UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
☒
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31 , 2021
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from: _____________to ______________
Commission
File Number: 001-39199
TRxADE
HEALTH, INC.
(Exact
name of registrant as specified in its charter)
Delaware
46-3673928
(State
or other jurisdiction of
(I.R.S.
Employer
incorporation
or organization)
Identification
No.)
2420
Brunello Trace.
Lutz ,
Florida
33558
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code: (800) 261-0281
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
Common
Stock, $0.00001 Par Value Per Share
MEDS
The
NASDAQ Stock Market LLC
(The
NASDAQ Capital Market)
Securities
registered pursuant to Section 12(g) of the Act:
None.
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
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 ☐ No ☒
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 ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “ large accelerated filer, ” “ accelerated filer ”
and “ smaller reporting company ” and “ emerging growth company ” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☒
Smaller
reporting company ☒
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant as of the last business day
of the registrant’s most recently completed second fiscal quarter was approximately $ 16,921,890 . For purposes of calculating the
aggregate market value of shares held by non-affiliates, we have assumed that all outstanding shares are held by non-affiliates, except
for shares held by each of our executive officers, directors and 5% or greater stockholders. In the case of 5% or greater stockholders,
we have not deemed such stockholders to be affiliates unless there are facts and circumstances which would indicate that such stockholders
exercise any control over our company, or unless they hold 10% or more of our outstanding common stock. These assumptions should not
be deemed to constitute an admission that all executive officers, directors and 5% or greater stockholders are, in fact, affiliates of
our company, or that there are no other persons who may be deemed to be affiliates of our company. Further information concerning shareholdings
of our officers, directors and principal stockholders is included or incorporated by reference in Part III, Item 12 of this Annual Report
on Form 10-K.
As
of March 28, 2022, there were 8,181,041
shares of common stock issued and outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions of the registrant’s definitive proxy statement relating to its 2022 annual meeting of stockholders (the “ 2022 Proxy Statement ”) are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. The 2022 Proxy Statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates.
TABLE
OF CONTENTS
Page
Glossary
3
Cautionary Statement Regarding Forward-Looking Information
5
PART I
Item
1.
Business
6
Item
1A.
Risk Factors
19
Item
1B.
Unresolved Staff Comments
51
Item
2.
Properties
51
Item
3.
Legal Proceedings
52
Item
4.
Mine Safety Disclosures
52
PART II
Item
5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
53
Item
6.
[Reserved]
54
Item
7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
54
Item
7A.
Quantitative and Qualitative Disclosures About Market Risk
63
Item
8.
Financial Statements and Supplemental Data
64
Item
9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
85
Item
9A.
Controls and Procedures
85
Item
9B.
Other Information
86
Item
9C.
Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
86
PART III
Item
10.
Directors, Executive Officers and Corporate Governance
87
Item
11.
Executive Compensation
87
Item
12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
87
Item
13.
Certain Relationships and Related Transactions, and Director Independence
87
Item
14.
Principal Accountant Fees and Services
87
PART IV
Item
15.
Exhibits, Financial Statements and Schedules
88
Item
16.
Form 10–K Summary
90
Signatures
91
2
GLOSSARY
The
following are abbreviations and definitions of certain terms used in this Report, which are commonly used in the pharmaceutical industry:
“ ACA ”
means the Patient Protection and Affordable Care Act, often shortened to the Affordable Care Act, nicknamed Obamacare, which is a U.S.
federal statute which provides numerous rights and protections that make health coverage fairer and easier to understand, along with
subsidies (through “ premium tax credits ” and “ cost-sharing reductions ”) to make it more affordable.
The law also expands the Medicaid program to cover more people with low incomes.
“ ADR ”
means Authorized Distributor of Record. Under current federal law, an ADR means a distributor with whom a manufacturer has established
an ongoing relationship to distribute such manufacturer’s products.
“ ANDA ”
means an abbreviated new drug application which contains data which is submitted to the FDA for the review and potential approval of
a generic drug product.
“ CMS ”
means the Centers for Medicare & Medicaid Services, which is a federal agency within the HHS that administers the Medicare program
and works in partnership with state governments to administer Medicaid.
“ CSA ”
means the Controlled Substances Act, the statute establishing federal U.S. drug policy under which the manufacture, importation, possession,
use, and distribution of certain substances is regulated.
“ DEA ”
means the Drug Enforcement Administration, a United States federal law enforcement agency under the United States Department of Justice,
tasked with combating drug trafficking and distribution within the United States.
“ DQSA ”
means the Drug Quality and Security Act which is a law that amended the FFDCA to grant the FDA more authority to regulate and monitor
the manufacturing of compounded drugs.
“ EUA ”
means an Emergency Use Authorization filed with the FDA. Under section 564 of the FFDCA, the FDA Commissioner may allow unapproved medical
products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening
diseases or when there are no adequate, approved, and available alternatives.
“ FDA ”
means U.S. The Food and Drug Administration, which is a federal agency of the United States Department of Health and Human Services.
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs,
biological products, and medical devices; and by ensuring the safety of U.S. food supply, cosmetics, and products that emit radiation.
“ FDAAA ”
means the Food and Drug Administration Amendments Act of 2007 which reviewed, expanded, and reaffirmed several existing pieces of legislation
regulating the FDA.
“ FFDCA ”
means the Federal Food, Drug and Cosmetic Act, which is a set of U.S. laws passed by Congress in 1938 giving authority to the FDA to
oversee the safety of food, drugs, medical devices, and cosmetics.
“ Generic
drugs ” are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration,
risks, safety, and strength as the original drug.
“ Health
plan ” means health insurance coverage provided by an individual or group that provides or pays the cost of medical care. Health
plans can be provided by public (Medicaid) or private (an employer) entities.
“ HHS ”,
the U.S. Department of Health and Human Services also known as the Health Department, is a cabinet-level department of the U.S. federal
government with the goal of protecting the health of all Americans and providing essential human services.
3
“ HIPAA ”
means the Health Insurance Portability and Accountability Act of 1996, which has the goal of making it easier for people to keep health
insurance, protect the confidentiality and security of healthcare information and help the healthcare industry control administrative
costs.
“ Individually
identifiable health information ” is defined by HIPPA to mean information that is a subset of health information, including
demographic information collected from an individual, and: (1) is created or received by a health care provider, health plan, employer,
or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual;
the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual;
and (a) that identifies the individual; or (b) with respect to which there is reasonable basis to believe the information can be used
to identify the individual.
“ Medicaid ”
is a federal and state health insurance program in the U.S. that helps with medical costs for some people with limited income and resources.
Medicaid also offers benefits not normally covered by Medicare, including nursing home care and personal care services.
“ Medicare ”
is a national health insurance program in the U.S. It primarily provides health insurance for Americans aged 65 and older, but also for
some younger people with disability status as determined by the Social Security Administration, as well as people with end stage renal
disease and amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease).
“ NDC ”
means a National Drug Code, a unique 10-digit, 3-segment number. It is a universal product identifier for human drugs in the United States.
The code is present on all non-prescription (OTC) and prescription medication packages and inserts in the U.S. The 3 segments of the
NDC identify the labeler, the product, and the commercial package size.
“ PBM ”
means a Pharmacy Benefits Manager. In the United States, a PBM is a third-party administrator of prescription drug programs for commercial
health plans, self-insured employer plans, Medicare Part D plans (prescription drug plans), the Federal Employees Health Benefits Program,
and state government employee plans.
“ PDMA ”
means the Prescription Drug Marketing Act of 1987. The PDMA establishes legal safeguards for prescription drug distribution to ensure
safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired
prescription drugs.
“ Pedigree
tracking laws ” mean laws which help ensure the integrity of the U.S. drug supply chain through the use of drug pedigrees, verifiable
written or electronic documents that track each move in a drug’s journey from manufacturer to patient.
“ PPE ”
means personal protective equipment, which is worn to minimize exposure to hazards that cause serious workplace injuries and illnesses.
When used below, PPE typically refers to protective equipment used by medical personnel, including masks, sanitizers and gloves.
“ Rebates ”
these are provided by manufacturers and are typically based on the ability of a payer to move market share for the manufacturer’s
product. Rebates are confidential.
“ SNI ”
means Serialized Numerical Identifier. Pursuant to FDA requirements, a product’s SNI has to include the item’s NDC and unique
Serial Number (SN).
“ Wholesaler ”
typically, the wholesaler is the first purchaser of a drug product – direct from the manufacturer. Wholesalers buy large quantities
and then resell either direct to provider-purchasers (like a large health system, pharmacy or pharmacy chain), or resell to smaller,
regional distributors for regional or local distribution to retail pharmacies and hospitals.
4
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING INFORMATION
This
Annual Report on Form 10-K (this “ Report ”) contains forward-looking statements within the meaning of the federal securities
laws, including the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the
following words: “ anticipate ,” “ believe ,” “ continue ,” “ could ,”
“ estimate ,” “ expect ,” “ intend ,” “ may ,” “ ongoing, ”
“ plan ,” “ potential ,” “ predict ,” “ project ,” “ should ,”
or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking
statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or
by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the
statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity,
performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in
this Report. These factors include those set forth below and those disclosed under “ Risk Factors ”, below. These factors
include, but are not limited to:
●
Risks
of our operations not being profitable;
●
Claims
relating to alleged violations of intellectual property rights of others;
●
Technical
problems with our websites;
●
Risks
relating to implementing our acquisition strategies;
●
Our
ability to manage our growth;
●
Negative
effects on our operations associated with the opioid pain medication health crisis;
●
Regulatory
and licensing requirement risks;
●
Risks
related to changes in the U.S. healthcare environment;
●
The
status of our information systems, facilities and distribution networks;
●
Risks
associated with the operations of our more established competitors;
●
Regulatory
changes;
●
Healthcare
fraud;
●
The
continued effects of COVID-19, governmental responses thereto, economic downturns and possible recessions caused thereby;
●
Inflation;
●
Changes
in laws or regulations relating to our operations;
●
Privacy
laws;
●
System
errors;
●
Dependence
on current management;
●
Our
growth strategy; and
●
Other
risks disclosed below under, and incorporated by reference in, “ Risk Factors ”.
You
should read the matters described and incorporated by reference in “ Risk Factors ” and the other cautionary statements
made in this Report, and incorporated by reference herein, as being applicable to all related forward-looking statements wherever they
appear in this Report. We cannot assure you that the forward-looking statements in this Report will prove to be accurate and therefore
prospective investors are encouraged not to place undue reliance on forward-looking statements.
Forward-looking
statements speak only as of the date of this Report or the date of any document incorporated by reference in this Report, as applicable.
Except to the extent required by applicable law or regulation, we do not undertake any obligation to update forward-looking statements
to reflect events or circumstances after the date of this Report or to reflect the occurrence of unanticipated events.
5
PART
I
ITEM
1.
BUSINESS
INTRODUCTION
This
information included in this Annual Report on Form 10-K should be read in conjunction with the consolidated financial statements and
related notes in “ Item 8. Financial Statements and Supplemental Data ” of this Report.
Please
see the “ Glossary ” above for a list of abbreviations and definitions used throughout this Report.
Our
logo and some of our trademarks and tradenames are used in this Report. This Report also includes trademarks, tradenames and service
marks that are the property of others. Solely for convenience, trademarks, tradenames and service marks referred to in this Report may
appear without the ®, ™ and SM symbols. References to our trademarks, tradenames and service marks are not intended to indicate
in any way that we will not assert to the fullest extent under applicable law our rights or the rights of the applicable licensors if
any, nor that respective owners to other intellectual property rights will not assert, to the fullest extent under applicable law, their
rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with,
or endorsement or sponsorship of us by, any other companies.
The
market data and certain other statistical information used throughout this Report are based on independent industry publications, reports
by market research firms or other independent sources that we believe to be reliable sources. Industry publications and third-party research,
surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do
not guarantee the accuracy or completeness of such information. We are responsible for all of the disclosures contained in this Report,
and we believe these industry publications and third-party research, surveys and studies are reliable. While we are not aware of any
misstatements regarding any third-party information presented in this Report, their estimates, in particular, as they relate to projections,
involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those
discussed under the section entitled “ Risk Factors ” beginning on page 19 of this Report. These and other factors could
cause our future performance to differ materially from our assumptions and estimates. Some market and other data included herein, as
well as the data of competitors as they relate to TRxADE HEALTH, INC., is also based on our good faith estimates.
Our
fiscal year ends on December 31st. Interim results are presented on a quarterly basis for the quarters ended March 31st, June 30th, and
September 30th, the first quarter, second quarter and third quarter, respectively, with the quarter ending December 31st being referenced
herein as our fourth quarter. Fiscal 2021 means the year ended December 31, 2021, whereas fiscal 2020 means the year ended December 31,
2020.
Unless
the context requires otherwise, references to the “ Company, ” “ we, ” “ us, ” “ our, ”
“ Trxade ”, “ Trxade Group ” and “ TRxADE HEALTH, INC. ” refer specifically to TRxADE
HEALTH, INC. and its consolidated subsidiaries.
In
addition, unless the context otherwise requires and for the purposes of this Report only:
●
“ Exchange
Act ” refers to the Securities Exchange Act of 1934, as amended;
●
“ SEC ”
or the “ Commission ” refers to the United States Securities and Exchange Commission; and
●
“ Securities
Act ” refers to the Securities Act of 1933, as amended.
Where
You Can Find Other Information
We
file annual, quarterly, and current reports, proxy statements and other information with the SEC. Our SEC filings are available to the
public over the Internet at the SEC’s website at www.sec.gov and are available for download, free of charge, soon after
such reports are filed with or furnished to the SEC, on the “ NASDAQ: MEDS ,” “ SEC Filings ” page
of our website at www.rx.trxade.com . Copies of documents filed by us with the SEC
are also available from us without charge, upon oral or written request to our Secretary, who can be contacted at the address and telephone
number set forth on the cover page of this Report. Our website addresses are www.rx.trxade.com
www.trxadegroup.com , www.rx.trxade.com , www.bonumhealth.com , www.comsprx.com , and www.rxintegra.com .
Information on our websites is not incorporated by reference into this Form 10-K. The information
on, or that may be accessed through, our website is not incorporated by reference into this Report and should not be considered a part
of this Report.
6
CORPORATE
AND ORGANIZATIONAL HISTORY
Background
of XCEL
Our
Company was incorporated in Delaware on July 15, 2005, as “ Bluebird Exploration Company ” (“ Bluebird ”).
Bluebird was originally formed to engage in the exploitation of mineral properties. In December 2008, Bluebird changed its name to “ Xcellink
International, Inc. ” (“ XCEL ”), and subsequently announced that its business plan was being expanded to include
the development and marketing of platform-independent customer-centric payment systems and methodologies. XCEL was unable to raise the
funds necessary to implement its business strategy, never generated any revenue and was reporting as a “ shell ” corporation.
On January 9, 2014, Trxade Group, Inc., a privately held Nevada corporation, merged with and into XCEL, and XCEL changed its name to
“ Trxade Group, Inc. ” On June 1, 2021, the Company changed its name from “Trxade Group, Inc” to “TRxADE
HEALTH, INC.”
Background
of Trxade
PharmaCycle
LLC, a Nevada limited liability company (“ PharmaCycle ”), was formed in August 2010 by Prashant Patel, our President,
to serve as a web-based market platform designed to enable trading among healthcare buyers and sellers of pharmaceuticals, accessories
and services. In January 2013, PharmaCycle converted into a Florida corporation and changed its name to Trxade, Inc. (“ Trxade
Florida ”). In May 2013, Trxade Florida created a new wholly-owned subsidiary, Trxade Group, Inc., a Nevada corporation (“ Trxade
Nevada ”). Trxade Nevada acquired Trxade Florida pursuant to a reverse triangular merger, resulting in Trxade Florida becoming
a wholly-owned subsidiary of Trxade Nevada (the “ Nevada-Florida Merger ”). The sole purpose of the Nevada-Florida Merger
was to provide for a holding company to own Trxade Florida, the operating company. At all times, up to the Nevada-Florida Merger, Trxade
Florida was capitalized exclusively by cash capital contributions from Messrs. Suren Ajjarapu and Patel, our Chief Executive Officer
and President, respectively. Immediately following the Nevada-Florida Merger, Messrs. Ajjarapu and Patel collectively owned 99% of Trxade
Nevada. After the Nevada-Florida Merger (but prior to the merger with XCEL), Trxade Nevada raised $670,000 through the sale of its preferred
stock in private placements made to third party investors.
Reverse
Merger with Trxade
On
September 26, 2008, Mark Fingarson, the former President, sole Director and controlling shareholder of XCEL, sold 80,000,000 shares of
XCEL (prior to the Merger Reverse Split and Reverse Stock Split (each discussed and defined below)) to XCEL’s then attorney, Ron
McIntyre. On November 22, 2013, Trxade Nevada acquired Mr. McIntyre’s controlling interest of 80,000,000 shares in XCEL pursuant
to a Purchase and Sale Agreement dated November 7, 2013. At the time of the sale, XCEL had 104,160,000 shares of common stock issued
and outstanding, including the 80,000,000 shares of stock acquired by Trxade Nevada (prior to the Merger Reverse Split and Reverse Stock
Split (each discussed and defined below)).
On
December 16, 2013, Trxade Nevada and XCEL entered into a definitive merger agreement (the “ Merger Agreement ”) providing
for the merger (the “ Merger ”) of Trxade Nevada with and into XCEL, with XCEL continuing as the surviving corporation.
The Merger closed on January 8, 2014. Under the terms of the Merger Agreement, we amended our certificate of incorporation and changed
our name to “ Trxade Group, Inc., ” and changed our trading symbol to “ TRXD ”.
7
Recapitalization
of Common Stock by a Reverse Split and Increase of Authorized Shares of Stock
We
also reversed our issued and outstanding stock at the ratio of one for one thousand (1:1,000) shares effective upon the closing of the
Merger (the “ Merger Reverse Split ”). In connection with the Merger Reverse Split, 104,160,000 outstanding shares of
our common stock, including the 80,000,000 shares held by Trxade Nevada, were exchanged for 104,160 post-Merger Reverse Split shares
of common stock. As a result of the Merger, Trxade Nevada stockholders holding 28,800,000 shares of common stock and 670,000 shares of
Series A Preferred Stock converted their shares on a one-to-one basis into 28,800,000 shares of our common stock and 670,000 shares of
our Series A Preferred Stock, for an aggregate total of 29,470,000 shares. Further, 100,000 shares of our common stock (on a post-Reverse
Split basis and considering the Reverse Stock Split (discussed below)) were issued following the Merger in connection with the conversion
of our promissory notes. The 80,000,000 pre-Merger shares held by Trxade Nevada, which amounted to 13,334 shares (on a post-Reverse Split
basis and taking into account the Reverse Stock Split), reverted to treasury stock of the Company. Except as otherwise disclosed, the
share amounts in the paragraph above have not been adjusted for the Merger Reverse Split or the Reverse Stock Split.
February
2020 Reverse Stock Split and NASDAQ Capital Market Listing
On
October 9, 2019, our Board of Directors, and on October 15, 2019, stockholders holding a majority of our outstanding voting shares, approved
resolutions authorizing a reverse stock split of the outstanding shares of our common stock in the range from one-for-two (1-for-2) to
one-for-ten (1-for-10), and provided authority to our Board of Directors to select the ratio of the reverse stock split in their discretion
(the “ Stockholder Authority ”). On February 12, 2020, the Board of Directors of the Company approved a stock split
ratio of 1-for-6 (“ Reverse Stock Split ”) in connection with the Stockholder Authority and the Company filed a Certificate
of Amendment with the Secretary of Delaware to affect the Reverse Stock Split. The Reverse Stock Split became effective at 12:01 a.m.
Eastern Standard Time on February 13, 2020. The Reverse Stock Split was completed in order to allow us to meet the initial criteria of
The NASDAQ Capital Market.
Our
common stock was approved for listing on The NASDAQ Capital Market under the symbol “ MEDS ”, on February 13, 2020.
Subsidiaries
We
own 100% of Trxade Inc. (a Florida corporation). This subsidiary is included in our attached consolidated financial statements and is
engaged in the same line of business as Trxade. Trxade Inc. is a web-based market platform that enables commerce among healthcare buyers
and sellers of pharmaceuticals, accessories and services.
We
own 100% of Integra Pharma Solutions, LLC (formerly Pinnacle Tek, Inc., a Florida corporation) founded by Mr. Suren Ajjarapu, our CEO,
in 2011 (“ Integra ”). Until the end of 2016, Integra served as our technology consultant provider, but we discontinued
that line of business in 2016. Integra now serves as our logistics company for pharmaceutical distribution.
We
own 100% of Community Specialty Pharmacy, LLC, an independent retail specialty pharmacy with a focus on specialty medications.
We
own 100% of Alliance Pharma Solutions, LLC (d.b.a. DelivMeds), a Florida limited liability company, which was founded in
January 2018 (“ Alliance ”). Alliance previously owned 30% of SyncHealth MSO, LLC (“ SyncHealth ”)
which was part of a joint venture formed in January 2019 with PanOptic Health, LLC (“ PanOptic ”) with the goal of enabling
independent retail pharmacies to better compete with large national pharmacies on pricing, distribution and logistics. We did not realize
any income from the joint venture, and we terminated the joint venture agreements pursuant to their terms effective as of January 31,
2020, and assigned the 30% ownership of SyncHealth back to PanOptic. As of February 1, 2020, we own no equity in SyncHealth and only
the terms of the agreements relating to confidentiality, non-solicitation and each party’s obligation to cease use of the other
party’s intellectual property survive the termination.
We
own 100% of Bonum Health, LLC, a Delaware limited liability company which owns our “ Bonum Health Hub ” assets and operations
as discussed in further detail below.
8
We
previously owned 100% of MedCheks, LLC, a Delaware limited liability company which was formed in January 2021, had no revenue in 2021
and was dissolved in December 2021.
We
previously owned 100% of PharmCentrix, LLC, a Delaware limited liability company which had no revenue in 2020 and was dissolved in December
2020.
Acquisition
of Community Specialty Pharmacy, LLC
On
October 15, 2018, the Company entered into and consummated the purchase of 100% of the equity interests of Community Specialty Pharmacy,
LLC, a Florida limited liability company, (“ CSP ”), pursuant to the terms and conditions of the Membership Interest
Purchase Agreement, entered into by and among the Company as the buyer, and CSP, and Nikul Panchal, the equity owner of CSP, a non-executive
officer of the Company (collectively, the “ Seller ”). The purchase price for the 100% equity interest in CSP was $300,000
in cash, a promissory note issued by the Company in the amount of $300,000, and warrants to purchase 67,585 shares of common stock of
the Company (on a post-Reverse Split basis and taking into account the Reverse Stock Split) of which 33% of such warrants were revocable
by the Company prior to October 15, 2019 (but were not revoked); 33% were revocable by the Company prior to October 15, 2020 (but were
not revoked); and the remaining 33% of such warrants are revocable by the Company prior to October 15, 2021 (which were revoked on September
23, 2021), which are exercisable for eight (8) years from the issuance date at a strike price of $0.06 per share. As of the date of this
Report, there are no warrants to purchase shares of common stock remain outstanding in connection with the purchase.
SyncHealth
MSO, LLC Joint Venture
On
January 17, 2019, the Company and Alliance Pharma Solutions, LLC, a Delaware limited liability company and wholly-owned subsidiary of
the Company (hereafter “ Alliance, ” with Alliance and Trxade referred to collectively herein as the “ Trxade
Parties ”), entered into a transaction effective as of January 17, 2019 with PanOptic Health, LLC, a Delaware limited liability
company (“ PanOptic ”), to create a new entity, SyncHealth MSO, LLC (“ SyncHealth ”) as part of a joint
venture to enable independent retail pharmacies to better compete with large national pharmacies on pricing, distribution and logistics.
As part of the transaction Alliance owned 30% of SyncHealth. We did not realize any income from the joint venture, and we terminated
the joint venture agreements pursuant to their terms effective as of January 31, 2020, and assigned the 30% ownership of SyncHealth back
to PanOptic. As of February 1, 2020, we own no equity in SyncHealth and only the terms of the agreements relating to confidentiality,
non-solicitation and each party’s obligation to cease use of the other party’s intellectual property survive the termination.
Bonum
Health Asset Acquisition
On
October 23, 2019, Bonum Health, LLC, a Delaware limited liability company, and a then newly formed wholly-owned subsidiary of the Company
(“ Bonum Health ”) entered into an Asset Purchase Agreement with Bonum Health, LLC, a Florida limited liability company
(“ Seller ”) and the sole member of the Seller (the “ Member ”). Pursuant to the Asset Purchase Agreement,
the Company (through Bonum Health) acquired from the Seller, certain specified assets and certain specified contracts associated with
the assets of the Seller’s operation as a telehealth service provider (the Tele Meds Platform)(the “ Assets ”).
Included with the acquisition of the Assets, were contracts (relating to the Assets), intellectual property for the Bonum Health Tele
Medicine software & Technology and personal computers. The Company agreed to provide the Seller consideration equal to 41,667 shares
of restricted common stock of the Company at the closing, and the Seller had the right to earn up to an additional 108,334 shares of
restricted common stock of the Company in the event certain milestones were met within the first anniversary of the Closing date, none
of which were met.
The
Asset Purchase Agreement includes a three year non-compete requirement, prohibiting the Seller and the Member from competing against
the Assets, customary representations and indemnification obligations, subject to a $25,000 minimal claim amount and certain limitations
on liability disclosed in the Asset Purchase Agreement.
Subsequent
to the acquisition, the Company determined that the assets were not usable and wrote off the value of the assets amounting to approximately
$369,000.
9
BUSINESS
OF TRXADE
Company
Overview
We
are a health services IT company focused on digitalizing the retail pharmacy experience by optimizing drug procurement, the prescription
journey and patient engagement in the U.S. and have designed and developed, and now own and operate, a business-to-business web-based
marketplace. Our core service brings the nation’s independent pharmacies, accredited national suppliers, and manufacturers of pharmaceuticals
together to provide efficient and transparent buying and selling opportunities.
We
began operations as Trxade Group, Inc., a Nevada corporation (“ Trxade Nevada ”) in August of 2010 and spent over two
years creating and enhancing our web-based services. The Company changed its name on June 1, 2021, from “Trxade Group, Inc”
to “TRxADE HEALTH, INC.” Our services provide pricing transparency, purchasing capabilities and other value-added services
on a single platform focused on serving the nation’s approximately 19,397 independent pharmacies with annual purchasing power of
$67.1 billion (according to the National Community of Pharmacists Association’s 2021 Digest). Our national wholesale supply partners
and manufacturers are able to fulfill orders on our platform in real-time and provide pharmacies and wholesale suppliers with cost-saving
payment terms and next-day delivery capabilities in unrestrictive states. We have expanded significantly since 2015 and now serve
approximately 13,100+ registered members on our sales platform.
Our
Principal Products and Services and their Markets.
Trxade.com
is a web-based pharmaceutical marketplace engaged in promoting and enabling commerce among independent pharmacies, small chains,
hospitals, clinics, and alternate dispensing sites with large pharmaceutical suppliers nationally. Our marketplace has over 60 national
and regional pharmaceutical suppliers providing over 120,000 branded and generic drugs, including over-the-counter drugs (OTCs), and
drugs available for purchase by pharmacists. We serve approximately 13,100+ registered members, providing access to Trxade’s
proprietary pharmaceutical database and data analytics regarding medication pricing. We generate revenue from these services by charging
a transaction fee to the seller of the products for sales conducted via the Trxade platform. The buyers do not bear the cost of transaction
fees for the purchases that they make, nor do they pay a fee to join or register with our platform. Substantially all of our revenues
during the years ended December 31, 2021 and 2020, were from platform revenue generated on www.rx.trxade.com , product sales through
Integra Pharma Solutions, LLC, and prescription sales through Community Specialty Pharmacy, LLC.
Status
of current products and services.
We
have a number of products and services still in development, which are described below.
Integra
Pharma Solutions, LLC . Integra is intended to serve as our logistics company for pharmaceutical distribution.
Community
Specialty Pharmacy, LLC . We acquired Community Specialty Pharmacy, LLC, a Florida limited liability company (“ CSP ”),
on October 15, 2018. CSP is an accredited pharmacy located in St. Petersburg, Florida. CSP has a focus on specialty medications. The
company operates with an innovative pharmacy model which offers home delivery services to any patient thereby providing convenience.
Delivmeds.com .
Delivmeds.com was launched in late 2018 as a consumer-based app to provide delivery of pharmaceutical products associated with
Alliance Pharma Solutions, LLC. We are currently working on reformulating the application from a prescription delivery portal to a fully
integrated, interoperable, end-to-end prescription delivery and medication adherence tool. The new product has been rebranded and is
targeted for consumer re-release and use in the near future. To date, we have not generated any revenue from this product.
Trxade
Prime. Trxade Prime allows pharmacy members on the Trxade platform to process, consolidate
and ship purchase orders that are placed directly with Trxade suppliers via the Trxade Prime service. This is at no cost, with the goal
of offering a single tool with one low order minimum, one invoice, one package and one delivery from multiple quality wholesalers and
distributors. Revenue has been generated from this service though our Integra subsidiary, which provides the consolidation of the orders.
10
Bonum
Health Hub and Application . The “ Bonum Health Hub ”, a self-enclosed, free standing virtual examination room, was
launched by the Company’s wholly-owned Bonum Health, LLC subsidiary, in November 2019 and was expected to be operational in April
2020; however, due to the COVID-19 pandemic, the Company does not anticipate installations moving forward, and has taken a write off
of the hubs purchased at June 30, 2021 in the amount of $143,891, which is included under loss on inventory investments in the statement
of operations for the year ended December 31, 2021, in Note 8 - Other Receivables ” to the Notes to Consolidated Financial Statements
included herein under “ Item 8. Financial Statements and Supplemental Data ”.
The
“ Bonum Health app ”, which provides an overall healthcare experience comparable to a Primary Care practitioner, and
an online portal as a personal electronic medical record and scheduling system is available on a subscription basis, primarily as a stand-alone
telehealth software application that can be licensed on a business-to-business (B2B) model to clients as an employment health benefit
for the clients’ employees. Revenue has been generated from this service through our Bonum subsidiary.
Bonum+
Business to Business (B2B). Bonum+ bundles telehealth, a COVID-19 risk assessment tool and a Personal Protective Equipment (PPE)
purchasing tool, through a secure mobile dashboard for corporate clients. The B2B platform eases pressure on employees who are required
to report any relevant health issues daily, centralizing communication and contact tracing to deliver risk scores. This allows employers
to monitor employee COVID-19 risk profiles and streamlines the ordering of new PPE as needed. An integrated artificial intelligence (AI)
tool offers health recommendations and connects employees with board certified physicians, as needed. To date, we have not generated
any revenue from this product.
MedCheks
Health Passport . The Health Passport is a patient-centered, digital, precision healthcare platform
that lets patients consolidate and control their health data via a digital Health Passport and allows them to share their health profile,
tests and vaccinations simply and safely. Secured in a blockchain, the Health Passport includes health and vaccination status verification
via a QR code, which is available for travel, entry into stadiums, concert venues, events, offices, industrial plants, warehouses, and
other physical access points. The Passport stores all of a user’s health records securely in one place. W e have not generated
any revenue from this product to date and the product was discontinued at the end of December 2021. We previously owned 100% of MedCheks,
LLC, a Delaware limited liability company which was formed in January 2021, had no revenue in 2021 and was dissolved in December 2021.
SOSRx,
LLC. On February 15, 2022, the Company entered into a relationship with Exchange
Health, LLC, a technology company providing an online platform for manufacturers and suppliers to sell and purchase pharmaceuticals (“ Exchange
Health ”). SOSRx LLC, a Delaware limited liability company (“ SOSRx ”), was formed, which is owned 51% by the
Company and 49% by Exchange Health.
All of our product offerings
are focused on the United States markets. Some products are restricted just to certain states, depending upon the various applicable
state regulations and guidelines pertaining to pharmaceuticals, particularly, and drug businesses, generally. Our services are distributed
through our online platform
11
Organizational
Structure
The
diagram below depicts our current organizational structure:
The
Pharmaceutical Industry
According
to the NCPA 2020 Digest Report, United States pharmaceutical companies comprise a burgeoning estimated $685
billion industry by 2023, consisting of over 65,000 pharmacy facilities. Management believes that few platforms are currently in place
to bring these participants together to share market knowledge, product pricing transparency and product availability. According to this,
the pharmaceutical market is comprised primarily of three wholesalers that control an estimated approximately 92% of the market. Our
management believes that this concentration has, over the years, led to a lack of price and cost transparency, thereby resulting in severe
limitations on the purchasing choices of industry participants. These market dynamics have enabled these large wholesalers (McKesson,
Cardinal Health and AmerisourceBergen), known as ADR distributors, to dominate the industry with respect to both generic and brand pharmaceuticals.
To
fuel this change, insurance companies (Pharmacy Benefits Management (“ PBM ”) and private health payers) and the federal
government have initiated lower medication reimbursement payments to healthcare providers. We believe that pharmacies face increasing
pressure to source medications as inexpensively as possible and improve operational efficiency. Trxade seeks to be in the forefront of
solving these transparency and pricing concerns by providing independent, retail pharmacies with real-time, pharmacy acquisition cost
(“ PAC ”) benchmarks to the National Drug Code (the “ NDC ”) standard. The NDC mark is a unique product
identifier used in the United States for drugs intended for human use.
Competitive
Business Conditions, Our competitive position in our Industry, and our Methods of Competition.
We
expect to face competition from the three large ADR distributors (McKesson, Cardinal Health and AmerisourceBergen), other pharmaceutical
distributors, buying groups, software products, and other start-up companies. Most of our competitors’ operations have substantially
greater financial- and manufacturer-backed resources, longer operating histories, greater name recognition, and more established relationships
in the industry.
Other
Start-up Companies Which Provide Competitive Services.
