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: September 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 November 13, 2023, was 25,678,290
shares.
TABLE
OF CONTENTS
Page
PART I. FINANCIAL INFORMATION
Item 1.
Financial Statements
3
Consolidated Balance Sheet as of
September 30, 2023 (Unaudited) and December 31, 2022
3
Consolidated Statements of
Operations for the Nine Months Ended September 30, 2023 and 2022 (Unaudited)
4
Consolidated Statements of Cash Flows
for the Nine Months Ended September 30, 2023 and 2022 (Unaudited)
5
Consolidated Statement of
Shareholders' Equity for the Nine Months Ended September 30, 2023 and 2022 (Unaudited)
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
September 30,
December 31,
2023
2022
(Unaudited)
ASSETS
Current Assets:
Cash and cash
equivalents
$ 18,846,140
$ 21,826,437
Accounts receivable
2,034,119
1,912,153
Inventory
4,517,044
3,289,945
Prepaid
expenses
37,556
283,799
Total Current Assets
25,434,859
27,312,334
Property and equipment
334,922
394,249
Intangible assets
1,216,207
776,856
Right-of-use-asset
664,296
760,409
TOTAL
ASSETS
$ 27,650,284
$ 29,243,848
LIABILITIES
Current Liabilities:
Accounts payable and accrued
expenses
$ 2,220,870
$ 2,802,797
Earnout payable
2,547,831
3,632,000
Income tax payable
201,541
373,191
Right-of-use-liability
117,840
123,026
Total Current Liabilities
5,088,082
6,931,014
Long-Term Liabilities:
Deferred tax liability
43,032
43,032
Right-of-use-liability
555,687
642,232
Total Long-Term Liabilities
598,719
685,264
TOTAL
LIABILITIES
5,686,801
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; 25,678,290 and 22,585,632 shares issued and outstanding as of
September 30, 2023 and December 31, 2022, respectively
25,678
22,585
Capital
paid in excess of par value
84,387,890
80,841,752
Accumulated
comprehensive income
204,549
161,847
Accumulated
(Deficit)
( 62,655,634 )
( 59,399,614 )
TOTAL
SHAREHOLDERS' EQUITY
21,963,483
21,627,570
TOTAL
LIABILITIES AND SHAREHOLDERS' EQUITY
$ 27,650,284
$ 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 September 30,
9
Months Ended September 30,
2023
2022
2023
2022
Sales
$ 5,957,668
$ 132,808
$ 16,412,586
$ 405,760
Cost of sales
3,967,412
65,783
10,641,461
200,311
Gross profit
1,990,256
67,025
5,771,125
205,449
General and Administrative Expenses:
Accounting
56,350
122,913
301,381
237,773
Consulting
221,781
162,852
745,850
270,033
Director fees
100,000
100,000
300,000
200,000
Legal
133,302
146,467
392,874
403,386
Marketing
241,897
217,666
502,987
400,386
Office
544,215
76,818
1,422,058
449,730
R&D
238,012
362,500
1,039,502
770,095
Salaries
1,144,377
595,000
4,344,801
1,105,000
Taxes
52,586
–
212,953
–
Depreciation
37,210
789
106,797
6,186
Total General and Administrative
Expenses:
2,769,730
1,785,005
9,369,203
3,842,589
(Loss) from operations
( 779,474 )
( 1,717,980 )
( 3,598,078 )
( 3,637,140 )
Other Income (Expense):
Foreign exchange
40
25
( 206 )
45
Interest income
207,431
260,938
624,361
406,984
Debt release
–
–
–
10,852
Interest
expense
( 38,527 )
( 2 )
( 107,198 )
( 12,866 )
Total Other Income (Expense)
168,944
260,961
516,957
405,015
Net (loss) before income taxes
( 610,530 )
( 1,457,019 )
( 3,081,121 )
( 3,232,125 )
Provision for income taxes
( 40,952 )
–
( 174,899 )
–
Net (Loss)
$ ( 651,482 )
$ ( 1,457,019 )
$ ( 3,256,020 )
$ ( 3,232,125 )
Gain (Loss) from foreign
exchange translation
( 460,507 )
( 45,126 )
42,702
( 56,764 )
Comprehensive (Loss)
$ ( 1,111,989 )
$ ( 1,502,145 )
$ ( 3,213,318 )
$ ( 3,288,889 )
Basic (Loss) per common share
$ ( 0.04 )
$ ( 0.08 )
$ ( 0.133 )
$ ( 0.26 )
Weighted Average Common
Shares Outstanding (Basic and Diluted)
25,690,449
18,885,632
24,507,122
12,789,733
The
accompanying notes are an integral part of these unaudited financial statements
4
Sunshine
Biopharma, Inc.
