Quarterlytics / Healthcare / Medical - Instruments & Supplies / Retractable Technologies, Inc.

Retractable Technologies, Inc.

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Employees 51-200
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FY2017 Annual Report · Retractable Technologies, Inc.
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Table of Contents

(Mark One)

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K

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

For the fiscal year ended December 31, 2017

or

oo            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 001-16465
Retractable Technologies, Inc.
(Exact name of registrant as specified in its charter)

Texas
(State or other jurisdiction of
incorporation or organization)

511 Lobo Lane
Little Elm, Texas
(Address of principal executive offices)

75-2599762
(I.R.S. Employer
Identification No.)

75068-5295
(Zip Code)

Securities registered pursuant to Section 12(b) of the Act:

972-294-1010
Registrant’s telephone number, including area code

Securities registered pursuant to Section 12(g) of the Act:

Title of each class
Common

Name of each exchange on which registered
NYSE American LLC

Preferred Stock
(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 o  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 Act.  Yes o  No  x

Indicate by check mark whether the registrant (1) 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 (2) has been subject to such filing requirements
for the past 90 days.  Yes  x  No  o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File
required to be submitted and posted 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 and post such files).  Yes  x  No  o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and
will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K.  x

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.

 See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer o
Non-accelerated filer o (Do not check if a smaller reporting company)

Accelerated filer o
Smaller reporting company x
Emerging growth company o

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. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes  o  No  x

State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common
equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal
quarter.  The aggregate market value of the common equity held by non-affiliates as of June 30, 2017, was $17,327,372, assuming a closing price of $1.27 and
outstanding shares held by non-affiliates of 13,643,600.

APPLICABLE ONLY TO REGISTRANTS INVOLVED IN BANKRUPTCY

PROCEEDINGS DURING THE PRECEDING FIVE YEARS:

Indicate  by  check  mark  whether  the  registrant  has  filed  all  documents  and  reports  required  to  be  filed  by  Section  12,  13,  or  15(d)  of  the  Securities

Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.  Yes  o  No  o

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.  As of March 1, 2018,

there were 32,666,454 shares of our Common Stock outstanding.

(APPLICABLE ONLY TO CORPORATE REGISTRANTS)

DOCUMENTS INCORPORATED BY REFERENCE

List hereunder the following documents if incorporated by reference and the Part of the Form 10-K (e.g., Part I, Part II, etc.) into which the document is
incorporated:    (1) Any  annual  report  to  security  holders;  (2) Any  proxy  or  information  statement;  and  (3) Any  prospectus  filed  pursuant  to  Rule  424(b)  or
(c) under the Securities Act of 1933.  The listed documents should be clearly described for identification purposes (e.g., annual report to security holders for fiscal
year ended December 24, 1980).

None except exhibits.

Table of Contents

Item 1. Business
Item 1A. Risk Factors
Item 1B. Unresolved Staff Comments
Item 2. Properties
Item 3. Legal Proceedings
Item 4. Mine Safety Disclosures

RETRACTABLE TECHNOLOGIES, INC.
FORM 10-K
For the Fiscal Year Ended December 31, 2017

TABLE OF CONTENTS

PART I

PART II

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity
Securities
Item 6. Selected Financial Data
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Item 8. Financial Statements and Supplementary Data
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9A. Controls and Procedures
Item 9B. Other Information

PART III

Item 10. Directors, Executive Officers and Corporate Governance
Item 11. Executive Compensation
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 13. Certain Relationships and Related Transactions, and Director Independence
Item 14. Principal Accounting Fees and Services

Item 15. Exhibits, Financial Statement Schedules
SIGNATURES

Table of Contents

FORWARD-LOOKING STATEMENT WARNING

PART IV

i

PART I

1
5
7
7
7
8

8
10
11
15
F-1
16
16
17

17
21
28
31
32

32
35

Certain  statements  included  by  reference  in  this  filing  containing  the  words  “could,”  “may,”  “believes,”  “anticipates,”

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
“intends,”  “expects,”  and  similar  such  words  constitute  forward-looking  statements  within  the  meaning  of  the  Private  Securities
Litigation Reform Act.  Any forward-looking statements involve known and unknown risks, uncertainties, and other factors that may
cause  our  actual  results,  performance,  or  achievements  to  be  materially  different  from  any  future  results,  performance,  or
achievements expressed or implied by such forward-looking statements.  Such factors include, among others, our ability to maintain
liquidity,  our  maintenance  of  patent  protection,  the  impact  of  current  and  future  Court  decisions  regarding  current  litigation,  our
ability to maintain favorable third party manufacturing and supplier arrangements and relationships, foreign  trade  risk,  our  ability  to
quickly  increase  capacity  in  response  to  an  increase  in  demand,  our  ability  to  access  the  market,  our  ability  to  maintain  or  lower
production costs, our ability to continue to finance research and development as well as operations and expansion of production, the
impact of larger market players, specifically Becton, Dickinson and Company (“BD”), in providing devices to the safety market, and
other factors referenced in Item 1A. Risk Factors.  Given these uncertainties, undue reliance should not be placed on forward-looking
statements.

Item 1. Business.

DESCRIPTION OF BUSINESS

General Development of Business

Retractable  Technologies,  Inc.  was  incorporated  in  Texas  in  1994.    Our  business  is  the  manufacturing  and  marketing  of
safety medical products (predominately syringes) for the healthcare industry.  We have manufacturing facilities in Little Elm, Texas
and  use  manufacturers  in  China  as  well.    We  have  developed  several  new  products  in  the  last  few  years,  including  the
EasyPoint  needle which can be used with, among other things, prefilled syringes.

®

In 2007, we filed a lawsuit claiming that we have been blocked from gaining market access due to actions taken by BD.  In
August  2017,  a  district  court  dismissed  our  remaining  claims  against  BD  and  entered  a  take  nothing  judgment.    We  have  filed  for
appeal.

Financial Information

We do not report in segments.  See Item 8 for our financial statements.

Principal Products, Markets, and Distribution

®

Our  goal  is  to  become  a  leading  provider  of  safety  medical  products.    Our  principal  products  were  designed  to  protect
healthcare  workers  and  others  from  needlestick  injuries,  cross-contamination  through  reuse,  and  reduce  disposal  costs.    The
VanishPoint  products accomplish these goals by retracting the needle when the plunger handle is fully depressed while the needle is
still  in  the  patient.    This  pre-removal  activation  virtually  eliminates  exposure  to  the  contaminated  needle,  reducing  the  risk  of
needlestick  injuries.   Activation  is  easily  accomplished  in  one  step,  using  one  hand.    Upon  activation  of  the  retraction  mechanism,
VanishPoint  products are rendered unusable, reducing the risk of disposal-related injuries or reuse.

®

VanishPoint  syringe sales have historically comprised most of our sales.  VanishPoint

®

®
  syringe  sales  were  98.2%,  93.0%

and 89.9% of our revenues in 2015, 2016, and 2017.

Our VanishPoint  safety products currently consist of tuberculin, insulin, and allergy antigen VanishPoint

®
®
 syringes; 0.5mL,
®
1  mL,  2mL,  3mL,  5mL,  and  10mL  VanishPoint
  autodisable  syringe.    We  also  sell  the
®
  blood  collection  set.    The  Patient
VanishPoint   IV  catheter;  the  VanishPoint
Safe   syringe  protects  patients  by  reducing  the  risk  of  bloodstream  infections  associated  with  catheter  hub  contamination.    Our
Patient Safe  products currently consist of 3mL, 5mL, 10mL, 20mL, 30mL, 60mL syringes and the Patient Safe  Luer cap.

®
  syringes;  and  the  VanishPoint
®
  blood  collection  tube  holder;  and  the  VanishPoint

®

®

®

®

Table of Contents

1

In the second quarter of 2016, we began selling the EasyPoint  needle.  EasyPoint needles  made  up  6.0%  of  revenues  in
2017.  The EasyPoint  is a retractable needle that can be used with Luer lock syringes, Luer slip syringes, and prefilled syringes to
give injections.  The EasyPoint  needle can also be used to aspirate fluids and collect blood.

®

®

® 

®

We currently have under development additional safety products that add to or build upon our current product line offering. 
These products include: retractable needles and syringes, glass syringes, dental syringes, IV catheter introducers, and blood collection
sets.

Our products are sold to and used by healthcare providers primarily in the U.S. (with 21.7% of revenues in 2017 generated
from  sales  outside  the  U.S.)  which  include,  but  are  not  limited  to,  acute  care  hospitals,  alternate  care  facilities,  doctors’  offices,
clinics, emergency centers, surgical centers, long-term care facilities, Veterans Administration facilities, military organizations, public
health facilities, and prisons.

Under  the  current  supply  chain  system  in  the  U.S.  acute  care  market,  the  vast  majority  of  decisions  relating  to  the

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
contracting for and purchasing of medical supplies are made by the representatives of group purchasing organizations (“GPOs”) and
purchasing representatives rather than the end-users of the product (nurses, doctors, and testing personnel).  The GPOs and larger
manufacturers often enter into contracts which can prohibit or limit entry in the marketplace by competitors.

We  distribute  our  products  throughout  the  U.S.  through  general  line  and  specialty  distributors.    We  also  use  international
distributors.  We have developed a national direct marketing network in order to market our products to health care customers and
their purchaser representatives.  Our marketers make contact with all of the departments that affect the decision-making process for
safety  products,  including  the  purchasing  agents.    They  call  on  acute  care  and  alternate  care  sites  and  speak  directly  with  the
decision-makers  of  these  facilities.    We  employ  trained  sales  representatives  and  clinicians,  including  nurses  and/or  medical
technologists that educate healthcare providers and healthcare workers on the use of safety devices through on-site clinical training,
exhibits at related tradeshows, and publications of relevant articles in trade journals and magazines.  These employees provide clinical
support  to  customers.    In  addition  to  marketing  our  products,  the  network  demonstrates  the  safety  and  cost  effectiveness  of  our
products to customers.

The American  Journal  of  Infection  Control  published  an  article  in  its  November  2017  issue  that  estimates  that  more  than
300,000 healthcare workers in the United States suffer sharps injuries (such as needlesticks) annually.  The article is the most recent
of a series of articles published over the past few years (several of which were published in the AOHP Journal).  The data shows
that the number of sharps injuries has remained essentially unchanged over the past several years.

Sources and Availability of Raw Materials

We own the printing plates used to print artwork on packaging and the molds used to manufacture the plastic components of
our products in the U.S.  Other product components, including needle adhesives and packaging materials, are purchased from various
suppliers.  There are a variety of such suppliers in the United States.

Intellectual Property

Intellectual property rights are material to our business, particularly patent rights.  The patents licensed to us by Thomas J.
Shaw, our founder and CEO, have varying expiration dates.  Importantly, the VanishPoint
syringes, which are constructed using a
variety of patents, will cease to be covered by a patent in 2020 unless further patented improvements are made to the design.  All of
our  products  are  manufactured  using  patents  owned  by  Thomas  J.  Shaw  and  we  have  a  Technology  License  Agreement  with
Mr. Shaw granting us the exclusive right to manufacture, market, and sell the products.  Mr. Shaw is paid a 5% royalty on our gross
sales pursuant to the terms of the Technology License Agreement.

® 

2

Table of Contents

®

The Company has registered the following trade names and trademarks for our products: VanishPoint

®
, EasyPoint , Patient
®
 products, the color coded spots
Safe , VanishPoint  logos, RT with a circle mark, the Spiral Logo used in packaging VanishPoint
on the ends of our VanishPoint  syringes and others.  Company slogans “The New Standard for Safety” and “We Make Safety Safe”
also have been granted registered trademark protection.

®

®

®

We are involved in patent litigation detailed in Item 3.

Seasonality

Historically,  unit  sales  have  increased  in  the  latter  part  of  the  year  due,  in  part,  to  the  demand  for  syringes  during  the  flu

season.

Working Capital Items

Our significant accounting policies are set forth in the notes to our financial statements in Item 8.  Our inventory practices

will vary in response to demand.  Order backlog is not material to our business.

Dependence on Customers

Although  our  business  has  historically  derived  significant  percentages  of  its  revenues  from  a  few  customers,  we  do  not

believe that the loss of any one of these customers would have a material adverse effect on our business.

We  do  not  believe  that  existing  contracts  or  subcontracts  with  the  government  are  reasonably  likely  to  be  renegotiated  or

terminated.

Government Approval and Government Regulations

For all products manufactured for sale in the domestic market, we have given notice of intent to market to the FDA, and the

devices were shown to be substantially equivalent to the predicate devices for the stated intended use.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
For all products manufactured for sale in the domestic market and foreign market, we hold a Quality Management System
certification to ISO 13485. For all products manufactured for sale into European Union countries, we hold a Full Quality Assurance
System certification to Directive 93/42/EEC Annex II (excluding section 4).  Both of these certifications are issued by our notified
body, bsi, and are reviewed annually.

We will continue to comply with applicable regulations of all countries in which our products are registered for sale.

Competitive Conditions

Major  domestic  competitors  include  BD  and  Medtronic  Minimally  Invasive  Therapies  (“Medtronic,”  formerly  known  as
Covidien).    Terumo  Medical  Corp.,  Smiths  Medical,  and  B  Braun  are  additional  competitors  with  smaller  market  shares.  BD  and
Medtronic  have  controlling  U.S.  market  share;  greater  financial  resources;  larger  and  more  established  sales,  marketing,  and
distribution organizations; and greater market influence, including long-term and/or exclusive contracts.  Additionally, BD may be able
to use its resources to improve its products through research or acquisitions or develop new products which may compete with our
products.

We compete primarily on the basis of healthcare worker and patient safety, product performance, and quality.  We believe
our competitive advantages include, but are not limited to, our leadership in quality and innovation. We believe our products continue
to  be  the  most  effective  safety  devices  in  today’s  market.    Our  syringe  products  include  passive  safety  activation,  require  less
disposal space, and are activated while in the patient, reducing exposure to the contaminated needle.  Our price per unit is competitive
or even lower than the competition once all the costs incurred during the life cycle of a syringe are considered. Such life cycle costs
include  disposal  costs,  testing  and  treatment  costs  for  needlestick  injuries,  and  treatment  for  contracted  illnesses  resulting  from
needlestick injuries.

3

Table of Contents

®

EasyPoint   retractable  needles  offer  unique  safety  benefits  not  found  in  other  commercially  available  safety  needles. 
Manually activated safety needles, such as BD’s SafetyGlide™ and Eclipse™ needles, and Medtronics’ Magellan™ needle, must be
removed from the patient, exposing the contaminated needle prior to activation of the manual safety mechanism.  EasyPoint  needles
allow  for  activation  of  the  automated  retraction  mechanism  while  the  needle  is  still  in  the  patient,  reducing  exposure  to  the
contaminated  needle  and  effectively  reducing  the  risk  of  needlestick  injuries.    BD’s  Integra™  needle  allows  for  retraction  from  the
patient but must be used in conjunction with a BD Integra™ 3mL syringe.  The Integra™ needle does not have a luer fitting, making
it  incompatible  with  commonly  used  luer-fitting  syringes  and  pre-filled  syringes.    In  addition,  the  safety  feature  of  the  Integra™
needle/syringe  combination  can  only  be  activated  when  the  plunger  handle  is  fully  depressed  and  the  contents  have  been  expelled. 
®
EasyPoint   retractable  needles  are  compatible  with 
  In  addition,
®
EasyPoint  retractable needles may be activated with fluid in the syringe, making it applicable for aspiration procedures such as blood
collection.

including  pre-filled  syringes. 

luer-fitting  syringes, 

®

Research and Development

We  spent  approximately  $609,000;  $572,000;  and  $608,000  in  2017,  2016,  and  2015,  respectively,  on  research  and

development.

Environmental Compliance

We believe that we do not incur material costs in connection with compliance with environmental laws.

Employees

As of March 1, 2018, we had 150 employees. 146 of such employees were full time employees.

Financial Information about Geographic Areas

We have minimal long-lived assets in foreign countries.  Shipments to international customers generally require a prepayment
either  by  wire  transfer  or  an  irrevocable  confirmed  letter  of  credit.    We  do  extend  credit  to  international  customers  on  some
occasions  depending  upon  certain  criteria,  including,  but  not  limited  to,  the  credit  worthiness  of  the  customer,  the  stability  of  the
country,  banking  restrictions,  and  the  size  of  the  order.   All  transactions  are  in  U.S.  currency.    If  customers  designate  a  specific
destination for its order, we attribute sales to countries based on the destination of shipment.

U.S. sales
North and South America sales (excluding U.S.)
Other international sales
Total sales

2017
27,015,712
6,380,745
1,097,381
34,493,838

$

$

2016
26,308,246
2,741,518
776,872
29,826,636

$

$

2015
23,029,976
5,668,785
853,439
29,552,200

$

$

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Long-lived assets
U.S.
International

$
$

11,215,583
137,619

$
$

11,930,293
161,744

$
$

11,282,192
185,869

Most large international sales of VanishPoint

®
 products are filled by production from Chinese manufacturers.  In the event
that we become unable to purchase such product from our Chinese manufacturers, we would need to find an alternate manufacturer
for the blood collection set, IV catheter, Patient Safe  syringe, 0.5mL insulin syringe, 0.5mL autodisable syringe, and 2mL, 5mL, and
10mL syringes and we would increase domestic production for the 1mL and 3mL syringes.

®

We do not maintain patent or trademark protection in all foreign countries, but, where possible, have taken steps to protect
our  patents  and  trademarks  in  those  countries  where  we  routinely  conduct  a  material  amount  of  business.    Our  lack  of  patent  and
trademark protection, particularly in certain foreign countries, heightens the risk that our designs may be copied by a competitor.

4

Table of Contents

We cannot anticipate the impact of potential changes in trade policy from the current administration.

Available Information

We make available, free of charge on our website (www.retractable.com), our Form 10-K Annual Report and Form 10-Q
Quarterly  Reports  and  Current  Reports  on  Form  8-K  (and  any  amendments  to  such  reports)  as  soon  as  reasonably  practical  after
such reports are filed.

Item 1A. Risk Factors.

We could be subject to complex and costly regulatory activities.  Our business could suffer if we or our suppliers encounter
manufacturing  problems.    We  could  be  subject  to  risks  associated  with  doing  business  outside  of  the  U.S.    Current  or  worsening
economic conditions may adversely affect our business and financial condition.

You should carefully consider the following material risks facing us.  If any of these risks occur, our business, results of

operations, or financial condition could be materially affected.

We Compete in a Marketplace Dominated by BD

We operate in an environment that is dominated by BD, the major syringe manufacturer in the U.S.  We initiated a lawsuit in
2007 against BD.  The suit was for patent infringement, antitrust practices, and false advertising.  The court severed the patent claims
from the other claims.  The antitrust and false advertising case was dismissed in district court in August 2017 and we were awarded
a take nothing judgment.  We have filed for appeal.

Although  we  have  made  limited  progress  in  some  areas,  such  as  the  alternate  care  and  some  international  markets,  our
volumes are not as high as they should be given the nature and quality of our products and the federal and state legislation requiring
the use of safe needle devices.  We believe this is due to BD’s activities, despite our litigation efforts described briefly above.

We Have Generally Been Unable to Gain Sufficient Market Access to Achieve Profitable Operations

We have a history of incurring net operating losses.  We may experience operating losses in the future.  If we are unable to
gain  sufficient  market  access  and  market  share,  we  may  be  unable  to  continue  to  finance  research  and  development  as  well  as
support operations and expansion of production.

We Are Dependent on Our Aging Patent Protection

Our main competitive strength is our technology.  We are dependent on patent rights, and if the patent rights are invalidated
or  circumvented,  our  business  would  be  adversely  affected.    Patent  protection  is  considered,  in  the  aggregate,  to  be  of  material
importance in the design, development, and marketing of products.

The  Company  holds  exclusive  rights  under  domestic  and  foreign  patents  and  has  pending  applications  related  to  the
technology  embodied  in  products  that  are  currently  marketed.    The  Company  also  holds  rights  related  to  new  products  under
development.    The  patent  rights  held  by  the  Company  for  various  commercial  products  have  remaining  terms  and  expiration  dates
®
presently  ranging  from  2020  to  2032.  Those  patent  rights  cover  significant  features  of  the  VanishPoint
  syringes,  blood  collection
®
sets and IV catheters, and of the Patient Safe  syringes and EasyPoint  retractable needles.

®

®

VanishPoint  syringes comprised 89.9% of sales in 2017 and patent coverage for those products will expire in 2020.  When
the current patents for those syringes and other products expire in coming years, the Company may experience a significant and rapid
loss of sales, and our competitive position in the marketplace may weaken if the Company becomes vulnerable to other competitors

 
 
  
  
  
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
utilizing its technology.  Such occurrences could have a material adverse effect on profitability.

We do not maintain patent or trademark protection in all foreign countries, but, where possible, have taken steps to protect
our  patents  and  trademarks  in  those  countries  where  we  routinely  conduct  a  material  amount  of  business.    Our  lack  of  patent  and
trademark protection, particularly in certain foreign countries, heightens the risk that our designs may be copied by a competitor.

5

Table of Contents

Our Patents Are Subject to Litigation

We have been sued by BD and MDC Investment Holdings, Inc. for patent infringement.  This case has been administratively
closed until our case against BD is resolved.  We expect this case may be reopened in 2018.  Patent litigation and challenges involving
our  patents  are  costly  and  unpredictable  and  may  deprive  us  of  market  exclusivity  for  a  patented  product  or,  in  some  cases,  third
party patents may prevent us from marketing and selling a product in a particular geographic area.

We Are Vulnerable to New Technologies

Because  we  have  a  narrow  focus  on  particular  product  lines  and  technology  (currently,  predominantly  retractable  needle
products), we are vulnerable to the development of superior competing products and to changes in technology which could eliminate
or reduce the need for our products.  If a superior technology is created, the demand for our products could greatly diminish.

Our Competitors Have Greater Resources

Our  competitors  have  greater  financial  resources,  larger  and  more  established  sales  and  marketing  and  distribution
organizations, and greater market influence, including long-term contracts.  These competitors may be able to use these resources to
improve their products through research and acquisitions or develop new products, which may compete more effectively with our
products.    If  our  competitors  choose  to  use  their  resources  to  create  products  superior  to  ours,  we  may  be  unable  to  sell  our
products and our ability to continue operations would be weakened.

International operations may be affected by legislation

We are subject to risks associated with our international operations.  In 2017, we used Chinese manufacturers to produce
82.9%  of  our  products.    Trade  protection  measures  and/or  changes  to  import  or  export  requirements  could  adversely  impact  our
operations.    We  cannot  predict  the  impact  of  potential  changes  to  U.S.  foreign  trade  policy.   Additionally,  we  derive  21.7%  of  our
revenues  from  international  sales.    International  sales,  particularly  in  emerging  market  countries,  are  further  subject  to  a  variety  of
regulatory, economic, and political risks as well.

