SUNSHINE BIOPHARMA INC. Form 10-Q
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, 2024
☐ 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.)
333
Las Olas Way
CU4 Suite 433
Fort Lauderdale ,
FL 33301
(Address of principal
executive offices)
954 - 330-0684
(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
SBFM
The NASDAQ Stock Market LLC
Common Stock Purchase Warrants
SBFMW
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 5, 2024, was 1,999,660
shares.
TABLE OF CONTENTS
Page
PART I. FINANCIAL INFORMATION
Item 1.
Financial Statements
3
Consolidated Balance Sheets as of September 30, 2024 (Unaudited) and December 31, 2023
3
Consolidated Statements of Operations for the Nine Months Ended September 30, 2024 and 2023 (Unaudited)
4
Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023 (Unaudited)
5
Consolidated Statement of Shareholders' Equity for the Nine Months Ended September 30, 2024 and 2023 (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
22
Item 4.
Controls and Procedures
22
PART II. OTHER INFORMATION
Item 1.
Legal Proceedings
23
Item 1A.
Risk Factors
23
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
23
Item 3.
Defaults Upon Senior Securities
23
Item 4.
Mine Safety Disclosures
23
Item 5.
Other Information
23
Item 6.
Exhibits
23
Signatures
24
2
PART I. FINANCIAL
INFORMATION
ITEM 1. FINANCIAL
STATEMENTS
Sunshine Biopharma Inc.
Consolidated Balance Sheets
September 30,
December 31,
2024
2023
(Unaudited)
ASSETS
Current Assets:
Cash and cash equivalents
$ 12,206,655
$ 16,292,347
Accounts receivable
3,218,682
2,552,362
Inventory
9,820,730
5,734,755
Prepaid expenses
735,796
310,591
Total Current Assets
25,981,863
24,890,055
Long-Term Assets:
Property & equipment
590,801
365,868
Intangible assets
2,942,684
1,444,259
Right-of-use-asset
541,468
646,779
Total Long-Term Assets
4,074,953
2,456,906
TOTAL ASSETS
$ 30,056,816
$ 27,346,961
LIABILITIES
Current Liabilities:
Accounts payable & accrued expenses
$ 4,157,253
$ 2,585,466
Earnout payable
–
2,547,831
Income tax payable
254,971
299,869
Current portion - right-of-use-liability
116,253
118,670
Total Current Liabilities
4,528,477
5,551,836
Long-Term Liabilities:
Deferred tax liability
48,729
48,729
Right-of-use-liability
440,298
539,035
Total Long-Term Liabilities
489,027
587,764
TOTAL LIABILITIES
5,017,504
6,139,600
SHAREHOLDERS' EQUITY
Preferred Stock, Series B $ 0.10
par value per share; 1,000,000
shares authorized; 130,000
and 10,000
shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively
13,000
1,000
Common Stock, $ 0.001 par value per share; 3,000,000,000 shares authorized; 1,999,660 and
14,012 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively
2,000
14
Capital paid in excess of par value
91,737,284
84,415,900
Accumulated comprehensive income
168,590
696,105
Accumulated (Deficit)
( 66,881,562 )
( 63,905,658 )
TOTAL SHAREHOLDERS' EQUITY
25,039,312
21,207,361
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
$ 30,056,816
$ 27,346,961
See Accompanying Notes To These Financial Statements
3
Sunshine Biopharma Inc.
Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
3 Months Ended
September 30,
9 Months Ended
September 30,
2024
2023
2024
2023
Sales
$ 8,435,178
$ 5,957,668
$ 25,279,291
$ 16,412,586
Cost of sales
5,569,027
3,967,412
17,702,546
10,641,461
Gross profit
2,866,151
1,990,256
7,576,745
5,771,125
General & Administrative Expenses:
Accounting
124,772
56,350
565,172
301,381
Consulting
475,032
221,781
576,481
745,850
Director fees
100,000
100,000
300,000
300,000
Legal
118,311
133,302
563,745
392,874
Marketing
282,745
241,897
737,116
502,987
Office
530,334
544,215
2,203,970
1,422,058
R&D
126,362
238,012
784,630
1,039,502
Salaries
2,093,850
1,144,377
5,183,738
4,344,801
Taxes
56,471
52,586
278,177
212,953
Depreciation
64,627
37,210
158,115
106,797
Total General & Administrative Expenses:
3,972,504
2,769,730
11,351,144
9,369,203
(Loss) from operations
( 1,106,353 )
( 779,474 )
( 3,774,399 )
( 3,598,078 )
Other Income (Expense):
Foreign exchange (loss)
15,153
40
295,921
( 206 )
Interest income
108,614
207,431
396,698
624,361
Interest expense
–
( 38,527 )
( 245 )
( 107,198 )
Total Other Income (Expense)
123,767
168,944
692,374
516,957
Net (loss) before income taxes
( 982,586 )
( 610,530 )
( 3,082,025 )
( 3,081,121 )
Provision for income taxes
( 215,217 )
( 40,952 )
106,121
( 174,899 )
Net (Loss)
$ ( 1,197,803 )
$ ( 651,482 )
$ ( 2,975,904 )
$ ( 3,256,020 )
Comprehensive Income (Loss):
Gain (Loss) from foreign exchange translation
851,640
( 460,507 )
( 527,515 )
42,702
Comprehensive Income (Loss)
$ ( 346,163 )
$ ( 1,111,989 )
$ ( 3,503,419 )
$ ( 3,213,318 )
Basic and fully diluted (Loss) per common share
$ ( 0.94 )
$ ( 50.72 )
$ ( 13.61 )
$ ( 265.71 )
Weighted Average Common Shares Outstanding (Basic)
1,267,565
12,845
218,634
12,254
See Accompanying Notes To These Financial Statements
4
Sunshine Biopharma Inc.
