  being  applied  increasingly  by  the  United  States  Federal  Trade
Commission,  or  FTC,  and  state  attorneys  general  to  regulate  the  collection,  use,  storage  and  disclosure  of  personal  or  patient
information,  through  websites  or  otherwise,  and  to  regulate  the  presentation  of  web  site  content.  Courts  may  also  adopt  the
standards for fair information practices promulgated by the FTC, which concern consumer notice,  choice,  security  and  access.
Numerous other countries have or are developing laws governing the collection, use, disclosure and transmission of personal or
patient information.

HIPAA as well as other federal and state laws apply to our receipt of patient identifiable health information in connection
with research and clinical trials. We collaborate with other individuals and entities in conducting research and all involved parties
must  comply  with  applicable  laws.  Therefore,  the  compliance  of  the  physicians,  hospitals  or  other  providers  or  entities  with
whom we collaborate also impacts our business.

Third-Party Reimbursement

Our ability to market our phototherapy products successfully depends in large part on the extent to which various third
parties are willing to reimburse patients or providers for the cost of medical procedures utilizing our treatment products. These
third  parties  include  government  authorities,  private  health  insurers  and  other  organizations,  such  as  health  maintenance
organizations. Third-party payers are systematically challenging the prices charged for medical products and services. They may
deny reimbursement if they determine that a prescribed device is not used in accordance with cost-effective treatment methods as
determined by the payer, or is experimental, unnecessary or inappropriate. Accordingly, if less costly drugs or other treatments
are available, third-party payers may not authorize, or may limit, reimbursement for the use of our products, even if our products
are  safer  or  more  effective  than  the  alternatives.  Additionally,  they  may  require  changes  to  our  pricing  structure  and  revenue
model before authorizing reimbursement.

9

 
 
 
 
 
  
 
 
 
 
Reimbursement systems in international markets vary significantly by country and by region within some countries, and
reimbursement  approvals  must  be  obtained  on  a  country-by-country  basis.  Many  international  markets  have  government-
managed  healthcare  systems  that  control  reimbursement  for  new  devices  and  procedures.  In  most  markets,  there  are  private
insurance  systems,  as  well  as  government-managed  systems.  Our  XTRAC  products  remain  substantially  without  approval  for
reimbursement in many international markets under either government or private reimbursement systems.

Many private plans key their reimbursement rates to rates set by the CMS under three distinct CPT codes based on the

total skin surface area being treated.

As of December 31, 2020, the national rates were as follows:

•
•
•

96920 - designated for: the total area less than 250 square centimeters. CMS assigned a 2020 national payment of $166.37 per treatment;
96921 - designated for: the total area 250 to 500 square centimeters. CMS assigned a 2020 national payment of $182.25 per treatment; and
96922 - designated for: the total area over 500 square centimeters. CMS assigned a 2020 national payment of $248.66 per treatment.

The national rates are adjusted by overhead factors applicable to each state.

Employees

As  of  December  31,  2020,  we  had  109  full-time  employees,  which  consisted  of  two  executive  officers,  two  vice
presidents,  56  sales  and  marketing  staff,  20  people  engaged  in  manufacturing  of  lasers,  14  customer-field service personnel, 4
engaged in research and development and 11 finance and administration staff.

Customers

Domestically,  our  customers  consist  of  dermatologists  and  dermatological  group  clinics  who  partner  with  us  in  our

recurring revenue model. As of December 31, 2020, we have 832 partner clinics throughout the United States.

Internationally,  we  have  been  transitioning  our  international  equipment  sales  through  our  master  distributor  to  a  direct
distribution model for equipment sales and recurring revenue on a country by country basis. We have signed contracts in Korea
(in 2019), Japan (in 2020) and China (in January 2021). The change from equipment sales to a recurring revenue business model,
internationally, will decrease sales in the short term, but will increase overall sales in the long term.

Available Information

We file annual, quarterly and current reports, proxy statements and other information with the Commission. These filings

are available to the public on the Internet at the Commission's website at http://www.sec.gov.

Our Internet address is http://www.strataskinsciences.com (this website address is not intended to function as a hyperlink
and the information contained on our website is not intended to be a part of this Report). We make available free of charge on
https://strataskinsciencesinc.gcs-web.com/sec-filings our annual, quarterly and current reports, and amendments to those reports,
as soon as reasonably practical after we electronically file such material with, or furnish it to, the Commission. We may from
time  to  time  provide  important  disclosures  to  investors  by  posting  them  in  the  Investor  Relations  section  of  our  website,  as
allowed by the Commission's rules. The information on the website listed above is not and should not be considered part of this
Report and is intended to be an inactive textual reference only.

10

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Item 1A. 

Risk Factors

In  addition  to  the  other  information  contained  in  this  Report  and  the  exhibits  hereto,  the  following  risk  factors  should  be
considered carefully in evaluating our business. Our business, financial condition, cash flows or results of operations could be
materially  adversely  affected  by  any  of  these  risks.  Additional  risks  not  presently  known  to  us  or  that  we  currently  deem
immaterial  may  also  adversely  affect  our  business,  financial  condition,  cash  flows  or  results  of  operations.  The  following
discussion  of  risk  factors  contains  forward-looking  statements  as  discussed  on  page  1.  Our  business  routinely  encounters  and
addresses risks, some of which may cause our future results to be different – sometimes materially different – than we presently
anticipate.

Risk Factor Summary
 Risks Relating to Our Business Operations

• We have incurred losses for a number of years and anticipate that we will incur continued losses for the foreseeable future.
•

The current outbreak of the novel coronavirus, or COVID-19, or the future outbreak of any other highly infectious or contagious diseases,
could materially and adversely affect our results of operations, financial condition and cash flows.
There is a high degree of uncertainty regarding the implementation and impact of the PPP. There can be no assurance as to whether we will
receive full forgiveness of the loan.

•

• We may acquire other assets or businesses, or form collaborations or make investments in other companies or technologies that could harm

our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.

• We may not be able to successfully integrate newly acquired businesses, joint ventures and other partnerships into our operations or achieve

•

expected profitability from our acquisitions.
Our  laser  treatments  of  psoriasis,  vitiligo,  atopic  dermatitis  and  leukoderma  and/or  any  of  our  future  products  or  services  may  fail  to  gain
market acceptance or be impacted by competitive products, services or therapies which could adversely affect our competitive position.

• We  have  introduced  a  new  business,  branded  “Home  by  XTRAC,”  with  which  we  have  little  experience  and  may  not  be  successful  in

•

•
•
•

•

•

launching or may need more resources than anticipated.
The success of our products depends on third-party reimbursement of patients' costs, which could result in potentially reduced prices or
reduced demand and adversely affect our revenues and business operations.
The continuing development of our products depends upon our developing and maintaining strong working relationships with physicians.
Any failure in our customer education efforts could have a material adverse effect on our revenue and cash flow.
If revenue from a significant customer declines, we may have difficulty replacing the lost revenue, which would negatively affect our results
and operations.
If we fail to execute our recurring revenue strategy outside the United States, we may have difficulty replacing the lost revenue from
equipment sales, which would negatively affect our results and operations.
If  we  fail  to  manage  our  sales  and  marketing  force  or  to  market  and  distribute  our  products  effectively,  we  may  experience  diminished
revenues and profits.

• We are reliant on a limited number of suppliers for production of our products.
•

Our failure to respond to rapid changes in technology and other applications in the medical devices industry or the development of a cure for
skin conditions treated by our products could make our treatment system obsolete.
Our customers, or physicians and technicians, as the case may be, may misuse certain of our products, and product liability lawsuits and other
damages imposed on us may exceed our insurance coverage, or we may be subject to claims that are not covered by insurance.

•

11

 
 
 
 
 
 
 
 
 
• We  must  comply  with  complex  statutes  prohibiting  fraud  and  abuse,  and  both  we  and  physicians  utilizing  our  products  could  be  subject  to

significant penalties for noncompliance.

• We  may  be  subject,  directly  or  indirectly,  to  federal  and  state  healthcare  fraud  and  abuse  laws  and  regulations  and  could  face  substantial

•

•

•

penalties if we are unable to fully comply with such laws.
If the effectiveness and safety of our devices are not supported by long-term data, and the level of acceptance of our products by dermatologists
does not increase or is not maintained, our revenues could decline.
Our failure to obtain or maintain necessary FDA clearances and approvals, or to maintain continued clearances, or equivalents thereof in the
U.S. and relevant foreign markets, could hurt our ability to distribute and market our products.
If required, clinical trials necessary to support a 510(k) notice or PMA application, for new or modified products, will be expensive and will
require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.
Our medical device operations are subject to FDA regulatory requirements

•
• Healthcare policy changes may have a material adverse effect on us.
• Our market acceptance in international markets requires regulatory approvals from foreign governments and may depend on third party

reimbursement of participants' cost

• We face substantial competition, which may result in others discovering, developing or commercializing products more successfully than us.
•
• We actively employ social media as part of our marketing strategy, which could give rise to regulatory violations, liability, breaches of data

Consolidation in the medical device industry could have an adverse effect on our revenue and results of operations.

security or reputational damage.

•

• We may become subject to claims of infringement or misappropriation of the intellectual property rights of others, which could prohibit us
from shipping affected products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to
substantial  monetary  damages  and  injunctive  relief.  Our  patents  may  also  be  subject  to  challenge  on  validity  grounds,  and  our  patent
applications may be rejected.
If  we  or  our  third-party  manufacturers  or  suppliers  fail  to  comply  with  the  FDA’s  Quality  System  Regulation  or  any  applicable  state
equivalent, our manufacturing operations could be interrupted and our potential product sales and operating results could suffer.
If we fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with products, these products could be
subject to restrictions or withdrawal from the market.
Our medical products may in the future be subject to product recalls that could harm our reputation, business and financial results.
If any of our medical products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical
device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

•
•

•

• We  may  have  a  need  for  additional  funds  in  the  future  and  there  is  no  guarantee  that  we  will  be  able  to  generate  those  funds  from  our

•
•

business.
If we do not have enough capital to fund operations, then we will have to cut costs or raise funds.
If our actual liability for state sales and use taxes is higher than our accrued liability, it could have a material impact on our financial
condition.

• We may be subject to disruptions or failures in our information technology systems and network infrastructures, including through cyber-

attacks or other third-party breaches that could have a material adverse effect on our business.
Environmental and health safety laws may result in liabilities, expenses and restrictions on our operations.

•

12

 
 
 
 
 
 
 
 
Risks Relating to Our Common Stock

•

•
•

In the event of certain contingencies, the investors in the May 2018 Equity Financing may receive additional shares issued pursuant to the
Retained Risk Provisions as defined in the purchase agreements.
Our stock price may be volatile, meaning purchasers of our common stock could incur substantial losses.
Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable and could also limit the market price of
our stock.

Risks Relating to Our Business Operations

We have incurred losses for a number of years and anticipate that we will incur continued losses for the foreseeable future.

Since  2015,  we  have  devoted  substantially  all  of  our  resources  in  the  commercialization  and  sales  of  the  XTRAC
products. Our net loss for the year ended December 31, 2020, was approximately $4.4 million, and as of December 31, 2020, we
had an accumulated deficit of approximately $219.0 million. Our losses, among other things, have had and may continue to have
an  adverse  effect  on  the  adequacy  of  our  capitalization  and  cash  flow.  We  believe  that  our  cash  and  cash  equivalents  as  of
December  31,  2020,  combined  with  the  anticipated  revenues  from  the  sale  of  our  products,  will  be  sufficient  to  satisfy  our
working  capital  needs,  lasers  placed-in-service,  capital  asset  purchases,  outstanding  commitments  and  other  liquidity
requirements associated with our existing operations through the next 12 months following the filing of this Report.

The  current  outbreak  of  the  novel  coronavirus,  or  COVID-19,  or  the  future  outbreak  of  any  other  highly  infectious  or
contagious  diseases,  could  materially  and  adversely  affect  our  results  of  operations,  financial  condition  and  cash  flows.
Further, the spread of the COVID-19 outbreak has caused severe disruptions in the U.S. and global economy and financial
markets and could potentially create widespread business continuity issues of an as yet unknown magnitude and duration.

In December 2019, a novel strain of coronavirus (COVID-19) was reported to have surfaced in Wuhan, China. COVID-19
has  since  spread  to  over  100  countries,  including  every  state  in  the  United  States.  On  March  11,  2020  the  World  Health
Organization  declared  COVID-19  a  pandemic,  and  on  March  13,  2020  the  United  States  declared  a  national  emergency  with
respect to COVID-19. In the last twelve months, the United States and the world have experienced various levels of government
shutdowns, closures and quarantines.

The outbreak of COVID-19 has severely impacted global economic activity and caused significant volatility and negative
pressure  in  financial  markets.  The  global  impact  of  the  outbreak  has  been  rapidly  evolving  and  many  countries,  including  the
United  States,  have  reacted  by  instituting  quarantines,  mandating  business  and  school  closures  and  restricting  travel.  This
outbreak has triggered a period of global economic slowdown or a global recession which could continue for some time which
cannot be predicted. COVID-19 or another pandemic has or could have material and adverse effects on our ability to successfully
operate our business due to, among other factors:

•
•

•

•
•

a general decline in business activity;
the destabilization of the markets and negative impacts on the healthcare system globally could negatively impact our ability to market and sell our
products, including through the disruption of health care activities in general and elective health care procedures in particular, the inability of our
sales team to contact and/or visit doctors in person, patients’ interest in starting or continuing procedures involving our products and our ability to
support patients that presently use our products;
difficulty  accessing  the  capital  and  credit  markets  on  favorable  terms,  or  at  all,  and  a  severe  disruption  and  instability  in  the  global  financial
markets, or deteriorations in credit and financing conditions which could affect our access to capital necessary to fund business operations;
the potential negative impact on the health of our employees, especially if a significant number of them are impacted;
the impact of the pandemic on the Company’s customers, which may result in an increase in past due accounts receivable, write-offs  and customer
bankruptcies;

13

 
 
 
   
 
 
 
 
 
 
 
•

•

a shut-down of suppliers within the Company’s supply chain has severely disrupted our ability to sell, place and repair our products, which has
had  a  material  impact  on  the  Company’s  financial  position  and  cash  flow,  and  the  continuation  will  likely  have  a  material  impact  on  the
Company’s financial position and cash flow in future periods; and
a deterioration in our ability to ensure business continuity during a disruption.

There is a high degree of uncertainty regarding the implementation and impact of the PPP. There can be no assurance as to
whether we will receive full forgiveness of the loan.

In April 2020, we closed on a loan of $2.0 million under the PPP of the CARES Act, or the PPP loan, all or a portion of
which may be forgiven dependent on our use of proceeds. The PPP loan matures on May 1, 2022 and bears interest at a rate of
1.0% per annum. We are required to pay the lender equal monthly payments of principal and interest as required to fully amortize
by May 1, 2022 on any principal amount outstanding on the PPP loan that has not been forgiven in accordance with the terms and
conditions of the PPP loan. All or a portion of the PPP loan may be forgiven by the SBA upon application by us beginning 60
days,  but  not  later  than  120  days,  after  loan  approval  and  upon  documentation  of  expenditures  in  accordance  with  the  SBA's
requirements.  Under  the  CARES  Act,  loan  forgiveness  is  available  for  the  sum  of  documented  payroll  costs,  covered  rent
payments, covered mortgage interest and covered utilities during the eight-week period beginning on the date of loan approval.
Not more than 25% of the forgiven amount may be for non-payroll costs. The amount of the PPP loan eligible to be forgiven will
be reduced if our full-time headcount declines, or if salaries and wages for employees with salaries of $100,000 or less annually
are reduced by more than 25%. We will be required to repay any portion of the outstanding principal that is not forgiven, along
with accrued interest, in accordance with the amortization schedule described above, and we cannot provide any assurance that
we will be eligible for loan forgiveness, that we will ultimately apply for forgiveness, or that any amount of the PPP loan will
ultimately be forgiven by the SBA. Furthermore, on April 28, 2020, the Secretary of the U.S. Department of the Treasury stated
that the SBA will perform a full review of any PPP loan over $2.0 million before forgiving the loan.

The PPP loan application required us to certify, among other things, that the current economic uncertainty made the PPP
loan request necessary to support our ongoing operations. While we made this certification in good faith after analyzing, among
other things, our financial situation and access to alternative forms of capital, and believe that we satisfied all eligibility criteria
for the PPP loan and that our receipt of the PPP loan is consistent with the broad objectives of the PPP and the CARES Act, the
certification described above does not contain any objective criteria as of this date and is subject to interpretation. In addition, the
SBA has stated that it is unlikely that a public company with substantial market value and access to capital markets will be able
to make the required certification in good faith. The SBA intends to provide further clarification by May 14, 2020. The lack of
clarity  as  of  the  date  of  this  Report  regarding  loan  eligibility  under  the  PPP  has  resulted  in  significant  media  coverage  and
controversy with respect to public companies applying for and receiving loans. If, despite our good faith belief that we satisfied
all eligibility requirements for the PPP loan, we are found to have been ineligible to receive the PPP loan or in violation of any of
the laws or governmental regulations that apply to us in connection with the PPP loan, including the False Claims Act, we may be
subject to penalties, including significant civil, criminal and administrative penalties and could be required to repay the PPP loan.
We have submitted our application for forgiveness of all of the PPP loan, in which we made certain certifications which will be
subject  to  audit  and  review  by  governmental  entities  and  could  subject  us  to  significant  penalties  and  liabilities  if  found  to  be
inaccurate,  including  under  the  False  Claims  Act.  In  addition,  our  receipt  of  the  PPP  loan  may  result  in  adverse publicity and
damage to our reputation, and a review or audit by the SBA or other government entity or claims under the False Claims Act
could  consume  significant  financial  and  management  resources.  Any  of  these  events  could  harm  our  business,  results  of
operations and financial condition.

We may acquire other assets or businesses, or form collaborations or make investments in other companies or technologies
that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant
expense.

14

 
 
 
 
 
 
 
 
As part of our business strategy, we may pursue acquisitions of assets, including preclinical, clinical or commercial stage
products or product candidates, or businesses, or strategic alliances and collaborations, to expand our existing technologies and
operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may
not  realize  the  anticipated  benefits  of  any  such  transaction,  any  of  which  could  have  a  detrimental  effect  on  our  financial
condition, results of operations and cash flows. We have limited experience with acquiring other companies, products or product
candidates,  and  limited  experience  with  forming  strategic  alliances  and  collaborations.  We  may  not  be  able  to  find  suitable
acquisition candidates, and if we make any acquisitions, we may not be able to integrate these acquisitions successfully into our
existing  business  and  we  may  incur  additional  debt  or  assume  unknown  or  contingent  liabilities  in  connection  therewith.
Integration of an acquired company or assets may also disrupt ongoing operations, require the hiring of additional personnel and
the implementation of additional internal systems and infrastructure, especially the acquisition of commercial assets, and require
management  resources  that  would  otherwise  focus  on  developing  our  existing  business.  We  may  not  be  able  to  find  suitable
strategic alliances or collaboration partners or identify other investment opportunities, and we may experience losses related to
any such investments.

To finance any acquisitions or collaborations, we may choose to issue debt or equity securities as consideration. Any such
issuance of shares would dilute the ownership of our stockholders. If the price of our common stock is low or volatile, we may
not be able to acquire other assets or companies or fund a transaction using our stock as consideration. Alternatively, it may be
necessary  for  us  to  raise  additional  funds  for  acquisitions  through  public  or  private  financings.  Additional  funds  may  not  be
available on terms that are favorable to us, or at all.

We may not be able to successfully integrate newly acquired businesses, joint ventures and other partnerships into our
operations or achieve expected profitability from our acquisitions.

If we cannot successfully integrate acquisitions, joint ventures and other partnerships on a timely basis, we may be unable
to generate sufficient revenue to offset acquisition costs, we may incur costs in excess of what we anticipate, and our expectations
of future results of operations, including certain cost savings and synergies, may not be achieved. Acquisitions involve substantial
risks, including:

•
•
•
•
•

unforeseen difficulties in integrating operations, technologies, services, accounting and personnel;
diversion of financial and management resources from existing operations;
unforeseen difficulties related to entering geographic regions where we do not have prior experience;
risks relating to obtaining sufficient equity or debt financing; and
potential loss of customers.

In  addition,  if  we  finance  acquisitions  by  issuing  equity  securities  or  securities  convertible  into  equity  securities,  our
existing stockholders’ interests would be diluted, which, in turn, could adversely impact the market price of our stock. Moreover,
we could finance an acquisition with debt, resulting in higher leverage and interest costs and could increase losses and losses per
share which could impact the price of our stock.

Our laser treatments of psoriasis, vitiligo, atopic dermatitis and leukoderma and/or any of our future products or services may
fail to gain market acceptance or be impacted by competitive products, services or therapies which could adversely affect our
competitive position.

We  have  generated  limited  worldwide  commercial  distribution  for  our  products.  In  the  United  States,  our  XTRAC
systems are placed at physician offices at no upfront charge to the physician and we are generally paid on a per-usage method
where we retain ownership of the system. We cannot assure you that our products and services will find sufficient acceptance in
the marketplace under our sales strategies.

We also face a risk that other companies in the market for dermatological products and services may be able to provide
dermatologists a higher overall financial return and therefore compromise our ability to increase our installed base of users and
ensure they engage in optimal usage of our products. If, for example, such other companies have products or medical devices that
require less time commitment from the dermatologist and yield an attractive return on a dermatologist’s time and investment, we
may find that our efforts to increase our base of users are hindered.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
15

We  also  face  a  risk  that  the  overall  cost  of  systemic  or  biologic  medications  or  treatment  modalities  become  less
expensive  through  the  development  of  generics  or  other  means.  We  may  be  faced  with  pressure  to  reduce  our  costs  to  be
competitive  which  may  negatively  impact  our  business.  In  addition,  our  business  could  be  negatively  impacted  if  these
medications  are  prescribed  for  less  severe  cases  of  the  diseases  or  if  new,  more  effective  or  less  expensive  medications  are
developed.

CPT codes for all procedures are subject to continued reevaluation. Should CMS reduce reimbursement for the CPT codes
for XTRAC treatment or raise reimbursement for competitive products we may see a decline in our recurring revenue business as
well as a decline in new XTRAC installations.

Whether a treatment may be delegated to non-physician staff members and, if so, to whom and to what extent, are matters
that  may  vary  state  by  state,  as  these  matters  are  within  the  province  of  the  state  medical  boards.  In  states  that  may  be  more
restrictive  in  such  delegation,  a  physician  may  decline  to  adopt  the  XTRAC  system  into  his  or  her  practice,  deeming  it  to  be
fraught  with  too  many  constraints  and  finding  other  outlets  for  the  physician’s  time  and  staff’s  time  to  be  more  remunerative.
There can be no assurance that we will be successful in persuading such medical boards that a liberal standard for delegation is
appropriate for the XTRAC system, based on its design for ease and safety of use. If we are not successful, we may find that even
if a geographic region has wide insurance reimbursement, the region’s physicians may decline to adopt the XTRAC system into
their practices.

We therefore cannot assure you that the marketplace will be receptive to our excimer laser technology over competing
products, services and therapies or that a cure will not be found for the underlying diseases we are focused on treating. Failure of
our products to achieve market acceptance could have a material adverse effect on our business, financial condition and results of
operations.

We  have  introduced  a  new  business,  branded  “Home  by  XTRAC,”  with  which  we  have  little  experience  and  may  not  be
successful in launching or may need more resources than anticipated.

We have introduced a new business which provides an at-home, insurance reimbursed treatment option for patients with
skin diseases that might not be able to avail themselves of in-office treatments. We do not have experience with at-home therapies
and  we  may  not  be  successful  at  launching  this  business.  The  business  relies  on  providers  to  prescribe  our  products  to  their
patients, which we do not control. As a company selling durable medical equipment, we do not have contracts with insurance
companies,  therefore  we  sell  our  products  through  a  third  party.  And,  as  previously  discussed,  insurance  companies’  and
Medicare reimbursements, as well as patients’ deductibles can impact and delay payment for our products, which could make the
business unprofitable. While we believe we will be able to leverage internal resources, we may find that additional resources are
necessary and those resources may negatively impact our cash flows and financial position.

In addition, while this introduction is specifically for those patients that might not be able to avail themselves of in-office
treatments, it may be viewed by our partner clinics as a channel conflict and cause a deterioration in our relationships with our
current partners or negatively impact our ability to grow the number of partner clinics.

The success of our products depends on third-party reimbursement of patients' costs, which could result in potentially reduced
prices or reduced demand and adversely affect our revenues and business operations.

Our  ability  to  market  our  products  successfully,  especially  XTRAC  treatments,  depends  in  large  part  on  the  extent  to
which  various  third  parties  are  willing  to  reimburse  patients  or  providers  for  the  costs  of  medical  procedures  utilizing  such
products.  These  third  parties  include  government  authorities,  private  health  insurers  and  other  organizations,  such  as  health
maintenance  organizations,  whose  patterns  of  reimbursement  may  change  as  a  result  of  new  standards  for  reimbursement
determined by these third parties or because of the programs and policies enacted under the ACA.

Third-party payers are systematically challenging the prices charged for medical products and services. They may deny
reimbursement  if  they  determine  that  a  prescribed  device  is  not  used  in  accordance  with  cost-effective  treatment  methods  as
determined  by  the  payer,  or  is  experimental,  unnecessary  or  inappropriate.  Further,  although  third  parties  may  approve
reimbursement, such approvals may be under terms and conditions that discourage use of

16

 
 
 
 
 
 
 
 
 
 
 
the XTRAC system. Accordingly, if less costly drugs or other treatments are available, third-party payers may not authorize or
may limit reimbursement for the use of our products, even if our products are safer or more effective than the alternatives.

In addition, medical insurance policies and treatment coverage have been and may be affected by the parameters of the
ACA or successor policies enacted by the current or any new administration. While the ACA's stated purpose is to expand access
to  coverage,  it  also  mandates  certain  requirements  regarding  the  types  and  limitations  of  insurance  coverage.  There  can  be  no
guarantee that the changes in coverage under the ACA will not affect the type and level of reimbursement for our products.

Although we have received reimbursement approvals from a majority of private healthcare plans for the XTRAC system,
we cannot give assurance that these private plans will continue to adopt or maintain favorable reimbursement policies or accept
the XTRAC system in its clinical role as a second-line therapy in the treatment of psoriasis. Additionally, third-party payers may
require  further  clinical  studies  or  changes  to  our  pricing  structure  and  revenue  model  before  authorizing  or  continuing
reimbursement.

As  of  March  10,  2020,  we  estimate,  based  on  published  coverage  policies  and  on  payment  practices  of  private  and
Medicare insurance plans, that more than 86% of the insured population in the U.S. is covered by insurance coverage or payment
policies that reimburse physicians for using the XTRAC system for treatment of psoriasis. We can give no assurance that health
insurers will not adversely modify their reimbursement policies for the use of the XTRAC system in the future.

The continuing development of our products depends upon our developing and maintaining strong working relationships with
physicians.

The research, development, marketing and sale of our current products and any potential new and improved products or
future  product  indications  for  which  we  receive  regulatory  clearance  or  approval  depend  upon  our  maintaining  working
relationships  with  physicians.  We  rely  on  these  professionals  to  provide  us  with  considerable  knowledge  and  experience
regarding  the  development,  marketing  and  sale  of  our  products.  Physicians  assist  us  as  researchers,  marketing  and  product
consultants and public speakers. If we cannot maintain our strong working relationships with these professionals and continue to
receive their advice and input, the development and marketing of our products could suffer, which could have a material adverse
effect on our business, financial condition, and results of operations. At the same time, companies in the medical device industry
are under increasing scrutiny by the U.S. Department of Health and Human Services Office of Inspector General, or OIG, and the
U.S.  Department  of  Justice,  or  DOJ  for  improper  relationships  with  physicians.  Our  failure  to  comply  with  requirements
governing  the  industry’s  relationships  with  physicians,  including  the  reporting  of  certain  payments  to  physicians  under  the
National Physician Payment Transparency Program (Open Payments) or an investigation into our compliance by the OIG or the
DOJ, could have a material adverse effect on our business, financial condition, and results of operations.

Any failure in our customer education efforts could have a material adverse effect on our revenue and cash flow.

It  is  important  to  the  success  of  our  marketing  efforts  to  educate  physicians  and  technicians  how  to  properly  use  our
products.  We  rely  on  physicians  to  spend  their  time  and  money  to  participate  in  our  pre-installation  educational  sessions.
Moreover, if physicians and technicians use our products improperly, they may have unsatisfactory patient outcomes or, in the
case of the XTRAC system, cause patient injury, which may give rise to negative publicity or lawsuits against us, any of which
could have a material adverse effect on our reputation, revenues and profitability.

If revenue from a significant customer declines, we may have difficulty replacing the lost revenue, which would negatively
affect our results and operations.

In our international business, we depend for a material portion of our sales in the international arena on several key sub-
distributors. Historically, we relied on a single master distributor, GlobalMed, for international sales of our XTRAC and VTRAC
products. We have recently entered into direct relationships with in-country distributors and have retained GlobalMed’s services
to facilitate the relationships and management of those parties. If we lose GlobalMed or one of these distributors, our sales of
phototherapy products are likely to suffer in the short term, which could have a negative effect on our revenues and profitability.

17

 
 
 
 
 
 
 
 
 
 
 
If we fail to execute our recurring revenue strategy outside the United States, we may have difficulty replacing the lost
revenue from equipment sales, which would negatively affect our results and operations.

As we begin to transition our international business from capital sales to the recurring revenue model, we will reduce our
capital sales in the short term for higher recurring revenue in the long term. If we and our in-country distributors fail to obtain
recurring customers timely, it could have a negative impact on our revenues and profitability.

If we fail to manage our sales and marketing force or to market and distribute our products effectively, we may experience
diminished revenues and profits.

There are significant risks involved in managing our sales and marketing force and marketing our products, including our

ability:

•

•

•

•

to  hire,  as  needed,  a  sufficient  number  of  qualified  sales  and  marketing  personnel  with  the  aptitude,  skills  and  understanding  to  market  our
products;
to adequately train our sales and marketing force in the use and benefits of all our products and services, thereby making them more effective
promoters;
to manage our sales and marketing force and our ancillary channels (e.g., telesales) such that variable and semi-fixed expenses grow at a lesser
rate than our revenues; and
to set the prices and other terms and conditions for treatments using the XTRAC system in a complex legal environment so that treatments will be
accepted as attractive skin health and appropriate alternatives to conventional modalities and treatments.

To  increase  acceptance  and  utilization  of  our  products,  we  may  expand  our  sales  and  marketing  programs  in  the  U.S.
While we may be able to draw on currently available personnel within our organization to meet this need, we also expect that we
will have to increase the number of representatives devoted to the sales and marketing programs and to broaden, through such
representatives,  the  talents  we  have  at  our  disposal.  In  some  cases,  we  may  look  outside  our  organization  for  assistance  in
marketing our products.

We are reliant on a limited number of suppliers for production of our products.

Production of our products requires specific component parts obtained from our suppliers. While we believe that we could
find  alternate  suppliers,  in  the  event  that  our  current  suppliers  fail  to  meet  our  needs,  a  change  in  suppliers  or  any  significant
delay in our ability to  have  access  to  such  resources  could  have  a  material  adverse effect on our delivery schedules, business,
operating results and financial condition. Moreover, in the event we can no longer utilize this supplier or acquire this resource and
must  identify  a  new  supplier  or  substitute  a  different  resource,  such  change  may  trigger  an  obligation  for  us  to  comply  with
additional  FDA  regulatory  requirements  including,  but  not  limited  to,  premarketing  authorization  and  Quality  System
Requirements (“QSR”).

Our  failure  to  respond  to  rapid  changes  in  technology  and  other  applications  in  the  medical  devices  industry  or  the
development of a cure for skin conditions treated by our products could make our treatment system obsolete.

The medical device industry is subject to rapid and substantial technological development and product innovations. To be
successful,  we  must  respond  to  new  developments  in  technology,  new  applications  of  existing  technology  and  new  treatment
methods. Our financial condition and operating results could be adversely affected if we fail to be responsive on a timely and
effective basis to competitors' new devices, applications, treatments or price strategies. For example, the development of a cure
for psoriasis, vitiligo, atopic dermatitis or leukoderma would eliminate the need for our XTRAC system for these diseases and
would  require  us  to  focus  on  other  uses  of  our  technology,  which  could  have  a  material  adverse  effect  on  our  business  and
prospects.

As  we  develop  new  products  or  improve  our  existing  products,  we  may  accelerate  the  economic  obsolescence  of  the
existing, unimproved products and their components. The obsolete products and related components may have little to no resale
value,  leading  to  an  increase  in  the  reserves  we  have  against  our  inventory.  Likewise,  there  is  a  risk  that  the  new  products  or
improved existing products may not achieve market acceptance and therefore may also lead to an increase in the reserves against
our inventory.

18

 
 
 
 
 
 
 
 
 
 
 
 
Our customers, or physicians and technicians, as the case may be, may misuse certain of our products, and product liability
lawsuits and other damages imposed on us may exceed our insurance coverage, or we may be subject to claims that are not
covered by insurance.

We face an inherent risk of product liability as a result of the marketing and sale of our products. For example, we may be
sued  if  our  products  cause  or  are  perceived  to  cause  injury  or  are  found  to  be  otherwise  unsuitable  during  manufacturing,
marketing  or  sale.  Any  such  product  liability  claim  may  include  allegations  of  defects  in  manufacturing,  defects  in  design,  a
failure  to  warn  of  dangers  inherent  in  the  product,  negligence,  strict  liability  or  breach  of  warranty.  Our  products  are  highly
complex,  and  some  are  used  to  treat  delicate  skin  conditions  on  and  near  a  patient's  face.  In  addition,  the  clinical  testing,
manufacturing,  marketing  and  use  of  certain  of  our  products  and  procedures  may  also  expose  us  to  product  liability,  FDA
regulatory and/or legal actions, or other claims. If a physician elects to apply an off-label use and the use leads to injury, we may
be involved in costly litigation. In addition, the fact that we train technicians whom we do not supervise in the use of our XTRAC
system during patient treatment may expose us to third-party claims if we are accused of providing inadequate training. We may
also  be subject to claims  against  us  even  if  the apparent injury is due to the actions of others or the pre-existing health of the
patient. For example, we rely on physicians in connection with the use of our products on patients. If these physicians are not
properly trained or are negligent, the capabilities and safety features of our products may be diminished or the patient may suffer
critical injury. We may also be subject to claims that are caused by the actions of our suppliers, such as those who provide us with
components and sub-assemblies.

We  presently  maintain  liability  insurance  with  coverage  limits  of  at  least  $5.0  million  per  occurrence  and  overall
aggregate, which we believe is an adequate level of product liability insurance, but product liability insurance is expensive and
we might not be able to obtain product liability insurance in the future on acceptable terms or in sufficient amounts to protect us,
if at all. Our insurance policy contains various exclusions, and we may be subject to a product liability claim for which we have
no coverage. A successful claim brought against us in excess of our insurance coverage could have a material adverse effect on
our  business,  results  of  operations  and  financial  condition.  Even  successful  defense  would  require  significant  financial  and
management  resources.  In  addition,  continuing  insurance  coverage  may  also  not  be  available  at  an  acceptable  cost,  if  at  all.
Therefore, we may not be able to obtain insurance coverage that will be adequate to satisfy a liability that may arise. Regardless
of  merit  or  eventual  outcome,  product  liability  claims  may  result  in  decreased  demand  for  a  product,  harm  to  our  reputation,
withdrawal of clinical trial volunteers, initiation of investigations by regulators, costs to defend the related litigation, diversion of
management’s time and our resources, monetary awards to trial participants or patients, product recalls, withdrawals or labeling,
marketing or promotional restrictions, exhaustion of any available insurance and our capital resources, a resulting decline in the
price of our common stock and loss of revenues. As a result, regardless of whether we are insured, a product liability claim or
product recall may result in losses that could result in the FDA taking legal or regulatory enforcement action against us and/or
our  products  including  recall,  and  could  have  a  material  adverse  effect  upon  our  business,  financial  condition  and  results  of
operations.

We must comply with complex statutes prohibiting fraud and abuse, and both we and physicians utilizing our products could
be subject to significant penalties for noncompliance.

There are extensive federal and state laws and regulations prohibiting fraud and abuse in the healthcare industry that can

result in significant criminal and civil penalties. These federal laws include:

•

•
•

•

the  anti-kickback  statute  which  prohibits  certain  business  practices  and  relationships,  including  the  payment  or  receipt  of  remuneration  for  the
referral of patients whose care will be paid by Medicare or other federal healthcare programs, as modified by the ACA;
the physician self-referral prohibition, commonly referred to as the Stark Law;
the anti-inducement law, which prohibits providers from offering anything to a Medicare or Medicaid beneficiary to induce that beneficiary to use
items or services covered by either program; the Civil False Claims Act, which prohibits any person from knowingly presenting or causing to be
presented false or fraudulent claims for payment by the federal government, including the Medicare and Medicaid programs; and
the Civil Monetary Penalties Law, which authorizes HHS to impose civil penalties administratively for fraudulent or abusive acts. Sanctions for
violating these federal laws include criminal and civil penalties that range from punitive sanctions, damage assessments, monetary penalties, and
imprisonment, denial of Medicare and Medicaid payments, or exclusion from the Medicare and Medicaid programs, or both.

19

 
 
 
 
 
 
 
 
 
As  federal  and  state  budget  pressures  continue,  federal  and  state  administrative  agencies  may  also  continue  to  escalate
investigation  and  enforcement  efforts  to  root  out  waste  and  to  control  fraud  and  abuse  in  governmental  healthcare  programs.
Private enforcement of healthcare fraud has also increased, due in large part to amendments to the Civil False Claims Act in 1986
that were designed to encourage private persons to sue on behalf of the government. A violation of any of these federal and state
fraud  and  abuse  laws  and  regulations  could  have  a  material  adverse  effect  on  our  liquidity  and  financial  condition.  An
investigation into the use of our products by physicians may dissuade physicians from either purchasing or using our products
and could have a material adverse effect on our revenues.