Consolidated
Statements of Cash Flows (Unaudited)
September 30,
September 30,
2023
2022
Cash Flows From Operating Activities:
Net (Loss)
$ ( 3,256,020 )
$ ( 3,232,125 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
106,794
6,186
Foreign exchange
( 374 )
45
Debt release
–
( 10,852 )
Accounts receivable
( 118,482 )
7,776
Inventory
( 1,221,112 )
( 163,991 )
Prepaid expenses
247,977
2,235
Accounts payable and accrued expenses
( 587,973 )
437,267
Income tax payable
( 172,076 )
–
Interest payable
( 1,084,169 )
( 48,287 )
Net Cash Flows (Used) in Operations
( 6,085,435 )
( 3,001,746 )
Cash Flows From Investing Activities:
Reduction in Right-of-use asset
97,498
–
Purchase of intangible assets
( 19,804 )
–
Purchase of equipment
( 464,614 )
–
Net Cash Flows (Used) in Investing Activities
( 386,920 )
–
Cash Flows From Financing Activities:
Common stock issued
4,089,218
43,560,363
Exercise of warrants
1,156
–
Purchase of treasury stock
( 541,143 )
( 99,000 )
Lease liability
( 93,125 )
–
Payments of notes payable
–
( 1,900,000 )
Net Cash Flows Provided by Financing Activities
3,456,106
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
( 3,016,249 )
38,559,617
Effect of exchange rate changes on cash
–
( 105,617 )
Foreign currency translation adjustment
35,952
56,764
Cash and Cash Equivalents at End of Period
$ 18,846,140
$ 40,555,931
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 September
30, 2023
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
Repurchase
stock
( 68,012 )
( 68 )
( 34,253 )
–
–
–
–
–
Net (loss)
–
–
–
–
–
( 460,507 )
( 651,482 )
( 1,111,989 )
Balance
at September 30, 2023
25,678,290
$ 25,678
$ 84,387,890
10,000
$ 1,000
$ 204,549
$ ( 62,655,634 )
$ 21,963,483
Nine Month Period Ended September
30, 2023
Balance
December 31, 2022
22,585,632
$ 22,585
$ 80,841,752
10,000
$ 1,000
$ 161,847
$ ( 59,399,614 )
$ 21,627,570
Repurchase
of common stock
( 513,723 )
( 514 )
( 540,629 )
–
–
–
–
–
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)
–
–
–
–
–
42,702
( 3,256,020 )
( 3,213,318 )
Balance
at September 30, 2023
25,678,290
$ 25,678
$ 84,387,890
10,000
$ 1,000
$ 204,549
$ ( 62,655,634 )
$ 21,963,483
Three Month Period Ended September
30, 2022
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
Net (loss)
–
–
–
–
–
( 45,126 )
( 1,457,019 )
( 1,502,145 )
Balance
at September 30, 2022
18,885,632
$ 18,886
$ 76,331,451
10,000
$ 1,000
$ ( 79,903 )
$ ( 35,887,299 )
$ 40,384,135
Nine Month Period Ended September
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)
–
–
–
–
–
( 56,764 )
( 3,232,125 )
( 3,288,889 )
Balance
at September 30, 2022
18,885,632
$ 18,886
$ 76,331,451
10,000
$ 1,000
$ ( 79,903 )
$ ( 35,887,299 )
$ 40,384,135
The
accompanying notes are an integral part of these unaudited financial statements
6
Sunshine
Biopharma, Inc.
Notes to
Unaudited Consolidated Financial Statements
For the
Nine Months Ended September 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 of pharmaceutical products consisting of 51 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. In addition to the 51 generic prescription drugs currently
on the market in Canada, the Company has 32 additional generic prescription drugs scheduled to be launched in 2024 and 2025 in Canada.
The
Company has determined that it has two reportable segments:
·
Prescription
Generic Pharmaceuticals (“Generic Pharmaceuticals”)
·
Nonprescription
Over-The-Counter Products (“OTC Products)
Through December 31, 2022 and as of September
30, 2023, sales from the Generic Pharmaceuticals segment represented approximately 97 % of total revenues of the Company while the remaining
approximately 3 % was generated from the sale of OTC Products. Based on these results, the Company deems segmentation reporting to be immaterial
at September 30, 2023.