Consolidated Statements of Cash Flows
(Unaudited)
September 30,
September 30,
2024
2023
Cash Flows From Operating Activities:
Net (Loss)
$ ( 2,975,904 )
$ ( 3,256,020 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
158,128
106,794
Foreign Exchange
–
( 374 )
Stock issued for services
12,000
–
Accounts receivable
( 1,321,173 )
( 118,482 )
Inventory
( 4,201,955 )
( 1,221,112 )
Prepaid expenses
251,391
247,977
Accounts Payable & accrued expenses
2,229,074
( 587,973 )
Earn-out payable
( 2,547,831 )
( 172,076 )
Income tax payable
( 727,628 )
( 1,084,169 )
Net Cash Flows (Used In) Operating Activities
( 9,123,898 )
( 6,085,435 )
Cash Flows From Investing Activities:
Reduction in right-of-use asset
92,231
97,498
Purchase of intangible assets
( 327,088 )
( 19,804 )
Purchase of equipment
( 1,554,455 )
( 464,614 )
Net Cash Flows (Used In) Investing Activities
( 1,789,312 )
( 386,920 )
Cash Flows From Financing Activities:
Proceeds from public offering net (common stock)
8,522,411
4,089,218
Exercise of warrants
1,940,610
1,156
Purchase of treasury stock
( 3,139,651 )
( 541,143 )
Lease liability
( 87,852 )
( 93,125 )
Net Cash Flows Provided by Financing Activities
7,235,518
3,456,106
Cash and Cash Equivalents at Beginning of Period
16,292,347
21,826,437
Net increase (decrease) in cash and cash equivalents
( 3,677,692 )
( 3,016,249 )
Foreign currency translation adjustment
( 408,000 )
35,952
Cash and Cash Equivalents at End of Period
$ 12,206,655
$ 18,846,140
Supplementary Disclosure of Cash Flow Information:
Cash paid for income taxes
$ 956,012
$ –
Stock issued for services
$ 12,000
$ –
See Accompanying Notes To These Financial Statements
5
Sunshine Biopharma Inc.
Consolidated Statements of Shareholders'
Equity (Unaudited)
Three
Months
Number Of Common Shares
Common
Capital Paid in Excess
of Par
Treasury
Number Of Preferred Shares
Preferred
Comprehensive
Accumulated
Periods
Issued
Stock
Value
Stock
Issued
Stock
Income
Deficit
Total
Balance
June 30, 2024
1,170,510
1,171
$ 89,842,503
$ –
130,000
$ 13,000
$ ( 683,050 )
$ ( 65,683,759 )
$ 23,489,865
Exercise of warrants
829,150
829
1,894,781
–
–
–
–
–
1,895,610
Net
(loss)
–
–
–
–
–
–
851,640
( 1,197,803 )
( 346,163 )
Balance
at September 30, 2024
1,999,660
$ 2,000
$ 91,737,284
$ –
130,000
13,000
$ 168,590
$ ( 66,881,562 )
25,039,312
Balance June 30,
2023
12,873
$ 13
$ 84,447,876
$ –
10,000
$ 1,000
$ 665,056
$ ( 62,004,152 )
$ 23,109,793
Repurchase stock
( 34 )
–
( 34,321 )
–
–
–
–
–
( 34,321 )
Net
(loss)
–
–
–
–
–
–
( 460,507 )
( 651,482 )
( 1,111,989 )
Balance
at September 30, 2023
12,839
$ 13
$ 84,413,555
$ –
10,000
$ 1,000
$ 204,549
$ ( 62,655,634 )
$ 21,963,483
Nine Months
Periods
Balance December
31, 2023
14,012
14
$ 84,415,900
$ –
10,000
$ 1,000
$ 696,105
$ ( 63,905,658 )
$ 21,207,361
Preferred Stock
issued to related party
–
–
–
–
120,000
12,000
–
–
12,000
Common stock and
pre-funded warrants issued in an underwritten offering
13,214
13
8,522,398
–
–
–
–
–
8,522,411
Exercise of warrants
1,972,434
1,973
1,938,637
–
–
–
–
–
1,940,610
Repurchase of warrants
–
–
( 3,139,651 )
–
–
–
–
–
( 3,139,651 )
Net
(loss)
–
–
–
–
–
–
( 527,515 )
( 2,975,904 )
( 3,503,419 )
Balance
at September 30, 2024
1,999,660
$ 2,000
$ 91,737,284
$ –
130,000
13,000
$ 168,590
$ ( 66,881,562 )
25,039,312
Balance December
31, 2022
11,293
$ 11
$ 80,864,326
$ –
10,000
$ 1,000
$ 161,847
$ ( 59,399,614 )
$ 21,627,570
Repurchase stock
( 257 )
–
( 541,143 )
–
–
–
–
–
( 541,143 )
Common stock and
prefunded warrants issued in a private offering
1,225
1
4,089,217
–
–
–
–
–
4,089,218
Exercise of warrants
578
1
1,155
–
–
–
–
–
1,156
Net
(loss)
–
–
–
–
–
–
42,702
( 3,256,020 )
( 3,213,318 )
Balance
at September 30, 2023
12,839
$ 13
$ 84,413,555
$ –
10,000
$ 1,000
$ 204,549
$ ( 62,655,634 )
$ 21,963,483
See Accompanying Notes To These Financial Statements
6
Sunshine Biopharma Inc.