We
have identified start-ups that provide for supplier-pharmacy trading such as PharmaBid, RxCherrypick, PharmSaver, MatchRx and GenericBid,
and provide web-based services similar to ours, allowing pharmacies to buy from several suppliers. Trxade differentiates itself from
these exchanges by providing our pharmacies with both brand and generic pharmaceutical products. Additional companies target “ direct-to-consumer ”
pharmacy deliveries, including Amazon.com ’s PillPack , Capsule, Costplusdrugs, and GetRoman.com .
Buying
Groups.
Buying
Groups provide discounted prices to their members by negotiating better pricing with one primary wholesaler, while charging administrative
fees generally ranging from 3 to 5 percent. Some Buying Groups are structured like co-operatives (such as Independent Pharmacy Cooperative
(IPC) and American Pharmacy Cooperative, Inc. (APCI)) and offer their members monthly or quarterly rebates. Although they can function
well to bring pricing competition to the industry, they often offer rebates only after the purchase. Management does not believe Buying
Groups will provide long-term savings to customers with this model given the increased transparency and competition in the industry.
12
Pharmaceutical
Software.
Some
pharmaceutical software companies compete with us to varying degrees at different levels. SureCost, for example, provides inventory management
software enabling pharmacies to comply with primary supplier contracts. This software is fee-based and requires training.
Pharmacies
may be reluctant to buy pharmaceuticals on the internet due to the historical negativity and uncertainty with respect to the origin and
purity of drugs purchased off the web. Trxade management believes that as we continue to develop our brand, our customer base, and our
vast product offerings, we will gain the trust of the market and overcome the negativity associated with purchasing via a pharmaceutical
online marketplace.
One
advantage that we believe we have over our competition is our ability to be flexible and fast moving in adjusting our business model
to address the needs of our customer base. Trxade started by offering pharmacies a reverse auction model to enhance savings on the purchase
of their pharmaceuticals. Customer feedback suggested that pharmacies prefer a more “ buy now ” format, which we implemented.
This resulted in a “ one-stop-one-search ” platform to buy quality pharmaceuticals for less and a data-rich platform
to help pharmacies overcome the complexities related to supply chain purchasing.
Telehealth
Providers
We
also anticipate facing competition in the telehealth industry (in connection with “ Bonum Health ”) from current and
future health care companies in the telehealth market including, Teladoc Health, Inc., MDLive, Inc., American Well Corporation and Grand
Rounds, Inc., among other smaller industry participants.
Sources
and Availability of Raw Materials; Principal Suppliers.
Trxade
is a web-based technology platform. Because we are not a manufacturing company, we do not need any raw materials. Our module on the platform
is drug supplier-to-retailer. We bring buyers and sellers together on this platform. Our suppliers include National Apothecary Solutions,
Integral RX, and South Pointe Wholesale, Inc.
Dependence
on One or More Major Customers.
As
of the date of this filing, we have approximately 13,100+ registered members and over 30 pharmaceutical suppliers as customers,
with an estimated market potential of approximately 19,397 independent pharmacies and 1,500 regional and local suppliers. We have
a working relationship with over 25 wholesalers and the nation’s largest buying group. Although we believe those entities are satisfied
with their business relationship with Trxade, if our buying group and two or three of the largest wholesalers decided no longer to do
business with Trxade, the resulting supplier void would materially and adversely affect our competitiveness in the marketplace.
Intellectual
Property.
Although
we believe that our name and brand are protected by applicable state common law trademark laws, we do not currently have any patents,
concessions, licenses, royalty agreements, or franchises, provided that we do currently maintain a number of registered trademarks and
our pharmaceutical pricing benchmarks, PAC. Our business operates under a proprietary software system which includes trade secrets within
our database, business practices and pricing model. We also maintain a number of websites.
We
believe that we have taken all necessary steps to protect our proprietary rights, but no assurance can be given that we will be able
to successfully enforce or protect our rights in the event that they are infringed upon by a third party.
13
Need
for Government Approval of Products and Services.
We
are required to hold business licenses and to follow applicable state and federal government regulations detailed herein. In October
2018, we acquired Community Specialty Pharmacy, LLC, an accredited independent retail pharmacy with a focus on specialty medications,
which requires state approval, which have been obtained in 36 states.
Effect
of Existing or Probable Government Regulations on the Business .
Federal
Drug Administration Guidelines
On
April 12, 1988, President Ronald Reagan signed into law the Prescription Drug Marketing Act of 1987 (PDMA), setting the baseline for
wholesale distribution regulations. The final regulations were published in 1999, establishing the minimum wholesale distribution requirements
for state licensure. With the intent to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs into
the distribution system, state licensing systems moved to update their standards to match those provided federally as guided under FDA’s
Guidelines for State Licensing of Wholesale Prescription Drug Distributors (21 CFR 205). PDMA established minimum federal pedigree requirements
to trace the ownership of prescription drugs through the supply chain. The principal goal of the PDMA was to further secure the nation’s
drug supply from counterfeit and substandard prescription drugs. The law establishes two types of distributors: “ Authorized
distributor[s] of record ” or ADRs; and “ Unauthorized distributor[s], ” such as wholesalers. The pedigree
requirement was to require each person engaged in the wholesale distribution of a prescription drug in interstate commerce, who is not
the manufacturer or an authorized distributor of record for that drug, to provide a pedigree to the recipient. After meeting resistance
from various stakeholders, the FDA delayed the effective date of the regulations several times, until final implementation in December
2006.
At
the federal level the implementation of the track and trace legislation which went into effect in 2018, requires the use of pharmaceutical
pedigree to track the movement of pharmaceuticals along the supply chain. The costs of complying with this new legislation may be too
burdensome for many of the smaller suppliers.
State
Drug Administration Guidelines
There
are a number of national and state-wide regulations that have an effect on our business. All drug wholesalers must be licensed under
state licensing systems, which must in turn meet the FDA guidelines under State Licensing of Wholesale Prescription Drug Distributors
(21 CFR Part 205). The regulations set forth minimum requirements for prescription drug storage and security as well as for the treatment
of returned, damaged, and outdated prescription drugs. Further, wholesale drug distributors must establish and maintain inventories and
records of all transactions regarding the receipt and distribution of prescription drugs and make these available for inspection and
copying by authorized federal, state, or local law enforcement officials. In most states, wholesale distributor licenses are issued by
the State Boards of Pharmacy and require periodic renewal. Approximately 40 states also require out-of-state wholesalers that distribute
drugs within their borders to be licensed as well.
California,
Florida, Nevada, New Mexico and Indiana define the normal distribution channel to not include the lateral sales of pharmaceuticals between
wholesalers. The Supply Chain Act, part of the Quality Drug Act, which was signed into federal law in December 2013, precludes all states
from restricting, investigating or inspecting the distribution channel and transactional history. Until the federal government provides
guidelines for the new federal law, no state regulation or guideline exists.
The
warehousing of pharmaceuticals is also restricted and requires additional state licenses. Some licenses require bonds and written exams
and may take some time to approve. Currently, Integra Pharma Solutions, LLC, our wholesale distributor, asks for formal pedigrees from
the ADR wholesalers and provides pedigrees to those entities they sell to in the marketplace. This requirement limits liability and provides
assurance if a recall is warranted that Trxade and its participants will receive value for the commodity.
Our
national wholesale supply partners are able to fulfill orders on our platform in real-time and provide pharmacies with cost-saving payment
terms and next-day delivery capabilities in unrestrictive states under the Model State Pharmacy Act and Model Rules of the National Association
of Boards of Pharmacy (Model Act).
14
Potential
New Regulations; Price Gouging Rules
In
addition to the above, regulatory mandates in response to certain unexpected events, such as viral outbreaks, could negatively impact
sales. For example, in December 2019 an outbreak of a coronavirus surfaced in China and resulted in governments around the world adopting
restrictions on public gatherings, travel and restrictions on companies’ (including our) ability to conduct normal business operations.
Price
gouging may be an issue in the coming months due to the continued effects of the coronavirus and responses thereto and supply chain issues
associated therewith and separately; as of the date of this Report, 42 states have enacted price gouging laws of one kind or another.
The laws vary from state to state, but one constant throughout is a prohibition to charge “excessive” or “unconscionable”
prices for consumer goods. Some states define “excessive” or “unconscionable” while others define what makes
a prima facia case for price gouging and what constitutes a prima facia defense, shifting the burden of proof to the accuser. In almost
all of the 42 states with price gouging laws on the books, a price is excessive or unconscionable if the price of a good has increased,
in some states by a certain percentage, over the price of the good prior to the onset of the abnormal
disruption of the market. Some states have clearly excepted from the price gouging definition a rise in prices caused by an increase
in the merchant’s cost of delivering that good for sale – whether it be increased shipping costs, gasoline prices or simply
the cost of the good itself. Other states have less defined exceptions – Virginia for example only treats the fact of increased
input costs as a merchant’s prima facia defense to an accusation of price gouging. Several states except from the price gouging
definition prices that do not exceed a normal margin (i.e., the merchant’s margin immediately prior to the market disruption) PLUS
10%. In general, while the l aw may not specifically define what constitutes an “unconscionably
excessive price,” the statutes typically provide that a price may be “unconscionably excessive” if: the amount charged
represents a “gross disparity” from the price such goods or services were sold or offered for sale immediately prior to the
onset of the abnormal disruption of the market. Merchants may provide evidence that justifies their higher prices were justified by increased
costs beyond their control. We will need to comply with the excessive price statutes; as of the date of this Report, we believe we were
in compliance with all 42 states’ price gouging laws.
U.S.
Federal and State Fraud and Abuse Laws
Federal
Stark Law
We
are subject to the federal self-referral prohibitions, commonly known as the Stark Law. Where applicable, this law prohibits a physician
from referring Medicare patients to an entity providing “designated health services” if the physician or a member of such
physician’s immediate family has a “financial relationship” with the entity, unless an exception applies. The penalties
for violating the Stark Law include the denial of payment for services ordered in violation of the statute, mandatory refunds of any
sums paid for such services, civil penalties, disgorgement and possible exclusion from future participation in the federally funded healthcare
programs. A person who engages in a scheme to circumvent the Stark Law’s prohibitions may be subject to fines for each applicable
arrangement or scheme. The Stark Law is a strict liability statute, which means proof of specific intent to violate the law is not required.
In addition, the government and some courts have taken the position that claims presented in violation of the various statutes, including
the Stark Law can be considered a violation of the federal False Claims Act (described below) based on the contention that a provider
impliedly certifies compliance with all applicable laws, regulations and other rules when submitting claims for reimbursement. A determination
of liability under the Stark Law could have a material adverse effect on our business, financial condition and results of operations.
Federal
Anti-Kickback Statute
We
are also subject to the federal Anti-Kickback Statute. The Anti-Kickback Statute is broadly worded and prohibits the knowing and willful
offer, payment, solicitation or receipt of any form of remuneration in return for, or to induce, (i) the referral of a person covered
by Medicare, Medicaid or other governmental programs, (ii) the furnishing or arranging for the furnishing of items or services reimbursable
under Medicare, Medicaid or other governmental programs or (iii) the purchasing, leasing or ordering or arranging or recommending purchasing,
leasing or ordering of any item or service reimbursable under Medicare, Medicaid or other governmental programs. In addition, a person
or entity does not need to have actual knowledge of this statute or specific intent to violate it to have committed a violation. Moreover,
the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes
a false or fraudulent claim for purposes of the False Claims Act, as discussed below. Violations of the Anti-Kickback Statute can result
in exclusion from Medicare, Medicaid or other governmental programs as well as civil and criminal penalties and fines. Imposition of
any of these remedies could have a material adverse effect on our business, financial condition and results of operations.
15
False
Claims Act
Both
federal and state government agencies have continued civil and criminal enforcement efforts as part of numerous ongoing investigations
of healthcare companies and their executives and managers. Although there are a number of civil and criminal statutes that can be applied
to healthcare providers, a significant number of these investigations involve the federal False Claims Act. These investigations can
be initiated not only by the government but also by a private party asserting direct knowledge of fraud. Penalties for False Claims Act
violations include fines, plus up to three times the amount of damages sustained by the federal government. A False Claims Act violation
may provide the basis for exclusion from the federally funded healthcare programs. In addition, some states have adopted similar fraud,
whistleblower and false claims provisions.
State
Fraud and Abuse Laws
Several
states in which we operate have also adopted similar fraud and abuse laws as described above. The scope of these laws and the interpretations
of them vary from state to state and are enforced by state courts and regulatory authorities, each with broad discretion. Some state
fraud and abuse laws apply to items or services reimbursed by any payor, including patients and commercial insurers, not just those reimbursed
by a federally funded healthcare program. A determination of liability under such state fraud and abuse laws could result in fines and
penalties and restrictions on our ability to operate in these jurisdictions.
Other
Healthcare Laws
The
federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and
Clinical Health Act, or HITECH, and their implementing regulations, which we collectively refer to as HIPAA, established several separate
criminal penalties for making false or fraudulent claims to insurance companies and other non-governmental payors of healthcare services.
Under HIPAA, these two additional federal crimes are: “Healthcare Fraud” and “False Statements Relating to Healthcare
Matters.” The Healthcare Fraud statute prohibits knowingly and recklessly executing a scheme or artifice to defraud any healthcare
benefit program, including private payors. A violation of this statute is a felony and may result in fines, imprisonment or exclusion
from government sponsored programs. The False Statements Relating to Healthcare Matters statute prohibits knowingly and willfully falsifying,
concealing or covering up a material fact by any trick, scheme or device or making any materially false, fictitious or fraudulent statement
in connection with the delivery of or payment for healthcare benefits, items or services. These provisions are intended to punish some
of the same conduct in the submission of claims to private payors as the federal False Claims Act covers in connection with governmental
health programs.
In
addition, the Civil Monetary Penalties Law imposes civil administrative sanctions for, among other violations, inappropriate billing
of services to federally funded healthcare programs and employing or contracting with individuals or entities who are excluded from participation
in federally funded healthcare programs. Moreover, a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration,
including waivers of copayments and deductible amounts (or any part thereof), that the person knows or should know is likely to influence
the beneficiary’s selection of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or services
may be liable for civil monetary penalties for each wrongful act. Moreover, in certain cases, providers who routinely waive copayments
and deductibles for Medicare and Medicaid beneficiaries can also be held liable under the Anti-Kickback Statute and civil False Claims
Act, which can impose additional penalties associated with the wrongful act. One of the statutory exceptions to the prohibition is non-routine,
unadvertised waivers of copayments or deductible amounts based on individualized determinations of financial need or exhaustion of reasonable
collection efforts. Although this prohibition applies only to federal healthcare program beneficiaries, the routine waivers of copayments
and deductibles offered to patients covered by commercial payers may implicate applicable state laws related to, among other things,
unlawful schemes to defraud, excessive fees for services, tortious interference with patient contracts and statutory or common law fraud.
16
Climate
Change Regulation
The
U.S. government and foreign governments are currently in the process of considering new or expanded laws to address climate change. Such
laws, if adopted, may include limitations on greenhouse gas (“ GHG ”) emissions, mandates that companies implement processes
to monitor and disclose climate-related matters, additional taxes or offset charges on specified energy sources, and other requirements.
Compliance with climate-related laws may be further complicated by different regulatory approaches and requirements in the various jurisdictions
in which we operate. New or expanded climate-related laws could impose substantial costs on us. Until the timing and extent of climate-related
laws are clarified, we cannot predict their potential effect on our capital expenditures or our results of operations .
Environmental
Regulations
Our
operations are subject to regulations under various federal, state, local and foreign laws concerning the environment, including laws
addressing the discharge of pollutants into the air and water, the management and disposal of hazardous substances and wastes, and the
cleanup of contaminated sites. We could incur substantial costs, including cleanup costs, fines and civil or criminal sanctions and third-party
damage or personal injury claims, if in the future we were to violate or become liable under environmental laws. We are not aware of
any costs or effects of our compliance with environmental laws.
Jumpstart
Our Business Startups Act
In
April 2012, the Jumpstart Our Business Startups Act (“ JOBS Act ”) was enacted into law. The JOBS Act provides, among
other things:
●
Exemptions
for “ emerging growth companies ” from certain financial disclosure and governance requirements for up to five years
and provides a new form of financing to small companies;
●
Amendments
to certain provisions of the federal securities laws to simplify the sale of securities and increase the threshold number of record
holders required to trigger the reporting requirements of the Exchange Act;
●
Relaxation
of the general solicitation and general advertising prohibition for Rule 506 offerings;
●
Adoption
of a new exemption for public offerings of securities in amounts not exceeding $50 million; and
●
Exemption
from registration by a non-reporting company of offers and sales of securities of up to $1,000,000 that comply with rules to be adopted
by the SEC pursuant to Section 4(6) of the Securities Act and exemption of such sales from state law registration, documentation
or offering requirements.
In
general, under the JOBS Act a company is an “ emerging growth company ” if its initial public offering (“ IPO ”)
of common equity securities was affected after December 8, 2011, and the company had less than $1.07 billion of total annual
gross revenues during its last completed fiscal year. A company will no longer qualify as an “ emerging growth company ”
after the earliest of
(i)
the
completion of the fiscal year in which the company has total annual gross revenues of $1.07 billion or more,
(ii)
the
completion of the fiscal year of the fifth anniversary of the company’s IPO;
(iii)
the
company’s issuance of more than $1 billion in nonconvertible debt in the prior three-year period, or
(iv)
the
company becoming a “ larger accelerated filer ” as defined under the Exchange Act.
17
The
JOBS Act provides additional new guidelines and exemptions for non-reporting companies and for non-public offerings. Those exemptions
that impact the Company are discussed below.
Financial
Disclosure. The financial disclosure in a registration statement filed by an “ emerging growth company ” pursuant
to the Securities Act, will differ from registration statements filed by other companies as follows:
(i)
audited
financial statements required for only two fiscal years (provided that “ smaller reporting companies ” such as the
Company are only required to provide two years of financial statements);
(ii)
selected
financial data required for only the fiscal years that were audited (provided that “ smaller reporting companies ”
such as the Company are not required to provide selected financial data as required by Item 301 of Regulation S-K); and
(iii)
executive
compensation only needs to be presented in the limited format now required for “ smaller reporting companies ”.
However,
the requirements for financial disclosure provided by Regulation S-K promulgated by the Rules and Regulations of the SEC already provide
certain of these exemptions for smaller reporting companies. The Company is a smaller reporting company. Currently a smaller reporting
company is not required to file as part of its registration statement selected financial data and only needs to include audited financial
statements for its two most current fiscal years with no required tabular disclosure of contractual obligations.
The
JOBS Act also exempts the Company’s independent registered public accounting firm from having to comply with any rules adopted
by the Public Company Accounting Oversight Board (“ PCAOB ”) after the date of the JOBS Act’s enactment, except
as otherwise required by SEC rule.
The
JOBS Act further exempts an “ emerging growth company ” from any requirement adopted by the PCAOB for mandatory rotation
of the Company’s accounting firm or for a supplemental auditor report about the audit.
Internal
Control Attestation. The JOBS Act also provides an exemption from the requirement of the Company’s independent registered public
accounting firm to file a report on the Company’s internal control over financial reporting, although management of the Company
is still required to file its report on the adequacy of the Company’s internal control over financial reporting.
Section
102(a) of the JOBS Act exempts “ emerging growth companies ” from the requirements in §14A(e) of the Exchange Act
for companies with a class of securities registered under the Exchange Act to hold stockholder votes for executive compensation and golden
parachutes.
Other
Items of the JOBS Act. The JOBS Act also provides that an “ emerging growth company ” can communicate with potential
investors that are qualified institutional buyers or institutions that are accredited to determine interest in a contemplated offering
either prior to or after the date of filing the respective registration statement. The JOBS Act also permits research reports by a broker
or dealer about an “ emerging growth company ” regardless of whether such report provides sufficient information for
an investment decision. In addition, the JOBS Act precludes the SEC and FINRA from adopting certain restrictive rules or regulations
regarding brokers, dealers and potential investors, communications with management and distribution of research reports on the “ emerging
growth company’s ” initial public offerings (IPOs).
Section
106 of the JOBS Act permits “ emerging growth companies ” to submit registration statements under the Securities Act
on a confidential basis provided that the registration statement and all amendments thereto are publicly filed at least 21 days before
the issuer conducts any road show (which time period has since been reduced to 15 days). This is intended to allow “ emerging
growth companies ” to explore the IPO option without disclosing to the market the fact that it is seeking to go public or disclosing
the information contained in its registration statement until the company is ready to conduct a roadshow.
Election
to Opt Out of Transition Period. Section 102(b)(1) of the JOBS Act exempts “ emerging growth companies ” from being
required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities
Act registration statement declared effective or do not have a class of securities registered under the Exchange Act) are required to
comply with the new or revised financial accounting standard.
18
The
JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to
non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of the transition
period.
Status
as Emerging Growth Company . Our first sale of common equity securities pursuant to an effective registration statement under the
Securities Act occurred on or around May 2019. As such, we will remain an emerging growth company, until no later than December 31, 2024,
the completion of the fiscal year of the fifth anniversary of the Company’s IPO.
Research
and Development.
During
the last two fiscal years, Trxade.com, DelivMeds, MedCheks Health Passport and Bonum Health have been developed as proprietary
software. For the years ended December 31, 2021, and 2020, $509,210 and $662,726, respectively, was
spent by the Company in research and development activities, which were included in general and administrative expenses. None of these
expenses were borne directly by customers.
Employees
Currently,
we have approximately 47 full-time employees. Our compensation programs are designed to align the compensation of our employees
with performance and to provide the proper incentives to attract, retain and motivate employees to achieve superior results. The structure
of our compensation programs balances incentives earnings for both short-term and long-term performance such as health insurance, paid
time off and flexibility schedules. To empower employees to unleash their potential, we provide onboarding training, development mentorship
with C-suite executives, and one on one coaching. The Company believes that its rich culture of inclusion and diversity enables it to
create, develop and fully leverage the strength of its workforce to exceed customer expectation and meet its growth objectives. The Company
places a high value on diversity and inclusion.
We
also utilize numerous outside consultants. Our future success will depend partially on our ability to attract, retain and motivate qualified
personnel. We are not a party to any collective bargaining agreements and have not experienced any strikes or work stoppages. We consider
our relations with our employees to be satisfactory.
Seasonality
Our
business is not directly affected by seasonal fluctuations but is affected indirectly by the fall and winter flu season, to the extent
it leads to an increased demand for certain generic pharmaceuticals.
ITEM
1A.
RISK
FACTORS
Summary
Risk Factors
Our
business is subject to numerous risks and uncertainties, many of which are beyond our control, including those highlighted in the section
titled “Risk Factors” immediately following this summary. These risks include, among others, the following:
●
We
have in the past been adversely affected by COVID-19 and may continue to be adversely affected by COVID-19 and/or governmental responses
thereto, supply chain issues relating thereto;
●
We
are currently unprofitable, have recently generated net losses, and we may incur losses in the future;
●
We
may need additional financing in the future, which may not be available on favorable terms, if at all;
●
We
may not be able to manage our future growth;
19
●
Many
of our competitors are better established and have resources significantly greater than we do;
●
We
will need to expand our member base or our profit margins to attain profitability;
●
We
face risks associated with our operations within the pharmaceutical distribution market;
●
We
are dependent on our current management;
●
We
rely on third party contracts, which may not be renewed or may be terminated;
●
We
are currently facing and may in the future face difficulties in sourcing products and inventory due to a variety of causes;
●
We
have in the past, and may in the future, not be able to sell our inventory, at or above the price we acquired such inventory for,
and have in the past, and may in the future, be forced to write-down inventory and certain of our other assets which may have a material
adverse effect on our balance sheet;
●
We
have in the past, and may in the future, not receive products or receive refunds for deposited amounts and have experience losses
in connection with such deposits;
●
We
may be subject to claims that we violated intellectual property rights of others, which are extremely costly to defend and could
require us to pay significant damages and limit our ability to operate;
●
Our
business and operations depend on the proper functioning of information systems, critical facilities and distribution networks and
a disruption, cyber-attack, failure or destruction of such networks, systems, or technologies may disrupt our business or result
in liability;
●
There
may be losses or unauthorized access to or releases of confidential information, including personally identifiable information, that
could subject the Company to significant reputational, financial, legal and operational consequences;
●
We
face risks associated with our business in the telehealth market, including risks associated with legal challenges, relationships
with third parties and affiliated professionals, our network of qualified providers, competition for services; new technologies,
failure to develop widespread brand awareness and regulatory risks;
●
Our
certificate of incorporation limits the liability of our officers and directors and provides for indemnification rights, mandatory
forum selection provisions and limits the ability of stockholders to call special meetings of stockholders;
●
We
incur significant costs to ensure compliance with U.S. and NASDAQ Capital Market reporting and corporate governance requirements;
●
We
may not be able to comply with NASDAQ’s continued listing standards;
●
Regulatory
changes that affect our distribution channels could harm our business;
●
Healthcare
fraud laws are often vague and uncertain, exposing us to potential liability;
●
New
and expanded laws or regulations could have a material adverse effect on our business operations, cash flows or future prospects;
20
●
The
public health crisis involving the abuse of prescription opioid pain medication could have a material negative effect on our business;
●
Consolidation
in the U.S. healthcare industry may negatively impact our results of operations;
●
We
have identified material weaknesses in our internal control over financial reporting and controls and procedures;
●
There
may not be sufficient liquidity in the market for our securities in order for investors to sell their shares. The market price of
our common stock may continue to be volatile;
●
Stockholders
may experience dilution to future equity sales, the exercise or conversion of outstanding convertible securities or future transactions;
●
Our
Chief Executive Officer and President are our two largest stockholders and, as a result, they can exert control over us and have
actual or potential interests that may differ from yours;
●
Risks
associated with the JOBS Act and our status as an emerging growth company;
●
Risks
associated with future acquisitions, including unknown liabilities and difficulty integrating such acquisitions;
●
Cyber
security attacks and website problems; and
●
Claims,
litigation, government investigations, and other proceedings that may adversely affect our business and results of operations
Risk
Factors
You
should be aware that there are substantial risks for an investment in our common stock. You should carefully consider these risk factors
before you decide to invest in our common stock.
If
any of the following risks were to occur, such as our business, financial condition, results of operations or other prospects, any of
these could materially affect our likelihood of success. If that happens, the market price of our common stock, if any, could decline,
and prospective investors would lose all or part of their investment in our common stock.
Risks
Related to Our Business Operations
Our
business, financial condition and results of operations are subject to various risks and uncertainties, including those described below.
This section discusses factors that, individually or in the aggregate, could cause our actual results to differ materially from expected
and historical results. Our business, financial condition or results of operations could be materially adversely affected by any of these
risks. It is not possible to predict or identify all such factors. Consequently, the following description of Risk Factors is not a complete
discussion of all potential risks or uncertainties applicable to our business.
21
We
have been, and may in the future be, adversely affected by the global COVID-19 pandemic, the duration and economic, governmental and
social impact of which is difficult to predict, which may significantly harm our business, prospects, financial condition and operating
results.
During
2020 and continuing into 2022, there has been a widespread worldwide impact from the COVID-19 pandemic, and we have been, and may in
the future be, adversely affected as a result. The outbreak of the COVID-19 coronavirus, the global response to such coronavirus, including
travel restrictions and quarantines that governments instituted during 2020 and 2021, adversely affected our operations, and future restrictions
or governmental requirements may have an adverse effect on our operations in the future, and/or may have a significant negative impact
on our results of operations, the production of pharmaceuticals and our ability to timely obtain pharmaceuticals for resale. Currently,
we are experiencing reductions to, and interruptions in, the delivery of supply chain pharmaceuticals that are having a negative impact
on our wholesalers and certain technology outsourcing in India and the Philippines and we are also having a hard time finding qualified
staff, due to the pandemic. Notwithstanding the above disruptions, our results of operations have not, to date, been materially adversely
affected by the pandemic. However, if we continue to experience production difficulties, quality control problems or further shortages
in supply of pharmaceuticals or personnel in the future, this could harm our business and results of operations, any of which could have
a material adverse effect on our operations and the value of our securities. In addition, employee sicknesses and remote working environments,
and the potential negative effect thereof on productivity and internal controls, related to the coronavirus and the federal, state and
local responses to such virus, could materially impact our consolidated results for the year 2022 and beyond. The COVID-19 outbreak could
also restrict our access to capital such as credit facilities and lead to material nonrecurring charges, write-downs, impairments and
expenses. The Company is actively and continually monitoring the pandemic’s effect on our businesses and endeavoring to adapt quickly
in real time to meet the rapidly-changing demands of our Customers and Suppliers.
To
mitigate the spread of COVID-19, we implemented sanitation and personal protection measures. The
Company’s corporate office reopened on January 3, 2022, in accordance to Center for Disease Control and Prevention (CDC) guidance,
allowing only management and certain key operational employees to return to the office, while hourly employees remain working remotely
until further notice. These measures might not fully mitigate COVID-19 risks to our workforce, and we could experience unusual
levels of absenteeism that might impair operations and delay delivery of products. The COVID-19 pandemic affects product manufacturing,
supply and transport availability and cost. The pandemic has in the past reduced demand for some products due to delays or cancellations
of elective medical procedures, consumer self-isolation and business closures, among other reasons, which may become issues again in
the future if the number of persons infected does not continue to decline. The COVID-19 pandemic also influences shortages of some products,
with product allocation resulting in delivery delays for customers. Additionally, as a result of
the coronavirus outbreak, various states have adopted price gouging laws. Our failure to comply with such laws and regulations could
subject us to claims, penalties, fines or lawsuits.
We
have been impacted and may be further impacted by COVID-19 as follows:
●
As
a result of COVID-19, various states have adopted price gouging laws. Our failure to comply with such laws and regulations could
subject us to claims, penalties, fines or lawsuits;
●
Inventory
price fluctuations as a result of supply and demand issues caused by COVID-19 have caused values of inventory to decrease, which
has had a direct impact on gross profit and has resulted in a direct write-off of certain inventory value;
●
Payment
Terms with customers may be altered or extended, which would have an impact on current ratios and cash flow; and
●
There
have previously been material impairments with respect to goodwill and may be future material
impairments and/or effects on right-of-use assets as the evaluation of the long-term impact
to delivery of service or physical space assessments changes.
●
There
have been shortages in the supply of generic pharmaceuticals which impact our revenues as
our transaction fees revenue rely on the sale of generic pharmaceuticals through our marketplace
platform
●
There
have been labor market challenges in hiring staff
22
COVID-19
may cause further disruptions to our business, including, but not limited to:
●
causing
one or more of our customers to file for bankruptcy protection or shut down, including as a result of broader economic disruption;
●
reducing
health system or health plan subscription agreement fees generated, as well as visit fees, by customers or providers, as a result
of funding constraints related to loss of revenue or employment;
●
negatively
impacting collections of accounts receivable;
●
negatively
impacting our ability to facilitate the provision of our telehealth services due to unpredictable demand;
●
negatively
impacting our ability to forecast our business’s financial outlook;
●
creating
regulatory uncertainty on our telehealth services, if certain restrictions on reimbursement or the practice of medicine across state
lines are reintroduced at some point in the future; and
●
harming
our business, results of operations and financial condition.
The
ongoing impacts of the pandemic may cause, or make more likely, a general economic slowdown or recession in one or more markets, disruptions
and volatility in global capital markets and other broad and adverse effects on the economy, business conditions, commercial activity
and the healthcare industry. The pandemic might impact our business operations, financial position and results of operation in unpredictable
ways that depend on highly-uncertain future developments, such as determining the effectiveness of current or future government actions
to address the public health or economic impacts of the pandemic. Any of these risks might have a materially adverse impact on our business
operations and our financial position or results of operations.
We
were recently unprofitable, we have recently generated net losses, and we may incur losses in the future.
Revenues
generated from our consolidated operations for the years ended December 31, 2021 and 2020 were $9,889,433 and $17,122,520,
respectively.
We
incurred a net loss of $5,315,883 for the year ended December 31, 2021, compared to a net loss of $2,536,051 for the year ended December
31, 2020. We may incur other losses in the foreseeable future due to the significant costs associated with our business development,
including costs associated with maintaining compliance under SEC reporting standards. We cannot assure you that our operations will annually
generate sufficient revenues to fund our continuing operations or to fully implement our business plan, and thereafter sustain profitability
in any future period.
The
likelihood of our success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered
in connection with the start and growth of a business, the implementation and execution of our business plan, and the regulatory environment
affecting the distribution of pharmaceuticals in which we operate.
If
we do not obtain additional financing, our business, prospects, financial condition and results of operations will be adversely affected.
Management
anticipates that we will require additional working capital in the future to pursue continued development of products, services, and
marketing operations. We cannot accurately predict the timing and amount of such capital requirements. Additional financing may not be
available to us when needed or, if available, it may not be obtained on commercially reasonable terms. If we are not able to obtain the
necessary additional financing on a timely or commercially reasonable basis, we will be forced to delay or scale down some or all of
our development activities (or perhaps even cease the operation of our business). Our access to additional capital may be negatively
affected by future recessions, downturns in the economy or the markets as a whole, or inflation.
We
have no commitments for any additional financing, and such commitments may not be obtained on favorable terms, if at all. Any additional
equity financing will be dilutive to our stockholders, and debt financing, if available, may involve restrictive covenants with respect
to dividends, raising future capital, and other financial and operational matters. If we are unable to obtain additional financing as
needed, we may be required to reduce the scope of our operations or our anticipated expansion, which could have a material adverse effect
on us.
23
U.S.
and global economic conditions could materially adversely affect the Company’s business, results of operations, financial condition
and growth.
Adverse
macroeconomic conditions, including inflation, slower growth or recession, new or increased tariffs, changes to fiscal and monetary policy,
tighter credit, higher interest rates, high unemployment and currency fluctuations could have a material adverse impact on demand for
the Company’s products and services. In addition, consumer confidence and spending could be adversely affected in response to financial
market volatility, negative financial news, conditions in the real estate and mortgage markets, declines in income or asset values, changes
to fuel and other energy costs, labor and healthcare costs and other economic factors.
In
addition to an adverse impact on demand for the Company’s products, uncertainty about, or a decline in, U.S. or global economic
conditions could have a significant impact on the Company’s suppliers, the pharmacy industry as a whole, the Company’s network
of independent pharmacies and other partners. Potential effects include financial instability; inability to obtain credit to finance
operations and purchases of the Company’s products, payment defaults and insolvency.
