Sunshine Biopharma, Inc - Annual Report: 2018 (Form 10-K)
U.S.
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, 2018
☐ TRANSITION REPORT UNDER SECTION 13 OR 15(D) OF
THE SECURITIES EXCHANGE ACT OF1934 for the transition period from
________________ to________________________.
Commission
File Number 000-52898
SUNSHINE BIOPHARMA, INC.
(Exact
name of registrant as specified in its charter)
Colorado
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20-5566275
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(State
or other jurisdiction of incorporation or
organization)
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(I.R.S.
Employer Identification No.)
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6500 Trans-Canada Highway
4th Floor
Pointe-Claire, Quebec, Canada H9R 0A5
(Address
of principal executive offices)
(514) 426-6161
(Registrant’s
Telephone Number, including area code)
Securities
registered pursuant to Section 12(b) of the Act: None
Securities
registered pursuant to Section 12(g) of the Act:
Title
of each class
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Name of
each exchange on which registered
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Common Stock, par value $0.001 per share
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OTC MARKETS
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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 Exchange 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 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
Regulation S-T (§ 232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☑ No ☐
Indicate
by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K (§ 229.405 of this chapter) is not
contained herein, and will not be contained, to the best of
registrant’s knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K. ☑ No ☐ Yes
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See definition of “large accelerated
filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large accelerated filer
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☐
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Accelerated filer
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☐
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Non-accelerated
filer
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☐ (Do not check if a smaller reporting
company)
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Smaller reporting company
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☒
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Emerging
growth company
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☒
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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 is a shell company (as defined
in Rule 12b-2 of the Act). Yes ☐ No ☑
State
the aggregate market value of the voting and non-voting common
equity held by non-affiliates computed by reference to the price at
which the common equity was last sold, or the average bid and asked
price of such common equity, as of the last business day of the
registrant’s most recently completed second fiscal quarter on
June 30, 2018 was $3,970,144 .
As of
April 11, 2019, the Registrant had 89,348,981 shares of Common
Stock issued and outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE - None
TABLE OF CONTENTS
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Page No.
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Index
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3
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Business
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3
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Risk
Factors
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11
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Unresolved
Staff Comments
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11
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Properties
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11
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Legal
Proceedings
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11
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Mine
Safety Disclosures
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11
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12
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Market
for the Registrant’s Common Equity and Related Stockholder
Matters and Issuer Purchases of Equity Securities
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12
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Selected
Financial Data
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14
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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14
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Quantitative
and Qualitative Disclosures About Market Risk
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20
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Financial
Statements and Supplementary Data
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20
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Changes
in and Disagreements on Accounting and Financial
Disclosure
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21
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Controls
and Procedures
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21
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Other
Information
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22
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23
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Directors,
Executive Officers and Corporate Governance
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23
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Executive
Compensation
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25
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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26
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Certain
Relationships and Related Transactions, and Director
Independence
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27
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Principal
Accounting Fees and Services
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28
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29
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Exhibits,
Financial Statement Schedules
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29
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Signatures
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31
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2
FORWARD LOOKING STATEMENTS
This
Annual Report on Form 10-K contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Act of 1934. The statements regarding
Sunshine Biopharma Inc. contained in this Report that are not
historical in nature, particularly those that utilize terminology
such as “may,” “will,”
“should,” “likely,” “expects,”
“anticipates,” “estimates,”
“believes” or “plans,” or comparable
terminology, are forward-looking statements based on current
expectations and assumptions, and entail various risks and
uncertainties that could cause actual results to differ materially
from those expressed in such forward-looking
statements.
Important factors
known to us that could cause such material differences are
identified in this Report. We undertake no obligation to correct or
update any forward-looking statements, whether as a result of new
information, future events or otherwise. You are advised, however,
to consult any future disclosures we make on related subjects in
future reports to the SEC.
PART I
ITEM 1. BUSINESS
History
We were
incorporated in the State of Colorado on August 31, 2006 under the
name “Mountain West Business Solutions, Inc.” Until
October 2009, our business was to provide management consulting
with regard to accounting, computer and general business issues for
small and home-office based companies.
In
October 2009, we acquired Sunshine Biopharma, Inc., a Colorado
corporation holding an exclusive license to a new anticancer drug
bearing the laboratory name, Adva-27a. As a result of this
transaction we changed our name to “Sunshine Biopharma, Inc.
and our officers and directors resigned their positions with us and
were replaced by Sunshine’s management at the time, including
our current CEO, Dr. Steve N. Slilaty, and our current CFO, Camille
Sebaaly each of whom remain part of our current management. Our
principal business became that of a pharmaceutical company focusing
on the development of our licensed Adva-27a anticancer compound. In
December 2015 we acquired all issued and pending patents pertaining
to our Adva-27a technology and terminated the license. See
“Part I, Item 1 – Business - Intellectual
Property,” below for a more detailed explanation of this
acquisition.
In July
2014, we formed a wholly owned Canadian subsidiary, Sunshine
Biopharma Canada Inc. (“Sunshine Canada”), for the
purposes of offering generic pharmaceutical products in Canada and
elsewhere around the world. In April and June 2016 Sunshine Canada
signed licensing agreements for four (4) generic prescription drugs
for the treatment of breast cancer, prostate cancer and BPH (Benign
Prostatic Hyperplasia).
In
January 2018, we acquired all of the issued and outstanding shares
of Atlas Pharma Inc., a Health Canada certified company dedicated
to chemical analysis of pharmaceutical and other industrial
samples.
In
March 2018, we formed NOX Pharmaceuticals, Inc., a wholly owned
Colorado corporation and assigned all of our interest in our
Adva-27a anticancer compound to that company.
In
December 2018, we launched our first over-the-counter Essential
Brandtm
product, Essential 9tm,
a dietary supplement comprised of the nine amino acids which the
human body cannot synthesize. Essential 9tm
has been authorized for marketing by Health Canada under NPN
80089663.
Effective February
1, 2019, we completed a 20 to 1 reverse split of our $0.001 par
value Common Stock reducing the issued and outstanding shares of
Common Stock from 1,713,046,242 to 85,652,400 (the “Reverse
Stock Split”). All references in this report to our issued
and outstanding Common Stock as well as the price per share of
Common Stock are presented on a post Reverse Stock Split
basis.
Our
principal place of business is located at 6500 Trans-Canada Highway, 4th Floor,
Pointe-Claire, Quebec, Canada H9R 0A5. Our phone number is
(514) 426-6161 and our website address is
www.sunshinebiopharma.com.
3
Business Operations
As of
the date of this report our operations include the
following:
Proprietary Drug Development Operations
Since
inception, our proprietary drug development activities have been
focused on the development of a small molecule called Adva-27a for
the treatment of aggressive forms of cancer. A Topoisomerase II
inhibitor, Adva-27a has been shown to be effective at destroying
Multidrug Resistant Cancer cells including Pancreatic Cancer cells,
Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine
Sarcoma cells (Published in ANTICANCER RESEARCH, Volume 32, Pages
4423-4432, October 2012). Sunshine Biopharma is direct owner of all
issued and pending worldwide patents pertaining to Adva-27a
including U.S. Patent Number 8,236,935. See “Part I, Item 1
– Business - Intellectual Property.”
Figure
1
Adva-27a is a
GEM-difluorinated C-glycoside derivative of Podophyllotoxin (see
Figure 1). Another derivative of Podophyllotoxin called Etoposide
is currently on the market and is used to treat various types of
cancer including leukemia, lymphoma, testicular cancer, lung
cancer, brain cancer, prostate cancer, bladder cancer, colon
cancer, ovarian cancer, liver cancer and several other forms of
cancer. Etoposide is one of the most widely used anticancer drugs.
Adva-27a and Etoposide are similar in that they both attack the
same target in cancer cells, namely the DNA unwinding enzyme,
Topoisomerase II. Unlike Etoposide, and other anti-tumor drugs
currently in use, Adva-27a is able to destroy Multidrug Resistant
Cancer cells. Adva-27a is the only compound known today that is
capable of destroying Multidrug Resistant Cancer. In addition,
Adva-27a has been shown to have distinct and more desirable
biological and pharmacological properties compared to Etoposide. In
side-by-side studies using Multidrug Resistant Breast Cancer cells
and Etoposide as a reference, Adva-27a showed markedly greater cell
killing activity (see Figure 2).
Figure
2
4
Our
preclinical studies to date have shown that:
●
Adva-27a
is effective at killing different types of Multidrug Resistant
cancer cells, including Pancreatic Cancer Cells (Panc-1), Breast
Cancer Cells (MCF-7/MDR), Small-Cell Lung Cancer Cells (H69AR), and
Uterine Sarcoma Cells (MES-SA/Dx5).
●
Adva-27a
is unaffected by P-Glycoprotein, the enzyme responsible for making
cancer cells resistant to anti-tumor drugs.
●
Adva-27a
has excellent clearance time (half-life = 54 minutes) as indicated
by human microsomes stability studies and pharmacokinetics data in
rats.
●
Adva-27a
clearance is independent of Cytochrome P450, a mechanism that is
less likely to produce toxic intermediates.
●
Adva-27a
is an excellent inhibitor of Topoisomerase II with an IC50 of only
13.7 micromolar (this number has recently been reduce to 1.44
micromolar as a result of resolving the two isomeric forms of
Adva-27a).
●
Adva-27a
has shown excellent pharmacokinetics profile as indicated by
studies done in rats.
●
Adva-27a
does not inhibit tubulin assembly.
These
and other preclinical data have been published in ANTICANCER
RESEARCH, a peer-reviewed International Journal of Cancer Research
and Treatment. The publication which is entitled “Adva-27a, a
Novel Podophyllotoxin Derivative Found to Be Effective Against
Multidrug Resistant Human Cancer Cells” [ANTICANCER RESEARCH
32: 4423-4432 (2012)] is available on our website at www.sunshinebiopharma.com.
We have
been delayed in our clinical development program due to lack of
funding. Our fund raising efforts are continuing and as soon as
adequate financing is in place we will continue our clinical
development program of Adva-27a by conducting the following next
sequence of steps:
●
GMP
Manufacturing of 2 kilogram for use in IND-Enabling Studies and
Phase I Clinical Trials
●
IND-Enabling
Studies
●
Regulatory
Filing (Fast-Track Status Anticipated)
●
Phase I
Clinical Trials (Pancreatic Cancer Indication)
Adva-27a’s
initial indication will be Pancreatic Cancer for which there are
currently little or no treatment options available. We are planning
to conduct our clinical trials at McGill University’s Jewish
General Hospital in Montreal, Canada. All aspects of the clinical
trials in Canada will employ FDA standards at all
levels.
5
According to the
American Cancer Society, nearly 1.5 million new cases of cancer are
diagnosed in the U.S. each year. While particularly
effective against Multidrug Resistant Cancer, we believe Adva-27a
can potentially treat all cancer types as it is general
chemotherapy drug. We believe that upon successful completion of
Phase I Clinical Trials we may receive one or more offers from
large pharmaceutical companies to buyout or license our
drug. However, there are no assurances that our Phase I
Trials will be successful, or if successful, that any
pharmaceutical companies will make an acceptable offer to
us. In the event we do not consummate such a
transaction, we will require significant capital in order to
manufacture and market our new drug. The following, Figure 3, is a
space-filling molecular model of our Adva-27a.
Figure 3
6
Generic Pharmaceuticals Operations
In
2016, our Canadian wholly owned subsidiary, Sunshine Biopharma
Canada Inc. (“Sunshine Canada”), signed Licensing
Agreements with a major pharmaceutical company for four
prescription generic drugs for the treatment of Breast Cancer,
Prostate Cancer and Enlarged Prostate. We have since been working
towards commencement of marketing of these pharmaceutical products
under our own, Sunshine Biopharma, label. These four generic
products are as follows:
●
Anastrozole
(brand name Arimidex® by AstraZeneca) for treatment of Breast
Cancer;
●
Letrozole
(brand name Femara® by Novartis) for treatment of Breast
Cancer;
●
Bicalutamide
(brand name Casodex® by AstraZeneca) for treatment of Prostate
Cancer;
●
Finasteride
(brand name Propecia® by Merck) for treatment of BPH (Benign
Prostatic Hyperplasia)
Sunshine Canada is
currently in the process of securing a Drug Identification Number
(“DIN”) for each of these products from Health Canada.
We are planning to use part of the already approved Atlas Pharma
Inc. space as a drug warehouse to facilitate the process of
obtaining a Drug Establishment License (“DEL”) from
Health Canada. Upon receipt of the DEL and DIN’s, we will be
able to accept orders for our own label SBI-Anastrozole,
SBI-Letrozole, SBI-Bicalutamide and SBI-Finasteride. We cannot
estimate the timing in our obtaining either the DIN’s or the
DEL due to variables involved that are out of our control. Figure 4
below shows our 30-Pill blister pack of Anastrozole.
Figure
4
We
currently have a number of additional Generic Pharmaceuticals under
review for in-licensing. While no assurances can be provided that
we will acquire the rights to all or any of these drugs, we are
confident we will acquire most, if not all of these rights. We
believe that a larger product portfolio will provide us with more
opportunities and a greater reach into the marketplace. We hope to
further build our generics portfolio of “SBI” label
Generic Pharmaceuticals over time. There are no assurances this
will occur.
Various
publicly available sources indicate that the worldwide sales of
generic pharmaceuticals are approximately $200 billion per year. In
the United States and Canada, the sales of generic pharmaceuticals
are approximately $50 billion and $5 billion, respectively. The
generic pharmaceuticals business is fairly competitive and there
are several multinational players in the field including Teva
(Israel), Novartis - Sandoz (Switzerland), Hospira (USA), Mylan
(Netherlands), Sanofi (France), Fresenius Kabi (Germany) and Apotex
(Canada). While no assurances can be provided, with our offering of
Canadian approved products we believe that we will be able to
access at least a small percentage of the generic pharmaceutical
marketplace.
While
no assurances can be provided and subject to the availability of
adequate financing, of which there is no assurance, we anticipate
that profits from the sales of Generic Products will be used to
finance our proprietary drug development program, including
Adva-27a, our flagship anticancer compound. In addition to
near-term revenue generation, building the generics business
infrastructure and securing the proper permits will render us
appropriately positioned for the marketing and distribution of our
proprietary Adva-27a drug candidate, provided that Adva-27a is
approved for such marketing and distribution, of which there can be
no assurance.
7
Analytical
Chemistry Services Operations
On
January 1, 2018, we acquired all of the issued and outstanding
shares of Atlas Pharma Inc. (“Atlas”). The purchase
price was $848,000 Canadian (approximately $676,748 US). Payment of
the purchase price was comprised of (i) a cash payment of $100,500
Canadian (approximately $80,300 US); (ii) the issuance of 1,000,000
shares of our Common Stock, and (iii) a promissory note in the
principal amount of $450,000 Canadian (approximately $360,000 US),
with interest payable at the rate of 3% per annum. We are required
to make payments of $10,000 Canadian (approximately $8,000 US) per
calendar quarter, due and payable on or before the end of each such
calendar quarter through December 31, 2023.
Atlas
is a Health Canada certified company dedicated to chemical analysis
of pharmaceutical and other industrial samples. Atlas has 9
full-time employees and generated revenues of $580,558 and $598,109
Canadian (approximately $464,000 and $478,000 US) in 2018 and 2017,
respectively. Housed in a 5,250 square foot facility, Atlas’s
operations are authorized by a Drug Establishment License (DEL)
issued by Health Canada and are fully compliant with the
requirements of Good Laboratory Practices (GLP). Atlas is also
registered with the FDA. Atlas Pharma Inc.’s website address
is www.atlaspharmainc.ca.
In June
2018, we acquired testing and other laboratory equipment as part of
our plan to expand Atlas’ business operations. Part of the
expansion will include hiring additional technical and sales
personnel and offering microbiology and other sample testing
capabilities.
Dietary Supplements Operations
In
2018, we completed the development of Essential 9tm,
the first in a line of essential micronutrients products that we
are planning to launch. On December 14, 2018, Health Canada issued
NPN 80089663 through which it authorized Sunshine Biopharma Inc. to
manufacture and sell the Essential 9tm
product. Our Essential 9tm
dietary supplement tablets contain a balanced formula of the 9
essential amino acids that the human body cannot make. Essential
Amino Acids are 9 out of the 20 amino acids required for protein
synthesis. Proteins are involved in all body functions – From
the musculature and immune system to hormones and
neurotransmitters. Like vitamins, Essential Amino Acids cannot be
made by the human body and must be obtained through diet.
Deficiency in one or more of the 9 Essential Amino Acids can lead
to loss of muscle mass, fatigue, weight gain and reduced ability to
build muscle mass in athletes. Sunshine Biopharma’s Essential
9tm
provides all 9 Essential Amino Acids in freeform and in the
proportions recommended by Health Canada. In addition to our own
website, Essential 9tm
is available on Amazon and other outlets. Figure 5 below shows our
60-Tablet Essential 9tm
product.
Figure
5
8
Intellectual Property
Effective October
8, 2015, we executed a patent purchase agreement, with Advanomics
Corporation (“Advanomics”), a related party, pursuant
to which we acquired all of the right, title and interest in and to
U.S. Patent Number 8,236,935 for our anticancer compound,
Adva-27a. On December 28, 2015, we executed a second
patent purchase agreement, with Advanomics, pursuant to which we
acquired all of the right, title and interest in and to all of the
remaining worldwide rights covered by issued and pending patents
under PCT/FR2007/000697 and PCT/CA2014/000029 for our anticancer
compound, Adva-27a (“Patent Purchase
Agreements”).