Notes to Unaudited Consolidated Financial
Statements
For the Nine Months Ended September
30, 2024 and 2023
Note 1 – Description
of Business
The Company was
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, the Company changed its name to Sunshine Biopharma Inc. and began operating as a pharmaceutical company.
Sunshine Biopharma
operates two wholly owned subsidiaries: (i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation with a portfolio of
pharmaceutical products consisting of 63 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 determined that it has
two reportable segments:
·
Prescription Generic Pharmaceuticals
(“Generic Pharmaceuticals”)
·
Nonprescription Over-The-Counter
Products (“OTC Products)
Through September
30, 2024, 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, 2024.
The Company is not
subject to material customer concentration risks as it sells its products directly to pharmacies in several Canadian provinces. However,
in Canada provincial governments reimburse patients for their prescription drugs expenditures to various degrees under drug reimbursement
programs, making generic drugs prices highly dependent on governmental policies which may change over time. The most recent negotiations
between the pan-Canadian Pharmaceutical Alliance and the Canadian Generic Pharmaceutical Association 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 may
be extended 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)
·
K1.1 mRNA, a lipid nano-particle
(LNP) targeted for liver cancer
·
SBFM-PL4, a protease inhibitor
for treatment of SARS Coronavirus infections
7
Note 2 – Basis
of Presentation
The unaudited consolidated
financial statements of the Company for the three and nine month periods ended September 30, 2024 and 2023, 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, 2023, was derived from the audited financial
statements included in the Company's financial statements as of and for the year ended December 31, 2023, included in the Company’s
Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2024. These financial
statements should be read in conjunction with that report.
On April 17, 2024
and August 8, 2024, the Company completed 1-for-100 and 1-for-20 reverse splits of its common stock, respectively (the “Reverse
Splits”). The share amounts, warrants, and related parameters specified in this report have been adjusted to reflect both Reverse
Splits on a retroactive basis.
Note 3 – Underwritten
Public Offering
On February 15,
2024, the Company completed an underwritten public offering for gross proceeds of approximately $ 10 million, before deducting fees to
the underwriter and other offering expenses payable by the Company. The net proceeds received by the Company were $ 8,522,411 .
The offering consisted
of 35,714 Units, consisting of (i) 13,214 Common Units, with each Common Unit consisting of one share of common stock, one-tenth of a
Series A warrant to purchase one share of common stock (“Series A Warrant”) and two-tenths of a Series B warrant to purchase
one share of common stock (“Series B Warrant”), and (ii) 22,500 Pre-Funded Units, with each Pre-Funded Unit consisting of
one pre-funded warrant to purchase one share of common stock (“Pre-Funded Warrants”), one-tenth of a Series A Warrant and
two-tenths of a Series B Warrant. The public offering price was $280 per Common Unit and $278 per Pre-Funded Unit. The Pre-Funded
Warrants have an exercise price of $2.00 per share. The Pre-Funded Warrants are immediately exercisable and may be exercised at any time
until exercised in full. The initial exercise price of each Series A Warrant was $4,200 per share of common stock or pursuant to an
alternative cashless exercise option. Under the alternative cashless exercise provision, which became effective following stockholder
approval in March 2024, each Series A Warrant was exercisable on a cashless basis for two shares of common stock. The Series A Warrants
were exercisable immediately and expire 30 months after the initial issuance date. The initial exercise price of each Series B Warrant
was $4,760 per share of common stock. The Series B Warrants are exercisable immediately and expire 60 months after the initial issuance
date.
In addition
(effective following stockholder approval), the Series A Warrants and Series B Warrants included a provision under which, following
a reverse split of the common stock, the exercise price will be adjusted to the lowest volume weighted average price
(“VWAP”) for the five trading days immediately preceding and immediately following the date of reverse stock split, and
the number of shares issuable upon exercise of the Series A Warrants or Series B Warrants will be adjusted such that the aggregate
exercise price of the Series A Warrants or Series B Warrants will remain unchanged. The Series B Warrants do not include an
alternate cashless exercise provision and can only be exercised for cash so long as the Company’s registration statement for
the underlying shares remains effective.