The Company is not subject to material customer
concentration risks as it sells its products directly to pharmacies in several Canadian Provinces. Provincial governments in Canada reimburse
patients for their prescription drugs expenditures to various degrees under drug reimbursement programs, making generic drugs prices
highly dependent on government regulations which may change over time. The most recent negotiations between the pan-Canadian Pharmaceutical
Alliance and the Canadian Generic Pharmaceutical Association have resulted in updated generic pricing for certain products which took
effect on October 1, 2023. The updated prices are valid for three years and the agreement contains an option to extend for an additional
two years.
In
addition, the Company is engaged in the development of the following proprietary drugs:
· Adva-27a,
a small chemotherapy molecule for treatment of pancreatic cancer (IND-enabling studies were paused on November 2, 2023 due to unfavorable
results. See Note 13 – Subsequent Events )
· K1.1
mRNA, a lipid nano-particle (LNP) targeted for liver cancer
· SBFM-PL4,
a protease inhibitor for treatment of Coronavirus infections
7
Note
2 – Basis of Presentation
The
unaudited financial statements of the Company for the nine months periods ended September 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 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) 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.
As of September 30, 2023, a total of 1,156,381
May Pre-Funded Warrants and no May Investor Warrants have been exercised. The net proceeds received from the exercise of May Pre-Funded
Warrants were $ 1,156 .
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), $ 14,346,637
of which was paid in cash and the remainder was paid through 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:
Schedule of 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 nine-month period ended September 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 September 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:
Schedule of 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 September 30, 2023:
Schedule of intangible assets
Balance June 30, 2023
$ 1,233,570
Dossier fee additions
13,905
Balance at September 30, 2023
1,247,475
Less accumulated amortization
( 31,268 )
Finite-lived intangible
assets, net, at September 30, 2023
$ 1,216,207
Balance December 31, 2022
$ 776,856
Dossier fee additions
470,619
Balance at September 30, 2023
1,247,475
Less accumulated amortization
( 31,268 )
Finite-lived intangible
assets, net, at September 30, 2023
$ 1,216,207
Amortization
expense for the three months period ended September 30, 2023, and the nine months period ended September 30, 2023, amounted to $ 10,797
and $ 26,746 , respectively.
As
of September 30, 2023, estimated amortization expense of the Company’s intangible assets for each of the next five years is as follows:
Schedule of estimated amortization expense
2024
$ 55,418
2025
55,418
2026
54,240
2027
15,599
2028
7,370
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 common stock, par value $ 0.001 ,
and 30,000,000
shares of preferred stock, $ 0.10
par value. As of December 31, 2022 and September 30, 2023, 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
September 30, 2023 and December 31, 2022, 10,000
shares of Series B Preferred Stock are outstanding and held by the Company’s chief executive officer.
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 could not be voted pursuant to a warrant agent agreement relating to the
Tradeable Warrants (the “Warrant Agent Agreement”). On October 12, 2023, the Company held a special meeting of the
holders of the outstanding Tradeable Warrants in which the holders of the majority of the outstanding Tradeable Warrants approved an
amendment to the Warrant Agent Agreement to eliminate the provision that prohibited the Company’s CEO from exercising his
voting rights under the Series B Preferred Stock, as well as to lower the exercise price of the Tradeable Warrants to $ 0.11 . The
Company entered into the amendment to the Warrant Agent Agreement on October 18, 2023.
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 (“Stock Repurchase
Program”). 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 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) 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 .
In
July 2023, the Company repurchased a total of 68,012 shares of common stock on the open market under the Stock Repurchase Program announced
on January 19, 2023, at an average price of $0.5046 per share for a total cost of $ 34,321 . In October 2023, the 68,012 repurchased common
shares were cancelled and returned to treasury reducing the number of issued and outstanding shares from 25,746,302 to 25,678,290.
As
of September 30, 2023 and December 31, 2022, the Company has a total of 25,678,290 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 during the first nine months of 2023, the Company completed four financing events, and in connection therewith, it
issued warrants as follows:
Schedule of 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 September 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 September 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
*
On
October 12, 2023, the Company held a special meeting of the holders of its outstanding Tradeable Warrants in which a majority of the
holders approved an amendment to the Warrant Agent Agreement to reduce the exercise price of the Tradeable Warrants to $0.11 per warrant.
The amendment was executed on October 18, 2023.
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.
13
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 September 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.
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 nine months ended September 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 nine months ended September 30, 2023, 1,156,381
of these warrants were exercised leaving 2,346,000
outstanding. These warrants were not included in the calculation
of weighted average outstanding shares as they would be ant-dilutive.