A
downturn in the economic environment could also lead to increased credit and collectability risk on the Company’s receivables;
limitations on the Company’s ability to raise new funding through the sale of debt or equity; reduced liquidity; and declines in
the value of the Company’s securities. These and other economic factors could materially adversely affect the Company’s business,
results of operations, financial condition and growth.
Our
business is subject to rigorous regulatory and licensing requirements.
As
described in greater detail in “ Item 1. Business ”, above, our business is highly regulated in the United States, at
both the federal and state level, and in foreign countries. If we fail to comply with regulatory requirements, or if allegations are
made that we fail to comply, our results of operations and financial condition could be adversely affected.
To
lawfully operate our businesses, we are required to obtain, and hold permits, product registrations, licenses and other regulatory approvals
from, and to comply with operating and security standards of, numerous governmental bodies. For example, as a wholesale distributor of
controlled substances, we must hold valid DEA registrations and state-level licenses, meet various security and operating standards,
and comply with the Controlled Substances Act (CSA). Failure to maintain or renew necessary permits, product registrations, licenses
or approvals, or to comply with required standards, could have an adverse effect on our results of operations and financial condition.
We are also required to comply with various state pricing gouging laws. Products that we source and distribute must also comply with
regulatory requirements.
Noncompliance
or concerns over noncompliance may result in suspension of our ability to distribute or import products, product bans, recalls or seizures,
or criminal or civil sanctions, which, in turn, could result in product liability claims and lawsuits, including class actions.
Many
of our competitors are better established and have resources significantly greater than we have, which may make it difficult to fend
off competition.
We
expect to compete with the three largest ADR distributors (McKesson, Cardinal Health and AmerisourceBergen), in addition to other pharmaceutical
distributors, buying groups, software products, and various start-up drug companies. Many of these companies have substantially greater
financial and manufacturer-backed resources, longer operating histories, greater name recognition and more established relationships
in the industry than us. In addition, a number of these competitors may combine or form strategic partnerships. As a result, our competitors
may establish a more favorable footing in the pharmaceutical industry with respect to pricing or other factors. Our failure to compete
successfully with any of these companies would have a material adverse effect on our business and the trading price of our common stock.
24
The
three distributors listed above have a strong control over our industry, as they have contracts with approximately 24,000 independent,
retail pharmacies that limit the participants’ ability to purchase pharmaceuticals outside of those primary distributors. Additional
restrictive elements exist within the pharmaceutical channels of distribution. For example, a number of the inventory management systems,
either developed by the distributors or third-party vendors, have been developed to require compliance to these restrictive purchasing
agreements. Management anticipates that other existing and prospective competitors will adopt technologies or business plans similar
to ours or seek other means to develop operations competitive with ours, particularly if our development of large-scale production progresses
as scheduled.
We
will need to expand our member base or our profit margins to attain profitability.
Currently,
we are paid an administrative fee of up to 6 percent of the buying price on the generic pharmaceuticals sold to pharmacies and up to
1 percent on brand pharmaceuticals that pass through our pharmaceutical exchanges. Our management is aware that the competitiveness
of the group of suppliers that participate in our system and price products on our exchange is a key factor in determining how many purchasing
pharmacies and wholesalers will purchase products through our platforms. However, price is not the only factor that influences where
retail pharmacies will obtain their product. Quality fulfillment services are also important, and retail pharmacies have historically
received quality fulfillment services from the three major ADR distributors. In order to be more competitive, we must improve our customer
service and wholesaler fulfillment efforts, because the independent, retail pharmacy has for years considered this element of the fulfillment
process as important as price. Other factors influencing the pharmacies purchasing behavior in the future will be changes brought upon
by the ACA, which regulates some aspects of pharmaceutical spending and pricing. Management believes that we should benefit substantially
from our pricing and product knowledge that is offered by our platform.
Profitability
may be further increased as a result of lower cost of goods, should the Company build stronger relationships with manufacturers and other
larger buying groups that serve wholesalers and distributors. On a larger scale, those margins are expected to drop depending upon the
breadth of products provided in the market and the sale turn rates required. We are currently undertaking a significant effort to increase
our membership base through attendance at annual conferences and other strategies. Trxade has an expanded e-mail marketing strategy based
on our competitive price advantages and price trend analysis tools.
There
are inherent risks associated with our operations within the Pharmaceutical Distribution Market.
There
are inherent risks involved with doing business within the pharmaceutical distribution market, including:
●
Improperly
manufactured products may prove dangerous to the end consumer.
●
Products
may become adulterated by improper warehousing methods or modes of shipment.
●
Counterfeit
products or products with fake pedigree papers.
●
Unlicensed
or unlawful participants in the distribution channel.
●
Risk
with default and the assumption of credit loss.
●
Regulatory
risks.
●
Risk
related to the loss of supply, or the loss of a number of suppliers, or in the delay of obtaining the supply of drugs.
Although
all of our end-user agreements require our customers to indemnify us and for any and all liabilities resulting from our participation
in the pharmaceutical distribution industry, we cannot assure you that the parties required to provide such indemnification will have
the financial resources to do so. Additionally, although we have evaluated appropriate state statutes and federal laws pertaining to
pharmaceutical distribution in an effort to diminish our risks, the Board of Pharmacy for each state is responsible for interpreting
their state laws, and their interpretations may not comport with our analysis. It is also possible that any third-party logistics arrangements
may disrupt service, create a loss of income, or other unforeseen disruptions should the service provider experience any legal, financial
or other difficulties of their own.
25
We
do not have a traditional credit facility with a financial institution, which may adversely impact our operations.
We
do not have a traditional credit facility with a financial institution, such as a working line of credit. The absence of such a facility
could adversely impact our operations, as it may constrain our ability to have available the working capital for equipment purchases
or other operational requirements. If adequate funds are not otherwise available, we may be required to delay, scale back or eliminate
portions of our business development efforts. Without credit facilities, we could be forced to cease operations and investors in our
securities could lose their entire investment.
We
offer limited credit to the pharmacies which limits the amount of the orders that they place and may result in us losing business and
a reduction in our revenues.
We
currently offer a limited amount of credit to our members. Such limited credit reduces the risk that such members do not pay for products;
however, it also limits the amount of revenue we generate per member. We believe that if we were to increase the amount of credit we
provide to members we would generate more revenues, but bear more risk of non-payment. We are currently exploring increasing the amount
of credit we provide to members, which may in turn result in an increase in receivables and write-offs.
We
are dependent upon our current management, who may have conflicts of interest.
We
are dependent upon the efforts of our current management. All of our officers and directors have duties and affiliations with other companies.
Even though these companies are not competitors or involved in pharmaceutical distribution, involvement of our officers and directors
in other businesses may still present a conflict of interest regarding decisions they make for Trxade or with respect to the amount of
time available for Trxade. The loss of any of our officers or directors and, in particular, Mr. Prashant Patel, our President or Mr.
Suren Ajjarapu, our Chief Executive Officer and Chairman of the Company, could have a materially adverse effect upon our business and
future prospects.
The
Company holds, on behalf of and for the benefit of Mr. Suren Ajjarapu, a personal disability insurance policy providing for a $1,500,000
lump sum benefit, payable to Mr. Ajjarapu, in the event of Mr. Ajjarapu’s disability. The premiums on such policy will be paid
by the Company for so long as Mr. Ajjarapu is employed by the Company.
The
Company also holds a $4,000,000 key-man life insurance policy on the life of Mr. Suren Ajjarapu, and a $1,500,000 lump sum disability
insurance policy on Mr. Ajjarapu, providing for the Company as beneficiary of such policies.
While
our management team has considerable information technology and entrepreneurial experience, none of our management was involved in pharmaceutical
distribution prior to joining the Company and, as such, did not have any technical experience in pharmaceutical distribution prior to
joining us. In the event of the loss of Mr. Ajjarapu’s services, we will seek to hire and retain a qualified professional. In the
event of the loss of his services in connection with his death, upon obtaining funding from the key-man life insurance, management intends
to hire qualified and experienced personnel. We may be unable to find a suitable or qualified replacement for Mr. Ajjarapu and as such
our operations and/or prospects may suffer.
We
rely on third party contracts.
We
depend on others to provide products and services to us. We do not manufacture pharmaceuticals and we do not sell pharmaceuticals to
the end consumer. We do not control these wholesalers, suppliers and purchasers, and although our arrangements with them will be terminable
or of limited length, a change may be difficult to implement. At this time, we have a working relationship with over 50 wholesalers and
the nation’s largest buying group. Although we believe that those entities are satisfied with their business relationship with
Trxade, if our buying group and two or three of the wholesalers decided no longer to do business with us, that supplier void would materially
and adversely affect our competitiveness in the marketplace.
26
We
depend on suppliers to make their drugs and other medical products available to us for resale and are subject to risks associated with
the availability of these drugs and other medical products.
We
do not directly manufacture any of the products we sell and instead we rely on third parties to manufacture and/or procure such drugs
and other medical products for us to resell. Supply chain constraints have, and may in the future have, a negative impact on the availability
of drugs and medical products that we sell. Our supplier relationships could be interrupted, become less favorable to us or be terminated
and the supply of these drugs or products could be interrupted or become insufficient. Supply interruptions or other disruptions in manufacturing
processes could be caused by events beyond our control, including natural disasters, supplier facility shut-downs, defective raw materials,
the impact of epidemics or pandemics, such as COVID-19, and actions by U.S. or international governments, including export restrictions
or tariffs. A sustained supply reduction or interruption, and an inability to develop alternative and additional sources for such supply,
could result in lost sales, increased cost, damage to our reputation, and may have an adverse effect on our business.
We
may have difficulties in sourcing or selling products due to a variety of causes.
We
might experience difficulties and delays in sourcing and selling products due to a variety of causes, such as: difficulties in complying
with the legal requirements for export or import of pharmaceuticals or supplies; suppliers’ failure to satisfy production demand;
manufacturing or supply problems such as inadequate resources; and real or perceived quality issues. Difficulties in product manufacturing
or access to raw materials could result in supplier production shutdowns, product shortages and other supply disruptions. The COVID-19
pandemic has adversely affected the availability of some products, resulting in product allocation and delivery delays. Any of these
risks might have a materially adverse impact on our business operations and our financial position or results of operations.
Rapid
technological change in our industry presents us with significant risks and challenges .
Our
industry is characterized by rapid technological change, changing consumer requirements, short product lifecycles and evolving industry
standards. Our success will depend on our ability to develop or to acquire and market new services. There is no guarantee that we will
possess the resources, either financial or personnel, for the research, design and development of new applications or services, or that
we will be able to utilize these resources successfully and avoid technological or market obsolescence. Further, there can be no assurance
that technological advances by one or more of our competitors or future competitors will not result in our present or future applications
and services becoming uncompetitive or obsolete.
We
are currently facing and may in the future face difficulties in sourcing products and inventory due to a variety of causes.
Due
to the continued effects of the COVID-19 pandemic, the governmental responses to contain the spread of such virus, we have
to date experienced issues with the availability of certain products, resulting in product allocation and delivery delays, which has
not to date, had a material adverse effect on our results of operations. We might also experience difficulties and delays in sourcing
products and inventory due to a variety of causes in the future, such as: difficulties in complying with the legal requirements for export
or import of pharmaceuticals or components; suppliers’ failures to satisfy production demand; manufacturing or supply problems
such as inadequate resources; real or perceived quality issues; and advanced deposits which are at risk of return if product is not delivered.
Difficulties in product manufacturing or access to raw materials could result in supplier production shutdowns, product shortages and
other supply disruptions. Any of these risks might have a materially adverse impact on our business operations and our financial position
or results of operations.
We
have in the past, and may in the future, not be able to sell our inventory, at or above the price we acquired such inventory for, and
have in the past, and may in the future, be forced to write-down inventory and certain of our other assets which may have a material
adverse effect on our balance sheet.
Due
to the supply and demand nature of our pharmaceutical business and the personal protective equipment (PPE) business, especially in connection
with the rapidly changing regulations, recommendations and guidance surrounding COVID-19, the inventory of products we have acquired,
or may acquire in the future, has been/may be, acquired at a cost higher than the price at which we may be able to resell such products.
As a result, in the past we have, and in the future we may not be able to, make a profit on such sales and have in the past and may in
the future, have to write-down a significant portion of our inventory. During the years ended December 31, 2021 and 2020, write-down
to market value was $376,348 and $1,220,269, respectively. A significant write-down of assets may have a material adverse effect on our
balance sheet and results of operations.
27
We
may not receive products or receive refunds for deposited amounts and may experience losses in connection with such deposits.
We
might not receive products or the return of funds on deposits that have been provided. We have two deposits outstanding as of the date
of this report in an aggregate amount of approximately $1,081,250. In the event we do not receive the return of our deposits (through
litigation or otherwise), this will cause us financial harm and as a result the Company has taken a significant charge on our financial
statements by taking a loss in the amount of such deposit amount. Additionally, in the future we may provide additional deposits for
products which may be material, which deposits may not be refunded timely, if at all, and which products may not be delivered, or may
be defective or unusable. Any significant losses of deposited funds could have a material adverse effect on our financial condition,
results of operations and the value of our securities.
In
July 2020, the Company’s wholly-owned subsidiary, Integra, entered into an agreement with Studebaker Defense Group, LLC (“Studebaker”)
wherein Integra would pay Studebaker a down payment of $500,000 and Studebaker would deliver 180,000 boxes of nitrile gloves by August
14, 2020. Integra wired the $500,000 to Studebaker, but to date, Studebaker has not delivered the gloves or provided a refund of the
deposit. On December 31, 2020, we filed a complaint against Studebaker in Florida state court, Case No. 20-CA-010118 in
the Circuit Court for the Thirteenth Judicial Circuit in Hillsborough County, for among other things, breach of contract. On January
29, 2021, Integra Pharma Solutions filed a motion for clerk’s default against Studebaker. On February 2, 2021, the clerk of court
issued default against Studebaker. On March 4, 2021, Integra Pharma Solutions filed a motion for final default judgment against Studebaker.
On March 22, 2021, counsel for Studebaker filed a notice of appearance in the case. On March 24, Studebaker filed a response in opposition
to the motion for final judgment, and on March 25, 2021, Studebaker filed a motion to dismiss the case. On May 14, 2021, the Court denied
Integra’s motion for final default judgment, granted Studebaker’s motion to set aside the clerk’s default, and denied
Studebaker’s motion to dismiss. An amended answer and affirmative defenses were filed by Studebaker on October 14, 2021. Integra’s
motion to strike the affirmative defenses, or in the alternative, motion for more definite statement is scheduled for hearing on April
27, 2022. We have also scheduled the deposition of Studebaker’s corporate representative on April 12, 2022, and moved to compel
better answers to outstanding discovery. The litigation remains pending and is in the discovery phase. Integra remains confident it can
successfully prosecute its claims against Studebaker on the merit. On June 30, 2021, the $500,000 was recorded as Loss on
Inventory Investment.
In
August 2020, Integra, entered into an agreement with Sandwave Group Dsn Bhd (“Sandwave”), wherein Integra would pay Sandwave
a down payment of $581,250 and Sandwave’s supplier, Crecom Burj Group SDN BHD (“Crecom”), would deliver 150,000 boxes
of nitrile gloves within 45 days. Integra wired the $581,250 to Sandwave, which in turn wired the purchase price to Crecom, which Crecom
accepted; however, to date, Crecom has not delivered the nitrile gloves. Integra demanded return of its $581,250 and Crecom has acknowledged
that Integra is entitled to a refund, but to date Crecom has failed to return Integra’s money. In February 2021, Integra filed
a complaint against Crecom in Malaysia: Case No. WA-22NCC-55-02/2021 in the High Court of Malaysia at Kuala Lumpur in the Federal Territory,
Malaysia for the Malaysian equivalent of breach of contract. Crecom filed an appearance on March 1, 2021. In April 2021, an Application
for Summary Judgment was filed with the court, and on May 25, 2021, the Court extracted the sealed application, and a copy thereof was
served on Crecom’s attorneys and Crecom, 14 days later, filed an Affidavit in Reply with the court alleging that there are issues
to be tried and that this case must go to a full trial. On June 28, 2021, the court directed both parties to file their written submissions/arguments
in relation to the application for summary judgment on or before July 12, 2021, and scheduled a hearing thereon for August 26, 2021.
At the final hearing on October 18, 2021, the ruling for the summary judgment was denied and a trial date is pending. The Company believes
that it will prevail in the lawsuit filed; but the steps to enforce a judgment in Malaysia, if any, may be cumbersome, time consuming
or costly. The Company cannot determine the timing of the judgment, nor the amount ultimately collected. At June 30, 2021, the $581,250
was recorded as Loss on Inventory Investment.
Our
quarterly results have in the past, and may in the future, fluctuate significantly due to certain non-recurring sales of products.
Our
quarterly revenues have in the past and may in the future fluctuate significantly due to certain non-recurring sales of personal protective
equipment (PPE) and other products and associated costs of revenues therewith, which may be compounded in our year over year financial
results. As such, we believe that quarter-to-quarter comparisons of our revenues, operating results and cash flows may not be meaningful
and should not be relied upon as an indication of future performance.
28
Our
investments in new businesses and new products, services, and technologies is inherently risky, and could disrupt our ongoing businesses.
We
have invested and expect to continue to invest in new businesses, products, services, and technologies. Such endeavors may involve significant
risks and uncertainties, including insufficient revenues from such investments to offset any new liabilities assumed and expenses associated
with these new investments, inadequate return of capital on our investments, distraction of management from current operations, and unidentified
issues not discovered in our due diligence of such strategies and offerings that could cause us to fail to realize the anticipated benefits
of such investments and incur unanticipated liabilities. Because these new ventures are inherently risky, no assurance can be given that
such strategies and offerings will be successful and will not adversely affect our reputation, financial condition, and operating results.
To date we have taken losses and/or write-downs on several businesses, products, services, and technologies. For example, (a) we had
$725,973 of loss on impairment of goodwill for the year ended December 31, 2020, in connection with the acquisition of Community
Specialty Pharmacy, LLC; (b) we designed and invested resources into the “Bonum Health Hub”, a self-enclosed, free standing
virtual examination room, which was launched by the Company’s wholly-owned Bonum Health, LLC, in November 2019 and was expected
to be operational in April 2020; however, due to the COVID-19 pandemic, the Company does not anticipate installations moving forward,
and has taken a write off of the hubs purchased at June 30, 2021 in the amount of $143,891, which is included under loss on inventory
investments in the statement of operations for the year ended December 31, 2021; and (c) we also used resources and funding
to create a Health Passport application during 2020 and 2021, which was planned to store a user’s health and vaccination status
and allow confirmation thereof via a QR code; however, we did not generate any revenue from this product and the product was discontinued
at the end of December 2021. The use of resources for new businesses and new products, services, and technologies, to the extent such
new businesses and new products, services, and technologies do not generate revenues or profits may take management’s focus and
time away from more profitable endeavors, may require the Company to take significant write-downs or write-offs, may take funding away
from the Company’s other operations or growth opportunities, which may ultimately be more profitable, and may have a material adverse
effect on the Company’s cash flows, liquidity and revenues, any or all of which may cause the value of the Company’s securities
to decline in value or become worthless.
Risks
Relating to Our Information Systems; Technology and Intellectual Property
We
may be subject to claims that we violated intellectual property rights of others, which are extremely costly to defend and could require
us to pay significant damages and limit our ability to operate.
Companies
on the Internet and technology industries, and other patent and trademark holders seeking to profit from royalties in connection with
grants of licenses, own large numbers of patents, copyrights, trademarks and trade secrets and frequently enter into litigation based
on allegations of infringement or other violations of intellectual property rights. There may be intellectual property rights held by
others, including issued or pending patents and trademarks, that cover significant aspects of our technologies, content, branding or
business methods. Any intellectual property claims against us, regardless of merit, could be time-consuming and expensive to settle or
litigate and could divert our management’s attention and other resources. These claims also could subject us to significant liability
for damages and could result in our having to stop using technology, content, branding or business methods found to be in violation of
another party’s rights. We might be required or may opt to seek a license for rights to intellectual property held by others, which
may not be available on commercially reasonable terms, or at all. If we cannot license or develop technology, content, branding or business
methods for any allegedly infringing aspect of our business, we may be unable to compete effectively. Even if a license is available,
we could be required to pay significant royalties, which could increase our operating expenses. We may also be required to develop alternative
non-infringing technology, content, branding or business methods, which could require significant effort and expense and be inferior.
Any of these results could harm our operating results.
29
Our
business and operations depend on the proper functioning of information systems, critical facilities and distribution networks.
We
rely on our and third-party service providers’ information systems for a wide variety of critical operations, including to obtain,
rapidly process, analyze and manage data to:
●
facilitate
the purchase and distribution of inventory items from distribution centers;
●
receive,
process and ship orders on a timely basis;
●
manage
accurate billing and collections for thousands of customers;
●
process
payments to suppliers; and
●
generate
financial information.
Our
business also depends on the proper functioning of our critical facilities and our distribution networks. Our results of operations could
be adversely affected if our or a service provider’s information systems, critical facilities or distribution networks are disrupted
(including disruption of access), are damaged or fail, whether due to physical disruptions, such as fire, natural disaster, pandemic
or power outage, or due to cyber-security incidents, ransomware or other actions of third parties, including labor strikes, political
unrest and terrorist attacks. Manufacturing disruptions also can occur due to regulatory action, production quality deviations, safety
issues or raw material shortages or defects, or because a key product or component is manufactured at a single manufacturing facility
with limited alternate facilities.
We
rely on network and information systems and other technologies and a disruption, cyber-attack, failure or destruction of such networks,
systems, or technologies may disrupt our business or result in liability .
Network
and information systems and other technologies, including those related to our computer, data back-up and processing systems, network
management, customer service operations and programming delivery, are critical to our business activities. Network and information systems-related
events, such as computer hackings, cyber-attacks, computer viruses, worms or other destructive or disruptive software, process breakdowns,
denial of service attacks, malicious social engineering or other malicious activities, or any combination of the foregoing, or power
outages, natural disasters, terrorist attacks or other similar events, could result in a degradation or disruption of our services or
damage to our properties, equipment and data. These events also could result in large expenditures to repair or replace the damaged properties,
networks or information systems or to protect them from similar events in the future.
The
risk of these systems-related events and security breaches occurring has intensified, in part because we maintain certain information
necessary to conduct our businesses in digital form stored on cloud servers. While we develop and maintain systems seeking to prevent
systems-related events and security breaches from occurring, the development and maintenance of these systems is costly and requires
ongoing monitoring and updating as technologies change and efforts to overcome security measures become more sophisticated. Despite these
efforts, there can be no assurance that these events and security breaches will not occur in the future. Moreover, we may provide certain
confidential, proprietary and personal information to third parties in connection with our businesses, and while we obtain assurances
that these third parties will protect this information, there is a risk that this information could be compromised.
If
any of our systems are damaged, fail to function properly or otherwise become unavailable, we may incur substantial costs to repair or
replace them, and may experience loss or corruption of critical data and interruptions or delays in our ability to perform critical functions,
which could adversely affect our business and results of operations. In addition, we are currently making, and expect to continue to
make, substantial investments in our information technology systems and infrastructure, some of which are significant. Upgrades involve
replacing existing systems with successor systems, making changes to existing systems, or cost-effectively acquiring new systems with
new functionality. Implementing new systems carries significant potential risks, including failure to operate as designed, potential
loss or corruption of data or information, cost overruns, implementation delays, disruption of operations, and the potential inability
to meet business and reporting requirements. While we are aware of inherent risks associated with replacing these systems and believe
we are taking reasonable action to mitigate known risks, these technology initiatives may not be deployed as planned or may not be timely
implemented without disruption to our operations.
30
In
the past, we had an incident with an email account being compromised and an attempt was made to get the us to wire outgoing money. We
did not fall victim to the attempt, conducted a thorough investigation, performed cleanup procedures, and instituted additional
security measure to mitigate the risk of this incident from occurring in the future. Risk mitigation includes the board of directors
inquiring with the information technology department on status of cyber risks management, on a quarterly basis.
There
may be losses or unauthorized access to or releases of confidential information, including personally identifiable information, that
could subject the Company to significant reputational, financial, legal and operational consequences.
The
Company’s business requires it to use, transmit and store confidential information including, among other things, personally identifiable
information (“ PII ”) with respect to the Company’s customers and employees. The Company devotes significant resources
to network and data security, including through the use of encryption and other security measures intended to protect its systems and
data. But these measures cannot provide absolute security, and losses or unauthorized access to or releases of confidential information
occur and could materially adversely affect the Company’s reputation, financial condition and operating results. The Company’s
business also requires it to share confidential information with third parties. Although the Company takes steps to secure confidential
information that is provided to third parties, such measures are not always effective and losses or unauthorized access to or releases
of confidential information occur and could materially adversely affect the Company’s reputation, financial condition and operating
results.
For
example, the Company may experience a security breach impacting the Company’s information technology systems that compromises the
confidentiality, integrity or availability of confidential information. Such an incident could, among other things, impair the Company’s
ability to attract and retain customers for its products and services, impact the Company’s stock price, materially damage supplier
relationships, and expose the Company to litigation or government investigations, which could result in penalties, fines or judgments
against the Company.
The
Company has implemented systems and processes intended to secure its information technology systems and prevent unauthorized access to
or loss of sensitive data. As with all companies, these security measures may not be sufficient for all eventualities and may be vulnerable
to hacking, employee error, malfeasance, system error, faulty password management or other irregularities. In addition to the risks relating
to general confidential information described above, the Company is also subject to specific obligations relating to health data and
payment card data. Health data is subject to additional privacy, security and breach notification requirements, and the Company can be
subject to audit by governmental authorities regarding the Company’s compliance with these obligations. If the Company fails to
adequately comply with these rules and requirements, or if health data is handled in a manner not permitted by law or under the Company’s
agreements with healthcare institutions, the Company could be subject to litigation or government investigations, may be liable for associated
investigatory expenses, and could also incur significant fees or fines.
Under
payment card rules and obligations, if cardholder information is potentially compromised, the Company could be liable for associated
investigatory expenses and could also incur significant fees or fines if the Company fails to follow payment card industry data security
standards. The Company could also experience a significant increase in payment card transaction costs or lose the ability to process
payment cards if it fails to follow payment card industry data security standards, which would materially adversely affect the Company’s
reputation, financial condition and operating results.
System
errors or failures of our platform or services to conform to specifications could cause unforeseen liabilities or injury, harm our reputation
and have a material adverse impact on our results of operations.
The
software and technology services that we operate are complex. As with complex systems offered by others, our software and technology
services may contain errors, especially when first introduced. Failure of a customer’s system to perform in accordance with our
documentation could constitute a breach of warranty and could require us to incur additional expense in order to make the system comply
with the documentation. If such failure is not remedied in a timely manner, it could constitute a material breach under a contract, allowing
the client to cancel the contract, obtain refunds of amounts previously paid, or assert claims for significant damages.
31
Risks
Associated with Bonum Health Telemedicine Services
The
telehealth market is immature and volatile.
The
telehealth market is relatively new and unproven, and it is uncertain whether it will achieve and sustain high levels of demand, consumer
acceptance and market adoption. Our success will depend to a substantial extent on the willingness of our clients’ members or patients
to use, and to increase the frequency and extent of their utilization of, our services, as well as on our ability to demonstrate the
value of telehealth to employers, health plans, government agencies and other purchasers of healthcare for beneficiaries. Negative publicity
concerning our services or the telehealth market as a whole could limit market acceptance of our services. If our clients, or their members
or patients, do not perceive the benefits of our services, or if our services are not competitive, then our market may not develop at
all, or it may develop more slowly than we expect. Similarly, individual and healthcare industry concerns or negative publicity regarding
patient confidentiality and privacy in the context of telehealth could limit market acceptance of our healthcare services. If any of
these events occurs, it could have a material adverse effect on our business, financial condition or results of operations.
Our
telehealth business could be adversely affected by legal challenges to our business model or by actions restricting our ability to provide
services in certain jurisdictions.
Our
ability to conduct telehealth services in a particular U.S. state is dependent upon the applicable laws governing remote healthcare and
the practice of medicine and healthcare delivery in general in such location which are subject to changing political, regulatory and
other influences. With respect to telehealth services, such services and our ability to offer such services are subject to rules established
or interpreted by state medical boards and whether such boards consider such services to be the practice of medicine. The definition
of practicing medicine is subject to change and open to evolving interpretations by medical boards and state attorneys’ generals,
among others. Accordingly, we must monitor our compliance with laws in the jurisdictions in which we operate, on an ongoing basis, and
we cannot provide assurance that our activities and arrangements, if challenged, will be found to be in compliance with the law. Additionally,
it is possible that the laws and rules governing the practice of medicine, including remote healthcare, in one or more jurisdictions
may change in a manner which negatively effects our ability to operate. If a successful legal challenge or an adverse change in the relevant
laws were to occur, and we were unable to adapt our business model accordingly, our operations in the affected jurisdictions would be
disrupted, which could have a material adverse effect on our business, financial condition and results of operations.
In
our telehealth business, we will be dependent on our relationships with affiliated professions and our business would be adversely affected
if those relationships were disrupted.
There
is a risk that state authorities in some jurisdictions may find that contractual relationships with physicians providing telehealth violate
laws prohibiting the corporate practice of medicine. State corporate practice of medicine doctrines also often impose penalties on physicians
themselves for aiding the corporate practice of medicine, which could discourage physicians from participating in our network of providers.
A material change in our relationship with our healthcare providers, whether resulting from a dispute among the entities, a change in
government regulation, or the loss of these affiliations, could impair our ability to provide services and could have a material adverse
effect on our business, financial condition and results of operations.
Our
“Bonum Health” telehealth business will depend on our ability to maintain and expand a network of qualified providers.
The
success of our “ Bonum Health ” telehealth services is dependent upon our ability to maintain a network of qualified
telehealth providers. If we are unable to recruit and retain board-certified physicians and other healthcare professionals, it would
have a material adverse effect on our “ Bonum Health ” business and ability to grow such operations. We may not be willing
to pay the costs demanded by such services providers and/or changes in Medicare and/or Medicaid reimbursement levels and other pressures
on healthcare providers and consolidation activity among hospitals, physician groups and healthcare providers may make such
providers harder or more expensive to find and contract with. The result of the above may be that our “ Bonum Health ”
telehealth services are unsuccessful, which may result in a material adverse effect to our operations.
32
Rapid
technological change in the telehealth industry presents us with significant risks and challenges.
The
telehealth market is characterized by rapid technological change, changing consumer requirements, short product lifecycles and evolving
industry standards. Our success will depend on our ability to enhance our offerings with next-generation technologies and to develop
or to acquire and market new services. There is no guarantee that we will possess the resources, either financial or personnel, for the
research, design and development of new applications or services, or that we will be able to utilize these resources successfully and
avoid technological or market obsolescence. Further, there can be no assurance that technological advances by one or more of our competitors
or future competitors will not result in our present or future software-based products and services becoming uncompetitive or obsolete.
The
telehealth industry is competitive, and if we are not able to compete effectively, our business, financial condition and results of operations
will be harmed.
While
the telehealth market is in an early stage of development, it is competitive and we expect it to attract increased competition, which
could make it difficult for us to succeed. We currently face competition in the telehealth industry from a range of companies, including
specialized software and solution providers that offer similar solutions, often at substantially lower prices, and that are continuing
to develop additional products and becoming more sophisticated and effective. These competitors include Doctor On Demand, MDLive, Teladoc
and others. In addition, large, well-financed health systems have in some cases developed their own telehealth tools and provide these
solutions to their customers at discounted prices. The surge in interest in telehealth, and in particular the relaxation of HIPAA privacy
and security requirements, has also attracted new competition from providers who utilize consumer-grade video conferencing platforms
such as Zoom, Microsoft Teams, Google Meet and Twilio. Competition from large software companies or other specialized solution providers,
communication tools and other parties could result in continued pricing pressures, which is likely to lead to price declines in certain
product segments, which could negatively impact our future market, sales, profitability and market share (if any). If we are unable to
successfully compete in the telehealth market, our business, financial condition and results of operations could be materially adversely
affected.
The
emergence of new technologies may render our telehealth solution obsolete or require us to expend significant resources in order to remain
competitive.
The
U.S. healthcare industry is massive, with a number of large market participants with conflicting agendas, and it is subject to significant
government regulation and is currently undergoing significant change. Changes in the telehealth industry, for example, such as the emergence
of new technologies as more competitors enter our market, could result in our telehealth solution being less desirable or relevant. If
healthcare benefits trends shift or entirely new technologies are developed that replace existing solutions, our existing or future products
could be rendered obsolete, and our business could be adversely affected. In addition, we may experience difficulties with industry standards,
design or marketing that could delay or prevent our development, introduction or implementation of new applications and enhancements.
If
we fail to develop widespread brand awareness cost-effectively, our business may suffer.
We
believe that developing and maintaining widespread awareness of our brand in a cost-effective manner is critical to achieving widespread
adoption of our products and attracting new clients. Our brand promotion activities may not generate client awareness or increase revenue,
and even if they do, any increase in revenue may not offset the expenses we incur in building our brand. If we fail to successfully promote
and maintain our brand, or incur substantial expenses in doing so, we may fail to attract or retain clients necessary to realize a sufficient
return on our brand-building efforts or to achieve the widespread brand awareness that is critical for broad client adoption of our solution.
33
Risks
Associated with Our Governing Documents and Delaware Law
Our
certificate of incorporation provides for indemnification of officers and directors at our expense and limits their liability, which
may result in a major cost to us and hurt the interests of our stockholders because corporate resources may be expended for the benefit
of officers or directors.