8
In addition, the
Company granted the underwriter, Aegis Capital Corp. ("Aegis"), a 45-day option to purchase up to an additional 15% of the
total number of shares of common stock and/or Pre-Funded Warrants and/or Series A Warrants and/or Series B Warrants sold in the offering,
solely to cover overallotments, if any. On February 15, 2024, Aegis partially exercised its over-allotment option for a total of 415
Series A Warrants and 830 Series B Warrants.
On February 13,
2024, the Company obtained stockholder approval for (i) adjustment of the number of underlying shares and exercise price for both the
Series A Warrants and the Series B warrants, and (ii) the alternate cashless exercise provision for the Series A warrants.
As of September
30, 2024, all of the Pre-Funded Warrants, all of the Series A warrants, and 678,865 Series B Warrants have been exercised resulting in
the Company issuing 22,500 , 1,120,784 , and 678,865 shares of common stock, respectively. In connection with such exercises, the Company
received net proceeds of $ 45,000 , $ 0 , and $ 1,892,608 , respectively.
As of September
30, 2024, the only warrants remaining outstanding in connection with this offering are 12,934,062 Series B Warrants exercisable at $ 2.7879
per share. The exercise price and number of underlying shares under the Series
B Warrants are subject to further adjustments.
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. (“Nora Pharma”), a Canadian privately held
pharmaceutical company. The purchase price for the shares was $ 18,860,637 , $ 14,346,637 of which was paid in cash and the remainder was
paid through the issuance of 1,850 shares of the Company’s common stock valued at $ 4,514,000 or $2,440 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.
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 1,850 shares issued as part of the consideration paid for Nora Pharma was determined based on the reverse splits adjusted
closing market price of the Company’s common stock on the acquisition date, October 20, 2022 ($2,440 per share). See Note 6 – Reverse Stock Splits
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) earn-out payable to Mr. Malek Chamoun, the Seller
of Nora Pharma and its current President. 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 earn-out amount
of $3,632,000 has been recorded as a salary payable. During the fiscal year ended December 31, 2023, the Company paid an earn-out
of $ 1,084,169 for the fiscal year ended December 31, 2022. On April 22, 2024, the Company paid an earn-out of $ 3,093,878 CAD (approximately
$ 2,291,761 USD) for the earn-out realized in fiscal year 2023. The current remaining earn-out balance is $ 479,207 CAD (approximately
$ 354,968 USD).
9
Note 5 – Intangible
Assets
Intangible assets, net consisted of the
following:
Schedule of intangible assets
September 30,
2024
December
31,
2023
Balance at beginning of the year
$ 1,444,259
776,856
Purchase of additional intangible assets
(licenses)
1,594,373
710,372
Total
3,038,632
1,487,228
Less accumulated amortization
( 95,948 )
( 42,969 )
Finite-lived intangible assets, net
$ 2,942,684
$ 1,444,259
As
of September 30, 2024, the estimated amortization amounts of the Company’s intangible assets for each of the next five years are
as follows:
Schedule of estimated amortization expense
2025
$ 105,462
2026
105,462
2027
105,462
2028
71,032
2029
19,621
Note 6 – Reverse
Stock Splits
Effective April 17, 2024 and August 8, 2024, the
Company completed 1-for-100 and 1-for-20 reverse splits of its common stock, respectively. The Company had previously completed three
(3) reverse stock splits including a 1-for-200 reverse split on February 9, 2022, and two 1-for-20 reverse splits, one in 2019 and the
other in 2020. The Company’s financial statements included in this report reflect all five (5) reverse stock splits on a retroactive
basis for all periods presented and for all references to common stock, unless specifically stated otherwise.
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 September 30, 2024, the Company had authorized 1,000,000
shares of Series B Preferred Stock. The Series B Preferred Stock is non-convertible and non-redeemable.
It has a liquidation preference equal to the stated value of $0.10 per share, relative to the common stock and gives the holder the right
to 1,000 votes per share. As of September 30, 2024, 130,000
shares of Series B Preferred Stock were 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 941 shares of common stock and 20,051 warrants to purchase shares of common stock (the “Tradeable
Warrants”).
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
from $4,440 to $220. The Company entered into the amendment to the Warrant Agent Agreement on October 18, 2023.
10
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) 1,150 shares of its common stock together with investor warrants (“Investor Warrants”) to purchase up to 1,150
shares of common stock, and (ii) 651 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 6,511 shares of common stock. Each share of common stock and accompanying Investor Warrant was sold
together at a combined offering price of $4,440 and each Pre-Funded Warrant and accompanying Investor Warrant were sold together at a
combined offering price of $4,438. The Pre-Funded Warrants were immediately exercisable, at an exercise price of $2.00, and could be exercised
at any time until all of the Pre-Funded Warrants were exercised in full. The Investor Warrants have an exercise price of $4,440 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) 1,236 shares of its common stock together with warrants (“April Warrants”) to purchase up to 2,472
shares of common stock, and (ii) 1,195 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 2,390 shares of common stock. Each share of common stock
and accompanying two April Warrants were sold together at a combined offering price of $8,020 and each Pre-Funded Warrant and accompanying
two April Warrants were sold together at a combined offering price of $8,018. The Pre-Funded Warrants were immediately exercisable,
at an exercise price of $2.00, 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 $7,520 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 1,850 shares of common stock as part of the acquisition of Nora Pharma. These shares were valued at $ 4,514,000 , or
$2,440 per share.