Our New Products May Not Replace Lost Vanishpoint® Sales After 2020

®
Presently existing patent coverage for VanishPoint
 syringes will expire in 2020.  Following the patent expiration, expected
®
declines  in  sales  of  VanishPoint
  syringes,  which  currently  comprise  89.9%  of  our  revenues,  means  that  our  future  success  is
dependent  on  new  products.    We  have  engaged  in  research  and  development  for  many  years  to  develop  other  commercially
successful  products.    Often,  new  products  take  a  number  of  years  to  develop  and  sales  of  a  new  product  may  be  disappointing. 
Based on industry-wide trends, we anticipate that demand may increase for one of our newer products, the EasyPoint  needle.  Sales
in 2017 for this product were 6.0% of our total revenues.

®

The Majority of Our Sales Are Filled Using Third Party Manufacturers

Most  international  sales,  as  well  as  a  substantial  portion  of  domestic  sales,  are  filled  by  production  from  Chinese
manufacturers.  In the event that we become unable to purchase such product from our Chinese manufacturers, we would need to
find  an  alternate  manufacturer  for  the  blood  collection  set,  IV  catheter,  Patient  Safe   syringe,  0.5mL  insulin  syringe,  0.5mL
autodisable syringe, and 2mL, 5mL, and 10mL syringes and we would increase domestic production for the 1mL and 3mL syringes. 
Even with increased domestic production, we may not be able to avoid a disruption in supply.  In 2017, the 1mL and 3mL syringes
made up 83.4% of our unit sales and 82.0% of our revenues. We have a strong relationship with our Chinese manufacturers and we
communicate with them frequently.

®

6

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Fluctuations in Supplies of Inventory Could Temporarily Increase Costs

Fluctuations  in  the  cost  and  availability  of  raw  materials  and  inventory  and  the  ability  to  maintain  favorable  third  party
manufacturing  arrangements  and  relationships  could  result  in  the  need  to  manufacture  all  of  our  products  in  the  U.S.    This  could

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
temporarily increase unit costs as we ramp up domestic production.

We Are Controlled by One Shareholder

Thomas J. Shaw, our President and Chief Executive Officer, has investment or voting power over a total of 53.8% of the
outstanding Common Stock.  Mr. Shaw therefore has the ability to direct our operations and financial affairs and to elect members of
our Board of Directors.  His interests may not always coincide with the Company’s interests or the interests of other stockholders. 
This  concentration  of  ownership,  for  example,  may  have  the  effect  of  delaying,  deferring,  or  preventing  a  change  in  control,
impeding  a  merger,  consolidation,  takeover,  or  other  business  combination  involving  us,  or  discouraging  a  potential  acquirer  from
making a tender offer or otherwise attempting to obtain control of us, which in turn could materially adversely affect the market price
of our Common Stock.  Mr. Shaw’s rights under the Technology License Agreement, as the owner of the technology we produce,
present similar conflicts of interest.

We Face Inherent Product Liability Risks

As a manufacturer and provider of safety needle products, we face an inherent business risk of exposure to product liability
claims.  If a product liability claim is made and damages are in excess of our product liability coverage, our competitive position could
be weakened by the amount of money we could be required to pay to compensate those injured by our products.  In the event of a
recall, we have recall insurance.

Our Business May Be Affected By Changes in The Health Care Regulatory Environment

In  the  U.S.  and  internationally,  government  authorities  may  enact  changes  in  regulatory  requirements,  reform  existing
reimbursement programs, and/or make changes to patient access to health care, all of which could adversely affect the demand for
our  products  and/or  put  downward  pressure  on  our  prices.    Future  health  care  rulemaking  could  affect  our  business.    We  cannot
predict the timing or impact of any future rulemaking or changes in the law.

Item 1B. Unresolved Staff Comments.

Not applicable and none.

Item 2. Properties.

Our  headquarters  is  located  at  511  Lobo  Lane,  on  35  acres,  which  we  own,  overlooking  Lake  Lewisville  in  Little  Elm,
Texas.  The headquarters is in good condition and houses our administrative offices and manufacturing facility.  The manufacturing
facility produced approximately 17.4% of the units that were manufactured in 2017.  In the event that we become unable to purchase
product from our Chinese manufacturers, we would need to find an alternate manufacturer for the blood collection set, IV catheter,
Patient Safe  syringe, 0.5mL insulin syringe, 0.5mL autodisable syringe, and 2mL, 5mL, and 10mL syringes and we would increase
domestic production for the 1mL and 3mL syringes.  The 5mL and 10mL syringes are sold principally in the international market.  In
2017, we used approximately 15% of our current U.S. productive capacity.

®

A loan in the original principal amount of approximately $4,210,000 is secured by our land and buildings.  See Note 7 to our

financial statements for more information.

In the opinion of Management, the property and equipment are suitable for their intended use and are adequately covered by

an insurance policy.

Item 3. Legal Proceedings.

In  May  2010,  our  and  Mr.  Shaw’s  suit  against  BD  in  the  U.S.  District  Court  for  the  Eastern  District  of  Texas,  Marshall
Division  alleging  violations  of  antitrust  acts,  false  advertising,  product  disparagement,  tortious  interference,  and  unfair  competition
was reopened.  The trial commenced on September 9, 2013 in the U.S. District Court for the

7

Table of Contents

Eastern District of Texas, Tyler Division, and the jury found that BD illegally engaged in anticompetitive conduct with the intent to
acquire or maintain monopoly power in the safety syringe market and engaged in false advertising under the Lanham Act.  The jury
awarded  us  $113,508,014  in  damages,  which  was  trebled  pursuant  to  statute.    The  Court  granted  injunctive  relief  to  take  effect
January  15,  2015  including,  among  other  things,  a  requirement  to  notify  certain  customers  and  others  regarding  misleading
disclosures.    In  connection  with  BD’s  subsequent  appeal,  on  December  2,  2016,  the  United  States  Court  of Appeals  for  the  Fifth
Circuit  overturned  the  antitrust  damages.    The  finding  of  false  advertising  liability  was  affirmed  and  the  case  was  remanded  to  the
Eastern District of Texas for a redetermination as to the amount of damages to which we are entitled.  On August 17, 2017, District
Court for the Eastern District of Texas issued the Court’s Final Judgment ordering that we take nothing in our suit against BD and
dismissing the case.  We filed a notice of Appeal with the United States Court of Appeals for the Fifth Circuit on November 3, 2017.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In  September  2007,  BD  and  MDC  Investment  Holdings,  Inc.  (“MDC”)  sued  us  in  the  United  States  District  Court  for  the
Eastern  District  of  Texas,  Texarkana  Division,  initially  alleging  that  we  are  infringing  two  U.S.  patents  of  MDC  (6,179,812  and
7,090,656)  that  are  licensed  to  BD.    BD  and  MDC  seek  injunctive  relief  and  unspecified  damages.    We  counterclaimed  for
declarations  of  non-infringement,  invalidity,  and  unenforceability  of  the  asserted  patents.    The  plaintiffs  subsequently  dropped
allegations with regard to patent no. 7,090,656 and we subsequently dropped our counterclaims for unenforceability of the asserted
patents.    On  June  30,  2015,  the  Court  ordered  that  further  proceedings  in  this  matter  be  stayed  and  that  this  case  remain
administratively  closed  until  resolution  of  all  appeals  in  the  case  detailed  in  the  preceding  paragraph.    The  case  remains  stayed  as  a
result of the ongoing proceedings regarding the claims in the separate proceeding described above.

Item 4. Mine Safety Disclosures.

Not applicable.

PART II

Item 5.  Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities.

MARKET INFORMATION

Our  Common  Stock  has  been  listed  on  the  NYSE American  (or  its  predecessor  entities)  under  the  symbol  “RVP”  since
May 4, 2001.  Our closing price on March 1, 2018, was $0.90 per share.  Shown below are the high and low sales prices of our
Common Stock as reported by the NYSE American for each quarter of the last two fiscal years:

2017
Fourth Quarter
Third Quarter
Second Quarter
First Quarter

2016
Fourth Quarter
Third Quarter
Second Quarter
First Quarter

SHAREHOLDERS

High

Low

0.80
1.48
1.33
1.26

2.74
2.79
2.90
3.15

$
$
$
$

$
$
$
$

0.58
0.54
0.92
0.88

0.88
2.10
2.13
2.10

Low

High

$
$
$
$

$
$
$
$

As of March 1, 2018, there were 32,666,454 shares of Common Stock held by 199 shareholders of record, not including

Cede & Co. participants or beneficial owners thereof.

8

Table of Contents

DIVIDENDS

We  have  not  ever  declared  or  paid  any  dividends  on  the  Common  Stock.    We  have  no  current  plans  to  pay  any  cash
dividends on the Common Stock.  We intend to retain all earnings, except those required to be paid to the holders of the Preferred
Stock  as  resources  allow,  to  support  operations  and  future  growth.    Dividends  on  Common  Stock  cannot  be  paid  so  long  as
preferred dividends are unpaid.  As of December 31, 2017, there was an aggregate of $11.3 million in preferred dividends in arrears. 
As of December 31, 2016, there was an aggregate of $10.8 million in preferred dividends in arrears.

EQUITY COMPENSATION PLAN INFORMATION

See Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

for a chart describing compensation plans under which equity securities are authorized.

STOCK PERFORMANCE GRAPH

The following graph compares the cumulative total return for our Common Stock from December 31, 2012 to December 31,
2017,  to  the  total  returns  for  the  Russell  Microcap   and  Becton,  Dickinson  and  Company  (or  “BDX”),  a  peer  issuer.    The  graph
assumes an investment of $100 in the aforementioned equities as of December 31, 2012, and that all dividends are reinvested.

®

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RECENT SALES OF UNREGISTERED SECURITIES

All 2017 sales of unregistered securities were previously included in Current Reports on Form 8-K.

PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS

Purchases  by  affiliate(s)  during  2017  were  not  repurchases  by  or  on  behalf  of  the  issuer.    Based  on  our  review,  affiliates

properly filed Section 16(a) beneficial ownership reports.

9

Table of Contents

Item 6. Selected Financial Data.

The  following  selected  financial  data  is  qualified  by  reference  to,  and  should  be  read  in  conjunction  with,  our  audited
financial statements and the notes to those statements and Management’s Discussion and Analysis of Financial Condition and Results
of  Operations  appearing  elsewhere  herein.    The  selected  Statements  of  Operations  data  presented  below  for  the  years  ended
December  31,  2014  and  2013  and  the  Balance  Sheet  data  as  of  December  31,  2015,  2014,  and  2013  have  been  derived  from  our
audited financial statements, which are not included herein.

(In thousands except for earnings per share, shares, and percentages)

Sales, net
Cost of sales
Gross profit
Total operating expenses
Loss from operations
Litigation proceeds
Interest and other income
Interest expense, net
Income (loss) before income taxes
Provision (benefit) for income taxes
Net income (loss)
Preferred Stock dividend requirements
Deemed capital contribution on extinguishment

of preferred stock

Income (loss) applicable to common

shareholders

Earnings (loss) per share — basic
Earnings (loss) per share — diluted
Weighted average shares outstanding — basic
Weighted average shares outstanding — diluted

Current assets
Current liabilities
Property, plant, and equipment, net
Total assets

$

$
$
$

$
$
$
$

As of and for the Years Ended December 31,
2015

2014

2016

$

2017

34,494
24,522
9,972
13,750
(3,778)
—
65
(211)
(3,924)
(188)
(3,736)
(705)

—

$

29,827
19,485
10,342
13,849
(3,507)
—
26
(213)
(3,694)
1
(3,695)
(705)

—

29,552
18,987
10,565
13,773
(3,208)
7,725
25
(220)
4,322
8
4,314
(709)

2,306

$

34,521
22,499
12,022
14,180
(2,158)
—
34
(223)
(2,347)
8
(2,355)
(915)

—

2013

30,785
20,475
10,310
16,241
(5,931)
—
39
(231)
(6,123)
91
(6,214)
(916)

—

(4,441) $
(0.14) $
(0.14) $

(4,400) $
(0.15) $
(0.15) $

31,958,121
31,958,121

29,354,437
29,354,437

5,911
0.21
0.20
27,822,593
29,481,294

26,608
7,900
11,353
38,155

$
$
$
$

26,677
7,172
12,092
38,779

$
$
$
$

30,811
8,096
11,468
42,294

(3,270) $
(0.12) $
(0.12) $

27,375,450
27,375,450

(7,130)
(0.26)
(0.26)
26,999,698
26,999,698

33,983
15,100
10,853
45,106

$
$
$
$

37,660
16,621
10,910
48,850

$

$
$
$

$
$
$
$

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Long-term debt, net of current maturities
Stockholders’ equity
Redeemable Preferred Stock (in shares)
Capital leases
Cash dividends per common share
Gross profit margin

$
$

$

3,081
27,174
781,445
—
—
28.9%

$
$

$

10

3,498
28,108
781,445
—
—
34.7%

$
$

$

3,417
30,781
781,445
—
—
35.8%

$
$

$

3,425
26,581
987,445
—
—
34.8%

$
$

$

3,577
28,653
994,945
—
—
33.5%

Table of Contents

Events that could affect the trends indicated above include changes in manufacturing costs, changing average sales prices,
changing  raw  material  cost,  the  gaining  of  market  access,  protection  of  our  patents,  foreign  currency  exchange  rates,  the  Medical
Device Excise Tax, the impact of flu season requirements, new or changing regulations or changes in trade policy, or new products. 
As our products are made from petroleum products, the changing cost of oil and transportation may have an impact on our costs to
the  extent  increases  may  not  be  recoverable  through  price  increases  of  our  products  and  reductions  in  oil  prices  may  not  quickly
affect petroleum product prices.  Our purchase of 200,000 shares of our Preferred Stock in 2015 reduced Preferred Stock Dividend
Requirements.  The receipt of $7,724,826 from BD pursuant to litigation affects both the current assets and current liabilities in 2013
and 2014.  The recognition of the $7,724,826 in the second quarter of 2015 had a significant impact on 2015 income.  The Medical
Device Excise Tax had an effect on our financials in 2013 through 2015.  The medical device excise tax is suspended until January 1,
2020.    In  2014,  we  took  steps  to  decrease  legal  and  compensation  costs.    Legal  expenses  were  further  reduced  in  2017.    Some
increases in compensation were instituted in 2016 and 2017, both for existing employees and new hires.  In 2016, we had charges for
impairment  of  assets.    In  2017,  the  mix  of  international  and  domestic  sales,  stock  option  expense,  bonuses,  the  receipt  and  use  of
insurance proceeds to repair our buildings, and Mr. Shaw’s private purchase of stock affected comparability to prior years.

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation.

FORWARD-LOOKING STATEMENT WARNING

Certain  statements  included  by  reference  in  this  filing  containing  the  words  “could,”  “may,”  “believes,”  “anticipates,”
“intends,”  “expects,”  and  similar  such  words  constitute  forward-looking  statements  within  the  meaning  of  the  Private  Securities
Litigation Reform Act.  Any forward-looking statements involve known and unknown risks, uncertainties, and other factors that may
cause  our  actual  results,  performance,  or  achievements  to  be  materially  different  from  any  future  results,  performance,  or
achievements expressed or implied by such forward-looking statements.  Such factors include, among others, our ability to maintain
liquidity,  our  maintenance  of  patent  protection,  the  impact  of  current  and  future  Court  decisions  regarding  current  litigation,  our
ability to maintain favorable third party manufacturing and supplier arrangements and relationships, foreign  trade  risk,  our  ability  to
quickly  increase  capacity  in  response  to  an  increase  in  demand,  our  ability  to  access  the  market,  our  ability  to  maintain  or  lower
production costs, our ability to continue to finance research and development as well as operations and expansion of production, the
impact of larger market players, specifically BD, in providing devices to the safety market, and other factors referenced in Item 1A.
Risk Factors.  Given these uncertainties, undue reliance should not be placed on forward-looking statements.

Overview

We  have  been  manufacturing  and  marketing  our  products  since  1997.    Safety  syringes  comprised  89.9%  of  our  sales  in
®
2017.    We  also  manufacture  and  market  the  EasyPoint
,  blood  collection  tube  holder,  IV  safety  catheter,  and  VanishPoint Blood
Collection  Set.    We  currently  provide  other  safety  medical  products  in  addition  to  safety  products  utilizing  retractable  technology. 
One  such  product  is  the  Patient  Safe   syringe,  which  is  uniquely  designed  to  reduce  the  risk  of  bloodstream  infections  associated
with catheter hub contamination.

® 

®

In the second quarter of 2016, we began selling the EasyPoint  needle.  EasyPoint needles  made  up  6.0%  of  revenues  in
2017.  The EasyPoint  is a retractable needle that can be used with Luer lock syringes, Luer slip syringes, and prefilled syringes to
®
give  injections.    The  EasyPoint   needle  can  also  be  used  to  aspirate  fluids  and  collect  blood.    Based  on  industry-wide  trends,  we
anticipate that demand may increase for the EasyPoint  needle.

®

®

® 

®

Historically,  unit  sales  have  increased  in  the  latter  part  of  the  year  due,  in  part,  to  the  demand  for  syringes  during  the  flu

season.

Our  products  have  been  and  continue  to  be  distributed  nationally  and  internationally  through  numerous  distributors. 
Although we have made limited progress in some areas, such as the alternate care market, our volumes are not as high as they should
be  given  the  nature  and  quality  of  our  products  and  the  federal  and  state  legislation  requiring  the  use  of  safe  needle  devices.  The
alternate  care  market  is  composed  of  facilities  that  provide  long-term  nursing  and  out-patient  surgery,  emergency  care,  physician
services, health clinics, and retail pharmacies.

11

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We  continue  to  pursue  various  strategies  to  have  better  access  to  the  hospital  market,  as  well  as  other  markets,  including
attempting  to  gain  access  to  the  market  through  our  sales  efforts,  our  innovative  technology,  introduction  of  new  products,  and,
when necessary, litigation.

We  have  reported  in  the  past  that  our  progress  is  limited  principally  due  to  the  practices  engaged  in  by  BD,  the  dominant
maker and seller of disposable syringes.  We initiated an antitrust and false advertising lawsuit in 2007 against BD.  Although a district
court  judgment  in  2015  awarded  us  $340  million  in  antitrust  damages  from  BD  and  the  Fifth  Circuit  affirmed  a  finding  of  false
advertising liability against BD, we were ultimately awarded a take nothing judgment in August 2017 and the case was dismissed.  We
have filed for appeal.

Our litigation expenses were significantly less in 2017 than previous years and we have expanded our sales and marketing
staff in an effort to gain market share.  Costs related to additional compensation, bonuses to Ms. Larios and Mr. Cowan, and stock
option expense related to options granted in 2016 affected 2017 results.

In  January  2018,  Congress  imposed  another  two-year  moratorium  on  the  2.3%  medical  device  excise  tax  imposed  by

Internal Revenue Code section 4191.  Thus, the medical device excise tax will not go into effect until January 1, 2020.

In 2016, we granted a right to three of our executive officers to purchase shares directly from the Company.  Thomas J.
Shaw exercised such right on January 12, 2017, buying two million shares at market price for an aggregate purchase price of $1.78
million and purchased one million shares at market price on August 23, 2017 for an aggregate purchase price of $570,100.

We  received  approximately  $1  million  from  our  insurance  carrier  in  the  second  quarter  of  2017  and  used  these  funds  to

repair our buildings from earlier storm damage.

Product  purchases  from  our  Chinese  manufacturers  have  enabled  us  to  increase  manufacturing  capacity  with  little  capital
outlay  and  have  provided  a  competitive  manufacturing  cost.    In  2017,  our  primary  Chinese  manufacturer  produced  approximately
90.4% of our VanishPoint syringes.  In the event that we become unable to purchase products from our Chinese manufacturers, we
would need to find an alternate manufacturer for the blood collection set, IV catheter, Patient Safe  syringe, 0.5mL insulin syringe,
0.5mL autodisable syringe, and 2mL, 5mL, and 10mL syringes and we would increase domestic production for the 1mL and 3mL
syringes.

® 

®

In  1995,  we  entered  into  a  license  agreement  with  Thomas  J.  Shaw  for  the  exclusive  right  to  manufacture,  market,  and
distribute products utilizing automated retraction technology.  This technology is the subject of various patents and patent applications
owned by Mr. Shaw.  The license agreement generally provides for quarterly payments of a 5% royalty fee on gross sales.

With increased volumes, our manufacturing unit costs have generally tended to decline.  Factors that could affect our unit
costs  include  increases  in  costs  by  third  party  manufacturers,  changing  production  volumes,  costs  of  petroleum  products,  and
transportation costs.  Increases in such costs may not be recoverable through price increases of our products.

RESULTS OF OPERATIONS

The  following  discussion  contains  trend  information  and  other  forward-looking  statements  that  involve  a  number  of  risks
and uncertainties.  Our actual future results could differ materially from our historical results of operations and those discussed in the
forward-looking  statements.   All  period  references  are  to  our  fiscal  years  ended  December  2017,  2016,  or  2015.    Dollar  amounts
have been rounded for ease of reading.

Comparison of Year Ended
December 31, 2017 and Year Ended December 31, 2016

Domestic  sales  accounted  for  78.3%  and  88.2%  of  the  revenues  in  2017  and  2016,  respectively.    Domestic  revenues

increased 2.7% principally due to increased sales of EasyPoint and the blood collection set.  Domestic unit

® 

12

Table of Contents

sales  increased  7.1%.    Domestic  unit  sales  were  69.5%  of  total  unit  sales  for  2017.    International  revenues  increased  from  $3.5
million  in  2016  to  $7.5  million  in  2017,  primarily  due  to  increased  volumes  mitigated  by  lower  average  prices.    Overall  unit  sales
increased  28.3%.    Our  international  orders  may  be  subject  to  significant  fluctuation  over  time.    Such  orders  may  fluctuate  due  to
health initiatives at various times as well as economic conditions.

Cost  of  manufactured  product  increased  $4.7  million  principally  due  to  higher  volumes.    Royalty  expense  increased  $337
thousand due to increased gross sales.  Gross profit margins decreased from 34.7% in 2016 to 28.9% in 2017 principally due to a
larger portion of international sales which bear a lower average sales price.

Operating expenses decreased 0.7% from the prior year due to decreased legal expenses and no impairment costs incurred in

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2017, offset by increased staffing in Sales and marketing, stock option expense, and bonuses paid in 2017.

The loss from operations was $3.8 million in 2017 compared to $3.5 million in 2016.

We recorded $188 thousand in tax benefits in connection with the enactment of the Tax Cut and Jobs Act (the “Act”) on
December  22,  2017.    The Act  establishes  new  tax  provisions  that  affect  us  including  the  elimination  of  the  corporate  alternative
minimum  tax  and  changing  rules  related  to  uses  and  limitations  of  net  operating  loss  carry  forwards  created  after  December  31,
2017.  Carry forward credits from alternative minimum taxes paid in prior years are now refundable in tax years beginning January 1,
2018.

Cash flow from operations was a negative $2.9 million for 2017 due to our Net loss, increased accounts receivable and other
current assets, mitigated by noncash expenses of depreciation and stock option expense, lower inventory levels, increased liabilities,
and insurance proceeds.

