Table of Contents
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
Form
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended: June 30, 2023
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
File Number: 001-41282
SUNSHINE BIOPHARMA, INC.
(Exact
name of registrant as specified in its charter)
Colorado
20-5566275
(State of other jurisdiction
of incorporation)
(IRS Employer ID No.)
6500 Trans-Canada Highway
4th Floor
Pointe-Claire ,
Quebec , Canada H9R 0A5
(Address
of principal executive offices)
(514)
426-6161
(Issuer’s
Telephone Number)
Securities registered
pursuant to Section 12(b) of the Act:
Title
of Each Class
Trading
Symbol
Name
of Each Exchange on Which Registered
Common
Stock
Common
Stock Purchase Warrants
SBFM
SBFMW
The
NASDAQ Stock Market LLC
The
NASDAQ Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days: Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”,
“smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one)
Large accelerated
filer ☐
Accelerated
filer ☐
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
The
number of shares of the registrant’s common stock, par value $0.001, issued and outstanding as of August 10, 2023, was 25,746,302
shares.
TABLE
OF CONTENTS
Page
PART I. FINANCIAL INFORMATION
Item 1.
Financial Statements
3
Consolidated Unaudited Balance Sheet as of June 30, 2023 and December 31, 2022
3
Consolidated Unaudited Statements of Operations for the Six Months Ended June 30, 2023 and 2022
4
Consolidated Unaudited Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022
5
Consolidated Unaudited Statement of Shareholders' Equity for the Six Months Ended June 30, 2023 and 2022
6
Notes to Unaudited Consolidated Financial Statements
7
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
16
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
24
Item 4.
Controls and Procedures
24
PART II. OTHER INFORMATION
Item 1.
Legal Proceedings
25
Item 1A.
Risk Factors
25
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
25
Item 3.
Defaults Upon Senior Securities
25
Item 4.
Mine Safety Disclosures
25
Item 5.
Other Information
25
Item 6.
Exhibits
25
Signatures
26
2
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
Sunshine
Biopharma, Inc.
Consolidated
Balance Sheets
June 30,
December 31,
2023
2022
(Unaudited)
ASSETS
Current Assets:
Cash and cash
equivalents
$ 19,729,491
$ 21,826,437
Accounts receivable
2,011,308
1,912,153
Inventory
4,250,887
3,289,945
Prepaid
expenses
107,023
283,799
Total Current Assets
26,098,709
27,312,334
Property and equipment
366,684
394,249
Intangible assets
1,233,570
776,856
Right-of-use-asset
711,059
760,409
TOTAL
ASSETS
$ 28,410,022
$ 29,243,848
LIABILITIES
Current Liabilities:
Accounts payable and accrued
expenses
$ 1,759,789
$ 2,802,797
Earnout payable
2,547,831
3,632,000
Income tax payable
230,581
373,191
Right-of-use-liability
122,146
123,026
Total Current Liabilities
4,660,347
6,931,014
Long-Term Liabilities:
Deferred tax liability
43,032
43,032
Right-of-use-liability
596,850
642,232
Total Long-Term Liabilities
639,882
685,264
TOTAL
LIABILITIES
5,300,229
7,616,278
SHAREHOLDERS' EQUITY
Preferred
Stock, Series B $ 0.10 par value per share; 1,000,000 shares authorized; 10,000 shares issued and outstanding
1,000
1,000
Common Stock, $ 0.001
par value per share; 3,000,000,000
shares authorized; 25,746,302
and 22,585,632
shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively
25,746
22,585
Capital paid in excess of par value
84,422,143
80,841,752
Accumulated comprehensive
income
665,056
161,847
Accumulated
(Deficit)
( 62,004,152 )
( 59,399,614 )
TOTAL
SHAREHOLDERS' EQUITY
23,109,793
21,627,570
TOTAL
LIABILITIES AND SHAREHOLDERS' EQUITY
$ 28,410,022
$ 29,243,848
The
accompanying notes are an integral part of these unaudited financial statements
3
Sunshine
Biopharma, Inc.
Consolidated
Statements of Operations and Comprehensive Loss (Unaudited)
3
Months Ended June 30,
6
Months Ended June 30,
2023
2022
2023
2022
Sales:
$ 5,560,865
$ 150,307
$ 10,454,918
$ 272,952
Cost of sales
3,608,118
74,683
6,674,049
134,528
Gross profit
1,952,747
75,624
3,780,869
138,424
General and Administrative Expenses:
Accounting
75,281
41,060
245,031
114,860
Consulting
392,454
101,683
524,069
107,181
Director fees
100,000
50,000
200,000
50,000
Legal
145,815
112,360
259,572
256,919
Marketing
133,177
87,680
261,090
182,720
Office
395,385
90,407
877,843
372,912
R&D
368,565
45,943
801,490
407,595
Salaries
1,200,167
240,000
3,200,424
560,000
Taxes
96,649
–
160,367
–
Depreciation
34,877
2,287
69,587
5,397
Total General and Administrative
Expenses
2,942,370
771,420
6,599,473
2,057,584
(Loss) from operations
( 989,623 )
( 695,796 )
( 2,818,604 )
( 1,919,160 )
Other Income (Expense):
Foreign exchange
( 261 )
29
( 246 )
20
Interest income
203,049
146,043
416,930
146,046
Debt release
–
10,852
–
10,852
Interest
expense
( 27,596 )
–
( 68,671 )
( 12,864 )
Total Other Income (Expense)
175,192
156,924
348,013
144,054
Net (loss) before income taxes
( 814,431 )
( 538,872 )
( 2,470,591 )
( 1,775,106 )
Provision for income taxes
( 87,677 )
–
( 133,947 )
–
Net (Loss)
$ ( 902,108 )
$ ( 538,872 )
$ ( 2,604,538 )
$ ( 1,775,106 )
Gain (Loss) from foreign
exchange translation
492,049
( 12,645 )
503,209
( 11,638 )
Comprehensive (Loss)
$ ( 410,059 )
$ ( 551,517 )
$ ( 2,101,329 )
$ ( 1,786,744 )
Basic (Loss) per common share
$ ( 0.02 )
$ ( 0.03 )
$ ( 0.09 )
$ ( 0.18 )
Weighted
average common shares outstanding (Basic and Diluted)
25,350,263
15,849,518
23,827,205
9,691,625
The
accompanying notes are an integral part of these unaudited financial statements
4
Sunshine
Biopharma, Inc.