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 2,228 shares of common stock at an average price of $2,274.20 per share for a
total cost of $ 506,822 . The 2,228 repurchased shares were cancelled and returned to treasury reducing the number of issued and
outstanding shares from 11,292 to 9,064.
On May 16, 2023,
the Company completed a private placement pursuant to a securities purchase agreement with an 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) 1,225 shares of common
stock, (ii) 1,751 pre-funded warrants (the “May Pre-Funded Warrants”), and (iii) investor warrants (the “May Warrants”)
to purchase up to 5,952 shares of common stock. Each share of common stock and accompanying two May Warrants were sold together at a
combined offering price of $1,680 and each May Pre-Funded Warrant and accompanying two May Warrants were sold together at a combined
offering price of $1,678. The May Pre-Funded Warrants are immediately exercisable, at an exercise price of $2.00, and may be exercised
at any time until all of the May Pre-Funded Warrants are exercised in full. The May Warrants have an exercise price of $1,180 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 2023,
the Company issued a total of 5,396 shares of common stock in connection with warrant exercises for aggregate net proceeds of $ 13,196,681 .
In July 2023, the
Company repurchased a total of 34 shares of common stock under the Stock Repurchase Program announced on January 19, 2023, at an average
price of $1,009.20 per share for a total cost of $ 34,321 . In October 2023, the 34 repurchased shares were cancelled and returned
to treasury reducing the number of issued and outstanding shares from 12,873 to 12,839.
11
On November 16,
2023, the Company issued 1,173 shares of common stock and received net proceeds of $ 2,346 in connection with the exercise of all 1,173
remaining May Pre-Funded Warrants at an exercise price of $2.00 per share.
On February 8, 2024,
the Company issued 20,000 shares of Series B Preferred Stock to the Company’s CEO for a purchase price of $ 0.10 per share.
On February 15,
2024, the Company completed an underwritten public offering and in connection therewith it issued an aggregate of 35,714 shares of common
stock, of which 22,500 shares were issued in connection with pre-funded warrant exercises.
On March 4, 2024,
the Company issued 100,000 shares of Series B Preferred Stock to the Company’s CEO for a purchase price of $ 0.10 per share.
On April 17, 2024,
the Company completed a 1-for-100 reverse split of its common stock.
In April and May
2024, the Company issued 1,120,784
shares of common stock in connection with the cashless exercise of all of the Series A Warrants
and received $ 0
in net proceeds.
On August 16, 2024,
the Company issued 150,285 shares of common stock in connection with the rounding up of fractional shares following the reverse stock
splits of April 17, 2024 and August 8, 2024.
In August and September
2024, the Company issued 678,865 shares of common stock in connection with the exercise of 678,865 Series B Warrants and received aggregate
net proceed of $ 1,892,608 .
As of September
30, 2024 and December 31, 2023, the Company had a total of 1,999,660 and 14,012 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, 2023, and
during the nine months ended September 30, 2024, the Company completed five (5) financing events, and in connection therewith, it issued
warrants as follows:
Schedule of warrants issued
with financing
Type
Number
Exercise Price
Expiry Date
2022 Pre-Funded Warrants
1,846
$ 2.00
Unlimited
Tradeable Warrants
2,051
$ 4,440.00
February
2027
Investor Warrants
1,801
$ 4,440.00
March
2027
April Warrants
4,862
$ 7,520.00
April
2027
May Pre-Funded Warrants
1,751
$ 2.00
Unlimited
May Investor Warrants
5,952
$ 1,180.00
November
2028
2024 Pre-Funded Warrants
22,500
$ 2.00
Unlimited
Series A Warrants
3,986 *
$ 4,200.00 *
August
2026
Series B Warrants
7,973 *
$ 4,760.00 *
February
2029
*
Subject
to adjustments per the Series A and Series B Warrant Agreements.
As of September
30, 2024, all of the 2022 Pre-Funded Warrants, all of the May Pre-Funded Warrants, all of the 2024 Pre-Funded Warrants, a total of 1,569
Tradeable Warrants, 1,401 Investor Warrants, all of the Series A Warrants, and 678,865 Series B Warrants were exercised resulting in
aggregate net proceeds of $ 15,134,289 received by the Company.
On February 11,
2024, the Company redeemed all of the April Warrants and all of the May Investor Warrants for an aggregate purchase price of $ 3,139,651 .
The Company’s
outstanding warrants as of September 30, 2024 consisted of the following:
Schedule of warrants outstanding
Type
Number
Exercise Price
Expiry Date
Tradeable Warrants
481
$ 220.00
February
2027
Investor Warrants
400
$ 4,440.00
March
2027
Series B Warrants
12,934,062 *
$ 2.7879 *
February
2029
*
As adjusted
and subject to further adjustments per the Series B Warrant Agreements.