Our
Certificate of Incorporation provides for indemnification as follows: “To the fullest extent permitted by applicable law, the Corporation
is authorized to provide indemnification of, and advancement of expenses to, such agents of the Corporation (and any other persons to
which Delaware law permits the Corporation to provide indemnification) through Bylaw provisions, agreements with such agents or other
persons, vote of stockholders or disinterested directors or otherwise, in excess of the indemnification and advancement otherwise permitted
by Section 145 of the Delaware General Corporation Law, subject only to limits created by applicable Delaware law (statutory or non-statutory),
with respect to actions for breach of duty to the Corporation, its stockholders and others.” Our obligation to indemnify our officers
and directors may discourage stockholders from bringing a lawsuit against our officers or directors for breach of their fiduciary duty.
These provisions also may have the effect of reducing the likelihood of derivative litigation against our officers and directors, even
though such an action, if successful, might otherwise benefit us and our stockholders. Furthermore, a stockholder’s investment
may be adversely affected to the extent we pay the costs of settlement and damage awards against our officers and directors pursuant
to these indemnification provisions.
We
have been advised that, in the opinion of the SEC, indemnification for liabilities arising under federal securities laws is against public
policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification for liabilities
arising under federal securities laws, other than the payment by us of expenses incurred or paid by a director, officer or controlling
person in the successful defense of any action, suit or proceeding, is asserted by a director, officer or controlling person in connection
with our activities, we will (unless in the opinion of our counsel, the matter has been settled by controlling precedent) submit to a
court of appropriate jurisdiction, the question whether indemnification by us is against public policy as expressed in the Securities
Act and will be governed by the final adjudication of such issue. The legal process relating to this matter if it were to occur is likely
to be very costly and may result in us receiving negative publicity, either of which factors is likely to materially reduce the market
and price for our shares.
Our
certificate of incorporation contains a specific provision that limits the liability of our directors for monetary damages to the Company
and the Company’s stockholders and requires us, under certain circumstances, to indemnify officers, directors and employees.
The
limitation of monetary liability against our directors, officers and employees under Delaware law and the existence of indemnification
rights to them may result in substantial expenditures by us and may discourage lawsuits against our directors, officers and employees.
Our
certificate of incorporation contains a specific provision that limits the liability of our directors for monetary damages to the Company
and the Company’s stockholders, including as a result of a breach of their fiduciary duties, except to the extent such exception
from liability is not permitted under Delaware General Corporation Law. We also have contractual indemnification obligations under our
employment and engagement agreements with our executive officers and directors, as well as pursuant to indemnification agreements. The
foregoing indemnification obligations could result in us incurring substantial expenditures to cover the cost of settlement or damage
awards against our directors and officers, which the Company may be unable to recoup. These provisions and resultant costs may also discourage
us from bringing a lawsuit against our directors and officers for breaches of their fiduciary duties and may similarly discourage the
filing of derivative litigation by our stockholders against our directors and officers, even though such actions, if successful, might
otherwise benefit us and our stockholders.
34
Our
directors have the right to authorize the issuance of shares of preferred stock and additional shares of our common stock.
Our
directors, within the limitations and restrictions contained in our certificate of incorporation and without further action by our stockholders,
have the authority to issue shares of preferred stock from time to time in one or more series and to fix the number of shares and the
relative rights, conversion rights, voting rights, and terms of redemption, liquidation preferences and any other preferences, special
rights and qualifications of any such series. Any issuance of shares of preferred stock could adversely affect the rights of holders
of our common stock. Should we issue additional shares of our common stock at a later time, each investor’s ownership interest
in our stock would be proportionally reduced.
Anti-takeover
provisions may impede the acquisition of the Company.
Certain
provisions of the Delaware General Corporation Law (DGCL) have anti-takeover effects and may inhibit a non-negotiated merger or other
business combination, notwithstanding the fact that our certificate of incorporation provides that we are not subject to Section 203
of Delaware General Corporation Law, which relates to certain restrictions on business combinations with interested stockholders. These
provisions are intended to encourage any person interested in acquiring the Company to negotiate with, and to obtain the approval of,
our directors, in connection with such a transaction. As a result, certain of these provisions may discourage a future acquisition of
the Company, including an acquisition in which the stockholders might otherwise receive a premium for their shares. In addition, we can
also authorize “ blank check ” preferred stock, which could be issued by our Board of Directors without stockholder
approval and may contain voting, liquidation, dividend and other rights superior to our common stock.
Compliance,
Reporting and Listing Risks
We
incur significant costs to ensure compliance with U.S. and NASDAQ Capital Market reporting and corporate governance requirements.
We
incur significant costs associated with our public company reporting requirements and with applicable U.S. and NASDAQ Capital Market
corporate governance requirements, including requirements under the Sarbanes-Oxley Act of 2002 and other rules implemented by the SEC
and The NASDAQ Capital Market. The rules of The NASDAQ Capital Market include requiring us to maintain independent directors, comply
with other corporate governance requirements and pay annual listing and stock issuance fees. All of such SEC and NASDAQ obligations require
a commitment of additional resources including, but not limited to, additional expenses, and may result in the diversion of our senior
management’s time and attention from our day-to-day operations. We expect all of these applicable rules and regulations to significantly
increase our legal and financial compliance costs and to make some activities more time consuming and costly. We also expect that these
applicable rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance
and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar
coverage. As a result, it may be more difficult for us to attract and retain qualified individuals to serve on our Board of Directors
or as executive officers.
We
will continue to incur increased costs as a result of being a reporting company, and given our limited capital resources, such additional
costs may have an adverse impact on our profitability.
We
are an SEC-reporting company. The rules and regulations under the Exchange Act require reporting companies to provide periodic reports
with interactive data files, which require that we engage legal, accounting and auditing professionals, and inline eXtensible Business
Reporting Language (iXBRL) and EDGAR (Electronic Data Gathering, Analysis, and Retrieval) service providers. The engagement of such services
can be costly, and we may continue to incur additional losses, which may adversely affect our ability to continue as a going concern.
In addition, the Sarbanes-Oxley Act of 2002, as well as a variety of related rules implemented by the SEC, have required changes in corporate
governance practices and generally increased the disclosure requirements of public companies. For example, as a result of being a reporting
company, we are required to file periodic and current reports and other information with the SEC, and we have adopted policies regarding
disclosure controls and procedures and regularly evaluate those controls and procedures.
The
additional costs we continue to incur in connection with becoming a reporting company (expected to be several hundred thousand dollars
per year) will continue to further stretch our limited capital resources. Due to our limited resources, we have to allocate resources
away from other productive uses in order to continue to comply with our obligations as an SEC reporting company. Further, there is no
guarantee that we will have sufficient resources to continue to meet our reporting and filing obligations with the SEC as they come due.
35
We
may not be able to comply with NASDAQ’s continued listing standards.
Our
common stock was approved for listing on The NASDAQ Capital Market under the symbol “ MEDS ”, in February 2020. Notwithstanding
such listing, there can be no assurance any broker will be interested in trading our stock. Therefore, it may be difficult to sell your
shares of common stock if you desire or need to sell them. Our underwriters are not obligated to make a market in our securities, and
even if they do make a market, they can discontinue market making at any time without notice. Neither we nor the underwriters can provide
any assurance that an active and liquid trading market in our securities will develop or, if developed, that such market will continue.
There
is also no guarantee that we will be able to maintain our listing on The NASDAQ Capital Market for any period of time by perpetually
satisfying NASDAQ’s continued listing requirements. Our failure to continue to meet these requirements may result in our securities
being delisted from NASDAQ.
Among
the conditions required for continued listing on The NASDAQ Capital Market, NASDAQ requires us to maintain at least $2.5 million in stockholders’
equity or $500,000 in net income over the prior two years or two of the prior three years, to have a majority of independent directors,
an audit committee of at least three independent directors (subject to certain limited exceptions), and to maintain a stock price over
$1.00 per share. Our stockholders’ equity may not remain above NASDAQ’s $2.5 million minimum, we may not generate over $500,000
of yearly net income, we may not be able to maintain independent directors or an audit committee of at least three independent directors
(subject to certain limited exceptions), and we may not be able to maintain a stock price over $1.00 per share. If we fail to timely
comply with the applicable requirements, our stock may be delisted. In addition, even if we demonstrate compliance with the requirements
above, we will have to continue to meet other objective and subjective listing requirements to continue to be listed on The NASDAQ Capital
Market. Delisting from The NASDAQ Capital Market could make trading our common stock more difficult for investors, potentially leading
to declines in our share price and liquidity. Without a NASDAQ Capital Market listing, stockholders may have a difficult time getting
a quote for the sale or purchase of our stock, the sale or purchase of our stock would likely be made more difficult, and the trading
volume and liquidity of our stock could decline. Delisting from The NASDAQ Capital Market could also result in negative publicity and
could also make it more difficult for us to raise additional capital. The absence of such a listing may adversely affect the acceptance
of our common stock as currency or the value accorded by other parties. Further, if we are delisted, we would also incur additional costs
under state blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity
of our common stock and the ability of our stockholders to sell our common stock in the secondary market. If our common stock is delisted
by NASDAQ, our common stock may be eligible to trade on an over-the-counter quotation system, such as the OTCQB Market or the OTC Pink
market, where an investor may find it more difficult to sell our stock or obtain accurate quotations as to the market value of our common
stock. In the event our common stock is delisted from The NASDAQ Capital Market, we may not be able to list our common stock on another
national securities exchange or obtain quotation on an over-the counter quotation system.
Regulatory
Risks
Regulatory
changes that affect our distribution channels could harm our business.
At
the federal level, track and trace legislation requiring the use of pharmaceutical pedigree may restrict and disrupt the movement of
pharmaceuticals along the supply chain should the cost of complying with this legislation be too burdensome for smaller suppliers. Changes
in the United States healthcare industry and regulatory environment could have a material adverse impact on our results of operations.
Many
of our products and services are intended to function within the structure of the healthcare financing and reimbursement system currently
being used in the United States. In recent years, the healthcare industry in the United States has changed significantly in an effort
to enhance efficiencies, reduce costs and improve patient outcomes. These changes have included cuts in Medicare and Medicaid reimbursement
levels, changes in the basis for payments, shifting away from fee-for-service and towards value-based payments and risk-sharing models,
increases in the use of managed care, and consolidation in the healthcare industry generally. We expect that the healthcare industry
in the United States shall continue to change and evolve in the near future. Changes in the healthcare industry’s (or our pharmaceutical
suppliers’) pricing, selling, inventory, distribution or supply policies or practices could significantly reduce our revenues and
net income. Additionally, if we experience disruptions in our supply of generic drugs, our margins could be adversely affected.
36
We
distribute generic pharmaceuticals, which can be subject to both price deflation and price inflation. Continued volatility
in the availability, pricing trends or reimbursement of these generic drugs, or significant fluctuations in the nature, frequency and
magnitude of generic pharmaceutical launches, could have a material adverse impact on our results of operations. Additionally, any future
changes in branded and generics drug pricing could be significantly different than our projections. Generic drug manufacturers are increasingly
challenging the validity or enforceability of patents on branded pharmaceutical products. During the pendency of these legal challenges,
a generics manufacturer may begin manufacturing and selling a generic version of the branded product prior to the final resolution of
its legal challenge over the branded product’s patent. To the extent we source, contract manufacture, and distribute such generic
products, the brand-name company could assert infringement claims against us. While we generally obtain indemnification against such
claims from generic manufacturers as a condition of distributing their products, these rights may not be adequate or sufficient to protect
us.
We
are also required to comply with various state pricing gouging laws.
The
healthcare industry is highly regulated, and further regulation of our distribution businesses and technology products and services could
impose increased costs, negatively impact our profit margins and the profit margins of our customers, delay the introduction or implementation
of our new products, or otherwise negatively impact our business and expose us to litigation and regulatory investigations.
Healthcare
fraud laws are often vague and uncertain, exposing us to potential liability.
We
are subject to extensive, and frequently changing, local, state and federal laws and regulations relating to healthcare fraud, waste
and abuse. Local, state and federal governments continue to strengthen their position and scrutiny over practices involving fraud, waste
and abuse affecting Medicare, Medicaid and other government healthcare programs. Many of the regulations applicable to us, including
those relating to marketing incentives, are vague or indefinite and have not been interpreted by the courts. The regulations may be interpreted
or applied by a prosecutorial, regulatory, or judicial authority in a manner that could require us to make changes in our operations.
If we fail to comply with applicable laws and regulations, we could become liable for damages and suffer civil and criminal penalties,
including the loss of licenses or our ability to participate in Medicare, Medicaid and other federal and state healthcare programs.
Laws
reducing reimbursements for pharmaceuticals could negatively affect our industry.
Both
our profit margins and the profit margins of our customers may be adversely affected by laws and regulations reducing reimbursement rates
for pharmaceuticals, medical treatments and related services, or changing the methodology by which reimbursement levels are determined.
The federal government may adopt measures that could reduce Medicare or Medicaid spending, or impose additional requirements on healthcare
entities. We cannot predict what alternative or additional deficit reduction initiatives or Medicare payment reductions, if any, will
ultimately be enacted into law, or the timing or affect any such initiatives or reductions would have on us. Any of the changes discussed
above may have a material adverse impact on our results of operations, cash flows, prospects and/or the value of our securities.
Operating,
security and licensure standards of federal agencies challenge our ability to comply with applicable laws and regulations.
We
are subject to the operating and security standards of the Drug Enforcement Administration (the DEA), the U.S. Food and Drug Administration
(the FDA), various state boards of pharmacy, state health departments, the U.S. Department of Health and Human Services (HHS), the Centers
for Medicare & Medicaid Services (CMS), and other comparable agencies. We are also subject to certain state laws relating to price
gouging. Although we have enhanced our procedures to ensure compliance, a regulatory agency or tribunal may conclude that our operations
are not compliant with applicable laws and regulations. In addition, we may be unable to maintain or renew existing permits, licenses
or any other regulatory approvals or obtain without significant delay, future permits, licenses or other approvals needed for the operation
of our businesses. Any noncompliance by us with applicable laws and regulations or the failure to maintain, renew or obtain necessary
permits and licenses could lead to litigation and have a material adverse impact on our results of operations.
37
Pedigree
tracking laws and regulations could increase our regulatory burdens.
Congress
and state and federal agencies, including state boards of pharmacy and departments of health and the FDA, have made increased efforts
in the past year to regulate the pharmaceutical distribution system in order to prevent the introduction of counterfeit, adulterated
or mislabeled drugs into the pharmaceutical distribution system (otherwise known as “ pedigree tracking ”). In November
2013, Congress passed (and President Barack Obama signed into law) the Drug Quality and Security Act (the “ DQSA ”).
The DQSA establishes federal standards requiring supply-chain stakeholders to participate in an electronic, interoperable, lot-level
prescription drug track-and-trace system. The law also preempts state drug pedigree requirements and establishes new requirements for
drug wholesale distributors and third-party logistics providers, including licensing requirements in states that had not previously licensed
such entities.
In
addition, the Food and Drug Administration Amendments Act of 2007 requires the FDA to establish standards and identify and validate effective
technologies for the purpose of securing the pharmaceutical supply chain against counterfeit drugs. These standards may include track-and-trace
or authentication technologies, such as radio frequency identification devices, 2D data matrix barcodes, and other similar technologies.
On March 26, 2010, the FDA released the Serialized Numerical Identifier (the “ SNI ”) guidance for manufacturers who
serialize pharmaceutical packaging. To date we have been able to accommodate these SNI regulations in our distribution operations. The
DQSA and other pedigree tracking laws and regulations have increased the overall regulatory burden and costs associated with our pharmaceutical
distribution business and have had a material adverse impact on our results of operations.
We
are uncertain how new privacy laws shall be interpreted.
There
are numerous federal and state laws and regulations related to the privacy and security of personal information. In particular, regulations
promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) establish privacy and security standards
that limit the use and disclosure of individually identifiable health information (known as “ protected health information ”)
and require the implementation of administrative, physical and technological safeguards to protect the privacy of protected health information
and ensure the confidentiality, integrity and availability of electronic protected health information. We are directly subject to certain
provisions of the regulations as a “ Business Associate ” through our relationships with customers. We are also directly
subject to the HIPAA privacy and security regulations as a “ Covered Entity ” with respect to our operations as a healthcare
clearinghouse, specialty pharmacy and medical surgical supply business. If we are unable to properly protect the privacy and security
of protected health information entrusted to us, we could be found to have breached our contracts with our customers. Further, if we
fail to comply with applicable HIPAA privacy and security standards, we could face civil and criminal penalties. Although we have implemented
and continue to maintain policies and processes to assist us in complying with these regulations and our contractual obligations, we
cannot provide assurances regarding how these regulations will be interpreted, enforced or applied by the government and regulators to
our operations. In addition to the risks associated with enforcement activities and potential contractual liabilities, our ongoing efforts
to comply with evolving laws and regulations at the federal and state level might also require us to make costly system purchases /or
modifications from time to time.
We might be adversely
impacted by healthcare reform such as changes in pricing and reimbursement models.
Many of our products and services
are designed and intended to function within the structure of current healthcare financing and reimbursement systems. The healthcare
industry and related government programs are changing. Some of these changes increase our risks and create uncertainties for our business.
For example, some changes
in reimbursement methodologies (including government rates) for pharmaceuticals, medical treatments and related service reduces profit
margins for us and our customers and impose new legal requirements on healthcare providers. Those changes have included cuts in Medicare
and Medicaid reimbursement levels, changes in the basis for payments, shifting away from fee-for-service and toward value-based payment
and risk-sharing models, and increases in the use of managed care.
In the U.S., the Patient Protection and Affordable
Care Act (“ACA”) significantly expanded health insurance covered to uninsured Americans and changed the way healthcare is
financed by both governmental and private payers. There are continued efforts to challenge the ACA. There are also efforts to broaden
healthcare coverage. U.S. lawmakers also have explored proposals to reduce drug prices, including requiring price transparency and drug
importation measures. These proposals might result in significant changes in the pharmaceutical value chain as manufacturers, PBM, managed
care organizations and other industry stakeholders look to implement new transactional flows and adapt their business models.
Provincial governments in
Canada that provide partial funding for the purchase of pharmaceuticals and independently regulate the sale and reimbursement of drugs
have sought to reduce the costs of publicly funded health programs. For example, provincial governments have taken steps to reduce consumer
prices for generic pharmaceuticals and, in some provinces, change professional allowances paid to pharmacists by generic manufacturers.
Many European governments
provide or subsidize healthcare to consumers and regulate pharmaceutical prices, patient eligibility and reimbursement levels in order
to control government healthcare system costs. Some European governments have implemented or are considering austerity measures to reduce
healthcare spending. These measures exert pressure on the pricing and reimbursement timelines for pharmaceuticals and may cause our customers
to purchase fewer of our products and services or influence us to reduce prices.
38
Medical
billing and coding laws may subject us to fines and investigations.
Medical
billing, coding and collection activities are governed by numerous federal and state civil and criminal laws. In connection with these
laws, we may be subjected to federal, or state government investigations and possible penalties may be imposed upon us, false claims
actions may have to be defended, private payers may file claims against us, and we may be excluded from Medicare, Medicaid or other government-funded
healthcare programs. Any such proceeding or investigation could have a material adverse impact on our results of operations.
It
may be difficult and costly for us to comply with the extensive government regulations to which our business is subject.
Our
operations are subject to extensive regulation by the U.S. federal and state governments. In addition, as we expand our operations, we
may also become subject to the regulations of foreign jurisdictions, as well as additional regulations relating to environmental matters,
transportation of pharmaceutical products, shipping restrictions, and import and export restrictions. We are also required to comply
with various state pricing gouging laws.
Further,
the enactment of new rules and regulations could adversely affect our business. Depending on future
enforcement or additional rules and regulations created around it, pharmaceutical pricing controls could be established resulting in
substantially reduced margins and limited reimbursement for pharmacies and all other healthcare provider bases. In turn, this may adversely
affect our cash flow, profitability, and growth.
Risks
Relating to Our Industry in General
The
public health crisis involving the abuse of prescription opioid pain medication could have a material negative effect on our business.
Our
Pharmaceutical segment distributes prescription opioid pain medications. In recent years, the abuse of prescription opioid pain medication
has become a public health crisis.
A
significant number of counties, municipalities and other plaintiffs, including a number of state attorney generals, have filed lawsuits
against pharmaceutical manufacturers, pharmaceutical wholesale distributors, retail chains and others relating to the manufacturing,
marketing or distribution of prescription opioid pain medications. The defense and resolution of future lawsuits and events relating
to these lawsuits could have a material adverse effect on our results of operations, financial condition, cash flows or liquidity or
have adverse reputational or operational effects on our business.
Other
legislative, regulatory or industry measures related to the public health crisis involving the abuse of prescription opioid pain medication
and the distribution of these medications could affect our business in ways that we may not be able to predict. For example, several
states have now adopted taxes or other fees on the sale of opioids, and several other states have proposed similar legislative initiatives.
These laws and proposals vary in the tax amounts imposed and the means of calculation. Liabilities for taxes or assessments under any
such laws could have an adverse impact on our results of operations unless we are able to mitigate them through operational changes or
commercial arrangements where permitted.
Changes
to the U.S. healthcare environment may not be favorable to us.
Over
a number of years, the U.S. healthcare industry has undergone significant changes designed to increase access to medical care, improve
safety and patient outcomes, contain costs and increase efficiencies. These changes include adoption of the Patient Protection and Affordable
Care Act (ACA), a general decline in Medicare and Medicaid reimbursement levels, efforts by healthcare insurance companies to limit or
reduce payments to pharmacies and providers, the basis for payments beginning to transition from a fee-for-service model to value-based
payments and risk-sharing models, and the industry shifting away from traditional healthcare venues like hospitals and into clinics,
physician offices and patients’ homes.
39
We
expect the U.S. healthcare industry to continue to change significantly in the future. Possible changes include repeal and replacement
of major parts of the Patient Protection and Affordable Care Act, further reduction or limitations on governmental funding at the state
or federal level, efforts by healthcare insurance companies to further limit payments for products and services or changes in legislation
or regulations governing prescription pharmaceutical pricing, healthcare services or mandated benefits. These possible changes, and the
uncertainty surrounding these possible changes, may cause healthcare industry participants to reduce the number of products and services
they purchase from us or the price they are willing to pay for our products and services, which could adversely affect us.
Consolidation
in the U.S. healthcare industry may negatively impact our results of operations.
In
recent years, U.S. healthcare industry participants, including distributors, manufacturers, suppliers, healthcare providers, insurers
and pharmacy chains, have consolidated or formed strategic alliances. Consolidations create larger enterprises with greater negotiating
power, and also could result in the possible loss of a customer where the combined enterprise selects one distributor from two incumbents.
If this consolidation trend continues, it could adversely affect our results of operations.
Accounting
Risks
We
have identified material weaknesses in our internal control over financial reporting and controls and procedures which could, if not
remediated, adversely affect our ability to report our financial condition, cash flows and results of operations in a timely and accurate
manner and/or increase the risk of future misstatements, which could have a material adverse effect on our business, financial condition,
cash flows and results of operations and could cause the market value of our shares of common stock and/or debt securities to decline.
Maintaining
effective internal control over financial reporting and effective disclosure controls and procedures are necessary for us to produce
reliable financial statements. As reported under “ Item 9A. Controls and Procedures ”, as of December 31, 2021, our CEO and
CFO have determined that our disclosure controls and procedures were not effective. Additionally, our 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. As disclosed
below under “ Item 9A. Controls and Procedures ”, based on reviews conducted by management, we have concluded that a material
weakness exists in the Company’s internal controls over financial reporting. A material weakness is a deficiency, or a combination
of deficiencies, in internal controls over financial reporting such that there is a reasonable possibility that a material misstatement
of our annual or interim financial statements will not be prevented or detected on a timely basis. Such internal control over financial
reporting and disclosure controls and procedures have been ineffective since approximately June 30, 2014 and December 31, 2015, respectively.
The
material weaknesses identified in our controls and procedures as of December 31, 2021, included the fact that (1) The Company did not
maintain a fully integrated financial consolidation and reporting system throughout the period and as a result, extensive manual analysis,
reconciliation and adjustments were required in order to produce financial statements for external reporting purposes. and (2) the Company
does not currently have a sufficient complement of technical accounting and external reporting personnel commensurate to support standalone
external financial reporting under public company or SEC requirements. Specifically, the Company did not effectively segregate certain
accounting duties due to the small size of its accounting staff and maintain a sufficient number of adequately trained personnel necessary
to anticipate and identify risks critical to financial reporting and the closing process. In addition, there were inadequate reviews
and approvals by the Company’s personnel of certain reconciliations and other processes in day-to-day operations due to the lack
of a full complement of accounting staff.
The
material weaknesses identified in our internal control over financial reporting include the fact that: the Company did not maintain a
fully integrated financial consolidation and reporting system throughout the period and as a result, extensive manual analysis, reconciliation
and adjustments were required in order to produce financial statements for external reporting purposes; and the Company does not currently
have a sufficient complement of technical accounting and external reporting personnel commensurate to support standalone external financial
reporting under public company or SEC requirements. Specifically, the Company did not effectively segregate certain accounting duties
due to the small size of its accounting staff and maintain a sufficient number of adequately trained personnel necessary to anticipate
and identify risks critical to financial reporting and the closing process. In addition, there were inadequate reviews and approvals
by the Company’s personnel of certain reconciliations and other processes in day-to-day operations due to the lack of a full complement
of accounting staff.
Maintaining
effective disclosure controls and procedures and effective internal control over financial reporting are necessary for us to produce
reliable financial statements and the Company is committed to remediating its material weaknesses in such controls as promptly as possible.
The
Company has identified certain remediation actions and is in the process of implementing them, but such efforts are not complete and
remain ongoing. If we do not complete our remediation in a timely manner or if our remedial measures are insufficient to address the
material weaknesses, or if additional material weaknesses in our internal controls and/or controls and procedures are discovered or occur
in the future, it may materially adversely affect our ability to report our financial condition and results of operations in a timely
and accurate manner and there will continue to be an increased risk of future misstatements. Although we regularly review and evaluate
internal controls systems to allow management to report on the effectiveness of our internal controls over financial reporting and controls
and procedures, we may discover additional weaknesses in our internal controls over financial reporting or disclosure controls and procedures.
The next time we evaluate our internal controls over financial reporting and disclosure controls and procedures, if we identify one or
more new material weaknesses or have been unable to timely remediate our existing material weaknesses, we would be unable to conclude
that our internal controls over financial reporting or disclosure controls and procedures are effective. If we are unable in the future
to conclude that our internal controls over financial reporting or our disclosure controls and procedures are effective, we may not be
able to report our financial condition and results of operations in a timely and accurate manner, which could have a material adverse
effect on our business, financial condition, cash flows and results of operations and could cause the market value of our shares of common
stock to decline. In addition, any potential future restatements could subject us to additional adverse consequences, including sanctions
by the SEC, stockholder litigation and other adverse actions. Moreover, we may be the subject of further negative publicity focusing
on such financial statement adjustments and resulting restatement and negative reactions from our stockholders, creditors or others with
whom we do business. The occurrence of any of the foregoing could have a material adverse effect on our business, financial condition,
cash flows and results of operations and could cause the market value of our shares of common stock to decline.
40
We
may experience adverse impacts on our reported results of operations as a result of adopting new accounting
standards or interpretations.
Our
implementation of and compliance with changes in accounting rules, including new accounting rules and interpretations, have not affected
our reported financial position or operating results to date or cause unanticipated fluctuations in our reported operating results in
future periods.
A
significant amount of our revenues has historically been due to only a small number of customers and we depend on a small number of major
wholesalers, and if we were to lose any of those customers or suppliers, our results of operations would be adversely affected .
During
the years ended December 31, 2021 and 2020, no sales to customers represented greater than 10% of revenue in 2021 and sales to two customers
represented 25% and 15% of revenue, respectively, in 2020. In the event our customers do not pay us amounts owed, sales to
such customers cease or we are unable to find new customers moving forward, it could have a materially adverse effect on our results
of operations. We have a working relationship with over 25 wholesalers and the nation’s largest buying group. Although we believe
those entities are satisfied with their business relationship with Trxade, if our buying group and two or three of the largest wholesalers
decided no longer to do business with Trxade, and we were unable to find additional entities to step into their shoes, the resulting
supplier void would materially and adversely affect our competitiveness in the marketplace, and could cause a material adverse effect
on our results of operations.
We
might be harmed by changes in our relationships or contracts with suppliers .
We
attempt to structure our agreements with wholesalers to ensure that we are appropriately and predictably compensated for the services
we provide. We cannot control the frequency or magnitude of pharmaceutical price changes. We might be unable to renew agreements with
wholesalers in a timely and favorable manner. Any of these risks might have a materially adverse impact on our business operations and
our financial positions or results of operations.
Risks
Related to Our Common Stock and Organizational Documents
Our
common stock has in the past been a “ penny stock ” under SEC rules, and may be subject to the “ penny stock ”
rules in the future. It may be more difficult to resell securities classified as “ penny stock. ”
In
the past (including immediately prior to our common stock being listed on The NASDAQ Capital Market in February 2020), our common stock
was a “ penny stock ” under applicable SEC rules (generally defined as non-exchange traded stock with a per-share price
below $5.00). While our common stock is not now considered a “ penny stock ” because it is listed on The NASDAQ Capital
Market, if we are unable to maintain that listing, unless we maintain a per-share price above $5.00, our common stock will become “ penny
stock. ” These rules impose additional sales practice requirements on broker-dealers that recommend the purchase or sale of
penny stocks to persons other than those who qualify as “ established customers ” or “ accredited investors. ”
For example, broker-dealers must determine the appropriateness for non-qualifying persons of investments in penny stocks. Broker-dealers
must also provide, prior to a transaction in a penny stock not otherwise exempt from the rules, a standardized risk disclosure document
that provides information about penny stocks and the risks in the penny stock market. The broker-dealer also must provide the customer
with current bid and offer quotations for the penny stock, disclose the compensation of the broker-dealer and its salesperson in the
transaction, furnish monthly account statements showing the market value of each penny stock held in the customer’s account, provide
a special written determination that the penny stock is a suitable investment for the purchaser, and receive the purchaser’s written
agreement to the transaction.
41
Legal
remedies available to an investor in “ penny stocks ” may include the following:
●
If
a “ penny stock ” is sold to the investor in violation of the requirements listed above, or other federal or states
securities laws, the investor may be able to cancel the purchase and receive a refund of the investment.
●
If
a “ penny stock ” is sold to the investor in a fraudulent manner, the investor may be able to sue the persons and
firms that committed the fraud for damages.
These
requirements may have the effect of reducing the level of trading activity, if any, in the secondary market for a security that becomes
subject to the penny stock rules. The additional burdens imposed upon broker-dealers by such requirements may discourage broker-dealers
from effecting transactions in our securities, which could severely limit the market price and liquidity of our securities. These requirements
may restrict the ability of broker-dealers to sell our common stock and may affect your ability to resell our common stock.
Many
brokerage firms will discourage or refrain from recommending investments in penny stocks. Most institutional investors will not invest
in penny stocks. In addition, many individual investors will not invest in penny stocks due, among other reasons, to the increased financial
risk generally associated with these investments.
For
these reasons, penny stocks may have a limited market and, consequently, limited liquidity. We can give no assurance at what time, if
ever, our common stock will not be classified as a “ penny stock ” in the future.
A
significant number of our shares are eligible for sale and their sale or potential sale may depress the market price of our common stock.
Sales
of a significant number of shares of our common stock in the public market could harm the market price of our common stock. Most of our
common stock is available for resale in the public market, and if sold would increase the supply of our common stock, thereby causing
a decrease in its price. Some or all of our shares of common stock may be offered from time to time in the open market pursuant to effective
registration statements and/or compliance with Rule 144, which sales could have a depressive effect on the market for our shares of common
stock. Subject to certain restrictions, a person who has held restricted shares for a period of six months may generally sell common
stock into the market. The sale of a significant portion of such shares when such shares are eligible for public sale may cause the value
of our common stock to decline in value.
There
may not be sufficient liquidity in the market for our securities in order for investors to sell their shares. The market price of our
common stock may continue to be volatile .
The
market price of our common stock will likely continue to be highly volatile. Some of the factors that may materially affect the market
price of our common stock are beyond our control, such as conditions or trends in the industry in which we operate or sales of our common
stock. This situation is attributable to a number of factors, including the fact that we are a small company which is relatively unknown
to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume,
and that even if we came to the attention of such persons, they tend to be risk-averse and would be reluctant to follow an unproven company
such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable.
As
a consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared
to a mature issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse
effect on share price. It is possible that a broader or more active public trading market for our common stock will not develop or be
sustained, or that trading levels will not continue. These factors may materially adversely affect the market price of our common stock,
regardless of our performance. In addition, the public stock markets have experienced extreme price and trading volume volatility. This
volatility has significantly affected the market prices of securities of many companies for reasons frequently unrelated to the operating
performance of the specific companies. These broad market fluctuations may adversely affect the market price of our common stock.
42
The
exercise of outstanding warrants, options and shares issued in connection with a joint venture and acquisition will be dilutive to our
existing stockholders .
As
of the date of this Report, we had 8,181,041 shares of our common stock issued and outstanding and the following securities,
which are exercisable into shares of our common stock:
●
44,535 shares of our common stock issuable upon the exercise of warrants with exercise prices ranging from $0.06 to $9.00 per share,
with a weighted average price of $0.32; and
●
410,964 shares of our common stock issuable upon the exercise of options with exercise prices ranging from $2.46 per share to $9.60 per
share, with a weighted average price of $4.88.
For
the life of the options and warrants, the holders have the opportunity to profit from a rise in the market price of our common stock
without assuming the risk of ownership. The issuance of shares upon the exercise of outstanding securities will also dilute the ownership
interests of our existing stockholders.
The
availability of these shares for public resale, as well as any actual resales of these shares, could adversely affect the trading price
of our common stock. Certain of the shares of common stock underlying outstanding options will be available for resale immediately in
the public market without restriction.
We
cannot predict the size of future issuances of our common stock pursuant to the exercise of outstanding options or warrants, or the effect,
if any, that future issuances and sales of shares of our common stock may have on the market price of our common stock. Sales or distributions
of substantial amounts of our common stock (including shares issued in connection with an acquisition), or the perception that such sales
could occur, may cause the market price of our common stock to decline.
We
have never paid or declared any dividends on our common stock.