Consolidated
Statements of Cash Flows (Unaudited)
June 30,
June 30,
2023
2022
Cash Flows From Operating
Activities:
Net (Loss)
$ ( 2,604,538 )
$ ( 1,775,106 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization
69,594
5,397
Foreign exchange
–
( 20 )
Debt release
–
( 10,852 )
Accounts receivable
( 55,160 )
7,774
Inventory
( 885,243 )
( 99,721 )
Prepaid expenses
182,852
( 18,937 )
Accounts payable and accrued
expenses
( 1,103,502 )
61,742
Income tax payable
( 147,980 )
–
Interest
payable
( 1,084,169 )
( 48,287 )
Net
Cash Flows (Used) in Operations
( 5,628,146 )
( 1,878,010 )
Cash Flows From Investing
Activities:
Reduction in Right-of-use
asset
66,846
–
Purchase of intangible assets
( 17,645 )
–
Purchase of equipment
( 454,980 )
–
Net
Cash Flows (Used) in Investing activities
( 405,779 )
–
Cash Flows From Financing
Activities:
Common stock issued
4,089,208
43,560,363
Exercise of warrants
1,156
–
Purchase of treasury stock
( 506,822 )
( 99,000 )
Lease liability
( 63,870 )
–
Payments
of notes payable
–
( 1,900,000 )
Net
Cash Flows Provided by Financing Activities
3,519,672
41,561,363
Cash and Cash Equivalents
at Beginning of Period
21,826,437
2,045,167
Net increase (decrease)
in cash and cash equivalents
( 2,514,253 )
39,683,353
Effect of exchange rate
changes on cash
9
( 12,383 )
Foreign
currency translation adjustment
417,298
11,638
Cash
and Cash Equivalents at End of Period
$ 19,729,491
$ 41,727,775
Supplementary Disclosure
Of Cash Flow Information:
Cash paid for interest
$ –
$ 61,151
Cash paid for income
taxes
$ –
$ –
The
accompanying notes are an integral part of these unaudited financial statements
5
Sunshine
Biopharma, Inc.
Consolidated
Statement of Shareholders' Equity (Unaudited)
Number
Of Common Shares
Common
Capital
Paid in Excess of Par
Number
Of Preferred Shares
Preferred
Comprehensive
Accumulated
Issued
Stock
Value
Issued
Stock
Income
Deficit
Total
Three Month Period Ended June
30, 2023
Balance
at March 31, 2023
22,139,921
$ 22,139
$ 80,335,376
10,000
$ 1,000
$ 173,007
$ ( 61,102,044 )
$ 19,429,478
Common
stock and pre-funded warrants issued in a private offering
2,450,000
2,451
4,086,767
–
–
–
–
4,089,218
Exercise
of warrants
1,156,381
1,156
–
–
–
–
–
1,156
Net (loss)
–
–
–
–
–
492,049
( 902,108 )
( 410,059 )
Balance
at June 30, 2023
25,746,302
$ 25,746
$ 84,422,143
10,000
$ 1,000
$ 665,056
$ ( 62,004,152 )
$ 23,109,793
Six Month Period Ended June
30, 2023
Balance
at December 31, 2022
22,585,632
$ 22,585
$ 80,841,752
10,000
$ 1,000
$ 161,847
$ ( 59,399,614 )
$ 21,627,570
Repurchased
stock
( 445,711 )
( 446 )
( 506,376 )
–
–
–
–
–
Common
stock and pre-funded warrants issued in a private offering
2,450,000
2,451
4,086,767
–
–
–
–
4,089,218
Exercise
of warrants
1,156,381
1,156
–
–
–
–
–
1,156
Net (loss)
–
–
–
–
–
503,209
( 2,604,538 )
( 2,101,329 )
Balance
at June 30, 2023
25,746,302
$ 25,746
$ 84,422,143
10,000
$ 1,000
$ 665,056
$ ( 62,004,152 )
$ 23,109,793
Three Month Period Ended June
30, 2022
Balance
at March 31, 2022
7,149,778
$ 7,150
$ 47,219,498
10,000
$ 1,000
$ ( 22,132 )
$ ( 33,891,408 )
$ 13,314,108
Common
stock and pre-funded warrants issued in public offering
2,472,820
2,473
16,750,442
–
–
–
–
16,752,915
Exercise
of warrants
9,263,034
9,263
12,361,511
–
–
–
–
12,370,774
Net (loss)
–
–
–
–
–
( 12,645 )
( 538,872 )
( 551,517 )
Balance
at June 30, 2022
18,885,632
$ 18,886
$ 76,331,451
10,000
$ 1,000
$ ( 34,777 )
$ ( 34,430,280 )
$ 41,886,280
Six Month Period Ended June
30, 2022
Balance
December 31, 2021
2,595,620
$ 2,596
$ 32,787,379
1,000,000
$ 100,000
$ ( 23,139 )
$ ( 32,655,174 )
$ 211,662
Common
stock and pre-funded warrants issued in public offering
6,656,526
6,657
30,360,528
–
–
–
–
30,367,185
Exercise
of warrants
9,633,486
9,633
13,183,544
–
–
–
–
13,193,177
Preferred
stock purchased from related party
–
–
–
( 990,000 )
( 99,000 )
–
–
( 99,000 )
Net (loss)
–
–
–
–
–
( 11,638 )
( 1,775,106 )
( 1,786,744 )
Balance
at June 30, 2022
18,885,632
$ 18,886
$ 76,331,451
10,000
$ 1,000
$ ( 34,777 )
$ ( 34,430,280 )
$ 41,886,280
The
accompanying notes are an integral part of these unaudited financial statements
6
Sunshine Biopharma,
Inc.
Notes to Consolidated
Financial Statements (Unaudited)
For the Six
Months Ended June 30, 2023 and 2022
Note
1 – Description of Business
The
Company was originally incorporated under the name Mountain West Business Solutions, Inc. on August 31, 2006, in the State of Colorado.
Effective October 15, 2009, the Company acquired Sunshine Biopharma, Inc. in a transaction classified as a reverse acquisition. Upon
completion of the reverse acquisition transaction, the Company changed its name to Sunshine Biopharma, Inc. and began operating as a
pharmaceutical company.
In
addition to conducting its own drug development activities, Sunshine
Biopharma operates two wholly owned subsidiaries: (i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation with a portfolio
consisting of 50 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc. (“Sunshine Canada”),
a Canadian corporation which develops and sells nonprescription over-the-counter
(“OTC”) products.
The
Company has identified two potential reportable segments:
· Prescription
Generic Pharmaceuticals (“Generic Pharmaceuticals”)
· Nonprescription
Over-The-Counter Products (“OTC Products)
Through
December 31, 2022 and as of June 30, 2023, sales from the Generic Pharmaceuticals segment represent approximately 97 % of total revenues
of the Company while the remaining approximately 3% is generated from the sale of OTC Products. Based on these results, the Company deems
segmentation to be immaterial at June 30, 2023.