We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and regulations and could face
substantial penalties if we are unable to fully comply with such laws.

While we do not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payers,
many healthcare laws and regulations apply to our business. For example, we could be subject to healthcare fraud and abuse and
patient privacy regulation and enforcement by both the federal government and the states in which we conduct our business. The
healthcare laws and regulations that may affect our ability to operate include:

•

•

•

•

the  federal  healthcare  programs’  anti-kickback  laws,  as  modified  by  the  ACA,  which  prohibits,  among  other  things,  persons  or  entities  from
soliciting, receiving, offering or providing remuneration, directly or indirectly, in return for or to induce either the referral of an individual for, or
the purchase order or recommendation of, any item or service for which payment may be made under a federal healthcare program such as the
Medicare and Medicaid programs;
federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims
for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, or are for items or services not provided as claimed
and which may apply to entities like us to the extent that our interactions with customers may affect their billing or coding practices;
HIPAA,  which  established  new  federal  crimes  for  knowingly  and  willfully  executing  a  scheme  to  defraud  any  healthcare  benefit  program  or
making false statements in connection with the delivery of or payment for healthcare benefits, items or services, as well as leading to regulations
imposing certain requirements relating to the privacy, security and transmission of individually identifiable health information; and
state  law  equivalents  of  each  of  the  above  federal  laws,  such  as  anti-kickback  and  false  claims  laws  which  may  apply  to  items  or  services
reimbursed  by  any  third-party  payer,  including  commercial  insurers,  and  state  laws  governing  the  privacy  of  health  information  in  certain
circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance
efforts.

The  medical  device  industry  has  been  under  heightened  scrutiny  as  the  subject  of  government  investigations  and
regulatory  or  legal  enforcement  actions  involving  manufacturers  who  allegedly  offered  unlawful  inducements  to  potential  or
existing customers in an attempt to procure their business, including arrangements with physician consultants. If our operations
or arrangements are found to be in violation of any of the laws described above or any other governmental regulations that apply
to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from the Medicare and
Medicaid programs and the curtailment or restructuring of its operations. Any penalties, damages, fines, exclusions, curtailment
or restructuring of our operations could adversely affect our ability to operate our business and our financial results. The risk of
us being found in violation of these laws is increased by the fact that many of these laws are broad and their provisions are open
to a variety of interpretations. Any action against us for violation of these laws, even if we successfully defend against that action
and the underlying alleged violations, could cause us to incur significant legal expenses and divert our management’s attention
from the operation of our business. If the physicians or other providers or entities with whom we do business are found to be non-
compliant with applicable laws, they may be subject to sanctions, which could also have a negative impact on our business.

20

 
 
 
 
 
 
 
 
 
 
If the effectiveness and safety of our devices are not supported by long-term data, and the level of acceptance of our products
by dermatologists does not increase or is not maintained, our revenues could decline.

Our products may not be accepted in the market if we do not produce clinical data supported by the independent efforts of
clinicians. We received clearance from the FDA for the use of the XTRAC system to treat psoriasis based upon our study of a
limited number of patients. Safety and efficacy data presented to the FDA for the XTRAC system was based on studies on these
patients. For the treatment of vitiligo, atopic dermatitis and leukoderma, we have received clearance from the FDA for the use of
the  XTRAC  system  based  primarily  on  a  showing  of  substantial  equivalence  to  other  previously  cleared  predicate  devices.
However, we may discover that physicians will expect clinical data on such treatments with the XTRAC system. We also may
find  that  data  from  longer-term  psoriasis  patient  follow-up  studies  may  be  inconsistent  with  those  indicated  by  our  relatively
short-term  data.  If  longer-term  patient  studies  or  clinical  experience  indicate  that  treatment  with  the  XTRAC  system  does  not
provide  patients  with  sustained  benefits  or  that  treatment  with  our  product  is  less  effective  or  less  safe  than  our  current  data
suggests, our revenues could decline. In addition, the FDA could then bring legal or regulatory enforcement actions against us
and/or  our  products  including,  but  not  limited  to,  recalls  or  requirements  for  premarket  510(k)  authorizations.  We  can  give  no
assurance that our data will be substantiated in studies involving more patients. In such a case, we may never achieve significant
revenues or profitability.

Our  failure  to  obtain  or  maintain  necessary  FDA  clearances  and  approvals,  or  to  maintain  continued  clearances,  or
equivalents thereof in the U.S. and relevant foreign markets, could hurt our ability to distribute and market our products.

In  both  our  U.S.  and  foreign  markets,  we  are  affected  by  extensive  laws,  governmental  regulations,  administrative
determinations, court decisions and similar constraints. Such laws, regulations and other constraints may exist at the federal, state
or  local  levels  in  the  U.S.  and  at  analogous  levels  of  government  in  foreign  jurisdictions.  In  addition,  the  formulation,
manufacturing, packaging, labeling, distribution, importation, sale and storage of our products are subject to extensive regulation
by various federal agencies, including, but not limited to, the FDA and the FTC, State Attorneys General in the U.S., as well as
by  various  other  federal,  state,  local  and  international  regulatory  authorities  in  the  countries  in  which  our  products  are
manufactured, distributed or sold. If we or our manufacturers fail to comply with those regulations, we could become subject to
significant penalties or claims, which could harm our results of operations or our ability to conduct our business. In addition, the
adoption of new regulations or changes in the interpretations of existing regulations may result in significant compliance costs or
discontinuation  of  product  sales  and  may  impair  the  marketing  of  our  products,  resulting  in  significant  loss  of  net  sales.  Our
failure  to  comply  with  federal  or  state  regulations,  or  with  regulations  in  foreign  markets  that  cover  our  product  claims  and
advertising,  including  direct  claims  and  advertising  by  us,  may  result  in  enforcement  actions  and  imposition  of  penalties  or
otherwise harm the distribution and sale of its products. Further, our businesses are subject to laws governing our accounting, tax
and import and export activities. Failure to comply with these requirements could result in legal and/or financial consequences
that might adversely affect our sales and profitability. Each medical device that we wish to market in the U.S. must first receive
either 510(k) clearance or PMA from the FDA unless an exemption applies. Either process can be lengthy and expensive. The
FDA's 510(k) clearance process may take from three to twelve months, or longer, and may or may not require human clinical
data. The PMA process is much more costly and lengthy. It may take from eleven months to three years, or even longer, and will
likely require significant supporting human clinical data. Delays in obtaining regulatory clearance or approval could adversely
affect our  revenues  and  profitability.  Although  we  have  obtained  510(k)  clearances  for  our  XTRAC  system  for  use  in  treating
psoriasis,  vitiligo,  atopic  dermatitis  and  leukoderma,  these  approvals  and  clearances  may  be  subject  to  revocation  if  post-
marketing data demonstrates safety issues or lack of effectiveness.

Many  medical  devices,  such  as  medical  lasers,  are  also  regulated  by  the  FDA  as  “electronic  products.”  In  general,
manufacturers and marketers of “electronic products” are subject to certain FDA regulatory requirements intended to ensure the
radiological safety of the products. These requirements include, but are not limited to, filing certain reports with the FDA about
the products and defects/safety issues related to the products as well as complying with radiological performance standards.

21

 
 
 
 
 
 
 
 
 
The  medical  device  industry  is  now  experiencing  greater  scrutiny  and  regulation  by  federal,  state  and  foreign
governmental authorities. Companies in our industry are subject to more frequent and more intensive reviews and investigations,
often involving the marketing, business practices, and product quality management. Such reviews and investigations may result
in civil and criminal proceedings; the imposition of substantial fines and penalties; the receipt of warning letters, untitled letters,
demands  for  recalls  or  the  seizure  of  our  products;  the  requirement  to  enter  into  corporate  integrity  agreements,  stipulated
judgments or other administrative remedies, and result in our incurring substantial unanticipated costs and the diversion of key
personnel  and  management’s  attention  from  their  regular  duties,  any  of  which  may  have  an  adverse  effect  on  our  financial
condition, results of operations and liquidity, and may result in greater and continuing governmental scrutiny of our business in
the future.

Additionally,  federal,  state  and  foreign  governments  and  entities  have  enacted  laws  and  issued  regulations  and  other
standards  requiring  increased  visibility  and  transparency  of  our  interactions  with  healthcare  providers.  For  example,  the  U.S.
Physician Payment Sunshine Act, now known as Open Payments, requires us to report to the Centers for Medicare & Medicaid
Services,  or  CMS,  payments  and  other  transfers  of  value  to  all  U.S.  physicians  and  U.S.  teaching  hospitals,  with  the  reported
information  made  publicly  available  on  a  searchable  website.  Effective  January  2022  we  will  also  be  required  to  collect  and
report  information  on  payments  or  transfers  of  value  to  physician  assistants,  nurse  practitioners,  clinical  nurse  specialists,
certified  registered  nurse  anesthetists  and  certified  nurse-midwives.  Failure  to  comply  with  these  legal  and  regulatory
requirements could impact our business, and we have had and will continue to spend substantial time and financial resources to
develop  and  implement  enhanced  structures,  policies,  systems  and  processes  to  comply  with  these  legal  and  regulatory
requirements,  which  may  also  impact  our  business  and  which  could  have  a  material  adverse  effect  on  our  business,  financial
condition, and results of operations.

International regulatory approval processes may take more or less time than the FDA clearance or approval process. If we
fail to comply with applicable FDA and comparable non-U.S. regulatory requirements, we may not receive regulatory clearances
or  approvals  or  may  be  subject  to  FDA  or  comparable  non-U.S.  enforcement  actions.  We  may  be  unable  to  obtain  future
regulatory clearance or approval in a timely manner, or at all, especially if existing regulations are changed or new regulations are
adopted.  For  example,  the  FDA  clearance  or  approval  process  can  take  longer  than  anticipated  due  to  requests  for  additional
clinical data and changes in regulatory requirements. A failure or delay in obtaining necessary regulatory clearances or approvals
would materially adversely affect our business, financial condition, and results of operations.

Further,  more  stringent  regulatory  requirements  or  safety  and  quality  standards  may  be  issued  in  the  future  with  an
adverse effect on our business. We have ceased manufacturing and marketing MelaFind but must still maintain records for FDA
and foreign regulatory purposes.

If  required,  clinical  trials  necessary  to  support  a  510(k)  notice  or  PMA  application,  for  new  or  modified  products,  will  be
expensive and will require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and
recruit. Delays or failures in our clinical trials will prevent us from commercializing any modified or new products and will
adversely affect our business, operating results and prospects.

Initiating and completing clinical trials necessary to support a 510(k) notice or a PMA application will be time-consuming
and  expensive  and  the  outcome  uncertain.  Moreover,  the  results  of  early  clinical  trials  are  not  necessarily  predictive  of  future
results, and any product we advance into clinical trials may not have favorable results in early or later clinical trials.

Conducting successful clinical studies will require the enrollment of large numbers of patients, and suitable patients may
be  difficult  to  identify  and  recruit.  Patient  enrollment  in  clinical  trials  and  completion  of  patient  participation  and  follow-up
depend on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the
discomforts  and  risks  associated  with,  the  treatments  received  by  patients  enrolled  as  subjects,  the  availability  of  appropriate
clinical trial investigators, support staff, and proximity of patients to clinical sites and ability to comply with the eligibility and
exclusion criteria for participation in the clinical  trial  and  patient  compliance.  For  example,  patients  may  be  discouraged  from
enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to
assess the safety and effectiveness of our products or if they determine that the treatments received under the trial protocols are
not attractive or involve unacceptable risks or discomforts. Patients may also not participate in our clinical trials if they choose to
participate in contemporaneous clinical trials of competitive products. In addition, patients participating in clinical trials may die
before completion of the trial or suffer adverse medical events unrelated to investigational products.

22

 
 
 
 
 
 
 
 
 
 
 
Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy may be required and we
may not adequately develop such protocols to support clearance and approval. Further, the FDA may require us to submit data on
a  greater  number  of  patients  than  we  originally  anticipated  and/or  for  a  longer  follow-up  period  or  change  the  data  collection
requirements or data analysis for any clinical trials. Delays in patient enrollment or failure of patients to continue to participate in
a  clinical  trial  may  cause  an  increase  in  costs  and  delays  in  the  approval  and  attempted  commercialization  of  our  products  or
result in the failure of the clinical trial. The FDA may not consider our data adequate to demonstrate safety and efficacy. Such
increased costs and delays or failures could adversely affect our business, operating results and prospects.

Our medical device operations are subject to FDA regulatory requirements.

Medical devices regulated by the FDA are subject to “general controls” which include: registration with the FDA; listing
commercially  distributed  products  with  the  FDA;  complying  with  good  manufacturing  practices  under  the  quality  system
regulations; filing reports with the FDA and keeping records relative to certain types of adverse events associated with devices
under  the  medical  device  reporting  regulation;  assuring  that  device  labeling  complies  with  device  labeling  requirements;
reporting  certain  device  field  removals  and  corrections  to  the  FDA;  and  obtaining  premarket  notification  510(k)  clearance  for
devices  prior  to  marketing.  Some  devices  known  as  “510(k)-exempt”  can  be  marketed  without  prior  marketing  clearance  or
approval  from  the  FDA.  In  addition  to  the  “general  controls,”  some  Class  II  medical  devices  are  also  subject  to  “special
controls,”  including  adherence  to  a  particular  guidance  document  and  compliance  with  the  performance  standard.  Instead  of
obtaining  510(k)  clearance,  some  Class  III  devices  are  subject  to  PMA.  In  general,  obtaining  PMA  to  achieve  marketing
authorization from the FDA is a more onerous process than seeking 510(k) clearance.

Many  medical  devices,  such  as  medical  lasers,  are  also  regulated  by  the  FDA  as  “electronic  products.”  In  general,
manufacturers and marketers of “electronic products” are subject to certain FDA regulatory requirements intended to ensure the
radiological safety of the products. These requirements include, but are not limited to, filing certain reports with the FDA about
the products and defects/safety issues related to the products as well as complying with radiological performance standards.

The  medical  device  industry  is  now  experiencing  greater  scrutiny  and  regulation  by  federal,  state  and  foreign
governmental authorities. Companies in our industry are subject to more frequent and more intensive reviews and investigations,
often  involving  the  marketing,  business  practices,  and  product  quality  management  including  standards  for  device  recalls  and
product labeling. Such reviews and investigations may result in civil and criminal proceedings; the imposition of substantial fines
and penalties; the receipt of warning letters, untitled letters, demands for recalls or the seizure of our products; the requirement to
enter  into  corporate  integrity  agreements,  stipulated  judgments  or  other  administrative  remedies,  and  result  in  our  incurring
substantial unanticipated costs and the diversion of key personnel and management’s attention from their regular duties, any of
which may have an adverse effect on our financial condition, results of operations and liquidity, and may result in greater and
continuing governmental scrutiny of our business in the future.

We must also have the appropriate FDA clearances and/or approvals from other governmental entities in order to lawfully
market  devices  and/or  drugs.  The  FDA,  federal,  state  or  foreign  governments  and  agencies  may  disagree  that  we  have  such
clearance and/or approvals for all of our products and may take action to prevent the marketing and sale of such devices until
such disagreements have been resolved.

Additionally,  federal,  state  and  foreign  governments  and  entities  have  enacted  laws  and  issued  regulations  and  other
standards  requiring  increased  visibility  and  transparency  of  our  interactions  with  healthcare  providers.  For  example,  the  U.S.
Physician Payment Sunshine Act requires us to disclose payments and other transfers of value to all U.S. physicians and U.S.
teaching hospitals at the U.S. federal level made. Failure to comply with these legal and regulatory requirements could impact our
business,  and  we  have  had  and  will  continue  to  spend  substantial  time  and  financial  resources  to  develop  and  implement
enhanced  structures,  policies,  systems  and  processes  to  comply  with  these  legal  and  regulatory  requirements,  which  may  also
impact our business.

23

 
 
 
 
 
 
 
 
 
 
 
 
Healthcare policy changes may have a material adverse effect on us.

Healthcare costs have risen significantly over the past decade. As a result, there have been and continue to be proposals
by federal, state and foreign governments and regulators as well as third-party insurance providers to limit the growth of these
costs.  Among  these  proposals  are  regulations  that  could  impose  limitations  on  the  prices  we  will  be  able  to  charge  for  our
products,  the  amounts  of  reimbursement  available  for  our  products  from  governmental  agencies  or  third-party  payers,
requirements  regarding  the  usage  of  comparative  studies,  technology  assessments  and  healthcare  delivery  structure  reforms  to
determine the effectiveness and select the products and therapies used for treatment of patients. While we believe our products
provide  favorable  clinical  outcomes,  value  and  cost  efficiency,  the  resources  necessary  to  demonstrate  this  value  to  our
customers,  patients,  payers,  and  regulators  is  significant  and  may  require  longer  periods  of  time  and  effort  in  which  to  obtain
acceptance of our products. There is no assurance that our efforts will be successful, and these limitations could have a material
adverse effect on our financial position and results of operations.

These changes and additional proposed changes in the future could adversely affect the demand for our products as well
as  the  way  in  which  we  conduct  our  business.  For  example,  the  ACA  was  enacted  into  law  in  the  U.S.  in  March  2010.  They
imposed, on medical device manufacturers, a requirement to research into the effectiveness of treatment modalities and institute
changes  to  the  reimbursement  and  payment  systems  for  patient  treatments.  In  addition,  governments  and  regulatory  agencies
continue to study and propose changes to the laws governing the clearance or approval, manufacture and marketing of medical
devices, which could adversely affect our business and results of operations.

FDA  regulations  and  guidance  are  often  revised  or  reinterpreted  by  the  FDA  in  ways  that  may  significantly  affect  our
business  and  our  products.  The  FDA  is  currently  exploring  ways  to  modify  its  510(k)  clearance  process.  In  addition,  due  to
changes at the FDA in general, it has become increasingly more difficult to obtain 510(k) clearance as data requirements have
increased. It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance or interpretations
changed,  and  what  the  impact  of  such  changes,  if  any,  may  be.  However,  any  changes  could  make  it  more  difficult  for  us  to
maintain or attain clearance or approval to develop and commercialize our products and technologies.

Various healthcare reform proposals have also emerged at the state level. We cannot predict what healthcare initiatives, if
any,  will  be  implemented  at  the  federal  or  state  level,  or  the  effect  any  future  legislation  or  regulation  will  have  on  us.
Furthermore,  an  expansion  in  government’s  role  in  the  U.S.  healthcare  industry  may  lower  reimbursements  for  our  products,
reduce  medical  procedure  volumes  and  adversely  affect  our  business,  possibly  materially.  In  addition,  if  the  excise  taxes
contained in the House or Senate health reform bills are enacted into law, our loss from continuing operations resulting from such
an excise tax and results of operations would be materially and adversely affected.

Our market acceptance in international markets requires regulatory approvals from foreign governments and may depend on
third party reimbursement of participants' cost.

We  have  introduced  our  XTRAC  and  VTRAC  products  into  markets  in  more  than  30  countries  in  Europe,  the  Middle
East, Asia, Australia, South Africa and parts of Central and South America through distributors. We cannot be certain that our
salesforce and distributor network will be successful in marketing our products in these or other countries or that our distributors
will purchase XTRAC or VTRAC systems beyond their current contractual obligations or in accordance with our expectations.

Even  if  we  obtain  and  maintain  the  necessary  foreign  regulatory  registrations  or  approvals,  market  acceptance  of  our
products in international markets may be dependent, in part, upon the availability of reimbursement within applicable healthcare
payment  systems.  Reimbursement  and  healthcare  payment  systems  in  international  markets  vary  significantly  by  country,  and
include  both  government-sponsored  healthcare  and  private  insurance.  We  may  seek  international  reimbursement  approvals  for
our products, but we cannot assure you that any such approvals will be obtained in a timely manner, if at all. Failure to receive
international reimbursement approvals in any given market could have a material adverse effect on the acceptance or growth of
our products in that market or others.

24

 
 
 
 
 
 
 
 
 
 
 
 
 
We face substantial competition, which may result in others discovering, developing or commercializing products more
successfully than us.

The medical device industry is intensely competitive and subject to rapid and significant technological change. Many of
our competitors have significantly greater financial, technical and human resources. Smaller and early-stage companies may also
prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Our competitors in medical device or pharmaceutical industries may also develop products that are more effective, more
convenient, more widely used, less costly, or have a better safety profile than our products and these competitors may also be
more successful than us in manufacturing and marketing their products.

Our  competitors  also  compete  with  us  in  recruiting  and  retaining  qualified  scientific,  management  and  commercial
personnel, as well as in acquiring technologies complementary to, or necessary for, our programs. Competition for these people in
the medical device industry is intense and we may face challenges in retaining and recruiting such individuals if, for example,
other  companies  may  provide  more  generous  compensation  and  benefits,  more  diverse  opportunities,  and  better  chances  for
career advancement than we do. Some of these advantages may be more appealing to high-quality candidates and employees than
those we have to offer. In addition, the decline in our stock price has created additional challenges by reducing the retention value
of our equity awards. Because of the complex and technical nature of our systems and the dynamic market in which we compete,
any  failure  to  attract  and  retain  a  sufficient  number  of  qualified  employees  could  materially  harm  our  ability  to  develop  and
commercialize our technology, which would have a material adverse effect on our business, financial condition, and results of
operations.

Consolidation in the medical device industry could have an adverse effect on our revenue and results of operations.

Many medical device industry companies are consolidating to create new companies with greater market power. As the
medical  device  industry  consolidates,  competition  to  provide  goods  and  services  to  industry  participants  will  become  more
intense. These industry participants may try to use their market power to bundle the sale of more products to our customers in
return for lower prices. If we reduce our prices because of consolidation in the healthcare industry, our revenue would decrease
and our earnings, financial condition, or cash flows would suffer, which would have a material adverse effect on our business,
financial condition, and results of operations.

We actively employ social media as part of our marketing strategy, which could give rise to regulatory violations, liability,
breaches of data security or reputational damage.

Despite our efforts to monitor evolving social media communication guidelines and comply with applicable rules, there is
risk that the use of social media by us, our employees or our customers to communicate about our products or business may cause
us to be found in violation of applicable requirements, including requirements of regulatory bodies such as the FDA and Federal
Trade  Commission.  For  example,  promotional  communications  and  endorsements  on  social  media  that,  among  other  things,
promote our products for uses or in patient populations that are not described in the product’s approved labeling (known as “off-
label uses”), do not contain a fair balance of information about risks associated with using our products, make comparative or
other claims about our products that are not supported by sufficient evidence, and/or do not contain required disclosures could
result  in  enforcement  actions  against  us.  In  addition,  adverse  events,  product  complaints,  off-label  usage  by  physicians,
unapproved marketing or other unintended messages posted on social media could require an active response from us, which may
not  be  completed  in  a  timely  manner  and  could  result  in  regulatory  action  by  a  governing  body.  Further,  our  employees  may
knowingly or inadvertently make use of social media in ways that may not comply with our corporate policies or other legal or
contractual requirements, which may give rise to liability, lead to the loss of trade secrets or other intellectual property, or result
in public exposure of personal information of our employees, clinical trial patients, customers and others. Furthermore, negative
posts or comments about us or our products in social media could seriously damage our reputation, brand image and goodwill,
which would have a material adverse effect on our business, financial condition, and results of operations.

25

 
 
 
 
 
 
 
 
 
 
 
 
 
We  may  become  subject  to  claims  of  infringement  or  misappropriation  of  the  intellectual  property  rights  of  others,  which
could prohibit us from shipping affected products, require us to obtain licenses from third parties or to develop non-infringing
alternatives,  and  subject  us  to  substantial  monetary  damages  and  injunctive  relief.  Our  patents  may  also  be  subject  to
challenge on validity grounds, and our patent applications may be rejected.

Third parties could, in the future, assert infringement or misappropriation claims against us with respect to our current or
future products. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is
often uncertain. Therefore, we cannot be certain that we have not infringed the intellectual property rights of such third parties.
Our potential competitors may assert that some aspect of our products infringes their patents. There also may be existing patents
of which we are unaware that one or more components of our products may inadvertently infringe.

Any  infringement  or  misappropriation  claim  could  cause  us  to  incur  significant  costs,  could  place  significant  strain  on  our
financial resources, divert management’s attention from our business and harm our reputation. If the relevant patents were upheld
as valid and enforceable and we were found to infringe, we could be prohibited from selling our product unless we could obtain
licenses to use the technology covered by the patent or are able to design around the patent. We may be unable to obtain a license
on terms acceptable to us, if at all, and we may not be able to redesign the affected product to avoid infringement. 

A  court  could  order  us  to  pay  compensatory  damages  for  such  infringement,  plus  prejudgment  interest  and  could,  in
addition,  treble  the  compensatory  damages  and  award  attorney  fees.  These  damages  could  be  substantial  and  could  harm  our
reputation, business, financial condition and operating results. A court also could enter orders that temporarily, preliminarily or
permanently enjoin us and our customers from making, using, selling, offering to sell or importing our products, and/or could
enter an order mandating that we undertake certain remedial activities. Depending on the nature of the relief ordered by the court,
we could become liable for additional damages to third parties.

We  rely  on  our  patents,  patent  applications  and  other  intellectual  property  rights  to  give  us  a  competitive  advantage.
Whether a patent is valid, or whether a patent application should be granted, is a complex matter of science and law. Therefore,
we cannot be certain that, if challenged, our patents, patent applications and/or other intellectual property rights would be upheld.
If  one  or  more  of  those  patents,  patent  applications  and  other  intellectual  property  rights  are  invalidated,  rejected  or  found
unenforceable, those outcomes could reduce or eliminate any competitive advantage we might otherwise have had.

If we or our third-party manufacturers or suppliers fail to comply with the FDA’s Quality System Regulation or any applicable
state  equivalent,  our  manufacturing  operations  could  be  interrupted  and  our  potential  product  sales  and  operating  results
could suffer.

We and some of our third-party manufacturers and suppliers are required to comply with some or all of the FDA’s Good
Manufacturing Practices or its QSR, which delineates the design controls, document controls, purchasing controls, identification
and  traceability,  production  and  process  controls,  acceptance  activities,  nonconforming  product  requirements,  corrective  and
preventive  action  requirements,  labeling  and  packaging  controls,  handling,  storage,  distribution  and  installation  requirements,
records requirements, servicing requirements, and statistical techniques potentially applicable to the production of our medical
devices.  We  and  our  manufacturers  and  suppliers  are  also  subject  to  the  regulations  of  foreign  jurisdictions  regarding  the
manufacturing  process  if  we  market  its  products  overseas.  The  FDA  enforces  the  QSR  through  periodic  and  announced  or
unannounced  inspections  of  manufacturing  facilities.  Our  facilities  have  been  inspected  by  the  FDA  and  other  regulatory
authorities,  and  we  anticipate  that  we  and  certain  of  our  third-party  manufacturers  and  suppliers  will  be  subject  to  additional
future inspections. If our facilities or those of our manufacturers or suppliers are found to be in non-compliance or fail to take
satisfactory corrective action in response to adverse QSR inspectional findings, FDA could take legal or regulatory enforcement
actions  against  us  and/or  our  products,  including  but  not  limited  to  the  cessation  of  sales  or  the  recall  of  distributed  products,
which  could  impair  our  ability  to  produce  our  products  in  a  cost-effective  and  timely  manner  in  order  to  meet  our  customers’
demands. We may also be required to bear other costs or take other actions that may have a negative impact on our future sales
and our ability to generate profits.

26

 
 
 
 
 
 
 
 
 
 
 
 
Current regulations depend heavily on administrative interpretation. If the FDA does not believe that we are in substantial
compliance with applicable FDA regulations, the agency could take legal or regulatory enforcement actions against us and/or our
products.  We  are  also  subject  to  periodic  inspections  by  the  FDA,  other  governmental  regulatory  agencies,  as  well  as  certain
third-party regulatory groups. Future interpretations made by the FDA or other regulatory bodies made during the course of these
inspections may vary from current interpretations and may adversely affect our business and prospects. The FDA’s and foreign
regulatory  agencies’  statutes,  regulations,  or  policies  may  change,  and  additional  government  regulation  or  statutes  may  be
enacted,  which  could  increase  post-approval  regulatory  requirements,  or  delay,  suspend,  prevent  marketing  of  any
cleared/approved products or necessitate the recall of distributed products. We cannot predict the likelihood, nature or extent of
adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.

The  medical  device  industry  has  been  under  heightened  FDA  scrutiny  as  the  subject  of  government  investigations  and
enforcement  actions.  If  our  operations  and  activities  are  found  to  be  in  violation  of  any  FDA  laws  or  any  other  governmental
regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines and other legal
and/or agency enforcement actions. Any penalties, damages, fines, or curtailment or restructuring of our operations or activities
could adversely affect our ability to operate our business and our financial results. The risk of us being found in violation of FDA
laws is increased by the fact that many of these laws are broad and their provisions are open to a variety of interpretations. Any
action  against  us  for  violation  of  these  laws,  even  if  we  successfully  defend  ourselves  against  that  action  and  its  underlying
allegations,  could  cause  us  to  incur  significant  legal  expenses  and  divert  management’s  attention  from  the  operation  of  our
business. Where there is a dispute with a federal or state governmental agency that cannot be resolved to the mutual satisfaction
of all relevant parties, we may determine that the costs, both real and contingent, are not justified by the commercial returns to us
from maintaining the dispute or the product.

Various claims, design features or performance characteristics of our medical devices, that we regarded as permitted by
the  FDA  without  marketing  clearance  or  approval,  may  be  challenged  by  the  FDA  or  state  regulators.  The  FDA  or  state
regulatory authorities may find that certain claims, design features or performance characteristics, in order to be made or included
in  the  products,  may  have  to  be  supported  by  further  studies  and  marketing  clearances  or  approvals,  which  could  be  lengthy,
costly and possibly unobtainable.

If we fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with products, these
products could be subject to restrictions or withdrawal from the market.

We  are  also  subject  to  similar  state  requirements  and  licenses.  Failure  by  us  to  comply  with  statutes  and  regulations
administered by the FDA and other regulatory bodies, discovery of previously unknown problems with our products (including
unanticipated  adverse  events  or  adverse  events  of  unanticipated  severity  or  frequency),  manufacturing  problems,  or  failure  to
comply with regulatory requirements, or failure to adequately respond to any FDA observations concerning these issues, could
result in, among other things, any of the following actions:

•
•
•
•
•
•
•
•
•

warning letters or untitled letters issued by the FDA;
fines, civil penalties, injunctions and criminal prosecution;
unanticipated expenditures to address or defend such actions;
delays in clearing or approving, or refusal to clear or approve, our products;
withdrawal or suspension of clearance or approval of our products by the FDA or other regulatory bodies;
product recall or seizure;
orders for physician or customer notification or device repair, replacement or refund;
interruption of production; and
operating restrictions.

If any of these actions were to occur, it would harm our reputation and adversely affect our business, financial condition

and results of operations.

27

 
 
 
  
 
 
 
 
 
 
 
 
Our medical products may in the future be subject to product recalls that could harm our reputation, business and financial
results.

The  FDA  has  the  authority  to  require  the  recall  of  commercialized  medical  device  products  in  the  event  of  material
deficiencies or defects in design or manufacture. In the case of the FDA, the authority to require a recall must be based on an
FDA finding that there is a reasonable probability that the device would cause serious injury or death. Manufacturers may, under
their own initiative, recall a product if any material deficiency in a device is found. A government-mandated or voluntary recall
by us or one of our distributors could occur as a result of component failures, manufacturing errors, design or labeling defects or
other deficiencies and issues. Recalls of any of our products would divert managerial and financial resources and have an adverse
effect on our financial condition and results of operations. The FDA requires that certain classifications of recalls be reported to
the FDA within ten working days after the recall is initiated. Companies are required to maintain certain records of recalls, even
if they are not reportable to the FDA. We may initiate voluntary recalls involving our products in the future that we determine do
not require notification of the FDA. If the FDA disagrees with our determinations, they could require us to report those actions as
recalls. A future recall announcement could harm our reputation with customers and negatively affect sales. In addition, the FDA
could take enforcement action for failing to report the recalls when they were conducted.

If any of our medical products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be
subject  to  medical  device  reporting  regulations,  which  can  result  in  voluntary  corrective  actions  or  agency  enforcement
actions.

Under  the  FDA  medical  device  reporting  regulations,  medical  device  manufacturers  are  required  to  report  to  the  FDA
information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that
would likely cause or contribute to death or serious injury if the malfunction of the device or one of our similar devices were to
recur.  If  we  fail  to  report  these  events  to  the  FDA  within  the  required  timeframes,  or  at  all,  the  FDA  could  take  enforcement
action against us. Any such adverse event involving our products also could result in future voluntary corrective actions, such as
recalls  or  customer  notifications,  or  agency  action,  such  as  inspection  or  enforcement  action.  Any  corrective  action,  whether
voluntary or involuntary, as well as defending ourselves in a lawsuit, will require our time and capital, distract management from
operating our business, and may harm our reputation and financial results.

We may have a need for additional funds in the future and there is no guarantee that we will be able to generate those funds
from our business.

Our existing cash position and ability to borrow funds and future revenue may not be sufficient to support the expenses of
our operations in the near term, although based upon our cash and cash equivalents, current budgeting and projected cash flow
models, we believe that we will be able to support our operations for at least the next twelve months following the filing of this
Report.  We  plan  to  fund  operations  by  the  recurring  revenue  generated  by  the  use  of  the  XTRAC  lasers  in  the  U.S.  and
international  markets,  as  well  as  domestic  and  international  sales  of  our  products.  If  revenues  from  the  sale  and  use  of  our
existing products are inadequate to fund our operations, we may need to raise additional financing. We cannot assure you that we
will be able to raise additional capital or secure alternate financing to fund operations, if necessary, or that we will be able to raise
additional capital under terms that are favorable to us. Further, we cannot assure that an acquisition will in any way negate or
mitigate our need for future capital. Any additional financing may dilute the ownership interest of our existing stockholders and
could adversely affect the market price of our common stock.

If we do not have enough capital to fund operations, then we will have to cut costs or raise funds.

If  we  are  unable  to  raise  additional  funds,  if  necessary,  under  terms  acceptable  to  us  and  in  the  interests  of  our

stockholders, then we will have to take measures to cut operating costs or obtain funds using alternative methods, such as:

•
•

•

Sell or license some of our technologies that we would not otherwise sell or license if we were in a stronger financial position;
Sell or license some of our technologies under terms that are less favorable than they otherwise might have been if we were in a stronger financial
position; and
Consider further business combination transactions with other companies or positioning ourselves to be acquired by another company.

28

 
 
 
 
 
 
 
 
 
 
 
 
 
If it became necessary to take one or more of the above-listed actions, then our perceived valuation may be lower, which
could impact the market price of our stock. Further, the effects on our operations, financial performance and stock price may be
significant  if  we  do  not  or  cannot  take  one  or  more  of  the  above-listed  actions  in  a  timely  manner  and  when  needed,  and  our
ability to do so may be limited significantly due to the instability of the global financial markets and the resulting limitations on
available financing to us and to potential licensees, buyers and investors. Additionally, these options may not be available to us as
all of our assets have been pledged as security for the various financings.

If our actual liability for state sales and use taxes is higher than our accrued liability, it could have a material impact on our
financial condition.

Included in accrued state sales and use taxes are certain known and estimated sales and use taxes and related penalties and
interest  to  taxing  authorities.  In  our  recurring  revenue  model,  we  place  the  XTRAC  system  in  the  physician’s  office  under  an
arrangement for no upfront charge and generate our revenue on a per-use basis.

In  the  ordinary  course  of  business,  we  are,  from  time  to  time,  subject  to  audits  performed  by  state  taxing  authorities.
These actions and proceedings are generally based on the state’s position that the arrangements entered into by the Company are
subject to state sales and use tax rather than exempt from applicable law. We are currently under audit by two taxing jurisdictions
as  it  pertains  to  state  sales  and/or  use  tax.  One  jurisdiction  has  assessed  us,  in  two  assessments,  an  aggregate  amount  of
$1,484,000  for  the  period  from  March  2014  through  February  2020  including  penalties  and  interest.  We  have  declined  an
informal offer to settle at a substantially lower amount and are currently in that jurisdiction’s administrative process of appeal. In
January 2021, we received notification that the administrative judge in this jurisdiction had issued an opinion finding in favor of
us that the sale of XTRAC treatment codes were not taxable as sales tax with respect to the first assessment. The jurisdiction has
30 days plus extensions to file an appeal and on March 25th we received an advisory from the jurisdiction that it would file an
appeal.  The  second  jurisdiction  has  made  an  assessment  of  $720  from  June  2015  through  March  2018  plus  interest  of  $171
through April 2020. We are in the administrative appeal process in this jurisdiction as well and the timing has been impacted by
the  COVID-19  pandemic.  In  the  event  there  is  a  determination  that  the  true  object  of  the  delivery  of  phototherapy  under  the
recurring revenue model is a sale or lease of property and it is not a prescription medication or we do not have other defenses
where  we  prevail,  we  may  be  subject  to  state  sales  taxes  in  those  particular  states  for  previous  years  and  in  the  future,  plus
interest and penalties for failure to pay such taxes. If it was determined that our recurring revenue model was not exempt from
sales taxes in all states where we do business, and taxes and penalties were imposed in each of those states for the entire period
through the expiration of each state’s statute of limitations, state sales and use tax, penalties and interest for such period would
have a material negative impact on our financial condition and cash flow. 