We
have never paid or declared any dividends on our common stock or preferred stock. Likewise, we do not anticipate paying, in the near
future, dividends or distributions on our common stock. Any future dividends on common stock will be declared at the discretion of our
Board of Directors and will depend, among other things, on our earnings, our financial requirements for future operations and growth,
and other facts as we may then deem appropriate. Since we do not anticipate paying cash dividends on our common stock, return on your
investment, if any, will depend solely on an increase, if any, in the market value of our common stock.
Our
common stock price is likely to be highly volatile because of several factors, including a limited public float.
The
market price of our common stock has been volatile in the past and the market price of our common stock is likely to be highly volatile
in the future. You may not be able to resell shares of our common stock following periods of volatility because of the market’s
adverse reaction to volatility.
Other
factors that could cause such volatility may include, among other things:
●
actual
or anticipated fluctuations in our operating results;
●
the
absence of securities analysts covering us and distributing research and recommendations about us;
●
we
may have a low trading volume for a number of reasons, including that a large portion of our stock is closely held;
●
overall
stock market fluctuations;
43
●
announcements
concerning our business or those of our competitors;
●
actual
or perceived limitations on our ability to raise capital when we require it, and to raise such capital on favorable terms;
●
conditions
or trends in our industry;
●
litigation;
●
changes
in market valuations of other similar companies;
●
future
sales of common stock;
●
departure
of key personnel or failure to hire key personnel; and
●
general
market conditions.
Any
of these factors could have a significant and adverse impact on the market price of our common stock. In addition, the stock market in
general has at times experienced extreme volatility and rapid decline that has often been unrelated or disproportionate to the operating
performance of particular companies. These broad market fluctuations may adversely affect the trading price of our common stock, regardless
of our actual operating performance.
Our
Chief Executive Officer and President are our two largest stockholders and, as a result, they can exert control over us and have actual
or potential interests that may differ from yours.
Mr.
Suren Ajjarapu, our CEO, and Mr. Prashant Patel, our President, beneficially own, in the aggregate, over 53% of our
common stock. As a result, these stockholders, acting together, will be able to influence many matters requiring stockholder approval,
including the election of directors and approval of mergers and other significant corporate transactions. This concentration of ownership
may have the effect of delaying, preventing or deterring a change in control, and could deprive our stockholders of an opportunity to
receive a premium for their shares of common stock as part of a sale of our company and may affect the market price of our stock.
Further,
Mr. Ajjarapu and Mr. Patel may have interests that differ from those of other holders of our common stock. As a result, Mr. Ajjarapu
and Mr. Patel may vote the shares they own or control or otherwise cause us to take actions that may conflict with your best interests
as a stockholder, which could adversely affect our results of operations and the trading price of our common stock.
Through
this control, Mr. Ajjarapu and Mr. Patel can control our management, affairs and all matters requiring stockholder approval, including
the approval of significant corporate transactions, a sale of our company, decisions about our capital structure and the composition
of our Board of Directors.
Our
common stock may continue to be followed by only a limited number of analysts and there may continue to be a limited number of institutions
acting as market makers for our common stock.
For
the foreseeable future, our common stock is unlikely to be followed by a significant number of market analysts, and there may be few
institutions acting as market makers for our common stock. Either of these factors could adversely affect the liquidity and trading price
of our common stock. Until our common stock is fully distributed, and an orderly market develops in our common stock, if ever, the price
at which it trades is likely to fluctuate significantly. Prices for our common stock are determined in the marketplace and may be influenced
by many factors, including the depth and liquidity of the market for shares of our common stock, developments affecting our business,
including the impact of the factors referred to elsewhere in these Risk Factors, investor perception of us and general economic and market
conditions. No assurances can be given that an orderly or liquid market will ever develop for the shares of our common stock.
44
Our
bylaws require, to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors, officers,
other employees or stockholders for breach of fiduciary duty and certain other actions may be brought only in the Court of Chancery in
the State of Delaware, and if brought outside of Delaware, the stockholder bringing the suit will, subject to certain exceptions, be
deemed to have consented to service of process on such stockholder’s counsel, which may have the effect of discouraging lawsuits
against our directors, officers, other employees or stockholders.
Our
bylaws require that unless the Company consents in writing to an alternative forum, the Court of Chancery of the State of Delaware shall,
to the fullest extent permitted by law, be the sole and exclusive forum for (a) any derivative action or proceeding brought on behalf
of the Company; (b) any action asserting a claim of breach of fiduciary duty owed by, or other wrongdoing by, any director, officer,
employee or agent of the Company to the Company or the Company’s stockholders; (c) any action asserting a claim arising pursuant
to any provision of Delaware General Corporation Law or the certificate of incorporation or bylaws of the Company; (d) any action to
interpret, apply, enforce or determine the validity of the certificate of incorporation or bylaws of the Company; or (e) any action asserting
a claim governed by the internal affairs doctrine, in each case subject to said Court of Chancery having personal jurisdiction over the
indispensable parties named as defendants therein (or such indispensable parties consenting to the personal jurisdiction of the Court
of Chancery within 10 days following any determination by the Court of Chancery that an indispensable party is not subject to such personal
jurisdiction); provided that, if the Court of Chancery of the State of Delaware dismisses any action for lack of subject matter jurisdiction,
such action may be brought in another state or federal court sitting in the State of Delaware. Any person or entity purchasing or otherwise
acquiring any interest in shares of our capital stock shall be deemed to have notice of and consented to the forum provisions in our
bylaws. This choice of forum provision may limit or make more costly a stockholder’s ability to bring a claim in a judicial forum
that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage
lawsuits with respect to such claims. Alternatively, if a court were to find the choice of forum provision contained in our bylaws to
be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions,
which could harm our business, operating results and financial condition.
As
described above, our bylaws provide that the exclusive forum provision will be applicable to the fullest extent permitted by applicable
law, subject to certain exceptions. However, Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought
to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. As a result, the exclusive forum
provision will not apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the
federal courts have exclusive jurisdiction. We also note that investors cannot waive compliance with the federal securities laws and
the rules and regulations thereunder. Section 22 of the Securities Act, creates concurrent jurisdiction for state and federal courts
over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.
Our
stockholders have no right to call special meetings of stockholders.
Our
bylaws provide that special meetings of our stockholders may be called only by the chairperson of the board of directors, the chief executive
officer or president (in the absence of a chief executive officer). Because our stockholders do not have the right to call a special
meeting, a stockholder could not force stockholder consideration of a proposal over the opposition of our board of directors by calling
a special meeting of stockholders prior to such time as the chairperson of the board of directors, the chief executive officer or president
(in the absence of a chief executive officer) believed the matter should be considered or until the next annual meeting provided that
the requestor met the notice requirements. The restriction on the ability of stockholders to call a special meeting means that a proposal
to replace our board of directors also could be delayed until the next annual meeting.
Provisions
in our certificate of incorporation and bylaws may inhibit a takeover of us, which could limit the value of our securities and could
entrench management.
Our
certificate of incorporation and bylaws contain provisions that may discourage unsolicited takeover proposals that stockholders may consider
to be in their best interests. These provisions include the ability of the board of directors to designate the terms of and issue new
series of preferred shares and the requirement to receive the affirmative vote of holders of at least two-thirds of the outstanding capital
stock of the Company to amend any provision of the bylaws of the Company, without Board of Directors approval (which Board of Directors
approved amendments may be affected solely by the Board of Directors, without stockholder approval, subject to certain exceptions, without
stockholder approval), which may make the removal of management more difficult and may discourage transactions that otherwise could involve
payment of a premium over prevailing market prices for our securities. These provisions may make the removal of management more difficult
and may discourage transactions that otherwise could involve payment of a premium over prevailing market prices for our securities.
45
Risks
Relating to The JOBS Act
The
JOBS Act allows us to postpone the date by which we must comply with certain laws and regulations and to reduce the amount of information
provided in reports filed with the SEC. We cannot be certain if the reduced disclosure requirements applicable to “ emerging
growth companies ” will make our common stock less attractive to investors.
We
are and we will remain an “ emerging growth company ” until the earliest to occur of (i) the last day of the fiscal
year during which our total annual revenues equal or exceed $1.07 billion (subject to adjustment for inflation), (ii) the last day of
the end of our 2024 fiscal year (5 years from our first public offering), (iii) the date on which we have, during the previous three-year
period, issued more than $1 billion in non-convertible debt, or (iv) the date on which we are deemed a “ large accelerated filer ”
(with at least $700 million in public float) under the Exchange Act. For so long as we remain an “ emerging growth company ”
as defined in the JOBS Act, we may take advantage of certain exemptions from various reporting requirements that are applicable to other
public companies that are not “ emerging growth companies ” as described in further detail in the risk factors below.
We cannot predict if investors will find our common stock less attractive because we will rely on some or all of these exemptions. If
some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and
our stock price may be more volatile. If we avail ourselves of certain exemptions from various reporting requirements, as is currently
our plan, our reduced disclosure may make it more difficult for investors and securities analysts to evaluate us and may result in less
investor confidence.
Our
election not to opt out of the JOBS Act extended accounting transition period may not make our financial statements easily comparable
to other companies.
Pursuant
to the JOBS Act, as an “ emerging growth company ”, we can elect to opt out of the extended transition period for any
new or revised accounting standards that may be issued by the Public Company Accounting Oversight Board (PCAOB) or the SEC. We have elected
not to opt out of such extended transition period which means that when a standard is issued or revised and it has different application
dates for public or private companies, we, as an “ emerging growth company ”, can adopt the standard for the private
company. This may make a comparison of our financial statements with any other public company which is not either an “ emerging
growth company ” nor an “ emerging growth company ” which has opted out of using the extended transition period,
more difficult or impossible as possible different or revised standards may be used.
The
JOBS Act also allows us to postpone the date by which we must comply with certain laws and regulations intended to protect investors
and to reduce the amount of information provided in reports filed with the SEC.
The
JOBS Act is intended to reduce the regulatory burden on “ emerging growth companies ”. The Company meets the definition
of an “ emerging growth company ” and so long as it qualifies as an “ emerging growth company, ” it
will, among other things:
●
be
exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that its independent registered public accounting
firm provide an attestation report on the effectiveness of its internal control over financial reporting;
●
be
exempt from the “ say on pay ” provisions (requiring a non-binding stockholder vote to approve compensation of certain
executive officers) and the “ say on golden parachute ” provisions (requiring a non-binding stockholder vote to
approve golden parachute arrangements for certain executive officers in connection with mergers and certain other business combinations)
of The Dodd–Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) and certain disclosure requirements of the
Dodd-Frank Act relating to compensation of Chief Executive Officers;
46
●
be
permitted to omit the detailed compensation discussion and analysis from proxy statements and reports filed under the Exchange Act
and instead provide a reduced level of disclosure concerning executive compensation; and
●
be
exempt from any rules that may be adopted by the PCAOB requiring mandatory audit firm rotation or a supplement to the auditor’s
report on the financial statements.
The
Company has and intends to continue to take advantage of all of the reduced regulatory and reporting requirements that will be available
to it so long as it qualifies as an “ emerging growth company ”. The Company has elected not to opt out of the extension
of time to comply with new or revised financial accounting standards available under Section 102(b)(1) of the JOBS Act. Among other things,
this means that the Company’s independent registered public accounting firm will not be required to provide an attestation report
on the effectiveness of the Company’s internal control over financial reporting so long as it qualifies as an “ emerging
growth company ”, which may increase the risk that weaknesses or deficiencies in the internal control over financial reporting
go undetected. Likewise, so long as it qualifies as an “ emerging growth company ”, the Company may elect not to provide
certain information, including certain financial information and certain information regarding compensation of executive officers, which
it would otherwise have been required to provide in filings with the SEC, which may make it more difficult for investors and securities
analysts to evaluate the Company. As a result, investor confidence in the Company and the market price of its common stock may be adversely
affected.
Notwithstanding
the above, we are also currently a “ smaller reporting company ”, meaning that we are not an investment company, an
asset-backed issuer, or a majority-owned subsidiary of a parent company that is not a smaller reporting company and have a public float
of less than $700 million and less than $100 million annual revenues or a public float of less than $250 million, during the most recently
completed fiscal year. In the event that we are still considered a “ smaller reporting company ”, at such time are we
cease being an “ emerging growth company ”, the disclosure we will be required to provide in our SEC filings will increase,
but will still be less than it would be if we were not considered either an “ emerging growth company ” or a “ smaller
reporting company ”. Specifically, similar to “ emerging growth companies ”, “ smaller reporting companies ”
are able to provide simplified executive compensation disclosures in their filings; are exempt from the provisions of Section 404(b)
of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report on the effectiveness
of internal control over financial reporting; except from the requirement to include the detailed compensation discussion and analysis
disclosures and have certain other decreased disclosure obligations in their SEC filings, including, among other things, only being required
to provide two years of audited financial statements in annual reports. Decreased disclosures in our SEC filings due to our status as
an “ emerging growth company ” or “ smaller reporting company ” may make it harder for investors to
analyze the Company’s results of operations and financial prospects.
General
Risk Factors
Failure
to adequately manage our planned aggressive growth strategy may harm our business or increase our risk of failure.
For
the foreseeable future, we intend to pursue an aggressive growth strategy for the expansion of our operations through increased product
development and marketing. Our ability to rapidly expand our operations will depend upon many factors, including our ability to work
in a regulated environment, market value-added products effectively to independent pharmacies, establish and maintain strategic relationships
with suppliers, and obtain adequate capital resources on acceptable terms. Any restrictions on our ability to expand may have a materially
adverse effect on our business, results of operations, and financial condition. Accordingly, we may be unable to achieve our targets
for sales growth, and our operations may not be successful or achieve anticipated operating results.
47
Additionally,
our growth may place a significant strain on our managerial, administrative, operational, and financial resources and our infrastructure.
Our future success will depend, in part, upon the ability of our senior management to manage growth effectively. This will require us
to, among other things:
●
implement
additional management information systems;
●
further
develop our operating, administrative, legal, financial, and accounting systems and controls;
●
hire
additional personnel;
●
develop
additional levels of management within our company;
●
locate
additional office space;
●
maintain
close coordination among our engineering, operations, legal, finance, sales and marketing, and client service and support organizations;
and
●
manage
our expanding international operations.
As
a result, we may lack the resources to deploy our services on a timely and cost-effective basis. Failure to accomplish any of these requirements
could impair our ability to deliver services in a timely fashion or attract and retain new customers.
If
we do not successfully implement any acquisition strategies, our operating results and prospects could be harmed.
We
face competition within our industry for acquisitions of businesses, technologies and assets, and, in the future, such competition may
become more intense. As such, even if we are able to identify an acquisition that we would like to consummate, we may not be able to
complete the acquisition on commercially reasonable terms or at all because of such competition. Furthermore, if we enter into negotiations
that are not ultimately consummated, those negotiations could result in diversion of management time and significant out-of-pocket costs.
Even if we are able to complete such acquisitions, we may additionally expend significant amounts of cash or incur substantial debt to
finance them, which indebtedness could result in restrictions on our business and use of available cash. In addition, we may finance
or otherwise complete acquisitions by issuing equity or convertible debt securities, which could result in dilution of our existing stockholders.
If we fail to evaluate and execute acquisitions successfully, we may not be able to realize their benefits. If we are unable to successfully
address any of these risks, our business, financial condition or operating results could be harmed.
If
we make any acquisitions, they may disrupt or have a negative impact on our business.
If
we make acquisitions in the future, funding permitting, which may not be available on favorable terms, if at all, we could have difficulty
integrating the acquired company’s assets, personnel and operations with our own. We do not anticipate that any acquisitions or
mergers we may enter into in the future would result in a change of control of the Company. In addition, the key personnel of the acquired
business may not be willing to work for us. We cannot predict the effect expansion may have on our core business. Regardless of whether
we are successful in acquiring, the negotiations could disrupt our ongoing business, distract our management and employees and increase
our expenses. In addition to the risks described above, acquisitions are accompanied by a number of inherent risks, including, without
limitation, the following:
●
the
difficulty of integrating acquired products, services or operations;
●
the
potential disruption of the ongoing businesses and distraction of our management and the management of acquired companies;
●
difficulties
in maintaining uniform standards, controls, procedures and policies;
●
the
potential impairment of relationships with employees and customers as a result of any integration of new management personnel;
48
●
the
potential inability or failure to achieve additional sales and enhance our customer base through cross-marketing of the products
to new and existing customers;
●
the
effect of any government regulations which relate to the business acquired;
●
potential
unknown liabilities associated with acquired businesses or product lines, or the need to spend significant amounts to retool, reposition
or modify the marketing and sales of acquired products or operations, or the defense of any litigation, whether or not successful,
resulting from actions of the acquired company prior to our acquisition; and
●
potential
expenses under the labor, environmental and other laws of various jurisdictions.
Our
business could be severely impaired if and to the extent that we are unable to succeed in addressing any of these risks or other problems
encountered in connection with an acquisition, many of which cannot be presently identified. These risks and problems could disrupt our
ongoing business, distract our management and employees, increase our expenses and adversely affect our results of operations.
We
may apply working capital and future funding to uses that ultimately do not improve our operating results or increase the value of our
securities.
In
general, we have complete discretion over the use of our working capital and any new investment capital we may obtain in the future.
Because of the number and variety of factors that could determine our use of funds, our ultimate expenditure of funds (and their uses)
may vary substantially from our current intended operating plan for such funds.
We
intend to use existing working capital and future funding to support the development of our products and services, product purchases
in our wholesale distribution division, the expansion of our marketing, or the support of operations to educate our customers. We will
also use capital for market and network expansion, acquisitions, and general working capital purposes. However, we do not have more specific
plans for the use and expenditure of our capital. Our management has broad discretion to use any or all of our available capital reserves.
Our capital could be applied in ways that do not improve our operating results or otherwise increase the value of a stockholder’s
investment.
Our
websites may encounter technical problems and service interruptions.
Our
websites may in the future experience slower response times or interruptions as a result of increased traffic or other reasons. These
delays and interruptions resulting from failure to maintain Internet service connections to our site could frustrate visitors and reduce
our future web site traffic, which could have a material adverse effect on our business.
The
sale of shares by our directors and officers may adversely affect the market price for our shares.
Sales
of significant amounts of shares held by our officers and directors, or the prospect of these sales, could adversely affect the market
price of our common stock. Management’s stock ownership may discourage a potential acquirer from making a tender offer or otherwise
attempting to obtain control of us, which in turn could reduce our stock price or prevent our stockholders from realizing a premium over
our stock price.
Stockholders
may be diluted significantly through our efforts to obtain financing and satisfy obligations through the issuance of additional shares
of our common stock.
Wherever
possible, our Board of Directors will attempt to use non-cash consideration to satisfy obligations. In many instances, we believe that
the non-cash consideration will consist of restricted shares of our common stock or where shares are to be issued to our officers, directors
and applicable consultants. Our Board of Directors has authority, without action or vote of the stockholders, but subject to NASDAQ rules
and regulations (which generally require shareholder approval for any transactions which would result in the issuance of more than 20%
of our then outstanding shares of common stock or voting rights representing over 20% of our then outstanding shares of stock), to issue
all or part of the authorized but unissued shares of common stock. In addition, we may attempt to raise capital by selling shares of
our common stock, possibly at a discount to market. These actions will result in dilution of the ownership interests of existing stockholders,
which may further dilute common stock book value, and that dilution may be material. Such issuances may also serve to enhance existing
management’s ability to maintain control of the Company because the shares may be issued to parties or entities committed to supporting
existing management.
49
Our
growth depends in part on the success of our strategic relationships with third parties.
In
order to grow our business, we anticipate that we will need to continue to depend on our relationships with third parties, including
our technology providers. Identifying partners, and negotiating and documenting relationships with them, requires significant time and
resources. Our competitors may be effective in providing incentives to third parties to favor their products or services, or utilization
of, our products and services. In addition, acquisitions of our partners by our competitors could result in a decrease in the number
of our current and potential customers. If we are unsuccessful in establishing or maintaining our relationships with third parties, our
ability to compete in the marketplace or to grow our revenue could be impaired and our results of operations may suffer. Even if we are
successful, we cannot assure you that these relationships will result in increased customer use of our products or increased revenue.
Claims,
litigation, government investigations, and other proceedings may adversely affect our business and results of operations.
As
a company offering a wide range of products and services, we are regularly subject to actual and threatened claims, litigation, reviews,
investigations, and other proceedings, including proceedings relating to goods and services offered by us and by third parties, and other
matters. Any of these types of proceedings, including currently pending proceedings as discussed herein, may have an adverse effect on
us because of legal costs, disruption of our operations, diversion of management resources, negative publicity, and other factors. The
outcomes of these matters are inherently unpredictable and subject to significant uncertainties. Determining legal reserves and possible
losses from such matters involves judgment and may not reflect the full range of uncertainties and unpredictable outcomes. Until the
final resolution of such matters, we may be exposed to losses in excess of the amount recorded, and such amounts could be material. Should
any of our estimates and assumptions change or prove to have been incorrect, it could have a material effect on our business, consolidated
financial position, results of operations, or cash flows. In addition, it is possible that a resolution of one or more such proceedings,
including as a result of a settlement, could require us to make substantial future payments, prevent us from offering certain products
or services, require us to change our business practices in a manner materially adverse to our business, requiring development of non-infringing
or otherwise altered products or technologies, damaging our reputation, or otherwise having a material effect on our operations.
We
may be adversely affected by climate change or by legal, regulatory or market responses to such change.
The
long-term effects of climate change are difficult to predict; however, such effects may be widespread. Impacts from climate change may
include physical risks (such as rising sea levels or frequency and severity of extreme weather conditions—which may affect our
current operations due to among other things, the fact that we are based in Florida, which is only on average 6 feet higher than current
sea level), social and human effects (such as population dislocations or harm to health and well-being), compliance costs and transition
risks (such as regulatory or technology changes) and other adverse effects. The effects of climate change could increase the cost of
certain products, commodities and energy (including utilities), which in turn may impact our ability to procure goods or services required
for the operation of our business. Climate change could also lead to increased costs as a result of physical damage to or destruction
of our facilities, loss of inventory, and business interruption due to weather events that may be attributable to climate change. These
events and impacts could materially adversely affect our business operations, financial position or results of operation.
50
We
might be adversely impacted by changes in accounting standards.
Our
consolidated financial statements are subject to the application of U.S. GAAP, which periodically is revised or reinterpreted. From time
to time, we are required to adopt new or revised accounting standards issued by recognized authoritative bodies, including the Financial
Accounting Standards Board (“ FASB ”) and the SEC. It is possible that future accounting standards may require changes
to the accounting treatment in our consolidated financial statements and may require us to make significant changes to our financial
systems. Such changes might have a materially adverse impact on our financial position or results of operations.
For
all of the foregoing reasons and others set forth herein, an investment in our securities involves a high degree of risk.
ITEM
1B.
UNRESOLVED
STAFF COMMENTS
None.
ITEM
2.
PROPERTIES
We
do not own any real property. We moved out of our previous corporate facility located at 3480 Land O’Lakes Blvd, Land O Lakes,
Florida 33556 on December 31, 2021 and entered into a lease for our current corporate office space at 2420 Brunello Trace, Lutz, Florida
33558 on November 8, 2021. The lease has a five-year term, beginning January 1, 2022, and ending December 31, 2026. Our office space
occupies approximately 9,850 square feet. Pursuant to the lease, the Company will also be responsible for water/sewer costs ($140 per
month) and its proportionate share of the building’s operating expenses, including property taxes. We paid a security deposit of
$38,500 in connection with our entry into the agreement.
Our
rental cost under the agreement during the term of the lease, is as follows:
Lease
Period
Monthly
Rent
January
1, 2022 to December 31, 2022
$ 18,469
January
1, 2023 to December 31, 2023
$ 19,023
January
1, 2024 to December 31, 2024
$ 19,594
January
1, 2025 to December 31, 2025
$ 20,181
January
1, 2026 to December 31, 2026
$ 20,787
Pursuant
to the lease, we have an option to renew the lease for two additional five-year terms with a mutually agreed increase in rental
cost.
The
Company’s obligations under the lease are guaranteed by Suren Ajjarapu, the Company’s Chief Executive Officer and Chairman
but has not been formally documented to date.
The
Company also has, pursuant to the terms of the lease, a right to match any offer for purchase on 4.12 acres of Sienna Village I, parcel
26-26-18-0000-04800-000 and 4 buildings totaling 23,048 square feet of office space in its entirety, for a 2-year period commencing with
the execution of the lease. We also have a right of first refusal to lease available vacant buildings at the then current market rate
only after the landlord has made such space available for leasing.
In
connection with our entry into the lease, we purchased certain furniture and assets of the landlord located at the leased premises for
(a) $60,000, payable in 12 installments of $5,000 each, with title to such assets transferring on the date of the last payment, December
1, 2022; and (b) $37,500, which was payable upon our entry into the lease agreement, upon which payment, title to such purchased assets
transferred.
The
lease contains customary indemnification and termination provisions. In addition, the lease contains customary events of default, including
payment defaults, breaches of covenants and/or certain representations and warranties, bankruptcy or insolvency proceedings and other
events of default customary for this type of transaction. The lease also contains remedies for such events of default, including the
landlord’s right to cure a default (together with our requirement to pay a 15% administrative fee in connection therewith), interest
and other amounts, the right to accelerate all amounts due during the remaining term of the lease, termination of the lease and other
remedies customary for this type of transaction.
51
We
entered into a lease for Integra Pharma Solutions, LLC at 6308 Benjamin Road, Tampa, Florida 33634 for approximately $43,000 per year
($3,583 per month) under a five-year lease agreement, effective October 17, 2018, occupying approximately 6,300 square feet.
We
believe our current and future facilities are adequate for our current and near-term needs. Additional space may be required as we expand
our activities. We do not currently foresee any significant difficulties in obtaining any required additional facilities.
ITEM
3.
LEGAL
PROCEEDINGS
In
the ordinary course of business, we may become a party to lawsuits involving various matters. The impact and outcome of litigation, if
any, is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm
our business. We believe the ultimate resolution of any such current proceeding will not have a material adverse effect on our continued
financial position, results of operations or cash flows, except as otherwise set forth below. However, assessment of the current litigation
or other legal claims could change in light of the discovery of facts not presently known to the Company or by judges, juries
or other finders of fact, which are not in accord with management’s evaluation of the possible liability or outcome of such litigation
or claims.
For
a description of our material pending legal proceedings, please see “ Note 8 - Other Receivables ” and
“ Note 9 – Contingencies ” to the Notes to Consolidated Financial Statements included herein under
“ Item 8. Financial Statements and Supplemental Data ”.
ITEM
4.
MINE
SAFETY DISCLOSURES
Not
applicable.
52
PART
II
ITEM
5.
MARKET
FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market
for Common Stock
Our
common stock was approved for listing on The NASDAQ Capital Market under the symbol “ MEDS ”, on February 13, 2020.
Prior to that, it traded on the OTCQB Market under the symbol “ TRXD ”. At present, there is a limited market for our
common stock.
Common
Stock and Preferred Stock Outstanding and Holders of Record
As
of March 28, 2022, we had 8,181,041 shares of common stock outstanding, held by 39 stockholders of record, not including holders who
hold their shares in street name, and no shares of Preferred Stock issued or outstanding.
Dividend
Policy
We
have never paid or declared any cash dividends on our common stock and do not anticipate paying cash dividends in the foreseeable future.
We anticipate that we will retain all of our future earnings for use in the operation of our business and for general corporate purposes.
Any determination to pay dividends in the future will be at the discretion of our board of directors. Accordingly, investors must rely
on sales of their common stock after price appreciation, which may never occur, as the only way to realize any future gains on their
investments.
Recent
Sales of Unregistered Securities
The
disclosures below include information on recent sales of unregistered securities during the three months ended December 31, 2021, and
from the period from January 1, 2022, to the filing date of this report, and do not include information which has previously been included
in a Quarterly Report on Form 10-Q or in a Current Report on Form 8-K:
In
January 2022, warrants to purchase 14,584 shares of common stock were exercised with an exercise price of $0.06 per share; the Company
issued 14,584 shares of common stock, and $875 in proceeds were received in connection with such exercise.
We
claim an exemption from registration pursuant to Section 4(a)(2) and/or Rule 506 of Regulation D of the Securities Act, since the foregoing
issuances did not involve a public offering, the recipients were (a) “ accredited investors ”; and/or (b) had access
to similar documentation and information as would be required in a Registration Statement under the Securities Act. The securities
are subject to transfer restrictions, and the certificates evidencing the securities contain an appropriate legend stating that such
securities have not been registered under the Securities Act and may not be offered or sold absent registration or pursuant to an exemption
therefrom.
53
Issuer
Purchases of Equity Securities
The
following table sets forth share repurchase activity for the respective periods:
Period
Total Number of Shares Purchased
Average
Price
Paid Per Share
Total Number of Shares Purchased
as Part of Publicly Announced Plans or Programs
Maximum
Approximate
Dollar Value of
Shares that May Yet Be Purchased Under the Plans or Programs (1)
Maximum
Number of
Shares that May Yet Be Purchased Under the Plans or Programs (2)
October 1, 2021 – October 31, 2021
—
$ —
—
$ 1,000,000
—
November 1, 2021 – November 30, 2021
—
$ —
—
$ 1,000,000
—
December 1, 2021 – December 31, 2021
—
$ —
—
$ 1,000,000
100,000
Total
—
$ —
—
(1)
On May 27, 2021, our Board of Directors authorized the repurchase up to $1 million of the currently outstanding shares of the Company’s
common stock. Under the stock repurchase program, shares may be repurchased from time to time in the open market or through negotiated
transactions at prevailing market rates, or by other means in accordance with federal securities laws. Repurchases will be made at management’s
discretion at prices management considers to be attractive and in the best interests of both the Company and its stockholders, subject
to the availability of stock, general market conditions, the trading price of the stock, alternative uses for capital, and the Company’s
financial performance. Open market purchases will be conducted in accordance with the limitations set forth in Rule 10b-18 of Exchange
Act and other applicable legal requirements. Repurchases may also be made under a Rule 10b5-1 plan. There was no time frame or expiration
date for the repurchase program, and such program was to remain in place until a maximum of $1.0 million of the Company’s common
stock had been repurchased or until such program was suspended or discontinued by the Board of Directors.
On
July 18, 2021, our Board of Directors approved an “at-the-market” offering and paused the Stock Repurchase Program until
the offering is complete.
On
July 22, 2021, our Board of Directors delayed the “at-the-market” offering and reactivated the Stock Repurchase Program.
On
August 5, 2021, our Board of Directors paused the Stock Repurchase Program until a planned “at-the-market” offering was complete,
which “at-the-market” offering was terminated effective on December 5, 2021.
Currently
no dollar amount of shares may be purchased pursuant to the terms of the Stock Repurchase Program, which as discussed in footnote (2)
below, has been modified to allow for the repurchase of 100,000 shares of common stock instead of a dollar amount.
(2)
On December 10, 2021, the Board of Directors authorized and approved the resumption of the Company’s prior share repurchase
program (as modified). The share repurchase program as approved by the Board of Directors on December 10, 2021, modified the prior repurchase
program to allow for the repurchase of up to 100,000 of the currently outstanding shares of the Company’s common stock. There is
no time frame for the repurchase program, and such program will remain in place until a maximum of 100,000 shares of the Company’s
common stock have been repurchased or until such program is discontinued by the Board of Directors.
ITEM
6.
[RESERVED]
ITEM
7.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion of the Company’s historical performance and financial condition should be read together with the consolidated
financial statements and related notes in “ Item 8. Financial Statements and Supplemental Data ” of this Report. This discussion
contains forward-looking statements based on the views and beliefs of our management, as well as assumptions and estimates made by our
management. See “ Cautionary Statement Regarding Forward-Looking Information ” above. These statements by their nature are
subject to risks and uncertainties and are influenced by various factors. As a consequence, actual results may differ materially from
those in the forward-looking statements. See “ Item 1A. Risk Factors ” of this report for the discussion of risk factors. For
all periods presented, the consolidated statements of income and consolidated balance sheet data have been adjusted for the reclassification
of discontinued operations information, unless otherwise noted. All references to years relate to the calendar year ended December 31
of the particular year.
54
Our
Management’s Discussion and Analysis of Financial Condition and Results of Operations (the “ MD&A ”) is provided
in addition to the accompanying consolidated financial statements and notes to assist readers in understanding our results of operations,
financial condition, and cash flows. MD&A is organized as follows:
●
Plan
of Operations . Summary of the Company’s plan of operations for the next 12 months.
●
Sources
of Revenue . Summary of the main sources of Company revenue during the reported periods.
●
Results
of Operations . An analysis of our financial results comparing the twelve months ended December 31, 2021, and 2020.
●
Liquidity
and Capital Resources . An analysis of changes in our balance sheets and cash flows and discussion of our financial condition.
●
Critical
Accounting Policies and Estimates . Accounting policies and estimates that we believe are important to understanding the assumptions
and judgments incorporated in our reported financial results and forecasts.
●
Recently
Issued Accounting Standards . A summary of recently issued accounting standards affecting the Company, if any.
Plan
of Operations
We
had working capital of $3,448,218 as of December 31, 2021, compared to $8,379,060 as of December 31, 2020. The decrease in working
capital of $4,930,842 was related to write off of other receivables of $1,087,675 and inventory write-offs of $376,348, and
spend on research and development expenses of $1,367,895. With our current cash on hand, expected revenues, and based on our current
average monthly expenses, we do not anticipate the need for additional funding in order to continue our operations at their current
levels, and to pay the costs associated with being a public company, for the next 12 months. We may require additional funding in
the future to expand or complete acquisitions. The sources of this capital are expected to be equity investments and notes payable.
Our plan for the next twelve months is to continue development of the information technology used in the Company subsidiaries, which
it is anticipated that current cash on hand is able to fund and continue providing a quality product with excellent customer service
while also seeking to expand our operations organically or through acquisitions as funding and opportunities arise. As our business
continues to grow, customer feedback will be integral in making small adjustments to improve the product and overall customer
experience. In the event we require additional funding, we plan to raise that through the sale of debt or equity, which may not be
available on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders. If we are unable to
access additional capital moving forward, it may hurt our ability to grow and to generate future revenues.