The
Company currently has 27 additional generic prescription drugs scheduled to be launched later this year and in 2024. In addition,
the Company is engaged in the development of the following proprietary drugs:
(1) Adva-27a
At
inception, Sunshine Biopharma, Inc. held an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a (the “License
Agreement”). In December 2015, the Company acquired all rights to Adva-27a by purchasing PCT/FR2007/000697 and PCT/CA2014/000029
and terminated the License Agreement. Adva-27a is a small chemotherapy molecule targeting pancreatic cancer.
(2) K1.1
mRNA
In
June 2021, the Company initiated an R&D project to determine if certain mRNA molecules can be used as anticancer agents. On April
20, 2022, the Company filed a patent application in the United States covering mRNA molecules capable of destroying cancer cells in vitro.
The K1.1 lead anticancer mRNA molecule arising from this technology is targeted for liver cancer.
(3) SBFM-PL4
On
May 22, 2020, the Company filed a provisional patent application in the United States for a new treatment for Coronavirus infections.
The Company’s patent application covers composition subject matter pertaining to small molecules for inhibition of the Coronavirus
main protease, Mpro, and the Papain-Like protease, PLpro. The Company’s lead Anti-Coronavirus compound arising from these patents
bears the laboratory name SBFM-PL4. The Company has been conducting research on this project in collaboration with the University of
Arizona and has recently entered into an exclusive worldwide license agreement with the University of Arizona for all of the technology
related to the collaboration.
7
Note
2 – Basis of Presentation
The
unaudited financial statements of the Company for the six months periods ended June 30, 2023 and 2022 have been prepared in accordance
with accounting principles generally accepted in the United States of America for interim financial information and pursuant to the requirements
for reporting on Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by accounting
principles generally accepted in the United States of America for complete financial statements. However, such information reflects all
adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation
of the financial position and the results of operations. Results shown for interim periods are not necessarily indicative of the results
to be obtained for a full fiscal year. The balance sheet information as of December 31, 2022 was derived from the audited financial statements
included in the Company's financial statements as of and for the year ended December 31, 2022 included in the Company’s Annual
Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on April 4, 2023. These financial statements
should be read in conjunction with that report.
Note
3 – Private Placement
On
May 16, 2023, the Company completed a private placement pursuant to a securities purchase agreement with a single healthcare-focused
institutional investor for gross proceeds of approximately $ 5 million, before deducting fees to the placement agent and other offering
expenses payable by the Company. The net proceeds received by the Company were $ 4,089,218 .
In
connection with the private placement, the Company issued (i) 2,450,000 shares
of common stock, (ii) 3,502,381 pre-funded
warrants (the “May Pre-Funded Warrants”), and (iii) 11,904,762 investor
warrants (the “May Investor Warrants”) to purchase up to 11,904,762 shares of common stock at $0.59 per share. Each
share of common stock and accompanying two May Investor Warrants were sold together at a combined offering price of $0.84, and each
May Pre-Funded Warrant and accompanying two May Investor Warrants were sold together at a combined offering price of $0.839. The May
Pre-Funded Warrants are immediately exercisable, at a nominal exercise price of $0.001, and may be exercised at any time until all
of the May Pre-Funded Warrants are exercised in full. The May Investor Warrants which have an exercise price of $0.59 per share
(subject to adjustment as set forth therein), are exercisable upon issuance and will expire five and a half years from the date of
issuance.
Note
4 – Acquisition of Nora Pharma Inc.
On
October 20, 2022, the Company acquired all of the issued and outstanding shares of Nora Pharma Inc. The purchase price for the shares
was $ 18,860,637
(USD) which was paid in cash ($ 14,346,637 )
and by the issuance of 3,700,000
shares of the Company’s common stock valued at $ 4,514,000
or $1.22 per share. Nora Pharma sells generic pharmaceutical products
in Canada. Nora Pharma’s operations are authorized by a Drug Establishment License issued by Health Canada.
8
The
following table summarizes the allocation of the purchase price as of October 20, 2022, the acquisition date using Nora Pharma’s
balance sheet assets and liabilities:
Allocation of purchase price
Accounts receivable
$
1,358,121
Inventory
3,181,916
Intangible assets
659,571
Equipment & furniture
210,503
Other assets
1,105,093
Total assets
6,515,204
Liabilities assumed
( 5,981,286
)
Net assets
533,918
Goodwill
18,326,719
Total Consideration
$
18,860,637
The
value of the 3,700,000 common shares issued as part of the consideration paid for Nora Pharma was determined based on the closing market
price of the Company’s common shares on the acquisition date, October 20, 2022 ($1.22 per share).
The Company impaired 100% of the goodwill amount
in 2022 and plans to depreciate the intangible assets as detailed in Note 5 below.
As
part of the consideration paid for Nora Pharma, the Company agreed to a $ 5,000,000 CAD ($ 3,632,000 USD) earnout amount payable to Mr.
Malek Chamoun, the Seller of Nora Pharma. The earnout is payable in the form of twenty (20) payments of $250,000 CAD for every $1,000,000
CAD increase in gross sales (as defined in the Purchase Agreement) above Nora Pharma’s June 30, 2022 gross sales, provided that
his employment with the Company is not terminated pursuant to the Company’s Employment Agreement with him. The total earnout amount
of $3,632,000 has been recorded as a salary payable. During the six-month period ended June 30, 2023, the Company paid an
earn-out amount of $ 1,084,169 leaving a balance earn-out to be paid of $ 2,547,831 at June 30, 2023.
The
unaudited financial information in the table below summarizes the combined results of operations of the Company and Nora Pharma for the
years ended December 31, 2022 and 2021, on a pro forma basis, as though the two companies had been combined as of January 1, 2021. The
unaudited pro forma financial information does not purport to be indicative of the Company's combined results of operations which would
have been obtained had the acquisition taken place on January 1, 2021, nor should it be taken as indicative of future consolidated results
of operations:
Pro Forma results from acquisition
Pro Forma
results from acquisition
December
31,
2022
December
31,
2021
Total revenues
$
14,758,115
$
7,927,165
Net (loss) from operations
$
( 26,192,503
)
$
( 2,224,253
)
Net (loss)
$
( 26,164,764
)
$
( 12,289,655
)
Basic and fully diluted (loss) per share
$
( 1.74
)
$
( 4.70
)
Weighted average number of shares outstanding
15,056,097
2,612,061
9
Note
5 – Intangible Assets
Intangible
assets, net consisted of the following at June 30, 2023:
Schedule
of intangible assets
Balance
at March 31, 2023
$ 948,240
Dossier
fee additions
305,801
Balance at June 30,
2023
1,254,041
Less
accumulated amortization
( 20,471 )
Finite-lived
intangible assets net at June 30, 2023
$ 1,233,570
Balance at December
31, 2022
$ 776,856
Dossier
fee additions
183,760
Balance at March 31,
2023
960,616
Less
accumulated amortization
( 12,376 )
Finite-lived
intangible assets net at March 31, 2023
$ 948,240
Amortization
expense for the three-month period ended March 31, 2023 and the three-month period ended June 30, 2023 amounted to $ 7,853 and $ 8,096 ,
respectively.
