Sunshine Biopharma, Inc. Form 10-Q
(1` 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: March 31, 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.)
1177 Avenue of the Americas
5th Floor
New York , NY 10036
(Address
of principal executive offices)
( 332 )
216-1177
(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 May 17, 2024, was 18,945,052
shares.
TABLE
OF CONTENTS
Page
PART I. FINANCIAL INFORMATION
Item 1.
Financial Statements
3
Consolidated Balance
Sheets as of March 31, 2024 (Unaudited) and December 31, 2023
3
Consolidated Statements
of Operations for the Three Months Ended March 31, 2024 and 2023 (Unaudited)
4
Consolidated Statements
of Cash Flows for the Three Months Ended March 31, 2024 and 2023 (Unaudited)
5
Consolidated Statement of
Shareholders' Equity for the Three Months Ended March 31, 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
March 31,
December 31,
2024
2023
(Unaudited)
ASSETS
Current Assets:
Cash and cash equivalents
$ 17,434,208
$ 16,292,347
Accounts receivable
2,827,720
2,552,362
Inventory
7,697,906
5,734,755
Prepaid expenses
871,390
310,591
Total Current Assets
28,831,224
24,890,055
Property & equipment
401,642
365,868
Intangible assets
2,065,603
1,444,259
Right-of-use-asset
600,248
646,779
TOTAL ASSETS
$ 31,898,717
$ 27,346,961
LIABILITIES
Current Liabilities:
Accounts payable & accrued expenses
$ 3,615,205
$ 2,585,466
Earnout payable
2,547,831
2,547,831
Income tax payable
254,971
299,869
Right-of-use-liability
115,398
118,670
Total Current Liabilities
6,533,405
5,551,836
Long-Term Liabilities:
Deferred tax liability
48,729
48,729
Right-of-use-liability
496,968
539,035
Total Long-Term Liabilities
545,697
587,764
TOTAL LIABILITIES
7,079,102
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 March 31, 2024 and December 31, 2023, respectively
13,000
1,000
Common Stock $ 0.001 par value per share; 3,000,000,000 shares authorized; 994,529 and 280,243 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively
995
28,024
Capital paid in excess of par value
89,842,680
84,387,890
Accumulated comprehensive income
152,400
696,105
Accumulated (Deficit)
( 65,189,459 )
( 63,905,658 )
TOTAL SHAREHOLDERS' EQUITY
24,819,615
21,207,361
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
$ 31,898,717
$ 27,346,961
See Accompanying Notes
To These Unaudited Financial Statements
3
Sunshine Biopharma, Inc.
Consolidated
Statements of Operations and Comprehensive Loss (Unaudited)
March 31,
March 31,
2024
2023
Sales
$ 7,541,046
$ 4,894,053
Cost of sales
5,186,709
3,065,931
Gross profit
2,354,337
1,828,122
General & Administrative Expenses:
Accounting
352,006
169,750
Consulting
47,401
131,615
Director fees
100,000
100,000
Legal
221,998
107,449
Marketing
198,046
127,913
Office
911,211
482,458
Patent fees
–
6,308
R&D
222,033
432,925
Salaries
1,533,712
2,000,257
Taxes
75,901
63,718
Depreciation & amortization
42,618
34,710
Total General & Administrative Expenses
3,704,926
3,657,103
(Loss) From Operations
( 1,350,589 )
( 1,828,981 )
Other Income:
Foreign exchange
( 5,767 )
15
Interest income
144,089
213,881
Interest expense
( 49,181 )
( 41,075 )
Total Other Income
89,141
172,821
Net (loss) before income taxes
( 1,261,448 )
( 1,656,160 )
Provision for income taxes
22,353
46,270
Net (Loss)
( 1,283,801 )
( 1,702,430 )
Foreign exchange translation
( 543,705 )
11,160
Comprehensive (Loss)
( 1,827,506 )
( 1,691,270 )
Basic and diluted (Loss) per common share
$ ( 2.00 )
$ ( 7.73 )
Weighted average common shares outstanding (basic & diluted)
641,310
220,363
See
Accompanying Notes To These Unaudited Financial Statements
4
Sunshine Biopharma, Inc.