Novel
Coronavirus (COVID-19)
In
December 2019, a novel strain of coronavirus, which causes the infectious disease known as COVID-19, was reported in Wuhan, China. The
World Health Organization declared COVID-19 a “Public Health Emergency of International Concern” on January 30, 2020, and
a global pandemic on March 11, 2020. In March and April 2020, many U.S. states and local jurisdictions began issuing ‘stay-at-home’
orders. For example, the state of Florida, where the Company’s principal business operations are, issued a ‘stay-at-home’
order effective on April 1, 2020, which remained in place, subject to certain exceptions, through June 2020, when the order was gradually
lifted until September 2020, when the order was completely lifted. The U.S. in general and Florida specifically, has recently
seen decreases in total new COVID-19 infections (after sharp increases in infections in mid-to-late January 2022), as vaccines and boosters
are now widely available and the number of individuals who have received vaccines has increased, and the pool of persons who do not have
natural or vaccine immunity have declined; however, it is unknown whether such decreases will continue, new strains of the virus will
cause current vaccines to be less effective or whether infection numbers will increase, and/or whether the state of Florida, or other
jurisdictions in which we operate, will issue new or expanded ‘stay-at-home’ orders, or how those orders, or others, may
affect our operations or whether such locations will see increases in infection rates, hospitalizations and deaths.
55
To
date, we have been deemed an essential healthcare technology provider under applicable governmental orders based on the critical nature
of the products we offer and the community we serve. As such, our business operations were not materially impacted by the prior restrictions
put in place by the State of Florida to slow the spread of COVID-19, which have since expired. Additionally, as shown in our results
of operations below, we have to date, not experienced any significant material negative impact to our operations, revenues or gross profit
due to COVID-19. We have however been adversely affected by reductions to, and interruptions in, the delivery of supply chain pharmaceuticals
that have had a negative impact on our wholesalers, certain technology outsourcing in India and the Philippines and finding qualified
staff due to the pandemic, which may become more frequent or material in the future. We are carefully managing our inventory supply network
while we work to overcome these hopefully temporary challenges. As a result of the above, the full extent of the impact of COVID-19 on
our business and operations currently cannot be estimated and will depend on a number of factors including the continued scope and duration
of the global pandemic.
Since
the start of the pandemic, we have taken steps to prioritize the health and safety of our employees. The Company’s employees started
working remotely around March 17, 2020, and our corporate office was closed through December 31, 2021. The office reopened for our management
team on January 3, 2022, while our remaining employees will continue to work remotely until further notice.
Currently
we believe that we have sufficient cash on hand and will generate sufficient cash through operations and potential future equity sales,
to support our operations for the foreseeable future; however, we will continue to evaluate our business operations based on new information
as it becomes available and will make changes that we consider necessary in light of any new developments regarding the ongoing pandemic.
We may also raise additional funding in the future through sales of debt or equity.
Sources
of Revenue
We
currently have three main revenue streams:
(1)
Trxade, Inc., our wholly-owned subsidiary, provides an online web-based buying and selling platform for licensed pharmaceutical wholesalers
(“ Suppliers ”) to sell products and services to licensed pharmacies (“ Customers ”). The Company charges
Suppliers a transaction fee, a percentage of the purchase price of the prescription drugs and other products sold through its website
service. The Company holds no inventory and assumes no responsibility for the shipment or delivery of any products or services from our
website. The Company considers itself an agent for this revenue stream and as such, reports revenue as net.
(2)
Integra Pharma Solutions, LLC, our wholly-owned subsidiary, is a licensed wholesaler of brand, generic and non-drug products to Customers.
The Company takes orders for products, creates invoices for each order and recognizes revenue at the time the Customer receives the product.
Customer returns, to date, have not been material.
(3)
Community Specialty Pharmacy, LLC, our wholly-owned subsidiary, is a licensed retail pharmacy. The Company fills prescriptions for drugs
written by a doctor and recognizes revenue at the time the patient confirms delivery of the prescription. Customer returns, to date,
have not been material.
56
Results
of Operations
For
the Year Ended December 31, 2021, compared to the Year Ended December 31, 2020
The
following selected consolidated financial data should be read in conjunction with the consolidated financial statements and the
notes to these statements included in “ Item 8. Financial Statements and Supplemental Data ” of this Report. For all years
presented, the consolidated statements of income and consolidated balance sheet data set forth in this Form 10-K have been adjusted
for the reclassification of discontinued operations information, unless otherwise noted.
Fiscal Year Ended
Percentage
December 31, 2021
December 31, 2020
Change
Change
Revenues
$ 9,889,433
$ 17,122,520
(7,233,087 )
(42.2 )%
Cost of Sales
5,143,468
11,415,198
(6,271,730 )
(54.9 )%
Gross Profit
4,745,965
5,707,322
(961,357 )
(16.8 )%
Operating Expenses:
Loss on Inventory Investment
1,226,426
-
1,226,426
100.0 %
Technology, Research & Development
1,367,895
662,726
705,169
106.4 %
Loss on Impairment of Goodwill
-
725,973
(725,973 )
(100.0 )%
Other General and Administrative
7,053,861
4,962,237
2,091,624
42.2 %
Warrants and Options Expense
390,076
1,863,048
(1,472,972 )
(79.1 )%
Total Operating Expense
10,038,258
8,213,984
1,824,274
22.2 %
Interest Expense
(23,590 )
(29,389 )
5,799
(19.7 )%
Income (Loss) from Operations
$ (5,315,883 )
$ (2,536,051 )
(2,779,832 )
(109.6 )%
Operations
Our
revenues during the years ended December 31, 2021, and 2020 were mainly from the Trxade Inc. platform, Community Specialty Pharmacy and
Integra Pharma Solutions. Revenues decreased by $7,233,087 for the 2021 year, compared to the prior year’s period. In Trxade, Inc.,
revenue decreased by $622,731 or 11% to $4,924,015, compared to $5,546,746, for the years ended December 31, 2021, and 2020, which is
attributable to larger amounts of personal protective equipment (PPE) items being sold on the platform in 2020 than in 2021 as
a result of the COVID-19 Pandemic and more brand pharmaceutical product being sold through the platform at a lower transaction
fee than generic pharmaceutical products with a higher transaction fee. Integra Pharma Solutions revenue decreased by $6,626,506,
which is attributable to non-recurring sales of personal protective equipment (PPE) items that were needed in large quantities in 2020
as a result of the COVID-19 Pandemic, and which line of products the Company did not continue in during 2021. The Trxade, Inc. platform
is a secondary marketplace for pharmaceuticals and medical supplies with consistent growth year over year. We see a trend that whenever
there is a supply shortage on the primary market, the platform being a secondary market, will see increase in traffic or sales. Therefore,
extraordinary events such as COVID-19 will results in larger increases in addition to the normal growth year over year.
Cost
of Sales was 5,143,468 and gross profit was $4,745,965, for the year ended December 31, 2021, compared to $11,415,198 and $5,707,322,
for the year ended December 31, 2020. As sales for PPE decreased in 2021, the cost of sales decreased.
Gross
profit as a percentage of sales was 48% for the year ended December 31, 2021, compared to 33% for the year ended December 31, 2020. The
reason for the increase in gross profit as a percentage of sales was a result of a larger percentage of our revenue being from the Trxade
Platform, which carries no cost of sales in 2021, while in 2020, a larger percentage of our revenue was related to orders of PPE related
product, which include a relatively high cost of sales.
57
Technology,
research and development expenditures increased to $1,367,895 for 2021, compared to $662,726 for 2020, as the Company continued to develop
apps for customers.
General
and administrative expenses (less stock-based compensation expense, technology, research and development, loss on inventory investments)
increased for the year ended December 31, 2021, to $7,053,861, compared to $4,962,237 for the comparable period in 2020. The increase
was mainly due to increases in employee compensation in order to complete in the current challenging labor market, legal expenses
related to historically disclosed lawsuits, and research and development expenses as a result of expanding and developing the newer business
units.
Total
stock-based compensation expense decreased by 79% for the year ended December 31, 2021, compared to the prior year’s period due
to the Company not granting warrants and bonus shares to executives in 2021, as described in greater detail under “ Item 8. Financial Statements and Supplemental Data ”– “ Note 4 – Stockholders’ Equity ”.
We
had $1,226,426 of loss on inventory investment for the year ended December 31, 2021, in connection with our write-down of our the Bonum
Health Hubs after we determined that the Hubs could not be assembled and placed into service to generate revenue without requiring further
investments and our write-down of other receivables related to inventory deposits we made to suppliers that were not refunded to us when
the suppliers could not fulfill our purchase order as described in greater detail under NOTE - 8 OTHER RECEIVABLES .
We
had $725,973 of loss on impairment of goodwill for the year ended December 31, 2020, in connection with the acquisition of
Community Specialty Pharmacy, LLC. In 2020, we performed a qualitative and quantitative assessment to determine the impairment of goodwill
and found that due to the decrease in patient prescription post acquisition and COVID-19 uncertainties that the company may have likely
overpaid for the acquisition and impaired goodwill to zero.
We
had interest expense of $23,590 for the year ended December 31, 2021, compared to interest expense of $29,389 for the year ended December
31, 2020, which decreased due to decreases in the amount of outstanding debt the Company had to $0 from $225,000 at the years ended December
31, 2021, and 2020, respectively.
Net
loss increased by $2,779,832, to a net loss of $5,315,883 for the year ended December 31, 2021, compared to net loss of $2,536,051
for the year ended December 31, 2020, mainly due to the increase in general and administrative expenses associated with research and
development cost for our new business units and write-off of other receivables related to inventory deposits as explained above
(see NOTE - 8 OTHER RECEIVABLES ).
Liquidity
and Capital Resources
Cash
and Cash Equivalents
Cash
and cash equivalents were $3,122,578 at December 31, 2021. We expect that our future available capital resources will consist primarily
of cash generated from operations, remaining cash balances, borrowings, and any additional funds raised through sales of debt and/or
equity.
Liquidity
Cash
and cash equivalents, current assets , current liabilities, short term debt and working capital at the end of each period were
as follows:
December 31, 2021
December 31, 2020
Cash
$ 3,122,578
$ 5,919,578
Current assets (excluding cash)
1,251,666
3,301,720
Current liabilities (excluding short term debt)
926,026
617,238
Short term debt*
-
225,000
Working Capital
3,448,218
8,379,060
*
Short term notes payable – related parties.
58
Our
principal sources of liquidity during the years ended December 31, 2021, and 2020 have been cash provided by operations (internal source),
and during 2020, equity capital and borrowings under various debt arrangements (external source). Our principal uses of cash have been
for operating expenses and research and development of our newer business units. We anticipate these uses will continue to be our principal
uses of cash in the future in addition to any necessary business acquisitions. We currently, do not have any material unused sources
of liquid assets.
Cash
and other current assets decreased by $2,797,000 and $2,050,054 respectively. The decrease in cash and cash equivalents was primarily
due to amounts spent on research and development expenses related to our newer business units. The decrease in our current assets was
primarily due to the write off other receivables related to inventory deposits to suppliers that we did not get refunded when the suppliers
could not fulfill our purchase order (see NOTE - 8 OTHER RECEIVABLES ).
Current
liabilities increased by $83,788. The increase is primarily due to an increase in operating accounts payable not being paid until January
4, 2022, after the account payable balance was recorded for the year ended December 31, 2021.
Liquidity
Outlook cash explanation
Cash
Requirements
Our
primary objectives for 2022 are to continue the development of the Trxade Platform, DelivMeds and Bonum Health and work to increase our
client base and operational revenue. As a result of our cash generated through operations and cash on hand, we believe we have sufficient
cash to support our operations for the foreseeable future. There can be no assurance that our operations will generate significant positive
cash flow, or that additional funds will be available to us, through borrowings or otherwise, on favorable terms if required in the future,
or at all.
We
estimate our operating expenses and working capital requirements for the next 12 months to be approximately as follows:
Projected Expenses for 2022
Amount
General and administrative (1)
$ 7,100,000
Total
$ 7,100,000
(1)
Includes
wages and payroll, legal and accounting, marketing, rent and technology development.
We
have historically funded our operations primarily through debt and equity capital raises and operational revenue. In 2021, common stock
was sold for net proceeds of $16,822 in connection with the exercise of warrants and stock options previously awarded. In
2020, common stock was sold for net proceeds of $5,262,068.
We
may require additional funding in the future to expand or complete acquisitions. The sources of this capital are expected to be equity
investments and notes payable. Our plan for the next twelve months is to continue using the same marketing and management strategies
and continue providing a quality product with excellent customer service while also seeking to expand our operations organically or through
acquisitions, as funding and opportunities arise. As our business continues to grow, customer feedback will be integral in making small
adjustments to improve our products and overall customer experience. In the event we require additional funding, we plan to raise that
through the sale of debt or equity, which may not be available on favorable terms, if at all, and may, if sold, cause significant dilution
to existing stockholders. If we are unable to access additional capital moving forward, it may hurt our ability to grow and to generate
future revenues.
We
believe that we have adequate cash to implement our plan to operate a business-to-business web-based marketplace focused on the United
States pharmaceutical industry. Our core service is designed to bring the nation’s independent pharmacies and accredited national
suppliers of pharmaceuticals together to provide efficient and transparent buying and selling opportunities.
59
Cash
Flows
The
following table summarizes our Consolidated Statements of Cash Flows for the fiscal years ended December 31, 2021, and 2020:
December 31, 2021
December 31, 2020
Change
Percent Change
Net Loss
$ (5,315,883 )
$ (2,536,051 )
$ (2,716,347 )
(107.11 )%
Net Cash Provided by (used in):
Operating Activities
(2,566,226 )
(2,214,786 )
(409,958 )
(18.51 )%
Investing Activities
(22,596 )
(37,505 )
294,747
195.78 %
Financing Activities
(208,178 )
5,300,175
(5,508,353 )
(103.93 )%
Net increase (decrease) in cash
$ (2,797,000 )
$ 3,047,884
$ (5,844,885 )
$ (191.77 )%
Cash used
by operations for the fiscal year ended December 31, 2021, was $2,566,226. This compared to $2,214,786 of cash used by operating activities
for the fiscal year ended December 31, 2020. The increase was primarily due to spending for research & development related to the
development MedCheks Health Passport Application, the development of DelivMeds Application, legal expenses related to outstanding lawsuits,
repayment of related party loan, and employee payroll. For additional information refer to Notes to Consolidated Financial Statements.
Cash
used by investing activities for the fiscal year ended December 31, 2021, was $22,596. This compared to $37,505 of cash used in investing
activities for the fiscal year ended 2020. In 2021, the cash was used to purchase a single delivery vehicle for Community Specialty Pharmacy,
LLC. In 2020, the cash was used to purchase a single forklift to the Integra Pharmacy Solution, LLC warehouse.
Cash
used by financing activities for the fiscal year ended December 31, 2021, was $208,178, which $225,000 was used to repay a related party
loan and $16,822 was received from the exercise of warrants and options. This compared to $5,994,424 of proceeds and $5,300,175 of cash
to the Company after expenses, and the exercise of warrants and options which generated cash of $38,107 for the fiscal year ended December
31, 2020.
Known
Contractual and Other Obligations & Commitments
In
addition to our long-term debt obligations to our various lenders, we have certain other known contractual working capital obligations,
including contractual purchase obligations related to various supply contracts, lease obligations, and other liabilities.
60
The
following table summarizes our contractual obligations as of December 31, 2021:
Payments due by Period
Contractual Obligations
Total
Less than 1 year
1-3 years
3-5 years
More than 5 years
Operating lease obligations
1,629,125
294,932
907,746
320,916
105,531
Total Contractual obligations
$ 1,629,125
294,932
907,746
320,916
105,531
Off-Balance
Sheet Arrangements
We
had no outstanding off-balance sheet arrangements as of December 31, 2021.
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which
have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these
financial statements requires us to make estimates and judgments 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 net sales and expenses for each
period. We consider an accounting estimate to be critical if the estimate requires us to make assumptions about matters that were uncertain
at the time the accounting estimate was made and if different estimates that we reasonable could have used in the current period, or
changes in the accounting estimate that are reasonably likely to occur from period to period, could have a material impact on our financial
condition or results from operations. Below are the estimates that we believe are critical to the understanding of our operation results
and financial condition. Other accounting policies are described in Financial NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES .
Because of the uncertainty inherent in such estimates, actual results may differ from these estimates.
Allowance
for Doubtful Accounts
We
provide short-term credit and other customer financing arrangements to customers who purchase our products. We estimate the receivables
for which we do not expect full collection based on historical collection rates and specific knowledge regarding the current creditworthiness
of our customers and record an allowance in our consolidated financial statements for these amounts.
We
consider historical experience, the current economic environment, customer credit ratings or bankruptcies, and reasonable and supportable
forecasts to develop its allowance for doubtful accounts. Management reviews these factors quarterly to determine if any adjustments
are needed to the allowance.
Reserve
methodologies are assessed annually based on historical losses and economic, business and market trends. In addition, reserves are reviewed
quarterly and updated if unusual circumstances or trends are present. We believe the reserves maintained and expenses recorded in 2021
are appropriate and consistent in the context of historical methodologies employed, as well as assessment of trends currently available.
Allowance
for Doubtful Accounts
In
determining whether an inventory valuation allowance is required, we consider various factors including estimated quantities of slow-moving
inventory by reviewing on-hand quantities, outstanding purchase obligations and forecasted sales. Shifts in market trends and conditions,
changes in customer preferences due to the introduction of generic drugs or new pharmaceutical products or the loss of one or more significant
customers are factors that could affect the value of our inventories. We write down inventories which are considered excess and obsolete
as a results of these revies. These factors could make our estimate of inventory valuation differ from actual results.
Business
Combinations
We
account for business combinations using the acquisition method of accounting whereby the identifiable assets and liabilities of the acquired
business, as well as any noncontrolling interest in the acquired business, are recorded at their estimated fair value as the date that
we obtain control of the acquired business. Any purchase consideration in excess of the fair values of the net assets acquired is recorded
as goodwill. Acquisition-related expenses and related restructuring costs are expensed as incurred.
Several
valuation methods may be used to determine the fair value of the assets acquired and liabilities assumed. For intangible assets, we typically
use a method that is a form of variation of the income approach, whereby a forecast of future cash flows attributable to the asset are
discounted to present value using a risk-adjusted discount rate. Some of the more significant estimates and assumptions inherent in the
income approach include the amount and timing of projected future cash flows, the discount rate selected to measure the risks inherent
in the future cash flows and the assessment of the asset’s expected useful life.
61
Goodwill
We
perform an impairment test on goodwill balances annually in the third quarter and more frequently if indicators for potential impairment
exist. Indicators that are considered include significant declines in performance relative to expected operating results, significant
changes in the use of the assets, significant negative industry or economic trends, or a significant decline in the Company’s stock
price and/or market capitalization for a sustained period of time.
Goodwill
impairment testing is conducted at the reporting unit level, which is generally defined as an operating segment or a component, one level
below our operating segment, for which discrete financial information is available and segment management regularly reviews the operating
results of the reporting unit.
To
estimate the fair value of our reporting units, we generally use a combination of the market approach and the income approach. Under
the market approach, we estimate fair value by comparing the business to similar business, or guideline companies whose securities are
actively traded in public markets. Under the income approach, we use a discounted cash flow (“DCF”) model in which cash flows
anticipated over several periods, plus a terminal value at the end of that time horizon, are discounted to their present value using
an appropriate rate that is commensurate with the risk inherent within the reporting unit. In addition, we compare the aggregate of the
reporting units’ fair values to our market capitalization as further corroboration of the fair values.
Estimates
of fair value result from a complex series of judgements about future events and uncertainties and rely heavily on estimates and assumptions
at a point in time. Judgements made in determining an estimate of fair value may materially impact our results of operations. The valuations
are based on information available as of the impairment testing date and are based on expectations and assumptions that have been deemed
reasonably by management. Any material changes in key assumptions, including failure to meet business plans, negative changes in government
reimbursement rates, deterioration in the U.S. and global financial markets, an increase in interest rates or an increase in the cost
of equity financing by market participants within the industry or other unanticipated events and circumstances, may decrease the projected
cash flows or increase the discount rate and could potentially result in an impairment charge. Under the market approach, significant
estimates and assumptions also include the selection of appropriate guideline companies and the determination of appropriate valuation
multiples to apply to the reporting unit. Under the income approach, significant estimates and assumptions also include the determination
of discount rates. The discount rates represent the weight-average cost of capital measuring the reporting unit’s cost of debt
and equity financing, which are weighted by the percentage of debt and percentage of equity in a company’s target capital structure.
Included in the estimate of the weight-average cost of capital is the assumption of an unsystematic risk premium to address the incremental
uncertainty related to the reporting units’ future cash flow projections. An increase in the unsystematic risk premium increases
the discount rate.
Valuation
of Equity Method Investments
We
evaluate our investments for other-than-temporary impairments when circumstances indicate those assets may be impaired. When the decline
in value is deemed to be other than temporary, an impairment is recognized to the extent that the fair value is less than the
carrying value of the investment. We consider various factors in determining whether a loss in value of investment is other than temporary
including: the length of time and the extent to which the fair value has been below the cost, the financial condition of the investees,
and our intent and ability to retain the investment for a period of time sufficient to allow for recovery of value. Management makes
certain judgments and estimates in its assessment including but not limited to: identifying if circumstances indicate a decline in value
is other than temporary, expectations about the business operations of investees, as well as industry, financial, and market factors.
Any significant changes in assumptions or judgments in assessing impairments could result in an impairment charge.
62
Income
Taxes
Our
income tax expenses, and deferred tax assets and liabilities reflect management’s best assessment of estimated current and future
taxes to be paid. We are subject to income taxes in the U.S. Significant judgments and estimates are required in determining the
consolidated income tax provision and in evaluating income tax uncertainties. We review our tax positions at the end of each quarter
and adjust the balances as new information becomes available.
Deferred
income taxes arise from temporary differences between the tax and financial statement recognition of revenue and expense. In evaluating
our ability to recover our deferred tax assets, we consider all available positive and negative evidence including our past operating
results, the existence of cumulative net operating losses in the most recent years, and our forecast of future taxable income. In estimating
the future taxable income, we develop assumptions including the amount of future federal operating income, the reversal of temporary
differences, and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about
the forecasts of future taxable income and are consistent with the plans and estimate we use to manage the underlying businesses.
Changes
in tax laws and rates could also affect recorded deferred tax assets and liabilities in the future. Should tax laws change, our tax expense
and cash flows could be materially impacted.
Loss
Contingencies
We
may be subject to various claims, including claims with customers and vendors, pending and potential legal actions for damages, investigations
relating to laws and regulations and other matters arising out of the normal conduct of our business. When a loss is considered probably
and reasonably estimable, we record a liability in the amount of our best estimate for the ultimate loss. However, the likelihood of
a loss with respect to a particular contingency is often difficult to predict and determining a meaningful estimate of the loss or a
range of loss may not be practicable based on the information available and the potential effect of future events and decisions by third
party that will determine the ultimate resolution of the contingency. Moreover, it is not uncommon for such matters to be resolved over
many years, during which time relevant developments and new information must be reevaluated at least quarterly to determine both the
likelihood of potential loss and whether it is possible to reasonably estimate a range of possible loss. When a material loss is reasonably
possible or probably, but a reasonable estimate cannot be made, disclosure of the proceeding is provided. Legal fees are recognized as
incurred when the legal services are provided.
We
review all contingencies at least quarterly to determine whether the likelihood of loss has changed and to assess whether a reasonable
estimate of the potential loss or range of the loss can be made. As discussed above, development of a meaningful estimate of loss or
a range of potential loss is complex when the outcome is directly dependent on future negotiations with our decision by third parties,
such as regulatory agencies, the court system and other interest parties.
Stock-Based
Compensation
We
account for stock-based compensation to employees in accordance with ASC 718, “ Compensation-Stock Compensation ”. ASC
718 requires companies to measure the cost of employee services received in exchange for an award of equity instruments, including stock
options, based on the grant date fair value of the award and to recognize it as compensation expense over the period the employee is
required to provide service in exchange for the award, usually the vesting period. Stock option forfeitures are recognized at the date
of employee termination. Effective January 1, 2019, the Company adopted ASU 2018-07 for the accounting of share-based payments granted
to non-employees for goods and services.
Recently
Issued Accounting Standards
For
more information on recently issued accounting standards, see “ Note 2 - Summary of Significant Accounting Policies ” ,
to the Notes to Consolidated Financial Statements included herein under “ Item 8. Financial Statements and Supplemental Data ”.
ITEM
7A.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Pursuant
to Item 305(e) of Regulation S-K (§ 229.305(e)), the Company is not required to provide the information required by this Item as
it is a “ smaller reporting company, ” as defined by Rule 229.10(f)(1).
63
ITEM
8.
FINANCIAL
STATEMENTS AND SUPPLEMENTAL DATA
TABLE
OF CONTENTS TO FINANCIAL STATEMENTS
Consolidated
Financial Statements
Table
of Contents
Report
of Independent Registered Public Accounting Firm
65
Consolidated Balance Sheets
66
Consolidated Statements of Operations
67
Consolidated Statements of Changes in Stockholders’ Equity
68
Consolidated Statements of Cash Flows
69
Notes to Consolidated Financial Statements
70
64
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Stockholders and Board of Directors of
TRxADE
HEALTH, INC.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of TRxADE HEALTH, INC. and its subsidiaries (collectively, the “Company”)
as of December 31, 2021, and 2020, and the related consolidated statements of operations, changes in stockholders’ equity, and
cash flows for the years then ended, and the related notes (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,
2021, and 2020, and the results of their operations and their cash flows for the years then ended, 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 that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
/s/
MaloneBailey, LLP
www.malonebailey.com
We
have served as the Company’s auditor since 2013.
Houston,
Texas
March
28, 2022
(PCAOB ID: 00 206 )
65
TRxADE
HEALTH, INC.
Consolidated
Balance Sheets
December
31, 2021 and 2020
December 31,
2021
December 31,
2020
Assets
Current Assets
Cash
$ 3,122,578
$ 5,919,578
Accounts Receivable, net
978,973
805,043
Inventory
56,279
1,257,754
Prepaid Assets
216,414
151,248
Other Receivables
-
1,087,675
Total Current Assets
4,374,244
9,221,298
Property Plant and Equipment, Net
98,751
162,397
Other Assets
Deposits
60,136
21,636
Right of use leased assets
1,233,033
387,371
Total Assets
$ 5,766,164
$ 9,792,702
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts Payable
$ 477,028
$ 256,829
Accrued Liabilities
270,437
219,256
Current Portion - Operating Lease Liabilities
178,561
131,153
Customer Deposits
-
10,000
Notes Payable – Related Party
-
225,000
Total Current Liabilities
926,026
842,238
Long Term Liabilities
Operating Lease Liabilities, net of current portion
1,069,965
271,306
Total Liabilities
1,995,991
1,113,544
Stockholders’ Equity
Series A Preferred Stock, $ 0.00001 par value; 10,000,000 shares authorized; none
issued and outstanding as of December 31, 2021, and December 31, 2020, respectively
-
-
Common Stock, $ 0.00001 par value; 100,000,000 shares authorized; 8,166,457 and 8,093,199
shares issued and outstanding as of December 31, 2021 and 2020, respectively
82
81
Additional Paid-in Capital
20,017,528
19,610,631
Retained Deficit
( 16,247,437 )
( 10,931,554 )
Total Stockholders’ Equity
3,770,173
8,679,158
Total Liabilities and Stockholders’ Equity
$ 5,766,164
$ 9,792,702
The
accompanying notes are an integral part of the consolidated financial statements.
66
TRxADE
HEALTH, INC.
Consolidated
Statements of Operations
Years
Ended December 31, 2021 and 2020
2021
2020
Revenues, net
$ 9,889,433
$ 17,122,520
Cost of Sales
5,143,468
11,415,198
Gross Profit
4,745,965
5,707,322
Operating Expenses
Loss on Inventory Investment
1,226,426
-
Loss on Impairment of Goodwill
-
725,973
General and Administrative
8,811,832
7,488,011
Total Operating Expenses
10,038,258
8,213,984
Operating Loss
( 5,292,293 )
( 2,506,662 )
Interest Expense
( 23,590 )
( 29,389 )
Net Loss
$ ( 5,315,883 )
$ ( 2,536,051 )
Net Loss per Common Share – Basic and Diluted
$ ( 0.65 )
$ ( 0.33 )
Weighted average Common Shares Outstanding – Basic and Diluted
8,136,740
7,705,620
The
accompanying notes are an integral part of the consolidated financial statements.
67
TRxADE
HEALTH, INC.
Consolidated
Statements of Changes in Stockholders’ Equity
Years
Ended December 31, 2021 and 2020
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Preferred Stock
Common Stock
Additional
Paid-in-
Accumulated
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance at December 31, 2019
-
$ -
6,539,415
$ 65
$ 12,535,655
$ ( 8,395,503 )
$ 4,140,217
Common Stock Issued from Offering
-
-
922,219
10
5,994,414
-
5,994,424
Fractional Common Stock Issued due to reverse split
-
-
40
-
-
-
-
Stock Issuance Costs
-
-
-
-
( 820,587 )
-
( 820,587 )
Common Stock Issued for Services
-
-
217,965
2
1,357,757
-
1,357,759
Options Exercised for Cash
-
-
167
-
501
-
501
Warrants Exercised for Cash
-
-
413,393
4
37,602
-
37,606
Warrants Expense
-
-
-
-
56,885
-
56,885
Options Expense
-
-
-
-
448,404
-
448,404
Net Loss
-
-
-
-
-
( 2,536,051 )
( 2,536,051 )
Balance at December 31, 2020
-
$ -
8,093,199
$ 81
$ 19,610,631
$ ( 10,931,554 )
$ 8,679,158
Common Stock Issued for Services
-
-
37,905
-
181,163
-
181,163
Options Exercised for Cash
-
-
30,353
-
1,821
-
1,821
Warrants Exercised for Cash
-
-
5,000
1
15,000
-
15,001
Warrants Expense
-
-
-
-
21,640
-
21,640
Options Expense
-
-
-
-
187,273
-
187,273
Net Loss
-
-
-
-
-
( 5,315,883 )
( 5,315,883 )
Balance at December 31, 2021
-
-
8,166,457
82
20,017,528
( 16,247,437 )
3,770,173
The
accompanying notes are an integral part of the consolidated financial statements.
68
TRxADE
HEALTH, INC.
Consolidated
Statements of Cash Flows
Years
ended December 31, 2021 and 2020
2021
2020
Operating Activities:
Net loss
$ ( 5,315,883 )
$ ( 2,536,051 )
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation Expense
7,351
5,500
Options Expense
187,273
448,404
Warrant Expense
21,640
56,885
Common Stock Issued for Services
181,163
1,357,759
Bad Debt Expense
615,657
10,539
Loss on Inventory Investment
143,891
-
Loss on Impairment of Goodwill
-
725,973
Loss on write-down of Inventory
376,348
1,218,020
Amortization of Right-of-Use Asset
131,558
97,020
Changes in operating assets and liabilities:
Accounts Receivable
( 789,587 )
( 23,532 )
Prepaid Assets and Other Current Assets
( 103,666 )
( 68,796 )
Inventory
825,127
( 2,419,013 )
Deposits for Inventory Purchases
-
( 1,087,675 )
Other Receivables
1,087,675
-
Lease Liability
( 131,153 )
( 97,033 )
Accounts Payable
220,199
( 33,190 )
Accrued Liabilities and Other Liabilities
( 13,819 )
120,404
Customer Deposits
( 10,000 )
10,000
Net cash used in operating activities
( 2,566,226 )
( 2,214,786 )
Investing Activities:
Purchase of Fixed Assets
( 22,596 )
( 37,505 )
Net cash used in Investing Activities
( 22,596 )
( 37,505 )
Financing Activities:
Repayments of Short-Term Promissory Notes – Related Parties
( 225,000 )
-
Payment of Stock Issuance Costs
-
( 732,356 )
Proceeds from Exercise of Warrants
15,001
37,606
Proceeds from Exercise of Stock Options
1,821
501
Proceeds from Issuance of Common Stock
-
5,994,424
Net Cash provided by (used in) financing activities
( 208,178 )
5,300,175
Net increase (decrease) in Cash
( 2,797,000 )
3,047,884
Cash at Beginning of the Year
5,919,578
2,871,694
Cash at End of the Year
$ 3,122,578
$ 5,919,578
Supplemental Cash Flow Information
Cash Paid for Interest
$ 28,337
$ 29,442
Cash Paid for Income Taxes
$ -
$ -
Non-Cash Transactions
Remeasurement of ROU Assets and Lease Liability for Nonrenewal of Lease
$ -
$ 273,319
The
accompanying notes are an integral part of the consolidated financial statements.
69
TRxADE
HEALTH, INC.
Notes
to Consolidated Financial Statements
For
the years ended December 31, 2021 and 2020
NOTE
1 – ORGANIZATION
TRxADE
HEALTH, INC. (“ we ”, “ our ”, “ Trxade ”, and the “ Company ”) owns
100 % of Trxade, Inc., Integra Pharma Solutions, LLC, Community Specialty Pharmacy, LLC, Alliance Pharma Solutions, LLC, Bonum Health,
LLC and MedCheks, LLC (from January 2021 to December 2021, when it was dissolved). The merger of Trxade, Inc. and TRxADE HEALTH, INC.
occurred in May 2013. Community Specialty Pharmacy was acquired in October 2018.
Trxade,
Inc. operates a web-based market platform that enables commerce among healthcare buyers and sellers of pharmaceuticals, accessories and
services.
Integra
Pharma Solutions, LLC is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products.
Community
Specialty Pharmacy, LLC is an accredited independent retail pharmacy with a focus on specialty medications and a community-based model
offering home delivery services to patients.
Alliance
Pharma Solutions, LLC (d.b.a. DelivMeds) has developed a same day Pharma delivery software – Delivmeds.com and invested in SyncHealth
MSO, LLC a managed services organization in January 2019, which investment was divested in February 2020.