As
of June 30 2023, estimated amortization expense of the Company’s intangible assets for each of the next five years is as follows:
Schedule of amortization expense
2024
$ 46,814
2025
46,814
2026
45,611
2027
6,153
2028
1,989
Note
6 – Reverse Stock Splits
Effective
February 9, 2022, the Company completed a 1 for 200 reverse split of its common stock. The Company had previously completed two 20 to
1 reverse stock splits, one in 2019 and the other in 2020. The Company’s financial statements reflect all three reverse stock splits
on a retroactive basis for all periods presented and for all references to common stock, unless specifically stated otherwise.
10
Note
7 – 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. As of December 31, 2021, the Company had authorized 1,000,000 shares
of Series B Preferred Stock. 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. As of December 31, 2021, the 1,000,000
shares of the Series B Preferred Stock were held by the CEO of the Company.
On
February 17, 2022, the Company completed a public offering and received net proceeds of $ 6,833,071 from the offering. Pursuant to the
public offering, the Company issued and sold an aggregate of 1,882,353 shares of common stock and 4,102,200 warrants to purchase shares
of common stock (the “Tradeable Warrants”).
On
February 22, 2022, the Company redeemed 990,000
shares of Series B Preferred Stock from the CEO of the Company
at a redemption price equal to the stated value of $0.10 per share. The remaining 10,000 shares of Series B Preferred Stock cannot be
voted pursuant to the Tradeable Warrants Agreement which expires in February 2027.
On
March 14, 2022, the Company completed a private placement and received net proceeds of $ 6,781,199 . In connection with this private placement,
the Company issued (i) 2,301,353 shares of its common stock together with investor warrants (“Investor Warrants”) to
purchase up to 2,301,353 shares of common stock, and (ii) 1,302,251 pre-funded warrants (“Pre-Funded Warrants”)
with each Pre-Funded Warrant exercisable for one share of common stock, together with Investor Warrants to purchase up to 1,302,251 shares
of common stock. Each share of common stock and accompanying Investor Warrant was sold together at a combined offering price of $2.22
and each Pre-Funded Warrant and accompanying Investor Warrant were sold together at a combined offering price of $2.219. The Pre-Funded
Warrants were immediately exercisable, at a nominal exercise price of $0.001, and may be exercised at any time until all of the Pre-Funded
Warrants are exercised in full. The Investor Warrants have an exercise price of $2.22 per share (subject to adjustment as set forth in
the warrant), are exercisable upon issuance and will expire five years from the date of issuance.
On
April 28, 2022, the Company completed another private placement and received net proceeds of $ 16,752,915 . In connection with this private
placement, the Company issued (i) 2,472,820 shares of its common stock together with warrants (“April Warrants”) to
purchase up to 4,945,640 shares of common stock, and (ii) 2,390,025 pre-funded warrants (“Pre-Funded Warrants”)
with each Pre-Funded Warrant exercisable for one share of common stock, together with April Warrants to purchase up to 4,780,050 shares
of common stock. Each share of common stock and accompanying two April Warrants were sold together at a combined offering price of $4.01
and each Pre-Funded Warrant and accompanying two April Warrants were sold together at a combined offering price of $4.009. The Pre-Funded
Warrants were immediately exercisable, at a nominal exercise price of $0.001, and may be exercised at any time until all of the Pre-Funded
Warrants are exercised in full. The April Warrants have an exercise price of $3.76 per share (subject to adjustment as set forth in the
warrant), are exercisable upon issuance and will expire five years from the date of issuance.
On
October 20, 2022, the Company issued 3,700,000
shares of common stock as part of the acquisition of Nora Pharma. These shares were valued at $ 4,514,000 ,
or $1.22
per share.
11
On
January 19, 2023, the Company announced a stock repurchase program of up to $ 2 million under SEC Rule 10B-18. During the six months ended
June 30, 2023, the Company repurchased a total of 445,711 shares of common stock at an average price of $1.1371 per share for a total
cost of $ 506,822 . The 445,711 repurchased common shares were cancelled and returned to treasury reducing the number of issued and outstanding
shares from 22,585,632 to 22,139,921.
On
May 16, 2023, the Company completed a private placement pursuant to a securities purchase agreement with a single healthcare-focused
institutional investor for gross proceeds of approximately $ 5
million, before deducting fees to the placement agent and other offering expenses payable by the Company. The net proceeds received
by the Company were $ 4,089,218 .
In connection with the private placement, the Company issued (i) 2,450,000
shares of common stock, (ii) 3,502,381
pre-funded warrants (the “May Pre-Funded Warrants”), and (iii) 11,904,762
investor warrants (the “May Investor Warrants”) to purchase up to 11,904,762 shares of common stock at $0.59 per share.
Each share of common stock and accompanying two May Investor Warrants were sold together at a combined offering price of $0.84, and
each May Pre-Funded Warrant and accompanying two May Investor Warrants were sold together at a combined offering price of $0.839.
The May Pre-Funded Warrants are immediately exercisable, at a nominal exercise price of $0.001, and may be exercised at any time
until all of the May Pre-Funded Warrants are exercised in full. The May Investor Warrants which have an exercise price of $0.59 per
share (subject to adjustment as set forth therein), are exercisable upon issuance and will expire five and a half years from the
date of issuance.
In
2022 and the first six months of 2023, the Company issued a total of 10,789,867 shares of common stock in connection with warrant exercises
for aggregate net proceeds of $ 13,194,335 .
As
of June 30, 2023 and December 31, 2022, the Company has a total of 25,746,302 and 22,585,632 shares
of common stock issued and outstanding, respectively.
The
Company has declared no dividends since inception.
Note
8 – Warrants
The
Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10 or ASC 815-40. Under ASC 480-10, warrants
are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number
of shares. If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to
determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement
for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are
measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after
the issuance date is recorded in the consolidated statements of operations as a gain or loss. If warrants do not require liability classification
under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed
to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified
warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.