Effective December
28, 2015, we entered into amendments (the “Amendments”)
of these Patent Purchase Agreements pursuant to which the total
purchase price was reduced from $17,142,499 to $618,810, the book
value of this intellectual property on the financial statements of
Advanomics. Further, the Amendments provided for
automatic conversion of the promissory notes representing the new
purchase price into an aggregate of 16,065,271 shares of our Common
Stock once we increased our authorized capital such that these
shares can be issued. In July 2016 we increased our authorized
capital and issued the 16,065,271 Common Shares to Advanomics
thereby completing all aspects of the patent purchase arrangements
and securing direct ownership of all worldwide patents and rights
pertaining to Adva-27a.
In 2016
we signed Licensing Agreements with a major pharmaceutical company
for four (4) prescription generic drugs for the treatment of Breast
Cancer, Prostate Cancer and Enlarged Prostate. These agreements
give us the right to register the four (4) generic products,
Anastrozole, Letrozole, Bicalutamide and Finasteride in Canada
under our own label and obtain a DIN for each in order to be able
to place them on the market.
Our new
wholly owned subsidiary, Atlas Pharma Inc., which we acquired on
January 1, 2018 holds a Drug Establishment License from Health
Canada and is registered with the FDA. Atlas Pharma Inc. is the
owner of a relatively large portfolio of analytical chemistry
methodology and Standard Operating Procedure. This intellectual
property is protected as company secrets and controlled through
employee and management confidentiality agreements.
In 2018
we completed the development of Essential 9tm,
our first dietary supplement. On December 14, 2018, Health Canada
issued NPN 80089663 through which it authorized Sunshine Biopharma
Inc. to manufacture and sell the Essential 9tm
product. We are currently preparing the necessary documents for
registration of our Essential 9tm
trademark in the United States.
Government Regulations
All of
our business operations, including the Proprietary Drug Development
Operations, the Generic Pharmaceutical Operations, the Analytical
Chemistry Services Operations, and Dietary Supplements Operations
are subject to extensive and frequently changing federal, state,
provincial and local laws and regulations.
In the
U.S, the Federal Government agency responsible for regulating drugs
and dietary supplements is the U.S. Food and Drug Administration
(“FDA”). The Canadian counterpart to the FDA is Health
Canada. Both the FDA and Health Canada have similar requirements
for drugs and supplements to be approved for marketing. In Canada,
drugs and dietary supplements are authorized through the issuance
by Health Canada of a Drug Identification Number (DIN) and a
Natural Product Number (NPN) on a per product basis, respectively.
In both the U.S. and Canada, the quality standards for brand name
drugs and generic drugs are the same. In addition, the ingredients,
manufacturing processes and facilities for all drugs and
supplements must meet the guidelines for Good Manufacturing
Practices (“GMP”). Moreover, all drug manufacturers
must perform a series of tests, both during and after production,
to show that every drug batch made meets the regulatory
requirements for that product.
In
connection with our development of the new chemical entity,
Adva-27a, we will be subject to significant regulations in the U.S.
in order to obtain approval of the FDA to offer our product on the
market. The approximate procedure for obtaining FDA
approval involves an initial filing of an IND application following
which the FDA would give the go ahead for the drug sponsor to
proceed with Phase I clinical (human) trials. Following
completion of Phase I, the results are filed with the FDA and a
request is made to proceed to Phase II. Similarly, following
completion of Phase II the data are filed with the FDA and a
request is made to proceed to Phase III. Following completion
of Phase III, a request is made for marketing approval.
Depending on various issues and considerations, the FDA could
provide limited marketing approval for
“compassionate-use” if the drug treats terminally ill
patients with limited other treatment options
available. As of the date of this Report we have not
made any filings with the FDA or other regulatory bodies in other
jurisdictions. We have however had discussions with
clinicians at the McGill University’s Jewish General Hospital
in Montreal where we plan to undertake our Phase I study for
pancreatic cancer and they believe that Health Canada is
likely to grant us a so-called “fast-track” process on
the basis of the terminal nature of the cancer type we will be
treating. There are no assurances this will
occur.
9
Employees
As of
the date of this Report we have a total of twelve (12) employees.
In addition to our management which comprises three (3) employees,
our new wholly owned subsidiary acquired on January 1, 2018, Atlas
Pharma Inc., has 9 employees. We anticipate that if we receive
financing we will need additional employees in both our generic
pharmaceuticals and proprietary drug development operations
including accounting, regulatory affairs, marketing, sales and
laboratory personnel.
Competition
In the
area of proprietary anticancer drug development, we are competing
with large publicly and privately held companies engaged in
developing new cancer therapies. There are numerous other entities
engaged in this business that have greater resources, both
financial and otherwise, than the resources presently available to
us. Nearly all major pharmaceutical companies including
Amgen, Roche, Pfizer, Bristol-Myers Squibb and Novartis, to name a
few, have on-going anticancer drug development programs and some of
the drugs they may develop could be in direct competition with our
own. Also, a number of small companies are also working
in the area of cancer and could develop drugs that may be in
competition with ours. However, none of these competitor
companies can use molecules similar to ours as they would be
infringing our patents.
The
generic pharmaceuticals business is fairly competitive and there
are many players in the field including several multinationals such
as Teva (Israel), Novartis - Sandoz (Switzerland), Hospira (USA),
Mylan (Netherlands), Sanofi (France), Fresenius Kabi (Germany) and
Apotex (Canada)with annual sales in the range of approximately $2
billion to over $10. With our offering of Canadian approved generic
products, we believe that we will be able to access at least a
small percentage of the generic pharmaceuticals
market.
Our
analytical chemistry services business is also subject to
significant competition. This competition however is entirely
regional as only entities operating in Canada require Health Canada
certified testing of their industrial samples. There are several
local service providers operating in the same sector as ours which
prevents us from obtaining greater value added for our services. We
believe we have managed to secure an advantage over the completion
by offering our clients faster turnaround.
Similarly, our
Essential 9tm,
together with our planned line of dietary supplement fall directly
within a very crowded and highly competitive product sector. As of
the date of this Report, Essential 9tm is the only Essential Amino
Acid product that comprises all 9 essential amino acids in tablet
form. We believe this will provide us with a competitive advantage,
at least for the near future.
Trademarks-Tradenames
We are
the exclusive owner of all worldwide rights pertaining to Adva-27a
covered by PCT/FR2007/000697 and PCT/CA2014/000029. The
patent applications filed under PCT/FR2007/000697 have been issued
in Europe, Canada, the United States (8,236,935) and
India. The patent application filed in the U.S. under
PCT/CA2014/000029 has recently been allowed. The remaining
international patent applications filed under the same PCT are
still pending.
We are
also the owner of Licensing Agreements for four (4) generic drugs
which we are planning to market and sell under the tradenames
SBI-Anastrozole, SBI-Letrozole, SBI-Bicalutamide and
SBI-Finasteride.
Our
newly acquired wholly owned subsidiary, Atlas Pharma Inc. holds
Drug Establishment License Number 102041 issued by Health
Canada.
In 2018
we completed the development of Essential 9tm,
our first dietary supplement product. On December 14, 2018, Health
Canada issued NPN 80089663 through which it authorized us to
manufacture and sell the Essential 9tm
product. We are currently preparing the necessary documents for
registration of our Essential 9tm
product and trademark in the United States in 2019.
10
ITEM 1A. RISK FACTORS
We are
a smaller reporting company and not required to include this
disclosure in this report.
ITEM 1B. UNRESOLVED STAFF
COMMENTS
None.
ITEM 2. PROPERTIES
During
the first half of 2017, our principal place of business was located
at 469 Jean-Talon West, 3rd Floor, Montreal, Quebec, Canada, H3N
1R4. On June 1, 2017 we moved our principal place of
business to our current location at 6500 Trans-Canada Highway, 4th
Floor, Pointe-Claire, Quebec, Canada H9R 0A5. We pay a minimum
monthly rate of $227 (Canadian), including tax, for this location.
Pursuant to our lease agreement our landlord is able to provide us
with increased office space for additional fees as may be requested
by us from time to time.
Our
newly acquired wholly owned subsidiary, Atlas Pharma Inc. leases an
office and laboratory space at 7582 Chemin Cote-de-Liesse,
Montréal, Quebec, Canada H4T 1E7. The lease expires on May 21,
2021. Minimum lease payments for the next remaining three (3) years
are Canadian $62,213 (approximataely $47,904 US) in 2019, $62,213
(approximately $47,904 US) in 2020, and $25,921 (approximately
$19,959 US) in 2021.
We
believe that our existing facilities and equipment are adequate. We
continuously review our anticipated requirements for facilities and
equipment, and on the basis of that review, may from time to time
acquire or lease additional facilities or equipment, or dispose of
some of the existing space or equipment.
ITEM 3. LEGAL
PROCEEDINGS
In November 2014,
we entered into a Manufacturing Services Agreement with Lonza Ltd.
and Lonza Sales Ltd. (hereinafter jointly referred to as
“Lonza”), whereby we engaged Lonza to be the
manufacturer of our Adva-27a anticancer drug. In June 2016 we
received a sample of the pilot manufacturing run for evaluation.
Our laboratory analyses showed that, while the sample meets all of
the required chemical, physical and biological specifications, the
amount of material generated (the “Yield”) by the pilot
run was found to be significantly lower than anticipated. We are
currently working towards finding possible solutions to increase
the Yield and define a path forward. During the course of our
discussions concerning the problem of the low Yield, Lonza informed
us that they required us to pay them $687,818 prior to moving
forward with any activity pertaining to the manufacturing agreement
we have with them. We have repeatedly indicated to Lonza that a
clear path defining exactly how the extremely low Yield issue would
be addressed is imperative prior to us making any payments. We
issued a letter to them in June 2017 advising of our position. As
of the date of this Report we have not received a response to our
letter and no further action has been taken by either
party.
In June
2018 we filed an action in the Superior Court of the Province of
Quebec in the District of Montreal (Canada) against one of our
existing shareholders residing in Quebec City (Canada) arising out
of a possible equity investment intended to be completed by August
2018. The complaint alleges among other things, claims of
misrepresentations and misleading conduct resulting in damages to
us in an amount of approximately $200,000 Canadian (approximately
$154,000 US). As of the date of this report we are awaiting a court
date for the hearings to commence.
To the
best of our management’s knowledge and belief, there are no
other material claims that have been brought against us nor any
claims threatened.
ITEM 4. MINE SAFETY
DISCLOSURES
Not
applicable.
11
PART II
ITEM 5. MARKET FOR
REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Trading
of our Common Stock commenced on the OTCBB in September 2007 under
the symbol “MWBN.” Effective November 30,
2009, the trading symbol for our Common Stock was changed to
“SBFM” as a result of our name change discussed
above.
In the
third quarter of 2016 our Common Stock began trading on OTC Pink
(otcmarkets.com) because the price of our stock had dropped below
$0.01 per share.
Effective February
1, 2019 we completed a 20 to 1 reverse split of our Common Stock,
reducing the issued and outstanding shares of Common Stock from
1,713,046,242 to 85,652,400 (the “Reverse Stock
Split”).
The
table below sets forth the reported high and low transaction prices
for the periods indicated taking into account and giving
retroactive effect to the Reverse Stock Split.
Quarter
Ended
|
High
|
Low
|
|
|
|
March 31,
2017
|
$0.0502
|
$0.0502
|
June 30,
2017
|
$0.2680
|
$0.2200
|
September 29,
2017
|
$0.3100
|
$0.2810
|
December 29,
2017
|
$0.2600
|
$0.2000
|
|
|
|
March 29,
2018
|
$0.1620
|
$0.1580
|
June 29,
2018
|
$0.1340
|
$0.1060
|
September 28,
2018
|
$0.0340
|
$0.0300
|
December 31,
2018
|
$0.0200
|
$0.0160
|
As of
April 11, 2019, the closing bid price of our Common Stock was
$0.012 per share.
Trading
volume in our Common Stock varies between a few thousand shares to
several hundred thousand shares per day. As a result,
the trading price of our Common Stock is subject to significant
fluctuations.
The Securities Enforcement and Penny Stock Reform Act of
1990
The
Securities and Exchange Commission (“Commission” or
“SEC”) has adopted rules that regulate broker-dealer
practices in connection with transactions in penny
stocks. Penny stocks are generally equity securities
with a price of less than $5.00 (other than securities registered
on certain national securities exchanges or quoted on the Nasdaq
system, provided that current price and volume information with
respect to transactions in such securities is provided by the
exchange or system).
As of
the date of this Report, our Common Stock is defined as a
“penny stock” under the Securities and Exchange
Act. It is anticipated that our Common Stock will remain
a penny stock for the foreseeable future. The
classification of penny stock makes it more difficult for a
broker-dealer to sell the stock into a secondary market, which
makes it more difficult for a purchaser to liquidate his/her
investment. Any broker-dealer engaged by the purchaser
for the purpose of selling his or her shares in us will be subject
to Rules 15g-1 through 15g-10 of the Securities and Exchange
Act. Rather than creating a need to comply with those
rules, some broker-dealers will refuse to attempt to sell penny
stock.
12
The
penny stock rules require a broker-dealer, prior to a transaction
in a penny stock not otherwise exempt from those rules, to deliver
a standardized risk disclosure document prepared by the Commission,
which:
●
contains
a description of the nature and level of risk in the market for
penny stocks in both public offerings and secondary
trading;
●
contains
a description of the broker's or dealer's duties to the customer
and of the rights and remedies available to the customer with
respect to a violation to such duties or other requirements of the
Securities Act of 1934, as amended;
●
contains
a brief, clear, narrative description of a dealer market, including
"bid" and "ask" prices for penny stocks and the significance of the
spread between the bid and ask price;
●
contains
a toll-free telephone number for inquiries on disciplinary
actions;
●
defines
significant terms in the disclosure document or in the conduct of
trading penny stocks; and
●
contains
such other information and is in such form (including language,
type, size and format) as the Securities and Exchange Commission
shall require by rule or regulation;
The
broker-dealer also must provide, prior to effecting any transaction
in a penny stock, to the customer:
●
the bid
and offer quotations for the penny stock;
●
the
compensation of the broker-dealer and its salesperson in the
transaction;
●
the
number of shares to which such bid and ask prices apply, or other
comparable information relating to the depth and liquidity of the
market for such stock; and
●
monthly
account statements showing the market value of each penny stock
held in the customer's account.
In
addition, the penny stock rules require that prior to a transaction
in a penny stock not otherwise exempt from those rules; the
broker-dealer must make a special written determination that the
penny stock is a suitable investment for the purchaser and receive
the purchaser's written acknowledgment of the receipt of a risk
disclosure statement, a written agreement to transactions involving
penny stocks, and a signed and dated copy of a written suitability
statement. These disclosure requirements will have the
effect of reducing the trading activity in the secondary market for
our stock because it will be subject to these penny stock
rules. Therefore, stockholders may have difficulty
selling their securities.
Holders
We had
147 holders of record of our Common Stock as of the date of this
Report, not including those persons who hold their shares in
“street name.”
Our
CEO, Dr. Steve N. Slilaty, holds all 500,000 shares of our Series
“B” Preferred Stock issued in 2015.
Stock Transfer Agent
The
stock transfer agent for our securities is Corporate Stock
Transfer, Inc. Their address is 3200 Cherry Creek South
Drive, Suite 430, Denver, Colorado, 80209. Their phone
number is (303) 282-4800.
13
Dividends
We have
not paid any dividends since our incorporation and do not
anticipate the payment of dividends in the foreseeable future. At
present, our policy is to retain earnings, if any, to develop and
market our products. The payment of dividends in the
future will depend upon, among other factors, our earnings, capital
requirements, and operating financial conditions.
Reports
We are
subject to certain reporting requirements and furnish annual
financial reports to our stockholders, certified by our independent
accountants, and furnish unaudited quarterly financial reports in
our quarterly reports filed electronically with the
SEC. All reports and information filed by us can be
found at the SEC website, www.sec.gov.
ITEM 6. SELECTED
FINANCIAL DATA.
Not
applicable.
ITEM
7. MANAGEMENT’S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The
following discussion should be read in conjunction with our audited
financial statements and notes thereto included
herein. In connection with, and because we desire to
take advantage of, the “safe harbor” provisions of the
Private Securities Litigation Reform Act of 1995, we caution
readers regarding certain forward looking statements in the
following discussion and elsewhere in this Report and in any other
statement made by, or on our behalf, whether or not in future
filings with the Securities and Exchange
Commission. Forward looking statements are statements
not based on historical information and which relate to future
operations, strategies, financial results or other developments.
Forward looking statements are necessarily based upon estimates and
assumptions that are inherently subject to significant business,
economic and competitive uncertainties and contingencies, many of
which are beyond our control and many of which, with respect to
future business decisions, are subject to change. These
uncertainties and contingencies can affect actual results and could
cause actual results to differ materially from those expressed in
any forward looking statements made by, or on our
behalf. We disclaim any obligation to update forward
looking statements.
Overview and History
We were
incorporated in the State of Colorado on August 31, 2006 under the
name “Mountain West Business Solutions, Inc.” Until
October 2009, our business was to provide management consulting
with regard to accounting, computer and general business issues for
small and home-office based companies.
In
October 2009, we acquired Sunshine Biopharma, Inc., a Colorado
corporation holding an exclusive license to a new anticancer drug
bearing the laboratory name, Adva-27a. As a result of this
transaction we changed our name to “Sunshine Biopharma, Inc.
and our officers and directors resigned their positions with us and
were replaced by Sunshine’s management at the time, including
our current CEO, Dr. Steve N. Slilaty, and our current CFO, Camille
Sebaaly each of whom remain part of our current management. Our
principal business became that of a pharmaceutical company focusing
on the development of our licensed Adva-27a anticancer compound. In
December 2015 we acquired all issued and pending patents pertaining
to our Adva-27a technology and terminated the license. See
“Part I, Item 1 – Business - Intellectual
Property,” below for a more detailed explanation of this
acquisition.