Bonum
Health, LLC, was formed to hold certain telehealth assets acquired in October 2019. The “ Bonum Health Hub ” was launched
in November 2019 and was expected to be operational in April 2020; however, due to the COVID-19 pandemic, the Company does not anticipate
installations moving forward, and has taken a write off of the hubs purchased at June 30, 2021, in Loss on Inventory Investments of $ 143,891
for the year ended December 31, 2021. The Bonum Health mobile application is available on a subscription basis, primarily as a stand-alone
telehealth software application that can be licensed on a business-to-business (B2B) model to clients as an employment health benefit
for the clients’ employees.
MedCheks,
LLC, was formed in January 2021 and is a patient-centered, digital, precision healthcare platform that lets patients consolidate
and control their health data via a digital Health Passport. This product has been discontinued and MedCheks, LLC was subsequently dissolved
in December 2021.
On
October 9, 2019, the Company’s Board of Directors, and on October 15, 2019, stockholders holding a majority of the Company’s
outstanding voting shares, approved resolutions authorizing a reverse stock split of the outstanding shares of the Company’s common
stock in the range from one-for-two (1-for-2) to one-for-ten (1-for-10) and provided authority to the Company’s Board of Directors
to select the ratio of the reverse stock split in their discretion (the “ Stockholder Authority ”). On February 12,
2020, the Board of Directors of the Company approved a stock split ratio of 1-for-6 (“ Reverse Stock Split ”) in connection
with the Stockholder Authority and the Company filed a Certificate of Amendment with the Secretary of Delaware to affect the Reverse
Stock Split.
Proportional
adjustments were made to the conversion and exercise prices of the Company’s outstanding warrants and stock options, and to the
number of shares issued and issuable under the Company’s stock incentive plans in connection with the Reverse Stock Split. The
Reverse Stock Split did not affect any stockholder’s ownership percentage of the Company’s common stock, except to the limited
extent that the Reverse Stock Split resulted in any stockholder owning a fractional share. Fractional shares of common stock were rounded
up to the nearest whole share based on each holder’s aggregate ownership of the Company. All issued and outstanding shares of common
stock, options and warrants to purchase common stock and per share amounts contained in the financial statements, have been retroactively
adjusted to reflect the Reverse Stock Split for all periods presented.
70
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States
of America (“ GAAP ”) in all material respects and have been consistently applied in preparing the accompanying financial
statements.
The
summary of significant accounting policies presented below is designed to assist in understanding the Company’s financial statements.
Such financial statements and accompanying notes are the representations of the Company’s management, who are responsible for their
integrity and objectivity.
Liquidity
– Historically, operations have been funded primarily through the sale of equity or debt securities and operating activities.
In 2020, the Company raised approximately $ 5.99 million in capital (See Note 4 – Stockholders’ Equity ). The Company has the
ability to maintain the current level of spending or reduce expenditures to maintain operations if funding is not available.
Use
of Estimates – In preparing these financial statements, management is required to make estimates and assumptions that effect
the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements
and the reported amount of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
Reclassification
– Certain prior year amounts have been reclassified to conform to the current year presentation.
Principle
of Consolidation – The Company’s consolidated financial statements include the accounts of TRxADE HEALTH, INC., Trxade,
Inc., Integra Pharma Solutions, Inc., Alliance Pharma Solutions, LLC, Community Specialty Pharmacy, LLC, Bonum Health, LLC and MedCheks,
LLC. All significant intercompany accounts and transactions have been eliminated.
Cash
and Cash Equivalents – Cash in bank accounts are at risk to the extent that they exceed U.S. Federal Deposit Insurance
Corporation insured amounts. All investments purchased with a maturity of three months or less are cash equivalents. Cash and cash equivalents
are available on demand and are generally within FDIC insurance limits for 2021.
Accounts
Receivable – The Company’s receivables are from customers and are collectible within 90 days. The Company determines
the allowance based on known troubled accounts, historical experience, and other currently available evidence. During the years ended
December 31, 2021, and 2020, $ 615,657 and $ 10,539 of bad debt expense, respectively and $ 0 of recovery of bad debt, was recognized.
Inventory
– Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first in first out basis.
These are merchandise inventories at Community Specialty Pharmacy, LLC and Integra Pharma Solutions, LLC. On a quarterly basis, we evaluate
inventory for net realizable value using estimates based on historical experience, current or projected pricing trends, specific categories
of inventory, age and expiration dates of on-hand inventory and manufacturer return policies. If actual conditions are less favorable
than our assumptions, additional inventory write-downs may be required, and no reserve is maintained as obsolete or expired inventories
are written off. We believe that the inventory valuation provides a reasonable approximation of the current value of inventory. There
is no reserve for inventory obsolescence and inventory is not pledged during the periods presented. During the years ended December 31,
2021 and 2020, included in cost of sales were write-downs to reduce inventory to net realizable value of $ 376,348 and $ 1,218,020 , respectively.
Beneficial
Conversion Features – The intrinsic value of a beneficial conversion feature inherent to a convertible note payable, which
is not bifurcated and accounted for separately from the convertible note payable and may not be settled in cash upon conversion, is treated
as a discount to the convertible note payable. This discount is amortized over the period from the date of issuance to the date the note
is due using the effective interest method. If the note payable is retired prior to the end of its contractual term, the unamortized
discount is expensed in the period of retirement to interest expense. In general, the beneficial conversion feature is measured by comparing
the effective conversion price, after considering the relative value of detachable instruments included in the financing transaction,
if any, to the fair value of the common shares at the commitment date to be received upon conversion.
71
Fair
Value of Financial Instruments – The Company measures its financial assets and liabilities in accordance with the requirements
of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 820, “ Fair Value Measurements and Disclosures ”.
ASC 820 clarifies the definition of fair value, prescribes methods for measuring fair value, and establishes a fair value hierarchy to
classify the inputs used in measuring fair value as follows:
Level
1 – Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets
are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on
an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities and
listed equities.
Level
2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly
observable as of the reported date and includes those financial instruments that are valued using models or other valuation methodologies.
These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities,
time value, volatility factors, and current market and contractual prices for the underlying instruments, as well as other relevant economic
measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be
derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments
in this category generally include non-exchange-traded derivatives such as commodity swaps, interest rate swaps, options and collars.
Level
3 – Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be
used with internally developed methodologies that result in management’s best estimate of fair value.
The
Company does not have any assets or liabilities that are required to be measured and recorded at fair value on a recurring basis.
The
carrying amounts of cash, accounts receivable, accounts payable, accrued liabilities and short-term debt approximate fair value because
of the short-term nature of these instruments. The carrying amount of long-term debt approximates fair value because the debt is based
on current rates at which the Company could borrow funds with similar maturities.
Goodwill
– The Company accounts for goodwill and intangible assets in accordance with ASC 350 “ Intangibles Goodwill and
Other ”. ASC 350 requires that goodwill and other intangibles with indefinite lives be tested for impairment annually or on
an interim basis if events or circumstances indicate that the fair value of an asset is more likely than not has decreased below its
carrying value. The Company performed impairment analysis using the quantitative analysis under ASC 350-20 and because of declining revenues
and operating losses an impairment of goodwill was recognized as of December 31, 2021 and 2020, was $ 0 and $ 725,973 , respectively.
Revenue
Recognition – In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2014-09
(Topic 606) “ Revenue from Contracts with Customers. ” Topic 606 supersedes the revenue recognition requirements in
Accounting Standards Codification Topic 605, “ Revenue Recognition ”, and requires entities to recognize revenue when
they transfer control of promised goods or services to customers in an amount that reflects the consideration to which the entity expects
to be entitled to in exchange for those goods or services. The Company adopted ASU 2014-09 using the modified retrospective approach
effective January 1, 2018, under which prior periods were not retrospectively adjusted. The adoption of Topic 606 did not have a material
impact on the Company’s consolidated financial statements, including the presentation of revenues in the Company’s Consolidated
Statements of Operations.
72
Trxade,
Inc. provides an online website service, a buying and selling marketplace for licensed Pharmaceutical Wholesalers to sell products and
services to licensed Pharmacies. The Company charges Suppliers a transaction fee, a percentage of the purchase price of the Prescription
Drugs and other products sold through its website service. The fulfillment of confirmed orders, including delivery and shipment of Prescription
Drugs and other products, is the responsibility of the Supplier and not of the Company. The Company holds no inventory and assumes no
responsibility for the shipment or delivery of any products or services from the Company’s website. The Company considers itself
an agent for this revenue stream and as such, reports revenue as net. Step One: Identify the contract with the customer – Trxade,
Inc.’s Terms and Use Agreement is acknowledged between the Wholesaler and Trxade, Inc. which outlines the terms and conditions.
The collection is probable based on the credit evaluation of the Wholesaler. Step Two: Identify the performance obligations in the contract
– The Company provides to the Supplier access to the online website, uploading of catalogs of products and Dashboard access to
review status of inventory posted and processed orders. The Agreement requires the supplier to provide a catalog of pharmaceuticals for
posting on the platform, deliver the pharmaceuticals and upon shipment remit the stated platform fee. Step Three: Determine the transaction
price – The Fee Agreement outlines the fee based on the type of product, generic, brand or non-drug. There are no discounts for
volume of transactions or early payment of invoices. Step Four: Allocate the transaction price – The Fee Agreement outlines the
fee. There is no difference between contract price and “ stand-alone selling price ”. Step Five: Recognize revenue when
or as the entity satisfies a performance obligation – Revenue is recognized the day the order has been processed by the Supplier.
Integra
Pharma Solutions, LLC is a licensed wholesaler and sells to licensed pharmacies brand, generic and non-drug products. The Company takes
orders for product and creates invoices for each order and recognizes revenue at the time the Customer receives the product. Customer
returns are not material. Step One: Identify the contract with the customer – The Company requires that an application and a credit
card for payment is completed by the Customer prior to the first order. Each transaction is evidenced by an order form sent by the customer
and an invoice for the product is sent by the Company. The collection is probable based on the application and credit card information
provided prior to the first order. Step Two: Identify the performance obligations in the contract – Each order is distinct and
evidenced by the shipping order and invoice. Step Three: Determine the transaction price – The consideration is variable if product
is returned. The variability is determined based on the return policy of the product manufacturer. There are no sales or volume discounts.
The transaction price is determined at the time of the order evidenced by the invoice. Step Four: Allocate the transaction price –
There is no difference between contract price and “ stand-alone selling price ”. Step Five: Recognize revenue when or
as the entity satisfies a performance obligation - The Revenue is recognized when the Customer receives the product.
Community
Specialty Pharmacy, LLC is in the retail pharmacy business. The Company fills prescriptions for drugs written by a doctor and recognizes
revenue at the time the patient confirms delivery of the prescription. Customer returns are not material. Step One: Identify the contract
with the customer – The prescription is written by a doctor for a customer and delivered to the Company. The prescription identifies
the performance obligations in the contract. The Company fills the prescription and delivers to the Customer the prescription, fulfilling
the contract. The collection is probable because there is confirmation that the customer has insurance for the reimbursement to the Company
prior to filling of the prescription. Step Two: Identify the performance obligations in the contract – Each prescription is distinct
to the Customer. Step Three: Determine the transaction price – The consideration is not variable. The transaction price is determined
to be the price of the prescription at the time of delivery which considers the expected reimbursements from third party payors (e.g.,
pharmacy benefit managers, insurance companies and government agencies). Step Four: Allocate the transaction price – The price
of the prescription invoiced represents the expected amount of reimbursement from third party payors. There is no difference between
contract price and “ stand-alone selling price ”. Step Five: Recognize revenue when or as the entity satisfies a performance
obligation – Revenue is recognized upon the delivery of the prescription.
Cost
of Goods Sold – The Company recognized cost of goods sold from activities in Integra Pharma Solutions, LLC and Community
Specialty Pharmacy, LLC.
Stock-Based
Compensation – The Company accounts for stock-based compensation to employees in accordance with ASC 718, “ Compensation-Stock
Compensation ”. ASC 718 requires companies to measure the cost of employee services received in exchange for an award of equity
instruments, including stock options, based on the grant date fair value of the award and to recognize it as compensation expense over
the period the employee is required to provide service in exchange for the award, usually the vesting period. Stock option forfeitures
are recognized at the date of employee termination. Effective January 1, 2019, the Company adopted ASU 2018-07 for the accounting of
share-based payments granted to non-employees for goods and services.
73
Income
Taxes – The Company accounts for income taxes utilizing ASC 740, “ Income Taxes ” (SFAS No. 109). ASC
740 requires the measurement of deferred tax assets for deductible temporary differences and operating loss carry forwards, and of deferred
tax liabilities for taxable temporary differences. Measurement of current and deferred tax liabilities and assets is based on provisions
of enacted tax law. The effects of future changes in tax rates are not included in the measurement. The Company recognizes the amount
of taxes payable or refundable for the current year and recognizes deferred tax liabilities and assets for the expected future tax consequences
of events and transactions that have been recognized in the Company’s financial statements or tax returns. The Company currently
has substantial net operating loss carry forwards. The Company has recorded a 100 % valuation allowance against net deferred tax assets
due to uncertainty of their ultimate realization. Valuation allowances are established when necessary to reduce deferred tax assets to
the amount expected to be realized. Tax years from 2018 forward are open to examination by the Internal Revenue Service.
Equity
Investments – If the investments are less than 50% owned and more than 20% owned, the entities use the equity method of
accounting in accordance with ASC 323-10 Investments – Equity Method and Joint Ventures.
The
share of income (loss) of such entities is recorded as a single amount as share in equity income (loss) of investments. Dividends, if
any, are recorded as a reduction of the investment.
The
Company had no equity investment for the year ended December 31, 2021.
Income
(loss) Per Share – Basic net income (loss) per common share is computed by dividing net loss available to common stockholders
by the weighted average number of common shares outstanding. Diluted net loss per common share is computed similar to basic net loss
per common share except that the denominator is increased to include the number of additional common shares that would have been outstanding
if the potential common shares had been issued and if the additional common shares were dilutive. The dilutive effect of the Company’s
options and warrants is computed using the treasury stock method. As of December 31, 2021, we had 44,535 outstanding warrants to purchase
shares of common stock and 410,964 options to purchase shares of common stock.
The
following table sets forth the computation of basic and diluted income (loss) per common share for the years ended December 31, 2021,
and 2020:
SCHEDULE
OF BASIC AND DILUTIVE INCOME (LOSS) PER COMMON SHARE
December 31, 2021
December 31, 2020
Numerator:
Net Income (Loss)
$ ( 5,315,883 )
$ ( 2,536,051 )
Numerator for basic and diluted EPS - income (loss) available to common Shareholders
$ ( 5,315,883 )
$ ( 2,536,051 )
Denominator:
Denominator for basic and diluted EPS – Weighted average shares
8,136,740
7,705,620
Basic Income (Loss) per common share
$ ( 0.65 )
$ ( 0.33 )
Concentration
of Credit Risks and Major Customers - Financial instruments that potentially subject the Company to credit risk consist principally
of cash and cash equivalents and receivables. The Company places its cash and cash equivalents with financial institutions. Deposits
are insured to Federal Deposit Insurance Corp limits. The amount of cash not insured by the FDIC as of December 31, 2021, is $ 2,332,137 .
During
the years ended December 31, 2021, no sales to customers represented greater than 10 % of revenue.
Recent
Accounting Pronouncements – The Company has implemented all new relevant accounting pronouncements that are in effect through
the date of these financial statements. The pronouncements did not have any material impact on the financial statements unless otherwise
disclosed, and the Company does not believe that there are any other new accounting pronouncements that have been issued that might have
a material impact on its consolidated financial position or results of operations.
Effective
January 1, 2019, the Company adopted ASU No. 2016-02, Leases (Topic 842 ) (“ ASU 2016-02 ”) using the required
modified retrospective approach. The most significant changes under the new guidance include clarification of the definition of a lease,
and the requirements for lessees to recognize a Right of Use (“ ROU ”) asset and a lease liability for all qualifying
leases with terms longer than twelve months in the consolidated balance sheet. In addition, under Topic 842, additional disclosures are
required to meet the objective of enabling users of financial statements to assess the amount, timing and uncertainty of cash flows arising
from leases. See Note 10 – Leases , below for more detail on the Company’s accounting with respect to leases.
74
Effective
January 1, 2019, the Company adopted ASU No. 2018-07, Compensation – Stock Based Compensation (Topic 718): Improvements to Nonemployee
Share-Based Payment Accounting (“ ASU 2018-7 ”), which aligns accounting for share-based payments issued to nonemployees
to that of employees under the existing guidance of Topic 718, with certain exceptions. This update supersedes previous guidance for
equity-based payments to nonemployees under Subtopic 505-50, Equity – Equity-Based Payments to Non-Employees. The adoption of ASU
2018-07 did not have a material impact on the Company’s consolidated financial statements.
Recently
Issued Accounting Pronouncements Not Yet Adopted - In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments
- Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ ASU 2016-13 ”). ASU 2016-13
requires financial assets measured at amortized cost to be presented at the net amount expected to be collected. The measurement of expected
credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable
and supportable forecasts that affect the collectability of the reported amounts. An entity must use judgment in determining the relevant
information and estimation methods that are appropriate in its circumstances. ASU 2016-13 is effective for annual reporting periods beginning
after December 15, 2019, including interim periods within those fiscal years, and a modified retrospective approach is required, with
a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective.
In November of 2019, the FASB issued ASU 2019-10, which delayed the implementation of ASU 2016-13 to fiscal years beginning after December
15, 2022, for smaller reporting companies.
The
Company does not expect the adoption of this new accounting guidance to have a material impact on its financial position, results of
operations, or cash flows.
NOTE
3 – SHORT-TERM DEBT AND RELATED PARTIES DEBT
Related
Party Promissory Notes
In
October 2018, in connection with the acquisition of Community Specialty Pharmacy, LLC, a $ 300,000 promissory note was issued to Nikul
Panchal, a non-executive officer of the Company, accruing simple interest at the rate of 10 % per annum, payable annually, and having
a maturity date on October 15, 2021 . In October 2019, $ 75,000 of the note was converted into 25,000 common shares at $ 3.00 per share,
leaving $ 225,000 of principal owed under the promissory note. There was a loss recognized on this conversion of $ 76,500 . In September
2021, the promissory note was paid in full.
At
December 31, 2021 and 2020, total related party debt was $ 0 and $ 225,000 , respectively.
NOTE
4 – STOCKHOLDERS’ EQUITY
In
August 2021, warrants to purchase 5,000 shares of common stock were granted with an exercise price of $ 3.00 per share, and were exercised
at $ 3.00 per share; the Company issued 5,000 shares of common stock, and $ 15,000 in proceeds were received in connection with such exercise.
2020
Equity Compensation Awards
On
April 14, 2020, the Compensation Committee approved the grant of (a) 5,000 shares of restricted common stock to the Company’s legal
counsel; and (b) 12,500 shares of restricted common stock to Howard A. Doss, the Company’s Chief Financial Officer, which shares
vested at the rate of ¼ th of such shares on July 1 and October 1, 2020, and January 1 and April 1, 2021. The shares
have a fair value of $ 107,100 and the Company recognized stock-based compensation expense of $ 53,550 for the twelve months ended December
31, 2021.
On
April 14, 2020, the then three independent members of the Board of Directors (Mr. Donald G. Fell, Dr. Pamela Tenaerts, and Mr. Michael
L. Peterson), were each awarded 8,987 shares of restricted stock, which vested at the rate of ¼ th of such shares on
July 1 and October 1, 2020, and January 1 and April 1, 2021. The shares have a fair value of $ 165,000 and the Company recognized stock-based
compensation expense of $ 82,501 for the twelve months ended December 31, 2021.
75
2021
Equity Compensation Awards
On
April 15, 2021, the Board of Directors, with the recommendation of the Compensation Committee, approved the grant of options to purchase
an aggregate of 17,500 shares of our common stock to certain employees of the Company, in consideration for services to be rendered by
such individuals through 2025. The options vest at the rate of ¼ th of such options per year, on the first, second,
third and fourth anniversaries of the grant date, subject to such option holders continuing to provide services to the Company on such
dates, subject to the terms of the Company’s Second Amended and Restated 2019 Equity Incentive Plan (the “Plan”) and
the option agreements entered into evidence such grants. The options were granted pursuant to, and are subject to, the Plan, and have
a term of five years from the grant date. The options have an exercise price of $ 4.76 per share, the closing price of the Company’s
common stock on the date of the grant of such options.
In
connection with and pursuant to the independent director compensation policy previously adopted by the Board of Directors, on April 15,
2021, the then three independent members of the Board of Directors (Mr. Donald G. Fell, Dr. Pamela Tenaerts, and Mr. Michael L. Peterson),
were each awarded 10,721 shares of restricted stock, valued at $ 55,000 ($ 5.13 per share) based on the closing sales price of the Company’s
common stock on the Nasdaq Capital Market on the effective date of the grant, April 1, 2021, which vest at the rate of ¼ th
of such shares on July 1 and October 1, 2021 and January 1 and April 1, 2022, subject to such persons continuing to provide services
to the Company on such dates, subject to the terms of the Plan and the Restricted Stock Grant Agreements entered into as evidence of
such awards. The shares have a fair value of $ 165,000 and the Company recognized stock-based compensation expense of $ 68,750 for the
twelve months ended December 31, 2021. Common Shares totaling 16,082 were cancelled on May 27, 2021, when the director services of Mr.
Peterson and Ms. Tenaerts were terminated.
The
Board of Directors of the Company, on May 27, 2021, confirmed the vesting of 2,680 shares of common stock previously issued to each of
Michael L. Peterson and Dr. Pamela Tenaerts on July 1, 2021, which were subject to forfeiture subject to such persons continued service
on the Board of Directors prior to the vesting date.
In
connection with and pursuant to the independent director compensation policy previously adopted by the Board of Directors, on May 27,
2021, the Board of Directors awarded Charles L. Pope, and Christine L. Jennings, each independent members of the Board of Directors appointed
to the Board of Directors on May 27, 2021, 10,912 shares of restricted stock each, valued at $ 41,250 each ($ 3.78 per share) based on
the closing sales price of the Company’s common stock on the Nasdaq Capital Market on the effective date of the grant, May 27,
2021, which vested at the rate of 1/3rd of such shares on October 1, 2021 and January 1, with the last tranche thereof vesting on April
1, 2022, subject to such persons continuing to provide services to the Company on such date. The Company recognized stock-based compensation
expense of $ 64,167 for the twelve months ended December 31, 2021.
Employment
Agreement with Suren Ajjarapu, Chief Executive Officer
In
connection with our employment agreement with Mr. Suren Ajjarapu, our Chief Executive Officer, no stock or other equity compensation
was granted for the year ended December 31, 2021.
Stock
Repurchase Program
On
May 27, 2021, the Board of Directors of the Company authorized and approved a stock repurchase program for up to $ 1 million of the currently
outstanding shares of the Company’s common stock. There is no time frame for the repurchase program, and such program will remain
in place until a maximum of $1.0 million of the Company’s common stock has been repurchased or until such program is suspended
or discontinued by the Board of Directors.
At
the Market Offering
On
August 5, 2021, our Board of Directors paused the Stock Repurchase Program until the “at-the-market” offering (discussed
below) was complete.
76
On
August 6, 2021, the Company entered into an Equity Distribution Agreement, relating to an “at-the-market” offering for the
sale of up to $ 9 million in shares of the common stock under which EF Hutton, division of Benchmark Investments, LLC, the distribution
agent, could sell the offering shares in public market transactions reported on the consolidated tape or privately negotiated transactions
which could include block trades pursuant to and in connection with the Company’s previously filed Form S-3 Shelf Registration
Statement filed with the Securities and Exchange Commission on August 28, 2020 and declared effective by the Commission on September
3, 2020 (File Number: 333-248473) and the Prospectus Supplement was filed with the Commission under Rule 424(b)(5) dated August 6, 2021
(the “ATM Program”).
Effective
on November 30, 2021, the Company provided the distribution agent notice of the termination of the Equity Distribution Agreement and
the ATM Program (each of which were terminated effective December 5, 2021, pursuant to the terms of the Equity Distribution Agreement),
and as a result, $ 128,000 of deferring offering costs were recognized.
No
shares of common stock were sold pursuant to the “at-the-market” offering prior to the termination date.
Continuation
of the Stock Repurchase Program
On
December 10, 2021, the Board of Directors authorized and approved the resumption of the Company’s prior share repurchase program.
The share repurchase program as approved by the Board of Directors on December 10, 2021, modified the prior repurchase program to allow
for the repurchase of up to 100,000 of the currently outstanding shares of the Company’s common stock. There is no time frame for
the repurchase program, and such program will remain in place until a maximum of 100,000 shares of the Company’s common stock has
been repurchased or until such program is discontinued by the Board of Directors.
As
of December 31, 2021, no shares have been repurchased.
NOTE
5 - WARRANTS
In
2021, warrants to purchase 5,000 shares of common stock were granted, 5,000 were exercised, and warrants to purchase 38,216 shares of
common stock expired and were forfeited. See Note 4 – Stockholders’ Equity .
For
the twelve-month period ended December 31, 2021, warrants to purchase 5,000 shares of common stock were exercised, resulting in proceeds
of $ 15,000 .
The
Company uses the Black-Scholes pricing model to estimate the fair value of stock-based awards on the date of the grant. The compensation
cost related to the warrants granted was $ 0 and $ 21,640 for the year ended December 31, 2021, and 2020, respectively.
The
following table summarizes the assumptions used to estimate the fair value of the warrants granted during the years ended December 31,
2021 and 2020.
SUMMARY OF ASSUMPTIONS USED TO ESTIMATE FAIR VALUE OF WARRANTS GRANTED
2021
2020
Expected dividend yield
0 %
0 %
Weighted-average expected volatility
217 %
217 %
Weighted-average risk-free interest rate
2.75 %
2.75 %
Expected life of warrants
5 years
5 years
77
The
Company’s outstanding and exercisable warrants as of December 31, 2021 and 2020 are presented below:
SCHEDULE OF OUTSTANDING AND EXERCISABLE WARRANTS
Number
Outstanding
Weighted
Average
Exercise
Price
Contractual
Life in
Years
Intrinsic
Value
Warrants Outstanding as of December 31, 2019
524,480
$ 0.42
2.39
$ 3,273,897
Warrants granted
5,000
$ 0.06
5.00
-
Warrants forfeited
( 33,336 )
$ 2.30
-
-
Warrants exercised
( 413,393 )
$ 0.09
-
-
Warrants Outstanding as of December 31, 2020
82,751
$ 1.33
2.73
$ 352,951
Warrants granted
5,000
$ 3.00
1.48
-
Warrants forfeited
( 38,216 )
$ 2.51
-
-
Warrants exercised
( 5,000 )
$ 3.00
-
-
Warrants Outstanding as of December 31, 2021
44,535
$ 0.32
0.95
$ 208,078
Warrants Exercisable as of December 31, 2021
44,535
$ 0.32
0.95
$ 208,078
NOTE
6 - OPTIONS
The
Company maintains stock option plans under which certain employees are awarded option grants based on a combination of performance and
tenure. The stock option plans provide for the grant of up to 2,333,333 shares, and the Company’s Second Amended and Restated 2019
Equity Incentive Plan provides for automatic increases in the number of shares available under such plan (currently 2,000,000 shares)
on April 1 st of each calendar year, beginning in 2021 and ending in 2029 (each a “Date of Determination”), in
each case subject to the approval and determination of the administrator of the plan (the Board of Directors or Compensation Committee)
on or prior to the applicable Date of Determination, equal to the lesser of (A) ten percent (10%) of the total shares of common stock
of the Company outstanding on the last day of the immediately preceding fiscal year and (B) such smaller number of shares as determined
by the administrator, provided that not more than 25 million shares of common stock may be issued pursuant to the exercise of incentive
stock options pursuant to the plan. The administrator did not approve an increase in the number of shares covered under the plan as of
April 1, 2021.
For
2021, options to purchase 36,700 shares of common stock were granted, 30,353 were exercised, 21,200 were forfeited, and none expired.
The options granted during the period vest over a four-year period, the average exercise price was $ 4.86 per share and the options have
a term of 5 years.
For
the twelve-month period ended December 31, 2021, options to purchase 30,353 shares of common stock were exercised, resulting in proceeds
of $ 1,821 .
Under
the Black-Scholes option price model, fair value of the options granted in 2021 and 2020 were $ 168,008 and $ 557,308 , respectively.
The
Company uses the Black-Scholes option pricing model to estimate the fair value of stock-based awards on the date of grant. The following
table summarizes the assumptions used to estimate the fair value of stock options granted during the years ended December 31, 2021 and
2020:
SCHEDULE OF ESTIMATE FAIR VALUE OF STOCK OPTIONS
2021
2020
Expected dividend yield
0 %
0 %
Weighted-average expected volatility
102 - 207 %
133 - 236 %
Weighted-average risk-free interest rate
0.25 %
0.25 %
Expected life of options
5 years
5 - 7 years
78
Total
compensation cost related to stock options was $ 187,273 and $ 448,404 for the years ended December 31, 2021 and 2020, respectively. As
of December 31, 2021, there was $ 135,118 of unrecognized compensation costs related to stock options, which is expected to be recognized
over a weighted average period of 5 years. The following table represents stock option activity for the two years ended December 31,
2021:
SCHEDULE OF STOCK OPTION ACTIVITY
Number
Outstanding
Weighted
Average
Exercise
Price
Contractual
Life in
Years
Intrinsic
Value
Options Outstanding as of December 31, 2019
346,998
$ 4.39
6.77
$ 817,220
Options Exercisable as of December 31, 2019
207,485
$ 5.29
5.53
314,338
Options granted
94,154
4.42
3.97
Options forfeited
( 15,168 )
3.18
7.12
Options expired
-
-
-
-
Options exercised
( 167 )
3.00
-
-
Options Outstanding as of December 31, 2020
425,817
$ 4.44
5.33
$ 597,322
Options Exercisable as of December 31, 2020
282,167
$ 4.52
4.56
$ 384,226
Options granted
36,700
5.74
4.19
-
Options forfeited
( 21,200 )
6.45
4.11
-
Options expired
-
-
-
-
Options exercised
( 30,353 )
0.06
-
-
Options Outstanding as of December 31, 2021
410,964
$ 4.78
4.67
$ 368,417
Options Exercisable as of December 31, 2021
302,191
$ 4.88
4.38
$ 257,186
NOTE
7 – INCOME TAXES
On
December 22, 2017, H.R. 1, originally known as the Tax Cuts and Jobs Act, (the “ Tax Act ”) was enacted. Among the significant
changes to the U.S. Internal Revenue Code, the Tax Act lowers the U.S. federal corporate income tax rate (“ Federal Tax Rate ”)
from 35 % to 21 % effective January 1, 2018.
The
statutory tax rate is the percentage imposed by law; the effective tax rate is the percentage of income actually paid by a company after
considering tax deductions, exemptions, credits and operating loss carry forwards.
At
December 31, 2021 and 2020 deferred tax assets consist of the following:
SCHEDULE OF DEFERRED TAX ASSETS
December 31, 2021
December 31, 2020
Federal loss carryforwards
$ 2,347,266
$ 1,309,534
Less: valuation allowance
( 2,347,266 )
( 1,309,534 )
Deferred
tax assets
$ -
$ -
The
Company has established a valuation allowance equal to the full amount of the deferred tax asset primarily due to uncertainty in the
utilization of the net operating loss carry forwards.
The
estimated net operating loss carry forwards of approximately $ 10,462,828 will be available based on the new carryover rules in section
172(a) passed with the Tax Cuts and Jobs Acts.
NOTE
8 – OTHER RECEIVABLES
In July 2020, the Company’s wholly-owned
subsidiary, Integra, entered into an agreement with Studebaker Defense Group, LLC (“Studebaker”) wherein Integra would pay
Studebaker a down payment of $ 500,000 and Studebaker would deliver 180,000 boxes of nitrile gloves by August 14, 2020. Integra wired
the $ 500,000 to Studebaker, but to date, Studebaker has not delivered the gloves or provided a refund of the deposit. On December 31,
2020, we filed a complaint against Studebaker in Florida state court, Case No. 20-CA-010118 in the Circuit Court for the Thirteenth Judicial
Circuit in Hillsborough County, for among other things, breach of contract. On January 29, 2021, Integra Pharma Solutions filed a motion
for clerk’s default against Studebaker. On February 2, 2021, the clerk of court issued default against Studebaker. On March 4,
2021, Integra Pharma Solutions filed a motion for final default judgment against Studebaker. On March 22, 2021, counsel for Studebaker
filed a notice of appearance in the case. On March 24, Studebaker filed a response in opposition to the motion for final judgment, and
on March 25, 2021, Studebaker filed a motion to dismiss the case. On May 14, 2021, the Court denied Integra’s motion for final
default judgment, granted Studebaker’s motion to set aside the clerk’s default, and denied Studebaker’s motion to dismiss.
An amended answer and affirmative defenses were filed by Studebaker on October 14, 2021. Integra’s motion to strike the affirmative
defenses, or in the alternative, motion for more definite statement is scheduled for hearing on April 27, 2022. We have also scheduled
the deposition of Studebaker’s corporate representative on April 12, 2022, and moved to compel better answers to outstanding discovery.
The litigation remains pending and is in the discovery phase. Integra remains confident it can successfully prosecute its claims against
Studebaker on the merit. On June 30, 2021, the $ 500,000 was recorded as Loss on Inventory Investment.