12
In
2022 and the first six months of 2023, the Company completed four financing events, and in connection therewith, it issued warrants as
follows:
Warrants issued with financing
Type
Number
Exercise Price
Expiry Date
Pre-Funded Warrants
3,692,276
$ 0.001
Unlimited
Tradeable Warrants
4,102,200
$ 2.22 *
February 2027
Investor Warrants
3,603,604
$ 2.22
March 2027
April Warrants
9,725,690
$ 3.76
April 2027
May
Pre-Funded Warrants
3,502,381
$ 0.001
Unlimited
May Investor Warrants
11,904,762
$ 0.59
November 2028
*
The
Tradeable Warrants had an initial exercise price of $4.25, subject to adjustment. Upon the closing of the Company's private placement
on March 14, 2022, the exercise price of the Tradeable Warrants was reduced to $2.22, in accordance with the terms thereof.
As
of June 30, 2023, all of the Pre-Funded Warrants and a total of 3,138,507 Tradeable Warrants, 2,802,703 Investor Warrants, and 1,156,381
May Pre-Funded Warrants were exercised resulting in aggregate proceeds of $ 13,194,335 received by the Company.
The Company’s
outstanding warrants at June 30, 2023 consisted of the following:
Schedule of outstanding warrants
Type
Number
Exercise Price
Expiry Date
Pre-Funded Warrants
None
$ 0.001
Unlimited
Tradeable Warrants
963,693
$ 2.22
February 2027
Investor Warrants
800,901
$ 2.22
March 2027
April
Warrants
9,725,690
$ 3.76
April 2027
May Pre-Funded Warrants
2,346,000
$ 0.001
Unlimited
May Investor Warrants
11,904,762
$ 0.59
November 2028
Note
9 – Net Loss Per Common Share
Basic
net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during
the period, without consideration for common stock equivalents.
Diluted
net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during
the period, taking into consideration common stock equivalents.
In
February 2022, the Company issued 4,102,200 Tradeable Warrants pursuant to the Company’s Public Offering. In March and April
2022, the Company issued 3,603,604 Investor Warrants and 9,725,690 April Warrants pursuant to two private placements. In May 2023, the
Company issued 11,904,762 May Investor Warrants pursuant
to two private placements. As of June 30, 2023, 3,138,507 Tradeable Warrants and 2,802,703 Investor Warrants were exercised, leaving
963,693 Tradeable Warrants, 800,901 Investor Warrants, 9,725,690 April Warrants, and 11,904,762 May Investor Warrants outstanding.
These warrants are dilutive and were included in the diluted earnings per share.
13
In
March and April 2022, the Company issued and sold Pre-Funded Warrants to purchase an aggregate of 3,692,276 shares of common stock at
a nominal exercise price of $0.001 per share. During the six months ended June 30, 2023, all of these warrants were exercised and therefore
had no remaining dilutive effect.
In
May 2023, the Company issued and sold May Pre-Funded Warrants to purchase an aggregate of 3,502,381
shares of common stock at a nominal exercise price of $0.001 per share. During the six months ended June
30, 2023, 1,156,381 of these warrants were exercised leaving 2,346,000 outstanding.
These warrants are dilutive and were included in the diluted earnings per share.
Note
10 – Lease
The
Company has obligations as a lessee for office space with initial non-cancellable terms in excess of one year. The Company classified
the lease as an operating lease. The lease contains a renewal option for a period of five years. Because the Company is certain to exercise
the renewal option, the optional period is included in determining the lease term, and associated payments under the renewal option are
included in the lease payments. The Company’s lease does not include termination options for either party to the lease or restrictive
financial or other covenants. Payments due under the lease contract include fixed payments plus a variable Payment. The Company’s
office space lease requires it to make variable payments for the Company’s proportionate share of building’s property taxes,
insurance, and common area maintenance. These variable lease payments are not included in lease payments used to determine lease liability
and are recognized as variable costs when incurred.
Amounts
reported on the balance sheet as of June 30, 2023 were as follows:
Schedule of lease information
Operating lease ROU asset
$ 711,059
Operating Lease liability - Short-term
$ 122,146
Operating lease liability - Long-term
$ 596,850
Remaining lease term
6 years 6 months
Discount rate
6 %
Amounts
disclosed for ROU assets obtained in exchange for lease obligations and reductions of ROU assets resulting from reductions of lease obligations
include amounts reduced from the carrying amount of ROU assets resulting from deferred rent.
Maturities
of lease liabilities under non-cancellable operating leases at June 30, 2023 are as follows:
Schedule of maturities of lease
payments
2023
$ 61,987
2024
$ 118,545
2025
$ 118,737
2026
$ 112,463
2027
$ 105,930
Thereafter
$ 201,335
14
Note
11 – Management and Director Compensation
The
Company paid its officers cash compensation totaling $ 225,000 and $ 240,000 and $ 1,045,000 and $ 510,000 for the three and six-month periods
ended June 30, 2023 and 2022, respectively.
The
Company paid its directors cash compensation totaling $ 100,000 and $ 50,000 and $ 200,000 and $ 50,000 for the three and six-month periods
ended June 30, 2023 and 2022, respectively.
Note
12 – Income Taxes
I n
calculating the provision for income taxes on an interim basis, the Company uses an estimate of the annual effective tax rate based upon
currently known facts and circumstances and applies that rate to its year-to-date earnings or losses. The Company’s effective tax
rate is based on expected income and statutory tax rates and takes into consideration permanent differences between financial statement
and tax return income applicable to the Company in the various jurisdictions in which the Company operates. The effect of discrete items,
such as changes in estimates, changes in rates or tax status, and unusual or infrequently occurring events, is recognized in the interim
period in which the discrete item occurs. The accounting estimates used to compute the provision for income taxes may change as new events
occur, additional information is obtained or as the result of new judicial interpretations or regulatory or tax law changes.
The Company’s
interim effective tax rate, inclusive of discrete items, for the three-month periods ended March 31, 2023 and 2022 was 26.83%.
Note
13 – Subsequent Events
On
January 19, 2023, the Company announced a stock repurchase program of up to $2 million. In July and August 2023, the Company
repurchased a total of 68,012 shares of common stock at an average price of approximately $0.5046 per share for a total cost of
$34,321. As of the date of this report, the repurchased shares have not been returned to treasury.
15
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion should be read in conjunction with our consolidated financial statements and notes thereto included herein. This
discussion includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. 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
and in our annual report on Form 10-K for the year ended December 31, 2022. We undertake no obligation to correct or update any forward-looking
statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law. You are
advised, however, to consult any future disclosures we make on related subjects in future reports to the SEC .