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 September 30, 2023 were as follows:
Schedule of lease information
Operating lease ROU asset
$ 664,296
Operating Lease liability - Short-term
$ 117,840
Operating lease liability - Long-term
$ 555,687
Remaining lease term
6 years 3 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.
14
Maturities
of lease liabilities under non-cancellable operating leases at September 30, 2023 are as follows:
Schedule of maturities of lease liabilities
2023
$
30,124
2024
116,090
2025
116,277
2026
110,134
2027
103,736
Thereafter
197,166
Note
11 – Management and Director Compensation
The
Company paid its officers cash compensation totaling $ 245,000 and $ 362,500 and $ 1,290,000 and $ 770,095 for the three and nine-month periods
ended September 30, 2023 and 2022, respectively.
The
Company paid its directors cash compensation totaling $ 100,000 and $ 300,000 and $ 100,000 and $ 200,000 for the three and nine-month periods
ended September 30, 2023 and 2022, respectively.
Note
12 – Income Taxes
In
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 nine-month periods ended September 30, 2023 and 2022 was 26.83 %.
Note
13 – Subsequent Events
On
October 12, 2023, the Company held a special meeting of the holders of its outstanding Tradeable Warrants in which the holders of the
majority of the outstanding Tradeable Warrants approved an amendment to the Warrant Agent Agreement to (i) reduce the exercise price
of the Tradeable Warrants to $0.11, subject to further adjustment as provided therein, and (ii) eliminate the provision that prohibits
the Company’s CEO from exercising his voting rights under his Series B Preferred Stock.
In
December 2022, the Company had entered into a research agreement with the Jewish General Hospital (“JGH”), Montreal, Canada
to conduct IND-enabling studies of the Company’s anticancer drug candidate, Adva-27a (the “Research Agreement”). In
August 2023, the Company was advised by JGH that the lab results on testing of the Adva-27a molecule were not favorable. After conclusion
of an internal review of the lab results on November 2, 2023, the Company provided notice of termination of the Research Agreement, which
will become effective on December 2, 2023, pursuant to the terms of the Research Agreement. The Company has now paused the IND-enabling
studies of Adva-27a pending a review of the possibility of chemical modification of the compound to address the suboptimal performance
of the molecule in certain studies.
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 pursuing our own drug development program, we
operate two wholly owned subsidiaries: (i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation with a portfolio consisting
of 51 generic prescription drugs on the market in Canada and 32 additional drugs scheduled to be launched in Canada in 2024 and 2025,
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 51 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 Plus®
Celecoxib
Anti-inflammatory
Celebrex®
Cetirizine
Allergy
Reactine®
Ciprofloxacin
Antibiotic
Cipro®
Citalopram
Central nervous system
Celexa®
Clindamycin
Antibiotic
Dalacin®
Clopidogrel
Cardiovascular
Plavix®
Dapagliflozin
Diabetes
Forxiga®
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®
Olmesartan
Cardiovascular
Olmetec®
Olmesartan HCTZ
Cardiovascular
Olmetec Plus®
Pantoprazole
Gastroenterology
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®
Topiramate
Anticonvulsant
Topamax®
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 51 drugs on the market, we currently have the following
roster of generic prescription drugs scheduled to be launched in 2024 and 2025:
Generic
Drugs
Therapeutic
Area(s)
Development
Stage
Launch
Date
Group A (2 Products)
Cardiovascular,
CNS*
Under manufacturing
2024Q1
Group B (6 Products)
Oncology, Gastroenterology,
CNS*
Under regulatory review
2024Q2
Group C (3 Products)
Central Nervous System,
Diabetes , CNS*
Under regulatory review
2024Q3
Group D (5 Products)
Cardiovascular, Urology,
Endocrinology
Under regulatory review
2024Q4
Group E (16 Products)
Cardiovascular, Oncology,
Anti-infectives, Anti-inflammatory, Diabetes, Gastroenterology, CNS*
Soon to be under regulatory
review
2025
* Central Nervous
System
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)
See Note
9 - Subsequent Events
TBD*
K1.1 (mRNA LNP)
Oncology (Liver Cancer)
Preclinical
TBD*
SBFM-PL4 (Small Molecule)
Antiviral (COVID-19)
Preclinical
TBD*
*
To be determined
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.
In
December 2022, we entered into a research agreement with the Jewish General Hospital (“JGH”), to conduct the IND-enabling
studies of Adva-27a (the “Research Agreement”). In August 2023, we were informed by the JGH that the lab results on testing
of the Adva-27a molecule were not favorable. After conclusion of an internal review of the lab results on November 2, 2023, we provided
notice to JGH of termination of the Research Agreement. We have now paused the IND-enabling studies of Adva-27a pending a review of the
possibility of chemical modification of the compound to address the suboptimal performance of the molecule in certain studies.