Comparison of Year Ended
December 31, 2016 and Year Ended December 31, 2015

Domestic  sales  accounted  for  88.2%  and  77.9%  of  the  revenues  in  2016  and  2015,  respectively.    Domestic  revenues
increased  14.2%  principally  due  to  sales  of  our  1  mL  syringe  and  EasyPoint needles.    Domestic  unit  sales  increased  15.6%. 
Domestic  unit  sales  were  83.3%  of  total  unit  sales  for  2016.    International  revenues  decreased  from  $6.5  million  in  2015  to  $3.5
million in 2016, primarily due to fluctuation in the timing of orders.  Overall unit sales decreased 7.0%.  Our international orders may
be  subject  to  significant  fluctuation  over  time.    Such  orders  may  fluctuate  due  to  health  initiatives  at  various  times  as  well  as
economic conditions.

® 

Cost  of  manufactured  product  increased  $448  thousand  principally  due  to  higher  manufacturing  costs.    Royalty  expense

increased $50 thousand due to increased gross sales.  Gross profit margins decreased from 35.8% in 2015 to 34.7% in 2016.

Operating  expenses  increased  0.6%  from  the  prior  year  due  to  an  impairment  charge  of  $456  thousand,  stock  option
expense,  consulting  costs,  and  401(k)  plan  matching  expense.    The  impairment  charge  of  $456  thousand  was  related  to  Patient
Safe   assembly  equipment.    These  expenses  were  largely  offset  by  decreases  in  the  Medical  Device  Excise  tax  of  $360  thousand,
severance pay, professional fees, and bonus pay.

®

A  non-recurring  recognition  of  $7.7  million  received  from  BD  in  the  second  quarter  of  2015  pursuant  to  a  patent
infringement  case  had  a  significant  impact  on  2015  income.    Recognizing  this  payment  also  significantly  decreased  2015  current
liabilities on the Balance Sheets.

In 2015, earnings per share was positively affected by our acquisition of 200,000 shares of IV Class B convertible preferred
stock. Under the guidelines of ASC 260-10-S99-2, Effect on the Calculation of Earnings per Share for the Redemption or Induced
Conversion  of  Preferred  Stock ,  we  reflected  the  gain  on  extinguishment  of  this  preferred  stock  in  net  income  per  common
stockholder  used  to  calculate  earnings  per  share.    This  accounting  treatment  had  the  effect  of  increasing  the  income  applicable  to
common shareholders by $2.3 million in 2015 which had a material effect on the determination of earnings per share for that year.

The loss from operations was $3.2 million in 2015 compared to an operating loss of $3.5 million in 2016.

13

Table of Contents

Cash  flow  from  operations  was  a  negative  $795  thousand  for  2016  due  to  our  Net  loss,  mitigated  by  noncash  expense

consisting principally of depreciation, impairment of assets, share based compensation, and reduced working capital.

LIQUIDITY AND CAPITAL RESOURCES

At  the  present  time,  Management  does  not  intend  to  publicly  raise  equity  capital.    Due  to  the  funds  received  from  prior
litigation, we have sufficient cash reserves and intend to rely on operations, cash reserves, and debt financing, when available, as the
primary ongoing sources of cash. Our ability to obtain additional funds through loans is uncertain.

Historical Sources of Liquidity

We have historically funded operations primarily from the proceeds from revenues, private placements, litigation settlements,

and loans.

Internal Sources of Liquidity

Margins and Market Access

To routinely achieve positive or break even quarters, we need increased access to hospital markets which has been difficult

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
to obtain.  We will continue to attempt to gain access to the market through our sales efforts, innovative technology, the introduction
of new products, and, when necessary, litigation.

We continue to focus on methods of upgrading our manufacturing capability and efficiency in order to reduce costs.

Fluctuations  in  the  cost  and  availability  of  raw  materials  and  inventory  and  our  ability  to  maintain  favorable  manufacturing
arrangements and relationships could result in the need to manufacture all (as opposed to 17.1%) of our products in the U.S.  This
could temporarily increase unit costs as we ramp up domestic production.

®

The mix of domestic and international sales affects the average sales price of our products.  Generally, the higher the ratio of
domestic  sales  to  international  sales,  the  higher  the  average  sales  price  will  be.    Typically,  large  international  sales  of
VanishPoint   products  are  shipped  directly  from  China  to  the  customer.    Purchases  of  product  manufactured  in  China  usually
decrease the average cost of manufacture for all units.  The number of units produced by us versus manufactured in China can have
a significant effect on the carrying costs of Inventory as well as Cost of sales.  We will continue to evaluate the appropriate mix of
products  manufactured  domestically  and  those  manufactured  in  China  to  achieve  economic  benefits  as  well  as  to  maintain  our
domestic manufacturing capability.

Seasonality

Historically, unit sales have increased during the flu season.

Cash Requirements

Due to funds received from prior litigation, we have sufficient cash reserves and intend to rely on operations, cash reserves,
and debt financing, when available, as the primary ongoing sources of cash.  We have taken steps to decrease our legal costs and we
continue to evaluate these costs.  In the future, if such cost cutting measures prove insufficient, we may reduce the number of units
being  produced,  reduce  the  workforce,  reduce  the  salaries  of  officers  and  other  employees,  and/or  defer  royalty  payments.    Some
increases in compensation were made in 2016 and 2017.

External Sources of Liquidity

We have obtained several loans since our inception, which have, together with the proceeds from the sales of equities and

litigation efforts, enabled us to pursue development and production of our products.  Our ability to

14

Table of Contents

obtain additional funds through loans is uncertain.  Due to the current market price of our Common Stock, it is unlikely we would
choose  to  raise  funds  by  the  public  sale  of  equity.    We  granted  a  right  to  three  of  our  executive  officers  to  engage  in  private
purchases  of  stock  at  market  prices.    Thomas  J.  Shaw  exercised  such  right  on  January  12,  2017,  buying  two  million  shares  at
market price for an aggregate purchase price of $1.78 million and purchased one million shares at market price on August 23, 2017
for an aggregate purchase price of $570,100.

Capital Resources

In  2017,  we  received  approximately  $1  million  to  make  necessary  repairs  to  our  buildings  from  storm  damage  and  have
utilized more than half of such amount to date. We expect that the remaining insurance proceeds will be sufficient to cover all future
related repairs.

OFF-BALANCE SHEET ARRANGEMENTS

None.

CONTRACTUAL OBLIGATIONS

Contractual Obligations and Commercial Commitments

The  following  chart  summarizes  our  material  obligations  and  commitments  to  make  future  payments  under  contracts  for

long-term debt and operating leases as of December 31, 2017:

Contractual Obligations
Long-term debt
Operating leases

Payments Due by Period

Total

Less
Than
1 Year

1-3
Years

3-5
Years

More
Than 5
Years

$ 3,849,792
245,180

$

606,418
79,331

$ 3,243,374
165,849

$

$

—
—

—
—

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
Total

$ 4,094,972 

$

685,749 

$ 3,409,223 

$

— 

$

— 

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

We  believe  that  our  market  risk  exposures  regarding  our  cash  and  cash  equivalents  are  immaterial  as  we  do  not  have
instruments  for  trading  purposes.   Additionally,  reasonable,  possible  near-term  changes  in  market  rates  or  prices  will  not  result  in
material changes in near-term earnings.

15

Table of Contents

Item 8. Financial Statements and Supplementary Data.

RETRACTABLE TECHNOLOGIES, INC.

FINANCIAL STATEMENTS AND
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

DECEMBER 31, 2017 AND 2016

F-1

Table of Contents

RETRACTABLE TECHNOLOGIES, INC.
INDEX TO FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm

Financial Statements:

Balance Sheets as of December 31, 2017 and 2016

Statements of Operations for the years ended December 31, 2017, 2016, and 2015

Statements of Changes in Stockholders’ Equity for the years ended December 31, 2017, 2016, and 2015

Statements of Cash Flows for the years ended December 31, 2017, 2016, and 2015

Notes to Financial Statements

Selected Quarterly Financial Data - Unaudited

Financial Statement Schedule:

Schedule II: Schedule of Valuation and Qualifying Accounts for the years ended December 31, 2017, 2016, and

2015

Table of Contents

F-2

Report of Independent Registered Public Accounting Firm

To the Stockholders and the Board of Directors of
Retractable Technologies, Inc.

Opinion on the Financial Statements

Page

F-3

F-4

F-5

F-6

F-8

F-9

F-25

32

We have audited the accompanying balance sheets of Retractable Technologies, Inc. (the “Company”) as of December 31, 2017 and
2016, the related statements of operations, changes in stockholders’ equity, and cash flows for each of the three years in the period

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ended December 31, 2017, and the related notes and schedules (collectively referred to as the “financial statements”). In our opinion,
the  financial  statements  present  fairly,  in  all  material  respects,  the  financial  position  of  the  Company  as  of  December  31,  2017  and
2016,  and  the  results  of  its  operations  and  its  cash  flows  for  each  of  the  three  years  in  the  period  ended  December  31,  2017,  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
audit 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 to 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.

/s/ Moss Adams LLP

Dallas, TX
April 2, 2018

We have served as the Company’s auditor since 2016.

F-3

Table of Contents

RETRACTABLE TECHNOLOGIES, INC.
BALANCE SHEETS

ASSETS
Current assets:

December 31,

2017

2016

Cash and cash equivalents
Accounts receivable, net of allowance for doubtful accounts of $101,872 and $1,731,985,

$

14,877,899

$

16,199,043

respectively
Inventories, net
Other current assets

Total current assets

Property, plant, and equipment, net
Income taxes receivable
Other assets

Total assets

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:

Accounts payable
Current portion of long-term debt
Accrued compensation
Dividends payable
Accrued royalties to shareholder
Insurance proceeds
Other accrued liabilities
Income taxes payable

Total current liabilities

$

$

5,105,556
6,206,161
418,154
26,607,770

11,353,202
188,456
6,052
38,155,480

4,957,750
410,949
547,021
55,113
793,489
466,293
657,923
11,407
7,899,945

$

$

3,267,838
7,017,224
192,548
26,676,653

12,092,037
—
10,289
38,778,979

4,471,756
430,393
536,456
55,113
659,443
—
1,008,699
10,584
7,172,444

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
 
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
   
   
 
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Long-term debt, net of current maturities

Total liabilities

Commitments and contingencies — See Note 8

Stockholders’ equity:

Preferred Stock, $1 par value:
Class B; authorized: 5,000,000 shares

Series I, Class B; outstanding: 98,500 shares (liquidation preference of $615,625)
Series II, Class B; outstanding: 171,200 shares (liquidation preference of $2,140,000)
Series III, Class B; outstanding: 129,245 shares (liquidation preference of $1,615,563)
Series IV, Class B; outstanding: 342,500 shares (liquidation preference of $3,767,500)
Series V, Class B; outstanding: 40,000 (liquidation preference of $176,000)
Common Stock, no par value; authorized: 100,000,000 shares; outstanding: 32,666,454

and 29,666,454, respectively

Additional paid-in capital
Accumulated deficit

Total stockholders’ equity
Total liabilities and stockholders’ equity

See accompanying notes to financial statements

F-4

3,081,409
10,981,354

3,498,244
10,670,688

98,500
171,200
129,245
342,500
40,000

98,500
171,200
129,245
342,500
40,000

—
62,092,206
(35,699,525)
27,174,126
38,155,480

—
59,290,333
(31,963,487)
28,108,291
38,778,979

$

$

Table of Contents

RETRACTABLE TECHNOLOGIES, INC.
STATEMENTS OF OPERATIONS

Sales, net
Cost of Sales

Costs of manufactured product
Royalty expense to shareholders

Total cost of sales

Gross profit

Operating expenses:

Sales and marketing
Research and development
General and administrative
Impairment of assets

Total operating expenses
Loss from operations

Litigation proceeds

Interest and other income
Interest expense, net
Income (loss) before income taxes
Provision (benefit) for income taxes

Net income (loss)
Preferred Stock dividend requirements
Deemed capital contribution on extinguishment of preferred stock

Income (loss) applicable to common shareholders

Basic earnings (loss) per share

Diluted earnings (loss) per share

Weighted average common shares outstanding:

Basic
Diluted

$

$

$

$

2017
34,493,838

Years Ended December 31,
2016
29,826,636

$

$

21,658,062
2,864,188
24,522,250
9,971,588

4,658,548
740,567
8,351,053
—
13,750,168
(3,778,580)

16,957,073
2,527,508
19,484,581
10,342,055

4,025,786
571,842
8,795,310
456,119
13,849,057
(3,507,002)

2015
29,552,200

16,509,446
2,477,583
18,987,029
10,565,171

3,837,491
607,527
9,328,029
—
13,773,047
(3,207,876)

—

—

7,724,826

65,695
(210,761)
(3,923,646)
(187,608)
(3,736,038)
(704,996)
—

26,522
(213,295)
(3,693,775)
1,132
(3,694,907)
(704,996)
—

(4,441,034) $

(4,399,903) $

(0.14) $

(0.15) $

(0.14) $

(0.15) $

24,917
(219,672)
4,322,195
7,877
4,314,318
(709,351)
2,305,678
5,910,645

0.21

0.20

31,958,121
31,958,121

29,354,437
29,354,437

27,822,593
29,481,294

 
 
  
  
 
 
 
 
 
 
 
 
  
  
 
   
   
 
 
  
  
 
   
   
 
   
   
 
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
  
  
  
 
 
 
 
  
  
  
 
   
   
   
 
 
 
 
 
 
 
 
 
See accompanying notes to financial statements

F-5

Table of Contents

RETRACTABLE TECHNOLOGIES, INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

Balance as of

December 31, 2014  

Conversion of Preferred

Stock into
Common Stock

Stock options exercised 

Issuance of new

Common Stock

Registration of new

shares

Retirement of treasury

stock

Dividends

Net income

Balance as of

December 31, 2015  

Stock options exercised 

Dividends

Stock option

compensation

Net loss

Balance as of

December 31, 2016  

Issuance of new

Common Stock

Dividends

Stock option

compensation

Net loss

Balance as of

December 31, 2017  

Series I Class B

  Shares   Amount

Series II Class B
  Shares   Amount

Series III Class B
  Shares   Amount

Series IV Class B

Shares

  Amount

Series V Class B
  Shares   Amount

Common

Shares

  Amount  

98,500  $

98,500 

176,200  $

176,200 

130,245  $

130,245 

542,500  $

542,500 

40,000  $

40,000 

27,613,397  $

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

(5,000)

(5,000)

(1,000)

(1,000)

(200,000)

(200,000)

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

206,000 

272,477 

528,000 

— 

— 

— 

— 

98,500 

98,500 

171,200 

171,200 

129,245 

129,245 

342,500 

342,500 

40,000 

40,000 

28,619,874 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

1,046,580 

— 

— 

— 

98,500 

98,500 

171,200 

171,200 

129,245 

129,245 

342,500 

342,500 

40,000 

40,000 

29,666,454 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

3,000,000 

— 

— 

— 

98,500

$

98,500

171,200

$

171,200

129,245

$

129,245

342,500

$

342,500

40,000

$

40,000

32,666,454

$

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

—

See accompanying notes to financial statements

F-6

Table of Contents

RETRACTABLE TECHNOLOGIES, INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

Additional
Paid-in
Capital

Accumulated
Deficit

Treasury
Stock

Total

Balance as of December 31, 2014

$

59,273,769

$

(32,582,898) $

(1,096,609) $

26,581,707

Conversion of Preferred Stock into Common Stock

Stock options exercised

Issuance of new Common Stock

206,000

283,933

—

—

—

—

—

—

—

—

283,933

—

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
Registration of new shares

Retirement of treasury stock

Dividends

Net income

(60,101)

(1,096,609)

(338,956)

—

—

—

—

4,314,318

Balance as of December 31, 2015

58,268,036

(28,268,580)

Stock options exercised

Dividends

Stock option compensation

Net loss

855,021

(220,450)

387,726

—

—

—

—

(3,694,907)

Balance as of December 31, 2016

59,290,333

(31,963,487)

Issuance of new Common Stock

Dividends

Stock option compensation

Net loss

2,350,100

(220,450)

672,223

—

—

—

—

(3,736,038)

—

(60,101)

1,096,609

—

—

—

—

—

—

—

—

—

—

—

—

(338,956)

4,314,318

30,780,901

855,021

(220,450)

387,726

(3,694,907)

28,108,291

2,350,100

(220,450)

672,223

(3,736,038)

Balance as of December 31, 2017

$

62,092,206

$

(35,699,525) $

—

$

27,174,126

See accompanying notes to financial statements

F-7

Table of Contents

RETRACTABLE TECHNOLOGIES, INC.
STATEMENTS OF CASH FLOWS

Cash flows from operating activities:
Net income (loss)
Adjustments to reconcile net income (loss) to net cash provided (used) by

2017

Years Ended December 31,
2016

2015

$

(3,736,038) $

(3,694,907) $

4,314,318

operating activities:
Depreciation and amortization
Share-based compensation
Inventories reserve
Provision for doubtful accounts
Impairment of assets
(Increase) decrease in assets:

Inventories
Accounts receivable
Other current assets
Income taxes receivable
Other assets

Increase (decrease) in liabilities:

Accounts payable
Litigation proceeds subject to stipulation
Other accrued liabilities
Income taxes payable
Insurance proceeds

Net cash used by operating activities

Cash flows from investing activities:

Purchase of property, plant, and equipment

834,951
672,223
—
24,272
—

811,063
(1,861,990)
(225,606)
(188,456)
—

485,994
—
(205,342)
—
466,293
(2,922,636)

872,868
387,726
176,424
92,000
456,119

(897,023)
1,541,159
1,375,484
—
(750)

(1,225,762)
—
119,342
2,408
—
(794,912)

858,391
—
—
116,395
—

(1,633,077)
624,699
(373,977)
—
—

554,722
(7,724,826)
11,312
(114)
—
(3,252,157)

(91,878)

(1,947,172)

(1,465,010)

 
 
  
  
  
  
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
  
  
  
  
 
 
   
 
 
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
   
 
 
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
   
   
   
 
Changes in restricted cash

Net cash used by investing activities

Cash flows from financing activities:

Repayments of long-term debt
Proceeds from long-term debt
Proceeds from sale of common stock
Proceeds from the exercise of stock options
Stock registration fees
Payment of Preferred Stock dividends
Net cash provided by financing activities

Net decrease in cash and cash equivalents
Cash and cash equivalents at:

Beginning of period
End of period

Supplemental schedule of cash flow information:

Interest paid
Income taxes paid

Supplemental schedule of noncash investing and financing activities:

Preferred dividends declared, not paid

— 
(91,878)

— 
(1,947,172)

600,897 
(864,113)

(436,280)
—
2,350,100
—
—
(220,450)
1,693,370

(263,200)
525,017
—
855,021
—
(220,755)
896,083

(184,447)
276,495
—
283,933
(60,101)
(283,543)
32,337

(1,321,144)

(1,846,001)

(4,083,933)

16,199,043
14,877,899

210,761
1,031

55,113

$

$
$

$

$

$
$

$

18,045,044
16,199,043

213,295
2,000

55,113

$

$
$

$

22,128,977
18,045,044

219,672
3,700

55,414

See accompanying notes to financial statements

F-8

Table of Contents

NOTES TO FINANCIAL STATEMENTS

1.      BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION

Business of the Company

Retractable  Technologies,  Inc.  (the  “Company”)  was  incorporated  in  Texas  on  May  9,  1994,  and  designs,  develops,
manufactures,  and  markets  safety  syringes  and  other  safety  medical  products  for  the  healthcare  profession.    The  Company
began to develop its manufacturing operations in 1995.  The Company’s manufacturing and administrative facilities are located
®
in Little Elm, Texas.  The Company’s products are the VanishPoint
 0.5mL insulin syringe; 1mL tuberculin, insulin, and allergy
antigen syringes; 0.5mL, 1mL, 2mL, 3mL, 5mL, and 10mL syringes; the small diameter tube adapter; the blood collection tube
®
holder; the allergy tray; the IV safety catheter; the Patient Safe  syringes; the Patient Safe  Luer Cap; the VanishPoint Blood
Collection Set; and the EasyPoint  needle.  The Company also sells VanishPoint autodisable syringes in the international market
in addition to the Company’s other products.

® 

® 

®

®

 2.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Accounting estimates

The  preparation  of  financial  statements  in  conformity  with  U.S.  generally  accepted  accounting  principles  (“GAAP”)  requires
Management  to  make  estimates  and  assumptions  that  affect  the  reported  amounts  of  assets  and  liabilities  and  disclosure  of
contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
the reporting period.  Actual results could differ significantly from those estimates.

Cash and cash equivalents

For purposes of reporting cash flows, cash and cash equivalents include cash, money market accounts, and investments with
original maturities of three months or less.

Accounts receivable

The  Company  records  trade  receivables  when  revenue  is  recognized.    No  product  has  been  consigned  to  customers.    The
Company’s allowance for doubtful accounts is primarily determined by review of specific trade receivables.  Those accounts
that  are  doubtful  of  collection  are  included  in  the  allowance.    This  provision  is  reviewed  to  determine  the  adequacy  of  the
allowance  for  doubtful  accounts.    Trade  receivables  are  charged  off  when  there  is  certainty  as  to  their  being  uncollectible. 
Trade receivables are considered delinquent when payment has not been made within contract terms.

 
 
 
 
  
  
  
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
   
   
   
 
 
 
 
 
 
 
 
 
 
  
  
  
 
   
   
   
 
 
 
 
 
 
 
 
 
 
  
  
  
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The  Company  requires  certain  customers  to  make  a  prepayment  prior  to  beginning  production  or  shipment  of  their  order. 
Customers  may  apply  such  prepayments  to  their  outstanding  invoices  or  pay  the  invoice  and  continue  to  carry  forward  the
deposit for future orders.  Such amounts are included in Other accrued liabilities on the Balance Sheets and are shown in Note
6, Other Accrued Liabilities.

The Company records an allowance for estimated returns as a reduction to Accounts receivable and Gross sales.  Historically,
returns have been immaterial.

Inventories

Inventories are valued at the lower of cost or net realizable value, with cost being determined using actual average cost.  The
Company  compares  the  average  cost  to  the  net  realizable  value  and  records  the  lower  value.    Net  realizable  value  is  the
estimated  selling  price  in  the  ordinary  course  of  business,  less  reasonably  predictable  costs  of  completion,  disposal,  and
transportation.    Management  considers  such  factors  as  the  amount  of  inventory  on  hand  and  in  the  distribution  channel,
estimated time to sell such inventory, the shelf life of

F-9

Table of Contents

inventory,  and  current  market  conditions  when  determining  excess  or  obsolete  inventories.   A  reserve  is  established  for  any
excess or obsolete inventories or they may be written off.

Property, plant, and equipment

Property,  plant,  and  equipment  are  stated  at  cost.    Expenditures  for  maintenance  and  repairs  are  charged  to  operations  as
incurred.  Cost includes major expenditures for improvements and replacements which extend useful lives or increase capacity
and interest cost associated with significant capital additions.  Gains or losses from property disposals are included in income.