As of December 31, 2020, and 2019, we have estimated our sales and use tax liability to be approximately $3.1 million
and $3.2 million, respectively. We believe our sales and use tax accruals have properly recognized that if our arrangements with
customers  are  deemed  more  likely  than  not  that  we  would  not  be  exempt  from  sales  tax  in  a  particular  state  are  the  basis  for
measurement of the state sales and use tax is calculated in accordance with ASC 405, Liabilities as a transaction tax. While we
believe we have strong positions that our recurring revenue is exempt from sales tax, if it is found that we are subject to sales tax
in those particular states where we believe it is more likely than not that we would be exempt from sales tax, then potential tax
liabilities  including  interest  and  penalties  would  be  higher  than  accrued  amounts.  If  and  when  we  are  successful  in  defending
ourselves or in settling the sales tax obligation for a lesser amount, the reversal of this liability is to be recorded in the period the
settlement is reached. However, the precise scope, timing and time period at issue, as well as the final outcome of any audit and
actual settlements remain uncertain.

We may be subject to disruptions or failures in our information technology systems and network infrastructures, including
through cyber-attacks or other third-party breaches that could have a material adverse effect on our business.

We rely on efficient and uninterrupted operation of complex information technology systems and network infrastructures
to  operate  our  business.  We  also  hold  data  in  various  data  center  facilities  upon  which  our  business  depends.  A  disruption,
infiltration  or  failure  of  our  information  technology  systems  or  any  of  our  data  centers  as  a  result  of  software  or  hardware
malfunctions,  system  implementations  or  upgrades,  computer  viruses,  third-party  security  breaches,  employee  error,  theft  or
misuse, malfeasance, power disruptions, natural disasters or accidents could cause breaches of data security, loss of intellectual
property and critical data and the release and misappropriation of sensitive competitive information.

29

 
 
 
  
 
 
 
 
 
 
 
 
While we have implemented a number of protective measures, including firewalls, antivirus, patches, data encryption, log
monitors,  routine  back-ups  with  offsite  retention  of  storage  media,  system  audits,  data  partitioning,  routine  password
modifications and disaster recovery procedures, such measures may not be adequate or implemented properly to prevent or fully
address the adverse effect of such events. If our systems were to fail or we are unable to successfully expand the capacity of these
systems,  or  we  are  unable  to  integrate  new  technologies  into  our  existing  systems,  our  operations  and  financial  results  could
suffer.

We have also outsourced significant elements of our information technology infrastructure and as a result we depend on
third parties who are responsible for maintaining significant elements of our information technology systems and infrastructure
and  who  may  or  could  have  access  to  our  confidential  information.  The  size  and  complexity  of  our  information  technology
systems,  and  those  of  our  third-party  vendors,  make  such  systems  potentially  vulnerable  to  service  interruptions  and  security
breaches  from  inadvertent  or  intentional  actions  by  its  employees,  partners  or  vendors.  These  systems  are  also  vulnerable  to
attacks  by  malicious  third  parties,  and  may  be  susceptible  to  intentional  or  accidental  physical  damage  to  the  infrastructure
maintained by us or by third parties. A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved
dissemination, misappropriation or misuse of trade secrets, proprietary information, or other confidential information, whether as
a  result  of  theft,  hacking,  fraud,  trickery  or  other  forms  of  deception,  or  for  any  other  cause,  could  enable  others  to  produce
competing  products,  use  our  proprietary  technology  or  information,  and/or  adversely  affect  our  business.  Further,  any  such
interruption,  security  breach,  loss  or  disclosure  of  confidential  information  could  result  in  financial,  legal,  business,  and
reputational harm to us and could have a material adverse effect on our business, results of operations and financial condition.

Environmental and health safety laws may result in liabilities, expenses and restrictions on our operations.

Federal,  state,  local  and  foreign  laws  regarding  environmental  protection,  hazardous  substances  and  human  health  and
safety may adversely affect our business. Using hazardous substances in our operations exposes us to the risk of accidental injury,
contamination  or  other  liability  from  the  use,  storage,  importation,  handling,  or  disposal  of  hazardous  materials.  If  our  or  our
suppliers’ operations result in the contamination of the environment or expose individuals to hazardous substances, we could be
liable  for  damages  and  fines,  and  any  liability  could  significantly  exceed  our  insurance  coverage  and  have  a  material  adverse
effect on our business, financial condition, and results of operations. Future changes to environmental and health and safety laws
could cause us to incur additional expenses or restrict our operations, which could have a material adverse effect on our business,
financial condition, and results of operations.

Risks Relating to Our Common Stock

In the event of certain contingencies, the investors in the May 2018 Equity Financing may receive additional shares issued
pursuant to the Retained Risk Provisions as defined in the purchase agreements.

In the event of certain contingencies, the investors in the May 2018 equity financing may receive additional shares issued
pursuant to the Retained Risk Provisions as defined in the Stock Purchase Agreements. At the closing, the Company determined
certain contingencies had been met and, in July 2018, the Company issued 153,004 shares associated with those contingencies.
There are additional contingencies included in the SPAs that the Company has determined are not probable or estimable and/or
contractually obligated in order to issue shares at this time.

Our stock price may be volatile, meaning purchasers of our common stock could incur substantial losses.

Our stock price has been and is likely to continue to be volatile. The stock market in general and the market for medical
technology  companies  in  particular  have  experienced  extreme  volatility  that  has  often  been  unrelated  to  the  operating
performance of particular companies. The following factors, in addition to other risk factors described in this section and general
market and economic conditions, may have a significant impact on the market price of our common stock:

•
•
•

failure of any of our products to achieve or continue to have commercial success;
the timing of regulatory approval for our future products;
adverse regulatory determinations with respect to our existing products;

30

 
 
 
 
 
 
 
 
 
 
 
 
 
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•

results of our research and development efforts and our clinical trials;
the announcement of new products or product enhancements by us or our competitors;
regulatory developments in the U.S. and foreign countries;
our ability to manufacture our products to commercial standards;
developments concerning our clinical collaborators, suppliers or marketing partners;
changes in financial estimates or recommendations by securities analysts;
public concern over our products;
developments or disputes concerning patents or other intellectual property rights;
product liability claims and litigation against us or our competitors;
the departure of key personnel;
the strength of our balance sheet and any perceived need to raise additional funds;
variations in our financial results from expected financial results or those of companies that are perceived to be similar to us;
changes in the structure of third-party reimbursement in the U.S. and other countries;
changes in accounting principles or practices;
general economic, industry and market conditions; and
future sales of our common stock.

A decline in the market price of our common stock could cause you to lose some or all of your investment, limit your
ability  to  sell  your  shares  of  stock  and  may  adversely  impact  our  ability  to  attract  and  retain  employees  and  raise  capital.  In
addition, stockholders have, and may in the future, initiate securities class action lawsuits if the market price of our stock drops
significantly. Whether or not meritorious, litigation brought against us could result in substantial costs and could divert the time
and attention of our management. Our insurance to cover claims of this sort may not be adequate.

Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable and could also limit the
market price of our stock.

Provisions of our restated certificate of incorporation and bylaws and applicable provisions of Delaware law may make it
more  difficult  for  or  prevent  a  third  party  from  acquiring  control  of  us  without  the  approval  of  our  board  of  directors.  These
provisions:

•
•

•

•
•

limit who may call a special meeting of stockholders;
establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon at
stockholder meetings;
do  not  permit  cumulative  voting  in  the  election  of  our  directors,  which  would  otherwise  permit  less  than  a  majority  of  stockholders  to  elect
directors;
prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; and
provide our board of directors the ability to designate the terms of and issue a new series of preferred stock without stockholder approval.

In addition, Section 203 of the Delaware General Corporation Law generally limits our ability to engage in any business
combination with certain persons who own 15% or more of our outstanding voting stock or any of our associates or affiliates who
at any time in the past three years have owned 15% or more of our outstanding voting stock. In connection with the financing in
May  2018,  our  board  of  directors  exempted  AGP  SPVI,  L.P.  from  the  application  of  this  provision  in  connection  with  its
investment.

These provisions may have the effect of entrenching our management team and may deprive you of the opportunity to sell
your shares to potential acquirers at a premium over prevailing prices. This potential inability to obtain a control premium could
reduce the price of our common stock.

Item 1B. 

Unresolved Staff Comments

Not applicable.

31

 
 
 
 
 
 
 
 
 
 
 
 
Item 2.

Properties

We lease an 8,513 sq. ft. facility in Horsham, Pennsylvania that houses our executive offices and marketing. The term of

the lease runs through January, 2023.

We lease a 17,000 sq. ft. facility consisting of office, manufacturing and warehousing space in Carlsbad, California. The
lease was set to expire on September 30, 2019. On May 1, 2019, we entered into the Fifth Amendment to the lease. The term of
the lease commenced on October 1, 2019 and expires on September 30, 2024. Our Carlsbad facility houses the manufacturing
and development operations for our excimer laser business, as well as the patient call center and reimbursement center.

Item 3. 

Legal Proceedings

From time to time in the ordinary course of our business, we may be a party to certain legal proceedings, incidental to the
normal  course  of  our  business.  These  may  include  controversies  relating  to  contract  claims  and  employment  related  matters,
some of which claims may be material, in which case, we will make separate disclosure as required.

We are currently under audit by two taxing jurisdictions, pertaining to sales and/or use tax. One jurisdiction has assessed
us an amount of $1,484,000, in two assessments, for the period from March 2014 through February 2020. We have declined an
informal offer to settle the first assessment at a substantially lower amount and are currently in that jurisdiction’s administrative
process of appeal.

In January 2021, we received notification that the administrative law judge had issued an opinion finding in favor of us
that the sale of XTRAC treatment codes are not taxable as sales tax with respect to the first assessment. The jurisdiction has 30
days plus potential extensions to file an appeal and on March 25th we received an advisory from the jurisdiction that it would file
an appeal.

A  second  jurisdiction  has  made  an  assessment  of  $720,000  from  June  2015  through  March  2018  plus  interest  of  $171
through April 2020.  We are in this jurisdiction’s administrative process of appeal as well and the timing of the process has been
impacted by the COVID-19 pandemic. If it is found we are not exempt from sales tax in these or other states then potential tax
liabilities including interest and penalties would be higher than accrued amounts.

Effective  August  10,  2020,  we  entered  into  a  Settlement  Agreement  and  Release  (“Settlement  Agreement”)  with  Ra
Medical Systems, Inc. (“Ra Medical”), under which the Company and Ra Medical agreed that within five business days of final
execution of the Settlement Agreement, the parties are to file stipulations and/or documentation necessary to cause each of the
pending  lawsuits  between  them  and  with  other  third-parties  to  be  dismissed  with  prejudice,  with  each  party  to  bear  its  own
attorneys’ fees and costs. The pending lawsuits were: Strata Skin Sciences, Inc. and Uri Geiger v. Ra Medical Systems, Inc., civil
action no. 18-21421, Court of Common Pleas, Montgomery County, Pennsylvania; and Ra Medical Systems, Inc. v. Uri Geiger,
Strata Skin Sciences, Inc., and Accelmed Growth Partners, L.P., civil action no. 3:19-cv-00920, United States District Court for
the Southern District of California.

Pursuant  to  the  terms  of  the  Settlement  Agreement,  each  party  agreed  to  release  the  opposing  parties  from  any  and  all
claims,  demands,  and  causes  of  action  of  any  kind  whatsoever,  whether  known  or  unknown,  fixed  or  contingent,  asserted  or
unasserted, arising in contract, tort, statute, or operation of law, which they now have or ever had against any of the Ra Medical
Releases,  from  the  beginning  of  time  to  the  date  of  the  Settlement  Agreement,  in  any  way  arising  from  or  relating  to  the
allegations, claims, causes of action, allegations and/or assertions set forth in the pending lawsuits.

Item 4. 

Mine Safety Disclosures

Not applicable.

32

 
 
 
 
 
 
 
 
 
PART II

Item 5. 
Securities

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity

As  of  March  17,  2021,  we  had  33,801,045  shares  of  common  stock  issued  and  outstanding.  This  did  not  include  (i)
options  to  purchase  6,925,478  shares  of  common  stock,  of  which  4,243,387  were  vested  as  of  March  17,  2021  or  (ii)  vested,
unissued restricted stock units of 88,194.

Dividend Policy

We  have  not  declared  or  paid  any  dividend  on  our  common  stock,  since  our  inception.  We  do  not  anticipate  that  any
dividends on our common stock will be declared or paid in the future. Any future determination relating to our dividend policy
will  be  made  at  the  discretion  of  our  board  of  directors  and  will  depend  on  then  existing  conditions,  including  our  earnings,
financial condition, results of operations, level of indebtedness, contractual restrictions, capital requirements, business prospects
and other factors our board of directors may deem relevant. Our board of directors’ ability to declare a dividend is also subject to
limits imposed by Delaware law and our credit facility.

Securities Authorized for Issuance Under Equity Compensation Plans

The  following  is  a  summary  of  all  of  our  equity  compensation  plans,  including  plans  that  were  assumed  through
acquisitions and individual arrangements that provide for the issuance of equity securities as compensation, as of December 31,
2020. See Notes 1 and 14 to the consolidated financial statements for additional discussion.

Number of
Securities
Remaining
Available
Under Equity
Compensation
Plans
(excluding
securities
reflected in
column (A))
(C)

Number of
Securities to be
issued Upon
Exercise of
Outstanding
Options
(A)

Weighted
Average
Exercise Price
of
Outstanding
Options
(B)

Equity compensation plans approved by security holders

5,292,888    $

1.87     

41,774 

Equity compensation plans not approved by security holders

-     
5,292,888    $

-     
1.87     

- 
41,774 

Recent Issuances of Unregistered Securities

None.

Purchases of Equity Securities

None.

Item 6. 

Selected Financial Data

Not applicable.

33

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
 
   
 
   
      
      
  
   
 
   
 
 
 
 
 
 
 
 
 
Item 7. 

Management's Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read in conjunction with the Consolidated Financial Statements and related
notes included elsewhere in this Report. Dollar amounts are reported in thousands, except per share and per treatment data.

Introduction, Outlook and Overview of Business Operations

STRATA Skin Sciences is a medical technology company in Dermatology and Plastic Surgery dedicated to developing,
commercializing  and  marketing  innovative  products  for  the  treatment  of  dermatologic  conditions.  Its  products  include  the
XTRAC®  excimer  laser  and  VTRAC®  lamp  systems  utilized  in  the  treatment  of  psoriasis,  vitiligo  and  various  other  skin
conditions.

The  XTRAC  device  is  utilized  to  treat  psoriasis,  vitiligo  and  other  skin  diseases.  The  XTRAC  device  received  FDA
clearance  in  2000  and  has  since  become  a  widely  recognized  treatment  among  dermatologists.  The  system  delivers  targeted
308um ultraviolet light to affected areas of skin, leading to psoriasis clearing and vitiligo repigmentation, following a series of
treatments.  As  of  December  31,  2020,  there  were  832  XTRAC  systems  placed  in  dermatologists’  offices  in  the  United  States
under  our  dermatology  recurring  procedure  model,  up  from  820  at  the  end  of  December  31,  2019.  Under  the  dermatology
recurring procedure model, the XTRAC system is placed in a physician's office and fees are charged on a per procedure basis or a
fee is charged on a periodic basis not to exceed an agreed upon number of procedures. The XTRAC system’s use for psoriasis is
covered  by  nearly  all  major  insurance  companies,  including  Medicare.  The  VTRAC  Excimer  Lamp  system,  offered
internationally in addition to the XTRAC, provides targeted therapeutic efficacy demonstrated by excimer technology with the
simplicity of design and reliability of a lamp system. There are approximately 7.5 million people in the United States and up to
125 million people worldwide suffering from psoriasis, and 1% to 2% of the world’s population suffers from vitiligo. In 2020,
domestically, we estimate over 241,000 XTRAC laser treatments were performed.

Effective February 1, 2017, we entered into an exclusive OEM distribution agreement with Esthetic Education, LLC to be
the exclusive marketer and seller of private label versions of the SkinStylus® MicroSystem and associated parts under the name
of  STRATAPEN.  This  three-year  agreement  has  minimum  annual  sales  requirements  for  renewal.  The  agreement  expired  in
January 2020, but we continue to sell the product on a purchase order basis.

Since  2019,  we  have  been  transitioning  our  international  equipment  sales  through  our  master  distributor  to  a  direct
distribution model for equipment sales and recurring revenue on a country by country basis.  We have signed contracts in Korea
(in 2019), Japan (in 2020) and China (in January 2021). 

These agreements are expected to increase recurring revenues over time, but will have an initial impact of reducing sales
of dermatology procedures equipment in the near term as the contract is to apply a similar recurring revenue model as we have in
the United States.

In late 2019, there was an outbreak of a new strain of coronavirus (“COVID-19”) which became a global pandemic. The
COVID-19  pandemic  has  negatively  impacted  the  global  economy,  disrupted  global  supply  chains,  constrained  work  force
participation and created significant volatility and disruption of financial markets. In addition, the pandemic led to the suspension
of elective procedures in the U.S. and to the temporary closure of many physician practices which are our primary customers. We
do not know the extent of the impact on our customers and their potential for permanent closure. While many offices have been
reopening, the on-going impact of the COVID-19 pandemic on the Company’s operational and financial performance, including
its  ability  to  execute  its  business  strategies  and  initiatives  in  the  expected  time  frames,  will  depend  on  future  developments,
including the duration and spread of the COVID-19 outbreak, continued restrictions on business operations and transport and the
continued impact on worldwide economic and geopolitical conditions, all of which are uncertain and cannot be predicted.

34

 
 
 
 
 
 
 
 
 
 
 
Domestically,  as  the  procedures  in  which  our  devices  are  used  are  elective  in  nature;  and  as  social  distancing,  travel
restrictions, quarantines and other restrictions have become prevalent in the United States, this has had a negative impact on our
recurring revenue model and our financial position and cash flow. The impact to the Company’s customers may also result in an
increase in past due accounts receivable or customer bankruptcies. The virus has disrupted the supply chain from China and other
countries and may continue to do so. We depend upon our supply chain to provide a steady source of components to manufacture
and repair our devices. A shut-down of suppliers  within  our  supply  chain  would  severely  disrupt  our  ability  to  sell,  place  and
repair our products, and this would have a material impact on our financial position and cash flow.

To  mitigate  the  impact  of  COVID-19,  the  Company  has  taken  a  variety  of  measures  to  ensure  the  availability  and
functioning of its critical infrastructure by implementing business continuity plans and to promote the safety and security of its
employees while complying with various government mandates, including work-from-home arrangements and social-distancing
initiatives  to  reduce  the  transmission  of  COVID-19,  such  as  providing  face  masks  for  employees  at  facilities  significantly
impacted  and  requiring  on-site  body  temperature  monitoring  before  entering  facilities.  In  addition,  we  have  created  programs
utilizing  its  direct  to  consumer  advertising  and  call  center  contact  to  patients  and  partner  clinics  to  restart  our  partners’
businesses. In order to conserve its cash during this time period, the Company furloughed employees, reduced all discretionary
spending,  reduced  all  inventory  purchases  and  delayed  payments  to  vendors.  We  continue  to  manage  our  expenses  and  cash
disbursements. Delayed payments to vendors were cumulatively, approximately $678 as of December 31, 2020. With the receipt
of the PPP loan, we brought back most of our employees on a leave of absence. In December 2020, we submitted an application
for loan forgiveness to the SBA and subject to the SBA’s approval, of 100% of the loan proceeds.

In the event our own employees are impacted through direct or ancillary contact with a person who has the virus, we may
need to devise other methods of transacting business in our offices by working from home and or potentially ceasing operations
for a period of time.

The COVID-19 pandemic has had a negative impact on the Company’s results of operations and financial performance
for  the  first  three  quarters  of  fiscal  2020,  and  the  Company  expects  it  will  continue  to  have  a  negative  impact  on  its  revenue,
earnings  and  cash  flows  in  the  next  quarter  and  as  long  as  the  pandemic  continues.  Accordingly,  current  results  and  financial
condition discussed herein may not be indicative of future operating results and trends.

Key Technology

•

•

•

•
•

XTRAC®  Excimer  Laser.  XTRAC  originally  received  FDA  clearance  in  2000  and  has  since  become  a  widely  recognized  treatment  among
dermatologists for psoriasis and other skin diseases. The XTRAC excimer laser delivers ultra-narrowband ultraviolet B (“UVB”) light to affected
areas of skin. Following a series of treatments typically performed twice weekly, psoriasis remission can be achieved, and vitiligo patches can be
re-pigmented.  XTRAC  is  endorsed  by  the  National  Psoriasis  Foundation,  and  its  use  for  psoriasis  is  covered  by  nearly  all  major  insurance
companies, including Medicare. We estimate that more than half of all major insurance companies now offer reimbursement for vitiligo as well, a
figure that is increasing.
In the third quarter of 2018 we announced the FDA granted clearance for our Multi Micro Dose (MMD) tip for our XTRAC excimer laser. The
MMD  tip  accessory  is  indicated  for  use  in  conjunction  with  the  XTRAC  laser  system  to  filter  the  Narrow  Band  UVB  (“NB-UVB”)  light  at
delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient.
In  the  third  quarter  of  2018  we  announced  the  launch  of  our  S3,  the  next  generation  XTRAC.  The  S3  is  smaller,  faster  and  has  a  smart  user
interface.
In January 2020, we announced the FDA granted clearance of our XTRAC Momentum Excimer Laser platform.
VTRAC® Lamp. VTRAC received FDA clearance in 2005 and provides targeted therapeutic efficacy demonstrated by excimer technology with
the simplicity of design and reliability of a lamp system.

35

 
 
 
 
 
 
 
Recent Developments

Home by XTRAC™

In January 2020, we introduced Home by XTRAC business, leveraging in-house resources including an at-home
insurance reimbursed treatment option for patients with certain skin diseases that do not qualify for in-office treatments.

Chinese Distribution Agreement

In February 2021, the Company signed an agreement with our Chinese distributor for a combination of direct capital sales

and recurring revenues for the country of China. The initial term ends December 2024 and thereafter automatically renews for a
period of twelve months subject to certain conditions.

Japanese Distribution Agreement

In September 2020, we signed a direct distribution agreement with our Japanese distributor for a combination of direct
capital sales and recurring revenue for the Country of Japan. This agreement is expected to increase recurring revenues over time,
but will have an initial impact of reducing sales of dermatology procedures equipment in the near term as the contract is to apply
a similar recurring revenue model as we have in the United States. The term ended December 2020 and is automatically renewed
for twelve months, subject to certain conditions.

Korean Distribution Agreement

In the third quarter of 2019, we signed a direct distribution agreement with our Korean distributor for a combination of
direct  capital  sales  and  recurring  revenues  for  the  country  of  South  Korea.  This  agreement  is  expected  to  increase  recurring
revenues over time, but will have an initial impact of reducing sales of dermatology procedures equipment in the near term as the
contract is to apply a similar recurring revenue model as we have in the United States. The current term is until July 2021 with up
to three additional twelve-month terms, subject to certain conditions.

MidCap Credit Facility Extinguishment and Fixed Rate-Term Promissory Note

On May 29, 2018, we entered into a Fourth Amendment to Credit Agreement (the “Amendment”), pursuant to which the
Company repaid $3.0 million in principal of the existing $10.6 million credit facility established with MidCap Financial Trust in
2015.  The  terms  of  the  credit  facility  were  amended  to  impose  less  restrictive  covenants  and  lower  prepayment  fees  for  the
Company  and  extended  the  maturity  date  to  May  2022.  The  Amendment  modified  the  principal  payments  payable  under  the
Credit Agreement including a period of 18 months where there were no principal payments due. Principal payments beginning
December 2019 were $252 plus interest per month. The interest rate on the credit facility was one-month LIBOR plus 7.25%.

On December 30, 2019, we closed on a $7.3 million loan with a commercial bank pursuant to a one-year Fixed Rate –
Term Promissory Note (the “Note”). Our obligations under the Note are secured by an Assignment and Pledge of Time Deposit,
under which we have pledged, to the commercial bank, the proceeds of a time deposit account in the amount of the Note. We
concurrently fully repaid (including payment of termination and exit fees) our existing long-term debt credit facility with MidCap
Financial Trust. The Note was renewed through December 30, 2021.

Paycheck Protection Program

On  April  22,  2020,  we  closed  on  a  loan  of  $2.0  million  (the  “PPP  loan”)  from  a  commercial  bank,  pursuant  to  the
Paycheck Protection Program (“PPP”) of the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”). The PPP
loan matures on May 1, 2022 and bears an interest rate of 1% per annum. Payments of principal and interest of any unforgiven
balance was scheduled  to  commence  on  December  1,  2020  but  is  deferred  until the SBA approves  of  the  forgiveness  amount.
Under the Paycheck Protection Program Flexibility Act of 2020 (the “PPP Flexibility Act”), (i) the first payment date for the PPP
loan will be the earlier of (a) 10 months after the end of the “covered period” (as determined under the PPP) or (b) the date the
bank receives a remittance of the forgiven amount from the SBA, and (ii) the PPP loan’s maturity is extended to five years (from
2 years).

36

 
 
 
 
 
 
 
 
All  or  a  portion  of  the  PPP  loan  may  be  forgiven  by  the  lender  upon  application  by  US  beginning  60  days  after  loan
approval  and  upon  documentation  of  expenditures  in  accordance  with  the  requirements  set  forth  by  the  Small  Business
Administration  (the  “SBA”)  pursuant  to  the  CARES  Act.  Under  the  CARES  Act,  loan  forgiveness  is  available  for  the  sum  of
documented  payroll  costs,  covered  rent  payments,  covered  mortgage  interest  and  covered  utilities  at  either;  our  discretion,  the
eight-week  period  or  twenty-four  week  period  beginning  on  the  date  of  disbursement  of  proceeds  from  the  PPP  loan.  For
purposes of the CARES Act, payroll costs exclude compensation of an individual employee in excess of $100, prorated annually.
Not more than 40% of the forgiven amount may be for non-payroll costs. Forgiveness is reduced under certain circumstances if
full-time  headcount  declines  or  if  salaries  and  wages  for  employees  with  salaries  of  $100  or  less  annually  are  reduced.  In  the
event  the  PPP  loan,  or  any  portion  thereof,  is  forgiven  pursuant  to  the  PPP,  the  amount  forgiven  is  applied  to  outstanding
principal. In December 2020, we submitted for forgiveness to the SBA, and subject to the SBA’s approval, of 100% of the loan
proceeds.

Economic Injury Disaster Loan

On  May  22,  2020,  we  executed  the  standard  loan  documents  required  for  securing  a  loan  (the  “EIDL  Loan”)  from  the
SBA under its Economic Injury Disaster Loan (“EIDL”) assistance program in light of the impact of the COVID-19 pandemic on
the Company’s business. The principal amount of the EIDL Loan is up to $500, with proceeds to be used for working capital
purposes. On June 12, 2020, we received these funds from the SBA. Interest accrues at the rate of 3.75% per annum. Installment
payments,  including  principal  and  interest,  are  due  monthly  beginning  March  26,  2021  (twelve  months  from  the  date  of  the
promissory note) in the amount of $2. The balance of principal and interest is payable over the next thirty years from the date of
the promissory note. There are no penalties for prepayment.  Based upon guidance issued by the SBA on June 19, 2020, the EIDL
Loan is not required to be refinanced by the PPP loan.

Sales and Marketing

As  of  December  31,  2020,  our  sales  and  marketing  personnel  consisted  of  57  full-time  employees,  inclusive  of  a  vice
president  of  sales,  a  direct  sales  organization,  as  well  as  an  in-house  call  center  staffed  with  patient  advocates  and  a
reimbursement group that provides necessary insurance information to our physician partners and their patients.

Critical Accounting Policies and Estimates

The  discussion  and  analysis  of  our  financial  condition  and  results  of  operations  in  this  Report  are  based  upon  our
consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the
United States of America (“U.S. GAAP”). The preparation of financial statements requires management to make estimates and
judgments  that  affect  the  reported  amounts  of  assets  and  liabilities,  revenues  and  expenses  and  disclosures  at  the  date  of  the
financial  statements.  On  an  on-going  basis,  we  evaluate  our  estimates,  including,  but  not  limited  to,  those  related  to  revenue
recognition, accounts receivable, deferred revenues, inventories, useful lives and impairment of property and equipment and of
intangibles and goodwill, fair value of equity-based awards, sales and use tax, deferred taxes, financial instruments (derivative
instruments  and  warrants)  and  accruals  for  warranty  claims.  We  use  authoritative  pronouncements,  historical  experience  and
other assumptions as the basis for making estimates. Actual results could differ from those estimates.

Management believes that the following critical accounting policies affect our more significant judgments and estimates

in the preparation of our consolidated financial statements.

Revenue Recognition

In  the Dermatology  Recurring  Procedures  Segment  we  have  two  types  of  arrangements for our phototherapy treatment
equipment  as  follows:  (i)  we  place  our  lasers  in  a  physician’s  office  at  no  charge  to  the  physician,  and  generally  charge  the
physician  a  fee  for  an  agreed  upon  number  of  treatments;  or  (ii)  we  place  our  lasers  in  a  physician’s  office  and  charge  the
physician  a  fixed  fee  for  a  specified  period  of  time  not  to  exceed  an  agreed  upon  number  of  treatments;  if  that  number  is
exceeded additional fees will have to be paid.

37

 
 
 
 
 
 
 
 
 
 
 
 
 
For the purposes of U.S. GAAP only, these two types of arrangements are treated under the guidance of ASC 842, Leases.
While these arrangements are not contractually operating leases, since we sell the physician access codes in order to operate the
treatment  equipment,  these  are  similar  to  operating  leases  for  accounting  purposes  since  we  provide  the  customers  limited
arrangement  rights  to  use  the  treatment  equipment  and  the  treatment  equipment  resides  in  the  physician’s  office  and  we  may
exercise the right to remove the equipment upon notice, under certain circumstances, while the physician controls the utility and
output of such equipment during the term of the arrangement as it pertains to the use of access codes to treat the patients. The
terms of the domestic arrangements are generally 36 months with automatic one-year renewals and include a termination clause
that can be affected at any time by either party with 30 to 60 day notice. Amounts paid are generally non-refundable. For the first
type of arrangement, sales of access codes are considered variable treatment code payments and are recognized as revenue over
the estimated usage period of the agreed upon number of treatments. For the second type of arrangement, customers purchase
access codes and revenue is recognized ratably on a straight-line basis as the lasers are being used over the term period specified
in the agreement. Variable treatment code payments that will be paid only if the customer exceeds the agreed upon number of
treatments are recognized only when such treatments are being exceeded and used. Internationally, through our Korean, Japanese
and, in 2021, Chinese distributors,  we  sell  access  codes  for  a  fixed  amount  on  a  monthly  basis  to  end  user  customers  and  the
terms are generally 48 months, with termination in the event of the customers’ failure to remit payments timely, and includes a
potential buy-out at  the  end  of  the  term  of  the  contract.  Pre-paid  amounts  are  recorded  in  deferred  revenue  and  recognized  as
revenue over the lease term in the patterns described above. Under both methods, pricing is fixed with the customer.

With respect to lease and non-lease components, we adopted the practical expedient to account for the arrangement as a

single lease component.

In  the  Dermatology  Procedures  Equipment  segment  we  sell  our  products  internationally  through  distributors  and
domestically,  directly  to  a  physician.  For  the  product  sales,  we  recognize  revenues  when  control  of  the  promised  products  is
transferred to either our distributors or end-user customers, in an amount that reflects the consideration we expect to be entitled to
in exchange for those products (the transaction price). Control transfers to the customer at a point in time. To indicate the transfer
of  control,  we  must  have  a  present  right  to  payment  and  legal  title  must  have  passed  to  the  customer.  We  ship  most  of  our
products FOB shipping point, and as such, we primarily transfer control and record revenue upon shipment. From time to time
we  will  grant  certain  customers,  for  example  governmental  customers,  FOB  destination  terms,  and  the  transfer  of  control  for
revenue recognition occurs upon receipt. We have elected to recognize the cost of freight and shipping activities as fulfillment
costs.  Amounts  billed  to  customers  for  shipping  and  handling  are  included  as  part  of  the  transaction  price  and  recognized  as
revenue when control of the underlying goods are transferred to the customer. The related shipping and freight charges incurred
by the Company are included in cost of revenues.

Remaining performance obligations related to ASC 606 represent the aggregate transaction price allocated to performance
obligations with an original contract term greater than one year, which are fully or partially unsatisfied at the end of the period.
Remaining  performance  obligations  include  the  potential  obligation  to  perform  under  extended  warranties  but  excludes  any
equipment accounted for as leases. Contract assets primarily relate to the Company’s rights to consideration for work completed
in relation to its services performed but not billed at the reporting date. The contract assets are transferred to receivables when the
rights  become  unconditional.  Currently,  the  Company  does  not  have  any  contract  assets  which  have  not  transferred  to  a
receivable. Contract liabilities primarily relate to extended warranties where the Company has received payments, but has not yet
satisfied  the  related  performance  obligations.  The  allocations  of  the  transaction  price  are  based  on  the  price  of  standalone
warranty contracts sold in the ordinary course of business. The advance consideration received from customers for the warranty
services is a contract liability that is recognized ratably over the warranty period.

With respect to contract acquisition costs, we applied the practical expedient and expense these costs immediately.

38

 
 
  
 
 
 
 
Inventory

We account for inventory at the lower of cost or net realizable value. Cost is determined to be the purchased cost for raw
materials  and  the  production  cost  (labor  and  indirect  manufacturing  cost)  for  work-in-process  and  finished  goods.  The  cost  is
determined  on  the  first-in,  first-out  method.  Throughout  the  laser  manufacturing  process,  the  related  production  costs  are
recorded  within  inventory.  Work-in-process  is  immaterial,  given  the  typically  short  manufacturing  cycle,  and  is  therefore
included  in  raw  materials.  We  perform  full  physical  inventory  counts  for  XTRAC  and  cycle  counts  on  the  other  inventory  to
maintain controls and obtain accurate data.

Our XTRAC laser is either (i) sold to distributors or physicians directly or (ii) placed in a physician's office and remains
our property. The cost to build a laser, whether for sale or for placement, is accumulated in inventory. When a laser is placed in a
physician’s office, the cost is transferred from inventory to “lasers in service” within property and equipment. At times, units are
shipped to distributors but revenue is not recognized until all of the revenue recognition criteria has been met and, until that time,
the unit is included in inventory.

Reserves for slow-moving, excess and obsolete inventories, reduce the historical carrying value of our inventories, and
are  provided  based  on  historical  experience  and  product  demand.  Management  evaluates  the  adequacy  of  these  reserves
periodically based on forecasted sales and market trends.

Allowance for Doubtful Accounts

Accounts receivable are reduced by an allowance for amounts that may become uncollectible in the future. From time to
time, our customers dispute the amounts due to us, and, in other cases, our customers experience financial difficulties and cannot
pay  on  a  timely  basis.  In  certain  instances,  these  factors  ultimately  result  in  uncollectible  accounts.  The  determination  of  the
appropriate reserve needed for uncollectible accounts involves significant judgment. Such factors include changes in the financial
condition of our customers as a result of industry, economic or customer-specific factors. A change in the factors used to evaluate
collectability could result in a significant change in the allowance needed. As of December 31, 2020, and 2019, allowance for
doubtful accounts was $274 and $184, respectively.

Property and Equipment

As of December 31, 2020, and 2019, we had net property and equipment of $5,529 and $5,369, respectively. The most
significant component relates to the XTRAC lasers placed by us in physicians’ offices. We own the equipment and charge the
physician for access codes for an agreed upon number of treatments. The recoverability of the net carrying value of the lasers is
predicated  on  continuing  revenues  from  the  recurring  revenue  business  model.  If  the  physician  does  not  generate  sufficient
treatments, then we may remove the laser from the physician’s office and redeploy it elsewhere. XTRAC lasers placed in service
are depreciated on a straight-line basis over the estimated useful life of five-years. For other property and equipment, depreciation
is  calculated  on  a  straight-line  basis  over  the  estimated  useful  lives  of  the  assets,  primarily  three  to  seven  years  for  computer
hardware and software, furniture and fixtures, and machinery  and  equipment.  Leasehold  improvements  are  amortized  over  the
lesser  of  the  useful  lives  or  lease  terms.  Useful  lives  are  determined  based  upon  an  estimate  of  either  physical  or  economic
obsolescence, or both.

Goodwill

Our balance sheet includes goodwill which is subject to an annual assessment for impairment under FASB ASC Topic
350, “Goodwill and Other Intangibles” and is not amortizable. Management’s judgments regarding the existence of impairment
indicators, on an interim or annual basis, are based on various factors, including market conditions and operational performance
of our business. As of December 31, 2020, and 2019, we had $8,803 of goodwill accounting for 18.8% and 18.6% of our total
assets,  respectively.  The  acquisition  of  the  XTRAC  and  VTRAC  businesses  that  gave  rise  to  the  recorded  goodwill  closed  on
June 22, 2015. The determination of the fair value of the reporting units to which the goodwill relates requires management to
make estimates and assumptions. We test our goodwill for impairment at least annually. This test is conducted in December of
each year in connection with the annual budgeting and forecast process. Also, on a quarterly basis, we evaluate whether events or
changes in circumstances have occurred that would negatively impact the realizable value of our intangibles or goodwill.

39

 
 
 
 
 
 
 
 
 
 
 
We organized our business into two operating segments, which also serve as our goodwill reporting units and are defined
as  Dermatology  Recurring  Procedures  and  Dermatology  Procedures  Equipment.  The  balance  of  our  goodwill  for  each  of  our
segments  as  of  December  31,  2020,  is  as  follows:  Dermatology  Recurring  Procedures  $7,958  and  Dermatology  Procedures
Equipment $845. We completed our annual goodwill impairment analysis as of December 31, 2020, for our reporting units. Our
assessment concluded that there was no impairment of goodwill. Our analysis employed the use of both a market and income
approach,  with  each  method  given  equal  weighting.  Significant  assumptions  used  in  the  income  approach  include  growth  and
discount  rates,  profit  margins  and  our  weighted  average  cost  of  capital.  We  used  historical  performance  and  management
estimates  of  future  performance  to  determine  profit  margins  and  growth  rates.  Discount  rates  selected  for  each  reporting  unit
varied. Our weighted average cost of capital included a review and assessment of market and capital structure assumptions. For
both  reporting  units  the  fair  value  was  in  excess  of  its  carrying  value.  Considerable  management  judgment  is  necessary  to
evaluate the impact of operating changes and to estimate future cash flows. Changes in our actual results and/or estimates or any
of our other assumptions used in our analysis could result in a different conclusion.