About
Sunshine Biopharma
We
are a pharmaceutical company offering and researching life-saving medicines in a wide variety of therapeutic areas, including
oncology and antivirals. In addition to conducting our own drug development operations, we operate two wholly owned subsidiaries:
(i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation with a portfolio consisting of 50 generic prescription
drugs on the market in Canada and 27 additional drugs scheduled to be launched during the next 18 months, and (ii) Sunshine
Biopharma Canada Inc. (“Sunshine Canada”), a Canadian corporation which develops and sells nonprescription
over-the-counter (“OTC”) products.
History
We
were incorporated in the State of Colorado on August 31, 2006 and on October 15, 2009 we acquired Sunshine Biopharma, Inc. in a transaction
classified as a reverse acquisition.
Sunshine
Biopharma, Inc. held an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a (the “License Agreement”).
Upon completion of the reverse acquisition transaction, we changed our name to Sunshine Biopharma, Inc. and began operating as a pharmaceutical
company.
In
December 2015, we acquired all worldwide issued (US Patent Number 8,236,935, and 10,272,065) and pending patents under PCT/FR2007/000697
and PCT/CA2014/000029 for the Adva-27a anticancer compound and terminated the License Agreement.
In
early 2020, we initiated a new R&D project focused on the development of a treatment for COVID-19 and on May 22, 2020, we filed a
provisional patent application in the United States for the new coronavirus treatment. The patent application covers composition subject
matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro. On April 30, 2021, we filed a PCT application
containing new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro.
In
June 2021, we initiated another R&D project in which we set out to determine if certain mRNA molecules can be used as anticancer
agents. The data obtained for mRNA molecules bearing the laboratory name K1.1 became the subject of a new patent application filed in
April 2022.
In
October 2022, we acquired Nora Pharma, a Canadian generic pharmaceuticals
company based in the greater Montreal area. Nora Pharma has 41 employees and operates in a 15,000 square foot facility certified by Health
Canada. Nora Pharma currently sells 50 generic prescription drugs in Canada. The consolidated financial statements contained in this report
include the results of operations of Nora Pharma and Sunshine Canada.
16
Generic
Prescription Drugs on the Market
As
a result of the acquisition of Nora Pharma we now have the following generic prescription drugs on the market in Canada:
Drug
Action/Indication
Reference
Brand
Alendronate
Osteoporosis
Fosamax®
Amlodipine
Cardiovascular
Norvasc®
Apixaban
Cardiovascular
Eliquis®
Atorvastatin
Cardiovascular
Lipitor®
Azithromycin
Antibacterial
Zithromax®
Candesartan
Hypertension
Atacand®
Candesartan HCTZ
Hypertension
Atacand®
Celecoxib
Anti-inflammatory
Celebrex®
Cetirizine
Allergy
Reactine®
Ciprofloxacin
Antibiotic
Cipro®
Citalopram
Central nervous system
Celexa®
Clindamycin
Antibiotic
Dalacin®
Clopidogrel
Cardiovascular
Plavix®
Donepezil
Central nervous system
Aricept®
Duloxetine
Central nervous system
Cymbalta®
Dutasteride
Urology
Avodart®
Escitalopram
Central nervous system
Cipralex®
Ezetimibe
Cardiovascular
Ezetrol®
Finasteride
Urology
Proscar®
Flecainide
Cardiovascular
Tambocor®
Fluconazole
Antifungal
Diflucan®
Fluoxetine
Central nervous system
Prozac®
Hydroxychloroquine
Antimalarial
Plaquenil®
Lacosamide
Central nervous system
Vimpat®
Letrozole
Oncology
Femara®
Levetiracetam
Central nervous system
Keppra®
Mirtazapine
Central nervous system
Remeron®
Metformin
Diabetes
Glucophage®
Montelukast
Allergy
Singulair®
Olanzapine ODT
Central nervous system
Zyprexa®
Olmesartan
Cardiovascular
Olmetec®
Olmesartan HCTZ
Cardiovascular
Olmetec Plus®
Pantoprazole
Acid Reflux
Pantoloc®
Paroxetine
Central nervous system
Paxil®
Perindopril
Cardiovascular
Coversyl®
Pravastatin
Cardiovascular
Pravachol®
Pregabalin
Central nervous system
Lyrica®
Quetiapine
Central nervous system
Seroquel®
Quetiapine XR
Central nervous system
Seroquel XR®
Ramipril
Cardiovascular
Altace®
Rizatriptan ODT
Central nervous system
Maxalt® ODT
Rosuvastatin
Cardiovascular
Crestor®
Sertraline
Central nervous system
Zoloft®
Sildenafil
Urology
Viagra®
Tadalafil
Urology
Cialis®
Telmisartan
Cardiovascular
Micardis®
Telmisartan HCTZ
Cardiovascular
Micardis Plus®
Tramadol Acetaminophen
Central nervous system
Tramacet®
Zolmitriptan
Central nervous system
Zomig®
Zopiclone
Central nervous system
Imovane®
17
Generic
Prescription Drugs Pipeline
In
addition to the 50 drugs on the market, we currently have the following roster of generic prescription drugs scheduled to be
launched later this year and in 2024:
Generic
Drugs
Therapeutic
Area(s)
Development
Stage
Launch
Date
Group A (7 Products)
Central
Nervous System, Gastrointestinal, Urology
Under Regulatory Review
2023Q3
Group B (1 Product)
Oncology
Under Regulatory Review
2023Q4
Group C (8 Products)
Central
Nervous System, Cardiovascular, Metabolism
Under Regulatory Review
2024Q1
Group D (5 Products)
Cardiovascular, Urology,
Endocrinology
Under Regulatory Review
2024Q2
Group E (6 Products)
Urology,
Cardiovascular, Oncology, Anti-infectives
Under Regulatory Review
2024Q3
We
believe the addition of these products to our existing portfolio will strengthen our presence in the Canadian generic drugs marketplace
and provide us with greater access to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.
Proprietary
Drugs in Development
We
are currently developing the following drug candidates:
Proprietary
Drugs
Therapeutic
Area
Development
Stage
Launch
Date
Adva-27a (Small Molecule)
Oncology (Pancreatic Cancer)
IND-Enabling Studies
TBD
K1.1 (mRNA LNP)
Oncology (Liver Cancer)
Animal Testing
TBD
SBFM-PL4 (Small Molecule)
Antiviral (COVID-19)
Animal Testing
TBD
18
Adva-27a
Anticancer Drug
Adva-27a
is a small molecule designed 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). We are the direct owner
of all patents pertaining to Adva-27a including U.S. Patents Number 8,236,935 and 10,272,065.