Depreciation and amortization are calculated using the straight-line method over the following useful lives:

Production equipment
Office furniture and equipment
Buildings
Building improvements

Long-lived assets

3 to 13 years
3 to 10 years
39 years
15 years

The Company assesses the recoverability of long-lived assets using an assessment of the estimated undiscounted future cash
flows related to such assets.  In the event that assets are found to be carried at amounts which are in excess of estimated gross
future  cash  flows,  the  assets  will  be  adjusted  for  impairment  to  a  level  commensurate  with  fair  value  determined  using  a
discounted cash flow analysis or appraised values of the underlying assets.

During  2016,  the  Company  recognized  an  impairment  charge  of  $456,119  associated  with  its  Patient  Safe   production
equipment.    The  Company  determined  it  was  more  cost  effective  to  outsource  this  production  through  an  overseas
manufacturer,  and  thus  the  Company’s  Patient  Safe   production  equipment  was  taken  out  of  service.    Minimal  cash  flows
were  expected  to  be  generated  by  this  equipment.    Accordingly,  the  Company  reduced  the  carrying  value  of  the  Patient
Safe  production equipment to an estimated fair value of zero.

®

®

®

The  Company’s  property,  plant,  and  equipment  primarily  consist  of  buildings,  land,  assembly  equipment,  molding  machines,
molds, office equipment, furniture, and fixtures.

Financial instruments

The Company estimates the fair value of financial instruments through the use of public market prices, quotes from financial
institutions,  and  other  available  information.    Judgment  is  required  in  interpreting  data  to  develop  estimates  of  fair  value  and,
accordingly, amounts are not necessarily indicative of the amounts that could be realized in a current market exchange.  Short-
term  financial  instruments,  including  cash  and  cash  equivalents,  accounts  receivable,  accounts  payable,  and  other  liabilities,
consist primarily of instruments without extended maturities, the fair value of which, based on Management’s estimates, equals
their  recorded  values.    The  fair  value  of  long-term  liabilities,  based  on  Management’s  estimates,  approximates  their  reported
values.

Concentration risks

The Company’s financial instruments exposed to concentrations of credit risk consist primarily of cash, cash equivalents, and
accounts  receivable.    Cash  balances,  some  of  which  exceed  federally  insured  limits,  are  maintained  in  financial  institutions;

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
however,  Management  believes  the  institutions  are  of  high  credit  quality.    The  majority  of  accounts  receivable  are  due  from
companies which are well-established entities.  As a consequence, Management considers any exposure from concentrations of
credit risks to be limited.

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Table of Contents

The following table reflects our significant customers in 2017, 2016, and 2015:

Number of significant customers
Aggregate dollar amount of net sales to significant customers
Percentage of net sales to significant customers

2017

Years Ended December 31,
2016

2
14.0 million

$

$

1
9.4 million

$

2015

2
13.5 million

40.5%

31.4%

45.7%

The Company decreased its allowance for doubtful accounts by approximately $1.6 million in 2017 due to a write-off of debit
rebates.

The Company manufactures syringes in Little Elm, Texas as well as utilizing manufacturers in China.  The Company purchases
most of its product components from single suppliers, including needle adhesives and packaging materials.  There are multiple
syringes  in  2017  from  its  primary
sources  of  these  materials.    The  Company  obtained  roughly  90.4%  of  its  VanishPoint
Chinese  manufacturer.    Purchases  from  this  Chinese  manufacturer  aggregated  86.3%  and  77.7%  of  VanishPoint
finished
products  in  2016  and  2015,  respectively.    In  the  event  that  the  Company  becomes  unable  to  purchase  products  from  its
Chinese  manufacturers,  the  Company  would  need  to  find  an  alternate  manufacturer  for  its  blood  collection  set,  IV  catheter,
Patient  Safe   syringe,  0.5mL  insulin  syringe,  0.5mL  autodisable  syringe,  and  2mL,  5mL,  and  10mL  syringes  and  would
increase domestic production for the 1mL and 3mL syringes.

® 

® 

®

Revenue recognition

Revenue  is  recognized  for  sales  when  title  and  risk  of  ownership  passes  to  the  customer,  generally  upon  shipment.    Under
certain  contracts,  revenue  is  recorded  on  the  basis  of  sales  price  to  distributors,  less  contractual  pricing  allowances. 
Contractual pricing allowances consist of: (i) rebates granted to distributors who provide tracking reports which show, among
other  things,  the  facility  that  purchased  the  products,  and  (ii)  a  provision  for  estimated  contractual  pricing  allowances  for
products for which the Company has not received tracking reports.  Rebates are recorded when issued and are applied against
the customer’s receivable balance.  Distributors receive a rebate for the difference between the Wholesale Acquisition Cost and
the appropriate contract price as reflected on a tracking report provided by the distributor to the Company. If product is sold by
a  distributor  to  an  entity  that  has  no  contract,  there  is  a  standard  rebate  (lower  than  a  contracted  rebate)  given  to  the
distributor.    One  of  the  purposes  of  the  rebate  is  to  encourage  distributors  to  submit  tracking  reports  to  the  Company.  The
provision  for  contractual  pricing  allowances  is  reviewed  at  the  end  of  each  quarter  and  adjusted  for  changes  in  levels  of
products for which there is no tracking report.  Additionally, if it becomes clear that tracking reports will not be provided by
individual distributors, the provision is further adjusted.  The estimated contractual allowance is included in Accounts payable in
the  Balance  Sheets  and  deducted  from  revenues  in  the  Statements  of  Operations.    Accounts  payable  included  estimated
contractual  allowances  for  $4,115,628  and  $3,591,534  as  of  December  31,  2017  and  2016,  respectively.    The  terms  and
conditions of contractual pricing allowances are governed by contracts between the Company and its distributors.  Revenue for
shipments directly to end-users is recognized when title and risk of ownership pass from the Company.  Any product shipped
or distributed for evaluation purposes is expensed.

The Company’s domestic return policy is set forth in its standard Distribution Agreement.  This policy provides that a customer
may return incorrect shipments within 10 days following arrival at the distributor’s facility.  In all such cases, the distributor
must obtain an authorization code from the Company and affix the code to the returned product.  The Company will not accept
returned goods without a returned goods authorization number.  The Company may refund the customer’s money or replace
the product.

The  Company’s  domestic  return  policy  also  generally  provides  that  a  customer  may  return  product  that  is  overstocked. 
Overstocking returns are limited to two times in each 12-month period up to 1% of distributor’s total purchase of products for
the prior 12-month period.  All product overstocks and returns are subject to inspection and acceptance by the Company.

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Table of Contents

The Company’s international distribution agreements generally do not provide for any returns.

Litigation proceeds

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Proceeds  from  litigation  are  recognized  when  realizable.    Generally,  realization  is  not  reasonably  assured  and  expected  until
proceeds are collected.

Income taxes

The  Tax  Cuts  and  Job  Act  (“the  Act”)  was  enacted  on  December  22,  2017,  and  the  U.S.  federal  corporate  tax  rate  was
reduced  from  35%  to  21%.    U.S.  generally  accepted  accounting  principles  require  companies  to  account  for  the  effects  of
changes in income tax rates and laws in the period the change is enacted. Financial results, including provisional amounts, have
been  calculated  for  the  income  tax  effects  of  the  change.  The  U.S.  Securities  and  Exchange  Commission  issued  Staff
Accounting Bulletin 118 (SAB 118) allowing companies to use provisioned estimates to record the effects of the Act.  SAB 118
allows companies to complete accounting for these effects no later than one year from the enactment date of the Act.

The Company evaluates tax positions taken or expected to be taken in a tax return for recognition in the financial statements
based  on  whether  it  is  “more-likely-than-not”  that  a  tax  position  will  be  sustained  based  upon  the  technical  merits  of  the
position.  Measurement of the tax position is based upon the largest amount of benefit that is greater than 50% likely of being
realized upon ultimate settlement.

The Company provides for deferred income taxes through utilizing an asset and liability approach for financial accounting and
reporting based on the tax effects of differences between the financial statement and tax bases of assets and liabilities, based on
enacted  rates  expected  to  be  in  effect  when  such  differences  reverse  in  future  periods.    Deferred  tax  assets  are  periodically
reviewed for realizability.  The Company has established a valuation allowance for its net deferred tax asset as future taxable
income cannot be reasonably assured.  Penalties and interest related to income tax are classified as General and administrative
expense and Interest expense, respectively, in the Statements of Operations.

Earnings per share

The Company computes basic earnings per share (“EPS”) by dividing net earnings for the period (adjusted for any cumulative
dividends  for  the  period)  by  the  weighted  average  number  of  common  shares  outstanding  during  the  period.    Diluted  EPS
includes  the  determinants  of  basic  EPS  and,  in  addition,  reflects  the  dilutive  effect,  if  any,  of  the  common  stock  deliverable
pursuant to stock options or common stock issuable upon the conversion of convertible preferred stock.  The calculation of
diluted  EPS  excluded  79,441  and  783,730  shares  of  Common  Stock  underlying  issued  and  outstanding  stock  options  at
December  31,  2017  and  December  31,  2016,  respectively,  as  their  effect  was  antidilutive.    The  potential  dilution,  if  any,  is
shown on the following schedule:

Net income (loss)
Preferred dividend requirements
Deemed capital contribution on extinguishment of preferred stock
Income (loss) applicable to common shareholders
Weighted average common shares outstanding
Weighted average common and common equivalent shares

outstanding - assuming dilution

Basic earnings (loss) per share
Diluted earnings (loss) per share

F-12

Table of Contents

2017
(3,736,038) $
(704,996)
—

Years Ended December 31,
2016
(3,694,907) $
(704,996)
—

(4,441,034) $
31,958,121

(4,399,903) $
29,354,437

31,958,121

29,354,437

(0.14) $
(0.14) $

(0.15) $
(0.15) $

$

$

$
$

2015
4,314,318
(709,351)
2,305,678
5,910,645
27,822,593

29,481,294
0.21
0.20

The  Financial  Accounting  Standards  Board  Accounting  Standards  Codification  260-10-S99-2,  Effect  on  the  Calculation  of
Earnings per Share for the Redemption or Induced Conversion of Preferred Stock, requires the gain or loss on extinguishment
of equity-classified preferred stock to be included in net income per common stockholder used to calculate earnings per share
(similar to the treatment of dividends paid on preferred stock). The difference between (1) the fair value of the consideration
transferred to the holders of the preferred stock and (2) the carrying amount of the preferred stock (net of issuance costs) is
subtracted from (or added to) net income to arrive at income available to common stockholders in the calculation of earnings
per share.  The Company has determined to apply this guidance to its accounting treatment of the preferred stock transaction
described in Note 18.  From a legal standpoint, the transaction was neither a redemption nor conversion pursuant of the terms
of the Certificate of Designation, Preferences, Rights and Limitations of the Series IV Class B Convertible Preferred Stock.

Shipping and handling costs

The Company classifies shipping and handling costs as part of Cost of sales in the Statements of Operations.

Research and development costs

Research and development costs are expensed as incurred.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Share-based compensation

The  Company’s  share-based  payments  are  accounted  for  using  the  fair  value  method.    The  Company  records  share-based
compensation  expense  on  a  straight-line  basis  over  the  requisite  service  period.    The  Company  incurred  the  following  share-
based compensation costs:

Cost of sales
Sales and marketing
Research and development
General and administrative

2017

Years Ended December 31,
2016

2015

$

$

272,811
143,255
45,174
210,983
672,223

$

$

141,782
77,583
23,623
144,738
387,726

$

$

—
—
—
—
—

Options awarded to employees in 2016 were amortized over twelve months.  The Company amortized four months’ expense
for options granted in September 2016 and amortized the remainder in 2017.  Non-employee Directors’ option expense was all
expensed in the fourth quarter of 2016.

The  Company  early-adopted  FASB  Accounting  Standards  Update  (“ASU”)  2016-09,  “Compensation  -  Stock  Compensation
(Topic 718): Improvements to Employee Share-Based Payment Accounting” for its annual period ended December 31, 2016.
This ASU  addresses  several  aspects  of  the  accounting  for  share-based  compensation  transactions  including:  (a)  income  tax
consequences when awards vest or are settled, (b) classification of awards as either equity or liabilities, (c) a policy election to
account  for  forfeitures  as  they  occur  rather  than  on  an  estimated  basis  and  (d)  classification  of  excess  tax  impacts  on  the
statement of cash flows.  As a result of adoption, excess tax benefits in 2016 resulting from the exercise of non-qualified stock
options  were  recognized  in  the  income  tax  provision  rather  than  in  additional-paid-in  capital.   As  there  were  previously  no
excess income tax benefits recognized in additional-paid-in capital or other material changes to the Company’s accounting for
share based compensation resulting from adoption of this ASU, no cumulative effect adjustments were required.

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Table of Contents

Insurance Proceeds

Receipts  from  insurance  up  to  the  amount  of  any  loss  recognized  by  the  Company  are  considered  recoveries.  Any  such
recoveries  are  recorded  when  they  are  received.    Insurance  recoveries  are  not  recognized  as  a  component  of  earnings  (loss)
from operations until all repairs are made.

Recent pronouncements

In  November  2016,  the  FASB  issued  ASU  2016-18,  “Statement  of  Cash  Flows  (Topic  230):  Restricted  Cash”.    These
amendments require that a statement of cash flows explain the change during the period in the total of cash, cash equivalents,
and amounts generally described as restricted cash or restricted cash equivalents. As a result, amounts generally described as
restricted  cash  and  restricted  cash  equivalents  should  be  included  with  cash  and  cash  equivalents  when  reconciling  the
beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The amendments do not provide a
definition of restricted cash or restricted cash equivalents. The updated guidance is effective for the Company’s quarter ending
March 31, 2018, with early adoption permitted.  The Company does not expect ASU 2016-18 to have a material effect on its
financial statements as the Company currently holds no restricted cash or restricted cash equivalents.

In  August  2016,  the  FASB  issued  ASU  2016-15,  “Statement  of  Cash  Flows  (Topic  230),  Classification  of  Certain  Cash
Receipts and Payments” (ASU 2016-15), clarifying guidance on the classification of certain cash receipts and payments in the
statement of cash flows.  This ASU is effective for the Company’s quarter ending March 31, 2018.  The Company does not
expect the adoption of ASU 2016-15 to have a material impact on its consolidated financial statements.

In  June  2016,  the  FASB  issued Accounting  Standards  Update  2016-13,  “Financial  Instruments  —Credit  Losses  (Topic  326):
Measurement of Credit Losses on Financial Instruments”.  Among other things, these amendments require the measurement of
all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and
reasonable and supportable forecasts.  Many of the loss estimation techniques applied today will still be permitted, although the
inputs  to  those  techniques  will  change  to  reflect  the  full  amount  of  expected  credit  losses.    This  ASU  is  effective  for  the
Company’s  quarter  ending  March  31,  2020  with  early  application  permitted  for  the  Company’s  quarter  ending  March  31,
2019.  The Company is currently assessing the impact that adoption of this guidance will have on its financial statements and
related disclosures.

In  February  2016,  the  FASB  issued ASU  No.  2016-02,  Leases  (topic  842).  Under  the  new ASU,  lessees  will  be  required  to
recognize the following for all leases (with the exception of short-term leases) at the commencement date: (1) a lease liability,
which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and (2) a right-of-

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term.
Under the new guidance lessor accounting is largely unchanged. The new lease guidance simplified the accounting for sale and
leaseback  transactions  primarily  because  lessees  must  recognize  lease  assets  and  lease  liabilities.  Lessees  (for  capital  and
operating  leases)  and  lessors  (for  sales-type,  direct  financing,  and  operating  leases)  must  apply  a  modified  retrospective
transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the
financial  statements.  The  modified  retrospective  approach  would  not  require  any  transition  accounting  for  leases  that  expired
before the earliest comparative period presented. This ASU is effective for the Company’s quarter ending March 31, 2019, with
early adoption permitted. The Company is currently evaluating the impact of this standard.

In  May  2014,  FASB  issued  ASU  No.  2014-09,  “Revenue  from  Contracts  with  Customers”,  which  provides  guidance  for
revenue recognition.  This ASU’s core principle is that a company will recognize revenue when it transfers promised goods or
services  to  customers  in  an  amount  that  reflects  consideration  to  which  the  company  expects  to  be  entitled  in  exchange  for
those  goods  or  services.    This ASU  also  requires  additional  disclosure  about  the  nature,  amount,  timing  and  uncertainty  of
revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments, and assets
recognized from costs incurred to obtain or fulfill a contract.  ASU No. 2014-09 allows for either full retrospective or modified
retrospective adoption.  In

F-14

Table of Contents

July 2015, the FASB voted to delay the effective date of this ASU by one year.  The ASU will now be effective commencing
with  the  Company’s  quarter  ending  March  31,  2018.    Early  adoption  of  this  ASU  is  allowed  no  sooner  than  the  original
effective date.  Management’s assessment is that the implementation of the amended guidance will not have a material impact
on  the  Company’s  balance  sheet,  statements  of  operations,  changes  in  stockholders’  equity  and  cash  flows,  but  will  include
expanded  disclosures.    The  Company’s  revenue  is  generated  from  sales  of  finished  goods  (disposable  medical  devices). 
Revenue  from  these  sales  will  continue  to  be  recognized  when  title  of  the  products  is  passed  to  the  customer.    Management
expects materially similar results under the amended guidance as compared to the Company’s current policies and procedures
regarding revenue recognition.  The Company will adopt this amended guidance on a Modified Retrospective basis in the first
quarter of 2018.

 3.     INVENTORIES

Inventories consist of the following:

Raw materials
Finished goods

Inventory reserve

4.      PROPERTY, PLANT, AND EQUIPMENT

Property, plant, and equipment consist of the following:

Land
Buildings and building improvements
Production equipment
Office furniture and equipment
Construction in progress

Accumulated depreciation

$

$

$

$

$

Year Ended December 31,
2016
2017
1,303,278
1,511,339
6,309,469
5,289,761
7,612,747
6,801,100
(595,523)
(594,939)
7,017,224
6,206,161

$

December 31,

2017

2016

261,893
11,566,115
19,742,577
3,500,834
65,693
35,137,112
(23,783,910)
11,353,202

$

$

261,893
11,561,320
17,864,346
3,415,985
1,941,687
35,045,231
(22,953,194)
12,092,037

Depreciation expense for the years ended December 31, 2017, 2016, and 2015 was $830,715; $867,080; and $849,804,
respectively.

5.      LICENSE AGREEMENT

In 1995, the Company entered into a license agreement with the Chief Executive Officer of the Company for the exclusive right
to manufacture, market, and distribute products utilizing automated retraction technology, which agreement has been amended
twice.  This technology is the subject of various patents and patent applications owned by such officer of the Company.  The

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
initial licensing fee of $500,000 was amortized over 17 years.  The license agreement also provides for quarterly payments of a
5%  royalty  fee  on  gross  sales.    The  royalty  fee  expense  is  recognized  in  the  period  in  which  it  is  earned.    Royalty  fees  of
$2,864,188; $2,527,508; and $2,477,583 are included in Cost of sales for the years ended December 31, 2017, 2016, and 2015,
respectively.    Royalties  payable  under  this  agreement  aggregated  $793,489  and  $659,443  at  December  31,  2017,  and  2016,
respectively.    Gross  sales  upon  which  royalties  are  based  were  $57,283,780;  $50,550,165;  and  $49,551,660  for  2017,  2016,
and 2015, respectively.

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Table of Contents

6.       OTHER ACCRUED LIABILITIES

Other accrued liabilities consist of the following:

Prepayments from customers
Accrued property taxes
Accrued professional fees
Other accrued expenses

7.     LONG-TERM DEBT

Long-term debt consists of the following:

December 31,

2017

2016

355,742
14,681
231,826
55,674
657,923

$

$

692,922
—
266,747
49,030
1,008,699

$

$

Loan from American First National Bank. It has a 20 year

amortization and 10 year maturity from December 10, 2009.
The loan, in the original amount of $4,209,608, provided
funding for the expansion of the warehouse, additional office
space, and a new Controlled Environment. The loan is secured
by the Company’s land and buildings. The interest rate is
5.968%.

Note payable to Deutsche Leasing USA, Inc. The interest rate is
3.69%. The original amount of the note was $276,495 with a
36 month maturity ending in July 2018. Beginning
August 2015, the loan became payable in equal installments of
principal and interest of approximately $8,100. Collateralized by
molding machines and ancillary equipment.

Note payable to Deutsche Leasing USA, Inc. The interest rate is
4.25%. The original amount of the note was $525,017 with a
36 month maturity ending in November 2019. Beginning
December 2016, the loan became payable in equal installments
of principal and interest of approximately $15,500.
Collateralized by molding machines and ancillary equipment.

Less: current portion

December 31,

2017

2016

$

3,094,301

$

3,269,397

56,180

149,727

341,877
3,492,358

$

(410,949)
3,081,409

$

509,513
3,928,637

(430,393)
3,498,244

The fair value of long-term liabilities, based on Management’s estimates, approximates their reported values.

The aggregate maturities of long-term debt as of December 31, 2017, are as follows:

2018
2019

$

$

410,949
3,081,409
3,492,358

 8.        COMMITMENTS AND CONTINGENCIES

In May 2010, the Company and an officer’s suit against Becton, Dickinson and Company (“BD”) in the U.S. District Court for
the  Eastern  District  of  Texas,  Marshall  Division  alleging  violations  of  antitrust  acts,  false  advertising,  product  disparagement,

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
tortious  interference,  and  unfair  competition  was  reopened.    The  trial  commenced  on  September  9,  2013  in  the  U.S.  District
Court for the Eastern District of Texas, Tyler Division, and the jury found that BD illegally engaged in anticompetitive conduct
with the intent to acquire or maintain monopoly power in the safety syringe market and engaged in false advertising under the
Lanham Act.    The  jury  awarded  the  Company  $113,508,014  in  damages,  which  was  trebled  pursuant  to  statute.    The  Court
granted

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injunctive relief to take effect January 15, 2015 including, among other things, a requirement to notify certain customers and
others regarding misleading disclosures.  In connection with BD’s subsequent appeal, on December 2, 2016, the United States
Court of Appeals for the Fifth Circuit overturned the antitrust damages.  The finding of false advertising liability was affirmed
and the case was remanded to the Eastern District of Texas for a redetermination as to the amount of damages to which the
Company is entitled.  On August 17, 2017, District Court for the Eastern District of Texas issued the Court’s Final Judgment
ordering that the Company take nothing in its suit against BD and dismissing the case.  The Company filed a notice of Appeal
with the United States Court of Appeals for the Fifth Circuit on November 3, 2017.

In September 2007, BD and MDC Investment Holdings, Inc. (“MDC”) sued the Company in the United States District Court
for the Eastern District of Texas, Texarkana Division, initially alleging that the Company is infringing two U.S. patents of MDC
(6,179,812  and  7,090,656)  that  are  licensed  to  BD.    BD  and  MDC  seek  injunctive  relief  and  unspecified  damages.    The
Company  counterclaimed  for  declarations  of  non-infringement,  invalidity,  and  unenforceability  of  the  asserted  patents.    The
plaintiffs  subsequently  dropped  allegations  with  regard  to  patent  no.  7,090,656  and  the  Company  subsequently  dropped  its
counterclaims for unenforceability of the asserted patents.  On June 30, 2015, the Court ordered that further proceedings in this
matter  be  stayed  and  that  this  case  remain  administratively  closed  until  resolution  of  all  appeals  in  the  case  detailed  in  the
preceding paragraph.  The case remains stayed as a result of the ongoing proceedings regarding the Lanham Act claims in the
separate proceeding described above.