Intangibles

All of our intangibles are definite lived assets, with amortization recorded over the estimated useful life on a straight-line
basis. As of December 31, 2020, and 2019, we had $6,345 and $7,955 of intangible assets accounting for approximately 13.6%
and  16.8%  of  our  total  assets,  respectively.  The  definite  lived  assets  are  tested  for  impairment  when  events  or  changes  in
circumstances indicate that the carrying value of the asset group may not be recoverable. Our intangible assets are grouped into
five categories: core technology, product technology, customer relationships, and trade names. Recoverability of assets to be held
and used is measured by a comparison of the carrying amount of an asset group to the undiscounted cash flows attributable to the
asset group. If the carrying amount of an asset group exceeds its undiscounted cash flows, an impairment charge is recognized in
the amount by which the carrying amount of the asset group exceeds its fair value of the asset group.

Considerable  management  judgment  is  necessary  to  assess  recoverable  amounts  of  intangible  assets  and  measure  fair
value of the intangible assets that were impaired as such measurements involve estimation of future revenues, royalty rates, profit
margins and other cash flows. Changes in our actual results and/or estimates or any of our other assumptions used in our analysis
could result in a different conclusion.

Income taxes

As part of the process of preparing our consolidated financial statements, we are required to estimate our income taxes in
each of the jurisdictions in which we operate. This process requires us to estimate our actual current tax exposure and make an
assessment  of  temporary  differences  resulting  from  differing  treatment  of  items,  for  tax  and  accounting  purposes.  These
differences result in deferred tax assets and liabilities, which are included within our consolidated balance sheet. We must then
assess the likelihood that our deferred tax assets will be recovered from future taxable income and, to the extent we believe that
recovery  is  not  more  likely  than  not,  we  establish  a  valuation  allowance.  To  the  extent  we  establish  a  valuation  allowance  or
increase  this  allowance  in  a  period,  we  must  include  an  expense  within  the  tax  provision  in  the  consolidated  statement  of
operations. Significant management judgment is required in determining any valuation allowance recorded against our deferred
tax  assets.  In  the  event  that  we  generate  taxable  income  in  the  jurisdictions  in  which  we  operate  and  in  which  we  have  net
operating loss carry forwards, we may be required to adjust our valuation allowance.

ASC Topic 740-10 requires that we recognize in our financial statements the impact of a tax position, if that position will
more likely than not be sustained upon examination, based on the technical merits of the position, without regard to the likelihood
that  the  tax  position  may  be  challenged.  If  an  uncertain  tax  position  meets  the  “more-likely-than-not”  threshold,  the  largest
amount  of  tax  benefit,  that  is  greater  than  50%,  likely  to  be  recognized  upon  ultimate  settlement  with  the  taxing  authority  is
recorded. We do not have any uncertain tax positions or accrued penalties and interest. If such matters were to arise, we would
recognize interest and penalties related to income tax matters in income tax expense.

40

 
 
 
 
 
 
 
 
 
 
Stock-based Compensation

We  account  for  stock-based  compensation  to  employees  in  accordance  with  the  “Share-Based  Payment”  accounting
standard. The standard requires estimating the fair value of equity-based payment awards on the date of grant using an option-
pricing  model.  The  value  of  the  award  is  recognized  as  an  expense  over  the  requisite  service  periods  in  our  consolidated
statements of operations. For performance-based awards, we recognize the expense only if we deem it probable that the vesting
condition will occur. There were no performance awards granted in 2020 or 2019.

The  fair  value  of  employee  stock  options  is  estimated  using  a  Black-Scholes  valuation  model.  Compensation  costs  are
recognized over the requisite service period. Total stock-based compensation expense was $1,633 and $1,195 for the years ended
December 31, 2020, and 2019, respectively.

Fair Value Measurements

We measure fair value in accordance with Financial Accounting Standards Board Accounting Standards Codification 820,
Fair Value Measurements and Disclosures (“ASC Topic 820”). ASC Topic 820 defines fair value, establishes a framework and
gives guidance regarding the methods used for measuring fair value, and expands disclosures about fair value measurements. Fair
value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants. As such, fair value is a market-based measurement that should be determined based on
assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions there
exists a three-tier fair-value hierarchy, which prioritizes the inputs used in measuring fair value.

Results of Operations

The  following  financial  data,  in  this  narrative,  are  expressed  in  thousands,  except  for  the  earnings  per  share  and  per

treatment data.

Revenues

The following table presents revenues from our two segments for the periods indicated below:

Dermatology Recurring Procedures
Dermatology Procedures Equipment
Total Revenues

Dermatology Recurring Procedures

For the Year Ended December 31,  

2020

2019

  $

  $

17,409    $
5,681     
23,090    $

23,713 
7,873 
31,586 

Revenues  from  Dermatology  Recurring  Procedures  for  the  year  ended  December  31,  2020  was  $17,409  which
approximates  249,000  treatments,  with  prices  ranging  from  $65  to  $95  per  treatment.  Revenues  from  Dermatology  Recurring
Procedures  for  the  year  ended  December  31,  2019  was  $23,713  which  approximates  337,000  treatments,  with  prices  ranging
from $65 to $95 per treatment.

Increases in procedures are dependent upon building market acceptance through marketing programs with our physician
partners and their patients to show that the XTRAC procedures will be of clinical benefit and will be generally reimbursed by
insurers.  We  believe  that  several  factors  had  an  impact  on  the  prescribed  use  of  XTRAC  treatments  for  psoriasis  and  vitiligo
patients.  Specifically,  we  believe  that  there  is  a  lack  of  awareness  of  the  positive  effects  of  XTRAC  treatments  among  both
sufferers and providers; and the treatment regimen which can sometimes require up to 12 or more treatments has limited XTRAC
use to certain patient populations. Therefore, we use a direct to patient awareness program for XTRAC advertising in the United
States, targeting psoriasis and vitiligo patients through a variety of media including television and radio; and through our use of
social media such as Facebook and Twitter. We monitor the results of our advertising expenditures in this area to reach the more
than 10 million patients in the United States afflicted with these diseases. We have and expect to continue to increase spending in

41

 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
the direct to patient programs to drive patients to our partner clinics to increase recurring revenue. The increase in these programs
precedes any increase in the recurring revenue as there is a lag between advertising and patients then receiving treatment, which
we estimated to be three to nine months.

During 2020, our recurring procedures revenue was negatively impacted by the COVID-19 pandemic.  The pandemic led
to the suspension of elective procedures, such as XTRAC procedures and to the temporary closure of many physician practices
which  are  our  primary  customers.  We  do  not  know  the  full  extent  of  the  impact  on  our  customers  including  the  potential  of
permanent closure.

Revenues  from  Dermatology  Recurring  Procedures  are  recognized  over  the  estimated  usage  period  of  the  agreed  upon
number of treatments, as the treatments are being used. As of December 31, 2020, and 2019, we deferred net revenues of $1,765
and $2,286, respectively, which will be recognized as revenue over the remaining usage period.

Dermatology Procedures Equipment

For  the  year  ended  December  31,  2020,  dermatology  equipment  revenues  were  $5,681.  Internationally,  we  sold  36
systems for the year ended December 31, 2020, 22 of which were VTRAC systems. Domestically, we sold 2 systems for the year
ended  December  31,  2020.  For  the  year  ended  December  31,  2019,  dermatology  equipment  revenues  were  $7,873.
Internationally, we sold 74 systems for the year ended December 31, 2019, 7 of which were VTRAC systems. Domestically, we
sold 6 systems for the year ended December 31, 2019.

Additionally, included in the year ended December 31, 2019, was $185 in revenues for 5 Nordlys units (and accessories).

Cost of Revenues
 The following table illustrates cost of revenues from our two business segments for the periods listed below:

Dermatology Recurring Procedures
Dermatology Procedures Equipment
Total Cost of Revenues

Gross Profit Analysis

For the Year Ended December 31  

2020

2019

  $

  $

5,832    $
3,124     
8,956    $

7,033 
4,283 
11,316 

Gross profit decreased to $14,134 for the year ended December 31, 2020, from $20,270 during the same period in 2019.
As a percentage of revenues, the gross margin was 61.2% for the year ended December 31, 2020, versus 64.2% during the same
period in 2019. The following tables analyze changes in our gross margin, by segment, for the periods presented below:

42

 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
Revenues

Percent (decrease)

Cost of revenues

Percent (decrease)

Gross profit

Gross profit percentage

Dermatology Recurring Procedures

Revenues

Percent (decrease)

Cost of revenues

Percent (decrease)

Gross profit

Gross profit percentage

Company Profit Analysis

  For the Year Ended December 31,  

2020

2019

  $

  $

23,090 

  $
(26.9%)   
8,956 
(20.9%)   
  $

14,134 

61.2%    

31,586 

11,316 

20,270 

64.2%

  For the Year Ended December 31,  

2020

2019

  $

  $

17,409 

  $
(26.6%)   
5,832 
(17.1%)   
  $

11,577 

66.5%    

23,713 

7,033 

16,680 

70.3%

The  primary  reasons  for  the  decrease  in  gross  profit  were  the  result  of  lower  revenues  as  a  result  of  the  COVID-19
pandemic and unapplied costs partially offset by lower depreciation expense on lasers placed in the field.  Decreases in utilization
of lasers placed in the field will result in lower margins as we have certain fixed costs in the business.

Dermatology Procedures Equipment

Revenues

Percent (decrease)

Cost of revenues

Percent (decrease)

Gross profit

Gross profit percentage

  For the Year Ended December 31,  

2020

2019

  $

  $

5,681 
  $
(27.8%)   
3,124 
(27.1%)   
  $
2,557 

45.0%    

7,873 

4,283 

3,590 

45.6%

The primary reason for the decrease in gross profit for the year ended December 31, 2020, compared to the same period in

2019, was primarily the result of lower sales and unapplied costs.

Engineering and Product Development

Engineering and product development expenses for the year ended December 31, 2020, increased to $1,274 from $1,002
for  the  year  ended  December  31,  2019.  The  increase  was  due  to  higher  consulting  costs  associated  with  certain  engineering
projects.

Selling and Marketing Expenses

For the year ended December 31, 2020, selling and marketing expenses decreased to $9,038 from $12,003 for the year
ended December 31, 2019. The decrease was primarily due to the downturn in business as a result of the COVID-19 pandemic.
We managed our costs with lower tradeshow costs, travel costs, direct to consumer advertising and compensation.

General and Administrative Expenses

For the year ended December 31, 2020, general and administrative expenses decreased to $7,898 from $10,275 for the
year ended December 31, 2019. The decrease was primarily the result of approximately $2.0 million in accounting and legal costs
associated with our restatement of our financial statements as disclosed in our Annual Report on Form 10-K in 2019. We did not
incur these costs in 2020.

43

 
 
 
 
 
 
 
   
  
   
   
   
  
   
 
 
 
 
 
   
  
   
   
   
  
   
 
 
 
 
 
 
 
   
  
   
   
   
  
   
 
 
 
 
 
 
 
 
 
Interest Expense, net

Interest expense for the year ended December 31, 2020 was $61 compared to $515 for the year ended December 31, 2019.
The  decrease  was  due  to  higher  interest  income  on  the  higher  cash  equivalent  balance  in  2020  and  lower  interest  expense,  in
connection with our refinancing.

Other (Expense) Income, net

  In  connection  with  our  pay-off  of  the  MidCap  debt  in  December  2019,  we  incurred  a  loss  on  debt  extinguishment  of

$414.

Income Taxes

 Income tax expense for the year ended December 31, 2020, was $275 compared to a benefit of $149 for the year ended
December 31, 2019. The activity was the result of the change in the Tax Cut and Jobs Act (the “Tax Act”) in the accounting for
the net operating losses.

Net Loss

 The factors described above resulted in net loss of $4,412 during the year ended December 31, 2020, as compared to a

net loss of $3,790 during the year ended December 31, 2019.

Non-GAAP adjusted EBITDA

  We  have  determined  to  supplement  our  consolidated  financial  statements,  prepared  in  accordance  with  U.S.  GAAP,
presented elsewhere within this Report, with certain non-GAAP measures of financial performance. These non-GAAP measures
include non-GAAP adjusted EBITDA.

This  non-GAAP  disclosure  has  limitations  as  an  analytical  tool,  should  not  be  viewed  as  a  substitute  for  Net  Earnings
(Loss) determined in accordance with U.S. GAAP, and should not be considered in isolation or as a substitute for analysis of the
Company's results as reported under U.S. GAAP, nor is it necessarily comparable to non-GAAP performance measures that may
be  presented  by  other  companies.  We  consider  these  non-GAAP  measures  in  addition  to  our  results  prepared  under  current
accounting  standards,  but  they  are  not  a  substitute  for,  nor  superior  to,  U.S.  GAAP  measures.  These  non-GAAP  measures  are
provided to enhance readers’ overall understanding of our current financial performance and to provide further information for
comparative purposes. This supplemental presentation should not be construed as an inference that the Company's future results
will be unaffected by similar adjustments to Net Earnings (Loss) determined in accordance with U.S. GAAP.

Specifically, we believe the non-GAAP measures provide useful information to management and investors by isolating
certain expenses, gains and losses that may not be indicative of our core operating results and business outlook. In addition, we
believe  non-GAAP  measures  enhance  the  comparability  of  results  against  prior  periods.  Reconciliation  to  the  most  directly
comparable GAAP measure of all non-GAAP measures included in this Report is as follows:

Net loss

Adjustments:

Income taxes
Depreciation and amortization *
Interest expense, net

Non-GAAP EBITDA

Stock-based compensation expense
Impairment of lasers placed-in-service
Loss on extinguishment of debt

Non-GAAP adjusted EBITDA

  For the Year Ended December 31, 

2020

2019

  $

(4,412)   $

(3,790)

275     
3,911     
61     
(165)    

1,633     
24     
-     
1,492    $

(149)
4,821 
515 
1,397 

1,195 
30 
414 
3,036 

  $

* Includes depreciation on lasers placed-in-service of $1,930 and $2,660 for the years ended December 31, 2020, and 2019,
respectively.

 
 
 
 
 
 
 
 
 
 
   
 
 
   
      
  
   
      
  
   
   
   
   
 
   
      
  
   
   
   
 
 
 
 
 
 
44

 
Liquidity and Capital Resources

 As of December 31, 2020, we had $5,993 of working capital compared to $6,121 as of December 31, 2019. Cash and
cash equivalents and restricted cash were $18,112 as of December 31, 2020, as compared to $15,629, as of December 31, 2019.
The increase to our cash was the result of the receipt of proceeds from the PPP and EIDL loans and management of payables.
Delayed payment to vendors totaled $678 at December 31, 2020.

On December 30, 2019, the Company closed on a $7,275 loan with a commercial bank pursuant to a one-year Fixed Rate
– Term Promissory Note (the “Note”), which was renewed effective December 30, 2020 primarily to extend the term of the Note
one-year.  The  Company's  obligations  under  the  Note  are  secured  by  an  Assignment  and  Pledge  of  Time  Deposit  (the
“Agreement”), under which the Company has pledged the proceeds of a time deposit account in the amount of the loan to the
commercial bank. The Company fully repaid (including payment of termination and exit fees) its existing long-term debt credit
facility with Midcap Financial Trust. The transaction was accounted for as a debt extinguishment and the Company recorded a
loss of $414. The Note was renewed for another year through December 30, 2021.

We have been negatively impacted by the COVID-19 pandemic, have historically experienced recurring losses and have
been  dependent  on  raising  capital  from  the  sale  of  securities  in  order  to  continue  to  operate  and  meet  our  obligations  in  the
ordinary course of business. Since the equity financing in May 2018 and a change in management, and prior to COVID, we had
improved revenues, gross profit, generated positive cash flow from operations, refinanced our debt at a lower interest rate and
received cash proceeds from the PPP loan and the EIDL loan. We believe that our cash and cash equivalents, combined with the
anticipated  revenues  from  the  sale  or  use  of  our  products  and  the  proceeds  from  the  PPP  loan  and  the  EIDL  loan,  will  be
sufficient to satisfy our working capital needs, capital asset purchases, outstanding commitments and other liquidity requirements
associated  with  our  existing  operations  through  the  next  12  months  following  the  date  of  the  issuance  of  these  consolidated
financial statements. However, the negative impact of the COVID-19 outbreak on the financial markets could interfere with our
ability to access financing and to access it on favorable terms, if at all.

Net cash provided by operating activities was $2,096 for the year ended December 31, 2020, compared to cash provided
by operating activities of $2,229 for the year ended December 31, 2019. The cash flows provided by operating activities for the
year  ended  December  31,  2020,  were  unfavorably  impacted  by  lower  accrued  expenses,  lower  deferred  revenue  and  net  loss,
lower depreciation and higher inventory partially offset by collection of accounts receivable, higher accounts payables as we are
managing our payments to vendors and the non-cash impact of higher stock-based compensation.

Net  cash  used  in  investing  activities  was  $2,159  for  the  year  ended  December  31,  2020,  compared  to  cash  used  in
investing activities of $2,791 for the year ended December 31, 2019. The primary reason for the decrease in cash used was our
investment in lasers placed in service in the dermatology recurring procedures business segment due to the impact of COVID-19.

Net cash provided by financing activities was $2,546 for the year ended December 31, 2020, compared to cash used in
financing activities of $296 for the year ended December 31, 2019 due to the receipt of the proceeds from the PPP and EIDL
loans in 2020 and the payoff of the MidCap debt in 2019.

Off-Balance Sheet Arrangements

At December 31, 2020, we had no off-balance sheet arrangements.

Impact of Inflation

We have not operated in a highly inflationary period, and we do not believe that inflation has had a material effect on our

revenues or expenses. If we enter an inflationary period, it could have a material impact on our expenses.

Item 7A. 

Quantitative and Qualitative Disclosure about Market Risk

Not applicable.

45

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Item 8. 

Financial Statements and Supplementary Data

The financial statements required by this Item 8 are included in this Report and begin on page F-1.

Item 9. 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

None.

Item 9A. 

Controls and Procedures

Limitations of Internal Control System

Because  of  the  inherent  limitations  in  a  cost-effective  control  system,  no  evaluation  of  internal  control  over  financial
reporting  can  provide  absolute  assurance  that  misstatements  due  to  error  or  fraud  will  not  occur  or  that  all  control  issues  and
instances of fraud, if any, within our company have been detected. Therefore, even those systems determined to be effective can
provide only reasonable assurance with respect to financial statement preparation and presentation. Management does not expect
that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all errors and all
fraud.

Evaluation of Disclosure Controls and Procedures

Our  management,  with  the  participation  of  our  Chief  Executive  Officer  and  Chief  Financial  Officer,  has  evaluated  the
effectiveness of the design and operation of our disclosure controls and procedures, (as such term is defined in Rules 13a-15(e)
and  15d-15(e)  under  the  Securities  Exchange  Act  of  1934  (the  “Exchange  Act”)),  as  of  December  31,  2020.  Based  on  that
evaluation,  management  has  concluded  that,  as  of  such  date,  our  disclosure  controls  and  procedures  were  effective  at  the
reasonable assurance level.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us
in  reports  that  we  file  or  submit  under  the  Exchange  Act  is  recorded,  processed,  summarized,  and  reported  within  the  time
periods  specified  in  SEC  rules  and  forms,  and  that  such  information  is  accumulated  and  communicated  to  our  management,
including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure.

In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and
procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives
of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management
necessarily  was  required  to  apply  its  judgment  in  evaluating  the  cost-benefit  relationship  of  possible  disclosure  controls  and
procedures.  The  design  of  any  disclosure  controls  and  procedures  also  is  based  in  part  upon  certain  assumptions  about  the
likelihood  of  future  events,  and  there  can  be  no  assurance  that  any  design  will  succeed  in  achieving  its  stated  goals  under  all
potential future conditions.

Management's Report on Internal Control over Financial Reporting

Our  Management  is  responsible  for  establishing  and  maintaining  adequate  internal  control  over  financial  reporting  as
defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our management conducted an assessment of the effectiveness
of  our  internal  control  over  financial  reporting  based  on  the  framework  established  in  the  2013  Internal  Control-Integrated
Framework  issued  by  the  Committee  of  Sponsoring  Organizations  of  the  Treadway  Commission  (COSO).  Based  on  this
assessment, our management has determined that our internal control over financial reporting was effective as of December 31,
2020.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting in our most recent fiscal quarter that has

materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Item 9B.

Other Information

None.

 
 
 
 
 
 
 
 
 
 
46

 
Item 10. 

Directors, Executive Officers and Corporate Governance

PART III

Our directors currently have terms which will end at our next annual meeting of the stockholders or until their successors
are  elected  and  qualify,  subject  to  their  prior  death,  resignation  or  removal.  Officers  serve  at  the  discretion  of  the  Board  of
Directors.  There  are  no  family  relationships  among  any  of  our  directors  and  executive  officers.  Members  of  our  Board  of
Directors are encouraged to attend meetings of the Board of Directors and the Annual Meeting of Stockholders. The Board of
Directors held nine meetings during 2020.

The following sets forth certain biographical information concerning our current directors and our executive officers as of

March 17, 2021.

Name

Dr. Uri Geiger
Robert J. Moccia
Samuel E. Navarro
Samuel Rubinstein
Nachum Shamir
LuAnn Via

Position
Chairperson of the Board
President, Chief Executive Officer and Director
Director
Director
Director
Vice Chairperson of the Board

Age
53
62
65
81
68
67

Dr. Uri Geiger  became  our  Chairperson  of  the  Board  of  Directors  of  the  Company  in  May  2018.  Dr.  Geiger  is  a  co-
founder and Managing Partner of Accelmed, a private equity investment firm he co-founded in 2009 focused on medical device
companies.  Prior  to  founding  Accelmed,  Dr.  Geiger  served  as  the  CEO  of  Exalenz  Bioscience  Ltd.,  a  medical  technology
company, from May 2006 until December 2008. Prior to that, Dr. Geiger co-founded and was the CEO of GalayOr Networks, a
developer of optical components from 2001 until 2003. Dr. Geiger was also the founding partner of Dragon Variation Fund in
2000, one of Israel’s first hedge funds, which was sold to Migdal in 2007. Dr. Geiger worked on Wall Street during the 1990s,
where  he  gained  a  broad  understanding  of  and  significant  experience  in  capital  markets.  Dr.  Geiger  was  formerly  an  adjunct
professor  at  Tel  Aviv  University’s  Recanati  School  of  Business  where  he  lectured  on  private  equity  and  venture  capital  and
authored  the  books  “Startup  Companies  and  Venture  Capital”  and  “From  Concept  to  Wall  Street.”  Dr.  Geiger  served  as  the
Chairman of the Board of Directors of Cogentix Medical from November 2016 until its sale in April 2018 and he is currently on
the board of a number of public and private medical device companies. We believe Dr. Geiger's qualifications to serve on our
Board of Directors includes his extensive entrepreneurial, management and investment know-how having created and built many
successful medical device enterprises.

Robert J. Moccia was appointed the Company’s Chief Executive Officer effective March 1, 2021. Mr. Moccia has more
than 20 years of executive management experience as President, COO, and CEO of small to mid-sized specialty pharmaceutical
companies  and  over  35  years  of  global  pharmaceutical  experience  with  expertise  in  general  management,  operations,  strategic
planning,  business  development,  product  development,  sales,  marketing,  and  building  customer  focused  organizations.  Most
recently,  Mr.  Moccia  co-founded  Encore  Dermatology  and  since  April  2015  until  February  2021,  served  as  its  President  and
CEO. Prior to founding Encore, Mr. Moccia was CEO of Precision Dermatology Inc., which was sold to Valeant in 2014. Mr.
Moccia  has  marketed  and/or  launched  over  30  dermatological  products  in  the  US  and  created  over  $1.2  billion  in  exit
transactions. He has completed multiple licenses, acquisitions and partnerships in the dermatology space. Mr. Moccia has held
executive  management  positions  at  Medicis  Pharmaceuticals  (Sr.  VP  of  Corporate  Development),  Graceway  Pharmaceuticals
(President  &  COO),  and  Bioglan  Pharmaceuticals  (President).  He  also  spent  time  at  Dermik  and  Stiefel  Laboratories  in  sales,
marketing,  and  business  development.  Mr.  Moccia  holds  a  B.S.  in  Biology  from  Stonehill  College.  We  believe  Mr.  Moccia’s
qualifications  to  serve  on  our  Board  of  Directors  includes  his  extensive  entrepreneurial  and  management  experience  including
those focused on the dermatology space.

47

 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Samuel Navarro became a director of the Company in March 2014 and serves as a member of the Audit Committee. Since
October 2008, Mr. Navarro has been Managing Partner at Gravitas Healthcare, LLC, which provides strategic advisory services
to medical technology companies. From September 2005 to October 2008, Mr. Navarro was Managing Director of Cowen & Co.
in New York City and head of their Medical Technology Investment Banking initiatives, leading a team of senior people, and was
responsible  for  building  the  franchise  across  all  product  categories,  including  M&A/Advisory  and  financing  services  and
products. From 2001 to 2005, Mr. Navarro was at The Galleon Group running the Galleon Healthcare Fund as a Senior Portfolio
Manager.  He  was  responsible  for  all  health  care  investments  across  all  sectors,  including  pharmaceutical/biopharmaceutical
industries,  medical  technology  and  hospital  supplies,  and  all  areas  of  healthcare  services.  From  July  1998  to  February  2001,
Mr. Navarro was Global Head of Healthcare Investment Banking at ING Barings. Mr. Navarro has also served or serves on the
boards of Arstasis, BioSig Technologies, Derma Sciences, Dextera Surgical, MicroTherapeutics, Jomed, Strata Skin Sciences and
Pixelux Entertainment. Mr. Navarro received an MBA in Finance from The Wharton School at the University of Pennsylvania, a
Master of Science in Engineering from Stanford University  and  a  Bachelor  of  Science  in  Engineering  from  The  University  of
Texas at Austin. We believe Mr. Navarro's qualifications to serve on the Board of Directors include his wealth of knowledge and
industry  expertise  in  finance,  investment  banking,  mergers  and  acquisitions,  equity  research  and  investment  management
experience in the medical device industry.

Shmuel (Milky) Rubinstein became a director of the Company in May 2018 and serves on the Audit Committee and on
the Compensation, Nominating and Governance Committee. Mr. Rubinstein has served for over 20 years as the Chief Executive
Officer  and  General  Manager  of  Taro  Pharmaceuticals  Industries,  a  NASDAQ  traded  dermatology  company.  Under  his
management,  Taro  grew  to  become  a  multinational  company  with  over  1,000  employees  worldwide  and  turnover  of  close  to
$450  million.  In  2003,  Mr.  Rubinstein  received  the  Exceptional  Industrialist  award.  During  these  years  he  also  finished  an
International  Marketing  Course  at  the  Wharton  School  of  the  University  of  Pennsylvania.  Mr.  Rubinstein  is  the  Chairman  of
Trima Pharma’s Board and serves, or has served, as a board member in Keystone Dental, Clal Biotechnology Industries, Exalenz,
Medison Biotech, Kamada, and as consultant to BDO and Sol-Gel Pharma. Milky is also a director at the Medical Research Fund
near  The  Tel  Aviv  Sourasky  Medical  Center  and  The  National  Authority  for  Yiddish  Culture.  We  believe  Mr.  Rubinstein's
qualifications to serve on the Board of Directors include his wealth of knowledge and industry expertise in finance, investment
banking, mergers and acquisitions, equity research and investment management experience in the dermatology industry.

Nachum (Homi) Shamir became a director of the Company in May 2018 and chairs our Compensation, /Nominating and
Governance  Committee.  Mr.  Shamir  has  been  the  President  and  Chief  Executive  Officer  of  Luminex  Corporation.  He  also
became Chairman of the Board in September 2020. Luminex develops, manufactures, and markets biological testing technologies
in the clinical diagnostic and life science industries, since October 2014. Mr. Shamir previously served, from 2006 to 2014, as
President and CEO of Given Imaging, a developer, manufacturer, and marketer of diagnostic products for the visualization and
detection of disorders of the gastrointestinal tract. Prior to joining Given Imaging, Mr. Shamir was Corporate Vice President of
Eastman Kodak Company and President of Eastman Kodak´s Transaction and Industrial Solutions Group. Additionally, he served
over 10 years at Scitex Corporation in positions of increasing responsibility, including President and CEO from 2003 to 2004.
Prior to Scitex Corporation, Mr. Shamir held senior management positions at various international companies mainly in the Asia
Pacific regions. Mr.  Shamir  currently  serves  as  a  director  in  Luminex  Corp  (LMNX)  and  previously  served  in  Given  Imaging
(GIVN),  Cogentix  Medical  (CGNT)  and  Invendo  Medical  GMBH.  Mr.  Shamir  holds  a  Bachelor  of  Science  from  the  Hebrew
University of Jerusalem and a Masters of Public Administration from Harvard University. We believe Mr. Shamir's qualifications
to  serve  on  the  Board  of  Directors  include  his  wealth  of  knowledge  and  industry  expertise  in  finance,  investment  banking,
mergers and acquisitions, equity research and investment management experience in the life science industry.

48

 
 
 
 
 
 
LuAnn Via has served as a member of the Board of Directors since April 2012, was named Vice Chairperson in March
of  2021  and    is  the  Chair  of  the  Audit  Committee.  She  has  also  served  as  a  member  of  the  Compensation,  Nominating  and
Governance  Committee.  Ms.  Via  is  currently  an  Independent  Public  and  Private  Board  Director  and  a  Retail/Manufacturing
Advisor. Prior to this from November 2012 through January 2017, Ms. Via was President, CEO and Executive Board Member of
Christopher & Banks Corporation, a women’s specialty retailer; a company operating more than 500 retail stores. Ms. Via served
as the President and Chief Executive Officer of Payless ShoeSource, a unit of Collective Brands, Inc., with over 4,000 stores in
50 countries from July 2008 to October 2012 when the company was acquired and taken private. Before joining Payless from
January  2006  Ms.  Via  served  as  group  divisional  President  of  Lane  Bryant  and  Cacique  store  chains  and  as  President  of
Catherines stores, both divisions of Charming Shoppes, Inc. Prior to this, and for more than 20 years, Ms. Via held several senior
leadership  positions  with  a  number  of  top  retailers.  Ms.  Via  is  a  member  of  Women  Corporate  Directors,  the  only  global
membership  organization of women directors of corporate and large privately held companies, and The Committee of 200, an
invitation only membership organization of the world’s most successful women entrepreneurs and corporate leaders. We believe
Ms.  Via's  qualifications  to  serve  on  the  Board  of  Directors  include  her  experience  in  retail/wholesale  sales,  manufacturing,
marketing, ecommerce and her extensive experience as a CEO and senior executive of several publicly-listed companies.

With respect to the incumbent members of the Board of Directors, none of the members has, in the past 10 years, been
subject to a federal or state judicial or administrative order, judgment, decree or finding, not subsequently reversed, suspended or
vacated,  relating  to  any  legal  proceedings,  which  include  judicial  or  administrative  proceedings  resulting  from  involvement  in
mail  or  wire  fraud  or  fraud  in  connection  with  any  business  entity  or  based  on  violations  of  federal  or  state  securities,
commodities, banking, or insurance laws and regulations, or any settlement to such actions, and any disciplinary sanction or order
imposed by a stock, commodities or derivatives exchange other self-regulatory organization.

Board Leadership Structure

Our Board of Directors administers its risk oversight function as a whole by making risk oversight a matter of collective
consideration. While management is responsible for identifying risks, our Board of Directors has charged the Audit Committee of
the Board of Directors with evaluating financial and accounting risk, the Compensation, Nominating & Governance Committee
of the Board of Directors with evaluating risks associated with employees and compensation. Investor-related risks are usually
addressed by the Board as a whole.

Compensation, Nominating and Corporate Governance and Audit Committees

General

Our Board of Directors maintains charters for its committees. In addition, our Board of Directors has adopted a written set
of corporate governance guidelines and a code of business conduct and ethics and a code of conduct for our chief executive and
senior financial officers that generally formalize practices that we already had in place. We have adopted a Code of Ethics, an
Anti-Fraud Program and a policy for compliance with the Foreign Corrupt Practices Act. To view the charters of our Audit and
Compensation, Nominating and Corporate Governance Committees, Code of Ethics, corporate governance guidelines, codes of
conduct  and  whistle  blower  policy,  please  visit  our  website  at  www.strataskinsciences.com,  under  the  Corporate  Governance
section  of  the  Investor  Relations  page  (this  website  address  is  not  intended  to  function  as  a  hyperlink  and  the  information
contained on our website is not intended to be a part of this Report). In compliance with Nasdaq rules, the majority of our Board
of Directors is comprised of independent directors. The Board of Directors determined in 2020 that, except for Dr. Geiger, who is
our Chairman and Dr. Rafaeli, who was our Chief Executive Officer until his separation on February 28, 2021, all other current
members of the Board of Directors are independent under the revised listing standards of Nasdaq.

49

 
 
  
 
 
 
 
 
 
 
 
Compensation, Nominating and Governance Committee.

In  2018,  the  Board  determined  that  the  role  of  the  Nominating  and  Governance  Committee  should  be  assumed  by  the
Compensation  Committee,  and  the  committee  was  renamed  the  Compensation,  Nominating  and  Governance  Committee  (the
“Compensation,  Nominating  Committee”).  Our  Compensation,  Nominating  Committee  discharges  the  Board  of  Directors’
responsibilities relating to compensation of our Chief Executive Officer and other executive officers, produces an annual report
on  executive  compensation  for  inclusion  in  our  annual  proxy  statement  and  this  Report  and  provides  general  oversight  of
compensation structure. Other specific duties and responsibilities of the Compensation, Nominating Committee include:

•
•

•
•
•
•
•

reviewing and approving objectives relevant to executive officer compensation;
evaluating  performance  and  recommending  to  the  Board  of  Directors  the  compensation,  including  any  incentive  compensation,  of  our  Chief
Executive Officer and other executive officers in accordance with such objectives;
reviewing employment agreements for executive officers;
recommending to the Board of Directors the compensation for our directors;
administering our equity compensation plans and other employee benefit plans;
evaluating human resources and compensation strategies, as needed; and
evaluating periodically the committee charter.

The  Compensation,  Nominating  and  Governance  Committee  reviews  executive  compensation  from  time  to  time  and
reports to the Board of Directors, which makes all final decisions with respect to executive compensation. The Compensation,
Nominating Committee adheres to several guidelines in carrying out its responsibilities, including performance by the employees,
our performance, enhancement of stockholder value, growth of new businesses and new markets and competitive levels of fixed
and  variable  compensation.  The  report  of  the  Compensation,  Nominating  and  Governance  Committee  for  2020  is  presented
below.

In absorbing the duties and responsibilities of the Nominating and Governance Committee, except where the Company is
legally required by contract, bylaw or otherwise to provide third parties with the right to nominate directors, the Compensation,
Nominating  Committee  is  responsible  for  recommending  to  the  Board  the  nominees  for  election  as  directors  at  the  annual
meeting  of  stockholders  and  the  persons  to  be  elected  by  the  Board  to  fill  any  vacancies  on  the  Board.  In  making  such
recommendations, the Compensation, Nominating Committee will consider candidates proposed by stockholders. The Committee
will  review  and  evaluate  information  available  to  it  regarding  candidates  proposed  by  stockholders  and  shall  apply  the  same
criteria,  and  will  follow  substantially  the  same  process  in  considering  them,  as  it  does  in  considering  other  candidates.  The
Compensation, Nominating Committee is charged with developing and periodically assessing and making recommendations to
the Board concerning appropriate corporate governance policies. The Compensation, Nominating Committee also has oversight
over  the  Company’s  corporate  governance  guidelines  and  policies  governing  the  full  Board.  Other  specific  duties  of  the
Compensation, Nominating Committee in its role of overseeing corporate governance and succession planning are:

reviewing and evaluating succession planning for our Chief Executive Officer and other executive officers;

developing and overseeing the corporate governance principles applicable to members of our Board of Directors, officers and employees;
reviewing and approving director compensation and administering the Non-Employee Director Plan;

•
• monitoring the independence of our directors;
•
•
• monitoring the continuing education for our directors; and
•

evaluating annually the committee charter.

Our Board of Directors has adopted a written charter for the Compensation, Nominating and Governance Committee. The
Compensation,  Nominating  and  Governance  Committee  is  currently  composed  of  Nachum  Shamir,  LuAnn  Via  and  Samuel
Rubinstein. Our Board of Directors determined that each member of the Compensation, Nominating and Governance Committee
as of December 31, 2020, satisfies the independence requirements of Nasdaq. The Compensation, Nominating and Governance
Committee held two formal meetings and several informal during 2020.

50

 
 
 
 
 
 
 
 
REPORT OF THE COMPENSATION, NOMINATING AND GOVERANANCE COMMITTEE OF THE BOARD OF
DIRECTORS

The  Compensation,  Nominating  and  Governance  Committee  which  is  composed  solely  of  independent  directors  of  the
Board  of  Directors,  assists  the  Board  in  fulfilling  its  responsibilities  with  regard  to  compensation  matters,  and  is  responsible
under  its  charter  for  determining  the  compensation  of  the  Company’s  executive  officers.  The  Committee  has  reviewed  and
discussed  the  “Executive  Compensation”  section  of  this  annual  report  statement  with  management  and  recommended  to  the
Board that the section be included in the Annual Report.