Consolidated
Statements of Cash Flows (Unaudited)
March 31,
March 31,
2024
2023
Cash Flows From Operating Activities:
Net (Loss)
$ ( 1,283,801 )
$ ( 1,702,430 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
42,618
34,710
Stock issued for services
12,000
–
Accounts receivable
( 536,261 )
135,891
Inventory
( 2,100,281 )
( 417,318 )
Prepaid expenses
( 568,981 )
129,849
Accounts Payable & accrued expenses
1,293,372
( 73,661 )
Income tax payable
( 43,824 )
42,853
Net Cash Flows (Used In) Operating Activities
( 3,185,159 )
( 1,850,106 )
Cash Flows From Investing Activities:
Reduction in right-of-use asset
31,066
32,934
Cash from Nora Pharma acquisition
–
( 1,135 )
Purchase of intangible assets
( 636,865 )
( 178,395 )
Purchase of equipment
( 62,937 )
293
Net Cash Flows (Used In) Investing Activities
( 668,736 )
( 146,303 )
Cash Flows From Financing Activities:
Proceeds from public offering net (common stock)
8,522,411
–
Exercise of warrants
45,000
–
Purchase of treasury stock
( 3,139,651 )
( 506,822 )
Lease liability
( 29,611 )
( 31,477 )
Net Cash Flows Provided by Financing Activities
5,398,149
( 538,299 )
Cash and Cash Equivalents at Beginning of Period
16,292,347
21,826,437
Net increase (decrease) in cash and cash equivalents
1,544,254
( 2,534,708 )
Effect of exchange rate changes on cash
141,312
2,489
Foreign currency translation adjustment
( 543,705 )
–
Cash and Cash Equivalents at End of Period
$ 17,434,208
$ 19,294,218
Supplementary Disclosure of Cash Flow Information:
Cash paid for income taxes
$ 956,012
$ –
Stock issued for services
$ 12,000
$ –
See
Accompanying Notes To These Unaudited Financial Statements
5
Sunshine Biopharma, Inc.
Consolidated
Statement of Shareholders' Equity (Unaudited)
Three Months
Number of Common Shares
Common
Capital Paid in Excess of Par
Treasury
Number of Preferred Shares
Preferred
Compre-
hensive
Accumulated
Period
Issued
Stock
Value
Stock
Issued
Stock
Income
Deficit
Total
Balance December 31, 2022
225,856
$ 226
$ 80,864,111
$ –
10,000
$ 1,000
$ 161,847
$ ( 59,399,614 )
$ 21,627,570
Repurchase Stock
( 4,457 )
( 4 )
( 506,818 )
–
–
–
–
–
( 506,822 )
Net (loss)
–
–
–
–
–
–
11,160
( 1,702,430 )
( 1,691,270 )
Balance at March 31, 2023
221,399
$ 222
$ 80,357,293
$ –
10,000
$ 1,000
$ 173,007
$ ( 61,102,044 )
$ 19,429,478
Balance December 31, 2023
280,243
$ 280
$ 84,415,634
$ –
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 public offering, net of issuance costs
264,286
265
8,522,146
–
–
–
–
–
8,522,411
Exercise of warrants
450,000
450
44,550
–
–
–
–
–
45,000
Repurchase warrants
–
–
( 3,139,651 )
–
–
–
–
–
( 3,139,651 )
Net (loss)
–
–
–
–
–
–
( 543,705 )
( 1,283,801 )
( 1,827,506 )
Balance at March 31, 2024
994,529
$ 995
$ 89,842,679
$ –
130,000
13,000
$ 152,400
$ ( 65,189,459 )
24,819,615
See Accompanying Notes
To These Unaudited Financial Statements
6
Sunshine
Biopharma, Inc.
Notes to
Unaudited Consolidated Financial Statements
For the
Three Months Ended March 31, 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 transaction, 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 52 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
March 31, 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 March 31, 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 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 may be extended for an additional two years.
On February 29, 2024, the Canadian federal government tabled new drug reimbursement legislation, a bill known as PharmaCare which, if
passed, would result in a single-payer program whereby the Canadian federal government would pay for the drugs sold in Canada rather than
the Provinces.
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)
·
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 three months periods ended March 31, 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, the Company completed a 1-for-100
reverse split of its common stock (the “Reverse Split”). The share amounts, warrants, and related parameters specified in this report have been adjusted to
reflect the Reverse Split 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 714,286 Units, consisting of (i) 264,286 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) 450,000 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 $14.00 per Common Unit and $13.9
per Pre-Funded Unit. The Pre-Funded Warrants have an exercise price of $0.10 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 is $210.00
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 is exercisable on a cashless basis for
two shares of common stock. The Series A Warrants are exercisable immediately and expire 30 months after the initial issuance date.
