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Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: June 30, 2025
☐ 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
Common Stock Purchase Warrants |
SBFM
SBFMW |
The NASDAQ Stock Market LLC
The NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant (1)
has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days: Yes ☒ No ☐
Indicate by check mark whether the registrant has
submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒
No ☐
Indicate by check mark whether the registrant is
a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”,
and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one)
|
Large accelerated filer ☐ |
Accelerated filer ☐ |
|
Non-accelerated filer ☒ |
Smaller reporting company ☒ |
|
|
Emerging growth company ☐ |
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is
a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
The number of shares of the registrant’s
common stock, par value $0.001, issued and outstanding as of August 12, 2025, was 4,555,945 shares.
TABLE OF CONTENTS
|
|
Page |
|
|
|
|
PART I. FINANCIAL INFORMATION |
|
|
|
|
Item 1. |
Financial Statements |
3 |
|
Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024 |
3 |
|
Consolidated Statements of Operations
for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited) |
4 |
|
Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024 (Unaudited) |
5 |
|
Consolidated Statement of
Shareholders' Equity for the Three and Six Months Ended June 30, 2025 and 2024 (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 |
23 |
Item 4. |
Controls and Procedures |
23 |
|
PART II. OTHER INFORMATION |
|
|
|
Item 1. |
Legal Proceedings |
24 |
Item 1A. |
Risk Factors |
24 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
24 |
Item 3. |
Defaults Upon Senior Securities |
24 |
Item 4. |
Mine Safety Disclosures |
24 |
Item 5. |
Other Information |
24 |
Item 6. |
Exhibits |
24 |
|
Signatures |
25 |
PART I. FINANCIAL
INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Sunshine Biopharma Inc.
Consolidated Balance Sheets
| |
| | | |
| | |
| |
June 30, | | |
December 31, | |
| |
2025 | | |
2024 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 10,305,320 | | |
$ | 9,686,529 | |
Accounts receivable | |
| 3,587,560 | | |
| 3,868,418 | |
Inventory | |
| 13,018,702 | | |
| 11,278,105 | |
Prepaid expenses | |
| 939,436 | | |
| 1,133,297 | |
Total Current Assets | |
| 27,851,018 | | |
| 25,966,349 | |
Long-Term Assets: | |
| | | |
| | |
Property & equipment | |
| 638,354 | | |
| 546,055 | |
Intangible assets | |
| 2,490,827 | | |
| 3,019,717 | |
Deferred tax asset | |
| 92,234 | | |
| 92,234 | |
Right-of-use-asset | |
| 892,817 | | |
| 936,037 | |
Total Long-Term Assets | |
| 4,114,232 | | |
| 4,594,043 | |
TOTAL ASSETS | |
$ | 31,965,250 | | |
$ | 30,560,392 | |
| |
| | | |
| | |
LIABILITIES | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable & accrued expenses | |
$ | 4,797,465 | | |
$ | 5,543,085 | |
Earnout payable | |
| 295,797 | | |
| 295,797 | |
Income tax payable | |
| 258,158 | | |
| 268,276 | |
Right-of-use-liability | |
| 222,496 | | |
| 207,756 | |
Total Current Liabilities | |
| 5,573,916 | | |
| 6,314,914 | |
Long-Term Liabilities: | |
| | | |
| | |
Right-of-use-liability | |
| 706,530 | | |
| 744,724 | |
Total Long-Term Liabilities | |
| 706,530 | | |
| 744,724 | |
TOTAL LIABILITIES | |
| 6,280,446 | | |
| 7,059,638 | |
| |
| | | |
| | |
SHAREHOLDERS' EQUITY | |
| | | |
| | |
Preferred Stock Series B $0.10 par value per share; 1,000,000 shares authorized, 130,000 shares issued and outstanding | |
| 13,000 | | |
| 13,000 | |
Common Stock $0.001 par value per share; 3,000,000,000 shares authorized, 4,555,945 and 2,580,098 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | |
| 4,555 | | |
| 2,580 | |
Capital paid in excess of par value | |
| 97,376,841 | | |
| 93,354,907 | |
Accumulated comprehensive income (loss) | |
| 280,787 | | |
| (829,959 | ) |
Accumulated (Deficit) | |
| (71,990,379 | ) | |
| (69,039,774 | ) |
TOTAL SHAREHOLDERS' EQUITY | |
| 25,684,804 | | |
| 23,500,754 | |
| |
| | | |
| | |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | |
$ | 31,965,250 | | |
$ | 30,560,392 | |
See Accompanying Notes
To These Unaudited Consolidated Financial Statements
Sunshine Biopharma Inc.