In July
2014, we formed a wholly owned Canadian subsidiary, Sunshine
Biopharma Canada Inc. (“Sunshine Canada”), for the
purposes of offering generic pharmaceutical products in Canada and
elsewhere around the world. In April and June 2016 Sunshine Canada
signed licensing agreements for four (4) generic prescription drugs
for the treatment of breast cancer, prostate cancer and BPH (Benign
Prostatic Hyperplasia).
In
January 2018, we acquired all of the issued and outstanding shares
of Atlas Pharma Inc., a Health Canada certified company dedicated
to chemical analysis of pharmaceutical and other industrial
samples.
In
March 2018, we formed NOX Pharmaceuticals, Inc., a wholly owned
Colorado corporation and assigned all of our interest in our
Adva-27a anticancer compound to that company.
In
December 2018, we launched our first over-the-counter Essential
Brandtm
product, Essential 9tm,
a dietary supplement comprised of the nine amino acids which the
human body cannot synthesize. Essential 9tm
has been authorized for marketing by Health Canada under NPN
80089663.
14
Effective February
1, 2019, we completed a 20 to 1 reverse split of our $0.001 par
value Common Stock reducing the issued and outstanding shares of
Common Stock from 1,713,046,242 to 85,652,400 (the “Reverse
Stock Split”). All references in this report to our issued
and outstanding Common Stock as well as price per share of our
Common Stock are presented on a post Reverse Stock Split
basis.
Our
principal place of business is located at 6500 Trans-Canada Highway, 4th Floor,
Pointe-Claire, Quebec, Canada H9R 0A5. Our phone number is
(514) 426-6161 and our website address is www.sunshinebiopharma.com.
We have
never been subject to any bankruptcy, receivership or similar
proceeding.
Going Concern
Our
financial statements accompanying this Report have been prepared
assuming that we will continue as a going concern, which
contemplates the realization of assets and liquidation of
liabilities in the normal course of business. The financial
statements do not include any adjustment that might result from the
outcome of this uncertainty. We have a minimal operating history
and minimal revenues or earnings from operations. We have no
significant assets or financial resources. We will, in all
likelihood, sustain operating expenses without corresponding
revenues for the immediate future. See “Financial
Statements and Notes.”
Results Of Operations
Comparison of Results of Operations for the fiscal years ended
December 31, 2018 and 2017
During
our fiscal years ended December 31, 2018 we generated revenues of
$447,200 from the operations of our new wholly owned subsidiary,
Atlas Pharma Inc. (“Atlas”), which we acquired on
January 1, 2018. The direct cost for generating these revenues was
$359,300, which is comprised of Atlas related salaries, laboratory
supplies, rent and depreciation. We did not generate any revenues
in 2017 or prior thereto.
General
and administrative expenses for our fiscal year ended December 31,
2018 were $1,222,656, compared to $857,190 during our fiscal year
ended December 31, 2017, an increase of $365,466. The expense
categories that saw an increase included accounting and legal fees,
which increased by $109,406, office expenses by $103,305, and
executive compensation by $234,944. These increases were offset to
some extent by a decrease in consulting fees by $90,768. The
decrease in consulting fees was due to the fact that a substantial
amount of the work required for our various operations was
performed in-house.
We also
incurred $159,420 in interest expense and $871,726 in losses from
debt conversion during the year ended December 31, 2018, compared
to $104,829 in interest expense and $76,929 in losses from debt
conversion during the similar period in 2017. The increase in
interest expense and losses from debt conversion in 2018 was due to
an increase in issuance of convertible debt instruments in order to
finance operations.
As a
result, we incurred a net loss of $2,156,155 (approximately $0.04
per share) for the year ended December 31, 2018, compared to a net
loss of $1,040,236 (approximately $0.02 per share) during the year
ended December 31, 2017.
Liquidity and Capital Resources
As of
December 31, 2018, we had cash and cash equivalents of
$115,216.
Net
cash used in operating activities was $512,806 during our fiscal
year ended December 31, 2018, compared to $543,520 during our
fiscal year ended December 31, 2017. We anticipate that
our cash requirements for our operations will increase in the
future before we reach profitability levels.
Cash
flows used in investing activities were $13,908 during our fiscal
year ended December 31, 2018. For the fiscal year ended
December 31, 2017, cash flows used in investing activities were
$84,008 arising primarily out of the purchase of laboratory
equipment. Net cash flows provided by financing
activities totaled $527,640 in 2018, compared to $670,705 during
our fiscal year ended December 31, 2017.
15
We have
issued convertible and non-convertible notes to both related and
unaffiliated parties in order to fund our operations. Following is
a description of our liquidity and capital resources events in
2018:
●
In
December 2016, we received monies from our CEO in exchange for a
note payable having a principal amount of $90,000 Canadian ($67,032
US) with interest at 12% due March 31, 2017. The note was
convertible any time after the date of issuance into shares of our
Common Stock at a price 35% below market value. At the time, this
note was collateralized by all of our assets. In the event of
default, the interest rate will increase to 18% per annum and a
penalty of $1,000 Canadian ($752 US) per day will accrue. On March
31, 2017, the note, together with accrued interest of $3,021
Canadian ($2,271 US) and an additional principal amount of $3,000
Canadian ($2,247 US) was renewed for a 90-day period under the same
terms and conditions as the original note. The new note then having
a face value of $96,021 Canadian ($72,198 US) was due on June 30,
2017. On June 30, 2017, the note, together with accrued interest of
$2,873 Canadian ($2,005 US), was renewed for a 90-day period under
the same terms and conditions as the original note except that the
new note was not- convertible. The new note then having a face
value of $98,894 Canadian ($76,072US) was due on September 30,
2017. On September 30, 2017, the note, together with accrued
interest of $2,991 Canadian ($2,397 US) was renewed for a 90-day
period under the same terms and conditions as the June 2017 note.
The note, then having a principal balance of $101,885 Canadian
($81,640 US) matured December 31, 2017. On December 31, 2017 the
note was renewed for a 12-month period under the same terms and
conditions as the September 2017 note except that this new note is
unsecured and nonconvertible. The new note has a face value of
$104,942 Canadian ($83,649 US) and matures on December 31, 2018. On
December 31, 2018 the note, together with interest of $9,227, was
renewed for a 12-month period under the same terms and conditions
as the previous note. The new has a face value of $117,535 Canadian
($86,118 US) and matures on December 31, 2019.
●
A note
payable held by a private individual who subsequently became a
principal shareholder of our Company, having a face value of
$100,000 at December 31, 2016 and a maturity date of March 31,
2017, accrues interest at 12%. The Note is convertible any time
from the date of issuance into shares of our Common Stock at a 35%
discount from market price. On March 31, 2017, the note’s
principal balance of $100,000 plus accrued interest of $11,715 was
renewed for a period of 90 days under the same terms and conditions
as the original note. The new note then having a face value of
$111,715 matured on June 30, 2017. On June 30, 2017, the
note’s principal balance of $111,715, plus accrued interest
of $3,342 was renewed for a period of 90 days under the same terms
and conditions as the original note. The new note then had a face
value of $115,057 and matured on September 30, 2017. On September
30, 2017, the note’s principal balance of $115.057 plus
accrued interest of $3,480 was renewed for a period of 90 days
under the same terms and conditions as the original note. The new
note then had a principal balance of $118,537, which matured on
December 31, 2017. On December 31, 2017 the note was renewed for a
12-month period under the same terms and conditions as before. The
new note has a face value of $122,093 and matures on December 31,
2018. On December 31, 2018 the note, together with accrued interest
of $14,651was renewed for a 12-month period. The new Note has a
face value of $136,744 and matures on December 31, 2019. The new
note is nonconvertible.
●
A Note
Payable having a Face Value of $21,439 at December 31, 2016 and
accruing interest at 12% was due December 31, 2017. On December 31,
2017, we renewed the note, together with accrued interest of
$2,573, for a 12-month period. The new note has a Face Value of
$24,012 and accrues interest at 12%. This note is convertible
anytime from the date of issuance into shares of our Common Stock
at a 35% discount from market price and is due December 31, 2018.
On December 31, 2018 we renewed this note, together with accrued
interest of $2,881, for a 12-month period. The new note has a Face
Value of $26,893 and accrues interest at 12%. This new note is not
convertible.
●
On
January 1, 2018, as part of the acquisition of Atlas Pharma Inc.,
we issued a note payable in the amount of $450,000 Canadian
($358,407 US) and accruing interest at the rate of 3% per annum.
The note is due on December 31, 2023. Payments on this note are
$10,000 Canadian (approximately $8,000 US) per quarter. The
outstanding principal balance at December 31, 2018 was $310,079.
The note is not convertible but is secured by our Atlas Pharma Inc.
shares.
●
On
January 12, 2018 we received monies in exchange for a Note Payable
having a Face Value of $102,000 with interest accruing at 8%, which
was due October 30, 2018. The Note is convertible after 180 days
from issuance into shares of our Common Stock at a price 35% below
market value. The Note, together with accrued interest of $4,080
was converted in 2018 into 3,569,333 shares of our Common Stock.
.
●
On
February 7, 2018, we received monies in exchange for a Note Payable
having a Face Value of $150,000 with interest accruing at 8%, which
became due February 7, 2019. The note was paid off in 2018 in part
by cash of $48,000 and the remainder, together with accrued
interest of $5,073, was converted into 5,710,642 shares of our
Common Stock.
●
On
February 20, 2018, we received monies in exchange for a Note
Payable having a Face Value of $85,000 with interest accruing at
8%, which became due November 30, 2018. The Note, together with
accrued interest of $3,400, was converted in 2018 into 4,376,238
shares of our Common Stock.
16
●
On May
29, 2018, we received monies in exchange for a Note Payable having
a Face Value of $26,750 with interest accruing at 8%, which became
due February 29, 2019. The note, together with accrued interest of
$1,353, was converted into 4,003,265 shares of our Common
Stock.
●
On June
27, 2018, we received monies in exchange for a Note Payable having
a Face Value of $53,000 with interest accruing at 8%, which is due
April 15, 2019. The Note, together with accrued interest of $5,332,
was paid by cash on January 1, 2019.
●
On
August 17, 2018, we received monies in exchange for a Note Payable
having a Face Value of $53,000 with interest accruing at 8%, which
is due April 15, 2019. The Note is convertible after 180 days from
issuance into shares of our Common Stock at a price 35% below
market value. Interest accrued at December 31, 2018 was $1,557. We
estimate that the fair value of this convertible debt approximates
the face value, so no value has been assigned to the beneficial
conversion feature. Any gain or loss will be recognized at
conversion.
●
On
September 10, 2018, we received monies in exchange for a Note
Payable having a Face Value of $20,000 with interest accruing at
8%, which is due April 15, 2019. The Note is convertible after 180
days from issuance into shares of our Common Stock at a price 35%
below market value. Interest accrued at December 31, 2018 was $487.
We estimate that the fair value of this convertible debt
approximates the face value, so no value has been assigned to the
beneficial conversion feature. Any gain or loss will be recognized
at conversion.
●
On
September 10, 2018, we received monies in exchange for a Note
Payable having a Face Value of $16,500 with interest accruing at
8%, which is due April 15, 2019. The Note is convertible after 180
days from issuance into shares of our Common Stock at a price 35%
below market value. Interest accrued at December 31, 2018 was $401.
We estimate that the fair value of this convertible debt
approximates the face value, so no value has been assigned to the
beneficial conversion feature. Any gain or loss will be recognized
at conversion.
●
On
October 23, 2018, we received monies in exchange for a Note Payable
having a Face Value of $90,000 with interest accruing at 8%, which
is due October 23, 2019. The Note is convertible after 180 days
from issuance into shares of our Common Stock at a price 35% below
market value. Interest accrued at December 31, 2018 was $1,361. We
estimate that the fair value of this convertible debt approximates
the face value, so no value has been assigned to the beneficial
conversion feature. Any gain or loss will be recognized at
conversion.
●
On
December 24, 2018, we received monies in exchange for a Note
Payable having a Face Value of $87,000 with interest accruing at
8%, which is due October 23, 2019. The Note is convertible after
180 days from issuance into shares of our Common Stock at a price
35% below market value. Interest accrued at December 31, 2018 was
$153. We estimate that the fair value of this convertible debt
approximates the face value, so no value has been assigned to the
beneficial conversion feature. Any gain or loss will be recognized
at conversion.
●
During
the fiscal year ended December 31, 2018, we issued an aggregate of
39,715,488 shares of our Common Stock as follows:
o
1,000,000 shares
for the acquisition of Atlas Pharma Inc.
o
1,456,737 shares
for the purchase of laboratory and generic drugs warehouse
equipment valued at $174,808
o
9,750,000 shares
valued at $600,300 as compensation to our Directors and
Officers
o
632,500 shares for
services rendered to us by third parties valued at
$83,400
o
26,876,251 valued
at $1,589,099 shares in connection with the conversion of $684,318
in debt and interest of $32,808 resulting in a $871,973 loss on
conversion
17
We
relied upon the exemption from registration provided by Section
4(2) of the Securities Act of 1933, as amended, to issue the
respective shares.
We are
not generating significant revenue from our operations, and our
ability to implement our business plan as set forth herein will
depend on the future availability of financing. Such
financing will be required to enable us to further develop our
proprietary drug development program, generic pharmaceuticals
business, dietary supplements sales, and analytical chemistry
operations. We intend to raise funds through private
placements of our Common Stock and/or debt financing. We estimate
that we will require approximately $10 million ($1 million for the
generic pharmaceutical operations, $1 million for expansion of the
analytical chemistry operations, $1 million for the development of
dietary supplements sales and $7 million for the proprietary drug
development program) to fully implement our business plan in the
future and there are no assurances that we will be able to raise
this capital.
In late
2017 we signed an agreement with Jitney Trade Inc.
(“Jitney”), a Canadian broker-dealer, to raise up to
$10 million Canadian (approximately $8 million US) in a private
offering in order to provide the funding we have estimated we need
to implement our business plan (the “Offering”). The
Offering, including a six-month extension, expired on August 31,
2018 without any funds having been raised. We are currently in
discussion with various investment groups for financing. There are
no assurances that we will be successful in raising any
funds.
Our
cost to continue operations are expected to increase as we move
forward with implementation of our enhanced business
plan. We do not have sufficient funds to cover the
anticipated increase in the relevant expenses. We need
to raise additional funds in order to continue our existing
operations and planned expansions.
Inflation
Although our
operations are influenced by general economic conditions, we do not
believe that inflation had a material effect on our results of
operations during our fiscal year ended December 31,
2018.
Critical Accounting Policies and Estimates
Critical Accounting Estimates
The
discussion and analysis of our financial condition and results of
operations are based upon our financial statements, which have been
prepared in accordance with accounting principles generally
accepted in the United States. The preparation of these
financial statements requires us to make estimates and judgments
that affect the amounts of assets, liabilities, revenues and
expenses, and related disclosure of contingent assets and
liabilities. On an on-going basis, we evaluate our estimates based
on historical experience and on various other assumptions that are
believed to be reasonable under the circumstances, the results of
which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates
under different assumptions or conditions.
Leases
We
follow the guidance in ASC 840 “Accounting for Leases,” as
amended, which requires us to evaluate the lease agreements we
enter into to determine whether they represent operating or capital
leases at the inception of the lease.
18
Recently Adopted Accounting Standards
In
February 2017, the FASB issued ASU No. 2017-02, Leases (Topic 842),
to provide guidance on recognizing lease assets and lease
liabilities on the balance sheet and disclosing key information
about leasing arrangements, specifically differentiating between
different types of leases. The core principle of Topic 842 is that
a lessee should recognize the assets and liabilities that arise
from all leases. The recognition, measurement, and presentation of
expenses and cash flows arising from a lease by a lessee have not
significantly changed from previous GAAP. There continues to be a
differentiation between finance leases and operating leases.
However, the principal difference from previous guidance is that
the lease assets and lease liabilities arising from operating
leases should be recognized in the balance sheet. The accounting
applied by a lessor is largely unchanged from that applied under
previous GAAP. The amendments will be effective for fiscal years
beginning after December 15, 2018, including interim periods within
those fiscal years, and early adoption is permitted. In transition,
lessees and lessors are required to recognize and measure leases at
the beginning of the earliest period presented using a modified
retrospective approach.
The
modified retrospective approach includes a number of optional
practical expedients that entities may elect to apply. These
practical expedients relate to the identification and
classification of leases that commenced before the effective date,
initial direct costs for leases that commenced before the effective
date, and the ability to use hindsight in evaluating lessee options
to extend or terminate a lease or to purchase the underlying
asset.
An
entity that elects to apply the practical expedients will, in
effect, continue to account for leases that commence before the
effective date in accordance with previous GAAP unless the lease is
modified, except that lessees are required to recognize a
right-of-use asset and a lease liability for all operating leases
at each reporting date based on the present value of the remaining
minimum rental payments that were tracked and disclosed under
previous GAAP. We are currently evaluating the impact of these
amendments on our financial statements.
19
Off-Balance Sheet Arrangements
We have
not entered into any off-balance sheet arrangements that have or
are reasonably likely to have a current or future effect on our
financial condition, changes in financial condition, revenues or
expenses, results of operations, liquidity, capital expenditures or
capital resources and would be considered material to
investors.
ITEM
7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
Not
applicable.
ITEM 8. FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA
Reference is made
to the Financial Statements, the notes thereto, and the Report of
Independent Public Accountants thereon commencing at page F-1 of
this Report, which Financial Statements, notes and report are
incorporated herein by reference.
20
Sunshine Biopharma, Inc.