The Compensation, Nominating and Governance Committee:
Nachum Shamir, Chair
LuAnn Via
Samuel Rubinstein

Audit Committee

Our  Board  of  Directors  has  established  an  Audit  Committee  to  assist  it  in  fulfilling  its  responsibilities  for  general
oversight  of  the  integrity  of  our  consolidated  financial  statements,  compliance  with  legal  and  regulatory  requirements,  the
independent  auditors’  qualifications  and  independence,  the  performance  of  our  independent  auditors  and  an  internal  audit
function and risk assessment and risk management. The duties of our Audit Committee include:

•
•
•

•
•
•
•
•

appointing, evaluating and determining the compensation of our independent auditors;
reviewing and approving the scope of the annual audit, the audit fee and the financial statements;
reviewing  disclosure  controls  and  procedures,  internal  control  over  financial  reporting,  any  internal  audit  function  and  corporate  policies  with
respect to financial information;
reviewing other risks that may have a significant impact on our financial statements;
preparing the Audit Committee report for inclusion in the annual proxy statement;
establishing procedures for the receipt, retention and treatment of complaints regarding accounting and auditing matters;
approving all related party transactions, as defined by applicable Nasdaq Rules, to which we are a party; and
evaluating annually the Audit Committee charter.

The Audit Committee works closely with management as well as our independent auditors. The Audit Committee has the
authority to obtain advice and assistance from, and receive appropriate funding from us for, outside legal, accounting or other
advisors as the Audit Committee deems necessary to carry out its duties.

Our Board of Directors has adopted a written charter for the Audit Committee that meets the applicable standards of the
Commission and Nasdaq. The Audit Committee members are LuAnn Via, Chair, Samuel Rubinstein and Samuel Navarro. The
Audit Committee meets regularly and held six meetings during 2020.

The  Board  of  Directors  determined  in  2020  that  each  member  of  the  Audit  Committee  satisfies  the  independence  and
other  composition  requirements  of  the  Commission  and  Nasdaq.  Our  Board  has  determined  that  each  member  of  the  Audit
Committee  qualifies  as  an  “audit  committee  financial  expert”  under  Item  407(d)(5)  of  Regulation  S-K  and  has  the  requisite
accounting or related financial expertise required by applicable Nasdaq rules.

Stockholder Communications with the Board of Directors

Our Board of Directors has established a process for stockholders to communicate with the Board of Directors or with
individual  directors.  Stockholders  who  wish  to  communicate  with  our  Board  of  Directors  or  with  individual  directors  should
direct written correspondence to Jay Sturm, General Counsel at jsturm@strataskin.com or to the following address (our principal
executive offices): Board of Directors, c/o Corporate Secretary, 5 Walnut Grove Drive, Suite 140, Horsham, Pennsylvania 19044.
Any such communication must contain:

•
•
•

a representation that the stockholder is a holder of record of our capital stock;
the name and address, as they appear on our books, of the stockholder sending such communication; and
the class and number of shares of our capital stock that are beneficially owned by such stockholder.

51

 
 
 
 
 
 
 
Mr.  Sturm,  as  the  Corporate  Secretary  will  forward  such  communications  to  our  Board  of  Directors  or  the  specified
individual director to whom the communication is directed unless such communication is unduly hostile, threatening, illegal or
similarly  inappropriate,  in  which  case  the  Corporate  Secretary  has  the  authority  to  discard  the  communication  or  to  take
appropriate legal action regarding such communication

REPORT OF THE AUDIT COMMITTEE OF THE BOARD OF DIRECTORS

The  Audit  Committee  oversees  the  Company’s  financial  reporting  process  on  behalf  of  the  Board  of  Directors.
Management  has  the  primary  responsibility  for  the  financial  statements  and  the  reporting  process,  including  the  systems  of
internal  control  over  financial  reporting  and  disclosure  controls  and  procedures.  In  fulfilling  its  oversight  responsibilities,  the
Audit  Committee  reviewed  the  audited  financial  statements  included  in  this  Annual  Report  on  Form  10-K  for  the  year  ended
December  31,  2020,  with  management,  including  a  discussion  of  the  quality,  not  just  the  acceptability,  of  the  accounting
principles, the reasonableness of significant judgments, and the clarity of disclosures in the financial statements.

The  Audit  Committee  is  responsible  for  reviewing,  approving  and  managing  the  engagement  of  the  Company’s
independent registered public accounting firm, including the scope, extent and procedures of the annual audit and compensation
to  be  paid  therefore,  and  all  other  matters  the  Audit  Committee  deems  appropriate,  including  the  Company’s  independent
registered  public  accounting  firm’s  accountability  to  the  Board  of  Directors  and  the  Audit  Committee.  The  Audit  Committee
reviewed with the Company’s independent registered public accounting firm, which is responsible for expressing an opinion on
the conformity of audited financial statements with generally accepted accounting principles, its judgment as to the quality, not
just  the  acceptability,  of  the  Company’s  accounting  principles  and  such  other  matters  as  are  required  to  be  discussed  with  the
Audit  Committee  by  the  Standards  of  the  Public  Company  Accounting  Oversight  Board  (“PCAOB”),  including  PCAOB
Auditing  Standard  No.  1301,  Communications  With  Audit  Committees,  the  rules  of  the  Securities  and  Exchange  Commission
(SEC) and other applicable regulations, and discussed and reviewed the results of the Company’s independent registered public
accounting  firm’s  examination  of  the  financial  statements.  In  addition,  the  Audit  Committee  discussed  with  the  Company’s
independent  registered  public  accounting  firm  the  independent  registered  public  accounting  firm’s  independence  from
management and the Company, including the matters in the written disclosures and the letter regarding its independence by Rule
3526 of the PCAOB regarding the independent registered public accounting firm’s communications with the Audit Committee
concerning  independence.  The  Audit  Committee  also  considered  whether  the  provision  of  non-audit  services  was  compatible
with maintaining the independent registered public accounting firm’s independence.

The Audit Committee discussed with the Company’s independent registered public accounting firm the overall scope and
plans  for  its  audit,  and  received  from  them  written  disclosures  and  letter  regarding  their  independence.  The  Audit  Committee
meets with the Company’s independent registered public accounting firm, with and without management present, to discuss the
results of its examinations, its evaluations of the Company’s internal control over financial reporting and the overall quality of the
Company’s financial reporting. The Audit Committee held six meetings during the fiscal year ended December 31, 2020.

In  reliance  on  the  reviews  and  discussions  referred  to  above,  the  Audit  Committee  recommended  to  the  Board  of
Directors (and the Board of Directors has approved) that the audited financial statements be included in the Company’s Annual
Report on Form 10-K for the year ended December 31, 2020, for filing with the Commission.

AUDIT COMMITTEE:

LuAnn Via, chair
Samuel Rubinstein
Samuel Navarro 

52

 
 
 
 
  
 
 
 
 
 
 
 
 
Section 16(a) Beneficial Ownership Reporting Compliance

Section 16(a) of the Exchange Act requires our directors and executive officers and beneficial holders of more than 10%
of our common stock to file with the Commission initial reports of ownership and reports of changes in ownership of our equity
securities.  As  of  March  17,  2021,  we  believe,  based  solely  on  a  review  of  the  copies  of  such  reports  furnished  to  us  and
representations  of  these  persons  that  all  Section  16(a)  filing  requirements  applicable  to  directors  and  officers  were  timely  met
during the year ended December 31, 2020.

Item 11. 

Executive Compensation

Executive Officers

During the year ended December 31, 2020, our named executive officers were:

•   Dolev Rafaeli, President and Chief Executive Officer (until his separation on February 28, 2021);

•   Matthew C. Hill, Chief Financial Officer;

The  biographical  information  for  our  current  executive  officers  (other  than  Dr.  Rafaeli,  which  is  included  above)  are

below:

Matthew C. Hill (age 52) assumed the duties of Chief Financial Officer on May 15, 2018. Prior to joining the Company,
he  was  the  chief  financial  officer  with  operational  responsibilities  with  SS  White  Dental,  a  privately  held  medical  device
company in the dental space, from 2010. Prior to SS White, Matt served as CFO at Velcera and EP Medsystems, both publicly
traded  companies,  where  he  was  also  responsible  for  public  company  compliance  and  participated  in  capital  raising  for  the
companies.  Mr.  Hill  has  over  20  years  of  experience  in  various  capacities  in  public  and  private  companies,  and  in  public
accounting with Grant Thornton LLP. Mr. Hill graduated with a B.S. in accounting from Lehigh University in 1991.

Components of Executive Compensation during 2020

Dr. Rafaeli, had an opportunity to earn an annual bonus based upon the performance of the Company’s business during
the relevant quarters in which he is employed of each fiscal year. Such bonus during 2020 is achieved, on a quarterly basis, but
paid annually, if (a) the Company achieved positive adjusted EBITDA of $5 million and (b) with such bonus amount determined
as a percentage of the average aggregate collected revenue during such quarter from all installed laser machines (pro-rated for
machines installed during a quarter) (“Average Revenue per Machine”) based upon the following schedule:

Average Revenue per Machine per

Bonus (as a percentage of total company revenue for the relevant

quarter

Up to $8,100
$8,101 to $9,600
$9,601 to $11,000
Above $11,001

quarter)

0.50%
0.80%
1.20%
1.50%

The  Average  Revenue  per  Machine  and  positive  adjusted  EBITDA  of  $5  million  results  achieved  on  a  quarterly  basis

resulted in no payout for 2020.

Mr. Hill had a target bonus of $95,000 in 2020, with 75% of such bonus based on achieving certain revenue goals. The
balance  of  the  bonus  was  based  on  achieving  personal  goals  as  agreed  with  the  Chief  Executive  Officer  and  approved  by  the
Compensation, Nominating and Governance Committee, which resulted in a total discretionary bonus payout of $47,500.

53

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The stock option grant was granted on November 13, 2020, and were made under the following terms:

Shares
Underlying
Option Grant

Exercise Price
per share

Option Term

Matthew C. Hill

150,000    $

1.46 

10 years

Vesting Period
1/3 on each anniversary of the date of
grant

The following table includes information for the years ended December 31, 2020, and 2019 concerning compensation for

our named executive officers.

SUMMARY COMPENSATION TABLE

Name and Principal Position
Dolev  Rafaeli  (1),  Director,  President
and Chief Executive Officer

Matthew C. Hill , Chief Financial Officer

Year
2020
2019

2020
2019

Salary ($)

400,000
400,000

246,941
240,000

Non-Equity
Incentive Plan
Compensation
($) (3)
-
277,930

47,500
149,287

Option Awards
($) (2)

All Other
Compensation
($) (4)

-
466,500

166,200
233,250

23,400
23,200

16,200
16,000

Total ($)

423,400
1,167,630

476,841
638,537

 (1) Dolev Rafaeli separated from the Company on February 28, 2021.
 (2)

These amounts are equal to the aggregate grant-date fair value with respect to the awards made in the respective year, computed in accordance with
FASB  ASC  Topic  718,  before  amortization  and  without  giving  effect  to  estimated  forfeitures.  See  the  “Stock-based  compensation”  Note  to  our
consolidated financial statements set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, for the assumptions
made in calculating these amounts.

 (3) Represents annual bonus amounts paid to the named individuals under the bonus plans in their respective employment agreements, and a special
bonus  awarded  in  connection  with  the  resolution  of  matters  related  to  managing  the  Company’s  efforts  to  become  compliant  with  all  of  the
Company’s  reporting  requirements  in  2019.  We  discuss  these  bonus  plans  in  further  detail  in  the  section  entitled  “Components  of  Executive
Compensation during 2020.”
“All Other Compensation” includes a car allowance for Dr. Rafaeli of $12,000 and $12,000 in 2020, and 2019, respectively, and a 401(k) match of
$11,400 in 2020 and $11,200 in 2019; and for Mr. Hill includes a car allowance of $4,800 in 2020 and 2019, respectively, and a 401(k) match of
$11,400 and $11,200 in 2020 and 2019, respectively.

 (4)

54

 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
Overview of Executive Employment Agreements and Payments upon Termination or Change of Control

Employment Agreement with Robert Moccia

On March 1, 2021, the Company entered into an employment agreement with Robert Moccia to become the Company’s
Chief  Executive  Officer,  (the  “Employment  Agreement”),  which  provides  for,  among  other  things,  (i)  a  three-year  term
commencing  on  March  1,  2021,  which  renews  for  successive  one  year  additional  terms  unless  a  party  gives  the  other  party  a
notice  of  non-renewal  at  least  90  days  prior  to  the  end  of  the  then  applicable  employment  term,  (ii)  an  annual  base  salary  of
$500,000, (iii) an incentive bonus opportunity equal to at least 65% of his base salary for such year, (iii) an initial option (the
“Option”) to purchase 1,632,590 shares of common stock, with a strike price as of the close of trading on March 1, 2021 which
was $1.73, vesting over a three year period, with 544,198 options vesting on the first anniversary of the date of grant and 136,049
options vesting every three months thereafter and subject to acceleration under certain conditions, (iv) participation in long-term
incentive plans and employee benefit plans, including health and 401(k) plans, (v) 20 days of annual vacation, plus 10 established
holiday days, per full calendar year of employment, (vi) an automobile allowance of $1,250 per month, and (vi) his appointment
to  the  Company’s  board  of  directors  as  of  March  1,  2021,  and  nomination  and  recommendation  for  election  as  a  director
thereafter at annual meetings of stockholders during his employment term when his election is to be considered. The Option is
intended  to  constitute  an  employment  inducement  grant  under  Nasdaq  Listing  Rule  5635(c)(5).  The  Company  will  also  pay
Mr. Moccia a bonus equal to two times his then base salary if, during the term of his employment, (a) a “Change in Control” (as
defined  in  the  Company’s  2016  Omnibus  Incentive  Plan,  as  amended  from  time  to  time)  occurs  and  (b)  as  of  such  Change  in
Control,  the  price  per  share  of  the  Company’s  common  stock  is  two  times  or  more  than  the  price  of  the  Company’s  common
stock as of March 1, 2021.

The Employment Agreement provides Mr. Moccia with severance benefits in the event that his employment is terminated
under certain circumstances, including by Mr. Moccia for “Good Reason” and by the Company without “Cause” (each as defined
in the Employment Agreement). Upon the termination of Mr. Moccia’s employment, he will automatically resign as a member of
the Company’s board of directors. Pursuant to the Employment Agreement, Mr. Moccia is subject to confidentiality, assignment
of intellectual property, and restricted activities covenants, the latter of which continues for 12 months after his separation from
employment.

Employment Agreement with Dr. Dolev Rafaeli

On  March  30,  2018,  the  Company  executed  an  employment  agreement  with  Dr.  Rafaeli.  On  February  24,  2020,  the
Company and Dr. Rafaeli entered into a Separation Agreement and Release terminating Dr. Rafaeli’s employment. The term of
his original employment agreement commenced on April 10, 2018 until the third anniversary of the closing under the Accelmed-
led investment, which term provided for  automatic renewal for one year unless either party provides 60 days' notice prior to the
end of the then current term. Dr. Rafaeli's employment with the Company would have terminated if the Accelmed-led investment
had terminated prior to closing for any reason.

Dr.  Rafaeli's  base  salary  was  $400  thousand  per  year,  and  he  is  entitled  to  bonus  compensation  based  upon  the
achievement of earnings targets. Dr. Rafaeli was awarded stock options under the Company's 2016 Omnibus Incentive Plan equal
to 7.5% of the Company's equity on a fully diluted basis as of immediately following the closing of the Accelmed-led investment.
The options were awarded as follows: (i) stock options exercisable for 1,557,628 shares of the Company's common stock were
granted on March 30, 2018, at an exercise price of $1.12; and (ii) the balance of the stock options were awarded upon approval
by the Company's stockholders of the Accelmed-led investment and the transactions contemplated thereby at the special meeting
of  stockholders,  and  the  exercise  price  was  equal  to    the  closing  trading  price  of  the  Company's  shares  of  common  stock  on
Nasdaq on the day of the special meeting. The shares of common stock purchasable upon exercise of the stock options are subject
to certain transferability restrictions under the employment agreement and fully vest upon a change of control. The employment
agreement  also  contains  provisions  for  fringe  benefits,  reimbursement  of  expenses,  nomination  for  election  to  the  Board,
indemnification,  vacation,  confidentiality,  assignment  of  certain  inventions  and  other  intellectual  property,  covenant  not  to
compete and payments of a lump sum payment equal to base salary over the initial term upon termination, depending upon the
type of termination.

55

 
 
 
 
 
 
 
Separation Agreement with Dr. Dolev Rafaeli

On February 24, 2021, the Company and Dr.  Rafaeli entered into an employment separation agreement and release (the
“Separation Agreement”), pursuant to which, among other things, Dr. Rafaeli resigned as the Company’s Chief Executive Officer
and  President  and  as  a  member  of  the  Company’s  board  of  directors  on  February  28,  2021.  In  connection  with  Dr.  Rafaeli’s
separation, upon the expiration of the revocation of a general release delivered by Dr. Rafaeli to the Company, the Company will
(i)  pay  Dr.  Rafaeli  (a)  his  base  salary,  less  applicable  legal  deductions,  through  May  29,  2021  consistent  with  normal  payroll
procedures,  (b)  a  lump  sum  amount  equal  to  12  weeks  of  pay  as  a  payout  of  his  accrued  but  unused  vacation  days,
(c)  reimbursements  of  his  monthly  COBRA  premium  payments  for  up  to  18  months  following  February  28,  2021,  and  (d)  an
amount up to $10,000 to reimburse Dr. Rafaeli for reasonable attorneys’ fees in connection with the negotiation of the Separation
Agreement,  and  (ii)  vest  all  outstanding  options  held  by  Dr.  Rafaeli  (to  the  extent  not  then  vested)  and  have  them  remain
exercisable until August 22, 2021. Subject to the foregoing restrictions and the Company’s insider trading policies, Dr. Rafaeli
will be permitted to exercise the options as permitted under the Company’s equity incentive plan, including cashless exercises,
until August 22, 2021. Certain provisions contained in DR. Rafaeli’s employment agreement, dated as of March 30, 2018 with
the Company survive and continue to apply under the Separation Agreement, including, but not limited to, covenants related to
confidentiality,  assignment  of  developments,  and  covenant  not  to  compete.  The  Company  and  Dr.  Rafaeli  also  agreed  to
mutual non-disparagement and communication restriction provisions and granted customary general releases to each other. Until
May 29, 2021, Dr. Rafaeli agreed to cooperate in good faith with the Company in transitioning his duties to one or more persons
as determined by the Company’s board of directors.

Employment Agreement with Matthew C. Hill

On May 15, 2018, Matthew Hill began employment as the Company's Chief Financial Officer. The Company and Mr. Hill
executed  an  employment  agreement  dated  May  15,  2018,  in  connection  with  the  appointment  to  the  Chief  Financial  Officer
position. Under the terms of the agreement, Mr. Hill receives a base salary of $249,500 and is eligible to receive an annual bonus
based on the Company achieving certain goals. The target bonus is set annually. In the event Mr. Hill's employment is terminated,
in conjunction with a change of control, he will be entitled to severance equal to 12 months of his base salary, payable subject to
execution of a general release in favor of the Company. The agreement also contains non-compete and non-solicitation periods.

Outstanding Equity Awards Value at Fiscal Year-End Table

The following table includes certain information with respect to the value of all unexercised options and unvested shares

of restricted stock previously awarded to the executive officers named above at the fiscal year end, December 31, 2020.

56

 
 
 
 
 
 
 
 
 
OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END TABLE

Equity
Incentive Plan
Awards
Number of
Securities
Underlying
Unexercised
Unvested
Options (#)

Option Awards

Option
Exercise
Price ($)

Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
(1)
100,000     
942,166     
1,427,825     
-     
50,000     
166,666     

Name                          
Dolev Rafaeli

Matthew Hill

            Grant Date            
11/22/2019
5/23/2018 
 3/30/2018 
11/13/2020
 11/22/2019 
 5/23/2018 

200,000    $
471,083    $
129,803    $
150,000    $
100,000    $
83,334    $

2.46 
1.66 
1.12 
1.46 
2.46 
1.66 

Option Expiration Date
11/22/2029
5/23/2028
3/30/2028
11/13/2030
11/22/2029
5/23/2028

 (1) Options granted were under the 2016 Omnibus Incentive Plan and options. Dr. Rafaeli’s options granted on March 30, 2018 contractually vested
quarterly over three years, all others had vested annually over three years. Upon Dr. Rafaeli’s separation on February 28, 2021, all options vested
(see Separation Agreement above). Mr. Hill’s options vest annually over three years.

Director Compensation

During 2020, non-management directors shall receive the following compensation as applicable to each particular

director.

1.   $70,000 base compensation

2.   $80,000 base compensation for the Chairman of the Board

3.   $10,000 for the Chairman of the Compensation, Nominating Committee.

4.   $20,000 for the Chairman of the Audit Committee

5.   $5,000 for membership on each committee (not to be paid to the Chair of the committees)

6.    New independent Board members shall receive a one-time grant of $20,000 in the form of restricted stock units.

Except for the Chairman, whose company rules prevent accepting equity, base compensation is to be paid generally no

more than 50% in cash; no Director is to receive more than $50,000 in cash; that non-cash payments will be in the form of
restricted stock units vesting equally in quarterly tranches over 12 months; and that payment will be made for each quarter in
advance.

57

 
 
 
 
 
   
   
 
   
   
   
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The table below sets forth our non-employee directors’ compensation for the year ended December 31, 2020.

DIRECTOR COMPENSATION TABLE

Name                                

Fees Earned ($) 

Stock Awards ($) (3) 

All Other Compensation ($) 

Total ($)

Uri Geiger (1)
David N. Gill (2)
Samuel E. Navarro
Samuel Rubinstein
Nachum Shamir
LuAnn Via

- 
19,231 
35,000 
45,000 
40,000 
52,100 

- 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 

-
19,231
35,000
45,000
40,000
52,100

(1)

(2)
(3)

Fees of $140,000 paid on behalf of Dr. Geiger were paid to Accelmed as a result of the fact that Accelmed’s partnership agreement precludes the
receipt of any equity.
Resigned from the board on May 22, 2020.
The Company has accrued the compensation for unissued stock awards.

Limitation on Directors' Liabilities; Indemnification of Officers and Directors

Our  Fifth  Amended  and  Restated  Certificate  of  Incorporation,  as  amended  (“Certificate  of  Incorporation”)  and  bylaws
designate the relative duties and responsibilities of our officers, establish procedures for actions by directors and stockholders and
other items. Our Certificate of Incorporation and bylaws also contain extensive indemnification provisions, which will permit us
to  indemnify  our  officers  and  directors  to  the  maximum  extent  provided  by  Delaware  law.  Pursuant  to  our  Certificate  of
Incorporation and under Delaware law, our directors are not liable to us or our stockholders for monetary damages for breach of
fiduciary duty, except for (i) any breach of the director’s duty of loyalty; (ii) acts or omissions not in good faith or which involve
intentional misconduct or a knowing violation of law; breach of duty with respect to dividends and other distributions; or (iv) any
transaction from which the director derived an improper personal benefit. We have also entered into indemnity agreements with
each director which provides for advancement of expenses and indemnification under certain circumstances.

Directors' and Officers' Liability Insurance

We have obtained directors' and officers' liability insurance, which expires on May 29, 2021. We are required under our

indemnification agreements to maintain such insurance for the officers and members of our Board of Directors.

Item 12. 
Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder

The information set forth in Item 5 of this Report under the heading “Securities Authorized for Issuance Under Equity

Compensation Plans” is hereby incorporated by reference.

The following table reflects, as of March 17, 2021, the beneficial common stock ownership of: (a) each of our directors,
(b) each executive officer, (c) each person known by us to be a beneficial holder of five percent (5%) or more of our common
stock, and (d) all of our executive officers and directors as a group. Unless otherwise provided in the accompanying footnotes, the
information used in the table below was obtained from the referenced beneficial owner.

58

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name and Address of Beneficial Owner (1)

Uri Geiger (8)
Robert J. Moccia(2)
Matthew Hill (3)
Samuel E. Navarro (4)
Samuel Rubinstein (5)
Nachum Shamir (6)
LuAnn Via (7)
All directors and officers as a group (seven persons)

Accelmed Growth Partners LP (8)
Kent Lake Partners LP(9)
Nantahala Capital Management, LLC (10)

*          Less than 1%.

Number of Shares
Beneficially Owned

Percentage of Shares
Beneficially Owned (1)

12,112,627

226,666
211,412
52,098
74,075
132,702
12,809,580

12,112,627
1,658,043
4,683,908

35.84%
*
*
*
*
*
*
37.33%

35.84%
4.91%
13.86%

(1)

Beneficial  ownership  is  determined  in  accordance  with  the  rules  of  the  Commission.  Shares  of  common  stock  subject  to  delivery,  or  subject  to
options or warrants currently exercisable, or exercisable within 60 days of March 17, 2021 are deemed outstanding for computing the percentage
ownership of the stockholder holding the options or warrants, but are not deemed outstanding for computing the percentage ownership of any other
stockholder.  Unless  otherwise  indicated  in  the  footnotes  to  this  table,  we  believe  stockholders  named  in  the  table  have  sole  voting  and  sole
investment power with respect to the shares set forth opposite such stockholder’s name. Unless otherwise indicated, the listed officers, directors and
stockholders  can  be  reached  at  our  principal  offices.  Percentage  of  ownership  is  based  on  33,801,045  shares  of  common  stock  outstanding  as  of
March 17, 2021.

(2)

Robert Moccia joined the Company on March 1, 2021.

(3)

Includes 10,000 shares of common stock and vested options to purchase 216,666 shares of common stock.

(4)

Includes 66,136 shares, 145,276 vested options to purchase shares of common stock.

(5)

Includes 11,300 shares of common stock and vested restricted stock units for 40,798 shares of common stock.

(6)

Includes 57,815 shares of common stock and vested restricted stock units for 16,260 shares of common stock.

(7)

(8)

(9)

Includes 40,571 shares, 60,995 vested options to purchase shares of common stock and vested restricted stock units of 31,136 shares of common
stock.

The  business  address  of  Accelmed  Growth  Partners  L.P.  ("Accelmed")  is  6  Hachochlim  Street,  6th  floor,  Herzliya  Pituach  L3  46120  Israel.
Accelmed Growth Partners GP ("Accelmed GP"), the General Partner of Accelmed, and Uri Geiger, the Managing Director of Accelmed Growth
Partners  Management  Ltd.,  which  is  the  management  company  of  Accelmed,  each  have  voting  and  investment  control  of  the  securities  held  by
Accelmed. Dr. Geiger is the Co-Founder and Managing Partner of Accelmed. Each of Accelmed GP and Uri Geiger disclaim beneficial ownership
over  the  securities  owned  by  Accelmed  except  to  the  extent  of  their  respective  pecuniary  interest  therein.  Accelmed  holds  12,112,627  shares  of
common stock. Dr. Geiger disclaims beneficial ownership of the 12,112,627 shares owned by Accelmed.

The business address of Kent Lake Partners LP (“Kent Lake”) is 591 Redwood Highway, Suite 3260 Mill Valley, California 94941. Kent Lake may
be deemed to be the beneficial owner of 1,658 shares of common stock held by funds and separately managed accounts under its control, and as the
managing member Benjamin Natter may be deemed to be the beneficial owner of those shares. The foregoing has been derived from a Schedule 13G
filed by Kent Lake on February 16, 2021.

59

 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(10)

The business address of Nantahala Capital Management, LLC ("Nantahala ") is 19 Old Kings Highway S, Suite 200, Darien, CT 06820. Nantahala
may be deemed to be the beneficial owner of 4,683,098 shares of common stock held by funds and separately managed accounts under its control,
and as the managing members of Nantahala, each of Wilmot B. Harkey and Daniel Mack may be deemed to be a beneficial owner of those shares.
The foregoing has been derived from a Schedule 13G filed by Nantahala on February 12, 2021.

Item 13. 

Certain Relationships and Related Transactions, Director Independence

Related Person Transactions

None

Director Independence

As required under the Nasdaq, listing standards, a majority of the members of a listed Company’s board of directors must
qualify  as  “independent,”  as  affirmatively  determined  by  the  board  of  directors.  Our  board  of  directors  consults  with  internal
counsel to ensure that the board’s determinations are consistent with relevant securities and other laws and regulations regarding
the  definition  of  “independent,”  including  those  set  forth  in  pertinent  Nasdaq  listing  standards,  as  in  effect  from  time  to  time.
Consistent with these considerations, after review of all relevant transactions or relationships between each director, or any of his
or  her  family  members,  and  our  company,  our  senior  management  and  our  independent  registered  public  accounting  firm,  the
board of directors has affirmatively determined that The Board of Directors determined in 2020 that, except for Dr. Geiger, who
is our Chairman and Dr. Rafaeli, who was our Chief Executive Officer, all other current members of the Board of Directors are
independent under the revised listing standards of Nasdaq.

Review, Approval or Ratification of Transactions with Related Persons

In accordance with its charter, the Audit Committee is responsible for reviewing all "related party transactions" (defined
as such transactions required to be disclosed pursuant to Item 404 of Regulation S-K) on an on-going basis. All such related party
transactions must be approved by the Audit Committee.

Item 14. 

Principal Accounting Fees and Services

The following table shows the fees paid or accrued by us for the audit and other services provided by Marcum LLP for

2020, and 2019:

Audit Fees (1)
Audit-Related Fees (2)
Tax Fees (3)
All Other Fees (4)
Total

2020

2019

276,500    $
-     
-     
-     
276,500    $

266,500 
- 
- 
- 
266,500  

  $

  $

(1) 

(2) 

(3) 

(4) 

Consists of fees billed for the audit of our annual financial statements, review of financial statements included in our Quarterly Reports on Form 10-
Q and services that are normally provided by the auditors in connection with statutory and regulatory filings or engagements.

Consists of assurance and related services that are reasonably related to the performance of the audit and reviews of our financial statements and are
not included in “audit fees” in this table.

Consists of all tax related services.

There were no other fees billed by Marcum LLP for the years ended December 31, 2020, and 2019.

60

 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
   
   
 
 
 
 
 
 
 
Engagement of the Independent Auditor

The  Audit  Committee  is  responsible  for  approving  every  engagement  of  Marcum  LLP  to  perform  audit  or  non-audit
services  for  us  before  Marcum  LLP  is  engaged  to  provide  those  services.  Under  applicable  Commission  rules,  the  Audit
Committee is required to pre-approve the audit and non-audit services performed by the independent auditors in order to ensure
that  they  do  not  impair  the  auditors’  independence.  The  Commission’s  rules  specify  the  types  of  non-audit  services  that  an
independent auditor may not provide to its audit client and establish the Audit Committee’s responsibility for administration of
the engagement of the independent auditors.

Consistent with the Commission’s rules, the Audit Committee Charter requires that the Audit Committee review and pre-
approve all audit services and permitted non-audit services provided by the independent auditors to us or any of our subsidiaries.
The Audit Committee may delegate pre-approval authority to a member of the Audit Committee and if it does, the decisions of
that member must be presented to the full Audit Committee at its next scheduled meeting.

The Audit Committee’s pre-approval policy provides as follows:

•

First, once a year when the base audit engagement is reviewed and approved, management will identify all other services (including fee
ranges)  for  which  management  knows  it  will  engage  Marcum  LLP  for  the  next  12  months.  Those  services  typically  include  quarterly
reviews,  specified  tax  matters,  certifications  to  the  lenders  as  required  by  financing  documents,  consultation  on  new  accounting  and
disclosure standards and, in future years, reporting on management’s internal controls assessment.

•

Second, if any new “unlisted” proposed engagement arises during the year, the engagement will require approval of the Audit Committee.

All fees to our independent accounting firms were approved by the Audit Committee.

Auditor Selection for Fiscal 2021

The Audit Committee has selected Marcum LLP to serve as our independent auditors for the year ending December 31,

2021.

61

 
 
 
 
 
 
 
 
 
 
Item 15.

Exhibits and Financial Statement Schedules 

(a)(1) 

Financial Statements

PART IV

Consolidated balance sheets of STRATA Skin Sciences, Inc. and subsidiary as of December 31, 2020, and 2019, and the
related  consolidated  statements  of  operations,  changes  in  stockholders’  equity  and  cash  flows  for  each  of  the  years  ended
December 31, 2020, and 2019.

(a)(2) 

Financial Statement Schedules

All schedules have been omitted because they are not required, not applicable, or the information is otherwise set forth in

the consolidated financial statements or notes thereto.

(a)(3) 

Exhibits

The exhibits listed under subsections (b) of this Item 15 are hereby incorporated by reference.

(b) 

Exhibits

3.1 

3.2 

3.3 

3.4 

3.5 

3.6 

3.7 

3.8 

3.9 

3.10 

4.1 

4.2 

4.3 

Fifth Amended and Restated Certificate of Incorporation of the Company (Incorporated by reference to Exhibit 3.1 contained  in  our
Registration Statement on Form S-3 (File No. 333-167113), as filed on May 26, 2010).
Fourth Amended and Restated Bylaws of the Company (Incorporated by reference to Exhibit 3.2 contained in our Form 8-K current
report as filed on January 8, 2016).
Certificate of Amendment to Fifth Amended and Restated Certificate of Incorporation of the Company (Incorporated by  reference  to
Exhibit 3.1 contained in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2013 filed on August 7, 2013).
Certificate of Amendment to Fifth Amended and Restated Certificate of Incorporation of the Company (Incorporated by  reference  to
Exhibit 3.1 contained in our Current Report on Form 8-K, filed on July 10, 2014).
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (Incorporated by reference to
Exhibit 3.1 contained in our Current Report on Form 8-K, filed on February 3, 2014).
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (Incorporated by reference to
Exhibit 3.1 contained in our Current Report on Form 8-K, filed on July 23, 2014).
Certificate of Amendment to Fifth Amended and Restated Certificate of Incorporation of the Company (Incorporated by reference  to
Exhibit 3.1 contained in our Current Report on Form 8-K, as filed on September 30, 2015).
Certificate of Amendment to Fifth Amended and Restated Certificate of Incorporation of the Company (Incorporated by reference  to
Exhibit 3.1 contained in our Current Report on Form 8-K, as filed on January 8, 2016).
Certificate of Designations of Series C Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1 contained in our Current
Report on Form 8-K, as filed on September 25, 2017).
Certificate of Amendment to Fifth Amended and Restated Certificate of Incorporation of STRATA Skin Sciences, Inc., dated December
30, 2020 (incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K filed on January 4, 2021)
Specimen Stock Certificate Incorporated by reference to our Registration Statement on Form S-1, as amended (File No. 333-125517),
as filed on August 8, 2005).
Warrant dated May 7, 2009 issued by Electro-Optical Sciences, Inc. to Kingsbridge Capital Limited (Incorporated by reference to our
Current Report on Form 8-K filed on May 8, 2009).
Warrant Agreement, dated as of April 26, 2013, by and between MELA  Sciences, Inc. and Hercules Technology Growth Capital, Inc.
(Incorporated  by  reference  to  our  Quarterly  Report  on  Form  10-Q  for  the  quarterly  period  ended  March  31,  2013  filed  on  April  30,
2013).

62

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.4 
4.5 
4.6 
4.7 

4.8 

4.9 

4.10 

4.11 

4.12 

4.13 

4.14* 

4.15* 

10.1* 

10.2* 

10.3 

10.4 

10.5 

10.6 

10.7 

10.8 

10.9 

10.10 

10.11 

10.12 

Form of Series A Warrant (Incorporated by reference to our Current Report on Form 8-K filed on October 30, 2013).
Form of Series B Prefunded Warrant (Incorporated by reference to our Current Report on Form 8-K filed on October 30, 2013).
Form of Common Stock Purchase Warrant (Incorporated by reference to our Current Report on Form 8-K filed on February 3, 2014).
Form of Series [A/B] Common Stock Purchase Warrant (Incorporated by reference to our Current Report on Form 8-K filed on July 23,
2014).
Form of 4% Senior Secured Convertible Debenture Due July 24, 2019 (Incorporated by reference to our Current Report on Form 8-K
filed on July 23, 2014).
Form of Common Stock Purchase Warrant (Incorporated by reference to Exhibit 4.1 contained in our Form 8-K current report, filed on
June 23, 2015).
Form of 9.0% Senior Secured Notes (Incorporated by reference to Exhibit 4.2 contained in our Form 8-K current report, filed on June
23, 2015).
Form of 2.25% Series A Senior Secured Convertible Debenture (Incorporated by reference to Exhibit 4.3 contained in our Form 10-Q
quarterly report for the quarter ended June 30, 2015 filed on August 14, 2015).
Form of 2.25% Series B Senior Unsecured Convertible Debenture (Incorporated by reference to Exhibit 4.4 contained in our Form 10-Q
quarterly report for the quarter ended June 30, 2015 filed on August 14, 2015).
Form of Warrant Amendment Agreement (Incorporated by reference to Exhibit 4.1 contained in our Current Report on Form 8-K, filed
on January 22, 2016).
Form of Incentive Stock Option Agreement. (Incorporated by reference to our Annual Report on Form 10-K for the year ended
December 31, 2015 filed on March 15, 2016)
Form of Nonqualified Stock Option Agreement. (Incorporated by reference to our Annual Report on Form 10-K for the year ended
December 31, 2015 filed on March 15, 2016)
Form of Indemnification Agreement for directors and executive officers. (Incorporated by reference to our Annual Report on Form 10-
K for the year ended December 31, 2013 filed on March 17, 2014).
2005 Stock Incentive Plan (Incorporated by reference to our Registration Statement on Form S-1, as amended (File No. 333-125517),
filed on August 8, 2005.
Form  of  Securities  Purchase  Agreement  dated  as  of  June  22,  2015  by  and  among  the  company  and  the  purchasers  (Incorporated  by
reference to our Form 8-K current report, as filed on June 23, 2015).
Registration Rights Agreement dated as of June 22, 2015 by and among the Company and the purchasers (Incorporated by reference to
our Form 8-K current report, as filed on June 23, 2015).
Security Agreement dated as of June 22, 2015 by and among the Company and parties thereto (Incorporated by reference to our Form 8-
K current report, as filed on June 23, 2015).
Licensing Agreement between the Registrant and KaVo Dental GmbH, dated as of December 5, 2006. (Incorporated by reference to our
Current Report on Form 8-K filed on December 11, 2006).
Securities Purchase Agreement dated as of July 21, 2014 between MELA Sciences, Inc. and the purchasers identified on the signature
pages thereto (Incorporated by reference to our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2014 filed
on November 14, 2014).
Registration Rights Agreement dated as of July 21, 2014 between MELA Sciences, Inc. and the purchasers identified on the signature
pages thereto (Incorporated by reference to our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2014 filed
on November 14, 2014).
Security Agreement dated as of July 21, 2014 among MELA Sciences, Inc., all of the Subsidiaries of the Registrant and the holders of
the Registrant’s 4% Senior Secured Convertible Debentures (Incorporated by reference to our Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2014 filed on November 14, 2014).
Agreement of Lease, dated as of July 14, 2009, by and between Stanford Bridge LLC and Electro-Optical Sciences, Inc. (Incorporated
by reference to our Current Report on Form 8-K filed on July 14, 2009).
Supply Agreement with Arrow Electronics, Inc., dated April 8, 2011 (Incorporated by reference to our Quarterly Report on Form 10-Q
for the quarterly period ended June 30, 2011 filed on August 5, 2011).
Production  Agreement,  dated  as  of  January  6,  2012,  by  and  between  MELA  Sciences,  Inc.  and  Askion  GmbH  (Incorporated  by
reference to our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2012 filed on May 3, 2012).