Consolidated Statements of Operations and
Comprehensive Loss (Unaudited)
| |
| | | |
| | | |
| | | |
| | |
| |
3 Months | | |
3 Months | | |
6 Months | | |
6 Months | |
| |
Ended | | |
Ended | | |
Ended | | |
Ended | |
| |
June 30, | | |
June 30, | | |
June 30, | | |
June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Revenue: | |
$ | 9,410,230 | | |
$ | 9,303,067 | | |
$ | 18,311,571 | | |
$ | 16,844,113 | |
Cost of Sales | |
| 5,987,364 | | |
| 6,946,810 | | |
| 12,158,279 | | |
| 12,133,519 | |
Gross profit | |
| 3,422,866 | | |
| 2,356,257 | | |
| 6,153,292 | | |
| 4,710,594 | |
| |
| | | |
| | | |
| | | |
| | |
General & Administrative Expenses: | |
| | | |
| | | |
| | | |
| | |
Accounting | |
| 75,611 | | |
| 88,394 | | |
| 369,370 | | |
| 440,400 | |
Consulting | |
| 736,727 | | |
| 54,048 | | |
| 1,102,014 | | |
| 101,449 | |
Director fees | |
| 100,000 | | |
| 100,000 | | |
| 200,000 | | |
| 200,000 | |
Legal | |
| 64,995 | | |
| 223,436 | | |
| 92,194 | | |
| 445,434 | |
Marketing | |
| 201,658 | | |
| 256,325 | | |
| 600,019 | | |
| 454,371 | |
Office | |
| 806,605 | | |
| 713,245 | | |
| 1,732,483 | | |
| 1,673,636 | |
R&D | |
| 196,232 | | |
| 436,235 | | |
| 411,509 | | |
| 658,268 | |
Salaries | |
| 2,048,676 | | |
| 1,556,176 | | |
| 3,574,122 | | |
| 3,089,888 | |
Taxes | |
| 112,675 | | |
| 145,805 | | |
| 222,851 | | |
| 221,706 | |
Impairment of intangible assets | |
| 1,061,809 | | |
| – | | |
| 1,061,809 | | |
| – | |
Depreciation | |
| 72,533 | | |
| 50,870 | | |
| 137,326 | | |
| 93,488 | |
Total General & Administrative Expenses | |
| 5,477,521 | | |
| 3,624,533 | | |
| 9,503,697 | | |
| 7,378,640 | |
(Loss) from operations | |
| (2,054,655 | ) | |
| (1,268,276 | ) | |
| (3,350,405 | ) | |
| (2,668,046 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other Income (Expense): | |
| | | |
| | | |
| | | |
| | |
Foreign exchange gain | |
| 1,940 | | |
| 286,535 | | |
| 2,391 | | |
| 280,768 | |
Interest income | |
| 72,715 | | |
| 143,995 | | |
| 148,082 | | |
| 288,084 | |
Interest expense | |
| – | | |
| (245 | ) | |
| – | | |
| (245 | ) |
Total Other Income (Expense) | |
| 74,655 | | |
| 430,285 | | |
| 150,473 | | |
| 568,607 | |
| |
| | | |
| | | |
| | | |
| | |
Provision for income taxes | |
| 209,166 | | |
| 343,691 | | |
| 249,327 | | |
| 321,338 | |
Net (Loss) | |
$ | (1,770,834 | ) | |
$ | (494,300 | ) | |
$ | (2,950,605 | ) | |
$ | (1,778,101 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive income: | |
| | | |
| | | |
| | | |
| | |
Gain (Loss) from foreign exchange translation | |
| 1,084,557 | | |
| (835,450 | ) | |
| 1,110,746 | | |
| (1,379,155 | ) |
Comprehensive (Loss) | |
$ | (686,277 | ) | |
$ | (1,329,750 | ) | |
$ | (1,839,859 | ) | |
$ | (3,157,256 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic (Loss) per common share | |
$ | (0.39 | ) | |
$ | (9.94 | ) | |
$ | (0.82 | ) | |
$ | (43.48 | ) |
Weighted Average Common Shares Outstanding (Basic ) | |
| 4,496,108 | | |
| 49,726 | | |
| 3,604,653 | | |
| 40,896 | |
See Accompanying Notes To
These Unaudited Consolidated Financial Statements
Sunshine Biopharma Inc.
Consolidated
Statements of Cash Flows (Unaudited)
| |
| | | |
| | |
| |
Six Months
Ended
June 30, | | |
Six Months
Ended
June 30, | |
| |
2025 | | |
2024 | |
Cash Flows From Operating Activities: | |
| | | |
| | |
Net (Loss) | |
$ | (2,950,605 | ) | |
$ | (1,778,101 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 137,326 | | |
| 93,494 | |
Intangible asset impairment | |
| 1,061,809 | | |
| – | |
Stock issued for services | |
| – | | |
| 12,000 | |
Accounts receivable | |
| 492,384 | | |
| (2,308,159 | ) |
Inventory | |
| (1,123,909 | ) | |
| (2,949,128 | ) |
Prepaid expenses | |
| 255,548 | | |
| 167,656 | |
Accounts Payable & accrued expenses | |
| (849,702 | ) | |
| 2,794,798 | |
Earn-out payable | |
| – | | |
| (2,547,831 | ) |
Income tax payable | |
| (10,118 | ) | |
| (1,247,671 | ) |
Net Cash Flows (Used In) Operating Activities | |
| (2,987,267 | ) | |
| (7,762,942 | ) |
| |
| | | |
| | |
Cash Flows From Investing Activities: | |
| | | |
| | |
Reduction in right-of-use asset | |
| 94,402 | | |
| 61,075 | |
Purchase of intangible assets | |
| (594,714 | ) | |
| (234,569 | ) |
Purchase of equipment | |
| (167,490 | ) | |
| (1,037,450 | ) |
Net Cash Flows (Used In) Investing Activities | |
| (667,802 | ) | |
| (1,210,944 | ) |
| |
| | | |
| | |
Cash Flows From Financing Activities: | |
| | | |
| | |
Proceeds from public offering net (common stock) | |
| 1,828,596 | | |
| 8,522,411 | |
Exercise of warrants | |
| 2,195,312 | | |
| 45,000 | |
Purchase of treasury stock | |
| – | | |
| (3,139,651 | ) |
Lease liability | |
| (75,536 | ) | |
| (58,194 | ) |
Net Cash Flows Provided by Financing Activities | |
| 3,948,372 | | |
| 5,369,566 | |
| |
| | | |
| | |
Cash and Cash Equivalents at Beginning of Period | |
| 9,686,529 | | |
| 16,292,347 | |
Net increase (decrease) in cash and cash equivalents | |
| 293,304 | | |
| (3,604,320 | ) |
Foreign currency translation adjustment | |
| 325,487 | | |
| (1,180,282 | ) |
Cash and Cash Equivalents at End of Period | |
$ | 10,305,320 | | |
$ | 11,507,745 | |
| |
| | | |
| | |
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 Consolidated Financial Statements
Sunshine Biopharma Inc.