Operating Leases

In 2010, the Company entered into a non-cancellable operating lease for additional office space.  Rent expense under this lease
for  the  years  ended  December  31,  2017,  2016,  and  2015  was  $77,015;  $74,772;  and  $64,683,  respectively.    The  Company
renewed the lease in 2015.  Future annual minimum rental payments as of December 31, 2017, are presented below:

2018
2019
2020
Total

$

$

79,331
81,694
84,155
245,180

9.      INCOME TAXES

The provision (benefit) for income taxes consists of the following:

Current tax provision (benefit)

Federal
State

Total current provision (benefit)

Deferred tax provision (benefit)

Federal
State

Total deferred tax provision (benefit)
Total income tax provision (benefit)

For the Years Ended December 31,
2016

2017

2015

$

$

$

—
848
848

(188,456)
—
(188,456)
(187,608) $

—
1,132
1,132

—
—
—
1,132

$

$

—
7,877
7,877

—
—
—
7,877

The  Company  has  $24.9  million  in  tax  benefits  attributable  to  net  operating  losses  for  federal  tax  purposes.    The  loss  carry
forwards  will  begin  to  expire  in  2028  for  federal  tax  purposes  and  will  begin  to  expire  for  state  tax  purposes  in  2021.    The
Company also has credits for alternative minimum taxes (“AMT”) paid of $202 thousand.  The alternative minimum tax was
repealed with the enactment of the Act.  AMT credits carried over may be used to offset regular tax liability for any tax year. 
Any  unused  credits  are  50%  refundable  for  tax  years  2018-2020,  and  100%  refundable  for  tax  years  beginning  2021.    The
Company has recorded the AMT

F-17

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents

credit as a tax receivable on its financial statements rather than as a deferred tax asset, as this amount is a refundable credit.

Deferred taxes are provided for those items reported in different periods for income tax and financial reporting purposes.  The
tax effects of temporary differences that give rise to significant portions of the deferred tax assets and liabilities are presented
below:

Deferred tax assets

Net operating loss carry forwards
Credit for alternative minimum tax paid
Accrued expenses and reserves
Employee stock option expense
Nonemployee stock option expense
Inventory
Impairment

Deferred tax assets

Deferred tax liabilities

Property and equipment
Deferred tax liabilities
Net deferred assets

Valuation allowance
Net deferred tax assets

December 31,

2017

2016

6,127,210
—
509,666
76,150
8,268
224,353
112,000
7,057,647

(1,231,693)
(1,231,693)
5,825,954
(5,825,954)
—

$

$

7,651,971
201,773
1,348,032
117,613
12,770
361,437
172,983
9,866,579

(669,246)
(669,246)
9,197,333
(9,197,333)
—

$

$

The  Company  has  made  a  reasonable  estimate  of  the  effects  of  the Act  on  its  existing  deferred  tax  balances.    The  Company
adjusted its deferred tax valuation account to offset the expected decrease in its deferred tax assets as a result of the change. 
The Company will adjust its calculations as additional facts and circumstances are known.

Utilization  of  the  net  operating  loss  carry  forwards  and  credits  may  be  subject  to  a  substantial  annual  limitation  due  to  the
ownership change limitations provided by the Internal Revenue Code of 1986, as amended, and similar state provisions.

Deferred  income  tax  calculations  reflect  the  effects  of  temporary  differences  between  the  carrying  amounts  of  assets  and
liabilities  and  their  tax  bases,  as  well  as  from  net  operating  loss  carry  forwards,  and  are  stated  at  the  U.S.  tax  rate  of  21%
beginning in 2018. Deferred income tax assets represent amounts available to reduce income taxes payable on taxable income in
future years. The Company has fully reserved these future tax deductions.

The valuation allowance decreased $3,371,379 for 2017.  The valuation allowance increased $1,445,361 for 2016.

A reconciliation of income taxes based on the federal statutory rate and the effective income tax rate is summarized as follows:

Income tax at the federal statutory rate
State tax, net of federal tax
Change in valuation allowance
Permanent differences
Return-to-provision and other
Tax Reform and Jobs Act tax rate change
Incentive stock options
Effective tax rate

2017

December 31,
2016

2015

35.0%
2.9
85.9
5.7
(37.6)
(81.1)
(6.0)
4.8%

35.0%
2.9
(39.1)
4.7
(3.5)
—
—
0.0%

35.0%
2.9
(37.8)
0.7
(0.6)
—
—
0.2%

F-18

Table of Contents

The  Company  files  income  tax  returns  in  the  U.S.  federal  jurisdiction  and  in  various  state  and  local  jurisdictions.    The
Company’s federal income tax returns for all tax years ended on or after December 31, 2014, remain subject to examination by
the Internal Revenue Service.  The Company’s state and local income tax returns are subject to examination by the respective
state and local authorities over various statutes of limitations, most ranging from three to five years from the date of filing.

10.    STOCK OPTION GRANTS AND EXERCISES

On  September  9,  2016,  the  Compensation  and  Benefits  Committee  approved  grants  of  incentive  stock  options  to  the
Company’s employees under the First Amended 2008 Stock Option Plan with exercise prices at fair market value ($2.75 per
share),  a  ten-year  term,  and  one-year  vesting  period,  except  to  the  extent  that  such  vesting  period  would  violate  the  First

 
 
 
 
 
 
 
 
 
 
 
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amended  2008  Stock  Option  Plan.    In  total,  the  stock  options  are  exercisable  into  500,400  shares  of  Common  Stock.    The
value  of  an  option  for  the  purchase  of  one  underlying  common  share  was  valued  at  $1.783,  using  the  Black  Scholes  Option
Pricing Model using a risk-free rate of 1.51%, a volatility factor of 67.1%, and a 7.1 year expected life.

On December 27, 2016, the Compensation and Benefits Committee approved grants of stock options to the Company’s chief
financial officer, general counsel, and all three independent directors for 50,000 shares each with ten-year terms under the First
Amended 2008 Stock Option Plan with exercise prices at fair market value ($1.05 per share).  The executive officers’ options
vested  on  December  27,  2017  and  the  independent  directors’  options  vested  immediately.    The  value  of  an  option  for  the
purchase of one underlying common share was valued at $0.728, using the Black Scholes Option Pricing Model using a risk-
free rate of 2.37%, a volatility factor of 72.5%, and a 7.1 year expected life.

No stock options were exercised in 2017.  Stock options were exercised at various dates in 2016 and 2015 and, consequently,
a total of 1,046,580 shares of Common Stock were issued in 2016 and 272,477 shares of Common Stock were issued in 2015
for  an  aggregate  payment  of  $855,021  in  2016  and  $283,933  in  2015.    These  options  were  granted  in  2008  and  2009  at
exercise prices of $0.81 and $1.30.

11.    DIVIDENDS

The Board declared and the Company paid dividends to Series I and Series II Class B Preferred Shareholders in the following
amounts: $37,891 and $132,926, respectively, on April 30, 2015, and paid such preferred shareholders $12,313 and $44,050,
respectively, on July 20, 2015 and October 22, 2015; and paid such preferred shareholders $12,313 and $43,101, respectively,
on  February  1,  2016.    The  Board  declared  and  the  Company  paid  dividends  to  Series  I  and  Series  II  Class  B  Preferred
Shareholders in the following amounts: $12,313 and $42,800, respectively, on April 21, 2016, July 28, 2016, October 20, 2016,
January 6, 2017, April 24, 2017, July 20, 2017, October 20, 2017, and January 19, 2018.

12.      STOCKHOLDERS’ EQUITY

Preferred Stock

The Company is authorized to issue 5,000,000 shares of Preferred Stock Class A with a par value of One Dollar ($1.00) per
share; 5,000,000 shares of Preferred Stock Class B with a par value of One Dollar ($1.00) per share; and 5,000,000 shares of
Preferred Stock Class C with a par value of One Dollar ($1.00) per share.

The  Company  has  one  class  of  Preferred  Stock  outstanding:  Class  B  Convertible  Preferred  Stock  (“Class  B  Stock”).    The
Class B Stock has five series: Series I, Series II, Series III, Series IV, and Series V.

The Class B Stock has been allocated among Series I, II, III, IV, and V in the amounts of 98,500; 171,200; 129,245; 342,500;
and 40,000 shares, respectively as of December 31, 2017.  The remaining 4,218,555 authorized shares have not been assigned
a series.

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Table of Contents

Series I Class B Stock

There  were  98,500  shares  of  $1  par  value  Series  I  Class  B  Stock  outstanding  at  December  31,  2017  and  2016.    Holders  of
Series I Class B Stock are entitled to receive a cumulative annual dividend of $0.50 per share, payable quarterly if declared by
the  Board  of  Directors.    The  Company  paid  dividends  of  $49,250;  $49,250;  and  $62,516  in  2017,  2016,  and  2015,
respectively.  At December 31, 2017, no dividends were in arrears.

Series  I  Class  B  Stock  is  redeemable  after  three  years  from  the  date  of  issuance  at  the  option  of  the  Company  at  a  price  of
$7.50  per  share,  plus  all  unpaid  dividends.    Each  share  of  Series  I  Class  B  Stock  may,  at  the  option  of  the  stockholder,  be
converted to one share of Common Stock after three years from the date of issuance or in the event the Company files an initial
registration  statement  under  the  Securities Act  of  1933.    No  shares  of  Series  I  Class  B  Stock  were  converted  into  Common
Stock in 2017 or 2016.  In the event of voluntary or involuntary dissolution, liquidation, or winding up of the Company, holders
of Series I Class B Stock then outstanding are entitled to $6.25 per share, plus all unpaid dividends prior to any distributions to
holders  of  Series  II  Class  B  Stock,  Series  III  Class  B  Stock,  Series  IV  Class  B  Stock,  Series  V  Class  B  Stock,  or  Common
Stock.

Series II Class B Stock

There were 171,200 shares of $1 par value Series II Class B Stock outstanding at December 31, 2017 and 2016.  Holders of
Series II Class B Stock are entitled to receive a cumulative annual dividend of $1.00 per share, payable quarterly if declared by
the  Board  of  Directors.    Holders  of  Series  II  Class  B  Stock  generally  have  no  voting  rights  until  dividends  are  in  arrears  and
unpaid for twelve consecutive quarters.  In such case, the holders of Series II Class B Stock have the right to elect one-third of
the Board of Directors of the Company.  The Company paid dividends of $171,200; $171,200; and $221,026 in 2017, 2016,

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and 2015, respectively.  At December 31, 2017, no dividends were in arrears.

Series II Class B Stock is redeemable after three years from the date of issuance at the option of the Company at a price of
$15.00  per  share  plus  all  unpaid  dividends.    Each  share  of  Series  II  Class  B  Stock  may,  at  the  option  of  the  stockholder,  be
converted to one share of Common Stock after three years from the date of issuance or in the event the Company files an initial
registration statement under the Securities Act of 1933.  No shares were converted in 2017 or 2016.  In the event of voluntary
or involuntary dissolution, liquidation, or winding up of the Company, holders of Series II Class B Stock then outstanding are
entitled  to  $12.50  per  share,  plus  all  unpaid  dividends,  after  distribution  obligations  to  holders  of  Series  I  Class  B  Stock  have
been satisfied and prior to any distributions to holders of Series III Class B Stock, Series IV Class B Stock, Series V Class B
Stock, or Common Stock.

Series III Class B Stock

There were 129,245 shares of $1 par value Series III Class B Stock outstanding at December 31, 2017 and 2016.  Holders of
Series III Class B Stock are entitled to receive a cumulative annual dividend of $1.00 per share, payable quarterly if declared by
the Board of Directors.  At December 31, 2017, approximately $4,145,604 of dividends which have not been declared were in
arrears.

Series III Class B Stock is redeemable after three years from the date of issuance at the option of the Company at a price of
$15.00 per share, plus all unpaid dividends.  Each share of Series III Class B Stock may, at the option of the stockholder, be
converted to one share of Common Stock after three years from the date of issuance or in the event the Company files an initial
registration statement under the Securities Act of 1933.  No shares were converted in 2017 or 2016.  In the event of voluntary
or involuntary dissolution, liquidation, or winding up of the Company, holders of Series III Class B Stock then outstanding are
entitled  to  $12.50  per  share,  plus  all  unpaid  dividends,  after  distribution  obligations  to  Series  I  Class  B  Stock  and  Series  II
Class B Stock have been satisfied and prior to any distributions to holders of Series IV Class B Stock, Series V Class B Stock,
or Common Stock.

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Table of Contents

Series IV Class B Stock

There were 342,500 shares of $1 par value Series IV Class B Stock outstanding at December 31, 2017 and 2016.  Holders of
Series IV Class B Stock are entitled to receive a cumulative annual dividend of $1.00 per share, payable quarterly, if declared by
the Board of Directors.  At December 31, 2017, approximately $6,141,118 of dividends which have not been declared were in
arrears.

Series IV Class B Stock is redeemable after three years from the date of issuance at the option of the Company at a price of
$11.00 per share plus all unpaid dividends.  Each share of Series IV Class B Stock may, at the option of the stockholder any
time  subsequent  to  three  years  from  date  of  issuance,  be  converted  into  one  share  of  Common  Stock,  or  in  the  event  the
Company files an initial registration statement under the Securities Act of 1933.  No shares of Series IV Class B Stock were
converted into Common Stock in 2017 or 2016.  In the event of voluntary or involuntary liquidation, dissolution, or winding up
of the Company, holders of Series IV Class B Stock then outstanding are entitled to receive liquidating distributions of $11.00
per  share,  unpaid  dividends  after  distribution  obligations  to  Series  I  Class  B  Stock,  Series  II  Class  B  Stock,  and  Series  III
Class B Stock have been satisfied and prior to any distribution to holders of Series V Class B Stock or Common Stock.

Series V Class B Stock

There  were  40,000  shares  of  $1  par  value  Series  V  Class  B  Stock  outstanding  at  December  31,  2017  and  2016.    Holders  of
Series V Class B Stock are entitled to receive a cumulative annual dividend of $0.32 per share, payable quarterly, if declared by
the Board of Directors.  At December 31, 2017, approximately $996,035 of dividends which have not been declared were in
arrears.

Series  V  Class  B  Stock  is  redeemable  after  two  years  from  the  date  of  issuance  at  the  option  of  the  Company  at  a  price  of
$4.40 per share plus all unpaid dividends.  Each share of Series V Class B Stock may, at the option of the stockholder any time
subsequent to the date of issuance, be converted into Common Stock.  No shares of Series V Class B Stock were converted
into  Common  Stock  in  2017  or  2016.    In  the  event  of  voluntary  or  involuntary  liquidation,  dissolution,  or  winding  up  of  the
Company, holders of Series V Class B Stock then outstanding are entitled to receive liquidating distributions of $4.40 per share,
plus unpaid dividends after distribution obligations to Series I Class B Stock, Series II Class B Stock, Series III Class B Stock,
and Series IV Class B Stock have been satisfied and prior to any distribution to the holders of the Common Stock.

Common stock

The Company is authorized to issue 100,000,000 shares of no par value Common Stock, of which 32,666,454 and 29,666,454
shares were outstanding at December 31, 2017, and 2016, respectively.  Additionally, a total of 2,644,464 shares of Common
Stock are issuable upon the conversion of Preferred Stock and the exercise of stock options.

 
 
 
 
 
 
 
 
 
 
 
 
 
13.            RELATED PARTY TRANSACTIONS

The Company has a license agreement with the Chief Executive Officer of the Company. See Note 5.

In 2016, the Company granted a right to three of its executive officers to purchase shares of Common Stock directly from the
Company  at  market  prices.  Thomas  J.  Shaw,  CEO,  exercised  his  purchase  rights  on  January  12,  2017,  buying  two  million
shares at market price for an aggregate purchase price of $1.78 million, and he exercised the remainder of his purchase rights
on August 23, 2017 by purchasing one million shares at market price for aggregate consideration of $570,100.  Mr. Cowan,
CFO, and Ms. Larios, Vice President and General Counsel, are authorized to purchase 500,000 shares each at market price any
time prior to December 9, 2018.  The approximate dollar value of these potential future purchases cannot be predicted.

In November 2016, the Company granted a stock option to its Chief Executive Officer for the purchase of three million shares
of  Common  Stock.    Such  stock  option  terminated  by  its  terms  before  becoming  exercisable  following  a  December  27,  2016
shareholder vote against such option.

F-21

Table of Contents

14.            STOCK OPTIONS

Stock options

The  Company  has  approved  stock  option  plans  for  the  granting  of  stock  options  to  employees,  Directors,  and  consultants. 
Options for the purchase of 3,649,508 shares of Common Stock have been issued under the 2008 Stock Option Plan, which,
pursuant to a 2014 amendment, authorizes a total of 6,000,000 shares of Common Stock upon the exercise of stock options. 
Options for the purchase of 1,863,019 shares under the 2008 Stock Option Plan were outstanding as of December 31, 2017. 
2,350,492 shares are available for future issuance under the 2008 Stock Option Plan until July 25, 2018.  A stock option for
3,000,000  shares  granted  to  Thomas  J.  Shaw  on  November  2,  2016  terminated  by  its  terms  prior  to  becoming  exercisable
following a December 27, 2016 shareholder vote against such option.

The  Compensation  and  Benefits  Committee  administers  all  plans  and  determines  and/or  recommends  to  the  Board  exercise
prices at which options are granted.  All executive compensation, including the granting of stock options, is determined by the
Compensation  and  Benefits  Committee.    Shares  issued  upon  exercise  of  options  come  from  the  Company’s  authorized  but
unissued Common Stock.  The options vested over periods up to three years from the date of grant and generally expire ten
years after the date of grant.  Unvested options issued under the 2008 Stock Option Plan expire immediately after termination of
employment.

Employee options

A summary of Director, officer, and employee options granted and outstanding under the 2008 Stock Option Plan is presented
below:

2017

Years Ended December 31,
2016

2015

Weighted
Average
Exercise
Price

Shares

Weighted
Average
Exercise
Price

1.52
—
—
(2.75)

$
2,125,069
750,400
$
(1,046,580) $
(10,970) $

0.94
2.18
(0.82)
(1.08)

Shares

$
1,817,919
$
—
—
$
(12,400) $

Weighted
Average
Exercise
Price

0.95
—
(1.05)
(1.30)

Shares

$
2,386,736
$
—
(259,977) $
(1,690) $

1,805,519

$

1.51

1,817,919

$

1.52

2,125,069

$

0.94

1,803,119

$

1.51

1,218,519

$

1.06

2,125,069

$

0.94

Outstanding at beginning

of period
Granted
Exercised
Forfeited

Outstanding at end of

period

Exercisable at end of

period

No options were issued in 2017 or 2015 to employees.  600,400 employee stock options were issued in 2016.  A grant of three
million options to the Company’s chief executive officer terminated by its terms prior to becoming exercisable.  The fair value
of  the  September  2016  grants  exercisable  into  500,400  shares  was  $1.783  per  share  of  underlying  Common  Stock  and  was
estimated on the date of the grant using the Black Scholes pricing model with the following assumptions: expected volatility of
67.1%, risk free interest rate of 1.51%, and an expected life of 7.1 years.  These options were issued under the First Amended

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
 
 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
2008 Stock Option Plan.  The fair value of the December 2016 grants exercisable into 100,000 shares was $0.728 per share of
underlying Common Stock and was estimated on the date of the grant using the Black Scholes pricing model with the following
assumptions:  expected  volatility  of  72.5%,  risk  free  interest  rate  of  2.37%,  and  an  expected  life  of  7.1  years.    These  options
were issued under the First Amended 2008 Stock Option Plan.

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Table of Contents

No  options  were  issued  to  non-employee  directors  in  2017  or  2015.    150,000  stock  options  were  issued  to  non-employee
directors in 2016.  The fair value of the 2016 grants was $0.728 per share of underlying Common Stock and was estimated on
the date of the grant using the Black Scholes pricing model with the following assumptions: expected volatility of 72.5%, risk
free interest rate of 2.37%, and an expected life of 7.1 years.  These options were issued under the First Amended 2008 Stock
Option Plan.

The following table summarizes information about Director, officer, and employee options outstanding under the stock option
plan at December 31, 2017:

Exercise Prices

Shares Outstanding

$
$
$
$
$

 1.30
 1.46
 0.81
 1.05
 2.75

Non-employee options

478,416
50,000
540,103
250,000
487,000

Weighted Average
Remaining Contractual Life
0.88
5.37
1.54
8.99
8.70

Shares Exercisable

478,416
50,000
540,103
250,000
484,600

A summary of options outstanding during the years ended December 31 and held by non-employees is as follows:

2017

Weighted
Average
Exercise
Price

Shares

Years Ended December 31,
2016

Weighted
Average
Exercise
Price

Shares

2015

Weighted
Average
Exercise
Price

Shares

57,500
—
—
—

57,500

$
$
$
$

$

0.81
—
—
—

0.81

57,500
—
—
—

57,500

$
$
$
$

$

0.81
—
—
—

$
70,000
$
—
(12,500) $
$
—

0.81
—
(0.81)
—

0.81

57,500

$

0.81

57,500

$

0.81

57,500

$

0.81

57,500

$

0.81

Outstanding at beginning

of period
Granted
Exercised
Forfeited

Outstanding at end of

period

Exercisable at end of

period

The  following  table  summarizes  information  about  non-employee  options  outstanding  under  the  stock  option  plan  at
December 31, 2017:

$

Exercise
Price

Shares
Outstanding

Weighted Average
Remaining Contractual Life

 0.81

57,500

1.54

Shares
Exercisable

57,500

The  Company  recorded  $388  thousand  of  stock-based  compensation  expense  in  2016.    In  2017,  the  Company  recognized
stock-based compensation expense of $672 thousand.  The Company recorded no stock-based compensation expense in 2015. 
The total intrinsic value of options exercised was $0; $1,414,892; and $856,269 in 2017, 2016, and 2015, respectively.  There
were no options outstanding and exercisable with exercise prices lower than market price at December 31, 2017.

F-23

Table of Contents

Options Pricing Models — Assumptions

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
 
 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The expected life is based on the Company’s historical experience with option exercise trends.  The assumptions for expected
volatility is based on a calculation of volatility over the five-years preceding the grant date.  Risk-free interest rates are set using
grant-date U.S. Treasury yield curves.  In its calculations, the Company assumed no dividends.

15.           401(k) PLAN

The Company implemented an employee savings and retirement plan (the “401(k) Plan”) in 2005 that is intended to be a tax-
qualified plan covering substantially all employees.  The 401(k) Plan is available to all employees on the first day of the month
after  90  days  of  service.    Under  the  terms  of  the  401(k)  Plan,  employees  may  elect  to  contribute  up  to  88%  of  their
compensation, or the statutory prescribed limit, if less.  The Company may, at its discretion, match employee contributions.  In
the  first  quarter  of  2016,  the  Company  reinstituted  a  policy  of  matching.    For  2016  and  2017,  the  Company  matched  each
participant’s elective deferrals up to 2% of the participant’s compensation for the pay period.  The total match was $122,369 in
2016 and $145,474 in 2017.  The Company did not match contributions in 2015.