Note 9 – Earnings
Per Share
The following table sets forth the computation
of basic and diluted net income per share for the quarters ended September 30:
Schedule of computation
of basic and diluted net income per share
2024
2023
Net gain (loss) attributable to common stock
$ ( 1,197,803 )
$ ( 651,482 )
Basic weighted average outstanding shares of common stock
1,267,565
12,845
Dilutive common share equivalents
–
–
Dilutive weighted average outstanding shares of common stock
1,267,565
12,845
Net gain (loss) per share attributable to common stock
$ ( 0.94 )
$ ( 50.72 )
13
Note 10 – Lease
The Company has
obligations as a lessee for office and warehouse 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 include fixed payments plus a variable payment. The Company’s 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, 2024, were as follows:
Schedule of lease information
Operating lease
ROU asset
$ 541,468
Operating lease liability
- Short-term
$ 116,253
Operating lease liability
- Long-term
$ 440,298
Remaining lease term
5
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.
Maturities of lease liabilities under
non-cancellable operating leases at September 30, 2024 are as follows:
Schedule of maturities of lease liabilities
2024
$
28,418
2025
$
116,458
2026
$
110,305
2027
$
103,897
2028
$
97,861
Thereafter
$
99,611
Note 11 – Management
and Director Compensation
The Company paid its officers cash compensation totaling $ 240,176 and $ 245,000 ,
and $ 1,595,711 and $ 1,290,000 for the three- and nine-month periods ended September 30, 2024 and 2023, respectively. Of the $1,595,711
amount, $ 400,000 was paid to Advanomics Corporation, a company controlled by the CEO of the Company.
The Company paid
its directors aggregate cash compensation totaling $ 100,000 for each of the three months periods ended September 30, 2024 and 2023, and
$ 300,000 for each of the nine-month periods ended September 30, 2024 and 2023.
14
Note 12 – Income
Taxes
Our
Income tax (expense) / benefit of $ ( 130,551 ) and $ 190,787 for the three and nine months ended September 30, 2024, respectively, is primarily
due to operations outside of the United States and changes in valuation allowance related to certain deferred tax assets generated or
utilized in the applicable period.
Our
income tax (expense) of $ ( 40,952 ) and $ ( 174,899 ) for the three and nine months ended September 30, 2023, respectively, is
primarily due to operations outside of the United States and changes in valuation allowance related to certain deferred tax assets
generated or utilized in the applicable period.
Deferred
tax assets are regularly reviewed for recoverability by jurisdiction and valuation allowances are established based on historical and
projected future taxable losses and the expected timing of the reversal of existing temporary differences. The Company has recorded valuation
allowances against the majority of its deferred tax assets of September 30, 2024, and the Company expects to maintain these valuation
allowances until there is sufficient evidence that future earnings can be achieved, which is uncertain at this time.
The
Company's consolidated financial statements contain various tax related entries the same being due to the operations of the two Canadian
subsidiaries and are in compliance with Canadian tax laws.
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 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, 2023. 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 we file with 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. We
operate two wholly owned subsidiaries: (i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation with a portfolio consisting
of 63 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, we
are conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA targeted for liver cancer, (ii) SBFM-PL4, a
PLpro protease inhibitor for SARS Coronavirus infections, and (iii) Adva-27a for pancreatic cancer. Development of the latter has been
paused pending further analysis of unfavorable in vitro results obtained in the second half of 2023. See “Drugs in Development”
below.
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, we changed our name to Sunshine Biopharma Inc. and
began operating as a pharmaceutical company.
In December 2015,
we acquired all 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. Development of Adva-27a has recently been paused pending further
analysis of unexpected in vitro results obtained in the latter part of 2023. See “Drugs in Development” below.
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 inhibitors for 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.
On October 20,
2022, we acquired Nora Pharma, a Canadian generic pharmaceuticals company based in the greater Montreal area. Nora Pharma has 46
employees and operates in a 23,500 square foot facility certified by Health Canada. Nora Pharma currently has 63 generic
prescription drugs on the market in Canada and is planning to launch 32 additional generic prescription drugs in the remainder of
2024 and 2025.