The initial exercise price of each Series B Warrant is $238.00 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 the 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 such warrants and underlying shares remains effective. As a result of the Reverse
Split, the exercise price of the Series A Warrants has been reduced to $ 1.026
and the number of Series A Warrants has been increased to 16,319,444 .
Also as a result of the Reverse Split, the exercise price of Series B Warrants was reduced to $ 1.026
and the number of Series B Warrants increased to 36,990,739 .
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 8,304 Series A Warrants and 16,607 Series B Warrants.
8
As
of March 31, 2024, all of the Pre-Funded Warrants, consisting of 450,000 warrants in total, have been exercised resulting in the Company
issuing 450,000 shares of common stock and receiving net proceed of $ 45,000 .
The following table sets forth the
outstanding warrants, as adjusted, issued in connection with this offering at March 31, 2024:
Schedule of securities issued
Security
Type
Number
Exercise Price
Expiry Date
Series
A Warrants
16,319,444 *
$ 1.026 *
August
2026
Series B Warrants
36,990,739 *
$ 1.026 *
February 2029
*
As adjusted and subject to further adjustments per the
Warrant Agreements.
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 (USD), $ 14,346,637 of which was paid in cash
and the remainder was paid through the issuance of 37,000 shares of the Company’s common stock valued at $ 4,514,000 or $122.00
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 37,000 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 ($122.00 per share).
9
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 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 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 amount of $ 1,084,169
for the fiscal year ended December 31, 2022. On April 22, 2024, the Company paid an earn-out amount 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).
Note
5 – Intangible Assets
Intangible assets, net consisted of the following:
Schedule of intangible assets
March 31,
2024
December
31,
2023
Balance at beginning of the year
$ 1,444,259
776,856
Purchase of additional intangible assets (licenses)
679,834
710,372
Total
2,124,093
1,487,228
Less accumulated amortization
( 58,490 )
( 42,969 )
Finite-lived intangible assets, net
$ 2,065,603
$ 1,444,259
As of March 31, 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
$ 73,998
2026
73,998
2027
73,998
2028
39,697
2029
1,908
Note
6 – Reverse Stock Splits
Effective April 17, 2024, the Company completed
a 1-for-100 reverse split of its common stock (the “Reverse Split”). The Company had previously completed three (3) reverse stock splits including a 1-for-200
on February 9, 2022, and two 1-for-20 reverse stock splits, one in 2019 and the other in 2020. The Company’s financial statements
included in this report reflect all four 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 March 31,
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, relative to the common stock and gives the holder the
right to 1,000 votes per share. As of March 31, 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 18,824 shares of common stock and 41,022 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 from $222.00 to
$11.00.
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) 23,014 shares of its common stock together with investor warrants (“Investor Warrants”) to
purchase up to 23,014 shares of common stock, and (ii) 13,023 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 130,225 shares
of common stock. Each share of common stock and accompanying Investor Warrant was sold together at a combined offering price of $222.00
and each Pre-Funded Warrant and accompanying Investor Warrant were sold together at a combined offering price of $221.9. The Pre-Funded
Warrants were immediately exercisable, at an exercise price of $0.1, 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 $222.00 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) 24,728
shares of its common stock together with warrants (“April Warrants”) to purchase up to 49,456 shares of common
stock, and (ii) 23,900 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 47,801 shares of common stock. Each share of common
stock and accompanying two April Warrants were sold together at a combined offering price of $401.00 and each Pre-Funded Warrant and
accompanying two April Warrants were sold together at a combined offering price of $400.90. The Pre-Funded Warrants were immediately
exercisable, at an exercise price of $0.1, 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 $376.00 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.
11
On
October 20, 2022, the Company issued 37,000 shares of common stock as part of the acquisition of Nora Pharma. These shares were valued
at $ 4,514,000 , or $122.00 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 44,571 shares of common stock at an average price of $113.71
per share for a total cost of $ 506,822 . The 44,571 repurchased common shares were cancelled and returned to treasury reducing the number
of issued and outstanding shares from 225,856 to 221,399.
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) 24,500
shares of common stock, (ii) 35,024 pre-funded warrants (the “May Pre-Funded Warrants”), and (iii) investor warrants (the
“May Warrants”) to purchase up to 119,048 shares of common stock at $59.00 per share. Each share of common stock and accompanying
two May Warrants were sold together at a combined offering price of $84.00 and each May Pre-Funded Warrant and accompanying two May Warrants
were sold together at a combined offering price of $83.90. The May Pre-Funded Warrants are immediately exercisable, at an exercise
price of $0.1, 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 $59.00 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 107,934 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
680 shares of common stock under the Stock Repurchase Program announced on January 19, 2023, at an average price of $50.46 per share
for a total cost of $ 34,321 . In October 2023, the 680 repurchased common shares were cancelled and returned to treasury reducing the
number of issued and outstanding shares from 257,463 to 256,783.