Consolidated Statements of Shareholders' Equity (Unaudited)
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Number Of Common Shares | | |
Common | | |
Capital Paid in Excess of Par | | |
Number Of Preferred Shares | | |
Preferred | | |
Compre- hensive | | |
Accumulated | | |
| |
Three Months
Period | |
Issued | | |
Stock | | |
Value | | |
Issued | | |
Stock | | |
Income | | |
Deficit | | |
Total | |
Balance March
31, 2025 | |
| 2,707,541 | | |
$ | 2,707 | | |
$ | 93,710,078 | | |
| 130,000 | | |
$ | 13,000 | | |
$ | (803,770 | ) | |
$ | (70,219,545 | ) | |
$ | 22,702,470 | |
Exercise of warrants | |
| 660,000 | | |
| 660 | | |
| 1,839,354 | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 1,840,014 | |
Common
stock and pre-funded warrants issued in an underwritten public offering, net of issuance costs | |
| 1,188,404 | | |
| 1,188 | | |
| 1,827,409 | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 1,828,597 | |
Net
(loss) | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 1,084,557 | | |
| (1,770,834 | ) | |
| (686,277 | ) |
Balance
at June 30, 2025 | |
| 4,555,945 | | |
$ | 4,555 | | |
$ | 97,376,841 | | |
| 130,000 | | |
| 13,000 | | |
$ | 280,787 | | |
$ | (71,990,379 | ) | |
$ | 25,684,804 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance March 31, 2024 | |
| 49,726 | | |
$ | 50 | | |
$ | 89,843,624 | | |
| 130,000 | | |
$ | 13,000 | | |
$ | 152,400 | | |
$ | (65,189,459 | ) | |
$ | 24,819,615 | |
Exercise of warrants | |
| 1,120,784 | | |
| 1,121 | | |
| (1,121 | ) | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
Net
(loss) | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (835,450 | ) | |
$ | (494,300 | ) | |
| (1,329,750 | ) |
Balance
June 30, 2024 | |
| 1,170,510 | | |
$ | 1,171 | | |
$ | 89,842,503 | | |
| 130,000 | | |
$ | 13,000 | | |
$ | (683,050 | ) | |
$ | (65,683,759 | ) | |
$ | 23,489,865 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Six Months Period | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance December 31,
2024 | |
| 2,580,098 | | |
$ | 2,580 | | |
$ | 93,354,907 | | |
| 130,000 | | |
$ | 13,000 | | |
$ | (829,959 | ) | |
$ | (69,039,774 | ) | |
$ | 23,500,754 | |
Exercise of warrants | |
| 787,443 | | |
| 787 | | |
| 2,194,525 | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 2,195,312 | |
Common
stock and pre-funded warrants issued in an underwritten public offering, net of issuance costs | |
| 1,188,404 | | |
| 1,188 | | |
| 1,827,409 | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 1,828,597 | |
Net
(loss) | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 1,110,746 | | |
| (2,950,605 | ) | |
| (1,839,859 | ) |
Balance
at June 30, 2025 | |
| 4,555,945 | | |
$ | 4,555 | | |
$ | 97,376,841 | | |
| 130,000 | | |
| 13,000 | | |
$ | 280,787 | | |
$ | (71,990,379 | ) | |
$ | 25,684,804 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
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 public offering , net of issuance costs | |
| 13,214 | | |
| 13 | | |
| 8,522,398 | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 8,522,411 | |
Exercise of warrants | |
| 1,143,284 | | |
| 1,144 | | |
| 43,856 | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 45,000 | |
Repurchase of warrants | |
| – | | |
| – | | |
| (3,139,651 | ) | |
| – | | |
| – | | |
| – | | |
| – | | |
| (3,139,651 | ) |
Net
(loss) | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (1,379,155 | ) | |
| (1,778,101 | ) | |
| (3,157,256 | ) |
Balance
at June 30, 2024 | |
| 1,170,510 | | |
$ | 1,171 | | |
$ | 89,842,503 | | |
| 130,000 | | |
| 13,000 | | |
$ | (683,050 | ) | |
$ | (65,683,759 | ) | |
| 23,489,865 | |
See Accompanying Notes
To These Unaudited Consolidated Financial Statements
Sunshine Biopharma Inc.
Notes to Unaudited Consolidated Financial Statements
For the Six Months Ended June 30, 2025 and 2024
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 has two wholly owned subsidiaries:
(i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation through which we currently have 74 generic prescription drugs
on the market in Canada, and (ii) Sunshine Biopharma Canada Inc. (“Sunshine Canada”), a Canadian corporation through which
we develop and sell nonprescription over-the-counter (“OTC”) supplements. The Company operates the two subsidiaries as a single
business segment.
The Company is not subject to material customer
concentration risks as it sells its products directly to pharmacies in several Canadian Provinces. However, Provincial governments in
Canada reimburse patients for their prescription drug expenditures to various degrees under drug reimbursement programs, making generic
drugs prices highly dependent on government policies which may change over time. The most recent negotiations between the pan-Canadian
Pharmaceutical Alliance (“pCPA”), the entity that negotiates drug prices on behalf of the government, 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 contains an option to extend for an additional two years. On February 10, 2024, the
Canadian federal government joined the generic drug reimbursement program as a payor under the Pharmacare Act. This development further
strengthened the Canadian generic drug market, which is the Company’s current focus.