16.            BUSINESS SEGMENTS

The following is a summary of the Company’s sales and long-lived assets by geography:

U.S. sales
North and South America sales (excluding U.S.)
Other international sales
Total sales

Long-lived assets

U.S.
International

2017
27,015,712
6,380,745
1,097,381
34,493,838

11,215,583
137,619

2016
26,308,246
2,741,518
776,872
29,826,636

11,930,293
161,744

$

$

$
$

2015
23,029,976
5,668,785
853,439
29,552,200

11,282,192
185,869

$

$

$
$

$

$

$
$

The  Company  does  not  operate  in  separate  reportable  segments.    The  Company  has  minimal  long-lived  assets  in  foreign
countries.    Shipments  to  international  customers  generally  require  a  prepayment  either  by  wire  transfer  or  an  irrevocable
confirmed  letter  of  credit.    The  Company  does  extend  credit  to  international  customers  on  some  occasions  depending  upon
certain  criteria,  including,  but  not  limited  to,  the  credit  worthiness  of  the  customer,  the  stability  of  the  country,  banking
restrictions, and the size of the order.  All transactions are in U.S. currency.

17.            TREASURY SHARES

The Board of Directors of the Company cancelled all treasury shares effective August 11, 2015.

18.            PREFERRED STOCK TRANSACTION

The Company exchanged 728,000 shares of Common Stock for 200,000 shares of our Series IV Class B Convertible Preferred
Stock as of November 30, 2015, pursuant to an agreement with a shareholder.  Such shareholder agreed to waive all unpaid
dividends in arrears associated with the tendered preferred stock, equaling $3,094,795.  The fair value of the common stock
issued ($2,606,240) over the carrying value of the preferred stock extinguished ($2,000,000) was $606,240.  The excess of the
dividend  arrearage  waived  less  the  excess  value  of  common  stock  issued,  less  the  preferred  dividend  requirements  for  2015
through the extinguishment date ($182,877) resulted in a deemed capital contribution of $2,305,678 for purposes of computing
net income available to common shareholders. Future dividend requirements of $200,000 per year were avoided as a result of
this transaction.

F-24

Table of Contents

19.                  BONUSES

In February of 2017, Mr. Cowan and Ms. Larios were each granted cash bonuses of $250,000.  Ms. Larios received her bonus
in the first quarter of 2017.  Mr. Cowan received his bonus in the fourth quarter of 2017.

20.                  STORM DAMAGE AND INSURANCE PROCEEDS

On  March  26,  2017,  a  hail  storm  passed  through  Little  Elm,  Texas,  resulting  in  damage  to  the  Company’s  two  buildings. 
During April  2017,  the  Company  performed  an  inspection  of  its  facilities  and  determined  that  possible  roof  damage  had  been
sustained.    In  late  April  2017,  the  Company’s  insurance  carrier  inspected  the  two  buildings  and  confirmed  that  damage
occurred from the hail storm.  This damage was principally to the roofs of the buildings but also many of the HVAC units and a
wall alongside one of the buildings.

The  Company’s  insurance  carrier  has  assessed  damages  of  $1,009,960  and  the  Company’s  deductible  is  $5,000.    The

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Company has received these funds from its carrier.  At this time, the Company does not expect the cost of repairs to the roofs,
the wall, and to the HVAC units to exceed its coverage.  Repairs commenced during the third quarter of 2017 and should be
completed in the first half of 2018.

During  2017,  the  Company  incurred  and  recognized  $538,667  in  repairs  due  to  the  storm  damage.    There  is  $466,293  of
remaining  insurance  proceeds.    This  repair  expense  was  offset  by  the  insurance  proceeds,  resulting  in  no  impact  to  the
Statement  of  Operations.    These  costs  and  offsets  are  included  in  General  and  administrative  expense  in  the  Statement  of
Operations.

                             SELECTED QUARTERLY FINANCIAL DATA - UNAUDITED

The  selected  quarterly  financial  data  for  the  periods  ended  December  31,  2017,  and  2016,  have  been  derived  from  the
Company’s  unaudited  financial  statements  and  include  all  adjustments,  consisting  only  of  normal  recurring  adjustments,
necessary for a fair presentation of the results of the interim periods.  Certain quarterly amounts may differ from full year totals
due to rounding.

Sales, net
Cost of sales
Gross profit
Total operating expenses
Loss from operations
Interest and other income
Interest expense, net
Provision (benefit) for income taxes
Net loss
Preferred stock dividend requirements
Loss applicable to common shareholders
Basic loss per share
Diluted loss per share
Weighted average common shares outstanding -

basic

Weighted average common shares outstanding -

diluted

Gross profit margin

Table of Contents

Sales, net
Cost of sales
Gross profit
Total operating expenses
Loss from operations
Interest and other income
Interest expense, net
Provision for income taxes
Net loss
Preferred stock dividend requirements
Loss applicable to common shareholders
Basic loss per share
Diluted loss per share
Weighted average common shares outstanding

- basic

Weighted average common shares outstanding

- diluted

Gross profit margin

$

$
$
$

$

$
$
$

(In thousands, except for per share and outstanding stock amounts)
2017

Quarter 1

Quarter 2

Quarter 3

Quarter 4

$

6,924
4,599
2,325
3,477
(1,152)
10
(48)
—
(1,190)
(176)
(1,366) $
(0.04) $
(0.04) $

$

7,646
5,437
2,209
3,514
(1,305)
14
(58)
—
(1,349)
(176)
(1,525) $
(0.05) $
(0.05) $

$

10,412
7,152
3,260
3,293
(33)
19
(53)
—
(67)
(176)
(243)
(0.01) $
(0.01) $

9,512
7,335
2,177
3,466
(1,289)
22
(52)
(188)
(1,131)
(176)
(1,307)
(0.04)
(0.04)

31,333,121

31,666,454

32,166,454

32,666,454

31,333,121

31,666,454

32,166,454

32,666,454

33.6%

28.9%

31.3%

22.9%

F-25

(In thousands, except for per share and outstanding stock amounts)
2016

Quarter 1

Quarter 2

Quarter 3

Quarter 4

$

5,922
3,732
2,190
3,084
(894)
5
(49)
1
(939)
(176)
(1,115) $
(0.04) $
(0.04) $

$

7,575
4,956
2,619
3,224
(605)
6
(57)
1
(657)
(176)
(833) $
(0.03) $
(0.03) $

$

8,840
5,580
3,260
3,341
(81)
9
(52)
1
(125)
(176)
(301) $
(0.01) $
(0.01) $

7,489
5,215
2,274
4,200
(1,926)
7
(55)
—
(1,974)
(176)
(2,150)
(0.07)
(0.07)

28,624,874

29,483,207

29,649,874

29,659,791

28,624,874

29,483,207

29,649,874

29,659,791

37.0%

34.6%

36.9%

30.4%

Major variances for 2017 as compared to 2016 include increased sales volumes in 2017, mitigated by lower average sales prices. 
Our operating expenses declined in 2017 primarily due to lower legal costs, mitigated by stock option expense and bonuses.  We

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
also incurred impairment costs in 2016.

F-26

Table of Contents

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

There were no reportable disagreements with accountants on accounting and financial disclosures.

Item 9A. Controls and Procedures.

Disclosure Controls and Procedures

Pursuant  to  Rule  13a-15(b)  under  the  Securities  Exchange  Act  of  1934  (the  “Exchange  Act”),  Management,  with  the
participation  of  our  President,  Chairman,  and  Chief  Executive  Officer,  Thomas  J.  Shaw  (the  “CEO”),  and  our  Vice  President  and
Chief Financial Officer, Douglas W. Cowan (the “CFO”), acting in their capacities as our principal executive and financial officers,
evaluated  the  effectiveness  of  our  disclosure  controls  and  procedures,  as  defined  in  Rule  13a-15(e)  under  the  Exchange Act.    The
term disclosure controls and procedures means controls and other procedures that are designed to ensure that information required to
be disclosed by us in our periodic reports is: i) recorded, processed, summarized, and reported within the time periods specified in the
Securities  and  Exchange  Commission’s  (the  “SEC”)  rules  and  forms;  and  ii)  accumulated  and  communicated  to  our  Management,
including  our  principal  executive  and  principal  financial  officers,  as  appropriate  to  allow  timely  decisions  regarding  required
disclosure.    Based  upon  this  evaluation,  the  CEO  and  CFO  concluded  that,  as  of  December  31,  2017,  our  disclosure  controls  and
procedures were effective.

Management’s Annual Report on Internal Control over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over our financial reporting as defined
in Rule 13a-15(f) under the Exchange Act. The term internal control over financial reporting means a process designed by, or under
the supervision of, our principal executive and principal financial officers and effected by our Board of Directors, Management and
other  personnel,  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  and  includes  those  policies  and
procedures that: (i) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and
dispositions  of  assets;  (ii)  provide  reasonable  assurance  that  our  transactions  are  recorded  as  necessary  to  permit  preparation  of
financial  statements  in  accordance  with  generally  accepted  accounting  principles,  and  that  our  receipts  and  expenditures  are  being
made  only  in  accordance  with  authorizations  of  Management  and  Directors;  and  (iii)  provide  reasonable  assurance  regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on our
financial statements.  Management used the Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring
Organizations of the Treadway Commission to evaluate the effectiveness of our internal control over financial reporting as required
by paragraph (c) of Rule 13a-15 under the Exchange Act.  Management, with the participation of our CEO and CFO, concluded that
our internal control over financial reporting as of December 31, 2017, was effective.  No material weaknesses in our internal control
over financial reporting were identified by Management.

Our Management, including the CEO and CFO, does not expect that our disclosure controls and procedures or our internal
control  over  financial  reporting  will  prevent  or  detect  all  errors  and  all  instances  of  fraud.   A  control  system,  no  matter  how  well
designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met.

As  reported  in  our  quarterly  report  on  Form  10-Q  for  the  period  ended  September  30,  2017,  we  remedied  an  earlier
weakness  by  increasing  our  review  procedures.    We  will  continue  to  run  parallel  accounting  systems  until  Oracle  is  fully
implemented.

Changes in Internal Control Over Financial Reporting

Except as noted above, there has been no change in our internal control over financial reporting during the fourth quarter of
2017  or  subsequent  to  December  31,  2017,  which  has  materially  affected,  or  is  reasonably  likely  to  materially  affect,  our  internal
control over financial reporting.

16

Table of Contents

Beginning  January  1,  2018,  we  implemented  internal  controls  to  ensure  we  have  adequately  evaluated  our  contracts  and
properly assessed the impact of the new accounting standard related to revenue recognition to facilitate adoption on that date.  We do
not expect significant changes to our internal control over financial reporting due to the adoption of the new standard.

Item 9B. Other Information.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
None.

Item 10. Directors, Executive Officers and Corporate Governance.

PART III

The following table sets forth information concerning our Directors, executives, and certain of our significant employees as
of the date of this report.  Our Board of Directors currently consists of a total of six (6) members, three (3) members of which are
Class 1 Directors and three (3) of which are Class 2 Directors which serve for two-year terms.

Name
EXECUTIVES
Thomas J. Shaw

Douglas W. Cowan

Russell B. Kuhlman
Michele M. Larios

INDEPENDENT DIRECTORS
Marco Laterza
Amy Mack
Walter O. Bigby, Jr.
Darren E. Findley

SIGNIFICANT EMPLOYEES
Kathryn M. Duesman
Lawrence G. Salerno
Shayne Blythe
John W. Fort III
James A. Hoover
R. John Maday
Judy Ni Zhu
Patti King

Executives

67

74

64
51

70
50
53
54

55
57
49
49
70
57
59
60

Age

Position

  Chairman, President, Chief Executive Officer, and

Class 2 Director

  Vice President, Chief Financial Officer, Treasurer,
Principal Accounting Officer, and Class 2 Director

  Vice President, Sales Development
  Vice President, General Counsel, and Secretary

  Class 1 Director
  Class 1 Director
  Class 2 Director
  Class 1 Director

Executive Director, Global Health

  Director of Operations
  Director of Sales and Marketing Logistics
  Director of Accounting
  Director of Quality Assurance

Production Manager

  Research and Development Manager
  Director of National Accounts

Term as
Director
Expires

2018

2018

N/A
N/A

2019
2019
2018
2019

N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A

Thomas J. Shaw, our Founder, has served as Chairman of the Board, President, Chief Executive Officer, and Director since
our inception.  We believe it is appropriate for Mr. Shaw to continue to serve as a Director and as the Chairman of the Board because
of  his  deep  knowledge  of  the  strengths  and  weaknesses  of  our  products  (as  their  primary  inventor)  and  of  the  Company  (as  its
Founder).  Further, his strategic knowledge of the Company and its competitive environment arising from his ongoing services as its
CEO is vital to the successful supervision of the Company by the Board of Directors.  Finally, Mr. Shaw’s educational background in
both Engineering and Accounting is helpful to Board deliberations.  In addition to his duties overseeing our Management, he continues
to lead our design team in product development of other medical safety devices that utilize, among other things, his unique patented

17

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friction  ring  technology.    Mr.  Shaw  has  extensive  experience  in  industrial  product  design  and  has  developed  several  solutions  to
complicated mechanical engineering challenges.

Douglas  W.  Cowan  is  a  Vice  President  and  our  Chief  Financial  Officer,  Treasurer,  Principal  Accounting  Officer,  and  a
Director.    Mr.  Cowan  joined  us  as  Chief  Financial  Officer  and  was  elected  to  the  Board  of  Directors  in  1999.    We  believe  it  is
appropriate Mr. Cowan continue to serve as a Director due to his level of involvement in the financial state of the Company (as its
CFO) as well as his lead role in supervising all internal control and disclosure control procedures and statements.  He also serves as
the  primary  contact  for  investors  which  enables  him  to  bring  their  concerns  to  the  Board  on  appropriate  topics  as  they  arise.    His
expertise  as  a  CPA  and  experience  as  the  Company’s  CFO  allow  him  to  guide  the  Board,  upon  request,  with  regard  to  financial
matters.  He is responsible for our financial, accounting, investor relations, information technology, risk management, and forecasting
functions.

Russell B. Kuhlman joined us in February 1997 and is our Vice President, Sales Development.  Mr. Kuhlman is responsible
for  development  of  national  and  international  customers,  and  liaison  with  GPOs  and  product  training  for  our  sales  organization,  as
well as distribution.  Mr. Kuhlman’s efforts with us have resulted in bringing onboard Specialty Distributors, influencing legislation,

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and educating influential healthcare representatives about the benefits of our product line.  Mr. Kuhlman is respected throughout the
industry and is a main contributor to the safety effort in this country.

Michele M. Larios joined us in February 1998 and currently serves as our Vice President, General Counsel, and Secretary. 
Ms. Larios is responsible for our legal and legislative, human resource, and regulatory functions.  In addition to working on all legal
matters,  both  internally  and  with  outside  counsel,  Ms.  Larios  oversees  work  on  any  pertinent  legislative  issues  and  all  relevant
regulatory matters.

Independent Directors

Marco Laterza joined us as a Director effective as of March 22, 2005.  We believe it is appropriate Mr. Laterza continue to
serve as a Director because of his skills as a CPA as well as his decades of experience in advising individuals and entities with regard
to  corporate  planning  and  financial  issues.    Such  skills  and  experience  provide  a  valuable  contribution  in  his  role  as  the  designated
financial  expert  on  the  Audit  Committee  as  well  as  provide  valuable  independent  accounting  advice  to  the  Board.    Since  2015,
Mr.  Laterza  has  owned  and  operated  an  accounting  practice  and  income  tax  consulting  practice.    From  1988  through  2014,
Mr. Laterza owned and operated a public accounting practice.  His practice included corporate, partnership and individual taxation,
compilation/review of financial statements, financial planning, business consulting, and trusts and estates.  Formerly, Mr. Laterza was
employed  in  a  number  of  positions  from  1977  to  1985  with  El  Paso  Natural  Gas  Company  eventually  serving  as  its  Director  of
Accounting.

Amy Mack joined us as a Director on November 19, 2007.  We believe it is appropriate that Ms. Mack continue as a Board
member due both to her experience as a nurse (the primary retail user of our products) as well as her experience in running her own
company.  Since April of 2000, she has been the Secretary of EmergiStaff & Associates, a nursing agency, and she served as the
Chief  Nursing  Officer  of  EmergiStaff  & Associates  from  2000  to  2010.    From  2003  to  2010,  she  was  the  owner  and Aesthetics
Nurse Specialist for Spa O2 & Medical Aesthetics.  Ms. Mack has served as an emergency room nurse in various emergency rooms
throughout her career as a nurse.

Walter O. Bigby, Jr. has served on our Board of Directors since July 2012.  We believe it is appropriate for Mr. Bigby to
continue to serve as a Director due to his experience in owning and operating healthcare-related businesses.  Mr. Bigby’s experience
includes  ownership  of  several  small  businesses,  including  hospitals,  nursing  homes,  commercial  real  estate,  and  office  equipment
providers.  Mr. Bigby has owned and operated Bastrop Rehabilitation Hospital, a rehabilitation hospital in Louisiana, since 2001.  He is
currently  a  minority  interest  owner  in  a  nursing  home  in  Louisiana.    In  1995,  Mr.  Bigby  sold  his  home  health  agency  to  Columbia
HCA and remained a contract employee of the company (Hayden Health, Inc.) for three years developing other home health markets. 
Mr. Bigby has over a decade of experience operating healthcare businesses heavily regulated by Federal agencies and has experience
with Medicare and Medicaid.

Darren  E.  Findley  has  served  on  our  Board  of  Directors  since  September  2017.    Mr.  Findley  has  over  thirty  years  of

experience in recruiting, talent, and engagement solutions experience.  He is President of Engage2Excel,

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where  he  leads  the  recruitment  solutions  team.    Mr.  Findley  worked  at  AMN  Healthcare  from  May  2015  to  May  2016,  as  vice
president and general manager of recruitment process outsourcing.  In this role, his primary focus was growing the business segment
and delivering top talent into healthcare facilities.  Prior to AMN Healthcare, his roles included vice president and managing director of
recruitment  solutions  at  IBM/Kenexa  from  July  1999  to  May  of  2015,  where  he  managed  a  $35  million  portfolio  and  led  global
recruitment-outsourcing  programs  for  clients,  including  UnitedHealth  Group,  US  Steel,  Flowserve,  Allstate  Insurance,  Express
Scripts and Sprint PCS.  He holds a BBA from Harding University.  We believe it is appropriate for Mr. Findley to stand for election
to the Board of Directors because he has nearly thirty years of management experience and brings a unique perspective to the Board
with experience in recruitment and staffing for healthcare and other industries.

Significant Employees

Kathryn M. Duesman, RN, joined us in 1996 and currently serves as the Executive Director, Global Health.  She provides
clinical  expertise  on  existing  products  as  well  as  those  in  development.    She  has  been  instrumental  in  developing  training  and
marketing materials and has spoken and been published on safety sharps issues.  Ms. Duesman works with international agencies to
promote the use of safe technologies in developing countries.

Lawrence G. Salerno has been employed with us since 1995 and has served as Director of Operations for us since 1998.  He
is  responsible  for  the  manufacture  of  all  our  products,  as  well  as  all  product  development  and  process  development  projects.    In
addition, he supervises all aspects of the construction and expansion of our facilities in Little Elm, Texas.  Mr. Salerno is the brother
of a 5% shareholder who ceased to be a 10% shareholder in 2008.

Shayne  Blythe  has  been  with  us  since  2001  and  is  our  Director  of  Sales  and  Marketing  Logistics.    She  is  responsible  for
developing and implementing strategic directions, objectives, comprehensive sales and marketing plans, and programs.  In addition,
she  directs  and  oversees  all  aspects  of  the  distribution  process  and  customer  service  policies  in  order  to  monitor  and  maintain

 
 
 
 
 
 
 
 
 
 
 
 
customer satisfaction.

John W. Fort III is our Director of Accounting.  Mr. Fort joined us in March of 2000 as a Financial Analyst and has served
as our Director of Accounting since October of 2002.  His primary responsibilities include managing the day-to-day operations of the
Accounting and Finance Department and coordination of the annual audits, and interim reviews by our independent accountants, as
well as our cost accounting and forecasting functions.

James A. Hoover joined us in February 1996 and is our Director of Quality Assurance.  Prior to his becoming Director of
Quality  Assurance  he  was  Production  Manager.    He  is  responsible  for  our  quality  assurance  functions.    Mr.  Hoover  has  also
developed and implemented FDA required procedures and has been involved in the FDA inspection process.

R. John Maday joined us in July 1999 and is our Production Manager.  He is responsible for supervision of the production of
our  products.    Prior  to  becoming  Production  Manager  on  January  1,  2005,  he  served  as  our  Production  General  Supervisor. 
Mr. Maday has extensive manufacturing experience in both class II and III medical devices.

Judy  Ni  Zhu  joined  us  in  1995  and  is  our  Research  and  Development  Manager.    Her  primary  focus  is  on  new  product
development and improvement of current products.  Prior to joining us, Ms. Zhu worked as a design engineer with Mr. Shaw on the
original 3mL syringe and other SBIR grant projects.

Patti S. King joined us in 2006 and is our Director of National Accounts.  Ms. King is responsible for managing all activities
with  healthcare  group  purchasing  organizations  (GPOs),  which  includes  national  contracting  negotiations  and  contract
implementation.  She has over 30 years of healthcare experience, including patient care in respiratory therapy and cardiopulmonary
technology,  clinical  data  research,  clinical  software  development,  sales,  sales  and  operations  management,  and  national  account
(group purchasing) business development.  In 2005 and 2006, Ms. King served on our Board of Directors.

FAMILY RELATIONSHIPS

There are no family relationships among the above persons except as set forth above.

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DIRECTORSHIPS IN OTHER COMPANIES

No Directors hold directorships in reporting companies.

INVOLVEMENT IN CERTAIN LEGAL PROCEEDINGS

None  of  the  above  persons  or  any  business  in  which  such  person  was  an  executive  officer  have  been  involved  in  a
bankruptcy petition, been subject to a criminal proceeding (excluding traffic violations and other minor offenses), been subject to any
order  enjoining  or  suspending  their  involvement  in  any  type  of  business,  or  been  party  to  an  alleged  violation  of  a  securities  law,
commodities law, law or regulation respecting financial institutions or insurance companies, law or regulation prohibiting mail or wire
fraud, or rules of any organization that has disciplinary authority over its members.

SECTION 16(a) BENEFICIAL OWNERSHIP REPORTING COMPLIANCE

Section  16  of  the  Exchange Act  requires  our  Directors,  executive  officers,  and  persons  who  own  more  than  10%  of  a
registered class of our equity securities to file with the SEC initial reports of beneficial ownership (Form 3) and reports of changes in
beneficial ownership (Forms 4 and 5) of our Common Stock and our other equity securities.  Officers, Directors, and greater than
10% shareholders are required by the SEC’s regulations to furnish us with copies of all Section 16(a) reports they file.  Based on our
review, all of our executive officers filed all reports timely.