CONSOLIDATED
FINANCIAL STATEMENTS
With
Independent Accountant’s Audit Report
At
December 31, 2018 and 2017
TABLE
OF CONTENTS
|
Page
|
|
|
Independent
Accountant’s Audit Report
|
F-1
|
|
|
Consolidated
Balance Sheet
|
F-2
|
|
|
Consolidated
Statement of Operations
|
F-3
|
|
|
Consolidated
Statement of Cash Flows
|
F-4
|
|
|
Consolidated
Statement of Shareholders’ Equity
|
F-5
|
|
|
Notes
to Consolidated Financial Statements
|
F-6
|
Report of Independent Registered Public Accounting
Firm
To the
shareholders and the board of directors of Sunshine Biopharma,
Inc.:
Opinion on the Financial Statements
We have
audited the accompanying consolidated balance sheets of Sunshine
Biopharma, Inc. (the "Company") as of December 31, 2018 and 2017,
the related consolidated statements of operations and comprehensive
loss, shareholders' equity (deficit), 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, 2018 and 2017 and the results of its
operations and its cash flows for the years then ended, in
conformity with accounting principles generally accepted in the
United States.
Going Concern Uncertainty
The
accompanying financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note
3 to the financial statements, the Company’s limited
operations and Working Capital deficit raise substantial doubt
about its ability to continue as a going concern. The financial
statements do not include any adjustments that might result from
the outcome of this uncertainty.
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 audit. We are a public
accounting firm registered with the Public Company Accounting
Oversight Board (United States) ("PCAOB") and are required to be
independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of
the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB.
Those standards require that we plan and perform the audits to
obtain reasonable assurance about whether the financial statements
are free of material misstatement, whether due to error or
fraud.
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/ BF
Borgers CPA
PC
We have
served as the Company's auditor since 2013.
Lakewood,
CO
April
12, 2019
F-1
Sunshine Biopharma, Inc.
|
|
|
Consolidated Balance Sheet
|
|
|
|
|
|
|
December
31,
|
December
31,
|
|
2018
|
2017
|
ASSETS
|
|
|
Current
Assets:
|
|
|
Cash
and cash equivalents
|
$115,216
|
$107,532
|
Accounts
receivable
|
94,955
|
-
|
Prepaid
expenses
|
1,341
|
9,667
|
|
|
|
Total
Current Assets
|
211,512
|
117,199
|
|
|
|
Equipment
(net of $57,964 and $9,132 depreciation)
|
269,362
|
59,996
|
|
|
|
Patents
(net of $58,918 amortization and $556,120 impairment)
|
-
|
-
|
|
|
|
Non-Current
Asset:
|
|
|
Goodwill
|
665,697
|
|
Deposits
|
-
|
80,290
|
|
|
|
TOTAL
ASSETS
|
$1,146,571
|
$257,485
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
Current
Liabilities:
|
|
|
Current
portion of notes payable
|
419,663
|
516,867
|
Current
portion of notes payable - Related party
|
243,094
|
205,742
|
Related
party advances
|
49,349
|
|
Accounts
payable & accrued expenses
|
191,080
|
19,314
|
Interest
payable
|
9,291
|
9,215
|
|
|
|
Total
Curent Liabilities
|
912,477
|
751,138
|
|
|
|
Long-Term
Liabilities - Related party note payable
|
289,847
|
79,710
|
|
|
|
TOTAL
LIABILITIES
|
1,202,324
|
830,848
|
|
|
|
SHAREHOLDERS'
EQUITY
|
|
|
|
|
|
Preferred Stock, Series A, $0.10 par value per share; Authorized
850,000 shares;
Issued
and outstanding -0- shares at December 31, 2018 and
2017.
|
-
|
-
|
|
|
|
Preferred Stock, Series B $0.10 par value per share; Authorized
500,000 Shares;
Issued
and outstanding 500,000 at December 31, 2018 and 2017.
|
50,000
|
50,000
|
|
|
|
Common Stock, $0.001 par value per share; Authorized 3,000,000,000
Shares;
Issued
and outstanding 85,652,400 and 45,936,825 at December 31, 2018 and
2017, respectively
|
85,652
|
45,936
|
Reserved
for issuance 97,321,836 At December 31, 2018
|
|
|
|
|
|
Capital
paid in excess of par value
|
15,586,678
|
12,948,387
|
|
|
|
Accumulated
other comprehesive Income (Loss)
|
(3,738)
|
504
|
|
|
|
Accumulated
(Deficit)
|
(15,774,345)
|
(13,618,190)
|
|
|
|
TOTAL
SHAREHOLDERS' DEFICIT
|
(55,753)
|
(573,363)
|
|
|
|
TOTAL
LIABILITIES AND SHAREHOLDERS' DEFICIT
|
$1,146,571
|
$257,485
|
See Accompanying Notes To These Financial Statements.
F-2
Sunshine Biopharma, Inc.
|
|
|
Consolidated Statement Of Operations and Comprehensive
Loss
|
||
|
2018
|
2017
|
|
|
|
Revenues
|
$447,200
|
$-
|
Cost of
Revenues
|
391,081
|
-
|
|
|
|
Gross
Profit
|
56,119
|
-
|
|
|
|
General
& Administrative Expenses:
|
|
|
Accounting
|
153,889
|
81,643
|
Legal
|
113,068
|
75,908
|
Consulting
|
36,245
|
127,013
|
Office
|
149,031
|
45,726
|
Officer
& Director remuneration
|
755,215
|
520,271
|
Research
& Development
|
12,800
|
-
|
Amortization
& Depreciation
|
2,408
|
6,629
|
|
|
|
Total
General & Administative
|
1,222,656
|
857,190
|
|
|
|
Income
(Loss) from Operations
|
(1,166,537)
|
(857,190)
|
|
|
|
Other
Expenses:
|
|
|
Interest
expense
|
(159,420)
|
(104,829)
|
Loss
on conversion of notes payable
|
(871,726)
|
(76,929)
|
Gain
(Loss) from foreign exchange transactions
|
41,528
|
(1,288)
|
|
|
|
Total
Other Expenses
|
(989,618)
|
(183,046)
|
|
|
|
Net
(loss)
|
$(2,156,155)
|
$(1,040,236)
|
|
|
|
Basic
Gain (Loss) per Common Share
|
$(0.04)
|
$(0.02)
|
|
|
|
Weighted
Average Common Shares Outstanding
|
60,936,164
|
43,634,280
|
|
|
|
Net
Income (Loss)
|
$(2,156,155)
|
$(1,040,236)
|
|
|
|
Unrealized
Comprehensive Gain (Loss) from foreign exchange
transactions
|
(4,242)
|
110
|
|
|
|
Comprehensive
Income (Loss)
|
(2,160,397)
|
(1,040,126)
|
|
|
|
Basic
(Loss) per Common Share
|
(0.04)
|
(0.02)
|
|
|
|
Weighted
Average Common Shares Outstanding
|
60,936,164
|
43,634,280
|
See Accompanying Notes To These Financial
Statements.
F-3
Sunshine Biopharma, Inc.
|
|
|
Consolidated Statement Of Cash Flows
|
|
|
|
|
|
|
December
31,
|
December
31,
|
|
2018
|
2017
|
Cash Flows From Operating Activities:
|
|
|
Net
(Loss)
|
$(2,156,155)
|
$(1,040,236)
|
Depreciation
and amortization
|
49,361
|
6,629
|
Foreign
exchange gain
|
(42,399)
|
|
Stock
issued for services
|
676,100
|
427,400
|
Loss
on conversion of notes payable
|
871,973
|
76,929
|
Stock
issued for payment of interest
|
33,977
|
3,022
|
Interest
forgiven
|
(247)
|
-
|
Increase
(decrease) in accounts receivable
|
(15,447)
|
|
Increase
(decrease) in prepaid expenses
|
8,326
|
(8,660)
|
Increase
(decrease) in Accounts Payable
|
61,629
|
(8,808)
|
Increase
(decrease) in interest payable
|
76
|
204
|
|
|
|
Net
Cash Flows (Used) in Operations
|
(512,806)
|
(543,520)
|
|
|
|
Cash Flows From Investing Activities:
|
|
|
Cash
received from purchase of subsidiary
|
4,942
|
|
Purchase
equipment
|
(18,850)
|
(3,718)
|
Deposits
on business acquisition
|
-
|
(80,290)
|
|
|
|
Net
Cash Flows (Used) in Investing Activities
|
(13,908)
|
(84,008)
|
|
|
|
Cash Flows From Financing Activities:
|
|
|
Proceed
from note payable
|
609,885
|
660,565
|
Note
payable - Interest expense
|
26,759
|
33,977
|
Payment
of notes payable
|
(194,184)
|
(115,000)
|
Advances
from related parties
|
29,930
|
2,251
|
Note
payable used to pay expenses
|
36,500
|
|
Note
payable used to pay origination fees & interest
|
18,750
|
25,000
|
Sale
of common stock
|
-
|
63,912
|
|
|
|
Net
Cash Flows Provided by Financing Activities
|
527,640
|
670,705
|
|
|
|
Net
Increase (Decrease) In Cash and Cash Equivalents
|
926
|
43,177
|
Foreign
currency translation adjustment
|
6,758
|
6,902
|
Cash
and cash equivalents at beginning of period
|
$107,532
|
$57,453
|
|
|
|
Cash
and cash equivalents at end of period
|
$115,216
|
$107,532
|
|
|
|
Supplementary Disclosure of Cash Flow Information:
|
|
|
Cash
paid for interest
|
$23,496
|
$21,900
|
Stock
issued for acquisition of Atlas Pharma Inc.
|
$238,000
|
$-
|
Stock
issued for services
|
$676,100
|
$427,400
|
Stock
issued for note and accrued interest conversions
|
$1,589,099
|
$128,451
|
Stock
issued to buy equipment
|
$174,808
|
$56,700
|
Loan
issued for interest
|
$45,509
|
$58,977
|
See Accompanying Notes To These Financial
Statements.
F-4
Sunshine Biopharma, Inc.
|
|
|
|
|
|
|
|
|
Statement of Shareholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
Of
|
|
Capital
Paid
|
Number
Of
|
|
|
|
|
|
Common
|
Common
|
in
Excess
|
Preferred
|
Preferred
|
Comprehensive
|
Accumulated
|
|
|
Shares
Issued
|
Stock
|
of Par
Value
|
Shares
Issued
|
Stock
|
Income
|
Deficit
|
Total
|
Balance at
December 31, 2016
|
38,469,993
|
$38,470
|
$12,279,390
|
500,000
|
$50,000
|
$394
|
$(12,577,954)
|
$(209,700)
|
|
|
|
|
|
|
|
|
|
Common stock issued for
cash
|
1,700,000
|
1,700
|
62,212
|
|
|
|
|
63,912
|
|
|
|
|
|
|
|
|
|
Common stock issued for
services
|
3,090,217
|
3,090
|
424,310
|
|
|
|
|
427,400
|
|
|
|
|
|
|
|
|
|
Common stock issued for
equipment
|
550,208
|
550
|
56,150
|
|
|
|
|
56,700
|
|
|
|
|
|
|
|
|
|
Common stock issued for the
reduction of notes payable
|
|
|
|
|
|
|
|
|
and payment of
interest
|
2,126,406
|
2,126
|
126,325
|
|
|
|
|
128,451
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income
(Loss)
|
-
|
-
|
-
|
|
|
110
|
(1,040,236)
|
(1,040,126)
|
Balance at
December 31, 2017
|
45,936,825
|
$45,936
|
$12,948,387
|
500,000
|
$50,000
|
$504
|
$(13,618,190)
|
$(573,363)
|
|
|
|
|
|
|
|
|
|
Common stock issued for the
acquisition of Atlas Pharma, Inc.
|
1,000,000
|
1,000
|
237,000
|
|
|
|
|
238,000
|
|
|
|
|
|
|
|
|
|
Common stock issued for
services
|
10,382,500
|
10,383
|
665,718
|
|
|
|
|
676,100
|
|
|
|
|
|
|
|
|
|
Common stock issued for
equipment
|
1,456,737
|
1,457
|
173,351
|
|
|
|
|
174,808
|
|
|
|
|
|
|
|
|
|
Common stock issued for the
reduction of notes payable and payment of
interest
|
26,876,338
|
26,876
|
1,562,223
|
|
|
|
|
1,589,099
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income
(Loss)
|
-
|
-
|
-
|
|
|
(4,242)
|
(2,156,155)
|
(2,160,397)
|
Balance at
December 31, 2018
|
85,652,400
|
$85,652
|
$15,586,678
|
500,000
|
$50,000
|
$(3,738)
|
$(15,774,345)
|
$(55,753)
|
See Accompanying Notes To These Financial
Statements.
F-5
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
Note 1 – Description of Business
The
Company was originally incorporated under the name Mountain West
Business Solutions, Inc. (“MWBS”) on August 31, 2006 in
the State of Colorado. Effective October 15, 2009, MWBS acquired
Sunshine Biopharma, Inc. in a transaction classified as a reverse
acquisition. MWBS concurrently changed its name to Sunshine
Biopharma, Inc. and Sunshine Biopharma, Inc. changed its name to
Sunshine Etopo, Inc. In 2015, Sunshine Etopo, Inc. became inactive
and was recently dissolved.
On July
25, 2014, the Company formed a Canadian wholly owned subsidiary,
Sunshine Biopharma Canada Inc., for the purposes of offering
generic prescription drugs and over-the-counter dietary
supplements.
On
January 1, 2018, the Company acquired Atlas Pharma Inc., a Health
Canada certified Canadian company offering chemical analysis of
pharmaceutical and other industrial samples.
On
March 23, 2018, the Company formed NOX Pharmaceuticals, Inc., a
Colorado company that now holds all of the patents and intellectual
property pertaining to Sunshine Biopharma Inc.’s proprietary
drugs including Adva-27a, a multi-purpose anti-tumor compound
targeted for the treatment of multidrug resistant
cancer.
On
December 17, 2018, the Company launched its first over-the-counter
product, Essential 9tm,
a dietary supplement comprised of the nine amino acids which the
human body cannot synthesize. Essential 9tm
has been authorized for marketing by Health Canada under NPN
80089663.
The
following are Sunshine Biopharma, Inc.’s
subsidiaries:
●
NOX Pharmaceuticals
Inc., a wholly owned Colorado company;
●
Sunshine Biopharma
Canada Inc., a wholly owned Canadian company; and
●
Atlas Pharma Inc.,
a wholly owned Canadian company.
Effective
February 1, 2019, the Company completed a 20 to 1 reverse split of
its $0.001 par value Common Stock reducing the issued and
outstanding shares of Common Stock from 1,713,046,242 to 85,652,400
(“Reverse Stock Split”).
The
financial statements reflect the Reverse Stock Split on a
retroactive basis and represent the consolidated activity of
Sunshine Biopharma, Inc. and its subsidiaries (hereinafter
collectively referred to as the "Company"). The Company was
originally formed for the purposes of conducting research,
development and commercialization of drugs for the treatment of
various forms of cancer. The Company may also engage in any other
business that is permitted by law, as designated by the Board of
Directors of the Company.
During
the last year the Company has continued to raise money through
stock sales and borrowings.
The
Company’s activities are subject to significant risks and
uncertainties, including failing to secure additional funding to
operationalize the Company’s generic pharmaceuticals business
and proprietary drug development program.
Note 2 – Summary of Significant Accounting
Policies
This summary of significant accounting policies
is presented to assist the reader in understanding the
Company's financial statements. The consolidated
financial statements and notes are representations of the Company's
management, which is responsible for their integrity and
objectivity. These accounting policies conform to generally
accepted accounting principles and have
been consistently applied in the
preparation of the financial
statements.
PRINCIPLES OF CONSOLIDATION
The
accompanying consolidated financial statements include the accounts
of the Company and its wholly owned subsidiary. All intercompany
accounts and transactions have been eliminated in
consolidation.
F-6
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
USE OF ESTIMATES
The preparation of financial
statements in conformity with U.S. generally
accepted accounting principles requires
management to make estimates and
assumptions that affect the reported amounts of
assets and liabilities and disclosure of
contingent assets and liabilities at the date of
the financial statements and the reported
amounts of revenues and expenses
during the reporting period. The more
significant estimates and assumptions made
by management are valuation of equity
instruments, depreciation of property and
equipment, and deferred tax asset valuation.
Actual results could differ from those estimates as the current
economic environment has increased the degree of uncertainty
inherent in these estimates and assumptions.
CASH AND CASH EQUIVALENTS
For
the Balance Sheets and Statements of
Cash Flows, all highly liquid investments with
maturity of 90 days or less are considered to be cash
equivalents. The Company had a cash balance of $115,216 and
$107,532 as of December 31, 2018 and December 31, 2017,
respectively. At times such cash balances may be in excess of the
FDIC limit of $250,000 or the equivalent in Canada.
PROPERTY AND EQUIPMENT
Property
and equipment is reviewed for recoverability when events or changes
in circumstances indicate that its carrying value may exceed future
undiscounted cash inflows. As of December 31, 2018 and 2017, the Company had not identified any such
impairment. Repairs and maintenance are charged to operations when
incurred and improvements and renewals are
capitalized.
Property
and equipment are stated at cost. Depreciation is calculated using
the straight-line method for financial reporting purposes and
accelerated methods for tax purposes. Their estimated useful lives
are as follows:
Office
Equipment:
|
5-7
Years
|
Laboratory
Equipment
|
5
Years
|
Vehicles
|
5
Years
|
INTELLECTUAL PROPERTY RIGHTS - PATENTS
The
cost of patents acquired is capitalized and is amortized over the
remaining life of the patents.
The
Company evaluates recoverability of identifiable intangible assets
whenever events or changes in circumstances indicate that
intangible assets carrying amount may not be recoverable. Such
circumstances include, but are not limited to: (1) a significant
decrease in the market value of an asset, (2) a significant adverse
change in the extent or manner in which an asset is used, or (3) an
accumulation of cost significantly in excess of the amount
originally expected for the acquisition of an asset. The Company
measures the carrying amount of the assets against the estimated
undiscounted future cash flows associated with it.
The
Company’s management determined that the expected cash flows
would be less than the carrying amount of certain intangible
assets; therefore an impairment loss was recognized in 2016. The
impairment loss was calculated as the amount by which the carrying
amount of the intangible assets exceeded fair value.