79
In
August 2020, Integra, entered into an agreement with Sandwave Group Dsn Bhd (“Sandwave”), wherein Integra would pay Sandwave
a down payment of $ 581,250 and Sandwave’s supplier, Crecom Burj Group SDN BHD (“Crecom”), would deliver 150,000 boxes
of nitrile gloves within 45 days. Integra wired the $ 581,250 to Sandwave, which in turn wired the purchase price to Crecom, which Crecom
accepted; however, to date, Crecom has not delivered the nitrile gloves. Integra demanded return of its $ 581,250 and Crecom has acknowledged
that Integra is entitled to a refund, but to date Crecom has failed to return Integra’s money. In February 2021, Integra filed
a complaint against Crecom in Malaysia: Case No. WA-22NCC-55-02/2021 in the High Court of Malaysia at Kuala Lumpur in the Federal Territory,
Malaysia for the Malaysian equivalent of breach of contract. Crecom filed an appearance on March 1, 2021. In April 2021, an Application
for Summary Judgment was filed with the court, and on May 25, 2021, the Court extracted the sealed application, and a copy thereof was
served on Crecom’s attorneys and Crecom, 14 days later, filed an Affidavit in Reply with the court alleging that there are issues
to be tried and that this case must go to a full trial. On June 28, 2021, the court directed both parties to file their written submissions/arguments
in relation to the application for summary judgment on or before July 12, 2021, and scheduled a hearing thereon for August 26, 2021.
At the final hearing on October 18 th , the ruling for the summary judgment was denied and a trial date is pending. The Company
believes that it will prevail in the lawsuit filed; but the steps to enforce a judgment in Malaysia, if any, may be cumbersome, time
consuming or costly. The Company cannot determine the timing of the judgment, nor the amount ultimately collected. At June 30, 2021,
the $ 581,250 was recorded as Loss on Inventory Investment.
On November 19, 2021, Integra filed a
complaint against GSG PPE, LLC (“GSG”) and Gary Waxman (“Waxman”), the owner, alleging three counts of
breach of contract for a purchase agreement, a promissory note, and a personal guaranty. Collectively, the company alleges that GSG
and Waxman have materially breached all three contracts. In late 2020, GSG and Integra executed a valid initial contract setting the
terms of a business transaction. GSG failed to pay Integra approximately 75% of the amount owed to Integra. GSG acknowledged it owed
the money and executed a promissory note in favor of Integra in the amount of $ 630,000
which matured on September 30, 2021. The note provides for attorney fees and interest in addition to the $ 630,000 .
Waxman’s personal guaranty confirmed that GSG owed Integra $ 630,000 . Integra has propounded discovery and plans to file a
motion for summary judgment on all three counts of breach of contract shortly after this filing. The company believes that the facts
of the case are favorable to Integra, but the outcome of the summary judgment hearing is unknown. On September 30, 2021, the $ 630,000 was
recorded as Bad Debt Expense.
NOTE
9 - CONTINGENCIES
Jain, et al., v. Memantine, et al.
In
January 2020, we became aware of a complaint filed by Jitendra Jain, Manish Arora, Scariy Kumaramangalam, Harsh Datta and Balvant Arora
(collectively, plaintiffs), against our wholly-owned subsidiary, Trxade, Inc. and our Chief Executive Officer, Suren Ajjarapu as well
as certain unrelated persons, Annapurna Gundlapalli, Gajan Mahendiran and Nexgen Memantine (collectively, defendants), in the Circuit
Court of Madison County, Alabama (Case:47-CV-2019-902216.00). The complaint alleged causes of actions against the defendants including
fraud in the inducement, relating to certain investments alleged to have been made by plaintiffs in Nexgen Memantine, breach of fiduciary
duty, conversion and voidable transactions. The complaint related to certain investments alleged made by the plaintiffs in Nexgen Memantine
and certain alleged fraudulent transfers of assets and funds alleged to have been taken by the defendants which are unrelated to the
Company.
On May 14, 2021, Plaintiffs filed a second amended
complaint against the defendants. The second amended complaint alleges causes of action against the defendants including securities fraud,
breach of fiduciary duty, violation of the Florida RICO Act, and breach of contract. The operative complaint relates to certain investments
alleged to have been made by the plaintiffs in Nexgen Memantine and certain alleged transfers of assets and funds alleged to have been
taken by the defendants which are unrelated to the Company. The amended complaint seeks injunctive relief, $ 425,000 in compensatory damages,
treble damages, punitive damages, and fees and costs
In February 2022, A settlement as to Suren Ajjarapu,
Annapurna Gundlapalli and Trxade Group has been reached and signed. This settlement involves no admission of liability and a full and
complete release of all actions after a lump-sum payment of $ 225,000
is made. Because the complaint purports to be a derivative action, court approval is required. A hearing was held on the
request to approve the settlement, and changes were made at the instruction of the court which should lead to it being approved by the
court. The settlement has been fully funded and the money transferred to the attorneys for the $ 225,000 .
A settlement has also been reached regarding
defendant Nexgen Memantine, Inc., to which defendant Gajan Mahendiran has objected because of some of the factual recitations. This dispute is before a court-appointed mediator and should not prevent the Ajjarapu/Trxade settlement from being approved, but this
is causing some delay. Mahendiran, Ajjarapu, Gundlapalli and Trxade have agreed to move the Court to dismiss all counter and
crossclaims that were filed between the defendants in this matter and will do so once the Court approves the settlement. Because the
suit against Gajan Mahendiran remains active, it is possible that Trxade may incur future expenses related to its employees being
called as witnesses by either or both of the sides. However, it is expected that all liability issues will be resolved once the
settlement is finally approved.
80
NOTE
10 – LEASES
The
Company elected the practical expedient under ASU 2018-11 “ Leases: Targeted Improvements ” which allows the Company
to apply the transition provision for Topic 842 at the Company’s adoption date instead of at the earliest comparative period presented
in the financial statements. Therefore, the Company recognized and measured leases existing at January 1, 2019, but without retrospective
application. In addition, the Company elected the optional practical expedient permitted under the transition guidance which allows the
Company to carry forward the historical accounting treatment for existing leases upon adoption. No impact was recorded to the beginning
retained earnings for Topic 842. The Company has two operating leases for corporate offices. The following table outlines the details
of such leases:
SCHEDULE OF OPERATING LEASES
Lease 1
Lease 2
Initial Lease Term
January 2021 to December 2021
November 2018 to November 2023
Renewal Lease Term
-
November 2023 to November 2028
New Initial Lease Term
January 2022 to December 2026
-
New Renewal Lease Term
January 2027 to December 2031
-
Initial Recognition of Right to use assets at January 1, 2019
$ 534,140
$ 313,301
New Initial Recognition of Right to use Assets at December 31, 2021
$ 977,220
$ -
Incremental Borrowing Rate
10 %
10 %
The
Company entered into a new corporate office lease (Lease 1) on January 2022. The Company determined that entering into the new lease
required remeasurement of the lease liability resulting in the increase of the right-of-use asset and the associated lease liability
by $ 977,220 . The new lease is still classified as an operating lease.
The
table below reconciles the fixed component of the undiscounted cash flows for each of the first five years and the total remaining years
to the operating lease liabilities recorded in the Consolidated Balance Sheet as of December 31, 2021.
SCHEDULE OF FUTURE MINIMUM PAYMENTS FOR OPERATING LEASE LIABILITIES
Amounts due within twelve months of December 31
2022
$ 294,932
2023
293,683
2024
302,494
2025
311,569
2026
320,916
Thereafter
105,531
Total minimum lease payments
1,629,125
Less: effect of discounting
( 380,599 )
Present value of future minimum lease payments
1,248,526
Less: current obligations under leases
178,561
Long-term lease obligations
$ 1,069,965
For
the years ended December 31, 2021, and 2020, amortization of assets was $ 131,558 and 97,020 , respectively.
For
the years ended December 31, 2021, and 2020, operating lease liabilities paid was $ 131,153 and 97,033 , respectively.
81
NOTE
11 – SEGMENT REPORTING
The
Company classifies its business interests into reportable segments which are Trxade, Inc., Community Specialty Pharmacy, LLC, Integra
Pharma, LLC and Other (Unallocated). Operating segments are defined as the components of an enterprise about which separate financial
information is available that is evaluated regularly by the chief operating decision makers in deciding how to allocate resources and
in assessing performance. The Company’s chief operating decision makers direct the allocation of resources to operating segments
based on the profitability, cash flows, and growth opportunities of each respective segment.
SCHEDULE OF BUSINESS INTERESTS INTO REPORTABLE SEGMENTS
Year Ended
December 31, 2021
Trxade, Inc.
Community
Specialty
Pharmacy, LLC
Integra
Pharma, LLC
Unallocated
Total
Revenue
$ 4,924,015
$ 1,652,841
$ 3,250,561
$ 62,016
$ 9,889,433
Gross Profit
$ 4,921,084
$ 156,785
$ ( 393,582 )
$ 61,678
$ 4,745,965
Segment Assets
$ 2,273,330
$ ( 431,593 )
$ 565,619
$ 3,358,808
$ 5,766,164
Segment Profit/Loss
$ 1,977,938
$ ( 128,563 )
$ ( 2,749,028 )
$ ( 4,416,230 )
$ ( 5,315,883 )
Year Ended
December 31, 2020
Trxade, Inc.
Community
Specialty
Pharmacy, LLC
Integra
Pharma, LLC
Unallocated
Total
Revenue
$ 5,546,746
$ 1,653,924
$ 9,877,067
$ 44,783
$ 17,122,520
Gross Profit
$ 5,546,746
107,771
8,374
$ 44,431
$ 5,707,322
Segment Assets
$ 2,076,934
$ ( 457,784 )
2,698,357
$ 5,475,195
$ 9,792,702
Segment Profit/Loss
$ 3,309,128
$ ( 900,427 )
$ ( 531,092 )
$ ( 4,413,660 )
$ ( 2,536,051 )
NOTE
12 – SUBSEQUENT EVENTS
STOCKHOLDERS’
EQUITY
In
January 2022, warrants to purchase 14,584 shares of common stock were exercised with an exercise price of $ 0.06 per share; the Company
issued 14,584 shares of common stock, and $ 875 in proceeds were received in connection with such exercise.
ENTRY
INTO A MATERIAL DEFINITIVE AGREEMENT – EXCHANGE HEALTH, LLC
On
February 15, 2022, the Company entered into a relationship with Exchange Health, LLC, a technology company providing an online
platform for manufacturers and suppliers to sell and purchase pharmaceuticals (“ Exchange Health ”). SOSRx LLC, a Delaware
limited liability company (“ SOSRx ”), was formed, which is owned 51 %
by the Company and 49 %
by Exchange Health.
On
February 15, 2022, the Company contributed cash to SOSRx in the amount of $ 325,000 , issued a promissory note to SOSRx in the amount of
$ 500,000 , which was immediately assigned to Exchange Health (the “ Promissory Note ”), and agreed to make an earn out
payment of up to $ 400,000 , payable, at the Company’s discretion, in cash or common stock of the Company, based on SOSRx achieving
certain revenue targets of SOSRx as discussed below (the “ Earn Out Payments ”); and entered into a Distribution Services
Agreement with SOSRx (the “ Distribution Agreement ”).
The
Earn Out Payments require the Company to pay (a) $25,000 to Exchange Health if total revenue for SOSRx are over $0.7 million, and $25,000
to Exchange Health if total EBITDA is over $0.5 million, for fiscal year ending 2022; (b) $87,500 to Exchange Health if total revenue
for SOSRx is over $3.3 million, and $87,500 to Exchange Health if total EBITDA is over $2.95 million, for fiscal year ending 2023; and
(c) $87,500 to Exchange Health if total revenue for SOSRx is over $5.7 million, and $87,500 to Exchange Health if total EBITDA is over
$4.9 million, for fiscal year ending 2024, provided that certain amounts will be payable in the event at least 95% of such milestones
are met, and such payments will be grossed up or down by up to 5% of such amounts, if such milestone amounts are between 95% and 105%
of the required thresholds. At the Company’s option, the Earn Out Payments may be paid in cash or shares of common stock, valued
at the then current trading price of the Company’s common stock. If one year’s milestones are not achieved, no earnout will
be payable for that year and those earn out payments will not be eligible to be earned in any other year.
Exchange
Health contributed certain property, contracts and licenses to SOSRx, having an agreed value of $ 792,500 , in exchange for its 49 % membership
interest in SOSRx and received a cash payment of $ 275,000 from SOSRx, LLC, pursuant to a Member Asset Contribution Agreement (the “ Asset
Contribution Agreement ”), also entered into on February 15, 2022.
82
Promissory
Note
The
Promissory Note, which was immediately assigned to Exchange Health, and represents amounts currently due to Exchange Health, bears interest
at the rate of the prime rate, plus 2 % per annum (currently 5.25 % per annum), with (i) one-third of the principal ($ 166,666.67 ) and interest
payable after one year (on February 15, 2023) and (ii) the remaining two-thirds of principal payable quarterly over the next two years
in eight equal installments of $ 41,666.67 , together with any unpaid accrued interest thereupon, at the end of every full fiscal quarter,
beginning, June 20, 2023. The Promissory Note may be prepaid by the Company, at its discretion, in whole or in part at any time, without
premium or penalty.
Notwithstanding
the foregoing, if the Company effectuates a Voluntary Withdrawal (defined below) under the Company Agreement (as discussed below) prior
to February 15, 2024 (the “ Earn Out Period ”), and SOSRx has failed to meet any of the revenue targets required by
the Earn Out Payments prior to the expiration of the Earn Out Period, then all remaining amounts of interest and principal not yet due
and payable under the Promissory Note shall immediately terminate and all related indebtedness evidenced hereby shall be deemed canceled.
Amounts
owed under the Promissory Note are secured by the Company’s membership interests in the SOSRx and are a non-recourse obligation
of the Company, secured solely by such membership interests.
In
the event that the Company is delinquent to pay when due (whether at maturity, by reason of acceleration or otherwise) any principal
of or interest on the Promissory Note, then if such payment is not made within fifteen days of the due date, then Exchange Health may
declare an additional interest fee of 2% of the delinquent amount to be due. If the delinquency is thirty days or more late from the
due date, then Exchange Health may declare another additional interest fee of 3%, to make a total of 5%, for the delinquent payment.
In
the event that we fail to pay when due (whether at maturity, by reason of acceleration or otherwise) any principal of or interest on
Promissory Note, then if such payment is not made within sixty days of the due date, then Exchange Health may declare all obligations
(including without limitation, outstanding principal and accrued and unpaid interest thereon) under the Promissory Note to be immediately
due and payable.
SOSRx
Operating Agreement
The
rights of the Company and Exchange Health in connection with SOSRx are set forth in the Operating Agreement of SOSRx (the “ Operating
Agreement ”), effective February 15, 2022. Pursuant to the Operating Agreement, SOSRx is to be managed by a management committee
consisting of three members, two of which are nominated by the Company, who currently include Suren Ajjarapu, the Company’s Chief
Executive Officer and Chairman and Prashant Patel, the Company’s President and director, and one person nominated by Exchange Health.
If either the Company or Exchange Health shall ever hold less than 25 % of the membership interests of SOSRx, such entity shall forfeit
its management appointment rights, and such appointment rights shall be held by such other member which holds over 50 % of the membership
interests.
The
Operating Agreement includes customary transfer restrictions on the SOSRx membership interests, right of first refusal rights upon receipt
of a bona fide third party offer for purchase of a member’s membership interest (exercisable first by SOSRx and then the other
members), preemptive rights (subject to certain exceptions), tag-along rights, and drag-along rights (applying if any greater than 50 %
owner desires to transfer their ownership in SOSRx).
Any
member of SOSRx has the right to effect a voluntary withdrawal from the Company (a “ Voluntary Withdrawal ”), provided
that such member must give ninety days prior written notice to all other members. Any member who effectuates a Voluntary Withdrawal is
not permitted to receive the fair value or any value of the member’s membership interest as of the date of the Voluntary Withdrawal,
and may instead effect a Voluntary Withdrawal by forfeiture of its membership interests in SOSRx without compensation or consideration;
provided however, that if the Company (a) effectuates a Voluntary Withdrawal prior to February 15, 2024, and (b) SOSRx has failed to
meet any of the revenue targets required by the Earn Out Payments prior to the date of withdrawal, then all obligations of the Company
under the Earn Out Payments and the Promissory Note shall terminate.
83
The
Company or its assigns may at any time by written notice to any other member, offer to purchase all (but not less than all) of such other
member’s membership interests, which shall be calculated and payable pursuant to a discounted cash flow model. If the buyout is
paid to Exchange Health or its successors or assigns, any remaining amounts payable under the Promissory Note become immediately due
and payable upon such payment.
The
Operating Agreement also provides, that without the prior written approval of the unanimous consent of the management committee, a manager
or member may not, directly or indirectly, (a) enter into a business relationship with any other person that is materially adverse to
the business of SOSRx or an affiliate of SOSRx, or (b) cause any person to reduce or terminate its relationship with SOSRx or any affiliate
of SOSRx. The foregoing covenants apply to each member, and each manager during the period in which each manager is a member.
Distribution
Agreement
On
February 15, 2022, SOSRx entered into the Distribution Agreement with Integra Pharma Solutions LLC, the Company’s wholly-owned
subsidiary (“ Integra ”). Pursuant to the Distribution Agreement, Integra appoints each SOSRx member an active account
for Manufacturer Non-Control (Schedule 2-5 as classified by the US Drug Enforcement Agency) products bought on the SOSRx platform. The
agreement remains in effect until December 31, 2023, and renews thereafter on a yearly basis until terminated; which agreement
can only be terminated by the non-breaching party, upon the breach of the agreement by a party thereto, with a 30-day cure right.
Pursuant to the Distribution Agreement, for each calendar quarter (or portion thereof) during the term, SOSRx agreed to pay Integra a
fee equal to 2% of the net price of all purchases of products during such period. Integra also agreed to participate in SOSRx’s
annual trade show, once established. Integra made certain representations and warranties in the Distribution Services Agreement, and
agreed to indemnify SOSRx against certain damages and losses. The Distribution Services Agreement included customary confidentiality
obligations.
Asset
Contribution Agreement
On
February 15, 2022, Exchange Health entered into a Member Asset Contribution Agreement with SOSRx, pursuant to which it contributed certain
assets and assigned certain contracts, relating to software, manufacturers and members, to SOSRx, in consideration for its 49 % membership
interest in SOSRx. SOSRx did not assume any of Exchange Health’s liabilities or obligations other than the obligations and commitments
of Exchange Health arising under the assumed contracts.
84
ITEM
9.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM
9A.
CONTROLS
AND PROCEDURES
Disclosure
controls and procedures are designed to ensure that information required to be disclosed in our reports filed or submitted under the
Exchange Act is recorded, processed, summarized and reported, within the time period specified in the SEC’s rules and forms and
is accumulated and communicated to the Company’s management, as appropriate, in order to allow timely decisions in connection with
required disclosure.
Evaluation
of Disclosure Controls and Procedures
Under
the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer,
Mr. Ajjarapu and Mr. Doss, respectively, we conducted an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the period covered by this
Annual Report (December 31, 2021). Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that
as of December 31, 2021, our disclosure controls and procedures were not effective to provide reasonable assurance that information required
to be disclosed in our reports filed with the SEC pursuant to the Exchange Act, is recorded, processed, summarized and reported within
the time periods specified in the rules and forms of the SEC and that such information is accumulated and communicated to our management,
including our CEO and CFO, as appropriate, to allow timely decisions regarding required disclosures.
As
a result of the formative stage of our development, the Company has not fully implemented the necessary internal controls. The matters
involving internal controls and procedures that the Company’s management considered to be material weaknesses under the standards
of the Committee of Sponsoring Organizations of the Treadway Commission (COSO) were: (1) The Company did not maintain a fully integrated
financial consolidation and reporting system throughout the period and as a result, extensive manual analysis, reconciliation and adjustments
were required in order to produce financial statements for external reporting purposes. and (2) The Company does not currently have a
sufficient complement of technical accounting and external reporting personnel commensurate to support standalone external financial
reporting under public company or SEC requirements. Specifically, the Company did not effectively segregate certain accounting duties
due to the small size of its accounting staff and maintain a sufficient number of adequately trained personnel necessary to anticipate
and identify risks critical to financial reporting and the closing process. In addition, there were inadequate reviews and approvals
by the Company’s personnel of certain reconciliations and other processes in day-to-day operations due to the lack of a full complement
of accounting staff.
Management
believes that the material weaknesses set forth above did not have an effect on the Company’s financial results reported herein.
We are committed to improving our financial organization. As part of this commitment, we have increased our personnel resources and technical
accounting expertise as we develop the internal and financial resources of the Company. In addition, the Company has prepared and implemented
sufficient written policies and checklists which will set forth procedures for accounting and financial reporting with respect to the
requirements and application of GAAP and SEC disclosure requirements.
Management
has prepared and is in the process of implementing sufficient written policies and checklists to remedy the following material
weaknesses (i) insufficient written policies and procedures for accounting and financial reporting with respect to the requirements and
application of GAAP and SEC disclosure requirements; and (ii) ineffective controls over period end financial close and reporting processes.
We
have improved our financial organization as we have increased our personnel resources and technical accounting expertise. We will continue
to monitor and evaluate the effectiveness of our internal controls and procedures and our internal controls over financial reporting
on an ongoing basis.
85
Management’s
Report on Internal Control Over Financial Reporting
Management
of the Company is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules
13a-15(f) and 15d-15(f) under the Exchange Act. The Company’s internal control over financial reporting is designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with GAAP, but because of its inherent limitations, internal control over financial reporting may not prevent or detect
misstatements. The Company’s internal control over financial reporting includes those policies and procedures that are designed
to:
●
pertain
to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the
assets of the Company;
●
provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with
GAAP, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors
of the Company; and
●
provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s
assets that could have a material effect on the financial statements.
Management
conducted an assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2021.
In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission
in Internal Control — Integrated Framework (2013). Based on our assessment, management concluded that the Company’s internal
controls over financial reporting were not effective as of December 31, 2021, to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements in accordance with GAAP. Specifically, management’s determination
was based on the following material weaknesses which existed as of December 31, 2021:
●
Financial
Reporting Systems : The Company did not maintain a fully integrated financial consolidation and reporting system throughout the
period and as a result, extensive manual analysis, reconciliation and adjustments were required in order to produce financial statements
for external reporting purposes.
●
Segregation
of Duties : The Company does not currently have a sufficient complement of technical accounting and external reporting personnel
commensurate to support standalone external financial reporting under public company or SEC requirements. Specifically, the Company
did not effectively segregate certain accounting duties due to the small size of its accounting staff and maintain a sufficient number
of adequately trained personnel necessary to anticipate and identify risks critical to financial reporting and the closing process.
In addition, there were inadequate reviews and approvals by the Company’s personnel of certain reconciliations and other processes
in day-to-day operations due to the lack of a full complement of accounting staff.
Limitations
on the Effectiveness of Controls
Management
of the Company, including its Chief Executive Officer and its Chief Financial Officer, does not expect that the Company’s disclosure
controls and procedures or its internal control over financial reporting will prevent or detect all error and all 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. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must
be considered relative to their costs. Furthermore, because of the inherent limitations in all control systems, no evaluation of controls
can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud,
if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that
breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons or
by the collusion of two or more persons. The design of any system of controls is based in part on certain assumptions about the likelihood
of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future
conditions. Projections of any evaluation of the effectiveness of controls to future periods are subject to risks. Over time, controls
may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
Changes
in Internal Control Over Financial Reporting.
There
have not been any changes in our internal control over financial reporting during the quarter ended December 31, 2021, that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
As
a result of COVID-19, our workforce operated primarily in a work from home environment for the year ended December 31, 2021. While pre-existing
controls were not specifically designed to operate in our current work from home operating environment, we do not believe that such work
from home actions have had a material adverse effect on our internal controls over financial reporting. We have continued to re-evaluate
and refine our financial reporting process to provide reasonable assurance that we could report our financial results accurately and
timely.
ITEM 9B.
OTHER INFORMATION
None.
ITEM
9C.
DISCLOSURE
REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not
applicable.
86
PART
III
Information
required by Items 10, 11, 12, 13 and 14 of Part III is omitted from this Annual Report and will be filed in a definitive proxy statement
or by an amendment to this Annual Report not later than 120 days after the end of the fiscal year covered by this Annual Report (subject
to any extension provided by Exchange Act Rule 0-3).
ITEM
10.
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The
information required by this Item will be set forth in the Company’s 2022 Proxy Statement to be filed with the SEC within 120 days
after December 31, 2021 (subject to any extension provided by Exchange Act Rule 0-3) in connection with the solicitation of proxies for
the Company’s 2022 annual meeting of stockholders including under the headings “ Election of Directors ”, “ Information
about our Executive Officers ”, “ Corporate Governance ”, “ Code of Ethics ”, “ Committees
of the Board ”, and “ Delinquent Section 16(a) Reports ” (to the extent applicable and warranted), and is incorporated
herein by reference.
ITEM
11.
EXECUTIVE
COMPENSATION
The
information required by this Item will be set forth in the Company’s 2022 Proxy Statement to be filed with the SEC within 120 days
after December 31, 2021 (subject to any extension provided by Exchange Act Rule 0-3) , including
under the headings “ Executive Compensation ”, “ Directors Compensation ”, “ Outstanding Equity
Awards at Fiscal Year-End ”, “ Compensation Committee Interlocks and Insider Participation ” and “ Compensation
Committee Report ” (to the extent required), and is incorporated herein by reference.
ITEM
12.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The
information required by this Item will be set forth under the heading “ Voting Rights and Principal Stockholders ” and
“ Equity Compensation Plan Information ” in the Company’s 2022 Proxy Statement to be filed with the SEC within
120 days after December 31, 2021 (subject to any extension provided by Exchange Act Rule 0-3) ,
and is incorporated herein by reference.
ITEM
13.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The
information required by this Item will be set forth in the Company’s 2022 Proxy Statement to be filed with the SEC within 120 days
after December 31, 2021 (subject to any extension provided by Exchange Act Rule 0-3) , including
under the headings “ Certain Relationships and Related Transactions ” and “ Committees of the Board ”
- “ Director Independence ”, and is incorporated herein by reference.
ITEM
14.
PRINCIPAL
ACCOUNTANT FEES AND SERVICES
The
information required by this Item will be set forth under the heading “ Ratification of Appointment of Auditors ” -
“ Audit Fees ” in the Company’s 2022 Proxy Statement to be filed with the SEC within 120 days after December 31,
2021 (subject to any extension provided by Exchange Act Rule 0-3) , and is incorporated herein
by reference.
87
PART
IV
ITEM
15.
EXHIBITS,
FINANCIAL STATEMENTS AND SCHEDULES
(a)
Documents filed as part of this Annual Report:
The
following is an index of the financial statements, schedules and exhibits included in this Form 10-K or incorporated herein by reference.
(1)
All
Financial Statements
Index
to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
65
Consolidated Balance Sheets
66
Consolidated Statements of Operations
67
Consolidated Statements of Changes in Stockholders’ Equity
68
Consolidated Statements of Cash Flows
69
Notes to Consolidated Financial Statements
70
(2)
Consolidated
Financial Statement Schedules
Except
as provided above, all financial statement schedules have been omitted, since the required information is not applicable or is not present
in amounts sufficient to require submission of the schedule, or because the information required is included in the consolidated financial
statements and notes thereto included in this Form 10-K.
(3)
Exhibits
Incorporated by Reference
Exhibit
No.
Description
Form
File
No.
Exhibit
Filing
Date
Filed/Furnished
Herewith
1.1
Equity Distribution Agreement, dated August 6, 2021 between the Company and EF Hutton, division of Benchmark Investments, LLC
8-K
001-39199
1.1
8/6/2021
3.1
Second Amended and Restated Certificate of Incorporation of Trxade Group, Inc.
S-1
333-234221
3.1
10/15/2019
3.3
Certificate of Amendment to Second Amended and Restated Certificate of Incorporation (1-for-6 Reverse Stock Split of Common Stock) filed with the Delaware Secretary of State on February 12, 2020, and effective February 13, 2020
8-K
001-39199
3.1
2/13/2020
3.4
Certificate of Amendment of Certificate of Incorporation (changing name TRxADE HEALTH, INC.)
8-K
001-39199
3.1
5/28/2021
3.5
Limited Liability Company Agreement of SOSRx LLC effective February 15, 2022
8-K
001-39199
3.1
2/16/2022
3.6
Amended and Restated Bylaws of Trxade Group, Inc.
10-12G/A
000-55218
3.1
7/24/2014
4.1*
Description of Registered Securities
X
88
10.1
$300,000 Promissory Note dated October 15, 2018 with Nikul Panchal
8-K
000-55218
2.02
10/16/2018
10.2
Revocable Warrant dated October 15, 2018 with Nikul Panchal
8-K
000-55218
2.03
10/16/2018
10.3 ***
Indemnification Agreement dated February 6, 2019 with Prashant Patel and Suren Ajjarapu
10-K
000-55218
10.1
3/22/2019
10.4
Form of Investment Warrant Agreement
8-K
000-55218
10.2
7/13/2018
10.5
Form of Warrant Agreement
8-K
000-55218
10.2
9/26/2014
10.6
Form of Registration Rights Agreement
8-K
000-55218
10.3
9/26/2014
10.7 ***
Employment Agreement between Trxade, Inc. and Prashant Patel dated May 24, 2013
10-12G/A
000-55218
10.6
7/24/2014
10.8 ***
2014 Equity Incentive Plan
10-12G
000-55218
10.3
6/11/2014
10.9 ***
Form of Indemnification Agreement entered into between Trxade Group, Inc. and its directors and certain officers
10-12G
000-55218
10.4
6/11/2014
10.10 ***
Second Amended and Restated Trxade Group, Inc. 2019 Equity Incentive Plan
8-K
001-39199
10.1
5/28/2021
10.11 ***
Form of Stock Option Agreement (April 2020 Grants to Employees) April 14, 2020
8-K
001-39199
10.2
4/16/2020
10.12 ***
Form of Restricted Stock Grant Agreement (Independent Directors 2020 Award, 2020 CFO Award and 2020 Legal Counsel) April 14, 2020
8-K
001-39199
10.3
4/16/2020
10.13 ***
April 14, 2020 Executive Employment Agreement with Suren Ajjarapu
8-K
001-39199
10.4
4/16/2020
10.14 ***
First Amendment to Executive Employment Agreement with Suren Ajjarapu dated May 5, 2020
8-K
001-39199
10.2
5/7/2020
10.15 ***
Restricted Stock Grant Agreement (Mr. Ajjarapu 2020 Performance Bonus)(Updated) May 5, 2020
8-K
001-39199
10.3
5/7/2020
10.16 ***
Executive Employment Agreement dated effective June 19, 2020, entered into by and between Trxade Group, Inc. and Howard A. Doss
8-K
001-39199
10.1
6/26/2020
10.17 ***
Trxade Group, Inc. Independent Director Compensation Policy adopted April 14, 2020
10-Q
001-39199
10.1
7/27/2020
89
10.18 ***
Form of First Amendment to Trxade Group, Inc. 2019 Equity Incentive Plan Restricted Stock Grant Agreement (April 2020 Grants to Employees; Independent Directors 2020 Award, 2020 CFO Award and 2020 Legal Counsel Award)
8-K
001-39199
10.4
8/4/2020
10.19 ***
Form of Stock Option Agreement Trxade Group, Inc. Amended and Restated 2019 Equity Incentive Plan
S-8
333-246318
10.6
8/14/2020
10.20 ***
Form of Restricted Stock Grant Agreement Trxade Group, Inc. Amended and Restated 2019 Equity Incentive Plan
S-8
333-246318
10.7
8/14/2020
10.21 ***
Form of Trxade Group, Inc. 2019 Equity Incentive Plan Restricted Stock Grant Agreement
S-8
333-246318
10.8
8/14/2020
10.22
Non-Recourse Promissory Note in the amount of $500,000, dated February 15, 2022, by TRxADE HEALTH, INC. in favor of Exchange Health, LLC
8-K
001-39199
10.4
2/16/2022
10.23
Distribution Services Agreement dated February 15, 2022, by and between SOSRx LLC and Integra Pharma Solutions LLC
8-K
001-39199
10.4
2/16/2022
10.24
Member Asset Contribution Agreement dated February 15, 2022, between Exchange Health, LLC and SOSRx LLC
8-K
001-39199
10.4
2/16/2022
14.1
Code of Ethics
10-K
000-55218
14.1
3/23/2015
21.1*
List of Subsidiaries
X
23.1*
Consent of Independent Registered Accounting Firm
X
31.1*
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act*
X
31.2*
Certification of Principal Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act*
X
32.1**
Certification of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act**
X
32.2**
Certification of Principal Accounting Officer Pursuant to Section 906 of the Sarbanes-Oxley Act**
X
101.INS
Inline
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within
the Inline XBRL document
X
101.SCH
XBRL
Taxonomy Extension Schema Document
X
101.CAL
XBRL
Taxonomy Extension Calculation Linkbase Document
X
101.DEF
XBRL
Taxonomy Extension Definition Linkbase Document
X
101.LAB
XBRL
Taxonomy Extension Label Linkbase Document
X
101.PRE
XBRL
Taxonomy Extension Presentation Linkbase Document
X
104
Inline
XBRL for the cover page of this Annual Report on Form 10-K, included in the Exhibit 101 Inline XBRL Document Set.
*
Filed herewith.
**
Furnished herewith.
***
Indicates management contract or compensatory plan or arrangement.
ITEM
16.
FORM
10–K SUMMARY
None.
90
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.
TRxADE
HEALTH, INC.
Date:
March 28, 2022
/s/ Suren Ajjarapu
By:
Suren
Ajjarapu, Chief Executive Officer (Principal Executive Officer)
Date:
March 28, 2022
/s/ Howard A. Doss
By:
Howard
A. Doss, Chief Financial Officer (Principal Financial and Accounting Officer)
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/
Suren Ajjarapu
Chairman
of the Board, Chief Executive Officer and Secretary
March
28, 2022
Suren
Ajjarapu
(Principal
Executive Officer)
/s/
Howard A. Doss
Chief
Financial Officer
March
28, 2022
Howard
A. Doss
(Principal
Financial and Accounting Officer)
/s/
Prashant Patel
Director,
President and Chief Operating Officer
March
28, 2022
Prashant
Patel
/s/
Donald G. Fell
Director
March
28, 2022
Donald
G. Fell
/s/
Charles L. Pope
Director
March
28, 2022
Charles
L. Pope
/s/
Christine L. Jennings
Director
March
28, 2022
Christine
L. Jennings
91
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