In addition, the Company is engaged in the development
of the following proprietary drugs:
|
· |
K1.1 mRNA, a Lipid Nano-Particle (LNP) targeted for liver cancer |
|
· |
SBFM-PL4, a PLpro protease inhibitor for treatment of SARS Coronavirus infections |
Note 2 – Basis
of Presentation
The unaudited financial statements of the Company
for the six month periods ended June 30, 2025 and 2024 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, 2024, was derived from the audited financial statements included in the Company's financial
statements as of and for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission (the “SEC”) on April 1, 2025. These financial statements should be read in conjunction with that report.
Note 3
– 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 4 – Registered
Direct Offering
On April 3, 2025, the Company completed a registered
direct offering of 1,188,404
shares of common stock (or pre-funded warrants) at an offering price of $2.07
per share (or $2.06999 per pre-funded warrant
which is equal to the offering price per share minus an exercise price of $0.001)
for gross proceeds of approximately $2.46
million, before deducting fees to the placement agent and other offering expenses payable by the Company. The net proceeds received by
the Company were $1,828,596.
The Pre-Funded Warrants were immediately exercisable and may be exercised at any time until exercised in full. The offering was made
pursuant to an effective shelf registration statement on Form S-3 (No. 333-284142) previously filed with the U.S. Securities and Exchange
Commission (SEC) and declared effective by the SEC on January 15, 2025.
Note 5 – 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 which was paid in cash ($14,346,637) and by the issuance of 1,850 shares of the Company’s
common stock valued at $4,514,000 or $2,440.00 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 as of the same date:
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 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 ($2,440.00 per share).
As part of the consideration for Nora Pharma, the
Company agreed to a $5,000,000 CAD ($3,632,000 USD) earnout amount payable to Mr. Malek Chamoun, the seller of Nora Pharma. The earnout
is payable in the form of twenty (20) payments of $250,000 CAD for every $1,000,000 CAD increase in gross sales (as defined in the Purchase
Agreement) above Nora Pharma’s June 30, 2022 gross sales, provided that his employment with the Company is not terminated pursuant
to the Company’s employment agreement with him. The total earnout amount of $3,632,000 has been recorded as a salary payable. During
the fiscal year ended December 31, 2023, the Company paid an earnout amount of $1,426,914 CAD (approximately $1,036,500 USD) for the fiscal
year ended December 31, 2022. On April 22, 2024, the Company paid another earnout amount of $3,093,878 CAD (approximately $2,247,400 USD)
for the fiscal year ended December 31, 2023. As of June 30, 2025, the remaining earnout balance was $479,208 CAD ($295,797 USD).
Note 6 – Intangible Assets
Intangible assets consisted of the following:
Schedule of intangible assets | |
| | | |
| | |
| |
June 30, 2025 | | |
December 31, 2024 | |
Balance at beginning of the year | |
$ | 3,019,717 | | |
| 1,444,259 | |
Purchase of additional intangible assets (licenses) | |
| 594,714 | | |
| 1,694,585 | |
Impairment of Intangible assets (licenses)* | |
| (1,061,809 | ) | |
| 0 | |
Total | |
| 2,671,749 | | |
| 3,138,844 | |
Less accumulated amortization | |
| (180,922 | ) | |
| (119,127 | ) |
Intangible assets, net | |
$ | 2,490,827 | | |
$ | 3,019,717 | |
________________________
Note 7 – Plant, Property and Equipment
Property, plant and equipment are stated at cost.
Depreciation of property, plant and equipment begins in the month when the asset is placed into service and is provided using the straight-line
method for financial reporting purposes at rates based on the estimated useful lives of the assets. Estimated useful lives range from
three to twenty years. Property, plant and equipment consist of the following:
Schedule of property and equipment | |
| | | |
| | |
| |
June 30, | | |
December 31, | |
| |
2025 | | |
2024 | |
Equipment | |
$ | 354,321 | | |
$ | 336,880 | |
Computer equipment | |
| 56,426 | | |
| 53,531 | |
Furniture and fixtures | |
| 45,672 | | |
| 50,686 | |
Leasehold improvements | |
| 93,135 | | |
| 88,306 | |
Vehicles | |
| 501,426 | | |
| 353,185 | |
Total | |
| 1,050,980 | | |
| 882,588 | |
Less: Accumulated depreciation | |
| (412,625 | ) | |
| (336,533 | ) |
Plant, property and equipment, net | |
$ | 638,354 | | |
$ | 546,055 | |
Note 8 – Inventory
Inventory is comprised of the following:
Schedule of inventory | |
| | |
| |
| |
June 30, | | |
December 31, | |
| |
2025 | | |
2024 | |
Finished goods | |
$ | 13,384,964 | | |
$ | 11,352,446 | |
Allowance for obsolete inventory | |
$ | (366,262 | ) | |
$ | (74,341 | ) |
Total Inventory, net of allowance | |
$ | 13,018,702 | | |
$ | 11,278,105 | |
Note 9 – Leases
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 contract include fixed payments plus a variable payment. The
Company’s lease requires the Company to make variable payments for the Company’s proportionate share of the
building’s property taxes, insurance, and common area maintenance. These variable lease payments are not included in lease
payments used to determine lease liability and are recognized as variable costs when incurred.
Amounts reported on the balance sheet as of June
30, 2025 were as follows:
Schedule of lease information | |
|
Operating lease ROU asset | |
$892,817 |
Operating Lease liability - Short-term | |
$222,496 |
Operating lease liability - Long-term | |
$706,530 |
Remaining lease term | |
4 Years 6 Months |
Discount rate | |
6% |
Amounts disclosed for ROU assets obtained in exchange
for lease obligations and reductions of ROU assets resulting from reductions of lease obligations include amounts reduced from the carrying
amount of ROU assets resulting from deferred rent.