On November 16, 2023, the Company issued 23,460
shares of common stock and received net proceeds of $ 2,346 in connection with the exercise of all 23,460 remaining May Pre-Funded Warrants
at the nominal exercise price of $0.1 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 714,286
shares of common stock, of which 450,000 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.
As
of March 31, 2024 and December 31, 2023, the Company had a total of 994,529 and 280,243 shares of common stock issued and outstanding,
respectively.
The
Company has declared no dividends since inception.
12
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.
In
2022, 2023, and during the three months ended March 31, 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
36,923
$ 0.10
Unlimited
Tradeable Warrants
41,022
$ 222.00 *
February 2027
Investor Warrants
36,036
$ 222.00
March 2027
April Warrants
97,257
$ 376.00
April 2027
May Pre-Funded Warrants
35,024
$ 0.10
Unlimited
May
Investor Warrants
119,048
$ 59.00
November
2028
2024 Pre-Funded Warrants
450,000
$ 0.10
Unlimited
Series A Warrants
79,732 **
$ 210.00 **
August 2026
Series B Warrants
159,464 **
$ 238.00 **
February 2029
*
The
Tradeable Warrants had an initial exercise price of $425.00, 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
$222.00, in accordance with the terms thereof.
**
Subject to adjustments per the Warrant Agreements.
As
of March 31, 2024, all of the 2022, May, and 2024 Pre-Funded Warrants, and a total of 31,385
Tradeable Warrants, and 28,027
Investor Warrants were exercised resulting in aggregate proceeds of $ 13,241,681
received by the Company.
13
On
February 11, 2024, the Company purchased back all of the April Warrants and the May Investor Warrants for an aggregate purchase price
of $ 3,139,651 .
The Company’s
outstanding warrants as of May 20, 2024 consisted of the following:
Schedule of warrants outstanding
Type
Number
Exercise Price
Expiry Date
Tradeable Warrants
9,636
$ 11.00 *
February 2027
Investor Warrants
8,009
$ 222.00
March 2027
Series
A Warrants
16,319,444 **
Cashless **
August 2026
Series B Warrants
36,990,739 **
$ 1.026 **
February 2029
*
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 from $222.00 to $11.00 per warrant. The amendment was executed on October 18, 2023.
**
As adjusted and subject to
further adjustments per the 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 March 31:
Schedule of earnings per share computation
2024
2023
Net gain (loss) attributable to common stock
$ ( 1,283,801 )
$ ( 1,702,430 )
Basic weighted average outstanding shares of common stock
641,310
220,363
Dilutive common share equivalents
–
–
Dilutive weighted average outstanding shares of common stock
641,310
220,363
Net gain (loss) per share attributable to common stock
$ ( 2.00 )
$ ( 7.73 )
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 March 31, 2024 were as follows:
Schedule of lease information
Operating lease ROU asset
$ 600,248
Operating lease liability - Short-term
$ 115,398
Operating lease liability - Long-term
$ 496,968
Remaining lease term
5 years 9 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 March 31, 2024 are as follows:
Schedule of maturities of lease liabilities
2024
$ 86,221
2025
$ 116,020
2026
$ 109,890
2027
$ 103,506
2028
$ 97,493
Thereafter
$ 99,236
Note
11 – Management and Director Compensation
The Company paid its officers cash compensation
totaling $ 262,486 and $ 820,000 for the three-month periods ended March 31, 2024 and 2023, respectively.
The
Company paid its directors aggregate cash compensation totaling $ 100,000
for each of the three-month periods ended March 31, 2024 and 2023.
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 three-month periods ended March 31, 2024 and 2023 was 26.83 %.
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.
Note
13 – Subsequent Events
Effective April 17, 2024, the Company completed
a 1-for-100 reverse split of its common stock (the “Reverse Split”). As a result of the Reverse Split, the exercise price
of the Series A Warrants has been reduced to $1.026 and the number of Series A Warrants has been increased to 16,319,444. Also as a result
of the Reverse Split, the exercise price of Series B Warrants was reduced to $1.026 and the number of Series B Warrants increased to
36,990,739. All share amounts, warrants, and related parameters specified in this report have been adjusted to reflect the Reverse Split.