63

 
 
 
 
 
 
 
 
 
10.13 

10.14 

10.15 

10.16 

10.17 

10.18 

10.19 

10.20 

10.21 

10.22 

10.23 
10.24 

10.25* 

10.26* 

10.27* 

10.28* 

10.31 

10.32 

10.33 

Service  Agreement,  dated  March  21,  2012,  by  and  between  MELA  Sciences,  Inc.  and  QUINTILES  Commercial  Germany  GmbH
(Incorporated by reference to our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2012 filed on May 3, 2012).
Asset Purchase Agreement dated as of June 22, 2015 by and among the Company and parties identified on the signature pages thereto.
(Incorporated by reference to our Form 8-K current report, as filed on June 23, 2015.)
Amended and Restated Security Agreement dated as of August 3, 2015 by and among the Company and the parties thereto. (Included in
Exhibit 10.8 filed incorporated by reference to our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, filed
on August 14, 2015).
MELA Sciences, Inc. Amended and Restated 2013 Stock Incentive Plan (Incorporated by reference to the Registrant’s Proxy Statement
on Schedule 14A filed on August 24, 2015).
Loan and Security Agreement, dated as of March 15, 2013, by and between MELA Sciences, Inc. and Hercules Technology Growth
Capital, Inc. (Incorporated by reference to our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2013 filed on
April 30, 2013).
Amended and Restated Security Agreement dated as of August 3, 2015 by and among the Company and the parties thereto. (Included in
Exhibit 10.8 filed incorporated by reference to our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, filed
on August 14, 2015.).
Form  of  Securities  Purchase  Agreement,  dated  as  of  October  29,  2013,  by  and  among  MELA  Sciences,  Inc.  and  the  purchasers
identified on the signature pages thereto (Incorporated by reference to our Current Report on Form 8-K filed on October 30, 2013).
Omnibus  Amendment  to  2014  Transaction  Documents  dated  as  of  August  3,  2015  by  and  among  the  Company  and  the  purchases
identified therein. (Incorporated by reference to our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, filed
on August 14, 2015.).
Form  of  Securities  Purchase  Agreement,  dated  as  of  January  31,  2014,  by  and  among  MELA  Sciences,  Inc.  and  the  purchasers
identified on the signature pages thereto (Incorporated by reference to our Current Report on Form 8-K filed on February 3, 2014).
Form  of  Registration  Rights  Agreement,  dated  as  of  February  5,  2014,  by  and  among  MELA  Sciences,  Inc.  and  the  purchasers
identified on the signature pages thereto (Incorporated by reference to our Current Report on Form 8-K filed on February 3, 2014).
Intentionally omitted.
Warrant  Amendment  Agreement  dated  as  of  June  22,  2015  (effective  September  30,  2015)  by  and  among  the  Company  and  parties
identified on the signature pages thereto (Incorporated by reference to Exhibit 10.5 contained in our Form 8-K current report filed on
June 23, 2015).
Consulting Agreement, dated as of November 4, 2015 between the Company and Jeffrey F. O’Donnell, Sr. (Incorporated by reference to
our Form 10-Q quarterly report for the quarter ended September 30, 2015 filed on November 16, 2015).
Consulting Agreement, dated as of November 4, 2015 between the Company and Samuel E. Navarro (Incorporated by reference to our
Form 10-Q quarterly report for the quarter ended September 30, 2015 filed on November 16, 2015).
Transition  Agreement  and  Release  dated  as  of  November  9,  2015  between  the  Company  and  Robert  W.  Cook  (Incorporated  by
reference to our Form 10-Q quarterly report for the quarter ended September 30, 2015 filed on November 16, 2015).
Employment Agreement dated as of November 9, 2015 between the Company and Christina L. Allgeier (Incorporated by reference to
our Form 10-Q quarterly report for the quarter ended September 30, 2015 filed on November 16, 2015).
Amended and Restated Employment Agreement, dated as of December 15, 2015 by and between the Company and Michael R. Stewart
(Incorporated by reference to Exhibit 10.1 contained in our Current Report on Form 8-K, as filed on December 15, 2015).
Restricted Stock Award Agreement, dated as of December 15, 2015 by and between the Company and Michael R. Stewart (Incorporated
by reference to Exhibit 10.2 contained in our Current Report on Form 8-K, as filed on December 15, 2015).
Warrant  to  purchase  shares  of  the  Company's  common  stock  issued  December  30,  2015  to  Lender  under  the  Credit  Agreement.
(Incorporated by reference to Exhibit 10.3 contained in our Current Report on Form 8-K, as filed on January 5, 2016).

64

 
 
 
 
 
 
 
 
10.34 

10.35 

10.36 

10.37 

10.38 

10.39 

10.40* 

10.41* 

10.42 

10.43 

10.44* 

10.45* 

10.46* 

10.50* 

10.51 

10.52 

10.53 

Subordination  Agreements  dated  as  of  December  30,  2015  among  subordinated  lenders,  the  Company  and  Midcap.  (Incorporated  by
reference to Exhibit 10.4 contained in our Current Report on Form 8-K, as filed on January 5, 2016).
Omnibus  Amendment  to  2014  Transaction  Documents  and  2015  Transaction  Documents  dated  as  of  December  30,  2015  among  the
Company and the holders of outstanding debentures under the 2014 and 2015 security purchase agreements. (Incorporated by reference
to Exhibit 10.5 contained in our Current Report on Form 8-K, as filed on January 5, 2016).
Warrant  to  purchase  shares  of  the  Company's  common  stock  issued  January  29,  2016  to  Lenders  under  the  Credit  Agreement.
(Incorporated by reference to Exhibit 10.1 contained in our Current Report on Form 8-K, as filed on February 1, 2016).
Omnibus  Amendment  to  2015  Transaction  Documents  dated  as  of  August  3,  2015  by  and  among  the  Company  and  the  purchases
identified therein. (Incorporated by reference to our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, filed
on August 14, 2015.).
Amended and Restated Intellectual Property Security Agreement dated as of August 3, 2015 by and among the Company and the parties
thereto. (Included in Exhibit 10.8 filed incorporated by reference to our Quarterly Report on Form 10-Q for the quarterly period ended
June 30, 2015, filed on August 14, 2015.).
Intercreditor Agreement dated as of August 3, 2015 by and among the Company and the parties thereto. (Incorporated by reference to
our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, filed on August 14, 2015.).
Extension  Agreement  dated  as  of  July  20,  2016  between  Strata  Skin  Sciences,  Inc.  and  Jeffrey  F.  O'Donnell,  Sr.  (Incorporated  by
reference to Exhibit 10.1 contained in our Current Report on Form 8-K, as filed on July 22, 2016).
Extension Agreement dated as of July 20, 2016 between Strata Skin Sciences, Inc. and Samuel E. Navarro. (Incorporated by reference to
Exhibit 10.2 contained in our Current Report on Form 8-K, as filed on July 22, 2016).
First Amendment to Credit and Security Agreement dated as of August 9, 2016 among MidCap Financial Trust, as administrative agent,
the Lenders as listed on the signature pages thereto and the Company. (Incorporated by reference to our Form 10-Q quarterly report for
the quarter ended September 30, 2015 filed on August 12, 2016).
Amended  and  Restated  Fee  Letter  Agreement  dated  as  of  August  9,  2016,  by  and  between  Midcap  Financial  Trust  as  Agent  and  the
Company. (Incorporated by reference to our Form 10-Q quarterly report for the quarter ended September 30, 2015 filed on August 12,
2016).
STRATA Skin Sciences 2016 Omnibus Option Plan. (Incorporated by reference to our Form 10-Q quarterly report for the quarter ended
September 30, 2015 filed on November 14, 2016).
Employment Agreement between the Company and Frank J. McCaney dated as of October 31, 2016. . (Incorporated by reference to our
Form 10-Q quarterly report for the quarter ended September 30, 2015 filed on November 14, 2016).
Stock Option Agreement between the Company and Frank J. McCaney dated as of October 31, 2016. (Incorporated by reference to our
Form 10-Q quarterly report for the quarter ended September 30, 2015 filed on November 14, 2016).
Severance  and  Release  Agreement  between  the  Company  and  Michael  R.  Stewart  dated  as  of  October  31,  2016.  (Incorporated  by
reference to our Form 10-Q quarterly report for the quarter ended September 30, 2015 filed on November 14, 2016).
Second  Amendment  to  Credit  and  Security  Agreement  dated  as  of  November  10,  2017,  among  MidCap  Financial  Trust,  as
administrative agent, the Lenders as listed on the signature pages thereto and the Company. Second Amendment to Credit and Security
Agreement dated as of November 10, 2017, among MidCap Company (Incorporated by reference to our Form 10-Q quarterly report for
the quarter ended September 30, 2017, filed on November 14, 2017).
Amended and Restated Fee Letter Agreement dated as of November 10, 2017, by and between MidCap Financial Trust as Agent and the
Company. (Incorporated by reference to our Form 10-Q quarterly report for the quarter ended September 30, 2017 filed on November
14, 2017).
Securities Purchase Agreement dated as of March 30, 2018, between the Company and Accelmed (Incorporated by reference to Exhibit
10.1 contained in our Current Report on Form 8-K, as filed on April 2, 2018)

65

 
 
 
 
 
 
10.54 

10.55 

10.56 

10.57 

10.58 

10.59 

10.60* 

10.61 

10.62* 

10.63* 

10.64 

10.65 

10.66 

10.67 

10.68 

10.69 

10.70 

10.71 

10.72 

Securities Purchase Agreement dated as of March 30, 2018, between the Company and Broadfin (Incorporated by reference to Exhibit
10.2 contained in our Current Report on Form 8-K, as filed on April 2, 2018).
Securities  Purchase  Agreement  dated  as  of  March  30,  2018,  between  the  Company  and  Sabby  (Incorporated  by  reference  to  Exhibit
10.3 contained in our Current Report on Form 8-K, as filed on April 2, 2018).
Form of Registration Rights Agreement (Incorporated by reference to Exhibit 10.4 contained in our Current Report on Form 8-K, as
filed on April 2, 2018).
Form  of  Leak-Out  Agreement  (Incorporated  by  reference  to  Exhibit  10.5  contained  in  our  Current  Report  on  Form  8-K,  as  filed on
April 2, 2018).
Form  of  Voting  Undertaking  (Incorporated  by  reference  to  Exhibit  10.6  contained  in  our  Current  Report  on  Form  8-K,  as  filed  on
April 2, 2018).
Form of Subscription Agreement (Incorporated by reference to Exhibit 10.7 contained in our Current Report on Form 8-K, as filed on
April 2, 2018).
Employment Agreement dated March 30, 2018, between the Company and Dr. Dolev Rafaeli (Incorporated by reference to Exhibit 10.8
contained in our Current Report on Form 8-K, as filed on April 2, 2018).
Third Amendment to Credit and Security Agreement, dated as of March 26, 2018, among the Company, MidCap Financial Trust and the
lenders signatory thereto (Incorporated by reference to Exhibit 10.1 contained in our Current Report on Form 8-K, as filed on April 2,
2018).
Employment Agreement effective as of May 15, 2018, between the Company and Matthew C. Hill (Incorporated
by reference to Exhibit 10.1 contained in our Current Report on Form 8-K, as filed on May 15, 2018).
Amended  and  Restated  Strata  Skin  Sciences,  Inc.  2016  Omnibus  Incentive  Plan  (Incorporated  by  reference  to  Appendix  B  to  our
Definitive Proxy Statement on Schedule 14A, as filed on April 27, 2018).
Fourth Amendment to Credit and Security Agreement, dated as of May 29, 2018, among the Company, MidCap Financial Trust and the
lenders signatory thereto (Incorporated by reference to Exhibit 10.1 contained in our Current Report on Form 8-K, as filed on May 29,
2018).
Sublease Agreement between Luigi Bormioli Corporation and the Company for office space at 5 Walnut Grove Drive, Horsham, PA
19044 (Incorporated by reference to Exhibit 10.1 contained in our Current Report on Form 8-K, as filed on October 3, 2018).
Fixed Rate – Term Promissory Note with Israel Discount Bank of New York as of December 31, 2019 (Incorporated by reference  to
Exhibit 10.1 contained in our Current Report on Form 8-K, as filed on January 6, 2019).
Promissory Note Fixed Rate-Term Note, dated December 30, 2019, by STRATA Skin Sciences, Inc. in favor of Israel Discount Bank of
New York (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on January 6, 2020)
Assignment and Pledge of Time Deposit, dated December 30, 2019, by STRATA Skin Sciences, Inc., as assignor, and Israel Discount
Bank of New York, as assignee (incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K filed on January 6, 2020)
Paycheck Protection Program Term Note, Disbursement Request & Authorization, and Errors and Omissions Agreement, dated April
22, 2020, between STRATA Skin Sciences, Inc. and Republic First Bank D/B/A Republic Bank (incorporated by reference to Exhibit
10.1 to our Current Report on Form 8-K filed on April 27, 2020)
U.S.  Small  Business  Administration  Loan  Authorization  and  Agreement,  dated  as  of  March  26,  2020  and  executed  May  22,  2020,
between the Small Business Administration and STRATA Skin Sciences, Inc. (incorporated by reference to Exhibit 10.1 to our Current
Report on Form 8-K filed on May 26, 2020)
U.S.  Small  Business  Administration  Note  (Secured  Disaster  Loans),  dated  as  of  March  26,  2020  and  executed  May  22,  2020,  by
STRATA  Skin  Sciences,  Inc.  for  the  benefit  of  the  Small  Business  Administration  (incorporated  by  reference  to  Exhibit  10.2  to  our
Current Report on Form 8-K filed on May 26, 2020)
U.S. Small Business Administration Security Agreement, dated as of March 26, 2020 and executed May 22, 2020, between the Small
Business Administration and STRATA Skin Sciences, Inc. (incorporated by reference to Exhibit 10.3 to our Current Report on Form 8-
K filed on May 26, 2020)

66

 
 
 
 
 
 
10.73 

10.74 

10.75 

10.76 

10.77 

23.1   
31.1   
31.2   
32.1** 

101.INS 
101.SCH 
101.CAL 
101.DEF 
101.LAB 
101.PRE 

Settlement Agreement and Release, dated as of August 10, 2020, between STRATA Skin Sciences, Inc. and Ra Medical Systems, Inc.
(incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on August 11, 2020)
First Amendment to Promissory Note, dated as of December 21, 2020, between STRATA Skin Sciences, Inc. and Israel Discount Bank
of New York (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on December 28, 2020)
Employment Separation Agreement and Release, dated as of February 24, 2021, between Dolev Rafaeli and STRATA Skin Sciences,
Inc. (incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K filed on March 1, 2021)
Employment Agreement, dated as of March 1, 2021, between Robert Moccia and STRATA Skin Sciences, Inc. (incorporated by
reference to Exhibit 10.3 to our Current Report on Form 8-K filed on March 1, 2021)
Form of Stock Option Agreement, dated as of March 1, 2021, between Robert Moccia and STRATA Skin Sciences, Inc. (incorporated
by reference to Exhibit 10.4 to our Current Report on Form 8-K filed on March 1, 2021)
Consent of Marcum, LLP
Rule 13a-14(a) Certificate of Chief Executive Officer
Rule 13a-14(a) Certificate of Chief Financial Officer
Certifications  of  Chief  Executive  Officer  and  Chief  Financial  Officer  pursuant  to  18  U.S.C.  Section  1350,  as  adopted  pursuant  to
Section 906 of the Sarbanes-Oxley Act of 2002
XBRL Instance Document
XBRL Taxonomy Schema
XBRL Taxonomy Calculation Linkbase
XBRL Taxonomy Definition Linkbase
XBRL Taxonomy Label Linkbase
XBRL Taxonomy Presentation Linkbase

*
**

Indicates management contract or compensatory plan.
The certifications attached as Exhibit 32.1 accompany this Annual Report on Form 10-K pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended.

 Item 16. 

Form 10-K Summary

None. 

67

 
 
 
 
 
 
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant

has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

SIGNATURES

March 25, 2021

STRATA SKIN SCIENCES, INC.

By:  /s/ Robert J. Moccia                          
Robert J. Moccia
President and Chief Executive Officer

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following

persons on behalf of the registrant and in the capacities and on the dates indicated.

Signature

Capacity in Which Signed

Date

/s/ Robert J. Moccia
Robert J. Moccia

/s/ Matthew Hill
Matthew Hill

/s/ Uri Geiger
Uri Geiger

/s/ Samuel Navarro
Samuel Navarro

/s/ Shmuel Rubinstein
Shmuel Rubinstein

/s/ Nachum Shamir
Nachum Shamir

/s/ LuAnn Via
LuAnn Via

President, Chief Executive Officer (Principal Executive Officer),
and Director

March 25, 2021

Chief Financial Officer (Principal Financial and Accounting
Officer)

Director, Chairperson of the Board

Director

Director

Director

Director, Vice Chairperson of the Board

March 25, 2021

March 25, 2021

March 25, 2021

March 25, 2021

March 25, 2021

March 25, 2021

68

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY

Index to Consolidated Financial Statements

Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets, December 31, 2020 and 2019
Consolidated Statements of Operations, for the Years ended December 31, 2020 and 2019
Consolidated Statements of Changes in Stockholders’ Equity, for the Years ended December 31, 2020 and 2019
Consolidated Statements of Cash Flows, for the Years ended December 31, 2020 and 2019
Notes to Consolidated Financial Statements

Page
F-2
F-5
F-6
F-7
F-8
F-10

F-1

 
 
 
 
 
 
 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Shareholders and Board of Directors of

STRATA Skin Sciences, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of STRATA Skin Sciences, Inc. and Subsidiary (the “Company”)
as of December 31, 2020 and 2019, the related consolidated statements of operations, changes in stockholders’ equity and cash
flows  for  each  of  the  two  years  in  the  period  ended  December  31,  2020,  and  the  related  notes  (collectively  referred  to  as  the
“financial statements”).  In our opinion, the financial statements present fairly, in all material respects, the consolidated financial
position of the Company as of December 31, 2020 and 2019, and the consolidated results of its operations and its cash flows for
each of the two years in the period ended December 31, 2020, in conformity with accounting principles generally accepted in the
United States of America.

Basis for Opinion

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on
the  Company's  financial  statements  based  on  our  audits.  We  are  a  public  accounting  firm  registered  with  the  Public  Company
Accounting  Oversight  Board  (United  States)  ("PCAOB")  and  are  required  to  be  independent  with  respect  to  the  Company  in
accordance  with  the  U.S.  federal  securities  laws  and  the  applicable  rules  and  regulations  of  the  Securities  and  Exchange
Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the
audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to
error  or  fraud.  The  Company  is  not  required  to  have,  nor  were  we  engaged  to  perform,  an  audit  of  its  internal  control  over
financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting
but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.
Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to
error  or  fraud,  and  performing  procedures  that  respond  to  those  risks.  Such  procedures  included  examining,  on  a  test  basis,
evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting
principles  used  and  significant  estimates  made  by  management,  as  well  as  evaluating  the  overall  presentation  of  the  financial
statements. We believe that our audits provide a reasonable basis for our opinion.

F-2

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the financial statements that
were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are
material  to  the  financial  statements  and  (2)  involved  our  especially  challenging,  subjective,  or  complex  judgments.  The
communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and
we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the
accounts or disclosures to which they relate.

Sales and Use Tax Liabilities:

As discussed in Note 8 to the consolidated financial statements, the Company recognizes sales tax liabilities, including interest
and  penalties,  for  its  domestic  recurring  revenue  in  those  states  which  management  determines  are  more-likely-than-not
(“MLTN”) non-exempt from sales tax.  Such amounts are accounted for as transaction tax liabilities that are extinguished upon
payment  or  settlement.    The  Company  recognizes  use  tax  liabilities,  including  interest  and  penalties,  for  those  states  that
management  determines  are  MLTN  to  be  exempt  from  sales  tax  obligations.  The  Company’s  sales  tax  expense  that  is  not
presently being collected and remitted for its domestic recurring revenue are recorded as general and administrative expenses. 
The Company is currently undergoing sales tax audits in two state jurisdictions which are each in the administrative process of
appeal.

We  identified  the  accounting  for  sales  and  use  tax  liabilities  as  a  critical  audit  matter  due  to  the  audit  effort  relating  to  the
following:

• Management utilized specialists in current and prior years to assist in determining MLTN conclusions.
• Complexity  in  the  interpretation  of  relevant  tax  laws  in  various  states  requires  significant  management  and  auditor

judgment.

• The  extent  of  specialized  skill  and  knowledge  and  consultation  outside  of  the  engagement  team  required  to  assess  the

appropriateness of management’s determinations.

Our principal audit procedures related to the Company's accounting for sales and use tax liabilities included the following:

• We  evaluated  management's  significant  accounting  policies  related  to  accounting  for  sales  and  use  tax  liabilities  for

reasonableness.

• We involved our firm’s tax professionals and subject-matter-experts, with specialized skills and knowledge, who assisted

in assessing the Company’s interpretation of the relevant tax laws.

• We inspected correspondence and determinations from relevant state taxing authorities for those states undergoing sales

tax audits.

F-3

 
 
 
 
 
 
 
 
 
 
 
• We tested the underlying data of management’s calculations and analyzed the expiration of statutes of limitations and tax

rates.

Goodwill:

As discussed in Note 7 to the consolidated financial statements, goodwill represents the excess of the purchase price over the fair
value of the net tangible and identifiable intangible assets acquired and liabilities assumed in a business combination. Goodwill is
tested for impairment at least annually at the reporting unit level. Management bypassed the qualitative impairment assessment
(step zero) and performed a quantitative impairment assessment.  The Company used a combination of the market and income
approaches to determine the estimated fair value of its reporting units as of December 31, 2020.

We identified the annual goodwill impairment test as a critical audit matter due to the audit effort relating to the following:

• The  determination  of  the  fair  value  of  the  reporting  unit  requires  management  to  make  significant  estimates  and
assumptions  related  to  forecasted  revenue  growth  rates,  estimated  expenses  and  discount  rates.    Such  estimates  and
assumptions  were  challenging  to  test  as  they  required  forward  looking  assumptions  with  a  high  degree  of  subjectivity
under the COVID-19 environment.

• The  extent  of  specialized  skill  and  knowledge  and  consultation  outside  of  the  engagement  team  required  to  assess  the

appropriateness of management’s valuation assumptions.

Our principal audit procedures related to the Company's goodwill impairment test included the following:

• We  evaluated  management's  significant  accounting  policies  related  to  goodwill  impairment  for  reasonableness.    This
included  controls  related  to  the  Company’s  goodwill  impairment  assessment  process  and  development  of  valuation
assumptions.

• We  obtained  an  understanding  and  evaluated  the  reasonableness  of  management’s  forecasts  of  future  revenue  and
estimated expenses by comparing these forecasts to historical operating results of the Company by applying procedures to
test the financial inputs used in the income approach, including sensitizing management’s cash flow forecasts.

• We  involved  our  firm’s  valuation  professionals,  with  specialized  skills  and  knowledge,  who  assisted  in  assessing
assumptions  utilized  under  the  income  and  market  approaches.    Such  assumptions  that  were  evaluated  included  the
discount  rate,  selected  comparable  companies,  market  multiples,  control  premium  and  market  capitalization
reconciliation.

/s/ Marcum LLP

Marcum LLP
We have served as the Company’s auditor since 2019.

Philadelphia, Pennsylvania
March 25, 2021

F-4

 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)

ASSETS
Current assets:

Cash and cash equivalents
Restricted cash
Accounts receivable, net
Inventories
Prepaid expenses and other current assets

Total current assets

Property and equipment, net
Operating lease right-of-use assets
Intangible assets, net
Goodwill
Other assets
Total assets

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Note payable
Current portion of long-term debt
Accounts payable
Other accrued liabilities
Deferred revenues
Current portion of operating lease liabilities

Total current liabilities

Long-term liabilities:
Long-term debt, net
Long-term operating lease liabilities; net
Deferred tax liability
Other liabilities

Total liabilities

Commitments and contingencies (see Note 11)

Stockholders' equity:

December 31,
2020

December 31,
2019

  $

  $

  $

10,604    $
7,508     
2,944     
3,444     
331     
24,831     

5,529     
988     
6,345     
8,803     
282     
46,778    $

7,275    $
1,478     
2,764     
4,690     
2,262     
369     
18,838     

1,050     
710     
254     
34     
20,886     

8,129 
7,500 
4,386 
3,027 
513 
23,555 

5,369 
1,314 
7,955 
8,803 
347 
47,343 

7,275 
- 
1,880 
5,134 
2,832 
313 
17,434 

- 
1,078 
- 
178 
18,690 

Series C Convertible Preferred Stock, $.10 par value, 10,000,000 shares authorized; 0 and 2,103 shares issued and
outstanding as of December 31, 2020 and 2019, respectively
Common Stock, $.001 par value, 150,000,000 shares authorized; 33,801,045 and 32,932,273 shares issued and
outstanding as of December 31, 2020 and 2019, respectively
Additional paid-in capital
Accumulated deficit
Total stockholders' equity

Total liabilities and stockholders’ equity

-     

1 

34     
244,831     
(218,973)    
25,892     
46,778    $

33 
243,180 
(214,561)
28,653 
47,343 

  $

The accompanying notes are an integral part of these consolidated financial statements.

F-5

 
 
 
 
   
 
   
     
 
   
     
 
   
   
   
   
   
 
   
      
  
   
   
   
   
   
 
   
      
  
   
      
  
   
      
  
   
   
   
   
   
   
 
   
      
  
   
      
  
   
   
   
   
   
 
   
      
  
   
      
  
 
   
      
  
   
      
  
   
   
   
   
   
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)

Revenues, net
Cost of revenues
Gross profit

Operating expenses:

Engineering and product development
Selling and marketing
General and administrative

Loss from operations
Other (expense) income, net:

Interest expense, net
Loss on extinguishment of debt

Loss before income taxes
Income tax (expense) benefit
Net loss

Loss attributable to common shares
Loss attributable to Preferred Series C shares
Loss per common share:

Basic

Diluted

Shares used in computing loss per common share:

Basic

Diluted

Loss per Preferred Series C share - basic and diluted

Shares used in computing loss per basic and diluted Preferred Series C shares

  For the Year Ended December 31, 

2020

2019

  $

  $

  $
  $

  $

  $

23,090    $
8,956     
14,134     

1,274     
9,038     
7,898     
18,210     
(4,076)    

(61)    
-     
(61)    
(4,137)    
(275)    
(4,412)   $

(4,394)   $
(18)   $

(0.13)   $

(0.13)   $

31,586 
11,316 
20,270 

1,002 
12,003 
10,275 
23,280 
(3,010)

(515)
(414)
(929)
(3,939)
149 
(3,790)

(3,597)
(193)

(0.11)

(0.11)

33,609,922     

31,978,665 

33,609,922     

31,978,665 

  $

(48.59)   $

368     

(42.24)

4,577 

The accompanying notes are an integral part of these consolidated financial statements.

F-6

 
 
 
 
 
   
 
   
   
   
      
  
   
   
   
 
   
   
   
      
  
   
   
 
   
   
   
   
      
  
   
      
  
   
   
 
   
      
  
   
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019
(In thousands, except share amounts)

BALANCE, JANUARY 1,
2019

Stock-based compensation
Conversion of convertible
preferred stock into common
stock
Exercise of stock options

Issuance of restricted stock

Net loss

BALANCE, DECEMBER 31,
2019

Stock-based compensation
Conversion of grantable
preferred stock into common
stock
Exercise of stock options

Issuance of restricted stock

Net loss

BALANCE, DECEMBER 31,
2020

Convertible Preferred Stock – Series C    

Common Stock

Shares

Amount

Shares

Amount

    Additional Paid-    
In Capital

Accumulated

Deficit

Total

9,968    $
-     

(7,865)    
-     
-     
-     

2,103    $
-     

(2,103)    
-     
-     
-     

-    $

1     
-     

-     
-     
-     
-     

1     
-     

(1)    
-     
-     
-     

-     

29,943,086    $
-     

2,923,791     
36,410     
28,986     
-     

32,932,273    $
-     

782,089     
15,000     
71,683     
-     

30    $
-     

3     
-     
-     
-     

33    $
-     

1     
-     
-     
-     

241,988    $
1,195     

(210,771)   $
-     

(3)    
-     
-     
-     

-     
-     
-     
(3,790)    

243,180    $
1,633     

(214,561)   $
-     

-     
18     
-     
-     

-     
-     
-     
(4,412)    

33,801,045    $

34    $

244,831    $

(218,973)   $

31,248 
1,195 

- 
- 
- 
(3,790)

28,653 
1,633 

- 
18 
- 
(4,412)

25,892 

The accompanying notes are an integral part of these consolidated financial statements.

F-7

 
 
 
 
     
 
 
 
   
   
   
   
   
   
 
   
   
   
   
   
   
   
   
   
   
   
   
   
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)

Cash Flows From Operating Activities:
Net loss
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation and amortization
Amortization of right-of-use assets
Provision for doubtful accounts
Impairment of lasers placed-in-service
Stock-based compensation
Deferred taxes
Amortization of deferred financing costs and debt discount
Changes in operating assets and liabilities:
Accounts receivable
Inventories
Prepaid expenses and other assets
Accounts payable
Other accrued liabilities
Other liabilities
Operating lease liabilities
Deferred revenues

Net cash provided by operating activities

Cash Flows From Investing Activities:

Lasers placed-in-service
Purchases of property and equipment

Net cash used in investing activities

  For the Year Ended December 31, 

2020

2019

  $

(4,412)   $

(3,790)

3,585     
326     
90     
24     
1,633     
254     
-     

1,352     
(417)    
247     
884     
(444)    
(144)    
(312)    
(570)    
2,096     

(2,133)    
(26)    
(2,159)    

4,503 
318 
43 
30 
1,195 
(111)
174 

(1,036)
(233)
104 
116 
634 
(210)
(241)
733 
2,229 

(2,676)
(115)
(2,791)

The accompanying notes are an integral part of these consolidated financial statements.

F-8

 
 
 
 
 
   
 
   
     
 
   
      
  
   
   
   
   
   
   
   
   
      
  
   
   
   
   
   
   
   
   
   
 
   
      
  
   
      
  
   
   
   
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
(continued)
(In thousands)

Cash Flows From Financing Activities:
Proceeds from exercise of stock options
Repayments of long-term debt
Proceeds on notes payable

Net cash provided by (used in) financing activities

Net increase (decrease) in cash and cash equivalents and restricted cash
Cash and cash equivalents and restricted cash, beginning of period
Cash and cash equivalents and restricted cash, end of period

Cash and cash equivalents
Restricted cash

Supplemental information:

Cash paid for interest
Cash paid for income taxes
Lease liabilities from obtaining right of use assets

  For the Year Ended December 31, 

2020

2019

  $

  $

  $

  $

  $
  $

18    $
-     
2,528     
2,546     

2,483     
15,629     
18,112    $

10,604    $
7,508     
18,112    $

211    $
-    $
-     

- 
(7,571)
7,275 
(296)

(858)
16,487 
15,629 

8,129 
7,500 
15,629 

766 
- 
1,632 

The accompanying notes are an integral part of these consolidated financial statements.

F-9

 
 
 
 
 
   
 
   
   
   
 
   
      
  
   
   
   
 
   
      
  
   
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Note 1
The Company:

Background
STRATA  Skin  Sciences  (the  “Company”)  is  a  medical  technology  company  in  Dermatology  and  Plastic  Surgery  dedicated  to
developing,  commercializing  and  marketing  innovative  products  for  the  treatment  of  dermatologic  conditions.  Its  products
include the XTRAC® excimer laser and VTRAC® lamp systems utilized in the treatment of psoriasis, vitiligo and various other
skin conditions.

The XTRAC is an ultraviolet light excimer laser system utilized to treat psoriasis, vitiligo and other skin diseases. The XTRAC
excimer laser system first received clearance from the United States Food and Drug Administration (the “FDA”) in 2000. As of
December  31,  2020,  there  were  832  XTRAC  systems  placed  in  dermatologists'  offices  in  the  United  States  and  28  systems
internationally  under  the  Company's  recurring  revenue  business  model.  The  XTRAC  systems  deployed  under  the  recurring
revenue model generate revenue on a per procedure basis or include a fixed payment over an agreed upon period with a capped
number of treatments, which if exceeded, domestically, would incur additional fees. The per-procedure charge is inclusive of the
use  of  the  system  and  the  services  provided  by  the  Company  to  the  customer  which  includes  system  maintenance,  and  other
services.  The  VTRAC  Excimer  Lamp  system,  offered  in  addition  to  the  XTRAC  system  internationally,  provides  targeted
therapeutic efficacy demonstrated by excimer technology with a lamp system.

In July 2019, the Company signed a direct distribution agreement with its Korean distributor for a combination of direct capital
sales and recurring revenues for the country of South Korea. 

In September 2020, the Company signed a direct distribution agreement with our Japanese distributor for a combination of direct
capital sales and recurring revenue for the Country of Japan. 

The Company has now introduced its Home by XTRAC™ business leveraging in-house resources including DTC advertising, in-
house call center and its insurance reimbursement team to provide an at-home, insurance-reimbursed treatment option for patients
with certain skin diseases that do not qualify for in-office treatments.

In February 2021, the Company signed an agreement with our Chinese distributor for a combination of direct capital sales and
recurring revenues for the country of China. 

In late 2019, there was an outbreak of a new strain of coronavirus (“COVID-19”) which became a global pandemic. The COVID-
19 pandemic has negatively impacted the global economy, disrupted global supply chains, constrained work force participation
and created significant volatility and disruption of financial markets. In addition, the pandemic lead to the suspension of elective
procedures in the U.S. and to the temporary closure of many physician practices which are our primary customers. We do not
know  the  extent  of  the  impact  on  our  customers  including  their  potential  for  permanent  closure.  While  many  offices  have
reopened, the on-going impact of the COVID-19 pandemic on the Company’s operational and financial performance, including
its  ability  to  execute  its  business  strategies  and  initiatives  in  the  expected  time  frames,  will  depend  on  future  developments,
including the duration and spread of the COVID-19 outbreak, continued restrictions on business operations and transport and the
continued impact on worldwide economic and geopolitical conditions, all of which are uncertain and cannot be predicted.

Domestically, as the procedures in which the Company’s devices are used are elective in nature; and as social distancing, travel
restrictions,  quarantines  and  other  restrictions  became  prevalent  in  the  United  States,  this  had  a  negative  impact  on  the
Company’s recurring revenue model and its financial position and cash flow. The virus has disrupted the supply chain from China
and other countries and the Company depends upon its supply chain to provide a steady source of components to manufacture
and repair our devices.

F-10

 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

To mitigate the impact of COVID-19 the Company has taken a variety of measures to ensure the availability and functioning of
its  critical  infrastructure  by  implementing  business  continuity  plans,  and  to  promote  the  safety  and  security  of  its  employees
while complying with various government mandates, including work-from-home arrangements and social-distancing initiatives
to  reduce  the  transmission  of  COVID-19,  such  as  providing  face  masks  for  employees  at  facilities  significantly  impacted  and
requiring  on-site  body  temperature  monitoring  before  entering  facilities.  In  addition,  the  Company  created  and  executed
programs  utilizing  its  direct  to  consumer  advertising  and  call  center  to  contact  patients  and  partner  clinics  to  restart  the
Company’s partners’ businesses. To conserve its cash in order to mitigate the on-going impact of the COVID-19 pandemic, in the
second quarter, the Company furloughed employees who returned to work after the Company received proceeds from the PPP
Loan.  The  Company  also  reduced  discretionary  spending,  reduced  all  inventory  purchases  and  delayed  payments  to  vendors.
Delayed  payments  to  vendors  were  approximately  $678  as  of  December  31,  2020.  See  Note  2,  Liquidity  for  discussion  on
Company liquidity.

Basis of Presentation:

Accounting Principles
The  consolidated  financial  statements  have  been  prepared  in  accordance  with  accounting  principles  generally  accepted  in  the
United States of America (“U.S. GAAP”).

Principles of Consolidation
The  consolidated  financial  statements  include  the  accounts  of  the  Company  and  its  wholly-owned  subsidiary  in  India.  All
significant  intercompany  balances  and  transactions  have  been  eliminated  in  consolidation.  In  2020  and  2019,  there  are  no
operations in the subsidiary in India.