Maturities of lease liabilities under non-cancellable
operating leases at June 30, 2025 are as follows:
Schedule of maturities of lease liabilities | |
| |
2025 | |
$ | 112,853 | |
2026 | |
$ | 216,632 | |
2027 | |
$ | 205,372 | |
2028 | |
$ | 194,689 | |
2029 | |
$ | 184,553 | |
Thereafter | |
$ | 14,927 | |
Note 10 – Income Taxes
The Company’s income tax (expense) /
benefit of $209,166
and $249,327
for the three and six months ended June 30, 2025, 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.
The Company’s income tax (expense)
/ benefit of $343,691
and $321,338
for the three and six months ended June 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.
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 June 30, 2025, 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 as a result of operations of the two Canadian subsidiaries and are in compliance with Canadian tax
laws. The Company only recognizes tax benefits from an uncertain tax position if it is more likely than not that the tax position will
be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the
financial statement from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of
being realized upon ultimate resolution. To date, the Company has not recognized such tax benefits in its financial statements.
On July 4, 2025, the One Big Beautiful Bill Act
("OBBBA") was enacted in the U.S. The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act, including 100% bonus
depreciation, domestic research cost expensing, and the business interest expense limitation. ASC Topic 740, Income Taxes, requires the
tax effects of changes in tax rates and laws to be recognized in the period in which the legislation is enacted. Those effects, both current
tax and deferred tax, are reported as part of continuing operations. The Company is assessing OBBBA’s impact on the Company’s
Consolidated Financial Statements but currently does not believe that OBBBA will have a material impact on the Company's income tax expense.
As the legislation was signed into law after the close of the Company's second quarter, the impact is not included in its operating results
for the three and six months ended June 30, 2025.
Note 11 – Management
and Director Compensation
The Company paid its officers aggregate cash
compensation of $524,504 and $1,120,356
for the three-month periods ended June 30, 2025 and 2024, respectively. For the six-month periods ended June 30, 2025 and 2024, the
Company paid its officers aggregate cash compensation of $988,801 and $1,382,842,
respectively. Of the $1,382,842
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 of $100,000 for each of the three-month periods ended June 30, 2025 and 2024, and $200,000 for each of the six-month periods
ended June 30, 2025 and 2024.
Note 12 – Capital
Stock
The Company’s authorized capital is
comprised of 3,000,000,000
shares of common stock, par value $0.001,
and 30,000,000
shares of preferred stock, $0.10
par value. As of December 31, 2024 and June 30, 2025, 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 December 31, 2024 and June 30, 2025, 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. Pursuant to the public offering, the Company issued and sold an aggregate of
941 shares of common stock and 2,051 warrants to purchase shares of common stock (the “Tradeable Warrants”).
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 651 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 initial exercise price
of $4,440 per share (subject to adjustment), 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 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), 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.
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.
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 and received $8,522,411
in net proceeds. In connection with this offering, the Company issued 22,500 pre-funded warrants (the “2024 Pre-Funded
Warrants”) exercisable at $2.00 per share, 3,986 Series A Warrants exercisable at $4,200.00 per share (subject to adjustment),
or pursuant to an alternative cashless exercise provision, and 7,973 Series B Warrants exercisable at $4,760.00 per share, subject
to adjustment. As of June 30, 2025, (i)
all of the 2024 Pre-Funded Warrants have been exercised resulting in the Company receiving net proceeds of $45,000, (ii) all of the
Series A Warrants have been exercised pursuant to the alternative cashless provision resulting in the Company receiving $0 in
proceeds, and (iii) 15,577,965 Series B Warrants remained outstanding and their exercise price had been adjusted to $2.07 as a
result of two reverse stock splits and a financing event which were conducted subsequent to their issuance. The Series B
Warrants expire in February 2029.
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.
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 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 $1,895,610.
In November and December 2024, the Company issued
580,438 shares of common stock in connection with the exercise of 580,438 Series B Warrants and received aggregate net proceeds of $1,618,203.
On January 3, 2025, the Company issued 127,443
shares of common stock upon the exercise of 127,443 Series B Warrants and received $355,298 in net proceeds.
On April 2, 2025, the Company issued 660,000 shares
of common stock upon the exercise of 660,000 Series B Warrants and received $1,840,014 in net proceeds.
On April 3, 2025, the Company issued an aggregate
of 1,188,404 shares of common stock in connection with a registered direct offering and received $1,828,596 in net proceeds.
As of June 30, 2025 and December 31, 2024, the
Company had 4,555,945 and 2,580,098 shares of common stock issued and outstanding, respectively.
The Company has declared no dividends since inception.
Note 13 – 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 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 |
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.
As of June 30, 2025, 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 1,919,303 Series B Warrants (as adjusted) were exercised resulting in aggregate net proceeds
of $17,412,492 received by the Company.