Subsequent to March 31, 2024, the Company issued
17,950,523 shares of common stock upon exercise of 8,975,262 Series A Warrants pursuant to the alternative cashless exercise of the Series
A Warrants.
On April 24, 2024, the Company paid Malek Chamoun,
the Seller of Nora Pharma, an earn-out amount of $3,093,878 CAD (approximately $2,291,761 USD), pursuant to its obligation under the applicable
Sale Agreement.
On May 3, 2024, the SEC announced that it had
settled charges against BF Borgers CPA PC (“Borgers”), the Company’s independent accounting firm, stating that Borgers
failed to conduct audits in accordance with the standards of the Public Company Accounting Oversight Board (the “PCAOB”).
As part of the settlement, Borgers agreed to a permanent ban on appearing or practicing before the SEC. As a result, the Company dismissed
Borgers as its independent accountant.
On May 7, 2024, the Company engaged Bush & Associates CPA LLC as
its new independent auditor.
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, 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 52 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, 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 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. 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 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 Inc. (“Nora Pharma”), a Canadian generic pharmaceuticals company based in the greater
Montreal area. Nora Pharma has 44 employees and operates in a 23,500 square foot facility certified by Health Canada. Nora Pharma currently
has 52 generic prescription drugs on the market in Canada and is planning to launch 32 additional generic prescription drugs in 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
Alendronate
Osteoporosis
Fosamax®
Amlodipine
Cardiovascular
Norvasc®
Apixaban
Cardiovascular
Eliquis®
Aripiprazole
Antipsychotic
Abilify®
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
In addition to the 52 drugs currently on the market, we have 32 additional
drugs scheduled to be launched in 2024 and 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®. Similar to 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.
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.
Products
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 results on testing 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.
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.
18
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.
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.
19
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 March 31, 2024 and 2023
During the three months ended March 31, 2024,
we generated $7,541,046 in sales, compared to $4,894,053 for the three months ended March 31, 2023, an increase of $2,646,993, or 54%.
The increase is attributable to new product launches and expanded marketing and sales efforts by our wholly owned subsidiary, Nora Pharma.
The direct cost for generating these sales was $5,186,709 (69%) for the three months ended March 31, 2024, compared to $3,065,931 (63%)
for the three months ended March 31, 2023. The increase in the cost of goods sold in 2024 is due to increased cost of manufacturing of
the generic prescription drugs sold by Nora Pharma. Our gross profit grew to $2,354,337 for the three months ended March 31, 2024, compared
to $1,828,122 for the three months ended March 31, 2023.
General and administrative expenses during the
three-month period ended March 31, 2024, were $3,704,926, compared to $3,657,103 during the three-month period ended March 31, 2023, an
increase of $47,823. This modest increase was the net result of increases and decreases in our specific expense categories. For example,
we saw increased costs in accounting ($182,256), legal ($114,549), marketing ($70,133) and office ($428,753). The categories that decreased
were consulting ($84,214), R&D ($210,892) and salaries ($466,545). Overall, we incurred a loss of $1,350,589 from our operations for
the three months ended March 31, 2024, compared to a loss of $1,828,981 from our operations in the three-month period ended March 31,
2023.
In addition, we had interest income of $144,089
during the three months ended March 31, 2024, compared to a net interest income of $213,881 during the three months ended March 31, 2023,
as a result of interest earned on less cash on hand.
As a result, we incurred a net loss of $1,283,801
($0.02 per share) for the three months ended March 31, 2024, compared to a net loss of $1,702,430 ($0.08 per share) for the three-month
period ended March 31, 2023.
20
Liquidity
and Capital Resources
As of March 31, 2024, we had cash and cash equivalents of $17,434,208.
Net cash used in operating activities was $3,185,159
during the three months ended March 31, 2024, compared to $1,850,106 during the three-month period ended March 31, 2023. The increase
was a result of increased business activities by Nora Pharma.
Cash flows used in investing activities were $668,736
for the three months ended March 31, 2024, compared to $146,303 for the three months ended March 31, 2023. The increase was the result
of cash invested in Nora Pharma.
Cash flows provided by financing activities were
$5,398,149 during the three months ended March 31, 2024, compared to $538,299 during the three months ended March 31, 2023. The increase
was primarily as a result of one offering made during the three months ended March 31, 2024, compared to no financing events completed
during the three months ended March 31, 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 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.
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
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.
21
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 March 31, 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 March 31, 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.
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 March 31, 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.
**
Furnished 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 May 20, 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.