16
Products on the Market
Through Nora Pharma we currently have
the following generic prescription drugs on the market in Canada:
Drug
Action/Indication
Reference
Brand
Abiraterone*
Oncology
Zytiga®
Alendronate
Osteoporosis
Fosamax®
Amlodipine
Cardiovascular
Norvasc®
Apixaban
Cardiovascular
Eliquis®
Aripiprazole
Antipsychotic
Abilify®
Atorvastatin
Cardiovascular
Lipitor®
Betahistine
Vertigo
Serc®
Azithromycin
Antibacterial
Zithromax®
Candesartan
Hypertension
Atacand®
Candesartan HCTZ
Hypertension
Atacand Plus®
Celecoxib
Anti-inflammatory
Celebrex®
Cetirizine
Allergy
Reactine®
Clobetasol*
Anti-inflammatory
Clobex®
Ciprofloxacin
Antibiotic
Cipro®
Citalopram
Central nervous system
Celexa®
Clindamycin
Antibiotic
Dalacin®
Clopidogrel
Cardiovascular
Plavix®
Dapagliflozin
Diabetes
Forxiga®
Daptomycin*
Antibacterial
Cubicin®
Dasatinib*
Oncology
Sprycel®
Donepezil
Central nervous system
Aricept®
Duloxetine
Central nervous system
Cymbalta®
Dutasteride
Urology
Avodart®
Ertapenem*
Antibacterial
Invanz®
Escitalopram
Central nervous system
Cipralex®
Ezetimibe
Cardiovascular
Ezetrol®
Finasteride
Urology
Proscar®
Flecainide
Cardiovascular
Tambocor®
Fluconazole
Antifungal
Diflucan®
Fluoxetine
Central nervous system
Prozac®
Hanzema®*
Dermatology
Toctino®
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®
Progesterone*
Women's Health
Prometrium®
Quetiapine
Central nervous system
Seroquel®
Quetiapine XR
Central nervous system
Seroquel XR®
Ramipril
Cardiovascular
Altace®
Rivaroxaban*
Cardiovascular
Xarelto®
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®
Varenicline
Smoking cessation
Champix®
Zoledronic Acid*
Osteoporosis
Aclasta®
Zolmitriptan
Central nervous system
Zomig®
Zopiclone
Central nervous system
Imovane®
*Sold through distribution agreements
17
In
addition to the 63 drugs currently on the market, we have 32 additional
drugs scheduled to be launched in Q4 2024 and in 2025. These new drugs will address various human health areas including cardiovascular,
oncology, gastroenterology, central nervous system, diabetes, urology, endocrinology, anti-infective, and anti-inflammatory. Among the
new drugs to be launched in 2024 is NIOPEG®, a biosimilar of NEULASTA®. Like NEULASTA®, NIOPEG® is a long-acting form
of recombinant human granulocyte colony-stimulating factor (filgrastim). It is indicated to decrease the incidence of infection in patients
with non-myeloid malignancies receiving anti-neoplastic therapy. Nora Pharma received Health Canada marketing approval for NIOPEG®
on April 17, 2024. NIOPEG® is anticipated to be on the market in Canada in Q4 2024.
We believe the addition
of these new products to our existing portfolio will strengthen our presence in the Canadian $9.7 billion a year generic drugs market
and provide us with greater access to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.
Drugs in Development
The following table summarizes our proprietary
drugs in development:
Drug
Candidate
Therapeutic
Area
Development
Stage
Adva-27a (Small Molecule)
Oncology (Pancreatic Cancer)
Paused*
K1.1 (mRNA LNP)
Oncology (Liver Cancer)
Animal Testing
SBFM-PL4 (Small Molecule)
Antiviral (SARS Coronavirus)
Animal Testing
* See “ Adva-27a Anticancer
Compound ” below
Adva-27a Anticancer
Compound
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 laboratory test results of the Adva-27a
molecule were not favorable. After conclusion of an internal review of the laboratory results on November 2, 2023, we provided notice
to JGH of termination of the Research Agreement. We have paused the IND-enabling studies of Adva-27a pending a review of the results
and 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.
In November 2022,
we concluded an agreement with a specialized commercial partner for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles
(“LNP”) for use to conduct xenograft mice studies. The initial results of our xenograft mice studies indicate that our K1.1
mRNA-LNP is effective at reducing the size of liver cancer xenograft tumors in mice. We are currently seeking to confirm these results
by conducting additional xenograft experiments on a broader scale and in more detailed dose-response studies.
SBFM-PL4 SARS 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 us 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, we and the University of Arizona have entered into
an option agreement (the “Option Agreement”) whereby we were 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
broadened our objective to include the development of an injectable drug 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 interactions and possible ‘rebound’ infections and other side effects.
19
Intellectual Property
We are the sole
owner of all 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 under US Patent Number 8,236,935 and 10,272,065.
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.
Effective February
24, 2023, we became the exclusive, worldwide licensee of the University of Arizona for three (3) patents related to small molecules which
inhibit the Coronavirus protease, PLpro.
Our wholly owned
subsidiary, Nora Pharma, owns 152 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 four (4) NPN’s issued by Health Canada including (i) NPN 80089663 which authorizes us to manufacture and sell
our in-house developed OTC product, Essential•9, (ii) NPN 80093432 which authorizes us to manufacture and sell the OTC product,
Calcium-Vitamin D under the brand name Essential Calcium-Vitamin D, (iii) NPN 80125047 which authorizes us to manufacture and sell the
OTC product, L-Citrulline, and (iv) NPN 80127436 which authorizes us to manufacture and sell the OTC product, Taurine.