The Company’s outstanding warrants as of
June 30, 2025 consisted of the following:
Schedule of warrants outstanding |
|
|
|
Type |
Number |
Exercise
Price |
Expiry Date |
Tradeable Warrants* |
482 |
$220.00 |
February
2027 |
Investor Warrants |
400* |
$4,000.00* |
March
2027 |
Series B Warrants |
15,577,965*** |
$2.07*** |
February
2029 |
|
* |
|
|
** |
Subject to adjustment of
the number of warrants and exercise price upon certain corporate actions such that the aggregate value of the warrants remains unchanged. |
|
*** |
|
Note
14 – Earnings Per Share
The following table sets forth the computation
of basic and diluted net income per share for the six months ended June 30:
Schedule of computation of basic and diluted net income per share | |
| | |
| |
| |
2025 | | |
2024 | |
Net gain (loss) attributable to common stock | |
$ | (2,950,605 | ) | |
$ | (1,778,101 | ) |
Weighted average common shares outstanding
(basic & diluted) | |
| 3,604,653 | | |
| 40,896 | |
Basic and diluted gain (loss) per
share attributable to common stock | |
$ | (0.82 | ) | |
$ | (43.48 | ) |
Note 15 – Employee
Termination
On April 14, 2025, the Company terminated the
employment of Mr. Malek Chamoun, president of the Company’s wholly owned Canadian subsidiary, Nora Pharma Inc., and appointed
Ms. Catherine Peloquin as the new president of Nora Pharma. Mr. Chamoun was terminated for cause. On April 17, 2025, the Company
received a demand letter (the “Demand Letter”) from the attorneys of Mr. Chamoun requesting that the Company pay to Mr.
Chamoun $7,307,025
CAD (approximately $5,300,000
USD) within five (5) days. In response to the Demand Letter, the Company issued a letter advising that the demands contained in the
Demand Letter, including the sum of $7,307,025 CAD (approximately $5,300,000 USD), are completely unfounded and that it intends to
defend itself vigorously. There has been no communications between the parties since June 11, 2025. No provision or accrual was made
in the financial statements for any litigation liability or legal expense which the Company may incur in connection with this alleged
claim.
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, 2024. 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 have two wholly
owned subsidiaries: (i) Nora Pharma Inc. (“Nora Pharma”), a Canadian corporation, through which we currently have 74
generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc. (“Sunshine Canada”), a
Canadian corporation through which we develop and sell OTC supplements.
In addition, we are conducting a proprietary drug
development program which is comprised of (i) K1.1 mRNA, an LNP encapsulated mRNA targeted for liver cancer, and (ii) SBFM-PL4, a protease
inhibitor for treatment of SARS Coronavirus infections.
Commercial Operations
Our commercial operations are focused on the procurement
of rights to generic pharmaceutical products for sale, currently in Canada and ultimately around the world. We seek to secure such rights
through various types of strategic arrangements, including:
|
· |
In-licensing and Supply Agreements: Nora Pharma acquires the rights to import, market, sell and distribute the products in Canada by purchasing the drug dossiers from strategic partners. Nora Pharma then files the dossiers with Health Canada to obtain regulatory approval prior to marketing. The approval process at Health Canada takes on average of 12 months. The products are sold under Nora Pharma label. |
|
· |
Cross-licensing: Nora Pharma acquires the rights to import, market, sell and distribute the products in Canada by receiving an authorization letter from pharmaceutical partners. The partners’ products are already approved in Canada but we are still required to obtain our own approval from Health Canada, which takes on average 45-60 days. The products are sold under Nora Pharma label. |
|
· |
Distribution Agreements: Nora Pharma acquires the rights to market, sell and distribute the products in Canada by signing a distribution agreement with pharmaceutical partners. The partners’ products are already approved by Health Canada. The products are sold under the partners’ label. |
Generic drugs are pharmaceutically equivalent
to the brand name drugs. They contain identical medicinal ingredients in the same amounts as the brands. Generic medications may have
different non-medicinal ingredients than the brand name drugs, but the generic developer must show that these do not affect the safety,
efficacy, or quality of the drug compared to the brand. When a generic drug company wants to sell a generic drug in Canada, it must file
a generic drug submission with Health Canada. The submission is called an Abbreviated New Drug Submission (ANDS). The submission is reviewed
by scientists and health care experts at Health Products and Food Branch (HPFB) of Health Canada. All generic drug submissions go through
the same process as the brand name drug submissions. If the evaluation shows that the generic drug meets all regulatory requirements (including
patent and data protection considerations), Health Canada will issue a Notice of Compliance (NOC) and a Drug Identification Number (DIN)
to the applicant. The NOC and DIN signal the drug's official approval in Canada and permit the applicant to market the drug in Canada.
Once a company obtains the NOC and DIN for a drug, then it begins the process with Pan-Canadian Pharmaceutical Alliance (pCPA) in order
to have the drug listed on the provincial and territorial formularies and federal government drug benefit plans.