EARNINGS PER SHARE
The
Company has adopted the Financial
Accounting Standards Board (FASB) ASC Topic 260 regarding
earnings / loss per share, which provides for calculation of
“basic” and “diluted” earnings / loss per
share. Basic earnings / loss per share includes no dilution and is
computed by dividing net income / loss available to common
shareholders by the weighted average common shares outstanding for
the period. Diluted earnings / loss per share reflect the potential
dilution of securities that could share in the earnings of an
entity similar to fully diluted earnings / loss per
share.
F-7
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
INCOME TAXES
In accordance with ASC 740 - Income Taxes, the provision for income
taxes is computed using the asset and liability method. The
liability method measures deferred income taxes by
applying enacted statutory rates in effect at the
balance sheet date to the differences between the tax
basis of assets and liabilities and their
reported amounts on the financial
statements. The resulting deferred tax assets or
liabilities have been adjusted to reflect changes in tax laws as
they occur. A valuation allowance is provided when it is
more likely than not that a deferred tax asset will not be
realized.
The Company expects to recognize the financial statement benefit of
an uncertain tax position only after considering the probability
that a tax authority would sustain the position in an examination.
For tax positions meeting a "more-likely-than-not" threshold, the
amount to be recognized in the financial statements will be the
benefit expected to be realized upon settlement with the tax
authority. For tax positions not meeting the threshold, no
financial statement benefit is recognized. As of December 31, 2018
the Company had no uncertain tax positions. The Company recognizes
interest and penalties, if any, related to uncertain tax positions
as general and administrative expenses. The Company currently has
no federal or state tax examinations nor has it had any federal or
state examinations since its inception. To date, the Company has
not incurred any interest or tax penalties.
For Canadian and US tax purposes, the Company’s 2015 through
2017 tax years remain open for examination by the tax authorities
under the normal three-year statute of limitations.
FUNCTIONAL CURRENCY
The
U.S. dollar is the functional currency of the Company which is
operating in the United States. The functional currency for the
Company's Canadian subsidiaries is the Canadian
dollar.
The
Company translates its Canadian subsidiary's financial statements
into U.S. dollars as follows:
●
Assets and
liabilities are translated at the exchange rate in effect as of the
financial statement date.
●
Income statement
accounts are translated using the weighted average exchange rate
for the period.
The
Company includes translation adjustments from currency exchange and
the effect of exchange rate changes on intercompany transactions of
a long-term investment nature as a separate component of
shareholders’ equity. There are currently no transactions of
a long-term investment nature, nor any gains or losses from non
U.S. currency transactions.
CONCENTRATION OF CREDIT RISKS
Financial
instruments that potentially subject the Company to concentrations
of credit risk consist principally of cash equivalents and trade
receivables. The Company places its cash equivalents with high
credit quality financial institutions.
FINANCIAL INSTRUMENTS AND FAIR VALUE OF FINANCIAL
INSTRUMENTS
The
Company applies the provisions of accounting guidance, FASB Topic
ASC 825, Financial
Instruments. ASC 825 requires all entities to disclose the
fair value of financial instruments, both assets and liabilities
recognized and not recognized on the balance sheet, for which it is
practicable to estimate fair value, and defines fair value of a
financial instrument as the amount at which the instrument could be
exchanged in a current transaction between willing parties. As of
December 31, 2018 and 2017, the fair value of cash, accounts
receivable and notes receivable, accounts payable, accrued
expenses, and other payables approximated carrying value due to the
short maturity of the instruments, quoted market prices or interest
rates which fluctuate with market rates.
The
Company defines fair value as the price that would be received to
sell an asset or be paid to transfer a liability in an orderly
transaction between market participants at the measurement date.
The Company applies the following fair value hierarchy, which
prioritizes the inputs used to measure fair value into three levels
and bases the categorization within the hierarchy upon the lowest
level of input that is available and significant to the fair value
measurement. The hierarchy gives the highest priority to unadjusted
quoted prices in active markets for identical assets or liabilities
(Level 1 measurements) and the lowest priority to unobservable
inputs (Level 3 measurements).
F-8
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
Level 1
– Level 1 inputs are quoted prices (unadjusted) in active
markets for identical assets or liabilities that the reporting
entity has the ability to access at the measurement
date.
Level 2
– Level 2 inputs are inputs other than quoted prices included
within Level 1 that are observable for the asset or liability,
either directly or indirectly. If the asset or liability has a
specified (contractual) term, a Level 2 input must be observable
for substantially the full term of the asset or
liability.
Level 3
– Level 3 inputs are unobservable inputs for the asset or
liability in which there is little, if any, market activity for the
asset or liability at the measurement date.
The
carrying value of financial assets and liabilities recorded at fair
value is measured on a recurring or nonrecurring basis. Financial
assets and liabilities measured on a non-recurring basis are those
that are adjusted to fair value when a significant event occurs.
The Company had no financial assets or liabilities carried and
measured on a nonrecurring basis during the reporting periods.
Financial assets and liabilities measured on a recurring basis are
those that are adjusted to fair value each time a financial
statement is prepared.
NOTES PAYABLE
Borrowings
are recognized initially at fair value, net of transaction costs
incurred. Borrowings are subsequently carried at amortized cost;
any difference between the proceeds (net of transaction costs) and
the redemption value is recognized in the income statement over the
period of the borrowings using the effective interest
method.
ACCOUNTING FOR DERIVATIVES LIABILITIES
The
Company evaluates stock options, stock warrants or other contracts
to determine if those contracts or embedded components of those
contracts qualify as derivatives to be separately accounted for
under the relevant sections of ASC Topic 815-40, Derivative Instruments and Hedging: Contracts
in Entity’s Own Equity. The result of this accounting
treatment could be that the fair value of a financial instrument is
classified as a derivative instrument and is marked-to-market at
each balance sheet date and recorded as a liability. In the event
that the fair value is recorded as a liability, the change in fair
value is recorded in the statement of operations as other income or
other expense.
Upon
conversion or exercise of a derivative instrument, the instrument
is marked to fair value at the conversion date and then that fair
value is reclassified to equity. Financial instruments that are
initially classified as equity that become subject to
reclassification under ASC Topic 815-40 are reclassified to a
liability account at the fair value of the instrument on the
reclassification date. The Company determined that none of the
Company’s financial instruments meet the criteria for
derivative accounting as of December 31, 2018 and
2017.
EQUITY INSTRUMENTS ISSUED TO NON-EMPLOYEES FOR AQUIRING GOODS OR
SERVICES
Issuances of the Company’s common stock or warrants for
acquiring goods or services are measured at the fair value of the
consideration received or the fair value of the equity instruments
issued, whichever is more reliably measurable. The measurement date
for the fair value of the equity instruments issued to consultants
or vendors is determined at the earlier of (i) the date at which a
commitment for performance to earn the equity instruments is
reached (a “performance commitment” which would include
a penalty considered to be of a magnitude that is a sufficiently
large disincentive for nonperformance) or (ii) the date at which
performance is complete. When it is appropriate for the Company to
recognize the cost of a transaction during financial reporting
periods prior to the measurement date, for purposes of recognition
of costs during those periods, the equity instrument is measured at
the then-current fair values at each of those interim financial
reporting dates.
F-9
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
NONCASH EQUITY TRANSACTIONS
Shares of equity instruments issued for noncash consideration are
recorded at the estimated fair market value of the consideration
granted based on the estimated market value of the equity
instrument, or at the estimated value of the goods or services
received whichever is more readily determinable.
RELATED PARTIES
A party is considered to be related to the Company if the party
directly or indirectly or through one or more intermediaries,
controls, is controlled by, or is under common control with the
Company. Related parties also include principal owners of the
Company, its management, members of the immediate families of
principal owners of the Company and its management and other
parties with which the Company may deal if one party controls or
can significantly influence the management or operating policies of
the other to an extent that one of the transacting parties might be
prevented from fully pursuing its own separate interests. A party
which can significantly influence the management or operating
policies of the transacting parties or if it has an ownership
interest in one of the transacting parties and can significantly
influence the other to an extent that one or more of the
transacting parties might be prevented from fully pursuing its own
separate interests is also a related party.
GENERAL AND ADMINISTRATIVE EXPENSES
General
and administrative expenses consisted of professional service fees,
rent and utility expenses, meals, travel and entertainment
expenses, and other general and administrative overhead costs.
Expenses are recognized when incurred.
BASIC AND DILUTED NET GAIN (LOSS) PER SHARE
The Company computes loss per share in accordance with ASC
260, Earnings per Share.
ASC 260 requires presentation of both
basic and diluted earnings per share (“EPS”) on the
face of the income statement.
Basic
net income (loss) per share is calculated by dividing net (loss) by
the weighted-average common shares outstanding. Diluted net income
per share is calculated by dividing net income by the
weighted-average common shares outstanding during the period using
the treasury stock method or the two-class method, whichever is
more dilutive. As the Company incurred net losses for the year
ended December 31, 2018 no potentially dilutive securities were
included in the calculation of diluted earnings per share as the
impact would have been anti-dilutive.
Therefore,
basic and dilutive net (loss) per share were the same as of
December 31, 2018 and 2017.
COMMON STOCK
The
Company completed a 20 to 1 reverse stock split of the $.001 par
value Common Stock affective February 1, 2019. All shares in this
filing have been restated to reflect the 20 to 1 reverse
split.
REVENUE RECOGNITION
As of
January 1, 2018, the Company adopted ASU No. 201409, “Revenue
from Contracts with Customers” (ASU 201409). Under the new
guidance, an entity will recognize revenue to depict the transfer
of promised goods or services to customers at an amount that the
entity expects to be entitled to in exchange for those goods or
services. A five-step model has been introduced for an entity to
apply when recognizing revenue. The new guidance also includes
enhanced disclosure requirements. The guidance was effective
January 1, 2018 and was applied on a modified retospective basis.
The adoption did not have an impact on the Company's financial
statements. All of the revenues of the Company are generated by
Atlas Pharma Inc., the Company's wholly owned Canadian subsidiary,
which provides laboratory testing services. Performance obligations
for testing services are recognized as revenue at a point in time
on the date results are delivered to a customer which is when
control is transferred.
Local
governmental regulations require that companies recognize revenues
upon completion of the work by issuing an invoice and remitting the
applicable sales taxes (GST and QST) to the appropriate government
agency. Atlas Pharma Inc.'s revenue recognition policy is in
compliance with these local regulations.
F-10
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
In
February 2016, the FASB issued Accounting Standards Update No.
2016-02, “Leases (Topic 842)” (“ASU
2016-02”). ASU 2016-02 will require lessees to recognize on
the balance sheet the assets and liabilities for the rights and
obligations created by those leases. Under ASU 2016-02, a lessee
will be required to recognize assets and liabilities for leases
with terms of more than 12 months. Lessor accounting remains
substantially similar to current GAAP. In addition, disclosures of
leasing activities are to be expanded to include qualitative along
with specific quantitative information. ASU 2016-02 will be
effective in fiscal years beginning after December 15, 2018 (with
early adoption permitted). ASU 2016-02 mandates a modified
retrospective transition method. The Company is currently
evaluating the potential impact of adopting this guidance on our
consolidated financial statements.
DIRECTOR AND OFFICER COMPENSATION
For the
period ended December 31, 2018, the Company issued 4,050,000 shares
of par value $0.001 Common Stock valued at $429,300 or $0.106 per
share and 5,700,000 shares of par value $0.001 Common Stock to the
Board of Directors valued at $171,000 or $0.03 per share. During
the year ended December 31, 2018 the Directors and officers were
paid $154,915 in cash. Of this amount, $85,000 was paid to
Advanomics Corporation, a company controlled by the CEO of the
Company.
For the
period ended December 31, 2017, the Company issued 2,100,000 of par
value $0.001 Common Stock to the three Company officers valued at
$336,000 or $0.16 per share. During the year ended December 31,
2017 the Directors and officers were paid $184,271 in cash. Of this
amount, $147,695 was paid to Advanomics Corporation, a company
controlled by the CEO of the Company.
LEGAL FEES
During
the years ended December 31, 2018 and 2017, the legal fees incurred
were related to services provided to the Company to assist with its
regulatory requirements with the Securities and Exchange
Commission, patenting costs and one ongoing
litigation.
DATE OF MANAGEMENT’S REVIEW
Subsequent
events have been evaluated through April 12, 2019, which is the
date the Financial Statements were available to be
issued.
Note 3 – Going Concern
In the
course of its life the Company has had limited operations and
Working Capital deficit. This raises substantial doubt about the
Company’s ability to continue as a going concern. The Company
believes it can raise capital through equity sales and borrowing to
fund its operations. Management believes this will contribute
toward its subsequent profitability. The accompanying Financial
Statements do not include any adjustments that might be necessary
if the Company is unable to continue as a going
concern.
F-12
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
Note 4 – Patents
The
following is a summary of the patents held by the Company at
December 31, 2018 and 2017:
On
October 8, 2015, the Company acquired U.S. Patent Number 8,236,935
(the “US Patent”) for the Adva-27a anticancer compound
from Advanomics Corporation (“Advanomics”), a related
party, in exchange for an interest-free note payable for
$4,320,000. Effective December 28, 2015, the parties executed an
amendment pursuant to which this note payable for $4,320,000 was
cancelled and replaced with a new interest-free convertible note
having a face value of $210,519, comprised of $155,940 in principal
amount which is the Advanomics book value of the US Patent, plus
$54,579 as an adjustment for the currency exchange difference. The
new note is automatically convertible into 4,048,449 shares of the
Company’s Common Stock upon the Company increasing its
authorized capital to a level that would permit the issuance of
such shares.
On
December 28, 2015, the Company acquired the remaining worldwide
issued and pending patents under PCT/FR2007/000697 and
PCT/CA2014/000029 (the “Worldwide Patents”) for the
Adva-27a anticancer compound from Advanomics, a related party, in
exchange for a note payable for $12,822,499. Effective December 28,
2015, the parties executed an amendment pursuant to which this note
payable for $12,822,499 was cancelled and replaced with a new
interest-free convertible note having a face value of $624,875,
comprised of $462,870 in principal amount, which is the Advanomics
book value of the Worldwide Patents, plus $162,005 as an adjustment
for the currency exchange difference. The new note is automatically
convertible into 12,016,823 shares of the Company’s Common
Stock upon the Company increasing its authorized capital to a level
that would permit the issuance of such shares.
In July
2016, the Company issued 16,065,271 shares of $0.001 par value
Common Stock in exchange for the aforementioned patents related
notes payable totaling $835,394. In 2016, the remaining value of
these patents was impaired. The Company is however continuing
development of the Adva-27a anticancer drug covered by these
patents.
Note 5 – Capital Stock
The
Company’s authorized capital is comprised of 3,000,000,000
shares of $0.001 par value Common Stock and 30,000,000 shares of
$0.10 par value Preferred Stock, to have such rights and
preferences as the Directors of the Company have or may assign from
time to time. Out of the authorized Preferred Stock, the Company
has designated 850,000 shares as Series “A” Preferred
Stock (“Series A”). The Series A is convertible at any
time after issuance into 20 shares of the Company's Common Stock
with no further consideration, has full voting rights at 20 votes
per share, and has superior liquidation rights to the Common Stock.
During the year ended December 31, 2015, the Company authorized
500,000 shares of $0.10 par value Series “B” Preferred
Stock (“Series B”). The Series B Preferred Stock is
non-convertible, non-redeemable and non-retractable. It has
superior liquidation rights to the Common Stock at $0.10 per share
and gives the holder the right to 1,000 votes per share. All shares
of the Series B Preferred Stock are held by the CEO of the Company.
Through December 31, 2018 and December 31, 2017, the Company has
issued and outstanding a total of 85,652,400 and 45,936,825 shares of Common Stock,
respectively. Through the same periods, the Company has issued and
outstanding a total of -0- and -0- shares of Series A Preferred
Stock and 500,000 and 500,000 shares of Series B Preferred Stock,
respectively. Effective February 1, 2019, the Company completed a
20 to 1 reverse split of its $0.001 par value Common Stock. All
stock and price per share amounts in this report have been restated
to reflect the 20 to 1 reverse split.
During
the fiscal year ended December 31, 2018, the Company issued an
aggregate of 39,715,575 shares of its Common Stock as
follows:
●
1,000,000 shares
for the acquisition of Atlas Pharma Inc.
●
1,456,737 shares
for the purchase of laboratory and generic drugs warehouse
equipment valued at $174,808
●
9,750,000 shares
valued at $600,300 as compensation to the Company’s Directors
and Officers
●
632,500
shares for services rendered to the Company by third parties valued
at $75,800
●
26,876,338 shares
valued at $1,589,099 connection with the conversion of $684,318 in
debt and interest of $32,808 resulting in a $871,973 loss on
conversion
F-13
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
During
the fiscal year ended December 31, 2017, the Company issued an
aggregate of 7,466,832 shares of its Common Stock as
follows:
●
1,700,000 shares
for cash in the amount of $100,000 Canadian or $78,312
US
●
550,208
shares for the purchase of laboratory and generic drugs warehouse
equipment valued at $56,700
●
2,400,000 shares
valued at $336,000 as compensation to the Company’s Directors
and Officers
●
690,218
shares for services rendered to the Company by third parties valued
at $77,000
●
2,126,406 shares
valued at $128,451 in connection with the conversion of $48,500 in
debt and interest of $3,022 resulting in a $76,929 loss on
conversion.
The
Company has declared no dividends since inception.