Results of Operations
Comparison
of results of operations for the three months ended September 30, 2024 and 2023
During
the three months ended September 30, 2024, we generated $8,435,178 in sales, compared to $5,957,668 for the three months ended September
30, 2023, an increase of $2,477,510, or 42%. The increase is attributable to expanded marketing and sales efforts by our wholly owned
subsidiary, Nora Pharma. The direct cost for generating these sales was $5,569,027 (66%) for the three months ended September 30, 2024,
compared to $3,967,412 (67%) for
the three months ended September 30, 2023. Our gross profit grew to $2,866,151 for the three months ended September 30, 2024, compared
to $1,990,256 for the three months ended September 30, 2023.
General and administrative
expenses during the three-month period ended September 30, 2024, were $3,972,504, compared to $2,769,730 during the three-month period
ended September 30, 2023, an increase of $1,202,774. The increase was due to increases in accounting fees ($68,422), consulting ($253,251),
marketing ($40,848), and salaries ($949,473). The increase in salaries was due to the hiring of two (2) new employees and a bonus paid
to the CEO of the Company. The only expense category that saw a decrease was R&D, which was reduced by $111,650. Overall, we incurred
a loss of $1,106,353 from our operations for the three months ended September 30, 2024, compared to a loss of $779,474 from our operations
in the three-month period ended September 30, 2023.
20
In addition, we
had interest income of $108,614 during the three months ended September 30, 2024, compared to net interest income of $168,904 during
the three months ended September 30, 2023, as a result of less interest earned on cash on hand.
As a result, we
incurred a net loss of $1,197,803 ($0.94 per share) for the three months ended September 30, 2024, compared to a net loss of $651,482
($50.72 per share) for the three-month period ended September 30, 2023.
Comparison of results
of operations for the nine months ended September 30, 2024 and 2023
During the nine
months ended September 30, 2024, we generated revenues of $25,279,291, compared to revenue of $16,412,586 for the nine months ended September
30, 2023, an increase of $8,866,705, or 54%. The increase is attributable to expanded marketing and sales efforts by our wholly owned
subsidiary, Nora Pharma. The direct cost for generating these revenues was $17,702,546 for the nine months ended September 30, 2024 (70%),
compared to $10,641,461 (65%) for the nine months ended September 30, 2023. The increase in the cost of sales in the nine-month
period of 2024 is related to greater retailer allowances offered to gain access to new regional markets. Our gross profit increased to
$7,576,745 for the nine months ended September 30, 2024, compared to a gross profit of $5,771,125 for the same period in 2023.
General and administrative
expenses during the nine-month period ended September 30, 2024, were $11,351,144, compared to $9,369,203 during the nine-month period
ended September 30, 2023, an increase of $1,981,941. The increase was a result of increases in accounting ($263,791), legal ($170,871),
marketing ($234,129), office costs ($781,912), and salaries ($838,937). The two expense categories that saw a decrease were consulting
($169,369), and R&D ($254,872). Overall, we incurred a loss of $3,774,399 from our operations in the nine-month period ended September
30, 2024, compared to a loss from operations of $3,598,078 in the similar period of 2023.
In addition, we
had interest income of $396,453 during the nine months ended September 30, 2024, compared to interest income of $517,163 during the nine
months ended September 30, 2023. The decrease was due to the Company having less cash on hand.
As a result, we
incurred a net loss of $2,975,904 ($13.61 per share) for the nine-month period ended September 30, 2024, compared to a net loss of $3,256,020
($265.71 per share) for the nine-month period ended September 30, 2023.
Liquidity and Capital
Resources
As of September
30, 2024, we had cash and cash equivalents of $12,206,655.
Net cash used in
operating activities was $9,123,898 during the nine months ended September 30, 2024, compared to $6,085,435 during the nine-month period
ended September 30, 2023. The increase was a result of increased business activities by Nora Pharma.
Cash flows used
in investing activities were $1,789,312 for the nine months ended September 30, 2024, compared to $386,920 for the nine months ended
September 30, 2023. The increase was the result of cash invested in Nora Pharma to finance increase in inventory and expansion of operations
and product line.
Cash flows provided
by financing activities were $7,235,518 during the nine months ended September 30, 2024, compared to $3,456,106 during the nine months
ended September 30, 2023. The increase was primarily a result of the approximately $10 million financing event completed in February
2024, compared to an approximately $5 million financing event completed in May 2023.
We are not generating
adequate revenues from our operations to fully implement our business plan as set forth herein. We believe our existing cash on hand
will be sufficient to fund our pharmaceuticals sales operations and research and development activities for the next 24 months. There
is no assurance our estimates will be accurate. We currently have no committed sources of capital and we anticipate that we will need
to raise additional capital in the future, including for further research and development activities and possibly clinical trials, as
well as expansion of our generic pharmaceuticals operations. Additional capital may not be available on terms acceptable to us, or at
all.
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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
we believe 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, 2023, including
our financial statements and notes thereto included therein as filed with the SEC on March 28, 2024.
Recently Adopted Accounting
Standards
We have adopted all new accounting standards impacting operations.
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 September 30, 2024,
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, 2024, that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting.
22
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, and we are unaware of any threatened actions.
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
During the quarter
ended September 30, 2024, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule
10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
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.
23
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 5, 2024.
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)
24
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.