We currently have the following generic prescription
drugs on the market in Canada:
|
|
|
Drug |
Therapeutic
Area |
Reference/Brand |
Abiraterone* |
Oncology |
Zytiga® |
Alendronate |
Osteoporosis |
Fosamax® |
Amlodipine |
Cardiovascular |
Norvasc® |
Apixaban |
Cardiovascular |
Eliquis® |
Aripiprazole |
Antipsychotic |
Abilify® |
Atorvastatin |
Cardiovascular |
Lipitor® |
Azithromycin |
Antibacterial |
Zithromax® |
Betahistine |
Vertigo |
Serc® |
Bilastine |
Allergy |
Blexten® |
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® |
Clobetasol* |
Anti-inflammatory |
Clobex® |
Clopidogrel |
Cardiovascular |
Plavix® |
Dapagliflozin |
Diabetes |
Forxiga® |
Daptomycin* |
Antibacterial |
Cubicin® |
Dasatinib* |
Oncology |
Sprycel® |
Dienogest* |
Gynecologic pathology |
Visanne® |
Donepezil |
Central nervous system |
Aricept® |
Duloxetine |
Central nervous system |
Cymbalta® |
Dutasteride |
Urology |
Avodart® |
Ertapenem* |
Antibacterial |
Invanz® |
Escitalopram |
Central nervous system |
Cipralex® |
Everolimus* |
Oncology |
Afinitor® |
Ezetimibe |
Cardiovascular |
Ezetrol® |
Drug |
Therapeutic
Area |
Reference/Brand |
Finasteride |
Urology |
Proscar® |
Flecainide |
Cardiovascular |
Tambocor® |
Fluconazole |
Antifungal |
Diflucan® |
Fluoxetine |
Central nervous system |
Prozac® |
Gabapentin |
Central nervous system |
Neurontin® |
Hanzema®* |
Dermatology |
Toctino® |
Hydroxychloroquine |
Antimalarial |
Plaquenil® |
Lacosamide |
Central nervous system |
Vimpat® |
Letrozole |
Oncology |
Femara® |
Levetiracetam |
Central nervous system |
Keppra® |
Lurasidone |
Antipsychotic |
Latuda® |
Metformin |
Diabetes |
Glucophage® |
Mirtazapine |
Central nervous system |
Remeron® |
Montelukast |
Allergy |
Singulair® |
Olanzapine |
Central nervous system |
Zyprexa® |
Olanzapine ODT |
Central nervous system |
Zyprexa® |
Olmesartan |
Cardiovascular |
Olmetec® |
Olmesartan HCTZ |
Cardiovascular |
Olmetec Plus® |
Pantoprazole |
Gastroenterology |
Pantoloc® |
Paroxetine |
Central nervous system |
Paxil® |
Pegfilgrastim (Niopeg) |
Oncology |
Neulasta® |
Perindopril |
Cardiovascular |
Coversyl® |
Pravastatin |
Cardiovascular |
Pravachol® |
Pregabalin |
Central nervous system |
Lyrica® |
Progesterone* |
Women's Health |
Prometrium® |
Prucalopride |
Women's Health |
Resotran® |
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® |
Sitagliptin-Metformin* |
Diabetes |
Janumet® |
Tadalafil |
Urology |
Cialis® |
Telmisartan |
Cardiovascular |
Micardis® |
Telmisartan HCTZ |
Cardiovascular |
Micardis Plus® |
Topiramate |
Anticonvulsant |
Topamax® |
Tramadol Acetaminophen |
Central nervous system |
Tramacet® |
Ursodiol |
Cholelithiasis |
Urso® |
Varenicline |
Smoking cessation |
Champix® |
Zoledronic Acid* |
Osteoporosis |
Aclasta® |
Zolmitriptan |
Central nervous system |
Zomig® |
Zopiclone |
Central nervous
system |
Imovane® |
* Sold through distribution agreements in which we act as distributor.
In addition to the 74 drugs currently on the market,
we have 17 additional drugs in our pipeline anticipated to be launched in 2026. These additional drugs will address various human health
areas including cardiovascular, oncology, gastroenterology, central nervous system, diabetes, urology, endocrinology, anti-infective,
and anti-inflammatory.
We believe the addition of these products to our
existing portfolio will strengthen our presence in the Canadian $9.7 billion a year generic drug market (Research and Markets)
and provide us with greater access to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.
Research and Development
The following table summarizes our proprietary
drugs in development:
Drug
Candidate |
|
Therapeutic
Area/Indication |
|
Development
Stage |
|
K1.1 (mRNA LNP) |
|
Oncology (Liver Cancer) |
|
Animal Testing |
|
SBFM-PL4
(Small Molecule) |
|
Antiviral
(SARS Coronavirus Infection) |
|
Animal
Testing |
|
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 side effects. These new mRNA molecules, bearing the laboratory name K1.1,
were adapted for delivery into patients using a lipid nanoparticle (LNP) technology similar to the one employed in the COVID-19 mRNA vaccines.
On April 20, 2022, we filed a provisional patent application in the United States covering our K1.1 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 specific lipid nanoparticles for use in
test animals including xenograft mice. The initial results of our animal testing indicated that our K1.1 mRNA-LNP constructs were effective
at reducing the size of liver cancer tumors in xenograft 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 since broadened our objective to include
the development of a 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.
Our current lead compound was recently found to
be active at sub micromolar concentrations against PLpro and exhibited antiviral activity in SRAS-CoV-2 infected cells as well as in cells
infected with several different variants of concern. In addition, our compound had favorable pharmacokinetics properties in rodent species
and exhibited preferred drug accumulation in the lungs over plasma. The compound was found to be orally active in a K18-human-ACE2 transgenic
mouse model and to significantly reduce virus load in the lungs of infected animals in a dose-dependent manner without gross toxicities.
In August 2024, we published these and other research results related to this project in the Journal of Medicinal Chemistry (J. Med.
Chem. 2024, 67, 13681−13702). A copy of this article is available on our website at: www.sunshinebiopharma.com/scientific-publications.
Intellectual Property
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
200 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. Nora Pharma also owns the rights to
sell 10 generic prescription drugs in Canada through distribution agreements with various international partners under which Nora Pharma
acts as distributor and receives a percentage of sales.
In addition, we own 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, (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 June 30, 2025 and 2024
During the three months ended June 30, 2025, we
generated $9,410,230 in sales, compared to $9,303,067 for the three months ended June 30, 2024, largely unchanged. The direct cost for
generating these sales was $5,987,364 (63.6%) for the three months ended June 30, 2025, compared to $6,946,810 (74.7%) for the three months
ended June 30, 2024, a decrease of approximately 11% largely due to procurement of better cost of finished products. Our gross profit
for the three months ended June 30, 2025 was $3,422,866, compared to $2,356,257 for the three months ended June 30, 2024, an increase
of $1,066,609.
General
and administrative expenses during the three-month period ended June 30, 2025, were $5,477,521, compared to $3,624,533 during the three-month
period ended June 30, 2024, an increase of $1,852,988. The significant increase was primarily attributable to a $1,061,809 impairment
of intangible assets resulting from the determination that certain product licenses could not be commercialized. The other expense categories
which contributed to this increase were consulting fees which increased by $682,679 due to fees paid in connection with warrant exercises
and salaries, which increased by $492,500 due to new hiring. Overall, we incurred a loss of $2,054,655 from our operations for the three
months ended June 30, 2025, compared to a loss of $1,268,276 from our operations in the three-month period ended June 30, 2024.