Reclassification
Certain reclassifications from the prior year presentation have been made to conform to the current year presentation.

Use of Estimates
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and  assumptions  that  affect  reported  amounts  of  assets  and  liabilities  at  the  date  of  the  financial  statements  and  the  reported
amount of revenues and expenses during the reporting periods. Actual results could differ from those estimates and be based on
events  different  from  those  assumptions.  The  more  significant  estimates  include  (1)  revenue  recognition,  in  regard  to  deferred
revenues and the contract term and valuation allowances of accounts receivable, (2) the inputs used in the impairment analyses of
goodwill, (3) the estimated useful lives of intangible assets and property and equipment, (4) the inputs used in determining the
fair  value  of  equity-based  awards,  (5)  the  valuation  allowance  related  to  deferred  tax  assets  (6)  the  fair  value  of  financial
instruments, including derivative instruments and warrants, (7) the inventory reserves, (8) state sales and use tax accruals and (9)
warranty claims.

Revenue Recognition
In the Dermatology Recurring Procedures Segment the Company has two types of arrangements for its phototherapy treatment
equipment  as  follows:  (i)  the  Company  places  its  lasers  in  a  physician’s  office  at  no  charge  to  the  physician,  and  generally
charges the physician a fee for an agreed upon number of treatments; or (ii) the Company places its lasers in a physician’s office
and charges the physician a fixed fee for a specified period of time not to exceed an agreed upon number of treatments; if that
number is exceeded additional fees will have to be paid.

F-11

 
 
 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

For the purposes of U.S. GAAP only, these two types of arrangements are treated under the guidance of ASC 842, Leases. While
these arrangements are not contractually operating leases, since the Company sells the physician access codes in order to operate
the treatment equipment, these arrangements are similar to operating leases for accounting purposes since the Company provides
the customers limited rights to use the treatment equipment and the treatment equipment resides in the physician’s office and the
Company may exercise the right to remove the equipment upon notice, under certain circumstances, while the physician controls
the utility and output of such equipment during the term of the arrangement as it pertains to the use of access codes to treat the
patients.  For  the  lasers  placed-in  service-  under  these  arrangements,  the  terms  of  the  domestic  arrangements  are  generally  36
months with automatic one-year renewals and include a termination clause that can be affected at any time by either party with 30
to  60  day  notice.  Amounts  paid  are  generally  non-refundable.  For  the  first  type  of  arrangement,  sales  of  access  codes  are
considered variable treatment code payments and are recognized as revenue over the estimated usage period of the agreed upon
number of treatments. For the second type of arrangement, customers purchase access codes and revenue is recognized ratably on
a  straight-line  basis  as  the  lasers  are  being  used  over  the  term  period  specified  in  the  agreement.  Variable  treatment  code
payments that will be paid only if the customer exceeds the agreed upon number of treatments are recognized only when such
treatments  are  being  exceeded  and  used.  Internationally,  through  its  Korean,  Japanese  and,  in  2021,  Chinese  distributors,  the
Company generally sells access codes for a fixed amount on a monthly basis to end user customers and the terms are generally 48
months, with termination in the event of the customers’ failure to remit payments timely, and include a potential buy-out at the
end of the term of the contract. Currently, this is the only foreign recurring revenue. Pre-paid amounts are recorded in deferred
revenue and recognized as revenue over the lease term in the patterns described above. Under both methods, pricing is fixed with
the customer.

With respect to lease and non-lease components, the Company adopted the practical expedient to account for the arrangement as
a single lease component.

In  the  Dermatology  Procedures  Equipment  segment  the  Company  sells  its  products  internationally  through  distributors  and
domestically,  directly  to  a  physician.  For  the  product  sales,  the  Company  recognizes  revenues  when  control  of  the  promised
products is transferred to either the Company's distributors or end-user customers, in an amount that reflects the consideration the
Company expects to be entitled to in exchange for those products (the transaction price). Control transfers to the customer at a
point in time. To indicate the transfer of control, the Company must have a present right to payment and legal title must have
passed  to  the  customer.  The  Company  ships  most  of  its  products  FOB  shipping  point,  and  as  such,  the  Company  primarily
transfers control and records revenue upon shipment. From time to time the Company will grant certain customers, for example
governmental  customers,  FOB  destination  terms,  and  the  transfer  of  control  for  revenue  recognition  occurs  upon  receipt.  The
Company has elected to recognize the cost of freight and shipping activities as fulfillment costs. Amounts billed to customers for
shipping  and  handling  are  included  as  part  of  the  transaction  price  and  recognized  as  revenue  when  control  of  the  underlying
goods are transferred to the customer. The related shipping and freight charges incurred by the Company are included in cost of
revenues.

Remaining  performance  obligations  related  to  ASC  606  represent  the  aggregate  transaction  price  allocated  to  performance
obligations with an original contract term greater than one year, which are fully or partially unsatisfied at the end of the period.
Remaining  performance  obligations  include  the  potential  obligation  to  perform  under  extended  warranties  but  excludes  any
equipment accounted for as leases. As of December 31, 2020, and 2019, the aggregate amount of the transaction price allocated
to remaining performance obligations was $115 and $324, respectively, and the Company expects to recognize $108 and $209,
respectively, of the remaining performance obligations within one year and the remainder over one to three years. Contract assets
primarily relate to the Company’s rights to consideration for work completed in relation to its services performed but not billed at
the  reporting  date.  The  contract  assets  are  transferred  to  receivables  when  the  rights  become  unconditional.  Currently,  the
Company  does  not  have  any  contract  assets  which  have  not  transferred  to  a  receivable.  Contract  liabilities  primarily  relate  to
extended  warranties  where  the  Company  has  received  payments,  but  has  not  yet  satisfied  the  related  performance  obligations.
The

F-12

STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

allocations  of  the  transaction  price  are  based  on  the  price  of  stand-alone  warranty  contracts  sold  in  the  ordinary  course  of
business. The advance consideration received from customers for the warranty services is a contract liability that is recognized
ratably  over  the  warranty  period.  As  of  December  31,  2020,  and  2019,  the  $108  and  $209  of  short-term  contract  liabilities,
respectively,  is  presented  as  deferred  revenues  and  the  $7  and  $115  of  long-term  contract  liabilities,  respectively,  is  presented
within Other Liabilities on the Consolidated Balance Sheet, respectively. For the year ended December 31, 2020, and 2019, the
Company  recognized  $209  and  $155,  respectively,  as  revenue  from  amounts  classified  as  contract  liabilities  (i.e.  deferred
revenues) as of December 31, 2019, and 2018.

With respect to contract acquisition costs, the Company applied the practical expedient and expenses these costs immediately.

The Company records co-pay reimbursements made to patients receiving laser treatments as a reduction of revenue. For the years
ended December 31, 2020, and 2019, the Company recorded such reimbursements in the amounts of $485 and $779, respectively.

Cash and Cash Equivalents and Restricted Cash
Cash and cash equivalents consisted of cash and money market accounts at December 31, 2020, and 2019. The Company invests
its  cash  in  highly  liquid  short-term  investments  and  credit  card  transactions  with  settlement  terms  of  less  than  five  days.  The
Company  considers  short-term  investments  that  are  purchased  with  an  original  maturity  of  three  months  or  less  to  be  cash
equivalents. Proceeds due from credit card transactions were $10 and $21 as of December 31, 2020, and 2019, respectively. In
connection with the Company’s note payable, the Company pledged the proceeds of a time-deposit account in the amount of the
loan and interest and recorded the cash security as restricted cash.

Accounts Receivable, net
The majority of the Company’s accounts receivable are due from physicians, distributors (international) and other entities in the
medical field. Accounts receivable are most often due within 30 to 90 days and are stated at amounts due from customers net of
an  allowance  for  doubtful  accounts.  Accounts  outstanding  longer  than  the  contractual  payment  terms  are  considered  past  due.
The Company determines its allowance for doubtful accounts by considering a number of factors, including the length of time
trade accounts receivable are past due, the Company’s previous loss history, the customer’s current ability to pay its obligation to
the Company and available information about their credit risk, and the condition of the general economy and the industry as a
whole. The Company writes off accounts receivable when they are considered uncollectible, and payments subsequently received
on  such  receivables  are  credited  to  the  bad  debt  expense.  The  Company  does  not  recognize  interest  accruing  on  accounts
receivable past due. The allowance for doubtful accounts was $274 and $184 at December 31, 2020, and 2019, respectively.

Inventories
Inventories are stated at the lower of cost or net realizable value. Cost is determined based on purchased cost for raw materials
and  all  production  cost  related  to  the  laser  manufacturing  process  (labor  and  indirect  manufacturing  cost,  including  sub-
contracted work components) for work-in-process and finished goods is classified as inventory. For the Company’s products, cost
is determined on the first-in, first-out method. Work-in-process is immaterial, given the typically short manufacturing cycle, and
therefore is disclosed in conjunction with raw materials.

The Company's equipment for the treatment of skin disorders (e.g. the XTRAC) will either (i) be placed in a physician's office
and remain the property of the Company (at which date such equipment is transferred to property and equipment) or (ii) be sold
to distributors or physicians directly. The cost to build a laser, whether for sale or for placement, is accumulated in inventory.

Reserves  for  slow  moving  and  obsolete  inventories  are  provided  based  on  historical  experience  and  product  demand.
Management evaluates the adequacy of these reserves periodically based on forecasted sales and market trends. As of December
31, 2020, and 2019, reserves on inventory were $225 at each date, respectively.

F-13

 
 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Property, Equipment and Depreciation
Property  and  equipment  are  recorded  at  cost,  net  of  accumulated  depreciation  and  amortization.  Excimer  lasers-in-service  are
depreciated on a straight-line basis over the estimated useful life of five years. For other property and equipment, depreciation is
calculated  on  a  straight-line  basis  over  the  estimated  useful  lives  of  the  assets,  primarily  three  to  seven  years  for  computer
hardware and software,  furniture  and  fixtures,  and  machinery  and  equipment. Leasehold improvements  are  amortized  over  the
lesser  of  the  useful  lives  or  lease  terms.  Expenditures  for  major  renewals  and  betterments  to  property  and  equipment  are
capitalized,  while  expenditures  for  maintenance  and  repairs  are  charged  as  an  expense  as  incurred.  Upon  retirement  or
disposition, the applicable property amounts are deducted from the accounts and any gain or loss is recorded in the consolidated
statements  of  operations.  Useful  lives  are  determined  based  upon  an  estimate  of  either  physical  or  economic  obsolescence  or
both.

Intangible Assets
Intangible  assets  consist  of  core  technology,  product  technology,  customer  relationships,  trademarks  and  distribution  rights.
Intangible  assets  are  amortized  over  the  period  of  estimated  benefit  using  the  straight-line  method  and  estimated  useful  lives
ranging from three to ten years.

Accounting for the Impairment of Goodwill
Goodwill  represents  the  excess  of  the  purchase  price  over  the  fair  value  of  the  net  tangible  and  identifiable  intangible  assets
acquired and liabilities assumed in a business combination. The Company evaluates the carrying value of goodwill annually in
December  of  each  year  in  connection  with  the  annual  budgeting  and  forecast  process  and  also  between  annual  evaluations  if
events  occur  or  circumstances  change  that  would  more  likely  than  not  reduce  the  fair  value  of  the  reporting  unit  to  which
goodwill was allocated to below its carrying amount. Such circumstances could include, but are not limited to: (1) a significant
adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a
regulator. When evaluating goodwill for impairment, the Company may first perform an assessment qualitatively whether it is
more likely than not that a reporting unit's carrying amount exceeds its fair value. Under Accounting Standards Update (“ASU”)
2017-04,  “Intangibles  -  Goodwill  and  Other  (Topic  350):  Simplifying  the  Test  for  Goodwill  Impairment,”  Step  2  from  the
goodwill impairment test has been eliminated and goodwill impairment is measured as the excess of the carrying amount of the
reporting unit over its fair value. As the Company has not identified a goodwill impairment loss, currently this guidance does not
have  an  impact  on  the  Company’s  financial  statements  but  could  have  an  effect  in  the  event  of  a  goodwill  impairment.  The
Company bypassed the qualitative assessment and did a quantitative assessment by comparing the fair value of a reporting unit
with its carrying amount. No goodwill impairment was identified in the years ended December 31, 2020, and 2019.

Impairment of Long-Lived Assets and Intangibles
Long-lived assets, such as property and equipment, right-of-use assets and definite-lived intangibles subject to amortization, are
reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset group may
not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset
group  to  the  undiscounted  cash  flows  attributable  to  the  asset  group.  If  the  carrying  amount  of  an  asset  group  exceeds  its
undiscounted  cash  flows,  an  impairment  charge  is  recognized  in  the  amount  by  which  the  carrying  amount  of  the  asset  group
exceeds its fair value.

Functional Currency
The currency of the primary economic environment in which the operations of the Company are conducted is the U.S. dollar ("$"
or  "dollars").  Substantially  all  of  the  Company's  revenues  are  derived  in  dollars  or  in  other  currencies  linked  to  the  dollar.
Purchases of most materials and components are carried out in, or linked to the dollar.

For foreign currency transactions, the exchange rates applicable to the relevant transaction dates are used. Transaction gains or
losses arising from changes in the exchange rates are recorded in financing income or expenses.

F-14

 
 
 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Fair Value Measurements
The Company measures and discloses fair value in accordance with Financial Accounting Standards Board (“FASB”) Accounting
Standards Codification 820, Fair Value Measurements and Disclosures (“ASC Topic 820”). ASC Topic 820 defines fair value,
establishes a framework and gives guidance regarding the methods used for measuring fair value, and expands disclosures about
fair value measurements. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-
based measurement that  should  be determined  based  on  assumptions  that  market  participants  would  use  in  pricing  an  asset  or
liability.  As  a  basis  for  considering  such  assumptions  there  exists  a  three-tier  fair-value  hierarchy,  which  prioritizes  the  inputs
used in measuring fair value as follows:

•

•

•

Level 1 – unadjusted quoted prices are available in active markets for identical assets or liabilities that the Company has the ability to access as of
the measurement date.
Level 2 – pricing inputs are other than quoted prices in active markets that are directly observable for the asset or liability or indirectly observable
through corroboration with observable market data.
Level 3 – pricing inputs are unobservable for the asset or liability and only used when there is little, if any, market activity for the asset or liability
at  the  measurement  date.  The  inputs  into  the  determination  of  fair  value  require  significant  management  judgment  or  estimation.  Fair  value  is
determined using comparable market transactions and other valuation methodologies, adjusted as appropriate for liquidity, credit, market and/or
other risk factors.

This hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable
inputs when determining fair value.

The fair value of cash and cash equivalents and restricted cash are based on their respective demand value, which are equal to the
carrying value. The fair value of derivative warrant liability was estimated using option pricing models that was based on the fair
value of the Company’s common stock as well as assumptions for volatility, remaining expected life, and the risk-free interest
rate. The derivative warrant liability was the only recurring Level 3 fair value measure which expired in 2019. The carrying value
of  all  other  short-term  monetary  assets  and  liabilities  is  estimated  to  be  approximate  to  their  fair  value  due  to  the  short-term
nature  of  these  instruments.  At  December  31,  2019,  the  Company  repaid  its  long-term  debt  and  now  has  a  short-term  note
payable  that  was  renewed  through  December  30,  2021.  The  carrying  value  of  this  note  and  the  Company's  long  tem  debt  are
estimated to approximate fair value.

The Company’s warrant liabilities were recorded at their fair value using binomial and Black-Scholes methods and continued- to
be recorded at their respective fair value at each subsequent balance sheet date until such terms expired in February and April,
2019. (See Note 12, Warrants, for additional discussion).

Accrued Warranty Costs
The  Company  offers  a  standard  warranty  on  product  sales  generally  for  a  one  to  two-year  period,  however,  the  Company  has
offered longer warranty periods, ranging from three to four years, in order to meet competition or meet customer demands. The
Company provides for the estimated cost of the future warranty claims on the date the product is sold. Total accrued warranty is
included  in  Other  Accrued  Liabilities  and  Other  liabilities  on  the  consolidated  balance  sheets.  The  activity  in  the  warranty
accrual during the years ended December 31, 2020, and 2019, is summarized as follows:

F-15

 
 
 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Accrual at beginning of year
Additions charged to warranty expense
Expiring warranties/claims satisfied
Total
Less: current portion
Total long-term accrued warranty costs

December 31,

2020

2019

  $

  $

232    $
67     
(186)    
113     
(87)    
26    $

238 
222 
(228)
232 
(170)
62 

Product Development Costs
Costs of research, new product development and product redesign are charged to expenses as incurred in engineering and product
development  in  the  accompanying  consolidated  statements  of  operations.  The  Company  incurred  $1,274  and  $1,002  in
engineering and product development costs for the years ended December 31, 2020, and 2019, respectively.

Advertising Costs
Advertising costs are charged to expenses as incurred. Advertising expenses amounted to approximately $697 and $1,936 for the
years ended December 31, 2020, and 2019, respectively.

Income Taxes
The  Company  accounts  for  income  taxes  using  the  asset  and  liability  method.  Under  this  method,  deferred  tax  assets  and
liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities, as well as on
net operating loss carryforwards, and are measured using enacted tax rates and laws that are expected to be in effect when the
differences reverse. Any resulting net deferred tax assets are evaluated for recoverability and, accordingly, a valuation allowance
is provided when it is not more likely than not that all or some portion of the deferred tax asset will be realized.

The  Company  accounts  for  uncertain  tax  positions  in  accordance  with  an  amendment  to  ASC  Topic  740-10,  Income  Taxes
(Accounting for Uncertainty in Income Taxes), which clarified the accounting for uncertainty in tax positions. This amendment
provides that the tax effects from an uncertain tax position can be recognized in the financial statements only if the position is
"more-likely-than-not" to be sustained were it to be challenged by a taxing authority. The assessment of the tax position is based
solely  on  the  technical  merits  of  the  position,  without  regard  to  the  likelihood  that  the  tax  position  may  be  challenged.  If  an
uncertain tax position meets the "more-likely-than-not" threshold, the largest amount of tax benefit that is more than 50% likely
to be recognized upon ultimate settlement with the taxing authority is recorded. The Company has no uncertain tax positions.

Concentration of Credit Risks
Financial instruments which subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents,
restricted cash and accounts receivable. The Company deposits cash and cash equivalents and restricted cash in major financial
institutions  in  the  US  which,  at  times  exceeds  Federal  Deposit  Insurance  Corporation  and  Securities  Investor  Protection
Corporation limits. The Company performs periodic evaluations of the relative credit standing of these institutions. The Company
is of the opinion that the credit risk in respect of these balances is immaterial. In addition, the Company performs periodic credit
evaluation and establishes an allowance for doubtful accounts based upon factors surrounding the credit risk of customers. (See
also Accounts receivable above).

F-16

 
 
 
 
 
 
   
 
 
   
     
 
   
   
   
   
 
 
 
 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

With the exception of the Company’s international distributor, as described in Note 18, Significant Customer Concentrations,
the  balance  of  the  Company’s  trade  receivables  does  not  represent  a  substantial  concentration  of  credit  risk.  Most  of  the
Company’s sales are generated in North America, to a large number of customers.

Management  periodically  evaluates  the  collectability  of  the  trade  receivables  to  determine  the  amounts  that  are  doubtful  of
collection and determine a proper allowance for doubtful accounts.

Earnings Per Share
The Company calculates loss per common share and Preferred Series C share in accordance with ASC 260, Earnings per Share.
Under  ASC  260,  basic  loss  per  common  share  and  Preferred  Series  C  share  is  calculated  by  dividing  net  loss  attributable  to
common shares and Preferred Series C shares by the weighted-average number of common shares and Preferred Series C shares
outstanding during the reporting period and excludes dilution for potentially dilutive securities. Diluted loss per common share
and Preferred Series C share gives effect to dilutive options, warrants and other potential common shares outstanding during the
period.

Shares of Company's Series C Convertible Preferred Stock are subordinate to all other securities at the same subordination level
as  common  stock  and  they  participate  in  all  dividends  and  distributions  declared  or  paid  with  respect  to  common  stock  of  the
Company, on an as-converted basis. Therefore, the Series C Convertible Preferred Stock meet the definition of common stock
under ASC 260. Earnings per share is presented for each class of security meeting the definition of common stock. The loss is
allocated to each class of security meeting the definition of common stock based on their contractual terms.

The  following  table  presents  the  calculation  of  basic  and  diluted  loss  per  share  by  each  class  of  security  for  the  years  ended
December 31, 2020, and 2019:

Year ended
December 31, 2020

Year ended
December 31, 2019

  Common Stock   

Series C
Convertible
Preferred Stock   

Common
Stock

Series C
Convertible
Preferred
Stock

Loss attributable to each class

  $

(4,394)   $

(18)   $

(3,597)   $

(193)

Weighted average number of shares outstanding during the period

33,609,922     

368     

31,978,665     

4,577 

Basic and Diluted loss per share

  $

(0.13)   $

(48.59)   $

(0.11)   $

(42.24)

The Company considered Series C Preferred Stock and 403,090 warrants issued on October 31, 2013 and February 14, 2014, to
be participating securities in the presentation of earnings per share. However, the warrants are excluded from the calculation of
earnings per share in periods of losses as the warrant holders do not have an obligation to fund such losses. The above referenced
warrants expired on April 30, 2019 and February 14, 2019.

For  the  years  ended  December  31,  2020,  and  2019,  diluted  loss  per  common  share  and  Series  C  Convertible  Preferred  Stock
share  is  equal  to  the  basic  loss  per  common  share  and  Series  C  Convertible  Preferred  Stock  share,  respectively,  since  all
potentially dilutive securities are anti-dilutive. All Series C Convertible Preferred Stock was converted to common stock during
the year ended December 31, 2020.

F-17

 
 
 
   
 
 
 
   
 
 
   
 
 
   
     
     
     
 
 
   
      
      
      
  
   
 
   
      
      
      
  
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

The following common stock equivalents outstanding during the years ended December 31, 2020, and 2019, have been excluded
from the loss per share calculation as their inclusion would have been anti-dilutive:

Common stock purchase warrants
Restricted stock units
Common stock options
Total

Year Ended December 31,

2020

2019

434,791
131,247
4,957,288
5,523,326

1,517,528
128,417
4,235,451
5,881,396

Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with ASC Topic 718, Compensation – Stock Compensation.
Under the fair value recognition provision of this statement, share-based compensation cost is measured at the grant date based
on the fair value of the award and is recognized as an expense over the requisite service period of the stock award on a straight-
line basis. Forfeitures are recognized when they occur. Performance-based awards are recognized only when it is probable that
the vesting conditions will be met. There were no performance awards granted in 2020 or 2019.

Accounting Pronouncements Recently Adopted
In  February  2016  the  FASB  issued  ASU  2016-02,  “Leases”  (Topic  842)  (“ASU  2016-02”),  which  will  require  lessees  to
recognize  assets  and  liabilities  for  leases  with  lease  terms  of  more  than  12  months.  Consistent  with  current  U.S.  GAAP,  the
recognition,  measurement  and  presentation  of  expenses  and  cash  flows  arising  from  a  lease  primarily  will  depend  on  its
classification  as  a  finance  or  operating  lease.  However,  unlike  current  U.S.  GAAP,  which  requires  only  capital  leases  to  be
recognized on the balance sheet, the new guidance requires both types of leases to be recognized on the balance sheet. The ASU
is effective for interim and annual periods beginning after December 15, 2018, with early adoption permitted. In August 2018 the
FASB issued ASU No. 2018-11, “Leases (Topic 842: Targeted Improvements”) which permits adoption of the guidance in ASU
2016-02 using either a modified retrospective transition, requiring application at the beginning of the earliest comparative period
presented  or  a  transition  method  whereby  companies  could  continue  to  apply  existing  lease  guidance  during  the  comparative
periods and apply the new lease requirements through a cumulative-effect adjustment in the period of adoption rather than in the
earliest period presented without adjusting historical financial statements.

The Company used the modified retrospective transition approach to ASU No. 2018-11 and applied the new lease requirements
through  a  cumulative-effect  adjustment  in  the  period  of  adoption.  The  new  standard  provides  a  number  of  optional  practical
expedients in transition. We elected the package of practical expedients, which permits us not to reassess, under the new standard,
our prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-
hindsight or the practical expedient pertaining to land easements; the latter not being applicable to us. This accounting standard
did not have a material impact on our debt covenants. The Company has completed an evaluation of ASU 2016-02, including a
review of our leases and other contracts for potential embedded leasing arrangements and has recognized approximately $848 in
right-of-use assets and lease liabilities in the balance sheet as of January 1, 2019. There was no impact on the Company’s revenue
recognition under ASC 842.

In  June  2018  the  FASB  issued  ASU  No.  2018-07,  “Compensation  -  Stock  Compensation  (Topic  718):  Improvements  to
Nonemployee  Share-Based  Payment  Accounting,”  with  the  objective  of  simplifying  several  aspects  of  the  accounting  for
nonemployee share-based payment transactions resulting from expanding the scope of Topic 718 to include share-based payment
transactions  for  acquiring  goods  and  services  from  nonemployees.  The  provisions  of  this  update  are  effective  for  fiscal  years
beginning after December 15, 2018, including interim periods within that year. The adoption of ASU No. 2018-07 on January 1,
2019, did not have a material effect on the Company’s consolidated financial statements.

F-18

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) – Disclosure Framework – Changes to
the Disclosure Requirements for Fair Value Measurement. The new guidance improves and clarifies the fair value measurement
disclosure requirement of ASC 820. The new disclosure requirements include the changes in unrealized gains or losses included
in  other  comprehensive  income  for  recurring  Level  3  fair  value  measurement  held  at  the  end  of  the  reporting  period  and  the
explicit requirement to disclose the range and weighted average used to develop significant unobservable inputs for Level 3 fair
value measurements. The other provisions of ASU 2018-13 also include eliminated and modified disclosure requirements. The
guidance is effective for fiscal years beginning after December 15, 2019, with early adoption permitted, including in an interim
period for which financial statements have not been issued or made available for issuance. The adoption of ASU No. 2018-13 did
not have a material effect on the Company’s consolidated financial statements.

In  January  2017,  the  FASB  issued  ASU  2017-04,  Intangibles  –  Goodwill  and  Other  (Topic  350):  Simplifying  the  Test  for
Goodwill Impairment. The new guidance eliminated Step 2 from the goodwill impairment test which was required in computing
the implied fair value of goodwill. Instead, under the new amendments, an entity should recognize an impairment charge for the
amount by which the carrying amount exceeds the reporting unit’s fair value, however, the loss recognized should not exceed the
total amount of goodwill allocated to that reporting unit. If applicable, an entity should consider income tax effects from any tax-
deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss. The amendments
in this guidance are effective for public business entities for annual and interim goodwill impairment tests performed in fiscal
years beginning after December 15, 2019 with early adoption permitted after January 1, 2017. The adoption of ASU No. 2017-04
on January 1, 2020, did not have a material effect on the Company’s consolidated financial statements.

Recent Accounting Pronouncements Not Yet Adopted

In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848) Facilitation of the Effects of Reference Rate
Reform on Financial Statements. This pronouncement provides temporary optional expedients and exceptions for applying U.S.
GAAP  principles  to  contract  modifications  and  hedging  relationships  to  ease  the  financial  reporting  burdens  of  the  expected
market  transition  from  LIBOR  and  other  interbank  offered  rates  to  alternative  reference  rates.  The  guidance  is  effective  upon
issuance  in  March  2020,  and  will  apply  through  December  31,  2022.  We  continue  to  evaluate  the  temporary  expedients  and
options available under this guidance, and the effects of these pronouncements and as the Company does not have any hedging
activities does not believe this will have a material effect on the Company’s consolidated financial statements.

In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivative and
Hedging  –  Contracts  in  Entity’s  Own  Equity  (Subtopic  815-40);  Accounting  for  Convertible  Instruments  and  Contracts  in  an
Entity’s  own  Equity.  The  pronouncement  simplifies  the  accounting  for  certain  financial  instruments  with  characteristics  of
liabilities and equity, including convertible instruments and contracts on an entity's own equity. Specifically, the ASU "simplifies
accounting for convertible instruments by removing major separation models required under current U.S. GAAP." In addition, the
ASU  "removes  certain  settlement  conditions  that  are  required  for  equity  contracts  to qualify for it" and "simplifies the diluted
earnings per share (EPS) calculations in certain areas. ”The guidance is effective beginning after December 15, 2021 and early
adoption is permitted.   The Company does not currently engage in contracts covered by this guidance and does not believe it will
have a material effect on the Company’s consolidated financial statements, but could in the future.

In  December  2019,  the  FASB  issued  ASU  No.  2019-12,  Income  Taxes  (Topic  740):  Simplifying  the  Accounting  for  Income
Taxes. ASU 2019-12 eliminated certain exceptions and changed guidance on other matters. The exceptions relate to the allocation
of  income  taxes  in  separate  company  financial  statements,  tax  accounting  for  equity  method  investments  and  accounting  for
income taxes when the interim period year-to-date loss exceeds the anticipated full year loss. Changes relate to the accounting for
franchise  taxes  that  are  income-based  and  non-income-based,  determining  if  a  step  up  in  tax  basis  is  part  of  a  business
combination or if it is a separate transaction, when enacted tax law changes should be included in the annual effective tax rate
computation, and the allocation of taxes in separate company financial statements to a legal entity that is not subject to income
tax. The new standard is effective for fiscal  years,  and  interim  periods  within  those  fiscal  years,  beginning  after  December15,
2020, with early adoption permitted.

F-19

 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

The Company is currently evaluating the potential impact but does not believe there will be an impact of the adoption of this
standard on its results of operations, financial position and cash flows and related disclosures.

Note 2
Liquidity

The Company has been negatively impacted by the COVID-19 pandemic, and has historically experienced recurring losses and
has  been  dependent  on  raising  capital  from  the  sale  of  securities  in  order  to  continue  to  operate  and  meet  the  Company’s
obligations in the ordinary course of business. Since the equity financing in May 2018 and a change in management, and prior to
COVID, the Company had improved revenues, gross profit, generated positive cash flow from operations, refinanced its debt at a
lower interest rate and received cash proceeds from the Paycheck Protection Program loan (the “PPP loan”) and the EIDL loan
(defined in Note 9 below). Management believes that the Company’s cash and cash equivalents, combined with the anticipated
revenues  from  the  sale  or  use  of  the  Company’s  products  and  the  proceeds  from  the  PPP  loan  and  the  EIDL  loan,  will  be
sufficient to satisfy our working capital needs, capital asset purchases, outstanding commitments and other liquidity requirements
associated  with  our  existing  operations  through  the  next  12  months  following  the  date  of  the  issuance  of  these  consolidated
financial statements. However, the negative impact of the COVID-19 outbreak on the financial markets could interfere with our
ability to access financing and to access it on favorable terms, if at all.

Note 3
Revenue:

The  following  table  presents  the  Company’s  revenue  disaggregated  by  geographical  region  for  the  years  ended  December  31,
2020, and 2019. Domestic refers to revenue from customers based in the United States, and foreign recurring revenue is derived
from the Company’s distributor for physicians based in Korea and dermatology procedures equipment revenue is derived from
sales to the Company’s international master distributors for physicians based in primarily Asia.

Domestic
Foreign
Total

Domestic
Foreign
Total

  $

  $

  $

  $

F-20

Year Ended December 31, 2020
Dermatology
Procedures
Equipment

Dermatology
Recurring
Procedures

TOTAL

16,848    $
561     
17,409    $

956    $
4,725     
5,681    $

17,804 
5,286 
23,090 

Year Ended December 31, 2019
Dermatology
Procedures
Equipment

Dermatology
Recurring
Procedures

TOTAL

23,645    $
68     
23,713    $

1,243    $
6,630     
7,837    $

24,888 
6,698 
31,586 

 
 
 
 
 
 
 
   
   
 
   
 
 
 
 
 
   
   
 
   
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

The following table summarizes the Company’s expected future undiscounted fixed treatment code payments from international
recurring revenue customers as of December 31,

 $

 $

948 
954 
867 
440 
35 
3,244 

2021
2022
2023
2024
2025
Total

Note 4
Inventories:

Raw materials and work in process
Finished goods

December 31,
2020

December 31,
2019

  $

  $

2,949    $
495     
3,444    $

2,651 
376 
3,027 

Work-in-process is immaterial, given the Company’s typically short manufacturing cycle, and therefore is included in with raw
materials.

Note 5
Property and Equipment, net:

Lasers placed-in-service
Equipment, computer hardware and software
Furniture and fixtures
Leasehold improvements

Accumulated depreciation and amortization
Property and equipment, net

December 31,
2020

December 31,
2019

  $

  $

22,942    $
146     
243     
43     
23,374     
(17,845)    
5,529    $

20,925 
146 
234 
26 
21,331 
(15,962)
5,369 

Depreciation  and  related  amortization  expense  was  $1,975  and  $2,693  for  the  years  ended  December  31,  2020,  and  2019,
respectively.

F-21

  
  
  
  
  
 
   
 
 
   
     
 
   
 
  
 
   
 
 
   
     
 
   
   
   
 
   
   
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Note 6
Intangible Assets, net:

Set forth below is a detailed listing of definite-lived intangible assets as of:

Core technology
Product technology
Customer relationships
Tradenames

December 31,

2020
Accumulated
Amortization  

Intangible
assets, net

2019
Intangible
assets, net

Balance

  $

  $

5,700    $
2,000     
6,900     
1,500     
16,100    $

(3,135)   $
(2,000)    
(3,795)    
(825)    
(9,755)   $

2,565    $
-     
3,105     
675     
6,345    $

3,135 
200 
3,795 
825 
7,955 

Related  amortization  expense  was  $1,610  and  $1,810  for  the  years  ended  December  31,  2020,  and  2019,  respectively.  Total
accumulated amortization at December 31, 2019 was $8,145. Intangible assets consist of core technology, product technology,
customer  relationships,  trademark  and  distribution  rights.  Intangible  assets  are  amortized  over  the  period  of  estimated  benefit
using the straight-line method and estimated useful lives ranging from three to ten years. 

Estimated amortization expense for the above amortizable intangible assets for the future periods is as follows:

2021
2022
2023
2024
2025
Total

Note 7
Goodwill:

 $

 $

1,410 
1,410 
1,410 
1,410 
705 
6,345 

Goodwill reflects the amount of the acquisition price in excess of the fair values assigned to identifiable tangible and intangible
assets and assumed liabilities. Goodwill is not amortized, but is reviewed annually for impairment. Goodwill was recorded on the
acquisition  of  the  XTRAC  and  VTRAC  businesses  on  June  22,  2015,  as  the  purchase  price  exceeded  the  fair  value  of  the
identifiable net assets of the business. The balance of goodwill at December 31, 2020, and 2019 consisted of the following:

Dermatology Recurring Procedures segment
Dermatology Procedures Equipment segment
Total

  $

  $

7,958 
845 
8,803 

The Company has incurred no impairment of goodwill as of December 31, 2020 and 2019.

F-22

 
 
 
   
 
 
 
   
 
 
 
   
   
     
 
   
   
   
 
 
  
  
  
  
 
   
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Note 8
Other Accrued Liabilities:

Accrued warranty, current, see Note 1
Accrued compensation, including commissions and vacation
Accrued state sales use and other taxes
Accrued professional fees and other accrued liabilities
Total other accrued liabilities

December 31,
2020

December 31,
2019

  $

  $

87    $
891     
3,105     
607     
4,690    $

170 
1,193 
3,193 
578 
5,134 

In the ordinary course of business, the Company is, from time to time, subject to audits performed by state taxing authorities.
These actions and proceedings are generally based on the position that the arrangements entered into by the Company are subject
to sales and use tax rather than exempt from tax under applicable law. The Company uses estimates when accruing its sales and
use tax liability. All of the Company’s tax positions are subject to audit. One state has assessed the Company, in two assessments,
an  aggregate  amount  of  $1,484  for  the  period  from  March  2014  through  February  2020  including  penalties  and  interest.  The
Company has declined an informal offer to settle at a substantially lower amount and the Company appealed in that jurisdiction’s
administrative process of appeal.

In January 2021, the Company received notification that the administrative judge from the respective state had issued an opinion
finding in favor of the Company that the sale of XTRAC treatment codes were not taxable as sales tax with respect to the first
assessment. The jurisdiction has 30 days plus extensions to file an appeal and on March 25th the Company received an advisory
from the jurisdiction that it would file an appeal.

A second jurisdiction has made an assessment of $720 from June 2015 through March 2018 plus interest of $171 through April
2020. The Company is also in that jurisdiction’s administrative process of appeal and the timing of the process has been impacted
by  the  COVID-19  pandemic.  If  there  is  a  determination  that  the  true  object  of  the  Company’s  recurring  revenue  model  is  not
exempt from sales taxes and is not a prescription medicine or the Company does not have other defenses where the Company
does not prevail, the Company may be subject to sales taxes in those particular states for previous years and in the future, plus
potential interest and penalties for failure to pay such taxes.

The  Company  believes  its  state  sales  and  use  tax  accruals  have  properly  recognized  such  that  if  the  Company’s  arrangements
with customers are deemed more likely than not that the Company would not be exempt from sales tax in a particular state are the
basis for measurement of the state sales and use tax is calculated in accordance with ASC 405, Liabilities as a transaction tax. If
and when the Company is successful in defending itself or in settling the sales tax obligation for a lesser amount, the reversal of
this liability is to be recorded in the period the settlement is reached. However, the precise scope, timing and time period at issue,
as well as the final outcome of any audit and actual settlement remains uncertain.

The Company records state sales tax collected and remitted for its customers on equipment sales on a net basis, excluded from
revenue. The Company’s sales tax expense that is not presently being collected and remitted for the recurring revenue business
are recorded in general and administrative expenses on the consolidated statements of operations.