Adva-27a
is a GEM-difluorinated C-glycoside derivative of Podophyllotoxin. 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 however, Adva-27a has the advantage of being able to penetrate and destroy
Multidrug Resistant Cancer cells. 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 1).
Figure
1
19
In
February 2023, we signed a research agreement with the Jewish General Hospital (“JGH”), to complete the IND-enabling studies.
The JGH has also agreed to negotiate with us the terms for Phase I Clinical Trials. Adva-27a’s initial indication will be pancreatic
cancer for which there are currently little or no treatment options available. All aspects of the clinical trials in Canada will employ
FDA standards at all levels.
K1.1
Anticancer mRNA
In
June 2021, we initiated a new research project in which we set out to determine if certain mRNA molecules can be used as anti-cancer
agents. The data collected to date have shown that a selected group of mRNA molecules are capable of destroying cancer cells in vitro
including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2).
Studies using non-transformed (normal) human cells (HMEC cells) showed that these mRNA molecules had little cytotoxic effects. These
new mRNA molecules, bearing the laboratory name K1.1, are readily adaptable for delivery into patients using the mRNA vaccine technology.
In April 2022, we filed a provisional patent application in the United States covering the subject mRNA molecules.
We
recently concluded an agreement with a specialized partner for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles,
ready for use to conduct studies in xenograft mice. We anticipate commencing such studies later this year.
SBFM-PL4
Coronavirus Treatment
The
initial genome expression products following infection by Betacoronavirus,
the causative agent of COVID-19, are two large polyproteins, referred to as pp1a and pp1ab. These two polyproteins are cleaved at 15 specific
sites by two virus encoded proteases, called Mpro and PLpro, to generate 16 different non-structural proteins essential for viral replication.
Mpro and PLpro represent attractive anti-viral drug development targets as they play a central role in the early stages of viral replication.
PLpro is of particular interest as a therapeutic target in that, in addition to processing essential viral proteins, it is also responsible
for suppression of the human immune system making the virus more life-threatening. PLpro is present only in Betacoronaviruses, the subgroup
of Coronaviruses represented by the highly pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.
Our
Anti-Coronavirus research effort has been focused on developing an inhibitor of PLpro and, on May 22, 2020, we filed a patent application
in the United States covering composition subject matter pertaining to small molecules for inhibition of the Coronavirus PLpro as well
as Mpro.
In
February 2022, we expanded our PLpro inhibitors research effort by entering into a research agreement with the University of Arizona
for the purposes of conducting research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of
three University of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research
Project”). Under the agreement, the University of Arizona granted the Company a first option to negotiate a commercial, royalty-bearing
license for all intellectual property developed by University of Arizona under the Research Project. In addition, the Company and the
University of Arizona entered into an option agreement (the “Option Agreement”) whereby the Company was granted a first option
to negotiate a royalty-bearing commercial license for the underlying technology of the Research Project. On September 13, 2022, we exercised
our options, and on February 24, 2023, we entered into an exclusive worldwide license agreement with the University of Arizona for all
of the technology related to the Research Project.
With
the evolution of the COVID-19 pandemic to its current state, we have expanded our objective to develop a late-preclinical injectable
candidate of first-in-class PLpro inhibitor to treat SARS-CoV2 (and potentially SARS-CoV and MERS-CoV) infection in patients who could
not use Paxlovid, Molnupiravir, or Remdesivir, due to concerns about drug interaction and possible ‘rebound’ infections and
other side effects.
20
Intellectual
Property
We
are the sole owner of all worldwide rights pertaining to Adva-27a. These patent rights are covered by PCT/FR2007/000697 and
PCT/CA2014/000029. The patent applications filed under these two PCT's have been issued in the United States (US Patent Number
8,236,935 and 10,272,065), Europe, and Canada.
On
May 22, 2020, we filed a provisional patent application in the United States for a new treatment for Coronavirus infections. Our patent
application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro, an
enzyme that is essential for viral replication. The patent application has a priority date of May 22, 2020. On April 30, 2021, we filed
a PCT application containing new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro. The
priority date of May 22, 2020 has been maintained in the newly filed PCT application.
On
April 20, 2022, we filed a provisional patent application in the United States covering mRNA molecules capable of destroying cancer cells
in vitro. The patent application contains composition and utility subject matter pertaining to the structure and sequence of the relevant
mRNA molecules.
Our
recently acquired wholly owned subsidiary, Nora Pharma, owns 179 Drug Identification Numbers (“DIN’s”) issued by Health
Canada for prescription drugs currently on the market in Canada. These DIN’s were secured through in-licenses or cross-licenses
from international manufacturers of generic pharmaceutical products.
In
addition, we are the owner of two Natural Product Numbers (“NPN’s”) issued by Health Canada: NPN 80089663 authorizes
us to manufacture and sell our in-house developed OTC product, Essential 9™, and NPN 80093432 authorizes us to manufacture and
sell the OTC product, Calcium-Vitamin D under the brand name Essential Calcium-Vitamin D ™ .
Results
of Operations
Comparison
of results of operations for the three months ended June 30, 2023 and 2022
During
the three months ended June 30, 2023, we generated $5,560,865 in sales, compared to $150,307 for the three months ended June 30, 2022,
an increase of $5,410,558. The increase is attributable to sales generated by our recently acquired wholly owned subsidiary, Nora Pharma.
The direct cost for generating these sales was $3,608,118 (64.9%) for the three months ended June 30, 2023, compared to $74,683 (49.7%)
for the three months ended June 30, 2022. The increase in the cost of goods sold in 2023 is due to the cost of manufacturing the generic
prescription drugs sold by Nora Pharma. Our gross profit grew to $1,952,747 for the three months ended June 30, 2023, compared to $75,624
for the three months ended June 30, 2022.
General
and administrative expenses during the three-month period ended June 30, 2023 were $2,942,370, compared to $771,420 during the three-month
period ended June 30, 2022, an increase of $2,170,950. This increase was the result of increased overhead associated with being a Nasdaq
listed company and expenses related to Nora Pharma operations. Specifically, we incurred increased costs in accounting ($34,221), consulting
($290,771), office ($304,978), research and development ($322,622), salaries ($960,167) and taxes ($96,649). Overall, we incurred a loss
of $989,623 from our operations for the three months ended June 30, 2023, compared to a loss of $695,796 from our operations in the three-month
period ended June 30, 2022.
21
In
addition, we had net interest income of approximately $175,453 during the three months ended June 30, 2023, compared to a net interest
income of approximately $146,043 during the three months ended June 30, 2022, as a result of interest earned on cash on hand.