We
had interest income of $72,715 during the three months ended June 30, 2025, compared to interest income of $143,995 during the three
months ended June 30, 2024, as a result of having less cash on hand.
As a result of the foregoing, we incurred a net
loss of $1,770,834 ($0.39 per share) for the three months ended June 30, 2025, compared to a net loss of $494,300 ($9.94 per share) for
the three-month period ended June 30, 2024.
Comparison of results of
operations for the six months ended June 30, 2025 and 2024
During
the six months ended June 30 2025, we generated revenues of $18,311,571, compared to revenue of $16,844,113 for the six months ended
June 30, 2024, an increase of $1,467,458, or 8.7%. The increase is attributable to enhanced marketing efforts in 2025. The direct cost
for generating these revenues was $12,158,279 for the six months ended June 30, 2025 (66.4%), compared to $12,133,519 (72.0%) for the
six months ended June 30, 2024. The decrease in the cost of goods sold in 2025 was due to the procurement of better cost of finished
products. Our gross profit increased by $1,442,698 from $4,710,594 for the six months ended June 30, 2024, to $6,153,292 for the same
period in 2025.
General
and administrative expenses during the six-month period ended June 30, 2025, were $9,503,697, compared to $7,378,640 during the six-month
period ended June 30, 2024, an increase of $2,125,057. The significant increase was primarily attributable to a $1,061,809 impairment
of intangible assets resulting from the determination that certain product licenses could not be commercialized. The other expense categories
which contributed to this increase were consulting fees which increased by $1,000,565 due to fees paid in connection with warrant exercises
and salaries which increased by $484,234 due to new hiring. These increases were offset to some extent by a decrease in legal fees by
$353,240 and R&D by $246,759. Overall, we incurred a loss of $3,350,405 from our operations in the six-month period ended June 30,
2025, compared to a loss from operations of $2,668,046 in the similar period of 2024.
We
had interest income of $148,082 during the six months ended June 30, 2025, compared to interest income of $288,084 during the six months
ended June 30, 2024. The decrease was a result of having less cash on hand.
As
a result of the foregoing we incurred a net loss of $2,950,605 ($0.82 per share) for the six-month period ended June 30, 2025, compared
to a net loss of $1,778,101 ($43.48 per share) for the six-month period ended June 30, 2024.
Liquidity and Capital Resources
As of June 30, 2025, we had cash and cash equivalents of $10,305,320.
Net cash used in operating activities was $2,987,267
during the six months ended June 30, 2025, compared to $7,762,942 during the six-month period ended June 30, 2024. The decrease was a
result of reduced cash required for the operations of Nora Pharma.
Cash flows used in investing activities were $667,802
for the six months ended June 30, 2025, compared to $1,210,944 for the six months ended June 30, 2024. The decrease was the result of
less cash invested in Nora Pharma.
Cash flows provided by financing activities were
$3,948,372 during the six months ended June 30, 2025, compared to $5,369,566 during the six months ended June 30, 2024. The decrease was
primarily as a result of a smaller financing event completed during the six months ended June 30, 2025, compared to an offering yielding
net proceeds of $8,522,411 completed during the six months ended June 30, 2024.
We are currently generating revenue of approximately
$9.4 million per quarter and incurring a quarterly deficit of approximately $1.0 million (not including the one-time intangible assets
impairment of $1,061,809 during the three months ended June 30, 2025). In addition to increasing sales and streamlining operations to
reduce expenses, we are currently focusing our attention on lowering our cost of goods sold from our current level of approximately 65%
to approximately 60%. We believe these measures could bring us to breakeven and make us less dependent on the capital markets for financing,
although there can be no assurances that we will be successful in achieving these reductions. We believe our existing cash on hand together
with cash we generate from sales will be sufficient to fund our operations 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, 2024, including our financial statements and notes thereto
included therein as filed with the SEC on April 1, 2025.
Recently Adopted Accounting
Standards
We have adopted all new accounting standards impacting
operations.
Off Balance-Sheet Arrangements
We have not entered into any off-balance sheet
arrangements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
We are a smaller reporting company and are not
required to provide the information under this item.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls
and Procedures
Our management, with the participation of our Chief
Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term
is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report.
These controls are designed to ensure that information
required to be disclosed in the reports we file or submit pursuant to the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the rules and forms of the Securities and Exchange Commission, and that such information is accumulated
and communicated to our management, including our CEO and CFO, to allow timely decisions regarding required disclosure.
Based on this evaluation, our management, including
our CEO and CFO concluded that our disclosure controls and procedures were effective as of June 30, 2025, at reasonable assurance levels.
Changes in Internal Control
Over Financial Reporting
There were no changes in our internal control over
financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
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 June 30, 2025, 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. |
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Description |
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31.1 |
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Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002* |
31.2 |
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Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2022* |
32.1 |
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Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002** |
101 |
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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 |
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Inline XBRL for the cover page of this Quarterly Report on Form 10-Q, included in the Exhibit 101 Inline XBRL Document Set.* |
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* |
Filed herewith. |
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** |
Furnished herewith. |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized,
on August 12, 2025.
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SUNSHINE BIOPHARMA INC. |
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By: |
/s/ Dr. Steve N. Slilaty |
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Dr. Steve N. Slilaty |
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Chief Executive Officer (principal executive officer) |
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By: |
/s/ Camille Sebaaly |
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Camille Sebaaly
Chief Financial Officer (principal financial and accounting officer) |
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