CODE OF ETHICS

Effective as of March 9, 2004, we adopted a code of ethics that applies to all employees, including, but not limited to, our
principal executive and financial officers.  Our Code of Business Conduct and Ethics is designed to deter wrongdoing and to promote:

1.         Honest  and  ethical  conduct,  including  the  ethical  handling  of  actual  or  apparent  conflicts  of  interests  between

personal and professional relationships;

2.         Full, fair, accurate, timely, and understandable disclosure in reports and documents that we file with, or submit to,

the SEC and in our other public communications;

3.        Compliance with applicable governmental laws, rules, and regulations;

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.         The prompt, internal reporting of violations of the code to an appropriate person or persons identified in the code;

and

5.        Accountability for adherence to the code.

A  copy  of  the  code  is  incorporated  herein  as  Exhibit  No.  14.  We  have  posted  a  copy  of  the  code  on  our  website  at
www.retractable.com.    Please  follow  the  link  to  “Investors”  then  click  “Governance”  then  click  “Charters,”  then  select  “RVP
Corporate Code of Conduct.”  Any amendment to this code or waiver of its application to the principal executive officer, principal
financial officer, principal accounting officer, or controller or similar person shall be disclosed to investors by means of a Form 8-K
filing  with  the  SEC.    We  will  provide  to  any  person  without  charge,  upon  request,  a  copy  of  such  code  of  ethics.    Such  requests
should be submitted in writing to Mr. Douglas W. Cowan at 511 Lobo Lane, P.O. Box 9, Little Elm, Texas 75068-0009.

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AUDIT COMMITTEE

We  have  a  separately-designated  standing  Audit  Committee  established  in  accordance  with  Section  3(a)(58)(A)  of  the
Exchange  Act  consisting  of  Marco  Laterza,  Walter  O.  Bigby,  Jr.,  and  Darren  E.  Findley.    Each  of  the  members  of  the  Audit
Committee  is  independent  as  determined  by  the  NYSE  American  rules.    During  2016,  the  Company  relied  on  a  provision  of
Section 801(h) allowing the Audit Committee to consist of only two members.  Effective September 8, 2017, the Company added a
third Audit Committee member.

Audit Committee Financial Expert

The  Board  of  Directors  has  determined  that  we  have  one  financial  expert  serving  on  the Audit  Committee.    Mr.  Marco
Laterza  serves  as  our  designated Audit  Committee  Financial  Expert.    Mr.  Laterza  is  independent  as  defined  for Audit  Committee
members by the listing standards of the NYSE American.

Item 11. Executive Compensation.

COMPENSATION DISCUSSION AND ANALYSIS

Compensation Consultant Reports

On October 13, 2016, the Company’s Compensation and Benefits Committee retained Longnecker Investment Group Inc.,
d/b/a  Longnecker  & Associates,  a  compensation  consulting  company.    Consistent  with  its  report,  the  Compensation  and  Benefits
Committee  granted  stock  options  for  the  purchase  of  50,000  shares  of  Common  Stock  to  Mr.  Cowan,  Ms.  Larios,  and  all  three
independent  directors  on  December  27,  2016.   Additionally,  in  accordance  with  a  separate  Longnecker  & Associates  report,  the
Compensation  and  Benefits  Committee  issued  to  Mr.  Cowan  and  Ms.  Larios  a  special  cash  bonus  of  $250,000  each  in
February 2017.  Additional information regarding these reports may be found in our annual report and proxy statement filed with the
U.S.  Securities  and  Exchange  Commission  in  2017.    Except  as  identified  therein,  we  have  not  otherwise  benchmarked  our
compensation in recent years.

The Objectives of Our Compensation Plan

Our  executive  officer  compensation  program  (the  “Compensation  Program”)  is  based  on  the  belief  that  competitive
compensation  is  essential  to  attract,  retain,  motivate,  and  reward  highly  qualified  and  industrious  executive  officers.    Our
Compensation Program is intended to accomplish the following:

·                  attract and retain highly talented and productive executive officers;

·                  provide incentives and rewards for superior performance by the executive officers; and

·                  align the interests of executive officers with the interests of our stockholders.

Our Compensation Program is designed to reward both superior long-term performance by our executive officers and their

loyalty.

Elements of Compensation

To  achieve  these  objectives,  the  Compensation  and  Benefits  Committee  has  approved  an  executive  officer  compensation

program that consists of four basic components:

·                  base salary;

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
·                  short-term incentive compensation in the form of cash bonuses;

·                  periodic long-term incentive compensation in the form of stock options; and

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·                  medical, life, and benefit programs (which are generally available to all employees).

Executive compensation is not based on the individual’s contribution to specific, quantitative corporate objectives due to the
fact that we compete in a market environment where significant achievement or performance is not always correlated with corporate
results.

Additionally,  in  2016,  we  granted  a  right  to  three  of  our  executive  officers  to  purchase  shares  of  Common  Stock  directly
from the Company at market prices. Thomas J. Shaw, CEO, exercised his purchase rights on January 12, 2017, buying two million
shares  at  market  price  for  an  aggregate  purchase  price  of  $1.78  million,  and  he  exercised  the  remainder  of  his  purchase  rights  on
August  23,  2017  by  purchasing  one  million  shares  at  market  price  for  aggregate  consideration  of  $570,100.    Mr.  Cowan  and
Ms. Larios are authorized to purchase 500,000 shares each at market price any time prior to December 9, 2018.

Base Salary

We choose to pay a significant component of our compensation in base salary due to the fact that our ability to grow has
been  constrained  by  larger  market  players.    Until  such  time  as  we  believe  that  we  have  access  to  the  market,  we  believe  that  it  is
appropriate to weigh our Compensation Program heavily in favor of base salaries rather than incentive compensation.

Management  establishes  the  initial  recommendations  regarding  compensation  for  all  employees.    Executive  compensation
remains the same until there is a review of such compensation by the Compensation and Benefits Committee.  Compensation, other
than  that  of  the  Chief  Executive  Officer,  has  generally  not  been  reviewed  annually.    Under  the  terms  of  Mr.  Shaw’s  employment
agreement, his compensation is reviewed annually.

The base salary for each of our executive officers is subjectively determined primarily on the basis of the following factors:
experience,  individual  performance,  contribution  to  our  performance,  level  of  responsibility,  duties  and  functions,  salary  levels  in
effect  for  comparable  positions  within  and  without  our  industry,  and  internal  base  salary  comparability  considerations.    However,
salaries can also be affected by our long-term needs.

Cash Bonuses

From time to time and when our cash reserves allow, we grant cash bonuses in order to reward significant efforts or the
accomplishment of short term goals.  The bonuses, when paid, are paid on a discretionary basis as determined by the Compensation
and  Benefits  Committee.    In  February  of  2017,  Mr.  Cowan  and  Ms.  Larios  were  each  granted  cash  bonuses  of  $250,000  which
amount  was  supported  by  the  compensation  consultant  report  referenced  above.    Prior  to  2017,  the  last  bonuses  were  granted  in
2010.

Long-Term Incentives: Stock Options

Long-term  incentives  are  provided  through  grants  of  stock  options.    The  grants  are  designed  to  align  the  interests  of
executive officers with those of stockholders and to provide each executive officer with a significant incentive to manage from the
perspective of an owner with an equity stake in the Company.

Effective September 9, 2016, we granted options for the purchase of 500,400 shares of Common Stock to our employees. 
Effective  December  27,  2016,  we  granted  options  for  the  purchase  of  a  total  of  250,000  shares  (50,000  shares  each)  to  our  chief
financial officer, general counsel, and our three independent directors serving at the time.

Generally, option awards to executive officers are granted by the Compensation and Benefits Committee and for others are
granted at the discretion of the Board after recommendation of the Compensation and Benefits Committee or on the committee’s own
initiative.  No awards are granted if the Compensation and Benefits Committee does not support a recommendation.  The Committee
will consider, among other factors, our financial condition and the expected expense of the grants.

Each  stock  option  grant  to  employees  allows  the  employee  to  acquire  shares  of  Common  Stock  at  a  fixed  price  per  share

(never less than the closing stock price of the Common Stock on the date of grant or the prior trading

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day,  as  applicable)  for  a  fixed  period  (usually  ten  years).    Options  granted  in  2016  vested  in  one  year  for  employees  and  vested
immediately for the independent directors receiving options.  Accordingly, generally stock option grants will provide a return to the
employee only if the employee remains employed by us during the vesting period, and then only if the market price of the underlying
Common Stock appreciates.  Future grants may vest over a shorter or longer period.

Awards are granted on the basis of historical performance.  Accordingly, there is no discretion to change the awards once

granted.

Shareholder Advisory Votes

A majority of the votes cast in 2016 on the say-on-pay proposal were voted in favor of the proposal.  The Compensation and
Benefits Committee will continue to take into account the outcome of say-on-pay votes when making compensation decisions for the
named executive officers.

Factors We Consider in Determining to Change Compensation Materially

We  consider  our  cash  position,  current  liquidity  trends,  and  the  short-term  and  long-term  needs  for  cash  reserves  when
evaluating whether we can change compensation materially at a given time.  On an individual-by-individual basis, we also consider the
value of past option compensation, the competitiveness of that individual’s base salary, and that individual’s contribution to our goals.

The Impact of the Accounting and Tax Treatments

Stock  options  granted  to  executives  and  other  employees  are  expensed  for  accounting  purposes  under  the  Stock
Compensation Topic of the Financial Accounting Standards Board Accounting Standards Codification.  We expense all of our option
costs as we do the costs of salaries and any periodic bonuses.  Stock option expense is not recognized for tax purposes, except in the
case of non-qualified stock options.  For non-qualified stock options, the intrinsic value of the option is recognized when the option is
exercised.

Section 162(m) of the Internal Revenue Code is not a material concern since our executives are not compensated over $1

million.

Compensation Pursuant to Employment Agreement

We  have  an  Employment Agreement  with  Mr.  Thomas  J.  Shaw  (the  “Employment Agreement”).    No  other  executives  or

Directors are compensated pursuant to employment agreements.

The Employment Agreement provides for an initial period of three years which ended December 31, 2010 and automatically
and  continuously  renews  for  consecutive  two-year  periods.    The  Employment Agreement  is  terminable  either  by  us  or  Mr.  Shaw
upon 30 days’ written notice or upon Mr. Shaw’s death.  The Employment Agreement details a variety of causes for termination and
payments owed to Mr. Shaw in each case.

The Employment Agreement dated January 1, 2008 provides for an annual salary of at least $416,400 with an annual salary
increase  equal  to  no  less  than  the  percentage  increase  in  the  CPI  over  the  prior  year.    The  Employment Agreement  requires  that
Mr.  Shaw’s  salary  be  reviewed  by  the  Compensation  and  Benefits  Committee  annually,  which  shall  make  such  increases  as  it
considers appropriate.  Accordingly, the Compensation and Benefits Committee increased his 2018 salary by $10,553 (2.20%) over
his 2017 salary in accordance with the percentage increase in the CPI over the prior year.

Under the Employment Agreement, we are obligated to provide certain benefits, including, but not limited to, participation in
qualified  pension  plan  and  profit-sharing  plans,  participation  in  the  Company’s  Cafeteria  Plan  and  other  such  insurance  benefits
provided to other executives, paid vacation, and sick leave.  We are also obligated to furnish him with a cellular telephone and suitable
office space as well as reimburse him for any reasonable and necessary out of pocket travel and entertainment expenses incurred by
him in carrying out his duties and responsibilities, membership dues to professional organizations, and any business-related seminars
and conferences.

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Mr. Shaw has the right under this agreement to resign in the event that there is a change in control.  A “Change of Control”
shall be deemed to have occurred on either of the following dates: (i) the date any one person (other than Mr. Shaw), or more than
one person acting as a group, acquires (or has acquired during the 12-month period ending on the date of the most recent acquisition
by such person or persons) ownership of stock of the Company possessing 30% or more of the total possible voting power of the
stock  of  the  Company  (assuming  the  immediate  conversion  of  all  then  outstanding  convertible  preferred  stock)  or  (ii)  the  date  a
majority of members of the Board of Directors is replaced during any 12-month period by Directors whose appointment or election is
not  endorsed  by  a  majority  of  the  members  of  the  Company’s  Board  of  Directors  before  the  date  of  the  appointment  or  election. 
Mr. Shaw further has the right to resign if there is a change in ownership.  A change in ownership is defined to have occurred on the

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
date that any one person (other than Mr. Shaw) or more than one person acting as a group acquires ownership of the Company’s
stock that, together with the stock previously held by such person or group, constitutes more than 50% of the total fair market value
or total voting power (assuming the immediate conversion of all then outstanding convertible preferred stock) of the Company.  In
such  event  Mr.  Shaw  is  entitled  to  salary  through  the  date  of  termination,  salary  for  24  months,  reimbursement  of  expenses,  and
applicable benefits.

Compensation Committee Report

The  Compensation  and  Benefits  Committee  has  reviewed  and  discussed  the  COMPENSATION  DISCUSSION  AND
ANALYSIS required by Item 402(b) of Regulation S-K with Management, and, based on the review and discussions referred to in
paragraph  (e)(5)(i)(A)  of  Item  407  of  Regulation  S-K,  has  recommended  to  the  Board  of  Directors  that  the  COMPENSATION
DISCUSSION AND ANALYSIS be included in this report on Form 10-K.

The  following  Summary  Compensation  Table  sets  forth  the  total  compensation  paid  or  accrued  by  us  over  the  past  three

fiscal years to or for the account of the named executive officers:

SUMMARY COMPENSATION TABLE FOR 2015-2017

WALTER O. BIGBY, JR.
AMY MACK
MARCO LATERZA
DARREN E. FINDLEY

Name and Principal Position
Thomas J. Shaw

President and CEO
(principal executive officer)

Michele M. Larios

Vice President,
General Counsel

Douglas W. Cowan

Vice President, CFO
(principal financial officer,
principal accounting
officer)

Russell B. Kuhlman

Vice President, Sales
Development

Year
2015
2016
2017

2015
2016
2017

2015
2016
2017

2015
2016
2017

Table of Contents

Salary
($)
484,506
469,827
479,694

363,462
350,000
350,000

301,154
290,000
290,000

151,351
153,522
148,741

24

Option
awards
($)

All Other
Compensation
($)

—
1,350,000
—

(1)

—
—
—

Bonus
($)

—
—
—

—
—
250,000

—
—

250,000  

—
36,400
—

(2)

—
36,400

(2)
—  

Total
($)
484,506
1,819,827
479,694

363,462
386,400
600,000

301,154
326,400
540,000

151,351
176,879
148,741

—
—
—

—
—

—
—
—

—
—
—

—
23,357
—

(2)

Name and Principal Position
Kathryn M. Duesman
Executive Director,
Global Health

(3)

Year
2015
2016
2017

Salary
($)
178,214
184,749
175,012

Bonus
($)

—
—
—

Option
awards
($)

—
36,908
—

(2)

All Other
Compensation ($)
—
—

Total
($)
178,214
221,657
175,012

(1)           This amount is the result of Mr. Shaw’s gain on exercising a portion of his stock option for 1,000,000 shares of Common
Stock.    This  gain  had  no  effect  on  our  financial  statements.    The  expense  related  to  the  stock  options  was  recognized  in  previous
years.

(2)           Assumptions for Ms. Larios and Mr. Cowan’s stock option awards include: 50,000 underlying shares each, exercise price
of  $1.05  per  share,  a  ten-year  term,  a  7.1  year  expected  life,  a  risk-free  rate  of  2.37%,  and  a  volatility  factor  of  72.5%.    These
options vested in December 2017.

Mr.  Kuhlman  was  granted  an  option  for  13,100  underlying  shares.    Ms.  Duesman  was  granted  an  option  for  20,700
underlying  shares.   Assumptions  for  Mr.  Kuhlman’s  and  Ms.  Duesman’s  stock  option  awards  include:  exercise  price  of  $2.75  per
share, a ten-year term, a 7.1 year expected life, a risk-free rate of 1.51%, and a volatility factor of 67.16%.  These options vested in
September 2017.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
(3)           Ms. Duesman is not an executive officer, but qualifies as a “named executive officer” by virtue of Item 402(m)(2)(iii) of
Regulation S-K.

Narrative Disclosure to Summary Compensation Table

Please 

see Compensation  Pursuant  to  Employment  Agreement  above  and  POTENTIAL  PAYMENTS  UPON

TERMINATION OR CHANGE IN CONTROL below for terms of our only employment agreement in effect.

Salary represents a substantial portion of the total compensation for all named executive officers.  This form of payment is

favored by the Company over equity awards due to the market environment in which the Company operates.

OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END

The  following  Outstanding  Equity Awards  at  Fiscal Year-End  Table  sets  forth  information  regarding  unexercised  options

held by the named executive officers as of December 31, 2017.

OUTSTANDING EQUITY AWARDS AT 2017 FISCAL YEAR END

Name
Thomas J. Shaw

President, CEO
(principal executive officer)

Michele M. Larios

Vice President,
General Counsel

Douglas W. Cowan

Vice President, CFO
(principal financial officer, principal accounting

officer)

Table of Contents

Name
Russell B. Kuhlman

Vice President, Sales Development

Kathryn M. Duesman

Executive Director, Global Health

PENSION BENEFITS

Number of Securities Underlying
Unexercised Options
Exercisable

Option Exercise
Price
($)

Option Awards

—

50,000
152,950
97,050

50,000
98,000

102,000

25

Number of Securities Underlying
Unexercised Options
Exercisable

13,100
43,450

20,700
53,550
66,450

—

1.05
0.81
1.30

1.05
0.81

1.30

Option Exercise
Price
($)

2.75
1.30

2.75
0.81
1.30

$
$
$

$
$

$

$
$

$
$
$

Option
Expiration
Date

—

12/27/2026
07/15/2019
11/18/2018

12/27/2026
07/15/2019

11/18/2018

Option
Expiration
Date
09/09/2026
11/18/2018

09/09/2026
07/15/2019
11/18/2018

We do not have a pension plan other than the 401(k) plan which is available to all employees on the first day of the month

after 90 days of service.

401(k) Plan

We implemented an employee savings and retirement plan (the “401(k) Plan”) in 2005 that is intended to be a tax-qualified
plan covering substantially all employees.  Under the terms of the 401(k) Plan, employees may elect to contribute up to 88% of their
compensation, or the statutory prescribed limit, if less.  We may, at our discretion, match employee contributions.  In the first quarter
of 2016, we reinstituted a policy of matching.  For 2016 and 2017, we matched each participant’s elective deferrals up to 2% of the
participant’s  compensation  for  the  pay  period.    We  made  matching  contributions  of  $145,474  in  2017,  of  which  $15,708  were  to
named  executive  officers.    We  made  matching  contributions  of  $122,369  in  2016,  of  which  $15,062  were  to  named  executive
officers.  There were no matching contributions in 2015.

POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE IN CONTROL

Other  than  the  information  set  forth  below  for  Mr.  Shaw,  no  other  named  executive  officer  has  a  contract  in  place  for

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
   
 
   
   
   
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
termination or change in control payments.

The following table identifies the types and amounts of payments that shall be made to Thomas J. Shaw, our CEO, in the
event of a termination of his employment or a change in control per his Employment Agreement.  Such payments shall be made by us
and  shall  be  one-time,  lump  sum  payments  except  as  indicated  below.    In  2017,  no  other  contract  existed  for  payments  upon
termination or change in control.

SUMMARY OF PAYMENTS UPON TERMINATION OR CHANGE IN CONTROL
ASSUMING OCCURRENCE AS OF DECEMBER 31, 2017

(1)

Salary
Through
Trigger
Event
Date
(2)
x

Amounts
Owed
Under
Benefit
Plans
(3)
x

Reimbursement of
Expenses
x

Undiscounted
Salary For a
Period of 24
Months

—

Payment
Equal to
90 Days’
Salary

Payment Triggering Event
Death

Disability

Termination With Cause

Termination Without Cause

Resignation (Other Than After a

Change in Control)

Resignation (After a Change in

Control)

Table of Contents

x

x

x

x

x

x

—

x

x

x

26

x

x

x

x

x

Value of
Payments

(4)
—

980,493

—

980,493

—

—

—

—

980,493

—

980,493

—

122,561

122,561

980,493

—

980,493

(1)           The above payments would be paid under Mr. Shaw’s agreement at certain times.  Any payments arising as a result of
disability  or  resignation  would  be  paid  no  sooner  than  six  months  and  one  day  from  the  termination  date  but  no  later  than  seven
months from the termination date.  Any payments arising as a result of death would be paid no later than the 90  day following the
death.  Payments arising as a result of termination with cause or termination without cause would be paid no later than the 30  day
following  the  date  of  termination,  except  that  any  amount  due  in  excess  of  an  amount  equal  to  the  lesser  of:  i)  two  times  annual
compensation or ii) two times the limit on compensation under section 401(17) of the Internal Revenue Code of 1986 shall be paid no
earlier than six months and one day after the date of termination but in no event later than seven months after the date of termination. 
Under  Mr.  Shaw’s  agreement,  Mr.  Shaw  has  agreed  to  a  one-year  non-compete,  not  to  hire  or  attempt  to  hire  employees  for  one
year, and not make known our customers or accounts or to call on or solicit our accounts or customers in the event of termination of
his employment for one year unless the termination is without cause or pursuant to a change of control.  However, it is not clear that
the above payments are conditioned on the performance of these contractual obligations.

th

th

(2)           Mr. Shaw is paid every two weeks.  Therefore, the maximum value for this column in the event the triggering event took
place immediately prior to a scheduled payment date is two weeks’ salary ($10,553).

(3)           Mr. Shaw participates in our benefit plans which do not discriminate in scope, terms, or operation in favor of executive
officers.  Such plans are generally available to all salaried employees.  Accordingly, the value of such payments is not included in the
“Value of Payments” column.

(4)           This value does not include payments under our benefit plans for reasons set forth in footnote 3 above.  In addition, this
value assumes that the triggering event occurred on December 31, 2017.  Authorized payments under the Employment Agreement are
also  capped  to  one  dollar  less  than  the  amount  that  would  cause  Mr.  Shaw  to  be  the  recipient  of  a  parachute  payment  under
Section 280G(b) of the Internal Revenue Code.

COMPENSATION OF DIRECTORS

The following table identifies the types and amounts of compensation earned by our current and former Directors (with the

exception of those that are named executive officers as described in footnote 1 to the table) in the last Fiscal Year:

DIRECTOR COMPENSATION TABLE FOR 2017

Name
(1)
Marco Laterza

Fees Earned or
Paid in Cash
($)

2,500

Total
($)

2,500

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amy Mack
Walter O. Bigby, Jr.
Darren E. Findley

2,500
2,500
1,000

2,500
2,500
1,000

(1)                      Thomas  J.  Shaw  and  Douglas  W.  Cowan  are  named  executive  officers  who  were  also  Directors  in  2017.    Their
compensation is reflected in the Summary Compensation and other tables presented earlier.