18
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.
We
have recently expanded our objective to include the development of an 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.
19
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 wholly owned subsidiary, Nora Pharma, owns 180 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 September 30, 2023 and 2022
During
the three months ended September 30, 2023, we generated $5,957,668 in sales, compared to $132,808 for the three months ended September
30, 2022, an increase of $5,824,860. The increase is attributable to sales generated by our wholly owned subsidiary,
Nora Pharma. The direct cost for generating these sales was $3,967,412 (66.6%) for the three months ended September 30, 2023, compared
to $65,783 (49.5%) for the three months ended September 30, 2022. The increase in the cost of goods sold in 2023 is due to increased
cost of manufacturing of the generic prescription drugs sold by Nora Pharma. Our gross profit grew to $1,990,256 for the three months
ended September 30, 2023, compared to $67,025 for the three months ended September 30, 2022.
General
and administrative expenses during the three-month period ended September 30, 2023, were $2,769,730, compared to $1,785,005 during the
three-month period ended September 30, 2022, an increase of $984,725. 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 consulting
($58,929), office ($467,397), salaries ($549,377) and taxes ($52,586). Overall, we incurred a loss of $779,474 from our operations for
the three months ended September 30, 2023, compared to a loss of $1,717,980 from our operations in the three-month period ended September
30, 2022.
20
In
addition, we had net interest income of $168,904 during the three months ended September 30, 2023, compared to a net interest income
of approximately $260,936 during the three months ended September 30, 2022, as a result of interest earned on cash on hand.
As
a result, we incurred a net loss of $651,482 ($0.04 per share) for the three months ended September 30, 2023, compared to a net loss
of $1,457,019 ($0.08 per share) for the three-month period ended September 30, 2022.
Comparison
of results of operations for the nine months ended September 30, 2023 and 2022
During
the nine months ended September 30 2023, we generated revenues of $16,412,586, compared to revenues of $405,760 for the nine months ended
September 30, 2022, an increase of $16,006,826. The increase is attributable to sales generated by our recently acquired wholly owned
subsidiary, Nora Pharma. The direct cost for generating these revenues was $10,641,461 (64.8%) for the nine months ended September 30,
2023, compared to $200,311 (49.4%) for the nine months ended September 30, 2022. The increase in the cost of goods sold in 2023 is due
to increased cost of manufacturing of the generic prescription drugs sold by Nora Pharma. Our gross profit increased to $5,771,125 for
the nine months ended September 30, 2023, compared to a gross profit of $205,449 for the same period in 2022.
General
and administrative expenses during the nine-month period ended September 30, 2023 were $9,369,203 compared to $3,842,589 during the nine-month
period ended September 30, 2022, an increase of $5,526,614. 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 ($63,608),
consulting ($475,817), office costs ($972,328), research and development ($269,407), salaries ($3,239,801) and taxes ($212,953). Overall,
we incurred a loss of $3,598,078 from our operations in the nine-month period ended September 30, 2023, compared to a loss from operations
of $3,637,140 in the similar period of 2022.
In
addition, we had net interest income of $517,163 during the nine months ended September 30, 2023, compared to a net interest income of
$394,118 during the nine months ended September 30, 2022, as a result of interest earned on cash on hand.
As
a result, we incurred a net loss of $3,256,020 ($0.12 per share) for the nine-month period ended September 30, 2023, compared to a net
loss of $3,232,125 ($0.26 per share) for the nine-month period ended September 30, 2022.
Liquidity
and Capital Resources
As of September
30, 2023, we had cash or cash equivalents of $18,846,140.
Net
cash used in operating activities was $6,085,435 during the nine months ended September 30, 2023, compared to $3,001,746 during the nine-month
period ended September 30, 2022. The increase was a result of the addition of Nora Pharma’s operations.
Cash
flows used in investing activities were $386,920 for the nine months ended September 30, 2023, compared to $0 for the nine months ended
September 30, 2022. The increase was the result of cash invested in Nora Pharma.
Cash
flows provided by financing activities were $3,456,106 during the nine months ended September 30, 2023, compared to $41,561,363 during
the nine months ended September 30, 2022. The decrease was primarily as a result of one offering made during the nine months ended September
30, 2023, compared to three offerings completed in February, March, and April 2022, and due to our repurchase of a total of $540,629
in common stock in the first and third quarter of 2023.
21
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 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.
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.
23
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 September 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 September 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 November 13, 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.