F-23

 
 
   
 
 
   
     
 
   
   
   
 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Note 9
Note Payable

On December 30, 2019, the Company closed on a $7,275 loan with a commercial bank pursuant to a one-year Fixed Rate – Term
Promissory Note (the “Note”), which was renewed effective December 30, 2020 at an interest rate of 1.40% and a rate of 0.40%
on the time deposit. For the year ended December 31, 2019 the Note had an interest rate of 2.79% and a rate of 1.79% on the time
deposit.  The  Company's  obligations  under  the  Note  are  secured  by  an  Assignment  and  Pledge  of  Time  Deposit  (the
“Agreement”),  under  which  the  Company  has  pledged  to  the  commercial  bank  the  proceeds  of  a  time  deposit  account  in  the
amount  of  the  loan  and  recorded  the  time  deposit  and  interest  as  restricted  cash  on  the  balance  sheet.  The  principal  is  due  on
December 30, 2021 with no penalties for prepayments. In 2019, the Company fully repaid (including payment of termination and
exit fees) its then existing long-term debt credit facility with Midcap Financial Trust (“MidCap”). The transaction was accounted
for as a debt extinguishment. See Note 10 Long-term Debt for further discussion on the extinguishment.

Note 10
Long-term Debt:

Term-Note Credit Facility
On  December  30,  2015,  the  Company  entered  into  a  $12,000  credit  facility  pursuant  to  a  Credit  and  Security  Agreement  (the
"Credit Agreement") and related financing documents with MidCap and the lenders listed therein. Under the Credit Agreement,
the credit facility could be drawn down in two tranches, the first of which was drawn for $10,500 on December 30, 2015. The
second tranche was drawn for $1,500 on January 29, 2016. The maturity date of the credit facility was December 1, 2020. The
Company's  obligations  under  the  credit  facility  were  secured  by  a  first  priority  lien  on  all  the  Company's  assets.  This  credit
facility had an interest rate of one-month LIBOR plus 8.25% and included both financial and non-financial covenants, including a
minimum  net  revenue  covenant.  On  November  10,  2017,  the  minimum  net  revenue  covenant  was  amended  prospectively  and
there was an increase in the exit fee. Additionally, on November 10, 2017, the Company entered into an amendment to modify
the principal payments, including a period of six months where there were no principal payments due.

On  March  26,  2018,  the  Company  entered  into  a  Third  Amendment  to  the  Credit  Agreement  with  MidCap.  For  the  period
beginning on the closing date of the loan and ending on January 31, 2018, the gross revenue in accordance with U.S. GAAP for
the twelve-month period ending on the last day of the most recently completed calendar month was amended to be less than the
minimum amount on the Covenant Schedule, as defined in the Credit Agreement. This amendment waived the event of default
related  to  the  revenue  covenant  for  the  period  ending  February  2018.  This  amendment  also  amended  the  monthly  net  revenue
covenant.

On May 29, 2018, the Company entered into a Fourth Amendment to Credit Agreement (the “Amendment”), pursuant to which
the Company repaid $3,000 in principal of then existing $10,571 credit facility. The terms of the credit facility were amended to
impose less restrictive covenants and lower prepayment fees for the Company and extended the maturity date to May 2022. The
Amendment  modified  the  principal  payments  including  a  period  of  18  months  where  there  were  no  principal  payments  due.
Principal payments beginning December 2019 were $252 plus interest per month. The interest rate on the credit facility was one-
month LIBOR plus 7.25%. On April 30, July 15, August 26, and October 15, 2019 the Company received waivers from MidCap,
as  administrative  agent  for  the  lenders  who  were  party  to  the  Credit  Agreement,  wherein  the  lenders  waived  the  Company’s
compliance  with  the  obligation  to  deliver  audited  financial  statements  within  120  days  of  year-end,  pursuant  to  the  Credit
Agreement. The waivers were effective through November 7, 2019. The Company delivered the audited financial statements on
or about October 29, 2019 to cure the event of default.

These amendments had been accounted for as debt modifications, as the present value of the cash flows changed by less than
10%.

F-24

 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

All  borrowings  under  the  Credit  Agreement  were  fully  repaid  in  connection  with  the  proceeds  from  a  Fixed  Rate-Promissory
Note  on  December  30,  2019.  The  Company  accounted  for  the  repayment  as  an  extinguishment  of  debt  and  recorded  a  loss  of
$414 in the consolidated statements operations for the year ended December 31, 2019.

Paycheck Protection Program Loan
On April 22, 2020, the Company closed a loan of $2,028 (the “PPP loan”) from a commercial bank, pursuant to the Paycheck
Protection Program (“PPP”) administered by the Small Business Administration (the “SBA”) pursuant to the CARES Act. The
PPP  loan  matures  on  May  1,  2022  and  bears  an  interest  rate  of  1%  per  annum.  Payments  of  principal  and  interest  of  any
unforgiven balance was scheduled to commence December 1, 2020, but is deferred until the SBA approves of the forgiveness
amount. Under the Paycheck Protection Program Flexibility Act of 2020 (the “PPP Flexibility Act”), (i) the first payment date for
the PPP loan will be the earlier of (a) 10 months after the end of the “covered period” (as determined under the PPP) or (b) the
date the bank receives a remittance of the forgiven amount from the SBA, and (ii) the PPP loan’s maturity is extended to five
years (from 2 years).

All or a portion of the PPP loan may be forgiven by the lender upon application by the Company beginning 60 days after loan
approval  and  upon  documentation  of  expenditures  in  accordance  with  the  requirements  set  forth  by  the  SBA  pursuant  to  the
CARES  Act.  Under  the  CARES  Act,  loan  forgiveness  is  available  for  the  sum  of  documented  payroll  costs,  covered  rent
payments, covered mortgage interest and covered utilities at either; the Company’s election, the eight-week period or twenty-four
week period beginning on the date of disbursement of proceeds from the PPP loan. For purposes of the CARES Act, payroll costs
exclude  compensation  of  an  individual  employee  in  excess  of  $100,  prorated  annually.  Not  more  than  40%  of  the  forgiven
amount may be for non-payroll costs. Forgiveness is reduced, under certain circumstances, if full-time headcount declines or if
salaries and wages for employees with salaries of $100 or less annually are reduced. In the event the PPP loan, or any portion
thereof, is forgiven pursuant to the PPP, the amount forgiven is applied to outstanding principal. In December 2020, the Company
has submitted for forgiveness to the SBA, and subject to the SBA’s approval, of 100% of the loan proceeds. The balance of the
loan at December 31, 2020 was $2,028.

Economic Injury Disaster Loan
On May 22, 2020, the Company executed the standard loan documents required for securing a loan (the “EIDL Loan”) from the
SBA under its Economic Injury Disaster Loan (“EIDL”) assistance program in light of the impact of the COVID-19 pandemic on
the Company’s business. The principal amount of the EIDL Loan is up to $500, with proceeds to be used for working capital
purposes and is collateralized by all the Company’s assets. On June 12, 2020, the Company received these funds from the SBA.
Interest  accrues  at  the  rate  of  3.75%  per  annum.  Installment  payments,  including  principal  and  interest,  are  due  monthly
beginning March 26, 2021 (twelve months from the date of the promissory note) in the amount of $2. The balance of principal
and interest is payable over the next thirty years from the date of the promissory note. There are no penalties for prepayment.
Based upon guidance issued by the SBA on June 19, 2020, the EIDL Loan is not required to be refinanced by the PPP loan. The
balance of the loan at December 31, 2020 was $500.

F-25

STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

The following summarizes the Company’s long term debt:

Term notes
Less: current portion
Total long-term debt

  $

  $

2,528 
(1,478)
1,050 

The  following  table  summarizes  the  future  payments  that  the  Company  is  obligated  to  make  for  long-term  debt  for  the  future
period as to the stated terms of the loans:

2021
2022
2023
2024
2025
Thereafter
Total

Note 11
Commitments and Contingencies:

  $

  $

1,478 
568 
10 
10 
10 
452 
2,528 

Leases
The Company recognizes right-of-use assets (“ROU Assets”) and operating lease liabilities (“Lease Liabilities”) when it obtains
the right to control an asset under a leasing arrangement with an initial term greater than twelve months. The Company adopted
the short-term accounting election for leases with a duration of less than one year. The Company leases its facilities and certain
IT and office equipment under non-cancellable operating leases.

All  of  the  Company's  leasing  arrangements  are  classified  as  operating  leases  with  remaining  lease  terms  ranging  from  1  to  4
years, and one facility lease has a renewal option for two years. Renewal options have been excluded from the determination of
the lease term as they are not reasonably certain of exercise. On May 1, 2019, the Company entered into an addendum with FR
National Life, LLC for the Carlsbad facility for five years which began on October 1, 2019.

Operating lease costs were $448 for each of the years ended December 31, 2020 and 2019. Cash paid for amounts included in the
measurement of operating lease liabilities was $436 and $371 for the years ended December 31, 2020 and 2019, respectively. As
of December 31, 2020, and 2019, the incremental borrowing rate was 9.76% and the weighted average remaining lease term was
3.1 and 4.1 years, respectively. The following table summarizes the Company’s operating lease maturities as of  December  31,
2020:

For the year ending December 31,
2021
2022
2023
2024

Total remaining lease payments

Less: imputed interest

Total lease liabilities

  $

  $

456 
371 
242 
186 
1,255 
(176)
1,079 

With  respect  to  lease  and  non-lease  components,  the  Company  adopted  the  practical  expedient  to  account  for  the  lessee
arrangement as a single lease component.

F-26

   
   
   
   
   
   
 
   
  
   
 
   
   
   
   
   
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Contingent Shares
In the event of certain contingencies, the investors in the an equity financing in May 2018 may receive additional shares issued
pursuant  to  the  Retained  Risk  Provisions  as  defined  in  the  Stock  Purchase  Agreements.  There  are  additional  contingencies
included in the SPAs that the Company has determined are not probable or estimable and/or contractually obligated in order to
issue shares at this time.

For contingencies related to sales and use taxes, see Note 8.

Litigation
In the ordinary course of business, the Company is routinely a defendant in or party to pending and threatened legal actions and
proceedings,  including  actions  brought  on  behalf  of  various  classes  of  claimants.  These  actions  and  proceedings  are  generally
based  on  alleged  violations  of  employment,  contract  and  other  laws.  In  some  of  these  actions  and  proceedings,  claims  for
substantial monetary damages are asserted against the Company. In the ordinary course of business, the Company is also subject
to  regulatory  and  governmental  examinations,  information  gathering  requests,  inquiries,  investigations,  and  threatened  legal
actions  and  proceedings.  In  connection  with  formal  and  informal  inquiries  by  federal,  state,  local  and  foreign  agencies,  the
Company  receives  numerous  requests,  subpoenas  and  orders  for  documents,  testimony  and  information  in  connection  with
various aspects of its activities.

Note 12
Warrants:

The Company accounts for warrants that require net cash settlement upon change of control of the Company as liabilities instead
of equity. There were 403,090 of such warrants with an exercise price of $3.75 per share which expired on February 5, 2019 and
April 30, 2019.

Note 13
Stockholders’ Equity:

Preferred Stock
The  Company  is  authorized  to  issue  10,000,000  shares  of  preferred  stock  with  a  par  value  of  $0.10  per  share  with  such
designation, rights and preferences as may be determined from time to time by the Company’s Board of Directors.

Other than the limitations on conversions to keep each such holder’s beneficial ownership below 9.99%, the terms of the Series C
Convertible Preferred Stock generally bestow the same rights to each holder as such holder would receive if they were common
stock shareholders and are not redeemable by the holders, except that the Series C Convertible Preferred Stock shares do not have
voting rights. The Series C Convertible Preferred Stock have the same level of subordination as common stock. Each share of
Series C Convertible Preferred Stock has a stated value of $1,000 and is convertible into shares of common stock at a conversion
price equal to $2.69 for a total of approximately 15,049,000 shares of common stock. There were 0 and 2,103 shares of Series C
Convertible  Preferred  Stock  issued  and  outstanding  on  December  31,  2020,  and  2019,  respectively.  For  the  years  ended
December  31,  2020,  and  2019,  investors  converted  shares  of  Series  C  Preferred  Stock  into  782,089  and  2,923,791  shares  of
common stock, respectively.

Common Stock and Warrants
The  Company  is  authorized  to  issue  150,000,000  shares  of  common  stock  with  a  par  value  of  $0.001  per  share.  There  were
33,801,045 and 32,932,273 shares of common stock issued and outstanding at December 31, 2020, and 2019, respectively.

At  December  31,  2020,  the  Company  had  19,812  outstanding  common  stock  warrants  with  an  exercise  price  of  $5.30.  These
warrants expired on January 29, 2021.

F-27

 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Note 14
Stock-based compensation:

Stock Options
On October 27, 2016, the Company’s stockholders approved the Company’s adoption of the new 2016 Omnibus Incentive Stock
Plan  (“2016  Plan”)  having  2,058,880  shares  available  for  issuance  in  respect  of  awards  made  thereunder.  The  Company
terminated  the  2013  Stock  Incentive  Plan  in  October  2016.  On  May  29,  2018,  the  Company’s  stockholders  approved  the
Company’s amendment to the 2016 Plan to increase the number of the Company’s common stock available for grants under the
plan by 3,134,365. As of December 31, 2020, the aggregate number of shares of common stock remaining available for issuance
for awards under the 2016 Plan totaled 41,774.

A summary of option transactions for all of the Company’s stock options during the years ended December 31, 2020, and 2019
follows: 

Outstanding at January 1, 2019

Granted
Exercised
Expired/forfeited

Outstanding at December 31, 2019

Granted
Exercised
Expired/forfeited

Outstanding at December 31, 2020

Exercisable at December 31, 2020

Options expected to vest at December 31, 2020

Number of

Stock Options    

Weighted
Average
Exercise Price  
2.02 
2.46 
1.74 
6.43 
1.90 
1.46 
1.29 
170.00 
1.87 

4,342,765    $
875,000     
(86,250)    
(223,477)    
4,908,038     
400,000     
(15,000)    
(150)    
5,292,888    $

3,442,501    $

1,850,387    $

1.87 

1.86 

The outstanding options at December 31, 2020, have a range of exercise prices and associated weighted remaining contractual
life and weighted average exercise price, as follows:

Options Range of
Exercise Prices

Outstanding Number
of Shares

1.11 - $2.00 
2.01 - $5.00 
5.01 - $181.00 

$
$
$
Total

4,185,877 
941,000 
166,011 
5,292,888 

Weighted Average
Remaining
Contractual Life
(years)

Weighted Average
Exercise Price

Exercisable Number
of Shares

Exercisable Weighted
Average Exercise
Price

7.59 
8.67 
4.54 
7.69 

  $

  $

1.47 
2.52 
8.07 
1.87 

2,918,323 
358,267 
165,911 
3,442,501 

  $

  $

1.43 
2.61 
8.03 
1.87 

The weighted average remaining contractual life of exercisable options was 7.30 years and 8.03 years at December 31, 2020, and
2019, respectively.

The share price as of December 31, 2020, was $1.50 and the aggregate intrinsic value for options outstanding and exercisable
was $611 and $546, respectively. The intrinsic value of the options that were exercised was $3 during the year ended December
31, 2020. The share price for December 31, 2019, was $2.08 and the intrinsic value for options outstanding and exercisable was
$2,300 and $1,156, respectively.

F-28

 
 
 
 
   
   
   
   
   
   
   
   
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Stock awards under the Company’s stock option plans have been granted with exercise prices that are no less than the market
value  of  the  stock  on  the  date  of  the  grant.  Options  granted  under  the  plans  are  generally  time-based  or  performance-based
options  and  vesting  varies  accordingly  (see  below  for  specific  vesting  conditions).  There  were  no  performance-based  options
granted in 2020 or 2019. Options under the plans expire up to a maximum of ten years from the date of grant. The fair value of
each option award granted during the period is estimated on the date of grant using the Black-Scholes option valuation model and
assumptions as noted in the following table:

Risk-free interest rate
Volatility
Expected dividend yield
Expected life

Years Ended December 31,

2020
.53%
94%
0%
6.0 years

2019
1.66%
71%
0%
6.0 years

The expected life of the options is based on the observed and expected time to full-vesting, forfeiture and exercise. Groups of
employees that have similar historical exercise behavior are considered separately for valuation purposes. Volatility is based on
Company historical volatility and comparable companies’ historical stock prices matching the expected term of the award. The
risk-free rate is based on rates provided by the U.S. Treasury with a term equal to the expected life of the option. The Company
has never paid dividends and does not currently anticipate paying any in the foreseeable future.

For the year ended December 31, 2019, 86,250 of options were exercised in a cashless exercise at a weighted average exercise
price  of  $1.74  which  resulted  in  the  issuance  of  36,410  of  shares  of  common  stock.  For  the  year  ended  December  31,  2020,
15,000 of options were exercised at a weighted average exercise price of $1.29.

On  November  21,  2019,  the  Company  granted  options  to  purchase  300,000  shares  of  common  stock  to  its  Chief  Executive
Officer, 150,000 shares of common stock to its Chief Financial Officer and 425,000 in additional grants to management at a strike
price  of  $2.46.  The  options  vest  over  three  years  and  expire  ten  years  from  the  date  of  grant.  The  aggregate  fair  value  of  the
options granted was $1,361.

On November 13, 2020, the Company granted options to purchase 150,000 shares of common stock to its Chief Financial Officer
and 250,000 in additional grants to management at a strike price of $1.46. The options vest over three years and expire ten years
from the date of grant. The aggregate fair value of the options granted was $443.

The following table summarizes the Company’s unvested stock option activity:

Unvested balance as of January 1, 2019
Granted
Vested
Forfeited/expired
Unvested balance as of December 31, 2019
Granted
Vested
Forfeited/expired
Unvested balance at December 31, 2020

F-29

Weighted
Average Grant
Date Fair
Value

Options

3,394,468    $
875,000     
(1,265,956)    
-     
3,003,512    $
400,000     
(1,553,125)    
-     
1,850,387    $

0.82 
1.56 
0.78 
- 
1.05 
1.11 
0.96 
- 
1.15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
   
   
   
   
   
   
   
   
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Restricted Stock Units
In connection with the closing of an equity financing in May 2018, there were changes to the board of directors and the Company
issued initial grants to new members as well as grants to all members as compensation. In total, the Company granted 140,097
restricted stock units to the board members at a fair value of $2.07. The restricted stock units vest quarterly over twelve months.
The  aggregate  fair  value  of  the  restricted  stock  units  granted  was  $290.  Restricted  stock  units  issued  to  the  Chairman  were
cancelled in January 2019.

On November 21, 2019, the Company granted 77,237 restricted stock units to certain board members at a fair value of $2.46. The
restricted stock units vest quarterly over twelve months. The aggregate fair value of the restricted stock units granted was $190.

Stock-based compensation expense, which is included in general and administrative expense, for the years ended December 31,
2020, and 2019, was $1,633 and $1,195, respectively. As of December 31, 2020, there was $1,715 in unrecognized compensation
expense, which will be recognized over a weighted average period of 1.05 years.

Restricted stock unit unvested are summarized in the following table:

Unvested balance at January 1, 2019
Granted
Vested/settled
Forfeited/expired
Unvested balance at December 31, 2019
Granted
Vested/settled
Forfeited/expired
Unvested balance at December 31, 2020

Number of
restricted stock
units

Weighted
Average Grant
Date Fair
Value

70,049    $
77,237     
(60,387)    
(9,662)    
77,237    $
-     
(68,091)    
(9,146)    
-    $

2.07 
2.46 
2.07 
2.07 
2.46 
- 
2.46 
2.46 
- 

At December 31, 2020 and 2019, restricted stock units vested but not issued were 88,194 and 91,787, respectively.

Note 15
Income Taxes:

Current:
Federal
State

Deferred:
Federal
State

Income tax expense (benefit)

Years Ended December 31,

2020

2019

  $

  $

-    $
21     
21     

129     
125     
254     
275    $

(58)
20 
(38)

(86)
(25)
(111)
(149)

The provision for income taxes includes federal, state and local income taxes currently payable and deferred taxes resulting from
net operating loss carryforwards and temporary differences between the financial statement and tax bases of assets and liabilities.
Valuation  allowances  are  recorded  to  reduce  deferred  tax  assets  when  it  is  not  more  likely  than  not  that  a  tax  benefit  will  be
realized.

F-30

 
 
 
 
   
 
   
   
   
   
   
   
   
   
   
 
 
 
 
 
 
 
   
 
   
     
 
   
 
   
   
      
  
   
   
 
   
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

The  CARES  ACT,  among  other  things  contains  numerous  income  tax  provisions.  Some  of  these  tax  provisions  are  effective
retroactively for the years ending before the date of enactment. The Company analyzed the impact of the CARES ACT and does
not foresee a significant impact on its consolidated financial position, results of operations, effective tax rate and cash flows.

The difference between the actual income tax expense (benefit) and that computed by applying the U.S. federal income tax rate to
pretax loss from continuing operations is summarized below:

Computed expected tax expense (benefit)
State tax (benefit)expense, net of federal effect
Other
Net increase (decrease) in valuation allowance
Provision for income taxes

For the Years Ended December 31,  

2020

2019

  $

  $

(869)   $
(272)    
221     
1,195     
275    $

(827)
(106)
377 
407 
(149)

The computed expected tax benefit was calculated using the U.S. federal income tax rates of 21% for the years ended December
31, 2020, and 2019, respectively.

The  tax  effects  of  temporary  differences  that  give  rise  to  significant  portions  of  the  deferred  tax  assets  and  liabilities  as  of
December 31, 2020, and 2019 are as follows:

Deferred tax assets/(liabilities):
Net operating loss carryforward
Intangible assets
Inventory
Reserves & accrued expenses
Property & equipment
Non-cash compensation
Goodwill
Right of use asset
Lease liability
Total net deferred tax assets
Less: valuation allowance
Net deferred tax assets/(liabilities)

December 31,

2020

2019

  $

  $

45,819    $
1,450     
51     
896     
(178)    
808     
(815)    
(249)    
272     
48,054     
(48,308)    
(254)   $

43,433 
2,046 
51 
992 
389 
850 
(667)
(331)
350 
47,113 
(47,113)
- 

The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in
which  those  temporary  differences  become  deductible.  Based  on  the  Company’s  historical  net  losses,  management  does  not
believe  that  it  is  more-likely-than  not  that  the  Company  will  realize  the  benefits  of  these  deferred  tax  assets  and,  accordingly,
nearly  a  full  valuation  allowance  has  been  recorded  against  the  deferred  tax  assets  as  of  December  31,  2020  and  2019.  The
Company’s valuation allowance against its deferred tax assets increased by $1,195 for the year ended December 31, 2020 and
increased by $407 for the year ended December 31, 2019.

F-31

 
 
 
 
 
 
   
 
   
   
   
 
 
 
 
 
 
   
 
 
   
     
 
   
     
 
   
   
   
   
   
   
   
   
   
   
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

At December 31, 2020, and 2019, the Company has federal net operating loss carryforwards of approximately $200,976 to offset
future taxable income. Net operating loss carryforwards prior to 2019 begin to expire in 2021 through 2036. The Company has
experienced  certain  ownership  changes  which,  under  the  provisions  of  Section  382  of  the  Internal  Revenue  Code  of  1986,  as
amended, result in annual limitations on the Company’s ability to utilize its net operating losses in the future. The February 2014,
July  2014,  June  2015  and  May  2018  equity  raises  by  the  Company  will  limit  the  annual  use  of  these  net  operating  loss
carryforwards. Although the Company has not performed a Section 382 study, any limitation of its pre-change net operating loss
carryforwards that would result in a reduction of its deferred tax asset would also have an equal and offsetting adjustment to the
valuation allowance.

FASB ASC 740 “Income Taxes” contains guidance with respect to uncertain tax positions which applies to all tax positions and
clarifies  the  recognition  of  tax  benefits  in  the  financial  statements  by  providing  for  a  two-step  approach  of  recognition  and
measurement. The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination
based upon its technical merits. The second step involves measurement of the amount to recognize. Tax positions that meet the
more-likely-than-not threshold are measured at the largest amount of tax benefit that is, greater than 50%, likely of being realized
upon ultimate finalization with the taxing authority.

The Company does not have any uncertain income tax positions or accrued penalties and interest. If such matters were to arise,
the Company would recognize interest and penalties related to income tax matters in income tax expense. The Company files tax
returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is
subject to examination by federal, state, and foreign jurisdictions, where applicable. The Company’s tax years are still under open
status from 2016 to present. All open years may be examined to the extent that net operating loss carryforward are used in future
periods.

Note 16
Business Segments:

The  Company  organized  its  business  into  two  operating  segments  to  better  align  its  organization  based  upon  the  Company’s
management  structure,  products  and  services  offered,  markets  served  and  types  of  customers,  as  follows:  The  Dermatology
Recurring  Procedures  segment  derives  its  revenues  from  the  usage  of  its  equipment  by  dermatologists  to  perform  XTRAC
procedures. The Dermatology Procedures Equipment segment generates revenues from the sale of equipment, such as lasers and
lamp products. Management reviews financial information presented on an operating segment basis for the purposes of making
certain operating decisions and assessing financial performance.

Unallocated operating expenses include costs that are not specific to a particular segment but are general to the group; included
are expenses incurred for administrative and accounting staff, general liability and other insurance, professional fees and other
similar corporate expenses. Interest and other financing income (expense), net, is also not allocated to the operating segments.

The following tables reflect results of operations from our business segments for the periods indicated below:

F-32

 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Year Ended December 31, 2020

Revenues
Costs of revenues
Gross profit
Gross profit %

Allocated operating expenses:
Engineering and product development
Selling and marketing expenses
Unallocated operating expenses

Income (loss) from operations
Interest expense, net
Income (loss) before income taxes

Year Ended December 31, 2019

Revenues
Costs of revenues
Gross profit
Gross profit %

Allocated operating expenses:
Engineering and product development
Selling and marketing expenses
Unallocated operating expenses

Income (loss) from operations
Interest expense, net
Loss on extinguishment of debt
Income (loss) before income taxes

Dermatology
Recurring
Procedures

Dermatology
Procedures
Equipment

  $

  $

17,409 
5,832 
11,577 

  $

5,681 
3,124 
2,557 

TOTAL

23,090 
8,956 
14,134 

66.5%   

45.0%   

61.2%

1,101 
8,437 
- 
9,538 
2,039 
- 
2,039 

  $

173 
601 
- 
774 
1,783 
- 
1,783 

  $

1,274 
9,038 
7,898 
18,210 
(4,076)
(61)
(4,137)

  $

Dermatology
Recurring
Procedures

Dermatology
Procedures
Equipment

  $

  $

23,713 
7,033 
16,680 

  $

7,873 
4,283 
3,590 

TOTAL

31,586 
11,316 
20,270 

70.3%   

45.6%   

64.2%

845 
11,191 
- 
12,036 
4,644 
- 
- 
4,644 

  $

157 
812 
- 
969 
2,621 
- 
- 
2,621 

  $

1,002 
12,003 
10,275 
23,280 
(3,010)
(515)
(414)
(3,939)

  $

As of December 31, 2020, and 2019, total assets by reportable segment were as follows:

Assets:
Dermatology Recurring Procedures
Dermatology Procedures Equipment
Other unallocated assets
     Consolidated total

December 31,

2020

2019

  $

  $

25,112    $
3,052     
18,614     
46,778    $

27,620 
3,382 
16,341 
47,343 

Substantially all long-lived assets were located in domestic markets for both of the years ended December 31, 2020, and 2019.

F-33

 
 
 
 
 
 
 
   
   
   
   
   
   
   
 
   
  
   
  
   
  
   
  
   
  
   
  
   
   
   
   
   
   
   
   
   
 
   
   
   
   
   
   
   
   
   
 
   
  
   
  
   
  
 
 
 
 
 
 
 
   
   
   
   
   
   
   
 
   
  
   
  
   
  
   
  
   
  
   
  
   
   
   
   
   
   
   
   
   
 
   
   
   
   
   
   
   
   
   
   
   
   
 
 
 
 
   
 
   
   
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

Note 17
Related Parties:

In connection with the certain litigation, the Company has agreed to indemnify Uri Geiger and Accelmed Growth Partners, L.P.
for  their  out  of  pocket  costs.  As  of  December  31,  2019,  the  Company  has  reimbursed  Accelmed  Growth  Partners,  L.P.
approximately $25.

Note 18
Significant Customer Concentration:

For the year ended December 31, 2020, revenue from sales to GlobalMed, the Company’s international master distributor, were
$2,679, or 11.6%, of total revenues. At December 31, 2020, the accounts receivable from GlobalMed was less than 10% of total
accounts  receivable.  For  the  year  ended  December  31,  2019,  revenues  from  sales  to  the  Company’s  international  master
distributor were $6,133, or 19.4% of total revenues for such year. At December 31, 2019, the accounts receivable balance from
GlobalMed  was  $661,  or  15.1%,  of  total  net  accounts  receivable.  No  other  customer  accounted  for  more  than  10%  of  the
Company’s revenues or accounts receivable.

Note 19
Employee 401(k) Savings Plan:

The Company sponsors a 401(k) defined contribution retirement savings plan that covers all eligible employees who have met the
minimum  age  and  service  requirements.  Under  the  plan,  eligible  employees  may  contribute  a  portion  of  their  annual
compensation into the plan up to IRS annual limits. The Company has elected to make matching contributions to the plan based
on percentage of the employee’s contribution. For the years ended December 31, 2020, and 2019, the Company’s contributions to
the plan were $240 and $248, respectively. On January 1, 2019, the Company elected a safe harbor match to the 401(k) defined
contribution plan.

Note 20
Subsequent Events:

On January 29, 2021, 19,812 outstanding common stock warrants expired.

On February 24, 2021, the Company and Dr. Dolev Rafaeli entered into an employment separation agreement and release (the
“Separation Agreement”), pursuant to which, among other things, Dr. Rafaeli resigned as the Company’s Chief Executive Officer
and  President  and  as  a  member  of  the  Company’s  board  of  directors  on  February  28,  2021.  In  connection  with  Dr.  Rafaeli’s
separation, upon the expiration of the revocation of a general release delivered by Dr. Rafaeli to the Company, the Company will
(i)  pay  Dr.  Rafaeli  (a)  his  base  salary,  less  applicable  legal  deductions,  through  May  29,  2021  consistent  with  normal  payroll
procedures,  (b)  a  lump  sum  amount  equal  to  12  weeks  of  pay  as  a  payout  of  his  accrued  but  unused  vacation  days,  (c)
reimbursements of his monthly COBRA premium payments for up to 18 months following February 28, 2021, and (d) an amount
up  to  $10,000  to  reimburse  Dr.  Rafaeli  for  reasonable  attorneys’  fees  in  connection  with  the  negotiation  of  the  Separation
Agreement,  and  (ii)  vest  all  outstanding  options  held  by  Dr.  Rafaeli  (to  the  extent  not  then  vested)  and  have  them  remain
exercisable until August 22, 2021. Subject to the foregoing restrictions and the Company’s insider trading policies, Dr. Rafaeli
will be permitted to exercise the options as permitted under the Company’s equity incentive plan, including cashless exercises,
until  August  22,  2021.  Certain  provisions  contained  in  the  employment  agreement,  dated  as  of  March  30,  2018  (the  “Rafaeli
Employment Agreement”), between the Company and Dr. Rafaeli survive and continue to apply under the Separation Agreement,
including, but not limited to, covenants related to confidentiality, assignment of developments, and covenant not to compete. The
Company  and  Dr.  Rafaeli  also  agreed  to  mutual  non-disparagement  and  communication  restriction  provisions  and  granted
customary general releases to each other. Until May 29, 2021, Dr. Rafaeli agreed to cooperate in good faith with the Company in
transitioning his duties to one or more persons as determined by the Company’s board of directors.

F-34

 
 
 
 
 
 
STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share, per share amounts and number of lasers)

On February 28, 2021, in connection with the separation of the Company’s Chief Executive Officer, the Company accelerated the
vesting of options to purchase 800,886 shares of common stock.

On  March  1,  2021,  the  Company  granted  an  options  to  purchase  1,632,590  shares  of  common  stock  to  its  incoming  Chief
Executive  Officer  with  a  strike  price  of  $1.73  vesting  over  a  three  year  period,  with  544,198  options  vesting  on  the  first
anniversary of the date of the grant and 136,049 vesting every three months thereafter, subject to acceleration of vesting under
certain circumstances.

F-35

EXHIBIT 23.1

INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENT

We consent to the incorporation by reference in the Registration Statement of STRATA Skin Sciences, Inc. and Subsidiary on
Amendment No. 1 to Form S-3 on Form S-1 (File No.’s 333-205797 and 333-226296) and Form S-8 (File No.’s 333-136183,
333-161286,  333-189119,  333-208397,  333-216712  and  333-226298)  of  our  report  dated  March  25,  2021, with  respect  to  our
audits of the consolidated financial statements of STRATA Skin Sciences, Inc. and Subsidiary as of December 31, 2020 and 2019
and for the years ended December 31, 2020 and 2019, which report is included in this Annual Report on Form 10-K of STRATA
Skin Sciences, Inc. for the year ended December 31, 2020.

/s/ Marcum LLP

Marcum LLP
Philadelphia, Pennsylvania
March 25, 2021

E-23.1

Exhibit 31.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

I, Robert Moccia, certify that:

(1)

(2)

(3)

(4)

I have reviewed this annual report on Form 10-K of STRATA Skin Sciences, Inc.;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to
make  the  statements  made,  in  light  of  the  circumstances  under  which  such  statements  were  made,  not  misleading  with  respect  to  the
period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

(b)

(c)

(d)

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known
to us by others within those entities, particularly during the period in which this report is being prepared;

designed such internal control over financial reporting or caused such internal control over financial reporting to be designed
under  our  supervision,  to  provide  reasonable  assurance  regarding  the  reliability  of  financial  reporting  and  the  preparation of
financial statements for external purposes in accordance with generally accepted accounting principles;

evaluated  the  effectiveness  of  the  registrant’s  disclosure  controls  and  procedures  and  presented  in  this  report  our  conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such
evaluation; and

disclosed  in  this  report  any  change  in  the  registrant’s  internal  control  over  financial  reporting  that  occurred  during  the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that  has  materially
affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

(5)

The  registrant's  other  certifying  officer(s)  and  I  have  disclosed,  based  on  our  most  recent  evaluation  of  internal  control  over  financial
reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent
functions):

(a)

(b)

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information;
and

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's
internal control over financial reporting.

Dated: March 25, 2021

STRATA SKIN SCIENCES, INC.

By: /s/ Robert J. Moccia                     
Robert J. Moccia
President & Chief Executive Officer

E-31.1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exhibit 31.2

CERTIFICATION OF CHIEF FINANCIAL OFFICER

I, Matthew C. Hill, certify that:

(1)

(2)

(3)

(4)

I have reviewed this annual report on Form 10-K of STRATA Skin Sciences, Inc.;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to
make  the  statements  made,  in  light  of  the  circumstances  under  which  such  statements  were  made,  not  misleading  with  respect  to  the
period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

(b)

(c)

(d)

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known
to us by others within those entities, particularly during the period in which this report is being prepared;

designed such internal control over financial reporting or caused such internal control over financial reporting to be designed
under  our  supervision,  to  provide  reasonable  assurance  regarding  the  reliability  of  financial  reporting  and  the  preparation  of
financial statements for external purposes in accordance with generally accepted accounting principles;

evaluated  the  effectiveness  of  the  registrant’s  disclosure  controls  and  procedures  and  presented  in  this  report  our  conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such
evaluation; and

disclosed  in  this  report  any  change  in  the  registrant’s  internal  control  over  financial  reporting  that  occurred  during  the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that  has  materially
affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

(5)

The  registrant's  other  certifying  officer(s)  and  I  have  disclosed,  based  on  our  most  recent  evaluation  of  internal  control  over  financial
reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent
functions):

(a)

(b)

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information;
and

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's
internal control over financial reporting.

Dated: March 25, 2021

STRATA SKIN SCIENCES, INC.

By: /s/ Matthew C. Hill                    
Matthew C. Hill
Chief Financial Officer

E-31.2

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SECTION 906 CERTIFICATION

CERTIFICATION (1)

Exhibit 32.1

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. § 1350, as adopted), Robert Moccia, the President
and Chief Executive Officer of STRATA Skin Sciences, Inc. (the “Company”), and Matthew C. Hill, the Chief Financial Officer
of the Company, each hereby certifies that, to the best of his knowledge:

1.

2.

The  Company’s  Annual  Report  on  Form  10-K  for  the  year  ended  December  31,  2020,  to  which  this  Certification  is  attached  as
Exhibit  32.1  (the  “Periodic  Report”),  fully  complies  with  the  requirements  of  Section  13(a)  or  Section  15(d)  of  the  Securities
Exchange Act of 1934, as amended, and

The  information  contained  in  the  Periodic  Report  fairly  presents,  in  all  material  respects,  the  financial  condition  and  results  of
operations of the Company.

Dated: March 25, 2021

/s/   Robert J. Moccia                            
Robert Moccia
President & Chief Executive Officer

/s/   Matthew C. Hill               
Matthew C. Hill
Chief Financial Officer

(1)

This  certification  accompanies  the  Annual  Report  on  Form  10-K  to  which  it  relates,  is  not  deemed  filed  with  the  Securities  and  Exchange
Commission  and  is  not  to  be  incorporated  by  reference  into  any  filing  of  STRATA  Skin  Sciences,  Inc.  under  the  Securities  Act  of  1933,  as
amended,  or  the  Exchange  Act  (whether  made  before  or  after  the  date  of  the  Form  10-K),  irrespective  of  any  general  incorporation  language
contained in such filing. A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided
to STRATA Skin Sciences, Inc. and will be retained by STRATA Skin Sciences, Inc. and furnished to the Securities and Exchange Commission or
its staff upon request.

E-32.1