Note 6 – Earnings Per Share
The
following table sets forth the computation of basic and diluted net
income per share for the years ended December 31:
|
2018
|
2017
|
Net (loss)
attributable to Common Stock
|
$(2,156,155)
|
$(1,040,236)
|
Basic weighted
average outstanding shares of Common
Stock
|
60,936,164
|
43,634,280
|
Dilutive effects of
common share equivalents
|
-0-
|
-0-
|
Dilutive weighted average
outstanding shares of common
stock
|
60,936,164
|
43,634,280
|
Net
(loss) attributable to Common Stock
|
$(0.04)
|
$(0.02)
|
Note 7 – Income Taxes
The Company files a United States federal income tax return and a
Canadian branch return on a calendar year basis. The
Company and its wholly-owned subsidiaries, Sunshine Biopharma
Canada Inc. and Atlas Pharma Inc., have not generated taxable
income since inception.
Deferred
income taxes arise from the temporary differences between financial
statement and income tax recognition of net operating losses. These
loss carryovers are limited under the Internal Revenue Code should
a significant change in ownership occur. The Company accounts for
income taxes pursuant to ASC 740.
Deferred
income taxes arise from the temporary differences between financial
statement and income tax recognition of net operating losses and
other items. Loss carryovers are limited under the Internal Revenue
Code should a significant change in ownership occur.
F-14
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
The
Company follows FASB Statement Accounting Standards Codification
No. 740, “Accounting for Income Taxes”, which requires,
among other things, an asset and liability approach to calculating
deferred income taxes. The components of the deferred income tax
assets and liabilities arising under ASC No. 740 were as
follows:
The
types of temporary differences between the tax basis of assets and
their financial reporting amounts that give rise to a significant
portion of the deferred assets and liabilities are as
follows:
|
December
31,
2018 |
December
31,
2017 |
||
|
Temporary
Difference
|
Tax
Effect
|
Temporary
Difference
|
Tax
Effect
|
Deferred tax
assets:
|
|
|
|
|
Net
operating loss US
|
$12,156,020
|
$2,997,675
|
$10,611,921
|
$3,932,778
|
Net
operating loss Canada
|
298,661
|
80,041
|
266,498
|
71,421
|
Total
|
12,454,681
|
3,077,716
|
10,878,419
|
4,004,199
|
Valuation
allowance
|
(12,454,681)
|
(3,077,716)
|
(10,878,419)
|
( 4,004,199)
|
Total
deferred tax asset
|
-0-
|
-0-
|
-0-
|
-0-
|
Net
deferred tax asset
|
-0-
|
-0-
|
-
|
-
|
Deferred
income taxes arise from the temporary differences between financial
statement and income tax recognition of net operating losses. These
loss carryovers are limited under the Internal Revenue Code should
a significant change in ownership occur.
At
December 31, 2018 and December 31, 2017, the Company had
approximately $12,454,681 and $10,878,419 respectively, in unused
federal net operating loss carryforwards, which begin to expire
principally in the year 2029. A deferred tax asset at each date of
approximately $3,077,716 and $4,004,199 resulting from the loss
carryforwards has been offset by a 100% valuation allowance. The
change in the valuation allowance for the period ended December 31,
2018 and December 31, 2017 was approximately $926,483 and $342,693,
respectively.
F-15
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
A
reconciliation of the U.S. statutory federal income tax rate to the
effective tax rate is as follows:
|
December
31,
|
|
|
2018
|
2017
|
U.S. Federal statutory graduated rate
|
21.00%
|
34.00%
|
State income tax rate,
net of federal benefit |
4.12%
|
3.06%
|
Net rate
|
25.12%
|
37.06%
|
|
|
|
Net operating loss used
|
0.00%
|
0.00%
|
Net
operating loss for which no
tax
benefit is currently available
|
-25.12%
|
-37.06%
|
|
0.00%
|
0.00%
|
|
|
|
Canada Federal statutory rate
|
15.00%
|
15.00%
|
Canada Provincial rate
|
11.80%
|
11.80%
|
Net Canada rate
|
26.80%
|
26.80%
|
|
|
|
Net operating loss used
(Canada)
|
0.00%
|
0.00%
|
Net
operating loss for which no tax
benefit
is currently available
(Canada) |
-26.80%
|
-26.80%
|
|
0.00%
|
0.00%
|
The
Company’s income tax filings are subject to audit by various
taxation authorities. The Company’s open audit periods are
2015, 2016, and 2017, although, the statute of limitations for the
2015 tax year will expire effective March 15, 2019. In evaluating
the Company’s provisions and accruals, future taxable income,
and reversal of temporary differences, interpretations and tax
planning strategies are considered. The Company believes its
estimates are appropriate based on current facts and
circumstances.
F-16
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
Note 8 – Notes Payable
Notes
payable consist of the following:
|
2018
|
2017
|
|
|
|
A Note Payable
having a Face Value of $24,012 at December 31, 2016 and accruing
interest at 12% was due December 31, 2017 (“2016
Note”). On December 31, 2017, the Company renewed the 2016
Note, together with accrued interest of $2,573, for a 12-month
period (“2017 Note”). On December 31, 2018 the Company
renewed the 2017 Note, together with accrued interest of $2,881,
for a 12-month period (“2018 Note”). The 2018 Note has
a Face Value of $26,893 and accrues interest at 12%. The 2018 Note
is nonconvertible.
|
$26,893
|
$24,012
|
|
|
|
On January 12, 2018
the Company received monies in exchange for a Note Payable having a
Face Value of $102,000 with interest accruing at 8% is due October
30, 2018. The Note is convertible after 180 days from issuance into
$0.001 par value Common Stock at a
price 35% below market value. The Note, together with
accrued interest of $4,080 was converted in 2018 into 3,569,333
shares of Common Stock valued at $166,085 resulting in a loss of
$60,005.
|
$-0-
|
-0-
|
|
|
|
On February 7,
2018, the Company received monies in exchange for a Note Payable
having a Face Value of $150,000 with interest accruing at 8% is due
February 7, 2019. The Note is convertible after 180 days from
issuance into $0.001 par value Common Stock at a price 35% below market value. The note
was paid off in 2018 in part by cash of $48,000 and the remainder,
together with accrued interest of $5,073, was converted into
5,710,642 shares of Common Stock valued at $183,411 resulting in a
loss of $76,338.
|
$-0-
|
$-0-
|
|
|
|
On February 20,
2018, the Company received monies in exchange for a Note Payable
having a Face Value of $85,000 with interest accruing at 8% is due
November 30, 2018. The Note is convertible after 180 days from
issuance into $0.001 par value Common Stock at a price 35% below market value. The Note,
together with accrued interest of $3,400, was converted in 2018
into 4,376,238 shares of Common Stock valued at $281,663 resulting
in a loss of $193,263.
|
$-0-
|
$-0-
|
|
|
|
On May 29, 2018,
the Company received monies in exchange for a Note Payable having a
Face Value of $26,750 with interest accruing at 8% is due February
29, 2019. The Note is convertible after 180 days from issuance into
$0.001 par value Common Stock at a
price 35% below market value. The note, together with
accrued interest of $1,353, was converted into 4,003,265 shares of
Common Stock valued at $192,157 resulting in a loss of
$164,054.
|
$-0-
|
$-0-
|
|
|
|
On June 27, 2018,
the Company received monies in exchange for a Note Payable having a
Face Value of $53,000 with interest accruing at 8% is due April 15,
2019. The Note is convertible after 180 days from issuance into
$0.001 par value Common Stock at a price 35%
below market value. Interest accrued at
December 31, 2018 was $2,137. We estimate that the fair value of
this convertible debt approximates the face value, so no value has
been assigned to the beneficial conversion feature. Any gain or
loss will be recognized at conversion.
|
$53,000
|
$-0-
|
|
|
|
On August 17, 2018,
the Company received monies in exchange for a Note Payable having a
Face Value of $53,000 with interest accruing at 8% is due April 15,
2019. The Note is convertible after 180 days from issuance into
$0.001 par value Common Stock at a
price 35% below market value. Interest accrued at December
31, 2018 was $1,557. We estimate that
the fair value of this convertible debt approximates the face value, so no value has been
assigned to the beneficial conversion feature. Any gain or
loss will be recognized at conversion.
|
$53,000
|
$-0-
|
|
|
|
On September 10,
2018, the Company received monies in exchange for two Notes Payable
having an aggregate Face Value of $36,500 with interest accruing at
8% are due June 20, 2019. Interest accrued at December 31, 2018 was
$888.
|
$36,500
|
$-0-
|
|
|
|
On October 23,
2018, the Company received monies in exchange for a Note Payable
having a Face Value of $90,000 with interest accruing at 8% is due
October 23, 2019. The Note is convertible after 180 days from
issuance into $0.001 par value Common Stock at a price 35%
below market value. Interest accrued at December 31, 2018
was $1,361. We estimate that the fair
value of this convertible debt approximates the face value, so no value has been
assigned to the beneficial
conversion feature. Any gain or loss will be recognized at
conversion.
|
$90,000
|
$-0-
|
F-17
On December 24,
2018, the Company received monies in exchange for a
Note Payable having a Face Value of $87,000 with
interest accruing
at 8% is due October 23, 2019. The Note is convertible after 180
days from issuance into $0.001 par value Common Stock at
a price
35% below market value. Interest accrued at December 31,
2018 was $153. We estimate that the
fair value of this convertible debt approximates
the face value, so no value has been assigned to
the beneficial
conversion feature. Any gain or loss will be recognized at
conversion.
|
$87,000
|
$-0-
|
|
|
|
On April 1, 2017 the Company received monies in
exchange for a Note Payable having a Face Value of
$100,000 Canadian ($73,270US) at December 31, 2018 and ($79,710 US)
at December 31, 2017 with interest payable quarterly at
9% is due April 1, 2019. The Note is convertible any
time after issuance into $0.001 par value Common Stock at
a price of $0.015
Canadian (approximately $0.012 US) per
share. We
estimate that the fair value of this convertible debt
approximates the face value, so no value has been assigned to the
beneficial conversion feature. Any gain or loss will be recognized at
conversion.
|
$73,270
|
$79,710
|
|
|
|
On August 3, 2017 the, Company received monies in
exchange for a Note Payable having a Face Value of $
80,000 with interest accruing at 8% is due August 3, 2018. The Note is
convertible after 180 days from issuance into $0.001 par value
Common Stock at a price 35% below market value. A
principal amount of $40,000 of
this note plus accrued interest of $1,712 was converted in 2018 into 327,788 shares of Common
Stock valued at $70,507 resulting in a loss of $28,795. The
remaining principal amount of $40,000 together with accrued interest
of $1,613 was paid in cash reducing the balance to
$-0-
|
$-0-
|
$80,000
|
|
|
|
On August 21, 2017 the Company received monies in
exchange for a Note Payable having a Face Value of $
83,000 with interest accruing at 8% is due May 30, 2018. The Note is
convertible after 180 days from issuance into $0.001 par value
Common Stock at a price 35% below market
value. The Note, plus accrued
interest of $3,419, was paid off in 2018.
|
$-0-
|
$83,000
|
|
|
|
On September 22,
2017 the Company received monies in exchange for a note having a
Face Value of $ 62,000 with interest accruing at 8% is due June 30,
2018. The Note is convertible after 180 days from issuance into
$0.001 par value Common Stock at a
price 35% below market value. The note, together with
accrued interest of $2,480 was converted in 2018 into 790,590
shares of Common Stock valued at $107,056 resulting in a loss of
$42,576.
|
$-0-
|
$62,000
|
|
|
|
On October 26, 2017 the Company received monies
in exchange for a Note Payable having a Face Value
of $ 115,000 with interest accruing at 8% is due October 26,
2018. The Note is convertible after 180 days from issuance into
$0.001 par value Common Stock at a price 35% below market
value. The note, together with
accrued interest of $6,126, was converted in
2018 into
2,921,146 shares of Common Stock valued at $208,661 resulting in a
loss of $87,535.
|
$-0-
|
$62,000
|
|
|
|
On November 14, 2017, the Company received monies
in exchange for a Note Payable having a Face Value
of $ 113,000 with interest accruing at 8% is due November 14,
2018. The Note is convertible after 180 days from issuance into
$0.001 par value Common Stock at a price 35% below market
value. The Note, together with
accrued interest of $7,018 was converted in 2018 into 4,917,251 shares of Common
Stock valued at $351,999 resulting in a loss of
$231,981.
|
$-0-
|
$115,000
|
|
|
|
On December 1, 2017, the Company received monies
in exchange for a Note Payable having a Face Value
of $50,000 Canadian ($38,568 US) at December 31, 2018 and
($39,855 US) at December 31, 2017 with interest accruing at 8% is
due November 30, 2018. The Note is convertible after
180 days from issuance into $0.001 par value Common Stock at
a price
35% below market value.
The Note, together with accrued
interest of $1,566 was converted in 2018 into 260,000 shares of
Common Stock valued at $27,560 resulting in a gain of
$12,574.
|
$-0-
|
$113,000
|
|
|
|
Total
Notes Payable
|
$419,663
|
$596,577
|
Interest
expense for the years ended December 31, 2018 and 2017 was $159,420
and $79,674, respectively. The balance of interest payable at
December 31, 2018 and 2017 was $9,291 and $9,215, respectively.
Loss on conversion of notes payable for the years ended December
31, 2018 and 2017 was $871,973 and $76,929
respectively.
F-18
Note 9 – Notes Payable Related Party
Notes payable to
related parties consist of the following:
|
2018
|
2017
|
|
|
|
A Note Payable held
by a private individual who became a principal shareholder of the
Company having a Face Value of $118,537 at September 30, 2017 and
a maturity date of December 31, 2017, accrues interest at
12%. The Note is convertible any time from the date of issuance
into $0.001 par value Common Stock at a 35% discount from market
price. On December 31, 2017 the Note together with accrued interest
was renewed for a 12-month period under the same terms and
conditions as before. The new Note has a Face Value of $122,093 and
matures on December 31, 2018. On December 31, 2018 the Note,
together with accrued interest of $14,651 was renewed for a
12-month period. The new Note has a Face value of $136,744 and
matures on December 31, 2019. The new Note is nonconvertible. This
individual ceased to be a principal shareholder of the Company in
the third quarter of 2018
|
$136,744
|
$122,093
|
|
|
|
In December 2016,
the Company received monies from its CEO in exchange for a note
payable having a principal amount of $90,000 Canadian ($67,032 US)
with interest at 12% due March 31, 2017. The note was convertible
any time after the date of issuance into $0.001 par value Common
Stock at a price 35% below market value. This note was
collateralized by all of the assets of the Company. In the event of
default, the interest rate will increased to 18% per annum and a
penalty of $1,000 Canadian ($752 US) per day will accrue. On March
31, 2017, the note, together with accrued interest of $3,021
Canadian ($2,271 US) and an additional principal amount of $3,000
Canadian ($2,247 US) paid to the Company on March 28, 2017, was
renewed for a 90-day period under the same terms and conditions as
the original note. The new note now having a face value of $96,021
Canadian ($72,198 US) was due on June 30, 2017. On June 30, 2017,
the note, together with accrued interest of $2,873 Canadian ($2,005
US), was renewed for a 90-day period under the same terms and
conditions as the original note except that the new note is
nonconvertible. The new note now having a face value of $98,894
Canadian ($76,072US) is due on September 30, 2017. On September 30,
2017, the note, together with accrued interest of $2,991 Canadian
($2,397 US) was renewed for a 90-day period under the same terms
and conditions as the original note except that the new note is
nonconvertible. The new note now having a principal balance of
$101,885 Canadian ($81,640 US) matures December 31, 2017. On
December 31, 2017 the note was renewed for a 12month period under
the same terms and conditions as before except that this new note
is unsecured and nonconvertible. The new note has a face value of
$104,942 Canadian ($83,649 US) and matures on December 31, 2018. On
December 31, 2018 the note was renewed for a 12-month period under
the same terms and conditions as the previous note. The new note
together with interest of $9,227, has a face value of $86,118 US
($117,535 CAD) and matures on December 31, 2019.
|
86,118
|
83,649
|
|
|
|
On January 1, 2018
as part of the acquisition of Atlas Pharma Inc., the Company issued
a note payable in the amount of $450,000 Canadian ($358,407 US) and
accruing interest at the rate of 3% per annum. The note is due on
December 31, 2023. Payments on this note are $10,000 Canadian
(approximately $8,000 US) per quarter. The outstanding principal
balance at December 31, 2018 was $310,079. The note is
nonconvertible and is secured by the Atlas Pharma Inc. shares held
by the Company. The holder of this note is currently a director and
officer of Atlas Pharma Inc.
|
$310,079
|
$-0-
|
|
|
|
Total Notes Payable
Related Party
|
$532,941
|
$205,742
|
|
|
|
Long-Term
Portion
|
$289,847
|
$79,710
|
F-19
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
Note 10 – Related Party Transactions
In
addition to the transactions specified under Note 9 above, during
the period ended December 31, 2018, the Company issued 4,050,000
shares of par value $0.001 Common Stock valued at $429,300 or
$0.106 per share and 5,700,000 shares of par value $0.001 Common
Stock to the Board of Directors valued at $171,000 or $0.03 per
share. During the year ended December 31, 2018 the Directors and
Officers were paid $154,915 in cash. Of this amount, $85,000 was
paid to Advanomics Corporation, a company controlled by the CEO of
the Company.
For the
period ended December 31, 2017, the Company issued 2,100,000 of par
value $0.001 Common Stock to the three Company officers valued at
$336,000 or $0.008 per share. During the year ended December 31,
2017 the Directors and officers were paid $184,271 in cash. Of this
amount, $147,695 was paid to Advanomics Corporation, a company
controlled by the CEO of the Company.
During
the year ended December 31, 2018, certain Directors of the Company
made interest free cash advances to the Company totaling
$49,349.
Note 11 – Royalties Payable
As part
of a subscription agreement entered into in 2016, the Company had
an obligation to pay a royalty of 5% of net sales on one of its
generic products (Anastrozole) for a period of three (3) years from
the date of the first sale of that product. In September 2018,
50,000 shares of the Company’s Common Stock valued at $5,900
were issued in exchange for cancellation of this royalty
obligation.