As
a result, we incurred a net loss of $902,108 ($0.02 per share) for the three months ended June 30, 2023, compared to a net loss of $538,872
($0.03 per share) for the three-month period ended June 30, 2022.
Comparison
of results of operations for the six months ended June 30, 2023 and 2022
During
the six months ended June 30 2023, we generated revenues of $10,454,918,
compared to revenue of $272,952 for the six months ended June 30, 2022, an increase of $10,181,966. The increase is attributable to sales
generated by our recently acquired wholly owned subsidiary, Nora Pharma. The direct cost for generating these revenues was $6,674,049
for the six months ended June 30, 2023 (63.8%), compared to $134,528 (49.3%) for the six months ended June 30, 2022. The increase in the
cost of goods sold in 2023 is due to the cost of manufacturing the generic prescription drugs sold by Nora Pharma. Our gross profit increased
to $3,780,869 for the six months ended June 30, 2023, compared to a gross profit of $138,424 for the same period in 2022.
General
and administrative expenses during the six-month period ended June 30, 2023 were $6,599,473 compared to $2,057,584 during the six-month
period ended June 30, 2022, an increase of $4,541,889. This increase was the result of increased overhead associated with being a Nasdaq
listed company and expenses related to Nora Pharma operations. Specifically, we incurred increased costs in accounting ($130,171), consulting
($416,888), office costs ($504,931), research and development ($393,895), salaries ($2,640,424) and taxes ($160,367). Overall, we incurred
a loss of $2,818,604 from our operations in the six-month period ended June 30, 2023, compared to a loss from operations of $1,919,160
in the similar period of 2022.
In
addition, we had net interest income of approximately $348,259 during the six months ended June 30, 2023, compared to a net interest
income of approximately $133,182 during the six months ended June 30, 2022, as a result of interest earned on cash on hand.
As
a result, we incurred a net loss of $2,604,538 ($0.09 per share) for the six-month period ended June 30, 2023, compared to a net loss
of $1,775,106 ($0.18 per share) for the six-month period ended June 30, 2022.
Liquidity
and Capital Resources
As of June 30,
2023, we had cash or cash equivalents of $19,729,491.
Net
cash used in operating activities was $5,628,146 during the six months ended June 30, 2023, compared to $1,878,010 during the six-month
period ended June 30, 2022. The increase was a result of the addition of Nora Pharma’s operations.
Cash
flows used in investing activities were $405,779 for the six months ended June 30, 2023, compared to $0 for the six months ended June
30, 2022. The increase was the result of cash invested in Nora Pharma.
Cash
flows provided by financing activities were $3,519,672 during the six
months ended June 30, 2023, compared to $41,561,363 during the six months ended June 30, 2022. The decrease was primarily as a result
of one offering made during the six months ended June 30, 2023, compared to three offerings completed in February, March, and April 2022,
and due to our purchase of $506,822 in common stock in the first quarter of 2023.
22
We
are not generating adequate revenues from our operations to fully implement our business plan as set forth herein. On February 17, 2022,
we received net proceeds of approximately $6.8 million from the sale of common stock and warrants in an underwritten public offering.
On March 14, 2022, we received net proceeds of approximately $6.8 million from the sale of common stock and warrants in a private placement.
On April 28, 2022, we received net proceeds of approximately $16.8 million from the sale of common stock and warrants in a private placement.
On May 16, 2023, we received net proceeds of approximately $4.1 million from the sale of common stock and warrants in a private placement.
We believe our existing cash will be sufficient to fund our operations, including general and administrative expenses, research and development
activities, and the generic pharmaceuticals sales business, for the next 18 to 24 months. There is no assurance our estimates will be
accurate.
Management
estimates that we will need additional capital in the amount of approximately $30 million for expansion of our drug development activities
and generic pharmaceuticals operations, including possibly a Phase I clinical trial. Additional capital may not be available on terms
acceptable to us, or at all. Currently, we do not have any firm committed arrangements for financing and can provide no assurance that
we will be able to obtain financing when required. No assurance can be given that we will obtain access to capital markets in the future
or that financing, adequate to satisfy the cash requirements of implementing our business will be available on acceptable terms. Our
inability to obtain acceptable financing could have an adverse effect upon the results of our operations and financial condition.
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.
For
a detailed list of significant accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31,
2022, including our financial statements and notes thereto included therein as filed with the SEC on April 4, 2023.
Recently
Adopted Accounting Standards
In
February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC
Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards
Update No. 2016-02, Leases (Topic 842) which amends the effective date of the original pronouncement for smaller reporting companies.
ASU 2016-13 and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after December
15, 2022. The Company believes the adoption will modify the way the Company analyzes financial instruments, but it does not anticipate
a material impact on results of operations. The Company is in the process of determining the effects adoption will have on its consolidated
financial statements.
23
In
August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging
– Contracts in Entity’s Own Equity (Subtopic 815 – 40), (“ASU 2020-06”). ASU 2020-06 simplifies the accounting
for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on
an entity’s own equity. The ASU2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim
periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including
interim periods within those fiscal years. The Company is evaluating the impact of this guidance on its unaudited consolidated financial
statements.
Off
Balance-Sheet Arrangements
None.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We
are a smaller reporting company and are not required to provide the information under this item.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our
disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under 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 Exchange Act
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 effective as
of June 30, 2023, at reasonable assurance levels.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting during the quarter ended June 30, 2023, that have materially affected,
or are reasonably likely to materially affect, our internal control over financial reporting.
24
PART
II. OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
We are not party
to, and our property is not the subject of, any material legal proceedings.
ITEM
1A. RISK FACTORS
We
are a smaller reporting company and are not required to provide the information under this item.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
Applicable.
ITEM
5. OTHER INFORMATION
None.
ITEM
6. EXHIBITS
Exhibit
No.
Description
31.1
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
31.2
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2022 *
32.1
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 **
101
Inline XBRL Document Set
for the financial statements and accompanying notes in Part I, Item 1, of this Quarterly Report on Form 10-Q.*
104
Inline XBRL for the cover
page of this Quarterly Report on Form 10-Q, included in the Exhibit 101 Inline XBRL Document Set.*
*
Filed herewith.
**
Furnished herewith.
25
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized, on August 10, 2023.
SUNSHINE BIOPHARMA, INC.
By:
/s/ Dr. Steve
N. Slilaty
Dr. Steve N. Slilaty
Chief Executive Officer (principal executive officer)
By:
/s/
Camille Sebaaly
Camille
Sebaaly
Chief Financial
Officer (principal financial and accounting officer)
26
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.