Narrative Explanation of Director Compensation Table for 2017

In  2017,  we  paid  each  non-employee  Director  a  fee  of  $500  per  meeting  and  reimbursed  travel  expenses,  if  airfare,  hotel,
and  other  reasonable  travel-related  expenses  were  incurred  to  attend  Board  meetings.    We  do  not  pay  any  additional  amounts  for
committee participation or special assignment.

Generally,  employee  Directors  are  compensated  on  an  at-will  basis  as  discussed  in  the  COMPENSATION  DISCUSSION
AND  ANALYSIS.    However,  one  employee,  Mr.  Thomas  J.  Shaw,  our  President  and  CEO,  is  compensated  pursuant  to  an
Employment Agreement.  Please see “Compensation Pursuant to Employment Agreement”, set forth above for an in depth summary
of the terms of such agreement.

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Compensation Committee Interlocks and Insider Participation

The Compensation and Benefits Committee is currently composed of Walter O. Bigby, Jr., Amy Mack, Marco Laterza, and
Darren E. Findley.  Each of these members of this committee is an independent Board member and none have ever been employees of
the Company.

There  are  no  interlocking  Directors  or  executive  officers  between  us  and  any  other  company.   Accordingly,  none  of  our
executive  officers  or  Directors  served  as  a  Director  or  executive  officer  for  another  entity  whose  executive  officers  or  Directors
served on our Board of Directors.

COMPENSATION POLICIES AND PRACTICES AS THEY RELATE TO RISK MANAGEMENT

We do not believe that risk-taking incentives are created by our compensation policies.  We do not have business units.  We
believe that our compensation expense is a reasonable percentage of revenues overall.  We have not set specific performance criteria
for the award of bonuses.  Salaries and bonuses, if any, are awarded based on skill, experience, and our overall revenues.  Non-cash
awards to employees are made periodically in the form of stock options, which we believe align the employees’ interests with those
of stockholders.  We review our compensation policies and practices as they relate to risk management objectives if compensation
amounts  are  materially  amended  or  if  our  risk  profile  changes.    No  changes  to  our  compensation  policies  and  practices  have  been
implemented as a result of changes to our risk profile.

PAY RATIO DISCLOSURE

The  ratio  of  the  Company’s  median  of  annual  total  compensation  for  employees  to  the  total  compensation  of  the  principal
executive officer is 1: 11.2.  The median of annual total compensation for all employees other than the principal executive officer was
$42,954.    The  total  compensation  for  the  principal  executive  officer  was  $479,694.    We  calculated  the  median  of  annual  total
compensation for all employees as of December 31, 2017 using payroll records.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

EQUITY COMPENSATION PLAN INFORMATION

The following table sets forth information relating to our equity compensation plans as of December 31, 2017:

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Equity Compensation Plan Information

Number of securities 
to be issued upon 
exercise of 

Weighted 
average exercise 
price of 
outstanding 
options, 

Number of securities 
remaining available for 
future issuance under 
equity compensation 
plans (excluding 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Plan category
Equity compensation plans approved by security holders

Total

outstanding options, 
warrants and rights
(a)
1,863,019
1,863,019

warrants and 
rights
(b)

securities reflected in 
column(a))
(c)

1.49
1.49

2,350,492
2,350,492

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS

The following table sets forth certain information regarding the beneficial ownership as of March 1, 2018, for each person
known by us to own beneficially 5% or more of our Common Stock.  Except pursuant to applicable community property laws, each
shareholder  identified  in  the  table  possesses  sole  voting  and  investment  power  with  respect  to  his  or  her  shares,  except  as  noted
below.

Title of Class
Common Stock

Name and Address of Beneficial Owner

Amount and Nature of 
Beneficial Ownership

Percent of
(1)
Class 

(2)
Thomas J. Shaw  
511 Lobo Lane 
Little Elm, TX 75068

(3)
Suzanne M. August
340 North Julia Circle 
St. Pete Beach, FL 33706

BML Investment Partners, L.P.
65 E Cedar - Suite 2 
Zionsville, IN 46077

(4)

(5)
Lillian E. Salerno  
777 7th Avenue Unit 308 
Washington DC 20001

17,585,854

3,800,000

2,137,540

1,646,000

53.8%

11.6%

6.5%

5.0%

(1)           The Percent of Class is calculated for the Common Stock class by dividing each beneficial owner’s Amount of Beneficial
Ownership, as shown in the table above, by the sum of the total outstanding Common Stock (32,666,454 shares) plus that beneficial
owner’s stock equivalents (options), if any.

(2)           2,770,000 of the shares are owned by the August 2010 Family Trust and August Gifting Trust (see footnote 3) but are
controlled by Mr. Shaw pursuant to a Voting Agreement.  These shares are permanently controlled by Mr. Shaw until such time as
they are sold. These shares are included in the share amounts and percentages for both Mr. Shaw and Ms. August in the above table. 
Mr. Shaw has investment power over 1,000,000 shares of Common Stock as Trustee pursuant to trust agreements for the benefit of
family members.  Ms. August has voting control over such 1,000,000 shares as Special Trustee (see footnote 3).  These shares are
included in the share amounts and percentages for both Mr. Shaw and Ms. August in the above table.

(3)           1,770,000 shares of these shares are controlled by Mr. Thomas J. Shaw pursuant to a Voting Agreement and are held by
the August 2010 Family Trust, for which Ms. August serves as Trustee.  These shares are included in the

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share amounts and percentages for both Mr. Shaw and Ms. August in the above table.  Ms. August has voting control over 1,000,000
shares  of  Common  Stock  as  Special  Trustee  pursuant  to  trust  agreements  for  the  benefit  of  family  members.    Mr.  Shaw  has
investment power over such 1,000,000 shares as Trustee.  These shares are included in the share amounts and percentages for both
Mr. Shaw and Ms. August in the above table.  Ms. August has investment power over 1,000,000 shares held by the August Gifting
Trust.

(4)           The number of shares held by this entity was obtained from a Schedule 13G filed on January 31, 2018.  Pursuant to the
Schedule 13G, this entity had only shared voting and dispositive power, not sole voting or dispositive power, for all of the indicated
shares.    A  footnote  to  the  Schedule  13G  filing  indicates  that  the  shared  ownership  may  be  with  Braden  M.  Leonard,  managing
member of the general partner of BML Investment Partners, L.P.

(5)           25,000 shares identified as Common Stock are shares which are obtainable by the exercise of a stock option.  500,000
shares identified as Common Stock are owned by a trust for which Ms. Salerno serves as trustee.

SECURITY OWNERSHIP OF MANAGEMENT AND DIRECTORS

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
   
 
 
 
 
  
  
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
The  following  table  sets  forth  certain  information  regarding  the  beneficial  ownership  of  our  capital  stock  as  of  March  1,
2018, for each named executive officer specified by Item 402 of Regulation S-K (i.e., our CEO, CFO, and three other highest paid
officers) and Director of the Company.  Except pursuant to applicable community property laws or as otherwise discussed below,
each shareholder identified in the table possesses sole voting and investment power with respect to his or her shares.

Title of Class
Common Stock
As a Group
As Individuals

Name of
Beneficial Owner

Amount and Nature of 
Beneficial Ownership

Percent
of Class
(1)

Named Executive Officers and Directors
(2)
Thomas J. Shaw
(3)
Michele M. Larios
Douglas W. Cowan
Russell B. Kuhlman
Marco Laterza
Walter O. Bigby, Jr.
Amy Mack

(4)
(5)

(7)

(8)

(6)

18,858,232
17,585,854
611,000
250,000
102,550
110,000
105,000
93,828

56.2%
53.8%
1.9%
<1%
<1%
<1%
<1%
<1%

(1)           The Percent of Class is calculated for the individuals holding Common Stock by dividing each beneficial owner’s Amount
of Beneficial Ownership, as shown in the table above, by the sum of the total outstanding Common Stock (32,666,454 shares) plus
that beneficial owner’s stock equivalents (options), if any.  The Percent of Class is calculated for the “As a Group” row by totaling all
of the Percent of Class percentages appearing in the chart.

(2)           2,770,000 of the shares are owned by the August 2010 Family Trust and the August Gifting Trust but are controlled by
Mr. Shaw pursuant to a Voting Agreement.  These shares are permanently controlled by Mr. Shaw until such time as they are sold. 
Mr. Shaw has investment power over 1,500,000 shares of Common Stock as Trustee pursuant to trust agreements for the benefit of
family members.

(3)           300,000 of these shares are acquirable by the exercise of stock options.  1,000 of these shares are owned by Ms. Larios’
children.  300,000 of these shares are owned by trusts for the benefit of non-family members for which Ms. Larios serves as trustee.

(4)           These shares are acquirable by the exercise of stock options.

(5)           56,550 of these shares are acquirable by the exercise of stock options.

(6)           65,000 of these shares are acquirable by the exercise of stock options.

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(7)           100,000 of these shares are acquirable by the exercise of stock options.

(8)           These shares are acquirable by the exercise of stock options.

Darren E. Findley, elected to the Board of Directors in September 2017, owns no shares of the Company.

There are no arrangements, the operation of which would result in a change in control of the Company, other than:

1.  The 2,770,000 shares owned by the August 2010 Family Trust and August Gifting Trust shall cease to be controlled by

Mr. Shaw under the Voting Agreement upon their sale to a third party for value; and

2.  Mr. Shaw has voting control over 16,085,854 shares of the currently outstanding shares of the Common Stock (49.2%)
and investment power over 14,815,854 shares (45.4%) and total beneficial ownership of 53.8% of the currently outstanding shares
of  the  Common  Stock.   Assuming  the  exercise  of  all  vested  options  and  conversion  of  all  outstanding  preferred  shares,  Mr.  Shaw
would have beneficial ownership of 49.8% of the Common Stock.  This calculation does not include the potential dilution from the
one million shares authorized for private sale to insiders.

Item 13. Certain Relati
onships and Related Transactions, and Director Independence

Related Party Transactions

We  believe  that  all  of  the  transactions  set  forth  below  were  made  on  terms  no  less  favorable  to  us  than  could  have  been
obtained  from  unaffiliated  third  parties.    In  accordance  with  our Audit  Committee  Charter,  the Audit  Committee  has  reviewed  and
approved  all  related  party  transactions.    In  particular,  the  Audit  Committee  reviews  all  proposed  transactions  where  the  amount
involved meets or exceeds $120,000.

 
 
 
 
 
 
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A royalty is paid to Thomas J. Shaw, our CEO, of 5% of gross sales of all licensed products sold to customers over the life
of  the  Technology  Licensing  Agreement  (See  Item  1  —  Patents,  Trademarks,  Licenses,  and  Proprietary  Rights).    A  royalty  of
$2,730,142 and $2,499,210 was paid to Thomas J. Shaw in 2017 and 2016, respectively.

In  2016,  the  Company  granted  a  right  to  three  of  our  executive  officers  to  purchase  shares  directly  from  the  Company. 
Thomas  J.  Shaw  exercised  such  right  on  January  12,  2017,  buying  two  million  shares  at  market  price  for  an  aggregate  purchase
price  of  $1.78  million  and  purchased  one  million  shares  at  market  price  on August  23,  2017  for  an  aggregate  purchase  price  of
$570,100.  Mr. Cowan and Ms. Larios are authorized to purchase 500,000 shares each at market price any time prior to December 9,
2018.  The approximate dollar value of these potential future purchases cannot be predicted.

In November 2016, the Compensation and Benefits Committee granted a stock option to Mr. Shaw for the purchase of three
million shares of Common Stock.  Such stock option terminated by its terms before becoming exercisable following a December 27,
2016 shareholder vote against such option.

Director Independence

The Board of Directors has the responsibility for establishing corporate policies and for our overall performance, although it
is  not  involved  in  day-to-day  operations.    Currently,  a  majority  of  the  Directors  serving  on  our  Board  of  Directors  are  independent
Directors  as  defined  in  the  listing  standards  of  the  NYSE American.    Our  current  independent  Directors  are  Marco  Laterza, Amy
Mack, Walter O. Bigby, Jr., and Darren E. Findley.  Each of our committees is constituted solely by independent Directors.

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Item 14. Principal Accounting Fees and Services.

AUDIT FEES

The  aggregate  fees  billed  by  Moss  Adams  LLP  for  professional  services  rendered  for  the  audit  of  our  annual  financial
statements for 2017 and 2016 and the reviews of the financial statements included in our Forms 10-Q for all quarters of 2017 and the
second  and  third  quarters  of  2016  and  services  normally  provided  by  the  accountant  in  connection  with  statutory  and  regulatory
filings for these periods were $203,232 and $176,876, respectively.

The aggregate fees billed by CF & Co., L.L.P. for professional services rendered for the reviews of the financial statements
included  in  our  Form  10-Q  for  the  first  quarter  of  2016  and  services  normally  provided  by  the  accountant  in  connection  with
statutory and regulatory filings for these periods were $30,000.

AUDIT RELATED FEES

The aggregate fees billed by Moss Adams LLP for professional services rendered for the audit of our 401(k) plan for 2017

and 2016 was $17,000 and $14,000, respectively.

TAX FEES

The  aggregate  fees  billed  by  Moss Adams  LLP  for  preparation  of  federal  and  state  income  tax  returns  and  tax  consulting

costs related to notices from taxing authorities for 2017 and 2016 was $72,755 and $52,980, respectively.

PRE-APPROVAL POLICIES AND PROCEDURES

The  engagement  of  the  independent  accountants  was  entered  into  pursuant  to  the  approval  policies  and  procedures  of  the
Audit Committee.  Before any independent accountant was engaged to render services, the engagement was approved by the Audit
Committee.    The  engagements  for  audit  and  tax  services  were  detailed  separately.    The Audit  Committee  implemented  its  approval
procedures, i.e., they were not delegated to any other party.  All of the services provided were pre-approved by the Audit Committee.

Item 15. Exhibits, Financial Statement Schedules.

PART IV

(a)

(1) All financial statements: See Retractable Technologies, Inc. Index to Financial Statements on Page F-2.

(2) Those financial statement schedules required to be filed by Item 8 of this form, and by paragraph (b) below. Schedule II-

Schedule of Valuation and Qualifying Accounts for the years ended December 31, 2017, 2016, and 2015:

Balance at
beginning
of period

Additions

Deductions

Balance at
end of period

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Provision for Inventories
Fiscal year ended 2015
Fiscal year ended 2016
Fiscal year ended 2017

Provision for Accounts Receivable

Fiscal year ended 2015
Fiscal year ended 2016
Fiscal year ended 2017

Table of Contents

Deferred Tax Valuation

Fiscal year ended 2015
Fiscal year ended 2016
Fiscal year ended 2017

Provision for Rebates

Fiscal year ended 2015
Fiscal year ended 2016
Fiscal year ended 2017

$
$
$

$
$
$

$
$
$

$
$
$

681,395
681,395
595,523

1,725,806
1,795,481
1,731,985

32

—
176,424
—

116,395
92,000
24,272

$
$
$

$
$
$

—
262,296
584

46,720
155,496
1,654,385

$
$
$

$
$
$

681,395
595,523
594,939

1,795,481
1,731,985
101,872

Balance at
beginning
of period

Additions

Deductions

$9,385,456
$7,751,972
$9,197,333

$            —
$1,445,361
$            —

$1,633,484
$            —
$3,371,379

Balance at
end of period

$7,751,972
$9,197,333
$5,825,954

(A)

(B)

(C)

$33,838,780
$41,171,880
$38,983,285

$19,488,956
$19,693,872
$21,738,072

$12,155,856
$21,882,467
$55,927,164

$41,171,880
$38,983,285
$4,794,193

(A)          Represents estimated rebates deducted from gross revenues

(B)          Represents rebates credited to the distributor and charge offs against the allowance

(C)                               Includes $4,115,628; $3,591,534; and $3,733,199 in Accounts payable for 2017, 2016, and 2015, respectively.

(3)           Exhibits:

The following exhibits are filed herewith or incorporated herein by reference to exhibits previously filed with the SEC.

(b)           Exhibits

Exhibit
No.
3(i)

3(ii)

4

10.1

10.2

10.3

10.4

10.5

10.6

10.7

10.8

Description of Document
Restated Certificate of Formation with Certificates of Designation, Preferences, Rights and Limitations of Class B
Preferred Stock (all Series)*

Fourth Amended and Restated Bylaws of RTI**

Restated Certificate of Formation with Certificates of Designation, Preferences, Rights and Limitations of Class B
Preferred Stock (all Series)*

Sample United States Distribution Agreement***

Sample Foreign Distribution Agreement***

Employment Agreement between RTI and Thomas J. Shaw dated as of January 1, 2008 (This is a management
compensation contract.)****

Technology License Agreement between Thomas J. Shaw and RTI dated the 23  day of June 1995***

rd

First Amendment to Technology License Agreement between Thomas J. Shaw and RTI dated the 3rd day of July,
2008*****

Second Amendment to Technology License Agreement between Thomas J. Shaw and Retractable
Technologies, Inc. dated as of the 7th day of September, 2012†

Retractable Technologies, Inc. First Amended 2008 Stock Option Plan††

◦
Thomas J. Shaw Nonqualified Stock Option Agreement Issued Outside of Any Plan

 
   
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
 
   
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents

33

Exhibit
No.
10.9

10.10

10.11

14

23

31.1

31.2

32

101

*

**

***

****

◦◦
Voting Agreement Between Thomas J. Shaw and Suzanne August dated November 8, 2006

Description of Document

Purchase Agreement dated as of January 12, 2017, by and between Retractable Technologies, Inc. and Thomas J.
Shaw†††

Purchase Agreement dated as of August 23, 2017, by and between Retractable Technologies, Inc. and Thomas J.
Shaw†††

Retractable Technologies, Inc. Code of Business Conduct and Ethics

◦◦◦

Consent of Independent Registered Public Accounting Firm

◦◦◦◦

Certification of Principal Executive Officer

◦◦◦◦

Certification of Principal Financial Officer

◦◦◦◦

Section 1350 Certifications

◦◦◦◦

The following materials from this report, formatted in XBRL (eXtensible Business Reporting Language): (i) Balance
Sheets  as  of  December  31,  2017,  and  2016, (ii)  the  Statements  of  Operations  for  the  years  ended  December  31,
2017,  2016,  and  2015,  (iii)  the  Statements  of  Changes  in  Stockholders’ Equity for the years ended December 31,
2017, 2016, and 2015, (iv) the Statements of Cash Flows for the years ended December 31, 2017, 2016, and 2015,
and (v) Notes to Financial Statements.

◦◦◦◦

Incorporated herein by reference to RTI’s Form 10-Q filed on November 15, 2010

Incorporated herein by reference to RTI’s Form 8-K filed on May 13, 2010

Incorporated herein by reference to RTI’s Registration Statement on Form 10-SB filed on June 23, 2000

Incorporated herein by reference to RTI’s Form 10-Q filed on November 14, 2008

*****

Incorporated herein by reference to RTI’s Form 10-K filed on March 31, 2009

†

††

†††

††††

◦

◦◦

◦◦◦

◦◦◦◦

(c)

Incorporated herein by reference to RTI’s Form 10-Q filed on November 14, 2012

Incorporated herein by reference to RTI’s Form 10-Q filed on November 14, 2014

Incorporated herein by reference to RTI’s Form 8-K filed on January 13, 2017

Incorporated herein by reference to RTI’s Form 8-K filed on August 24, 2017

Incorporated herein by reference to RTI’s Form 10-K filed on March 31, 2010

Incorporated herein by reference to RTI’s Schedule TO filed on October 17, 2008

Incorporated herein by reference to RTI’s Form 8-K filed on February 19, 2010

Filed herewith

Excluded Financial Statement Schedules: None

Table of Contents

34

SIGNATURES

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused

this report to be signed on its behalf by the undersigned, thereunto duly authorized.

RETRACTABLE TECHNOLOGIES, INC.
(Registrant)

By:

/s/ Thomas J. Shaw
THOMAS J. SHAW
CHAIRMAN, PRESIDENT, AND CHIEF EXECUTIVE
OFFICER

Date: April 2, 2018

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.

/s/ Douglas W. Cowan
DOUGLAS W. COWAN
VICE PRESIDENT, CHIEF FINANCIAL OFFICER, PRINCIPAL
ACCOUNTING OFFICER, TREASURER, AND DIRECTOR

April 2, 2018

/s/ Amy Mack
AMY MACK
DIRECTOR

April 2, 2018

/s/ Marco Laterza
MARCO LATERZA
DIRECTOR

April 2, 2018

/s/ Walter O. Bigby, Jr.
WALTER O. BIGBY, JR.
DIRECTOR

April 2, 2018

/s/ Darren E. Findley
DARREN E. FINDLEY
DIRECTOR

April 2, 2018

35

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We  consent  to  the  incorporation  by  reference  in  the  Registration  Statements  on  Form  S-8  (Nos.  333-155875  and  333-206310)  of
Retractable Technologies, Inc. of our report dated April 2, 2018, relating to the financial statements and financial statement schedule
of  Retractable  Technologies,  Inc.,  appearing  in  this Annual  Report  on  Form  10-K  of  Retractable  Technologies,  Inc.  for  the  year
ended December 31, 2017.

Exhibit 23

/s/ Moss Adams LLP

Dallas, Texas
April 2, 2018

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

Exhibit 31.1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
I, Thomas J. Shaw, certify that:

1. I have reviewed this annual report on Form 10-K of Retractable Technologies, Inc.;

2.  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;

3.  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;

4.  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)    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;

b)    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;

c)     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

d)        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) 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

b) 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.

Date:      April 2, 2018

/s/ Thomas J. Shaw
THOMAS J. SHAW
PRESIDENT, CHAIRMAN, AND
CHIEF EXECUTIVE OFFICER

Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

I, Douglas W. Cowan, certify that:

1. I have reviewed this annual report on Form 10-K of Retractable Technologies, Inc.;

2.  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;

3.  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;

4.  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)    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;

b )    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;

c)     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

d)        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) 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

b) 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.

Date:      April 2, 2018

/s/ Douglas W. Cowan
DOUGLAS W. COWAN
VICE PRESIDENT, CHIEF FINANCIAL
OFFICER AND PRINCIPAL
ACCOUNTING OFFICER

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Exhibit 32

Solely in connection with the filing of the Annual Report of Retractable Technologies, Inc. (the “Company”) on Form 10-K for the
period  ended  December  31,  2017,  as  filed  with  the  United  States  Securities  and  Exchange  Commission  on  the  date  hereof  (the
“Report”), the undersigned Thomas J. Shaw, Chief Executive Officer, and Douglas W. Cowan,  Chief  Financial  Officer,  do  hereby
certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of
the Company.

Date:      April 2, 2018

/s/ Thomas J. Shaw
THOMAS J. SHAW
PRESIDENT, CHAIRMAN, AND CHIEF EXECUTIVE
OFFICER

/s/ Douglas W. Cowan
DOUGLAS W. COWAN
VICE PRESIDENT, CHIEF FINANCIAL OFFICER,
AND PRINCIPAL ACCOUNTING OFFICER