Note 12 – Acquisition of Atlas Pharma Inc.
On
January 1, 2018 the Company acquired all of the issued and
outstanding shares of Atlas Pharma Inc. (“Atlas”), a
Canadian privately held company. The purchase price for the shares
was Eight Hundred Forty Thousand Dollars $848,000 Canadian
($676,748 US). The purchase price included a cash payment of
$100,500 Canadian ($80,289 US), plus the issuance of 1,000,000
shares of the Company’s Common Stock valued at $238,000 or
$0.238 per share, and a promissory note in the principal amount of
$450,000 Canadian ($358,407 US), with interest payable at the rate
of 3% per annum. Atlas is a certified company dedicated to chemical
analysis of pharmaceutical and other industrial samples.
Atlas’ operations are authorized by a Drug Establishment
License issued by Health Canada. Atlas is also registered with the
FDA. The Company has performed analysis of the fair market value of
Atlas Pharma Inc. assets and liabilities. The following table
summarizes the allocation of the purchase price as of the
acquisition date:
Cash
|
$4,942
|
Accounts
receivable
|
$79,508
|
Prepaids
|
$1,428
|
Property
and equipment
|
$62,990
|
Goodwill
|
$665,697
|
Less:
Liabilities assumed ($172,899 Canadian)
|
$(137,817)
|
Total
consideration
|
$676,748
|
Note 13 – Accounts Receivable
Accounts
receivable consist of trade accounts arising in the normal course
of business and are classified as current assets and carried at
original invoice amounts less an estimate for doubtful receivables
based on a review of outstanding balances on a monthly basis. The
estimate of allowance for doubtful accounts is based on the
Company's bad debt experience, market conditions, and aging of
accounts receivable, among other factors. If the financial
condition of the Company's customers deteriorates resulting in the
customer's inability to pay the Company's receivables as they come
due, additional allowances for doubtful accounts will be
required.
F-20
Sunshine Biopharma, Inc.
Notes
to Consolidated Financial Statements
December
31, 2018 and 2017
Note 14 – Commitments
The
Company’s subsidiary, Atlas Pharma Inc., has entered into
long-term lease agreements for the rental of buildings which call
for minimum aggregate lease payments of $150,347 Canadian
(approximately $115,767 US) and additional lease payments based on
operating expenses. The lease expires on May 21, 2021. Minimum
lease payments for the next three years are $62,213 (approximately
$47,904 US) in 2019, $62,213 (approximately
$47,904 US) in 2020, and $25,921 (approximately
$19,959 US) in 2021.
Note 15 – Subsequent Events
On
January 1, 2019, the Company paid $69,931 to pay off the principal
($53,000) and accrued interest ($16,931) on a note payable dated
June 27, 2018.
On
January 8, 2019, the Company received net proceeds of $50,500 in
exchange for a note payable having a face value of $54,000 and
accruing interest at the rate of 8% per annum. The note, due on
January 8, 2020, is convertible after 180 days from issuance into
$0.001 par value Common Stock at a price 35% below market
value.
On
January 10, 2019, the Company received net proceeds of $38,000 in
exchange for a note payable having a face value of $40,660 and
accruing interest at the rate of 8% per annum. The note, due on
October 10, 2019, is convertible after 180 days from issuance into
$0.001 par value Common Stock at a price 35% below market
value.
On
February 5, 2019, the Company received net proceeds of $35,000 in
exchange for a note payable having a face value of $37,450 and
accruing interest at the rate of 8% per annum. The note, due on
October 10, 2019, is convertible after 180 days from issuance into
$0.001 par value Common Stock at a price 35% below market
value.
On
February 11, 2019, the Company received net proceeds of $50,000 in
exchange for a note payable having a face value of $52,000 and
accruing interest at the rate of 8% per annum. The note, due on
November 30, 2019, is convertible after 180 days from issuance into
$0.001 par value Common Stock at a price 35% below market
value.
On
March 4 and 13, 2019 the holder of a note payable dated August 17,
2018 elected to convert $25,000 in principal into 3,696,581 shares
of Common Stock leaving a principal balance of
$28,000.
On March 18, 2019, the Company received net proceeds of $38,000 in
exchange for a note payable having a face value of $40,660 and
accruing interest at the rate of 8% per annum. The note, due on
December 18, 2019, is convertible after 180 days from issuance into
$0.001 par value Common Stock at a price 35% below market
value.
On
March 18, 2019, the Company received another $38,000 of net
proceeds in exchange for a note payable having a face value of
$40,660 and accruing interest at the rate of 8% per annum. The
note, due on December 18, 2019, is convertible after 180 days from
issuance into $0.001 par value Common Stock at a price 35% below
market value.
F-21
ITEM 9. CHANGES IN
AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None
ITEM 9A. CONTROLS
AND PROCEDURES
Disclosure Controls and Procedures
Disclosure
Controls and Procedures – Our
management, with the participation of our Chief Executive Officer,
Chief Financial Officer, and Chief Operations Officer, has
evaluated the effectiveness of our disclosure controls and
procedures (as such term is defined in Rules 13a-15(e) and
15d-15(e) under the Securities Exchange Act of 1934, as amended
(the “Exchange Act”) as of the end of the period
covered by this Report.
These
controls are designed to ensure that information required to be
disclosed in the reports we file or submit pursuant to the
Securities Exchange Act of 1934 is recorded, processed, summarized
and reported within the time periods specified in the rules and
forms of the Securities and Exchange Commission, and that such
information is accumulated and communicated to our management,
including our CEO and CFO, to allow timely decisions regarding
required disclosure.
Based
on this evaluation, our management, including our CEO and CFO,
concluded that our disclosure controls and procedures were not
effective as of December 31, 2018, at reasonable assurance level,
for the following reasons:
●
ineffective
control environment and lack of qualified full-time CFO who has SEC
experience to focus on our financial affairs;
●
lack of
qualified and sufficient personnel, and processes to adequately and
timely identify making any and all required public
disclosures;
●
deficiencies
in the period-end reporting process and accounting
policies;
●
inadequate
internal controls over the application of new accounting principles
or the application of existing accounting principles to new
transactions;
●
inadequate
internal controls relating to the authorization, recognition,
capture, and review of transactions, facts, circumstances, and
events that could have a material impact on the company’s
financial reporting process;
●
deficient
revenue recognition policies;
●
inadequate
internal controls with respect to inventory tracking and
transactions; and
●
improper
and lack of timely accounting for accruals such as prepaid
expenses, accounts payable and accrued liabilities.
Our
Board of Directors has assigned a priority to the short-term and
long-term improvement of our internal control over financial
reporting. We are reviewing various potential solutions to remedy
the processes that would eliminate the issues that may arise due to
the absence of separation of duties within the financial reporting
functions. Additionally, the Board of Directors will work with
management to continuously review controls and procedures to
identified deficiencies and implement remediation within our
internal controls over financial reporting and our disclosure
controls and procedures.
21
We
believe that our financial statements presented in this annual
report on Form 10-K fairly present, in all material respects, our
financial position, results of operations, and cash flows for all
periods presented herein.
Inherent
Limitations – Our management, including our Chief
Executive Officer and Chief Financial Officer, does not expect that
our disclosure controls and procedures will prevent all error and
all fraud. A control system, no matter how well
conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of the control system are
met. The design of any system of controls is based in
part upon certain assumptions about the likelihood of future
events, and there can be no assurance that any design will succeed
in achieving its stated goals under all potential future
conditions. Further, 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.
Because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, within our company
have been detected. These inherent limitations include
the realities that judgments in decision-making can be faulty, and
that breakdown can occur because of simple error or mistake. In
particular, many of our current processes rely upon manual reviews
and processes to ensure that neither human error nor system
weakness has resulted in erroneous reporting of financial
data.
Changes in
Internal Control over Financial Reporting – There were
no changes in our internal control over financial reporting during
our fiscal year ended December 31, 2018, which were identified in
conjunction with management’s evaluation required by
paragraph (d) of Rules 13a-15 and 15d-15 under the Exchange Act,
that have materially affected, or are reasonably likely to
materially affect, our internal control over financial
reporting.
This
Annual Report does not include an attestation report of our
registered public accounting firm regarding internal control over
financial reporting. Management’s report was not
subject to attestation by our registered public accounting firm
pursuant to temporary rules of the Securities and Exchange
Commission that permit us to provide only management’s report
in this Annual Report.
Management Report on Internal Control over Financial
Reporting
Our
management is responsible for establishing and maintaining adequate
internal control over financial reporting as defined in Rule
13a-15(f) or 15d-15(f) promulgated under the Exchange
Act. Those rules define internal control over financial
reporting as a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in
accordance with generally accepted accounting principles and
includes those policies and procedures that:
●
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
generally accepted accounting principles, and the 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 acquisitions, use or disposition of the
company’s assets that could have a material effect on the
financial statements.
Because
of its inherent limitations, internal controls over financial
reporting may not prevent or detect
misstatements. Projections of any evaluation of
effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions, or
that the degree of compliance with the policies or procedures may
deteriorate.
Management assessed
the effectiveness of our internal control over financial reporting
as of December 31, 2018. In making this assessment, our management
used the criteria established in Internal Control-Integrated
Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission (COSO).
Based
on an assessment carried out April 1-10, 2018, management believes
that, as of December 31, 2018, our internal control over financial
reporting were ineffective based in part on the issues discussed
above.
ITEM 9B. OTHER
INFORMATION
None
22
PART III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND
CORPORATE GOVERNANCE
Following is a list
of our officers and directors:
Name
|
Age
|
Position(s)
|
|
|
|
Dr. Steve N.
Slilaty
|
66
|
President, Chief
Executive Officer, and Chairman
|
|
|
|
Dr. Abderrazzak
Merzouki
|
55
|
Chief Operating
Officer and Director
|
|
|
|
Camille
Sebaaly
|
58
|
Chief Financial
Officer, Secretary and Director
|
Our
directors serve as directors until our next Annual Meeting of
Stockholders and the election and qualification of the
director’s respective successor or until the director’s
earlier death, removal or resignation.
Following is biographical information of our current
management:
Dr. Steve N. Slilaty
was appointed as our CEO, President and Chairman of our Board of
Directors on October 15, 2009. Dr. Slilaty is an
accomplished scientist and business executive. His scientific
publications are widely cited including university textbooks.
Sunshine Biopharma is the third in a line of biotechnology
companies that Dr. Slilaty founded and managed through their early
and mid-stages of development. The first, Quantum Biotechnologies Inc. later
known as Qbiogene Inc., was
founded in 1991 and grew to over $60 million in annual
sales. Today, Qbiogene is a member of a family of
companies owned by MP
Biomedicals, one of the largest international suppliers of
biotechnology reagents and other research products. The
second company which Dr. Slilaty founded, Genomics One Corporation, later known
as Alert B&C
Corporation, conducted an initial public offering (IPO) of
its capital stock in 1999 and, on the basis of its ownership of Dr.
Slilaty’s patented TrueBlue® Technology, Genomics One became one of the key
participants in the Human Genome Project. Formerly a
research team leader of the Biotechnology Research Institute, a
division of the National Research
Council of Canada, Dr. Slilaty also served as a consultant
in a management and advisory capacity for a major Canadian
biotechnology company between 1995 and 1997 during which time the
company completed one of the largest biotechnology IPO‘s in
Canada. Dr. Slilaty is one of the pioneers of Gene Therapy
having developed the first gene delivery system applicable to
humans in 1983 [Science 220:725-727 (1983)]. Dr. Slilaty's other
distinguished scientific career accomplishments include the
discovery of a new class of enzymes, the S24 Family of Proteases
(IUBMB Enzyme Nomenclature: EC 3.4.21.88), development of the first
site-directed mutagenesis system applicable to double-stranded DNA,
cloning the gene for the first yeast-lytic enzyme (lytic
b-1,3-glucanase), developing a new molecular strategy for
increasing the rate of enzyme reactions, inventing a powerful new
cloning system for genomic cloning and gene discovery
(TrueBlue® Technology) and developing a new transcriptomics
technology for generating entire RNA profiles. These and other
works of Dr. Slilaty are cited in research papers, editorials,
review articles and textbooks. Dr. Slilaty received his
Ph.D. degree in Molecular Biology from the University of Arizona in
1983 and Bachelor of Science degree in Genetics and Biochemistry
from Cornell University in 1976. In addition, Dr.
Slilaty holds a position as Adjunct Professor at Université du
Québec in the Department of Microbiology and
Biotechnology. He devotes approximately 50% of his time
to our business affairs.
Dr. Abderrazzak
Merzouki was appointed as a Director and our Chief Operating
Officer in February 2016. In addition to his new
positions with our Company, since January 2016 he has been
self-employed as a consultant in the fields of biotechnology and
pharmacology. From July 2007 through December 2016, Dr.
Merzouki worked at the Institute of Biomedical Engineering in the
Department of Chemical Engineering at Ecole Polytechnique de
Montreal, where he taught and acted as a senior scientist involved
in the research and development of plasmid and siRNA-based
therapies. Dr. Merzouki is a molecular biologist and an
immunologist with extensive experience in the area of gene therapy
where he performed several preclinical studies for pharmaceutical
companies involving the use of adenoviral vectors for cancer
therapy and plasmid vectors for the treatment of peripheral
arterial occlusions. Dr. Merzouki also has extensive
expertise in the design of expression vectors, and production and
purification of recombinant proteins. He developed
technologies for production of biogeneric therapeutic proteins for
the treatment of various diseases including cancer, diabetes,
hepatitis and multiple sclerosis. Dr. Merzouki obtained
his Ph.D. in Virology and Immunology from Institut Armand-Frappier
in Quebec and received his post-doctoral training at the University
of British Columbia and the BC Center for Excellence in HIV/AIDS
research. Dr. Merzouki has over 30 publications and 70
communications in various, highly respected scientific journals in
the field of cellular and molecular biology. He will
devote approximately 50% of his time to our business
affairs.
23
Camille Sebaaly was
appointed as our Chief Financial Officer, Secretary and a Director
of our Company on October 15, 2009. Since 2001, Mr.
Sebaaly has been self-employed as a business consultant, primarily
in the biotechnology and biopharmaceutical sectors. He
held a number of senior executive positions in various areas
including, financial management, business development, project
management and finance. As an executive and an entrepreneur, he
combines expertise in strategic planning and finance with strong
skills in business development and deal structure and
negotiations. In addition, Mr. Sebaaly worked in
operations, general management, investor relations, marketing and
business development with emphasis on international business and
marketing of advanced technologies including hydrogen generation
and energy saving. In the area of marketing, Mr. Sebaaly
has evaluated market demands and opportunities, created strategic
marketing and business development plans, designed marketing
communications and launched market penetration
programs. Mr. Sebaaly was a cofounder of Advanomics
Corporation with Dr. Slilaty. Mr. Sebaaly graduated from
State University of New York at Buffalo with an Electrical and
Computer Engineering Degree in 1987. He devotes
approximately 50% of his time to our business affairs.
There
are no family relationships between any of our former or current
officers and directors.
Section 16(a) Beneficial Ownership Reporting
Compliance
Section
16(a) of the Securities Exchange Act of 1934 (the “34
Act”) requires our officers and directors and persons owning
more than ten percent of the Common Stock, to file initial reports
of ownership and changes in ownership with the Securities and
Exchange Commission (“SEC”). Additionally,
Item 405 of Regulation S-K under the 34 Act requires us to
identify in our Form 10-K and proxy statement those individuals for
whom one of the above referenced reports was not filed on a timely
basis during the most recent year or prior years. To our best
knowledge, all reports that were required to be filed were filed,
though some were filed late.
Code of Ethics
Our
board of directors has not adopted a code of ethics but plans to do
so in the near future.
Committees of the Board of Directors
There
are no committees of the Board of Directors but it is anticipated
that we will establish an audit committee, nominating committee and
governance committee once independent directors are appointed,
which is expected to occur at such time as financing for our drug
development program is secured, of which there are no
assurances.
24
ITEM
11. EXECUTIVE COMPENSATION
The
following table sets forth information concerning all cash and
non-cash compensation awarded to, earned by or paid to our
executive officers. We do not currently have an established policy
to provide compensation to members of our Board of Directors for
their services in that capacity, although we may choose to adopt a
policy in the future.
SUMMARY COMPENSATION TABLE
Name and
Principal Position
|
|
Year
|
|
Salary
($)
|
|
Bonus
($)
|
|
Stock Awards
($)
|
|
All Other
Compensation ($)
|
|
Total
($)
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. Steve N. Slilaty,
|
|
2016
|
|
1,000
|
|
|
-
|
|
164,600
|
(1)
|
|
-
|
|
165,600
|
Chief
Executive Officer and Director
|
|
2017
|
|
155,641
|
(2)
|
|
-
|
|
112,000
|
(3)
|
|
-
|
|
267,641
|
|
|
2018
|
|
85,000
|
(4)
|
|
-
|
|
200,100
|
(5)
|
|
-
|
|
285,100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Camille Sebaaly,
|
|
2016
|
|
4,597
|
|
|
-
|
|
164,600
|
(1)
|
|
-
|
|
169,197
|
Chief
Financial Officer and Director
|
|
2017
|
|
16,099
|
|
|
-
|
|
112,000
|
(3)
|
|
-
|
|
128,099
|
|
|
2018
|
|
37,500
|
|
|
-
|
|
200,100
|
(5)
|
|
-
|
|
237,600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. Abderrazzak Merzouki,
|
|
2016
|
|
-0-
|
|
|
-
|
|
164,600
|
(1)
|
|
-
|
|
164,600
|
Chief
Operating Officer and Director
|
|
2017
|
|
12,531
|
|
|
-
|
|
112,000
|
(3)
|
|
-
|
|
124,531
|
|
|
2018
|
|
32,415
|
|
|
-
|
|
200,100
|
(5)
|
|
-
|
|
232,515
|
(1)
In 2016, each member of our Board of Directors
was issued 1,300,000 and 600,000 shares of our Common Stock valued
at $80,600 and $84,000, respectively.
(2)
This includes $147,695 paid to Advanomics Corporation, a company
controlled by our CEO.
(3)
In
2017, each member of our Board of Directors was issued 700,000
shares of our Common Stock valued at $112,000.
(4)
This amount was paid to Advanomics Corporation, a company
controlled by our CEO.
(5)
In 2018, each member of our Board of Directors was issued 1,350,000
and 1,900,000 shares of our Common Stock valued at $143,100 and
$57,000, respectively.
Salaries are
established by our Board of Directors. We currently do
not have a Compensation Committee but expect to have one in place
in the future once we have independent directors. We
have not and do not expect to pay any other compensation to our
current executive officers or directors until such time as we are
able to secure adequate funding for our operations.
Employment Agreements
None of
our executive officers is party to an employment agreement with
us.
Stock Plan
We have
not adopted any stock option or other employee plans as of the date
of this Report. We may adopt such plans in the
future.
25
ITEM 12. SECURITY OWNERSHIP OF CERTAIN
BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
The
following table sets forth certain information regarding the
ownership of Common Stock and Preferred Stock voting with the
Common Stock as of the date of this Report by (i) each person known
to us to own more than 5% of our outstanding Common Stock as of the
date of this Report, (ii) each of our directors, (iii) each of our
executive officers, and (iv) all of our directors and executive
officers as a group. Unless otherwise indicated, all
shares are owned directly and the indicated person has sole voting
and investment power. The information provided is based upon
87,041,289 Common Shares and 500,000 Series B Preferred Shares
issued and outstanding as of the date of this Report.
Title of Class
|
|
Name and Address of Beneficial Owner
|
|
Amount and Nature of Beneficial Ownership
|
|
Percent of Common Class
|
|
Percent of Voting Shares
|
|
|
|
|
|
|
|
|
|
Common
|
|
Dr. Steve N. Slilaty(1)
579 Rue Lajeunesse
Laval, Quebec
Canada H7X 3K4
|
|
16,619,930(2)
|
|
19.09%
|
|
2.83%
|
Series B Preferred
|
|
|
|
500,000,000(3)
|
|
0%
|
|
85.17%
|
|
|
|
|
|
|
|
|
|
Common
|
|
Camille Sebaaly(1)
14464 Gouin West, #B
Montreal, Quebec
Canada H9H 1B1
|
|
12,335,165(4)
|
|
14.17%
|
|
2.10%
|
|
|
|
|
|
|
|
|
|
Common
|
|
Dr. Abderrazzak Merzouki(1)
731 Place de l’Eeau Vive
Laval, Quebec
Canada H7Y 2E1
|
|
5,923,350
|
|
6.81%
|
|
1.01%
|
|
|
|
|
|
|
|
|
|
Common
|
|
All Officers and Directors
As Group (3 persons)
|
|
534,878,445
|
|
40.07%
|
|
91.11%
|
(1)
Officer and
Director.
(2)
Includes 10,750,712 shares held in
the name of Advanomics Corporation. Dr. Slilaty is an officer,
director and principal shareholder of Advanomics Corporation and,
as a result, controls the disposition of these
shares.
(3)
Comprised of 500,000 shares of
$0.10 par value Series “B” Preferred Stock having 1,000
votes per share. The Series “B” Preferred Stock is
non-convertible, non-redeemable, non-retractable and has a superior
liquidation value of $0.10 per share.
(4)
Includes 6,474,447 shares held in
the name of 4019318 Canada, Inc. Mr. Sebaaly is the sole officer
and director of this company and, as a result, controls the
disposition of these shares.
26
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS AND DIRECTOR INDEPENDENCE
Related Party Transactions
On
November 27, 2014, we issued a note payable in the principal amount
of $128,000 to an individual who subsequently became a principal
shareholder. The note accrues interest at 10% per annum and was
convertible into shares of our Common Stock at a price of $0.20 per
share. On June 30, 2015, we renewed this note with the addition of
accrued interest of $7,540 and an origination fee of $25,600. The
new Note had a face value of $161,140 and accrued interest at 12%
per annum. The new note was due December 31, 2015 and was
convertible any time from the date of issuance into shares of our
Common Stock at a 35% discount from market price. On December 31,
2015, we again renewed this note with the addition of accrued
interest amounting to $9,668 and an origination fee of $32,228. The
new note now has a face value of $203,036 and accrues interest at
12% per annum. The new note was due June 30, 2016 and was
convertible anytime from the date of issuance into shares of our
Common Stock at a 35% discount from market price. In January 2016,
$38,036 of the principal was converted, leaving a principal balance
of $165,000. In connection therewith, 7,705,186 shares of our
Common Stock, valued $231,156 were issued generating a loss on
conversion of $193,120. On June 30, 2016, we renewed this note
again with the addition of accrued interest amounting to $9,852.
The renewed note had a face value of $174,852 and accrues interest
at 12% per annum. It was due on March 31, 2017. In October 2016,
$74,852 of the principal amount was converted, leaving a principal
balance of $100,000. On March 31, 2017, the note’s principal
balance of $100,000 plus accrued interest of $11,715 was renewed
for a period of 90 days under the same terms and conditions as the
previous note. The new note now had a face value of $111,715 and
matured on June 30, 2017. On June 30, 2017, the note’s
principal balance of $111,715 plus accrued interest of $3,342 was
renewed for a period of 90 days under the same terms and conditions
as its predecessor. The new note had a face value of $115,057 and
matured on September 30, 2017. On September 30, 2017, the
note’s principal balance of $115.057 plus accrued interest of
$3,480 was renewed for a period of 90 days under the same terms and
conditions as the previous note. The new note had a principal
balance of $118,537 and matured on December 31, 2017. On December
31, 2017 the note was renewed for a 12-month period under the same
terms and conditions as the prior note. The new note has a face
value of $122,093 and matures on December 31, 2018. On December 31,
2018 the note, together with accrued interest of $14,651 was
renewed for a 12-month period. The new Note has a face value of
$136,744 and matures on December 31, 2019. The new note is not
convertible. In the third quarter of 2018, this individual ceased
to be a principal shareholder of the Company.
In
December 2016, we received monies from our CEO in exchange for a
note payable having a principal amount of $90,000 Canadian ($67,032
US) with interest at 12%. The note was convertible any time after
the date of issuance into shares of our Common Stock at
a price 35% below market value. In
addition, the note was collateralized by all our assets. On
March 31, 2017, the note, together with all accrued interest
thereon and an additional principal amount of $3,000 Canadian paid
to us in March 2017, was renewed for a 90-day period under the same
terms and conditions as the original note. The new note now having
a face value of $96,021 Canadian ($72,198 US) was due on June 30,
2017. On June 30, 2017, the note, together with accrued interest of
$2,873 Canadian ($2,005 US), was renewed for a 90-day period under
the same terms and conditions as the original note except that the
new note is nonconvertible. The new note now having a face value of
$98,894 Canadian ($76,072US) was due on September 30, 2017. On
September 30, 2017, the note, together with accrued interest of
$2,991 Canadian ($2,397 US), was renewed for a 90-day period under
the same terms and conditions as its predecessor. The new note now
having a principal balance of $101,885 Canadian ($81,640 US)
matured on December 31, 2017. On December 31, 2017 the note was
renewed for a 12-month period under the same terms and conditions
as before except that this new note is unsecured and now
non-convertible. The new note has a face value of $104,942 Canadian
($83,649 US) and matures on December 31, 2018. On December 31, 2018
the note, together with accrued interest of $9,227, was renewed for
a 12-month period under the same terms and conditions as the
previous note. The new has a face value of $117,535 Canadian
($86,118 US) and matures on December 31, 2019.
On
October 8, 2015, we acquired U.S. Patent Number 8,236,935 (the
“US Patent”) for the anticancer compound, Adva-27a from
a related entity (Advanomics Corporation), which includes all
rights to this intellectual property within the United States, in
exchange for an interest-free note payable for $4,320,000 (the
“October Patent Purchase Agreement”). On
December 28, 2015, we acquired the remaining worldwide issued and
pending patents under PCT/FR2007/000697 and PCT/CA2014/000029 (the
“Worldwide Patents”) for the Adva-27a anticancer
compound from the same related entity (Advanomics Corporation) in
exchange for a note payable for $12,822,499 (the “December
Patent Purchase Agreement”). We believe that purchase of the
US Patent and the Worldwide Patents (the “Patents”)
would facilitate our ability to obtain the funding necessary to
complete the development and FDA approval process for Adva-27a. In
related party transactions, purchased patents are required to be
recorded at the purchase price or the book value on the
seller’s financial statements, whichever is lower. Effective
December 28, 2015, the parties agreed to amend the October Patent
Purchase Agreement and the December Patent Purchase Agreement.
Pursuant to the amendment agreements (the
“Amendments”), the Patents were purchased from the
related party, Advanomics Corporation, at Advanomics’ cost
less the amortization through December 28, 2015, the effective date
of the transfer. The Amendments amended the purchase price of the
Patents to $835,394, eliminated all cash payments obligations and
replaced the non-convertible notes totaling $17,142,499 with two
(2) convertible notes totaling $835,394 that automatically convert
into an aggregate of 321,305,415 shares of our Common Stock when we
successfully amend our Articles of Incorporation to increase our
authorized capital of Common Stock to 3 billion. In July 2016,
having completed the increase of our authorized capital to 3
billion shares of Common Stock, we issued the 321,305,415 Common
Shares to Advanomics thereby completing all aspects of the patent
purchase arrangements and securing direct ownership of all
worldwide patents and rights pertaining to Adva-27a.
27
In 2016 and 2017 our principal place of business was located at 469
Jean-Talon West, 3rd Floor, Montreal, Quebec, Canada, H3N
1R4. This was also the location of our former licensor,
Advanomics Corporation, who provided this space to us on a
rent-free basis. Dr. Steve N. Slilaty, our Chief
Executive Officer and a Director, is an Officer, Director and
principal shareholder of Advanomics. Starting January 1
2017 we assumed the lease from Advanomics until we moved on June 1,
2017.
During
the year ended December 31, 2018, we issued an aggregate of
9,750,000 shares of our Common Stock valued at $600,300 to the
members of our Board of Directors in equal amounts. During the year
ended December 31, 2018 our Directors and Officers were paid
$154,915 in cash. Of this amount, $85,000 was paid to Advanomics
Corporation, a company controlled by our CEO.
During
the year ended December 31, 2018, certain of our Directors made
interest-free cash advances to us totaling $49,349. At December 31,
2018, the outstanding balance of these loans was
$49,349.
During
the fiscal ended December 31, 2017, we issued 2,100,000 shares of
our Common Stock to our Board of Directors in equal amounts. These
shares were valued at $336,000 or $0.16 per share. During the same
period, our Directors and Officers were paid $184,271 in cash. Of
this amount, $147,695 was paid to Advanomics Corporation, a company
controlled by our CEO.
On
January 1, 2018 as part of the acquisition of Atlas Pharma Inc., we
issued a note payable in the amount of $450,000 Canadian ($358,407
US), accruing interest at the rate of 3% per annum. The note is due
on December 31, 2023. Payments on this note are $10,000 Canadian
(approximately $8,000 US) per quarter. The outstanding principal
balance at December 31, 2018 was $310,079. The note is
nonconvertible and is secured by the Atlas Pharma Inc. shares held
by us. The holder of this note is currently a director and officer
of Atlas Pharma Inc., now our wholly owned subsidiary.
There
are no other related party transactions that are required to be
disclosed pursuant to Regulation S-K promulgated under the
Securities Act of 1933, as amended.
Director Independence
None of
our current directors are deemed “independent” pursuant
to SEC rules. We anticipate appointing independent
directors in the foreseeable future.
ITEM
14. PRINCIPAL ACCOUNTING FEES AND
SERVICES.
Fees Paid to Independent Registered Public Accounting
Firms
The
following table presents fees for professional audit services
rendered by B F Borgers CPA PC, our independent auditors, during
our fiscal years ended December 31, 2018 and 2017:
|
December
31,
2018
|
December
31,
2017
|
Audit
Fees
|
$81,198
|
$21,600
|
Tax
Fees
|
|
|
All Other
Fees
|
|
|
Total
|
$81,198
|
$21,600
|
Audit Fees. Consist of amounts billed
for professional services rendered for the audit of Atlas Pharma
Inc. for the years ended December 31, 2018 and 2017 and for our
annual financial statements included in our Annual Reports on Forms
10-K for our fiscal years ended December 31, 2018 and 2017 and for
reviews of our interim financial statements included in our
Quarterly Reports on Form 10-Q..
Tax Fees. Consists of amounts billed for
professional services rendered for tax return preparation, tax
planning and tax advice.
All Other Fees. Consists of
amounts billed for services other than Audit Fees.
We do
not have an audit committee and as a result our entire Board of
Directors performs the duties of an audit committee. Our
Board of Directors evaluates the scope and cost of the engagement
of an auditor before the auditor renders audit and non-audit
services.
28
PART IV
ITEM
15. EXHIBITS, FINANCIAL STATEMENT
SCHEDULES
The
following exhibits are included herewith:
Exhibit No.
|
|
Description
|
|
|
|
|
|
|
|
Certification
of Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
Certification
of Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
Certification
of Chief Executive Officer and Chief Financial Officer Pursuant to
18 U.S.C. Section 1350
|
101.INS
|
XBRL
Instances Document
|
|
|
101.SCH
|
XBRL
Taxonomy Extension Schema Document
|
|
|
101.CAL
|
XBRL
Taxonomy Extension Calculation Linkbase Document
|
|
|
101.DEF
|
XBRL
Taxonomy Extension Definition Linkbase Document
|
|
|
101.LAB
|
XBRL
Taxonomy Extension Label Linkbase Document
|
|
|
101.PRE
|
XBRL
Taxonomy Extension Presentation Linkbase Document
|
29
Following
are a list of exhibits which we previously filed in other reports
which we filed with the SEC, including the Exhibit No., description
of the exhibit and the identity of the Report where the exhibit was
filed.
No.
|
|
Description
|
|
Filed With
|
|
Date
|
|
Articles
of Incorporation
|
|
Form
SB-2 Registration Statement
|
|
October
19, 2007
|
|
|
Bylaws
|
|
Form
SB-2 Registration Statement
|
|
October
19, 2007
|
|
|
Articles
of Amendment (Name Change)
|
|
Form
8-K Dated November 2, 2009
|
|
November
6, 2009
|
|
|
Statement
of Share and Equity Capital Exchange
|
|
Form
10-Q For Quarter Ended 06/30/10
|
|
August
4, 2010
|
|
|
Articles
of Amendment (Add Preferred and Series A Preferred to
Authorized)
|
|
Form
10-Q For Quarter Ended 06/30/10
|
|
August
4, 2010
|
|
|
Share
Exchange Agreement with Sunshine Biopharma, Inc.
|
|
Form
8-K Dated October 15, 2009
|
|
October
20, 2009
|
|
|
License
Agreement with Advanomics, Inc.
|
|
Form
8-K/A1 Dated October 15, 2009
|
|
January
19, 2010
|
|
|
Amendment
No. 1 to License Agreement with Advanomics, Inc.
|
|
Form
8-K/A1 Dated October 15, 2009
|
|
January
19, 2010
|
|
|
Research
Agreement with The Research Foundation of the State University of
New York
|
|
Form
8-K Dated January 17, 2011
|
|
January
19, 2011
|
|
|
Research
Agreement with Jewish General Hospital
|
|
Form
8-K Dated June 14, 2011
|
|
June
17, 2011
|
|
|
Amendment
No. 2 to License Agreement with Advanomics
|
|
Form
8-K Dated December 21, 2011
|
|
December
27, 2011
|
|
|
Investment
Agreement with Dutchess Investment Group II
|
|
Form
8-K dated April 28, 2014
|
|
April
28, 2014
|
|
|
Registration
Rights Agreement with Dutchess Investment Group II
|
|
“
|
|
“
|
|
|
Patent
Purchase Agreement with Advanomics Corporation
|
|
Form
8-K dated October 8, 2016
|
|
October
9, 2016
|
|
|
Second
Patent Purchase Agreement with Advanomics Corporation
|
|
Form
8-K dated December 28, 2015
|
|
December
28, 2015
|
|
|
Amendment
No. 1 to Patent Purchase Agreement with Advanomics Corporation
dated October 8, 2016, including Secured Convertible Promissory
Note.
|
|
Form
8-K dated March 14, 2016
|
|
March
14, 2016
|
|
|
Amendment
No. 1 to Patent Purchase Agreement with Advanomics Corporation
dated December 28, 2016, including Secured Convertible Promissory
Note
|
|
Form
8-K dated March 14, 2016
|
|
March
14, 2016
|
30
SIGNATURES
Pursuant to the
requirements of Section 13 or 15(d) of the Securities Exchange Act
of 1934, the Registrant has duly caused this Annual Report to be
signed on its behalf by the undersigned thereunder duly
authorized.
|
SUNSHINE BIOPHARMA, INC.
|
|
|
|
|
|
|
Dated:
April 12, 2019
|
By:
|
/s/ Dr.
Steve N. Slilaty
|
|
|
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Dr.
Steve N. Slilaty, Principal Executive Officer
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/s/
Camille Sebaaly
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Camille
Sebaaly, Principal Financial and Accounting Officer
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In
accordance with the Exchange Act, this Annual Report has been
signed below by the following persons on behalf of the registrant
and in the capacities indicated on April 12, 2019.
s/ Dr. Steve N. Slilaty
Dr.
Steve N. Slilaty, Director
s/ Camille Sebaaly
Camille
Sebaaly, Director
s/ Dr. Abderrazzak Merzouki
Dr.
Abderrazzak Merzouki, Director
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